tag:blogger.com,1999:blog-386602752024-03-07T19:35:32.892-08:00vCJD transfusion-associated Fourth Case UKTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.comBlogger44125tag:blogger.com,1999:blog-38660275.post-79771631034667191342015-11-13T10:44:00.001-08:002015-11-13T10:44:32.209-08:00No evidence of asymptomatic variant CJD infection in immunodeficiency patients treated with UK-sourced immunoglobulin ?<div>
No evidence of asymptomatic variant CJD infection in immunodeficiency
patients treated with UK-sourced immunoglobulin </div>
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M. R. Helbert1,*, C. Bangs1, M. Bishop2, A. Molesworth2 and J. Ironside2
Article first published online: 3 NOV 2015</div>
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DOI: 10.1111/vox.12358</div>
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© 2015 International Society of Blood Transfusion </div>
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Keywords:immunoglobulins; prions</div>
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Surveillance of 75 immunodeficiency patients exposed to UK-sourced
immunoglobulin, including batches derived from donors who went on to develop
vCJD, has not detected any clinical cases of vCJD, or of asymptomatic infection
in 15 patients with available tissue samples of sufficient quality for testing.
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<a href="http://onlinelibrary.wiley.com/doi/10.1111/vox.12358/abstract?campaign=wolearlyview">http://onlinelibrary.wiley.com/doi/10.1111/vox.12358/abstract?campaign=wolearlyview</a>
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‘’No evidence of asymptomatic variant CJD infection in immunodeficiency
patients treated with UK-sourced immunoglobulin’’ </div>
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in my opinion, that title should read ;</div>
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‘no evidence of asymptomatic variant CJD infection of immunodeficiency
patients treated with UK-sourced immunoglobulin from 15 out of 75, of which 60
were NOT of sufficient quality for testing’’'</div>
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SO, the other 60 could/might have had a vCJD infection in that study?</div>
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Inquiry: variant Creutzfeldt-Jakob Disease (vCJD)</div>
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Submission by Dr Matthew Helbert on behalf of the UK Primary
Immunodeficiency Network</div>
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1 Executive summary</div>
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Immunoglobulin is a type of plasma product. About 5000 PID patients in the
UK rely on life long immunoglobulin infusions. In 1997 use of British plasma to
manufacture immunoglobulin was stopped as a precautionary measure. PID patients
subsequently received immunoglobulin manufactured from non UK sourced plasma.
However by 1997, some PID patients had already been exposed to immunoglobulin
manufactured from blood donated by people who went on to develop vCJD.</div>
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In 2004, an individual risk assessment was carried out, using tracking of
which batches of immunoglobulin had been infused into which patients. The risk
assessment suggested a low risk of exposure for any given PID patient. No
special precautions were subsequently required for PID patients, who have thus
not experienced stigmatisation or anxiety. Since 2006, ongoing surveillance,
relying on tissue sampling, has shown no evidence of prion infection in PID
patients. In the future, it would be difficult to recommend that patients choose
immunoglobulin manufactured from UK sourced plasma, unless each donor had been
screened for prion infection with a well evaluated blood or urine test. The safe
reintroduction of UK sourced immunoglobulin would be further enhanced by
electronic batch tracking, to facilitate individual risk assessment and product
recall in the event of further prion infection (or other pathogen)
outbreaks.</div>
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2 UKPIN</div>
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UKPIN (<a href="http://ukpin.org.uk)is/">http://ukpin.org.uk)is/</a> the
professional body for doctors, nurses and scientists involved in the care of
patients with primary immunodeficiency disorders (PID). In 2006, UKPIN initiated
a study on surveillance of prion infection in these patients, lead by Dr M
Helbert. Contact: Dr Matthew Helbert, Consultant Immunologist, Central
Manchester University Hospitals NHS FT. matthew.helbert@cmft.nhs.uk 0161 276
6468</div>
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3 Background to immunoglobulin and prions</div>
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Approximately 5000 primary immunodeficiency patients in the UK require
lifelong injections with immunoglobulin. Immunoglobulin is manufactured from
donated plasma, along with Factor VIII (for haemophilia). Manufacture of these
plasma products (or 'blood products') requires pooling several thousand plasma
donations. As a result, plasma products have transmitted blood borne pathogens
and, in the past, immunoglobulin and has caused outbreaks of hepatitis C.</div>
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Factor VIII is manufactured slightly differently has been contaminated with
HIV and hepatitis C virus. As a precautionary response to the BSE and vCJD
epidemics, processing of UK sourced plasma ceased in 1997. Since then, PID
patients have only received immunoglobulin manufactured from plasma imported
from overseas. There has been no evidence of prion transmission via
immunoglobulin, although there is some evidence that a haemophiliac patient was
infected via Factor VIII.</div>
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4 2004 prion infection risk assessment</div>
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Once it became clear that some blood donors went on to develop vCJD, The
CJD Incidents Panel initiated risk assessment programmes for patients who had
received UK sourced plasma products, as part of the strategy to reduce the risk
of secondary infection. UKPIN and patient representatives decided that an
individual risk assessment approach was best for PID patients: Data were
collected on how much of any given implicated batch of immunoglobulin each
patient had received. A noteworthy observation is that it was often very
difficult to track down which batches of immunoglobulin had been dispensed by
pharmacies and infused into patients. To do this, paper records had to be
searched by hand for evidence of batch tracking. However, the result of the
individual risk assessments was that no PID patient was assessed at being at
more than 1% risk of exposure to abnormal prions. Thus PID patients did not
require special measures, such as quarantining of endoscopes after procedures.
On the other hand, the haemophilia community chose to undergo a collective risk
assessment, and when this established that some patients could be at risk,
several thousand haemophiliacs faced difficulties arranging surgical and
endoscopic procedures, along with stigmatisation and anxiety.</div>
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5 Immunoglobulin manufacture since 1997</div>
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In the UK, plasma is currently discarded (at a value of about £65 per
donation – G Grazzini, Blood Transfusion, 2013). Immunoglobulin continues to be
manufactured in the UK and abroad, using pooled plasma sourced overseas. Unlike
any other blood borne infection, no laboratory screening test is available to
rule out prion infection in donors. Donor screening questions are used to
eliminate those perceived as being at high risk of prion infection, although
given uncertainties of the biology of prion infection, the utility of these is
very unclear. The manufacturing process includes steps to reduce the infectivity
of plasma, should a donor have undiagnosed prion infection. Immunoglobulin
products used in the EU contain statements about blood borne pathogens in their
Summaries of Product Characteristics.</div>
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6 The impact of the vCJD epidemic on PID patients - 2004 onwards</div>
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British PID patients now only receive immunoglobulin manufactured from non
UK plasma. This has placed PID patients at the mercy of a finite global
immunoglobulin market, with occasional supply problems and increases in prices.
The DH now operates a demand management scheme for immunoglobulins. Even though
currently available immunoglobulins are perceived as safe from the point of view
of prion infection, good practice is to inform patients of this theoretical risk
as part of obtaining informed consent to start, or stay on, immunoglobulin. PID
patients are not be able to be blood donors because they have received plasma
product infusions, but also because of their underlying illness. Following the
2004 risk assessment, PID patients have not required other measures to reduce
secondary infection. Despite these ongoing concerns, these is no evidence that
prion infection has been a significant source of anxiety for British PID
patients, including the subset exposed to UK sourced immunoglobulin prior to
1997. I am not aware of any prion – specific life insurance problems in this
group.</div>
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7 PID Prion surveillance project 2006 onwards</div>
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In 2006, the DH funded a surveillance programme for PID patients exposed to
UK sourced immunoglobulin. To date, 60 patients have given consent to
participate and tissue samples are available on just over half of these. These
samples were collected during routine surgical procedures or post mortem a
median of 8 years after potential exposure to prion infection. No tissue samples
show evidence of prion infection. The major limitations on these data are the
long incubation period of prion infection after expsoure, the inevitable poor
access to tissue samples and absence of a blood or urine test. Thus, these data
can not yet reassure that no PID patients were infected with prions in the 1990s
or, by inference, that it would be safe to re commence processing of British
plasma.</div>
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8 Should UK sourced plasma be used to manufacture immunoglobulin?</div>
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There are no data on the opinions of PID patients or their clinicians on
this question. However, any patient embarking on life long immunoglobulin
treatment could receive either a product manufactured from plasma sourced
overseas, from a country with no history of BSE or vCJD, or UK sourced plasma.
In the UK there is thought to be a measurable rate of background asymptomatic
prion infection, but no blood or urine test to screen individual donors. Even
though prion transmission has not been shown to take place via immunoglobulin,
it would be illogical for a patient to choose immunoglobulin manufactured from
UK sourced plasma, until a sensitive prion screening blood or urine test is in
routine use.</div>
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9 Lessons Learnt</div>
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9.1 If plasma processing is resumed in the UK, robust means of batch
tracking are required for on going risk assessment. The process must enable
rapid identification of which batches of product have been infused into which
patients and also enable rapid product recall in the event of any future
pathogen outbreaks.</div>
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9.2 Individual risk assessment was negative in all PID patients. No PID
patients required expensive quarantining of equipment and there has been no
lasting anxiety or stigmatisation. In the event of future outbreaks or donor
infection, we recommend this approach over 'umbrella' risk assessment.</div>
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9.3 A blood or urine test for asymptomatic prion infection is a pre
requisite for the re establishment of processing of UK sourced plasma. There is
a reasonable chance that such a test would be adopted for screening plasma
donors from outside the UK. A blood or urine test would be an invaluable
research tool, for example to validate our prion surveillance study.</div>
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10 Response to TOR</div>
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Are UK policies governing who can donate blood and blood products, tissues
and organs sufficiently evidence-based? Is NHS Blood and Transplant overly
restrictive about who can donate, or should greater precautions be taken to
further reduce risk?</div>
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Current policies are sufficiently evidence based given current technical
and scientific constraints. A well evaluated prion blood or urine test would
further mitigate risk. Is the Government and its scientific advisory structure
sufficiently responsive to the threat posed by emerging diseases being
transmitted through blood and blood products, tissues and organs?</div>
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Up until about 2011 there were clear lines of accountability and
management. For example, had our study detected a PID patient with prion
infection, I would have known who to contact the CJD Incidents Panel – and this
was enshrined I the ethics application for our project. However, this is no
longer the case and I do not know who to contact or how they would respond. Has
the threat of ongoing transmission of vCJD through the blood and blood product
supply been adequately mitigated?</div>
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Blood supply – the risk would be better mitigated with a well evaluated
prion blood or urine test.</div>
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Blood products (plasma products) - currently, well mitigated, although with
an expensive solution, ie using products manufactured from non UK plasma.</div>
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What are the strengths and weaknesses of NHS Blood and Transplant’s
strategy, “Taking Organ Transplantation to 2020”? What further changes could be
made to safely increase the supply of blood and blood products, tissues and
organs?</div>
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No specific response.</div>
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What lessons could be learnt from the screening and donation practices of
other countries? No specific response. </div>
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<a href="http://www.piduk.org/static/media/up/UKPINresponsevariantCJDinquiry.pdf">http://www.piduk.org/static/media/up/UKPINresponsevariantCJDinquiry.pdf</a>
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Inquiry: variant CreutzfeldtJakob Disease (vCJD)</div>
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Submitted by Primary Immunodeficiency UK (www.piduk.org) Director: Dr Susan
Walsh susan.walsh@piduk.org</div>
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1. About PID UK</div>
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PID UK is a national organisation working for patients is an organisation
supporting people affected by primary immunodeficiencies in the UK.</div>
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Our aims are to help ensure that every individual and family affected by a
primary immunodeficiency has the knowledge needed:</div>
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• To manage their condition effectively</div>
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• To ensure that their health needs are understood and addressed by those
involved in policy and delivery of healthcare.</div>
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2. Our role in ensuring safety of plasma derived products for patients A
large majority of patients with PIDs (approx 5000) need life‐long treatment with
immunoglobulin (Ig) infusions. The safety of this product is of paramount
importance to affected patients who cope with the health burden of these complex
chronic conditions and for whom Ig infusion is an integral and essential
medicine.</div>
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To ensure safety issues concerning plasma products is maintained we work
with other patient groups, both national and international and UKPIN, the
professional body for doctors, nurses and scientists involved in the care of PID
patients. PID UK fully endorses the work of UK PIN and their work on the
surveillance of prion infection in these patients, led by Dr M Helbert.</div>
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Currently PID patients receive Ig infusions derived from plasma ONLY from
non‐UK sources.</div>
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This was put in place following exposure of PID patients in the UK to
plasma from people who went onto develop vCJD.</div>
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3. Response to terms of reference PID UK fully endorses the response and
recommendations made by UKPIN in response to this consultation.</div>
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3a. Are UK policies governing who can donate blood and blood products,
tissues and organs sufficiently evidencebased?</div>
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Is NHS Blood and Transplant overly restrictive about who can donate, or
should greater precautions be taken to further reduce risk?</div>
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The use of UK‐sourced plasma would be a cause of extreme anxiety to PID
patients without full mitigation of risk of prion contamination. It would be
essential to have in place a prion screening procedure. We understand that this
would require a blood or urine test for asymptomatic prion infection if UK
plasma were to be used in the future. Tracking of donations would be essential
to ensure traceability back to individual donors.</div>
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3b.Is the Government and its scientific advisory structure sufficiently
responsive to the threat posed by emerging diseases being transmitted through
blood and blood products, tissues and organs?</div>
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PID UK understands from UKPIN that there are currently no clear lines of
communication and accountability about relaying incidences of prion infection
through their study.</div>
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3c. Has the threat of ongoing transmission of vCJD through the blood and
blood product supply been adequately mitigated?</div>
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This has been well mitigated through the use of non‐UK sourced plasma.
Through education of patients of the processes involved in sourcing donors and
isolating Ig there is confidence within the community about its safety. Steps to
mitigate risk using UK plasma would need to include essential screening
procedures for prion contamination and robust traceability mechanisms.</div>
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Declaration of interests</div>
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PID UK over the last year has been in receipt of two donations from CSL
Behring. </div>
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<a href="http://www.piduk.org/static/media/up/PIDUKvCJDinquiry.pdf">http://www.piduk.org/static/media/up/PIDUKvCJDinquiry.pdf</a>
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please see ; </div>
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2015 PRION CONFERENCE</div>
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*** RE-P.164: Blood transmission of prion infectivity in the squirrel
monkey: The Baxter study</div>
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***suggest that blood donations from cases of GSS (and perhaps other
familial forms of TSE) carry more risk than from vCJD cases, and that little or
no risk is associated with sCJD. *** </div>
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P.164: Blood transmission of prion infectivity in the squirrel monkey: The
Baxter study</div>
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Paul Brown1, Diane Ritchie2, James Ironside2, Christian Abee3, Thomas
Kreil4, and Susan Gibson5 1NIH (retired); Bethesda, MD USA; 2University of
Edinburgh; Edinburgh, UK; 3University of Texas; Bastrop, TX USA; 4Baxter
Bioscience; Vienna, Austria; 5University of South Alabama; Mobile, AL USA</div>
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Five vCJD disease transmissions and an estimated 1 in 2000 ‘silent’
infections in UK residents emphasize the continued need for information about
disease risk in humans. A large study of blood component infectivity in a
non-human primate model has now been completed and analyzed. Among 1 GSS, 4
sCJD, and 3 vCJD cases, only GSS leukocytes transmitted disease within a 5–6
year surveillance period. A transmission study in recipients of multiple whole
blood transfusions during the incubation and clinical stages of sCJD and vCJD in
ic-infected donor animals was uniformly negative. These results, together with
other laboratory studies in rodents and nonhuman primates and epidemiological
observations in humans, suggest that blood donations from cases of GSS (and
perhaps other familial forms of TSE) carry more risk than from vCJD cases, and
that little or no risk is associated with sCJD. The issue of decades-long
incubation periods in ‘silent’ vCJD carriers remains open.</div>
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<a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf">https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf</a>
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ran across an old paper from 1984 ; </div>
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***The occurrence of contact cases raises the possibility that transmission
in families may be effected by an unusually virulent strain of the agent.
***</div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html</a>
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From: Terry S. Singeltary Sr. </div>
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Sent: Saturday, November 15, 2014 9:29 PM </div>
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To: Terry S. Singeltary Sr. </div>
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Subject: THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE R. G. WILL
1984</div>
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THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE </div>
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R. G. WILL </div>
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1984</div>
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snip...</div>
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<a href="http://web.archive.org/web/20050425210551/http://www.bseinquiry.gov.uk/files/mb/m26/tab01.pdf">http://web.archive.org/web/20050425210551/http://www.bseinquiry.gov.uk/files/mb/m26/tab01.pdf</a>
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THE BAXTER STUDY...SEE MORE HERE ;</div>
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<a href="http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html">http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html</a>
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<a href="http://tseac.blogspot.com/">http://tseac.blogspot.com/</a></div>
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<a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf">https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf</a>
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Results We sampled blood 19 times from the inoculated monkeys at various
stages of the disease over a period of 29 months, generating liters of
vCJD-infected macaque blood. vCJD was confirmed in all inoculated macaques.
After PMCA, PrPTSE was detected in plasma from infected monkeys, but not from
uninfected animals. Both mouse models were more sensitive to infection with
macaque-adapted vCJD agent than to primary human vCJD agent. </div>
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<a href="http://onlinelibrary.wiley.com/enhanced/doi/10.1111/trf.12841/">http://onlinelibrary.wiley.com/enhanced/doi/10.1111/trf.12841/</a>
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see much more here ; </div>
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<a href="http://vcjdtransfusion.blogspot.com/2014/08/blood-reference-materials-from-macaques.html">http://vcjdtransfusion.blogspot.com/2014/08/blood-reference-materials-from-macaques.html</a></div>
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<a href="http://vcjdtransfusion.blogspot.com/">http://vcjdtransfusion.blogspot.com/</a></div>
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Detection of cellular prion protein in exosome derived from ovine plasma
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Authors: Elena Berrone1, Cristiano Corona2, Maria Mazza3, Elena Vallino
Costassa4, Monica Lo Faro5, Francesca Properzi6, Chiara Guglielmetti7, Cristiana
Maurella8, Maria Caramelli9, Maria Chiara Deregibus10, Giovanni Camussi11,
Cristina Casalone12 </div>
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VIEW AFFILIATIONS Affiliations: 1 1Istituto Zooprofilattico Sperimentale
del Piemonte, Turin 2 2Istituto Zooprofilattico Sperimentale del Piemonte, Turin
3 3Istituto Zooprofilattico Sperimentale del Piemonte, Turin 4 4Istituto
Zooprofilattico Sperimentale del Piemonte, Turin 5 5Istituto Zooprofilattico
Sperimentale del Piemonte, Turin 6 6Istituto Superiore di Sanità, Rome 7
7Istituto Zooprofilattico Sperimentale del Piemonte, Turin 8 8Istituto
Zooprofilattico Sperimentale del Piemonte, Turin 9 9Istituto Zooprofilattico
Sperimentale del Piemonte, Turin 10 10University of Turin 11 11University of
Turin 12 12Istituto Zooprofilattico Sperimetale del Piemonte, Turin </div>
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<div>
</div>
<br />
<div>
Published Ahead of Print: 22 September, 2015 Journal of General Virology
doi: 10.1099/jgv.0.000291 Published Online: 22/09/2015 Prion protein (PrP) is
present at extremely low levels in the blood of animals and its detection is
complicated by the poor sensitivity of current standard methodologies.
Interesting results have been obtained with recent advanced technologies that
are able to detect minute amounts of the pathological PrP (PrPSc), but their
efficiency is reduced by various factors present in blood. In this study, we
were able to extract cellular PrP (PrPC) from plasma-derived exosomes by a
simple, fast method without the use of differential ultracentrifugation and to
visualize it by Western blotting, reducing the presence of most plasma proteins.
This result confirms that blood is capable of releasing PrP in association with
exosomes and could be useful to better study its role in TSEs
pathogenesis.</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://jgv.microbiologyresearch.org/content/journal/jgv/10.1099/jgv.0.000291">http://jgv.microbiologyresearch.org/content/journal/jgv/10.1099/jgv.0.000291</a></div>
<br />
<div>
</div>
<br />
<div>
Thursday, August 13, 2015 </div>
<br />
<div>
</div>
<br />
<div>
Iatrogenic CJD due to pituitary-derived growth hormone with genetically
determined incubation times of up to 40 years</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2015/08/iatrogenic-cjd-due-to-pituitary-derived.html">http://creutzfeldt-jakob-disease.blogspot.com/2015/08/iatrogenic-cjd-due-to-pituitary-derived.html</a></div>
<br />
<div>
</div>
<br />
<div>
Wednesday, December 11, 2013 </div>
<br />
<div>
</div>
<br />
<div>
*** Detection of Infectivity in Blood of Persons with Variant and Sporadic
Creutzfeldt-Jakob Disease *** </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/">http://creutzfeldt-jakob-disease.blogspot.com/</a>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, December 14, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** ALERT new variant Creutzfeldt Jakob Disease nvCJD or vCJD, sporadic CJD
strains, TSE prion aka Mad Cow Disease United States of America Update December
14, 2014 Report ***</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/12/alert-new-variant-creutzfeldt-jakob.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/12/alert-new-variant-creutzfeldt-jakob.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, March 09, 2014 </div>
<br />
<div>
</div>
<br />
<div>
A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of
Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease </div>
<br />
<div>
</div>
<br />
<div>
FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, September 10, 2015 </div>
<br />
<div>
</div>
<br />
<div>
25th Meeting of the Transmissible Spongiform Encephalopathies Advisory
Committee Food and Drug Administration Silver Spring, Maryland June 1, 2015
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://tseac.blogspot.com/2015/09/25th-meeting-of-transmissible.html">http://tseac.blogspot.com/2015/09/25th-meeting-of-transmissible.html</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://tseac.blogspot.com/">http://tseac.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
Thursday, October 1, 2015 </div>
<br />
<div>
</div>
<br />
<div>
Alzheimergate, re-Evidence for human transmission of amyloid-β pathology
and cerebral amyloid angiopathy, Singeltary Submission to Nature </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://betaamyloidcjd.blogspot.com/2015/10/alzheimergate-re-evidence-for-human.html">http://betaamyloidcjd.blogspot.com/2015/10/alzheimergate-re-evidence-for-human.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
BSE INQUIRY DFAs</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bseinquiry.blogspot.com/">http://bseinquiry.blogspot.com/</a>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, May 18, 2008 </div>
<br />
<div>
</div>
<br />
<div>
BSE Inquiry DRAFT FACTUAL ACCOUNT DFA </div>
<br />
<div>
</div>
<br />
<div>
BSE Inquiry DRAFT FACTUAL ACCOUNTS DFA's </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html">http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, May 18, 2008 </div>
<br />
<div>
</div>
<br />
<div>
BSE, CJD, and Baby foods (the great debate 1999 to 2005) </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bseinquiry.blogspot.com/2008/05/bse-cjd-and-baby-foods-great-debate.html">http://bseinquiry.blogspot.com/2008/05/bse-cjd-and-baby-foods-great-debate.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, May 18, 2008 </div>
<br />
<div>
</div>
<br />
<div>
MAD COW DISEASE BSE CJD CHILDREN VACCINES </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html">http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date </div>
<br />
<div>
</div>
<br />
<div>
Subheading 300210: ANTISERA AND OTHER BLOOD FRACTIONS, AND MODIFIED
IMMUNOLOGICAL PRODUCTS 3002.10.0010: HUMAN BLOOD PLASMA </div>
<br />
<div>
</div>
<br />
<div>
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs
Value, in Thousands of Dollars) (Units of Quantity: Kilograms) </div>
<br />
<div>
</div>
<br />
<div>
<--- ---="" 1998="" country="" dec="" div="" quantity="" value="" ytd="">
<br />
<div>
</div>
<br />
<div>
================================================================= </div>
<br />
<div>
</div>
<br />
<div>
WORLD TOTAL . . . . . . . 25,740 1,827 270,357 20,476 </div>
<br />
<div>
</div>
<br />
<div>
Belgium . . . . . . . . . 14 8 145 60 </div>
<br />
<div>
</div>
<br />
<div>
France . . . . . . . . . --- --- 134 60 </div>
<br />
<div>
</div>
<br />
<div>
Netherlands . . . . . . . --- --- 11 5 </div>
<br />
<div>
</div>
<br />
<div>
Switzerland . . . . . . . 10,462 597 86,101 5,894 </div>
<br />
<div>
</div>
<br />
<div>
United Kingdom . . . . . --- --- 335 62 </div>
<br />
<div>
</div>
<br />
<div>
3002.10.0020: NORMAL HUMAN BLOOD SERA, WHETHER OR NOT FREEZE-DRIED </div>
<br />
<div>
</div>
<br />
<div>
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs
Value, in Thousands of Dollars) (Units of Quantity: Kilograms) </div>
<br />
<div>
</div>
<br />
<div>
<--- ---="" 1998="" country="" dec="" div="" quantity="" value="" ytd="">
<br />
<div>
</div>
<br />
<div>
================================================================= </div>
<br />
<div>
</div>
<br />
<div>
WORLD TOTAL . . . . . . . 1,039 817 19,056 22,678 </div>
<br />
<div>
</div>
<br />
<div>
Austria . . . . . . . . . --- --- 9,194 18,707 </div>
<br />
<div>
</div>
<br />
<div>
Belgium . . . . . . . . . --- --- 22 15 </div>
<br />
<div>
</div>
<br />
<div>
Netherlands . . . . . . . 353 2 6,733 41 </div>
<br />
<div>
</div>
<br />
<div>
Switzerland . . . . . . . 374 218 1,084 440 </div>
<br />
<div>
</div>
<br />
<div>
United Kingdom . . . . . --- --- 1 4 </div>
<br />
<div>
</div>
<br />
<div>
3002.10.0030: HUMAN IMMUNE BLOOD SERA </div>
<br />
<div>
</div>
<br />
<div>
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs
Value, in Thousands of Dollars) (Units of Quantity: Kilograms) </div>
<br />
<div>
</div>
<br />
<div>
<--- ---="" 1998="" country="" dec="" div="" quantity="" value="" ytd="">
<br />
<div>
</div>
<br />
<div>
================================================================= </div>
<br />
<div>
</div>
<br />
<div>
WORLD TOTAL . . . . . . . 1,926 461 14,484 3,563... </div>
<br />
<div>
</div>
<br />
<div>
United Kingdom . . . . . 2 8 464 192 </div>
<br />
<div>
</div>
<br />
<div>
3002.10.0040: FETAL BOVINE SERUM (FBS) </div>
<br />
<div>
</div>
<br />
<div>
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs
Value, in Thousands of Dollars) (Units of Quantity: Kilograms) </div>
<br />
<div>
</div>
<br />
<div>
<--- ---="" 1998="" country="" dec="" div="" quantity="" value="" ytd="">
<br />
<div>
</div>
<br />
<div>
================================================================= </div>
<br />
<div>
</div>
<br />
<div>
WORLD TOTAL . . . . . . . 2,727 233 131,486 8,502... </div>
<br />
<div>
</div>
<br />
<div>
Belgium . . . . . . . . . --- --- 17 32 </div>
<br />
<div>
</div>
<br />
<div>
United Kingdom . . . . . 329 82 743 756 </div>
<br />
<div>
</div>
<br />
<div>
3002.10.0090: OTHER BLOOD FRACTIONS NOT ELSEWHERE SPECIFIED OR INCLUDED
</div>
<br />
<div>
</div>
<br />
<div>
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs
Value, in Thousands of Dollars) (Units of Quantity: Kilograms) </div>
<br />
<div>
</div>
<br />
<div>
<--- ---="" 1998="" country="" dec="" div="" quantity="" value="" ytd="">
<br />
<div>
</div>
<br />
<div>
================================================================= </div>
<br />
<div>
</div>
<br />
<div>
WORLD TOTAL . . . . . . . 88,467 27,343 944,412 309,947... </div>
<br />
<div>
</div>
<br />
<div>
United Kingdom . . . . . 1,887 2,300 26,823 23,585 </div>
<br />
<div>
</div>
<br />
<div>
=================================================================== </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.ita.doc.gov/industry/otea/Trade-Detail/Latest-December/Imports/30/300290.html">http://www.ita.doc.gov/industry/otea/Trade-Detail/Latest-December/Imports/30/300290.html</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date </div>
<br />
<div>
</div>
<br />
<div>
Subheading 300290: HUMAN BLOOD; ANIMAL BLOOD PREPARED FOR THERAPEUTIC, ETC.
USES; TOXINS, CULTURES OF MICRO-ORGANISMS (EXCLUDING YEASTS) AND SIMILAR
PRODUCTS NESOI </div>
<br />
<div>
</div>
<br />
<div>
<--- ---="" 1998="" country="" dec="" div="" quantity="" value="" ytd="">
<br />
<div>
</div>
<br />
<div>
================================================================= </div>
<br />
<div>
</div>
<br />
<div>
WORLD TOTAL . . . . . . . 36,178 643 250,982 11,604... </div>
<br />
<div>
</div>
<br />
<div>
United Kingdom . . . . . 584 39 11,292 588 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.ita.doc.gov/industry/otea/Trade-Detail/Latest-Month/Imports/05/051199.html">http://www.ita.doc.gov/industry/otea/Trade-Detail/Latest-Month/Imports/05/051199.html</a></div>
<br />
<div>
</div>
<br />
<div>
snip...see more here ;</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh">http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.mad-cow.org/dec98_late_news.html" title="http://www.mad-cow.org/dec98_late_news.html">http://www.mad-cow.org/dec98_late_news.html</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.mad-cow.org/00/jan00_news.html#aaa" title="http://www.mad-cow.org/00/jan00_news.html#aaa">http://www.mad-cow.org/00/jan00_news.html#aaa</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html" title="http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html">http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjd.blogspot.com/2014/07/after-storm-uk-blood-safety-and-risk-of.html" title="http://vcjd.blogspot.com/2014/07/after-storm-uk-blood-safety-and-risk-of.html">http://vcjd.blogspot.com/2014/07/after-storm-uk-blood-safety-and-risk-of.html</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
-------- Original Message -------- </div>
<br />
<div>
</div>
<br />
<div>
Subject: TSE Advisory Committee October 14-15, 2004 </div>
<br />
<div>
</div>
<br />
<div>
Date: Fri, 10 Sep 2004 16:34:24 –0500 </div>
<br />
<div>
</div>
<br />
<div>
From: "Terry S. Singeltary Sr." </div>
<br />
<div>
</div>
<br />
<div>
To: Bovine Spongiform Encephalopathy </div>
<br />
<div>
</div>
<br />
<div>
Transmissible Spongiform Encephalopathies Advisory Committee </div>
<br />
<div>
</div>
<br />
<div>
Committee Roster </div>
<br />
<div>
</div>
<br />
<div>
Suzette Priola PhD, National Institute of Allergy & Infectious Diseases
(Chair) 1/31/05 Val Bias, National Hemophilia Foundation 1/31/07 Lynn Creekmore
DVM, U.S. Department of Agriculture 1/31/07 Lisa Ferguson DVM, U.S. Department
of Agriculture Animal & Plant Health Inspection Service 1/31/04 R. Nick
Hogan MD/PhD, University of Texas Southwestern Medical School 1/31/07 Rima
Khabbaz MD, National Center for Infectious Disease Shirley Walker, Dallas Urban
League (Consumer Representative) 1/31/04 John Bailar MD/PhD, University of
Chicago 1/31/05 Arthur Bracey MD, St. Luke's Episcopal Hospital 1/31/07 Stephen
DeArmond MD/PhD, University of California San Francisco School of Medicine
1/31/05 Pierluigi Gambetti MD, Case Western Reserve University 1/31/05 Richard
Johnson MD, Johns Hopkins University Schoo of Medicine 1/31/06 Stephen Petteway
PhD, Bayer (Non-voting Industry Representative) 1/31/05 Sidney Wolfe MD, Public
Citizen's Health Research Group 1/31/04 William Freas PhD, FDA (Executive
Secretary) </div>
<br />
<div>
</div>
<br />
<div>
Tentative Meetings </div>
<br />
<div>
</div>
<br />
<div>
October 14-15, 2004 </div>
<br />
<div>
</div>
<br />
<div>
Upcoming Meetings Date </div>
<br />
<div>
</div>
<br />
<div>
Plasma-Derived Product Label Claims For TSE Testing; BSE Diagnosis, Food
Rules; vCJD Transmission </div>
<br />
<div>
</div>
<br />
<div>
Plasma-Derived Product Labeling Claims For TSE Clearance To Be Discussed By
Cmte. </div>
<br />
<div>
</div>
<br />
<div>
FDA s Transmissible Spongiform Encephalopathies Advisory Committee will
discuss labeling claims for TSE clearance studies for plasma-derived products on
Oct. 14. </div>
<br />
<div>
</div>
<br />
<div>
The committee will also receive updates on U.S. Department of Agriculture
licensed tests for the diagnosis of bovine spongiform encephalopathy, FDA BSE
food safety rules, and the BSE situation worldwide. </div>
<br />
<div>
</div>
<br />
<div>
Presumptive transfusion transmissions of variant Creutzfeldt-Jakob Disease
and FDA recommended safeguards will also be addressed by the committee. </div>
<br />
<div>
</div>
<br />
<div>
To watch a webcast of this meeting, click the button below. To arrange for
live videoconferencing, or to order videotapes & DVDs, email
webcasthelp@elsevier.com or call 800-627-8171. </div>
<br />
<div>
</div>
<br />
<div>
Posted: Friday, September 10, 2004 </div>
<br />
<div>
</div>
<br />
<div>
Sign up to view this meeting. </div>
<br />
<div>
</div>
<br />
<div>
October 14, 2004 </div>
<br />
<div>
</div>
<br />
<div>
------------------------------------------------------------------------
</div>
<br />
<div>
</div>
<br />
<div>
Previous Meetings Date Mad Cow Disease: FDA Recommendations To Minimize
Risk From TSE Agents In Medical Products -Day 2 </div>
<br />
<div>
</div>
<br />
<div>
February 13, 2004 </div>
<br />
<div>
</div>
<br />
<div>
------------------------------------------------------------------------
</div>
<br />
<div>
</div>
<br />
<div>
Mad Cow Disease: Risk Models For Bovine Sourcing For Medical Products;
First U.S. Case </div>
<br />
<div>
</div>
<br />
<div>
February 12, 2004 </div>
<br />
<div>
</div>
<br />
<div>
------------------------------------------------------------------------</div>
<br />
<div>
</div>
<br />
<div>
TSE Removal From Medical Devices and Equipment </div>
<br />
<div>
</div>
<br />
<div>
July 18, 2003 </div>
<br />
<div>
</div>
<br />
<div>
------------------------------------------------------------------------
</div>
<br />
<div>
</div>
<br />
<div>
Bovine Bone Gelatin Safety; BSE In Canada </div>
<br />
<div>
</div>
<br />
<div>
July 17, 2003 </div>
<br />
<div>
</div>
<br />
<div>
------------------------------------------------------------------------
</div>
<br />
<div>
</div>
<br />
<div>
Variant Creutzfeldt-Jakob Disease Guidance Implementation </div>
<br />
<div>
</div>
<br />
<div>
February 20, 2003 </div>
<br />
<div>
</div>
<br />
<div>
------------------------------------------------------------------------
</div>
<br />
<div>
</div>
<br />
<div>
Blood Donor Deferral Implementation </div>
<br />
<div>
</div>
<br />
<div>
June 27, 2002 </div>
<br />
<div>
</div>
<br />
<div>
------------------------------------------------------------------------
</div>
<br />
<div>
</div>
<br />
<div>
CJD Transmission Risk Reduction Draft Guidance </div>
<br />
<div>
</div>
<br />
<div>
June 26, 2002 </div>
<br />
<div>
</div>
<br />
<div>
------------------------------------------------------------------------
</div>
<br />
<div>
</div>
<br />
<div>
TSE/Blood Products Joint Cmte. Meeting </div>
<br />
<div>
</div>
<br />
<div>
January 17, 2002 </div>
<br />
<div>
</div>
<br />
<div>
------------------------------------------------------------------------
</div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt-Jakob Disease FDA Draft Guidance </div>
<br />
<div>
</div>
<br />
<div>
October 25, 2001 </div>
<br />
<div>
</div>
<br />
<div>
------------------------------------------------------------------------
</div>
<br />
<div>
</div>
<br />
<div>
For information about additional meetings, email webcasthelp@elsevier.com
or call Julie D. Robenson at (800) 332-1370. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Transmissible+Spongiform+Encephalopathies/default.htm">http://www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Transmissible+Spongiform+Encephalopathies/default.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
GREETINGS LIST MEMBERS, </div>
<br />
<div>
</div>
<br />
<div>
talk about spooky. i was just going over a few old Advisory Committee
meetings; </div>
<br />
<div>
</div>
<br />
<div>
FOOD AND DRUG ADMINISTRATION </div>
<br />
<div>
</div>
<br />
<div>
NATIONAL INSTITUTES OF HEALTH </div>
<br />
<div>
</div>
<br />
<div>
Advisory Committee on: </div>
<br />
<div>
</div>
<br />
<div>
TRANSMISSIBLE </div>
<br />
<div>
</div>
<br />
<div>
SPONGIFORM </div>
<br />
<div>
</div>
<br />
<div>
ENCEPHALOPATHIES </div>
<br />
<div>
</div>
<br />
<div>
December 18, 1998 </div>
<br />
<div>
</div>
<br />
<div>
Holiday Inn </div>
<br />
<div>
</div>
<br />
<div>
8120 Wisconsin Avenue </div>
<br />
<div>
</div>
<br />
<div>
Bethesda, Maryland </div>
<br />
<div>
</div>
<br />
<div>
Proceedings by: </div>
<br />
<div>
</div>
<br />
<div>
CASET Associates, Ltd </div>
<br />
<div>
</div>
<br />
<div>
10201 Lee Highway, Suite 160 </div>
<br />
<div>
</div>
<br />
<div>
Fairfax, Virginia 22030 </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
DR. ROOS: I have a question for Dr. Metters. I guess I just wanted to make
sure that I understood the rationale for the present policies in the United
Kingdom; that is that there is no pooled plasma products that have UK donors.
Nevertheless, there is no curtailment of blood transfusions and labile products
from UK individuals. </div>
<br />
<div>
</div>
<br />
<div>
I just wanted to make sure I understood the rationale for that. That was
just -- in other words, if there is a safety problem with a particular unit
bearing CJD, then presumably those individual blood transfusions also carry that
risk. Maybe you could explain that. </div>
<br />
<div>
</div>
<br />
<div>
DR. METTERS: First of all, all blood products. At the moment there are,
because we haven't completed the change-over from UK source to non-UK source.
Once that change-over takes place, there will be no UK sourced blood products.
We are making that change as soon as possible. </div>
<br />
<div>
</div>
<br />
<div>
The reason why blood products may be different from blood is that, of
course, blood products go into an enormous pool. </div>
<br />
<div>
</div>
<br />
<div>
The potential disbursement of a unit that is contaminated with new variant
depends on the size of the pool, whether it is a pool of 500 or 6,500 units.
</div>
<br />
<div>
</div>
<br />
<div>
As I said, we have to find an alternative source of blood products. The
most units it would go to is three recipients. </div>
<br />
<div>
</div>
<br />
<div>
The other point to make is that this relates to the follow up. By far,
those who receive blood in the United Kingdom will die from the current disease
for which they receive the blood within 12 to 18 months. That is a real problem
when you come to holding it up, because of the attenuation and so on. </div>
<br />
<div>
</div>
<br />
<div>
The blood products, that does present a disbursal factor. As I said, we do
actually have steps to monitor who receives the blood, and are taking steps to
out-source blood products. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Just to add, on the disbursal factor, we don't know what is
going on in new variant. We don't know if there are a million infectious units
per unit of blood. We just don't know. </div>
<br />
<div>
</div>
<br />
<div>
I received this comment about CJD. If new variant is, indeed, like ordinary
CJD, there is a logical curiosity about the disposal factor. Infectivity is a
functional definition. We don't necessarily know what it is. </div>
<br />
<div>
</div>
<br />
<div>
So, if there are 15 infectious units, we are talking about 15 transmissions
of the disease. It is likely, after all the experimental and epidemiologic
evidence that any level of infectivity in the blood of normal CJD is very, very
low. </div>
<br />
<div>
</div>
<br />
<div>
It doesn't much matter if that 100 infectious units is distributed to
10,000 or a million. There are going to be 100 transmissions. The notion that
you can dilute out infectivity has no scientific basis. </div>
<br />
<div>
</div>
<br />
<div>
The other thing, if the unit of blood that is donor is fractionated with an
infectious agent, then disbursal may be higher. Unfortunately, we don't know the
answer to that yet. </div>
<br />
<div>
</div>
<br />
<div>
DR. SCHONBERGER: I am wondering if our colleagues from the United Kingdom
can tell us what type of screening for blood donors is done to reduce the
chances of new variant disease specifically in the donor group. </div>
<br />
<div>
</div>
<br />
<div>
Is there any kind of screening specifically directed toward new variant
CJD. </div>
<br />
<div>
</div>
<br />
<div>
The other issue, again, of screening, is there any screening that is done
in the United Kingdom that is focused specifically on ruling out somebody who is
symptomatic, for example, with new variant. </div>
<br />
<div>
</div>
<br />
<div>
I understand that new variant's onset can be subtle and not really very
apparent for a while. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: So, what you are asking is whether or not there are any special
criteria that are in place or being thought of to reduce the risk of a new
variant patient who is either -- according to Bob Will's criteria -- either
probable or definite. I can't imagine a definite, but shall we say a suspect.
</div>
<br />
<div>
</div>
<br />
<div>
DR. METTERS: I think the general answer has to be no. There is nothing you
can ask somebody. There is, on the other hand, the donor is at least asked about
their general health. </div>
<br />
<div>
</div>
<br />
<div>
Then if there is any suspicion at the time that they are not 100 percent
fit, and they have their blood count done before they are accepted. </div>
<br />
<div>
</div>
<br />
<div>
If someone is physically unwell in any way, hopefully they will not get
through the screening system. So, while it isn't specific to that, it is -- I
would be doing a very bad job if I let someone who was unhealthy in any way to
get through our screening system. </div>
<br />
<div>
</div>
<br />
<div>
DR. SCHONBERGER: So, there is no set of questions that is standard --
</div>
<br />
<div>
</div>
<br />
<div>
DR. METTERS: The questions of about CJD are there, right. To avoid getting
classes of donors, you may be able to avoid getting classes of donors. </div>
<br />
<div>
</div>
<br />
<div>
I would be very interested if any of you at the table could answer the
question that was asked. </div>
<br />
<div>
</div>
<br />
<div>
We haven't yet had one who has been identified that in the time that they
were labile, was a donor. </div>
<br />
<div>
</div>
<br />
<div>
DR. METTERS: As you know, most of the patients, or many of them, have
psychiatric onsets. So, if their response to the very first question you ask is
moo, you know to be suspicious. </div>
<br />
<div>
</div>
<br />
<div>
DR. ROHWER: I have a question for Dr. Ferguson. When the provisions against
importations from the United Kingdom were extended in February of 1998, was
there any attempt by the USDA to go back to see what level of exposure the
United States had to European bovine products and cattle since 1980, for
example, or since 1988 when the provisions were put in place for the United
Kingdom? </div>
<br />
<div>
</div>
<br />
<div>
For example, between 1980 and 1989, apparently we imported some 500 cattle.
Now that we have recognized that there may have also been a risk from imports
from Europe and others before this change in policy, have we gone back and
looked at how exposed we were from that risk? I mean, how many imports were
there, and what kind of things were imported. </div>
<br />
<div>
</div>
<br />
<div>
DR. FERGUSON: Yes, actually we have gone back and looked at live animal
imports from continental Europe at that same time. </div>
<br />
<div>
</div>
<br />
<div>
They were fairly restricted at that point in time because cattle in Europe
were infected with other animal diseases, such as FMB. </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
MR. SUDIERI(?): My name is Sal Sudieri. I am the vice president for medical
affairs at the New York Blood Center. </div>
<br />
<div>
</div>
<br />
<div>
Regarding this section A, there is a piece of information that I think is
important for you to have. </div>
<br />
<div>
</div>
<br />
<div>
For the last 25 years, the American Blood Center has had a program with
Switzerland, Holland and Germany, where centers that produce plasma derivatives
in this country collect units of whole blood from volunteer donors. </div>
<br />
<div>
</div>
<br />
<div>
They became licensed centers, collection centers, from the New York Blood
Center, by our FDA license, and they will ship us the red cells, where we do the
processing, dedicate the plasma and the plasma is fractionated. </div>
<br />
<div>
</div>
<br />
<div>
About 30 percent of the blood, or about 200,000 units of red cells a year,
come to New York through this method. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Is the committee happy about what everybody considers and knows
to be an other BSE country or do we want to get clarification of that? </div>
<br />
<div>
</div>
<br />
<div>
DR. LEITMAN: Clarification. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Are we talking about the United Kingdom plus France, plus
Portugal, plus the whole of Europe? What are we talking about? </div>
<br />
<div>
</div>
<br />
<div>
DR. LURIE: Who is to make that decision? </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: That is what we want to know. Is that a decision that is going
to be made? If they can't tell us what is meant by other BSE country, we can't
really answer the question. </div>
<br />
<div>
</div>
<br />
<div>
DR. LURIE: The procedural approach would be to vote on it separately. I
think the vote is more providing guidance. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Good suggestion. Ditto for periods of higher and lower risk, I
suppose, and ditto for possible versus probable. We can move along in that way.
That is a good idea. </div>
<br />
<div>
</div>
<br />
<div>
DR. LURIE: Another parallel type suggestion would be, I think the question
that we do need some clarification on is the definition of reside. </div>
<br />
<div>
</div>
<br />
<div>
While obviously it is more efficient to exclude residents from Britain and
visitors from Britain because, a, there are presumably fewer residents than
there are visitors, and the duration of exposure and presumably severity of
exposure would be different. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Maybe the best way to do it is to go piecemeal and nibble, in
which case we might, for example, phrase the first question, should the FDA
recommend excluding donors who are British citizens and see what you get in
answer to that, and see just how far the committee is willing to go. </div>
<br />
<div>
</div>
<br />
<div>
On the other hand, that is going to require about 117 votes this afternoon.
</div>
<br />
<div>
</div>
<br />
<div>
DR. HOEL: There is another approach. First, we have to answer the first
question first. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: I know. That was going to be my next point. Depending on our
answer to one, we can either dismiss A through E or take them up. I think that
is why Dr. Epstein phrased these two questions in this way. Maybe I am wrong,
but that is the way it is going to be done. </div>
<br />
<div>
</div>
<br />
<div>
If the committee is ready to vote without further discussion on question
one -- not A, B, C, D and E, but just question one as a question -- we will then
vote and see what we then have to do, or we can have a little, a moderate or a
large amount of discussion before we get to that. </div>
<br />
<div>
</div>
<br />
<div>
DR. LEITMAN: I have always had a problem with reducing a theoretical risk
or reducing a hypothetical risk or reducing a potential risk, because perhaps,
as I was talking to one of my colleagues earlier today, perhaps it is a
speculative risk and not a theoretical risk that, in actuality, hasn't occurred.
</div>
<br />
<div>
</div>
<br />
<div>
How do we reduce speculative risk? How do you reduce zero? </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: That is an interesting kind of semantic question. It is the
virtual reduction of a theoretical risk. Does anyone want to get into semantics?
</div>
<br />
<div>
</div>
<br />
<div>
DR. CLIVER: Clearly question one turns on the perception of nvCJD as a food
borne disease that is somehow derived from cattle. </div>
<br />
<div>
</div>
<br />
<div>
I think I am prepared to accept that. The period of emphasis ending at
1990, though, I think is not indicated. The observations that Dr. Detweiler had
before, the data on this would have been very valuable for risk on people on
farms, however, there is no imputation here that the risk was associated with
people on farms with cattle. </div>
<br />
<div>
</div>
<br />
<div>
[try 15 times more likely to get CJD...TSS] </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1995/01/31004001.pdf">http://www.bseinquiry.gov.uk/files/yb/1995/01/31004001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1989/10/13007001.pdf">http://www.bseinquiry.gov.uk/files/yb/1989/10/13007001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf">http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1995/10/20006001.pdf">http://www.bseinquiry.gov.uk/files/yb/1995/10/20006001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
CONFIRMATION OF CJD IN FOURTH FARMER </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1995/11/03008001.pdf">http://www.bseinquiry.gov.uk/files/yb/1995/11/03008001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
now story changes from; </div>
<br />
<div>
</div>
<br />
<div>
SEAC concluded that, if the fourth case were confirmed, it would be
worrying, especially as all four farmers with CJD would have had BSE cases on
their farms. </div>
<br />
<div>
</div>
<br />
<div>
to; </div>
<br />
<div>
</div>
<br />
<div>
This is not unexpected... </div>
<br />
<div>
</div>
<br />
<div>
was another farmer expected? </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1995/11/13010001.pdf">http://www.bseinquiry.gov.uk/files/yb/1995/11/13010001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
4th farmer, and 1st teenager </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1996/02/27003001.pdf">http://www.bseinquiry.gov.uk/files/yb/1996/02/27003001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: The question, Robert, is there any instance of maternal
transmission of new variant CJD? </div>
<br />
<div>
</div>
<br />
<div>
DR. WILL: The answer is no, although tragically, at least one of the
individuals was pregnant when diagnosed with new variant CJD. </div>
<br />
<div>
</div>
<br />
<div>
MS. HARRELL: Was she delivered? </div>
<br />
<div>
</div>
<br />
<div>
DR. WILL: She did delivered. The child is alive and well, but we are only
talking two or three years. Of course, therefore, we rely on previous evidence,
which does not suggest that there was maternal transmission. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: It is an interesting question. If it were to have occurred, it
would be one more very striking example of a particular biological behavior of
new variant from sporadic. </div>
<br />
<div>
</div>
<br />
<div>
We have information about half a dozen children born to patients who were
sick with CJD on delivery, who now have -- they have lived for as long as 30
years after that event -- that is, after they were born -- and are quite
healthy... </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
DON'T count your chickens again before they hatch there Dr. Brown, remember
the 38 years incubation period on the iCJD of a small dose; </div>
<br />
<div>
</div>
<br />
<div>
SHORT REPORT </div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt-Jakob disease 38 years after diagnostic use of human growth
hormone </div>
<br />
<div>
</div>
<br />
<div>
E A Croes, G Roks, G H Jansen, P C G Nijssen, C M van Duijn </div>
<br />
<div>
</div>
<br />
<div>
............................................................... </div>
<br />
<div>
</div>
<br />
<div>
J Neurol Neurosurg Psychiatry 2002;72:792-793 </div>
<br />
<div>
</div>
<br />
<div>
We describe the second patient with hGH related CJD in the Netherlands. The
patient developed the disease 38 years after hGH injections. To our knowledge,
this is the longest incubation period described for any form of iatrogentic CJD.
Furthermore, our patient was _not_ treated with hGH, but only received a _low_
dose as part of a diagnostic procedure... </div>
<br />
<div>
</div>
<br />
<div>
and this was not a case of nv/v CJD, but spordic CJD...TSS </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3484t1.rtf">http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3484t1.rtf</a>
</div>
<br />
<div>
</div>
<br />
<div>
ACTION TAKEN BY THE UK MEDICINES CONTROL AGENCY ON BOVINE INGREDIENTS IN
MEDICINAL PRODUCTS </div>
<br />
<div>
</div>
<br />
<div>
6.1 Information is held on a especial data base from the initial BSE survey
in 1989. More current products, which were vetted during their initial licensing
assessment, after the UK BSE quideline was published, may not appear in the
listing, since BSE was considering in their initial licensing assessment. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1994/09/01003001.pdf">http://www.bseinquiry.gov.uk/files/yb/1994/09/01003001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
RESTRICTED-COMMERCIAL..............CSM/BIOLS/94/6th Meeting </div>
<br />
<div>
</div>
<br />
<div>
NOT FOR PUBLICATION </div>
<br />
<div>
</div>
<br />
<div>
COMMITTEE ON SAFETY OF MEDICINES </div>
<br />
<div>
</div>
<br />
<div>
SUB-COMMITTEE ON BIOLOGICALS </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
1.1 The chairman reminded the Sub-Committee that the papers and proceedings
were confidential and should not be disclosed... </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
4.6 BOVINE SERA </div>
<br />
<div>
</div>
<br />
<div>
4.6.1 There was a discussion of the problem of the paper trail audit, and
countries of sourcing for bovine sera. Concern was expressed about the fact that
bogus certificates of origin had been produced and circulated. It was noted that
in the USA bovine protein was still being fed to cattle. Sera from the USA could
be used in the initial production and subsequent large scale manufacture of
hybridomas, rDNA products and vaccines (some of which may be used in healthy
children)... </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1994/09/14003001.pdf">http://www.bseinquiry.gov.uk/files/yb/1994/09/14003001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
RESTRICTED-COMMERCIAL CSM/94/8th Meeting </div>
<br />
<div>
</div>
<br />
<div>
NOT FOR PUBLICATION </div>
<br />
<div>
</div>
<br />
<div>
COMMITTEE ON SAFETY OF MEDICINES </div>
<br />
<div>
</div>
<br />
<div>
(7 blank pages to follow...TSS) </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1994/09/22006001.pdf">http://www.bseinquiry.gov.uk/files/yb/1994/09/22006001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bseinquiry.gov.uk/files/yb/1994/09/22007001.pdf">http://www.bseinquiry.gov.uk/files/yb/1994/09/22007001.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
7.4 The Committee was informed that, since the publication of Hunter et al.
(2002), two further sheep had succumbed to BSE; one of these sheep had been
transfused with buffy coat, while the other had been transfused with whole
blood. Of the remaining 20 sheep that received transfusions, one died of
unrelated causes and 19 animals remain apparently healthy. The healthy animals
are at varying times post-transfusion ranging from less than 100 to over 1000
days. </div>
<br />
<div>
</div>
<br />
<div>
7.5 Members were informed that among the 21 sheep transfused with blood
from scrapie infected animals (761 to 1080 days of age), 4 had developed scrapie
between 614 and 737 days post-transfusion. One animal received the buffy coat
preparation from the blood of an animal with clinical disease. The remaining 3
animals received whole blood from donors not yet showing clinical signs. Of the
remaining 17 transfused sheep, one died of unrelated causes and two further
sheep were showing clinical signs of scrapie; one of these had received buffy
coat, while the other had received whole blood. </div>
<br />
<div>
</div>
<br />
<div>
7.6 The Committee noted that it would not be possible to confirm that the
negative controls are free of TSEs until the end of the study, when they would
be culled and analysed post mortem for signs of subclinical infection. Of the 10
positive controls that received BSE-infected cattle brain homogenate
intravenously, 5 have developed disease or appear to be in the early stages of
the disease. </div>
<br />
<div>
</div>
<br />
<div>
3 Hunter, N., Foster, J., Chong, A., McCutcheon, S., Parnham, D., Eaton,
S., MacKenzie, C. and Houston, F. (2002). Transmission of prion disease by blood
transfusion. Journal of General Virology 83. </div>
<br />
<div>
</div>
<br />
<div>
www.socgenmicrobiol.org.uk/JGVDirect/18580/18580ft.pdf </div>
<br />
<div>
</div>
<br />
<div>
CJD: Transmission </div>
<br />
<div>
</div>
<br />
<div>
Lord Lucas asked Her Majesty's Government: </div>
<br />
<div>
</div>
<br />
<div>
Further to the Written Answer by Lord Hunt of Kings Heath on 27 March (WA
59), what is the "strong epidemiological evidence to suggest that classic CJD is
not transmitted through blood"; which of the many variants of "classic CJD" this
evidence applies to; and whether they will place copies of the relevant papers
in the Library of the House.[HL1864] </div>
<br />
<div>
</div>
<br />
<div>
The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt
of Kings Heath): The following, peer reviewed articles, relate to this subject
and will be placed in the Library: </div>
<br />
<div>
</div>
<br />
<div>
T F G Esmonde et al, 1993, Creutzfeldt-Jakob disease and blood transfusion,
Lancet 341; 205-207; </div>
<br />
<div>
</div>
<br />
<div>
P Brown, 1995, Can Creutzfeldt-Jakob disease be transmitted by
transfusion?, Current Opinion in Haematology, vol 2, pp 472-477; </div>
<br />
<div>
</div>
<br />
<div>
C M van Duijn et al, 1998, Case-control study of risk factors of
Creutzfeldt-Jakob disease in Europe during 1993-95, Lancet 351: 1081-1085;
</div>
<br />
<div>
</div>
<br />
<div>
11 Apr 2000 : Column WA32 </div>
<br />
<div>
</div>
<br />
<div>
Ricketts MN et al: Is Creutzfeldt-Jakob Disease transmitted in blood?,
Energ Infect Dids 1997:3, 155-166; and </div>
<br />
<div>
</div>
<br />
<div>
Heye N et al: Creutzfeldt-Jakob Disease and blood transfusion, Lancet 1994;
343; 298-299. </div>
<br />
<div>
</div>
<br />
<div>
These studies cover all types of CJD. Sporadic (classic) CJD, however,
accounts for some 85 per cent of non-variant cases. </div>
<br />
<div>
</div>
<br />
<div>
The European Committee for Proprietory Medicinal Products (CPMP) reviewed
the evidence in December 1995 and advised that there was no experimental or
epidemiological evidence that classical CJD is transmitted by blood transfusions
or plasma-derived products. A recall policy was not considered justified for
plasma derived products from plasma pools incorporating a donation implicated
for classical CJD. It reaffirmed that advice in March 1997. CPMP concluded on
the basis of currently available information from epidemiological and
experimental studies that there is no scientific justification for changing from
the current CPMP position on classical CJD. CPMP further stated there to be no
evidence that classical CJD is transmitted via blood or plasma derived products.
This issue was also subsequently considered by the US Food and Drugs
Administration, which came to the same conclusion. </div>
<br />
<div>
</div>
<br />
<div>
New-variant CJD </div>
<br />
<div>
</div>
<br />
<div>
Lord Lucas asked Her Majesty's Government: </div>
<br />
<div>
</div>
<br />
<div>
Further to the Written Answer by Lord Hunt of Kings Heath on 27 March (WA
55-6), whether they will provide data on those who have died from, or been
diagnosed with, new-variant CJD in the United Kingdom as to: </div>
<br />
<div>
</div>
<br />
<div>
(a) the status of nucleotide-21 preceding the prion ATG start codon; </div>
<br />
<div>
</div>
<br />
<div>
(b) the status of codons 26, 56 and 174 of doppel; </div>
<br />
<div>
</div>
<br />
<div>
(c) the dates of onset and confirmation for those patients diagnosed with
new-variant CJD but still living; </div>
<br />
<div>
</div>
<br />
<div>
(d) the definition of "onset"; and </div>
<br />
<div>
</div>
<br />
<div>
(e) the age of the patients at onset to the nearest month.[HL1807] </div>
<br />
<div>
</div>
<br />
<div>
Lord Hunt of Kings Heath: The genetic information requested is not
available. However, extensive studies of polymorphisms in and around the prion
protein and doppel genes have been under way for some time at the St Mary's
Prion Unit, London. The results of these investigations will be published in the
scientific literature, subject to peer review, in due course. </div>
<br />
<div>
</div>
<br />
<div>
Confirmation of a diagnosis of vCJD is currently obtained by postmortem
neuropathology. There are therefore no "confirmed" patients still living. The
dates of onset for patients still living and defined as "probable" to the
nearest month are as follows: </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.publications.parliament.uk/pa/ld199900/ldhansrd/vo000411/text/00411w02.htm">http://www.publications.parliament.uk/pa/ld199900/ldhansrd/vo000411/text/00411w02.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
25 Apr 2002 : Column WA58 </div>
<br />
<div>
</div>
<br />
<div>
Bovine Embryos and Live Cattle: Imports from North America </div>
<br />
<div>
</div>
<br />
<div>
The Earl of Caithness asked her Majesty's Government: </div>
<br />
<div>
</div>
<br />
<div>
When the ban on the importation of embryos and live cattle from North
America will be lifted; and [HL3912] </div>
<br />
<div>
</div>
<br />
<div>
What is the scientific evidence for the imposition of a ban on the
importation of embryos and live cattle from North America. [HL3913] </div>
<br />
<div>
</div>
<br />
<div>
Lord Whitty: Her Majesty's Government have not imposed a ban on imports of
bovine embryos and live cattle from North America. </div>
<br />
<div>
</div>
<br />
<div>
The European Parliament and European Council introduced legislation in May
last year laying down rules for the prevention, control and eradication of
certain transmissible spongiform encephalopathies (TSEs). The legislation was
introduced in response to the recommendations of the Office International des
Epizooties (OIE the international animal health organisation) and advice from
the Commission's scientific comittees. The legislation (and the transitional
measures which came into effect in October last year) includes requirement that
imports into the EU of bovine embryos and live cattle must be accompanied by
certification confirming that the feeding of ruminants with protein derived from
mammals has been banned and that the ban has been effectively enforced. Some
exporting countries, such as Canada and the USA, are currently unable to meet
these new requirements. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds02/text/20425w04.htm">http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds02/text/20425w04.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
BSE: US Export of Specified Risk Material </div>
<br />
<div>
</div>
<br />
<div>
Lord Kennet asked Her Majesty's Government: </div>
<br />
<div>
</div>
<br />
<div>
Whether the United States contends that under the provisions enforceable by
the World Trade Organisation the European Union may not ban the import into
Europe from the United States of "specified risk material" (that is, material at
possible risk of BSE infection). </div>
<br />
<div>
</div>
<br />
<div>
Lord Donoughue: Yes. But their position on the Specified Risk Material
legislation is based on the assumption that the United States can safely be
regarded as a "BSE free" country. Their case for such treatment has not been
accepted by the EU Commission's Scientific Veterinary Committee. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.publications.parliament.uk/pa/ld199798/ldhansrd/vo971215/text/71215w02.htm">http://www.publications.parliament.uk/pa/ld199798/ldhansrd/vo971215/text/71215w02.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
Baroness Masham of Ilton: My Lords, as blood products which infected
haemophiliacs with HIV came from the USA, is the Minister confident that
something else nasty may not come again from imported blood from the USA? Is he
aware that there are ways of cleaning blood to make it safer? I know that that
is done in Vienna, in Austria. Will the Minister look into that? Following the
question asked by the noble Lord, Lord Clement-Jones, about people using their
own blood, I am sure that, when this Statement goes out into the wider
community, people will want to know that information. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds03/text/31217-09.htm">http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds03/text/31217-09.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
However, the Bio Products Laboratory who produce plasma products did export
surplus products, under the Income Generation Regulations for the NHS, and used
the income for the benefit of the health service.[21] </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/20703.htm#n21">http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/20703.htm#n21</a>
</div>
<br />
<div>
</div>
<br />
<div>
43. Do you sell any of it abroad at all? </div>
<br />
<div>
</div>
<br />
<div>
(Mr Gorham) No. The only circumstances in which we would export blood would
be if there was an approach to the British Government and the British Government
felt that it was appropriate to support an international emergency or something
like that. We do supply the British Forces. We occasionally help out our
colleagues in Wales and Scotland and they would reciprocate with us if that was
appropriate. At the moment it is more or less totally contained within the
United Kingdom. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/1012904.htm">http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/1012904.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
Blood and Blood Products </div>
<br />
<div>
</div>
<br />
<div>
Mr. Hinchliffe: To ask the Secretary of State for Health what estimate he
has made of the number of persons who have been inoculated with blood or blood
products over the past three years in the United Kingdom. [61681] </div>
<br />
<div>
</div>
<br />
<div>
Ms Jowell [holding answer 2 December 1998]: It is estimated that about one
million people in the United Kingdom receive blood and blood products every
year. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.parliament.the-stationery-office.co.uk/pa/cm199899/cmhansrd/vo990210/text/90210w02.htm">http://www.parliament.the-stationery-office.co.uk/pa/cm199899/cmhansrd/vo990210/text/90210w02.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
CJD blood products given to 3,000 patients </div>
<br />
<div>
</div>
<br />
<div>
December 16 1997 BY AUDREY MAGEE AND IAN MURRAY </div>
<br />
<div>
</div>
<br />
<div>
UP TO 3,000 people treated in 100 British hospitals may have been injected
with blood products taken from a donor who died six weeks ago from new variant
Creutzfeldt-Jakob disease, the human form of BSE. None of them is to be told
because the Health Department believes the risk of them developing the disease
is so slight that there is no reason to cause alarm. </div>
<br />
<div>
</div>
<br />
<div>
Although hospitals have been advised to return the product, used in X-ray
screenings to detect lung disease, so far only 15 per cent has been recovered.
There is no order obliging hospitals to return it and some clinicians may go on
using up stocks on the basis that patients are far more likely to die from
infections or cancer that can be diagnosed with the product than from CJD.
</div>
<br />
<div>
</div>
<br />
<div>
Another 268 patients in Ireland are known to have been given injections
from the same batch of the product. The Irish Health Ministry has decided to
notify all the patients concerned. </div>
<br />
<div>
</div>
<br />
<div>
Even though the identity of all those who have been given an injection of
the product is known, it was decided not to tell them because there is no
evidence that the illness can be transmitted through the blood or the serum
derived from it to make the product and the risk of developing CJD is regarded
as negligible. </div>
<br />
<div>
</div>
<br />
<div>
"You are putting an enormous burden on people by telling them they have a
remote risk of contracting the disease," the department said last night. "The
ethics committee which advises us on these matters decided it was just not
appropriate to tell them." </div>
<br />
<div>
</div>
<br />
<div>
The blood from the donor was sent 18 months ago to the National Blood
Authority laboratory, where it was split into a number of different products.
The donor's plasma was mixed with some taken from 49,000 other donors to make
8,174 bottles of albumin, the water-soluble protein found in blood. </div>
<br />
<div>
</div>
<br />
<div>
Many were exported but 210 of the 50ml bottles remained in Britain and were
sent to eight different hospitals and companies. Some of the bottles were used
intravenously to rehydrate burn victims. </div>
<br />
<div>
</div>
<br />
<div>
One bottle was sent to Nycomed Amersham which used it to produce 14,000
vials of Amerscan Pulmonate II, an agent which is injected into the lungs so
that infections and cancer show up under X-ray. The company sent almost 3,700
vials to 100 British hospitals. </div>
<br />
<div>
</div>
<br />
<div>
At the end of October the European Committee on Proprietary Medicinal
Products called for the withdrawal of blood products derived from donors who
were confirmed CJD cases. On November 1 the Blood Transfusion Service was
notified that one of its donors had died from the disease so the Amersham
company was told. </div>
<br />
<div>
</div>
<br />
<div>
In turn the company got in touch with the Medicines Control Agency which
informed the Health Department and it recommended withdrawal of the product on
November 17. </div>
<br />
<div>
</div>
<br />
<div>
Despite regular alarms, there has never been any convincing evidence that
blood or blood products can transmit CJD (Nigel Hawkes writes). Unless new
variant CJD, the human form of "mad cow" disease, is more easily transmitted
than classic CJD via blood or blood products, there does not appear to be any
cause for concern. [This is no medical basis for this statement -- webmaster]
</div>
<br />
<div>
</div>
<br />
<div>
For classic CJD the risk seems negligible. About 50 people a year die of
the disease, so it is certain that every year some of them give blood after they
have the infection but before its symptoms appear. Studies show that classic CJD
can be passed on in human tissue, but not - so far as we know - in blood. [This
is not an accurate summary of current scientific knowledge -- webmaster] </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.mad-cow.org/~tom/dec15_news.html">http://www.mad-cow.org/~tom/dec15_news.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
South Africa has been exporting plasma for many years. From 1983-86, human
plasma was falsely labelled "animal plasma" and illegally exported to Europe.
This illegal practice resulted in a court case and one conviction in Belgium. In
1996, Austrian police seized 4000 L of infected blood from a Linz-based company,
Albovina. </div>
<br />
<div>
</div>
<br />
<div>
The Sunday Times report said that Austrian officials have investigated two
British companies, based in Guernsey and Berkshire. Police are still trying to
find out where the companies' plasma products were used. Johann Kurz, head of
unit for biologicals with the federal Ministry of Social Security &
Generation in Vienna, Austria, told The Lancet, "We suspect that in 1996 and
earlier, some products coming from South Africa were transferred to India,
China, and Hong Kong, among other countries". The products were albumin and
intravenous immunoglobulins. </div>
<br />
<div>
</div>
<br />
<div>
Nevertheless, Luc Noel, Coordinator of Blood Safety with the WHO in Geneva,
Switzerland, emphasised that: "There should not be any confusion of the
transfusion services in South Africa--which are now world class--with these
criminal activities". While it is important that this trafficking is exposed,
the public can be confident in their blood services, Noel added. </div>
<br />
<div>
</div>
<br />
<div>
Sanjay Kumar </div>
<br />
<div>
</div>
<br />
<div>
Kirsten Myhr, MScPharm, MPH Bygdøy alle 58B 0265 Oslo, Norway Tel.: +47 22
56 05 85, fax: +47 22 24 90 17 myhr@online.no </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.freerepublic.com/focus/f-news/889385/posts">http://www.freerepublic.com/focus/f-news/889385/posts</a>
</div>
<br />
<div>
</div>
<br />
<div>
TSS </div>
<br />
<div>
</div>
<br />
<div>
Thursday, September 10, 2015 </div>
<br />
<div>
</div>
<br />
<div>
25th Meeting of the Transmissible Spongiform Encephalopathies Advisory
Committee Food and Drug Administration Silver Spring, Maryland June 1, 2015
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://tseac.blogspot.com/2015/09/25th-meeting-of-transmissible.html" style="href: "http://tseac.blogspot.com/2015/09/25th-meeting-of-transmissible.html";">http://tseac.blogspot.com/2015/09/25th-meeting-of-transmissible.html</a></div>
<br />
<div>
</div>
<br />
<div>
Sunday, December 14, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** ALERT new variant Creutzfeldt Jakob Disease nvCJD or vCJD, sporadic CJD
strains, TSE prion aka Mad Cow Disease United States of America Update December
14, 2014 Report ***</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/12/alert-new-variant-creutzfeldt-jakob.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/12/alert-new-variant-creutzfeldt-jakob.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, March 09, 2014 </div>
<br />
<div>
</div>
<br />
<div>
A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of
Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease </div>
<br />
<div>
</div>
<br />
<div>
FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://tseac.blogspot.com/">http://tseac.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Please send your reply to the Food and Drug Administration, Attention: Tyra
S. Wisecup, Compliance Officer, at the address on the letterhead. If you have
questions regarding any issues in this letter, please contact Ms. Wisecup at
(612) 758-7114. Sincerely, /S/ Michael Dutcher, DVM Director Minneapolis
District </div>
<br />
<div>
</div>
<br />
<div>
--------------------------------------------------------------------------------</div>
<br />
<div>
</div>
<br />
<div>
[1] Specified risk materials include the brain, skull, eyes, trigeminal
ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the
tonsils and distal ileum of the small intestine of all cattle. - Page Last
Updated: 11/15/2012 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm328152.htm">http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm328152.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
I made a submission to the BSE Inquiry long ago during the BSE Inquiry
days, and they seemed pretty interested. see on down ;</div>
<br />
<div>
</div>
<br />
<div>
Sender: "Patricia Cantos" </div>
<br />
<div>
</div>
<br />
<div>
To: "Terry S Singeltary Sr. (E-mail)" </div>
<br />
<div>
</div>
<br />
<div>
Subject: Your submission to the Inquiry </div>
<br />
<div>
</div>
<br />
<div>
Date: Fri, 3 Jul 1998 10:10:05 +0100 </div>
<br />
<div>
</div>
<br />
<div>
3 July 1998 </div>
<br />
<div>
</div>
<br />
<div>
Mr Terry S Singeltary Sr. </div>
<br />
<div>
</div>
<br />
<div>
E-Mail: Flounder at wt.net </div>
<br />
<div>
</div>
<br />
<div>
Ref: E2979 </div>
<br />
<div>
</div>
<br />
<div>
Dear Mr Singeltary, </div>
<br />
<div>
</div>
<br />
<div>
Thank you for your E-mail message of the 30th of June 1998 providing the
Inquiry with your further comments. </div>
<br />
<div>
</div>
<br />
<div>
Thank you for offering to provide the Inquiry with any test results on the
nutritional supplements your mother was taking before she died. </div>
<br />
<div>
</div>
<br />
<div>
As requested I am sending you our general Information Pack and a copy of
the Chairman's letter. Please contact me if your system cannot read the
attachments. </div>
<br />
<div>
</div>
<br />
<div>
Regarding your question, the Inquiry is looking into many aspects of the
scientific evidence on BSE and nvCJD. I would refer you to the transcripts of
evidence we have already heard which are found on our internet site at ; </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bse.org.uk/">http://www.bse.org.uk</a>. </div>
<br />
<div>
</div>
<br />
<div>
Could you please provide the Inquiry with a copy of the press article you
refer to in your e-mail? If not an approximate date for the article so that we
can locate it? </div>
<br />
<div>
</div>
<br />
<div>
In the meantime, thank you for you comments. Please do not hesitate to
contact me on... </div>
<br />
<div>
</div>
<br />
<div>
snip...end...tss </div>
<br />
<div>
</div>
<br />
<div>
everyone I tell this too gets it screwed up...MY MOTHER WAS NOT TAKING
THOSE SUPPLEMENTS IPLEX (that I ever knew of). this was my neighbors mother that
died exactly one year _previously_ and to the day of sporadic CJD that was
diagnosed as Alzheimer’s at first. my mother died exactly a year later from the
Heidenhain Variant of Creutzfeldt Jakob Disease hvCJD, and exceedingly rare
strains of the ever growing sporadic CJD’s. _both_ cases confirmed. ...kind
regards, terry </div>
<br />
<div>
</div>
<br />
<div>
TSEs i.e. mad cow disease's BSE/BASE and NUTRITIONAL SUPPLEMENTS </div>
<br />
<div>
</div>
<br />
<div>
IPLEX, mad by standard process; </div>
<br />
<div>
</div>
<br />
<div>
vacuum dried bovine BRAIN, bone meal, bovine EYE, veal Bone, bovine liver
powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine
stomach. </div>
<br />
<div>
</div>
<br />
<div>
also; </div>
<br />
<div>
</div>
<br />
<div>
what about potential mad cow candy bars ? </div>
<br />
<div>
</div>
<br />
<div>
see their potential mad cow candy bar list too... </div>
<br />
<div>
</div>
<br />
<div>
THESE are just a few of MANY of just this ONE COMPANY...TSS </div>
<br />
<div>
</div>
<br />
<div>
DEPARTMENT OF HEALTH AND HUMAN SERVICES </div>
<br />
<div>
</div>
<br />
<div>
FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
</div>
<br />
<div>
</div>
<br />
<div>
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE </div>
<br />
<div>
</div>
<br />
<div>
Friday, January 19, 2001 snip... </div>
<br />
<div>
</div>
<br />
<div>
17 But I think that we could exhibit some quite </div>
<br />
<div>
</div>
<br />
<div>
18 reasonable concern about blood donors who are taking dietary </div>
<br />
<div>
</div>
<br />
<div>
19 supplements that contain a certain amount of unspecified- </div>
<br />
<div>
</div>
<br />
<div>
20 origin brain, brain-related, brain and pituitary material. </div>
<br />
<div>
</div>
<br />
<div>
21 If they have done this for more than a sniff or something </div>
<br />
<div>
</div>
<br />
<div>
22 like that, then, perhaps, they should be deferred as blood </div>
<br />
<div>
</div>
<br />
<div>
23 donors. </div>
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<div>
</div>
<br />
<div>
24 That is probably worse than spending six months in </div>
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<div>
</div>
<br />
<div>
25 the U.K. </div>
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<div>
</div>
<br />
<div>
1/19/01 </div>
<br />
<div>
</div>
<br />
<div>
3681t2.rtf(845) page 501 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.fda.gov/ohrms/dockets/ac/cber01.htm">http://www.fda.gov/ohrms/dockets/ac/cber01.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in
Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2
Accepted - Volume 7 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm">http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_07.pdf">http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_07.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
see full text ; </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html">http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
snip...see full list of potential mad cow products ;</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, August 5, 2015 </div>
<br />
<div>
</div>
<br />
<div>
Federal judge enters permanent injunction against Wisconsin dietary
supplement manufacturers prohibited cattle materials BSE TSE Prion </div>
<br />
<div>
</div>
<br />
<div>
Singeltary Submission to BSE Inquiry on Nutritional Supplements containing
SRM 1998</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bovineprp.blogspot.com/2015/08/federal-judge-enters-permanent.html">http://bovineprp.blogspot.com/2015/08/federal-judge-enters-permanent.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Tue, 13 Feb 2001 JAMA Vol. 285 No. 6, February 14, 2001 Letters </div>
<br />
<div>
</div>
<br />
<div>
Diagnosis and Reporting of Creutzfeldt-Jakob Disease � � To the Editor:
</div>
<br />
<div>
</div>
<br />
<div>
In their Research Letter in JAMA. 2000;284:2322-2323, Dr Gibbons and
colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob
disease (CJD) has been stable since 1985. These estimates, however, are based
only on reported cases, and do not include misdiagnosed or preclinical cases. It
seems to me that misdiagnosis alone would drastically change these figures. An
unknown number of persons with a diagnosis of Alzheimer disease in fact may have
CJD, although only a small number of these patients receive the postmortem
examination necessary to make this diagnosis. Furthermore, only a few states
have made CJD reportable. Human and animal transmissible spongiform
encephalopathies should be reportable nationwide and internationally. </div>
<br />
<div>
</div>
<br />
<div>
Terry S. Singeltary, Sr Bacliff, Tex </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://jama.jamanetwork.com/article.aspx?articleid=1031186">http://jama.jamanetwork.com/article.aspx?articleid=1031186</a>
</div>
<br />
<div>
</div>
<br />
<div>
To the Editor: </div>
<br />
<div>
</div>
<br />
<div>
At the time of my mother's death, various diagnoses were advanced such as
"rapid progressive Alzheimer disease," psychosis, and dementia. Had I not
persisted and personally sought and arranged a brain autopsy, her death
certificate would have read cardiac failure and not CJD. </div>
<br />
<div>
</div>
<br />
<div>
Through CJD Voice1 I have corresponded with hundreds of grief-stricken
families who are so devastated by this horrific disease that brain autopsy is
the furthest thing from their minds. In my experience, very few physicians
suggest it to the family. After the death and when families reflect that they
never were sure what killed their loved one it is too late to find the true
cause of death. In the years since my mother died I think that the increasing
awareness of the nature of CJD has only resulted in fewer pathologists being
willing to perform an autopsy in a suspected case of CJD. </div>
<br />
<div>
</div>
<br />
<div>
People with CJD may die with incorrect diagnoses of dementia, psychosis,
Alzheimer disease, and myriad other neurological diseases. The true cause of
death will only be known if brain autopsies are suggested to the families. Too
often the physician's comment is, "Well, it could be CJD but that is so rare it
isn't likely." </div>
<br />
<div>
</div>
<br />
<div>
Until CJD is required to be reported to state health departments, as other
diseases are, there will be no accurate count of CJD deaths in the United States
and thus no way to know if the number of deaths is decreasing, stable, or
increasing as it has recently in the United Kingdom. </div>
<br />
<div>
</div>
<br />
<div>
Dorothy E. Kraemer Stillwater, Okla </div>
<br />
<div>
</div>
<br />
<div>
In Reply: </div>
<br />
<div>
</div>
<br />
<div>
Mr Singeltary and Ms Kraemer express an underlying concern that our
recently reported mortality surveillance estimate of about 1 CJD case per
million population per year in the United States since 1985 may greatly
underestimate the true incidence of this disease. Based on evidence from
epidemiologic investigations both within and outside the United States, we
believe that these national estimates are reasonably accurate. </div>
<br />
<div>
</div>
<br />
<div>
Even during the 1990s in the United Kingdom, where much attention and
public health resources have been devoted to prion disease surveillance, the
reported incidence of classic CJD is similar to that reported in the United
States. [The elderly demented in a country with a medical system like England's
rarely reach a neurologist. However, it is precisely the elderly where the
disease is concentrated. -- webmaster] </div>
<br />
<div>
</div>
<br />
<div>
In addition, in 1996, active US surveillance for CJD and new variant (nv)
CJD in 5 sites detected no evidence of the occurrence of nvCJD and showed that
86% of the CJD cases in these sites were identifiable through routinely
collected mortality data. [This again was merely "death certificate" CJD. --
webmaster] </div>
<br />
<div>
</div>
<br />
<div>
Our report provides additional evidence against the occurrence of nvCJD in
the United States based on national mortality data analyses and enhanced
surveillance. It specifically mentions a new center for improved pathology
surveillance. We hope that the described enhancements along with the
observations of Singeltary and Kraemer will encourage medical care providers to
suggest brain autopsies for more suspected CJD cases to facilitate the
identification of potentially misdiagnosed CJD cases and to help monitor the
possible occurrence of nvCJD. </div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt-Jakob disease is not on the list of nationally notifiable
diseases. In those states where surveillance personnel indicate that making this
disease officially notifiable would meaningfully facilitate collection of data
that are needed to monitor the incidence of CJD and nvCJD, including the
obtaining of brain autopsy results, we encourage such a change. However, adding
CJD to the notifiable diseases surveillance system may lead to potentially
wasteful, duplicative reporting because the vast majority of the diagnosed cases
would also be reported through the mortality surveillance system. </div>
<br />
<div>
</div>
<br />
<div>
Furthermore, making CJD a notifiable disease may not necessarily help
identify undiagnosed CJD cases. The unique characteristics of CJD make mortality
data a useful surrogate for ongoing surveillance. Unlike many other neurologic
diseases, CJD is invariably fatal and in most cases rapidly progressive and
distinguishable clinically from other neurologic diseases. [Essentially all
elderly dementia is "fatal" in the sense that no one gets better. -- webmaster]
</div>
<br />
<div>
</div>
<br />
<div>
Because CJD is least accurately diagnosed early in the course of the
illness, notifiable disease surveillance of CJD could be less accurate than
mortality surveillance of CJD. In addition, because death as a condition is more
completely and consistently reported, mortality surveillance has the advantage
of being ongoing and readily available. </div>
<br />
<div>
</div>
<br />
<div>
The absence of CJD and nvCJD from the list of nationally notifiable
diseases should not be interpreted to mean that they are not important to public
health; this list does not include all such diseases. We encourage medical
caregivers to report to or consult with appropriate public health authorities
about any diagnosed case of a transmissible disease for which a special public
health response may be needed, including nvCJD, and any patient in whom
iatrogenic transmission of CJD may be suspected. </div>
<br />
<div>
</div>
<br />
<div>
Robert V. Gibbons, MD, MPH Robert C. Holman, MS Ermias D. Belay, MD
Lawrence B. Schonberger, MD, MPH Division of Viral and Rickettsial Diseases
National Center for Infectious Diseases Centers for Disease Control and
Prevention Atlanta, Ga </div>
<br />
<div>
</div>
<br />
<div>
Opinion (webmaster): Behind the polite words, CDC is waging a bitter battle
to prevent CJD incidences from becoming known, to protect its clients in the
blood and transplant industries. The best available study is that of Boller et
al. from 1989. In this study 7.5% of Alzheimer patients were actually CJD.
Numerous other diseases were confused as well. </div>
<br />
<div>
</div>
<br />
<div>
With CJD, the real issue is how many people die with it, rather from it in
the sense of the death certificate. Even if the true cause of death was a heart
attack, as a hypothetical, who would want an untested cornea from someone with
preclinical CJD ? </div>
<br />
<div>
</div>
<br />
<div>
Diagnosis of dementia: clinicopathologic correlations. Neurology 1989
Jan;39(1):76-79 Boller F, Lopez OL, Moossy J Based on 54 demented patients
consecutively autopsied at the University of Pittsburgh, we studied the accuracy
of clinicians in predicting the pathologic diagnosis. Thirty-nine patients
(72.2%) had Alzheimer's disease, while 15 (27.7%) had other CNS diseases (four
multi-infarct dementia; three Creutzfeldt-Jakob disease; two thalamic and
subcortical gliosis; three Parkinson's disease; one progressive supranuclear
palsy; one Huntington's disease; and one unclassified). Two neurologists
independently reviewed the clinical records of each patient without knowledge of
the patient's identity or clinical or pathologic diagnoses; each clinician
reached a clinical diagnosis based on criteria derived from those of the
NINCDS/ADRDA. In 34 (63%) cases both clinicians were correct, in nine (17%) one
was correct, and in 11 (20%) neither was correct. These results show that in
patients with a clinical diagnosis of dementia, the etiology cannot be
accurately predicted during life. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.mad-cow.org/00/feb01_news_mid.html">http://www.mad-cow.org/00/feb01_news_mid.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.mad-cow.org/00/feb01_news_mid.html#mmm">http://www.mad-cow.org/00/feb01_news_mid.html#mmm</a>
</div>
<br />
<div>
</div>
<br />
<div>
26 March 2003 </div>
<br />
<div>
</div>
<br />
<div>
Views & Reviews </div>
<br />
<div>
</div>
<br />
<div>
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in
the United States </div>
<br />
<div>
</div>
<br />
<div>
Ermias D. Belay, MD, Ryan A. Maddox, MPH, Pierluigi Gambetti, MD and
Lawrence B. Schonberger, MD </div>
<br />
<div>
</div>
<br />
<div>
+ Author Affiliations </div>
<br />
<div>
</div>
<br />
<div>
From the Division of Viral and Rickettsial Diseases (Drs. Belay and
Schonberger and R.A. Maddox), National Center for Infectious Diseases, Centers
for Disease Control and Prevention, Atlanta, GA; and National Prion Disease
Pathology Surveillance Center (Dr. Gambetti), Division of Neuropathology,
Institute of Pathology, Case Western Reserve University, Cleveland, OH. </div>
<br />
<div>
</div>
<br />
<div>
Address correspondence and reprint requests to Dr. Ermias D. Belay, 1600
Clifton Road, Mailstop A-39, Atlanta, GA 30333. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.neurology.org/content/60/2/176">http://www.neurology.org/content/60/2/176</a>
</div>
<br />
<div>
</div>
<br />
<div>
26 March 2003 </div>
<br />
<div>
</div>
<br />
<div>
Terry S. Singeltary, retired (medically) CJD WATCH </div>
<br />
<div>
</div>
<br />
<div>
I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment
on the CDC's attempts to monitor the occurrence of emerging forms of CJD.
Asante, Collinge et al [1] have reported that BSE transmission to the
129-methionine genotype can lead to an alternate phenotype that is
indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD
and all human TSEs are not reportable nationally. CJD and all human TSEs must be
made reportable in every state and internationally. I hope that the CDC does not
continue to expect us to still believe that the 85%+ of all CJD cases which are
sporadic are all spontaneous, without route/source. We have many TSEs in the USA
in both animal and man. CWD in deer/elk is spreading rapidly and CWD does
transmit to mink, ferret, cattle, and squirrel monkey by intracerebral
inoculation. With the known incubation periods in other TSEs, oral transmission
studies of CWD may take much longer. Every victim/family of CJD/TSEs should be
asked about route and source of this agent. To prolong this will only spread the
agent and needlessly expose others. In light of the findings of Asante and
Collinge et al, there should be drastic measures to safeguard the medical and
surgical arena from sporadic CJDs and all human TSEs. I only ponder how many
sporadic CJDs in the USA are type 2 PrPSc? </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.neurology.org/content/60/2/176/reply#neurology_el_535">http://www.neurology.org/content/60/2/176/reply#neurology_el_535</a>
</div>
<br />
<div>
</div>
<br />
<div>
The Pathological Protein: </div>
<br />
<div>
</div>
<br />
<div>
Mad Cow, Chronic Wasting, and Other Deadly Prion Diseases </div>
<br />
<div>
</div>
<br />
<div>
Philip Yam </div>
<br />
<div>
</div>
<br />
<div>
''Answering critics like Terry Singeltary, who feels that the US
undercounts CJD, Schonberger _conceded_ that the current surveillance system has
errors but stated that most of the errors will be confined to the older
population''....end </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.amazon.com/The-Pathological-Protein-Chronic-Diseases/dp/0387955089">http://www.amazon.com/The-Pathological-Protein-Chronic-Diseases/dp/0387955089</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/12/terry-s-singeltary-sr-publications-tse.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/12/terry-s-singeltary-sr-publications-tse.html</a></div>
<br />
<div>
</div>
<br />
<div>
2015</div>
<br />
<div>
</div>
<br />
<div>
Clinically Unsuspected Prion Disease Among Patients With Dementia Diagnoses
in an Alzheimer’s Disease Database </div>
<br />
<div>
</div>
<br />
<div>
Ryan A. Maddox, PhD1⇑ J. L. Blase, MPH1 N. D. Mercaldo, MS2,3 A. R. Harvey,
MSPH1 L. B. Schonberger, MD1 W. A. Kukull, PhD3 E. D. Belay, MD1 1Division of
High-Consequence Pathogens and Pathology, National Center for Emerging and
Zoonotic Infectious Diseases, Centers for Disease Control and Prevention,
Atlanta, GA, USA 2Department of Biostatistics, Vanderbilt University, Nashville,
TN, USA 3National Alzheimer’s Coordinating Center, University of Washington,
Seattle, WA, USA Ryan A. Maddox, PhD, Centers for Disease Control and
Prevention, 1600 Clifton Road, Mailstop A-30, Atlanta, GA 30333, USA. Email:
rmaddox@cdc.gov </div>
<br />
<div>
</div>
<br />
<div>
Abstract Background: Brain tissue analysis is necessary to confirm prion
diseases. Clinically unsuspected cases may be identified through neuropathologic
testing. </div>
<br />
<div>
</div>
<br />
<div>
Methods: National Alzheimer’s Coordinating Center (NACC) Minimum and
Neuropathologic Data Set for 1984 to 2005 were reviewed. Eligible patients had
dementia, underwent autopsy, had available neuropathologic data, belonged to a
currently funded Alzheimer’s Disease Center (ADC), and were coded as having an
Alzheimer’s disease clinical diagnosis or a nonprion disease etiology. For the
eligible patients with neuropathology indicating prion disease, further clinical
information, collected from the reporting ADC, determined whether prion disease
was considered before autopsy. </div>
<br />
<div>
</div>
<br />
<div>
Results: Of 6000 eligible patients in the NACC database, 7 (0.12%) were
clinically unsuspected but autopsy-confirmed prion disease cases. </div>
<br />
<div>
</div>
<br />
<div>
Conclusion: The proportion of patients with dementia with clinically
unrecognized but autopsy-confirmed prion disease was small. Besides confirming
clinically suspected cases, neuropathology is useful to identify unsuspected
clinically atypical cases of prion disease. </div>
<br />
<div>
</div>
<br />
<div>
prion disease Creutzfeldt–Jakob disease Alzheimer’s disease dementia
diagnosis </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://aja.sagepub.com/content/early/2015/08/26/1533317515602218.abstract">http://aja.sagepub.com/content/early/2015/08/26/1533317515602218.abstract</a>
</div>
<br />
<div>
</div>
<br />
<div>
> Results: Of 6000 eligible patients in the NACC database, 7 (0.12%)
were clinically unsuspected but autopsy-confirmed prion disease cases. </div>
<br />
<div>
</div>
<br />
<div>
those figures seem large... tss</div>
<br />
<div>
</div>
<br />
<div>
***Miracles do happen. it just took 3 decades of denial from these authors
cdc et al to finally come up with this conclusion, during that time period how
many humans have been exposed due to their continued denial over those decades?
</div>
<br />
<div>
</div>
<br />
<div>
see full text with old studies confirming misdiagnosis figures over the
decades...tss Wednesday, September 2, 2015 </div>
<br />
<div>
</div>
<br />
<div>
Clinically Unsuspected Prion Disease Among Patients With Dementia Diagnoses
in an Alzheimer’s Disease Database </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://betaamyloidcjd.blogspot.com/2015/09/clinically-unsuspected-prion-disease.html">http://betaamyloidcjd.blogspot.com/2015/09/clinically-unsuspected-prion-disease.html</a></div>
<br />
<div>
</div>
<br />
<div>
Thursday, August 13, 2015 </div>
<br />
<div>
</div>
<br />
<div>
Iatrogenic CJD due to pituitary-derived growth hormone with genetically
determined incubation times of up to 40 years</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2015/08/iatrogenic-cjd-due-to-pituitary-derived.html">http://creutzfeldt-jakob-disease.blogspot.com/2015/08/iatrogenic-cjd-due-to-pituitary-derived.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Self-Propagative Replication of Ab Oligomers Suggests Potential
Transmissibility in Alzheimer Disease</div>
<br />
<div>
</div>
<br />
<div>
Received July 24, 2014; Accepted September 16, 2014; Published November 3,
2014</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.plosone.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0111492&representation=PDF">http://www.plosone.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0111492&representation=PDF</a>
</div>
<br />
<div>
</div>
<br />
<div>
*** Singeltary comment ***</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.plosone.org/annotation/listThread.action?root=82860">http://www.plosone.org/annotation/listThread.action?root=82860</a>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, October 1, 2015 </div>
<br />
<div>
</div>
<br />
<div>
Alzheimergate, re-Evidence for human transmission of amyloid-β pathology
and cerebral amyloid angiopathy, Singeltary Submission to Nature </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://betaamyloidcjd.blogspot.com/2015/10/alzheimergate-re-evidence-for-human.html">http://betaamyloidcjd.blogspot.com/2015/10/alzheimergate-re-evidence-for-human.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, November 12, 2015 </div>
<br />
<div>
</div>
<br />
<div>
Evaluation of the protection of primates transfused with variant
Creutzfeldt-Jakob disease–infected blood products filtered with prion removal
devices: a 5-year update </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjdtransfusion.blogspot.com/2015/11/evaluation-of-protection-of-primates.html">http://vcjdtransfusion.blogspot.com/2015/11/evaluation-of-protection-of-primates.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
2 January 2000 </div>
<br />
<div>
</div>
<br />
<div>
British Medical Journal </div>
<br />
<div>
</div>
<br />
<div>
U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bmj.com/rapid-response/2011/10/28/us-scientist-should-be-concerned-cjd-epidemic-us-well">http://www.bmj.com/rapid-response/2011/10/28/us-scientist-should-be-concerned-cjd-epidemic-us-well</a>
</div>
<br />
<div>
</div>
<br />
<div>
15 November 1999 </div>
<br />
<div>
</div>
<br />
<div>
British Medical Journal </div>
<br />
<div>
</div>
<br />
<div>
vCJD in the USA * BSE in U.S. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.bmj.com/rapid-response/2011/10/28/re-vcjd-usa-bse-us">http://www.bmj.com/rapid-response/2011/10/28/re-vcjd-usa-bse-us</a>
</div>
<br />
<div>
</div>
<br />
<div>
The Lancet Infectious Diseases, Volume 3, Issue 8, Page 463, August 2003
doi:10.1016/S1473-3099(03)00715-1Cite or Link Using DOI </div>
<br />
<div>
</div>
<br />
<div>
Tracking spongiform encephalopathies in North America </div>
<br />
<div>
</div>
<br />
<div>
Original </div>
<br />
<div>
</div>
<br />
<div>
Xavier Bosch </div>
<br />
<div>
</div>
<br />
<div>
“My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my
mom to hvCJD (Heidenhain variant CJD) and have been searching for answers ever
since. What I have found is that we have not been told the truth. CWD in deer
and elk is a small portion of a much bigger problem.” 49-year—old Singeltary is
one of a number of people who have remained largely unsatisfied after being told
that a close relative died from a rapidly progressive dementia compatible with
spontaneous Creutzfeldt—Jakob ... </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(03)00715-1/abstract">http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(03)00715-1/abstract</a>
</div>
<br />
<div>
</div>
<br />
<div>
Suspect symptoms </div>
<br />
<div>
</div>
<br />
<div>
What if you can catch old-fashioned CJD by eating meat from a sheep
infected with scrapie? </div>
<br />
<div>
</div>
<br />
<div>
28 Mar 01 </div>
<br />
<div>
</div>
<br />
<div>
Most doctors believe that sCJD is caused by a prion protein deforming by
chance into a killer. But Singeltary thinks otherwise. He is one of a number of
campaigners who say that some sCJD, like the variant CJD related to BSE, is
caused by eating meat from infected animals. Their suspicions have focused on
sheep carrying scrapie, a BSE-like disease that is widespread in flocks across
Europe and North America. Now scientists in France have stumbled across new
evidence that adds weight to the campaigners' fears. To their complete surprise,
the researchers found that one strain of scrapie causes the same brain damage in
mice as sCJD. </div>
<br />
<div>
</div>
<br />
<div>
"This means we cannot rule out that at least some sCJD may be caused by
some strains of scrapie," says team member Jean-Philippe Deslys of the French
Atomic Energy Commission's medical research laboratory in Fontenay-aux-Roses,
south-west of Paris. Hans Kretschmar of the University of Göttingen, who
coordinates CJD surveillance in Germany, is so concerned by the findings that he
now wants to trawl back through past sCJD cases to see if any might have been
caused by eating infected mutton or lamb... </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.newscientist.com/article/mg16922840.300-like-lambs-to-the-slaughter.html">http://www.newscientist.com/article/mg16922840.300-like-lambs-to-the-slaughter.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
cwd to humans, iatrogenic, what if ?</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://chronic-wasting-disease.blogspot.com/">http://chronic-wasting-disease.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes
contaminated during neurosurgery. </div>
<br />
<div>
</div>
<br />
<div>
Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC.
Laboratory of Central Nervous System Studies, National Institute of Neurological
Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892. </div>
<br />
<div>
</div>
<br />
<div>
Stereotactic multicontact electrodes used to probe the cerebral cortex of a
middle aged woman with progressive dementia were previously implicated in the
accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger
patients. The diagnoses of CJD have been confirmed for all three cases. More
than two years after their last use in humans, after three cleanings and
repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were
implanted in the cortex of a chimpanzee. Eighteen months later the animal became
ill with CJD. This finding serves to re-emphasise the potential danger posed by
reuse of instruments contaminated with the agents of spongiform
encephalopathies, even after scrupulous attempts to clean them. </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8006664&dopt=Abstract">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8006664&dopt=Abstract</a>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, May 26, 2015 </div>
<br />
<div>
</div>
<br />
<div>
*** Minimise transmission risk of CJD and vCJD in healthcare settings
***</div>
<br />
<div>
</div>
<br />
<div>
Last updated 15 May 2015 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2015/05/minimise-transmission-risk-of-cjd-and.html">http://creutzfeldt-jakob-disease.blogspot.com/2015/05/minimise-transmission-risk-of-cjd-and.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/">http://creutzfeldt-jakob-disease.blogspot.com/</a>
</div>
<br />
<div>
</div>
<br />
<div>
***however in 1 C-type challenged animal, Prion 2015 Poster Abstracts S67
PrPsc was not detected using rapid tests for BSE. </div>
<br />
<div>
</div>
<br />
<div>
***Subsequent testing resulted in the detection of pathologic lesion in
unusual brain location and PrPsc detection by PMCA only. </div>
<br />
<div>
</div>
<br />
<div>
IBNC Tauopathy or TSE Prion disease, it appears, no one is sure</div>
<br />
<div>
</div>
<br />
<div>
Posted by flounder on 03 Jul 2015 at 16:53 GMT</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.plosone.org/annotation/listThread.action?root=86610">http://www.plosone.org/annotation/listThread.action?root=86610</a>
</div>
<br />
<div>
</div>
<br />
<div>
31 Jan 2015 at 20:14 GMT </div>
<br />
<div>
</div>
<br />
<div>
*** Ruminant feed ban for cervids in the United States? ***</div>
<br />
<div>
</div>
<br />
<div>
Singeltary et al</div>
<br />
<div>
</div>
<br />
<div>
31 Jan 2015 at 20:14 GMT </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.plosone.org/annotation/listThread.action?root=85351">http://www.plosone.org/annotation/listThread.action?root=85351</a>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, October 26, 2015 </div>
<br />
<div>
</div>
<br />
<div>
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OIA UPDATE October 2015 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://madcowusda.blogspot.com/2015/10/fda-part-589-substances-prohibited-from.html" style="href: "http://madcowusda.blogspot.com/2015/10/fda-part-589-substances-prohibited-from.html";" title="http://madcowusda.blogspot.com/2015/10/fda-part-589-substances-prohibited-from.html">http://madcowusda.blogspot.com/2015/10/fda-part-589-substances-prohibited-from.html</a></div>
<br />
<div>
</div>
<br />
<div>
PL1 </div>
<br />
<div>
</div>
<br />
<div>
Using in vitro prion replication for high sensitive detection of prions and
prionlike proteins and for understanding mechanisms of transmission. </div>
<br />
<div>
</div>
<br />
<div>
Claudio Soto </div>
<br />
<div>
</div>
<br />
<div>
Mitchell Center for Alzheimer's diseases and related Brain disorders,
Department of Neurology, University of Texas Medical School at Houston. </div>
<br />
<div>
</div>
<br />
<div>
Prion and prion-like proteins are misfolded protein aggregates with the
ability to selfpropagate to spread disease between cells, organs and in some
cases across individuals. I n T r a n s m i s s i b l e s p o n g i f o r m
encephalopathies (TSEs), prions are mostly composed by a misfolded form of the
prion protein (PrPSc), which propagates by transmitting its misfolding to the
normal prion protein (PrPC). The availability of a procedure to replicate prions
in the laboratory may be important to study the mechanism of prion and
prion-like spreading and to develop high sensitive detection of small quantities
of misfolded proteins in biological fluids, tissues and environmental samples.
Protein Misfolding Cyclic Amplification (PMCA) is a simple, fast and efficient
methodology to mimic prion replication in the test tube. PMCA is a platform
technology that may enable amplification of any prion-like misfolded protein
aggregating through a seeding/nucleation process. In TSEs, PMCA is able to
detect the equivalent of one single molecule of infectious PrPSc and propagate
prions that maintain high infectivity, strain properties and species
specificity. Using PMCA we have been able to detect PrPSc in blood and urine of
experimentally infected animals and humans affected by vCJD with high
sensitivity and specificity. Recently, we have expanded the principles of PMCA
to amplify amyloid-beta (Aβ) and alphasynuclein (α-syn) aggregates implicated in
Alzheimer's and Parkinson's diseases, respectively. Experiments are ongoing to
study the utility of this technology to detect Aβ and α-syn aggregates in
samples of CSF and blood from patients affected by these diseases. </div>
<br />
<div>
</div>
<br />
<div>
========================= </div>
<br />
<div>
</div>
<br />
<div>
***Recently, we have been using PMCA to study the role of environmental
prion contamination on the horizontal spreading of TSEs. These experiments have
focused on the study of the interaction of prions with plants and
environmentally relevant surfaces. Our results show that plants (both leaves and
roots) bind tightly to prions present in brain extracts and excreta (urine and
feces) and retain even small quantities of PrPSc for long periods of time.
Strikingly, ingestion of prioncontaminated leaves and roots produced disease
with a 100% attack rate and an incubation period not substantially longer than
feeding animals directly with scrapie brain homogenate. Furthermore, plants can
uptake prions from contaminated soil and transport them to different parts of
the plant tissue (stem and leaves). Similarly, prions bind tightly to a variety
of environmentally relevant surfaces, including stones, wood, metals, plastic,
glass, cement, etc. Prion contaminated surfaces efficiently transmit prion
disease when these materials were directly injected into the brain of animals
and strikingly when the contaminated surfaces were just placed in the animal
cage. These findings demonstrate that environmental materials can efficiently
bind infectious prions and act as carriers of infectivity, suggesting that they
may play an important role in the horizontal transmission of the disease. </div>
<br />
<div>
</div>
<br />
<div>
======================== </div>
<br />
<div>
</div>
<br />
<div>
Since its invention 13 years ago, PMCA has helped to answer fundamental
questions of prion propagation and has broad applications in research areas
including the food industry, blood bank safety and human and veterinary disease
diagnosis. </div>
<br />
<div>
</div>
<br />
<div>
<a href="https://prion2015.files.wordpress.com/2015/05/programguide1.pdf">https://prion2015.files.wordpress.com/2015/05/programguide1.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
see ; </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.tandfonline.com/doi/pdf/10.4161/pri.28467">http://www.tandfonline.com/doi/pdf/10.4161/pri.28467</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0058630">http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0058630</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3567181/pdf/ppat.1003113.pdf">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3567181/pdf/ppat.1003113.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.nature.com/srep/2015/150210/srep08358/full/srep08358.html?WT.ec_id=SREP-639-20150217">http://www.nature.com/srep/2015/150210/srep08358/full/srep08358.html?WT.ec_id=SREP-639-20150217</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.cell.com/cell-reports/pdfExtended/S2211-1247(15)00437-4">http://www.cell.com/cell-reports/pdfExtended/S2211-1247(15)00437-4</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
98 | Veterinary Record | January 24, 2015 </div>
<br />
<div>
</div>
<br />
<div>
EDITORIAL </div>
<br />
<div>
</div>
<br />
<div>
Scrapie: a particularly persistent pathogen </div>
<br />
<div>
</div>
<br />
<div>
Cristina Acín </div>
<br />
<div>
</div>
<br />
<div>
Resistant prions in the environment have been the sword of Damocles for
scrapie control and eradication. Attempts to establish which physical and
chemical agents could be applied to inactivate or moderate scrapie infectivity
were initiated in the 1960s and 1970s,with the first study of this type focusing
on the effect of heat treatment in reducing prion infectivity (Hunter and
Millson 1964). Nowadays, most of the chemical procedures that aim to inactivate
the prion protein are based on the method developed by Kimberlin and
collaborators (1983). This procedure consists of treatment with 20,000 parts per
million free chlorine solution, for a minimum of one hour, of all surfaces that
need to be sterilised (in laboratories, lambing pens, slaughterhouses, and so
on). Despite this, veterinarians and farmers may still ask a range of questions,
such as ‘Is there an official procedure published somewhere?’ and ‘Is there an
international organisation which recommends and defines the exact method of
scrapie decontamination that must be applied?’ </div>
<br />
<div>
</div>
<br />
<div>
From a European perspective, it is difficult to find a treatment that could
be applied, especially in relation to the disinfection of surfaces in lambing
pens of affected flocks. A 999/2001 EU regulation on controlling spongiform
encephalopathies (European Parliament and Council 2001) did not specify a
particular decontamination measure to be used when an outbreak of scrapie is
diagnosed. There is only a brief recommendation in Annex VII concerning the
control and eradication of transmissible spongiform encephalopathies (TSE s).
</div>
<br />
<div>
</div>
<br />
<div>
Chapter B of the regulation explains the measures that must be applied if
new caprine animals are to be introduced to a holding where a scrapie outbreak
has previously been diagnosed. In that case, the statement indicates that
caprine animals can be introduced ‘provided that a cleaning and disinfection of
all animal housing on the premises has been carried out following destocking’.
</div>
<br />
<div>
</div>
<br />
<div>
Issues around cleaning and disinfection are common in prion prevention
recommendations, but relevant authorities, veterinarians and farmers may have
difficulties in finding the specific protocol which applies. The European Food
and Safety Authority (EFSA ) published a detailed report about the efficacy of
certain biocides, such as sodium hydroxide, sodium hypochlorite, guanidine and
even a formulation of copper or iron metal ions in combination with hydrogen
peroxide, against prions (EFSA 2009). The report was based on scientific
evidence (Fichet and others 2004, Lemmer and others 2004, Gao and others 2006,
Solassol and others 2006) but unfortunately the decontamination measures were
not assessed under outbreak conditions. </div>
<br />
<div>
</div>
<br />
<div>
The EFSA Panel on Biological Hazards recently published its conclusions on
the scrapie situation in the EU after 10 years of monitoring and control of the
disease in sheep and goats (EFSA 2014), and one of the most interesting findings
was the Icelandic experience regarding the effect of disinfection in scrapie
control. The Icelandic plan consisted of: culling scrapie-affected sheep or the
whole flock in newly diagnosed outbreaks; deep cleaning and disinfection of
stables, sheds, barns and equipment with high pressure washing followed by
cleaning with 500 parts per million of hypochlorite; drying and treatment with
300 ppm of iodophor; and restocking was not permitted for at least two years.
Even when all of these measures were implemented, scrapie recurred on several
farms, indicating that the infectious agent survived for years in the
environment, even as many as 16 years after restocking (Georgsson and others
2006). </div>
<br />
<div>
</div>
<br />
<div>
In the rest of the countries considered in the EFSA (2014) report,
recommendations for disinfection measures were not specifically defined at the
government level. In the report, the only recommendation that is made for sheep
is repopulation with sheep with scrapie-resistant genotypes. This reduces the
risk of scrapie recurrence but it is difficult to know its effect on the
infection. </div>
<br />
<div>
</div>
<br />
<div>
Until the EFSA was established (in May 2003), scientific opinions about TSE
s were provided by the Scientific Steering Committee (SSC) of the EC, whose
advice regarding inactivation procedures focused on treating animal waste at
high temperatures (150°C for three hours) and high pressure alkaline hydrolysis
(SSC 2003). At the same time, the TSE Risk Management Subgroup of the Advisory
Committee on Dangerous Pathogens (ACDP) in the UK published guidance on safe
working and the prevention of TSE infection. Annex C of the ACDP report
established that sodium hypochlorite was considered to be effective, but only if
20,000 ppm of available chlorine was present for at least one hour, which has
practical limitations such as the release of chlorine gas, corrosion,
incompatibility with formaldehyde, alcohols and acids, rapid inactivation of its
active chemicals and the stability of dilutions (ACDP 2009). </div>
<br />
<div>
</div>
<br />
<div>
In an international context, the World Organisation for Animal Health (OIE)
does not recommend a specific disinfection protocol for prion agents in its
Terrestrial Code or Manual. Chapter 4.13 of the Terrestrial Code, General
recommendations on disinfection and disinsection (OIE 2014), focuses on
foot-and-mouth disease virus, mycobacteria and Bacillus anthracis, but not on
prion disinfection. Nevertheless, the last update published by the OIE on bovine
spongiform encephalopathy (OIE 2012) indicates that few effective
decontamination techniques are available to inactivate the agent on surfaces,
and recommends the removal of all organic material and the use of sodium
hydroxide, or a sodium hypochlorite solution containing 2 per cent available
chlorine, for more than one hour at 20ºC. </div>
<br />
<div>
</div>
<br />
<div>
The World Health Organization outlines guidelines for the control of TSE s,
and also emphasises the importance of mechanically cleaning surfaces before
disinfection with sodium hydroxide or sodium hypochlorite for one hour (WHO
1999). </div>
<br />
<div>
</div>
<br />
<div>
Finally, the relevant agencies in both Canada and the USA suggest that the
best treatments for surfaces potentially contaminated with prions are sodium
hydroxide or sodium hypochlorite at 20,000 ppm. This is a 2 per cent solution,
while most commercial household bleaches contain 5.25 per cent sodium
hypochlorite. It is therefore recommended to dilute one part 5.25 per cent
bleach with 1.5 parts water (CDC 2009, Canadian Food Inspection Agency 2013).
</div>
<br />
<div>
</div>
<br />
<div>
So what should we do about disinfection against prions? First, it is
suggested that a single protocol be created by international authorities to
homogenise inactivation procedures and enable their application in all
scrapie-affected countries. Sodium hypochlorite with 20,000 ppm of available
chlorine seems to be the procedure used in most countries, as noted in a paper
summarised on p 99 of this issue of Veterinary Record (Hawkins and others 2015).
But are we totally sure of its effectiveness as a preventive measure in a
scrapie outbreak? Would an in-depth study of the recurrence of scrapie disease
be needed? </div>
<br />
<div>
</div>
<br />
<div>
What we can conclude is that, if we want to fight prion diseases, and
specifically classical scrapie, we must focus on the accuracy of diagnosis,
monitoring and surveillance; appropriate animal identification and control of
movements; and, in the end, have homogeneous and suitable protocols to
decontaminate and disinfect lambing barns, sheds and equipment available to
veterinarians and farmers. Finally, further investigations into the resistance
of prion proteins in the diversity of environmental surfaces are required.
</div>
<br />
<div>
</div>
<br />
<div>
References </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
98 | Veterinary Record | January 24, 2015 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://veterinaryrecord.bmj.com/content/176/4/97.extract">http://veterinaryrecord.bmj.com/content/176/4/97.extract</a>
</div>
<br />
<div>
</div>
<br />
<div>
Persistence of ovine scrapie infectivity in a farm environment following
cleaning and decontamination </div>
<br />
<div>
</div>
<br />
<div>
Steve A. C. Hawkins, MIBiol, Pathology Department1, Hugh A. Simmons, BVSc
MRCVS, MBA, MA Animal Services Unit1, Kevin C. Gough, BSc, PhD2 and Ben C.
Maddison, BSc, PhD3 + Author Affiliations </div>
<br />
<div>
</div>
<br />
<div>
1Animal and Plant Health Agency, Woodham Lane, New Haw, Addlestone, Surrey
KT15 3NB, UK 2School of Veterinary Medicine and Science, The University of
Nottingham, Sutton Bonington, Loughborough, Leicestershire LE12 5RD, UK 3ADAS
UK, School of Veterinary Medicine and Science, The University of Nottingham,
Sutton Bonington, Loughborough, Leicestershire LE12 5RD, UK E-mail for
correspondence: ben.maddison@adas.co.uk Abstract Scrapie of sheep/goats and
chronic wasting disease of deer/elk are contagious prion diseases where
environmental reservoirs are directly implicated in the transmission of disease.
In this study, the effectiveness of recommended scrapie farm decontamination
regimens was evaluated by a sheep bioassay using buildings naturally
contaminated with scrapie. Pens within a farm building were treated with either
20,000 parts per million free chorine solution for one hour or were treated with
the same but were followed by painting and full re-galvanisation or replacement
of metalwork within the pen. Scrapie susceptible lambs of the PRNP genotype
VRQ/VRQ were reared within these pens and their scrapie status was monitored by
recto-anal mucosa-associated lymphoid tissue. All animals became infected over
an 18-month period, even in the pen that had been subject to the most stringent
decontamination process. These data suggest that recommended current guidelines
for the decontamination of farm buildings following outbreaks of scrapie do
little to reduce the titre of infectious scrapie material and that environmental
recontamination could also be an issue associated with these premises. </div>
<br />
<div>
</div>
<br />
<div>
SNIP... </div>
<br />
<div>
</div>
<br />
<div>
Discussion </div>
<br />
<div>
</div>
<br />
<div>
Thorough pressure washing of a pen had no effect on the amount of
bioavailable scrapie infectivity (pen B). The routine removal of prions from
surfaces within a laboratory setting is treatment for a minimum of one hour with
20,000 ppm free chlorine, a method originally based on the use of brain
macerates from infected rodents to evaluate the effectiveness of decontamination
(Kimberlin and others 1983). Further studies have also investigated the
effectiveness of hypochlorite disinfection of metal surfaces to simulate the
decontamination of surgical devices within a hospital setting. Such treatments
with hypochlorite solution were able to reduce infectivity by 5.5 logs to lower
than the sensitivity of the bioassay used (Lemmer and others 2004). Analogous
treatment of the pen surfaces did not effectively remove the levels of scrapie
infectivity over that of the control pens, indicating that this method of
decontamination is not effective within a farm setting. This may be due to the
high level of biological matrix that is present upon surfaces within the farm
environment, which may reduce the amount of free chlorine available to
inactivate any infectious prion. Remarkably 1/5 sheep introduced into pen D had
also became scrapie positive within nine months, with all animals in this pen
being RAMALT positive by 18 months of age. Pen D was no further away from the
control pen (pen A) than any of the other pens within this barn. Localised hot
spots of infectivity may be present within scrapie-contaminated environments,
but it is unlikely that pen D area had an amount of scrapie contamination that
was significantly different than the other areas within this building.
Similarly, there were no differences in how the biosecurity of pen D was
maintained, or how this pen was ventilated compared with the other pens. This
observation, perhaps, indicates the slower kinetics of disease uptake within
this pen and is consistent with a more thorough prion removal and
recontamination. These observations may also account for the presence of
inadvertent scrapie cases within other studies, where despite stringent
biosecurity, control animals have become scrapie positive during challenge
studies using barns that also housed scrapie-affected animals (Ryder and others
2009). </div>
<br />
<div>
</div>
<br />
<div>
***The bioassay data indicate that the exposure of the sheep to a farm
environment after decontamination efforts thought to be effective in removing
scrapie is sufficient for the animals to become infected with scrapie. The main
exposure routes within this scenario are likely to be via the oral route, during
feeding and drinking, and respiratory and conjunctival routes. It has been
demonstrated that scrapie infectivity can be efficiently transmitted via the
nasal route in sheep (Hamir and others 2008), as is the case for CWD in both
murine models and in white-tailed deer (Denkers and others 2010, 2013). </div>
<br />
<div>
</div>
<br />
<div>
Recently, it has also been demonstrated that CWD prions presented as dust
when bound to the soil mineral montmorillonite can be infectious via the nasal
route (Nichols and others 2013). When considering pens C and D, the actual
source of the infectious agent in the pens is not known, it is possible that
biologically relevant levels of prion survive on surfaces during the
decontamination regimen (pen C). With the use of galvanising and painting (pen
D) covering and sealing the surface of the pen, it is possible that scrapie
material recontaminated the pens by the movement of infectious prions contained
within dusts originating from other parts of the barn that were not
decontaminated or from other areas of the farm. </div>
<br />
<div>
</div>
<br />
<div>
Given that scrapie prions are widespread on the surfaces of affected farms
(Maddison and others 2010a), irrespective of the source of the infectious prions
in the pens, this study clearly highlights the difficulties that are faced with
the effective removal of environmentally associated scrapie infectivity. This is
likely to be paralleled in CWD which shows strong similarities to scrapie in
terms of both the dissemination of prions into the environment and the facile
mode of disease transmission. These data further contribute to the understanding
that prion diseases can be highly transmissible between susceptible individuals
not just by direct contact but through highly stable environmental reservoirs
that are refractory to decontamination. </div>
<br />
<div>
</div>
<br />
<div>
The presence of these environmentally associated prions in farm buildings
make the control of these diseases a considerable challenge, especially in
animal species such as goats where there is lack of genetic resistance to
scrapie and, therefore, no scope to re-stock farms with animals that are
resistant to scrapie. </div>
<br />
<div>
</div>
<br />
<div>
Scrapie Sheep Goats Transmissible spongiform encephalopathies (TSE)
Accepted October 12, 2014. Published Online First 31 October 2014 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://veterinaryrecord.bmj.com/content/early/2014/10/31/vr.102743.abstract">http://veterinaryrecord.bmj.com/content/early/2014/10/31/vr.102743.abstract</a>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, November 3, 2014 </div>
<br />
<div>
</div>
<br />
<div>
Persistence of ovine scrapie infectivity in a farm environment following
cleaning and decontamination </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/11/persistence-of-ovine-scrapie.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/11/persistence-of-ovine-scrapie.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
PPo3-22: </div>
<br />
<div>
</div>
<br />
<div>
Detection of Environmentally Associated PrPSc on a Farm with Endemic
Scrapie </div>
<br />
<div>
</div>
<br />
<div>
Ben C. Maddison,1 Claire A. Baker,1 Helen C. Rees,1 Linda A. Terry,2 Leigh
Thorne,2 Susan J. Belworthy2 and Kevin C. Gough3 1ADAS-UK LTD; Department of
Biology; University of Leicester; Leicester, UK; 2Veterinary Laboratories
Agency; Surry, KT UK; 3Department of Veterinary Medicine and Science; University
of Nottingham; Sutton Bonington, Loughborough UK </div>
<br />
<div>
</div>
<br />
<div>
Key words: scrapie, evironmental persistence, sPMCA </div>
<br />
<div>
</div>
<br />
<div>
Ovine scrapie shows considerable horizontal transmission, yet the routes of
transmission and specifically the role of fomites in transmission remain poorly
defined. Here we present biochemical data demonstrating that on a
scrapie-affected sheep farm, scrapie prion contamination is widespread. It was
anticipated at the outset that if prions contaminate the environment that they
would be there at extremely low levels, as such the most sensitive method
available for the detection of PrPSc, serial Protein Misfolding Cyclic
Amplification (sPMCA), was used in this study. We investigated the distribution
of environmental scrapie prions by applying ovine sPMCA to samples taken from a
range of surfaces that were accessible to animals and could be collected by use
of a wetted foam swab. Prion was amplified by sPMCA from a number of these
environmental swab samples including those taken from metal, plastic and wooden
surfaces, both in the indoor and outdoor environment. At the time of sampling
there had been no sheep contact with these areas for at least 20 days prior to
sampling indicating that prions persist for at least this duration in the
environment. These data implicate inanimate objects as environmental reservoirs
of prion infectivity which are likely to contribute to disease transmission.
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099">http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099</a>
</div>
<br />
<div>
</div>
<br />
<div>
the tse prion aka mad cow type disease is not your normal pathogen. </div>
<br />
<div>
</div>
<br />
<div>
The TSE prion disease survives ashing to 600 degrees celsius, that’s around
1112 degrees farenheit. </div>
<br />
<div>
</div>
<br />
<div>
you cannot cook the TSE prion disease out of meat. you can take the ash and
mix it with saline and inject that ash into a mouse, and the mouse will go down
with TSE. </div>
<br />
<div>
</div>
<br />
<div>
Prion Infected Meat-and-Bone Meal Is Still Infectious after Biodiesel
Production as well. </div>
<br />
<div>
</div>
<br />
<div>
the TSE prion agent also survives Simulated Wastewater Treatment Processes.
</div>
<br />
<div>
</div>
<br />
<div>
IN fact, you should also know that the TSE Prion agent will survive in the
environment for years, if not decades. </div>
<br />
<div>
</div>
<br />
<div>
you can bury it and it will not go away. </div>
<br />
<div>
</div>
<br />
<div>
The TSE agent is capable of infected your water table i.e. Detection of
protease-resistant cervid prion protein in water from a CWD-endemic area. </div>
<br />
<div>
</div>
<br />
<div>
it’s not your ordinary pathogen you can just cook it out and be done with.
</div>
<br />
<div>
</div>
<br />
<div>
that’s what’s so worrisome about Iatrogenic mode of transmission, a simple
autoclave will not kill this TSE prion agent. </div>
<br />
<div>
</div>
<br />
<div>
cwd to humans, consumption, exposure, sub-clinical, iatrogenic, what if ?
</div>
<br />
<div>
</div>
<br />
<div>
Saturday, January 31, 2015 </div>
<br />
<div>
</div>
<br />
<div>
European red deer (Cervus elaphus elaphus) are susceptible to Bovine
Spongiform Encephalopathy BSE by Oral Alimentary route</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2015/01/european-red-deer-cervus-elaphus.html">http://transmissiblespongiformencephalopathy.blogspot.com/2015/01/european-red-deer-cervus-elaphus.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
*** Singeltary reply ; Molecular, Biochemical and Genetic Characteristics
of BSE in Canada Singeltary reply ; </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.plosone.org/annotation/listThread.action;jsessionid=635CE9094E0EA15D5362B7D7B809448C?root=7143">http://www.plosone.org/annotation/listThread.action;jsessionid=635CE9094E0EA15D5362B7D7B809448C?root=7143</a>
</div>
<br />
<div>
</div>
<br />
<div>
Saturday, March 21, 2015 </div>
<br />
<div>
</div>
<br />
<div>
*** Canada and United States Creutzfeldt Jakob TSE Prion Disease Incidence
Rates Increasing </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2015/03/canada-and-united-states-creutzfeldt.html">http://creutzfeldt-jakob-disease.blogspot.com/2015/03/canada-and-united-states-creutzfeldt.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
*** O.05: Transmission of prions to primates after extended silent
incubation periods: ***Implications for BSE and scrapie risk assessment in human
populations </div>
<br />
<div>
</div>
<br />
<div>
Emmanuel Comoy, Jacqueline Mikol, Valerie Durand, Sophie Luccantoni,
Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys
Atomic Energy Commission; Fontenay-aux-Roses, France </div>
<br />
<div>
</div>
<br />
<div>
Prion diseases (PD) are the unique neurodegenerative proteinopathies
reputed to be transmissible under field conditions since decades. The
transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that
an animal PD might be zoonotic under appropriate conditions. Contrarily, in the
absence of obvious (epidemiological or experimental) elements supporting a
transmission or genetic predispositions, PD, like the other proteinopathies, are
reputed to occur spontaneously (atpical animal prion strains, sporadic CJD
summing 80% of human prion cases). Non-human primate models provided the first
evidences supporting the transmissibiity of human prion strains and the zoonotic
potential of BSE. Among them, cynomolgus macaques brought major information for
BSE risk assessment for human health (Chen, 2014), according to their
phylogenetic proximity to humans and extended lifetime. We used this model to
assess the zoonotic potential of other animal PD from bovine, ovine and cervid
origins even after very long silent incubation periods. </div>
<br />
<div>
</div>
<br />
<div>
*** We recently observed the direct transmission of a natural classical
scrapie isolate to macaque after a 10-year silent incubation period, </div>
<br />
<div>
</div>
<br />
<div>
***with features similar to some reported for human cases of sporadic CJD,
albeit requiring fourfold longe incubation than BSE. Scrapie, as recently evoked
in humanized mice (Cassard, 2014), </div>
<br />
<div>
</div>
<br />
<div>
***is the third potentially zoonotic PD (with BSE and L-type BSE), </div>
<br />
<div>
</div>
<br />
<div>
***thus questioning the origin of human sporadic cases. We will present an
updated panorama of our different transmission studies and discuss the
implications of such extended incubation periods on risk assessment of animal PD
for human health.</div>
<br />
<div>
</div>
<br />
<div>
===============</div>
<br />
<div>
</div>
<br />
<div>
***thus questioning the origin of human sporadic cases...TSS</div>
<br />
<div>
</div>
<br />
<div>
=============== </div>
<br />
<div>
</div>
<br />
<div>
<a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf">https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
2014 </div>
<br />
<div>
</div>
<br />
<div>
***Moreover, L-BSE has been transmitted more easily to transgenic mice
overexpressing a human PrP [13,14] or to primates [15,16] than C-BSE. </div>
<br />
<div>
</div>
<br />
<div>
***It has been suggested that some sporadic CJD subtypes in humans may
result from an exposure to the L-BSE agent. </div>
<br />
<div>
</div>
<br />
<div>
*** Lending support to this hypothesis, pathological and biochemical
similarities have been observed between L-BSE and an sCJD subtype (MV genotype
at codon 129 of PRNP) [17], and between L-BSE infected non-human primate and
another sCJD subtype (MM genotype) [15]. </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4213560/pdf/viruses-06-03766.pdf">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4213560/pdf/viruses-06-03766.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
PRION 2015 CONFERENCE FT. COLLINS CWD RISK FACTORS TO HUMANS </div>
<br />
<div>
</div>
<br />
<div>
*** LATE-BREAKING ABSTRACTS PRION 2015 CONFERENCE *** </div>
<br />
<div>
</div>
<br />
<div>
O18 </div>
<br />
<div>
</div>
<br />
<div>
Zoonotic Potential of CWD Prions </div>
<br />
<div>
</div>
<br />
<div>
Liuting Qing1, Ignazio Cali1,2, Jue Yuan1, Shenghai Huang3, Diane Kofskey1,
Pierluigi Gambetti1, Wenquan Zou1, Qingzhong Kong1 1Case Western Reserve
University, Cleveland, Ohio, USA, 2Second University of Naples, Naples, Italy,
3Encore Health Resources, Houston, Texas, USA </div>
<br />
<div>
</div>
<br />
<div>
*** These results indicate that the CWD prion has the potential to infect
human CNS and peripheral lymphoid tissues and that there might be asymptomatic
human carriers of CWD infection. </div>
<br />
<div>
</div>
<br />
<div>
================== </div>
<br />
<div>
</div>
<br />
<div>
***These results indicate that the CWD prion has the potential to infect
human CNS and peripheral lymphoid tissues and that there might be asymptomatic
human carriers of CWD infection.*** </div>
<br />
<div>
</div>
<br />
<div>
================== </div>
<br />
<div>
</div>
<br />
<div>
P.105: RT-QuIC models trans-species prion transmission </div>
<br />
<div>
</div>
<br />
<div>
Kristen Davenport, Davin Henderson, Candace Mathiason, and Edward Hoover
Prion Research Center; Colorado State University; Fort Collins, CO USA </div>
<br />
<div>
</div>
<br />
<div>
Conversely, FSE maintained sufficient BSE characteristics to more
efficiently convert bovine rPrP than feline rPrP. Additionally, human rPrP was
competent for conversion by CWD and fCWD. </div>
<br />
<div>
</div>
<br />
<div>
***This insinuates that, at the level of protein:protein interactions, the
barrier preventing transmission of CWD to humans is less robust than previously
estimated. </div>
<br />
<div>
</div>
<br />
<div>
================ </div>
<br />
<div>
</div>
<br />
<div>
***This insinuates that, at the level of protein:protein interactions, the
barrier preventing transmission of CWD to humans is less robust than previously
estimated.*** </div>
<br />
<div>
</div>
<br />
<div>
================ </div>
<br />
<div>
</div>
<br />
<div>
<a href="https://prion2015.files.wordpress.com/2015/05/programguide1.pdf">https://prion2015.files.wordpress.com/2015/05/programguide1.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
From: Terry S. Singeltary Sr. </div>
<br />
<div>
</div>
<br />
<div>
Sent: Saturday, November 15, 2014 9:29 PM </div>
<br />
<div>
</div>
<br />
<div>
To: Terry S. Singeltary Sr. </div>
<br />
<div>
</div>
<br />
<div>
Subject: THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE R. G. WILL 1984
</div>
<br />
<div>
</div>
<br />
<div>
THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE </div>
<br />
<div>
</div>
<br />
<div>
R. G. WILL </div>
<br />
<div>
</div>
<br />
<div>
1984 </div>
<br />
<div>
</div>
<br />
<div>
*** The association between venison eating and risk of CJD shows similar
pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK
OF CJD (p = 0.04). (SEE LINK IN REPORT HERE...TSS) PLUS, THE CDC DID NOT PUT
THIS WARNING OUT FOR THE WELL BEING OF THE DEER AND ELK ; </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://web.archive.org/web/20050425210551/http://www.bseinquiry.gov.uk/files/mb/m26/tab01.pdf">http://web.archive.org/web/20050425210551/http://www.bseinquiry.gov.uk/files/mb/m26/tab01.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
*** These results would seem to suggest that CWD does indeed have zoonotic
potential, at least as judged by the compatibility of CWD prions and their human
PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests
that if zoonotic CWD occurred, it would most likely effect those of the PRNP
codon 129-MM genotype and that the PrPres type would be similar to that found in
the most common subtype of sCJD (MM1).*** </div>
<br />
<div>
</div>
<br />
<div>
<a href="https://www.landesbioscience.com/journals/prion/article/28124/?nocache=112223249">https://www.landesbioscience.com/journals/prion/article/28124/?nocache=112223249</a>
</div>
<br />
<div>
</div>
<br />
<div>
*** The potential impact of prion diseases on human health was greatly
magnified by the recognition that interspecies transfer of BSE to humans by beef
ingestion resulted in vCJD. While changes in animal feed constituents and
slaughter practices appear to have curtailed vCJD, there is concern that CWD of
free-ranging deer and elk in the U.S. might also cross the species barrier.
Thus, consuming venison could be a source of human prion disease. Whether BSE
and CWD represent interspecies scrapie transfer or are newly arisen prion
diseases is unknown. Therefore, the possibility of transmission of prion disease
through other food animals cannot be ruled out. There is evidence that vCJD can
be transmitted through blood transfusion. There is likely a pool of unknown size
of asymptomatic individuals infected with vCJD, and there may be asymptomatic
individuals infected with the CWD equivalent. These circumstances represent a
potential threat to blood, blood products, and plasma supplies. *** </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://cdmrp.army.mil/prevfunded/nprp/NPRP_Summit_Final_Report.pdf">http://cdmrp.army.mil/prevfunded/nprp/NPRP_Summit_Final_Report.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.rdehospital.nhs.uk/docs/patients/services/infection_control/CJD_policy.pdf">http://www.rdehospital.nhs.uk/docs/patients/services/infection_control/CJD_policy.pdf</a></div>
<br />
<div>
</div>
<br />
<div>
PRION CONFERENCE 2014 HELD IN ITALY RECENTLY CWD BSE TSE UPDATE </div>
<br />
<div>
</div>
<br />
<div>
> First transmission of CWD to transgenic mice over-expressing bovine
prion protein gene (TgSB3985) </div>
<br />
<div>
</div>
<br />
<div>
PRION 2014 - PRIONS: EPIGENETICS and NEURODEGENERATIVE DISEASES – Shaping
up the future of prion research</div>
<br />
<div>
</div>
<br />
<div>
Animal TSE Workshop 10.40 – 11.05 Talk Dr. L. Cervenakova First
transmission of CWD to transgenic mice over-expressing bovine prion protein gene
(TgSB3985) </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.prion2014.org/images/Animal_TSE_workshop.pdf">http://www.prion2014.org/images/Animal_TSE_workshop.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
Friday, August 14, 2015 </div>
<br />
<div>
</div>
<br />
<div>
*** Susceptibility of cattle to the agent of chronic wasting disease from
elk after intracranial inoculation</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://chronic-wasting-disease.blogspot.com/2015/08/susceptibility-of-cattle-to-agent-of.html">http://chronic-wasting-disease.blogspot.com/2015/08/susceptibility-of-cattle-to-agent-of.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
July's Milwaukee Journal Sentinel article did prod state officials to ask
CDC to investigate the cases of the three men who shared wild game feasts. The
two men the CDC is still investigating were 55 and 66 years old. But there's
also Kevin Boss, a Minnesota hunter who ate Barron County venison and died of
CJD at 41. And there's Jeff Schwan, whose Michigan Tech fraternity brothers used
to bring venison sausage back to the frat house. His mother, Terry, says that in
May 2001, Jeff, 26, began complaining about his vision. A friend noticed
misspellings in his e-mail, which was totally unlike him. Jeff began losing
weight. He became irritable and withdrawn. By the end of June, he couldn't
remember the four-digit code to open the garage door or when and how to feed his
parents' cats. At a family gathering in July, he stuck to his parents and
girlfriend, barely talking. "On the night we took him to the hospital, he was
speaking like he was drunk or high and I noticed his pupils were so dilated I
couldn't see the irises," his mother says. By then, Jeff was no longer able to
do even simple things on his computer at work, and "in the hospital, he couldn't
drink enough water." When he died on September 27, 2001, an autopsy confirmed he
had sporadic CJD. </div>
<br />
<div>
</div>
<br />
<div>
In 2000, Belay looked into three CJD cases reported by The Denver Post, two
hunters who ate meat from animals killed in Wyoming and the daughter of a hunter
who ate venison from a plant that processed Colorado elk. All three died of CJD
before they were 30 years old. The CDC asked the USDA to kill 1,000 deer and elk
in the area where the men hunted. Belay and others reported their findings in
the Archives of Neurology, writing that although "circumstances suggested a link
between the three cases and chronic wasting disease, they could find no 'causal'
link." Which means, says Belay, "not a single one of those 1,000 deer tested
positive for CWD. For all we know, these cases may be CWD. What we have now
doesn't indicate a connection. That's reassuring, but it would be wrong to say
it will never happen." </div>
<br />
<div>
</div>
<br />
<div>
So far, says NIH researcher Race, the two Wisconsin cases pinpointed by the
newspaper look like spontaneous CJD. "But we don't know how CWD would look in
human brains. It probably would look like some garden-variety sporadic CJD."
What the CDC will do with these cases and four others (three from Colorado and
Schwan from Upper Michigan), Race says, is "sequence the prion protein from
these people, inject it into mice and wait to see what the disease looks like in
their brains. That will take two years." </div>
<br />
<div>
</div>
<br />
<div>
CJD is so rare in people under age 30, one case in a billion (leaving out
medical mishaps), that four cases under 30 is "very high," says Colorado
neurologist Bosque. "Then, if you add these other two from Wisconsin [cases in
the newspaper], six cases of CJD in people associated with venison is very, very
high." Only now, with Mary Riley, there are at least seven, and possibly eight,
with Steve, her dining companion. "It's not critical mass that matters,"
however, Belay says. "One case would do it for me." The chance that two people
who know each other would both contact CJD, like the two Wisconsin sportsmen, is
so unlikely, experts say, it would happen only once in 140 years. </div>
<br />
<div>
</div>
<br />
<div>
Given the incubation period for TSEs in humans, it may require another
generation to write the final chapter on CWD in Wisconsin. "Does chronic wasting
disease pass into humans? We'll be able to answer that in 2022," says Race.
Meanwhile, the state has become part of an immense experiment. </div>
<br />
<div>
</div>
<br />
<div>
<a href="https://www.organicconsumers.org/old_articles/madcow/killer123103.php">https://www.organicconsumers.org/old_articles/madcow/killer123103.php</a>
</div>
<br />
<div>
</div>
<br />
<div>
I urge everyone to watch this video closely...terry</div>
<br />
<div>
</div>
<br />
<div>
*** you can see video here and interview with Jeff's Mom, and scientist
telling you to test everything and potential risk factors for humans *** </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://zoomify.uzh.ch:8080/zoomify/videos/video-004/video-004.html">http://zoomify.uzh.ch:8080/zoomify/videos/video-004/video-004.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, October 25, 2015 </div>
<br />
<div>
</div>
<br />
<div>
USAHA Detailed Events Schedule – 119th USAHA Annual Meeting CAPTIVE
LIVESTOCK CWD SCRAPIE TSE PRION</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://chronic-wasting-disease.blogspot.com/2015/10/usaha-detailed-events-schedule-119th.html">http://chronic-wasting-disease.blogspot.com/2015/10/usaha-detailed-events-schedule-119th.html</a></div>
<br />
<div>
</div>
<br />
<div>
Sunday, October 18, 2015 </div>
<br />
<div>
</div>
<br />
<div>
World Organisation for Animal Health (OIE) and the Institut Pasteur
Cooperating on animal disease and zoonosis research </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bovineprp.blogspot.com/2015/10/world-organisation-for-animal-health.html">http://bovineprp.blogspot.com/2015/10/world-organisation-for-animal-health.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
31 Jan 2015 at 20:14 GMT </div>
<br />
<div>
</div>
<br />
<div>
*** Ruminant feed ban for cervids in the United States? ***</div>
<br />
<div>
</div>
<br />
<div>
Singeltary et al</div>
<br />
<div>
</div>
<br />
<div>
31 Jan 2015 at 20:14 GMT </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.plosone.org/annotation/listThread.action?root=85351">http://www.plosone.org/annotation/listThread.action?root=85351</a>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, October 26, 2015 </div>
<br />
<div>
</div>
<br />
<div>
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OIA UPDATE October 2015 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://madcowusda.blogspot.com/2015/10/fda-part-589-substances-prohibited-from.html">http://madcowusda.blogspot.com/2015/10/fda-part-589-substances-prohibited-from.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Mad deer disease can infect normal human brains in laboratory tests </div>
<br />
<div>
</div>
<br />
<div>
Monday, May 8, 2000 </div>
<br />
<div>
</div>
<br />
<div>
www.ems.org has further information and facts on CJD. Jennifer Kelly or Amy
Leska, EMS 202/463-6670 Washington, D.C. </div>
<br />
<div>
</div>
<br />
<div>
Public health advocates are demanding that the Food and Drug Administration
close loopholes in animal feed regulations to prevent the spread of U.S. mad
cow-type diseases now at epidemic levels in Western deer and elk that might
infect people who eat meat. In a letter sent today to the FDA, the Center for
Food Safety (CFS), the Humane Farming Association, and families of U.S. victims
of the human version of mad cow disease, Creutzfeldt-Jakob disease (CJD) are
demanding new efforts to protect public health and food safety. The FDA was
asked to respond to a legal petition filed in January 1999 that would change
U.S. animal feed regulations to prevent the spread of U.S. mad cow-type diseases
already occurring in deer, elk, sheep and humans, and suspected in pigs and
cattle. </div>
<br />
<div>
</div>
<br />
<div>
Under current FDA regulations animals known to be infected with mad
cow-type disease such as deer and elk infected with 'chronic wasting disease'
and scrapie-infected sheep, can be legally fed to pigs, chickens and pets, which
in turn can be rendered and fed to cows. Billions of pounds of slaughterhouse
waste in the form of rendered animal by-products are fed to US livestock every
year as fat and protein supplements, despite this practice being the known route
of transmission of British mad cow disease. </div>
<br />
<div>
</div>
<br />
<div>
A fatal 'mad deer' disease called chronic wasting disease or CWD is
occurring at epidemic levels in deer and elk in Western states and on game
farms, CFS legal director Joseph Mendelson wrote in the letter to the FDA. This
may already be claiming human lives as is suggested by the alarming appearance
of unusually young victims of Creutzfeldt-Jakob disease. </div>
<br />
<div>
</div>
<br />
<div>
*** Today at the first CJD Foundation conference in Miami, government
researcher Byron W. Caughey, Ph.D., announced that in laboratory tests CWD from
deer can infect human brain tissue at rate similar to British mad cow disease.
In Britain 56 people have died of human mad cow disease, the death toll is
climbing and some scientists suspect it will claim hundreds of thousands of
lives in the decades ahead. Caughey's research on US mad deer disese was
conducted at the National Institutes of Health Rocky Mountain Laboratories in
Hamilton, Montana, and has not yet been published. </div>
<br />
<div>
</div>
<br />
<div>
The most recent suspected victim of US mad deer disease is Jay Dee Whitlock
II of Oklahoma, who died of CJD on April 7, 2000. Whitlock, 28, was an avid deer
hunter and venison consumer. He is the second young hunter to die of CJD in the
past year. </div>
<br />
<div>
</div>
<br />
<div>
John Stauber, co-author of Mad Cow USA and a speaker at the CJD Foundation
conference, said, "The announcement that US mad deer disease can infect the
human brain, and that it happens at a rate similar to British mad cow disease,
is extremely disturbing. A deadly human dementia might be already spreading from
deer and elk into hunters in Western states, and the policies of the FDA and
other agencies are completely inadequate to protect public health. </div>
<br />
<div>
</div>
<br />
<div>
Could 'mad cow type epidemics happen in the US John Stauber, talk given 7
May 00 CJD Foundation conference Miami Center for Media & Democracy 520
University Avenue, Suite #310 Madison, WI 53703</div>
<br />
<div>
</div>
<br />
<div>
"Three years ago Sheldon Rampton and I were finishing our book Mad Cow USA
published in November of 97. In our introduction we wrote that ours is not a
biology book nor a diet guide, but a "book about politics and how it operates in
the real world. It explains how government officials have placed concerns for
the food industry over human health and welfare. In addition to telling the
story of an exotic, mysterious and frightening disease, we have written this
book to report on equally dangerous legal and political trends which threaten
not only our physical health, but also our fundamental democratic rights..." The
title of this session asks a question: "Could 'mad cow type epidemics happen in
the US.?" My answer is not only could they, but they are. Sheep scrapie arrived
in the US a half century ago and thanks to government bungling is now widely
spread throughout the US, with dozens of different strains. Chronic wasting
disease may have begun as sheep scrapie but now it is spreading through deer and
elk in western states and on game farms. </div>
<br />
<div>
</div>
<br />
<div>
In the past two years two western state hunters under the age of 30 have
died of CJD, and some of us suspect they may be human victims of a new strain of
TSE in sheep, deer or elk that has begun claiming young human victims in the US.
</div>
<br />
<div>
</div>
<br />
<div>
Since 1964 researchers have suspected that transmissible mink
encephalopathy TME in the US is from a hidden TSE in cattle, and the late Dr.
Richard Marsh, to whom we dedicate our book, believed that he isolated that TSE
in mink in Wisconsin in 1985, a year before the British strain of TSE dubbed mad
cow disease was observed. </div>
<br />
<div>
</div>
<br />
<div>
As our book was going to completion, we discovered that USDA inspectors
felt they had identified a TSE in pigs way back in the the 1970s, when few
researchers other than a small group in what Paul Brown calls the Club were very
concerned or aware of TSE diseases. </div>
<br />
<div>
</div>
<br />
<div>
Of course, British mad cow disease and the looming specter of hundreds of
thousands of people condemned to death in the decades ahead has changed
everything. Everything, that is, except public policy here in the US. For
despite the fact that two Nobel prize winners in this area of research are from
the US, there is a public relations cover-up of massive proportions in this
country that is preventing us from effectively establishing public policies that
can monitor, prevent and eventually treat TSE diseases. </div>
<br />
<div>
</div>
<br />
<div>
Please note that I said a public relations cover-up; that's important. I
suspect that if TSE diseases were spread by mosquitoes, we'd be spraying
pesticides all over the US to try and irradiate sheep scrapie and chronic
wasting disease. But these diseases are spread by agribusiness through animal
livestock products fed to people and animals, and thus instead of putting the
concerns of people first, we have see that consistently governments have put the
concerns of industry first. </div>
<br />
<div>
</div>
<br />
<div>
We've heard eminent and hard working scientists talk about TSE diseases in
terms that dizzy the head of even other scientists. This is a very contentious
and mysterious area of research because TSE diseases break many rules. </div>
<br />
<div>
</div>
<br />
<div>
Luckily, my co-author and I are not experts or scientists. However, we did
have the benefit of being able to interview top TSE researchers like Richard
Marsh and Dr. Gajdusek, have them review parts of our manuscript, and thus
deliver a book that is based on solid, sound science regarding what is known,
and what is unknown, what is proven, and what is not. </div>
<br />
<div>
</div>
<br />
<div>
From my perspective, this is the most important point and perspective to
keep in mind: </div>
<br />
<div>
</div>
<br />
<div>
For the past thirty years a massive unregulated experiment in creating new
strains of TSE disease has been undertaken by the livestock industry, and we're
the guinea pigs. The experiment is ongoing. The experiment began as a really
neat idea: lets take the billions and billions of pounds of slaughterhouse
waste, blood and offal that is produced every year from cattle and pigs and
sheep and roadkill and pets and zoo animals, and let's recycle it. Let's turn it
into protein fat supplements, and let's feed it back to the livestock we eat.
</div>
<br />
<div>
</div>
<br />
<div>
It seemed like a good idea. Unfortunately, what it didn't take into account
was the infectious prion agent. As Dr. Gibbs has pointed out, probably every
mammalian species has a TSE disease at some minute level: people, pigs, cows,
sheep, mink, cats and dogs, deer, elk. Grind up the most infectious parts of
millions and millions of animals, concentrate them into feed supplements, and
you are creating an environment not only for spreading and amplifying existing
agents such as scrapie in sheep, but also for creating an untold number of new
strains of TSE. </div>
<br />
<div>
</div>
<br />
<div>
This is especially important to grasp. In laboratory experiments, when TME
or scrapie or CJD is injected into new animal species, whole new strains of TSE
are created, and they can have different potential to infect new host species.
The process of rendering animal waste into animal feed has been a massive and
ongoing experiment in the creation of new TSEs, one of which emerged in Britain
in the mid 1980s as mad cow disease, has clearly spread into humans claiming
over fifty so far, and in my guess will in the years ahead be founded to have
infected hundreds of thousands of Britons. </div>
<br />
<div>
</div>
<br />
<div>
I said that this outbreak of BSE in Britain changed everything, but what
really changed everything was what caused that outbreak: feeding rendered animal
by-products back to animals as food. </div>
<br />
<div>
</div>
<br />
<div>
I wish I could tell you that this practice has been stopped, but it has
not. I wish I could tell you that well informed and courageous officials in the
FDA, the USDA and the CDC have taken the mad bull by the horns, and are right
now executing a precautionary policy to insure that what has happened in Britain
does not happen in the US. Unfortunately, that is not the case. </div>
<br />
<div>
</div>
<br />
<div>
Dr. Hansen will shortly explain why the much heralded FDA feed regulations
on rendered animal by-products announced in 1997 are in many ways a farce. For
instance, in the US calves are literally being weaned on cattle blood protein,
and scrapie infected sheep can be used as feed for pigs which can be used as
feed for cattle. </div>
<br />
<div>
</div>
<br />
<div>
But the problem is beyond just the poor US animal feed regulations. You
need look no further than your favorite vitamin and nutritional supplement
stores. Right now, with the full knowledge of the FDA, the NIH, the CDC,
millions of Americans are popping over the counter as glandular supplements.
These unregulated products contain the most infectious parts of slaughtered
animals, the very parts that make up the so-called Specified Bovine Offal that
should be banned from cattle feed, such as the brain, pituitary, and glandular
system. These pills are pooled, collected from hundreds of thousands of animals
and taken daily by untold numbers of Americans, probably millions given the
popularity of supplements. </div>
<br />
<div>
</div>
<br />
<div>
Again, this amounts to an unregulated human experiment, minus laboratory
controls or knowledgeable consent, feeding humans the most infectious parts of
animals, possible creating new TSEs by passaging animal TSE from pooled
glandular products. </div>
<br />
<div>
</div>
<br />
<div>
I've brought along four different bottles of the pills I'm talking about,
and I've asked that they be pass around so you can look at them yourself and
read the label. </div>
<br />
<div>
</div>
<br />
<div>
Some would say that FDA's hands are tied, that thanks to lobbying by the
nutritional supplement industry the FDA lacks the power to prevent sales of
these glandular. Actually this points to another frightening disease rampant
among otherwise good people who populate government agencies which I call BCD
for Bureaucratic Cowardice Disease. FDAs hands might be tied and they can't yank
these products from the market, but their mouths are not gagged and concerned
officials should be speaking out loudly warning the American public that they
are consuming animal brains and glands and might want to consider the potential
risks. </div>
<br />
<div>
</div>
<br />
<div>
There is a reason why scientists in agencies and universities, not to
mention corporations, avoid sticking their necks out, and we need look no
further than Richard Marsh, a dedicated and conservative scientist who took it
upon himself to speak up in 1993 in an interview in Wisconsin's largest farm
paper. Richard Marsh warned Wisconsin farmers, thousands of whom were feeding
rendered cow by-products back to their cows, that given the mad cow outbreak in
Britain they should, despite the reassurances from USDA that such feeding was
safe, stop. </div>
<br />
<div>
</div>
<br />
<div>
The day after that article appeared Dr. Marsh was literally called on the
carpet in the office of the dean of the school of agriculture at the University
of Wisconsin, and read the riot act. he was told that industry funders were
threaten to sue him, sue the school, cut off money for research, and who did he
think he was? </div>
<br />
<div>
</div>
<br />
<div>
Within months the school scrambled and pulled together a symposium on the
subject, which served to dismiss and marginalize Dr. Marsh's views. When Dr.
Marsh died of cancer in 1997, after the British announcement that mad cow
disease was killing young people, the same University had the gall to praise Dr.
Marsh and his work as in the best tradition of the University. Some of us feel
that the stress and abuse heaped on Dr. Marsh> from 1993 to 1997 had an
impact on his health that contributed to his demise. </div>
<br />
<div>
</div>
<br />
<div>
This is what happens to scientists who break ranks and speak out, and it is
a great loss to us today because I think if Dick Marsh was still alive he would
be leading the charge to confront the ignorance and the cow-towing to industry
that typifies this issue. </div>
<br />
<div>
</div>
<br />
<div>
Dr. Marsh was a colleague and contemporary of many of the researchers in
this room. As Paul Brown whom he once worked with might say, he was a member of
the club. But Dr. Marsh was able to make realizations that I'm afraid most of
the club members haven't yet come to, and he was able to put his sense of
scientific obligation to society in front of concerns about his funding, or even
his personal and professional safety. </div>
<br />
<div>
</div>
<br />
<div>
I first began investigating mad cow type diseases in the early 1990s when I
was working in Wisconsin organizing farmers and consumers opposed to Monsanto's
genetically engineered bovine growth hormone, the cattle equivalent of human
growth hormone which when injected into cattle forced them to produce more milk.
Well, its not quite that biologically simple as I'm sure any woman here who has
had children can imagine. </div>
<br />
<div>
</div>
<br />
<div>
It was brought to my attention by a retired industry veterinary researcher
that in order to make the hormone work, cows need to be fed additional fat and
protein supplements, and that the cheapest supplements were rendered byproducts
from other cows. This veterinarian told me this was very bad because it was
exactly what had cause the outbreak of BSE in Britain. </div>
<br />
<div>
</div>
<br />
<div>
I investigated and found this was true - massive feeding of cows to cows
was going on in the US, despite the fact that as early as the Fall of 1987
British epidemiology had shown that is was this practice that spread mad cow
disease. </div>
<br />
<div>
</div>
<br />
<div>
I remember one of my first meetings with Dr. Marsh. We talked about his
believe that a US BSE agent, different than the British strain, was in cattle at
low levels and was the cause of occasional outbreaks of TME. I know that eminent
researchers in this room dispute that, but frankly Dr. Marsh never doubted it
and I think the evidence and commons sense remains in his favor. </div>
<br />
<div>
</div>
<br />
<div>
I had just been to a holistic chiropractor for my chronically bad lower
back, and had been sold a bottle of adrenal gland extract which I showed to Dr.
Marsh - he practically fell out of his chair and I immediately stopped taking
them. </div>
<br />
<div>
</div>
<br />
<div>
He was shocked to learn that such glandular were sold. Imagine what he
might think today, that at this late stage of the game with kids in their 20s in
the US dying of CJD, that these glandulars are sold without warning. </div>
<br />
<div>
</div>
<br />
<div>
Of course, I may be taking a risk myself in saying this. After all, we are
in Florida, one of 13 states in the US in which the Animal Feed Industry
Association members have succeeded in lobbying into law a food product
disparagement bill. I could end up like Oprah Winfrey and her guest Howard
Lyman, forced to spend millions and millions of dollars (which in my case would
be thousands and thousands and then bankruptcy) to convince a jury that my
remarks today are based on sound science. </div>
<br />
<div>
</div>
<br />
<div>
Having written two books in the past five years, one on political PR and
the other on the politics of food, I can tell you that a major reason why there
has not been more news media coverage of this issue is the multi-million dollar
PR campaign and litigation threats of the food industry which we document
extensively in our book. </div>
<br />
<div>
</div>
<br />
<div>
I find it ironic that this weekend as we're meeting here President Clinton
announced Saturday a new initiative to address the safety of hot dogs. Philip
Brasher of the Associated Press speculates that as he is leaving office the
President wants to burnish his image with food safety initiatives. </div>
<br />
<div>
</div>
<br />
<div>
The irony is that it is under this administration that the food industry
has launched an all out attack on our first amendment rights by lobbying food
libel laws onto the books, and the administration has remained silent. Despite
knowing of the risks of cow cannibalism since the beginning of his presidency,
his administration did nothing until 1997, and as we reveal in our book and Dr.
Hansen will explain, the regulations are severely inadequate. </div>
<br />
<div>
</div>
<br />
<div>
I am circulating a letter being delivered by the Center for Food Safety
urging the agency to respond to the petition filed by that group and many of the
families in this room that calls on FDA to severely tighten its regulations.
Yet, probably to avoid publicity, the FDA stonewalls. </div>
<br />
<div>
</div>
<br />
<div>
A couple weeks ago I was in Washington and I attended a conference that was
paid for in part by the lobbyists responsible for putting food censorships laws
on the books, the Animal Feed Industry Association and the law firm of Ollsen
Frank and Weeda that drafted the model bill that was then lobbied for at the
state level by the American Farm Bureau. I picked up this glossy brochure in
which the FDA is slapping itself on the back for its food safety initiatives. In
it I read that the FDA's BSE Educational Activities have Gained an award from
the vice president: </div>
<br />
<div>
</div>
<br />
<div>
The US feed regulations and the FDA were honored with VP Al Gore's Hammer
Award. Dr. Stephen F. Sundlof, the directory of FDA's Center for Veterinary
Medicine, the man who since January 1999 has been unable to respond to the legal
petition to close gaping loopholes in the FDA regulations stated: "thanks to the
development of the BSE regulation, we can continue to say that there has not
been a single case of BSE reported in the United States. Educational efforts ...
will help assure that we can continue to make that claim." </div>
<br />
<div>
</div>
<br />
<div>
In researching our books we had access to documents obtained through the
Freedom on Information Act. One 1991 document of the USDA was titled "BSE Public
Relations," and if someday attorneys in a class action lawsuit on behalf of CJD
patients in the US are looking for a smoking gun demonstrating that concerns for
industry were place over concerns for people, this is it. </div>
<br />
<div>
</div>
<br />
<div>
(p.148-149) According to this document, the mere perception that BSE might
exist in the United States could have devastating effects on our domestic
markets for beef and dairy products." The report examined how the British
handled their PR, and it fretted over a story in the British magazine The
Economist which, quote, "could potentially create alarm among US consumers,"
unquote, because it reported that, quote,"many veterinarians and medical experts
have come around to the belief that humans could catch the mystery brain
disease." </div>
<br />
<div>
</div>
<br />
<div>
This USDA PR document approvingly noted a quote in the Washington Post by
Dr. Joseph Gibbs at NIH in 1990 saying "I don't think there is any danger in
consuming British beef." Remember, this was in 1991. It had known for four years
that it was feeding cows to cows that was spreading BSE in Britain. More and
more were fearing that humans would die. Meanwhile, in the US, billions of
pounds of cow by-products were still being fed, in fact the amount was
increasing each year. </div>
<br />
<div>
</div>
<br />
<div>
Was there no one inside the USDA or FDA who saw the lunacy, indeed the
criminality, in knowing this and letting cannibalistic feeding go one in the US?
Some did. The report notes that "some (USDA APHIS) staff members... argue that
because there is evidence that pigs, cats, mink, deer and a variety of
experimental animals may b e susceptible to trans. spongiform. encephalopathy,
the only prudent policy is to not feed products that contain these agents to ANY
SPECIES OF ANIMAL." </div>
<br />
<div>
</div>
<br />
<div>
That's it. That's what we should have done then, and that's what we should
be doing now, but are not. Instead we are still exposing ourselves and US
livestock to a massive TSE experiment. </div>
<br />
<div>
</div>
<br />
<div>
So, in 1991 the USDA and FDA rejected this advice by some anonymous
staffers, as they do today. This 1991 USDA PR report admitted that a more
cautious policy would be, quote, "to prohibit the feeding of sheep and
cattle-origin protein products to all ruminants, regardless of age. The
advantage of this option is that it minimized the risk of BSE. The disadvantage
is that the cost to the livestock and rendering industries would be
substantial." </div>
<br />
<div>
</div>
<br />
<div>
In fact, absolutely nothing of substance was done until August of 1997,
when FDA announced its sham feed regulation, winner of the coveted Al Gore
hammer award, designed as a PR fig leaf so that FDA can say 'we are keeping
British mad cow disease out of our livestock." </div>
<br />
<div>
</div>
<br />
<div>
Let me say that the only bright spot in this story of corporate and
government collusion, irresponsibility and censorship has been a few brave souls
like Richard Marsh, Richard Lacey in England, others who have bucked the tide
and spoken out, and those of you who are the families and loved ones of CJD
victims. </div>
<br />
<div>
</div>
<br />
<div>
*** Through CJD Foundation and CJD Voice you have found each other, and you
will eventually force responsibility onto government and industry because if you
don't no one else will. </div>
<br />
<div>
</div>
<br />
<div>
In conclusion, we need a massive commitment in the United States to address
TSE diseases. We need to start by admitting the shortcomings of our failed
federal feed policies and change them. We need to dedicate hundreds of millions
of research dollars, if necessary, to try to eradicate scrapie in sheep,
eradicate CWD in deer and in elk, and investigate, research, test and monitor
for TSEs in humans and animals. We need money for research to develop
treatments, because while this disease used to be rare disease, I suspect we are
about to see it emerge full blown in Britain with hundreds of thousands of
victims, and more and younger victims appearing in the United States, as a
result of our thirty year experiment in animal cannibalism. </div>
<br />
<div>
</div>
<br />
<div>
The leadership for this will not come from politicians in bed with the
agribusiness industry. It will not come from researchers who while brilliant are
stuck back in pre-BSE days, still viewing this as a rare unusual disorder. It
will come from average citizens who husbands and mothers and children are dying
of this bizarre class of dementia diseases in increasing numbers, and who are
not afraid to demand that the right policies be implemented and funded. It is
upon your shoulders that leadership falls, and so far you are doing admirably."
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.mad-cow.org/00/may00_late_news.html#ccc" style="href: "http://www.mad-cow.org/00/may00_late_news.html#ccc";">http://www.mad-cow.org/00/may00_late_news.html#ccc</a>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
snip...please see this and more here ;</div>
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<div>
</div>
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<div>
<span new="" roman="" style="face: "Times";">Friday, October 23, 2015 <br /><br />CJD
FOUNDATION CREUTZFELDT JAKOB DISEASE TSE PRION QUESTIONNAIRE UPDATE OCTOBER
2015<br /></span><a 10="" 2015="" cjd-foundation-creutzfeldt-jakob.html="" cjdquestionnaire.blogspot.com="" href="http://cjdquestionnaire.blogspot.com/2015/10/cjd-foundation-creutzfeldt-jakob.html"><span new="" roman="" style="face: "Times";">http://cjdquestionnaire.blogspot.com/2015/10/cjd-foundation-creutzfeldt-jakob.html</span></a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, November 12, 2015 </div>
<br />
<div>
</div>
<br />
<div>
Evaluation of the protection of primates transfused with variant
Creutzfeldt-Jakob disease–infected blood products filtered with prion removal
devices: a 5-year update </div>
<br />
<div>
</div>
<br />
<div>
<a 11="" 2015="" evaluation-of-protection-of-primates.html="" href="http://vcjdtransfusion.blogspot.com/2015/11/evaluation-of-protection-of-primates.html" title="http://vcjdtransfusion.blogspot.com/2015/11/evaluation-of-protection-of-primates.html" vcjdtransfusion.blogspot.com="">http://vcjdtransfusion.blogspot.com/2015/11/evaluation-of-protection-of-primates.html</a></div>
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<div>
</div>
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<div>
<br /> </div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/">http://creutzfeldt-jakob-disease.blogspot.com/</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/">http://transmissiblespongiformencephalopathy.blogspot.com/</a>
</div>
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<div>
</div>
<br />
<div>
<a href="http://vcjd.blogspot.com/">http://vcjd.blogspot.com/</a></div>
<br />
<div>
</div>
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<div>
<a href="http://kuru-tse.blogspot.com/">http://kuru-tse.blogspot.com/</a></div>
<br />
<div>
</div>
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<div>
<a href="http://sporadicffi.blogspot.com/">http://sporadicffi.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vpspr.blogspot.com/">http://vpspr.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://betaamyloidcjd.blogspot.com/">http://betaamyloidcjd.blogspot.com/</a>
</div>
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<div>
</div>
<br />
<div>
<a href="http://prionoid.blogspot.com/">http://prionoid.blogspot.com/</a></div>
<br />
<div>
</div>
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<div>
<a href="http://prionopathy.blogspot.com/">http://prionopathy.blogspot.com/</a></div>
<br />
<div>
</div>
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<div>
<a href="http://proteinopathies.blogspot.com/">http://proteinopathies.blogspot.com/</a></div>
<br />
<div>
</div>
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<div>
<a href="http://earlyonsetdementia.blogspot.com/">http://earlyonsetdementia.blogspot.com/</a></div>
<br />
<div>
</div>
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<div>
<a href="http://bovineprp.blogspot.com/">http://bovineprp.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bseusa.blogspot.com/">http://bseusa.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://madcowusda.blogspot.com/">http://madcowusda.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bse-atypical.blogspot.com/">http://bse-atypical.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://scrapie-usa.blogspot.com/">http://scrapie-usa.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://nor-98.blogspot.com/">http://nor-98.blogspot.com/</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://felinespongiformencephalopathyfse.blogspot.com/">http://felinespongiformencephalopathyfse.blogspot.com/</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://caninespongiformencephalopathy.blogspot.com/">http://caninespongiformencephalopathy.blogspot.com/</a>
</div>
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<div>
</div>
<br />
<div>
<a href="http://madporcinedisease.blogspot.com/">http://madporcinedisease.blogspot.com/</a></div>
<br />
<div>
</div>
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</div>
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</div>
<br />
<div>
Terry S. Singeltary Sr.</div>
<br />
<div>
</div>
</---></div>
</---></div>
</---></div>
</---></div>
</---></div>
</---></div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-63292474318768317602015-11-12T11:31:00.001-08:002015-11-13T11:53:01.735-08:00Evaluation of the protection of primates transfused with variant Creutzfeldt-Jakob disease–infected blood products filtered with prion removal devices: a 5-year update<div class="citation articleInformationHeader" id="titleMeta" xmlns="http://www.w3.org/1999/xhtml">
<div>
TRANSFUSION COMPLICATIONS</div>
<div>
</div>
<div>
Evaluation of the protection of primates transfused with variant
Creutzfeldt-Jakob disease–infected blood products filtered with prion removal
devices: a 5-year update Nathalie Lescoutra-Etchegaray1,†, Nina Jaffré1,†,
Chryslain Sumian2, Valérie Durand3, Evelyne Correia3, Jacqueline Mikol3, Sophie
Luccantoni-Freire3, Audrey Culeux1, Jean-Philippe Deslys3 and Emmanuel E.
Comoy3,* Article first published online: 3 FEB 2015</div>
<div>
</div>
<div>
DOI: 10.1111/trf.12999</div>
<div>
</div>
<div>
© 2015 AABB</div>
<div>
</div>
<div>
Issue </div>
<div>
</div>
<div>
Transfusion Volume 55, Issue 6, pages 1231–1241, June 2015</div>
<div>
</div>
<div>
Lescoutra-Etchegaray, N., Jaffré, N., Sumian, C., Durand, V., Correia, E.,
Mikol, J., Luccantoni-Freire, S., Culeux, A., Deslys, J.-P. and Comoy, E. E.
(2015), Evaluation of the protection of primates transfused with variant
Creutzfeldt-Jakob disease–infected blood products filtered with prion removal
devices: a 5-year update. Transfusion, 55: 1231–1241. doi: 10.1111/trf.12999
Author Information 1 Macopharma, Fontenay-aux-Roses, France</div>
<div>
</div>
<div>
2 Macopharma, Tourcoing, France</div>
<div>
</div>
<div>
3 Division of Prions and Related Diseases (SEPIA), CEA, Institute of
Emerging Diseases and Innovative Therapies (iMETI), Fontenay-aux-Roses,
France</div>
<div>
</div>
<div>
† These authors contributed equally to the work.</div>
<div>
</div>
<div>
*Address reprint requests to: Emmanuel Comoy, CEA, Division of Prions and
Related Diseases (SEPIA), Institute of Emerging Diseases and Innovative
Therapies (iMETI), 18 Route Du Panorama, BP6, 92265 Fontenay-aux-Roses, France;
e-mail: emmanuel.comoy@cea.fr.</div>
<div>
</div>
<div>
This work was supported by a grant from Agence Nationale de la Recherche
(ANR), Project PRIONSECUR ANR05PRIB02302.</div>
<div>
</div>
<div>
Publication History Issue published online: 13 JUN 2015 Article first
published online: 3 FEB 2015 Manuscript Accepted: 30 OCT 2014 Manuscript
Revised: 27 OCT 2014 Manuscript Received: 30 DEC 2013 BACKGROUND Analysis of
archived appendix samples reveals that one in 2000 individuals in the United
Kingdom may carry the infectious prion protein associated with variant
Creutzfeldt-Jakob disease (vCJD), raising questions about the risk of
transfusion transmission from apparently healthy carriers. Blood leukoreduction
shows limited efficiency against prions. Therefore, in absence of antemortem
diagnostic tests, prion removal filters, including the P-Capt filter were
designed to improve blood transfusion safety.</div>
<div>
</div>
<div>
STUDY DESIGN AND METHODS We evaluated the performances of two filters, the
P-Capt and one prototype (PMC#005), with blood-borne infectivity in two
independent experiments. Blood was drawn twice from prion-infected macaques.
Corresponding RBCCs were prepared according to two different procedures: in
Study A, the leukoreduction step was followed by the filtration through the
P-Capt. In Study B, the leukoreduction and prion removal were performed
simultaneously through the PMC#005. For each study, two groups of three animals
were transfused twice with samples before or after filtration.</div>
<div>
</div>
<div>
RESULTS Among the six macaques transfused with nonfiltered samples, five
developed neurologic signs but only four exhibited peripheral detectable
protease-resistant prion protein (PrPres) accumulation. In Study A, the three
animals transfused with P-Capt–filtered samples remain asymptomatic and devoid
of PrPres in lymph node biopsies 6 years after the transfusion. In Study B, one
animal transfused with PMC#005-filtered samples developed vCJD.</div>
<div>
</div>
<div>
CONCLUSION After 5 to 6 years of progress, this ongoing study provides
encouraging results on the prion blood removal performances of the P-Capt filter
in macaques, an utmost relevant model for human prion diseases.</div>
<div>
</div>
<div>
<a href="http://onlinelibrary.wiley.com/doi/10.1111/trf.12999/abstract;jsessionid=BF6B7590C347432AD8B80AA220BC28B2.f03t01">http://onlinelibrary.wiley.com/doi/10.1111/trf.12999/abstract;jsessionid=BF6B7590C347432AD8B80AA220BC28B2.f03t01</a></div>
<div>
</div>
<div>
Research Project: TRANSMISSION, DIFFERENTIATION, AND PATHOBIOLOGY OF
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES </div>
<div>
</div>
<div>
*** Title: Transmission of scrapie prions to primate after an extended
silent incubation period </div>
<div>
</div>
<div>
Authors item Comoy, Emmanuel - item Mikol, Jacqueline - item
Luccantoni-Freire, Sophie - item Correia, Evelyne - item Lescoutra-Etchegaray,
Nathalie - item Durand, Valérie - item Dehen, Capucine - item Andreoletti,
Olivier - item Casalone, Cristina - item Richt, Juergen item Greenlee, Justin
item Baron, Thierry - item Benestad, Sylvie - item Hills, Bob - item Brown, Paul
- item Deslys, Jean-Philippe - Submitted to: Scientific Reports Publication
Type: Peer Reviewed Journal Publication Acceptance Date: May 28, 2015
Publication Date: June 30, 2015 Citation: Comoy, E.E., Mikol, J.,
Luccantoni-Freire, S., Correia, E., Lescoutra-Etchegaray, N., Durand, V., Dehen,
C., Andreoletti, O., Casalone, C., Richt, J.A., Greenlee, J.J., Baron, T.,
Benestad, S., Brown, P., Deslys, J. 2015. </div>
<div>
</div>
<div>
Transmission of scrapie prions to primate after an extended silent
incubation period. </div>
<div>
</div>
<div>
Scientific Reports. 5:11573. </div>
<div>
</div>
<div>
Interpretive Summary: The transmissible spongiform encephalopathies (also
called prion diseases) are fatal neurodegenerative diseases that affect animals
and humans. The agent of prion diseases is a misfolded form of the prion protein
that is resistant to breakdown by the host cells. Since all mammals express
prion protein on the surface of various cells such as neurons, all mammals are,
in theory, capable of replicating prion diseases. One example of a prion
disease, bovine spongiform encephalopathy (BSE; also called mad cow disease),
has been shown to infect cattle, sheep, exotic undulates, cats, non-human
primates, and humans when the new host is exposed to feeds or foods contaminated
with the disease agent. The purpose of this study was to test whether non-human
primates (cynomologous macaque) are susceptible to the agent of sheep scrapie.
</div>
<div>
</div>
<div>
After an incubation period of approximately 10 years a macaque developed
progressive clinical signs suggestive of neurologic disease. Upon postmortem
examination and microscopic examination of tissues, there was a widespread
distribution of lesions consistent with a transmissible spongiform
encephalopathy. This information will have a scientific impact since it is the
first study that demonstrates the transmission of scrapie to a non-human primate
with a close genetic relationship to humans. </div>
<div>
</div>
<div>
This information is especially useful to regulatory officials and those
involved with risk assessment of the potential transmission of animal prion
diseases to humans. </div>
<div>
</div>
<div>
Technical Abstract: Classical bovine spongiform encephalopathy (c-BSE) is
an animal prion disease that also causes variant Creutzfeldt-Jakob disease in
humans. Over the past decades, c-BSE's zoonotic potential has been the driving
force in establishing extensive protective measures for animal and human health.
In complement to the recent demonstration that humanized mice are susceptible to
scrapie, we report here the first observation of direct transmission of a
natural classical scrapie isolate to a macaque after a 10-year incubation
period. Neuropathologic examination revealed all of the features of a prion
disease: spongiform change, neuronal loss, and accumulation of PrPres throughout
the CNS. </div>
<div>
</div>
<div>
***This observation strengthens the questioning of the harmlessness of
scrapie to humans, at a time when protective measures for human and animal
health are being dismantled and reduced as c-BSE is considered controlled and
being eradicated. Our results underscore the importance of precautionary and
protective measures and the necessity for long-term experimental transmission
studies to assess the zoonotic potential of other animal prion strains. </div>
<div>
</div>
<div>
<a href="http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160">http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=313160</a></div>
<div>
</div>
<div>
Eurosurveillance, Volume 12, Issue 3, 18 January 2007 Articles Editorial
team1 + Author affiliations </div>
<div>
</div>
<div>
--------------------------------------------------------------------------------</div>
<div>
</div>
<div>
Citation style for this article: Editorial team. Fourth case of
transfusion-associated vCJD infection in the United Kingdom. Euro Surveill.
2007;12(3):pii=3117. </div>
<div>
</div>
<div>
Available online: <a href="http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=3117">http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=3117</a>
Date of submission:</div>
<div>
</div>
<div>
--------------------------------------------------------------------------------</div>
<div>
</div>
<div>
Fourth case of transfusion-associated vCJD infection in the United
Kingdom</div>
<div>
</div>
<div>
Editorial team (eurosurveillance.weekly@hpa.org.uk), Eurosurveillance
editorial office</div>
<div>
</div>
<div>
A case of variant Creutzfeldt-Jakob disease (vCJD) has recently been
diagnosed in a patient in the United Kingdom (UK), who received a blood
transfusion from a donor who later developed vCJD [1]. This is the fourth case
of probable transfusion transmission of vCJD infection in the UK. Three of the
four recipients developed symptoms of vCJD. The first symptomatic case of vCJD
associated with blood transfusion was identified in December 2003. This
individual developed vCJD six and a half years after transfusion of red cells
donated by an individual who developed symptoms of vCJD three and a half years
after donation. </div>
<div>
</div>
<div>
A second case of vCJD 'infection' was identified a few months later in a
person who had received red cells from a donor who developed symptoms of vCJD 18
months after donation. This patient (the second case) died from causes unrelated
to vCJD five years after transfusion. Post-mortem investigations found abnormal
prion protein in the spleen and a cervical lymph node., However, prion protein
was not found in the brain, and no pathological features of vCJD were found.
</div>
<div>
</div>
<div>
A third case developed symptoms of vCJD six years after receiving a
transfusion of red blood cells, and died two years and eight months later. The
donor of the blood involved developed vCJD about 20 months after donating it.
</div>
<div>
</div>
<div>
These three cases have been published as case reports and in the findings
of the ongoing collaborative study between the National Blood Services, the
National CJD Surveillance Unit, and the Office for National Statistics. This
study aims to collect evidence about transmission of CJD or vCJD via the blood
supply [2,3,4,5]. </div>
<div>
</div>
<div>
The new, fourth case is in a patient who developed symptoms of vCJD eight
and a half years after receiving a transfusion of red blood cells from a donor
who developed vCJD about 17 months after this blood was donated [1]. The donor
to this case also donated the vCJD-implicated blood transfused to the third
case. As for all other reported clinical vCJD cases that have been tested for
genotype, this patient is a methionine homozygote at codon 129 of the prion
protein gene. The patient is currently alive. </div>
<div>
</div>
<div>
All four cases had received transfusions of non-leucodepleted red blood
cells between 1996 and 1999. Since October 1999, leucocytes have been removed
from all blood used for transfusion in the UK. The effect of leucodepletion on
the reduction of the risk of transmission of vCJD from an infective donation is
uncertain. </div>
<div>
</div>
<div>
This fourth case of vCJD infection associated with blood transfusion
further increases the level of concern about the risk of vCJD transmission
between humans by blood transfusion, although much remains unknown. This
reinforces the importance of the existing precautions that have been introduced
to reduce the risk of transmission of vCJD infection by blood and blood products
[6]. No cases of vCJD have been associated with fractionated plasma products.
The small group of living recipients of vCJD-implicated blood transfusion in the
UK have been informed of their potential exposure to vCJD by blood transfusion,
asked to take certain precautions to reduce the risk of onward person-to-person
transmission of vCJD during health care, and offered specialist neurological
evaluation and advice. </div>
<div>
</div>
<div>
This article has been adapted from reference 1 </div>
<div>
</div>
<div>
References: Health Protection Agency. Fourth case of variant CJD associated
with blood transfusion (press release). Press release, 18 January 2007. (<a href="http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/070118_vCJD.htm)">http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/070118_vCJD.htm)</a>
Llewelyn CA, Hewitt PE, Knight RSG, Amar K, Cousens S, Mackenzie J, et al.
Possible transmission of variant CJD disease by blood transfusion. Lancet 2004;
363:417-21. Peden AH, Head MW, Ritchie DL, Bell JE, Ironside JW. Preclinical
vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet
2004 ; 364: 527-9. Wroe SJ, Pal S, Siddique D, Hyare H, Macfarlane R, et al
Clinical presentation and pre-mortem diagnosis of blood transfusion-associated
variant CJD. Lancet 2006;368:2061-67. Hewitt PE, Llewelyn CA, Mackenzie J, Will
RG. Creutzfeldt-Jakob disease and blood transfusion: results of the UK
Transfusion Medicine Epidemiology review study. Vox Sang. 2006;91(3):221-230.
Department of Health [London]. Further precautions to protect blood supply.
Press release 2004/0104, 16 March 2004. (<a href="http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4076608&chk=MTwE%2Bl)">http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4076608&chk=MTwE%2Bl)</a>
<a href="http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=3117">http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=3117</a></div>
<div>
</div>
<div>
<a href="http://vcjdtransfusion.blogspot.com/2007_01_01_archive.html">http://vcjdtransfusion.blogspot.com/2007_01_01_archive.html</a></div>
<div>
</div>
<div>
*** The UK first reported a presumptive clinical case of TTvCJD in 2003,
followed by two other clinical cases and two preclinical or subclinical
infections,..</div>
<div>
</div>
<div>
<a href="http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/transmissiblespongiformencephalopathiesadvisorycommittee/ucm447993.pdf">http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/transmissiblespongiformencephalopathiesadvisorycommittee/ucm447993.pdf</a></div>
<div>
</div>
<div>
<a href="http://vcjdtransfusion.blogspot.com/">http://vcjdtransfusion.blogspot.com/</a></div>
<div>
</div>
<div>
Thursday, September 10, 2015 </div>
<div>
</div>
<div>
25th Meeting of the Transmissible Spongiform Encephalopathies Advisory
Committee Food and Drug Administration Silver Spring, Maryland June 1, 2015
</div>
<div>
</div>
<div>
<a href="http://tseac.blogspot.com/2015/09/25th-meeting-of-transmissible.html">http://tseac.blogspot.com/2015/09/25th-meeting-of-transmissible.html</a></div>
<div>
</div>
<div>
Sunday, November 23, 2014 </div>
<div>
</div>
<div>
Confirmed Variant Creutzfeldt-Jakob Disease (variant CJD) Case in Texas in
June 2014 confirmed as USA case NOT European </div>
<div>
</div>
<div>
Confirmed Variant Creutzfeldt-Jakob Disease (variant CJD) Case in Texas
</div>
<div>
</div>
<div>
Updated: October 7, 2014 </div>
<div>
</div>
<div>
CDC and the Texas Department of State Health Services (DSHS) have completed
the investigation of the recently reported fourth vCJD case in the United
States. It confirmed that the case was in a US citizen born outside the Americas
and indicated that the patient's exposure to the BSE/vCJD agent most likely
occurred before he moved to the United States; the patient had resided in
Kuwait, Russia and Lebanon. The completed investigation did not support the
patient's having had extended travel to European countries, including the United
Kingdom, or travel to Saudi Arabia. </div>
<div>
</div>
<div>
***The specific overseas country where this patient’s infection occurred is
less clear largely because the investigation did not definitely link him to a
country where other known vCJD cases likely had been infected. </div>
<div>
</div>
<div>
<a href="http://www.cdc.gov/ncidod/dvrd/vcjd/other/confirmed-case-in-texas.htm">http://www.cdc.gov/ncidod/dvrd/vcjd/other/confirmed-case-in-texas.htm</a>
</div>
<div>
</div>
<div>
2015 PRION CONFERENCE</div>
<div>
</div>
<div>
*** RE-P.164: Blood transmission of prion infectivity in the squirrel
monkey: The Baxter study</div>
<div>
</div>
<div>
***suggest that blood donations from cases of GSS (and perhaps other
familial forms of TSE) carry more risk than from vCJD cases, and that little or
no risk is associated with sCJD. *** </div>
<div>
</div>
<div>
P.164: Blood transmission of prion infectivity in the squirrel monkey: The
Baxter study</div>
<div>
</div>
<div>
Paul Brown1, Diane Ritchie2, James Ironside2, Christian Abee3, Thomas
Kreil4, and Susan Gibson5 1NIH (retired); Bethesda, MD USA; 2University of
Edinburgh; Edinburgh, UK; 3University of Texas; Bastrop, TX USA; 4Baxter
Bioscience; Vienna, Austria; 5University of South Alabama; Mobile, AL USA</div>
<div>
</div>
<div>
Five vCJD disease transmissions and an estimated 1 in 2000 ‘silent’
infections in UK residents emphasize the continued need for information about
disease risk in humans. A large study of blood component infectivity in a
non-human primate model has now been completed and analyzed. Among 1 GSS, 4
sCJD, and 3 vCJD cases, only GSS leukocytes transmitted disease within a 5–6
year surveillance period. A transmission study in recipients of multiple whole
blood transfusions during the incubation and clinical stages of sCJD and vCJD in
ic-infected donor animals was uniformly negative. These results, together with
other laboratory studies in rodents and nonhuman primates and epidemiological
observations in humans, suggest that blood donations from cases of GSS (and
perhaps other familial forms of TSE) carry more risk than from vCJD cases, and
that little or no risk is associated with sCJD. The issue of decades-long
incubation periods in ‘silent’ vCJD carriers remains open.</div>
<div>
</div>
<div>
<a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf">https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf</a>
</div>
<div>
</div>
<div>
ran across an old paper from 1984 ; </div>
<div>
</div>
<div>
***The occurrence of contact cases raises the possibility that transmission
in families may be effected by an unusually virulent strain of the agent.
***</div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html</a>
</div>
<div>
</div>
<div>
From: Terry S. Singeltary Sr. </div>
<div>
</div>
<div>
Sent: Saturday, November 15, 2014 9:29 PM </div>
<div>
</div>
<div>
To: Terry S. Singeltary Sr. </div>
<div>
</div>
<div>
Subject: THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE R. G. WILL
1984</div>
<div>
</div>
<div>
THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE </div>
<div>
</div>
<div>
R. G. WILL </div>
<div>
</div>
<div>
1984</div>
<div>
</div>
<div>
snip...</div>
<div>
</div>
<div>
<a href="http://web.archive.org/web/20050425210551/http://www.bseinquiry.gov.uk/files/mb/m26/tab01.pdf">http://web.archive.org/web/20050425210551/http://www.bseinquiry.gov.uk/files/mb/m26/tab01.pdf</a>
</div>
<div>
</div>
<div>
THE BAXTER STUDY...SEE MORE HERE ;</div>
<div>
</div>
<div>
<a href="http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html">http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html</a>
</div>
<div>
</div>
<div>
<a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf">https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf</a>
</div>
<div>
</div>
<div>
Saturday, May 30, 2015 </div>
<div>
</div>
<div>
PRION 2015 ORAL AND POSTER CONGRESSIONAL ABSTRACTS </div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2015/05/prion-2015-oral-and-poster.html">http://transmissiblespongiformencephalopathy.blogspot.com/2015/05/prion-2015-oral-and-poster.html</a>
</div>
<div>
</div>
<div>
Wednesday, December 11, 2013 </div>
<div>
</div>
<div>
*** Detection of Infectivity in Blood of Persons with Variant and Sporadic
Creutzfeldt-Jakob Disease ***</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html</a>
</div>
<div>
</div>
<div>
THE BAXTER STUDY...SEE MORE HERE ;</div>
<div>
</div>
<div>
<a href="http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html">http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html</a>
</div>
<div>
</div>
<div>
Thursday, September 10, 2015 </div>
<div>
</div>
<div>
25th Meeting of the Transmissible Spongiform Encephalopathies Advisory
Committee Food and Drug Administration Silver Spring, Maryland June 1, 2015
</div>
<div>
</div>
<div>
<a href="http://tseac.blogspot.com/2015/09/25th-meeting-of-transmissible.html">http://tseac.blogspot.com/2015/09/25th-meeting-of-transmissible.html</a></div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/">http://creutzfeldt-jakob-disease.blogspot.com/</a></div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/">http://transmissiblespongiformencephalopathy.blogspot.com/</a></div>
<div>
</div>
<div>
*** The potential impact of prion diseases on human health was greatly
magnified by the recognition that interspecies transfer of BSE to humans by beef
ingestion resulted in vCJD. While changes in animal feed constituents and
slaughter practices appear to have curtailed vCJD, there is concern that CWD of
free-ranging deer and elk in the U.S. might also cross the species barrier.
Thus, consuming venison could be a source of human prion disease. Whether BSE
and CWD represent interspecies scrapie transfer or are newly arisen prion
diseases is unknown. Therefore, the possibility of transmission of prion disease
through other food animals cannot be ruled out. There is evidence that vCJD can
be transmitted through blood transfusion. There is likely a pool of unknown size
of asymptomatic individuals infected with vCJD, and there may be asymptomatic
individuals infected with the CWD equivalent. These circumstances represent a
potential threat to blood, blood products, and plasma supplies. ***</div>
<div>
</div>
<div>
<a href="http://cdmrp.army.mil/prevfunded/nprp/NPRP_Summit_Final_Report.pdf">http://cdmrp.army.mil/prevfunded/nprp/NPRP_Summit_Final_Report.pdf</a>
</div>
<div>
</div>
<div>
*** These results would seem to suggest that CWD does indeed have zoonotic
potential, at least as judged by the compatibility of CWD prions and their human
PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests
that if zoonotic CWD occurred, it would most likely effect those of the PRNP
codon 129-MM genotype and that the PrPres type would be similar to that found in
the most common subtype of sCJD (MM1).*** </div>
<div>
</div>
<div>
<a href="https://www.landesbioscience.com/journals/prion/article/28124/?nocache=112223249">https://www.landesbioscience.com/journals/prion/article/28124/?nocache=112223249</a>
</div>
<div>
</div>
<div>
*** Brain and lymphoid tissue contain the highest levels of the abnormal
prion protein, the marker for disease, and transmission in white tailed deer can
be accomplished by blood transfusion from experimentally infected deer to naive
deer. *** </div>
<div>
</div>
<div>
Research Project: TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES: THE ROLE OF
GENETICS, STRAIN VARIATION, AND ENVIRONMENTAL CONTAMINATION IN DISEASE CONTROL
Title: Chronic Wasting Disease Prions in Elk Antler Velvet </div>
<div>
</div>
<div>
Authors </div>
<div>
</div>
<div>
item Angers, R - UNIVERSITY OF KENTUCKY item Napier, D - UNIVERSITY OF
KENTUCKY item Seward, T - UNIVERSITY OF KENTUCKY item Green, M - UNIVERSITY OF
KENTUCKY item Spraker, T - COLORADO STATE UNIVERSITY item O'Rourke, Katherine
item Balachandran, A - CANADIAN FOOD INSPCTN AG item Telling, G - UNIVERSITY OF
KENTUCKY </div>
<div>
</div>
<div>
Submitted to: Emerging Infectious Diseases Publication Type: Peer Reviewed
Journal Publication Acceptance Date: February 1, 2009 Publication Date: May 1,
2009 Repository URL: <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2687044/pdf/08-1458_finalR.pdf">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2687044/pdf/08-1458_finalR.pdf</a>
Citation: Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al.
2009. </div>
<div>
</div>
<div>
Chronic wasting disease prions in elk antler velvet. </div>
<div>
</div>
<div>
Emerg Infect Dis 15(5):696-703. </div>
<div>
</div>
<div>
Interpretive Summary: Chronic wasting disease (CWD) is a fatal neurologic
disease of deer and elk in the United States and Canada. The disease is
associated with accumulations of infectious proteins in the brain, nervous
system, blood, and a limited number of other tissues. In this study, the
investigators examined elk antler velvet, the covering that grows on elk antlers
every year. Antler velvet is rich in blood and nervous supply and may represent
a source of infectious material as the velvet is shed every year. Antler velvet
and brain tissue from four infected elk was examined by immunohistochemistry and
biochemical methods, with no evidence of the abnormal prion protein in antler
velvet. The same preparations were tested in genetically engineered mice
susceptible to CWD. Mice in both inoculated groups developed prion disease. This
finding demonstrates that antler velvet from CWD infected elk contain infectious
material and may represent a risk material to other elk. Technical Abstract:
Chronic wasting disease (CWD) is a transmissible spongiform encephalopathy or
prion disease of captive and free ranging white tailed deer, mule deer, Rocky
Mountain elk and moose in the some parts of the United States and Canada. The
presence of the disease has sharply curtailed movement of captive animals and
reduced the domestic or international market for some cervid by-products. The
disease appears to be transmitted by Rocky Mountain elk relatively late in the
disease course, but the sources of the infectious material remain undefined.
Brain and lymphoid tissue contain the highest levels of the abnormal prion
protein, the marker for disease, and transmission in white tailed deer can be
accomplished by blood transfusion from experimentally infected deer to naive
deer. In this study, the investigators examined the transmission potential of
antler velvet, a highly vascularized and innervated epidermal tissue covering
the growing antler. Antler velvet is shed each year and is widely used as a
nutritional supplement. Genetically engineered mice susceptible to CWD were
inoculated with homogenates of paired brain and antler velvet from 4 elk with
CWD. Mice in both groups developed a transmissible spongiform encephalopathy.
These findings demonstrate prion infectivity accumulates in antler velvet and
may have impact on marketing of this product. </div>
<div>
</div>
<div>
<a href="http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=227882">http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=227882</a>
</div>
<div>
</div>
<div>
*** Brain and lymphoid tissue contain the highest levels of the abnormal
prion protein, the marker for disease, and transmission in white tailed deer can
be accomplished by blood transfusion from experimentally infected deer to naive
deer. *** </div>
<div>
</div>
<div>
see; </div>
<div>
</div>
<div>
<a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2687044/pdf/08-1458_finalR.pdf">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2687044/pdf/08-1458_finalR.pdf</a>
</div>
<div>
</div>
<div>
Thursday, March 19, 2009 </div>
<div>
</div>
<div>
Chronic Wasting Disease Prions in Elk Antler Velvet (Nutritional
Supplements and CJD) 10.3201/eid1505.081458 Suggested citation for this article:
Angers RC, Seward TS, Napier D, Green M, Hoover E, Spraker T, et al. </div>
<div>
</div>
<div>
Chronic wasting disease prions in elk antler velvet. </div>
<div>
</div>
<div>
Emerg Infect Dis. 2009 May; [Epub ahead of print] </div>
<div>
</div>
<div>
<a href="http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html">http://chronic-wasting-disease.blogspot.com/2009/03/chronic-wasting-disease-prions-in-elk.html</a>
</div>
<div>
</div>
<div>
SNIP...</div>
<div>
</div>
<div>
SEE MUCH MORE HERE ; </div>
<div>
</div>
<div>
Wednesday, August 5, 2015 Federal judge enters permanent injunction against
Wisconsin dietary supplement manufacturers prohibited cattle materials BSE TSE
Prion </div>
<div>
</div>
<div>
*** Singeltary Submission to BSE Inquiry on Nutritional Supplements
containing SRM 1998 ***</div>
<div>
</div>
<div>
<a href="http://bovineprp.blogspot.com/2015/08/federal-judge-enters-permanent.html">http://bovineprp.blogspot.com/2015/08/federal-judge-enters-permanent.html</a>
</div>
<div>
</div>
<div>
*** PRION 2015 CONFERENCE FT. COLLINS CWD RISK FACTORS TO HUMANS *** </div>
<div>
</div>
<div>
*** LATE-BREAKING ABSTRACTS PRION 2015 CONFERENCE *** </div>
<div>
</div>
<div>
O18 </div>
<div>
</div>
<div>
Zoonotic Potential of CWD Prions </div>
<div>
</div>
<div>
Liuting Qing1, Ignazio Cali1,2, Jue Yuan1, Shenghai Huang3, Diane Kofskey1,
Pierluigi Gambetti1, Wenquan Zou1, Qingzhong Kong1 1Case Western Reserve
University, Cleveland, Ohio, USA, 2Second University of Naples, Naples, Italy,
3Encore Health Resources, Houston, Texas, USA </div>
<div>
</div>
<div>
***These results indicate that the CWD prion has the potential to infect
human CNS and peripheral lymphoid tissues and that there might be asymptomatic
human carriers of CWD infection.*** </div>
<div>
</div>
<div>
P.105: RT-QuIC models trans-species prion transmission </div>
<div>
</div>
<div>
Kristen Davenport, Davin Henderson, Candace Mathiason, and Edward Hoover
Prion Research Center; Colorado State University; Fort Collins, CO USA </div>
<div>
</div>
<div>
Additionally, human rPrP was competent for conversion by CWD and fCWD.
</div>
<div>
</div>
<div>
***This insinuates that, at the level of protein:protein interactions, the
barrier preventing transmission of CWD to humans is less robust than previously
estimated.*** </div>
<div>
</div>
<div>
<a href="https://prion2015.files.wordpress.com/2015/05/programguide1.pdf">https://prion2015.files.wordpress.com/2015/05/programguide1.pdf</a>
</div>
<div>
</div>
<div>
From: Terry S. Singeltary Sr. </div>
<div>
</div>
<div>
Sent: Saturday, November 15, 2014 9:29 PM </div>
<div>
</div>
<div>
To: Terry S. Singeltary Sr. </div>
<div>
</div>
<div>
Subject: THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE R. G. WILL 1984
</div>
<div>
</div>
<div>
THE EPIDEMIOLOGY OF CREUTZFELDT-JAKOB DISEASE </div>
<div>
</div>
<div>
R. G. WILL </div>
<div>
</div>
<div>
1984 </div>
<div>
</div>
<div>
*** The association between venison eating and risk of CJD shows similar
pattern, with regular venison eating associated with a 9 FOLD INCREASE IN RISK
OF CJD (p = 0.04). (SEE LINK IN REPORT HERE...TSS) PLUS, THE CDC DID NOT PUT
THIS WARNING OUT FOR THE WELL BEING OF THE DEER AND ELK ; </div>
<div>
</div>
<div>
snip... </div>
<div>
</div>
<div>
<a href="http://web.archive.org/web/20050425210551/http://www.bseinquiry.gov.uk/files/mb/m26/tab01.pdf">http://web.archive.org/web/20050425210551/http://www.bseinquiry.gov.uk/files/mb/m26/tab01.pdf</a>
</div>
<div>
</div>
<div>
85%+ of all human tse prion disease is sporadic CJD.</div>
<div>
</div>
<div>
see what the NIH prion Gods say themselves ;</div>
<div>
</div>
<div>
‘’In the Archives of Neurology you quoted (the abstract of which was
attached to your email), we did not say CWD in humans will present like variant
CJD. That assumption would be wrong.’’</div>
<div>
</div>
<div>
‘’Also, we do not claim that "no-one has ever been infected with prion
disease from eating venison." Our conclusion stating that we found no strong
evidence of CWD transmission to humans in the article you quoted or in any other
forum is limited to the patients we investigated.’’ </div>
<div>
</div>
<div>
*** These results would seem to suggest that CWD does indeed have zoonotic
potential, at least as judged by the compatibility of CWD prions and their human
PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests
that if zoonotic CWD occurred, it would most likely effect those of the PRNP
codon 129-MM genotype and that the PrPres type would be similar to that found in
the most common subtype of sCJD (MM1).*** </div>
<div>
</div>
<div>
<a href="https://www.landesbioscience.com/journals/prion/article/28124/?nocache=112223249">https://www.landesbioscience.com/journals/prion/article/28124/?nocache=112223249</a>
</div>
<div>
</div>
<div>
now, let’s see what the authors said about this casual link, personal
communications years ago. see where it is stated NO STRONG evidence. so, does
this mean there IS casual evidence ???? “Our conclusion stating that we found no
strong evidence of CWD transmission to humans” </div>
<div>
</div>
<div>
From: TSS (216-119-163-189.ipset45.wt.net) </div>
<div>
</div>
<div>
Subject: CWD aka MAD DEER/ELK TO HUMANS ??? </div>
<div>
</div>
<div>
Date: September 30, 2002 at 7:06 am PST </div>
<div>
</div>
<div>
From: "Belay, Ermias" </div>
<div>
</div>
<div>
To: Cc: "Race, Richard (NIH)" ; ; "Belay, Ermias" </div>
<div>
</div>
<div>
Sent: Monday, September 30, 2002 9:22 AM </div>
<div>
</div>
<div>
Subject: RE: TO CDC AND NIH - PUB MED- 3 MORE DEATHS - CWD - YOUNG HUNTERS
</div>
<div>
</div>
<div>
Dear Sir/Madam, </div>
<div>
</div>
<div>
In the Archives of Neurology you quoted (the abstract of which was attached
to your email), we did not say CWD in humans will present like variant CJD. That
assumption would be wrong. I encourage you to read the whole article and call me
if you have questions or need more clarification (phone: 404-639-3091). Also, we
do not claim that "no-one has ever been infected with prion disease from eating
venison." Our conclusion stating that we found no strong evidence of CWD
transmission to humans in the article you quoted or in any other forum is
limited to the patients we investigated. </div>
<div>
</div>
<div>
Ermias Belay, M.D. Centers for Disease Control and Prevention </div>
<div>
</div>
<div>
-----Original Message----- </div>
<div>
</div>
<div>
From: Sent: Sunday, September 29, 2002 10:15 AM </div>
<div>
</div>
<div>
To: rr26k@nih.gov; rrace@niaid.nih.gov; ebb8@CDC.GOV </div>
<div>
</div>
<div>
Subject: TO CDC AND NIH - PUB MED- 3 MORE DEATHS - CWD - YOUNG HUNTERS
</div>
<div>
</div>
<div>
Sunday, November 10, 2002 6:26 PM ......snip........end..............TSS
</div>
<div>
</div>
<div>
Thursday, April 03, 2008 </div>
<div>
</div>
<div>
A prion disease of cervids: Chronic wasting disease 2008 1: Vet Res. 2008
Apr 3;39(4):41 A prion disease of cervids: Chronic wasting disease Sigurdson CJ.
</div>
<div>
</div>
<div>
snip... </div>
<div>
</div>
<div>
*** twenty-seven CJD patients who regularly consumed venison were reported
to the Surveillance Center***, </div>
<div>
</div>
<div>
snip... full text ; </div>
<div>
</div>
<div>
<a href="http://chronic-wasting-disease.blogspot.com/2008/04/prion-disease-of-cervids-chronic.html">http://chronic-wasting-disease.blogspot.com/2008/04/prion-disease-of-cervids-chronic.html</a>
</div>
<div>
</div>
<div>
July's Milwaukee Journal Sentinel article did prod state officials to ask
CDC to investigate the cases of the three men who shared wild game feasts. The
two men the CDC is still investigating were 55 and 66 years old. But there's
also Kevin Boss, a Minnesota hunter who ate Barron County venison and died of
CJD at 41. And there's Jeff Schwan, whose Michigan Tech fraternity brothers used
to bring venison sausage back to the frat house. His mother, Terry, says that in
May 2001, Jeff, 26, began complaining about his vision. A friend noticed
misspellings in his e-mail, which was totally unlike him. Jeff began losing
weight. He became irritable and withdrawn. By the end of June, he couldn't
remember the four-digit code to open the garage door or when and how to feed his
parents' cats. At a family gathering in July, he stuck to his parents and
girlfriend, barely talking. "On the night we took him to the hospital, he was
speaking like he was drunk or high and I noticed his pupils were so dilated I
couldn't see the irises," his mother says. By then, Jeff was no longer able to
do even simple things on his computer at work, and "in the hospital, he couldn't
drink enough water." When he died on September 27, 2001, an autopsy confirmed he
had sporadic CJD. </div>
<div>
</div>
<div>
In 2000, Belay looked into three CJD cases reported by The Denver Post, two
hunters who ate meat from animals killed in Wyoming and the daughter of a hunter
who ate venison from a plant that processed Colorado elk. All three died of CJD
before they were 30 years old. The CDC asked the USDA to kill 1,000 deer and elk
in the area where the men hunted. Belay and others reported their findings in
the Archives of Neurology, writing that although "circumstances suggested a link
between the three cases and chronic wasting disease, they could find no 'causal'
link." Which means, says Belay, "not a single one of those 1,000 deer tested
positive for CWD. For all we know, these cases may be CWD. What we have now
doesn't indicate a connection. That's reassuring, but it would be wrong to say
it will never happen." </div>
<div>
</div>
<div>
So far, says NIH researcher Race, the two Wisconsin cases pinpointed by the
newspaper look like spontaneous CJD. "But we don't know how CWD would look in
human brains. It probably would look like some garden-variety sporadic CJD."
What the CDC will do with these cases and four others (three from Colorado and
Schwan from Upper Michigan), Race says, is "sequence the prion protein from
these people, inject it into mice and wait to see what the disease looks like in
their brains. That will take two years." </div>
<div>
</div>
<div>
CJD is so rare in people under age 30, one case in a billion (leaving out
medical mishaps), that four cases under 30 is "very high," says Colorado
neurologist Bosque. "Then, if you add these other two from Wisconsin [cases in
the newspaper], six cases of CJD in people associated with venison is very, very
high." Only now, with Mary Riley, there are at least seven, and possibly eight,
with Steve, her dining companion. "It's not critical mass that matters,"
however, Belay says. "One case would do it for me." The chance that two people
who know each other would both contact CJD, like the two Wisconsin sportsmen, is
so unlikely, experts say, it would happen only once in 140 years. </div>
<div>
</div>
<div>
Given the incubation period for TSEs in humans, it may require another
generation to write the final chapter on CWD in Wisconsin. "Does chronic wasting
disease pass into humans? We'll be able to answer that in 2022," says Race.
Meanwhile, the state has become part of an immense experiment. </div>
<div>
</div>
<div>
<a href="https://www.organicconsumers.org/old_articles/madcow/killer123103.php">https://www.organicconsumers.org/old_articles/madcow/killer123103.php</a></div>
<div>
</div>
<div>
I urge everyone to watch this video closely...terry</div>
<div>
</div>
<div>
*** you can see video here and interview with Jeff's Mom, and scientist
telling you to test everything and potential risk factors for humans *** </div>
<div>
</div>
<div>
<a href="http://zoomify.uzh.ch:8080/zoomify/videos/video-004/video-004.html">http://zoomify.uzh.ch:8080/zoomify/videos/video-004/video-004.html</a>
</div>
<div>
</div>
<div>
<a href="http://chronic-wasting-disease.blogspot.com/">http://chronic-wasting-disease.blogspot.com/</a></div>
<div>
</div>
<div>
*** These results would seem to suggest that CWD does indeed have zoonotic
potential, at least as judged by the compatibility of CWD prions and their human
PrPC target. Furthermore, extrapolation from this simple in vitro assay suggests
that if zoonotic CWD occurred, it would most likely effect those of the PRNP
codon 129-MM genotype and that the PrPres type would be similar to that found in
the most common subtype of sCJD (MM1).*** </div>
<div>
</div>
<div>
<a href="https://www.landesbioscience.com/journals/prion/article/28124/?nocache=112223249">https://www.landesbioscience.com/journals/prion/article/28124/?nocache=112223249</a>
</div>
<div>
</div>
<div>
O.05: Transmission of prions to primates after extended silent incubation
periods: Implications for BSE and scrapie risk assessment in human populations
</div>
<div>
</div>
<div>
Emmanuel Comoy, Jacqueline Mikol, Val erie Durand, Sophie Luccantoni,
Evelyne Correia, Nathalie Lescoutra, Capucine Dehen, and Jean-Philippe Deslys
Atomic Energy Commission; Fontenay-aux-Roses, France </div>
<div>
</div>
<div>
Prion diseases (PD) are the unique neurodegenerative proteinopathies
reputed to be transmissible under field conditions since decades. The
transmission of Bovine Spongiform Encephalopathy (BSE) to humans evidenced that
an animal PD might be zoonotic under appropriate conditions. Contrarily, in the
absence of obvious (epidemiological or experimental) elements supporting a
transmission or genetic predispositions, PD, like the other proteinopathies, are
reputed to occur spontaneously (atpical animal prion strains, sporadic CJD
summing 80% of human prion cases). Non-human primate models provided the first
evidences supporting the transmissibiity of human prion strains and the zoonotic
potential of BSE. Among them, cynomolgus macaques brought major information for
BSE risk assessment for human health (Chen, 2014), according to their
phylogenetic proximity to humans and extended lifetime. We used this model to
assess the zoonotic potential of other animal PD from bovine, ovine and cervid
origins even after very long silent incubation periods. *** We recently observed
the direct transmission of a natural classical scrapie isolate to macaque after
a 10-year silent incubation period, ***with features similar to some reported
for human cases of sporadic CJD, albeit requiring fourfold longe incubation than
BSE. Scrapie, as recently evoked in humanized mice (Cassard, 2014), ***is the
third potentially zoonotic PD (with BSE and L-type BSE), ***thus questioning the
origin of human sporadic cases. We will present an updated panorama of our
different transmission studies and discuss the implications of such extended
incubation periods on risk assessment of animal PD for human health.</div>
<div>
</div>
<div>
===============</div>
<div>
</div>
<div>
***thus questioning the origin of human sporadic cases...TSS</div>
<div>
</div>
<div>
=============== </div>
<div>
</div>
<div>
<a href="https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf">https://prion2015.files.wordpress.com/2015/05/prion2015abstracts.pdf</a>
</div>
<div>
</div>
<div>
Saturday, January 31, 2015 </div>
<div>
</div>
<div>
European red deer (Cervus elaphus elaphus) are susceptible to Bovine
Spongiform Encephalopathy BSE by Oral Alimentary route</div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2015/01/european-red-deer-cervus-elaphus.html" style="href: "http://transmissiblespongiformencephalopathy.blogspot.com/2015/01/european-red-deer-cervus-elaphus.html";">http://transmissiblespongiformencephalopathy.blogspot.com/2015/01/european-red-deer-cervus-elaphus.html</a>
</div>
<div>
</div>
<div>
I strenuously once again urge the FDA and its industry constituents, to
make it MANDATORY that all ruminant feed be banned to all ruminants, and this
should include all cervids as soon as possible for the following
reasons...</div>
<div>
</div>
<div>
======</div>
<div>
</div>
<div>
In the USA, under the Food and Drug Administrations BSE Feed Regulation (21
CFR 589.2000) most material (exceptions include milk, tallow, and gelatin) from
deer and elk is prohibited for use in feed for ruminant animals. With regards to
feed for non-ruminant animals, under FDA law, CWD positive deer may not be used
for any animal feed or feed ingredients. For elk and deer considered at high
risk for CWD, the FDA recommends that these animals do not enter the animal feed
system. </div>
<div>
</div>
<div>
***However, this recommendation is guidance and not a requirement by law.
</div>
<div>
</div>
<div>
======</div>
<div>
</div>
<div>
31 Jan 2015 at 20:14 GMT </div>
<div>
</div>
<div>
*** Ruminant feed ban for cervids in the United States? ***</div>
<div>
</div>
<div>
31 Jan 2015 at 20:14 GMT </div>
<div>
</div>
<div>
<a href="http://www.plosone.org/annotation/listThread.action?root=85351" style="href: "http://www.plosone.org/annotation/listThread.action?root=85351";">http://www.plosone.org/annotation/listThread.action?root=85351</a>
</div>
<div>
</div>
<div>
Sunday, October 25, 2015 </div>
<div>
</div>
<div>
USAHA Detailed Events Schedule – 119th USAHA Annual Meeting CAPTIVE
LIVESTOCK CWD SCRAPIE TSE PRION</div>
<div>
</div>
<div>
<a href="http://chronic-wasting-disease.blogspot.com/2015/10/usaha-detailed-events-schedule-119th.html" style="href: "http://chronic-wasting-disease.blogspot.com/2015/10/usaha-detailed-events-schedule-119th.html";">http://chronic-wasting-disease.blogspot.com/2015/10/usaha-detailed-events-schedule-119th.html</a>
</div>
<div>
</div>
<div>
Monday, October 26, 2015 </div>
<div>
</div>
<div>
FDA PART 589 -- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
VIOLATIONS OFFICIAL ACTION INDICATED OIA UPDATE October 2015 </div>
<div>
</div>
<div>
<a 10="" 2015="" fda-part-589-substances-prohibited-from.html="" href="http://madcowusda.blogspot.com/2015/10/fda-part-589-substances-prohibited-from.html" madcowusda.blogspot.com="">http://madcowusda.blogspot.com/2015/10/fda-part-589-substances-prohibited-from.html</a>
</div>
<div>
</div>
<div>
</div>
<div>
Abstract </div>
<div>
</div>
<div>
Although Bovine Spongiform Encephalopathy (BSE) is the cause of variant
Creutzfeldt Jakob disease (vCJD) in humans, the zoonotic potential of scrapie
prions remains unknown. Mice genetically engineered to overexpress the human
prion protein (tgHu) have emerged as highly relevant models for gauging the
capacity of prions to transmit to humans. These models can propagate human
prions without any apparent transmission barrier and have been used used to
confirm the zoonotic ability of BSE. Here we show that a panel of sheep scrapie
prions transmit to several tgHu mice models with an efficiency comparable to
that of cattle BSE. The serial transmission of different scrapie isolates in
these mice led to the propagation of prions that are phenotypically identical to
those causing sporadic CJD (sCJD) in humans. These results demonstrate that
scrapie prions have a zoonotic potential and raise new questions about the
possible link between animal and human prions.</div>
<div>
</div>
<div>
Subject terms: Biological sciences• Medical research At a glance</div>
<div>
</div>
<div>
<a href="http://www.nature.com/ncomms/2014/141216/ncomms6821/full/ncomms6821.html">http://www.nature.com/ncomms/2014/141216/ncomms6821/full/ncomms6821.html</a></div>
<div>
</div>
<div>
why do we not want to do TSE transmission studies on chimpanzees $ </div>
<div>
</div>
<div>
5. A positive result from a chimpanzee challenged severly would likely
create alarm in some circles even if the result could not be interpreted for
man. I have a view that all these agents could be transmitted provided a large
enough dose by appropriate routes was given and the animals kept long enough.
Until the mechanisms of the species barrier are more clearly understood it might
be best to retain that hypothesis. </div>
<div>
</div>
<div>
snip... </div>
<div>
</div>
<div>
R. BRADLEY </div>
<div>
</div>
<div>
<a href="http://collections.europarchive.org/tna/20080102222950/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf">http://collections.europarchive.org/tna/20080102222950/http://www.bseinquiry.gov.uk/files/yb/1990/09/23001001.pdf</a>
</div>
<div>
</div>
<div>
1: J Infect Dis 1980 Aug;142(2):205-8 </div>
<div>
</div>
<div>
Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to
nonhuman primates. </div>
<div>
</div>
<div>
Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC. </div>
<div>
</div>
<div>
Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep
and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were
exposed to the infectious agents only by their nonforced consumption of known
infectious tissues. The asymptomatic incubation period in the one monkey exposed
to the virus of kuru was 36 months; that in the two monkeys exposed to the virus
of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the
two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively.
Careful physical examination of the buccal cavities of all of the monkeys failed
to reveal signs or oral lesions. One additional monkey similarly exposed to kuru
has remained asymptomatic during the 39 months that it has been under
observation. </div>
<div>
</div>
<div>
snip... </div>
<div>
</div>
<div>
The successful transmission of kuru, Creutzfeldt-Jakob disease, and scrapie
by natural feeding to squirrel monkeys that we have reported provides further
grounds for concern that scrapie-infected meat may occasionally give rise in
humans to Creutzfeldt-Jakob disease. </div>
<div>
</div>
<div>
PMID: 6997404 </div>
<div>
</div>
<div>
<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract</a>
</div>
<div>
</div>
<div>
Recently the question has again been brought up as to whether scrapie is
transmissible to man. This has followed reports that the disease has been
transmitted to primates. One particularly lurid speculation (Gajdusek 1977)
conjectures that the agents of scrapie, kuru, Creutzfeldt-Jakob disease and
transmissible encephalopathy of mink are varieties of a single "virus". The U.S.
Department of Agriculture concluded that it could "no longer justify or permit
scrapie-blood line and scrapie-exposed sheep and goats to be processed for human
or animal food at slaughter or rendering plants" (ARC 84/77)" The problem is
emphasized by the finding that some strains of scrapie produce lesions identical
to the once which characterize the human dementias" </div>
<div>
</div>
<div>
Whether true or not. the hypothesis that these agents might be
transmissible to man raises two considerations. First, the safety of laboratory
personnel requires prompt attention. Second, action such as the "scorched meat"
policy of USDA makes the solution of the scrapie problem urgent if the sheep
industry is not to suffer grievously. </div>
<div>
</div>
<div>
snip... </div>
<div>
</div>
<div>
76/10.12/4.6 </div>
<div>
</div>
<div>
<a href="http://web.archive.org/web/20010305223125/www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf">http://web.archive.org/web/20010305223125/www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf</a>
</div>
<div>
</div>
<div>
Nature. 1972 Mar 10;236(5341):73-4. </div>
<div>
</div>
<div>
Transmission of scrapie to the cynomolgus monkey (Macaca fascicularis).
</div>
<div>
</div>
<div>
Gibbs CJ Jr, Gajdusek DC. </div>
<div>
</div>
<div>
Nature 236, 73 - 74 (10 March 1972); doi:10.1038/236073a0 </div>
<div>
</div>
<div>
Transmission of Scrapie to the Cynomolgus Monkey (Macaca fascicularis)
</div>
<div>
</div>
<div>
C. J. GIBBS jun. & D. C. GAJDUSEK </div>
<div>
</div>
<div>
National Institute of Neurological Diseases and Stroke, National Institutes
of Health, Bethesda, Maryland </div>
<div>
</div>
<div>
SCRAPIE has been transmitted to the cynomolgus, or crab-eating, monkey
(Macaca fascicularis) with an incubation period of more than 5 yr from the time
of intracerebral inoculation of scrapie-infected mouse brain. The animal
developed a chronic central nervous system degeneration, with ataxia, tremor and
myoclonus with associated severe scrapie-like pathology of intensive astroglial
hypertrophy and proliferation, neuronal vacuolation and status spongiosus of
grey matter. The strain of scrapie virus used was the eighth passage in Swiss
mice (NIH) of a Compton strain of scrapie obtained as ninth intracerebral
passage of the agent in goat brain, from Dr R. L. Chandler (ARC, Compton,
Berkshire). </div>
<div>
</div>
<div>
<a href="http://www.nature.com/nature/journal/v236/n5341/abs/236073a0.html">http://www.nature.com/nature/journal/v236/n5341/abs/236073a0.html</a>
</div>
<div>
</div>
<div>
<a href="http://scrapie-usa.blogspot.com/2010/04/scrapie-and-atypical-scrapie.html">http://scrapie-usa.blogspot.com/2010/04/scrapie-and-atypical-scrapie.html</a>
</div>
<div>
</div>
<div>
<a href="http://scrapie-usa.blogspot.com/">http://scrapie-usa.blogspot.com/</a></div>
<div>
</div>
<div>
<a href="http://nor-98.blogspot.com/">http://nor-98.blogspot.com/</a></div>
<div>
</div>
<div>
Friday, January 30, 2015</div>
<div>
</div>
<div>
*** Scrapie: a particularly persistent pathogen ***</div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2015/01/scrapie-particularly-persistent-pathogen.html">http://transmissiblespongiformencephalopathy.blogspot.com/2015/01/scrapie-particularly-persistent-pathogen.html</a>
</div>
<div>
</div>
<div>
Thursday, March 26, 2015 </div>
<div>
</div>
<div>
Increased Infectivity of Anchorless Mouse Scrapie Prions in Transgenic Mice
Overexpressing Human Prion Protein </div>
<div>
</div>
<div>
<a href="http://scrapie-usa.blogspot.com/2015/03/increased-infectivity-of-anchorless.html">http://scrapie-usa.blogspot.com/2015/03/increased-infectivity-of-anchorless.html</a>
</div>
<div>
</div>
<div>
</div>
<div>
Increased susceptibility of human-PrP transgenic mice to bovine spongiform
encephalopathy following passage in sheep </div>
<div>
</div>
<div>
J. Virol. doi:10.1128/JVI.01578-10 Copyright (c) 2010, American Society for
Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.</div>
<div>
</div>
<div>
Increased susceptibility of human-PrP transgenic mice to bovine spongiform
encephalopathy following passage in sheep.</div>
<div>
</div>
<div>
Chris Plinston, Patricia Hart, Angela Chong, Nora Hunter, James Foster,
Pedro Piccardo, Jean C. Manson, and Rona M Barron* Neuropathogenesis Division,
The Roslin Institute and R(D)SVS, University of Edinburgh, Roslin, Midlothian,
UK; Laboratory of Bacterial and TSE Agents, Food and Drug Administration,
Rockville, MD, USA</div>
<div>
</div>
<div>
* To whom correspondence should be addressed. Email:
rona.barron@roslin.ed.ac.uk .</div>
<div>
</div>
<div>
Abstract</div>
<div>
</div>
<div>
The risk of transmission of ruminant transmissible spongiform
encephalopathy (TSE) to humans was thought to be low due to the lack of
association between sheep scrapie and incidence of human TSE. However a single
TSE agent strain has been shown to cause both bovine spongiform encephalopathy
(BSE) and human vCJD, indicating that some ruminant TSEs may be transmissible to
humans. While the transmission of cattle BSE to humans in transgenic mouse
models has been inefficient, indicating the presence of a significant
transmission barrier between cattle and humans, BSE has been transmitted to a
number of other species. Here we aimed to further investigate the human
transmission barrier following passage of BSE in a sheep. Following inoculation
with cattle BSE, gene targeted transgenic mice expressing human PrP showed no
clinical or pathological signs of TSE disease. However following inoculation
with an isolate of BSE that had been passaged through a sheep, TSE associated
vacuolation and proteinase-K resistant PrP deposition were observed in mice
homozygous for the codon 129-methionine PRNP gene. This observation may be due
to higher titres of the BSE agent in sheep, or an increased susceptibility of
humans to BSE prions following passage through a sheep. ***However these data
confirm that, contrary to previous predictions, it is possible that a sheep
prion may be transmissible to humans and that BSE from other species may be a
public health risk.</div>
<div>
</div>
<div>
<a href="http://jvi.asm.org/cgi/content/abstract/JVI.01578-10v1?etoc">http://jvi.asm.org/cgi/content/abstract/JVI.01578-10v1?etoc</a>
</div>
<div>
</div>
<div>
<a href="http://bse-atypical.blogspot.com/2010/11/increased-susceptibility-of-human-prp.html">http://bse-atypical.blogspot.com/2010/11/increased-susceptibility-of-human-prp.html</a></div>
<div>
</div>
<div>
Suspect symptoms</div>
<div>
</div>
<div>
What if you can catch old-fashioned CJD by eating meat from a sheep
infected with scrapie?</div>
<div>
</div>
<div>
28 Mar 01 </div>
<div>
</div>
<div>
Most doctors believe that sCJD is caused by a prion protein deforming by
chance into a killer. But Singeltary thinks otherwise. He is one of a number of
campaigners who say that some sCJD, like the variant CJD related to BSE, is
caused by eating meat from infected animals. Their suspicions have focused on
sheep carrying scrapie, a BSE-like disease that is widespread in flocks across
Europe and North America.</div>
<div>
</div>
<div>
Now scientists in France have stumbled across new evidence that adds weight
to the campaigners' fears. To their complete surprise, the researchers found
that one strain of scrapie causes the same brain damage in mice as sCJD.</div>
<div>
</div>
<div>
"This means we cannot rule out that at least some sCJD may be caused by
some strains of scrapie," says team member Jean-Philippe Deslys of the French
Atomic Energy Commission's medical research laboratory in Fontenay-aux-Roses,
south-west of Paris. Hans Kretschmar of the University of Göttingen, who
coordinates CJD surveillance in Germany, is so concerned by the findings that he
now wants to trawl back through past sCJD cases to see if any might have been
caused by eating infected mutton or lamb...</div>
<div>
</div>
<div>
2001</div>
<div>
</div>
<div>
Suspect symptoms </div>
<div>
</div>
<div>
What if you can catch old-fashioned CJD by eating meat from a sheep
infected with scrapie? </div>
<div>
</div>
<div>
28 Mar 01 </div>
<div>
</div>
<div>
Like lambs to the slaughter </div>
<div>
</div>
<div>
31 March 2001 </div>
<div>
</div>
<div>
by Debora MacKenzie Magazine issue 2284. </div>
<div>
</div>
<div>
FOUR years ago, Terry Singeltary watched his mother die horribly from a
degenerative brain disease. Doctors told him it was Alzheimer's, but Singeltary
was suspicious. The diagnosis didn't fit her violent symptoms, and he demanded
an autopsy. It showed she had died of sporadic Creutzfeldt-Jakob disease.</div>
<div>
</div>
<div>
Most doctors believe that sCJD is caused by a prion protein deforming by
chance into a killer. But Singeltary thinks otherwise. He is one of a number of
campaigners who say that some sCJD, like the variant CJD related to BSE, is
caused by eating meat from infected animals. Their suspicions have focused on
sheep carrying scrapie, a BSE-like disease that is widespread in flocks across
Europe and North America.</div>
<div>
</div>
<div>
Now scientists in France have stumbled across new evidence that adds weight
to the campaigners' fears. To their complete surprise, the researchers found
that one strain of scrapie causes the same brain damage in mice as sCJD.</div>
<div>
</div>
<div>
"This means we cannot rule out that at least some sCJD may be caused by
some strains of scrapie," says team member Jean-Philippe Deslys of the French
Atomic Energy Commission's medical research laboratory in Fontenay-aux-Roses,
south-west of Paris. Hans Kretschmar of the University of Göttingen, who
coordinates CJD surveillance in Germany, is so concerned by the findings that he
now wants to trawl back through past sCJD cases to see if any might have been
caused by eating infected mutton or lamb.</div>
<div>
</div>
<div>
Scrapie has been around for centuries and until now there has been no
evidence that it poses a risk to human health. But if the French finding means
that scrapie can cause sCJD in people, countries around the world may have
overlooked a CJD crisis to rival that caused by BSE.</div>
<div>
</div>
<div>
Deslys and colleagues were originally studying vCJD, not sCJD. They
injected the brains of macaque monkeys with brain from BSE cattle, and from
French and British vCJD patients. The brain damage and clinical symptoms in the
monkeys were the same for all three. Mice injected with the original sets of
brain tissue or with infected monkey brain also developed the same
symptoms.</div>
<div>
</div>
<div>
As a control experiment, the team also injected mice with brain tissue from
people and animals with other prion diseases: a French case of sCJD; a French
patient who caught sCJD from human-derived growth hormone; sheep with a French
strain of scrapie; and mice carrying a prion derived from an American scrapie
strain. As expected, they all affected the brain in a different way from BSE and
vCJD. But while the American strain of scrapie caused different damage from
sCJD, the French strain produced exactly the same pathology.</div>
<div>
</div>
<div>
"The main evidence that scrapie does not affect humans has been
epidemiology," says Moira Bruce of the neuropathogenesis unit of the Institute
for Animal Health in Edinburgh, who was a member of the same team as Deslys.
"You see about the same incidence of the disease everywhere, whether or not
there are many sheep, and in countries such as New Zealand with no scrapie." In
the only previous comparisons of sCJD and scrapie in mice, Bruce found they were
dissimilar.</div>
<div>
</div>
<div>
But there are more than 20 strains of scrapie, and six of sCJD. "You would
not necessarily see a relationship between the two with epidemiology if only
some strains affect only some people," says Deslys. Bruce is cautious about the
mouse results, but agrees they require further investigation. Other trials of
scrapie and sCJD in mice, she says, are in progress.</div>
<div>
</div>
<div>
People can have three different genetic variations of the human prion
protein, and each type of protein can fold up two different ways. Kretschmar has
found that these six combinations correspond to six clinical types of sCJD: each
type of normal prion produces a particular pathology when it spontaneously
deforms to produce sCJD.</div>
<div>
</div>
<div>
But if these proteins deform because of infection with a disease-causing
prion, the relationship between pathology and prion type should be different, as
it is in vCJD. "If we look at brain samples from sporadic CJD cases and find
some that do not fit the pattern," says Kretschmar, "that could mean they were
caused by infection."</div>
<div>
</div>
<div>
There are 250 deaths per year from sCJD in the US, and a similar incidence
elsewhere. Singeltary and other US activists think that some of these people
died after eating contaminated meat or "nutritional" pills containing dried
animal brain. Governments will have a hard time facing activists like Singeltary
if it turns out that some sCJD isn't as spontaneous as doctors have
insisted.</div>
<div>
</div>
<div>
Deslys's work on macaques also provides further proof that the human
disease vCJD is caused by BSE. And the experiments showed that vCJD is much more
virulent to primates than BSE, even when injected into the bloodstream rather
than the brain. This, says Deslys, means that there is an even bigger risk than
we thought that vCJD can be passed from one patient to another through
contaminated blood transfusions and surgical instruments.</div>
<div>
</div>
<div>
<a href="http://www.newscientist.com/article/mg16922840.300-like-lambs-to-the-slaughter.html">http://www.newscientist.com/article/mg16922840.300-like-lambs-to-the-slaughter.html</a>
</div>
<div>
</div>
<div>
Like lambs to the slaughter </div>
<div>
</div>
<div>
Thursday, December 20, 2012 </div>
<div>
</div>
<div>
OIE GROUP RECOMMENDS THAT SCRAPE PRION DISEASE BE DELISTED AND SAME OLD BSe
WITH BOVINE MAD COW DISEASE </div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/12/oie-group-recommends-that-scrape-prion.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/12/oie-group-recommends-that-scrape-prion.html</a></div>
<div>
</div>
<div>
Monday, November 30, 2009</div>
<div>
</div>
<div>
USDA AND OIE COLLABORATE TO EXCLUDE ATYPICAL SCRAPIE NOR-98 ANIMAL HEALTH
CODE</div>
<div>
</div>
<div>
<a href="http://nor-98.blogspot.com/2009/11/usda-and-oie-collaborate-to-exclude.html">http://nor-98.blogspot.com/2009/11/usda-and-oie-collaborate-to-exclude.html</a>
</div>
<div>
</div>
<div>
Monday, April 25, 2011 </div>
<div>
</div>
<div>
Experimental Oral Transmission of Atypical Scrapie to Sheep Volume 17,
Number 5-May 2011 </div>
<div>
</div>
<div>
<a href="http://nor-98.blogspot.com/2011/04/experimental-oral-transmission-of.html">http://nor-98.blogspot.com/2011/04/experimental-oral-transmission-of.html</a>
</div>
<div>
</div>
<div>
Friday, February 11, 2011</div>
<div>
</div>
<div>
Atypical/Nor98 Scrapie Infectivity in Sheep Peripheral Tissues</div>
<div>
</div>
<div>
<a href="http://nor-98.blogspot.com/2011/02/atypicalnor98-scrapie-infectivity-in.html">http://nor-98.blogspot.com/2011/02/atypicalnor98-scrapie-infectivity-in.html</a>
</div>
<div>
</div>
<div>
Monday, June 27, 2011</div>
<div>
</div>
<div>
Comparison of Sheep Nor98 with Human Variably Protease-Sensitive
Prionopathy and Gerstmann-Sträussler-Scheinker Disease</div>
<div>
</div>
<div>
<a href="http://prionopathy.blogspot.com/2011/06/comparison-of-sheep-nor98-with-human.html">http://prionopathy.blogspot.com/2011/06/comparison-of-sheep-nor98-with-human.html</a>
</div>
<div>
</div>
<div>
Thursday, October 22, 2015 </div>
<div>
</div>
<div>
Former Ag Secretary Ann Veneman talks women in agriculture and we talk mad
cow disease USDA and what really happened </div>
<div>
</div>
<div>
<a href="http://madcowusda.blogspot.com/2015/10/former-ag-secretary-ann-veneman-talks.html" style="href: "http://madcowusda.blogspot.com/2015/10/former-ag-secretary-ann-veneman-talks.html";">http://madcowusda.blogspot.com/2015/10/former-ag-secretary-ann-veneman-talks.html</a></div>
<div>
</div>
<div style="display: inline;">
<div dir="ltr">
<div>
<div id="ygrp-text">
<div dir="ltr">
<div>
<div>
<div dir="ltr">
<div>
<div>
Sunday, October 18, 2015 </div>
<div>
</div>
<div>
*** World Organisation for Animal Health (OIE) and the Institut Pasteur
Cooperating on animal disease and zoonosis research </div>
<div>
</div>
<div>
<a 10="" 2015="" bovineprp.blogspot.com="" href="http://bovineprp.blogspot.com/2015/10/world-organisation-for-animal-health.html" world-organisation-for-animal-health.html="">http://bovineprp.blogspot.com/2015/10/world-organisation-for-animal-health.html</a></div>
</div>
<div>
</div>
<div>
Friday, October 23, 2015
</div>
</div>
</div>
</div>
</div>
</div>
</div>
</div>
</div>
<span style="font-family: "calibri";">
</span><br />
<div>
</div>
<div>
CJD FOUNDATION CREUTZFELDT JAKOB DISEASE TSE PRION QUESTIONNAIRE UPDATE
OCTOBER 2015</div>
<div>
</div>
<div>
<a href="http://cjdquestionnaire.blogspot.com/2015/10/cjd-foundation-creutzfeldt-jakob.html">http://cjdquestionnaire.blogspot.com/2015/10/cjd-foundation-creutzfeldt-jakob.html</a></div>
<div>
</div>
<div>
<div>
Self-Propagative Replication of Ab Oligomers Suggests Potential
Transmissibility in Alzheimer Disease</div>
<div>
</div>
<div>
Received July 24, 2014; Accepted September 16, 2014; Published November 3,
2014</div>
<div>
</div>
<div>
<a href="http://www.plosone.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0111492&representation=PDF" style="href: "http://www.plosone.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0111492&representation=PDF";">http://www.plosone.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0111492&representation=PDF</a>
</div>
<div>
</div>
<div>
*** Singeltary comment ***</div>
<div>
</div>
<div>
<a href="http://www.plosone.org/annotation/listThread.action?root=82860" style="href: "http://www.plosone.org/annotation/listThread.action?root=82860";">http://www.plosone.org/annotation/listThread.action?root=82860</a>
</div>
<div>
</div>
<div>
Thursday, October 1, 2015 </div>
<div>
</div>
<div>
Alzheimergate, re-Evidence for human transmission of amyloid-β pathology
and cerebral amyloid angiopathy, Singeltary Submission to Nature </div>
<div>
</div>
<div>
<a href="http://betaamyloidcjd.blogspot.com/2015/10/alzheimergate-re-evidence-for-human.html" style="href: "http://betaamyloidcjd.blogspot.com/2015/10/alzheimergate-re-evidence-for-human.html";">http://betaamyloidcjd.blogspot.com/2015/10/alzheimergate-re-evidence-for-human.html</a>
</div>
<div>
</div>
<div>
Tuesday, August 26, 2014 </div>
<div>
</div>
<div>
Blood reference materials from macaques infected with variant
Creutzfeldt-Jakob disease agent</div>
<div>
</div>
<div>
Results We sampled blood 19 times from the inoculated monkeys at various
stages of the disease over a period of 29 months, generating liters of
vCJD-infected macaque blood. vCJD was confirmed in all inoculated macaques.
After PMCA, PrPTSE was detected in plasma from infected monkeys, but not from
uninfected animals. Both mouse models were more sensitive to infection with
macaque-adapted vCJD agent than to primary human vCJD agent.</div>
<div>
</div>
<div>
<a href="http://vcjdtransfusion.blogspot.com/2014/08/blood-reference-materials-from-macaques.html">http://vcjdtransfusion.blogspot.com/2014/08/blood-reference-materials-from-macaques.html</a>
</div>
</div>
<div>
<br />
<br />
<div>
<div>
</div>
<div>
Mad deer disease can infect normal human brains in laboratory tests </div>
<br />
<div>
</div>
<br />
<div>
Monday, May 8, 2000 </div>
<br />
<div>
</div>
<br />
<div>
www.ems.org has further information and facts on CJD. Jennifer Kelly or Amy
Leska, EMS 202/463-6670 Washington, D.C. </div>
<br />
<div>
</div>
<br />
<div>
Public health advocates are demanding that the Food and Drug Administration
close loopholes in animal feed regulations to prevent the spread of U.S. mad
cow-type diseases now at epidemic levels in Western deer and elk that might
infect people who eat meat. In a letter sent today to the FDA, the Center for
Food Safety (CFS), the Humane Farming Association, and families of U.S. victims
of the human version of mad cow disease, Creutzfeldt-Jakob disease (CJD) are
demanding new efforts to protect public health and food safety. The FDA was
asked to respond to a legal petition filed in January 1999 that would change
U.S. animal feed regulations to prevent the spread of U.S. mad cow-type diseases
already occurring in deer, elk, sheep and humans, and suspected in pigs and
cattle. </div>
<br />
<div>
</div>
<br />
<div>
Under current FDA regulations animals known to be infected with mad
cow-type disease such as deer and elk infected with 'chronic wasting disease'
and scrapie-infected sheep, can be legally fed to pigs, chickens and pets, which
in turn can be rendered and fed to cows. Billions of pounds of slaughterhouse
waste in the form of rendered animal by-products are fed to US livestock every
year as fat and protein supplements, despite this practice being the known route
of transmission of British mad cow disease. </div>
<br />
<div>
</div>
<br />
<div>
A fatal 'mad deer' disease called chronic wasting disease or CWD is
occurring at epidemic levels in deer and elk in Western states and on game
farms, CFS legal director Joseph Mendelson wrote in the letter to the FDA. This
may already be claiming human lives as is suggested by the alarming appearance
of unusually young victims of Creutzfeldt-Jakob disease. </div>
<br />
<div>
</div>
<br />
<div>
*** Today at the first CJD Foundation conference in Miami, government
researcher Byron W. Caughey, Ph.D., announced that in laboratory tests CWD from
deer can infect human brain tissue at rate similar to British mad cow disease.
In Britain 56 people have died of human mad cow disease, the death toll is
climbing and some scientists suspect it will claim hundreds of thousands of
lives in the decades ahead. Caughey's research on US mad deer disese was
conducted at the National Institutes of Health Rocky Mountain Laboratories in
Hamilton, Montana, and has not yet been published. </div>
<br />
<div>
</div>
<br />
<div>
The most recent suspected victim of US mad deer disease is Jay Dee Whitlock
II of Oklahoma, who died of CJD on April 7, 2000. Whitlock, 28, was an avid deer
hunter and venison consumer. He is the second young hunter to die of CJD in the
past year. </div>
<br />
<div>
</div>
<br />
<div>
John Stauber, co-author of Mad Cow USA and a speaker at the CJD Foundation
conference, said, "The announcement that US mad deer disease can infect the
human brain, and that it happens at a rate similar to British mad cow disease,
is extremely disturbing. A deadly human dementia might be already spreading from
deer and elk into hunters in Western states, and the policies of the FDA and
other agencies are completely inadequate to protect public health. </div>
<br />
<div>
</div>
<br />
<div>
Could 'mad cow type epidemics happen in the US </div>
<br />
<div>
</div>
<br />
<div>
John Stauber, talk given 7 May 00 </div>
<br />
<div>
</div>
<br />
<div>
*** CJD Foundation conference Miami Center for Media & Democracy
520 University Avenue, Suite #310 Madison, WI 53703 </div>
<br />
<div>
</div>
<br />
<div>
"Three years ago Sheldon Rampton and I were finishing our book Mad Cow USA
published in November of 97. In our introduction we wrote that ours is not a
biology book nor a diet guide, but a "book about politics and how it operates in
the real world. It explains how government officials have placed concerns for
the food industry over human health and welfare. In addition to telling the
story of an exotic, mysterious and frightening disease, we have written this
book to report on equally dangerous legal and political trends which threaten
not only our physical health, but also our fundamental democratic rights..." The
title of this session asks a question: "Could 'mad cow type epidemics happen in
the US.?" My answer is not only could they, but they are. Sheep scrapie arrived
in the US a half century ago and thanks to government bungling is now widely
spread throughout the US, with dozens of different strains. Chronic wasting
disease may have begun as sheep scrapie but now it is spreading through deer and
elk in western states and on game farms. </div>
<br />
<div>
</div>
<br />
<div>
In the past two years two western state hunters under the age of 30 have
died of CJD, and some of us suspect they may be human victims of a new strain of
TSE in sheep, deer or elk that has begun claiming young human victims in the US.
</div>
<br />
<div>
</div>
<br />
<div>
Since 1964 researchers have suspected that transmissible mink
encephalopathy TME in the US is from a hidden TSE in cattle, and the late Dr.
Richard Marsh, to whom we dedicate our book, believed that he isolated that TSE
in mink in Wisconsin in 1985, a year before the British strain of TSE dubbed mad
cow disease was observed. </div>
<br />
<div>
</div>
<br />
<div>
As our book was going to completion, we discovered that USDA inspectors
felt they had identified a TSE in pigs way back in the the 1970s, when few
researchers other than a small group in what Paul Brown calls the Club were very
concerned or aware of TSE diseases. </div>
<br />
<div>
</div>
<br />
<div>
Of course, British mad cow disease and the looming specter of hundreds of
thousands of people condemned to death in the decades ahead has changed
everything. Everything, that is, except public policy here in the US. For
despite the fact that two Nobel prize winners in this area of research are from
the US, there is a public relations cover-up of massive proportions in this
country that is preventing us from effectively establishing public policies that
can monitor, prevent and eventually treat TSE diseases. </div>
<br />
<div>
</div>
<br />
<div>
Please note that I said a public relations cover-up; that's important. I
suspect that if TSE diseases were spread by mosquitoes, we'd be spraying
pesticides all over the US to try and irradiate sheep scrapie and chronic
wasting disease. But these diseases are spread by agribusiness through animal
livestock products fed to people and animals, and thus instead of putting the
concerns of people first, we have see that consistently governments have put the
concerns of industry first. </div>
<br />
<div>
</div>
<br />
<div>
We've heard eminent and hard working scientists talk about TSE diseases in
terms that dizzy the head of even other scientists. This is a very contentious
and mysterious area of research because TSE diseases break many rules. </div>
<br />
<div>
</div>
<br />
<div>
Luckily, my co-author and I are not experts or scientists. However, we did
have the benefit of being able to interview top TSE researchers like Richard
Marsh and Dr. Gajdusek, have them review parts of our manuscript, and thus
deliver a book that is based on solid, sound science regarding what is known,
and what is unknown, what is proven, and what is not. </div>
<br />
<div>
</div>
<br />
<div>
From my perspective, this is the most important point and perspective to
keep in mind: </div>
<br />
<div>
</div>
<br />
<div>
For the past thirty years a massive unregulated experiment in creating new
strains of TSE disease has been undertaken by the livestock industry, and we're
the guinea pigs. The experiment is ongoing. The experiment began as a really
neat idea: lets take the billions and billions of pounds of slaughterhouse
waste, blood and offal that is produced every year from cattle and pigs and
sheep and roadkill and pets and zoo animals, and let's recycle it. Let's turn it
into protein fat supplements, and let's feed it back to the livestock we eat.
</div>
<br />
<div>
</div>
<br />
<div>
It seemed like a good idea. Unfortunately, what it didn't take into account
was the infectious prion agent. As Dr. Gibbs has pointed out, probably every
mammalian species has a TSE disease at some minute level: people, pigs, cows,
sheep, mink, cats and dogs, deer, elk. Grind up the most infectious parts of
millions and millions of animals, concentrate them into feed supplements, and
you are creating an environment not only for spreading and amplifying existing
agents such as scrapie in sheep, but also for creating an untold number of new
strains of TSE. </div>
<br />
<div>
</div>
<br />
<div>
This is especially important to grasp. In laboratory experiments, when TME
or scrapie or CJD is injected into new animal species, whole new strains of TSE
are created, and they can have different potential to infect new host species.
The process of rendering animal waste into animal feed has been a massive and
ongoing experiment in the creation of new TSEs, one of which emerged in Britain
in the mid 1980s as mad cow disease, has clearly spread into humans claiming
over fifty so far, and in my guess will in the years ahead be founded to have
infected hundreds of thousands of Britons. </div>
<br />
<div>
</div>
<br />
<div>
I said that this outbreak of BSE in Britain changed everything, but what
really changed everything was what caused that outbreak: feeding rendered animal
by-products back to animals as food. </div>
<br />
<div>
</div>
<br />
<div>
I wish I could tell you that this practice has been stopped, but it has
not. I wish I could tell you that well informed and courageous officials in the
FDA, the USDA and the CDC have taken the mad bull by the horns, and are right
now executing a precautionary policy to insure that what has happened in Britain
does not happen in the US. Unfortunately, that is not the case. </div>
<br />
<div>
</div>
<br />
<div>
Dr. Hansen will shortly explain why the much heralded FDA feed regulations
on rendered animal by-products announced in 1997 are in many ways a farce. For
instance, in the US calves are literally being weaned on cattle blood protein,
and scrapie infected sheep can be used as feed for pigs which can be used as
feed for cattle. </div>
<br />
<div>
</div>
<br />
<div>
But the problem is beyond just the poor US animal feed regulations. You
need look no further than your favorite vitamin and nutritional supplement
stores. Right now, with the full knowledge of the FDA, the NIH, the CDC,
millions of Americans are popping over the counter as glandular supplements.
These unregulated products contain the most infectious parts of slaughtered
animals, the very parts that make up the so-called Specified Bovine Offal that
should be banned from cattle feed, such as the brain, pituitary, and glandular
system. These pills are pooled, collected from hundreds of thousands of animals
and taken daily by untold numbers of Americans, probably millions given the
popularity of supplements. </div>
<br />
<div>
</div>
<br />
<div>
Again, this amounts to an unregulated human experiment, minus laboratory
controls or knowledgeable consent, feeding humans the most infectious parts of
animals, possible creating new TSEs by passaging animal TSE from pooled
glandular products. </div>
<br />
<div>
</div>
<br />
<div>
I've brought along four different bottles of the pills I'm talking about,
and I've asked that they be pass around so you can look at them yourself and
read the label. </div>
<br />
<div>
</div>
<br />
<div>
Some would say that FDA's hands are tied, that thanks to lobbying by the
nutritional supplement industry the FDA lacks the power to prevent sales of
these glandular. Actually this points to another frightening disease rampant
among otherwise good people who populate government agencies which I call BCD
for Bureaucratic Cowardice Disease. FDAs hands might be tied and they can't yank
these products from the market, but their mouths are not gagged and concerned
officials should be speaking out loudly warning the American public that they
are consuming animal brains and glands and might want to consider the potential
risks. </div>
<br />
<div>
</div>
<br />
<div>
There is a reason why scientists in agencies and universities, not to
mention corporations, avoid sticking their necks out, and we need look no
further than Richard Marsh, a dedicated and conservative scientist who took it
upon himself to speak up in 1993 in an interview in Wisconsin's largest farm
paper. Richard Marsh warned Wisconsin farmers, thousands of whom were feeding
rendered cow by-products back to their cows, that given the mad cow outbreak in
Britain they should, despite the reassurances from USDA that such feeding was
safe, stop. </div>
<br />
<div>
</div>
<br />
<div>
The day after that article appeared Dr. Marsh was literally called on the
carpet in the office of the dean of the school of agriculture at the University
of Wisconsin, and read the riot act. he was told that industry funders were
threaten to sue him, sue the school, cut off money for research, and who did he
think he was? </div>
<br />
<div>
</div>
<br />
<div>
Within months the school scrambled and pulled together a symposium on the
subject, which served to dismiss and marginalize Dr. Marsh's views. When Dr.
Marsh died of cancer in 1997, after the British announcement that mad cow
disease was killing young people, the same University had the gall to praise Dr.
Marsh and his work as in the best tradition of the University. Some of us feel
that the stress and abuse heaped on Dr. Marsh> from 1993 to 1997 had an
impact on his health that contributed to his demise. </div>
<br />
<div>
</div>
<br />
<div>
This is what happens to scientists who break ranks and speak out, and it is
a great loss to us today because I think if Dick Marsh was still alive he would
be leading the charge to confront the ignorance and the cow-towing to industry
that typifies this issue. </div>
<br />
<div>
</div>
<br />
<div>
Dr. Marsh was a colleague and contemporary of many of the researchers in
this room. As Paul Brown whom he once worked with might say, he was a member of
the club. But Dr. Marsh was able to make realizations that I'm afraid most of
the club members haven't yet come to, and he was able to put his sense of
scientific obligation to society in front of concerns about his funding, or even
his personal and professional safety. </div>
<br />
<div>
</div>
<br />
<div>
I first began investigating mad cow type diseases in the early 1990s when I
was working in Wisconsin organizing farmers and consumers opposed to Monsanto's
genetically engineered bovine growth hormone, the cattle equivalent of human
growth hormone which when injected into cattle forced them to produce more milk.
Well, its not quite that biologically simple as I'm sure any woman here who has
had children can imagine. </div>
<br />
<div>
</div>
<br />
<div>
It was brought to my attention by a retired industry veterinary researcher
that in order to make the hormone work, cows need to be fed additional fat and
protein supplements, and that the cheapest supplements were rendered byproducts
from other cows. This veterinarian told me this was very bad because it was
exactly what had cause the outbreak of BSE in Britain. </div>
<br />
<div>
</div>
<br />
<div>
I investigated and found this was true - massive feeding of cows to cows
was going on in the US, despite the fact that as early as the Fall of 1987
British epidemiology had shown that is was this practice that spread mad cow
disease. </div>
<br />
<div>
</div>
<br />
<div>
I remember one of my first meetings with Dr. Marsh. We talked about his
believe that a US BSE agent, different than the British strain, was in cattle at
low levels and was the cause of occasional outbreaks of TME. I know that eminent
researchers in this room dispute that, but frankly Dr. Marsh never doubted it
and I think the evidence and commons sense remains in his favor. </div>
<br />
<div>
</div>
<br />
<div>
I had just been to a holistic chiropractor for my chronically bad lower
back, and had been sold a bottle of adrenal gland extract which I showed to Dr.
Marsh - he practically fell out of his chair and I immediately stopped taking
them. </div>
<br />
<div>
</div>
<br />
<div>
He was shocked to learn that such glandular were sold. Imagine what he
might think today, that at this late stage of the game with kids in their 20s in
the US dying of CJD, that these glandulars are sold without warning. </div>
<br />
<div>
</div>
<br />
<div>
Of course, I may be taking a risk myself in saying this. After all, we are
in Florida, one of 13 states in the US in which the Animal Feed Industry
Association members have succeeded in lobbying into law a food product
disparagement bill. I could end up like Oprah Winfrey and her guest Howard
Lyman, forced to spend millions and millions of dollars (which in my case would
be thousands and thousands and then bankruptcy) to convince a jury that my
remarks today are based on sound science. </div>
<br />
<div>
</div>
<br />
<div>
Having written two books in the past five years, one on political PR and
the other on the politics of food, I can tell you that a major reason why there
has not been more news media coverage of this issue is the multi-million dollar
PR campaign and litigation threats of the food industry which we document
extensively in our book. </div>
<br />
<div>
</div>
<br />
<div>
I find it ironic that this weekend as we're meeting here President Clinton
announced Saturday a new initiative to address the safety of hot dogs. Philip
Brasher of the Associated Press speculates that as he is leaving office the
President wants to burnish his image with food safety initiatives. </div>
<br />
<div>
</div>
<br />
<div>
The irony is that it is under this administration that the food industry
has launched an all out attack on our first amendment rights by lobbying food
libel laws onto the books, and the administration has remained silent. Despite
knowing of the risks of cow cannibalism since the beginning of his presidency,
his administration did nothing until 1997, and as we reveal in our book and Dr.
Hansen will explain, the regulations are severely inadequate. </div>
<br />
<div>
</div>
<br />
<div>
I am circulating a letter being delivered by the Center for Food Safety
urging the agency to respond to the petition filed by that group and many of the
families in this room that calls on FDA to severely tighten its regulations.
Yet, probably to avoid publicity, the FDA stonewalls. </div>
<br />
<div>
</div>
<br />
<div>
A couple weeks ago I was in Washington and I attended a conference that was
paid for in part by the lobbyists responsible for putting food censorships laws
on the books, the Animal Feed Industry Association and the law firm of Ollsen
Frank and Weeda that drafted the model bill that was then lobbied for at the
state level by the American Farm Bureau. I picked up this glossy brochure in
which the FDA is slapping itself on the back for its food safety initiatives. In
it I read that the FDA's BSE Educational Activities have Gained an award from
the vice president: </div>
<br />
<div>
</div>
<br />
<div>
The US feed regulations and the FDA were honored with VP Al Gore's Hammer
Award. Dr. Stephen F. Sundlof, the directory of FDA's Center for Veterinary
Medicine, the man who since January 1999 has been unable to respond to the legal
petition to close gaping loopholes in the FDA regulations stated: "thanks to the
development of the BSE regulation, we can continue to say that there has not
been a single case of BSE reported in the United States. Educational efforts ...
will help assure that we can continue to make that claim." </div>
<br />
<div>
</div>
<br />
<div>
In researching our books we had access to documents obtained through the
Freedom on Information Act. One 1991 document of the USDA was titled "BSE Public
Relations," and if someday attorneys in a class action lawsuit on behalf of CJD
patients in the US are looking for a smoking gun demonstrating that concerns for
industry were place over concerns for people, this is it. </div>
<br />
<div>
</div>
<br />
<div>
(p.148-149) According to this document, the mere perception that BSE might
exist in the United States could have devastating effects on our domestic
markets for beef and dairy products." The report examined how the British
handled their PR, and it fretted over a story in the British magazine The
Economist which, quote, "could potentially create alarm among US consumers,"
unquote, because it reported that, quote,"many veterinarians and medical experts
have come around to the belief that humans could catch the mystery brain
disease." </div>
<br />
<div>
</div>
<br />
<div>
This USDA PR document approvingly noted a quote in the Washington Post by
Dr. Joseph Gibbs at NIH in 1990 saying "I don't think there is any danger in
consuming British beef." Remember, this was in 1991. It had known for four years
that it was feeding cows to cows that was spreading BSE in Britain. More and
more were fearing that humans would die. Meanwhile, in the US, billions of
pounds of cow by-products were still being fed, in fact the amount was
increasing each year. </div>
<br />
<div>
</div>
<br />
<div>
Was there no one inside the USDA or FDA who saw the lunacy, indeed the
criminality, in knowing this and letting cannibalistic feeding go one in the US?
Some did. The report notes that "some (USDA APHIS) staff members... argue that
because there is evidence that pigs, cats, mink, deer and a variety of
experimental animals may b e susceptible to trans. spongiform. encephalopathy,
the only prudent policy is to not feed products that contain these agents to ANY
SPECIES OF ANIMAL." </div>
<br />
<div>
</div>
<br />
<div>
That's it. That's what we should have done then, and that's what we should
be doing now, but are not. Instead we are still exposing ourselves and US
livestock to a massive TSE experiment. </div>
<br />
<div>
</div>
<br />
<div>
So, in 1991 the USDA and FDA rejected this advice by some anonymous
staffers, as they do today. This 1991 USDA PR report admitted that a more
cautious policy would be, quote, "to prohibit the feeding of sheep and
cattle-origin protein products to all ruminants, regardless of age. The
advantage of this option is that it minimized the risk of BSE. The disadvantage
is that the cost to the livestock and rendering industries would be
substantial." </div>
<br />
<div>
</div>
<br />
<div>
In fact, absolutely nothing of substance was done until August of 1997,
when FDA announced its sham feed regulation, winner of the coveted Al Gore
hammer award, designed as a PR fig leaf so that FDA can say 'we are keeping
British mad cow disease out of our livestock." </div>
<br />
<div>
</div>
<br />
<div>
Let me say that the only bright spot in this story of corporate and
government collusion, irresponsibility and censorship has been a few brave souls
like Richard Marsh, Richard Lacey in England, others who have bucked the tide
and spoken out, and those of you who are the families and loved ones of CJD
victims. </div>
<br />
<div>
</div>
<br />
<div>
*** Through CJD Foundation and CJD Voice you have found each other, and you
will eventually force responsibility onto government and industry because if you
don't no one else will. </div>
<br />
<div>
</div>
<br />
<div>
In conclusion, we need a massive commitment in the United States to address
TSE diseases. We need to start by admitting the shortcomings of our failed
federal feed policies and change them. We need to dedicate hundreds of millions
of research dollars, if necessary, to try to eradicate scrapie in sheep,
eradicate CWD in deer and in elk, and investigate, research, test and monitor
for TSEs in humans and animals. We need money for research to develop
treatments, because while this disease used to be rare disease, I suspect we are
about to see it emerge full blown in Britain with hundreds of thousands of
victims, and more and younger victims appearing in the United States, as a
result of our thirty year experiment in animal cannibalism. </div>
<br />
<div>
</div>
<br />
<div>
The leadership for this will not come from politicians in bed with the
agribusiness industry. It will not come from researchers who while brilliant are
stuck back in pre-BSE days, still viewing this as a rare unusual disorder. It
will come from average citizens who husbands and mothers and children are dying
of this bizarre class of dementia diseases in increasing numbers, and who are
not afraid to demand that the right policies be implemented and funded. It is
upon your shoulders that leadership falls, and so far you are doing admirably."
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.mad-cow.org/00/may00_late_news.html#ccc">http://www.mad-cow.org/00/may00_late_news.html#ccc</a>
</div>
<br />
<div>
</div>
<br />
<div>
snip...please see this and more here ; </div>
<br />
<div>
</div>
<br />
<div>
Friday, October 23, 2015 </div>
<br />
<div>
</div>
<br />
<div>
CJD FOUNDATION CREUTZFELDT JAKOB DISEASE TSE PRION QUESTIONNAIRE UPDATE
OCTOBER 2015 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://cjdquestionnaire.blogspot.com/2015/10/cjd-foundation-creutzfeldt-jakob.html">http://cjdquestionnaire.blogspot.com/2015/10/cjd-foundation-creutzfeldt-jakob.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Friday, November 13, 2015 </div>
<br />
<div>
</div>
<br />
<div>
No evidence of asymptomatic variant CJD infection in immunodeficiency
patients treated with UK-sourced immunoglobulin ? </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjdtransfusion.blogspot.com/2015/11/no-evidence-of-asymptomatic-variant-cjd.html">http://vcjdtransfusion.blogspot.com/2015/11/no-evidence-of-asymptomatic-variant-cjd.html</a>
</div>
<br />
<div>
</div>
<div>
</div>
</div>
</div>
</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-60080184947316233892014-09-18T14:30:00.000-07:002014-09-18T16:46:43.720-07:00Development of Dose-Response Models of Creutzfeldt-Jakob Disease Infection in Nonhuman Primates for Assessing the Risk of Transfusion-Transmitted variant Creutzfeldt-Jakob Disease <div>
Development of Dose-Response Models of Creutzfeldt-Jakob Disease Infection
in Nonhuman Primates for Assessing the Risk of Transfusion-Transmitted variant
Creutzfeldt-Jakob Disease </div>
<br />
<div>
</div>
<br />
<div>
Yin Huanga, Luisa Gregorib, Steven A. Andersona, David M. Asherb and Hong
Yanga# + Author Affiliations</div>
<br />
<div>
</div>
<br />
<div>
Office of Biostatistics & Epidemiology, U.S. Food and Drug
Administration, Silver Spring, Maryland, USAa Office of Blood Research and
Review, U.S. Food and Drug Administration, Silver Spring, Maryland, USAb </div>
<div>
</div>
<div>
ABSTRACT </div>
<div>
</div>
<div>
Estimates for the risk of transmitting variant Creutzfeldt-Jakob
disease (vCJD) via blood transfusion have largely relied on data from rodent
experiments, but the relationship between dose (amount of infected blood) and
response (vCJD infection) has never been well quantified. The goal of this study
was to develop a dose-response model based on nonhuman primate data to better
estimate the likelihood of transfusion-transmitted vCJD (TTvCJD) in humans. Our
model used dose-response data from nonhuman primates inoculated intracerebrally
(IC) with brain tissues of patients with sporadic and familial CJD. We analyzed
the data statistically using a beta-Poisson dose-response model. We further
adjusted model parameters to account for the differences in infectivity between
blood and brain tissue and in transmission efficiency between intravenous (IV)
and IC routes to estimate dose-dependent TTvCJD infection. </div>
<div>
</div>
<div>
*** The model estimates a
mean infection rate of 76% among recipients who receive one unit of whole blood
collected from an infected donor near the end of the incubation period. The
nonhuman primate model provides estimates that are more consistent with those
derived from a risk analysis of transfused non-leukoreduced red blood cells in
United Kingdom compared to prior estimates based on rodent models. </div>
<br />
<div>
</div>
<br />
<div>
IMPORTANCE TTvCJD was recently identified as one of three emerging
infectious diseases posing the greatest immediate threat to the safety of the
blood supply. Cases of TTvCJD were reported in recipients of non-leukoreduced
red blood cells and coagulation Factor VIII manufactured from blood of UK
donors. As the quantity of abnormal prions (the causative agent of TTvCJD)
varies significantly in different blood components and products, it is necessary
to quantify the dose-response relationship for a wide range of doses for the
vCJD agent in transfused blood and plasma derivatives. In this paper we suggest
the first mechanistic dose-response model for TTvCJD infection based on data
from experiments with nonhuman primates. This new model may improve estimates of
the possible risk to humans. </div>
<br />
<div>
</div>
<br />
<div>
FOOTNOTES ↵#Address correspondence to Hong Yang, Hong.Yang@fda.hhs.gov
Copyright © 2014, American Society for Microbiology. All Rights Reserved.</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://jvi.asm.org/content/early/2014/09/11/JVI.01805-14.abstract?papetoc">http://jvi.asm.org/content/early/2014/09/11/JVI.01805-14.abstract?papetoc</a>
</div>
<br />
<div>
</div>
<br />
<div>
can anyone say TSEAC meeting in 2014 ???</div>
<br />
<div>
</div>
<br />
<div>
negative...tss</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, August 26, 2014 </div>
<br />
<div>
</div>
<br />
<div>
Blood reference materials from macaques infected with variant
Creutzfeldt-Jakob disease agent</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjdtransfusion.blogspot.com/2014/08/blood-reference-materials-from-macaques.html">http://vcjdtransfusion.blogspot.com/2014/08/blood-reference-materials-from-macaques.html</a></div>
<br />
<div>
</div>
<br />
<div>
Thursday, August 21, 2014 </div>
<br />
<div>
</div>
<br />
<div>
FDA Switzerland Reason For Recall Blood product, collected from a donor who
was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed
2014-05-16 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjdtransfusion.blogspot.com/2014/08/fda-switzerland-reason-for-recall-blood.html">http://vcjdtransfusion.blogspot.com/2014/08/fda-switzerland-reason-for-recall-blood.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Friday, January 10, 2014 </div>
<br />
<div>
</div>
<br />
<div>
vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial type
prion disease, what it ??? </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, May 19, 2014 </div>
<br />
<div>
</div>
<br />
<div>
Variant CJD: 18 years of research and surveillance </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjd.blogspot.com/2014/05/variant-cjd-18-years-of-research-and.html">http://vcjd.blogspot.com/2014/05/variant-cjd-18-years-of-research-and.html</a></div>
<br />
<div>
</div>
<br />
<div>
Sunday, June 29, 2014 </div>
<br />
<div>
</div>
<br />
<div>
Transmissible Spongiform Encephalopathy TSE Prion Disease North America
2014 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/06/transmissible-spongiform-encephalopathy.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/06/transmissible-spongiform-encephalopathy.html</a></div>
<br />
<div>
</div>
<br />
<div>
Tuesday, August 12, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** MAD COW USDA TSE PRION COVER UP or JUST IGNORANCE, for the record
AUGUST 2014 ***</div>
<br />
<div>
</div>
<br />
<div>
see history of record of either the biggest cover up of mad cow disease, or
one of the biggest blunders of the mad cow debacle, just my opinion of the
facts...tss</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://madcowusda.blogspot.com/2014/08/mad-cow-usda-tse-prion-cover-up-or-just.html">http://madcowusda.blogspot.com/2014/08/mad-cow-usda-tse-prion-cover-up-or-just.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, June 02, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** Confirmed Human BSE aka mad cow Variant CJD vCJD or nvCJD Case in Texas
***</div>
<br />
<div>
</div>
<br />
<div>
WHAT IS THE BIG SECRET HERE ?</div>
<br />
<div>
</div>
<br />
<div>
why no information on this case $</div>
<br />
<div>
</div>
<br />
<div style="display: inline;">
<div style="line-height: normal;">
<div style="background: rgb(245, 245, 245);">
<div style="font-color: black;">
<span style="font-family: Tahoma;"><b><span style="font-size: 10pt;">From:</span></b><span style="font-size: 10pt;">
</span></span><span style="font-size: 10pt;"><a href="https://www.blogger.com/null" style="href: "mailto:Carrie.Williams@dshs.state.tx.us";" title="Carrie.Williams@dshs.state.tx.us"><span style="color: blue; font-family: Tahoma;">Williams,Carrie C (DSHS)</span></a></span><span style="font-family: Tahoma;"><span style="font-size: 10pt;"> </span></span></div>
<div>
<span style="font-family: Tahoma;"><b><span style="font-size: 10pt;">Sent:</span></b><span style="font-size: 10pt;"> Wednesday, June 04, 2014 11:52 AM</span></span></div>
<div>
<span style="font-family: Tahoma;"><b><span style="font-size: 10pt;">To:</span></b><span style="font-size: 10pt;"> </span></span><span style="font-size: 10pt;"><a href="https://www.blogger.com/null" style="href: "mailto:flounder9@verizon.net";" title="flounder9@verizon.net"><span style="color: blue; font-family: Tahoma;">Terry S. Singeltary Sr.</span></a></span><span style="font-family: Tahoma;"><span style="font-size: 10pt;"> </span></span></div>
<div>
<span style="font-family: Tahoma;"><b><span style="font-size: 10pt;">Subject:</span></b><span style="font-size: 10pt;"> RE: nvCJD Texas ???</span></span></div>
</div>
</div>
<div>
</div>
</div>
<span style="font-family: Calibri;">
</span><br />
<div style="display: inline;">
<div class="WordSection1">
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="font-size: 11pt;">Adult male from
Texas with extensive travel history. That’s the extent of the information I can
provide at this time. </span><!--?xml:namespace prefix = "o"
/--><o:p></o:p></div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p><span style="font-family: Times New Roman;"> </span></div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="font-size: 11pt;">......................................................</span><o:p></o:p></div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="font-size: 11pt;">Carrie
Williams</span><o:p></o:p></div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="font-size: 11pt;">Director of Media
Relations</span><o:p></o:p></div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="font-size: 11pt;">512-776-7119</span><o:p></o:p></div>
</div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p><span style="font-family: Times New Roman;"> </span></div>
<div>
<div style="border-color: rgb(181, 196, 223) currentColor currentColor; border-style: solid none none; border-width: 1pt medium medium; padding: 3pt 0in 0in;">
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<b><span style="font-family: Tahoma;"><span style="font-size: 10pt;">From:</span></span></b><span style="font-family: Tahoma;"><span style="font-size: 10pt;"> Terry S.
Singeltary Sr. [mailto:flounder9@verizon.net] <br /><b>Sent:</b> Wednesday, June
04, 2014 11:51 AM<br /><b>To:</b> Williams,Carrie C (DSHS)<br /><b>Subject:</b> Re:
nvCJD Texas ???</span><o:p></o:p></span></div>
</div>
</div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p><span style="font-family: Times New Roman;"> </span></div>
<div>
<div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
Thank you for your kind reply. can you please
tell me anything else? age? sex? length of stay here in USA, diet, surgeries,
blood, etc., anything??? <o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
kind regards, terry<o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p></div>
</div>
<div>
<div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="font-family: Tahoma;"><span style="font-size: 10pt;"> </span><o:p></o:p></span></div>
</div>
<div>
<div>
<div class="MsoNormal" style="background: whitesmoke; margin: 0in 0in 0pt;">
<span style="font-family: Tahoma;"><b><span style="font-size: 10pt;">From:</span></b><span style="font-size: 10pt;"> <a href="https://www.blogger.com/null" style="href: "mailto:Carrie.Williams@dshs.state.tx.us";" title="Carrie.Williams@dshs.state.tx.us"><span style="color: blue;">Williams,Carrie C (DSHS)</span></a>
</span><o:p></o:p></span></div>
</div>
<div>
<div class="MsoNormal" style="background: whitesmoke; margin: 0in 0in 0pt;">
<span style="font-family: Tahoma;"><b><span style="font-size: 10pt;">Sent:</span></b><span style="font-size: 10pt;"> Tuesday, June 03,
2014 9:08 AM</span><o:p></o:p></span></div>
</div>
<div>
<div class="MsoNormal" style="background: whitesmoke; margin: 0in 0in 0pt;">
<span style="font-family: Tahoma;"><b><span style="font-size: 10pt;">To:</span></b><span style="font-size: 10pt;"> <a href="https://www.blogger.com/null" style="href: "mailto:flounder9@verizon.net";" title="flounder9@verizon.net"><span style="color: blue;">Terry S. Singeltary Sr.</span></a>
</span><o:p></o:p></span></div>
</div>
<div>
<div class="MsoNormal" style="background: whitesmoke; margin: 0in 0in 0pt;">
<span style="font-family: Tahoma;"><b><span style="font-size: 10pt;">Subject:</span></b><span style="font-size: 10pt;"> Re: nvCJD Texas
???</span><o:p></o:p></span></div>
</div>
</div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p></div>
</div>
</div>
<div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
Yes, we have some info and links on our home page
- <a href="https://www.blogger.com/null" style="href: "http://www.dshs.state.tx.us";"><span style="color: blue;">www.dshs.state.tx.us</span></a><br />
<br />
Sent from my
iPhone<o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 12pt;">
<br />
On Jun 2, 2014, at 8:12 PM, "Terry S.
Singeltary Sr." <<a href="https://www.blogger.com/null" style="href: "mailto:flounder9@verizon.net";"><span style="color: blue;">flounder9@verizon.net</span></a>>
wrote:<o:p></o:p></div>
</div>
<blockquote style="margin-bottom: 5pt; margin-top: 5pt;">
<div>
<div>
<div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
Greetings Carrie, <o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
I am wondering if there is any validity to this
news report, and if so, is there a statement from DSHS or anyone else in Texas
?<o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
Published On: Mon, Jun 2nd, 2014
<o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
Outbreak News / US News | By Robert Herriman
<o:p></o:p></div>
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<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
Texas: Variant Creutzfeldt-Jakob Disease death
confirmed, infection likely occurred overseas<o:p></o:p></div>
</div>
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</div>
</div>
</div>
</div>
</div>
</blockquote>
<br />
<br />
<br />
<a href="http://www.theglobaldispatch.com/texas-variant-creutzfeldt-jakob-disease-death-confirmed-infection-likely-occurred-overseas-94391/">http://www.theglobaldispatch.com/texas-variant-creutzfeldt-jakob-disease-death-confirmed-infection-likely-occurred-overseas-94391/</a> <br />
<br />
<br />
<br />
<blockquote style="margin-bottom: 5pt; margin-top: 5pt;">
<div>
<div>
<div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p><br /></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
kind regards, <o:p></o:p></div>
</div>
<div>
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
terry<o:p></o:p></div>
</div>
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</div>
</div>
</div>
</div>
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</blockquote>
</div>
</div>
</div>
</div>
</div>
<span style="font-family: Calibri;">
</span><br />
<div>
</div>
Monday, June 02, 2014 <br />
<br />
<div>
</div>
<br />
<div>
*** Confirmed Human BSE aka mad cow Variant CJD vCJD or nvCJD Case in Texas
***</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjd.blogspot.com/2014/06/confirmed-variant-cjd-case-in-texas.html">http://vcjd.blogspot.com/2014/06/confirmed-variant-cjd-case-in-texas.html</a></div>
<br />
<div>
</div>
<br />
<div>
Tuesday, April 01, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** Questions linger in U.S. CJD cases 2005, and still do in 2014 ***</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/04/questions-linger-in-us-cjd-cases-2005.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/04/questions-linger-in-us-cjd-cases-2005.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, August 18, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** Barriers to Creutzfeldt-Jakob Disease Autopsies, California and the
USA</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/08/barriers-to-creutzfeldt-jakob-disease.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/08/barriers-to-creutzfeldt-jakob-disease.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Saturday, July 07, 2012</div>
<br />
<div>
</div>
<br />
<div>
Class II, Blood products, collected from a donor who was at risk for
variant Creutzfeldt-Jakob disease ( vCJD) USA </div>
<br />
<div>
</div>
<br />
<div>
Enforcement Report </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html">http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html</a></div>
<br />
<div>
</div>
<br />
<div>
Monday, June 11, 2012 </div>
<br />
<div>
</div>
<br />
<div>
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products” </div>
<br />
<div>
</div>
<br />
<div>
IN SHORT ; </div>
<br />
<div>
</div>
<br />
<div>
“However, based on animal studies, as well as on FDA risk assessments, the
possibility of vCJD transmission by a U.S.-licensed plasma derivative, while
extremely small, cannot be absolutely ruled out. For these reasons, the
recommendations for labeling for plasma derivatives will include mention of vCJD
for the first time, and the potential risk for its transmission. The recommended
elements of the warning label for CJD are unchanged and continue to describe its
transmission as a theoretical risk, given that there is no confirmed evidence
that CJD is transmitted by blood (Refs. 4-7).“ </div>
<br />
<div>
</div>
<br />
<div>
IN FULL, as follows ; </div>
<br />
<div>
</div>
<br />
<div>
Monday, June 11, 2012 </div>
<br />
<div>
</div>
<br />
<div>
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products” </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html</a></div>
<br />
<div>
</div>
<br />
<div>
Friday, June 29, 2012</div>
<br />
<div>
</div>
<br />
<div>
Highly Efficient Prion Transmission by Blood Transfusion </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html</a></div>
<br />
<div>
</div>
<br />
<div>
Sunday, June 3, 2012</div>
<br />
<div>
</div>
<br />
<div>
A new neurological disease in primates inoculated with prion-infected blood
or blood components </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, March 09, 2014 </div>
<br />
<div>
</div>
<br />
<div>
A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of
Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease </div>
<br />
<div>
</div>
<br />
<div>
FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html</a></div>
<br />
<div>
</div>
<br />
<div>
Sunday, April 06, 2014 </div>
<br />
<div>
</div>
<br />
<div>
SPORADIC CJD and the potential for zoonotic transmission there from, either
directly or indirectly via friendly fire iatrogenic mode, evidence to date</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/04/sporadic-cjd-and-potential-for-zoonotic.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/04/sporadic-cjd-and-potential-for-zoonotic.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, December 11, 2013 </div>
<br />
<div>
</div>
<br />
<div>
*** Detection of Infectivity in Blood of Persons with Variant and Sporadic
Creutzfeldt-Jakob Disease ***</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
what is the BIG SECRET about this recent case of nvCJD in Texas ??? </div>
<br />
<div>
</div>
<br />
<div>
Monday, June 02, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** Confirmed Human BSE aka mad cow Variant CJD vCJD or nvCJD Case in Texas
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjd.blogspot.com/2014/06/confirmed-variant-cjd-case-in-texas.html">http://vcjd.blogspot.com/2014/06/confirmed-variant-cjd-case-in-texas.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, April 01, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** Questions linger in U.S. CJD cases 2005, and still do in 2014 ***
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/04/questions-linger-in-us-cjd-cases-2005.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/04/questions-linger-in-us-cjd-cases-2005.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, March 09, 2014 </div>
<br />
<div>
</div>
<br />
<div>
A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of
Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease </div>
<br />
<div>
</div>
<br />
<div>
FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html</a> </div>
<br />
<div>
</div>
<br />
<div>
Sunday, April 06, 2014 </div>
<br />
<div>
</div>
<br />
<div>
SPORADIC CJD and the potential for zoonotic transmission there from, either
directly or indirectly via friendly fire iatrogenic mode, evidence to date
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/04/sporadic-cjd-and-potential-for-zoonotic.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/04/sporadic-cjd-and-potential-for-zoonotic.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, September 10, 2014 </div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt-Jakob disease (CJD) biannual update (August 2014), with updated
guidance on decontamination of gastrointestinal endoscopy equipment Research and
analysis </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/09/creutzfeldt-jakob-disease-cjd-biannual.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/09/creutzfeldt-jakob-disease-cjd-biannual.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, September 16, 2014 </div>
<br />
<div>
</div>
<br />
<div>
mad cow scaremongers consumerfreedom.com December 20, 2003 article and a
2014 review </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://madcowusda.blogspot.com/2014/09/mad-cow-scaremongers-consumerfreedomcom.html">http://madcowusda.blogspot.com/2014/09/mad-cow-scaremongers-consumerfreedomcom.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, September 17, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** Cost benefit analysis of the development and use of ante-mortem tests
for transmissible spongiform encephalopathies ***</div>
<br />
<div>
</div>
<br />
<div>
snip... In summary, none of the respondents indicated that a live test for
BSE was likely to be available in the immediate future. Nevertheless, it is
known that at least three commercial companies that were not amongst the
respondents are still interested in marketing a test for CJD in humans, and can
legitimately be considered to have a real interest in the testing of bovines.
This is no longer a priority for them however, and will probably not be
progressed if they fail to gain approval for the testing of human blood.</div>
<br />
<div>
</div>
<br />
<div>
snip...see full text ;</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, September 17, 2014 </div>
<div>
</div>
<div>
*** Cost benefit analysis of the development and use of ante-mortem tests for
transmissible spongiform encephalopathies ***</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/09/cost-benefit-analysis-of-development.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/09/cost-benefit-analysis-of-development.html</a></div>
<br />
<div>
</div>
<br />
<div>
U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html">http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://madcowusda.blogspot.com/2012/02/eight-former-secretaries-of-agriculture.html">http://madcowusda.blogspot.com/2012/02/eight-former-secretaries-of-agriculture.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Transmissible Spongiform Encephalopathy TSE Prion Disease North America
2014</div>
<br />
<div>
</div>
<br />
<div>
Transmissible Spongiform Encephalopathy TSE Prion Disease have now been
discovered in a wide verity of species across North America. typical C-BSE,
atypical L-type BASE BSE, atypical H-type BSE, atypical H-G BSE, of the bovine,
typical and atypical Scrapie strains, in sheep and goats, with atypical Nor-98
Scrapie spreading coast to coast in about 5 years. Chronic Wasting Disease CWD
in cervid is slowly spreading without any stopping it in Canada and the USA and
now has mutated into many different strains. Transmissible Mink Encephalopathy
TME outbreaks. These Transmissible Spongiform Encephalopathy TSE Prion Disease
have been silently mutating and spreading in different species in North America
for decades. </div>
<br />
<div>
</div>
<br />
<div>
The USDA, FDA, et al have assured us of a robust Triple BSE TSE prion
Firewall, of which we now know without a doubt, that it was nothing but ink on
paper. Since the 1997 mad cow feed ban in the USA, literally tons and tons of
banned mad cow feed has been put out into commerce, never to return, as late as
December of 2013, serious, serious breaches in the FDA mad cow feed ban have
been documented. The 2004 enhanced BSE surveillance program was so flawed, that
one of the top TSE prion Scientist for the CDC, Dr. Paul Brown stated ; Brown,
who is preparing a scientific paper based on the latest two mad cow cases to
estimate the maximum number of infected cows that occurred in the United States,
said he has "absolutely no confidence in USDA tests before one year ago" because
of the agency's reluctance to retest the Texas cow that initially tested
positive. </div>
<br />
<div>
</div>
<br />
<div>
see ; </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.upi.com/Health_News/2006/03/15/Analysis-What-that-mad-cow-means/UPI-12841142465253/">http://www.upi.com/Health_News/2006/03/15/Analysis-What-that-mad-cow-means/UPI-12841142465253/</a>
</div>
<br />
<div>
</div>
<br />
<div>
The BSE surveillance and testing have also been proven to be flawed, and
the GAO and OIG have both raised serious question as to just how flawed it has
been (see GAO and OIG reports). North America has more documented TSE prion
disease, in different documented species (excluding the Zoo BSE animals in the
EU), then any other place on the Globe. This does not include the very
likelihood that TSE prion disease in the domestic feline and canine have been
exposed to high doses of the TSE prion disease vid pet food. To date, it’s still
legal to include deer from cwd zone into pet food or deer food. Specified Risk
Material i.e. SRM bans still being breach, as recently as just last month.
</div>
<br />
<div>
</div>
<br />
<div>
nvCJD or what they now call vCJD, another case documented in Texas last
month, with very little information being released to the public on about this
case? with still the same line of thought from federal officials, ‘it can’t
happen here’, so another vCJD blamed on travel of a foreign animal disease from
another country, while ignoring all the BSE TSE Prion risk factors we have here
in the USA and Canada, and the time that this victim and others, do spend in the
USA, and exposed to these risk factors, apparently do not count in any way with
regard to risk factor. a flawed process of risk assessment. </div>
<br />
<div>
</div>
<br />
<div>
sporadic CJD, along with new TSE prion disease in humans, of which the
young are dying, of which long duration of illness from onset of symptoms to
death have been documented, only to have a new name added to the pot of prion
disease i.e. sporadic GSS, sporadic FFI, and or VPSPR. I only ponder how a
familial type disease could be sporadic with no genetic link to any family
member? when the USA is the only documented Country in the world to have
documented two different cases of atypical H-type BSE, with one case being
called atypical H-G BSE with the G meaning Genetic, with new science now showing
that indeed atypical H-type BSE is very possible transmitted to cattle via oral
transmission (Prion2014). sporadic CJD and VPSPR have been rising in Canada,
USA, and the UK, with the same old excuse, better surveillance. You can only use
that excuse for so many years, for so many decades, until one must conclude that
CJD TSE prion cases are rising. a 48% incease in CJD in Canada is not just a
blip or a reason of better surveillance, it is a mathematical rise in numbers.
More and more we are seeing more humans exposed in various circumstance in the
Hospital, Medical, Surgical arenas to the TSE Prion disease, and at the same
time in North America, more and more humans are becoming exposed to the TSE
prion disease via consumption of the TSE prion via deer and elk, cattle, sheep
and goats, and for those that are exposed via or consumption, go on to further
expose many others via the iatrogenic modes of transmission of the TSE prion
disease i.e. friendly fire. I pondered this mode of transmission via the victims
of sporadic FFI, sporadic GSS, could this be a iatrogenic event from someone
sub-clinical with sFFI or sGSS ? what if? </div>
<br />
<div>
</div>
<br />
<div>
Two decades have passed since Dr. Ironside first confirmed his first ten
nvCJD victims in 1995. Ten years later, 2005, we had Dr. Gambetti and his first
ten i.e. VPSPR in younger victims. now we know that indeed VPSPR is
transmissible. yet all these TSE prion disease and victims in the USA and Canada
are being pawned off as a spontaneous event, yet science has shown, the
spontaneous theory has never been proven in any natural case of TSE prion
disease, and scientist have warned, that they have now linked some sporadic CJD
cases to atypical BSE, to atypical Scrapie, and to CWD, yet we don’t here about
this in the public domain. We must make all human and animal TSE prion disease
reportable in every age group, in ever state and internationally, we must have a
serious re-evaluation and testing of the USA cattle herds, and we must ban
interstate movement of all cervids. Any voluntary effort to do any of this will
fail. Folks, we have let the industry run science far too long with regards to
the TSE prion disease. While the industry and their lobbyist continues to funnel
junk science to our decision policy makers, Rome burns. ...end </div>
<br />
<div>
</div>
<br />
<div>
REFERENCES</div>
<br />
<div>
</div>
<br />
<div>
Sunday, June 29, 2014 </div>
<br />
<div>
</div>
<br />
<div>
Transmissible Spongiform Encephalopathy TSE Prion Disease North America
2014 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/06/transmissible-spongiform-encephalopathy.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/06/transmissible-spongiform-encephalopathy.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, August 12, 2014 </div>
<br />
<div>
</div>
<br />
<div>
MAD COW USDA TSE PRION COVER UP or JUST IGNORANCE, for the record AUGUST
2014 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://madcowusda.blogspot.com/2014/08/mad-cow-usda-tse-prion-cover-up-or-just.html">http://madcowusda.blogspot.com/2014/08/mad-cow-usda-tse-prion-cover-up-or-just.html</a></div>
<br />
<div>
</div>
<br />
<div>
Monday, July 28, 2014 </div>
<br />
<div>
</div>
<br />
<div>
Mitigating the Risk of Transmission and Environmental Contamination of
Transmissible Spongiform Encephalopathies 2013 Annual Report</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/07/mitigating-risk-of-transmission-and.html">http://transmissiblespongiformencephalopathy.blogspot.com/2014/07/mitigating-risk-of-transmission-and.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, September 10, 2014 </div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt-Jakob disease (CJD) biannual update (August 2014), with updated
guidance on decontamination of gastrointestinal endoscopy equipment </div>
<br />
<div>
</div>
<br />
<div>
Research and analysis</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/09/creutzfeldt-jakob-disease-cjd-biannual.html">http://creutzfeldt-jakob-disease.blogspot.com/2014/09/creutzfeldt-jakob-disease-cjd-biannual.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
PLEASE REMEMBER ;</div>
<br />
<div>
</div>
<br />
<div>
The Akron, Ohio-based CJD Foundation said the Center for Disease Control
revised that number in October of 2004 to about one in 9,000 CJD cases per year
in the population group age 55 and older.</div>
<br />
<div>
</div>
<br />
<div>
HAVE YOU GOT YOUR CJD QUESTIONNAIRE ASKING REAL QUESTIONS PERTAINING TO
ROUTE AND SOURCE OF THE TSE AGENT THAT KILLED YOUR LOVED ONE ???</div>
<br />
<div>
</div>
<br />
<div>
if not, why not...</div>
<br />
<div>
</div>
<br />
<div>
Friday, November 30, 2007</div>
<br />
<div>
</div>
<br />
<div>
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://cjdquestionnaire.blogspot.com/2007/11/cjd-questionnaire.html">http://cjdquestionnaire.blogspot.com/2007/11/cjd-questionnaire.html</a></div>
<br />
<div>
</div>
<br />
<div>
<a href="http://cjdquestionnaire.blogspot.com/">http://cjdquestionnaire.blogspot.com/</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
TSS</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-81911658712184559532014-08-26T07:31:00.002-07:002014-08-26T07:31:26.014-07:00Blood reference materials from macaques infected with variant Creutzfeldt-Jakob disease agent<div class="article-header__intro">
<span class="article-header__category article-category"><span style="font-family: Times New Roman;">ORIGINAL ARTICLE</span></span>
<h1 class="article-header__title">
<span style="font-family: Times New Roman;">Blood reference
materials from macaques infected with variant Creutzfeldt-Jakob disease
agent</span></h1>
<div class="article-header__authors-container">
<h2 class="is-accessible">
<span style="font-family: Times New Roman;">Authors</span></h2>
<ul class="article-header__authors_list js-module" data-module="keyboardHover">
<li class="article-header__authors-item" data-author-name="Kristy L. McDowell" data-hover-container="author1">
<h3 class="article-header__authors-name" data-hover-control="author1">
<a class="js-hover-helper" href="https://www.blogger.com/null" style="href: "http://onlinelibrary.wiley.com/enhanced/doi/10.1111/trf.12841/#author1";"><span style="font-family: Times New Roman;">Kristy L. McDowell,</span></a></h3>
<div class="article-header__author-content js-module" data-hover-content="author1" data-module="contentRevealer">
<a class="js-hover-closer icon icon__infopane-close" href="https://www.blogger.com/null" style="href: "http://onlinelibrary.wiley.com/enhanced/doi/10.1111/trf.12841/#author1";" title="Close author notes "><span class="is-accessible"><span style="font-family: Times New Roman;">Close author notes
</span></span></a>
<div id="author1">
<ol class="article-header__authors-item-aff-addr">
<li><span style="font-family: Times New Roman;">Division of Emerging and
Transfusion-Transmitted Diseases, Office of Blood Research and Review, Food and
Drug Administration, Silver Spring, Maryland</span></li>
</ol>
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<li class="article-header__authors-item" data-author-name="Nabanita Nag" data-hover-container="author2">
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<li><span style="font-family: Times New Roman;">Division of Emerging and
Transfusion-Transmitted Diseases, Office of Blood Research and Review, Food and
Drug Administration, Silver Spring, Maryland</span></li>
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Transfusion-Transmitted Diseases, Office of Blood Research and Review, Food and
Drug Administration, Silver Spring, Maryland</span></li>
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<li class="article-header__authors-item" data-author-name="Ming Bu" data-hover-container="author4">
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Transfusion-Transmitted Diseases, Office of Blood Research and Review, Food and
Drug Administration, Silver Spring, Maryland</span></li>
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Transfusion-Transmitted Diseases, Office of Blood Research and Review, Food and
Drug Administration, Silver Spring, Maryland</span></li>
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Transfusion-Transmitted Diseases, Office of Blood Research and Review, Food and
Drug Administration, Silver Spring, Maryland</span></li>
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<li class="article-header__authors-item" data-author-name="Jean‐Philippe Deslys" data-hover-container="author7">
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<li><span style="font-family: Times New Roman;">Division of Prions and Related Diseases
(SEPIA), Institute of Emerging Diseases and Innovative Therapies (iMETI), Atomic
Energy Commission, Fontenay-aux-Roses, France</span></li>
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<li class="article-header__authors-item" data-author-name="Emmanuel Comoy" data-hover-container="author8">
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<li><span style="font-family: Times New Roman;">Division of Prions and Related Diseases
(SEPIA), Institute of Emerging Diseases and Innovative Therapies (iMETI), Atomic
Energy Commission, Fontenay-aux-Roses, France</span></li>
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<li class="article-header__authors-item" data-author-name="David M. Asher" data-hover-container="author9">
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<li><span style="font-family: Times New Roman;">Division of Emerging and
Transfusion-Transmitted Diseases, Office of Blood Research and Review, Food and
Drug Administration, Silver Spring, Maryland</span></li>
</ol>
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<li class="article-header__authors-item" data-author-name="Luisa Gregori" data-hover-container="author10">
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<span class="article-header__corresponding-auth"><span style="font-family: Times New Roman;">Corresponding author</span></span>
<ol class="article-header__authors-item-aff-addr">
<li><span style="font-family: Times New Roman;">Division of Emerging and
Transfusion-Transmitted Diseases, Office of Blood Research and Review, Food and
Drug Administration, Silver Spring, Maryland</span></li>
</ol>
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<li><i class="icon icon__authors-corresp-addr"></i>
<span style="font-family: Times New Roman;">Address correspondence to: Luisa Gregori, 10903
New Hampshire Avenue, Silver Spring, MD 20993; e-mail: </span><a href="https://www.blogger.com/null" style="href: "mailto:Luisa.gregori@fda.hhs.gov";" title="Link to email address"><span style="font-family: Times New Roman;">Luisa.gregori@fda.hhs.gov</span></a><span style="font-family: Times New Roman;">.</span></li>
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<li class="article-header__meta-info-item"><span style="font-family: Times New Roman;"><span class="article-header__meta-info-label">First published: </span><time class="article-header__meta-info-data" datetime="2014-08-25" id="first-published-date">25 August 2014</time></span><a class="article-header__meta-info-2nd-data js-publication-history" href="https://www.blogger.com/null" style="href: "http://onlinelibrary.wiley.com/enhanced/doi/10.1111/trf.12841/#publication-history";"><span style="font-family: Times New Roman;">Full publication history</span></a></li>
<li class="article-header__meta-info-item"><span style="font-family: Times New Roman;"><span class="article-header__meta-info-label" id="header-section-doi">DOI: </span><span class="article-header__meta-info-data">10.1111/trf.12841</span></span></li>
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</ul>
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</div>
<br />
<hr />
<br />
<div class="article-header__references-container">
<ul class="article-header__references-list">
<li class="article-header__references-item" id="trf12841-note-0001"><span style="font-family: Times New Roman;">This article reflects the views of the authors and should
not be construed to represent FDA's views or policies.</span></li>
<li class="article-header__references-item" id="trf12841-note-0002"><span style="font-family: Times New Roman;">This work was supported by the US Food and Drug
Administration and by an award from the FDA Office of the Chief Scientist. Part
of this work was also funded by a grant from the Alliance BioSecure
Foundation.</span></li>
</ul>
</div>
<section class="article-section article-section--abstract" id="abstract">
<div class="article-section__content mainAbstract">
<h2 class="article-section__header">
<span style="font-family: Times New Roman;">Abstract</span></h2>
<section class="article-section article-body-section" id="trf12841-sec-0001">
<h3>
<span style="font-family: Times New Roman;">Background</span></h3>
<span style="font-family: Times New Roman;">Variant Creutzfeldt-Jakob disease (vCJD) is a
fatal neurodegenerative infection that can be transmitted by blood and blood
products from donors in the latent phase of the disease. Currently, there is no
validated antemortem vCJD blood screening test. Several blood tests are under
development. Any useful test must be validated with disease-relevant blood
reference panels.</span></section><section class="article-section article-body-section" id="trf12841-sec-0002">
<h3>
<span style="font-family: Times New Roman;">Study Design and Methods</span></h3>
<span style="font-family: Times New Roman;">To generate blood reference materials, we
infected four cynomolgus macaques with macaque-adapted vCJD brain homogenates.
Blood was collected throughout the preclinical and clinical phases of infection.
In parallel, equivalent blood was collected from one uninfected macaque. For
each blood collection, an aliquot was stored as whole blood and the remainder
was separated into components. Aliquots of plasma from terminally ill macaques
were assayed for the presence of PrP<sup>TSE</sup> with the protein misfolding
cyclic amplification (PMCA) method. Infectivity of the macaque brain homogenate
used to infect macaques was titrated in C57BL/6 and RIII J/S inbred wild-type
mice.</span></section><section class="article-section article-body-section" id="trf12841-sec-0003">
<h3>
<span style="font-family: Times New Roman;">Results</span></h3>
<span style="font-family: Times New Roman;">We sampled blood 19 times from the inoculated
monkeys at various stages of the disease over a period of 29 months, generating
liters of vCJD-infected macaque blood. vCJD was confirmed in all inoculated
macaques. After PMCA, PrP<sup>TSE</sup> was detected in plasma from infected
monkeys, but not from uninfected animals. Both mouse models were more sensitive
to infection with macaque-adapted vCJD agent than to primary human vCJD
agent.</span></section><section class="article-section article-body-section" id="trf12841-sec-0004">
<h3>
<span style="font-family: Times New Roman;">Conclusion</span></h3>
<span style="font-family: Times New Roman;">The macaque vCJD blood panels generated in this
study provide a unique resource to support vCJD assay development and to
characterize vCJD infectivity in blood.</span><br />
<a href="http://onlinelibrary.wiley.com/enhanced/doi/10.1111/trf.12841/" title="http://onlinelibrary.wiley.com/enhanced/doi/10.1111/trf.12841/">http://onlinelibrary.wiley.com/enhanced/doi/10.1111/trf.12841/</a><br />
<table border="1" class="ProductInfo" padding="2" style="color: black; margin-top: 20px; width: 900px;">
<tbody>
<tr>
<th scope="row"><span new="" roman="" style="face: "Times";">Reason For Recall
</span></th>
<td><span new="" roman="" style="face: "Times";">Blood product, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
</span></td></tr>
</tbody></table>
<div>
</div>
<table border="1" class="EventInfo" padding="2" sizcache="2" sizset="29" style="color: black; width: 700px;">
<tbody sizcache="2" sizset="29">
<tr>
<th scope="row"><span new="" roman="" style="face: "Times";">Voluntary / Mandated
</span></th>
<td><span new="" roman="" style="face: "Times";">Voluntary: Firm
Initiated</span></td></tr>
<tr>
<th scope="row"><span new="" roman="" style="face: "Times";">Recall Initiation Date
</span></th>
<td><span new="" roman="" style="face: "Times";">2014-05-16 </span></td></tr>
<tr>
<th scope="row"><span new="" roman="" style="face: "Times";">Initial Firm Notification of
Consignee or Public </span></th>
<td><span new="" roman="" style="face: "Times";">E-Mail</span></td></tr>
<tr>
<th scope="row"><span new="" roman="" style="face: "Times";">Distribution Pattern
</span></th>
<td><span new="" roman="" style="face: "Times";">Switzerland
</span></td></tr>
</tbody></table>
<div>
</div>
<div>
</div>
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-0869-14&w=08202014&lang=eng" style="href: "http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-0869-14&w=08202014&lang=eng";" title="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-0869-14&w=08202014&lang=eng">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-0869-14&w=08202014&lang=eng</a></div>
<div>
</div>
<div>
see more ;</div>
<div>
</div>
<table class="tablesorter" jquery1408640279278="21" padding="2" sizcache="2" sizset="43" style="color: black;">
<tbody sizcache="2" sizset="49">
<tr class="Biol even" sizcache="2" sizset="68">
<td><span new="" roman="" style="face: "Times";">Biologics</span></td>
<td sizcache="2" sizset="68"><a href="https://www.blogger.com/null" style="target: _blank;"><span new="" roman="" style="face: "Times";">Red Blood Cells Leukocytes
Reduced</span></a></td>
<td><span new="" roman="" style="face: "Times";">W089813410351; </span></td>
<td align="center"><span new="" roman="" style="face: "Times";">Class II</span></td>
<td><span new="" roman="" style="face: "Times";">Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were
distributed.</span></td>
<td><span new="" roman="" style="face: "Times";">Inova Health Care Services, Inova
Blood Donor Services</span></td></tr>
<tr class="Biol odd" sizcache="2" sizset="69">
<td><span new="" roman="" style="face: "Times";">Biologics</span></td>
<td sizcache="2" sizset="69"><a href="https://www.blogger.com/null" style="target: _blank;"><span new="" roman="" style="face: "Times";">Blood and Blood Products for
Reprocessing</span></a></td>
<td><span new="" roman="" style="face: "Times";">W089813410351; </span></td>
<td align="center"><span new="" roman="" style="face: "Times";">Class III</span></td>
<td><span new="" roman="" style="face: "Times";">Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were
distributed.</span></td>
<td><span new="" roman="" style="face: "Times";">Inova Health Care Services, Inova
Blood Donor Services</span></td></tr>
<tr class="Biol even" sizcache="2" sizset="70">
<td><span new="" roman="" style="face: "Times";">Biologics</span></td>
<td sizcache="2" sizset="70"><a href="https://www.blogger.com/null" style="target: _blank;"><span new="" roman="" style="face: "Times";">Cryoprecipitated AHF</span></a></td>
<td><span new="" roman="" style="face: "Times";">W089813410351; </span></td>
<td align="center"><span new="" roman="" style="face: "Times";">Class II</span></td>
<td><span new="" roman="" style="face: "Times";">Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were
distributed.</span></td>
<td><span new="" roman="" style="face: "Times";">Inova Health Care Services, Inova
Blood Donor Services</span></td></tr>
<tr class="Biol odd" sizcache="2" sizset="71">
<td><span new="" roman="" style="face: "Times";">Biologics</span></td>
<td sizcache="2" sizset="71"><a href="https://www.blogger.com/null" style="target: _blank;"><span new="" roman="" style="face: "Times";">Red Blood Cells Leukocytes
Reduced</span></a></td>
<td><span new="" roman="" style="face: "Times";">W088414515528; W088414516606;
</span></td>
<td align="center"><span new="" roman="" style="face: "Times";">Class II</span></td>
<td><span new="" roman="" style="face: "Times";">Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were
distributed.</span></td>
<td><span new="" roman="" style="face: "Times";">Blood Bank Of
Hawaii</span></td></tr>
</tbody></table>
<div>
</div>
<div>
</div>
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&utm_medium=email&utm_source=govdelivery&w=08202014" style="href: "http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&utm_medium=email&utm_source=govdelivery&w=08202014";" title="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&utm_medium=email&utm_source=govdelivery&w=08202014">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&utm_medium=email&utm_source=govdelivery&w=08202014</a></div>
<div>
</div>
<div>
</div>
<div>
Saturday, July 07, 2012<br /><br />Class II, Blood products, collected from a
donor who was at risk for variant Creutzfeldt-Jakob disease ( vCJD) USA
<br /><br />Enforcement Report <br /><br /><a href="http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html">http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html</a></div>
<div>
<br />Monday, June 11, 2012 <br /><br />Guidance for Industry Draft Guidance for
Industry: Amendment to “Guidance for Industry: Revised Preventive Measures to
Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and
Variant Creutzfeldt-Jakob Disease by Blood and Blood Products” <br /><br />IN SHORT
; <br /><br />“However, based on animal studies, as well as on FDA risk assessments,
the possibility of vCJD transmission by a U.S.-licensed plasma derivative, while
extremely small, cannot be absolutely ruled out. For these reasons, the
recommendations for labeling for plasma derivatives will include mention of vCJD
for the first time, and the potential risk for its transmission. The recommended
elements of the warning label for CJD are unchanged and continue to describe its
transmission as a theoretical risk, given that there is no confirmed evidence
that CJD is transmitted by blood (Refs. 4-7).“ <br /><br />IN FULL, as follows ;
<br /><br />Monday, June 11, 2012 <br /><br />Guidance for Industry Draft Guidance for
Industry: Amendment to “Guidance for Industry: Revised Preventive Measures to
Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and
Variant Creutzfeldt-Jakob Disease by Blood and Blood Products” <br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html";">http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html</a></div>
<div>
<br />Friday, June 29, 2012<br /><br />Highly Efficient Prion Transmission by
Blood Transfusion <br /><br /><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html" style="href: "http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html";">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html</a></div>
<div>
<br />Sunday, June 3, 2012<br /><br />A new neurological disease in primates
inoculated with prion-infected blood or blood components <br /><br /><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html" style="href: "http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html";">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html</a>
</div>
<div>
</div>
<div>
Sunday, March 09, 2014 </div>
<div>
</div>
<div>
A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of
Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease </div>
<div>
</div>
<div>
FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html";">http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html</a></div>
<div>
</div>
<div>
Sunday, April 06, 2014 </div>
<div>
</div>
<div>
SPORADIC CJD and the potential for zoonotic transmission there from, either
directly or indirectly via friendly fire iatrogenic mode, evidence to date</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/04/sporadic-cjd-and-potential-for-zoonotic.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2014/04/sporadic-cjd-and-potential-for-zoonotic.html";">http://creutzfeldt-jakob-disease.blogspot.com/2014/04/sporadic-cjd-and-potential-for-zoonotic.html</a>
</div>
<div>
</div>
<div>
Wednesday, December 11, 2013 </div>
<div>
</div>
<div>
*** Detection of Infectivity in Blood of Persons with Variant and Sporadic
Creutzfeldt-Jakob Disease ***</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html";">http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html</a>
</div>
<div>
</div>
<div>
Friday, January 10, 2014 </div>
<div>
</div>
<div>
vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial type
prion disease, what it ??? </div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html" style="href: "http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html";">http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html</a>
</div>
<div>
</div>
<div>
Monday, May 19, 2014 </div>
<div>
</div>
<div>
Variant CJD: 18 years of research and surveillance </div>
<div>
</div>
<div>
<a href="http://vcjd.blogspot.com/2014/05/variant-cjd-18-years-of-research-and.html" style="href: "http://vcjd.blogspot.com/2014/05/variant-cjd-18-years-of-research-and.html";" title="http://vcjd.blogspot.com/2014/05/variant-cjd-18-years-of-research-and.html">http://vcjd.blogspot.com/2014/05/variant-cjd-18-years-of-research-and.html</a></div>
<div>
</div>
<div>
Sunday, June 29, 2014 </div>
<div>
</div>
<div>
Transmissible Spongiform Encephalopathy TSE Prion Disease North America
2014 </div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/06/transmissible-spongiform-encephalopathy.html" style="href: "http://transmissiblespongiformencephalopathy.blogspot.com/2014/06/transmissible-spongiform-encephalopathy.html";">http://transmissiblespongiformencephalopathy.blogspot.com/2014/06/transmissible-spongiform-encephalopathy.html</a></div>
<div>
</div>
<div>
Tuesday, August 12, 2014 </div>
<div>
</div>
<div>
*** MAD COW USDA TSE PRION COVER UP or JUST IGNORANCE, for the record
AUGUST 2014 ***</div>
<div>
</div>
<div>
see history of record of either the biggest cover up of mad cow disease, or
one of the biggest blunders of the mad cow debacle, just my opinion of the
facts...tss</div>
<div>
</div>
<div>
<a href="http://madcowusda.blogspot.com/2014/08/mad-cow-usda-tse-prion-cover-up-or-just.html" style="href: "http://madcowusda.blogspot.com/2014/08/mad-cow-usda-tse-prion-cover-up-or-just.html";">http://madcowusda.blogspot.com/2014/08/mad-cow-usda-tse-prion-cover-up-or-just.html</a> </div>
<div>
</div>
<div>
Monday, June 02, 2014 </div>
<div>
</div>
<div>
*** Confirmed Human BSE aka mad cow Variant CJD vCJD or nvCJD Case in Texas
</div>
<div>
</div>
<div>
<a href="http://vcjd.blogspot.com/2014/06/confirmed-variant-cjd-case-in-texas.html" style="href: "http://vcjd.blogspot.com/2014/06/confirmed-variant-cjd-case-in-texas.html";">http://vcjd.blogspot.com/2014/06/confirmed-variant-cjd-case-in-texas.html</a></div>
<div>
</div>
<div>
Tuesday, April 01, 2014 </div>
<div>
</div>
<div>
*** Questions linger in U.S. CJD cases 2005, and still do in 2014 ***</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/04/questions-linger-in-us-cjd-cases-2005.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2014/04/questions-linger-in-us-cjd-cases-2005.html";">http://creutzfeldt-jakob-disease.blogspot.com/2014/04/questions-linger-in-us-cjd-cases-2005.html</a>
</div>
<div>
</div>
<div>
Monday, August 18, 2014 </div>
<div>
</div>
<div>
*** Barriers to Creutzfeldt-Jakob Disease Autopsies, California and the
USA</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/08/barriers-to-creutzfeldt-jakob-disease.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2014/08/barriers-to-creutzfeldt-jakob-disease.html";">http://creutzfeldt-jakob-disease.blogspot.com/2014/08/barriers-to-creutzfeldt-jakob-disease.html</a>
</div>
<div>
</div>
<div>
PLEASE REMEMBER ;</div>
<div>
</div>
<div>
The Akron, Ohio-based CJD Foundation said the Center for Disease Control
revised that number in October of 2004 to about one in 9,000 CJD cases per year
in the population group age 55 and older.</div>
<div>
</div>
<div>
HAVE YOU GOT YOUR CJD QUESTIONNAIRE ASKING REAL QUESTIONS PERTAINING TO
ROUTE AND SOURCE OF THE TSE AGENT THAT KILLED YOUR LOVED ONE ???</div>
<div>
</div>
<div>
if not, why not...</div>
<div>
</div>
<div>
Friday, November 30, 2007</div>
<div>
</div>
<div>
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION</div>
<div>
</div>
<div>
<a href="http://cjdquestionnaire.blogspot.com/2007/11/cjd-questionnaire.html" style="href: "http://cjdquestionnaire.blogspot.com/2007/11/cjd-questionnaire.html";">http://cjdquestionnaire.blogspot.com/2007/11/cjd-questionnaire.html</a></div>
<div>
</div>
<div>
<a href="http://cjdquestionnaire.blogspot.com/" style="href: "http://cjdquestionnaire.blogspot.com/";">http://cjdquestionnaire.blogspot.com/</a>
</div>
<div>
</div>
<div>
Thursday, August 21, 2014 </div>
<div>
</div>
<div>
FDA Switzerland Reason For Recall Blood product, collected from a donor who
was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed
2014-05-16 </div>
<div>
</div>
<div>
<a href="http://vcjdtransfusion.blogspot.com/2014/08/fda-switzerland-reason-for-recall-blood.html" style="href: "http://vcjdtransfusion.blogspot.com/2014/08/fda-switzerland-reason-for-recall-blood.html";" title="http://vcjdtransfusion.blogspot.com/2014/08/fda-switzerland-reason-for-recall-blood.html">http://vcjdtransfusion.blogspot.com/2014/08/fda-switzerland-reason-for-recall-blood.html</a></div>
<div>
</div>
TSS</section></div>
</section>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-28677580684005640482014-08-21T10:15:00.000-07:002014-08-21T10:15:04.852-07:00FDA Switzerland Reason For Recall Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed 2014-05-16 <table border="1" class="ProductInfo" padding="2" style="color: black; margin-top: 20px; width: 900px;">
<tbody>
<tr>
<th scope="row"><span style="font-family: Times New Roman;">Reason For Recall </span></th>
<td><span style="font-family: Times New Roman;">Blood product, collected from a donor who was
at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
</span></td></tr>
</tbody></table>
<br />
<div>
</div>
<br />
<table border="1" class="EventInfo" padding="2" sizcache="2" sizset="29" style="color: black; width: 700px;">
<tbody sizcache="2" sizset="29">
<tr>
<th scope="row"><span style="font-family: Times New Roman;">Voluntary / Mandated </span></th>
<td><span style="font-family: Times New Roman;">Voluntary: Firm Initiated</span></td></tr>
<tr>
<th scope="row"><span style="font-family: Times New Roman;">Recall Initiation Date </span></th>
<td><span style="font-family: Times New Roman;">2014-05-16 </span></td></tr>
<tr>
<th scope="row"><span style="font-family: Times New Roman;">Initial Firm Notification of
Consignee or Public </span></th>
<td><span style="font-family: Times New Roman;">E-Mail</span></td></tr>
<tr>
<th scope="row"><span style="font-family: Times New Roman;">Distribution Pattern </span></th>
<td><span style="font-family: Times New Roman;">Switzerland </span></td></tr>
</tbody></table>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-0869-14&w=08202014&lang=eng" title="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-0869-14&w=08202014&lang=eng">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-0869-14&w=08202014&lang=eng</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
see more ;</div>
<br />
<div>
</div>
<br />
<table class="tablesorter" jquery1408640279278="21" padding="2" sizcache="2" sizset="43" style="color: black;">
<tbody sizcache="2" sizset="49">
<tr class="Biol even" sizcache="2" sizset="68">
<td><span style="font-family: Times New Roman;">Biologics</span></td>
<td sizcache="2" sizset="68"><a href="https://www.blogger.com/null" style="href: "?action=select&recall_number=B-0808-14&w=08202014&lang=eng";" target="_blank"><span style="font-family: Times New Roman;">Red Blood Cells Leukocytes
Reduced</span></a></td>
<td><span style="font-family: Times New Roman;">W089813410351; </span></td>
<td align="center"><span style="font-family: Times New Roman;">Class II</span></td>
<td><span style="font-family: Times New Roman;">Blood products, collected from a donor who was
at risk for variant Creutzfeldt-Jakob disease (vCJD), were
distributed.</span></td>
<td><span style="font-family: Times New Roman;">Inova Health Care Services, Inova Blood Donor
Services</span></td></tr>
<tr class="Biol odd" sizcache="2" sizset="69">
<td><span style="font-family: Times New Roman;">Biologics</span></td>
<td sizcache="2" sizset="69"><a href="https://www.blogger.com/null" style="href: "?action=select&recall_number=B-0809-14&w=08202014&lang=eng";" target="_blank"><span style="font-family: Times New Roman;">Blood and Blood Products for
Reprocessing</span></a></td>
<td><span style="font-family: Times New Roman;">W089813410351; </span></td>
<td align="center"><span style="font-family: Times New Roman;">Class III</span></td>
<td><span style="font-family: Times New Roman;">Blood products, collected from a donor who was
at risk for variant Creutzfeldt-Jakob disease (vCJD), were
distributed.</span></td>
<td><span style="font-family: Times New Roman;">Inova Health Care Services, Inova Blood Donor
Services</span></td></tr>
<tr class="Biol even" sizcache="2" sizset="70">
<td><span style="font-family: Times New Roman;">Biologics</span></td>
<td sizcache="2" sizset="70"><a href="https://www.blogger.com/null" style="href: "?action=select&recall_number=B-0810-14&w=08202014&lang=eng";" target="_blank"><span style="font-family: Times New Roman;">Cryoprecipitated AHF</span></a></td>
<td><span style="font-family: Times New Roman;">W089813410351; </span></td>
<td align="center"><span style="font-family: Times New Roman;">Class II</span></td>
<td><span style="font-family: Times New Roman;">Blood products, collected from a donor who was
at risk for variant Creutzfeldt-Jakob disease (vCJD), were
distributed.</span></td>
<td><span style="font-family: Times New Roman;">Inova Health Care Services, Inova Blood Donor
Services</span></td></tr>
<tr class="Biol odd" sizcache="2" sizset="71">
<td><span style="font-family: Times New Roman;">Biologics</span></td>
<td sizcache="2" sizset="71"><a href="https://www.blogger.com/null" style="href: "?action=select&recall_number=B-0811-14&w=08202014&lang=eng";" target="_blank"><span style="font-family: Times New Roman;">Red Blood Cells Leukocytes
Reduced</span></a></td>
<td><span style="font-family: Times New Roman;">W088414515528; W088414516606; </span></td>
<td align="center"><span style="font-family: Times New Roman;">Class II</span></td>
<td><span style="font-family: Times New Roman;">Blood products, collected from a donor who was
at risk for variant Creutzfeldt-Jakob disease (vCJD), were
distributed.</span></td>
<td><span style="font-family: Times New Roman;">Blood Bank Of
Hawaii</span></td></tr>
</tbody></table>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&utm_medium=email&utm_source=govdelivery&w=08202014" title="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&utm_medium=email&utm_source=govdelivery&w=08202014">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&utm_medium=email&utm_source=govdelivery&w=08202014</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Saturday, July 07, 2012<br /><br />Class II, Blood products, collected from a
donor who was at risk for variant Creutzfeldt-Jakob disease ( vCJD) USA
<br /><br />Enforcement Report <br /><br /><a href="http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html" style="href: "http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html";">http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html</a></div>
<br />
<div>
<br />Monday, June 11, 2012 <br /><br />Guidance for Industry Draft Guidance for
Industry: Amendment to “Guidance for Industry: Revised Preventive Measures to
Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and
Variant Creutzfeldt-Jakob Disease by Blood and Blood Products” <br /><br />IN SHORT
; <br /><br />“However, based on animal studies, as well as on FDA risk assessments,
the possibility of vCJD transmission by a U.S.-licensed plasma derivative, while
extremely small, cannot be absolutely ruled out. For these reasons, the
recommendations for labeling for plasma derivatives will include mention of vCJD
for the first time, and the potential risk for its transmission. The recommended
elements of the warning label for CJD are unchanged and continue to describe its
transmission as a theoretical risk, given that there is no confirmed evidence
that CJD is transmitted by blood (Refs. 4-7).“ <br /><br />IN FULL, as follows ;
<br /><br />Monday, June 11, 2012 <br /><br />Guidance for Industry Draft Guidance for
Industry: Amendment to “Guidance for Industry: Revised Preventive Measures to
Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and
Variant Creutzfeldt-Jakob Disease by Blood and Blood Products” <br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html";">http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html</a></div>
<br />
<div>
<br /><br />Friday, June 29, 2012<br /><br />Highly Efficient Prion Transmission by
Blood Transfusion <br /><br /><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html" style="href: "http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html";">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html</a></div>
<br />
<div>
<br /><br />Sunday, June 3, 2012<br /><br />A new neurological disease in primates
inoculated with prion-infected blood or blood components <br /><br /><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html" style="href: "http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html";">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html</a>
</div>
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<div>
</div>
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<div>
</div>
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<div>
Sunday, March 09, 2014 </div>
<br />
<div>
</div>
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<div>
A Creutzfeldt-Jakob Disease (CJD) Lookback Study: Assessing the Risk of
Blood Borne Transmission of Classic Forms of Creutzfeldt-Jakob Disease </div>
<br />
<div>
</div>
<br />
<div>
FDA TSEAC CIRCUS AND TRAVELING ROAD SHOW FOR THE TSE PRION DISEASES</div>
<br />
<div>
</div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html";">http://creutzfeldt-jakob-disease.blogspot.com/2014/03/a-creutzfeldt-jakob-disease-cjd.html</a></div>
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</div>
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<div>
Sunday, April 06, 2014 </div>
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<div>
</div>
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<div>
SPORADIC CJD and the potential for zoonotic transmission there from, either
directly or indirectly via friendly fire iatrogenic mode, evidence to date</div>
<br />
<div>
</div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/04/sporadic-cjd-and-potential-for-zoonotic.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2014/04/sporadic-cjd-and-potential-for-zoonotic.html";">http://creutzfeldt-jakob-disease.blogspot.com/2014/04/sporadic-cjd-and-potential-for-zoonotic.html</a>
</div>
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</div>
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<div>
Wednesday, December 11, 2013 </div>
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</div>
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<div>
*** Detection of Infectivity in Blood of Persons with Variant and Sporadic
Creutzfeldt-Jakob Disease ***</div>
<br />
<div>
</div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html";">http://creutzfeldt-jakob-disease.blogspot.com/2013/12/detection-of-infectivity-in-blood-of.html</a>
</div>
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</div>
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<div>
</div>
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<div>
Friday, January 10, 2014 </div>
<br />
<div>
</div>
<br />
<div>
vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial type
prion disease, what it ??? </div>
<br />
<div>
</div>
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<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html" style="href: "http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html";">http://transmissiblespongiformencephalopathy.blogspot.com/2014/01/vpspr-sgss-sffi-tse-iatrogenic-by.html</a>
</div>
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</div>
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</div>
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<div>
Monday, May 19, 2014 </div>
<br />
<div>
</div>
<br />
<div>
Variant CJD: 18 years of research and surveillance </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjd.blogspot.com/2014/05/variant-cjd-18-years-of-research-and.html" style="href: "http://vcjd.blogspot.com/2014/05/variant-cjd-18-years-of-research-and.html";" title="http://vcjd.blogspot.com/2014/05/variant-cjd-18-years-of-research-and.html">http://vcjd.blogspot.com/2014/05/variant-cjd-18-years-of-research-and.html</a></div>
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</div>
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</div>
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<div>
Sunday, June 29, 2014 </div>
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</div>
<br />
<div>
Transmissible Spongiform Encephalopathy TSE Prion Disease North America
2014 </div>
<br />
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</div>
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<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2014/06/transmissible-spongiform-encephalopathy.html" style="href: "http://transmissiblespongiformencephalopathy.blogspot.com/2014/06/transmissible-spongiform-encephalopathy.html";">http://transmissiblespongiformencephalopathy.blogspot.com/2014/06/transmissible-spongiform-encephalopathy.html</a></div>
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<div>
Tuesday, August 12, 2014 </div>
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</div>
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<div>
*** MAD COW USDA TSE PRION COVER UP or JUST IGNORANCE, for the record
AUGUST 2014 ***</div>
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<div>
</div>
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<div>
see history of record of either the biggest cover up of mad cow disease, or
one of the biggest blunders of the mad cow debacle, just my opinion of the
facts...tss</div>
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</div>
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<div>
<a href="http://madcowusda.blogspot.com/2014/08/mad-cow-usda-tse-prion-cover-up-or-just.html" style="href: "http://madcowusda.blogspot.com/2014/08/mad-cow-usda-tse-prion-cover-up-or-just.html";">http://madcowusda.blogspot.com/2014/08/mad-cow-usda-tse-prion-cover-up-or-just.html</a>
</div>
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</div>
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<div>
Monday, June 02, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** Confirmed Human BSE aka mad cow Variant CJD vCJD or nvCJD Case in Texas
</div>
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<div>
</div>
<br />
<div>
<a href="http://vcjd.blogspot.com/2014/06/confirmed-variant-cjd-case-in-texas.html" style="href: "http://vcjd.blogspot.com/2014/06/confirmed-variant-cjd-case-in-texas.html";">http://vcjd.blogspot.com/2014/06/confirmed-variant-cjd-case-in-texas.html</a></div>
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</div>
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<div>
Tuesday, April 01, 2014 </div>
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<div>
</div>
<br />
<div>
*** Questions linger in U.S. CJD cases 2005, and still do in 2014 ***</div>
<br />
<div>
</div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/04/questions-linger-in-us-cjd-cases-2005.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2014/04/questions-linger-in-us-cjd-cases-2005.html";">http://creutzfeldt-jakob-disease.blogspot.com/2014/04/questions-linger-in-us-cjd-cases-2005.html</a>
</div>
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<div>
</div>
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</div>
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<div>
Monday, August 18, 2014 </div>
<br />
<div>
</div>
<br />
<div>
*** Barriers to Creutzfeldt-Jakob Disease Autopsies, California and the
USA</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2014/08/barriers-to-creutzfeldt-jakob-disease.html" style="href: "http://creutzfeldt-jakob-disease.blogspot.com/2014/08/barriers-to-creutzfeldt-jakob-disease.html";">http://creutzfeldt-jakob-disease.blogspot.com/2014/08/barriers-to-creutzfeldt-jakob-disease.html</a>
</div>
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<div>
</div>
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</div>
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<div>
PLEASE REMEMBER ;</div>
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</div>
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<div>
The Akron, Ohio-based CJD Foundation said the Center for Disease Control
revised that number in October of 2004 to about one in 9,000 CJD cases per year
in the population group age 55 and older.</div>
<br />
<div>
</div>
<br />
<div>
HAVE YOU GOT YOUR CJD QUESTIONNAIRE ASKING REAL QUESTIONS PERTAINING TO
ROUTE AND SOURCE OF THE TSE AGENT THAT KILLED YOUR LOVED ONE ???</div>
<br />
<div>
</div>
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<div>
if not, why not...</div>
<br />
<div>
</div>
<br />
<div>
Friday, November 30, 2007</div>
<br />
<div>
</div>
<br />
<div>
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://cjdquestionnaire.blogspot.com/2007/11/cjd-questionnaire.html" style="href: "http://cjdquestionnaire.blogspot.com/2007/11/cjd-questionnaire.html";">http://cjdquestionnaire.blogspot.com/2007/11/cjd-questionnaire.html</a></div>
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<div>
</div>
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<div>
<a href="http://cjdquestionnaire.blogspot.com/" style="href: "http://cjdquestionnaire.blogspot.com/";">http://cjdquestionnaire.blogspot.com/</a>
</div>
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</div>
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TSS</div>
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</div>
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<div>
</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-27798689128509321592013-10-11T07:45:00.001-07:002013-10-11T07:45:07.114-07:00Removal of exogenous prion infectivity in leukoreduced red blood cells unit by a specific filter designed for human transfusion<div>
ORIGINAL ARTICLE</div>
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</div>
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<div>
Removal of exogenous prion infectivity in leukoreduced red blood cells unit
by a specific filter designed for human transfusion </div>
<br />
<div>
</div>
<br />
<div>
Nathalie Lescoutra-Etchegaray1,*, Chryslain Sumian2, Audrey Culeux1,
Valérie Durand3, Patrick V. Gurgel4, Jean-Philippe Deslys3, Emmanuel E. Comoy3
Article first published online: 10 OCT 2013</div>
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<div>
</div>
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<div>
DOI: 10.1111/trf.12420</div>
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<div>
© 2013 American Association of Blood Banks </div>
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<div>
Lescoutra-Etchegaray, N., Sumian, C., Culeux, A., Durand, V., Gurgel, P.
V., Deslys, J.-P. and Comoy, E. E. (2013), Removal of exogenous prion
infectivity in leukoreduced red blood cells unit by a specific filter designed
for human transfusion. Transfusion. doi: 10.1111/trf.12420 </div>
<br />
<div>
</div>
<br />
<div>
Author Information 1 Macopharma, Fontenay-aux-Roses, France 2 Macopharma,
Tourcoing, France 3 Institute of Emerging Diseases and Innovative Therapies
(iMETI), Division of Prions and Related Diseases (SEPIA), CEA,
Fontenay-aux-Roses, France 4 ProMetic Biosciences, Raleigh, North Carolina
*Address reprint requests to: Nathalie Lescoutra-Etchegaray, Macopharma, 18
Route du Panorama, Bâtiment 60, 92265 Fontenay-aux-Roses, France; e-mail:
nathalie.lescoutra@macopharma.com.</div>
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<div>
</div>
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<div>
This work was supported by grants from Agence Nationale de la Recherche
(ANR), Project PRIONSECUR ANR05PRIB02302.</div>
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</div>
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<div>
Publication History Article first published online: 10 OCT 2013 Manuscript
Accepted: 12 JUL 2013 Manuscript Revised: 10 JUL 2013 Manuscript Received: 23
APR 2013 Funded by Agence Nationale de la Recherche (ANR). Grant Number:
PRIONSECUR ANR05PRIB02302 </div>
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<div>
</div>
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<div>
Background </div>
<br />
<div>
</div>
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<div>
Five cases of variant Creutzfeldt-Jakob disease (vCJD) infections were
attributed to infusion of contaminated blood components, turning to real the
interhuman transmissibility of this prion disease from asymptomatic carriers.
Preventive policies rely on exclusion from blood donation and benefit of
leukoreduction initially implemented against leukotropic viruses. In the absence
of available antemortem diagnostic tests, the updated prevalence of silent vCJD
infections (1/2000 in the United Kingdom) urges the necessity to enforce blood
safety with more efficient active measures able to remove the remaining
infectivity.</div>
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<div>
</div>
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<div>
Study Design and Methods Several affinity resins were demonstrated to
reduce high levels of brain-spiked infectivity from human leukoreduced red blood
cells (L-RBCs). One was integrated in a device adapted to field constraints
(volumes, duration) of human transfusion. We assessed here the ability of the
resulting removal filter, termed P-Capt, to remove infectivity from human L-RBC
units spiked with scrapie-infected hamster brain (≥10,000 infectious units/mL),
through inoculation of hamsters with pre- and post–blood filtration
samples.</div>
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</div>
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<div>
Results Incubation periods of recipient animals suggest around a 3-log
removal of brain-derived prion infectivity by filtration through the
P-Capt.</div>
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<div>
</div>
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<div>
Conclusion On brain-derived spiked infectivity, the P-Capt filter provided
a performance similar to the resin packed in columns used for initial
proof-of-concept studies, suggesting an appropriate scale-up to efficiently
remove infectivity from an individual human blood bag. According to the ability
of resin to completely remove apparent endogenous infectivity from hamster
leukoreduced blood, the implementation of such a filter, now commercially
available, might seriously improve blood safety toward prions. </div>
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<div>
</div>
<br />
<div>
<a href="http://onlinelibrary.wiley.com/doi/10.1111/trf.12420/abstract">http://onlinelibrary.wiley.com/doi/10.1111/trf.12420/abstract</a>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
Sunday, September 29, 2013 </div>
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<div>
</div>
<br />
<div>
Recalls raise questions on safety practices for donated blood CJD TSE PRION
</div>
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<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/09/recalls-raise-questions-on-safety.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/09/recalls-raise-questions-on-safety.html</a>
</div>
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</div>
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</div>
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</div>
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<div>
Sent: Monday, October 07, 2013 9:54 PM </div>
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<div>
</div>
<br />
<div>
To: <a href="mailto:CJD-L@LISTS.AEGEE.ORG">CJD-L@LISTS.AEGEE.ORG</a> </div>
<br />
<div>
</div>
<br />
<div>
Subject: [CJD-L] Coexistence of Distinct Prion Types Enables Conformational
Evolution of Human PrPSc by Competitive Selection </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/10/coexistence-of-distinct-prion-types.html" title="http://creutzfeldt-jakob-disease.blogspot.com/2013/10/coexistence-of-distinct-prion-types.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/10/coexistence-of-distinct-prion-types.html</a></div>
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<div>
</div>
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<div>
</div>
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</div>
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<div>
</div>
<br />
<div>
TSS</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-16747078617220046102013-09-02T10:03:00.000-07:002013-09-02T10:03:32.219-07:00Lessons from the response to the threat of transfusion-transmitted vCJD in Ireland<div>
Original article </div>
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<div>
</div>
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<div>
Lessons from the response to the threat of transfusion-transmitted vCJD in
Ireland </div>
<br />
<div>
</div>
<br />
<div>
Leçons tirées de la gestion du risque de transmission-tranfusionnelle du
vMCJ en Irelande W.G. Murphya, b, Corresponding author contact
information<img alt="Corresponding author contact information" cor.gif="" entities="" http:="" origin-cdn.els-cdn.com="" sd="" src="<a href=" />http://origin-cdn.els-cdn.com/sd/entities/REcor.gif"</div>
>,
E-mail the corresponding author<img email.gif="" entities="" http:="" origin-cdn.els-cdn.com="" sd="" src="<a href=" />http://origin-cdn.els-cdn.com/sd/entities/REemail.gif"
alt="E-mail the corresponding author"> a Irish Blood Transfusion Service,
James's Street, Dublin 8, Ireland b School of Medicine & Medical Science,
University College, Dublin, Ireland Available online 31 August 2013 Referred to
by J. Coste Symposium on prions and transfusion safety Transfusion Clinique et
Biologique, Available online 6 August 2013, PDF (236 K)
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--------------------------------------------------------------------------------</div>
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Abstract </div>
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</div>
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</div>
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<div>
By the time vCJD was first described in 1996, it was already far too late
to offset further disaster from transmission of the disease by blood
transfusion: almost all the humans who would be infected and infectious were
already diseased. Nothing done by the blood transfusion services around that
time, with the exception of excluding transfusion recipients as blood donors,
would have made any useful contribution to containing the extent of the
epidemic. The ability to spread emerging diseases before the problem is manifest
or understood is a fixed and unavoidable feature of blood transfusion as it is
practiced today. A second fixed property of blood transfusion is that the root
cause of disaster is not within the control of the blood transfusion universe.
Strategies that have emerged to cope with similar threat in other enterprises
that also contain these properties comprise the components of robust design:
surveillance, preparedness for action, engagement, herding together, evasion or
avoidance, early adoption of potentially useful measures, engineered resilience,
defence in depth, damage limitation including modularity and removal of feedback
loops, and contingency, redundancy and failure management, and ultimately,
individual escape. Early adoption of leucodepletion based on the possibility
that it might work rather than any hard evidence was a good example of threat
management. Exclusion of previously transfused donors is a robust mechanism for
containing any future infection; optimal blood use structures that provide a
national transfusion rate as low as possible also constitute an effective threat
management strategy. </div>
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--------------------------------------------------------------------------------</div>
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<div>
Résumé Lorsque la maladie fut décrite pour la première fois en 1996, il
était déjà trop tard pour mettre en place des actions préventives contre ce
nouveau désastre potentiel de transmission transfusionnelle de la maladie : en
effet, tous les sujets contaminés et probablement infectieux étaient déjà
décédés. Aucune des mesures déjà mises en place à cette époque, à l’exception de
l’exclusion des donneurs ayant été transfusés, auraient permis de lutter
efficacement contre l’épidémie. La capacité qu’ont les maladies émergentes de se
propager avant même que le problème soit identifié et compris est un
caractéristique classique et courante en transfusion sanguine dans sa pratique
actuelle. Une seconde caractéristique est que la racine du mal n’est pas sous
contrôle en la transfusion sanguine. Les stratégies préventives vis-à-vis de
risques émergents similaires rencontrés dans d’autres entreprises forment un
plan d’actions robustes comprenant : la veille, la préparation à l’action,
l’engagement, l’esprit d’équipe, l’évitement, la mise en place de mesures
préventives précoces, la gestion de l’urgence, etc. La mise en place anticipée
de la déleucocytation fondée sur le pari que cela pourrait avoir une action
bénéfique est un bon exemple de gestion de risque. L’utilisation des produits
sanguins à bon escient constitue également une stratégie de management efficace
pour diminuer le risque potentiel de transmission par transfusion.</div>
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<div>
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</div>
<br />
<div>
Choose an option to locate/access this article: Check if you have access
through your login credentials or your institution Check access Purchase
$31.50</div>
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<div>
</div>
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</div>
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<div>
Keywords Prion; vCJD; Blood transfusion; Risk management Mots clés Prion;
vMCJ; Transfusion sanguine; Gestion du risque </div>
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</div>
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</div>
<br />
<div>
<a href="http://www.sciencedirect.com/science/article/pii/S1246782013004837">http://www.sciencedirect.com/science/article/pii/S1246782013004837</a>
</div>
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</div>
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<div>
Sunday, July 21, 2013 </div>
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<div>
</div>
<br />
<div>
Welsh Government and Food Standards Agency Wales Joint Public Consultation
on the Proposed Transmissible Spongiform Encephalopathies (Wales) Regulations
2013 Singeltary Submission WG18417 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2013/07/welsh-government-and-food-standards.html">http://transmissiblespongiformencephalopathy.blogspot.com/2013/07/welsh-government-and-food-standards.html</a>
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<div>
Sunday, August 25, 2013 </div>
<br />
<div>
</div>
<br />
<div>
Prion2013 Chronic Wasting Disease CWD risk factors, humans, domestic cats,
blood, and mother to offspring transmission</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://chronic-wasting-disease.blogspot.com/2013/08/prion2013-chronic-wasting-disease-cwd.html">http://chronic-wasting-disease.blogspot.com/2013/08/prion2013-chronic-wasting-disease-cwd.html</a>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
Friday, August 16, 2013 </div>
<br />
<div>
</div>
<br />
<div>
*** Creutzfeldt-Jakob disease (CJD) biannual update August 2013 U.K. and
Contaminated blood products induce a highly atypical prion disease devoid of
PrPres in primates </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/08/creutzfeldt-jakob-disease-cjd-biannual.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/08/creutzfeldt-jakob-disease-cjd-biannual.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, May 6, 2013 </div>
<br />
<div>
</div>
<br />
<div>
Warning of mad cow disease threat to blood transfusions </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2013/05/warning-of-mad-cow-disease-threat-to.html">http://transmissiblespongiformencephalopathy.blogspot.com/2013/05/warning-of-mad-cow-disease-threat-to.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, September 1, 2013 </div>
<br />
<div>
</div>
<br />
<div>
Evaluation of the Zoonotic Potential of Transmissible Mink Encephalopathy
</div>
<br />
<div>
</div>
<br />
<div>
We previously described the biochemical similarities between PrPres derived
from L-BSE infected macaque and cortical MM2 sporadic CJD: those observations
suggest a link between these two uncommon prion phenotypes in a primate model
(it is to note that such a link has not been observed in other models less
relevant from the human situation as hamsters or transgenic mice overexpressing
ovine PrP [28]). We speculate that a group of related animal prion strains
(L-BSE, c-BSE and TME) would have a zoonotic potential and lead to prion
diseases in humans with a type 2 PrPres molecular signature (and more
specifically type 2B for vCJD)</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
snip...</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Together with previous experiments performed in ovinized and bovinized
transgenic mice and hamsters [8,9] indicating similarities between TME and
L-BSE, the data support the hypothesis that L-BSE could be the origin of the TME
outbreaks in North America and Europe during the mid-1900s. </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2013/09/evaluation-of-zoonotic-potential-of.html">http://transmissiblespongiformencephalopathy.blogspot.com/2013/09/evaluation-of-zoonotic-potential-of.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, August 11, 2013 </div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt-Jakob Disease CJD cases rising North America updated report
August 2013 </div>
<br />
<div>
</div>
<br />
<div>
*** Creutzfeldt-Jakob Disease CJD cases rising North America with Canada
seeing an extreme increase of 48% between 2008 and 2010 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/08/creutzfeldt-jakob-disease-cjd-cases.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/08/creutzfeldt-jakob-disease-cjd-cases.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<div>
<div>
</div>
<div>
</div>
<div>
<a href="http://vcjdtransfusion.blogspot.com/" title="http://vcjdtransfusion.blogspot.com/b/post-preview?token=z99X4UABAAA.JTDUXYj_0zEOn3UfeIpnRA.zWVF0ZefAc9ErdNGVYpSLA&postId=1674707861722004610&type=POST">http://vcjdtransfusion.blogspot.com/</a></div>
<div>
</div>
<div>
</div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
TSS</div>
<div>
</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-14636934327809091542013-04-30T12:48:00.002-07:002013-04-30T12:48:11.849-07:00Mad cow infected blood 'to kill 1,000’ <div>
Mad cow infected blood 'to kill 1,000’ </div>
<br />
<div>
</div>
<br />
<div>
Up to 1,000 people could die of the human form of “mad cow” disease through
infected blood given to them in British hospitals, ministers have been told.
</div>
<br />
<div>
</div>
<br />
<div>
By Rowena Mason, Political Correspondent</div>
<br />
<div>
</div>
<br />
<div>
10:00PM BST 28 Apr 2013 </div>
<br />
<div>
</div>
<br />
<div>
Government experts believe there is still a risk of people contracting
variant Creutzfeldt-Jakob Disease (vCJD) through blood transfusions, as about
30,000 Britons are likely to be carrying the brain-wasting illness in a dormant
form — double the previous estimate. </div>
<br />
<div>
</div>
<br />
<div>
They warn the current total death toll of 176 from vCJD could rise more
than five-fold as the infection has not been wiped out of the blood supply like
it has been in the food chain. </div>
<br />
<div>
</div>
<br />
<div>
Frank Dobson, a former health secretary, tonight urged ministers to develop
a nationwide screening programme for blood donors to stop future infections of
vCJD, which has the potential to cause “horrendous deaths”. </div>
<br />
<div>
</div>
<br />
<div>
People are no longer in danger of getting vCJD from eating British beef,
after ministers ordered the slaughter of millions of cows when the “mad cow”
disease scandal broke in 1989. Fears that hundreds of thousands of people could
contract the human form of bovine spongiform encephalopathy (BSE) proved
unfounded. </div>
<br />
<div>
</div>
<br />
<div>
However, the Government acknowledges that one in 2,000 Britons – or
approximately 30,000 people- are already “silent” carriers of infectious
proteins that lead some people to develop vCJD. </div>
<br />
<div>
</div>
<br />
<div>
A little-reported study last summer concluded the prevalence of this
“silent” vCJD is likely to be twice as high as previously thought. </div>
<br />
<div>
</div>
<br />
<div>
These 30,000 carriers can unknowingly pass on the infectious proteins –
known as prions – to new potential sufferers through donated blood. </div>
<br />
<div>
</div>
<br />
<div>
Because so little is known about vCJD, there is no telling which carriers
will go on to develop the disease or whether any new cases will actually
materialise at all. </div>
<br />
<div>
</div>
<br />
<div>
There have been no new cases for two years and there are thought to be no
surviving sufferers of vCJD, which has always historically proved fatal. </div>
<br />
<div>
</div>
<br />
<div>
However a new risk assessment published this month by the Government’s
Health Protection Analytical team reveals that infected blood donations could
cause up to 1,000 deaths in a high case scenario. </div>
<br />
<div>
</div>
<br />
<div>
About half of the cases could develop in people who have already received
blood transfusions and up to 580 cases from people who are yet to be infected
with the disease. The central estimate of infections yet to occur is 205. </div>
<br />
<div>
</div>
<br />
<div>
It suggests ministers could consider recruiting young blood donors born
after 1996 once they become eligible, as they will not have eaten infected beef.
</div>
<br />
<div>
</div>
<br />
<div>
“The number of “silent” vCJD infections associated with transfusion would
be much higher than the number of clinical cases,” it said. “It is therefore
important to maintain, and if possible enhance, measures to prevent onward
transmission of infection, notably the exclusion of recipients from donating
blood.” </div>
<br />
<div>
</div>
<br />
<div>
Mr Dobson, the former Labour Health Secretary, said “everything humanly
possible should be done to develop a blood test”. </div>
<br />
<div>
</div>
<br />
<div>
“There is no room at all for complacency,” he told The Daily Telegraph.
“With a blood test, you would be able to screen every potential donor. If that
screening showed the incidence was higher than thought then maybe you would do
it for the whole population.” </div>
<br />
<div>
</div>
<br />
<div>
Professor John Collinge, an expert from University College London, whose
research unit has developed a blood test for vCJD, said there is an element of
“wishful thinking” within the Government, with officials hoping the problem has
gone away. </div>
<br />
<div>
</div>
<br />
<div>
He said he is “sceptical of guesstimates” of future cases and believes
ministers need to start a study of vCJD in blood, rather than appendices, to get
a proper grip on the risk of infection through transfusions. </div>
<br />
<div>
</div>
<br />
<div>
“The figure of one in 2,000 in the appendix study was pretty worrying,” he
said. “I was pretty alarmed by that. It’s clear there is a very substantial pool
of infection in the community. There needs to be blood testing to answer this
question of prevalance properly.” </div>
<br />
<div>
</div>
<br />
<div>
Sir Paul Beresford, an MP and former Conservative environment minister,
also believes the Government must wake up to the potential for future vCJD
infections and is campaigning for more filtering of donated blood. </div>
<br />
<div>
</div>
<br />
<div>
“If we’ve got it wrong our grandchildren are going to potentially have an
epidemic of vCJD that we can do nothing about but we can prevent it if we act
now,” he said. </div>
<br />
<div>
</div>
<br />
<div>
“There’s some quite simple things they can do. For example, there’s a new
system that’s being developed that will filter red blood cells before
transfusion. </div>
<br />
<div>
</div>
<br />
<div>
“[The system] is not adequate at the moment but the Government’s argument
is that there’s no sign of a risk because the number of people turning up with
vCJD is going down. But it can take 10, 15, 20, 25 years for this to pop up.”
</div>
<br />
<div>
</div>
<br />
<div>
A spokesman for the Department of Health said the Government continues to
encourage “people of all ages to give blood”, adding “we have one of the safest
blood supplies in the world”. </div>
<br />
<div>
</div>
<br />
<div>
“Independent experts from the Advisory Committee on the Safety of Blood,
Tissues and Organs have used this study during their considerations of measures
to reduce the potential risk of transmission through blood transfusions,” she
said. “There is no evidence of any UK clinical cases of vCJD being linked to a
blood transfusion given after 1999. </div>
<br />
<div>
</div>
<br />
<div>
“In fact there have been no new cases in the UK for more than two years.”
</div>
<br />
<div>
</div>
<br />
<div>
She said the study relates to people’s future potential to develop vCJD,
not actual new cases that have occured. </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.telegraph.co.uk/health/healthnews/10024078/Mad-cow-infected-blood-to-kill-1000.html">http://www.telegraph.co.uk/health/healthnews/10024078/Mad-cow-infected-blood-to-kill-1000.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.globalpost.com/dispatch/news/health/130429/mad-cow-the-uk-about-30000-britons-likely-carrying-disease-dormant-form">http://www.globalpost.com/dispatch/news/health/130429/mad-cow-the-uk-about-30000-britons-likely-carrying-disease-dormant-form</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.medicaldaily.com/articles/14978/20130429/mad-cow-disease-british-blood-transfusion-infection-1-000.htm">http://www.medicaldaily.com/articles/14978/20130429/mad-cow-disease-british-blood-transfusion-infection-1-000.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://frenchtribune.com/teneur/1317730-human-form-mad-cow-disease-could-kill-1000-britons-experts">http://frenchtribune.com/teneur/1317730-human-form-mad-cow-disease-could-kill-1000-britons-experts</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
nothing like missing the bigger picture, but they been missing (ignroing)
it since 1985 $$$ </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
*** The discovery of previously unrecognized prion diseases in both humans
and animals (i.e., Nor98 in small ruminants) demonstrates that the range of
prion diseases might be wider than expected and raises crucial questions about
the epidemiology and strain properties of these new forms. We are investigating
this latter issue by molecular and biological comparison of VPSPr, GSS and
Nor98. </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.landesbioscience.com/journals/prion/01-Prion6-2-OralPresentations.pdf?nocache=1216084967">http://www.landesbioscience.com/journals/prion/01-Prion6-2-OralPresentations.pdf?nocache=1216084967</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, March 28, 2012 </div>
<br />
<div>
</div>
<br />
<div>
VARIABLY PROTEASE-SENSITVE PRIONOPATHY IS TRANSMISSIBLE, price of prion
poker goes up again $ </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://prionopathy.blogspot.com/2012/03/variably-protease-sensitve-prionopathy.html">http://prionopathy.blogspot.com/2012/03/variably-protease-sensitve-prionopathy.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, August 12, 2010 </div>
<br />
<div>
</div>
<br />
<div>
Seven main threats for the future linked to prions </div>
<br />
<div>
</div>
<br />
<div>
First threat </div>
<br />
<div>
</div>
<br />
<div>
The TSE road map defining the evolution of European policy for protection
against prion diseases is based on a certain numbers of hypotheses some of which
may turn out to be erroneous. In particular, a form of BSE (called atypical
Bovine Spongiform Encephalopathy), recently identified by systematic testing in
aged cattle without clinical signs, may be the origin of classical BSE and thus
potentially constitute a reservoir, which may be impossible to eradicate if a
sporadic origin is confirmed. </div>
<br />
<div>
</div>
<br />
<div>
***Also, a link is suspected between atypical BSE and some apparently
sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases
constitute an unforeseen first threat that could sharply modify the European
approach to prion diseases. </div>
<br />
<div>
</div>
<br />
<div>
Second threat </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.neuroprion.org/en/np-neuroprion.html">http://www.neuroprion.org/en/np-neuroprion.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, August 12, 2010 </div>
<br />
<div>
</div>
<br />
<div>
Seven main threats for the future linked to prions </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://prionpathy.blogspot.com/2010/08/seven-main-threats-for-future-linked-to.html">http://prionpathy.blogspot.com/2010/08/seven-main-threats-for-future-linked-to.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, October 10, 2011 </div>
<br />
<div>
</div>
<br />
<div>
EFSA Journal 2011 The European Response to BSE: A Success Story </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
EFSA and the European Centre for Disease Prevention and Control (ECDC)
recently delivered a scientific opinion on any possible epidemiological or
molecular association between TSEs in animals and humans (EFSA Panel on
Biological Hazards (BIOHAZ) and ECDC, 2011). This opinion confirmed Classical
BSE prions as the only TSE agents demonstrated to be zoonotic so far but the
possibility that a small proportion of human cases so far classified as
"sporadic" CJD are of zoonotic origin could not be excluded. Moreover,
transmission experiments to non-human primates suggest that some TSE agents in
addition to Classical BSE prions in cattle (namely L-type Atypical BSE,
Classical BSE in sheep, transmissible mink encephalopathy (TME) and chronic
wasting disease (CWD) agents) might have zoonotic potential. </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.efsa.europa.eu/en/efsajournal/pub/e991.htm?emt=1">http://www.efsa.europa.eu/en/efsajournal/pub/e991.htm?emt=1</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.efsa.europa.eu/en/efsajournal/doc/e991.pdf">http://www.efsa.europa.eu/en/efsajournal/doc/e991.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Rural and Regional Affairs and Transport References Committee </div>
<br />
<div>
</div>
<br />
<div>
The possible impacts and consequences for public health, trade and
agriculture of the Government's decision to relax import restrictions on beef
Final report June 2010 </div>
<br />
<div>
</div>
<br />
<div>
2.65 At its hearing on 14 May 2010, the committee heard evidence from Dr
Alan Fahey who has recently submitted a thesis on the clinical neuropsychiatric,
epidemiological and diagnostic features of Creutzfeldt-Jakob disease.48 Dr Fahey
told the committee of his concerns regarding the lengthy incubation period for
transmissible spongiform encephalopathies, the inadequacy of current tests and
the limited nature of our current understanding of this group of diseases.49
</div>
<br />
<div>
</div>
<br />
<div>
2.66 Dr Fahey also told the committee that in the last two years a link
has been established between forms of atypical CJD and atypical BSE. Dr Fahey
said that: They now believe that those atypical BSEs overseas are in fact
causing sporadic Creutzfeldt-Jakob disease. They were not sure if it was due to
mad sheep disease or a different form. If you look in the textbooks it looks
like this is just arising by itself. But in my research I have a summary of a
document which states that there has never been any proof that sporadic
Creutzfeldt-Jakob disease has arisen de novo-has arisen of itself. There is no
proof of that. The recent research is that in fact it is due to atypical forms
of mad cow disease which have been found across Europe, have been found in
America and have been found in Asia. These atypical forms of mad cow disease
typically have even longer incubation periods than the classical mad cow
disease.50 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.aph.gov.au/senate/committee/rrat_ctte/mad_cows/report/report.pdf">http://www.aph.gov.au/senate/committee/rrat_ctte/mad_cows/report/report.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Atypical BSE in Cattle </div>
<br />
<div>
</div>
<br />
<div>
To date the OIE/WAHO assumes that the human and animal health standards
set out in the BSE chapter for classical BSE (C-Type) applies to all forms of
BSE which include the H-type and L-type atypical forms. This assumption is
scientifically not completely justified and accumulating evidence suggests that
this may in fact not be the case. Molecular characterization and the spatial
distribution pattern of histopathologic lesions and immunohistochemistry (IHC)
signals are used to identify and characterize atypical BSE. Both the L-type and
H-type atypical cases display significant differences in the conformation and
spatial accumulation of the disease associated prion protein (PrPSc) in brains
of afflicted cattle. Transmission studies in bovine transgenic and wild type
mouse models support that the atypical BSE types might be unique strains because
they have different incubation times and lesion profiles when compared to C-type
BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian
hamster the resulting molecular fingerprint had changed, either in the first or
a subsequent passage, from L-type into C-type BSE. </div>
<br />
<div>
</div>
<br />
<div>
In addition, non-human primates are specifically susceptible for atypical
BSE as demonstrated by an approximately 50% shortened incubation time for L-type
BSE as compared to C-type. Considering the current scientific information
available, it cannot be assumed that these different BSE types pose the same
human health risks as C-type BSE or that these risks are mitigated by the same
protective measures. </div>
<br />
<div>
</div>
<br />
<div>
This study will contribute to a correct definition of specified risk
material (SRM) in atypical BSE. The incumbent of this position will develop new
and transfer existing, ultra-sensitive methods for the detection of atypical BSE
in tissue of experimentally infected cattle. </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2">http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2</a>
</div>
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</div>
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<div>
P.4.23 </div>
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<div>
</div>
<br />
<div>
Transmission of atypical BSE in humanized mouse models </div>
<br />
<div>
</div>
<br />
<div>
Liuting Qing1, Wenquan Zou1, Cristina Casalone2, Martin Groschup3,
Miroslaw Polak4, Maria Caramelli2, Pierluigi Gambetti1, Juergen Richt5,
Qingzhong Kong1 1Case Western Reserve University, USA; 2Instituto
Zooprofilattico Sperimentale, Italy; 3Friedrich-Loeffler-Institut, Germany;
4National Veterinary Research Institute, Poland; 5Kansas State University
(Previously at USDA National Animal Disease Center), USA </div>
<br />
<div>
</div>
<br />
<div>
Background: Classical BSE is a world-wide prion disease in cattle, and the
classical BSE strain (BSE-C) has led to over 200 cases of clinical human
infection (variant CJD). Atypical BSE cases have been discovered in three
continents since 2004; they include the L-type (also named BASE), the H-type,
and the first reported case of naturally occurring BSE with mutated bovine PRNP
(termed BSE-M). The public health risks posed by atypical BSE were largely
undefined. </div>
<br />
<div>
</div>
<br />
<div>
Objectives: To investigate these atypical BSE types in terms of their
transmissibility and phenotypes in humanized mice. Methods: Transgenic mice
expressing human PrP were inoculated with several classical (C-type) and
atypical (L-, H-, or Mtype) BSE isolates, and the transmission rate, incubation
time, characteristics and distribution of PrPSc, symptoms, and histopathology
were or will be examined and compared. </div>
<br />
<div>
</div>
<br />
<div>
Results: Sixty percent of BASE-inoculated humanized mice became infected
with minimal spongiosis and an average incubation time of 20-22 months, whereas
only one of the C-type BSE-inoculated mice developed prion disease after more
than 2 years. Protease-resistant PrPSc in BASE-infected humanized Tg mouse
brains was biochemically different from bovine BASE or sCJD. PrPSc was also
detected in the spleen of 22% of BASE-infected humanized mice, but not in those
infected with sCJD. Secondary transmission of BASE in the humanized mice led to
a small reduction in incubation time.*** The atypical BSE-H strain is also
transmissible with distinct phenotypes in the humanized mice, but no BSE-M
transmission has been observed so far. </div>
<br />
<div>
</div>
<br />
<div>
Discussion: Our results demonstrate that BASE is more virulent than
classical BSE, has a lymphotropic phenotype, and displays a modest transmission
barrier in our humanized mice. BSE-H is also transmissible in our humanized Tg
mice. The possibility of more than two atypical BSE strains will be discussed.
</div>
<br />
<div>
</div>
<br />
<div>
Supported by NINDS NS052319, NIA AG14359, and NIH AI 77774. </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.prion2009.com/sites/default/files/Prion2009_Book_of_Abstracts.pdf">http://www.prion2009.com/sites/default/files/Prion2009_Book_of_Abstracts.pdf</a>
</div>
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<div>
</div>
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</div>
<br />
<div>
P26 TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN
HUMANIZED MOUSE MODELS </div>
<br />
<div>
</div>
<br />
<div>
Liuting Qing1, Fusong Chen1, Michael Payne1, Wenquan Zou1, Cristina
Casalone2, Martin Groschup3, Miroslaw Polak4, Maria Caramelli2, Pierluigi
Gambetti1, Juergen Richt5*, and Qingzhong Kong1 1Department of Pathology, Case
Western Reserve University, Cleveland, OH 44106, USA; 2CEA, Istituto
Zooprofilattico Sperimentale, Italy; 3Friedrich-Loeffler-Institut, Germany;
4National Veterinary Research Institute, Poland; 5Kansas State University,
Diagnostic Medicine/Pathobiology Department, Manhattan, KS 66506, USA. *Previous
address: USDA National Animal Disease Center, Ames, IA 50010, USA </div>
<br />
<div>
</div>
<br />
<div>
Classical BSE is a world-wide prion disease in cattle, and the classical
BSE strain (BSE-C) has led to over 200 cases of clinical human infection
(variant CJD). Two atypical BSE strains, BSE-L (also named BASE) and BSE-H, have
been discovered in three continents since 2004. The first case of naturally
occurring BSE with mutated bovine PrP gene (termed BSE-M) was also found in 2006
in the USA. The transmissibility and phenotypes of these atypical BSE
strains/isolates in humans were unknown. We have inoculated humanized transgenic
mice with classical and atypical BSE strains (BSE-C, BSE-L, BSE-H) and the BSE-M
isolate. We have found that the atypical BSE-L strain is much more virulent than
the classical BSE-C. *** The atypical BSE-H strain is also transmissible in the
humanized transgenic mice with distinct phenotype, but no transmission has been
observed for the BSE-M isolate so far. </div>
<br />
<div>
</div>
<br />
<div>
III International Symposium on THE NEW PRION BIOLOGY: BASIC SCIENCE,
DIAGNOSIS AND THERAPY 2 - 4 APRIL 2009, VENEZIA (ITALY) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf">http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf</a>
</div>
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</div>
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<div>
I ask Professor Kong ; </div>
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</div>
<br />
<div>
Thursday, December 04, 2008 3:37 PM Subject: RE: re--Chronic Wating
Disease (CWD) and Bovine Spongiform Encephalopathies (BSE): Public Health Risk
Assessment </div>
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<div>
</div>
<br />
<div>
''IS the h-BSE more virulent than typical BSE as well, or the same as
cBSE, or less virulent than cBSE? just curious.....'' </div>
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<div>
</div>
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<div>
Professor Kong reply ; </div>
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<div>
</div>
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<div>
.....snip </div>
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</div>
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<div>
''As to the H-BSE, we do not have sufficient data to say one way or
another, but we have found that H-BSE can infect humans. I hope we could publish
these data once the study is complete. Thanks for your interest.'' </div>
<br />
<div>
</div>
<br />
<div>
Best regards, Qingzhong Kong, PhD Associate Professor Department of
Pathology Case Western Reserve University Cleveland, OH 44106 USA </div>
<br />
<div>
</div>
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<div>
END...TSS </div>
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</div>
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<div>
Thursday, December 04, 2008 2:37 PM </div>
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<div>
</div>
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<div>
"we have found that H-BSE can infect humans." </div>
<br />
<div>
</div>
<br />
<div>
personal communication with Professor Kong. ...TSS </div>
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<div>
</div>
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<div>
BSE-H is also transmissible in our humanized Tg mice. </div>
<br />
<div>
</div>
<br />
<div>
The possibility of more than two atypical BSE strains will be discussed.
</div>
<br />
<div>
</div>
<br />
<div>
Supported by NINDS NS052319, NIA AG14359, and NIH AI 77774. </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.prion2009.com/sites/default/files/Prion2009_Book_of_Abstracts.pdf">http://www.prion2009.com/sites/default/files/Prion2009_Book_of_Abstracts.pdf</a>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/experimental-h-type-bovine-spongiform.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/experimental-h-type-bovine-spongiform.html</a>
</div>
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</div>
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<div>
<a href="http://bse-atypical.blogspot.com/2012/03/experimental-h-type-and-l-type-bovine.html">http://bse-atypical.blogspot.com/2012/03/experimental-h-type-and-l-type-bovine.html</a>
</div>
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</div>
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<div>
Atypical BSE (BASE) Transmitted from Asymptomatic Aging Cattle to a Primate
</div>
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<div>
</div>
<br />
<div>
Emmanuel E. Comoy1*, Cristina Casalone2, Nathalie Lescoutra-Etchegaray1,
Gianluigi Zanusso3, Sophie Freire1, Dominique Marcé1, Frédéric Auvré1,
Marie-Magdeleine Ruchoux1, Sergio Ferrari3, Salvatore Monaco3, Nicole Salès4,
Maria Caramelli2, Philippe Leboulch1,5, Paul Brown1, Corinne I. Lasmézas4,
Jean-Philippe Deslys1 </div>
<br />
<div>
</div>
<br />
<div>
1 Institute of Emerging Diseases and Innovative Therapies, CEA,
Fontenay-aux-Roses, France, 2 Istituto Zooprofilattico Sperimentale del
Piemonte, Turin, Italy, 3 Policlinico G.B. Rossi, Verona, Italy, 4 Scripps
Florida, Jupiter, Florida, United States of America, 5 Genetics Division,
Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts,
United States of America </div>
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<div>
</div>
<br />
<div>
Abstract Top Background Human variant Creutzfeldt-Jakob Disease (vCJD)
results from foodborne transmission of prions from slaughtered cattle with
classical Bovine Spongiform Encephalopathy (cBSE). Atypical forms of BSE, which
remain mostly asymptomatic in aging cattle, were recently identified at
slaughterhouses throughout Europe and North America, raising a question about
human susceptibility to these new prion strains. </div>
<br />
<div>
</div>
<br />
<div>
Methodology/Principal Findings Brain homogenates from cattle with
classical BSE and atypical (BASE) infections were inoculated intracerebrally
into cynomolgus monkeys (Macacca fascicularis), a non-human primate model
previously demonstrated to be susceptible to the original strain of cBSE. The
resulting diseases were compared in terms of clinical signs, histology and
biochemistry of the abnormal prion protein (PrPres). The single monkey infected
with BASE had a shorter survival, and a different clinical evolution,
histopathology, and prion protein (PrPres) pattern than was observed for either
classical BSE or vCJD-inoculated animals. Also, the biochemical signature of
PrPres in the BASE-inoculated animal was found to have a higher proteinase K
sensitivity of the octa-repeat region. We found the same biochemical signature
in three of four human patients with sporadic CJD and an MM type 2 PrP genotype
who lived in the same country as the infected bovine. </div>
<br />
<div>
</div>
<br />
<div>
Conclusion/Significance Our results point to a possibly higher degree of
pathogenicity of BASE than classical BSE in primates and also raise a question
about a possible link to one uncommon subset of cases of apparently sporadic
CJD. Thus, despite the waning epidemic of classical BSE, the occurrence of
atypical strains should temper the urge to relax measures currently in place to
protect public health from accidental contamination by BSE-contaminated
products. </div>
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<div>
</div>
<br />
<div>
Citation: Comoy EE, Casalone C, Lescoutra-Etchegaray N, Zanusso G, Freire
S, et al. (2008) Atypical BSE (BASE) Transmitted from Asymptomatic Aging Cattle
to a Primate. PLoS ONE 3(8): e3017. doi:10.1371/journal.pone.0003017 </div>
<br />
<div>
</div>
<br />
<div>
Editor: Neil Mabbott, University of Edinburgh, United Kingdom </div>
<br />
<div>
</div>
<br />
<div>
Received: April 24, 2008; Accepted: August 1, 2008; Published: August 20,
2008 </div>
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<div>
</div>
<br />
<div>
Copyright: © 2008 Comoy et al. This is an open-access article distributed
under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the
original author and source are credited. </div>
<br />
<div>
</div>
<br />
<div>
Funding: This work has been supported by the Network of Excellence
NeuroPrion. </div>
<br />
<div>
</div>
<br />
<div>
Competing interests: CEA owns a patent covering the BSE diagnostic tests
commercialized by the company Bio-Rad. </div>
<br />
<div>
</div>
<br />
<div>
* E-mail: emmanuel.comoy@cea.fr </div>
<br />
<div>
</div>
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<div>
</div>
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<div>
</div>
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<div>
snip... </div>
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</div>
<br />
<div>
In summary, we have transmitted one atypical form of BSE (BASE) to a
cynomolgus macaque monkey that had a shorter incubation period than monkeys
infected with classical BSE, with distinctive clinical, neuropathological, and
biochemical features; and have shown that the molecular biological signature
resembled that seen in a comparatively uncommon subtype of sporadic CJD. We
cannot yet say whether BASE is more pathogenic for primates (including humans)
than cBSE, nor can we predict whether its molecular biological features
represent a clue to one cause of apparently sporadic human CJD. However, the
evidence presented here and by others justifies concern about a potential human
health hazard from undetected atypical forms of BSE, and despite the waning
epizoonosis of classical BSE, it would be premature to abandon the precautionary
measures that have been so successful in reversing the impact of cBSE. We would
instead urge a gradual, staged reduction that takes into account the evolving
knowledge about atypical ruminant diseases, and both a permanent ban on the use
of bovine central nervous system tissue for either animal or human use, and its
destruction so as to eliminate any risk of environmental contamination. </div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
<a href="http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003017">http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003017</a>
</div>
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<div>
Proc Natl Acad Sci U S A. 2004 March 2; 101(9): 3065–3070. Published online
2004 February 17. doi: 10.1073/pnas.0305777101 PMCID: PMC365745 Medical Sciences
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
Identification of a second bovine amyloidotic spongiform encephalopathy:
Molecular similarities with sporadic Creutzfeldt-Jakob disease </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Cristina Casalone,*† Gianluigi Zanusso,†‡ Pierluigi Acutis,* Sergio
Ferrari,‡ Lorenzo Capucci,§ Fabrizio Tagliavini,¶ Salvatore Monaco,‡ and Maria
Caramelli* </div>
<br />
<div>
</div>
<br />
<div>
Abstract </div>
<br />
<div>
</div>
<br />
<div>
Transmissible spongiform encephalopathies (TSEs), or prion diseases, are
mammalian neurodegenerative disorders characterized by a posttranslational
conversion and brain accumulation of an insoluble, protease-resistant isoform
(PrPSc) of the host-encoded cellular prion protein (PrPC). Human and animal TSE
agents exist as different phenotypes that can be biochemically differentiated on
the basis of the molecular mass of the protease-resistant PrPSc fragments and
the degree of glycosylation. Epidemiological, molecular, and transmission
studies strongly suggest that the single strain of agent responsible for bovine
spongiform encephalopathy (BSE) has infected humans, causing variant
Creutzfeldt-Jakob disease. The unprecedented biological properties of the BSE
agent, which circumvents the so-called ”species barrier” between cattle and
humans and adapts to different mammalian species, has raised considerable
concern for human health. To date, it is unknown whether more than one strain
might be responsible for cattle TSE or whether the BSE agent undergoes
phenotypic variation after natural transmission. Here we provide evidence of a
second cattle TSE. The disorder was pathologically characterized by the presence
of PrP-immunopositive amyloid plaques, as opposed to the lack of amyloid
deposition in typical BSE cases, and by a different pattern of regional
distribution and topology of brain PrPSc accumulation. In addition, Western blot
analysis showed a PrPSc type with predominance of the low molecular mass
glycoform and a protease-resistant fragment of lower molecular mass than
BSE-PrPSc. Strikingly, the molecular signature of this previously undescribed
bovine PrPSc was similar to that encountered in a distinct subtype of sporadic
Creutzfeldt-Jakob disease. </div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
Phenotypic Similarities Between BASE and sCJD. The transmissibility of CJD
brains was initially demonstrated in primates (27), and classification of
atypical cases as CJD was based on this property (28). To date, no systematic
studies of strain typing in sCJD have been provided, and classification of
different subtypes is based on clinical, neuropathological, and molecular
features (the polymorphic PRNP codon 129 and the PrPSc glycotype) (8, 9, 15,
19). The importance of molecular PrPSc characterization in assessing the
identity of TSE strains is underscored by several studies, showing that the
stability of given disease-specific PrPSc types is maintained upon experimental
propagation of sCJD, familial CJD, and vCJD isolates in transgenic PrP-humanized
mice (8, 29). Similarly, biochemical properties of BSE- and vCJD-associated
PrPSc molecules remain stable after passage to mice expressing bovine PrP (30).
Recently, however, it has been reported that PrP-humanized mice inoculated with
BSE tissues may also propagate a distinctive PrPSc type, with a
”monoglycosylated-dominant” pattern and electrophoretic mobility of the
unglycosylated fragment slower than that of vCJD and BSE (31). Strikingly, this
PrPSc type shares its molecular properties with the a PrPSc molecule found in
classical sCJD. This observation is at variance with the PrPSc type found in
M/V2 sCJD cases and in cattle BASE, showing a monoglycosylated-dominant pattern
but faster electrophoretic mobility of the protease-resistant fragment as
compared with BSE. In addition to molecular properties of PrPSc, BASE and M/V2
sCJD share a distinctive pattern of intracerebral PrP deposition, which occurs
as plaque-like and amyloid-kuru plaques. Differences were, however, observed in
the regional distribution of PrPSc. While in M/V2 sCJD cases the largest amounts
of PrPSc were detected in the cerebellum, brainstem, and striatum, in cattle
BASE these areas were less involved and the highest levels of PrPSc were
recovered from the thalamus and olfactory regions. </div>
<br />
<div>
</div>
<br />
<div>
In conclusion, decoding the biochemical PrPSc signature of individual
human and animal TSE strains may allow the identification of potential risk
factors for human disorders with unknown etiology, such as sCJD. However,
although BASE and sCJD share several characteristics, caution is dictated in
assessing a link between conditions affecting two different mammalian species,
based on convergent biochemical properties of disease-associated PrPSc types.
Strains of TSE agents may be better characterized upon passage to transgenic
mice. In the interim until this is accomplished, our present findings suggest a
strict epidemiological surveillance of cattle TSE and sCJD based on molecular
criteria. </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC365745/">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC365745/</a>
</div>
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</div>
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</div>
<br />
<div>
FC5.1.1 </div>
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</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
Transmission Results in Squirrel Monkeys Inoculated with Human sCJD, vCJD,
and GSS Blood Specimens: the Baxter Study </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Brown, P1; Gibson, S2; Williams, L3; Ironside, J4; Will, R4; Kreil, T5;
Abee, C3 1Fondation Alliance BioSecure, France; 2University of South Alabama,
USA; 3University of Texas MD Anderson Cancer Center, USA; 4Western General
Hospital, UK; 5Baxter BioSience, Austria </div>
<br />
<div>
</div>
<br />
<div>
Background: Rodent and sheep models of Transmissible Spongiform
Encephalopathy (TSE) have documented blood infectivity in both the pre-clinical
and clinical phases of disease. Results in a (presumably more appropriate)
non-human primate model have not been reported. </div>
<br />
<div>
</div>
<br />
<div>
Objective: To determine if blood components (red cells, white cells,
platelets, and plasma) from various forms of human TSE are infectious. </div>
<br />
<div>
</div>
<br />
<div>
Methods: Blood components were inoculated intra-cerebrally (0.1 ml) and
intravenously (0.5 ml) into squirrel monkeys from 2 patients with sporadic
Creutzfeldt- Jakob disease (sCJD) and 3 patients with variant Creutzfeldt-Jakob
disease (vCJD). Additional monkeys were inoculated with buffy coat or plasma
samples from chimpanzees infected with either sCJD or
Gerstmann-Sträussler-Scheinker disease (GSS). Animals were monitored for a
period of 5 years, and all dying or sacrificed animals had post-mortem
neuropathological examinations and Western blots to determine the presence or
absence of the misfolded prion protein (PrPTSE). </div>
<br />
<div>
</div>
<br />
<div>
Results: No transmissions occurred in any of the animals inoculated with
blood components from patients with sporadic or variant CJD. All donor
chimpanzees (sCJD and GSS) became symptomatic within 6 weeks of their
pre-clinical phase plasmapheresis, several months earlier than the expected
onset of illness. One monkey inoculated with purified leukocytes from a
pre-clinical GSS chimpanzee developed disease after 36 months. </div>
<br />
<div>
</div>
<br />
<div>
Conclusion: No infectivity was found in small volumes of blood components
from 4 patients with sporadic CJD and 3 patients with variant CJD. ***However, a
single transmission from a chimpanzee-passaged strain of GSS shows that
infectivity may be present in leukocytes, and the shock of general anaesthesia
and plasmspheresis appears to have triggered the onset of illness in
pre-clinical donor chimpanzees. </div>
<br />
<div>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
Saturday, September 5, 2009 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS </div>
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<div>
</div>
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<div>
</div>
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<div>
snip... </div>
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</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://tseac.blogspot.com/2011/06/tseac-meeting-august-1-2011-donor.html">http://tseac.blogspot.com/2011/06/tseac-meeting-august-1-2011-donor.html</a>
</div>
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<div>
</div>
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</div>
<br />
<div>
Saturday, September 5, 2009 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
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</div>
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</div>
<br />
<div>
But the first thing is our own study, and as I mentioned, it's a Baxter
primate study, and those are the major participants. And the goal was twofold,
and here is the first one: to see whether CJD, either sporadic or familial --
actually it turns out to be the familial CJD is incorrect. It really should be
the Fukuoka strain of Gerstmann-Straussler-Scheinker disease. So it's really GSS
instead of familial CJD -- when passaged through chimps into squirrel monkeys
using purified blood components, very pure blood components. </div>
<br />
<div>
</div>
<br />
<div>
So this addresses the question that was raised just recently about whether
or not red cell infectivity that's been found in rodents is really in the red
cells or is it contaminated. </div>
<br />
<div>
</div>
<br />
<div>
We prepared these samples with exquisite care, and they are
ultra-ultra-ultra purified. There's virtually no contamination of any of the
components that we looked at ? platelets, red cells, plasma, white cells -- with
any other component. </div>
<br />
<div>
</div>
<br />
<div>
These are a sort of new set of slides, and what I've tried to do is make
them less complicated and more clear, but I'm afraid I haven't included the
build. So you'll just have to try and follow what I explain with this little red
pointer. </div>
<br />
<div>
</div>
<br />
<div>
There were three initial patients. Two of them had sporadic CJD. One of
them had Gerstmann-Straussler-Scheinker syndrome. Brain tissue from each
individual patient was inoculated intracerebrally into a pair of chimpanzees.
All right? </div>
<br />
<div>
</div>
<br />
<div>
From those chimps, either plasma or ultra purified -- in fact, everything
is ultra-purified. I'll just talk about purified plasma, purified white cells --
were inoculated intracerebrally and intravenously to get the maximum amount of
infective load into a pair of squirrel monkeys. </div>
<br />
<div>
</div>
<br />
<div>
The same thing was done for each of these three sets. This monkey died
from non-CJD causes at 34 months post inoculation. </div>
<br />
<div>
</div>
<br />
<div>
Let me go back for a second. I didn't point out the fact that these were
not sacrificed at this point. These chimpanzees were apheresed at 27 weeks when
they were still asymptomatic. In this instance, we apheresed them terminally
when they were symptomatic. </div>
<br />
<div>
</div>
<br />
<div>
And before I forget, I want to mention just a little sidelight of this.
Chimpanzees in our experience -- and I think we may be the only people that have
ever inoculated chimpanzees, and that's no longer a possibility, so this was 20,
30 years ago -- the shortest incubation period of any chimpanzee that we have
ever seen with direct intracerebral inoculation is 13 months. </div>
<br />
<div>
</div>
<br />
<div>
So we chose 27 weeks, which is about seven months, and incidentally
typically the incubation period is more like 16 or 18 months. The shortest was
13 months. We chose the 27th week, which is about six and a half months,
thinking that this would be about halfway through the incubation period, which
we wanted to check for the presence or absence of infectivity. </div>
<br />
<div>
</div>
<br />
<div>
But within four weeks after the apheresis, which was conducted under
general anesthesia for three or four hours apiece, every single one of the six
chimpanzees became symptomatic. That is another experiment that I would love to
conclude, perhaps because this is simply not heard of, and it very much smells
like we triggered clinical illness. We didn't trigger the disease, but it
certainly looks like we triggered symptomatic disease at a point that was much
earlier than one would have possibly expected. </div>
<br />
<div>
</div>
<br />
<div>
Maybe it will never be done because it would probably open the floodgates
of litigation. There's no end of little things that you can find out from CJD
patients after the fact. For example, the neighbor's dog comes over, barks at a
patient, makes him fall down, and three weeks later he gets CJD. So you have a
lawsuit against the neighbor. </div>
<br />
<div>
</div>
<br />
<div>
I mean, this is not an unheard of matter, but I do think that physical
stress in the form of anesthesia and four hours of whatever goes on with
anesthesia, low blood pressure, sometimes a little hypoxemia looks like it's a
bad thing. </div>
<br />
<div>
</div>
<br />
<div>
So here we have the 31st week. All of the chimps are symptomatic, and here
what we did was in order to make the most use of the fewest monkeys, which is
always a problem in primate research, we took these same three patients and
these six chimps. Only now we pooled these components; that is to say, we pooled
the plasma from all six chimps. We pooled ultra-purified white cells from all
six chimps because here we wanted to see whether or not we could distinguish a
difference between intracerebral route of infection and intravenous route of
infection. </div>
<br />
<div>
</div>
<br />
<div>
With respect to platelets and red blood cells, we did not follow that. We
inoculated both intracerebral and intravenously, as we had done earlier because
nobody has any information on whether or not platelets and red cells are
infectious, and so we wanted again to get the maximum. </div>
<br />
<div>
</div>
<br />
<div>
This is an IV versus IC goal. This one, again, is just getting the maximum
load in to see whether there is, in fact, any infectivity in pure platelets, in
pure red cells. </div>
<br />
<div>
</div>
<br />
<div>
And of all of the above, the only transmission of disease related to the
inoculation was in a squirrel monkey that received pure leukocytes from the
presymptomatic apheresis. So that goes some way to address the question as to
whether or not it's a matter of contamination. To date the red cells have not
been -- the monkeys that receive red cells have not been observed for more than
a year because that was a later experiment. </div>
<br />
<div>
</div>
<br />
<div>
So we still can't say about red cells, but we're about four and a half
years down the road now, and we have a single transmission from purified
leukocytes, nothing from plasma and nothing from platelets. </div>
<br />
<div>
</div>
<br />
<div>
That was the first part of the experiment. The second part was undertaken
with the cooperation of Bob Will and others supplying material to us. These were
a couple of human, sporadic cases of CJD and three variant cases of CJD from
which we obtained buffy coat and plasma separated in a normal way. That is,
these are not purified components. </div>
<br />
<div>
</div>
<br />
<div>
The two cases of sporadic CJD, the plasma was pooled from both patients.
The buffy coat was pooled from both patients, and then inoculated
intracerebrally and intravenously into three squirrel monkeys each. This is a
non-CJD death five years after inoculation. The other animals are still alive.
</div>
<br />
<div>
</div>
<br />
<div>
For variant CJD we decided not to pool. It was more important to eliminate
the possibility that there was just a little bit of infectivity in one patient
that would have been diluted to extinction, if you like, by mixing them if it
were to so occur with two patients, for example, who did not have infectivity.
So each one of these was done individually, but the principle was the same:
plasma and buffy coat for each patient was inoculated into either two or three
squirrel monkeys. This is, again, a non-CJD related death. </div>
<br />
<div>
</div>
<br />
<div>
In addition to that, we inoculated rain as a positive control from the two
sporadic disease cases of human -- from the two human sporadic cases at ten to
the minus one and ten to the minus three dilutions. We have done this many, many
times in the past with other sporadic patients. So we knew what to expect, and
we got exactly what we did expect, namely, after an incubation period not quite
two years, all four monkeys developed disease at this dilution and at the minus
three dilution, not a whole lot of difference between the two. </div>
<br />
<div>
</div>
<br />
<div>
Now, these are the crucial monkeys because each one of these monkeys every
three to four months was bled and the blood transfused into a new healthy
monkey, but the same monkey all the time. So this monkey, for example, would
have received in the course of 21 months about six different transfusions of
blood from this monkey into this monkey, similarly with this pair, this pair,
and this pair. So you can call these buddies. This is sort of the term that was
used. These monkeys are still alive. </div>
<br />
<div>
</div>
<br />
<div>
In the same way, the three human variant CJD specimens, brain, were
inoculated into four monkeys, and again, each one of these monkeys has been
repeatedly bled at three to four month intervals and that blood transfused into
a squirrel monkey, the same one each time. Ideally we would love to have taken
bleeding at three months and inoculated a monkey and then let him go, watch him,
and then done the same thing at six months. It would have increased the number
of monkeys eightfold and just unacceptably expensive. So we did the best we
could. </div>
<br />
<div>
</div>
<br />
<div>
That, again, is a non-CJD death, as is this. </div>
<br />
<div>
</div>
<br />
<div>
This was of interest mainly to show that the titer of infectivity in brain
from variant CJD is just about the same as it from sporadic. We didn't do a
minus five and a minus seven in sporadic because we have an enormous experience
already with sporadic disease in squirrel monkeys, and we know that this is
exactly what happens. It disappears at about ten to the minus five. So the brain
titer in monkeys receiving human vCJD is identical to the brain titer in monkeys
that have been inoculated with sporadic CJD. </div>
<br />
<div>
</div>
<br />
<div>
That's the experiment. All of the monkeys in aqua are still alive. They
are approaching a five-year observation period, and I think the termination of
this experiment will now need to be discussed very seriously in view of a
probable six-year incubation period in the U.K. case. The original plan was to
terminate the experiment after five years of observation with the understanding
that ideally you would keep these animals for their entire life span, which is
what we used to do when had unlimited space, money, and facilities. We can't do
that anymore. </div>
<br />
<div>
</div>
<br />
<div>
It's not cheap, but I think in view of the U.K. case, it will be very
important to think very seriously about allowing at least these buddies and the
buddies from the sporadic CJD to go on for several more years because although
you might think that the U.K. case has made experimental work redundant, in
point of fact, anything that bears on the risk of this disease in humans is
worthwhile knowing, and one of the things we don't know is frequency of
infection. We don't know whether this case in the U.K. is going to be unique and
never happen again or whether all 13 or 14 patients have received blood
components are ultimately going to die. Let's hope not. </div>
<br />
<div>
</div>
<br />
<div>
The French primate study is primarily directed now by Corinne Lasmezas. As
you know, the late Dominique Dromont was the original, originally initiated this
work, and they have very active primate laboratory in France, and I'm only going
to show two very simple slides to summarize what they did. </div>
<br />
<div>
</div>
<br />
<div>
The first one is simply to show you the basis of their statement that the
IV route of infection looks to be pretty efficient because we all know that the
intracerebral route of infection is the most efficient, and if you look at this
where they inoculated the same infective load either intracerebrally or
intravenously, the incubation periods were not substantially different, which
suggests but doesn't prove, but doesn't prove that the route of infection is
pretty efficient. </div>
<br />
<div>
</div>
<br />
<div>
Lower doses of brain material given IV did extend the incubation period
and presumably it's because of the usual dose response phenomenon that you see
in any infectious disease. </div>
<br />
<div>
</div>
<br />
<div>
With a whopping dose of brain orally, the incubation period was even
lower. Again, just one more example of inefficiency of the route of infection
and the necessity to use more infective material to get transmissions. </div>
<br />
<div>
</div>
<br />
<div>
And they also have blood inoculated IV which is on test, and the final
slide or at least the penultimate slide shows you what they have on test and the
time of observation, that taken human vCJD and like us inoculated buffy coat,
they've also inoculated whole blood which we did not do. </div>
<br />
<div>
</div>
<br />
<div>
So to a great extent their studies are complementary to ours and makes it
all worthwhile. </div>
<br />
<div>
</div>
<br />
<div>
We have about -- oh, I don't know -- a one to two-year lead time on the
French, but they're still getting into pretty good observation periods. Here's
three-plus years. </div>
<br />
<div>
</div>
<br />
<div>
They have variant CJD adapted to the macaque. That is to say this one was
passaged in macaque monkeys, the cynomolgus, and they did the same thing. Again,
we're talking about a study here in which like ours there are no transmissions.
I mean, we have that one transmission from leukocytes, and that's it. </div>
<br />
<div>
</div>
<br />
<div>
Here is a BSE adapted to the macaque. Whole blood, and then they chose to
inoculate leukodepleted whole blood, in both instances IV. Here they are out to
five years without a transmission. </div>
<br />
<div>
</div>
<br />
<div>
And then finally oral dosing of the macaque, which had been infected with
-- which was infected with BSE, but a macaque passaged BSE, whole blood buffy
coat and plasma, all by the IC route, and they're out to three years. </div>
<br />
<div>
</div>
<br />
<div>
So with the single exception of the leukocyte transmission from our chimp
that was inoculated with a sporadic case of CJD or -- excuse me -- with a GSS,
Gerstmann-Straussler, in neither our study nor the French study, which are not
yet completed have we yet seen a transmission. </div>
<br />
<div>
</div>
<br />
<div>
And I will just close with a little cartoon that appeared in the
Washington Post that I modified slightly lest you get too wound up with these
questions of the risk from blood. This should be a "corrective." </div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Thanks. </div>
<br />
<div>
</div>
<br />
<div>
Questions? </div>
<br />
<div>
</div>
<br />
<div>
CHAIRPERSON PRIOLA: Yes. Any questions for Dr. Brown? Dr. Linden. </div>
<br />
<div>
</div>
<br />
<div>
DR. LINDEN: I just want to make sure I understand your study design
correctly. When you mention the monkeys that have the IV and IC inoculations,
the individual monkeys had both or -- </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Yes, yes, yes. That's exactly right. </div>
<br />
<div>
</div>
<br />
<div>
DR. LINDEN: So an individual monkey had both of those as opposed to some
monkeys had one and some had the other? </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Correct, correct. Where IC and IV are put down together was IC
plus IV into a given monkey. </div>
<br />
<div>
</div>
<br />
<div>
DR. LINDEN: Into a given monkey. Okay. </div>
<br />
<div>
</div>
<br />
<div>
And the IC inoculations, where were those given? </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Right parietal cortex, Southern Alabama. </div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Oh, it can't be that clear. Yeah, here, Pierluigi. </div>
<br />
<div>
</div>
<br />
<div>
CHAIRPERSON PRIOLA: Dr. Epstein. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Pierluigi always damns me with feint praise. He always says
that's a very interesting study, but. I'm waiting for that, Pierluigi. </div>
<br />
<div>
</div>
<br />
<div>
I think Jay Epstein -- </div>
<br />
<div>
</div>
<br />
<div>
DR. GAMBETTI: I will say that there's an interesting study and will say,
but I just -- </div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
DR. GAMBETTI: -- I just point of review. You talk about a point of
information. You say that -- you mention GSS, I guess, and the what, Fukuowa
(phonetic) -- </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Yes, Fukuoka 1. </div>
<br />
<div>
</div>
<br />
<div>
DR. GAMBETTI: Fukuowa, and is that from the 102, if I remember correctly,
of the -- </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Yes, that is correct. </div>
<br />
<div>
</div>
<br />
<div>
DR. GAMBETTI: Because that is the only one that also -- </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: No, it's not 102. It's 101. It's the standard. It's a classical
GSS. Oh, excuse me. You're right. One, oh, two is classical GSS. It's been so
long since I've done genetics. You're right. </div>
<br />
<div>
</div>
<br />
<div>
DR. GAMBETTI: Because that is the only one I know, I think, that I can
remember that has both the seven kv fragment that is characteristic of GSS, but
also the PrPsc 2730. So in a sense, it can be stretching a little bit compared
to the sporadic CJD. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Yeah, I think that's right. That's why I want to be sure that I
made you aware on the very first slide that that was not accurate, that it truly
was GSS. </div>
<br />
<div>
</div>
<br />
<div>
There's a GSS strain that has been adapted to mice, and it's a hot strain,
and therefore, it may not be translatable to sporadic disease, correct. All we
can say for sure is that it is a human TSE, and it is not variant. I think
that's about it. </div>
<br />
<div>
</div>
<br />
<div>
DR. GAMBETTI: I agree, but this is also not perhaps the best -- </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: No, it is not the best. We understand -- </div>
<br />
<div>
</div>
<br />
<div>
DR. GAMBETTI: -- of GSS either. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Yeah. If we had to do it over again, we'd look around for a --
well, I don't know. We'd probably do it the same way because we have two
sporadics already on test they haven't transmitted, and so you can take your
pick of what you want to pay attention to. </div>
<br />
<div>
</div>
<br />
<div>
Jay? </div>
<br />
<div>
</div>
<br />
<div>
DR. EPSTEIN: Yes, Paul. Could you just comment? If I understood you
correctly, when you did the pooled apheresis plasma from the six chimps when
they were symptomatic at 31 weeks, you also put leukocytes into squirrel monkeys
in that case separately IV and IC, but in that instance you have not seen an
infection come down in squirrel monkey, and the question is whether it's
puzzling that you got transmission from the 27-week asymptomatic sampling,
whereas you did not see transmission from the 31-week sampling in symptomatic
animals. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Yes, I think there are two or three possible explanations, and
I don't know if any of them are important. The pre-symptomatic animal was almost
symptomatic as it turned out so that we were pretty close to the period at which
symptoms would being, and whether you can, you know, make much money on saying
one was incubation period and the other was symptomatic in this particular case
because both bleedings were so close together. That's one possibility. </div>
<br />
<div>
</div>
<br />
<div>
The other possibility is we're dealing with a very irregular phenomenon
and you're not surprised at all by surprises, so to speak so that a single
animal, you could see it almost anywhere. </div>
<br />
<div>
</div>
<br />
<div>
The third is that we, in fact, did just what I suggested we didn't want to
do for the preclinical, namely, by pooling we got under the threshold. See?
</div>
<br />
<div>
</div>
<br />
<div>
You can again take that for what it's worth. It is a possible explanation,
and again, until we know what the levels of infectivity are and whether by
pooling we get under the threshold of transmission, we simply cannot make
pronouncements. </div>
<br />
<div>
</div>
<br />
<div>
CHAIRPERSON PRIOLA: Dr. DeArmond. </div>
<br />
<div>
</div>
<br />
<div>
DR. DeARMOND: Yeah, it was very interesting data, but the -- </div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: I just love it. Go ahead. </div>
<br />
<div>
</div>
<br />
<div>
DR. DeARMOND: Two comments. The first one was that the GSS cases, as I
remember from reading your publications -- I think Gibbs was involved with them
-- when you transmitted the GSS into animals, into monkeys, perhaps I think it
was chimps, the transmission was more typical of CJD rather than GSS. There were
no amyloid plaques. It was vacuolar degeneration so that you may be transmitting
a peculiar form, as I criticized once in Bali and then you jumped all over me
about. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: I may do it again. </div>
<br />
<div>
</div>
<br />
<div>
DR. DeARMOND: Calling me a bigot and some other few things like that.
</div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Surely not. I wouldn't have said that. </div>
<br />
<div>
</div>
<br />
<div>
DR. DeARMOND: So there could be something strange about that particular --
</div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Yeah. I think you and Pierluigi are on the same page here. This
may be an unusual strain from a number of points of view. </div>
<br />
<div>
</div>
<br />
<div>
DR. DeARMOND: The other question though has to do with species barrier
because the data you're showing is kind of very reassuring to us that it's hard
to transmit from blood, but the data from the sheep and from the hamsters and
some of the work, I think, that has been done by others, that it's easy in some
other animals to transmit, hamster to hamster, mouse to mouse. </div>
<br />
<div>
</div>
<br />
<div>
Could you comment on the -- </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: That's exactly why we went to primates. That's exactly it,
because a primate is closer to a human than a mouse is, and that's just common
sense. </div>
<br />
<div>
</div>
<br />
<div>
And so to try and get a little closer to the human situation and not
totally depend on rodents for transferrable data, that is why you would use a
primate. Otherwise you wouldn't use them. They're too expensive and they cause
grief to animal care study people and protocol makers and the whole thing.
</div>
<br />
<div>
</div>
<br />
<div>
Primate studies are a real pain. </div>
<br />
<div>
</div>
<br />
<div>
DR. DeARMOND: But right now it's inconclusive and you need more time on
it. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: I believe that's true. I think if we cut it off at six years
you could still say it was inconclusive, and cutting it off at all will be to
some degree inconclusive, and that's just the way it is. </div>
<br />
<div>
</div>
<br />
<div>
DR. DeARMOND: So what has to be done? Who do you have to convince, or who
do we all have to convince to keep that going? </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Thomas? </div>
<br />
<div>
</div>
<br />
<div>
Without trying to be flip at all, the people that would be the first
people to try to convince would be the funders of the original study. If that
fails, and it might for purely practical reasons of finance, then we will have
to look elsewhere because I really don't want to see those animals sacrificed,
not those eight buddies. Those are crucial animals, and they don't cost a whole
lot to maintain. You can maintain eight -- well, they cost a lot from my point
of view, but 15 to $20,000 a year would keep them going year after year. </div>
<br />
<div>
</div>
<br />
<div>
CHAIRPERSON PRIOLA: Dr. Johnson. </div>
<br />
<div>
</div>
<br />
<div>
DR. JOHNSON: Yeah, Paul, I'm intrigued as you are by the shortening of the
incubation period. Have you in all of the other years of handling these animals
when they were transfused, when they were flown out to Louisiana at night -- a
lot of the stressful things have happened to some of these chimps. Have you ever
noticed that before or is this a new observation? </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Brand new. </div>
<br />
<div>
</div>
<br />
<div>
MR. JOHNSON: Brand new. Okay. </div>
<br />
<div>
</div>
<br />
<div>
CHAIRPERSON PRIOLA: Bob, did you want to say something? Dr. Rohwer. </div>
<br />
<div>
</div>
<br />
<div>
DR. ROHWER: The Frederick fire, wasn't that correlated with a lot of --
</div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Not that I k now of, but you may -- </div>
<br />
<div>
</div>
<br />
<div>
DR. ROHWER: Well, that occurred shortly after I came to NIH, and what I
remember is that there were a whole bunch of conversions that occurred within
the few months following the fire. That was fire that occurred adjacent to the
NINDS facility, but in order to protect it, they moved the monkeys out onto the
tarmac because they weren't sure it wouldn't burn as well. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: Well, if you're right, then it's not brand new, but I mean, I'm
not sure how we'll ever know because if I call Carlton and ask him, I'm not sure
but what I would trust the answer that he gives me, short of records. </div>
<br />
<div>
</div>
<br />
<div>
You know, Carlot is a very enthusiastic person, and he might say, "Oh,
yeah, my God, the whole floor died within three days," but I would want to
verify that. </div>
<br />
<div>
</div>
<br />
<div>
On the other hand, it may be verifiable. There possibly are records that
are still extant. </div>
<br />
<div>
</div>
<br />
<div>
DR. ROHWER: Actually I thought I heard the story from you. </div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: You didn't because it's brand new for me. I mean, either that
or I'm on the way </div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
CHAIRPERSON PRIOLA: Dr. Bracey. </div>
<br />
<div>
</div>
<br />
<div>
DR. BRACEY: I was wondering if some of the variability in terms of the
intravenous infection route may be related to intraspecies barriers, that is,
the genetic differences, the way the cells, the white leukocytes are processed,
whether or not microchimerism is established, et cetera. </div>
<br />
<div>
</div>
<br />
<div>
DR. BROWN: I don't think that processing is at fault, but the question,
the point that you raise is a very good one, and needless to say, we have
material with which we can analyze genetically all of the animals, and should it
turn out that we get, for example, -- I don't know -- a transmission in one
variant monkey and no transmissions in another and a transmission in three
sporadic monkeys, we will at that point genetically analyze every single animal
that has been used in this study, but we wanted to wait until we could see what
would be most useful to analyze. </div>
<br />
<div>
</div>
<br />
<div>
but the material is there, and if need be, we'll do it. </div>
<br />
<div>
</div>
<br />
<div>
CHAIRPERSON PRIOLA: Okay. Thank you very much, Dr. Brown. </div>
<br />
<div>
</div>
<br />
<div>
I think we'll move on to the open public hearing section of the morning.
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4019t1.DOC">http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4019t1.DOC</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
snip... </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
see full text ; </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html">http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Saturday, January 20, 2007 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Fourth case of transfusion-associated vCJD infection in the United Kingdom
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjdtransfusion.blogspot.com/2007/01/fourth-case-of-transfusion-associated.html">http://vcjdtransfusion.blogspot.com/2007/01/fourth-case-of-transfusion-associated.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Friday, June 29, 2012 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Highly Efficient Prion Transmission by Blood Transfusion </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, August 24, 2011 </div>
<br />
<div>
</div>
<br />
<div>
All Clinically-Relevant Blood Components Transmit Prion Disease following
a Single Blood Transfusion: A Sheep Model of vCJD </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/all-clinically-relevant-blood.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/all-clinically-relevant-blood.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, August 24, 2011 </div>
<br />
<div>
</div>
<br />
<div>
There Is No Safe Dose of Prions </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/there-is-no-safe-dose-of-prions.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/there-is-no-safe-dose-of-prions.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, May 1, 2011 </div>
<br />
<div>
</div>
<br />
<div>
W.H.O. T.S.E. PRION Blood products and related biologicals May 2011 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/who-tse-prion-blood-products-and.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/who-tse-prion-blood-products-and.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, February 7, 2011 </div>
<br />
<div>
</div>
<br />
<div>
FDA’s Currently-Recommended Policies to Reduce the Possible Risk of
Transmission of CJD and vCJD by Blood and Blood Products 2011 ??? </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html">http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, August 01, 2010 </div>
<br />
<div>
</div>
<br />
<div>
Blood product, collected from a donors possibly at increased risk for vCJD
only, was distributed USA JULY 2010 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html">http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
(Laughter.) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
atypical L-type BASE BSE California 2012 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
SUMMARY REPORT CALIFORNIA BOVINE SPONGIFORM ENCEPHALOPATHY CASE
INVESTIGATION JULY 2012 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Summary Report BSE 2012 </div>
<br />
<div>
</div>
<br />
<div>
Executive Summary </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/summary-report-california-bovine.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/summary-report-california-bovine.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Saturday, August 4, 2012 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
*** Final Feed Investigation Summary - California BSE Case - July 2012
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
(see tons and tons of banned highly suspect mad cow feed in ALABAMA 2006,
and 2007, one decade post partial and voluntary mad cow feed ban in the USA, see
where 10,000,000 pounds of blood laced banned meat and bone meal was fed out
into commerce) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/final-feed-investigation-summary.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/final-feed-investigation-summary.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Saturday, August 4, 2012 </div>
<br />
<div>
</div>
<br />
<div>
Update from APHIS Regarding Release of the Final Report on the BSE
Epidemiological Investigation </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/update-from-aphis-regarding-release-of.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/update-from-aphis-regarding-release-of.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, November 02, 2010 </div>
<br />
<div>
</div>
<br />
<div>
BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only)
diagnostic criteria CVL 1992 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html">http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Saturday, December 15, 2012 </div>
<br />
<div>
</div>
<br />
<div>
Bovine spongiform encephalopathy: the effect of oral exposure dose on
attack rate and incubation period in cattle -- an update 5 December 2012 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bse-atypical.blogspot.com/2012/12/bovine-spongiform-encephalopathy-effect.html">http://bse-atypical.blogspot.com/2012/12/bovine-spongiform-encephalopathy-effect.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, February 14, 2013 </div>
<br />
<div>
</div>
<br />
<div>
The Many Faces of Mad Cow Disease Bovine Spongiform Encephalopathy BSE and
TSE prion disease </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bse-atypical.blogspot.com/2013/02/the-many-faces-of-mad-cow-disease.html">http://bse-atypical.blogspot.com/2013/02/the-many-faces-of-mad-cow-disease.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, March 5, 2013 </div>
<br />
<div>
</div>
<br />
<div>
Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening
of the Comment Period FDA-2004-N-0188-0051 (TSS SUBMISSION) </div>
<br />
<div>
</div>
<br />
<div>
FDA believes current regulation protects the public from BSE but reopens
comment period due to new studies </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2013/03/use-of-materials-derived-from-cattle-in_6452.html">http://transmissiblespongiformencephalopathy.blogspot.com/2013/03/use-of-materials-derived-from-cattle-in_6452.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
CJD Incidents Panel to be disbanded </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
The Creutzfeldt-Jakob Disease (CJD) Incidents Panel will be dissolved at
the end of March 2013. Subsequently, the following arrangements will apply:
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
From 1 April 2013, responsibility for investigating, assessing and managing
CJD incidents (and where appropriate notifying patients) will be with local
trusts, health boards and health protection teams in the same way as most other
incidents that place patients at risk; National guidance on CJD incident
management will be available to support this and will be published on the legacy
Health Protection Agency website [1]. Novel issues that arise with respect to
CJD risk management and infection control can be referred to the Advisory
Committee on Dangerous Pathogens (ACDP) Transmissible Spongiform Encephalopathy
(TSE) Risk Management Sub-Group; Long term public health surveillance of CJD
exposures will continue and trusts, health boards and health protection teams
are asked to continue reporting the occurrence of incidents to Public Health
England, in particular if they involve a patient notification exercise;
Infection control guidance from the Advisory Committee on Dangerous Pathogens
Transmissible Spongiform Encephalopathy Risk Management Subgroup (ACDP TSE RM
SG, formerly the TSE Working Group) to reduce the risk of spread of TSEs in
healthcare and community settings can be found at: <a href="http://www.dh.gov.uk/health/2012/11/acdp-guidance/">http://www.dh.gov.uk/health/2012/11/acdp-guidance/</a>.
Further/background information: </div>
<br />
<div>
</div>
<br />
<div>
What is a CJD Incident? – A surgical incident has occurred when a patient
with, or at increased risk of, any human prion disease, including all forms of
CJD, has had an invasive procedure involving high or medium infectivity tissues
for CJD and where TSE instrument precautions were not taken. Patients
subsequently exposed to the implicated instruments may need to be informed that
they are at increased risk of CJD, depending on the specific circumstances.
Questions relating to the interpretation of the guidance should be sent to the
HPA/PHE CJD team either via the CJD mailbox cjd@hpa.org.uk (cjd@phe.gov.uk,
after 1 April 2013), or to: katy.sinka@hpa.org.uk, emma.hollis@phe.gov.uk.
</div>
<br />
<div>
</div>
<br />
<div>
Note </div>
<br />
<div>
</div>
<br />
<div>
1. The guidance will be available on the HPA website: Topics › Infectious
Diseases › Infections A-Z › Creutzfeldt-Jakob Disease (CJD) › CJD Guidance and
Advice. </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.hpa.org.uk/hpr/infections/ei_cjd.htm#cjd">http://www.hpa.org.uk/hpr/infections/ei_cjd.htm#cjd</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, February 10, 2013 </div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt-Jakob disease (CJD) biannual update (February 2013) Infection
report/CJD </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/02/creutzfeldt-jakob-disease-cjd-biannual.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/02/creutzfeldt-jakob-disease-cjd-biannual.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, January 17, 2013 </div>
<br />
<div>
</div>
<br />
<div>
TSE guidance, surgical, dental, blood risk factors, Part 4 Infection
control of CJD, vCJD and other human prion diseases in healthcare and community
settings (updated January 2013) </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2013/01/tse-guidance-surgical-dental-blood-risk.html">http://transmissiblespongiformencephalopathy.blogspot.com/2013/01/tse-guidance-surgical-dental-blood-risk.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, December 10, 2012 </div>
<br />
<div>
</div>
<br />
<div>
Report on the monitoring of ruminants for the presence of Transmissible
Spongiform Encephalopathies (TSEs) in the EU in 2011 Final version 18 October
2012 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/12/report-on-monitoring-of-ruminants-for.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/12/report-on-monitoring-of-ruminants-for.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Friday, August 24, 2012 </div>
<br />
<div>
</div>
<br />
<div>
Iatrogenic prion diseases in humans: an update </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/iatrogenic-prion-diseases-in-humans.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/iatrogenic-prion-diseases-in-humans.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Friday, August 10, 2012 </div>
<br />
<div>
</div>
<br />
<div>
Incidents of Potential iatrogenic Creutzfeldt-Jakob disease (CJD) biannual
update (July 2012) </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/08/incidents-of-potential-iatrogenic.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/08/incidents-of-potential-iatrogenic.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, July 05, 2012</div>
<br />
<div>
</div>
<br />
<div>
Incidence of variant Creutzfeldt-Jakob disease diagnoses and deaths in the
UK January 1994 – December 2011 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjd.blogspot.com/2012/07/incidence-of-variant-creutzfeldt-jakob.html">http://vcjd.blogspot.com/2012/07/incidence-of-variant-creutzfeldt-jakob.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, April 12, 2012</div>
<br />
<div>
</div>
<br />
<div>
Health professions and risk of sporadic Creutzfeldt–Jakob disease, 1965 to
2010 </div>
<br />
<div>
</div>
<br />
<div>
Eurosurveillance, Volume 17, Issue 15, 12 April 2012 </div>
<br />
<div>
</div>
<br />
<div>
Research articles </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/04/health-professions-and-risk-of-sporadic.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/04/health-professions-and-risk-of-sporadic.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, August 24, 2011</div>
<br />
<div>
</div>
<br />
<div>
All Clinically-Relevant Blood Components Transmit Prion Disease following a
> Single Blood Transfusion: A Sheep Model of vCJD </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/all-clinically-relevant-blood.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/all-clinically-relevant-blood.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Saturday, March 23, 2013 </div>
<br />
<div>
</div>
<br />
<div>
CJD Incidents Panel to be disbanded </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/03/cjd-incidents-panel-to-be-disbanded.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/03/cjd-incidents-panel-to-be-disbanded.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, March 05, 2013 </div>
<br />
<div>
</div>
<br />
<div>
A closer look at prion strains Characterization and important implications
Prion </div>
<br />
<div>
</div>
<br />
<div>
7:2, 99–108; March/April 2013; © 2013 Landes Bioscience </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/03/a-closer-look-at-prion-strains.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/03/a-closer-look-at-prion-strains.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, February 21, 2013 </div>
<br />
<div>
</div>
<br />
<div>
National Prion Disease Pathology Surveillance Center Cases Examined January
16, 2013 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://prionunitusaupdate2008.blogspot.com/2013/02/national-prion-disease-pathology.html">http://prionunitusaupdate2008.blogspot.com/2013/02/national-prion-disease-pathology.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
16 YEAR OLD SPORADIC FFI ? </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, January 14, 2013 </div>
<br />
<div>
</div>
<br />
<div>
Gambetti et al USA Prion Unit change another highly suspect USA mad cow
victim to another fake name i.e. sporadic FFI at age 16 CJD Foundation goes
along with this BSe </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2013/01/gambetti-et-al-usa-prion-unit-change.html">http://transmissiblespongiformencephalopathy.blogspot.com/2013/01/gambetti-et-al-usa-prion-unit-change.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, December 31, 2012 </div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt Jakob Disease and Human TSE Prion Disease in Washington State,
2006–2011-2012 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/12/creutzfeldt-jakob-disease-and-human-tse.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/12/creutzfeldt-jakob-disease-and-human-tse.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, December 25, 2012 </div>
<br />
<div>
</div>
<br />
<div>
CREUTZFELDT JAKOB TSE PRION DISEASE HUMANS END OF YEAR REVIEW DECEMBER 25,
2012 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/12/creutzfeldt-jakob-tse-prion-disease.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/12/creutzfeldt-jakob-tse-prion-disease.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, June 26, 2012 </div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt Jakob Disease Human TSE report update North America, Canada,
Mexico, and USDA PRION UNIT as of May 18, 2012 </div>
<br />
<div>
</div>
<br />
<div>
type determination pending Creutzfeldt Jakob Disease (tdpCJD), is on the
rise in Canada and the USA </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/06/creutzfeldt-jakob-disease-human-tse.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/06/creutzfeldt-jakob-disease-human-tse.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, June 13, 2012 </div>
<br />
<div>
</div>
<br />
<div>
MEXICO IS UNDER or MIS DIAGNOSING CREUTZFELDT JAKOB DISEASE AND OTHER PRION
DISEASE SOME WITH POSSIBLE nvCJD </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/06/mexico-is-under-or-mis-diagnosing.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/06/mexico-is-under-or-mis-diagnosing.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
*** The discovery of previously unrecognized prion diseases in both humans
and animals (i.e., Nor98 in small ruminants) demonstrates that the range of
prion diseases might be wider than expected and raises crucial questions about
the epidemiology and strain properties of these new forms. We are investigating
this latter issue by molecular and biological comparison of VPSPr, GSS and
Nor98. </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
VARIABLY PROTEASE-SENSITVE PRIONOPATHY IS TRANSMISSIBLE ...price of prion
poker goes up again $ </div>
<br />
<div>
</div>
<br />
<div>
OR-10: Variably protease-sensitive prionopathy is transmissible in bank
voles </div>
<br />
<div>
</div>
<br />
<div>
Romolo Nonno,1 Michele Di Bari,1 Laura Pirisinu,1 Claudia D’Agostino,1
Stefano Marcon,1 Geraldina Riccardi,1 Gabriele Vaccari,1 Piero Parchi,2 Wenquan
Zou,3 Pierluigi Gambetti,3 Umberto Agrimi1 1Istituto Superiore di Sanità; Rome,
Italy; 2Dipartimento di Scienze Neurologiche, Università di Bologna; Bologna,
Italy; 3Case Western Reserve University; Cleveland, OH USA </div>
<br />
<div>
</div>
<br />
<div>
Background. Variably protease-sensitive prionopathy (VPSPr) is a recently
described “sporadic”neurodegenerative disease involving prion protein
aggregation, which has clinical similarities with non-Alzheimer dementias, such
as fronto-temporal dementia. Currently, 30 cases of VPSPr have been reported in
Europe and USA, of which 19 cases were homozygous for valine at codon 129 of the
prion protein (VV), 8 were MV and 3 were MM. A distinctive feature of VPSPr is
the electrophoretic pattern of PrPSc after digestion with proteinase K (PK).
After PK-treatment, PrP from VPSPr forms a ladder-like electrophoretic pattern
similar to that described in GSS cases. The clinical and pathological features
of VPSPr raised the question of the correct classification of VPSPr among prion
diseases or other forms of neurodegenerative disorders. Here we report
preliminary data on the transmissibility and pathological features of VPSPr
cases in bank voles. </div>
<br />
<div>
</div>
<br />
<div>
Materials and Methods. Seven VPSPr cases were inoculated in two genetic
lines of bank voles, carrying either methionine or isoleucine at codon 109 of
the prion protein (named BvM109 and BvI109, respectively). Among the VPSPr cases
selected, 2 were VV at PrP codon 129, 3 were MV and 2 were MM. Clinical
diagnosis in voles was confirmed by brain pathological assessment and western
blot for PK-resistant PrPSc (PrPres) with mAbs SAF32, SAF84, 12B2 and 9A2.
</div>
<br />
<div>
</div>
<br />
<div>
Results. To date, 2 VPSPr cases (1 MV and 1 MM) gave positive transmission
in BvM109. Overall, 3 voles were positive with survival time between 290 and 588
d post inoculation (d.p.i.). All positive voles accumulated PrPres in the form
of the typical PrP27–30, which was indistinguishable to that previously observed
in BvM109 inoculated with sCJDMM1 cases. </div>
<br />
<div>
</div>
<br />
<div>
In BvI109, 3 VPSPr cases (2 VV and 1 MM) showed positive transmission until
now. Overall, 5 voles were positive with survival time between 281 and 596
d.p.i.. In contrast to what observed in BvM109, all BvI109 showed a GSS-like
PrPSc electrophoretic pattern, characterized by low molecular weight PrPres.
These PrPres fragments were positive with mAb 9A2 and 12B2, while being negative
with SAF32 and SAF84, suggesting that they are cleaved at both the C-terminus
and the N-terminus. Second passages are in progress from these first successful
transmissions. </div>
<br />
<div>
</div>
<br />
<div>
Conclusions. Preliminary results from transmission studies in bank voles
strongly support the notion that VPSPr is a transmissible prion disease.
Interestingly, VPSPr undergoes divergent evolution in the two genetic lines of
voles, with sCJD-like features in BvM109 and GSS-like properties in BvI109.
</div>
<br />
<div>
</div>
<br />
<div>
The discovery of previously unrecognized prion diseases in both humans and
animals (i.e., Nor98 in small ruminants) demonstrates that the range of prion
diseases might be wider than expected and raises crucial questions about the
epidemiology and strain properties of these new forms. We are investigating this
latter issue by molecular and biological comparison of VPSPr, GSS and Nor98.
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.landesbioscience.com/journals/prion/01-Prion6-2-OralPresentations.pdf?nocache=1216084967">http://www.landesbioscience.com/journals/prion/01-Prion6-2-OralPresentations.pdf?nocache=1216084967</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, March 28, 2012 </div>
<br />
<div>
</div>
<br />
<div>
VARIABLY PROTEASE-SENSITVE PRIONOPATHY IS TRANSMISSIBLE, price of prion
poker goes up again $ </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://prionopathy.blogspot.com/2012/03/variably-protease-sensitve-prionopathy.html">http://prionopathy.blogspot.com/2012/03/variably-protease-sensitve-prionopathy.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, April 4, 2013</div>
<br />
<div>
</div>
<br />
<div>
Variably protease-sensitive prionopathy in the UK: a retrospective review
1991–2008 </div>
<br />
<div>
</div>
<br />
<div>
Brain (2013) 136 (4): 1102-1115. doi: 10.1093/brain/aws366 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://prionopathy.blogspot.com/2013/04/variably-protease-sensitive-prionopathy.html">http://prionopathy.blogspot.com/2013/04/variably-protease-sensitive-prionopathy.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, March 31, 2013 </div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt Jakob Disease CJD worlds youngest documented victim, 11 years
old, shall we pray </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/03/creutzfeldt-jakob-disease-cjd-worlds.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/03/creutzfeldt-jakob-disease-cjd-worlds.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, April 24, 2013 </div>
<br />
<div>
</div>
<br />
<div>
Dissociation between Transmissible Spongiform Encephalopathy (TSE)
Infectivity and Proteinase K-Resistant PrPSc Levels in Peripheral Tissue from a
Murine Transgenic Model of TSE Disease</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2013/04/dissociation-between-transmissible.html">http://transmissiblespongiformencephalopathy.blogspot.com/2013/04/dissociation-between-transmissible.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, August 21, 2011</div>
<br />
<div>
</div>
<br />
<div>
The British disease, or a disease gone global, The TSE Prion Disease</div>
<br />
<div>
</div>
<br />
<div>
(see video here) </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/british-disease-or-disease-gone-global.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/british-disease-or-disease-gone-global.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ?</div>
<br />
<div>
</div>
<br />
<div>
(see video at bottom) </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html">http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, September 6, 2009</div>
<br />
<div>
</div>
<br />
<div>
MAD COW USA 1997</div>
<br />
<div>
</div>
<br />
<div>
(SEE SECRET VIDEO) </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://madcowusda.blogspot.com/2009/09/mad-cow-usa-1997-video.html">http://madcowusda.blogspot.com/2009/09/mad-cow-usa-1997-video.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt-Jakob Disease Public Health Crisis </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.youtube.com/watch?v=zf3lfz9NrT4">http://www.youtube.com/watch?v=zf3lfz9NrT4</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.youtube.com/watch?v=c0tWkNvhO4g">http://www.youtube.com/watch?v=c0tWkNvhO4g</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.youtube.com/watch?v=zf3lfz9NrT4&feature=results_main&playnext=1&list=PL780BE2AF0B62A944">http://www.youtube.com/watch?v=zf3lfz9NrT4&feature=results_main&playnext=1&list=PL780BE2AF0B62A944</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/terry-singeltary-sr-on-creutzfeldt.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/terry-singeltary-sr-on-creutzfeldt.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, August 09, 2009 </div>
<br />
<div>
</div>
<br />
<div>
CJD...Straight talk with...James Ironside...and...Terry Singeltary... 2009
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2009/08/cjdstraight-talk-withjames.html">http://creutzfeldt-jakob-disease.blogspot.com/2009/08/cjdstraight-talk-withjames.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
BOUGHT AND PAID FOR BY YOUR LOCAL CATTLE DEALERS AND LOBBYIEST
EVERYWHERE... </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
IN A NUT SHELL ; </div>
<br />
<div>
</div>
<br />
<div>
(Adopted by the International Committee of the OIE on 23 May 2006) </div>
<br />
<div>
</div>
<br />
<div>
11. Information published by the OIE is derived from appropriate
declarations made by the official Veterinary Services of Member Countries. The
OIE is not responsible for inaccurate publication of country disease status
based on inaccurate information or changes in epidemiological status or other
significant events that were not promptly reported to the Central Bureau, </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.oie.int/eng/Session2007/RF2006.pdf">http://www.oie.int/eng/Session2007/RF2006.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
i pulled this comment off another board about the OIE and all it's lobby
groups...tss </div>
<br />
<div>
</div>
<br />
<div>
Having been to their offices in Paris and talked personally with the Head
of the Animal Test Section, you would choke if you knew how many lobby groups
attend that office daily. There is a steady stream of paid lobby groups that
have one goal in life and that is to sway the Section Heads of each department
within the OIE to suit the needs of different juristictions around the world,
which curiously enough, also includes the USA and Canada. Anyone can go there
and chat with them - providing they can privide valid cause to be let in. To say
that the only goal of the OIE is animal health is actually only part of their
function. They are more than that and my discussions with Dr. Diaz there has
showed me that. But to blindly make a statement regarding what they do when you
have no idea what they actually do is like eating the skin of the orange and not
knowing what is actually under. Interstingly you state that the US Government
applied pressure (to the OIE) I assume and that is a great example of the lobby
groups doing their job. So, at the end of the day, one can safely assume that it
is the pressure applied by certain influential lobby groups that will determine
a likely aoutcome to an apparent OIE directive. Man alive, isn't it great to
live in a democracy wherein the people get to make the choices and not just some
"other" interested party or group - say like........Cargyll or Tyson for
example? </div>
<br />
<div>
</div>
<br />
<div>
So, one last question, question? </div>
<br />
<div>
</div>
<br />
<div>
Who wags the tail of that dog?? And for what reason other than one that is
purely associated with trade and international agreements and greed? </div>
<br />
<div>
</div>
<br />
<div>
Location: Edmonton, Alberta, Canada </div>
<br />
<div>
</div>
<br />
<div>
Occupation: CEO of BSE Prion Solutions Inc. </div>
<br />
<div>
</div>
<br />
<div>
Interests: Prion Diseases and Live Animal Testing </div>
<br />
<div>
</div>
<br />
<div>
end...tss </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, July 17, 2012 </div>
<br />
<div>
</div>
<br />
<div>
O.I.E. BSE, CWD, SCRAPIE, TSE PRION DISEASE Final Report of the 80th
General Session, 20 - 25 May 2012 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/07/oie-bse-cwd-scrapie-tse-prion-disease.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/07/oie-bse-cwd-scrapie-tse-prion-disease.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, May 25, 2011 </div>
<br />
<div>
</div>
<br />
<div>
O.I.E. Terrestrial Animal Health Standards Commission and prion (TSE)
disease reporting 2011 </div>
<br />
<div>
</div>
<br />
<div>
----- Original Message ----- </div>
<br />
<div>
</div>
<br />
<div>
From: Terry S. Singeltary Sr. </div>
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<div>
</div>
<br />
<div>
To: BSE-L@LISTS.AEGEE.ORG </div>
<br />
<div>
</div>
<br />
<div>
Cc: trade@oie.int ; oie@oie.int ; f.diaz@oie.int ; scientific.dept@oie.int
; cjdvoice@yahoogroups.com ; <a href="mailto:BLOODCJD@YAHOOGROUPS.COM">BLOODCJD@YAHOOGROUPS.COM</a> </div>
<br />
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</div>
<br />
<div>
</div>
<br />
<div>
Sent: Tuesday, May 24, 2011 2:24 PM </div>
<br />
<div>
</div>
<br />
<div>
Subject: O.I.E. Terrestrial Animal Health Standards Commission and prion
(TSE) disease reporting 2011 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/oie-terrestrial-animal-health-standards.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/oie-terrestrial-animal-health-standards.html</a>
</div>
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</div>
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</div>
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<div>
Saturday, December 18, 2010 </div>
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<div>
</div>
<br />
<div>
OIE Global Conference on Wildlife Animal Health and Biodiversity -
Preparing for the Future (TSE AND PRIONS) Paris (France), 23-25 February 2011
</div>
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<div>
</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2010/12/oie-global-conference-on-wildlife.html">http://transmissiblespongiformencephalopathy.blogspot.com/2010/12/oie-global-conference-on-wildlife.html</a>
</div>
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</div>
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<div>
Monday, November 23, 2009 </div>
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<div>
</div>
<br />
<div>
BSE GBR RISK ASSESSMENTS UPDATE NOVEMBER 23, 2009 COMMISSION OF THE
EUROPEAN COMMUNITIES AND O.I.E. COMMISSION DECISION of 11 November 2009 amending
the Annex to Decision 2007/453/EC as regards the BSE status of Chile, Colombia
and Japan (notified under document C(2009) 8590) </div>
<br />
<div>
</div>
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<div>
<a href="http://docket-aphis-2006-0041.blogspot.com/2009/11/bse-gbr-risk-assessments-update.html">http://docket-aphis-2006-0041.blogspot.com/2009/11/bse-gbr-risk-assessments-update.html</a>
</div>
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</div>
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<div>
Tuesday, January 1, 2008 </div>
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</div>
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<div>
BSE OIE USDA </div>
<br />
<div>
</div>
<br />
<div>
Subject: OIE BSE RECOMMENDATION FOR USA, bought and paid for by your local
cattle dealers i.e. USDA </div>
<br />
<div>
</div>
<br />
<div>
Date: May 14, 2007 at 9:00 am PST </div>
<br />
<div>
</div>
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<div>
OIE BSE RECOMMENDATION FOR USA, bought and paid for by your local cattle
dealers i.e. USDA </div>
<br />
<div>
</div>
<br />
<div>
STATEMENT BY DR. RON DEHAVEN REGARDING OIE RISK RECOMMENDATION </div>
<br />
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</div>
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<div>
March 9, 2007 </div>
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</div>
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<div>
<a href="http://madcowtesting.blogspot.com/2008/01/bse-oie-usda.html">http://madcowtesting.blogspot.com/2008/01/bse-oie-usda.html</a>
</div>
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Tuesday, November 02, 2010 </div>
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</div>
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<div>
IN CONFIDENCE </div>
<br />
<div>
</div>
<br />
<div>
The information contained herein should not be disseminated further except
on the basis of "NEED TO KNOW". </div>
<br />
<div>
</div>
<br />
<div>
BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only)
diagnostic criteria CVL 1992 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html">http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
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<div>
</div>
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<div>
2009 UPDATE ON ALABAMA AND TEXAS MAD COWS 2005 and 2006 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://bse-atypical.blogspot.com/2006/08/bse-atypical-texas-and-alabama-update.html">http://bse-atypical.blogspot.com/2006/08/bse-atypical-texas-and-alabama-update.html</a>
</div>
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<div>
</div>
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<div>
Comments on technical aspects of the risk assessment were then submitted
to FSIS. </div>
<br />
<div>
</div>
<br />
<div>
Comments were received from Food and Water Watch, Food Animal Concerns
Trust (FACT), Farm Sanctuary, R-CALF USA, Linda A Detwiler, and Terry S.
Singeltary. </div>
<br />
<div>
</div>
<br />
<div>
This document provides itemized replies to the public comments received on
the 2005 updated Harvard BSE risk assessment. Please bear the following points
in mind: </div>
<br />
<div>
</div>
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<div>
<a href="http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf">http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf</a>
</div>
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</div>
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<div>
Owens, Julie </div>
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</div>
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<div>
From: Terry S. Singeltary Sr. [flounder9@verizon.net] </div>
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</div>
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<div>
Sent: Monday, July 24, 2006 1:09 PM </div>
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</div>
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To: FSIS RegulationsComments </div>
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</div>
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<div>
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE) </div>
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Page 1 of 98 </div>
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<a href="http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf">http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf</a>
</div>
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FSIS, USDA, REPLY TO SINGELTARY </div>
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</div>
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<div>
<a href="http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf">http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf</a>
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<div>
U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001 </div>
<br />
<div>
</div>
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<div>
</div>
<br />
<div>
<a href="http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html">http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html</a>
</div>
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</div>
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</div>
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<div>
<a href="http://madcowusda.blogspot.com/2012/02/eight-former-secretaries-of-agriculture.html">http://madcowusda.blogspot.com/2012/02/eight-former-secretaries-of-agriculture.html</a>
</div>
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</div>
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<div>
<a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108292.htm">http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108292.htm</a>
</div>
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</div>
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<div>
<a href="http://oversight-archive.waxman.house.gov/documents/20040608105007-72922.pdf">http://oversight-archive.waxman.house.gov/documents/20040608105007-72922.pdf</a>
</div>
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<div>
</div>
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<a href="http://oversight-archive.waxman.house.gov/documents/20040607142914-86912.pdf">http://oversight-archive.waxman.house.gov/documents/20040607142914-86912.pdf</a>
</div>
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<a href="http://oversight-archive.waxman.house.gov/documents/20040817120642-85052.pdf">http://oversight-archive.waxman.house.gov/documents/20040817120642-85052.pdf</a>
</div>
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</div>
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</div>
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<div>
<a href="http://oversight-archive.waxman.house.gov/documents/20040817120805-51929.pdf">http://oversight-archive.waxman.house.gov/documents/20040817120805-51929.pdf</a>
</div>
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</div>
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</div>
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<div>
<a href="http://www.usda.gov/oig/webdocs/Testimony7-2004.pdf">http://www.usda.gov/oig/webdocs/Testimony7-2004.pdf</a>
</div>
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<div>
</div>
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</div>
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<div>
<a href="http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/bse_final_epi_report8-05.pdf">http://www.aphis.usda.gov/newsroom/hot_issues/bse/downloads/bse_final_epi_report8-05.pdf</a>
</div>
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<div>
</div>
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</div>
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<div>
<a href="http://www.usda.gov/wps/portal/usda/usdahome?contentidonly=true&contentid=2005/06/0235.xml">http://www.usda.gov/wps/portal/usda/usdahome?contentidonly=true&contentid=2005/06/0235.xml</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.cidrap.umn.edu/cidrap/content/other/bse/news/june3005bse.html">http://www.cidrap.umn.edu/cidrap/content/other/bse/news/june3005bse.html</a>
</div>
<br />
<div>
</div>
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<div>
</div>
<br />
<div>
<a href="http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/UCM091074.pdf">http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/UCM091074.pdf</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm107472.htm">http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm107472.htm</a>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf">http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf</a>
</div>
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<div>
</div>
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<div>
</div>
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<div>
<a href="http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf">http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf</a>
</div>
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</div>
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<div>
Friday, April 19, 2013 </div>
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<div>
</div>
<br />
<div>
APHIS 2013 Stakeholder Meeting (March 2013) BSE TSE PRION</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://madcowusda.blogspot.com/2013/04/aphis-2013-stakeholder-meeting-march.html">http://madcowusda.blogspot.com/2013/04/aphis-2013-stakeholder-meeting-march.html</a>
</div>
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TSS</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-56105773961638678942013-03-01T07:43:00.001-08:002013-03-01T11:03:10.533-08:00Prion infectivity in the spleen of a PRNP heterozygous individual with subclinical variant Creutzfeldt–Jakob disease <div>
Prion infectivity in the spleen of a PRNP heterozygous individual with
subclinical variant Creutzfeldt–Jakob disease </div>
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<div>
Matthew T. Bishop1,*, Abigail B. Diack2,*, Diane L. Ritchie1, James W.
Ironside1, Robert G. Will1,* and Jean C. Manson2,* + Author Affiliations</div>
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1 National Creutzfeldt–Jakob Disease Research and Surveillance Unit,
University of Edinburgh, Bryan Matthews Building, Western General Hospital,
Crewe Road, Edinburgh, EH4 2XU, UK 2 Neurobiology Division, The Roslin Institute
and Royal (Dick) School of Veterinary Studies, University of Edinburgh, Easter
Bush, Midlothian, EH25 9RG, UK Correspondence to: Professor Jean Manson, Head of
Neurobiology Division, The Roslin Institute and Royal (Dick) School of
Veterinary Studies, University of Edinburgh, Easter Bush, Midlothian, EH25 9RG,
UK E-mail: jean.manson@roslin.ed.ac.uk Received August 13, 2012. Revision
received January 10, 2013. Accepted January 14, 2013. </div>
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Summary </div>
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</div>
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<div>
Blood transfusion has been identified as a source of human-to-human
transmission of variant Creutzfeldt–Jakob disease. Three cases of variant
Creutzfeldt–Jakob disease have been identified following red cell transfusions
from donors who subsequently developed variant Creutzfeldt–Jakob disease and an
asymptomatic red cell transfusion recipient, who did not die of variant
Creutzfeldt–Jakob disease, has been identified with prion protein deposition in
the spleen and a lymph node, but not the brain. This individual was heterozygous
(MV) at codon 129 of the prion protein gene (PRNP), whereas all previous
definite and probable cases of variant Creutzfeldt–Jakob disease have been
methionine homozygotes (MM). A critical question for public health is whether
the prion protein deposition reported in peripheral tissues from this MV
individual correlates with infectivity. Additionally it is important to
establish whether the PRNP codon 129 genotype has influenced the transmission
characteristics of the infectious agent. Brain and spleen from the MV blood
recipient were inoculated into murine strains that have consistently
demonstrated transmission of the variant Creutzfeldt–Jakob disease agent. Mice
were assessed for clinical and pathological signs of disease and transmission
data were compared with other transmission studies in variant Creutzfeldt–Jakob
disease, including those on the spleen and brain of the donor to the index case.
Transmission of variant Creutzfeldt–Jakob disease was observed from the MV blood
recipient spleen, but not from the brain, whereas there was transmission from
both spleen and brain tissues from the red blood cell donor. Longer incubation
times were observed for the blood donor spleen inoculum compared with the blood
donor brain inoculum, suggesting lower titres of infectivity in the spleen. The
distribution of vacuolar pathology and abnormal prion protein in infected mice
were similar following inoculation with both donor and recipient spleen
homogenates, providing initial evidence of similar transmission properties after
propagation in PRNP codon 129 MV and MM individuals. These studies demonstrate
that spleen tissue from a PRNP MV genotype individual can propagate the variant
Creutzfeldt–Jakob disease agent and that the infectious agent can be present in
the spleen without CNS involvement. </div>
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snip... </div>
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Discussion </div>
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This study provides definitive evidence that spleen tissue from an
asymptomatic individual contains variant Creutzfeldt–Jakob disease infectivity
and that the variant Creutzfeldt–Jakob disease agent retains infectivity
following passage through an MV genotype host. The findings are of importance as
there has been uncertainty as to whether prion protein immunostaining in
peripheral tissues from non-clinical variant Creutzfeldt–Jakob disease
necessarily correlated with infectivity (Hilton et al., 2004; Wadsworth et al.,
2011). The demonstration of infectivity in such tissues underlines the potential
for asymptomatic carriers of variant Creutzfeldt– Jakob disease infection to
pose a risk of secondary transmission of infection through blood transfusion or
contamination of surgical instruments. The incubation times recorded in this
study would suggest moderate but significant levels of infectivity are present
in the spleen of the MV genotype recipient, raising the possibility that other
peripheral tissues and the blood of this individual are also infected, as
indicated by immunohistochemistry in the initial report of this case (Peden et
al., 2004). Furthermore the confirmation that there is prion infectivity in an
individual with a PRNP codon 129 MV genotype indicates that this genetic
subgroup, which accounts for 50% of the UK population, can act as carriers of
variant Creutzfeldt–Jakob disease infection. </div>
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Our results also provide initial evidence that the variant
Creutzfeldt–Jakob disease transmission properties in the MV blood recipient
spleen tissue are similar to those of the MM blood donor. This is a critical
issue for public health as there is a potential for these infectious agents to
change characteristics, including virulence, after serial transmission or
following passage in a different genetic background. The relative stability of
the agent also makes it more likely that the clinical phenotype of variant
Creutzfeldt–Jakob disease infection in an MV background may be similar to that
of the well-recognized clinical phenotype in an MM background. While a first
passage of an agent between species is not normally sufficient to confirm strain
identity, the similarities identified at first passage in this study are
striking. We are now undertaking a more extensive strain comparison by our
standard serial-passage method using inocula derived from this primary
transmission experiment (Ritchie et al., 2009). This will help establish whether
the strain characteristics have indeed remained stable following passage through
an MV host. </div>
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This study has established that variant Creutzfeldt–Jakob disease
infectivity can be replicated within a PRNP codon 129 MV genotype host and
within a non-CNS tissue, in the absence of variant Creutzfeldt–Jakob disease
pathology in the brain. This demonstrates the potential for asymptomatic
carriage of variant Creutzfeldt–Jakob disease infection in the UK population,
underlining the risk of a silent subclinical epidemic that could result from
transfer of infection through blood transfusion or surgery (Garske and Ghani,
2010). It is imperative therefore that continued active surveillance and
infection control measures for variant Creutzfeldt– Jakob disease are continued
into the future. </div>
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<div>
Key words variant Creutzfeldt–Jakob disease infection subclinical blood
transfusion prion</div>
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Abbreviations</div>
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HuMM transgenic mouse line expressing human prion protein with MM genotype
at codon 129 PrPSc disease associated (‘scrapie’) form of the prion
protein</div>
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<div>
© The Author (2013). Published by Oxford University Press on behalf of the
Guarantors of Brain.</div>
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<div>
This is an Open Access article distributed under the terms of the Creative
Commons Attribution Non-Commercial License (<a href="http://creativecommons.org/licenses/by-nc/3.0/)">http://creativecommons.org/licenses/by-nc/3.0/)</a>,
which permits unrestricted non-commercial use, distribution, and reproduction in
any medium, provided the original work is properly cited. </div>
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<div>
<a href="http://brain.oxfordjournals.org/content/early/2013/02/28/brain.awt032.abstract">http://brain.oxfordjournals.org/content/early/2013/02/28/brain.awt032.abstract</a>
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<a href="http://brain.oxfordjournals.org/content/early/2013/02/28/brain.awt032.full.pdf+html">http://brain.oxfordjournals.org/content/early/2013/02/28/brain.awt032.full.pdf+html</a>
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<div>
MARCH 2010</div>
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CJD SUPPORT NETWORK</div>
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In a fourth case an elderly lady died of un-related causes and was found to
show evidence of accumulation of prions in her spleen and one lymph node. </div>
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<div>
</div>
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<div>
A fifth, plasma related transmission has recently been identified in a
patient with haemophilia who also died of other causes and was found to have
evidence of abnormal prion protein accumulation in his spleen. </div>
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<div>
<a href="http://www.cjdsupport.net/UserFiles/File/CJD%20news%200310%20printers%20copy.pdf">http://www.cjdsupport.net/UserFiles/File/CJD%20news%200310%20printers%20copy.pdf</a>
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<div>
Saturday, January 20, 2007 </div>
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</div>
<div>
Fourth case of transfusion-associated vCJD
infection in the United Kingdom </div>
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</div>
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<div>
Saturday, January 20, 2007 </div>
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</div>
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</div>
<div>
Fourth case of transfusion-associated vCJD
infection in the United Kingdom</div>
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</div>
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<div>
Subject: Fourth case of transfusion-associated vCJD infection in the United
Kingdom </div>
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</div>
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</div>
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</div>
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</div>
<div>
Date: January 18, 2007 at 8:32 am PST</div>
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</div>
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<div>
Fourth case of transfusion-associated vCJD infection in the United
Kingdom</div>
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</div>
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<div>
Editorial team (eurosurveillance.weekly@hpa.org.uk), Eurosurveillance
editorial office</div>
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</div>
<br />
<div>
A suspected case of variant Creutzfeldt-Jakob disease (vCJD) has recently
been diagnosed in a patient in the United Kingdom (UK), who received a blood
transfusion from a donor who later developed vCJD [1]. This is the fourth case
of probable transfusion transmission of vCJD infection in the UK. Three of the
four recipients developed symptoms of vCJD. The first symptomatic case of vCJD
associated with blood transfusion was identified in December 2003. This
individual developed vCJD six and a half years after transfusion of red cells
donated by an individual who developed symptoms of vCJD three and a half years
after donation.</div>
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</div>
<br />
<div>
A second case of vCJD 'infection' was identified a few months later in a
person who had received red cells from a donor who developed symptoms of vCJD 18
months after donation. This patient (the second case) died from causes unrelated
to vCJD five years after transfusion. Post-mortem investigations found abnormal
prion protein in the spleen and a cervical lymph node., However, prion protein
was not found in the brain, and no pathological features of vCJD were
found.</div>
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<div>
</div>
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<br />
<br />
<div>
A third case developed symptoms of vCJD six years after receiving a
transfusion of red blood cells, and died two years and eight months later. The
donor of the blood involved developed vCJD about 20 months after donating
it.</div>
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<div>
</div>
<div>
</div>
<div>
</div>
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<div>
These three cases have been published as case reports and in the findings
of the ongoing collaborative study between the National Blood Services, the
National CJD Surveillance Unit, and the Office for National Statistics. This
study aims to collect evidence about transmission of CJD or vCJD via the blood
supply [2,3,4,5].</div>
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<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
The new, fourth case is in a patient who developed symptoms of vCJD eight
and a half years after receiving a transfusion of red blood cells from a donor
who developed vCJD about 17 months after this blood was donated [1]. The donor
to this case also donated the vCJD-implicated blood transfused to the third
case. As for all other reported clinical vCJD cases that have been tested for
genotype, this patient is a methionine homozygote at codon 129 of the prion
protein gene. The patient is currently alive.</div>
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<br />
<br />
<div>
</div>
<br />
<div>
All four cases had received transfusions of non-leucodepleted red blood
cells between 1996 and 1999. Since October 1999, leucocytes have been removed
from all blood used for transfusion in the UK. The effect of leucodepletion on
the reduction of the risk of transmission of vCJD from an infective donation is
uncertain.</div>
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<br />
<br />
<div>
</div>
<br />
<div>
This fourth case of vCJD infection associated with blood transfusion
further increases the level of concern about the risk of vCJD transmission
between humans by blood transfusion, although much remains unknown. This
reinforces the importance of the existing precautions that have been introduced
to reduce the risk of transmission of vCJD infection by blood and blood products
[6]. No cases of vCJD have been associated with fractionated plasma products.
The small group of living recipients of vCJD-implicated blood transfusion in the
UK have been informed of their potential exposure to vCJD by blood transfusion,
asked to take certain precautions to reduce the risk of onward person-to-person
transmission of vCJD during health care, and offered specialist neurological
evaluation and advice.</div>
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</div>
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</div>
<div>
</div>
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<div>
This article has been adapted from reference 1</div>
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</div>
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</div>
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</div>
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<div>
References: Health Protection Agency. </div>
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</div>
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</div>
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</div>
<div>
Fourth case of variant CJD associated
with blood transfusion (press release). </div>
<div>
</div>
<div>
</div>
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</div>
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</div>
<div>
</div>
<div>
Press release, 18 January 2007. </div>
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<div>
(<a href="http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/070118_vCJD.htm">http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/070118_vCJD.htm</a>
) </div>
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<div>
Llewelyn CA, Hewitt PE, Knight RSG, Amar K, Cousens S, Mackenzie J, et al.
</div>
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</div>
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</div>
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</div>
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</div>
<div>
Possible transmission of variant CJD disease by blood transfusion. Lancet 2004;
363:417-21. Peden AH, Head MW, Ritchie DL, Bell JE, Ironside JW. Preclinical
vCJD after blood transfusion in a PRNP codon 129 heterozygous patient. Lancet
2004 ; 364: 527-9. Wroe SJ, Pal S, Siddique D, Hyare H, Macfarlane R, et al
Clinical presentation and pre-mortem diagnosis of blood transfusion-associated
variant CJD. Lancet 2006;368:2061-67. Hewitt PE, Llewelyn CA, Mackenzie J, Will
RG. Creutzfeldt-Jakob disease and blood transfusion: results of the UK
Transfusion Medicine Epidemiology review study. Vox Sang. 2006;91(3):221-230.
Department of Health [London]. Further precautions to protect blood supply.
Press release 2004/0104, 16 March 2004. </div>
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<div>
(<a href="http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4076608&chk=MTwE%2Bl">http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4076608&chk=MTwE%2Bl</a>)</div>
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<a href="http://www.eurosurveillance.org/ew/2007/070118.asp#4">http://www.eurosurveillance.org/ew/2007/070118.asp#4</a>
</div>
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</div>
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</div>
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<div>
HPA Press Statement</div>
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</div>
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<div>
18 January 2007</div>
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</div>
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<div>
4th case of variant CJD infection associated with blood transfusion</div>
<br />
<div>
</div>
<br />
<br />
<div>
A new case of variant-Creutzfeldt-Jakob disease (vCJD ) associated with a
blood transfusion has recently been diagnosed.</div>
<br />
<br />
<div>
</div>
<br />
<div>
This latest patient has been diagnosed with vCJD about nine years after
receiving a blood transfusion from a donor who later went on to develop vCJD. A
transfusion from the same blood donor was also associated with one of the
previously identified cases. The patient is still alive and is under specialist
care.</div>
<br />
<div>
</div>
<br />
<div>
This fourth case of vCJD infection associated with blood transfusion
increases the concern about the risk of vCJD transmission between humans via
blood transfusion. All four cases relate to the transfusion of blood components:
no cases have been reported relating to treatment with plasma products.</div>
<br />
<div>
</div>
<br />
<div>
The patient is one of a small number (less than 30) of living individuals
who are known to have received a blood transfusion in the UK from a donor who
later developed vCJD. All these individuals have previously been informed of
their potential exposure to vCJD and asked to take certain precautions to reduce
the chance of passing on vCJD to other people via healthcare procedures, such as
surgery.</div>
<br />
<div>
</div>
<br />
<div>
The Health Protection Agency has been in contact with doctors caring for
the other patients who have been exposed to blood transfusions from donors who
later developed vCJD. This is to ensure that they are informed of this new
development and provide access to the latest information and specialist advice
about their risk due to blood transfusion.</div>
<br />
<div>
</div>
<br />
<div>
Professor Peter Borriello, Director of the HPA's Centre for Infections
said, "This new case of vCJD infection increases our concern about the risk to
the small group of people who had blood transfusions from donors who unknowingly
at the time of donation must have had vCJD infection. However, this new case
does not change our understanding of the risk for other people in any specific
way. It does however reinforce the importance of the precautions that have
already been taken to reduce the risk of transmission of vCJD infection by
blood."</div>
<br />
<div>
</div>
<br />
<div>
Dr Angela Robinson, Medical Director of NHS Blood and Transplant said,
"Blood transfusions are often given to save or prolong the life of patients who
are very ill and the benefit of receiving a transfusion when needed must always
be balanced against any possible risk. Nonetheless, our primary concern is the
safety of our patients through maintaining the quality of blood used for medical
treatment. Since 1997, the NBS has introduced a range of precautionary measures
against the risk of vCJD."</div>
<br />
<div>
</div>
<br />
<div>
vCJD is a rare disease, and less than 2% of the vCJD cases reported to date
in the UK have been associated with blood transfusion.</div>
<br />
<div>
</div>
<br />
<div>
Notes to Editors:</div>
<br />
<div>
</div>
<br />
<div>
To date, there have been 66 people identified in the UK who have received
vCJD implicated blood transfusions. The transfusions received by these 66
individuals were donated by eighteen different donors who were diagnosed with
vCJD after their blood donation. Of these 66 people, 40 have died of illnesses
other than vCJD, including one patient who was found to have evidence of vCJD in
parts of their body after their death. Including the new (4th) case, 3 of these
people who have received vCJD implicated blood transfusions have developed
symptoms of vCJD. There are 23 people who have received vCJD implicated blood
transfusions who are alive and have not been diagnosed with vCJD.</div>
<br />
<div>
</div>
<br />
<div>
The identification of cases of variant-CJD associated with blood
transfusion has depended on the Transfusion Medicine Epidemiology Review, a
collaborative study between the National Blood Services, the National CJD
Surveillance Unit and the Office of National Statistics. For further information
about this study see Hewitt et al Creutzfeldt-Jakob disease and blood
transfusion: results of the UK Transfusion Epidemiology Review study. Vox
Sanguinis 2006 91:221-230.</div>
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<div>
</div>
<br />
<div>
'Blood Transfusion' means transfusion with labile blood components (e.g.
red cells, platelets, fresh frozen plasma). This latest case (and the previous
three referred to) relate to transfusion of blood components and not treatment
with plasma products (i.e. products that are manufactured from plasma). To date,
no case of vCJD has been associated with treatment with plasma-products (e.g.
clotting factors used to treat individuals with bleeding disorders such as
haemophilia).</div>
<br />
<div>
</div>
<br />
<div>
This fourth case has been classified by the National CJD Surveillance Unit
( www.cjd.ed.ac.uk ) as a 'probable' case of vCJD. Of the 158 vCJD cases that
have died (data to 5 Jan 2007), all 112 that have undergone post-mortem (46 have
not) have been 'confirmed' by neuropathological examination (examination of
brain tissue).</div>
<br />
<div>
</div>
<br />
<div>
The first clinical case of vCJD associated with transfusion was identified
in December 2003. A case of vCJD 'infection' associated with transfusion was
identified a few months later. The patient had no symptoms but evidence of
infection (abnormal prion proteins) was identified in a post mortem
investigation. The individual died from causes unrelated to vCJD.</div>
<br />
<div>
</div>
<br />
<div>
Following the first case of vCJD associated with a blood transfusion in
2003, the Department of Health asked all recipients of blood transfusions not to
donate blood as a precautionary measure to protect the blood supply from
vCJD.</div>
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<div>
</div>
<br />
<div>
Patients who are informed that they are considered to be 'at risk' of vCJD
for public health purposes are asked to take the following precautions to reduce
the chance of passing on vCJD to other people: Not to donate blood, tissues or
organs and To inform their healthcare providers of their 'at-risk' status so
that special procedures may be arranged for certain instruments used in their
healthcare (NB. Their GPs are also asked to do this.)</div>
<br />
<div>
</div>
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<div>
A range of measures have been put in place by the Department of Health to
minimise the possible risk of vCJD being passed through blood:</div>
<br />
<div>
</div>
<br />
<div>
Since 1997 all cases of vCJD that are reported to the National CJD
Surveillance Unit and diagnosed as having 'probable' vCJD, result in a searc h
of the UK Blood Services blood donor records. If the patient has donated blood,
any unused parts of that blood are immediately removed from stock. The fate of
all used components of blood from the donor is traced, and surviving recipients
informed of their risk. In July 1998, the Department of Health announced that
plasma for the manufacture of blood products, such as clotting factors, would be
obtained from non-UK sources. Since October 1999, white blood cells (which may
carry the greatest risk of transmitting vCJD) have been removed from all blood
used for transfusion. In August 2002 the Department of Health announced that
fresh frozen plasma for treating babies and young children born after 1 January
1996 would be obtained from the USA, extended to all children under 16 years of
age (Summer 2005). In December 2002, the Department of Health completed its
purchase of the largest remaining independent US plasma collector, Life
Resources Incorporated. This secures long-term supplies of non-UK blood plasma
for the benefit of NHS patients. Since April 2004, blood donations have not been
accepted from people who have themselves received a blood transfusion in the UK
since 1980. This has been extended to include apheresis donors and donors who
are unsure if they had previously had a blood transfusion (August 2004). Since
late 2005, blood donations have not been accepted from donors whose blood was
transfused to patients who later developed vCJD. The UK Blood Services continue
to promote the appropriate use of blood and tissues and alternatives throughout
the NHS.</div>
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<div>
</div>
<br />
<div>
The likelihood of a person who may be infected with vCJD going onto develop
symptoms of the disease is uncertain, and may depend on individual
susceptibility. It is possible that infected individuals may never develop
symptoms.</div>
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<div>
</div>
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<div>
For further information contact the HPA press office on 0208 327
7098/7097/6055</div>
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<div>
</div>
<br />
<div>
Specialist care for vCJD is available from The NHS National Prion Clinic,
based at The Hospital for Neurology and Neurosurgery, Queen Square, London <a href="http://www.nationalprionclinic.org/">http://www.nationalprionclinic.org/</a></div>
<br />
<div>
</div>
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<div>
The National CJD Surveillance Unit is based at the Western General Hospital
Edinburgh: www.cjd.ed.ac.uk</div>
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<div>
</div>
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<div>
For further information about vCJD go to: </div>
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<div>
</div>
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<div>
</div>
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<div>
<a href="http://www.hpa.org.uk/infections/topics_az/cjd/menu.htm">http://www.hpa.org.uk/infections/topics_az/cjd/menu.htm</a>
<a href="http://www.dh.gov.uk/PolicyAndGuidan...pics/CJD/fs/en">http://www.dh.gov.uk/PolicyAndGuidan...pics/CJD/fs/en</a>
</div>
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</div>
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</div>
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<div>
<a href="http://www.blood.co.uk/">http://www.blood.co.uk/</a> <a href="http://www.cjd.ed.ac.uk/">http://www.cjd.ed.ac.uk</a> <a href="http://www.nationalprionclinic.org/">http://www.nationalprionclinic.org/</a></div>
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<div>
</div>
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<div>
<a href="http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/070118_vCJD.htm">http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/070118_vCJD.htm</a>
</div>
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</div>
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</div>
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</div>
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<div>
<a href="http://vcjdtransfusion.blogspot.com/2007/01/fourth-case-of-transfusion-associated.html">http://vcjdtransfusion.blogspot.com/2007/01/fourth-case-of-transfusion-associated.html</a>
</div>
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<div>
Thursday, February 14, 2013 </div>
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</div>
<br />
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</div>
<br />
<div>
Unique Properties of the Classical Bovine Spongiform Encephalopathy Strain
and Its Emergence From H-Type Bovine Spongiform Encephalopathy Substantiated by
VM Transmission Studies </div>
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</div>
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please see ;</div>
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>>> Fourth, PrPSc was consistently detected in the spleen, similar
to mice infected with BSE-C.</div>
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Thursday, February 14, 2013 </div>
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</div>
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</div>
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</div>
<br />
<div>
Unique Properties of the Classical Bovine Spongiform Encephalopathy Strain
and Its Emergence From H-Type Bovine Spongiform Encephalopathy Substantiated by
VM Transmission Studies </div>
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<div>
</div>
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<div>
</div>
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<a href="http://bse-atypical.blogspot.com/2013/02/unique-properties-of-classical-bovine.html">http://bse-atypical.blogspot.com/2013/02/unique-properties-of-classical-bovine.html</a>
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see latest nvCJD USA blood recalls;</div>
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<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&w=02272013">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&source=govdelivery&w=02272013</a>
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<div>
Thursday, February 14, 2013 </div>
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</div>
<br />
<div>
The Many Faces of Mad Cow Disease Bovine Spongiform Encephalopathy BSE and
TSE prion disease </div>
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</div>
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</div>
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<div>
<a href="http://bse-atypical.blogspot.com/2013/02/the-many-faces-of-mad-cow-disease.html">http://bse-atypical.blogspot.com/2013/02/the-many-faces-of-mad-cow-disease.html</a>
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Thursday, February 21, 2013 </div>
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</div>
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<div>
National Prion Disease Pathology Surveillance Center Cases Examined January
16, 2013 </div>
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</div>
<br />
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</div>
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<a href="http://prionunitusaupdate2008.blogspot.com/2013/02/national-prion-disease-pathology.html">http://prionunitusaupdate2008.blogspot.com/2013/02/national-prion-disease-pathology.html</a>
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16 YEAR OLD SPORADIC FFI ?</div>
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Monday, January 14, 2013 </div>
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</div>
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<div>
Gambetti et al USA Prion Unit change another highly suspect USA mad cow
victim to another fake name i.e. sporadic FFI at age 16 CJD Foundation goes
along with this BSe </div>
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</div>
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</div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2013/01/gambetti-et-al-usa-prion-unit-change.html">http://transmissiblespongiformencephalopathy.blogspot.com/2013/01/gambetti-et-al-usa-prion-unit-change.html</a>
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Sunday, February 10, 2013 </div>
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<div>
Creutzfeldt-Jakob disease (CJD) biannual update (February 2013) Infection
report/CJD </div>
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<div>
</div>
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<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2013/02/creutzfeldt-jakob-disease-cjd-biannual.html">http://creutzfeldt-jakob-disease.blogspot.com/2013/02/creutzfeldt-jakob-disease-cjd-biannual.html</a>
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</div>
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<div>
Thursday, January 17, 2013 </div>
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<div>
</div>
<br />
<div>
TSE guidance, surgical, dental, blood risk factors, Part 4 Infection
control of CJD, vCJD and other human prion diseases in healthcare and community
settings (updated January 2013) </div>
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<div>
</div>
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<div>
</div>
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<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2013/01/tse-guidance-surgical-dental-blood-risk.html">http://transmissiblespongiformencephalopathy.blogspot.com/2013/01/tse-guidance-surgical-dental-blood-risk.html</a>
</div>
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</div>
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</div>
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<div>
Tuesday, July 31, 2012 </div>
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</div>
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<div>
11 patients may have been exposed to fatal disease Creutzfeldt-Jakob
Disease CJD Greenville Memorial Hospital </div>
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</div>
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<div>
</div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/07/11-patients-may-have-been-exposed-to.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/07/11-patients-may-have-been-exposed-to.html</a>
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</div>
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<div>
Thursday, August 02, 2012 </div>
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</div>
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<div>
CJD case in Saint John prompts letter to patients Canada CJD case in Saint
John prompts letter to patients </div>
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<div>
</div>
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<div>
</div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/08/cjd-case-in-saint-john-prompts-letter.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/08/cjd-case-in-saint-john-prompts-letter.html</a>
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</div>
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<div>
Friday, February 10, 2012 </div>
<br />
<div>
</div>
<br />
<div>
Creutzfeldt-Jakob disease (CJD) biannual update (2012/1) potential
iatrogenic (healthcare-acquired) exposure to CJD, and on the National Anonymous
Tonsil Archive </div>
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<div>
</div>
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<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/02/creutzfeldt-jakob-disease-cjd-biannual.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/02/creutzfeldt-jakob-disease-cjd-biannual.html</a>
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<div>
Monday, November 26, 2012 </div>
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</div>
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<div>
Aerosol Transmission of Chronic Wasting Disease in White-tailed Deer </div>
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</div>
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</div>
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<div>
<a href="http://chronic-wasting-disease.blogspot.com/2012/11/aerosol-transmission-of-chronic-wasting.html">http://chronic-wasting-disease.blogspot.com/2012/11/aerosol-transmission-of-chronic-wasting.html</a>
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<div>
Thursday, December 29, 2011 </div>
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</div>
<br />
<div>
Aerosols An underestimated vehicle for transmission of prion diseases?
</div>
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</div>
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<div>
PRION <a href="http://www.landesbioscience.com/">www.landesbioscience.com</a> </div>
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</div>
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</div>
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<div>
please see more on Aerosols and TSE prion disease here ; </div>
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</div>
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</div>
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<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/aerosols-underestimated-vehicle-for.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/aerosols-underestimated-vehicle-for.html</a>
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<div>
Saturday, February 12, 2011 </div>
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</div>
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<div>
Another Pathologists dies from CJD, another potential occupational death ?
</div>
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</div>
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<div>
another happenstance of bad luck, a spontaneous event from nothing, or
friendly fire ??? </div>
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</div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/02/another-pathologists-dies-from-cjd.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/02/another-pathologists-dies-from-cjd.html</a>
</div>
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<div>
Tuesday, December 14, 2010 </div>
<br />
<div>
</div>
<br />
<div>
Infection control of CJD, vCJD and other human prion diseases in healthcare
and community settings part 4, Annex A1, Annex J, </div>
<br />
<div>
</div>
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<div>
UPDATE DECEMBER 2010 </div>
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</div>
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</div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/12/infection-control-of-cjd-vcjd-and-other.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/12/infection-control-of-cjd-vcjd-and-other.html</a>
</div>
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</div>
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</div>
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<div>
Tuesday, September 14, 2010 </div>
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<div>
</div>
<br />
<div>
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of
Meeting October 28 and 29, 2010 (COMMENT SUBMISSION) </div>
<br />
<div>
</div>
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<div>
</div>
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<div>
<a href="http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html">http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html</a>
</div>
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</div>
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</div>
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<div>
Thursday, September 02, 2010 </div>
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</div>
<br />
<div>
NEUROSURGERY AND CREUTZFELDT-JAKOB DISEASE Health Law, Ethics, and Human
Rights The Disclosure Dilemma </div>
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<div>
</div>
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<div>
</div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/09/neurosurgery-and-creutzfeldt-jakob.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/09/neurosurgery-and-creutzfeldt-jakob.html</a>
</div>
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</div>
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<div>
Thursday, August 12, 2010 </div>
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<div>
</div>
<br />
<div>
USA Blood products, collected from a donor who was at risk for vCJD, were
distributed July-August 2010 </div>
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<div>
</div>
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<div>
</div>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html</a>
</div>
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</div>
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<div>
Sunday, August 01, 2010 </div>
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<div>
</div>
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<div>
Blood product, collected from a donors possibly at increased risk for vCJD
only, was distributed USA JULY 2010 </div>
<br />
<div>
</div>
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<div>
</div>
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<div>
<a href="http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html">http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html</a>
</div>
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</div>
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<div>
</div>
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<div>
<a href="http://vcjdtransfusion.blogspot.com/">http://vcjdtransfusion.blogspot.com/</a>
</div>
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</div>
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</div>
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<div>
Thursday, July 08, 2010 </div>
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<div>
</div>
<br />
<div>
Nosocomial transmission of sporadic Creutzfeldt–Jakob disease: results from
a risk-based assessment of surgical interventions Public release date:
8-Jul-2010 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/07/nosocomial-transmission-of-sporadic.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/07/nosocomial-transmission-of-sporadic.html</a>
</div>
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</div>
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</div>
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<div>
</div>
<br />
<div>
Thursday, July 08, 2010 </div>
<br />
<div>
</div>
<br />
<div>
GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW 2010 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html</a>
</div>
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</div>
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</div>
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</div>
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<div>
Wednesday, June 02, 2010 </div>
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<div>
</div>
<br />
<div>
CJD Annex H UPDATE AFTER DEATH PRECAUTIONS Published: 2 June 2003 Updated:
May 2010 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/06/cjd-annex-h-update-after-death.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/06/cjd-annex-h-update-after-death.html</a>
</div>
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</div>
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</div>
<br />
<div>
</div>
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<div>
Tuesday, May 11, 2010 </div>
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<div>
</div>
<br />
<div>
Current risk of iatrogenic Creutzfeld–Jakob disease in the UK: efficacy of
available cleaning chemistries and reusability of neurosurgical instruments
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/05/current-risk-of-iatrogenic.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/05/current-risk-of-iatrogenic.html</a>
</div>
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</div>
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</div>
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</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
Tuesday, May 04, 2010 </div>
<br />
<div>
</div>
<br />
<div>
Review of the Human Pituitary Trust Account and CJD Issue 20 January 2010
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/05/review-of-human-pituitary-trust-account.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/05/review-of-human-pituitary-trust-account.html</a>
</div>
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<div>
</div>
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</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, March 16, 2010 </div>
<br />
<div>
</div>
<br />
<div>
Transmissible Spongiform Encephalopathy Agents: Safe Working and the
Prevention of Infection: Part 4 REVISED FEB. 2010 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/03/transmissible-spongiform-encephalopathy.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/03/transmissible-spongiform-encephalopathy.html</a>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, August 17, 2009 </div>
<br />
<div>
</div>
<br />
<div>
Transmissible Spongiform Encephalopathy Agents: Safe Working and the
Prevention of Infection: Annex J,K, AND D Published: 2009 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2009/08/transmissible-spongiform-encephalopathy.html">http://creutzfeldt-jakob-disease.blogspot.com/2009/08/transmissible-spongiform-encephalopathy.html</a>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, July 20, 2009 </div>
<br />
<div>
</div>
<br />
<div>
Pre-surgical risk assessment for variant Creutzfeldt-Jakob disease (vCJD)
risk in neurosurgery and eye surgery units </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://vcjdtransfusion.blogspot.com/2009/07/pre-surgical-risk-assessment-for.html">http://vcjdtransfusion.blogspot.com/2009/07/pre-surgical-risk-assessment-for.html</a>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
Friday, July 17, 2009 </div>
<br />
<div>
</div>
<br />
<div>
Revision to pre-surgical assessment of risk for vCJD in neurosurgery and
eye surgery units Volume 3 No 28; 17 July 2009 </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2009/07/revision-to-pre-surgical-assessment-of.html">http://creutzfeldt-jakob-disease.blogspot.com/2009/07/revision-to-pre-surgical-assessment-of.html</a>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Sunday, May 10, 2009 </div>
<br />
<div>
</div>
<br />
<div>
Meeting of the Transmissible Spongiform Encephalopathies Committee On June
12, 2009 (Singeltary submission) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html">http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html</a>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Thursday, January 29, 2009 </div>
<br />
<div>
</div>
<br />
<div>
Medical Procedures and Risk for Sporadic Creutzfeldt-Jakob Disease, Japan,
1999-2008 (WARNING TO Neurosurgeons and Ophthalmologists) Volume 15, Number
2-February 2009 Research </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2009/01/medical-procedures-and-risk-for.html">http://creutzfeldt-jakob-disease.blogspot.com/2009/01/medical-procedures-and-risk-for.html</a>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Wednesday, August 20, 2008 </div>
<br />
<div>
</div>
<br />
<div>
Tonometer disinfection practice in the United Kingdom: A national survey
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2008/08/tonometer-disinfection-practice-in.html">http://creutzfeldt-jakob-disease.blogspot.com/2008/08/tonometer-disinfection-practice-in.html</a>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Tuesday, August 12, 2008 </div>
<br />
<div>
</div>
<br />
<div>
Biosafety in Microbiological and Biomedical Laboratories Fifth Edition 2007
(occupational exposure to prion diseases) </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2008/08/biosafety-in-microbiological-and.html">http://creutzfeldt-jakob-disease.blogspot.com/2008/08/biosafety-in-microbiological-and.html</a>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Monday, December 31, 2007 </div>
<br />
<div>
</div>
<br />
<div>
Risk Assessment of Transmission of Sporadic Creutzfeldt-Jakob Disease in
Endodontic Practice in Absence of Adequate Prion Inactivation </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2007_12_01_archive.html">http://creutzfeldt-jakob-disease.blogspot.com/2007_12_01_archive.html</a>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Subject: CJD: update for dental staff </div>
<br />
<div>
</div>
<br />
<div>
Date: November 12, 2006 at 3:25 pm PST </div>
<br />
<div>
</div>
<br />
<div>
1: Dent Update. 2006 Oct;33(8):454-6, 458-60. </div>
<br />
<div>
</div>
<br />
<div>
CJD: update for dental staff. </div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
<a href="http://seac992007.blogspot.com/2008/06/seac-2008-one-hundredth-meeting-of.html">http://seac992007.blogspot.com/2008/06/seac-2008-one-hundredth-meeting-of.html</a>
</div>
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<div>
</div>
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<div>
</div>
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<div>
</div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Saturday, January 16, 2010 </div>
<br />
<div>
</div>
<br />
<div>
Evidence For CJD TSE Transmission Via Endoscopes 1-24-3 re-Singeltary to
Bramble et al </div>
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Evidence For CJD/TSE Transmission Via Endoscopes </div>
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From Terry S. Singletary, Sr flounder@wt.net 1-24-3 </div>
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/01/evidence-for-cjd-tse-transmission-via.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/01/evidence-for-cjd-tse-transmission-via.html</a>
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Thursday, October 25, 2012 </div>
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Current limitations about the cleaning of luminal endoscopes and TSE prion
risk factors there from </div>
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Article in Press</div>
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/10/current-limitations-about-cleaning-of.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/10/current-limitations-about-cleaning-of.html</a></div>
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2011 TO 2012 UPDATE </div>
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Saturday, December 3, 2011 </div>
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Candidate Cell Substrates, Vaccine Production, and Transmissible Spongiform
Encephalopathies </div>
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Volume 17, Number 12—December 2011 </div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/candidate-cell-substrates-vaccine.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/candidate-cell-substrates-vaccine.html</a>
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Sunday, June 26, 2011 </div>
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Risk Analysis of Low-Dose Prion Exposures in Cynomolgus Macaque </div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/risk-analysis-of-low-dose-prion.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/risk-analysis-of-low-dose-prion.html</a>
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Monday, February 7, 2011 </div>
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FDA’s Currently-Recommended Policies to Reduce the Possible Risk of
Transmission of CJD and vCJD by Blood and Blood Products 2011 ??? </div>
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<a href="http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html">http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html</a>
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Sunday, August 21, 2011 </div>
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The British disease, or a disease gone global, The TSE Prion Disease (SEE
VIDEO) </div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/british-disease-or-disease-gone-global.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/british-disease-or-disease-gone-global.html</a>
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U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ? (see video at
bottom) </div>
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html">http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html</a>
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Wednesday, April 25, 2012 </div>
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USA MAD COW DISEASE AND CJD THERE FROM SINGELTARY ET AL 1999 – 2012 </div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/usa-mad-cow-disease-and-cjd-there-from.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/usa-mad-cow-disease-and-cjd-there-from.html</a>
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<div>
Terry S. Singeltary Sr. on the Creutzfeldt-Jakob Disease Public Health
Crisis </div>
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<a href="http://www.youtube.com/watch?v=zf3lfz9NrT4">http://www.youtube.com/watch?v=zf3lfz9NrT4</a>
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<a href="http://www.youtube.com/watch?v=c0tWkNvhO4g">http://www.youtube.com/watch?v=c0tWkNvhO4g</a>
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<a href="http://www.youtube.com/watch?v=zf3lfz9NrT4&feature=results_main&playnext=1&list=PL780BE2AF0B62A944">http://www.youtube.com/watch?v=zf3lfz9NrT4&feature=results_main&playnext=1&list=PL780BE2AF0B62A944</a>
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full text with source references ; </div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/terry-singeltary-sr-on-creutzfeldt.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/terry-singeltary-sr-on-creutzfeldt.html</a>
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Tuesday, July 29, 2008 </div>
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Heidenhain Variant Creutzfeldt Jakob Disease Case Report </div>
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FINAL AUTOPSY DIAGNOSIS </div>
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I. Brain: Creutzfeldt-Jakob disease, Heidenhain variant. </div>
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SKROLL down a bit for Mom's autopsy of hvCJD. ... </div>
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2008/07/heidenhain-variant-creutzfeldt-jakob.html">http://creutzfeldt-jakob-disease.blogspot.com/2008/07/heidenhain-variant-creutzfeldt-jakob.html</a>
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TSS</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-69914317541491319052012-09-19T10:44:00.001-07:002012-09-19T10:44:31.611-07:00Prion reduction of red-blood-cells<div>
INTERNATIONAL FORUM</div>
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Prion reduction of red-blood-cells</div>
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J. Coste, C. Prowse, C. Grabmer, H. Schennach, P. Santos Prado Scuracchio,
S. N. Wendel, M. Germain, G. Delage, T. Krusius, S. Ekblom-Kullberg, P.
Tiberghien, J. O’Riordan, W. G. Murphy, Ø. Flesland, M. Turner, L. Williamson,
L. Gregori, J. Epstein, D. Asher, S. Panzer, H. W. Reesink</div>
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Article first published online: 20 APR 2012 </div>
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DOI: 10.1111/j.1423-0410.2012.01597.x </div>
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© 2012 The Author(s). Vox Sanguinis </div>
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© 2012 International Society of Blood Transfusion </div>
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J. Coste, C. Prowse, C. Grabmer, H. Schennach, P. Santos Prado Scuracchio,
S. N. Wendel, M, Germain, G. Delage, T. Krusius, S. Ekblom-Kullberg. P,
Tiberghien, J. O'Riordan, W. G, Murphy, Ø. Flesland, M. Turner, L Williamson, L
Gregori, J. Epstein, D. Asher, S. Panzer, H. W. Reesink </div>
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First page of article </div>
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It is now very likely that the infectious agent responsible for variant
Creutzfeldt-Jakob disease (vCJD), a fatal disease of the brain, can he passed
from person to person through blood transfusion and that this infectious agent
is present in the blood or affected individuals long before clinical signs of
the disease become apparent. This has led to major concerns that a pool of such
infectious, symptomless indi- viduals could exist and that some of these could
be rou- tinely donating blood leading to further cases or transfusion-related
person-to-person disease transmission. In the UK to date, four instances of
probable transmission of vCJD by blood transfusion have been identified by the
UK Transfusion Medicine Epidemiology Review (TMER), including three clinical
cases of vCJD and one sub- or pre- clinical infection. Recently, a fifth case of
vCJD has been identified with a history of blood transfusion in infancy. The
donors who provided the components transfused could not be identified, but a
blood donor known to have donated blood to another individual who subsequently
developed vCJD could have been a donor to the index case [1]. In February 2009.
it was announced that PrPTSE infection was found in the spleen or a 74-year-old
neurological asymp- tomatic patient with haemophilia, who had received units of
FVIII concentrate prepared from plasma pools known to include donations from a
vCJD donor. He had also received 14 units of red cell concentrates (RCCs) [2].
One method of preventing transfusion-related disease transmission would be
routinely screening all blood donations for the presence of the infectious
agent. Several techniques aim to detect PrPTSE in blood, but none have reached
the licensing stage for human use. However, recently, Edgeworth el al. [3]
reported a new test to identify vCJD-infected blood. The assay was applied on a
coded panel of blood samples. The only samples that were reactive were from
patients in clini- cal stage of vCJD. But work is still needed to develop the
assay into a screening assay with sufficient sensitivity to detect the
presumably lower concentrations that are expected to be present in blood of
asymptomatic carriers. A different approach is to reduce prion infectivity from
blood and blood components. At present, three companies have developed filters
to remove infectious prions from </div>
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260 </div>
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RCCs. The MacoPharma P-Capt Prion Capture, which can be connected to any
leucoreduced RCC, is 3 prion-specific filter incorporating PRDT patented ligand
technology for the selective adsorption of prions. The P-Capt Filter was CE
marked in September 2006. lndependent UK evaluations have been performed in
terms of operational use, of quality of filtered components and whether
filtration resulted in any changes to blood group antigens [4]. Pall Corporation
has CE marked in 2009 a Leukotrap Affinity Prion Reduc- tion Filter System that
concurrently reduces leucocytes and infectious prions [5]. Moreover,
Asahi/Fenwal and Pall Corporation have developed a New Combination Filter for
Prion and Leukoreduction. These filters are not CE marked yet. Finally,
manufacturers of pooled plasma and plasma products have been introducing
specific steps to remove infectious prion agents from their products [6]. </div>
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Such a prion removal method may be implemented in some countries on RCCs in
the near future, It seemed. there- fore, of interest to collect information by
sending the fol- lowing quesuons to expert in the field. </div>
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Question 1 </div>
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Is it likely that a prion removal filter of RCCs will be imple- mented in
your country/centre? </div>
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(a) If so, will it concern all RCC or RCCs for only certain groups of
patients </div>
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(b) How many filtered RCCs have been transfused and what was the
experience? </div>
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(c) Have you noticed any untoward reactions or effects that were going to
the filtration process? </div>
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(d) If the product is less potent (e.g. less haemoglobin con- tent) as a
result of processing is this of any concern </div>
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Question 2 </div>
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<div>
If a prion removal device of RCCs will probably not be implemented in your
country/centre. what ale the reasons for this decision? </div>
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</div>
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(a) Are there still doubts about the efficacy and the safety </div>
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(b) Is it an economic question? </div>
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(c) Is it because no vCJD cases have been notified in your country? </div>
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</div>
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<div>
<a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1423-0410.2012.01597.x/abstract">http://onlinelibrary.wiley.com/doi/10.1111/j.1423-0410.2012.01597.x/abstract</a>
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Wednesday, September 12, 2012 </div>
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</div>
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<div>
Blood test closer for mad cow disease, Alzheimers and Parkinson's</div>
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<a href="http://madcowtesting.blogspot.com/2012/09/blood-test-closer-for-mad-cow-disease.html">http://madcowtesting.blogspot.com/2012/09/blood-test-closer-for-mad-cow-disease.html</a>
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Monday, August 13, 2012 </div>
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</div>
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<div>
Summary results of the second national survey of abnormal prion prevalence
in archived appendix specimens August 2012 </div>
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</div>
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/08/summary-results-of-second-national.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/08/summary-results-of-second-national.html</a>
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Thursday, August 16, 2012</div>
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</div>
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<div>
Blood products, collected from a donor who was at risk for variant
Creutzfeldt-Jakob disease ( vCJD) USA JUNE, JULY, AUGUST 2012 </div>
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</div>
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<div>
<a href="http://vcjdtransfusion.blogspot.com/2012/08/blood-products-collected-from-donor-who.html">http://vcjdtransfusion.blogspot.com/2012/08/blood-products-collected-from-donor-who.html</a>
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</div>
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Monday, June 11, 2012 </div>
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</div>
<br />
<div>
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products” </div>
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<div>
</div>
<br />
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html</a>
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Friday, June 29, 2012</div>
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</div>
<br />
<div>
Highly Efficient Prion Transmission by Blood Transfusion </div>
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</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html</a>
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Sunday, June 3, 2012 </div>
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</div>
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<div>
A new neurological disease in primates inoculated with prion-infected blood
or blood components </div>
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</div>
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<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html</a>
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Monday, July 23, 2012 </div>
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</div>
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<div>
The National Prion Disease Pathology Surveillance Center July 2012 </div>
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</div>
<br />
<div>
<a href="http://prionunitusaupdate2008.blogspot.com/2012/07/the-national-prion-disease-pathology.html">http://prionunitusaupdate2008.blogspot.com/2012/07/the-national-prion-disease-pathology.html</a>
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<a href="http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html">http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html</a>
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<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/">http://creutzfeldt-jakob-disease.blogspot.com/</a></div>
<br />
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<div>
<a href="http://madcowusda.blogspot.com/"><span style="font-family: Times New Roman;">http://madcowusda.blogspot.com/</span></a></div>
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</div>
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</div>
<br />
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/">http://transmissiblespongiformencephalopathy.blogspot.com/</a>
</div>
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</div>
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</div>
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</div>
<br />
<div>
TSS</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-32692896887911264912012-09-06T08:09:00.001-07:002012-09-06T08:09:25.032-07:00HANSARD, vCJD, blood, FFP, 5 Sep 2012 : Column 353W SaBTO<div>
HANSARD, vCJD, blood, FFP, 5 Sep 2012 : Column 353W SaBTO</div>
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5 Sep 2012 : Column 353W </div>
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Health Blood: Contamination Sir Paul Beresford: To ask the Secretary of
State for Health (1) pursuant to the answer of 14 May 2012, Official Report,
column 26W, on blood: contamination; for what reason the Advisory Committee on
the Safety of Blood, Tissues and Organs, reversed its 2009 recommendation on the
importation of Fresh Frozen Plasma although the risk of transmitted variant
Creutzfeldt-Jacob Disease by blood remains unchanged; and if he will make a
statement; [119254]</div>
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(2) with reference to the minutes of the Advisory Committee on the Safety
of Blood, Tissues and Organs meeting of 9 March 2012, to what extent
cost-effectiveness is used to inform Government policy on public health safety
measures on (a) blood safety and (b) variant Creutzfeldt-Jacob Disease;
[119255]</div>
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(3) if he will publish the data his Department used to inform its decision
to accept the recommendation of the Advisory Committee on the Safety of Blood,
Tissues and Organs on Fresh Frozen Plasma of 9 March 2012; and if he will make a
statement; [119256]</div>
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5 Sep 2012 : Column 362W</div>
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(4) for what reason the data his Department used to inform its decision on
the importation of fresh frozen plasma is not publicly available; [119257]</div>
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(5) what the names are of the companies his Department and its relevant
committees approached to (a) inform their thinking on extending importation of
fresh frozen plasma and (b) estimate the cost of extending importation of fresh
frozen plasma; and when each company was approached. [119258]</div>
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Dr Poulter: On making the March 2012 decision on the importation of fresh
frozen plasma, the independent scientific Advisory Committee on the Safety of
Blood, Tissues and Organs (SaBTO) considered all the available evidence
including safety, efficacy and cost-effectiveness. SaBTO concluded that there
should be no extension of the importation of fresh frozen plasma (FFP) to
patients beyond those for whom it is already recommended (high-usage adult
patients, and those aged 16 and under (i.e. born since 1996), who are unlikely
to have been exposed to BSE through diet). SaBTO's terms of reference require
consideration of cost-effectiveness evidence when making recommendations. A key
consideration is the number of potential future clinical vCJD cases that might
be caused by transfusion of FFP in the absence of any extension to importation.
Given the continuing scientific uncertainties, a precautionary approach remains
justified, and a wide range of scenarios have been considered. Nevertheless, the
continuing absence to date of any known clinical cases attributable to FFP
transfusion restricts the range of future possibilities, and the
cost-effectiveness calculations used by SaBTO reflect this point.</div>
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Information used by SaBTO in making their recommendation is publicly
available, redacted in accordance with freedom of information principles, at:
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<a href="http://www.transparency.dh.gov.uk/2012/04/24/sabto-9-march-2012/">http://www.transparency.dh.gov.uk/2012/04/24/sabto-9-march-2012/</a>
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A copy has also been placed in the Library.</div>
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Details that could provide commercial information are not included for
reasons of commercial confidentiality. </div>
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<a href="http://www.publications.parliament.uk/pa/cm201213/cmhansrd/cm120905/text/120905w0002.htm#12090538000011">http://www.publications.parliament.uk/pa/cm201213/cmhansrd/cm120905/text/120905w0002.htm#12090538000011</a>
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Friday, May 11, 2012</div>
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</div>
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<div>
ProMetic Life Sciences Inc.: P-Capt® Filtration Prevents Transmission of
Endogenous Blood-Borne Infectivity in Primates </div>
<br />
<div>
</div>
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<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/05/prometic-life-sciences-inc-p-capt.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/05/prometic-life-sciences-inc-p-capt.html</a>
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Wednesday, May 9, 2012</div>
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Detection of Prion Protein Particles in Blood Plasma of Scrapie Infected
Sheep</div>
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</div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/05/detection-of-prion-protein-particles-in.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/05/detection-of-prion-protein-particles-in.html</a>
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Wednesday, February 1, 2012 </div>
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CJD and PLASMA / URINE PRODUCTS EMA Position Statements Alberto Ganan
Jimenez, European Medicines Agency PDA TSE Safety Forum, 30 June 2011 </div>
<br />
<div>
</div>
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<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/02/cjd-and-plasma-urine-products-ema.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/02/cjd-and-plasma-urine-products-ema.html</a>
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<div>
ENFORCEMENT REPORT</div>
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Enforcement Report - Week of August 29, 2012 </div>
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<div>
Class II, Blood products, collected from a donor who was at risk for
variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Belle Bonfils
Memorial Blood ...</div>
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<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08292012">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=Expand+Index&w=08292012</a>
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Thursday, August 16, 2012</div>
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Blood products, collected from a donor who was at risk for variant
Creutzfeldt-Jakob disease ( vCJD) USA JUNE, JULY, AUGUST 2012 </div>
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</div>
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<a href="http://vcjdtransfusion.blogspot.com/2012/08/blood-products-collected-from-donor-who.html">http://vcjdtransfusion.blogspot.com/2012/08/blood-products-collected-from-donor-who.html</a>
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Sunday, June 3, 2012</div>
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A new neurological disease in primates inoculated with prion-infected blood
or blood components </div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html</a>
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Friday, June 29, 2012</div>
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Highly Efficient Prion Transmission by Blood Transfusion</div>
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</div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html</a>
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Thursday, August 16, 2012</div>
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</div>
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Blood products, collected from a donor who was at risk for variant
Creutzfeldt-Jakob disease ( vCJD) USA JUNE, JULY, AUGUST 2012 </div>
<br />
<div>
</div>
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<div>
<a href="http://vcjdtransfusion.blogspot.com/2012/08/blood-products-collected-from-donor-who.html">http://vcjdtransfusion.blogspot.com/2012/08/blood-products-collected-from-donor-who.html</a>
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<div>
price of prion poker goes up again $$$ </div>
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Monday, June 11, 2012 </div>
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<div>
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products”</div>
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</div>
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html</a>
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Saturday, August 18, 2012 </div>
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RedCross Request Jerome H. Holland Laboratory is collecting small volumes
of blood from patients afflicted with various forms of transmissible spongiform
encephalopathies (TSE)/prion diseases and their blood-related family members
2012</div>
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</div>
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/08/redcross-request-jerome-h-holland.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/08/redcross-request-jerome-h-holland.html</a>
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Monday, August 13, 2012 </div>
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Summary results of the second national survey of abnormal prion prevalence
in archived appendix specimens August 2012 </div>
<br />
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</div>
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/08/summary-results-of-second-national.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/08/summary-results-of-second-national.html</a>
</div>
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Friday, August 24, 2012 </div>
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<div>
Iatrogenic prion diseases in humans: an update </div>
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</div>
<br />
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/iatrogenic-prion-diseases-in-humans.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/iatrogenic-prion-diseases-in-humans.html</a>
</div>
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TSS</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-60176771881288397992012-08-16T10:32:00.001-07:002012-08-16T10:44:00.264-07:00Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease ( vCJD) USA JUNE, JULY, AUGUST 2012<div>
Blood products, collected from a donor who was at risk for variant
Creutzfeldt-Jakob disease ( vCJD) USA JUNE, JULY, AUGUST 2012</div>
<div>
</div>
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</div>
<div>
</div>
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</div>
<div>
Enforcement Report for June 13, 2012 <br />
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</div>
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</div>
<div>
PRODUCT</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1583-12;<br />
<br />
</div>
<div>
</div>
<div>
2) Red Blood Cells Leukocytes Reduced. Recall # B-1584-12;<br />
<br />
</div>
<div>
</div>
<div>
3) Cryoprecipitated AHF. Recall # B-1585-12;<br />
<br />
</div>
<div>
</div>
<div>
4) Cryoprecipitated AHF, Pooled. Recall # B-1586-12;<br />
<br />
</div>
<div>
</div>
<div>
5) Plasma Cryoprecipitated Reduced. Recall # B-1587-12<br />
<br />
</div>
<div>
</div>
<div>
6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall #
B-1588-12;<br />
<br />
</div>
<div>
</div>
<div>
7) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall #
B-1589-12;<br />
<br />
</div>
<div>
</div>
<div>
8) Fresh Frozen Plasma. Recall # B-1590-12;<br />
<br />
</div>
<div>
</div>
<div>
9) Recovered Plasma. Recall # B-1591-12<br />
<br />
</div>
<div>
</div>
<div>
CODE</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
1) Units: 1697475; 1652549; 1677134;<br />
<br />
</div>
<div>
</div>
<div>
2) Units: 1683520; 1646887; 1608557; 1192475; 0952938; 0940117; 0920215;
0872595;</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
3) Unit: 1683520;<br />
<br />
</div>
<div>
</div>
<div>
4) Units: 1646887; 1677134; 1608557;<br />
<br />
</div>
<div>
</div>
<div>
5) Units: 1652549; 1646887;<br />
<br />
</div>
<div>
</div>
<div>
6) Units: 1153405; 1138376; 1060176; 1005776; 1013230; 0955842;<br />
<br />
</div>
<div>
</div>
<div>
7) Unit: 1104684;</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
8) Units: 1192475; 0952938; 0940117;<br />
<br />
</div>
<div>
</div>
<div>
9) Units: 1697475; 1683520; 1677134; 1608557; 0920215; 0872595<br />
<br />
</div>
<div>
</div>
<div>
RECALLING FIRM/MANUFACTURER<br />
<br />
</div>
<div>
</div>
<div>
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati,
OH, by telephone and letters dated October 19, 2006. Firm initiated recall is
complete.<br />
<br />
</div>
<div>
</div>
<div>
REASON</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Blood products, collected from a donor who was at risk for variant
Creutzfeldt-Jakob disease (vCJD), were distributed.</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
VOLUME OF PRODUCT IN COMMERCE<br />
<br />
</div>
<div>
</div>
<div>
33 units<br />
<br />
</div>
<div>
</div>
<div>
DISTRIBUTION<br />
<br />
</div>
<div>
</div>
<div>
KY, OH<br />
<br />
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
___________________________________ </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
PRODUCT<br />
<br />
</div>
<div>
</div>
<div>
1) Recovered Plasma. Recall # B-1471-12;<br />
<br />
</div>
<div>
</div>
<div>
2) Red Blood Cells Leukocytes Reduced. Recall # B-1472-12<br />
<br />
</div>
<div>
</div>
<div>
CODE<br />
<br />
</div>
<div>
</div>
<div>
1) and 2) Unit: 0886922<br />
<br />
</div>
<div>
</div>
<div>
RECALLING FIRM/MANUFACTURER<br />
<br />
</div>
<div>
</div>
<div>
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by
telephone and e-mail on October 5, 2005.<br />
<br />
</div>
<div>
</div>
<div>
Manufacturer: Blood Centers of the Pacific, Redding, CA. Firm initiated
recall is complete.<br />
<br />
</div>
<div>
</div>
<div>
REASON<br />
<br />
</div>
<div>
</div>
<div>
Blood products, collected from a donor considered to be at increased risk
for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br />
<br />
</div>
<div>
</div>
<div>
VOLUME OF PRODUCT IN COMMERCE<br />
<br />
</div>
<div>
</div>
<div>
2 units</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
DISTRIBUTION</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
CA and Switzerland <br />
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
___________________________________ </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
PRODUCT</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Fresh Frozen Plasma. Recall # B-1562-12</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
CODE<br />
</div>
<div>
</div>
<div>
Unit: 42S18958</div>
<div>
</div>
<div>
</div>
<div>
RECALLING FIRM/MANUFACTURER</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
The American National Red Cross, Cleveland, OH, by telephone on July 11,
2007 and by letter dated July 19, 2007. Firm initiated recall is complete.<br />
<br />
</div>
<div>
</div>
<div>
REASON Blood product, collected from a donor who was at risk for variant
Creutzfeldt-Jakob Disease (vCJD), was distributed.</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
VOLUME OF PRODUCT IN COMMERCE<br />
<br />
</div>
<div>
</div>
<div>
1 unit</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
DISTRIBUTION<br />
</div>
<div>
</div>
<div>
OH </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
___________________________________ </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm308307.htm">http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm308307.htm</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Enforcement Report for June 6, 2012 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
PRODUCT<br />
<br />
</div>
<div>
</div>
<div>
Recovered Plasma. Recall # B-1477-12</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
CODE<br />
<br />
</div>
<div>
</div>
<div>
Unit: W088411552400<br />
<br />
</div>
<div>
</div>
<div>
RECALLING FIRM/MANUFACTURER<br />
<br />
</div>
<div>
</div>
<div>
Blood Bank Of Hawaii, Honolulu, HI, by e-mail on March 13, 2012. Firm
initiated recall is complete.</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
REASON Blood product, collected from a donor considered to be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.<br />
<br />
</div>
<div>
</div>
<div>
VOLUME OF PRODUCT IN COMMERCE<br />
<br />
</div>
<div>
</div>
<div>
1 unit<br />
<br />
</div>
<div>
</div>
<div>
DISTRIBUTION<br />
</div>
<div>
</div>
<div>
Austria </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
___________________________________ </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm307229.htm">http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm307229.htm</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Enforcement Report - Week of July 25, 2012 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Event Detail<br />
<br />
</div>
<div>
</div>
<div>
Event ID 47718 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Product Type Biologics <br />
<br />
</div>
<div>
</div>
<div>
Status Terminated </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Recalling Firm Coral Blood Services, Inc. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
City Scarborough <br />
<br />
</div>
<div>
</div>
<div>
State ME </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Country US </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Voluntary/Mandated Voluntary: Firm Initiated <br />
<br />
</div>
<div>
</div>
<div>
Recall Initiation Date 2008-03-11 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Initial Firm Notification of <br />
<br />
</div>
<div>
</div>
<div>
Consignee or Public Letter </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Distribution Pattern ME <br />
<br />
</div>
<div>
</div>
<div>
Product Detail<br />
</div>
<div>
</div>
<div>
Product Description Code Info Classification Reason for Recall Product
Quantity Recall Number </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Red Blood Cells (Apheresis) Leukocytes Reduced 7795181 Class II Blood
products, collected from a donor who was at risk for variant Creutzfeldt-Jakob
disease (vCJD), were distributed. 1 unit B-1428-12 <br />
<br />
</div>
<div>
</div>
<div>
Fresh Frozen Plasma 7795181 Class II Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
1 unit B-1429-12 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=47718&w=07252012&">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=47718&w=07252012&</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Enforcement Report - Week of July 5, 2012 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Event Detail</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Event ID 61992 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Product Type Biologics <br />
<br />
</div>
<div>
</div>
<div>
Status Terminated <br />
<br />
</div>
<div>
</div>
<div>
Recalling Firm Blood Assurance Inc <br />
<br />
</div>
<div>
</div>
<div>
City Chattanooga <br />
<br />
</div>
<div>
</div>
<div>
State TN <br />
<br />
</div>
<div>
</div>
<div>
Country US </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Voluntary/Mandated Voluntary: Firm Initiated <br />
<br />
</div>
<div>
</div>
<div>
Recall Initiation Date 2012-05-01 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Initial Firm Notification of <br />
<br />
</div>
<div>
</div>
<div>
Consignee or Public FAX <br />
<br />
</div>
<div>
</div>
<div>
Distribution Pattern TN, GA, NY <br />
<br />
</div>
<div>
</div>
<div>
Product Detail</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Product Description Code Info Classification Reason for Recall Product
Quantity Recall Number </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Plasma Cryoprecipitated Reduced W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2009-12 <br />
<br />
</div>
<div>
</div>
<div>
Red Blood Cells (Apheresis) Leukocytes Reduced W043211094961-A;
W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B;
W043211025338-B Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 6 units
B-2010-12 <br />
<br />
</div>
<div>
</div>
<div>
Cryoprecipitated AHF, Pooled W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2011-12 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Red Blood Cells Leukocytes Reduced V89413; V26698; W043210088572;
W043210075817 Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 4 units
B-2012-12 <br />
<br />
</div>
<div>
</div>
<div>
Plasma Frozen within 24 hours (FP24) W043210075817 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2013-12 <br />
<br />
</div>
<div>
</div>
<div>
Blood and Blood Products for Reprocessing V89413 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2014-12 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Fresh Frozen Plasma V26698 Class II Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
1 unit B-2015-12 <br />
<br />
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=61992&w=07052012&">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=61992&w=07052012&</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Enforcement Report - Week of August 15, 2012</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Event Detail</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Event ID 61992 <br />
<br />
</div>
<div>
</div>
<div>
Product Type Biologics </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Status Terminated <br />
<br />
</div>
<div>
</div>
<div>
Recalling Firm Blood Assurance Inc <br />
<br />
</div>
<div>
</div>
<div>
City Chattanooga </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
State TN </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Country US Voluntary/Mandated Voluntary: Firm Initiated </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Recall Initiation Date 2012-05-01 <br />
<br />
</div>
<div>
</div>
<div>
Initial Firm Notification of </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Consignee or Public FAX <br />
<br />
</div>
<div>
</div>
<div>
Distribution Pattern TN, GA, NY <br />
<br />
</div>
<div>
</div>
<div>
Product Detail</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Product Description Code Info Classification Reason for Recall Product
Quantity Recall Number </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Plasma Cryoprecipitated Reduced W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2009-12 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Red Blood Cells (Apheresis) Leukocytes Reduced W043211094961-A;
W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B;
W043211025338-B Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 6 units
B-2010-12 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Cryoprecipitated AHF, Pooled W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2011-12 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Red Blood Cells Leukocytes Reduced V89413; V26698; W043210088572;
W043210075817 Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 4 units
B-2012-12 <br />
<br />
</div>
<div>
</div>
<div>
Plasma Frozen within 24 hours (FP24) W043210075817 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2013-12 <br />
<br />
</div>
<div>
</div>
<div>
Blood and Blood Products for Reprocessing V89413 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2014-12 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Fresh Frozen Plasma V26698 Class II Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
1 unit B-2015-12 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=61992&w=08152012&">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=61992&w=08152012&</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Monday, August 13, 2012 <br />
<br />
</div>
<div>
</div>
<div>
Summary results of the second national survey of abnormal prion prevalence
in archived appendix specimens August 2012 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/08/summary-results-of-second-national.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/08/summary-results-of-second-national.html</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Friday, August 10, 2012 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Incidents of Potential iatrogenic Creutzfeldt-Jakob disease (CJD) biannual
update (July 2012) </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/08/incidents-of-potential-iatrogenic.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/08/incidents-of-potential-iatrogenic.html</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Tuesday, July 31, 2012 <br />
<br />
</div>
<div>
</div>
<div>
11 patients may have been exposed to fatal disease Creutzfeldt-Jakob
Disease CJD Greenville Memorial Hospital <br />
<br />
</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/07/11-patients-may-have-been-exposed-to.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/07/11-patients-may-have-been-exposed-to.html</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Saturday, July 07, 2012</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Class II, Blood products, collected from a donor who was at risk for
variant Creutzfeldt-Jakob disease ( vCJD) USA </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Enforcement Report <br />
<br />
</div>
<div>
</div>
<div>
<a href="http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html">http://vcjdtransfusion.blogspot.com/2012/07/class-ii-blood-products-collected-from.html</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Monday, June 11, 2012 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products” <br />
<br />
</div>
<div>
</div>
<div>
IN SHORT ; <br />
<br />
</div>
<div>
</div>
<div>
“However, based on animal studies, as well as on FDA risk assessments, the
possibility of vCJD transmission by a U.S.-licensed plasma derivative, while
extremely small, cannot be absolutely ruled out. For these reasons, the
recommendations for labeling for plasma derivatives will include mention of vCJD
for the first time, and the potential risk for its transmission. The recommended
elements of the warning label for CJD are unchanged and continue to describe its
transmission as a theoretical risk, given that there is no confirmed evidence
that CJD is transmitted by blood (Refs. 4-7).“ </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
IN FULL, as follows ; </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Monday, June 11, 2012 <br />
<br />
</div>
<div>
</div>
<div>
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products” <br />
<br />
</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html</a></div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Friday, June 29, 2012</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Highly Efficient Prion Transmission by Blood Transfusion <br />
<br />
</div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html</a></div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Sunday, June 3, 2012<br />
<br />
</div>
<div>
</div>
<div>
A new neurological disease in primates inoculated with prion-infected blood
or blood components </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Thursday, August 02, 2012 <br />
<br />
</div>
<div>
</div>
<div>
CJD case in Saint John prompts letter to patients Canada CJD case in Saint
John prompts letter to patients </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/08/cjd-case-in-saint-john-prompts-letter.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/08/cjd-case-in-saint-john-prompts-letter.html</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Monday, July 23, 2012<br />
<br />
</div>
<div>
</div>
<div>
The National Prion Disease Pathology Surveillance Center July 2012 <br />
<br />
</div>
<div>
</div>
<div>
<a href="http://prionunitusaupdate2008.blogspot.com/2012/07/the-national-prion-disease-pathology.html">http://prionunitusaupdate2008.blogspot.com/2012/07/the-national-prion-disease-pathology.html</a>
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</div>
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<div>
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Date: Tue, 9 Jan 2001 16:49:00 –0800 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
From: "Terry S. Singeltary Sr." <a href="mailto:flounder@wt.net">flounder@wt.net</a> <br />
</div>
<div>
</div>
<div>
</div>
<div>
Reply-To: Bovine Spongiform Encephalopathy <a href="mailto:BSE-L@uni-karlsruhe.de">BSE-L@uni-karlsruhe.de</a> <br />
<br />
</div>
<div>
</div>
<div>
To: <a href="mailto:BSE-L@uni-karlsruhe.de">BSE-L@uni-karlsruhe.de</a>
</div>
<div>
</div>
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<div>
######### Bovine Spongiform Encephalopathy <bse -l="-l">
######### </bse><br />
<br />
</div>
<div>
</div>
<div>
</div>
<div>
Greetings List Members, </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
I was lucky enough to sit in on this BSE conference call today and even
managed to ask a question. that is when the trouble started. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
I submitted a version of my notes to Sandra Blakeslee of the New York
Times, whom seemed very upset, and rightly so. <br />
<br />
</div>
<div>
</div>
<div>
"They tell me it is a closed meeting and they will release whatever
information they deem fit. Rather infuriating." <br />
<br />
</div>
<div>
</div>
<div>
and i would have been doing just fine, until i asked my question. i was
surprised my time to ask a question so quick. <br />
<br />
</div>
<div>
</div>
<div>
(understand, these are taken from my notes for now. the spelling of names
and such could be off.) </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
[host Richard Barns] and now a question from Terry S. Singeltary of CJD
Watch. <br />
<br />
</div>
<div>
</div>
<div>
[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for
serum or tissue donor herds? </div>
<br />
<div>
</div>
<div>
[no answer, you could hear in the back ground, mumbling and 'we can't. have
him ask the question again.] <br />
<br />
</div>
<div>
</div>
<div>
[host Richard] could you repeat the question? </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue
donor herds? <br />
<br />
</div>
<div>
</div>
<div>
[not sure whom ask this] what group are you with? <br />
<br />
</div>
<div>
</div>
<div>
[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide. <br />
<br />
</div>
<div>
</div>
<div>
[not sure who is speaking] could you please disconnect Mr. Singeltary <br />
<br />
</div>
<div>
</div>
<div>
[TSS] you are not going to answer my question? <br />
<br />
</div>
<div>
</div>
<div>
[not sure whom speaking] NO <br />
<br />
</div>
<div>
</div>
<div>
from this point, i was still connected, got to listen and tape the whole
conference. at one point someone came on, a woman, and ask again; <br />
<br />
</div>
<div>
</div>
<div>
[unknown woman] what group are you with? <br />
<br />
</div>
<div>
</div>
<div>
[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD
and other human TSE's world wide. i was invited to sit in on this from someone
inside the USDA/APHIS and that is why i am here. do you intend on banning me
from this conference now? <br />
<br />
</div>
<div>
</div>
<div>
at this point the conference was turned back up, and i got to finish
listening. They never answered or even addressed my one question, or even
addressed the issue. BUT, i will try and give you a run-down for now, of the
conference. <br />
<br />
</div>
<div>
</div>
<div>
IF i were another Country, I would take heed to my notes, BUT PLEASE do not
depend on them. ask for transcript from; <br />
<br />
</div>
<div>
</div>
<div>
RBARNS@ORA.FDA.GOV 301-827-6906 <br />
<br />
</div>
<div>
</div>
<div>
he would be glad to give you one ;-) <br />
<br />
</div>
<div>
</div>
<div>
Rockville Maryland, Richard Barns Host </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
BSE issues in the U.S., How they were labelling ruminant feed? Revising
issues. <br />
<br />
</div>
<div>
</div>
<div>
The conference opened up with the explaining of the U.K. BSE epidemic
winding down with about 30 cases a week. <br />
<br />
</div>
<div>
</div>
<div>
although new cases in other countries were now appearing. <br />
<br />
</div>
<div>
</div>
<div>
Look at Germany whom said NO BSE and now have BSE. <br />
<br />
</div>
<div>
</div>
<div>
BSE increasing across Europe. <br />
<br />
</div>
<div>
</div>
<div>
Because of Temporary Ban on certain rendered product, heightened interest
in U.S. <br />
<br />
</div>
<div>
</div>
<div>
A recent statement in Washington Post, said the New Administration (old GW)
has a list of issues. BSE is one of the issues. <br />
<br />
</div>
<div>
</div>
<div>
BSE Risk is still low, minimal in U.S. with a greater interest in MBM not
to enter U.S. <br />
<br />
</div>
<div>
</div>
<div>
HOWEVER, if BSE were to enter the U.S. it would be economically disastrous
to the render, feed, cattle, industries, and for human health. <br />
<br />
</div>
<div>
</div>
<div>
(human health-they just threw that in cause i was listening. I will now jot
down some figures in which they told you, 'no need to write them down'. just
hope i have them correct. hmmm, maybe i hope i don't ???) <br />
<br />
</div>
<div>
</div>
<div>
80% inspection of rendering </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
*Problem-Complete coverage of rendering HAS NOT occurred. <br />
<br />
</div>
<div>
</div>
<div>
sizeable number of 1st time FAILED INITIAL INSPECTION, have not been
reinspected (70% to 80%). </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Compliance critical, Compliance poor in U.K. and other European Firms. <br />
<br />
</div>
<div>
</div>
<div>
Gloria Dunason Major Assignment 1998 goal TOTAL compliance. This _did not_
occur. Mixed level of compliance, depending on firm. <br />
<br />
</div>
<div>
</div>
<div>
Rendering FDA license and NON FDA license <br />
<br />
</div>
<div>
</div>
<div>
system in place for home rendering & feed 76% in compliance 79% cross
contamination 21% DID NOT have system 92% record keeping less than 60% total
compliance <br />
<br />
</div>
<div>
</div>
<div>
279 inspectors 185 handling prohibited materials <br />
<br />
</div>
<div>
</div>
<div>
Renderer at top of pyramid, significant part of compliance. 84% compliance
</div>
<div>
</div>
<div>
</div>
<br />
<div>
failed to have caution statement render 72% compliance & cross
contamination caution statement on feed, 'DO NOT FEED TO CATTLE' <br />
<br />
</div>
<div>
</div>
<div>
56 FIRMS NEVER INSPECTED <br />
<br />
</div>
<div>
</div>
<div>
1240 FDA license feed mills 846 inspected </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
"close to 400 feed mills have not been inspected" <br />
<br />
</div>
<div>
</div>
<div>
80% compliance for feed. <br />
<br />
</div>
<div>
</div>
<div>
10% don't have system. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
NON-FDA licensed mills There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ??? 4,344 ever inspected. "FDA does not have a
lot of experience with" <br />
<br />
</div>
<div>
</div>
<div>
40% do NOT have caution statement 'DO NOT FEED'. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
74% Commingling compliance </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
"This industry needs a lot of work and only half gotten to" <br />
<br />
</div>
<div>
</div>
<div>
"700 Firms that were falitive, and need to be re-inspected, in addition to
the 8,000 Firms." <br />
<br />
</div>
<div>
</div>
<div>
Quote to do BSE inspection in 19 states by end of January or 30 days, and
other states 60 days. to change feed status??? Contract check and ask questions
and pass info. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
At this time, we will take questions. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
[I was about the third or fourth to ask question. then all B.S.eee broke
loose, and i lost my train of thought for a few minutes. picked back up here] <br />
<br />
</div>
<div>
</div>
<div>
someone asking about nutritional supplements and sourcing, did not get
name. something about inspectors not knowing of BSE risk??? the conference
person assuring that Steve Follum? and the TSE advisory Committee were handling
that. <br />
<br />
</div>
<div>
</div>
<div>
Some other Dr. Vet, whom were asking questions that did not know what to
do??? <br />
<br />
</div>
<div>
</div>
<div>
[Dennis Wilson] California Food Agr. Imports, are they looking at imports? <br />
<br />
</div>
<div>
</div>
<div>
[Conference person] they are looking at imports, FDA issued imports
Bulletin. <br />
<br />
</div>
<div>
</div>
<div>
[Linda Singeltary ??? this was a another phone in question, not related i
don't think] Why do we have non-licensed facilities? <br />
<br />
</div>
<div>
</div>
<div>
(conference person) other feed mills do not handle as potent drugs??? <br />
<br />
</div>
<div>
</div>
<div>
Dennis Blank, Ken Jackson licensed 400 non FDA 4400 inspected of a total of
6000 to 8000, </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
(they really don't know how many non licensed Firms in U.S. they guess 6000
to 8000??? TSS) </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Linda Detwiler asking everyone (me) not to use emergency BSE number, unless
last resort. (i thought of calling them today, and reporting the whole damn U.S.
cattle herd ;-) 'not' <br />
<br />
</div>
<div>
</div>
<div>
Warren-Maryland Dept. Agr. Prudent to re-inspect after 3 years. concerned
of Firms that have changed owners. <br />
<br />
</div>
<div>
</div>
<div>
THE END </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
TSS </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
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<div>
</div>
<div>
############ <a href="http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a>
############ </div>
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<div>
</div>
<div>
FROM New York TIMES <br />
<br />
</div>
<div>
</div>
<div>
Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version... Date: Thu, 11 Jan 2001 22:02:47 -0700 From: "Sandy
Blakeslee" <sblakeslee mindspring.com="mindspring.com"> To: "Terry S. Singeltary Sr."
<flounder wt.net="wt.net"> References: 1 </flounder></sblakeslee><br />
<br />
</div>
<div>
</div>
<div>
Hi terry -- thanks for all your help. I know it made a difference with the
FDA getting out that release. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
----- Original Message ----- <br />
<br />
</div>
<div>
</div>
<div>
From: "Terry S. Singeltary Sr." <a href="mailto:flounder@wt.net">flounder@wt.net</a> <br />
<br />
</div>
<div>
</div>
<div>
To: <a href="mailto:sblakeslee@mindspring.com">sblakeslee@mindspring.com</a> </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Sent: Thursday, January 11, 2001 2:06 PM <br />
<br />
</div>
<div>
</div>
<div>
Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA Posting
of cut version... </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
snip...<br />
<br />
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
> > hi sandy, <br />
<br />
</div>
<div>
</div>
<div>
>From the New York Times NYTimes.com, January 11, 2001 <br />
<br />
</div>
<div>
</div>
<div>
Many Makers of Feed Fail to Heed Rules on Mad Cow Disease By SANDRA
BLAKESLEE <br />
<br />
</div>
<div>
</div>
<div>
Large numbers of companies involved in manufacturing animal feed are not
complying with regulations meant to prevent the emergence and spread of mad cow
disease in the United States, the Food and Drug Administration said yesterday. <br />
<br />
</div>
<div>
</div>
<div>
The widespread failure of companies to follow the regulations, adopted in
August 1997, does not mean that the American food supply is unsafe, Dr. Stephen
Sundlof, director of the Center for Veterinary Medicine at the F.D.A., said in
an interview. <br />
<br />
</div>
<div>
</div>
<div>
But much more needs to be done to ensure that mad cow disease does not
arise in this country, Dr. Sundlof said. <br />
<br />
</div>
<div>
</div>
<div>
The regulations state that feed manufacturers and companies that render
slaughtered animals into useful products generally may not feed mammals to
cud-chewing animals, or ruminants, which can carry mad cow disease. <br />
<br />
</div>
<div>
</div>
<div>
All products that contain rendered cattle or sheep must have a label that
says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers must also have
a system to prevent ruminant products from being commingled with other rendered
material like that from chicken, fish or pork. Finally, all companies must keep
records of where their products originated and where they were sold. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Under the regulations, F.D.A. district offices and state veterinary offices
were required to inspect all rendering plants and feed mills to make sure
companies complied. But results issued yesterday demonstrate that more than
three years later, different segments of the feed industry show varying levels
of compliance. <br />
<br />
</div>
<div>
</div>
<div>
Among 180 large companies that render cattle and another ruminant, sheep,
nearly a quarter were not properly labeling their products and did not have a
system to prevent commingling, the F.D.A. said. And among 347 F.D.A.-licensed
feed mills that handle ruminant materials - these tend to be large operators
that mix drugs into their products - 20 percent were not using labels with the
required caution statement, and 25 percent did not have a system to prevent
commingling. <br />
<br />
</div>
<div>
</div>
<div>
Then there are some 6,000 to 8,000 feed mills so small they do not require
F.D.A. licenses. They are nonetheless subject to the regulations, and of 1,593
small feed producers that handle ruminant material and have been inspected, 40
percent were not using approved labels and 25 percent had no system in place to
prevent commingling. <br />
<br />
</div>
<div>
</div>
<div>
On the other hand, fewer than 10 percent of companies, big and small, were
failing to comply with the record-keeping regulations. <br />
<br />
</div>
<div>
</div>
<div>
The American Feed Industry Association in Arlington, Va., did not return
phone calls seeking comment. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://www.nytimes.com/2001/01/11/science/11COW.html">http://www.nytimes.com/2001/01/11/science/11COW.html</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Subject: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL Jan.
9, 2001 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Date: Wed, 10 Jan 2001 14:04:21 –0500 <br />
<br />
</div>
<div>
</div>
<div>
From: "Gomez, Thomas M." <a href="mailto:tmg1@CDC.GOV">tmg1@CDC.GOV</a> <br />
<br />
</div>
<div>
</div>
<div>
Reply-To: Bovine Spongiform Encephalopathy <a href="mailto:BSE-L@uni-karlsruhe.de">BSE-L@uni-karlsruhe.de</a> <br />
<br />
</div>
<div>
</div>
<div>
To: <a href="mailto:BSE-L@uni-karlsruhe.de">BSE-L@uni-karlsruhe.de</a> <br />
<br />
</div>
<div>
</div>
<div>
######### Bovine Spongiform Encephalopathy <bse -l="-l">
######### </bse><br />
<br />
</div>
<div>
</div>
<div>
USDA/APHIS would like to provide clarification on the following point from
Mr. Singeltary's 9 Jan posting regarding the 50 state conference call. <br />
<br />
</div>
<div>
</div>
<div>
[Linda Detwiler asking everyone (me) not to use emergency BSE number,
unless last resort. (i thought of calling them today, and reporting the whole
damn U.S. cattle herd ;-) 'not'] <br />
<br />
</div>
<div>
</div>
<div>
Dr. Detwiler was responding to an announcement made during the call to use
the FDA emergency number if anyone wanted to report a cow with signs suspect for
BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants to use the
FDA emergency number as a last resort to report cattle suspect for BSE. What Mr.
Singeltary failed to do was provide the List with Dr. Detwiler's entire
statement. Surveillance for BSE in the United States is a cooperative effort
between states, producers, private veterinarians, veterinary hospitals and the
USDA. The system has been in place for over 10 years. Each state has a system in
place wherein cases are reported to either the State Veterinarian, the federal
Veterinarian in Charge or through the veterinary diagnostic laboratory system.
The states also have provisions with emergency numbers. Dr. Detwiler asked
participants to use the systems currently in place to avoid the possibility of a
BSE-suspect report falling through the cracks. Use of the FDA emergency number
has not been established as a means to report diseased cattle of any nature. <br />
<br />
</div>
<div>
</div>
<div>
############ <a href="http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a>
############ <br />
<br />
<br />
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Subject: Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL
Jan.9, 2001 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Date: Wed, 10 Jan 2001 13:44:49 –0800 <br />
<br />
</div>
<div>
</div>
<div>
From: "Terry S. Singeltary Sr." <a href="mailto:flounder@wt.net">flounder@wt.net</a> <br />
<br />
</div>
<div>
</div>
<div>
Reply-To: Bovine Spongiform Encephalopathy <a href="mailto:BSE-L@uni-karlsruhe.de">BSE-L@uni-karlsruhe.de</a> <br />
<br />
</div>
<div>
</div>
<div>
To: BSE-L@uni-karlsruhe.de References: 1 <br />
<br />
</div>
<div>
</div>
<div>
</div>
<div>
######### Bovine Spongiform Encephalopathy <bse -l="-l">
######### </bse><br />
<br />
</div>
<div>
</div>
<div>
</div>
<div>
Hello Mr. Thomas, <br />
<br />
</div>
<div>
</div>
<div>
> What Mr. Singeltary failed to do was provide > the List with Dr.
Detwiler's entire statement. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
would you and the USDA/APHIS be so kind as to supply this list with a full
text version of the conference call and or post on your web-site? if so when,
and thank you. if not, why not? <br />
<br />
</div>
<div>
</div>
<div>
> The system has been in place for over 10 years. <br />
<br />
</div>
<div>
</div>
<div>
that seems to be a very long time for a system to be in place, and only
test 10,700 cattle from some 1.5 BILLION head (including calf crop). Especially
since French are testing some 20,000 weekly and the E.U. as a whole, are testing
many many more than the U.S., with less cattle, same risk of BSE/TSEs. <br />
<br />
</div>
<div>
</div>
<div>
Why does the U.S. insist on not doing massive testing with the tests which
the E.U. are using? Why is this, please explain? <br />
<br />
</div>
<div>
</div>
<div>
Please tell me why my question was not answered? <br />
<br />
</div>
<div>
</div>
<div>
> U.S. cattle, what kind of guarantee can you > give for serum or
tissue donor herds? <br />
<br />
</div>
<div>
</div>
<div>
It was a very simple question, a very important question, one that
pertained to the topic of BSE/feed, and asked in a very diplomatic way. why was
it not answered? <br />
<br />
</div>
<div>
</div>
<div>
If all these years, we have been hearing that pharmaceutical grade bovines
were raised for pharmaceuticals vaccines etc. But yet the USA cannot comply with
feed regulations of the ruminant feed ban, PLUS cannot even comply with the
proper labelling of the feed, cross contamination etc. Then how in the world can
you Guarantee the feed fed to pharmaceutical grade bovine, were actually non
ruminant feed? <br />
<br />
</div>
<div>
</div>
<div>
Before i was ask to be 'disconnected', i did hear someone in the background
say 'we can't'-- have him ask the question again. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
could you please be so kind, as to answer these questions? <br />
<br />
</div>
<div>
</div>
<div>
thank you, Terry S. Singeltary Sr. Bacliff, Texas USA <br />
<br />
</div>
<div>
</div>
<div>
P.S. if you will also notice, i did not post that emergency phone number
and do not intend on passing it on to anyone. I was joking when i said i should
call and report the whole damn U.S. Herd. So please pass that on to Dr.
Detwiler, so she can rest easily. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
BUT, they should be reported, some are infected with TSE. The U.S. is just
acting as stupid as Germany and other Countries that insist they are free of
BSE. </div>
<div>
</div>
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</div>
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</div>
<div>
TSS </div>
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</div>
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</div>
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</div>
<div>
Subject: Report on the assessment of the Georgraphical BSE-risk of the USA
July 2000 (not good) </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Date: Wed, 17 Jan 2001 21:23:51 –0800 <br />
<br />
</div>
<div>
</div>
<div>
From: "Terry S. Singeltary Sr." <a href="mailto:flounder@wt.net">flounder@wt.net</a> <br />
<br />
</div>
<div>
</div>
<div>
Reply-To: Bovine Spongiform Encephalopathy <a href="mailto:BSE-L@uni-karlsruhe.de">BSE-L@uni-karlsruhe.de</a> <br />
<br />
</div>
<div>
</div>
<div>
To: <a href="mailto:BSE-L@uni-karlsruhe.de">BSE-L@uni-karlsruhe.de</a>
</div>
<div>
</div>
<div>
</div>
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</div>
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</div>
<div>
######### Bovine Spongiform Encephalopathy <bse -l="-l">
######### </bse><br />
<br />
</div>
<div>
</div>
<div>
</div>
<div>
Greetings List Members and ALL EU Countries, <br />
<br />
</div>
<div>
</div>
<div>
Because of this report, and the recent findings of the 50-state BSE
Conference call, I respectfully seriously suggest that these Countries and the
SSC re-evaluate the U.S.A. G.B.R. to a risk factor of #3. <br />
<br />
</div>
<div>
</div>
<div>
I attempted to post this to list in full text, but would not accept... <br />
<br />
</div>
<div>
</div>
<div>
thank you, kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA <br />
<br />
</div>
<div>
</div>
<div>
Report on the assessment of the Geographical BSE-risk of the USA July 2000 <br />
<br />
</div>
<div>
</div>
<div>
PART II <br />
<br />
</div>
<div>
</div>
<div>
REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE RISK OF THE UNITED STATES
OF AMERICA <br />
<br />
</div>
<div>
</div>
<div>
- 29 - </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Report on the assessment of the Geographical BSE-risk of the USA July 2000 <br />
<br />
</div>
<div>
</div>
<div>
EXECUTIVE SUMMARY </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
OVERALL ASSESSMENT <br />
<br />
</div>
<div>
</div>
<div>
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely
but cannot be excluded that domestic cattle are (clinically or pre-clinically)
infected with the BSE-agent. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Stability: Before 1990 the system was extremely unstable because feeding of
MBM to cattle happened, rendering was inappropriate with regard to deactivation
of the BSE-agent and SRM and fallen stock were rendered for feed. From 1990 to
1997 it improved to very unstable, thanks to efforts undertaken to trace
imported animals and exclude them from the feed chain and intensive
surveillance. In 1998 the system became neutrally stable after the RMBM-ban of
1997. <br />
<br />
</div>
<div>
</div>
<div>
External challenges: A moderate external challenge occurred in the period
before 1990 because of importation of live animals from BSE-affected countries,
in particular from the UK and Ireland. It cannot be excluded that some
BSE-infected animals have been imported by this route and did enter the US
rendering and feed production system. The efforts undertaken since 1990 to trace
back UK-imported cattle and to exclude them from the feed chain reduced the
impact of the external challenge significantly. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Interaction of external challenges and stability: While extremely unstable,
the US system was exposed to a moderate external challenge, mainly resulting
from cattle imports from the UK. It can not be excluded that BSE-infectivity
entered the country by this route and has been recycled to domestic cattle. The
resulting domestic cases would have been processed while the system was still
very unstable or unstable and would hence have initiated a number of second or
third generation cases. However, the level of the possible domestic prevalence
must be below the low detection level of the surveillance in place. <br />
<br />
</div>
<div>
</div>
<div>
As long as there are no changes in stability or challenge the probability
of cattle to be (pre-clinically or clinically) infected with the BSE-agent will
remain at the current level. <br />
<br />
</div>
<div>
</div>
<div>
JUSTIFICATION <br />
<br />
</div>
<div>
</div>
<div>
1. DATA <br />
<br />
</div>
<div>
</div>
<div>
The available information was suitable to carry out the GBR risk
assessment. <br />
<br />
</div>
<div>
</div>
<div>
- 30 - </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Report on the assessment of the Geographical BSE-risk of the USA July 2000 <br />
<br />
</div>
<div>
</div>
<div>
2. STABILITY <br />
<br />
</div>
<div>
</div>
<div>
2.1 Overall appreciation of the ability to identify BSE-cases and to
eliminate animals at risk of being infected before they are processed <br />
<br />
</div>
<div>
</div>
<div>
· Before 1989, the ability of the system to identify (and eliminate) BSE
cases was limited. · Since 1990 this ability is significantly improved, thanks
to a good BSE-surveillance and culling system (contingency plan). · Today the
surveillance should be able to detect clinical BSE-cases within the limits set
by an essential passive surveillance system, i.e. some cases might remain
undetected. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
2.2 Overall appreciation of the ability to avoid recycling BSE-infectivity,
should it enter processing <br />
<br />
</div>
<div>
</div>
<div>
· Before 1997 the US rendering and feed producing system would not have
been able to avoid recycling of the BSE agent to any measurable extent. If the
BSE-agent was introduced the feed chain, it could probably have reached cattle.
· After the introduction of the RMBM-to-ruminants-ban in August 1997 the ability
of the system to avoid recycling of BSE-infectivity was somewhat increased. It
is still rather low due to the rendering system of ruminant material (including
SRM and fallen stock) and the persisting potential for cross-contamination of
cattle feed with other feeds and hence RMBM. <br />
<br />
</div>
<div>
</div>
<div>
2.3 Overall assessment of the Stability </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
· Until 1990 the US BSE/cattle system was extremely unstable as RMBM was
commonly fed to cattle, the rendering system was not able to reduce
BSE-infectivity and SRM were rendered. This means that incoming BSE infectivity
would have been most probably recycled to cattle and amplified and the disease
propagated. · Between 1990 and 1995 improvements in the BSE surveillance and the
efforts to trace back and remove imported cattle gradually improved the
stability but the system remained very unstable. In 1998 the system became
unstable because of an RMBM-ban introduced in 1997. After 1998 the ban was fully
implemented and the system is regarded to be neutrally stable since 1998. The US
system is therefore seen to neither be able to amplify nor to reduce circulating
or incoming BSE-infectivity. <br />
<br />
</div>
<div>
</div>
<div>
3. CHALLENGES <br />
<br />
</div>
<div>
</div>
<div>
A moderate external challenge occurred in the period 1980-1989 because of
importation of live animals from the UK. imports from other countries are
regarded to have been negligible challenges. · As a consequence of this external
challenge, infectivity could have entered the feed cycle and domestic animals
could have been exposed to the agent. These domestic BSE-incubating animals
might have again entered processing, leading to an internal challenge since
1991. · This internal challenge could have produced domestic cases of BSE, yet
prevalence levels could have been below the detection limits of the surveillance
system until now. (According to US calculations, the current surveillance </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
-31 - </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Report on the assessment of the Geographical BSE-risk of the USA July 2000 <br />
<br />
</div>
<div>
</div>
<div>
system could detect clinical incidence of 1-3 cases per year per million
adult cattle, i.e. in absolute numbers 43-129 cases per year). Between 1990 und
1995, with the exclusion of the imported animals from Europe from the feed
chain, the effect of the external challenges decreased. <br />
<br />
</div>
<div>
</div>
<div>
4. CONCLUSION ON THE RESULTING RISKS <br />
<br />
</div>
<div>
</div>
<div>
4.1 Interaction of stability and challenqe <br />
<br />
</div>
<div>
</div>
<div>
· In the late 80s, early 90s a moderate external challenges met an
extremely unstable system. This would have amplified the incoming
BSE-infectivity and propagated the disease. · With the exclusion of the imported
animals from Europe from the feed chain between 1990 and 1995 the effect of the
external challenge decreased. · Before 1998 an internal challenge, if it
developed, would have met a still unstable system (inappropriate rendering, no
SRM ban, RMBM ban only after 1997) and the BSE-infectivity could have been
recycled and amplified. · After 1998 the neutrally stable system could still
recycle the BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity
circulating in the system would probably not be amplified. <br />
<br />
</div>
<div>
</div>
<div>
4.2 Risk that BSE-infectivity enters processing <br />
<br />
</div>
<div>
</div>
<div>
· A very low processing risk developed in the late 80s when the UK-imports
were slaughtered or died. It increased until 1990 because of the higher risk to
be infected with BSE of cattle imported from the UK in 1988/89, as these animals
could have been processed prior to the back-tracing of the UK-imports in 1990. ·
From 1990 to 1995 a combination of surviving non-traced UK imports and some
domestic (pre-)clinical cases could have arrived at processing resulting in an
assumed constant low but non-negligible processing risk. · After 1995 any
processing risk relates to assumed domestic cases arriving at processing. · The
fact that no domestic cases have been shown-up in the BSE-surveillance is
reassuring - it indicates that BSE is in fact not present in the country at
levels above the detection limits of the country's surveillance system. This
detection level has been calculated according to US-experts to be between 1
& 3 clinical cases per million adult cattle per year. <br />
<br />
</div>
<div>
</div>
<div>
Note: The high turnover in parts of the dairy cattle population with a
young age at slaughter makes it unlikely that fully developed clinical cases
would occur (and could be detected) or enter processing. However, the
theoretical infective load of the pre-clinical BSE-cases that under this
scenario could be processed, can be assumed to remain relatively low. <br />
<br />
</div>
<div>
</div>
<div>
4.3 Risk that BSE-infectivity is recycled and propagated </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
· During the period covered by this assessment (1980-1999) the US-system
was not able to prevent propagation of BSE should it have entered, even if this
ability was significantly improved with the MBM-ban of 1997. · However, since
the likelihood that BSE-infectivity entered the system is regarded to be small
but non-negligible, the risk that propagation of the disease took place is also
small but not negligible. <br />
<br />
</div>
<div>
</div>
<div>
- 32 - <br />
<br />
</div>
<div>
</div>
<div>
Report on the assessment of the Geographical BSE-risk of the USA July 2000 <br />
<br />
</div>
<div>
</div>
<div>
5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK <br />
<br />
</div>
<div>
</div>
<div>
5.1 The current GBR </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely
but cannot be excluded that domestic cattle are (clinically or pre-clinically)
infected with the BSE-agent. <br />
<br />
</div>
<div>
</div>
<div>
5.2 The expected development of the GBR <br />
<br />
</div>
<div>
</div>
<div>
As long as there are no changes in stability or challenge the probability
of cattle to be (pre-clinically or clinically) infected with the BSE-agent
remains at the current level. <br />
<br />
</div>
<div>
</div>
<div>
5.3 Recommendations for influencin.q the future GBR <br />
<br />
</div>
<div>
</div>
<div>
· As long as the stability of the US system is not significantly enbanced
above neutral levels it remains critically important to avoid any new external
challenges. · All measures that would improve the stability of the system, in
particular with regard to its ability to avoid recycling of the BSE-agent should
it be present in the cattle population, would reduce, over time, the probability
that cattle could be infected with the BSE-agent. Possible actions include:
removal of SRMs and/or fallen stock from rendering, better rendering processes,
improved compliance with the MBM-ban including control and reduction of
cross-contamination. · Results from an improved intensive surveillance
programme, targeting at risk sub-populations such as adult cattle in fallen
stock or in emergency slaughter, could verify the current assessment. </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
snip... <br />
<br />
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html">http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html</a>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Saturday, August 4, 2012 </div>
<div>
</div>
<div>
</div>
<div>
Final Feed Investigation Summary - California BSE Case - July 2012 </div>
<div>
</div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/final-feed-investigation-summary.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/final-feed-investigation-summary.html</a> </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
SUMMARY REPORT CALIFORNIA BOVINE SPONGIFORM ENCEPHALOPATHY CASE INVESTIGATION JULY 2012 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Summary Report BSE 2012 Executive Summary </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/summary-report-california-bovine.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/summary-report-california-bovine.html</a> </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Saturday, August 4, 2012 </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
Update from APHIS Regarding Release of the Final Report on the BSE Epidemiological Investigation </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/update-from-aphis-regarding-release-of.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/08/update-from-aphis-regarding-release-of.html</a> </div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
</div>
<div>
TSS</div>
Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-21172932924582267832012-07-07T15:22:00.000-07:002012-07-07T15:22:29.079-07:00Class II, Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease ( vCJD) USA<div>
Enforcement Report </div>
<br />
<div>
</div>
<br />
<div>
FDA Home3 </div>
<br />
<div>
</div>
<br />
<div>
Enforcement Reports4 </div>
<br />
<div>
</div>
<br />
<div>
Back to Event List </div>
<br />
<div>
</div>
<br />
<div>
Event Detail</div>
<br />
<div>
</div>
<br />
<div>
Event ID 61992 </div>
<br />
<div>
</div>
<br />
<div>
Product Type Biologics </div>
<br />
<div>
</div>
<br />
<div>
Status Terminated </div>
<br />
<div>
</div>
<br />
<div>
Recalling Firm Blood Assurance Inc </div>
<br />
<div>
</div>
<br />
<div>
City Chattanooga </div>
<br />
<div>
</div>
<br />
<div>
State TN </div>
<br />
<div>
</div>
<br />
<div>
Country US </div>
<br />
<div>
</div>
<br />
<div>
Voluntary/Mandated Voluntary: Firm Initiated </div>
<br />
<div>
</div>
<br />
<div>
Recall Initiation Date 2012-05-01 </div>
<br />
<div>
</div>
<br />
<div>
Initial Firm Notification of </div>
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<div>
</div>
<br />
<div>
Consignee or Public FAX </div>
<br />
<div>
</div>
<br />
<div>
Distribution Pattern TN, GA, NY </div>
<br />
<div>
</div>
<br />
<div>
Product Detail</div>
<br />
<div>
</div>
<br />
<div>
Product Description Code Info Classification Reason for Recall Product
Quantity Recall Number </div>
<br />
<div>
</div>
<br />
<div>
Plasma Cryoprecipitated Reduced W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2009-12 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2009-12">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2009-12</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Red Blood Cells (Apheresis) Leukocytes Reduced W043211094961-A;
W043211094961-B; W043211044082-A; W043211025338-A; W043211044082-B;
W043211025338-B Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 6 units
B-2010-12 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2010-12">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2010-12</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Cryoprecipitated AHF, Pooled W043210088572 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2011-12 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2011-12">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2011-12</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Red Blood Cells Leukocytes Reduced V89413; V26698; W043210088572;
W043210075817 Class II Blood products, collected from a donor who was at risk
for variant Creutzfeldt-Jakob disease (vCJD), were distributed. 4 units
B-2012-12 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2012-12">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2012-12</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Plasma Frozen within 24 hours (FP24) W043210075817 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2013-12 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2013-12">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2013-12</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Blood and Blood Products for Reprocessing V89413 Class II Blood products,
collected from a donor who was at risk for variant Creutzfeldt-Jakob disease
(vCJD), were distributed. 1 unit B-2014-12 </div>
<br />
<div>
</div>
<br />
<div>
<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2014-12">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2014-12</a></div>
<br />
<div>
</div>
<br />
<div>
</div>
<br />
<div>
Fresh Frozen Plasma V26698 Class II Blood products, collected from a donor
who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
1 unit B-2015-12 </div>
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<div>
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<a href="http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2015-12">http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=B-2015-12</a></div>
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Monday, June 11, 2012 </div>
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<div>
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products” </div>
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IN SHORT ; </div>
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</div>
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<div>
“However, based on animal studies, as well as on FDA risk assessments, the
possibility of vCJD transmission by a U.S.-licensed plasma derivative, while
extremely small, cannot be absolutely ruled out. For these reasons, the
recommendations for labeling for plasma derivatives will include mention of vCJD
for the first time, and the potential risk for its transmission. The recommended
elements of the warning label for CJD are unchanged and continue to describe its
transmission as a theoretical risk, given that there is no confirmed evidence
that CJD is transmitted by blood (Refs. 4-7).“ </div>
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IN FULL, as follows ; </div>
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Monday, June 11, 2012 </div>
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</div>
<br />
<div>
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products” </div>
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</div>
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/06/guidance-for-industry-draft-guidance.html</a></div>
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Friday, June 29, 2012</div>
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Highly Efficient Prion Transmission by Blood Transfusion </div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/highly-efficient-prion-transmission-by.html</a></div>
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Sunday, June 3, 2012</div>
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A new neurological disease in primates inoculated with prion-infected blood
or blood components </div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/new-neurological-disease-in-primates.html</a>
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Wednesday, June 27, 2012</div>
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First US BSE Case Since 2006 Underscores Need for Vigilance </div>
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Neurology Today 21 June 2012 </div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/first-us-bse-case-since-2006.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/06/first-us-bse-case-since-2006.html</a>
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Tuesday, June 26, 2012 </div>
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Creutzfeldt Jakob Disease Human TSE report update North America, Canada,
Mexico, and USDA PRION UNIT as of May 18, 2012 </div>
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</div>
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<div>
type determination pending Creutzfeldt Jakob Disease (tdpCJD), is on the
rise in Canada and the USA</div>
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</div>
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2012/06/creutzfeldt-jakob-disease-human-tse.html">http://creutzfeldt-jakob-disease.blogspot.com/2012/06/creutzfeldt-jakob-disease-human-tse.html</a>
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Wednesday, April 25, 2012 </div>
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USA MAD COW DISEASE AND CJD THERE FROM SINGELTARY ET AL 1999 – 2012 </div>
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/usa-mad-cow-disease-and-cjd-there-from.html">http://transmissiblespongiformencephalopathy.blogspot.com/2012/04/usa-mad-cow-disease-and-cjd-there-from.html</a>
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TSS</div>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-6035436461663795132012-01-26T11:13:00.000-08:002012-01-26T11:13:14.868-08:00Prionemia and Leukocyte-Platelet-Associated Infectivity in Sheep Transmissible Spongiform Encephalopathy Models<div>Prionemia and Leukocyte-Platelet-Associated Infectivity in Sheep Transmissible Spongiform Encephalopathy Models </div><br />
<div> </div><br />
<div> </div><br />
<div>Caroline Lacrouxa, Didier Vilettea, Natalia Fernández-Borgesb, Claire Litaisea, Séverine Lugana, Nathalie Moreld, Fabien Corbièrea, Stéphanie Simond, Hugh Simmonse, Pierrette Costesa, Jean-Louis Weisbeckerf, Isabelle Lantierg, Frederic Lantierg, François Schelchera, Jacques Grassid, Joaquin Castillab,c and Olivier Andréolettia</div><br />
<div> </div><br />
<div>+ Author Affiliations</div><br />
<div> </div><br />
<div>aUMR INRA ENVT 1225, Interactions Hôtes Agents Pathogènes, Ecole Nationale Vétérinaire de Toulouse, Toulouse, France </div><br />
<div> </div><br />
<div>bCIC bioGUNE, Parque Tecnológico de Bizkaia, Derio, Spain </div><br />
<div> </div><br />
<div>cIKERBASQUE, Basque Foundation for Science, Bilbao, Spain </div><br />
<div> </div><br />
<div>dCEA, Service de Pharmacologie et d'Immunoanalyse, IBiTec-S, DSV, CEA/Saclay, Gif sur Yvette, France </div><br />
<div> </div><br />
<div>eVLA Weybridge, ASU, New Haw, Addlestone, Surrey, United Kingdom </div><br />
<div> </div><br />
<div>fINRA Domaine de Langlade, Pompertuzat, France </div><br />
<div> </div><br />
<div>gINRA IASP, Centre INRA de Tours, Nouzilly, France </div><br />
<div> </div><br />
<div> ABSTRACT</div><br />
<div> </div><br />
<div>The dynamics of the circulation and distribution of transmissible spongiform encephalopathy (TSE) agents in the blood of infected individuals remain largely unknown. This clearly limits the understanding of the role of blood in TSE pathogenesis and the development of a reliable TSE blood detection assay. Using two distinct sheep scrapie models and blood transfusion, this work demonstrates the occurrence of a very early and persistent prionemia. This ability to transmit disease by blood transfusion was correlated with the presence of infectivity in white blood cells (WBC) and peripheral blood mononucleated cells (PBMC) as detected by bioassay in mice overexpressing the ovine prion protein PrP (tg338 mice) and with the identification of abnormal PrP in WBC after using protein misfolding cyclic amplification (PMCA). Platelets and a large variety of leukocyte subpopulations also were shown to be infectious. The use of endpoint titration in tg338 mice indicated that the infectivity in WBC (per ml of blood) was 106.5-fold lower than that in 1 g of posterior brainstem sample. In both WBC and brainstem, infectivity displayed similar resistance to PK digestion. The data strongly support the concept that WBC are an accurate target for reliable TSE detection by PMCA. The presence of infectivity in short-life-span blood cellular elements raises the question of the origin of prionemia. </div><br />
<div> </div><br />
<div> FOOTNOTES Received 11 October 2011. Accepted 18 November 2011. Address correspondence to O. Andreoletti, o.andreoletti@envt.fr. </div><br />
<div> </div><br />
<div>Published ahead of print 7 December 2011 </div><br />
<div> </div><br />
<div>Copyright © 2012, American Society for Microbiology. All Rights Reserved. </div><br />
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<div><a href="http://jvi.asm.org/content/86/4/2056.abstract?sid=8698b701-1122-4a5c-bcec-f959a6dda499" title="http://jvi.asm.org/content/86/4/2056.abstract?sid=8698b701-1122-4a5c-bcec-f959a6dda499">http://jvi.asm.org/content/86/4/2056.abstract?sid=8698b701-1122-4a5c-bcec-f959a6dda499</a></div><br />
<div> </div><br />
<div> </div><br />
<div> </div><br />
<span style="font-family: Times New Roman;">Wednesday, August 24, 2011<br />
<br />
All Clinically-Relevant Blood Components Transmit Prion Disease following a Single Blood Transfusion: A Sheep Model of vCJD <br />
</span><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/all-clinically-relevant-blood.html"><span style="font-family: Times New Roman;">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/all-clinically-relevant-blood.html</span></a><span style="font-family: Times New Roman;"> <br />
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Wednesday, August 24, 2011 <br />
<br />
There Is No Safe Dose of Prions <br />
</span><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/there-is-no-safe-dose-of-prions.html"><span style="font-family: Times New Roman;">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/there-is-no-safe-dose-of-prions.html</span></a><span style="font-family: Times New Roman;"> </span><br />
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<span style="font-family: Times New Roman;">Tuesday, September 14, 2010<br />
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Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)<br />
</span><a href="http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html"><span style="font-family: Times New Roman;">http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html</span></a><span style="font-family: Times New Roman;"> <br />
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Monday, February 7, 2011<br />
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FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???<br />
</span><a href="http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html"><span style="font-family: Times New Roman;">http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html</span></a><span style="font-family: Times New Roman;"> <br />
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Thursday, December 29, 2011 <br />
<br />
Aerosols An underestimated vehicle for transmission of prion diseases? <br />
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PRION </span><a href="http://www.landesbioscience.com/"><span style="font-family: Times New Roman;">www.landesbioscience.com</span></a><span style="font-family: Times New Roman;"> <br />
<br />
please see more on Aerosols and TSE prion disease here ; <br />
</span><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/aerosols-underestimated-vehicle-for.html"><span style="font-family: Times New Roman;">http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/aerosols-underestimated-vehicle-for.html</span></a><span style="font-family: Times New Roman;"> </span><br />
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<span style="font-family: Times New Roman;">Tuesday, January 17, 2012<br />
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<br />
American Red Cross Fined $9.6 Million for Blood-Safety Lapses AGAIN <br />
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</span><a href="http://transmissiblespongiformencephalopathy.blogspot.com/2012/01/american-red-cross-fined-96-million-for.html"><span style="font-family: Times New Roman;">http://transmissiblespongiformencephalopathy.blogspot.com/2012/01/american-red-cross-fined-96-million-for.html</span></a><br />
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<div> </div><div> </div><div> </div><div> </div><br />
<div>TSS</div>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-32173298226561701182011-12-18T09:54:00.000-08:002011-12-18T10:05:46.437-08:00A blood test for variant Creutzfeldt‐Jakob disease: briefing note for patients, carers and health professionalsA blood test for variant Creutzfeldt‐Jakob disease: briefing note for patients, carers and health professionals <br />
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A blood test for variant Creutzfeldt‐Jakob disease (vCJD) has been an important goal of medical research laboratories and companies around the world for many years. It has been very difficult to achieve because the infectious agent (germ) causing vCJD, known as a prion, has unique features that mean that the sensitive methods doctors normally use to detect the presence of a germ (detecting the body’s antibody response to the germ or the germ’s own genetic material) do not work. <br />
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The Medical Research Council (MRC) Prion Unit, working with the NHS National Prion Clinic at the National Hospital for Neurology and Neurosurgery (NHNN) in London, has now developed an entirely new type of test following a number of years of intensive research.<br />
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The test is at an early (prototype) stage but is able to correctly identify the large majority of patients with symptoms of vCJD and has not yet given any false results in patients with other brain diseases or in healthy individuals. We think this is an important breakthrough and it raises a number of issues which need to be carefully considered. Details of the test have been published by the leading medical journal, the Lancet, on 3rd February 2011. The full text of the paper is available here.<br />
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This brief article describes CJD and other so‐called prion diseases, why a blood test is important, how the test works and how to approach us at the National Prion Clinic to inquire further about this test. It is important to be cautious about this news, because although the results so far are very encouraging, we want to go on to look at blood samples from much larger numbers of healthy people and those with other brain diseases to get a better idea of how specific the test is in practice. This will be vital before a version of this test could be considered to routinely screen healthy blood donors.<br />
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What are prion diseases? Also known as transmissible spongiform encephalopathies, prion diseases are a group of rare fatal conditions affecting the brain. Prion diseases are caused by one of the body’s normal proteins, called the prion protein, changing its shape and forming clumps of protein in the brain. This process damages and eventually kills brain cells. In humans, there are three different ways these diseases can start. The commonest form is called sporadic CJD and this form is seen all over the world and appears to occur at random as an unlucky event when the production of prions in the brain is triggered spontaneously. Secondly, the disease can be passed down from generation to generation as a genetic condition in some families with a faulty prion protein gene. Thirdly, and most importantly from the point of view of this new test, someone can “catch” a prion infection by being exposed to infectious prions.<br />
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These illnesses affect both animals and humans. The animal prion diseases include scrapie, a common prion disease affecting sheep and goats which is not thought to pose a threat to human health and bovine spongiform encephalopathy (BSE or mad cow disease) in cattle which can jump species to infect humans. BSE prions are responsible for variant CJD which was first recognised in 1996 and which has so far affected about 200 people, most from the UK. It is thought that people become infected by BSE prions by eating food containing material from BSE‐infected cattle, although other sources of exposure are possible. Much of the UK population born before 1996 (when rigorous measures to limit exposure were enforced) have potentially been exposed to BSE‐contaminated food and the number of people who may carry the infection but remain healthy is unknown.<br />
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Why is a blood test important? vCJD (as with other forms of CJD) tends to be diagnosed only when the patient has had the disease for some time and has developed symptoms that are associated with extensive damage to the brain. There are several reasons why this is the case. The early symptoms of the disease (such as anxiety, depression and tingling pains in the legs) have many much more common causes and so doctors will understandably not attribute these symptoms to something much more serious until other features such as difficulty with movement or balance and loss of mental abilities occur. At this stage, it will be apparent there is a serious brain condition but a series of tests are required to make the diagnosis and these take time to organise and interpret. Because the disease itself typically progresses quite rapidly (over weeks and months), the patient is likely to be showing quite advanced symptoms by the time a confident diagnosis is reached. A simple blood test gives us an opportunity to make the diagnosis at a much earlier stage. While at present there is no treatment we know is effective in stopping progression of these diseases, an early diagnosis does avoid the need for other tests and gives the patient and their family a clear answer. This enables them to make the best use of their time together and spend less of this precious time in hospital. However, experimental drugs are being developed at the MRC Prion Unit and elsewhere with a view to clinical trials in the next few years and we would want to try such treatments at the earliest stage before irreversible brain damage has occurred.<br />
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It is now known that vCJD can be passed on by blood transfusion. Several vCJD patients had been blood donors before they developed symptoms of the disease. To date, three individuals who had received blood transfusions from such donors have themselves developed and died from the disease. A further individual, who had also received prion‐infected blood, died of unrelated causes but showed evidence of prion infection at autopsy examination.<br />
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Only a very small number of individuals are definitely known to have received such potentially infected blood transfusions. However, several thousand individuals have been notified by the Health Protection Agency that they have received possibly infected blood products such as plasma, clotting factors, or purified antibodies. One individual who had received a clotting factor from a donor who went on to get vCJD died of unrelated causes but showed signs of vCJD infection at autopsy. It is not known whether this individual would have gone on to develop the disease had he not died of other causes.<br />
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Prion diseases are known to exist in “carrier states” in laboratory animals and these would be expected in humans too. A “carrier” is a person infected with prions but who does not show any signs of disease in their natural lifetime. Such carrier states are well recognised with other infectious diseases in humans. In the UK population, following an anonymous study of archived tissue specimens, the Department of Health uses an estimate that 1 in 4000 individuals may be silently infected with vCJD prions in its risk calculations. There is considerable uncertainty about this figure, that is, the true number could be significantly higher or lower than 1 in 4000. It is also not known how many of those infected will eventually go on to develop the disease itself. We do know that incubation periods in human prion diseases can be very long, over 50 years in some cases. As these infected but healthy individuals cannot currently be identified in the population, many will be active blood donors and could pass on infection to other people in this way or by medical and surgical instruments used on them becoming contaminated by prions (since prions are quite resistant to normal sterilisation methods). The National Blood Service has taken several actions to try to minimise this risk, for example, by removing white cells from blood, however it is uncertain how effective these measures are at reducing risk, or indeed whether they are really justified should the real number of infected people turn out to be extremely small.<br />
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A future development of our blood test may allow us to screen donated blood and further increase the safety of blood transfusions. Also it may in the future allow individuals who have been exposed to vCJD infection to find out if there is evidence that the infection has taken hold in their body. However, considerable further research will need to be done first to find out how specific the test is when tested on large numbers of health donors and to understand how good the test will be at detecting infected blood from healthy individuals rather than those with the established disease.<br />
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How well does the test work? It has been hard to develop a test for prion disease because the body’s immune system does not fight off prion infection by making antibodies (that can be readily detected in a blood test) in the same way it does against germs like bacteria or viruses. It has been challenging to develop a test that can distinguish between the normal prion protein, which we all have in our blood, and the abnormal form linked to the disease which is chemically very similar.<br />
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Scientists in the MRC Prion Unit have developed a prototype test. This involves taking a small blood sample from a patient as with any other blood test. A small sample of blood is mixed with special metal beads to which the rogue prion proteins stick tightly. These are then washed to remove the normal prion protein and other blood components that would interfere with the test. Finally, the amount of rogue prion protein attached to the beads is measured using antibodies we have developed that bind very tightly to the prion protein.<br />
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The test was applied to a number patient samples including from patients with vCJD, those with sporadic CJD, other neurological diseases that might be confused with vCJD and a number of healthy blood donors. As vCJD is a rare disease, only relatively small numbers of samples were available for this testing. All samples were given code numbers and the scientists carrying out the test in our laboratory did not know which sample was which. We were able to try the test on 21 samples from different vCJD patients. 15 of these 21 patient samples (around 70%) were shown to be positive by the test. So far, all samples from other neurological diseases or healthy blood donors have tested negative but only relatively small numbers of these have been looked at so far (about 200). We are testing larger numbers of samples now. At present the test does not work in other forms of prion disease such as sporadic CJD but we are hoping this will be possible with further work in the future.<br />
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What happens now and how is the test going to be made available? We are ready to use the test to assist with diagnosis of patients who are suspected of having vCJD or other diseases that might be mistaken for vCJD. Working with neurological colleagues to begin to use the test will also help us get more information on the test itself and hopefully lead to further improvements and understanding of its usefulness. A request card needs to be completed which can be obtained here. We require at least 2 x 5ml EDTA vacutainer tubes. For sample delivery please see further details here. While we are working to increase the throughput of the test, at this stage it remains relatively labour intensive. Whilst we will attempt to return results at the earliest opportunity, clinicians should allow up to four weeks for results. Please call the Clinic for further details.<br />
<br />
The National Prion Clinic at the National Hospital for Neurology is happy to take telephone enquiries about suspected prion disease patients. We are particularly interested in referrals of patients at an early stage of their illness when diagnosis is most difficult.<br />
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Please visit the NHS National Prion Clinic website http://www.uclh.nhs.uk/ourservices/servicea-z/neuro/npc/Pages/Home.aspx for more details and telephone/email contact details. <br />
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<a href="http://www.prion.ucl.ac.uk/clinic-services/investigations-tests/#BloodTest">http://www.prion.ucl.ac.uk/clinic-services/investigations-tests/#BloodTest</a> <br />
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hmmm, most all of the iatrogenic CJD cases have been sporadic type iCJD. only the 5 or so cases (documented) has been associated with blood transfusion from vCJD. seems it would be more important to find a blood test for the sporadic CJD types that pass it on via the friendly fire and or pass if forward mode. why is it the UK scientist can develop and implement a test for their vCJD cases, but yet it can’t be done for the sporadic CJD cases in North America and or the UK ?<br />
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from the iatrogenic aspect, and considering that 85%+ of all human TSE is of the sporadic CJD strains, and the potential of iatrogenic transmission there from, seems to me we should be testing for sporadic CJD, considering also now that science has linked atypical BSE and atypical Scrapie to the sporadic CJD in humans, and most likely some cases from CWD once science crawls along and finally admits..............oops, I mean proves it.<br />
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you know the rest of the story $$$ <br />
<br />
FC5.1.1<br />
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Transmission Results in Squirrel Monkeys Inoculated with Human sCJD, vCJD, and GSS Blood Specimens: the Baxter Study<br />
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Brown, P1; Gibson, S2; Williams, L3; Ironside, J4; Will, R4; Kreil, T5; Abee, C3 1Fondation Alliance BioSecure, France; 2University of South Alabama, USA; 3University of Texas MD Anderson Cancer Center, USA; 4Western General Hospital, UK; 5Baxter BioSience, Austria<br />
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Background: Rodent and sheep models of Transmissible Spongiform Encephalopathy (TSE) have documented blood infectivity in both the pre-clinical and clinical phases of disease. Results in a (presumably more appropriate) non-human primate model have not been reported.<br />
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Objective: To determine if blood components (red cells, white cells, platelets, and plasma) from various forms of human TSE are infectious.<br />
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Methods: Blood components were inoculated intra-cerebrally (0.1 ml) and intravenously (0.5 ml) into squirrel monkeys from 2 patients with sporadic Creutzfeldt- Jakob disease (sCJD) and 3 patients with variant Creutzfeldt-Jakob disease (vCJD). Additional monkeys were inoculated with buffy coat or plasma samples from chimpanzees infected with either sCJD or Gerstmann-Sträussler-Scheinker disease (GSS). Animals were monitored for a period of 5 years, and all dying or sacrificed animals had post-mortem neuropathological examinations and Western blots to determine the presence or absence of the misfolded prion protein (PrPTSE).<br />
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Results: No transmissions occurred in any of the animals inoculated with blood components from patients with sporadic or variant CJD. All donor chimpanzees (sCJD and GSS) became symptomatic within 6 weeks of their pre-clinical phase plasmapheresis, several months earlier than the expected onset of illness. One monkey inoculated with purified leukocytes from a pre-clinical GSS chimpanzee developed disease after 36 months.<br />
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Conclusion: No infectivity was found in small volumes of blood components from 4 patients with sporadic CJD and 3 patients with variant CJD. ***However, a single transmission from a chimpanzee-passaged strain of GSS shows that infectivity may be present in leukocytes, and the shock of general anaesthesia and plasmspheresis appears to have triggered the onset of illness in pre-clinical donor chimpanzees. <br />
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Saturday, September 5, 2009 <br />
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TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS<br />
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snip...<br />
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<a href="http://tseac.blogspot.com/2011/06/tseac-meeting-august-1-2011-donor.html">http://tseac.blogspot.com/2011/06/tseac-meeting-august-1-2011-donor.html</a> <br />
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Wednesday, June 29, 2011<br />
<br />
TSEAC Meeting August 1, 2011 donor deferral Saudi Arabia vCJD risk blood and blood products<br />
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<a href="http://tseac.blogspot.com/2011/06/tseac-meeting-august-1-2011-donor.html">http://tseac.blogspot.com/2011/06/tseac-meeting-august-1-2011-donor.html</a> <br />
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<br />
Transmission of sporadic Creutzfeldt-Jakob disease by blood transfusion: risk factor or possible biases<br />
<br />
Maria Puopolo, Anna Ladogana, Vito Vetrugno, Maurizio Pocchiari<br />
<br />
Article first published online: 7 JAN 2011 <br />
<br />
DOI: 10.1111/j.1537-2995.2010.03004.x<br />
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© 2010 American Association of Blood Banks <br />
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BACKGROUND: The occurrence of transfusion transmissions of variant Creutzfeldt-Jakob disease (CJD) cases has reawakened attention to the possible similar risk posed by other forms of CJD. <br />
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STUDY DESIGN AND METHODS: CJD with a definite or probable diagnosis (sporadic CJD, n = 741; genetic CJD, n = 175) and no-CJD patients with definite alternative diagnosis (n = 482) with available blood transfusion history were included in the study. The risk of exposure to blood transfusion occurring more than 10 years before disease onset and for some possible confounding factors was evaluated by calculating crude odds ratios (ORs). Variables with significant ORs in univariate analyses were included in multivariate logistic regression analyses. <br />
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RESULTS: In the univariate model, blood transfusion occurring more than 10 years before clinical onset is 4.1-fold more frequent in sporadic CJD than in other neurologic disorders. This significance is lost when the 10-year lag time was not considered. Multivariate analyses show that the risk of developing sporadic CJD after transfusion increases (OR, 5.05) after adjusting for possible confounding factors. Analysis conducted on patients with genetic CJD did not reveal any significant risk factor associated with transfusion. <br />
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CONCLUSION: This is the first case-control study showing a significant risk of transfusion occurring more than 10 years before clinical onset in sporadic CJD patients. It remains questionable whether the significance of these data is biologically plausible or the consequence of biases in the design of the study, but they counterbalance previous epidemiologic negative reports that might have overestimated the assessment of blood safety in sporadic CJD. <br />
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<br />
<br />
<a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2010.03004.x/abstract;jsessionid=656FB07EE4507FB2632BA3E691D3B824.d03t02">http://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2010.03004.x/abstract;jsessionid=656FB07EE4507FB2632BA3E691D3B824.d03t02</a> <br />
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<a href="http://www.whale.to/v/singeltary4.html">http://www.whale.to/v/singeltary4.html</a> <br />
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<a href="http://www.whale.to/v/singeltary3.html">http://www.whale.to/v/singeltary3.html</a> <br />
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<br />
Wednesday, March 2, 2011 <br />
<br />
<br />
Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript <br />
<br />
Posted: 3/2/2011 Posted: 3/2/2011 <br />
<br />
<a href="http://tseac.blogspot.com/2011/03/transmissible-spongiform.html">http://tseac.blogspot.com/2011/03/transmissible-spongiform.html</a> <br />
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<br />
<br />
Thursday, June 23, 2011<br />
<br />
Experimental H-type bovine spongiform encephalopathy characterized by plaques and glial- and stellate-type prion protein deposits<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/experimental-h-type-bovine-spongiform.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/experimental-h-type-bovine-spongiform.html</a> <br />
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<br />
Thursday, July 21, 2011<br />
<br />
A Second Case of Gerstmann-Sträussler-Scheinker Disease Linked to the G131V Mutation in the Prion Protein Gene in a Dutch Patient Journal of Neuropathology & Experimental Neurology:<br />
<br />
August 2011 - Volume 70 - Issue 8 - pp 698-702<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/07/second-case-of-gerstmann-straussler.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/07/second-case-of-gerstmann-straussler.html</a> <br />
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<br />
Wednesday, August 24, 2011<br />
<br />
All Clinically-Relevant Blood Components Transmit Prion Disease following a Single Blood Transfusion: A Sheep Model of vCJD <br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/all-clinically-relevant-blood.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/all-clinically-relevant-blood.html</a> <br />
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<br />
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<br />
Wednesday, August 24, 2011 <br />
<br />
There Is No Safe Dose of Prions <br />
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/there-is-no-safe-dose-of-prions.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/there-is-no-safe-dose-of-prions.html</a> <br />
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<br />
Saturday, December 3, 2011<br />
<br />
Candidate Cell Substrates, Vaccine Production, and Transmissible Spongiform Encephalopathies <br />
<br />
Volume 17, Number 12—December 2011 <br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/candidate-cell-substrates-vaccine.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/candidate-cell-substrates-vaccine.html</a> <br />
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<br />
Friday, December 16, 2011 <br />
<br />
Creutzfeldt-Jacob Disease Question Asked by Lord Walton of Detchant P-Capt filter <br />
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/12/creutzfeldt-jacob-disease-question.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/12/creutzfeldt-jacob-disease-question.html</a> <br />
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<br />
<br />
<br />
Wednesday, May 11, 2011 House of Commons CJD May 2011 UPDATE <br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/house-of-commons-cjd-may-2011-update.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/house-of-commons-cjd-may-2011-update.html</a> <br />
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Monday, December 12, 2011<br />
<br />
Second iatrogenic CJD case confirmed Korea <br />
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/12/second-iatrogenic-cjd-case-confirmed.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/12/second-iatrogenic-cjd-case-confirmed.html</a> <br />
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<br />
Thursday, December 08, 2011<br />
<br />
A case of Iatrogenic Creutzfeldt Jakob Disease (iCJD) in a patient who had received a German-manufactured human dura mater graft 23 years ago <br />
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/12/case-of-iatrogenic-creutzfeldt-jakob.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/12/case-of-iatrogenic-creutzfeldt-jakob.html</a> <br />
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Saturday, November 19, 2011 <br />
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<br />
Novel Prion Protein in BSE-affected Cattle, Switzerland <br />
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<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/11/novel-prion-protein-in-bse-affected.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/11/novel-prion-protein-in-bse-affected.html</a> <br />
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Saturday, December 3, 2011<br />
<br />
Isolation of Prion with BSE Properties from Farmed Goat <br />
<br />
Volume 17, Number 12—December 2011 <br />
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/isolation-of-prion-with-bse-properties.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/12/isolation-of-prion-with-bse-properties.html</a> <br />
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Saturday, June 25, 2011 <br />
<br />
Transmissibility of BSE-L and Cattle-Adapted TME Prion Strain to Cynomolgus Macaque <br />
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<br />
"BSE-L in North America may have existed for decades" <br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/transmissibility-of-bse-l-and-cattle.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/06/transmissibility-of-bse-l-and-cattle.html</a> <br />
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<br />
<br />
<br />
Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME. <br />
<br />
<br />
snip... <br />
<br />
The rancher was a ''dead stock'' feeder using mostly (>95%) downer or dead dairy cattle... <br />
<br />
<br />
<a href="http://web.archive.org/web/20030516051623/http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf">http://web.archive.org/web/20030516051623/http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf</a> <br />
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<br />
<br />
<br />
<br />
2010-2011 <br />
<br />
When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures. <br />
<br />
This study will contribute to a correct definition of specified risk material (SRM) in atypical BSE. The incumbent of this position will develop new and transfer existing, ultra-sensitive methods for the detection of atypical BSE in tissue of experimentally infected cattle. <br />
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<br />
<a href="http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2">http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2</a> <br />
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<br />
2011 Monday, September 26, 2011 <br />
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L-BSE BASE prion and atypical sporadic CJD <br />
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<br />
<a href="http://bse-atypical.blogspot.com/2011/09/l-bse-base-prion-and-atypical-sporadic.html">http://bse-atypical.blogspot.com/2011/09/l-bse-base-prion-and-atypical-sporadic.html</a> <br />
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Monday, June 27, 2011 <br />
<br />
<br />
Zoonotic Potential of CWD: Experimental Transmissions to Non-Human Primates <br />
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<br />
<a href="http://chronic-wasting-disease.blogspot.com/2011/06/zoonotic-potential-of-cwd-experimental.html">http://chronic-wasting-disease.blogspot.com/2011/06/zoonotic-potential-of-cwd-experimental.html</a> <br />
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<br />
This is an interesting editorial about the Mad Cow Disease debacle, and it's ramifications that will continue to play out for decades to come ; Monday, October 10, 2011 EFSA Journal 2011 The European Response to BSE: A Success Story snip... EFSA and the European Centre for Disease Prevention and Control (ECDC) recently delivered a scientific opinion on any possible epidemiological or molecular association between TSEs in animals and humans (EFSA Panel on Biological Hazards (BIOHAZ) and ECDC, 2011). This opinion confirmed Classical BSE prions as the only TSE agents demonstrated to be zoonotic so far but the possibility that a small proportion of human cases so far classified as "sporadic" CJD are of zoonotic origin could not be excluded. Moreover, transmission experiments to non-human primates suggest that some TSE agents in addition to Classical BSE prions in cattle (namely L-type Atypical BSE, Classical BSE in sheep, transmissible mink encephalopathy (TME) and chronic wasting disease (CWD) agents) might have zoonotic potential. snip... <br />
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<br />
<a href="http://www.efsa.europa.eu/en/efsajournal/pub/e991.htm?emt=1">http://www.efsa.europa.eu/en/efsajournal/pub/e991.htm?emt=1</a> <br />
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<br />
<br />
<br />
<a href="http://www.efsa.europa.eu/en/efsajournal/doc/e991.pdf">http://www.efsa.europa.eu/en/efsajournal/doc/e991.pdf</a> <br />
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<br />
<br />
<br />
<br />
<br />
see follow-up here about North America BSE Mad Cow TSE prion risk factors, and the ever emerging strains of Transmissible Spongiform Encephalopathy in many species here in the USA, including humans ; <br />
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<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/10/efsa-journal-2011-european-response-to.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/10/efsa-journal-2011-european-response-to.html</a> <br />
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<br />
Thursday, August 4, 2011 <br />
<br />
<br />
Terry Singeltary Sr. on the Creutzfeldt-Jakob Disease Public Health Crisis, Date aired: 27 Jun 2011 (SEE VIDEO) <br />
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<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/terry-singeltary-sr-on-creutzfeldt.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/terry-singeltary-sr-on-creutzfeldt.html</a> <br />
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Sunday, August 21, 2011 <br />
<br />
The British disease, or a disease gone global, The TSE Prion Disease (SEE VIDEO) <br />
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<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/british-disease-or-disease-gone-global.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/british-disease-or-disease-gone-global.html</a> <br />
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<br />
Saturday, March 5, 2011 <br />
<br />
<br />
MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE RISE IN NORTH AMERICA <br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html</a> <br />
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<br />
<br />
<br />
Tuesday, November 01, 2011 <br />
<br />
Could we face the return of CJD? Experts fear it may lie dormant in thousands<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/11/could-we-face-return-of-cjd-experts.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/11/could-we-face-return-of-cjd-experts.html</a> <br />
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<br />
Tuesday, November 08, 2011 <br />
<br />
Can Mortality Data Provide Reliable Indicators for Creutzfeldt-Jakob Disease Surveillance? A Study in France from 2000 to 2008 Vol. 37, No. 3-4, 2011<br />
<br />
Original Paper <br />
<br />
Conclusions:These findings raise doubt about the possibility of a reliable CJD surveillance only based on mortality data. <br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/11/can-mortality-data-provide-reliable.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/11/can-mortality-data-provide-reliable.html</a> <br />
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<br />
<br />
Thursday, August 12, 2010 <br />
<br />
USA Blood products, collected from a donor who was at risk for vCJD, were distributed July-August 2010 <br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html</a> <br />
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<br />
<br />
<br />
Sunday, August 01, 2010 <br />
<br />
Blood product, collected from a donors possibly at increased risk for vCJD only, was distributed USA JULY 2010 <br />
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<br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html">http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html</a> <br />
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<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/">http://vcjdtransfusion.blogspot.com/</a> <br />
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<br />
<br />
<br />
Saturday, August 13, 2011<br />
<br />
Sensitive detection of prion proteins in blood <br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/sensitive-detection-of-prion-proteins.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/08/sensitive-detection-of-prion-proteins.html</a><br />
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<br />
<br />
Friday, July 8, 2011 <br />
<br />
<br />
Blood Test Could Quickly Detect Prion Diseases <br />
<br />
Prion Diseases <br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/07/blood-test-could-quickly-detect-prion.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/07/blood-test-could-quickly-detect-prion.html</a> <br />
<br />
<br />
<br />
Monday, February 7, 2011<br />
<br />
FDA’s Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???<br />
<br />
<a href="http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html">http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html</a> <br />
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<br />
<br />
<br />
Tuesday, September 14, 2010 <br />
<br />
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION) <br />
<br />
<a href="http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html">http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html</a> <br />
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<br />
<br />
Saturday, October 24, 2009 <br />
<br />
SaBTO Advisory Committee on the Safety of Blood, Tissues and Organs 2nd Public Meeting 27 October 2009 <br />
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SaBTO<br />
<br />
<a href="http://seac992007.blogspot.com/2009/10/sabto-advisory-committee-on-safety-of.html">http://seac992007.blogspot.com/2009/10/sabto-advisory-committee-on-safety-of.html</a><br />
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<br />
<br />
<br />
<br />
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission) <br />
<br />
<a href="http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html">http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html</a> <br />
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<br />
Sunday, July 27, 2008<br />
<br />
Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission) <br />
<br />
-------- Original Message -------- <br />
<br />
Subject: Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)<br />
<br />
Date: Sun, 11 Jul 2004 21:34:22 –0500<br />
<br />
From: "Terry S. Singeltary Sr."<br />
<br />
To: fdadockets@oc.fda.gov CC: regulations@aphis.usda.gov, burt.pritchett@fda.gov<br />
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<br />
<a href="http://madcowfeed.blogspot.com/2008/07/docket-no-04-047-l-regulatory.html">http://madcowfeed.blogspot.com/2008/07/docket-no-04-047-l-regulatory.html</a><br />
<br />
<br />
<br />
Response to Public Comments<br />
<br />
on the<br />
<br />
Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005<br />
<br />
INTRODUCTION<br />
<br />
The United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) held a public meeting on July 25, 2006 in Washington, D.C. to present findings from the Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 (report and model located on the FSIS website: http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp). Comments on technical aspects of the risk assessment were then submitted to FSIS. Comments were received from Food and Water Watch, Food Animal Concerns Trust (FACT), Farm Sanctuary, R-CALF USA, Linda A Detwiler, and Terry S. Singeltary. This document provides itemized replies to the public comments received on the 2005 updated Harvard BSE risk assessment. Please bear the following points in mind: <br />
<br />
<br />
<br />
<a href="http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf">http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf</a> <br />
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<br />
<br />
<br />
Suppressed peer review of Harvard study October 31, 2002. <br />
<br />
October 31, 2002 Review of the Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States Conducted by the Harvard Center for Risk Analysis, Harvard School of Public Health and Center for Computational Epidemiology, College of Veterinary Medicine, Tuskegee University Final Report Prepared for U.S. Department of Agriculture Food Safety and Inspection Service Office of Public Health and Science Prepared by RTI Health, Social, and Economics Research Research Triangle Park, NC 27709 RTI Project Number 07182.024 <br />
<br />
<a href="http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf">http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf</a> <br />
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<br />
Sunday, February 14, 2010 <br />
<br />
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) <br />
<br />
<a href="http://bseusa.blogspot.com/2010/02/docket-no-fsis-2006-0011-fsis-harvard.html">http://bseusa.blogspot.com/2010/02/docket-no-fsis-2006-0011-fsis-harvard.html</a> <br />
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<br />
Thursday, April 9, 2009 <br />
<br />
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Thursday, April 09, 2009 <br />
<br />
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed <br />
<br />
mailto:burt.pritchett@fda.hhs.gov <br />
<br />
Greetings FDA et al, <br />
<br />
I kindly wish to comment on the following ; <br />
<br />
[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273) RIN 0910-AF46 <br />
<br />
[Federal Register: April 9, 2009 (Volume 74, Number 67)] [Proposed Rules] [Page 16160-16161] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09ap09-18] <br />
<br />
<br />
<a href="http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html">http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html</a> <br />
<br />
<br />
<br />
Owens, Julie <br />
<br />
<br />
From: Terry S. Singeltary Sr. [flounder9@verizon.net] <br />
<br />
<br />
Sent: Monday, July 24, 2006 1:09 PM To: FSIS RegulationsComments <br />
<br />
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Page 1 of 98 8/3/2006 <br />
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Greetings FSIS, I would kindly like to comment on the following ; <br />
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<a href="http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf">http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf</a> <br />
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<a href="http://www.scribd.com/doc/1490709/USDA-200600111">http://www.scribd.com/doc/1490709/USDA-200600111</a> <br />
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03-025IFA<br />
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03-025IFA-2<br />
<br />
Terry S. Singeltary <br />
<br />
From: Terry S. Singeltary Sr. [flounder9@verizon.net]<br />
<br />
Sent: Thursday, September 08, 2005 6:17 PM<br />
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To: fsis.regulationscomments@fsis.usda.gov<br />
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Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle<br />
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Greetings FSIS,<br />
<br />
I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle <br />
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<a href="http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf">http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf</a> <br />
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<a href="http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4189oph_1.pdf">http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4189oph_1.pdf</a> <br />
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PLEASE be aware, for 4 years, the USDA fed our children all across the Nation (including TEXAS) dead stock downer cows, the most high risk cattle for BSE aka mad cow disease and other dangerous pathogens. <br />
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<br />
who will watch our children for CJD for the next 5+ decades ??? <br />
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WAS your child exposed to mad cow disease via the NSLP ??? <br />
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SCHOOL LUNCH PROGRAM FROM DOWNER CATTLE UPDATE<br />
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<a href="http://downercattle.blogspot.com/2009/05/who-will-watch-children.html">http://downercattle.blogspot.com/2009/05/who-will-watch-children.html</a> <br />
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<a href="http://downercattle.blogspot.com/">http://downercattle.blogspot.com/</a> <br />
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DID YOUR CHILD CONSUME SOME OF THESE DEAD STOCK DOWNER COWS, THE MOST HIGH RISK FOR MAD COW DISEASE ???<br />
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you can check and see here ;<br />
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<a href="http://www.fns.usda.gov/fns/safety/pdf/Hallmark-Westland_byState.pdf">http://www.fns.usda.gov/fns/safety/pdf/Hallmark-Westland_byState.pdf</a> <br />
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Docket Management Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305<br />
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Comment Number: EC –254<br />
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Accepted - Volume 11 <br />
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Sources: World Trade Atlas What is the level of passenger traffic arriving in the United States from the affected country? Approximately 185,000 direct flights from Greece arrived to US airports in fiscal year 2000. Also, an unknown number of passengers from Greece arrived via indirect flights. Under APHIS-PPQ's agriculture quarantine inspection monitoring, 584 air passengers from Greece were sampled for items of agricultural interest in fiscal year 2000. Of these passengers, 14 carried meat (non-pork) items that could potentially transmit pathogens that cause BSE; most passengers carried from one to two kilograms (kg) of meat, although one passenger in November 1999 carried 23 kg of meat in a suitcase. Florida, Massachusetts, and New York were the reported destinations of these passengers. None of the passengers with meat items reported plans to visit or work on a ranch or farm while in the US. Source: US Department of Transportation, and APHIS-PPQ Agricultural Quarantine Inspection data base<br />
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<a href="http://www.aphis.usda.gov/vs/ceah/cei/bse_greece0701.htm">http://www.aphis.usda.gov/vs/ceah/cei/bse_greece0701.htm</a> <br />
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Greetings list members, i just cannot accept this; <br />
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<br />
> 23 kg of meat in a suitcase (suitcase bomb...TSS)<br />
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> The data do not provide a species of origin code for these<br />
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> products, therefore they may not contain any ruminant product. <br />
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what kind of statement is this? how stupid do they think we are? it could also very well mean that _all_ of it was ruminant based products ! <br />
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<a href="http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm">http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm</a> <br />
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Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a<br />
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Comment Number: EC –2 <br />
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Accepted - Volume 7 <br />
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<a href="http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm">http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm</a><br />
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Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7 <br />
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snip...<br />
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what did Paul Brown say about this previously; <br />
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i bring your attention to (page 500) Dr. Paul Brown statements; <br />
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253 1 DR. BOLTON: I have an additional question about 2 that. What is the assurance that additional locally sourced 3 tracheas are not added into that manufacturing process, thus 4 boosting the yield, if you will, but being returned to the 5 U.S. as being produced from U.S.-sourced raw material? 6 DR. McCURDY: Are there data to indicate how many 7 grams, or whatever, of infected brain are likely to infect 8 an organism, either animal or man, when taken orally? 9 DR. BROWN: If I am not mistaken, and I can be 10 corrected, I think a half a gram is enough in a cow, orally; [FULL TEXT ABOUT 600 PAGES] 3681t2.rtf http://www.fda.gov/ohrms/dockets/ac/cber01.htm <br />
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snip...<br />
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<a href="http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm">http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/96n0417/96N-0417-EC-2.htm</a> <br />
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Unregulated "foods" such as 'nutritional supplements' containing various extracts from ruminants, whether imported or derived from 3 US cattle/sheep/cervids ("antler velvet" extracts!) should be forbidden or at least very seriously regulated.<br />
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(neighbors Mom, whom also died from CJD, had been taking bovine based supplement, which contained brain, eye, and many other bovine/ovine tissues for years, 'IPLEX'). <br />
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<a href="http://www.fda.gov/OHRMS/DOCKETS/AC/01/slides/3681s2_09.pdf">http://www.fda.gov/OHRMS/DOCKETS/AC/01/slides/3681s2_09.pdf</a><br />
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my plight with metabolife and there 'bovine complex' about risk factors of TSE in there product ;<br />
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Terry S. Singeltary Sr. wrote: <br />
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######## Bovine Spongiform Encephalopathy<bse-l at="" uni-karlsruhe.de=""> #########<br />
<br />
1. Dietary Supplements: Review of Health-Related Call Records for > Users of Metabolife 356. GAO-03-494, March 31. <br />
</bse-l><br />
<bse-l at="" uni-karlsruhe.de=""><br />
<a href="http://www.gao.gov/cgi-bin/getrpt?GAO-03-494">http://www.gao.gov/cgi-bin/getrpt?GAO-03-494</a> <br />
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<a href="http://www.gao.gov/highlights/d03494high.pdf">http://www.gao.gov/highlights/d03494high.pdf</a> <br />
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<br />
-------- Original Message -------- <br />
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<br />
<br />
Subject: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''<br />
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Date: Thu, 01 May 2003 11:23:01 –0500<br />
<br />
From: "Terry S. Singeltary Sr." <flounder at="" wt.net=""><br />
<br />
To: NelliganJ at gao.gov<br />
<br />
The General Accounting Office (GAO) today released the following reports > and testimonies:<br />
<br />
REPORTS ;<br />
<br />
1. Dietary Supplements: Review of Health-Related Call Records for > Users of Metabolife 356. GAO-03-494, March 31.<br />
</flounder><br />
<flounder at="" wt.net=""><br />
<br />
<a href="http://www.gao.gov/cgi-bin/getrpt?GAO-03-494">http://www.gao.gov/cgi-bin/getrpt?GAO-03-494</a><br />
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<a href="http://www.gao.gov/highlights/d03494high.pdf">http://www.gao.gov/highlights/d03494high.pdf</a> <br />
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<br />
<div> </div><br />
<div> </div><br />
<div>> GREETINGS GAO: </div><br />
<div> </div><br />
<div>> i was suprised that i did not see any listing of bovine tissue in metabolife > on it's label. have they ceased using these desiccated tissues???</div><br />
<div> </div><br />
<div>> > i see that the lable on this product METABOLIFE 356, > does not state that it has any tissues of desiccated bovine organs? i no the product use to, so i am curious if they have </div><br />
<div> </div><br />
<div>> ceased the use of the tissues of cattle they _use_ to use (see below)??? </div><br />
<div> </div><br />
<div> </div><br />
<div>> METABOLIFE 356</div><br />
<div> </div><br />
<div>> BOVINE COMPLEX/GLANDULAR SYSTEM</div><br />
<div> </div><br />
<div>> OVARIES, PROSTATE, SCROTUM AND ADRENAL</div><br />
<div> </div><br />
<div>> USDA SOURCE CATTLE </div><br />
<div> </div><br />
<div>> > i tried warning them years ago of this potential threat of CJD/TSEs; </div><br />
<div> </div><br />
<div> </div><br />
<div>> > From: Randy Smith</div><br />
<div> </div><br />
<div>> To: "'flounder at wt.net'"</div><br />
<div> </div><br />
<div>> Subject: Metabolife</div><br />
<div> </div><br />
<div>> Date: Mon, 7 Dec 1998 14:21:35 –0800 </div><br />
<div> </div><br />
<div> </div><br />
<div>> > Dear Sir,</div><br />
<div> </div><br />
<div>> > We are looking at reformulation. I agree that slow virus diseases > present a problem in some areas of the world. </div><br />
<div> </div><br />
<div>> > Our product uses healthy USDA inspected cattle for the glandular > extract. </div><br />
<div> </div><br />
<div>> > If you have any links to more information on this subject I would like > to examine them. </div><br />
<div> </div><br />
<div>> > Thank you for your interest and concern, </div><br />
<div> </div><br />
<div>> > Dr. Smith </div><br />
<div> </div><br />
<div> </div><br />
<div>> ============ </div><br />
<div> </div><br />
<div> </div><br />
<div>> > From: Randy Smith</div><br />
<div> </div><br />
<div>> To: "'flounder at wt.net'"</div><br />
<div> </div><br />
<div>> Subject: RE: [Fwd: Your submission to the Inquiry]</div><br />
<div> </div><br />
<div>> Date: Wed, 9 Dec 1998 10:37:07 –0800</div><br />
<div> </div><br />
<div>> > Terry,</div><br />
<div> </div><br />
<div>> > Thank you for your note and the information links you forwarded to me. > I am new to Metabolife International, however hopefully as my role here > enlarges I well have a greater impact on formulation and product > development. </div><br />
<div> </div><br />
<div>> > Metabolife International does believe in placing safety first. And I am > going to do my best to see that we continue to do so. </div><br />
<div> </div><br />
<div>> > Sincerely,</div><br />
<div> </div><br />
<div>> Dr. Smith </div><br />
<div> </div><br />
<div> </div><br />
<div>> ============ </div><br />
<div> </div><br />
<div> </div><br />
<div>> -----Original Message-----</div><br />
<div> </div><br />
<div>> From: Terry S. Singeltary Sr. [mailto:flounder at wt.net] </div><br />
<div> </div><br />
<div>> Sent: Wednesday, December 09, 1998 5:49 PM</div><br />
<div> </div><br />
<div>> To: rsmith at metabolife.com</div><br />
<div> </div><br />
<div>> Subject: [Fwd: Your submission to the Inquiry] </div><br />
<div> </div><br />
<div> </div><br />
<div>> > Dr. Smith, I am truly impressed with you honesty, THANKS.....I am not > just spouting off about the potential dangers, here. THEY ARE REAL.....I > have forwarded an e-mail from the BSE Inquiry, in which I made a > statement about them........You might want to go to the site and read > through it........IT WILL TAKE A WHILE........ THINGS ARE HAPPENING HERE > SIR, THAT YOU ARE NOT AWARE OF, AND AS MOST PEOPLE ARE > NOT...............I JUST HOPE, THAT THE REFORMULATION YOU SPEAK OF, IS > IN FACT GOING TO TAKE PLACE. </div><br />
<div> </div><br />
<div> </div><br />
<div>> The Department of Health, here in the U.S., is also worried about the > potential dangers involved hear............Terry/MADSON </div><br />
<div> </div><br />
<div> </div><br />
<div>> ================================================== ======= </div><br />
<div> </div><br />
<div> </div><br />
<div>> From: Randy Smith</div><br />
<div> </div><br />
<div>> To: "'flounder at wt.net'"</div><br />
<div> </div><br />
<div>> Subject: RE: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]</div><br />
<div> </div><br />
<div>> Date: Fri, 18 Dec 1998 09:55:17 –0800</div><br />
<div> </div><br />
<div>> Return-Receipt-To: Randy Smith</div><br />
<div> </div><br />
<div>> > Thanks very much for the info. I appreciate all these articles I can > get. It does sound very familiar - just follow the green ($) trail. </div><br />
<div> </div><br />
<div> </div><br />
<div>> > -----Original Message-----</div><br />
<div> </div><br />
<div> </div><br />
<div>> From: Terry S. Singeltary Sr. [mailto:flounder at wt.net]</div><br />
<div> </div><br />
<div>> Sent: Friday, December 18, 1998 5:15 PM</div><br />
<div> </div><br />
<div>> To: rsmith at metabolife.com</div><br />
<div> </div><br />
<div>> Subject: [Fwd: MEDICINES "GREATER BSE RISK THAN BEEF"!!!!]</div><br />
<div> </div><br />
<div>> > Randy, thought you might be interested in this...............MADSON!!!!!1 </div><br />
<div> </div><br />
<div>> > snip... </div><br />
<div> </div><br />
<div> </div><br />
<div>> =============================== </div><br />
<div> </div><br />
<div> </div><br />
<div>> Sender: "Patricia Cantos" <patricia.cantos at="" bse.org.uk=""></patricia.cantos></div><br />
<div> </div><br />
<div>> To: "Terry S Singeltary Sr. (E-mail)" <flounder at="" wt.net=""></flounder></div><br />
<div> </div><br />
<div>> Subject: Your submission to the Inquiry</div><br />
<div> </div><br />
<div>> Date: Fri, 3 Jul 1998 10:10:05 +0100</div><br />
<div> </div><br />
<div>> > 3 July 1998</div><br />
<div> </div><br />
<div>> Mr Terry S Singeltary Sr.</div><br />
<div> </div><br />
<div>> E-Mail: Flounder at wt.net</div><br />
<div> </div><br />
<div>> Ref: E2979</div><br />
<div> </div><br />
<div>> > Dear Mr Singeltary,</div><br />
<div> </div><br />
<div>> > Thank you for your E-mail message of the 30th of June 1998 providing the > Inquiry with your further comments. Thank you for offering to provide the > Inquiry with any test results on the nutritional supplements your > mother was taking before she died.</div><br />
<div> </div><br />
<div>> > As requested I am sending you our general Information Pack and a copy of the > Chairman's letter. Please contact me if your system cannot read the attachments.</div><br />
<div> </div><br />
<div>> > Regarding your question, the Inquiry is looking into many aspects of the > scientific evidence on BSE and nvCJD. I would refer you to the > transcripts > of evidence we have already heard which are found on our internet site at > </div><br />
<div> </div><br />
<div><a href="http://www.bse.org.uk/">http://www.bse.org.uk</a>. </div><br />
<div> </div><br />
<div> </div><br />
<div>> > Could you please provide the Inquiry with a > copy of > the press article you refer to in your e-mail? If not an approximate date > for the article so that we can locate it? > In the meantime, thank you for you comments. Please do not hesitate to > contact me on 0171 261 8332 should you have any queries. </div><br />
<div> </div><br />
<div> </div><br />
<div> > > Yours sincerely</div><br />
<div> </div><br />
<div> </div><br />
<div>> Patricia Cantos</div><br />
<div> </div><br />
<div> </div><br />
<div>> Families Team Leader</div><br />
<div> </div><br />
<div> </div><br />
<div>> Attachments</div><br />
<div> </div><br />
<div> </div><br />
<div>> TSS </div><br />
<div> </div><br />
<div> </div><br />
<div>> ============== </div><br />
<div> </div><br />
<div> </div><br />
<div> > -------- Original Message -------- </div><br />
<div> </div><br />
<div> > Subject: re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''</div><br />
<div> </div><br />
<div>> Date: Thu, 01 May 2003 16:04:35 –0400</div><br />
<div> </div><br />
<div>> From: "Marcia G Crosse" <crossem at="" gao.gov=""></crossem></div><br />
<div> </div><br />
<div>> To: <flounder at="" wt.net=""></flounder></div><br />
<div> </div><br />
<div>> CC: "Charles W Davenport" <davenportc at="" gao.gov="">, "Carolyn Feis Korman" > <feiskormanc at="" gao.gov="">, "Martin Gahart" <gahartm at="" gao.gov=""> ></gahartm></feiskormanc></davenportc></div><br />
<div> </div><br />
<div> </div><br />
<div>> Mr. Singletary,</div><br />
<div> </div><br />
<div> </div><br />
<div>> > We were informed by representatives of Metabolife, Inc. that Metabolife </div><br />
<div> </div><br />
<div>> 356 was reformulated to remove bovine complex as an ingredient in the </div><br />
<div> </div><br />
<div>> product, approximately September 2001. We did not independently verify </div><br />
<div> </div><br />
<div>> the contents of the product.</div><br />
<div> </div><br />
<div> </div><br />
<div>> > Sincerely,</div><br />
<div> </div><br />
<div>> Marcia Crosse</div><br />
<div> </div><br />
<div>> Acting Director</div><br />
<div> </div><br />
<div>> Health CarePublic Health and Science Issues</div><br />
<div> </div><br />
<div>> U.S. General Accounting Office</div><br />
<div> </div><br />
<div>> 441 G Street, N.W.</div><br />
<div> </div><br />
<div>> Washington, D.C. 20548</div><br />
<div> </div><br />
<div> </div><br />
<div>> ===================</div><br />
<div> </div><br />
<div> </div><br />
<div>> > -------- Original Message --------</div><br />
<div> </div><br />
<div>> Subject: Re: METABOLIFE AND TSEs GAO-03-494 ''URGENT DATA''</div><br />
<div> </div><br />
<div>> Date: Thu, 01 May 2003 15:48:52 –0500</div><br />
<div> </div><br />
<div>> From: "Terry S. Singeltary Sr." <flounder at="" wt.net=""></flounder></div><br />
<div> </div><br />
<div>> To: Marcia G Crosse <crossem at="" gao.gov=""></crossem></div><br />
<div> </div><br />
<div>> CC: Charles W Davenport <davenportc at="" gao.gov="">, Carolyn Feis Korman > <feiskormanc at="" gao.gov="">, Martin Gahart <gahartm at="" gao.gov=""> > References: <seb14599.014 at="" gaogwia1.gao.gov=""> > </seb14599.014></gahartm></feiskormanc></davenportc></div><br />
<div> </div><br />
<div>> THANK YOU! > > MIRACLES DO HAPPEN! ;-) > > now all we need to do is; ></div><br />
<div> </div><br />
<div>> snip......</div><br />
<div> </div><br />
<div>> > one small step for man, one giant leap for mankind ;-)</div><br />
<div> </div><br />
<div>> > however; ></div><br />
<div> </div><br />
<div>> ''We did not independently verify the contents of the product''</div><br />
<div> </div><br />
<div>> > ???</div><br />
<div> </div><br />
<div>></div><br />
<div> </div><br />
<div>> TSS ></div><br />
<div> </div><br />
<div> </div><br />
<div>> ####### <a href="http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html">http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html</a> ######## </div><br />
<div> </div><br />
<div> </div><br />
<patricia.cantos at="" bse.org.uk=""><flounder at="" wt.net=""><crossem at="" gao.gov=""><flounder at="" wt.net=""><davenportc at="" gao.gov=""><feiskormanc at="" gao.gov=""><gahartm at="" gao.gov=""><flounder at="" wt.net=""><crossem at="" gao.gov=""><davenportc at="" gao.gov=""><feiskormanc at="" gao.gov=""><gahartm at="" gao.gov=""><seb14599.014 at="" gaogwia1.gao.gov=""><br />
<br />
<a href="http://bseinquiry.blogspot.com/">http://bseinquiry.blogspot.com/</a> <br />
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<a href="http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm">http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm</a> <br />
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<br />
Could you get mad cow from a pill ? Some doctors say a class of pills that promise smarts, energy, and sexual vitality may cause mad-cow disease. <br />
<br />
The government isn't worried. Should you be?<br />
<br />
June 1, 2001 <br />
<br />
Health Magazine <br />
<br />
by Susan Freinkel<br />
<br />
<a href="http://www.organicconsumers.org/madcow/pill6101.cfm">http://www.organicconsumers.org/madcow/pill6101.cfm</a> <br />
<br />
<br />
<br />
<br />
GERMAN DER SPIEGEL MAGAZINEDie <br />
<br />
BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden sind lax. <br />
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<a href="http://www.spiegel.de/spiegel/0,1518,119306,00.html">http://www.spiegel.de/spiegel/0,1518,119306,00.html</a> <br />
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From: Terry S. Singeltary Sr. [flounder@wt.net] <br />
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Sent: Tuesday, July 29, 2003 1:03 PM <br />
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To: fdadockets@oc.fda.govCc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L <br />
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Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSIONTO DOCKET 2003N-0312] <br />
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<a href="http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt">http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt</a> <br />
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Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA [takes a few minutes to load...TSS] <br />
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<a href="https://web01.aphis.usda.gov/BSEcom.nsf/BSEFrameset?OpenFrameSet&Frame=BottomFrame&Src=_25t156hb3dtmisrjjconjcc9n6ph6ccr66oqjgdpo74qm6e1l68qjcp9hc4o30dhgckq34phfc8rjgoj16orjep9ic8o66c9i64s3achl6pi68cpg60r38eb675i3ujrgcln48rr3elmmarjk4p0nat3f8pp62rb5cg0">https://web01.aphis.usda.gov/BSEcom.nsf/BSEFrameset?OpenFrameSet&Frame=BottomFrame&Src=_25t156hb3dtmisrjjconjcc9n6ph6ccr66oqjgdpo74qm6e1l68qjcp9hc4o30dhgckq34phfc8rjgoj16orjep9ic8o66c9i64s3achl6pi68cpg60r38eb675i3ujrgcln48rr3elmmarjk4p0nat3f8pp62rb5cg0</a>_<br />
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Docket Management Docket: 02N-0273 - Substances Prohibited From Use in<br />
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Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed<br />
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Comment Number: EC -10<br />
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Accepted - Volume 2 <br />
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<a href="http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html">http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html</a> <br />
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PART 2 <br />
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http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html <br />
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Asante/Collinge et al, that BSE transmission to the 129-methionine<br />
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genotype can lead to an alternate phenotype that is indistinguishable<br />
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from type 2 PrPSc, the commonest _sporadic_ CJD; <br />
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<a href="http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm">http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm</a> <br />
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Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients a Comment Number: EC -2 Accepted - Volume 7<br />
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<a href="http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm">http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm</a> <br />
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Dockets Entered On October 2, 2003 Table of Contents, Docket #,Title, 1978N-0301,<br />
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OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr. Vol #: 1, ...<br />
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<a href="http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm">www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm</a> <br />
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Daily Dockets Entered on 02/05/03<br />
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DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2. ... Vol#: 1.<br />
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03N-0009 Federal Preemption of State & Local Medical Device Requireme. ... <br />
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<a href="http://www.fda.gov/ohrms/dockets/dailys/03/Feb03/020503/020503.htm">www.fda.gov/ohrms/dockets/dailys/03/Feb03/020503/020503.htm</a> <br />
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Docket Management<br />
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Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater<br />
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Comment Number: EC -1<br />
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Accepted - Volume 1 <br />
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<a href="http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html">http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html</a> <br />
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<a href="http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfe.html">http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfe.html</a> <br />
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<a href="http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfc.html">http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfc.html</a> <br />
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<br />
Freas, William <br />
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Terry S. Singeltary Sr. [flounder@wt.net] <br />
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Monday, January 08,200l 3:03 PM <br />
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<a href="mailto:freas@CBS5055530.CBER.FDA.GOV">freas@CBS5055530.CBER.FDA.GOV</a> <br />
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CJD/BSE (aka madcow) Human/Animal TSE’s--U.S.--Submission To Scientific Advisors and Consultants Staff January 2001 Meeting (short version) <br />
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<a href="http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf">http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf</a> <br />
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[PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1 <br />
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Agent, Weapons of Mass Destruction Operations Unit Federal Bureau of those who provided comments in response to Docket No. ... Meager 8/18/01 Terry S. Singeltary Sr ... <br />
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<a href="http://www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf">www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf</a> <br />
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Tuesday, February 8, 2011 U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001 <br />
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<a href="http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html">http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html</a> <br />
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<a href="http://tseac.blogspot.com/">http://tseac.blogspot.com/</a> <br />
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Friday, December 16, 2011 <br />
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OIG VULNERABILITIES IN FDA’S OVER SIGHT OF STATE FOOD FACILITY INSPECTIONS <br />
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FDA faulted over state inspections <br />
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<a href="http://fdafailedus.blogspot.com/2011/12/oig-vulnerabilities-in-fdas-over-sight.html">http://fdafailedus.blogspot.com/2011/12/oig-vulnerabilities-in-fdas-over-sight.html</a> <br />
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Sunday, November 13, 2011 <br />
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California BSE mad cow beef recall, QFC, CJD, and dead stock downer livestock <br />
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/11/california-bse-mad-cow-beef-recall-qfc.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/11/california-bse-mad-cow-beef-recall-qfc.html</a> <br />
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TSS<br />
</seb14599.014></gahartm></feiskormanc></davenportc></crossem></flounder></gahartm></feiskormanc></davenportc></flounder></crossem></flounder></patricia.cantos></flounder></bse-l>Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-49947325532095898712011-07-27T09:54:00.000-07:002011-07-28T18:02:46.325-07:00HIQA says vCJD blood filter not justifiedHIQA says vCJD blood filter not justified<br />
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[Posted: Wed 27/07/2011 <a href="http://www.irishhealth.com/">http://www.irishhealth.com/</a>]<br />
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The health safety body HIQA has ruled that the cost of introducing a new filter system to prevent vCJD infection through blood transfusions in Ireland cannot be justified.<br />
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Implementing such a filter system would initially cost €11 million per year a would potentially prevent two deaths over a 10-year period, HIQA said.<br />
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HIQA has carried out a cost-benefit analysis on introducing a new filtering technology with the potential to reduce further the low risk of transmitting vCJD through transfusions.<br />
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It said the prion filters appeared to be safe and would remove almost all the residual risk of vCJD from blood for transfusion.<br />
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However, the safety body concluded that the introduction of prion filters, either for all people getting transfusions or for limited sub-groups of patients, could not be justified when the costs and benefits were weighed up.<br />
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The origin of vCJD infection has been linked to the consumption of BSE-infected beef. It may also be transmitted via a blood transfusion from an infected donor who has not developed symptoms of the disease.<br />
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HIQA said in arriving at its recommendation about prion filters, it noted the 'substantial undertainty around the risk of vCJD in Ireland.'<br />
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The safety body said the level of undiagnosed cases of the disease in Ireland wa slikely to be low and that the corresponding risk of transfusion-transmitted infection was extremely low.<br />
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Dr Patricia Harrington of HIQA said the cost of implementing universal prion filtration was high compared to the likely benefits.<br />
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HIQA has submitted its recommendation on prion filters to the Minister for Health for consideration.<br />
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<a href="http://www.irishhealth.com/article.html?id=19541">http://www.irishhealth.com/article.html?id=19541</a><br />
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SEE UPDATE ;<br />
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HIQA publishes assessment of vCJD filter technology<br />
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Date of publication: Wednesday, July 27, 2011 <br />
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The Health Information and Quality Authority has today (27 July 2011) published the results of a health technology assessment (HTA) of prion filters, a new technology with the potential to further reduce the low risk of transmitting variant-Creutzfeldt-Jakob disease (vCJD) through a blood transfusion.<br />
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The Authority's assessment found that, based on current published evidence, the filters appear to be safe and would remove almost all the residual risk of vCJD transmission from red cell concentrates (blood from which most of the plasma and platelets has been removed). However, introduction of prion filters, either for all transfusion recipients or for limited sub-groups, was found to be not cost-effective when measured against traditional standards of cost-effectiveness.<br />
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vCJD is one of a group of rare, progressive and ultimately fatal degenerative disease of the nervous system, also known as prion diseases. They are thought to be caused by an abnormal form of a naturally occurring protein in the brain (the prion protein) that has been acquired through infection. The origin of vCJD has been linked to the consumption of BSE-infected beef. However, vCJD may also be transmitted via a blood transfusion from an infected donor who has not developed symptoms of the disease. Prion filtration is a new technology to be used in conjunction with existing blood safety strategies which aim to reduce the risk of vCJD transmission. The filters are designed to remove infectious prion protein from donated blood rendering the transfused blood safer to recipients.<br />
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The assessment notes the substantial uncertainty around the risk of vCJD transmission in Ireland. It notes the level of undiagnosed vCJD in Ireland is likely to be low and that the corresponding risk of transfusion-transmitted infection would be extremely low.<br />
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Dr Patricia Harrington, Head of Assessment with the Authority's Health Technology Assessment Directorate, said: "The Authority's HTA found that to filter red cell concentrates as proposed by the blood service would initially cost ?11 million per year. It was estimated that such a measure would, over a 10-year period, potentially prevent two deaths from vCJD."<br />
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The Board of the Authority has approved the HTA report and it has been submitted to the Minister for Health for his consideration.<br />
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Dr Harrington concluded: "The HTA has concluded that the cost of universal prion filtration is substantial. This financial cost, of further minimising what is most likely a low risk, is high compared to the likely benefits. In Ireland, the risk of acquiring vCJD from a transfusion of red cell concentrates in the absence of prion filtration is low. It notes therefore, that in the context of a finite healthcare budget, a decision to invest in prion filtration may have implications for the funding of other technologies and services in our health system."<br />
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For a full copy of the report please go to: www.hiqa.ie. You can also find us on Facebook and Twitter by searching 'HIQA'.<br />
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Further Information:<br />
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Marty Whelan Head of Communications and Stakeholder Engagement Directorate 01 8147481 / 086 2447623 or email mwhelan@hiqa.ie<br />
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Notes to the Editor:<br />
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The Health Information and Quality Authority is the statutory organisation in Ireland with a responsibility to carry out national health technology assessments (HTAs) and to develop guidelines for the conduct of HTAs across our health system. Whole donated blood is not generally re-transfused to recipients. It is first separated into its constituent parts, including units of red blood cells (referred to as units or red cell concentrates or RCC), units of platelets and units of plasma. The term 'blood transfusion' typically refers to a transfusion of RCC. Prion filters are new technologies that aim to reduce any residual infectious prion protein that may be present in donated blood, rendering it safer for transfusion. The IBTS has proposed adoption of prion filtration of RCC as an additional safety control measure. There is currently no commercially available human blood test to identify the presence of the abnormal prion protein associated with vCJD. The origin of vCJD has been linked to the consumption of BSE-infected beef. The incidence of BSE and vCJD peaked in the UK in 1992-1993 and 2000, respectively, declining since. There have been 170 deaths from vCJD in the UK and 4 deaths in Ireland, two of which are thought to have originated in the UK. vCJD may potentially be transmitted via a blood transfusion from an infected donor who may not have developed symptoms of the disease. Worldwide there have been five documented cases of transfusion-related vCJD infection, resulting in three deaths from clinical vCJD. It is predicted that prion filtration of all RCCs will initially cost ?11 million per annum and, over a 10-year time period, will prevent two deaths from vCJD and result in 19.4 discounted life years gained. The incremental cost-effectiveness ratio (ICER) of prion filtration is ?2.6 million per quality of life year gained (QALY). As a comparison, a HTA of population-based colorectal cancer screening carried out by the Authority found that this measure had an estimated ICER of ?1,696 per QALY compared to a policy of no screening. This screening was estimated to cost ?15 million per annum at full implementation, averting 160 cases of colorectal cancer and 270 deaths from colorectal cancer in year 10 of the screening programme.<br />
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<a href="http://www.hiqa.ie/press-release/2011-07-27-hiqa-publishes-assessment-vcjd-filter-technology-0">http://www.hiqa.ie/press-release/2011-07-27-hiqa-publishes-assessment-vcjd-filter-technology-0</a><br />
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The Health Information and Quality Authority has today (27 July 2011) published the results of a health technology assessment (HTA) of prion filters, a new technology with the potential to further reduce the low risk of transmitting variant-Creutzfeldt-Jakob disease (vCJD) through a blood transfusion.<br />
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<a href="http://www.hiqa.ie/system/files/HTA-Prion-Filtration.pdf">http://www.hiqa.ie/system/files/HTA-Prion-Filtration.pdf</a><br />
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TSS<br />
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tell that to the victims of the nvCJD, there families and friends. ...TSS<br />
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----- Original Message -----<br />
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From: Emery, Bryan (CBER)<br />
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To: 'Terry S. Singeltary Sr.'<br />
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Cc: Emery, Bryan (CBER)<br />
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Sent: Friday, July 22, 2011 9:47 AM<br />
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Subject: RE: TSEAC Meeting August 1, 2011 donor deferral Saudi Arabia vCJD risk blood and blood products<br />
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Hi Mr. Singeltary,<br />
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Your statement will be provided to the members and will be placed in the meetings display folder for the public to see. Come or attend via webcast.<br />
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thanks for your public participation<br />
<br />
LCDR Bryan Emery<br />
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--------------------------------------------------------------------------------<br />
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From: Terry S. Singeltary Sr. [mailto:flounder9@verizon.net]<br />
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Sent: Wednesday, June 29, 2011 3:54 PM<br />
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To: Emery, Bryan (CBER)<br />
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Cc: Harvey, Rosanna; BSE-L@LISTS.AEGEE.ORG; CJD-L@LISTS.AEGEE.ORG; cjdvoice@yahoogroups.com; BLOODCJD@YAHOOGROUPS.COM; Advocatejr@aol.com; COTTWEST@SILCOM.COM; Dave Cavenaugh<br />
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Subject: TSEAC Meeting August 1, 2011 donor deferral Saudi Arabia vCJD risk blood and blood products<br />
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Meeting of the Transmissible Spongiform Encephalopathies Advisory Committee<br />
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Center Date Time Location<br />
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CBER August 1, 2011 9:00 a.m. - 4:30 p.m.<br />
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Hilton Washington DC/North, 620 Perry Pkwy., Gaithersburg, MD<br />
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Agenda<br />
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snip...end...TSS<br />
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Wednesday, June 29, 2011<br />
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TSEAC Meeting August 1, 2011 donor deferral Saudi Arabia vCJD risk blood and blood products<br />
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<a href="http://tseac.blogspot.com/2011/06/tseac-meeting-august-1-2011-donor.html">http://tseac.blogspot.com/2011/06/tseac-meeting-august-1-2011-donor.html</a><br />
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Bio.108: Transmission of Prion Disease by Multiple, Clinically-Relevant Blood Components Following a Single Blood Transfusion<br />
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Sandra McCutcheon,2,† Anthony R. Alejo Blanco,2 E. Fiona Houston,1 Christopher de Wolf,2 Boon Chin Tan,2 Nora Hunter,2 Valerie Hornsey,3 Ian R. MacGregor,3 Christopher V. Prowse,3 Marc Turner3, 4 and Jean C. Manson2<br />
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1The University of Glasgow; Glasgow, UK; 2The Roslin Institute and R(D)SVS, University of Edinburgh; Edinburgh, UK; 3Scottish National Blood Transfusion Service; Edinburgh, UK; 4The University of Edinburgh; Edinburgh, UK;†Presenting author; Email: sandra.mccutcheon@roslin.ed.ac.uk<br />
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Variant CJD (vCJD) is an incurable, infectious human disease, likely arising from the consumption of BSE-contaminated meat products. While the epidemic appears to be waning, there is much concern that vCJD infection may be amplified/prolonged in humans by the transfusion of contaminated blood products. Since 2004, several cases of transfusion-associated vCJD transmission have been reported. Using the most appropriate animal model available, in which the disease manifested resembles that of humans affected with vCJD, we examined which blood components used in human medicine are likely to pose the greatest risk of transmitting vCJD via transfusion. We collected two full units of blood from BSE-infected donor animals during the pre-clinical phase of infection. Using methods employed by transfusion services we prepared red cell concentrates, plasma and platelets units (including leucoreduced equivalents). Following transfusion to recipients, we showed that all components contain sufficient levels of infectivity to cause disease following only a single transfusion and also that leucoreduction did not prevent disease transmission. These data suggest that all blood components can act as potential vectors for prion transmission and highlight the importance of multiple control measures to minimize the risk of human to human transmission of vCJD by blood transfusion.<br />
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PPPM.18: Induction of Ab Amyloidogenesis In Vivo by Blood Transfusion<br />
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Rodrigo Morales,1,† Claudia Duran-Aniotz,1, 2 Akihiko Urayama,1 Lisbell Estrada,3 Diego Morales-Scheihing1, 2 and Claudio Soto1<br />
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1University of Texas Health Science Center at Houston; Houston, TX USA; 2Universidad de Los Andes; Santiago, Chile; 3Universidad Catolica de Chile; Santiago, Chile†Presenting author; Email: Rodrigo.MoralesLoyola@uth.tmc.edu<br />
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Alzheimer disease (AD) is the most common type of senile dementia. Disease manifestation is characterized by progressive impairment of memory and cognition which is triggered by synaptic dysfunction and neuronal loss. Compelling evidence suggests that misfolding and aggregation of Ab is a hallmark event in the disease pathogenesis. An important unanswered question related to AD involves its etiology since over 90% of the AD cases arise sporadically. Interestingly, misfolding and aggregation of proteins is the main feature of other diseases -termed Protein Misfolding Disorders (PMDs)] which include Transmissible Spongiform Encephalopathies (TSEs), among others. Convincing experimental evidences have shown that the only component of the infectious agent in TSEs is the misfolded form of the prion protein. Strikingly, the molecular mechanisms responsible for prion replication are very similar to the process of amyloid formation in all PMDs, suggesting that all these diseases have the inherent capability of being transmissible. Recent reports have shown that intra-cerebral and intra-peritoneal administration of brain homogenates containing Ab aggregates can accelerate the generation of senile plaques in mice models of AD. However, it remains to be demonstrated if this phenomenon can occur by more relevant routes of administration. The aim of this study was to assess whether AD pathogenesis can be induced intravenously, mimicking the know transmission of prion diseases through blood transfusion. For this purpose we used young tg2576 mice which were injected with blood obtained from 12 months old tg2576 mice (AD-blood) that contains a substantial quantity of cerebral Ab deposits. Mice were sacrificed at 250 days old, a time in which these animals scarcely develop Ab deposits. Interestingly, we observed that infusion of AD-blood induces substantial Ab accumulation in animals that without treatment or injected with wild type blood would barely have any detectable Ab lesion. Plaque deposition was mainly present in cortex and hippocampus, being more abundant in the former. In addition, we observed a decrease in memory in mice challenged with AD-blood. Other features such as brain inflammation and synaptic integrity were also measured. Importantly, similar results were obtained in a second and independent experiment performed in a double transgenic mouse model that develops AD plaques as early as 4 months old. Our results indicate that an AD-like pathogenesis can be induced by intravenous administration of AD-blood, presumably through induction of protein misfolding in a similar way as prion diseases. These findings may open a new avenue to understand the origin of sporadic AD and may provide new strategies for disease intervention and prevention.<br />
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<a href="http://www.prion2011.ca/files/PRION_2011_-_Posters_(May_5-11).pdf">http://www.prion2011.ca/files/PRION_2011_-_Posters_(May_5-11).pdf</a><br />
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Sir Paul Beresford: To ask the Secretary of State for Health whether his Department has conducted a cost analysis to compare the proposed use of prion filters and existing costs of risk reduction measures against the introduction of a variant Creutzfeldt-Jakob disease blood screening test which may replace or remove the need for these measures. [54816]<br />
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Anne Milton: There is currently no blood screening test that is proven to identify asymptomatic variant Creutzfeldt-Jakob disease infection. For this reason it is not possible to carry out a cost analysis to compare these measures.<br />
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Sir Paul Beresford: To ask the Secretary of State for Health pursuant to the contribution of the Minister of State for Health of 28 April 2011, Official Report, column 430 on variant Creutzfeldt-Jakob Disease (vCJD), what pathway his Department proposes to use to develop a prototype vCJD blood test in the event that no commercial company believes there is a business case to develop such a test. [54896]<br />
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Anne Milton: The Department is aware of a number of commercial organisations and academic institutions currently developing prototype blood tests for the abnormal prion protein associated with variant Creutzfeldt-Jakob Disease.<br />
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<a href="http://www.publications.parliament.uk/pa/cm201011/cmhansrd/cm110509/text/110509w0004.htm#11050951000005">http://www.publications.parliament.uk/pa/cm201011/cmhansrd/cm110509/text/110509w0004.htm#11050951000005</a><br />
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SEE FULL TEXT ;<br />
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Wednesday, May 11, 2011<br />
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House of Commons CJD May 2011 UPDATE<br />
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Jason McCartney: To ask the Secretary of State for Health how many people died from variant Creutzfeldt-Jakob disease in England in each of the last five years. [54620] Anne Milton: The National Creutzfeldt-Jakob disease Research and Surveillance Unit (NCJDRSU) has provided the following information about deaths from variant Creutzfeldt-Jakob disease (vCJD). This information is available on NCJDRSU website at:<br />
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/house-of-commons-cjd-may-2011-update.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/house-of-commons-cjd-may-2011-update.html</a><br />
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Tuesday, July 26, 2011<br />
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Irhad Rizvo Durakovic has lost his fight to nvCJD R.I.P.<br />
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/07/irhad-rizvo-durakovic-has-lost-his.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/07/irhad-rizvo-durakovic-has-lost-his.html</a><br />
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/">http://transmissiblespongiformencephalopathy.blogspot.com/</a><br />
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<a href="http://vcjdtransfusion.blogspot.com/">http://vcjdtransfusion.blogspot.com/</a><br />
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/">http://creutzfeldt-jakob-disease.blogspot.com/</a><br />
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<a href="http://www.wellsphere.com/cjd-article/large-scale-immunohistochemical-examination-for-lymphoreticular-prion-protein-in-tonsil-specimens-collected-in-britain/1242673">http://www.wellsphere.com/cjd-article/large-scale-immunohistochemical-examination-for-lymphoreticular-prion-protein-in-tonsil-specimens-collected-in-britain/1242673</a><br />
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TSSTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-70498940545859235362011-06-03T19:54:00.000-07:002011-06-03T19:54:08.145-07:00Estimation of variant Creutzfeldt-Jakob disease infectivity titers in human bloodEstimation of variant Creutzfeldt-Jakob disease infectivity titers in human blood<br />
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Luisa Gregori, Hong Yang, Steven AndersonArticle first published online: 3 JUN 2011<br />
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DOI: 10.1111/j.1537-2995.2011.03199.x<br />
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Gregori, L., Yang, H. and Anderson, S. (2011), Estimation of variant Creutzfeldt-Jakob disease infectivity titers in human blood. Transfusion, 51: no. doi: 10.1111/j.1537-2995.2011.03199.x<br />
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Author Information From the Division of Emerging and Transfusion-Transmitted Diseases, Office of Blood Research and Review, Rockville, Maryland; and the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland. *Correspondence: Luisa Gregori, DETTD/OBRR/CBER/FDA, 1401 Rockville Pike, FDA HFM-313, Rockville, MD 20852; e-mail: luisa.gregori@fda.hhs.gov.<br />
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This work was funded by the US Food and Drug Administration.<br />
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The findings and conclusions in this article have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy.<br />
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Publication History Article first published online: 3 JUN 2011 Received for publication January 4, 2011; revision received April 7, 2011, and accepted April 10, 2011.<br />
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BACKGROUND: Blood of individuals with variant Creutzfeldt-Jakob disease (vCJD) is infectious but the titer is unknown. Current estimates of possible vCJD infectivity titers in blood have largely relied on an assumption that the titers of vCJD agent in human blood are likely to be similar to those in blood of rodents infected with model transmissible spongiform encephalopathy agents, assayed by intracerebral inoculations of rodents of the same species.<br />
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STUDY DESIGN AND METHODS: We analyzed published descriptions of experimental transfusion-transmitted (TT) bovine spongiform encephalopathy and scrapie in sheep and reports of TTvCJD in humans, applying statistical approaches to estimate the probable number of intravenous infectious doses (IDiv) per unit of transfused blood (IDiv/unit). For humans, IDiv/unit of nonleukoreduced red blood cells (NLR-RBCs) were estimated by two statistical models.<br />
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RESULTS: Sheep blood collected at or near onset of clinical illness contained a mean of 0.80 IDiv/unit. Estimates of infectivity in NLR-RBCs from donors incubating vCJD indicated a probable mean infectivity of 0.29 IDiv/unit (Model 1) and 0.75 IDiv/unit (Model 2). The analysis predicted a mean of 21 vCJD-infected recipients expected in a cohort transfused with vCJD-implicated NLR-RBCs in the United Kingdom.<br />
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CONCLUSION: Our analysis suggested that, while less than one IDiv is likely to be present in a given unit of NLR-RBCs collected from a donor incubating vCJD, there is a high probability of TT infection among recipients of vCJD-implicated blood components. The analysis supports continuing measures currently recommended to reduce the risk of TTvCJD.<br />
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<a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2011.03199.x/abstract">http://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2011.03199.x/abstract</a><br />
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FC5.1.1<br />
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Transmission Results in Squirrel Monkeys Inoculated with Human sCJD, vCJD, and GSS Blood Specimens: the Baxter Study<br />
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Brown, P1; Gibson, S2; Williams, L3; Ironside, J4; Will, R4; Kreil, T5; Abee, C3 1Fondation Alliance BioSecure, France; 2University of South Alabama, USA; 3University of Texas MD Anderson Cancer Center, USA; 4Western General Hospital, UK; 5Baxter BioSience, Austria<br />
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Background: Rodent and sheep models of Transmissible Spongiform Encephalopathy (TSE) have documented blood infectivity in both the pre-clinical and clinical phases of disease. Results in a (presumably more appropriate) non-human primate model have not been reported.<br />
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Objective: To determine if blood components (red cells, white cells, platelets, and plasma) from various forms of human TSE are infectious.<br />
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Methods: Blood components were inoculated intra-cerebrally (0.1 ml) and intravenously (0.5 ml) into squirrel monkeys from 2 patients with sporadic Creutzfeldt- Jakob disease (sCJD) and 3 patients with variant Creutzfeldt-Jakob disease (vCJD). Additional monkeys were inoculated with buffy coat or plasma samples from chimpanzees infected with either sCJD or Gerstmann-Sträussler-Scheinker disease (GSS). Animals were monitored for a period of 5 years, and all dying or sacrificed animals had post-mortem neuropathological examinations and Western blots to determine the presence or absence of the misfolded prion protein (PrPTSE).<br />
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Results: No transmissions occurred in any of the animals inoculated with blood components from patients with sporadic or variant CJD. All donor chimpanzees (sCJD and GSS) became symptomatic within 6 weeks of their pre-clinical phase plasmapheresis, several months earlier than the expected onset of illness. One monkey inoculated with purified leukocytes from a pre-clinical GSS chimpanzee developed disease after 36 months.<br />
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Conclusion: No infectivity was found in small volumes of blood components from 4 patients with sporadic CJD and 3 patients with variant CJD. ***However, a single transmission from a chimpanzee-passaged strain of GSS shows that infectivity may be present in leukocytes, and the shock of general anaesthesia and plasmspheresis appears to have triggered the onset of illness in pre-clinical donor chimpanzees.<br />
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<a href="http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099">http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099</a><br />
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Saturday, September 5, 2009<br />
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TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS<br />
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snip...<br />
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But the first thing is our own study, and as I mentioned, it's a Baxter primate study, and those are the major participants. And the goal was twofold, and here is the first one: to see whether CJD, either sporadic or familial -- actually it turns out to be the familial CJD is incorrect. It really should be the Fukuoka strain of Gerstmann-Straussler-Scheinker disease. So it's really GSS instead of familial CJD -- when passaged through chimps into squirrel monkeys using purified blood components, very pure blood components.<br />
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So this addresses the question that was raised just recently about whether or not red cell infectivity that's been found in rodents is really in the red cells or is it contaminated.<br />
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We prepared these samples with exquisite care, and they are ultra-ultra-ultra purified. There's virtually no contamination of any of the components that we looked at ? platelets, red cells, plasma, white cells -- with any other component.<br />
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These are a sort of new set of slides, and what I've tried to do is make them less complicated and more clear, but I'm afraid I haven't included the build. So you'll just have to try and follow what I explain with this little red pointer.<br />
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There were three initial patients. Two of them had sporadic CJD. One of them had Gerstmann-Straussler-Scheinker syndrome. Brain tissue from each individual patient was inoculated intracerebrally into a pair of chimpanzees. All right?<br />
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From those chimps, either plasma or ultra purified -- in fact, everything is ultra-purified. I'll just talk about purified plasma, purified white cells -- were inoculated intracerebrally and intravenously to get the maximum amount of infective load into a pair of squirrel monkeys.<br />
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The same thing was done for each of these three sets. This monkey died from non-CJD causes at 34 months post inoculation.<br />
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Let me go back for a second. I didn't point out the fact that these were not sacrificed at this point. These chimpanzees were apheresed at 27 weeks when they were still asymptomatic. In this instance, we apheresed them terminally when they were symptomatic.<br />
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And before I forget, I want to mention just a little sidelight of this. Chimpanzees in our experience -- and I think we may be the only people that have ever inoculated chimpanzees, and that's no longer a possibility, so this was 20, 30 years ago -- the shortest incubation period of any chimpanzee that we have ever seen with direct intracerebral inoculation is 13 months.<br />
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So we chose 27 weeks, which is about seven months, and incidentally typically the incubation period is more like 16 or 18 months. The shortest was 13 months. We chose the 27th week, which is about six and a half months, thinking that this would be about halfway through the incubation period, which we wanted to check for the presence or absence of infectivity.<br />
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But within four weeks after the apheresis, which was conducted under general anesthesia for three or four hours apiece, every single one of the six chimpanzees became symptomatic. That is another experiment that I would love to conclude, perhaps because this is simply not heard of, and it very much smells like we triggered clinical illness. We didn't trigger the disease, but it certainly looks like we triggered symptomatic disease at a point that was much earlier than one would have possibly expected.<br />
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Maybe it will never be done because it would probably open the floodgates of litigation. There's no end of little things that you can find out from CJD patients after the fact. For example, the neighbor's dog comes over, barks at a patient, makes him fall down, and three weeks later he gets CJD. So you have a lawsuit against the neighbor.<br />
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I mean, this is not an unheard of matter, but I do think that physical stress in the form of anesthesia and four hours of whatever goes on with anesthesia, low blood pressure, sometimes a little hypoxemia looks like it's a bad thing.<br />
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So here we have the 31st week. All of the chimps are symptomatic, and here what we did was in order to make the most use of the fewest monkeys, which is always a problem in primate research, we took these same three patients and these six chimps. Only now we pooled these components; that is to say, we pooled the plasma from all six chimps. We pooled ultra-purified white cells from all six chimps because here we wanted to see whether or not we could distinguish a difference between intracerebral route of infection and intravenous route of infection.<br />
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With respect to platelets and red blood cells, we did not follow that. We inoculated both intracerebral and intravenously, as we had done earlier because nobody has any information on whether or not platelets and red cells are infectious, and so we wanted again to get the maximum.<br />
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This is an IV versus IC goal. This one, again, is just getting the maximum load in to see whether there is, in fact, any infectivity in pure platelets, in pure red cells.<br />
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And of all of the above, the only transmission of disease related to the inoculation was in a squirrel monkey that received pure leukocytes from the presymptomatic apheresis. So that goes some way to address the question as to whether or not it's a matter of contamination. To date the red cells have not been -- the monkeys that receive red cells have not been observed for more than a year because that was a later experiment.<br />
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So we still can't say about red cells, but we're about four and a half years down the road now, and we have a single transmission from purified leukocytes, nothing from plasma and nothing from platelets.<br />
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That was the first part of the experiment. The second part was undertaken with the cooperation of Bob Will and others supplying material to us. These were a couple of human, sporadic cases of CJD and three variant cases of CJD from which we obtained buffy coat and plasma separated in a normal way. That is, these are not purified components.<br />
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The two cases of sporadic CJD, the plasma was pooled from both patients. The buffy coat was pooled from both patients, and then inoculated intracerebrally and intravenously into three squirrel monkeys each. This is a non-CJD death five years after inoculation. The other animals are still alive.<br />
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For variant CJD we decided not to pool. It was more important to eliminate the possibility that there was just a little bit of infectivity in one patient that would have been diluted to extinction, if you like, by mixing them if it were to so occur with two patients, for example, who did not have infectivity. So each one of these was done individually, but the principle was the same: plasma and buffy coat for each patient was inoculated into either two or three squirrel monkeys. This is, again, a non-CJD related death.<br />
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In addition to that, we inoculated rain as a positive control from the two sporadic disease cases of human -- from the two human sporadic cases at ten to the minus one and ten to the minus three dilutions. We have done this many, many times in the past with other sporadic patients. So we knew what to expect, and we got exactly what we did expect, namely, after an incubation period not quite two years, all four monkeys developed disease at this dilution and at the minus three dilution, not a whole lot of difference between the two.<br />
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Now, these are the crucial monkeys because each one of these monkeys every three to four months was bled and the blood transfused into a new healthy monkey, but the same monkey all the time. So this monkey, for example, would have received in the course of 21 months about six different transfusions of blood from this monkey into this monkey, similarly with this pair, this pair, and this pair. So you can call these buddies. This is sort of the term that was used. These monkeys are still alive.<br />
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In the same way, the three human variant CJD specimens, brain, were inoculated into four monkeys, and again, each one of these monkeys has been repeatedly bled at three to four month intervals and that blood transfused into a squirrel monkey, the same one each time. Ideally we would love to have taken bleeding at three months and inoculated a monkey and then let him go, watch him, and then done the same thing at six months. It would have increased the number of monkeys eightfold and just unacceptably expensive. So we did the best we could.<br />
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That, again, is a non-CJD death, as is this.<br />
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This was of interest mainly to show that the titer of infectivity in brain from variant CJD is just about the same as it from sporadic. We didn't do a minus five and a minus seven in sporadic because we have an enormous experience already with sporadic disease in squirrel monkeys, and we know that this is exactly what happens. It disappears at about ten to the minus five. So the brain titer in monkeys receiving human vCJD is identical to the brain titer in monkeys that have been inoculated with sporadic CJD.<br />
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That's the experiment. All of the monkeys in aqua are still alive. They are approaching a five-year observation period, and I think the termination of this experiment will now need to be discussed very seriously in view of a probable six-year incubation period in the U.K. case. The original plan was to terminate the experiment after five years of observation with the understanding that ideally you would keep these animals for their entire life span, which is what we used to do when had unlimited space, money, and facilities. We can't do that anymore.<br />
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It's not cheap, but I think in view of the U.K. case, it will be very important to think very seriously about allowing at least these buddies and the buddies from the sporadic CJD to go on for several more years because although you might think that the U.K. case has made experimental work redundant, in point of fact, anything that bears on the risk of this disease in humans is worthwhile knowing, and one of the things we don't know is frequency of infection. We don't know whether this case in the U.K. is going to be unique and never happen again or whether all 13 or 14 patients have received blood components are ultimately going to die. Let's hope not.<br />
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The French primate study is primarily directed now by Corinne Lasmezas. As you know, the late Dominique Dromont was the original, originally initiated this work, and they have very active primate laboratory in France, and I'm only going to show two very simple slides to summarize what they did.<br />
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The first one is simply to show you the basis of their statement that the IV route of infection looks to be pretty efficient because we all know that the intracerebral route of infection is the most efficient, and if you look at this where they inoculated the same infective load either intracerebrally or intravenously, the incubation periods were not substantially different, which suggests but doesn't prove, but doesn't prove that the route of infection is pretty efficient.<br />
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Lower doses of brain material given IV did extend the incubation period and presumably it's because of the usual dose response phenomenon that you see in any infectious disease.<br />
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With a whopping dose of brain orally, the incubation period was even lower. Again, just one more example of inefficiency of the route of infection and the necessity to use more infective material to get transmissions.<br />
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And they also have blood inoculated IV which is on test, and the final slide or at least the penultimate slide shows you what they have on test and the time of observation, that taken human vCJD and like us inoculated buffy coat, they've also inoculated whole blood which we did not do.<br />
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So to a great extent their studies are complementary to ours and makes it all worthwhile.<br />
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We have about -- oh, I don't know -- a one to two-year lead time on the French, but they're still getting into pretty good observation periods. Here's three-plus years.<br />
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They have variant CJD adapted to the macaque. That is to say this one was passaged in macaque monkeys, the cynomolgus, and they did the same thing. Again, we're talking about a study here in which like ours there are no transmissions. I mean, we have that one transmission from leukocytes, and that's it.<br />
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Here is a BSE adapted to the macaque. Whole blood, and then they chose to inoculate leukodepleted whole blood, in both instances IV. Here they are out to five years without a transmission.<br />
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And then finally oral dosing of the macaque, which had been infected with -- which was infected with BSE, but a macaque passaged BSE, whole blood buffy coat and plasma, all by the IC route, and they're out to three years.<br />
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So with the single exception of the leukocyte transmission from our chimp that was inoculated with a sporadic case of CJD or -- excuse me -- with a GSS, Gerstmann-Straussler, in neither our study nor the French study, which are not yet completed have we yet seen a transmission.<br />
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And I will just close with a little cartoon that appeared in the Washington Post that I modified slightly lest you get too wound up with these questions of the risk from blood. This should be a "corrective."<br />
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(Laughter.)<br />
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DR. BROWN: Thanks.<br />
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Questions?<br />
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CHAIRPERSON PRIOLA: Yes. Any questions for Dr. Brown? Dr. Linden.<br />
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DR. LINDEN: I just want to make sure I understand your study design correctly. When you mention the monkeys that have the IV and IC inoculations, the individual monkeys had both or --<br />
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DR. BROWN: Yes, yes, yes. That's exactly right.<br />
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DR. LINDEN: So an individual monkey had both of those as opposed to some monkeys had one and some had the other?<br />
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DR. BROWN: Correct, correct. Where IC and IV are put down together was IC plus IV into a given monkey.<br />
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DR. LINDEN: Into a given monkey. Okay.<br />
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And the IC inoculations, where were those given?<br />
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DR. BROWN: Right parietal cortex, Southern Alabama.<br />
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(Laughter.)<br />
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DR. BROWN: Oh, it can't be that clear. Yeah, here, Pierluigi.<br />
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CHAIRPERSON PRIOLA: Dr. Epstein.<br />
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DR. BROWN: Pierluigi always damns me with feint praise. He always says that's a very interesting study, but. I'm waiting for that, Pierluigi.<br />
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I think Jay Epstein --<br />
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DR. GAMBETTI: I will say that there's an interesting study and will say, but I just --<br />
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(Laughter.)<br />
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DR. GAMBETTI: -- I just point of review. You talk about a point of information. You say that -- you mention GSS, I guess, and the what, Fukuowa (phonetic) --<br />
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DR. BROWN: Yes, Fukuoka 1.<br />
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DR. GAMBETTI: Fukuowa, and is that from the 102, if I remember correctly, of the --<br />
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DR. BROWN: Yes, that is correct.<br />
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DR. GAMBETTI: Because that is the only one that also --<br />
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DR. BROWN: No, it's not 102. It's 101. It's the standard. It's a classical GSS. Oh, excuse me. You're right. One, oh, two is classical GSS. It's been so long since I've done genetics. You're right.<br />
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DR. GAMBETTI: Because that is the only one I know, I think, that I can remember that has both the seven kv fragment that is characteristic of GSS, but also the PrPsc 2730. So in a sense, it can be stretching a little bit compared to the sporadic CJD.<br />
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DR. BROWN: Yeah, I think that's right. That's why I want to be sure that I made you aware on the very first slide that that was not accurate, that it truly was GSS.<br />
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There's a GSS strain that has been adapted to mice, and it's a hot strain, and therefore, it may not be translatable to sporadic disease, correct. All we can say for sure is that it is a human TSE, and it is not variant. I think that's about it.<br />
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DR. GAMBETTI: I agree, but this is also not perhaps the best --<br />
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DR. BROWN: No, it is not the best. We understand --<br />
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DR. GAMBETTI: -- of GSS either.<br />
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DR. BROWN: Yeah. If we had to do it over again, we'd look around for a -- well, I don't know. We'd probably do it the same way because we have two sporadics already on test they haven't transmitted, and so you can take your pick of what you want to pay attention to.<br />
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Jay?<br />
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DR. EPSTEIN: Yes, Paul. Could you just comment? If I understood you correctly, when you did the pooled apheresis plasma from the six chimps when they were symptomatic at 31 weeks, you also put leukocytes into squirrel monkeys in that case separately IV and IC, but in that instance you have not seen an infection come down in squirrel monkey, and the question is whether it's puzzling that you got transmission from the 27-week asymptomatic sampling, whereas you did not see transmission from the 31-week sampling in symptomatic animals.<br />
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DR. BROWN: Yes, I think there are two or three possible explanations, and I don't know if any of them are important. The pre-symptomatic animal was almost symptomatic as it turned out so that we were pretty close to the period at which symptoms would being, and whether you can, you know, make much money on saying one was incubation period and the other was symptomatic in this particular case because both bleedings were so close together. That's one possibility.<br />
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The other possibility is we're dealing with a very irregular phenomenon and you're not surprised at all by surprises, so to speak so that a single animal, you could see it almost anywhere.<br />
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The third is that we, in fact, did just what I suggested we didn't want to do for the preclinical, namely, by pooling we got under the threshold. See?<br />
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You can again take that for what it's worth. It is a possible explanation, and again, until we know what the levels of infectivity are and whether by pooling we get under the threshold of transmission, we simply cannot make pronouncements.<br />
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CHAIRPERSON PRIOLA: Dr. DeArmond.<br />
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DR. DeARMOND: Yeah, it was very interesting data, but the --<br />
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(Laughter.)<br />
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DR. BROWN: I just love it. Go ahead.<br />
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DR. DeARMOND: Two comments. The first one was that the GSS cases, as I remember from reading your publications -- I think Gibbs was involved with them -- when you transmitted the GSS into animals, into monkeys, perhaps I think it was chimps, the transmission was more typical of CJD rather than GSS. There were no amyloid plaques. It was vacuolar degeneration so that you may be transmitting a peculiar form, as I criticized once in Bali and then you jumped all over me about.<br />
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DR. BROWN: I may do it again.<br />
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DR. DeARMOND: Calling me a bigot and some other few things like that.<br />
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(Laughter.)<br />
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DR. BROWN: Surely not. I wouldn't have said that.<br />
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DR. DeARMOND: So there could be something strange about that particular --<br />
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DR. BROWN: Yeah. I think you and Pierluigi are on the same page here. This may be an unusual strain from a number of points of view.<br />
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DR. DeARMOND: The other question though has to do with species barrier because the data you're showing is kind of very reassuring to us that it's hard to transmit from blood, but the data from the sheep and from the hamsters and some of the work, I think, that has been done by others, that it's easy in some other animals to transmit, hamster to hamster, mouse to mouse.<br />
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Could you comment on the --<br />
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DR. BROWN: That's exactly why we went to primates. That's exactly it, because a primate is closer to a human than a mouse is, and that's just common sense.<br />
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And so to try and get a little closer to the human situation and not totally depend on rodents for transferrable data, that is why you would use a primate. Otherwise you wouldn't use them. They're too expensive and they cause grief to animal care study people and protocol makers and the whole thing.<br />
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Primate studies are a real pain.<br />
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DR. DeARMOND: But right now it's inconclusive and you need more time on it.<br />
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DR. BROWN: I believe that's true. I think if we cut it off at six years you could still say it was inconclusive, and cutting it off at all will be to some degree inconclusive, and that's just the way it is.<br />
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DR. DeARMOND: So what has to be done? Who do you have to convince, or who do we all have to convince to keep that going?<br />
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DR. BROWN: Thomas?<br />
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Without trying to be flip at all, the people that would be the first people to try to convince would be the funders of the original study. If that fails, and it might for purely practical reasons of finance, then we will have to look elsewhere because I really don't want to see those animals sacrificed, not those eight buddies. Those are crucial animals, and they don't cost a whole lot to maintain. You can maintain eight -- well, they cost a lot from my point of view, but 15 to $20,000 a year would keep them going year after year.<br />
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CHAIRPERSON PRIOLA: Dr. Johnson.<br />
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DR. JOHNSON: Yeah, Paul, I'm intrigued as you are by the shortening of the incubation period. Have you in all of the other years of handling these animals when they were transfused, when they were flown out to Louisiana at night -- a lot of the stressful things have happened to some of these chimps. Have you ever noticed that before or is this a new observation?<br />
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DR. BROWN: Brand new.<br />
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MR. JOHNSON: Brand new. Okay.<br />
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CHAIRPERSON PRIOLA: Bob, did you want to say something? Dr. Rohwer.<br />
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DR. ROHWER: The Frederick fire, wasn't that correlated with a lot of --<br />
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DR. BROWN: Not that I k now of, but you may --<br />
<br />
DR. ROHWER: Well, that occurred shortly after I came to NIH, and what I remember is that there were a whole bunch of conversions that occurred within the few months following the fire. That was fire that occurred adjacent to the NINDS facility, but in order to protect it, they moved the monkeys out onto the tarmac because they weren't sure it wouldn't burn as well.<br />
<br />
DR. BROWN: Well, if you're right, then it's not brand new, but I mean, I'm not sure how we'll ever know because if I call Carlton and ask him, I'm not sure but what I would trust the answer that he gives me, short of records.<br />
<br />
You know, Carlot is a very enthusiastic person, and he might say, "Oh, yeah, my God, the whole floor died within three days," but I would want to verify that.<br />
<br />
On the other hand, it may be verifiable. There possibly are records that are still extant.<br />
<br />
DR. ROHWER: Actually I thought I heard the story from you.<br />
<br />
(Laughter.)<br />
<br />
DR. BROWN: You didn't because it's brand new for me. I mean, either that or I'm on the way<br />
<br />
(Laughter.)<br />
<br />
CHAIRPERSON PRIOLA: Dr. Bracey.<br />
<br />
DR. BRACEY: I was wondering if some of the variability in terms of the intravenous infection route may be related to intraspecies barriers, that is, the genetic differences, the way the cells, the white leukocytes are processed, whether or not microchimerism is established, et cetera.<br />
<br />
DR. BROWN: I don't think that processing is at fault, but the question, the point that you raise is a very good one, and needless to say, we have material with which we can analyze genetically all of the animals, and should it turn out that we get, for example, -- I don't know -- a transmission in one variant monkey and no transmissions in another and a transmission in three sporadic monkeys, we will at that point genetically analyze every single animal that has been used in this study, but we wanted to wait until we could see what would be most useful to analyze.<br />
<br />
but the material is there, and if need be, we'll do it.<br />
<br />
CHAIRPERSON PRIOLA: Okay. Thank you very much, Dr. Brown.<br />
<br />
I think we'll move on to the open public hearing section of the morning.<br />
<br />
snip...<br />
<br />
<a href="http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4019t1.DOC">http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4019t1.DOC</a><br />
<br />
<br />
<br />
snip...<br />
<br />
<br />
<br />
see full text ;<br />
<br />
<br />
<a href="http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html">http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html</a><br />
<br />
<br />
<br />
<br />
Tuesday, May 17, 2011 <br />
<br />
<br />
blood supply Creutzfeldt-Jakob Disease 16 May 2011 : Column 61W Commons Hansard<br />
<br />
Creutzfeldt-Jakob Disease<br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2011/05/blood-supply-creutzfeldt-jakob-disease.html">http://vcjdtransfusion.blogspot.com/2011/05/blood-supply-creutzfeldt-jakob-disease.html</a><br />
<br />
<br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/">http://vcjdtransfusion.blogspot.com/</a><br />
<br />
<br />
<br />
<br />
<br />
Saturday, May 14, 2011<br />
<br />
USA Blood products, collected from a donor who was at risk for vCJD, were distributed Nationally and Internationally MAY 11, 2011<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2011/05/usa-blood-products-collected-from-donor.html">http://vcjdtransfusion.blogspot.com/2011/05/usa-blood-products-collected-from-donor.html</a><br />
<br />
<br />
Wednesday, February 2, 2011<br />
<br />
Detection of prion infection in variant Creutzfeldt-Jakob disease: a blood-based assay<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/02/detection-of-prion-infection-in-variant.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/02/detection-of-prion-infection-in-variant.html</a><br />
<br />
<br />
Monday, February 7, 2011<br />
<br />
FDA's Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???<br />
<br />
<a href="http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html">http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html</a><br />
<br />
<br />
Thursday, August 12, 2010<br />
<br />
USA Blood products, collected from a donor who was at risk for vCJD, were distributed July-August 2010<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html</a><br />
<br />
<br />
Sunday, August 01, 2010<br />
<br />
Blood product, collected from a donors possibly at increased risk for vCJD only, was distributed USA JULY 2010<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html">http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html</a><br />
<br />
<br />
<br />
<br />
<br />
Tuesday, September 14, 2010<br />
<br />
<br />
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)<br />
<br />
<br />
<a href="http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html">http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html</a><br />
<br />
<br />
<br />
<br />
Sunday, May 10, 2009<br />
<br />
Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)<br />
<br />
TO : william.freas@fda.hhs.gov <william.freas@fda.hhs.gov><br />
<br />
May 8, 2009<br />
<br />
Greetings again Dr. Freas, TSEAC et al,<br />
<br />
I would kindly, once again, wish to comment at this meeting about the urgent actions that need to be taken asap, to the Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009. Due to my disability from my neck injury, I will not be attending this meeting either, however I hope for my submission to be read and submitted. ...<br />
<br />
IN reply to ;<br />
<br />
<a href="http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html">http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html</a><br />
<br />
<br />
From: Terry S. Singeltary Sr.<br />
<br />
To: FREAS@CBER.FDA.GOV<br />
<br />
Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov<br />
<br />
Sent: Friday, December 01, 2006 2:59 PM<br />
<br />
Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION<br />
<br />
snip...<br />
<br />
ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)<br />
<br />
THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone.<br />
<br />
These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...<br />
<br />
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518<br />
<br />
snip... 48 pages...<br />
<br />
<a href="http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8">http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8</a><br />
<br />
<br />
<br />
APHIS-2006-0041-0006 TSE advisory committee for the meeting December 15, 2006<br />
<br />
(this starts out in part III, then part II, and part I and the beginning is at the bottom. ...tss)<br />
<br />
<a href="http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8">http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8</a><br />
<br />
<br />
Owens, Julie<br />
<br />
From: Terry S. Singeltary Sr. [flounder9@verizon.net]<br />
<br />
Sent: Monday, July 24, 2006 1:09 PM<br />
<br />
To: FSIS Regulations<br />
<br />
Comments<br />
<br />
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)<br />
<br />
Page 1 of 98<br />
<br />
8/3/2006<br />
<br />
Greetings FSIS,<br />
<br />
I would kindly like to comment on the following ;<br />
<br />
<br />
<a href="http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf">http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf</a><br />
<br />
<br />
<a href="http://www.scribd.com/doc/1490709/USDA-200600111">http://www.scribd.com/doc/1490709/USDA-200600111</a><br />
<br />
<br />
[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)<br />
<br />
<a href="http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf">http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf</a><br />
<br />
<br />
suppressed peer review of Harvard study October 31, 2002<br />
<br />
<a href="http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf">http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf</a><br />
<br />
<br />
Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005<br />
<br />
INTRODUCTION<br />
<br />
The United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) held a public meeting on July 25, 2006 in Washington, D.C. to present findings from the Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 (report and model located on the FSIS website:<br />
<br />
<a href="http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp">http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp</a>).<br />
<br />
<br />
Comments on technical aspects of the risk assessment were then submitted to FSIS. Comments were received from Food and Water Watch, Food Animal Concerns Trust (FACT), Farm Sanctuary, R-CALF USA, Linda A Detwiler, and Terry S. Singeltary.<br />
<br />
<br />
This document provides itemized replies to the public comments received on the 2005 updated Harvard BSE risk assessment. Please bear the following points in mind:<br />
<br />
<a href="http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf">http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf</a><br />
<br />
<br />
<br />
-----Original Message-----<br />
<br />
From: Terry S. Singeltary Sr. [mailto:flounder@wt.net]<br />
<br />
Sent: Tuesday, February 18, 2003 12:45 PM<br />
<br />
To: Freas, William<br />
<br />
Cc: Langford, Sheila<br />
<br />
Subject: Re: re-vCJD/blood and meeting of Feb. 20, 2003<br />
<br />
Greetings FDA,<br />
<br />
Asante/Collinge et al, that BSE transmission to the 129-methionine<br />
<br />
genotype can lead to an alternate phenotype that is indistinguishable<br />
<br />
from type 2 PrPSc, the commonest _sporadic_ CJD;<br />
<br />
<a href="http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm">http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm</a><br />
<br />
<br />
<br />
PDF]Freas, William TSS SUBMISSION<br />
<br />
File Format: PDF/Adobe Acrobat -<br />
<br />
Page 1. J Freas, William From:<br />
<br />
Sent: To:<br />
<br />
Subject: Terry S. Singeltary Sr. [flounder@wt.net]<br />
<br />
Monday, January 08, 200l 3:03 PM freas ...<br />
<br />
<a href="http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf">http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf</a><br />
<br />
<br />
<br />
Tuesday, February 8, 2011<br />
<br />
U.S.A. 50 STATE BSE MAD COW CONFERENCE CALL Jan. 9, 2001<br />
<br />
<a href="http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html">http://tseac.blogspot.com/2011/02/usa-50-state-bse-mad-cow-conference.html</a><br />
<br />
<br />
<br />
Monday, May 30, 2011<br />
<br />
CEPs for gelatin and impact of the revised EU Note for Guidance on the TSE risk EMEA/410/01 Rev.3) will come into force in July 2011<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/ceps-for-gelatin-and-impact-of-revised.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/ceps-for-gelatin-and-impact-of-revised.html</a><br />
<br />
<br />
<br />
Friday, May 13,<br />
<br />
2011 EFSA Joint Scientific Opinion on any possible epidemiological or molecular association between TSEs in animals and humans<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/efsa-joint-scientific-opinion-on-any.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/efsa-joint-scientific-opinion-on-any.html</a><br />
<br />
<br />
Tuesday, May 24, 2011 2:24 PM<br />
<br />
O.I.E. Terrestrial Animal Health Standards Commission and prion (TSE) disease reporting 2011<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/oie-terrestrial-animal-health-standards.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/oie-terrestrial-animal-health-standards.html</a><br />
<br />
<br />
Topics in Current Chemistry, 2011, 1-28, DOI: 10.1007/128_2011_161<br />
<br />
Atypical Prion Diseases in Humans and Animals<br />
<br />
Michael A. Tranulis, Sylvie L. Benestad, Thierry Baron and Hans Kretzschmar<br />
<br />
Abstract<br />
<br />
Although prion diseases, such as Creutzfeldt–Jakob disease (CJD) in humans and scrapie in sheep, have long been recognized, our understanding of their epidemiology and pathogenesis is still in its early stages. Progress is hampered by the lengthy incubation periods and the lack of effective ways of monitoring and characterizing these agents. Protease-resistant conformers of the prion protein (PrP), known as the “scrapie form” (PrPSc), are used as disease markers, and for taxonomic purposes, in correlation with clinical, pathological, and genetic data. In humans, prion diseases can arise sporadically (sCJD) or genetically (gCJD and others), caused by mutations in the PrP-gene (PRNP), or as a foodborne infection, with the agent of bovine spongiform encephalopathy (BSE) causing variant CJD (vCJD). Person-to-person spread of human prion disease has only been known to occur following cannibalism (kuru disease in Papua New Guinea) or through medical or surgical treatment (iatrogenic CJD, iCJD). In contrast, scrapie in small ruminants and chronic wasting disease (CWD) in cervids behave as infectious diseases within these species. Recently, however, so-called atypical forms of prion diseases have been discovered in sheep (atypical/Nor98 scrapie) and in cattle, BSE-H and BSE-L. These maladies resemble sporadic or genetic human prion diseases and might be their animal equivalents. This hypothesis also raises the significant public health question of possible epidemiological links between these diseases and their counterparts in humans.<br />
<br />
Keywords Animal - Atypical - Atypical/Nor98 scrapie - BSE-H - BSE-L - Human - Prion disease - Prion strain - Prion type<br />
<br />
<a href="http://resources.metapress.com/pdf-preview.axd?code=f433r34h34ugg617&size=largest">http://resources.metapress.com/pdf-preview.axd?code=f433r34h34ugg617&size=largest</a><br />
<br />
<br />
<br />
Monday, May 23, 2011<br />
<br />
Atypical Prion Diseases in Humans and Animals 2011<br />
<br />
Top Curr Chem (2011)<br />
<br />
DOI: 10.1007/128_2011_161<br />
<br />
# Springer-Verlag Berlin Heidelberg 2011<br />
<br />
<a href="http://bse-atypical.blogspot.com/2011/05/atypical-prion-diseases-in-humans-and.html">http://bse-atypical.blogspot.com/2011/05/atypical-prion-diseases-in-humans-and.html</a><br />
<br />
<br />
<br />
<br />
Wednesday, March 31, 2010<br />
<br />
Atypical BSE in Cattle<br />
<br />
To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE.<br />
<br />
When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.<br />
<br />
This study will contribute to a correct definition of specified risk material (SRM) in atypical BSE. The incumbent of this position will develop new and transfer existing, ultra-sensitive methods for the detection of atypical BSE in tissue of experimentally infected cattle.<br />
<br />
<a href="http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2">http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2</a><br />
<br />
<br />
<br />
<br />
<br />
Thursday, August 12, 2010<br />
<br />
Seven main threats for the future linked to prions<br />
<br />
First threat<br />
<br />
The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed.<br />
<br />
***Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.<br />
<br />
Second threat<br />
<br />
snip...<br />
<br />
<a href="http://www.neuroprion.org/en/np-neuroprion.html">http://www.neuroprion.org/en/np-neuroprion.html</a><br />
<br />
<br />
<a href="http://prionpathy.blogspot.com/2010/08/seven-main-threats-for-future-linked-to.html">http://prionpathy.blogspot.com/2010/08/seven-main-threats-for-future-linked-to.html</a><br />
<br />
<br />
<a href="http://prionpathy.blogspot.com/">http://prionpathy.blogspot.com/</a><br />
<br />
<br />
<br />
Rural and Regional Affairs and Transport References Committee<br />
<br />
The possible impacts and consequences for public health, trade and agriculture of the Government’s decision to relax import restrictions on beef Final report June 2010<br />
<br />
2.65 At its hearing on 14 May 2010, the committee heard evidence from Dr Alan Fahey who has recently submitted a thesis on the clinical neuropsychiatric, epidemiological and diagnostic features of Creutzfeldt-Jakob disease.48 Dr Fahey told the committee of his concerns regarding the lengthy incubation period for transmissible spongiform encephalopathies, the inadequacy of current tests and the limited nature of our current understanding of this group of diseases.49<br />
<br />
2.66 Dr Fahey also told the committee that in the last two years a link has been established between forms of atypical CJD and atypical BSE. Dr Fahey said that: They now believe that those atypical BSEs overseas are in fact causing sporadic Creutzfeldt-Jakob disease. They were not sure if it was due to mad sheep disease or a different form. If you look in the textbooks it looks like this is just arising by itself. But in my research I have a summary of a document which states that there has never been any proof that sporadic Creutzfeldt-Jakob disease has arisen de novo—has arisen of itself. There is no proof of that. The recent research is that in fact it is due to atypical forms of mad cow disease which have been found across Europe, have been found in America and have been found in Asia. These atypical forms of mad cow disease typically have even longer incubation periods than the classical mad cow disease.50<br />
<br />
<a href="http://www.aph.gov.au/senate/committee/rrat_ctte/mad_cows/report/report.pdf">http://www.aph.gov.au/senate/committee/rrat_ctte/mad_cows/report/report.pdf</a><br />
<br />
<br />
Wednesday, January 19, 2011<br />
<br />
EFSA and ECDC review scientific evidence on possible links between TSEs in animals and humans Webnachricht 19 Januar 2011<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-and-ecdc-review-scientific.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-and-ecdc-review-scientific.html</a><br />
<br />
<br />
Tuesday, January 18, 2011<br />
<br />
Agent strain variation in human prion disease: insights from a molecular and pathological review of the National Institutes of Health series of experimentally transmitted disease<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html</a><br />
<br />
<br />
something that disturbs me very much, iatrogenic prion TSE exposure and accumulation there from all of the above ???<br />
<br />
<br />
Tuesday, March 29, 2011<br />
<br />
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY EXPOSURE SPREADING VIA HOSPITALS AND SURGICAL PROCEDURES AROUND THE GLOBE<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/transmissible-spongiform-encephalopathy.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/transmissible-spongiform-encephalopathy.html</a><br />
<br />
<br />
Saturday, March 5, 2011<br />
<br />
MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE RISE IN NORTH AMERICA<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html</a><br />
<br />
<br />
Tuesday, April 26, 2011<br />
<br />
sporadic CJD RISING Text and figures of the latest annual report of the NCJDRSU covering the period 1990-2009 (published 11th March 2011)<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/04/sporadic-cjd-rising-text-and-figures-of.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/04/sporadic-cjd-rising-text-and-figures-of.html</a><br />
<br />
<br />
PRION MAD COW UDPATE NORTH AMERICA 2011<br />
<br />
Sunday, April 3, 2011<br />
<br />
PRION 2011 NEWWORLD MONTREAL CANADA MAY 16 - 19<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/04/prion-2011-newworld-montreal-canada-may.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/04/prion-2011-newworld-montreal-canada-may.html</a><br />
<br />
<br />
Tuesday, April 5, 2011<br />
<br />
Action Plan National Program 103 Animal Health 2012-2017 PRIONS AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY<br />
<br />
Action Plan National Program 103 Animal Health 2012-2017<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/04/action-plan-national-program-103-animal.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/04/action-plan-national-program-103-animal.html</a><br />
<br />
<br />
Greetings,<br />
<br />
WITH more and more atypical Transmissible Spongiform Encephalopathy cases showing up in more and more species here in North America, and the enormous monumental amount of banned mad cow protein in commerce since the infamous partial and voluntary mad cow feed ban inked on paper, with tons and tons crossing back and forth between the USA, Canada, and Mexico, it just does not surprise me of all these "PENDING CLASSIFICATIONS" of human TSE in Canada, and the USA. UK c-BSE transmitted to humans became nvCJD. WE now have atypical strains of BSE in cattle. Mission Texas experiments long ago showed that transmitted USA sheep scrapie to USA bovine, produced a TSE much different than the UK typical c-BSE. SO why would human TSE in the USA look like UK human TSE ? The corruption is mind boggling. The UK saw a suspicious TSE in humans, and science linked it to cattle. North America is awash with human and animal TSE, CJD is rising in young and old, with the same pathology and same symptoms, and none of it is related to the other. isn't that nice. who, what, bestowed such miracles upon North America $<br />
<br />
Archive Number 20100405.1091 Published Date 05-APR-2010<br />
<br />
Subject PRO/AH/EDR> Prion disease update 1010 (04)<br />
<br />
snip...<br />
<br />
[Terry S. Singeltary Sr. has added the following comment:<br />
<br />
"According to the World Health Organisation, the future public health threat of vCJD in the UK and Europe and potentially the rest of the world is of concern and currently unquantifiable. However, the possibility of a significant and geographically diverse vCJD epidemic occurring over the next few decades cannot be dismissed.<br />
<br />
The key word here is diverse. What does diverse mean? If USA scrapie transmitted to USA bovine does not produce pathology as the UK c-BSE, then why would CJD from there look like UK vCJD?"<br />
<br />
<br />
<br />
<a href="http://www.promedmail.org/pls/apex/f?p=2400:1001:568933508083034::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,82101">http://www.promedmail.org/pls/apex/f?p=2400:1001:568933508083034::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,82101</a><br />
<br />
<br />
<br />
CANADA CJD UPDATE 2011<br />
<br />
<br />
CJD Deaths Reported by CJDSS1, 1994-20112 As of January 31, 2011<br />
<br />
3. Final classification of 49 cases from 2009, 2010, 2011 is pending.<br />
<br />
snip...<br />
<br />
<a href="http://www.phac-aspc.gc.ca/hcai-iamss/cjd-mcj/cjdss-ssmcj/pdf/stats_0111-eng.pdf">http://www.phac-aspc.gc.ca/hcai-iamss/cjd-mcj/cjdss-ssmcj/pdf/stats_0111-eng.pdf</a><br />
<br />
<br />
<br />
USA 2011<br />
<br />
USA<br />
<br />
National Prion Disease Pathology Surveillance Center<br />
<br />
Cases Examined1<br />
<br />
(November 1, 2010)<br />
<br />
Year Total Referrals2 Prion Disease Sporadic Familial Iatrogenic vCJD<br />
<br />
1996 & earlier 51 33 28 5 0 0<br />
<br />
1997 114 68 59 9 0 0<br />
<br />
1998 87 51 43 7 1 0<br />
<br />
1999 121 73 65 8 0 0<br />
<br />
2000 146 103 89 14 0 0<br />
<br />
2001 209 119 109 10 0 0<br />
<br />
2002 248 149 125 22 2 0<br />
<br />
2003 274 176 137 39 0 0<br />
<br />
2004 325 186 164 21 0 13<br />
<br />
2005 344 194 157 36 1 0<br />
<br />
2006 383 197 166 29 0 24<br />
<br />
2007 377 214 187 27 0 0<br />
<br />
2008 394 231 205 25 0 0<br />
<br />
2009 425 258 215 43 0 0<br />
<br />
2010 333 213 158 33 0 0<br />
<br />
TOTAL 38315 22656 1907 328 4 3<br />
<br />
1 Listed based on the year of death or, if not available, on year of referral;<br />
<br />
2 Cases with suspected prion disease for which brain tissue and/or blood (in familial cases) were submitted;<br />
<br />
3 Disease acquired in the United Kingdom;<br />
<br />
4 Disease was acquired in the United Kingdom in one case and in Saudi Arabia in the other case;<br />
<br />
5 Includes 18 cases in which the diagnosis is pending, and 18 inconclusive cases;<br />
<br />
6 Includes 23 (22 from 2010) cases with type determination pending in which the diagnosis of vCJD has been excluded.<br />
<br />
<a href="http://www.cjdsurveillance.com/pdf/case-table.pdf">http://www.cjdsurveillance.com/pdf/case-table.pdf</a><br />
<br />
<br />
Please notice where sporadic CJD cases in 1996 went from 28 cases, to 215 cases in 2009, the highest recorded year to date. sporadic CJD is on a steady rise, and has been since 1996.<br />
<br />
I also urge you to again notice these disturbing factors in lines 5 and 6 ;<br />
<br />
5 Includes 18 cases in which the diagnosis is pending, and 18 inconclusive cases;<br />
<br />
6 Includes 23 (22 from 2010) cases with type determination pending in which the diagnosis of vCJD has been excluded.<br />
<br />
<br />
<br />
========end=====tss=====2011<br />
<br />
<br />
Monday, August 9, 2010<br />
<br />
National Prion Disease Pathology Surveillance Center Cases Examined (July 31, 2010)<br />
<br />
(please watch and listen to the video and the scientist speaking about atypical BSE and sporadic CJD and listen to Professor Aguzzi)<br />
<br />
<a href="http://prionunitusaupdate2008.blogspot.com/2010/08/national-prion-disease-pathology.html">http://prionunitusaupdate2008.blogspot.com/2010/08/national-prion-disease-pathology.html</a><br />
<br />
<br />
<br />
DID EVERYONE THAT LOST A LOVED ONE FILL OUT THEIR CJD QUESIONNAIRE FROM THE CDC AND OR THE CJD FOUNDATION ???<br />
<br />
<br />
Friday, November 30, 2007<br />
<br />
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION<br />
<br />
<a href="http://cjdquestionnaire.blogspot.com/2007/11/cjd-questionnaire.html">http://cjdquestionnaire.blogspot.com/2007/11/cjd-questionnaire.html</a><br />
<br />
<br />
<a href="http://cjdquestionnaire.blogspot.com/">http://cjdquestionnaire.blogspot.com/</a><br />
<br />
<br />
<br />
The statistical incidence of CJD cases in the United States has been revised to reflect that there is one case per 9000 in adults age 55 and older. Eighty-five percent of the cases are sporadic, meaning there is no known cause at present.<br />
<br />
<br />
<a href="http://www.cjdfoundation.org/fact.html">http://www.cjdfoundation.org/fact.html</a><br />
<br />
<br />
<a href="http://cjdusa.blogspot.com/">http://cjdusa.blogspot.com/</a><br />
<br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/">http://transmissiblespongiformencephalopathy.blogspot.com/</a><br />
<br />
<br />
PLEASE REMEMBER ;<br />
<br />
AS implied in the Inset 25 we must not _ASSUME_ that transmission of BSE to other species will invariably present pathology typical of a scrapie-like disease.<br />
<br />
snip.<br />
<br />
<a href="http://web.archive.org/web/20010305222642/www.bseinquiry.gov.uk/files/yb/1991/01/04004001.pdf">http://web.archive.org/web/20010305222642/www.bseinquiry.gov.uk/files/yb/1991/01/04004001.pdf</a><br />
<br />
<br />
<br />
OR nvCJD. ......could look like anyone or all of the sporadic CJD's. ...TSS<br />
<br />
<br />
<br />
Friday, April 15, 2011<br />
<br />
PRION TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY PROJECTS, RESEARCH FUNDING, BSE VOLUNTARY TESTING UPDATE IN NORTH AMERICA 2011<br />
<br />
<a href="http://prionunitusaupdate2008.blogspot.com/2011/04/prion-transmissible-spongiform.html">http://prionunitusaupdate2008.blogspot.com/2011/04/prion-transmissible-spongiform.html</a><br />
<br />
<br />
Wednesday, March 9, 2011<br />
<br />
27 U.S. Senators want to force feed Japan Highly Potential North America Mad Cow Beef TSE PRION CJD March 8, 2011<br />
<br />
President Barack Obama The White House<br />
<br />
1600 Pennsylvania Avenue, W Washington, DC 20500<br />
<br />
Dear President Obama:<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/27-us-senators-want-to-force-feed-japan.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/27-us-senators-want-to-force-feed-japan.html</a><br />
<br />
<br />
Thursday, May 26, 2011<br />
<br />
Travel History, Hunting, and Venison Consumption Related to Prion Disease Exposure, 2006-2007 FoodNet Population Survey<br />
<br />
Journal of the American Dietetic Association Volume 111, Issue 6 , Pages 858-863, June 2011.<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/travel-history-hunting-and-venison.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/travel-history-hunting-and-venison.html</a><br />
<br />
<br />
WHAT about funding in the USA for 2010 on prion disease. a big fat zero dollars $ 0.0 $<br />
<br />
<br />
PRION TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY RESEARCH FUNDING U.S.A.<br />
<br />
COMPARE TO USA PRION FUNDING 2011<br />
<br />
"which includes the ___elimination___ of Prion activities ($5,473,000),"<br />
<br />
All Other Emerging and Zoonotic Infectious Diseases CDC‘s FY 2012 request of $52,658,000 for all other emerging and zoonotic infectious disease activities is a decrease of $13,607,000 below the FY 2010 level, which includes the elimination of Prion activities ($5,473,000), a reduction for other cross-cutting infectious disease activities, and administrative savings. These funds support a range of critical emerging and zoonotic infectious disease programs such Lyme Disease, Chronic Fatigue Syndrome, and Special Pathogens, as well as other activities described below.<br />
<br />
<a href="http://www.cdc.gov/fmo/topic/Budget%20Information/appropriations_budget_form_pdf/FY2012_CDC_CJ_Final.pdf">http://www.cdc.gov/fmo/topic/Budget%20Information/appropriations_budget_form_pdf/FY2012_CDC_CJ_Final.pdf</a><br />
<br />
<br />
<br />
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518Terry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-19281183161338747172011-05-17T11:49:00.000-07:002011-05-17T11:49:29.659-07:00blood supply Creutzfeldt-Jakob Disease 16 May 2011 : Column 61W Commons HansardCreutzfeldt-Jakob Disease<br />
<br />
<br />
Jason McCartney: To ask the Secretary of State for Health what steps his Department is taking to protect the blood supply from variant Creutzfeldt-Jakob disease. [55158]<br />
<br />
Anne Milton: The following precautionary measures have been implemented to protect the blood supply and products made by fractionating plasma:<br />
<br />
From December 1997, blood components, plasma products or tissues obtained from any individual who later develops variant Creutzfeldt-Jakob disease (vCJD), have been withdrawn/recalled to prevent their use;<br />
<br />
From October 1999, white blood cells (which may carry a risk of transmitting vCJD) have been reduced in all blood used for transfusion, a process known as leucodepletion or leucoreduction;<br />
<br />
Following the report of the first possible case of transmission of vCJD by blood transfusion in December 2003, individuals who had themselves received a transfusion of blood components since January 1980 were excluded from donating blood. This took effect from April 2004, and in July 2004, this exclusion criterion for blood donation was extended to include two further groups, who had received transfusions of blood components since 1980:<br />
<br />
Previously transfused platelet donors,<br />
<br />
Donors who were unsure if they had previously had a blood transfusion. This now applies to donors who have been transfused anywhere in the world;<br />
<br />
Since 1999, plasma for the manufacture of fractionated plasma products, such as clotting factors, has been obtained from non-United Kingdom sources;<br />
<br />
16 May 2011 : Column 61W<br />
<br />
Since 2004, fresh frozen plasma for treating babies and young children born on or after 1 January 1996 has been obtained from non-UK sources, and from July 2005 its use was extended to all children up to the age of 16; and<br />
<br />
Cryoprecipitate, for use in the under-16s, is now produced from imported methylene blue treated-plasma.<br />
<br />
All of these measures were recommended or endorsed by the Advisory Committee on the Safety of Blood, Tissues and Organs (which first met in January 2008) or its predecessor committees.<br />
<br />
Additionally, considerable effort is being extended to promote appropriate use of blood throughout the national health service, to target blood use to where it is clinically essential, and for bleeding disorder patients (such as haemophiliacs) UK plasma has not been used for the manufacture of clotting factors since 1999 and recombinant clotting factors are now available for all patients for whom they are suitable.<br />
<br />
Jason McCartney: To ask the Secretary of State for Health (1) what estimate he has made of the number of people who are considered to be at risk of contracting variant Creuztfeldt-Jakob disease; [55157]<br />
<br />
(2) what estimate his Department has made of the number of people carrying the infective prions that cause variant Creuztfeldt-Jakob disease; and what proportion of such people he estimates are registered as blood donors. [55160]<br />
<br />
Anne Milton: A study published in 2004 of stored appendix and tonsil tissue samples found abnormal prion protein in three appendices out of 12,674 samples. This suggested a population prevalence of about one in 4,000, though with very wide confidence interval of between one in 1,400 and one in 20,000. A further study of over 96,000 tonsils pairs is nearing completion, and a study of 30,000 appendix samples is due to be completed in 2012. Prevalence estimates are kept under active review by the relevant expert scientific advisory committees, who will review all the evidence on the completion of these ongoing studies.<br />
<br />
In England about 4.4% of the population are blood donors, and the prevalence of potentially infective blood donors remains unknown. Not all of the individuals in the 2004 published study would be of an age eligible to donate blood, nor is it clear whether presence of abnormal prion protein in tissues such as the appendix or tonsils indicates that the blood of such a donor would transmit variant Creutzfeldt-Jakob disease. All precautionary measures are assessed in the context of the fundamental uncertainties about prevalence.<br />
<br />
Jason McCartney: To ask the Secretary of State for Health what estimate his Department has made of the number of people diagnosed with variant Creuztfeldt-Jakob disease. [55159]<br />
<br />
Anne Milton: Since 1995 175 patients have been identified with definite or probable variant Creutzfeldt-Jakob disease (vCJD) in the United Kingdom.<br />
<br />
The National Creutzfeldt-Jakob disease Research and Surveillance Unit publishes monthly figures on all cases of human prion disease, including vCJD, on the website at:<br />
<br />
<a href="http://www.cjd.ed.ac.uk/">www.cjd.ed.ac.uk/</a><br />
<br />
<br />
<br />
16 May 2011 : Column 62W<br />
<br />
Dental Services<br />
<br />
Andrew Rosindell: To ask the Secretary of State for Health how many dentists' surgeries he has visited in an official capacity in the last 12 months. [55229]<br />
<br />
Mr Simon Burns: In the last 12 months my right hon. Friend the Secretary of State for Health (Mr Lansley) has visited one community dental service in an official capacity. My noble Friend the Parliamentary Under-Secretary of State (Earl Howe) leads on dentistry within the ministerial team and has visited two dental practices in the last 12 months, one in Worcester and one in London. He has also visited dentists providing oral health promotion services for children provided in a children's centre in Preston.<br />
<br />
<br />
<br />
<a href="http://www.publications.parliament.uk/pa/cm201011/cmhansrd/cm110516/text/110516w0003.htm#11051625000037">http://www.publications.parliament.uk/pa/cm201011/cmhansrd/cm110516/text/110516w0003.htm#11051625000037</a><br />
<br />
<br />
<br />
<br />
<br />
<br />
CREUTZFELDT JAKOB DISEASE<br />
<br />
<br />
<br />
Monday, May 16, 2011<br />
<br />
<br />
Does Poor Dental Health Have a Role in the Emergence of Variant Creutzfeldt Jakob Disease in the United Kingdom?<br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/does-poor-dental-health-have-role-in.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/does-poor-dental-health-have-role-in.html</a><br />
<br />
<br />
<br />
<br />
<br />
<br />
=============================<br />
<br />
<br />
Since 2004, fresh frozen plasma for treating babies and young children born on or after 1 January 1996 has been obtained from non-UK sources, and from July 2005 its use was extended to all children up to the age of 16; and Cryoprecipitate, for use in the under-16s, is now produced from imported methylene blue treated-plasma.<br />
<br />
<br />
<br />
=============================<br />
<br />
<br />
<br />
Saturday, May 14, 2011 <br />
<br />
<br />
USA Blood products, collected from a donor who was at risk for vCJD, were distributed Nationally and Internationally MAY 11, 2011<br />
<br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2011/05/usa-blood-products-collected-from-donor.html">http://vcjdtransfusion.blogspot.com/2011/05/usa-blood-products-collected-from-donor.html</a><br />
<br />
<br />
<br />
<br />
<br />
Tuesday, March 29, 2011<br />
<br />
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY EXPOSURE SPREADING VIA HOSPITALS AND SURGICAL PROCEDURES AROUND THE GLOBE<br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/transmissible-spongiform-encephalopathy.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/transmissible-spongiform-encephalopathy.html</a><br />
<br />
<br />
<br />
<br />
<br />
Tuesday, April 26, 2011<br />
<br />
sporadic CJD RISING Text and figures of the latest annual report of the NCJDRSU covering the period 1990-2009 (published 11th March 2011) <br />
<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/04/sporadic-cjd-rising-text-and-figures-of.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/04/sporadic-cjd-rising-text-and-figures-of.html</a><br />
<br />
<br />
<br />
<br />
Friday, May 13,<br />
<br />
<br />
2011 EFSA Joint Scientific Opinion on any possible epidemiological or molecular association between TSEs in animals and humans<br />
<br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/efsa-joint-scientific-opinion-on-any.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/efsa-joint-scientific-opinion-on-any.html</a><br />
<br />
<br />
<br />
<br />
<br />
Sunday, May 01, 2011<br />
<br />
STUDY OF ATYPICAL BSE 2010 Annual Report May 2011<br />
<br />
<br />
<a href="http://bse-atypical.blogspot.com/2011/05/study-of-atypical-bse-2010-annual.html">http://bse-atypical.blogspot.com/2011/05/study-of-atypical-bse-2010-annual.html</a><br />
<br />
<br />
<br />
<br />
Saturday, March 5, 2011<br />
<br />
MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE RISE IN NORTH AMERICA<br />
<br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html</a><br />
<br />
<br />
<br />
<br />
<br />
TSSTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-73700134732476506592011-05-14T11:07:00.000-07:002011-05-14T11:07:16.863-07:00USA Blood products, collected from a donor who was at risk for vCJD, were distributed Nationally and Internationally MAY 11, 2011PRODUCT <br />
<br />
1) Red Blood Cells. Recall # B-1215-11;<br />
<br />
2) Plasma Frozen. Recall # B-1216-11<br />
<br />
CODE<br />
<br />
1) and 2) Unit: W071910008550<br />
<br />
RECALLING FIRM/MANUFACTURER<br />
<br />
So Ca Permamente Med Group Blood Donor Center, Los Angeles, CA, by facsimile and letter on February 01, 2011. Firm initiated recall is complete.<br />
<br />
REASON<br />
<br />
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br />
<br />
VOLUME OF PRODUCT IN COMMERCE<br />
<br />
2 units<br />
<br />
DISTRIBUTION<br />
<br />
CA<br />
<br />
<br />
___________________________________<br />
<br />
<br />
<br />
PRODUCT <br />
<br />
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1235-11;<br />
<br />
2) Red Blood Cells (Apheresis). Recall # B-1236-11;<br />
<br />
3) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1237-11;<br />
<br />
4) Fresh Frozen Plasma (Apheresis). Recall # B-1238-11<br />
<br />
CODE<br />
<br />
1) Units: FM16083, FM16085, FM23853, FM16158, FM16180, FM25344 (part 1), FM25344 (part 2), FM25353, FM16234, FM16235 (part 1), FM16235 (part 2), FM16235 (part 3);<br />
<br />
2) Units: FM16085, FM16180;<br />
<br />
3) Unit: FM16085;<br />
<br />
4) Unit: FM16180<br />
<br />
RECALLING FIRM/MANUFACTURER<br />
<br />
Sacramento Medical Foundation, Sacramento, CA, by telephone on August 19, 2004, October 25, 2004 and October 28, 2004. Firm initiated recall is complete. <br />
<br />
REASON<br />
<br />
Blood products, collected from unsuitable donors based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br />
<br />
VOLUME OF PRODUCT IN COMMERCE<br />
<br />
16 units<br />
<br />
DISTRIBUTION<br />
<br />
CA, TN, MA, AZ<br />
<br />
<br />
___________________________________<br />
<br />
<br />
<br />
<br />
PRODUCT <br />
<br />
Source Plasma. Recall # B-1275-11<br />
<br />
CODE<br />
<br />
Units: 07JWIE6717; 07JWIE6226; 07JWIE5416; 07JWIE4636; 07JWIE4074; 07JWIE2386; 07JWIE1783; 07JWID7602; 07JWID7072; 07JWID2830; 07JWID2280; 07JWID1683; 07JWID1149; 07JWID0420; 07JWIC9864; 07JWIC9102; 07JWIC8527; 07JWIC7817 06JWID8466; 06JWID8869; 06JWIE0195; 06JWIE0828 ; 06JWIE1608; 06JWIE1927; 06JWIE2619; 06JWIE2943; 06JWIE3592 ; 06JWIE4190; 06JWIE4779; 06JWIE5392; 06JWIE5762; 06JWIE6218; 06JWIE6577; 07JWIA0385; 07JWIA0858; 06JWIA1602; 07JWIA2048; 07JWIA3215; 07JWIA3495; 07JWIA4652; 07WIA5096; 07JWIB1404 ; 07JWIB1837; 07JWIB2611; 07JWIB3529; 07JWIB3976; 07JWIC4846; 07JWIC5307; 07JWIC5970; 07JWIC6517; 07JWIC7252; 07JWIB5981; 07JWIB7770 07JWIB8514; 07JWIB9064; 07JWIC0083; 07JWIC0561; 07JWIC1550; 07JWIC2286; 07JWIC2808; 07JWIC3548; 07JWIC4104<br />
<br />
RECALLING FIRM/MANUFACTURER<br />
<br />
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on December 7, 2007.<br />
Manufacturer: BioLife Plasma Services, L.P., Janesville, WI. Firm initiated recall is complete.<br />
<br />
REASON<br />
<br />
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.<br />
<br />
VOLUME OF PRODUCT IN COMMERCE<br />
<br />
62 units<br />
<br />
DISTRIBUTION<br />
<br />
Austria, CA<br />
<br />
___________________________________<br />
<br />
<br />
<br />
END OF ENFORCEMENT REPORT FOR MAY 11, 2011<br />
<br />
#<br />
<br />
<br />
<a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm255019.htm">http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm255019.htm</a><br />
<br />
<br />
<br />
Friday, May 13,<br />
<br />
2011 EFSA Joint Scientific Opinion on any possible epidemiological or molecular association between TSEs in animals and humans<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/efsa-joint-scientific-opinion-on-any.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/efsa-joint-scientific-opinion-on-any.html</a><br />
<br />
<br />
<br />
Tuesday, May 3, 2011<br />
<br />
PRION, TSE, typical, atypical BSE, aka mad cow disease, spray dried blood, feed, and a recipe for disaster<br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/prion-tse-typical-atypical-bse-aka-mad.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/prion-tse-typical-atypical-bse-aka-mad.html</a><br />
<br />
<br />
<br />
Sunday, May 01, 2011<br />
<br />
STUDY OF ATYPICAL BSE 2010 Annual Report May 2011<br />
<br />
<a href="http://bse-atypical.blogspot.com/2011/05/study-of-atypical-bse-2010-annual.html">http://bse-atypical.blogspot.com/2011/05/study-of-atypical-bse-2010-annual.html</a><br />
<br />
<br />
<br />
Sunday, May 1, 2011<br />
<br />
W.H.O. T.S.E. PRION Blood products and related biologicals May 2011<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/who-tse-prion-blood-products-and.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/who-tse-prion-blood-products-and.html</a><br />
<br />
<br />
<br />
Saturday, April 30, 2011<br />
<br />
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed APRIL 27, 2011<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2011/04/blood-product-collected-from-donor-who.html">http://vcjdtransfusion.blogspot.com/2011/04/blood-product-collected-from-donor-who.html</a><br />
<br />
<br />
<br />
Saturday, March 5, 2011<br />
<br />
MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE RISE IN NORTH AMERICA<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html</a><br />
<br />
<br />
<br />
<br />
TSSTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-46108264345434454312011-04-30T20:00:00.000-07:002011-04-30T20:00:45.983-07:00Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed APRIL 27, 2011Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed APRIL 27, 2011<br />
<br />
PRODUCT Recovered Plasma. Recall # B-0017-11 CODE Unit: W086510003037 RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA, by electronic mail on January 9, 2011. Firm initiated recall is complete. REASON Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION IN<br />
<br />
___________________________________<br />
<br />
PRODUCT Source Plasma. Recall # B-0781-11 CODE Unit:07LWIG5594 RECALLING FIRM/MANUFACTURER Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by fax on January 17, 2008. Manufacturer: BioLife Plasma Services, L.P., Onalaska, WI. Firm initiated recall is complete. REASON Blood product, collected from a donor who did not respond to questions regarding increased risk for vCJD, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Austria<br />
<br />
___________________________________<br />
<br />
PRODUCT Source Plasma. Recall # B-1212-11 CODE Unit:08LWIB5812 RECALLING FIRM/MANUFACTURER Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by fax, on June 3, 2008. Manufacturer: BioLife Plasma Services, L.P., Onalaska, WI. Firm initiated recall is complete. REASON Blood product, collected from a donor who did not respond to questions regarding increased risk for vCJD, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Austria<br />
<br />
___________________________________<br />
<br />
PRODUCT Recovered Plasma. Recall # B-1229-11 CODE Unit: W036510029868 RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Monroe, LA, by electronic notification on March 8, 2011. Firm initiated recall is complete. REASON Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Switzerland<br />
<br />
___________________________________<br />
<br />
END OF ENFORCEMENT REPORT FOR APRIL 27, 2011<br />
<br />
#<br />
<br />
<a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm252912.htm">http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm252912.htm</a><br />
<br />
<br />
<br />
Friday, September 24, 2010<br />
<br />
USA Blood products, collected from a donor who was at risk for vCJD, were distributed SEPTEMBER 2010<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2010/09/usa-blood-products-collected-from-donor.html">http://vcjdtransfusion.blogspot.com/2010/09/usa-blood-products-collected-from-donor.html</a><br />
<br />
<br />
<br />
Thursday, August 12, 2010<br />
<br />
USA Blood products, collected from a donor who was at risk for vCJD, were distributed July-August 2010<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html</a><br />
<br />
<br />
<br />
<br />
Thursday, May 27, 2010 <br />
<br />
<br />
Guidance for Industry: Revised Preventive Measures to Reduce Possible Risk of Transmission of CJD and vCJD by blood and blood products; Availability<br />
<br />
[Federal Register: May 27, 2010 (Volume 75, Number 102)] [Notices] [Page 29768-29769] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr27my10-66]<br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2010/05/guidance-for-industry-revised.html">http://vcjdtransfusion.blogspot.com/2010/05/guidance-for-industry-revised.html</a><br />
<br />
<br />
<br />
<br />
Monday, February 7, 2011<br />
<br />
FDA's Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???<br />
<br />
<a href="http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html">http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html</a><br />
<br />
<br />
Sunday, January 30, 2011<br />
<br />
Vaccines and Transmissible Spongiform Encephalopathy the Prion Disease, what if ?<br />
<br />
COMMERCIAL IN CONFIDENCE<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/vaccines-and-transmissible-spongiform.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/vaccines-and-transmissible-spongiform.html</a><br />
<br />
<br />
<br />
Saturday, February 26, 2011<br />
<br />
Supreme Court Protects Vaccine Manufacturers, Not Injured Children there from Bruesewitz vs Wyeth<br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2011/02/supreme-court-protects-vaccine.html">http://vcjdtransfusion.blogspot.com/2011/02/supreme-court-protects-vaccine.html</a><br />
<br />
<br />
<br />
Wednesday, January 19, 2011<br />
<br />
EFSA and ECDC review scientific evidence on possible links between TSEs in animals and humans Webnachricht 19 Januar 2011<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-and-ecdc-review-scientific.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/efsa-and-ecdc-review-scientific.html</a><br />
<br />
<br />
<br />
<br />
Tuesday, January 18, 2011<br />
<br />
Agent strain variation in human prion disease: insights from a molecular and pathological review of the National Institutes of Health series of experimentally transmitted disease<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/agent-strain-variation-in-human-prion.html</a><br />
<br />
<br />
Tuesday, December 14, 2010<br />
<br />
Infection control of CJD, vCJD and other human prion diseases in healthcare and community settings part 4, Annex A1, Annex J, UPDATE DECEMBER 2010<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/12/infection-control-of-cjd-vcjd-and-other.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/12/infection-control-of-cjd-vcjd-and-other.html</a><br />
<br />
<br />
<br />
<br />
Wednesday, September 08, 2010<br />
<br />
Emerging Infectious Diseases: CJD, BSE, SCRAPIE, CWD, PRION, TSE Evaluation to Implementation for Transfusion and Transplantation September 2010<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2010/09/emerging-infectious-diseases-cjd-bse.html">http://vcjdtransfusion.blogspot.com/2010/09/emerging-infectious-diseases-cjd-bse.html</a><br />
<br />
<br />
<br />
Saturday, January 20, 2007<br />
<br />
Fourth case of transfusion-associated vCJD infection in the United Kingdom<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2007_01_01_archive.html">http://vcjdtransfusion.blogspot.com/2007_01_01_archive.html</a><br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2010/07/cjd-uk-parliament-12-july-2010-column.html">http://vcjdtransfusion.blogspot.com/2010/07/cjd-uk-parliament-12-july-2010-column.html</a><br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/">http://vcjdtransfusion.blogspot.com/</a><br />
<br />
<br />
The EMBO Journal (2002) 21, 6358 - 6366 doi:10.1093/emboj/cdf653<br />
<br />
BSE prions propagate as either variant CJD-like or sporadic CJD-like prion strains in transgenic mice expressing human prion protein<br />
<br />
Emmanuel A. Asante1, Jacqueline M. Linehan1, Melanie Desbruslais1, Susan Joiner1, Ian Gowland1, Andrew L. Wood1, Julie Welch1, Andrew F. Hill1, Sarah E. Lloyd1, Jonathan D.F. Wadsworth1 and John Collinge1<br />
<br />
1.MRC Prion Unit and Department of Neurodegenerative Disease, Institute of Neurology, University College, Queen Square, London WC1N 3BG, UK Correspondence to:<br />
<br />
John Collinge, E-mail: j.collinge@prion.ucl.ac.uk<br />
<br />
Received 1 August 2002; Accepted 17 October 2002; Revised 24 September 2002<br />
<br />
--------------------------------------------------------------------------------<br />
<br />
Abstract<br />
<br />
Variant Creutzfeldt–Jakob disease (vCJD) has been recognized to date only in individuals homozygous for methionine at PRNP codon 129. Here we show that transgenic mice expressing human PrP methionine 129, inoculated with either bovine spongiform encephalopathy (BSE) or variant CJD prions, may develop the neuropathological and molecular phenotype of vCJD, consistent with these diseases being caused by the same prion strain. Surprisingly, however, BSE transmission to these transgenic mice, in addition to producing a vCJD-like phenotype, can also result in a distinct molecular phenotype that is indistinguishable from that of sporadic CJD with PrPSc type 2. These data suggest that more than one BSE-derived prion strain might infect humans; it is therefore possible that some patients with a phenotype consistent with sporadic CJD may have a disease arising from BSE exposure.<br />
<br />
Keywords:BSE, Creutzfeldt–Jakob disease, prion, transgenic<br />
<br />
<a href="http://www.nature.com/emboj/journal/v21/n23/abs/7594869a.html">http://www.nature.com/emboj/journal/v21/n23/abs/7594869a.html</a><br />
<br />
<br />
<br />
Wednesday, March 31, 2010<br />
<br />
Atypical BSE in Cattle<br />
<br />
To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.<br />
<br />
This study will contribute to a correct definition of specified risk material (SRM) in atypical BSE. The incumbent of this position will develop new and transfer existing, ultra-sensitive methods for the detection of atypical BSE in tissue of experimentally infected cattle.<br />
<br />
<a href="http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2">http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2</a><br />
<br />
<br />
<br />
U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ? see video at bottom<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html">http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html</a><br />
<br />
<br />
<br />
Thursday, August 12, 2010<br />
<br />
Seven main threats for the future linked to prions<br />
<br />
First threat<br />
<br />
The TSE road map defining the evolution of European policy for protection against prion diseases is based on a certain numbers of hypotheses some of which may turn out to be erroneous. In particular, a form of BSE (called atypical Bovine Spongiform Encephalopathy), recently identified by systematic testing in aged cattle without clinical signs, may be the origin of classical BSE and thus potentially constitute a reservoir, which may be impossible to eradicate if a sporadic origin is confirmed. ***Also, a link is suspected between atypical BSE and some apparently sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases constitute an unforeseen first threat that could sharply modify the European approach to prion diseases.<br />
<br />
Second threat<br />
<br />
snip...<br />
<br />
<a href="http://www.neuroprion.org/en/np-neuroprion.html">http://www.neuroprion.org/en/np-neuroprion.html</a><br />
<br />
<br />
Archive Number 20101206.4364 Published Date 06-DEC-2010 Subject PRO/AH/EDR> Prion disease update 2010 (11)<br />
<br />
PRION DISEASE UPDATE 2010 (11)<br />
<br />
<a href="http://www.promedmail.org/pls/apex/f?p=2400:1001:5492868805159684::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,86129">http://www.promedmail.org/pls/apex/f?p=2400:1001:5492868805159684::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,86129</a><br />
<br />
<br />
<br />
14th ICID International Scientific Exchange Brochure -<br />
<br />
Final Abstract Number: ISE.114<br />
<br />
Session: International Scientific Exchange<br />
<br />
Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009<br />
<br />
T. Singeltary<br />
<br />
Bacliff, TX, USA<br />
<br />
Background:<br />
<br />
An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and fed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.<br />
<br />
Methods:<br />
<br />
12 years independent research of available data<br />
<br />
Results:<br />
<br />
I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.<br />
<br />
Conclusion:<br />
<br />
I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.<br />
<br />
<a href="http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf">http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf</a><br />
<br />
<br />
<br />
International Society for Infectious Diseases Web: <a href="http://www.isid.org/">http://www.isid.org/</a><br />
<br />
<br />
Monday, May 11, 2009<br />
<br />
Rare BSE mutation raises concerns over risks to public health<br />
<br />
<a href="http://bse-atypical.blogspot.com/2009/05/rare-bse-mutation-raises-concerns-over.html">http://bse-atypical.blogspot.com/2009/05/rare-bse-mutation-raises-concerns-over.html</a><br />
<br />
<br />
<br />
The most recent assessments (and reassessments) were published in June 2005 (Table I; 18), and included the categorisation of Canada, the USA, and Mexico as GBR III. Although only Canada and the USA have reported cases, the historically open system of trade in North America suggests that it is likely that BSE is present also in Mexico.<br />
<br />
<a href="http://www.oie.int/boutique/extrait/06heim937950.pdf">http://www.oie.int/boutique/extrait/06heim937950.pdf</a><br />
<br />
<br />
Archive Number 20101206.4364 Published Date 06-DEC-2010 Subject PRO/AH/EDR> Prion disease update 2010 (11)<br />
<br />
PRION DISEASE UPDATE 2010 (11)<br />
<br />
SEE;<br />
<br />
TAFS1 Position Paper on Position Paper on Relaxation of the Feed Ban in the EU Berne, 2010 TAFS<br />
<br />
INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation<br />
<br />
<a href="http://www.promedmail.org/pls/apex/f?p=2400:1001:5492868805159684::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,86129">http://www.promedmail.org/pls/apex/f?p=2400:1001:5492868805159684::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,86129</a><br />
<br />
<br />
<br />
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007<br />
<br />
Date: March 21, 2007 at 2:27 pm PST<br />
<br />
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II<br />
<br />
___________________________________<br />
<br />
PRODUCT<br />
<br />
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007<br />
<br />
CODE<br />
<br />
Cattle feed delivered between 01/12/2007 and 01/26/2007<br />
<br />
RECALLING FIRM/MANUFACTURER<br />
<br />
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.<br />
<br />
Firm initiated recall is ongoing.<br />
<br />
REASON<br />
<br />
Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.<br />
<br />
VOLUME OF PRODUCT IN COMMERCE<br />
<br />
42,090 lbs.<br />
<br />
DISTRIBUTION<br />
<br />
WI<br />
<br />
___________________________________<br />
<br />
PRODUCT<br />
<br />
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007<br />
<br />
CODE<br />
<br />
The firm does not utilize a code - only shipping documentation with commodity and weights identified.<br />
<br />
RECALLING FIRM/MANUFACTURER<br />
<br />
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.<br />
<br />
REASON<br />
<br />
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.<br />
<br />
VOLUME OF PRODUCT IN COMMERCE<br />
<br />
9,997,976 lbs.<br />
<br />
DISTRIBUTION<br />
<br />
ID and NV<br />
<br />
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007<br />
<br />
<a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm">http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm</a><br />
<br />
<br />
Discussion: The C, L and H type BSE cases in Canada exhibit molecular characteristics similar to those described for classical and atypical BSE cases from Europe and Japan. This supports the theory that the importation of BSE contaminated feedstuff is the source of C-type BSE in Canada. *It also suggests a similar cause or source for atypical BSE in these countries.<br />
<br />
<a href="http://www.prion2009.com/sites/default/files/Prion2009_Book_of_Abstracts.pdf">http://www.prion2009.com/sites/default/files/Prion2009_Book_of_Abstracts.pdf</a><br />
<br />
<br />
<br />
Saturday, November 6, 2010<br />
<br />
TAFS1 Position Paper on Position Paper on Relaxation of the Feed Ban in the EU Berne, 2010 TAFS<br />
<br />
INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation<br />
<br />
<a href="http://madcowfeed.blogspot.com/2010/11/tafs1-position-paper-on-position-paper.html">http://madcowfeed.blogspot.com/2010/11/tafs1-position-paper-on-position-paper.html</a><br />
<br />
<br />
<br />
<br />
Saturday, August 14, 2010<br />
<br />
BSE Case Associated with Prion Protein Gene Mutation (g-h-BSEalabama) and VPSPr PRIONPATHY<br />
<br />
(see mad cow feed in COMMERCE IN ALABAMA...TSS)<br />
<br />
<a href="http://prionpathy.blogspot.com/2010/08/bse-case-associated-with-prion-protein.html">http://prionpathy.blogspot.com/2010/08/bse-case-associated-with-prion-protein.html</a><br />
<br />
<br />
<br />
<br />
Tuesday, September 14, 2010<br />
<br />
Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)<br />
<br />
<a href="http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html">http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html</a><br />
<br />
<br />
Wednesday, March 9, 2011<br />
<br />
27 U.S. Senators want to force feed Japan Highly Potential North America Mad Cow Beef TSE PRION CJD March 8, 2011<br />
<br />
President Barack Obama The White House<br />
<br />
1600 Pennsylvania Avenue, W Washington, DC 20500<br />
<br />
Dear President Obama:<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/27-us-senators-want-to-force-feed-japan.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/27-us-senators-want-to-force-feed-japan.html</a><br />
<br />
<br />
Sunday, April 17, 2011<br />
<br />
Transmission of Prion Strains in a Transgenic Mouse Model Overexpressing Human A53T Mutated [alpha]-Synuclein<br />
<br />
Journal of Neuropathology & Experimental Neurology:<br />
<br />
POST AUTHOR CORRECTIONS, 8 April 2011 doi: 10.1097/NEN.0b013e318217d95f<br />
<br />
<a href="http://bse-atypical.blogspot.com/2011/04/transmission-of-prion-strains-in.html">http://bse-atypical.blogspot.com/2011/04/transmission-of-prion-strains-in.html</a><br />
<br />
<br />
Sunday, August 10, 2008<br />
<br />
A New Prionopathy OR more of the same old BSe and sporadic CJD<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2008/08/new-prionopathy-or-more-of-same-old-bse.html">http://creutzfeldt-jakob-disease.blogspot.com/2008/08/new-prionopathy-or-more-of-same-old-bse.html</a><br />
<br />
<br />
<br />
Sunday, September 6, 2009<br />
<br />
MAD COW USA 1997 SECRET VIDEO<br />
<br />
<a href="http://madcowusda.blogspot.com/2009/09/mad-cow-usa-1997-video.html">http://madcowusda.blogspot.com/2009/09/mad-cow-usa-1997-video.html</a><br />
<br />
<br />
<br />
Friday, March 4, 2011<br />
<br />
Alberta dairy cow found with mad cow disease<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/alberta-dairy-cow-found-with-mad-cow.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/alberta-dairy-cow-found-with-mad-cow.html</a><br />
<br />
<br />
Wednesday, August 11, 2010<br />
<br />
REPORT ON THE INVESTIGATION OF THE SIXTEENTH CASE OF BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN CANADA<br />
<br />
<a href="http://bse-atypical.blogspot.com/2010/08/report-on-investigation-of-sixteenth.html">http://bse-atypical.blogspot.com/2010/08/report-on-investigation-of-sixteenth.html</a><br />
<br />
<br />
Thursday, August 19, 2010<br />
<br />
REPORT ON THE INVESTIGATION OF THE SEVENTEENTH CASE OF BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN CANADA<br />
<br />
<a href="http://bseusa.blogspot.com/2010/08/report-on-investigation-of-seventeenth.html">http://bseusa.blogspot.com/2010/08/report-on-investigation-of-seventeenth.html</a><br />
<br />
<br />
Thursday, February 10, 2011<br />
<br />
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY REPORT UPDATE CANADA FEBRUARY 2011 a nd how to hide mad cow disease in Canada Current as of: 2011-01-31<br />
<br />
<a href="http://madcowtesting.blogspot.com/2011/02/transmissible-spongiform-encephalopathy.html">http://madcowtesting.blogspot.com/2011/02/transmissible-spongiform-encephalopathy.html</a><br />
<br />
<br />
i wonder if CFIA Canada uses the same OBEX ONLY diagnostic criteria as the USDA ?<br />
<br />
<br />
Tuesday, November 02, 2010<br />
<br />
BSE - ATYPICAL LESION DISTRIBUTION (RBSE 92-21367) statutory (obex only) diagnostic criteria CVL 1992<br />
<br />
<a href="http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html">http://bse-atypical.blogspot.com/2010/11/bse-atypical-lesion-distribution-rbse.html</a><br />
<br />
<br />
Monday, April 25, 2011<br />
<br />
Experimental Oral Transmission of Atypical Scrapie to Sheep<br />
<br />
Volume 17, Number 5-May 2011<br />
<br />
<a href="http://nor-98.blogspot.com/2011/04/experimental-oral-transmission-of.html">http://nor-98.blogspot.com/2011/04/experimental-oral-transmission-of.html</a><br />
<br />
<br />
PUTTING THE CART BEFORE THE HORSE, in terms of human health risk $$$<br />
<br />
<br />
Monday, November 30, 2009<br />
<br />
USDA AND OIE COLLABORATE TO EXCLUDE ATYPICAL SCRAPIE NOR-98 ANIMAL HEALTH CODE<br />
<br />
<a href="http://nor-98.blogspot.com/2009/11/usda-and-oie-collaborate-to-exclude.html">http://nor-98.blogspot.com/2009/11/usda-and-oie-collaborate-to-exclude.html</a><br />
<br />
<br />
Saturday, December 18, 2010<br />
<br />
OIE Global Conference on Wildlife Animal Health and Biodiversity - Preparing for the Future (TSE AND PRIONS) Paris (France), 23-25 February 2011<br />
<br />
snip...<br />
<br />
Greetings,<br />
<br />
<br />
<br />
"Thank for your support to the OIE objectives for a safe world."<br />
<br />
<br />
NOT !<br />
<br />
I see again that the OIE has done little to help eradicate all animal TSE from the globe, and in fact in my opinion, have help enhance the spread of BSE and other animal TSE globally by their industry friendly regulations. I tried to warn the OIE in 2002 about CWD and the potential, but very real threat of CWD to humans. I was told that they were seriously considering this. what happened ? NOW, the OIE and the USDA collaborate to make legal the trading of all strains of atypical BSE legal, and in fact have done so with the atypical scrapie, when science has made perfectly clear the risk factors to humans and other species. I have said it once (see below), and i will say again ;<br />
<br />
"THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE. AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they should do everyone a favor and dissolve there organization."<br />
<br />
NOW, some history on the failed OIE BSE/TSE policy, and why the OIE allowed BSE and other TSE to spread around the globe $$$<br />
<br />
snip...<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2010/12/oie-global-conference-on-wildlife.html">http://transmissiblespongiformencephalopathy.blogspot.com/2010/12/oie-global-conference-on-wildlife.html</a><br />
<br />
<br />
<br />
Sunday, March 27, 2011<br />
<br />
SCRAPIE USA UPDATE FEBRUARY 2011<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/scrapie-usa-update-february-2011.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/scrapie-usa-update-february-2011.html</a><br />
<br />
<br />
Sunday, April 18, 2010<br />
<br />
SCRAPIE AND ATYPICAL SCRAPIE TRANSMISSION STUDIES A REVIEW 2010<br />
<br />
<a href="http://scrapie-usa.blogspot.com/2010/04/scrapie-and-atypical-scrapie.html">http://scrapie-usa.blogspot.com/2010/04/scrapie-and-atypical-scrapie.html</a><br />
<br />
<br />
Wednesday, February 16, 2011<br />
<br />
IN CONFIDENCE<br />
<br />
SCRAPIE TRANSMISSION TO CHIMPANZEES<br />
<br />
IN CONFIDENCE<br />
<br />
<a href="http://scrapie-usa.blogspot.com/2011/02/in-confidence-scrapie-transmission-to.html">http://scrapie-usa.blogspot.com/2011/02/in-confidence-scrapie-transmission-to.html</a><br />
<br />
<br />
Thursday, April 28, 2011<br />
<br />
Chronic Wasting Disease Testing and Prevalence Wisconsin April 2011<br />
<br />
<a href="http://chronic-wasting-disease.blogspot.com/2011/04/chronic-wasting-disease-testing-and.html">http://chronic-wasting-disease.blogspot.com/2011/04/chronic-wasting-disease-testing-and.html</a><br />
<br />
<br />
Wednesday, January 5, 2011<br />
<br />
ENLARGING SPECTRUM OF PRION-LIKE DISEASES Prusiner Colby et al 2011<br />
<br />
Prions<br />
<br />
David W. Colby1,* and Stanley B. Prusiner1,2<br />
<br />
<a href="http://betaamyloidcjd.blogspot.com/2011/01/enlarging-spectrum-of-prion-like.html">http://betaamyloidcjd.blogspot.com/2011/01/enlarging-spectrum-of-prion-like.html</a><br />
<br />
<br />
Saturday, January 2, 2010<br />
<br />
Human Prion Diseases in the United States January 1, 2010 ***FINAL***<br />
<br />
<a href="http://prionunitusaupdate2008.blogspot.com/2010/01/human-prion-diseases-in-united-states.html">http://prionunitusaupdate2008.blogspot.com/2010/01/human-prion-diseases-in-united-states.html</a><br />
<br />
<br />
my comments to PLosone here ;<br />
<br />
<br />
<a href="http://www.plosone.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd&root=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd">http://www.plosone.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd&root=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd</a><br />
<br />
<br />
<br />
Friday, March 25, 2011 <br />
<br />
Detection of Prion Protein in Urine-Derived Injectable Fertility Products by a Targeted Proteomic Approach<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/detection-of-prion-protein-in-urine.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/detection-of-prion-protein-in-urine.html</a><br />
<br />
<br />
<br />
<br />
Saturday, March 5, 2011<br />
<br />
MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE RISE IN NORTH AMERICA<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/mad-cow-atypical-cjd-prion-tse-cases.html</a><br />
<br />
<br />
<br />
<br />
Tuesday, April 26, 2011<br />
<br />
sporadic CJD RISING Text and figures of the latest annual report of the NCJDRSU covering the period 1990-2009 (published 11th March 2011)<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/04/sporadic-cjd-rising-text-and-figures-of.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/04/sporadic-cjd-rising-text-and-figures-of.html</a><br />
<br />
<br />
<br />
<br />
Tuesday, March 29, 2011<br />
<br />
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY EXPOSURE SPREADING VIA HOSPITALS AND SURGICAL PROCEDURES AROUND THE GLOBE<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/transmissible-spongiform-encephalopathy.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/03/transmissible-spongiform-encephalopathy.html</a><br />
<br />
<br />
<br />
Thursday, July 08, 2010<br />
<br />
GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW 2010<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html</a><br />
<br />
<br />
<br />
<br />
Tuesday, September 28, 2010 <br />
<br />
<br />
Variant CJD: where has it gone, or has it?<br />
<br />
Pract Neurol 2010; 10: 250–251<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2010/09/variant-cjd-where-has-it-gone-or-has-it.html">http://vcjdtransfusion.blogspot.com/2010/09/variant-cjd-where-has-it-gone-or-has-it.html</a><br />
<br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/">http://vcjdtransfusion.blogspot.com/</a><br />
<br />
<br />
<br />
<br />
<br />
<br />
DID EVERYONE THAT LOST A LOVED ONE FILL OUT THEIR CJD QUESIONNAIRE FROM THE CDC AND OR THE CJD FOUNDATION ???<br />
<br />
<br />
Friday, November 30, 2007<br />
<br />
<br />
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION<br />
<br />
<br />
<br />
<a href="http://cjdquestionnaire.blogspot.com/">http://cjdquestionnaire.blogspot.com/</a><br />
<br />
<br />
<br />
NOW, tell me again how safe the blood supply is from TSE prions in North America ???<br />
<br />
<br />
WITH an incubation period of up to 50 years ???<br />
<br />
<br />
<br />
Prion infection begins after one minute of exposure 26 April 2011<br />
<br />
<br />
<a href="http://www.ucl.ac.uk/ion/articles/news/110419">http://www.ucl.ac.uk/ion/articles/news/110419</a><br />
<br />
<br />
<br />
Rapid cell-surface prion protein conversion revealed using a novel cell system<br />
<br />
R. Goold,1, 4 S. Rabbanian,1, 4 L. Sutton,1 R. Andre,1 P. Arora,2 J. Moonga,1 A.R. Clarke,2 G. Schiavo,3 P. Jat,1 J. Collinge1, 2 & S.J. Tabrizi1 AffiliationsContributionsCorresponding author Journal name: Nature Communications Volume: 2,Article number:281 DOI: doi:10.1038/ncomms1282 Received08 October 2010Accepted17 March 2011Published19 April 2011<br />
<br />
Abstract<br />
<br />
Prion diseases are fatal neurodegenerative disorders with unique transmissible properties. The infectious and pathological agent is thought to be a misfolded conformer of the prion protein. Little is known about the initial events in prion infection because the infecting prion source has been immunologically indistinguishable from normal cellular prion protein (PrPC). Here we develop a unique cell system in which epitope-tagged PrPC is expressed in a PrP knockdown (KD) neuroblastoma cell line. The tagged PrPC, when expressed in our PrP-KD cells, supports prion replication with the production of bona fide epitope-tagged infectious misfolded PrP (PrPSc). Using this epitope-tagged PrPSc, we study the earliest events in cellular prion infection and PrP misfolding. We show that prion infection of cells is extremely rapid occurring within 1 min of prion exposure, and we demonstrate that the plasma membrane is the primary site of prion conversion.<br />
<br />
<br />
<a href="http://www.nature.com/ncomms/journal/v2/n4/abs/ncomms1282.html">http://www.nature.com/ncomms/journal/v2/n4/abs/ncomms1282.html</a><br />
<br />
<br />
<br />
<a href="http://www.nature.com/ncomms/journal/v2/n4/full/ncomms1282.html">http://www.nature.com/ncomms/journal/v2/n4/full/ncomms1282.html</a><br />
<br />
<br />
<br />
<a href="http://www.nature.com/ncomms/journal/v2/n4/extref/ncomms1282-s1.pdf">http://www.nature.com/ncomms/journal/v2/n4/extref/ncomms1282-s1.pdf</a><br />
<br />
<br />
<br />
Subject: Transmission of BSE by blood transfusion in sheep... <br />
<br />
Date: Thu, 14 Sep 2000 18:19:06 -0700 <br />
<br />
From: "Terry S. Singeltary Sr." <br />
<br />
Reply-To: Bovine Spongiform Encephalopathy <br />
<br />
To: BSE-L@uni-karlsruhe.de<br />
<br />
<br />
<br />
######### Bovine Spongiform Encephalopathy #########<br />
<br />
Greetings List Members,<br />
<br />
More Dredful news, but predictable...<br />
<br />
kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA <br />
<br />
===========================================<br />
<br />
It is possible to transmit BSE to a sheep by transfusion with whole blood taken from another sheep during the symptom-free phase of an experimental BSE infection'<br />
<br />
It is well known that variant Creutzfeldt-Jakob disease (vCJD) is caused by the same strain of agent that causes bovine spongiform encephalopathy (BSE) in cattle. F Houston and colleagues report the preliminary findings of transfusing blood from 19 UK Cheviot sheep fed with 5 g BSE-affected cattle brain into Cheviot sheep from scrapie-free flock of New Zealand-derived animals. The investigators found BSE clinical signs and pathology in one recipient of blood taken from a BSE infected animal. Immunocytochemistry on tissues taken from the transfused sheep showed widespread PrPSC deposition throughout the brain and the periphery. This finding suggests that blood donated by symptom-free vCJD-infected human beings could transmit infection to recipients of blood transfusions. In a Commentary, Paul Brown states that these observations are consistent with previous reports in experimentally infected rodents.<br />
<br />
==================<br />
<br />
Research letters Volume 356, Number 9234 16 September 2000<br />
<br />
Transmission of BSE by blood transfusion in sheep<br />
<br />
Lancet 2000; 356: 999 - 1000 Download PDF (1 Mb)<br />
<br />
F Houston, J D Foster, Angela Chong, N Hunter, C J Bostock<br />
<br />
See Commentary<br />
<br />
We have shown that it is possible to transmit bovine spongiform encephalopathy (BSE) to a sheep by transfusion with whole blood taken from another sheep during the symptom-free phase of an experimental BSE infection. BSE and variant Creutzfeldt-Jakob disease (vCJD) in human beings are caused by the same infectious agent, and the sheep-BSE experimental model has a similar pathogenesis to that of human vCJD. Although UK blood transfusions are leucodepleted--a possible protective measure against any risk from blood transmission--this report suggests that blood donated by symptom-free vCJD-infected human beings may represent a risk of spread of vCJD infection among the human population of the UK.<br />
<br />
The demonstration that the new variant of Creutzfeldt-Jakob disease (vCJD) is caused by the same agent that causes bovine spongiform encephalopathy (BSE) in cattle1 has raised concerns that blood from human beings in the symptom-free stages of vCJD could transmit infection to recipients of blood transfusions. There is no evidence that iatrogenic CJD has ever occurred as a result of the use of blood or blood products, but vCJD has a different pathogenesis and could present different risks. CJD is one of the transmissible spongiform encephalopathies (TSEs) characterised by the deposition of an abnormal form of a host protein, PrPSc; the normal isoform (PrPC) is expressed in many body tissues. Available evidence, based on detection of infectivity in blood in rodent models, and absence of infectivity in naturally occurring TSEs, adds to the uncertainty in risk assessments of the safety of human blood. PrPSc has been reported in blood taken from preclinical TSE-infected sheep,2 but it does not follow that blood is infectious. Bioassays of human blood can only be carried out in non-human species, limiting the sensitivity of the test. One way of avoiding such a species barrier is to transfer blood by transfusion in an appropriate animal TSE model. BSE-infected sheep harbour infection in peripheral tissues3 and are thus similar to humans infected with vCJD.4 BSE infectivity in cattle does not have widespread tissue distribution.<br />
<br />
We report preliminary data from a study involving blood taken from UK Cheviot sheep challenged orally with 5 g BSE-affected cattle brain and transfused into Cheviot sheep from a scrapie-free flock of New Zealand-derived animals (MAFF/SF flock). MAFF/SF sheep do not develop spontaneous TSE and the transfused animals are housed separately from other sheep. All sheep in the study have the PrP genotype AA136QQ171 which has the shortest incubation period of experimental BSE in sheep.5 19 transfusions from BSE-challenged sheep have been done, mostly with whole blood. Sheep have complex blood groups and only simple cross-matching can be done by mixing recipient serum and donor erythrocytes and vice versa. Therefore single transfusions only were made between sedated cross-matched animals to minimise the risk of severe reactions. Negative controls were MAFF/SF sheep transfused with blood from uninfected UK Cheviot sheep. As a positive control, MAFF/SF sheep were intravenously injected with homogenised BSE-affected cattle brain.<br />
<br />
We have seen BSE clinical signs and pathological changes in one recipient of blood from a BSE-infected animal, and we regard this finding as sufficiently important to report now rather than after the study is completed, several years hence. The blood donation resulting in transmission of BSE to the recipient was 400 mL of whole blood taken from a healthy sheep 318 days after oral challenge with BSE. BSE subsequently developed in this donor animal 629 days after challenge, indicating that blood was taken roughly half way through the incubation period. 610 days after transfusion, the transfused sheep (D505) itself developed typical TSE signs: weight loss, moderate pruritus, trembling and licking of the lips, hind-limb ataxia, and proprioceptive abnormalities. This is the first experimental transmission of BSE from sheep to sheep and so we have nothing with which to compare this incubation period directly. In cross-species transmissions, bovine BSE injected intracerebrally gives incubation periods of about 450 days in these sheep,5 and the donor animal had an oral BSE incubation period of 629 days (see above). There are no similar data available on other infection routes. Immunocytochemistry with the antibody BG4 on tissues taken from sheep D505 showed widespread PrPSc deposition throughout the brain and periphery. Western blot analysis of brain tissue with the antibody 6H4 showed that the PrPSc protein had a glycoform pattern similar to that of experimental BSE in sheep and unlike that of UK natural scrapie (figure), indicating that the TSE signs resulted from transmission of the BSE agent. All other recipients of transfusions and positive and negative controls are alive and healthy. The positive controls, which involve a species barrier, are expected to have lengthy incubation periods. With one exception, all transfused animals are at earlier stages post-transfusion than was D505. The exception is a sheep which is healthy 635 days after transfusion with BSE-blood donated at less than 30% of the BSE incubation period of the donor sheep.<br />
<br />
PrPSc (proteinase K treated) analysed by SDS-PAGE, immunoblotted with 6H4, and visualised with a chemiluminescent substrate<br />
<br />
All lanes are from the same gel with different exposure times. Size markers are to the left of lane 1. Lane1: natural scrapie sheep brain, 3 min exposure. Lane 2: as lane 1, 10 min exposure. Lane 3: sheep D505, blood-transfusion recipient, 10 min exposure. Lane 4: experimental BSE-affected sheep brain, 30 s exposure. Lane 5: as lane 4, 10 min exposure. Each lane loaded with amount of protein extracted from 0·1 g wet weight of brain, except lane 3 which was extracted from 0·2 g brain.<br />
<br />
Although this result was in only one animal, it indicates that BSE can be transmitted between individuals of the same species by whole-blood transfusion. We have no data on blood fractions or on levels of infectivity in blood of preclinical vCJD cases, but whole blood is not now used in UK transfusions. The presence of BSE infectivity in sheep blood at an early stage in the incubation period suggests that it should be possible to identify which cells are infected, to test the effectiveness of leucodepletion, and to develop a diagnostic test based on a blood sample.<br />
<br />
We thank Karen Brown, Moira Bruce, Calum McKenzie, David Parnham, Diane Ritchie, and the Scottish Blood Transfusion Service. The project is funded by the Department of Health.<br />
<br />
1 Bruce ME, Will RG, Ironside JW, et al. Transmissions to mice indicate that 'new variant' CJD is caused by the BSE agent. Nature 1997; 389: 488-501 [PubMed].<br />
<br />
2 Schmerr MJ, Jenny A, Cutlip RC. Use of capillary sodium dodecyl sulfate gel electrophoresis to detect the prion protein extracted from scrapie-infected sheep. J Chromatogr B Biomed Appl 1997; 697: 223-29 [PubMed].<br />
<br />
3 Foster JD, Bruce M, McConnell I, Chree A, Fraser H. Detection of BSE infectivity in brain and spleen of experimentally infected sheep. Vet Rec 1996; 138: 546-48 [PubMed].<br />
<br />
4 Hill AF, Zeidler M, Ironside J, Collinge J. Diagnosis of new variant Creutzfeldt-Jakob disease by tonsil biopsy. Lancet 1997; 349: 99-100.<br />
<br />
5 Goldmann W, Hunter N, Smith G, Foster J, Hope J. PrP genotype and agent effects in scrapie: change in allelic interaction with different isolates of agent in sheep, a natural host of scrapie. J Gen Virol 1994; 75: 989-95 [PubMed].<br />
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Institute for Animal Health, Compton, Newbury, UK (F Houston PhD, CJ Bostock PhD); and Institute for Animal Health, Neuropathogenesis Unit, Edinburgh, EH9 3JF, UK (N Hunter PhD, JD Foster BSc, Angela Chong BSc)<br />
<br />
Correspondence to: Dr N Hunter<br />
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Commentary Volume 356, Number 9234 16 September 2000<br />
<br />
BSE and transmission through blood<br />
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Lancet 2000; 356: 955 - 956 Download PDF (55 Kb) Wether the outbreak of variant Creutzfeldt-Jakob disease (vCJD) in the UK will ultimately affect hundreds, or tens of thousands of people, cannot yet be predicted.1 If large numbers of apparently healthy people are now silently incubating infections with bovine spongiform encephalopathy (BSE), the implications for public health include the possiblity that blood from such individuals may be infectious. Established facts about infectivity in the blood of human beings and animals with transmissible spongiform encephalopathies (TSEs) are as follows:2-4<br />
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Blood, especially the buffy-coat component, from animals experimentally infected with scrapie or CJD and from either a clinical or preclinical incubation phase, is consistently infectious when bioassayed by intracerebral or intraperitoneal inoculation into the same species;<br />
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In naturally infected animals (sheep and goats with scrapie, mink with transmissible mink encephalopathy, and cows with BSE), all attempts to transmit disease through the inoculation of blood have failed;<br />
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Blood from four of 37 human beings with clinically evident sporadic CJD has been reported to transmit the disease after intracerebral inoculation into guineapigs, mice, or hamsters. But each success has been questioned on technical grounds and has not been reproducible; and<br />
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Epidemiological data have not revealed a single case of CJD that could be attributed to the administration of blood or blood products among patients with CJD, or among patients with haemophilia and other congenital clotting or immune deficiencies who receive repeated doses of plasma concentrates.<br />
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No comparable information about vCJD is available. However, since lymphoreticular organs, such as tonsils have been shown to contain the prion protein (which is an excellent index of infectivity), whereas it is not detectable in patients with sporadic CJD, there is some reason to worry that blood from individuals incubating vCJD might be infectious.5 Data from studies into the ability of blood from experimentally infected rodents and primates with vCJD to transmit the disease will not be available for months or years.<br />
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In this issue of The Lancet, F Houston and co-workers report convincing evidence that blood from a seemingly healthy sheep incubating BSE (infected by the oral route with brain from a diseased cow) was able to cause the disease when transfused into another sheep. This observation is entirely consistent with past experience in experimentally infected rodents. It extends current knowledge about blood infectivity in experimental models to a host/TSE strain pair that is closer to the human vCJD situation than the earlier rodent studies. It is also the first successful transfusion of BSE from blood taken during the all-important incubation period of infection. This result is part of a larger study (n=19) that includes both positive and negative control animals, all still healthy and in various early stages of the incubation period.<br />
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Is it appropriate to publish an experimental result from a single animal in a study that is not far enough along even to have validated its positive controls? Especially a result that does not in any fundamental way change our current thinking about BSE and vCJD and which would not seem to have any practical consequences for public health? The UK National Blood Transfusion Service has already implemented leucodepletion of donated blood, and imports all plasma and plasma derivatives from BSE-free countries. No further measures would seem possible--short of a draconian decision to shut down the whole UK blood-donor system. What, therefore, is the rationale for this publishing urgency? The answer, evidently, is a perceived need to "defuse", by an immediate and accurate scientific report, public reaction to possibly inaccurate media accounts. The full study, when it appears, will be an important addition to our knowledge of TSEs, but science should not be driven to what in certain medical quarters might be termed a premature emission through fear of media misrepresentation.<br />
<br />
Paul Brown<br />
<br />
Laboratory of Central Nervous System Studies, National Institutes of Health, Bethesda, MD 20892, USA<br />
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1 Ghani AC, Ferguson NM, Donnelly CA, Anderson RM. Predicted vCJD mortality in Great Britain. Nature 2000; 406: 583-84 [PubMed].<br />
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2 Brown P. Can Creutzfeldt-Jakob disease be transmitted by transfusion? Curr Opin Hematol 1995; 2: 472-77 [PubMed].<br />
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3 Brown P, Cervenáková L, McShane LM, Barber P, Rubenstein R, Drohan WN. Further studies of blood infectivity in an experimental model of transmissible spongiform encephalopathy, with an explanation of why blood components do not transmit Creutzfeldt-Jakob disease in humans. Transfusion 1999; 39: 1169-78 [PubMed].<br />
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4 Rohwer RG. Titer, distribution, and transmissibility of blood-borne TSE infectivity. Presented at Cambridge Healthtech Institute 6th Annual Meeting "Blood Product Safety: TSE, Perception versus Reality", MacLean, VA, USA, Feb 13-15, 2000.<br />
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5 Hill AF, Butterworth RJ, Joiner S, et al. Investigation of variant Creutzfeldt-Jakob disease and other human prion diseases with tonsil biopsy samples. Lancet 1999; 353: 183-89.<br />
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<a href="http://www.thelancet.com/">http://www.thelancet.com/</a> <br />
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Journal of General Virology (2002), 83, 2897–2905. Printed in Great Britain Published ahead of print (16 July 2000) in JGV Direct as DOI 10.1099/vir.0.18580-0 Transmission of prion diseases by blood transfusion Nora Hunter,1 James Foster,1 Angela Chong,1 Sandra McCutcheon,2 David Parnham,1 Samantha Eaton,1 Calum MacKenzie1 and Fiona Houston2<br />
<br />
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Abstract <br />
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Attempts to detect infectivity in the blood of humans and animals affected with transmissible spongiform encephalopathies (TSEs or prion diseases) have often been inconclusive because of the limitations of cross-species bioassays and the small volumes of blood that can be injected by the intracerebral route. A model has been developed for the experimental study of TSE transmission by blood transfusion using sheep experimentally infected with bovine spongiform encephalopathy (BSE) or natural scrapie as donors and susceptible scrapie-free sheep as recipients. Donors and recipients of the same species greatly increase the sensitivity of the bioassay and in sheep large volumes of blood can be injected by the intravenous (i.v.) route. Transmission of BSE to a single animal using this approach was reported recently. This study confirms this result with a second transmission of BSE and four new cases of transmission of natural scrapie. Positive transmissions occurred with blood taken 2 at pre-clinical and clinical stages of infection. Initial studies indicate that following such infection by the i.v. route, deposition of the abnormal prion protein isoform, PrPSc, in peripheral tissues may be much more limited than is seen following oral infection. These results confirm the risks of TSE infection via blood products and suggest that the measures taken to restrict the use of blood in the UK have been fully justified.<br />
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<a href="http://www.socgenmicrobiol.org.uk/JGVDirect/18580/18580ft.pdf">http://www.socgenmicrobiol.org.uk/JGVDirect/18580/18580ft.pdf</a><br />
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TSSTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-62338178538761210652011-02-26T20:46:00.000-08:002011-02-26T21:26:56.705-08:00Supreme Court Protects Vaccine Manufacturers, Not Injured Children there from Bruesewitz vs WyethOCTOBER TERM, 2010<br />
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Syllabus<br />
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NOTE: Where it is feasible, a syllabus (headnote) will be released, as isbeing done in connection with this case, at the time the opinion is issued.The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader. See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.<br />
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SUPREME COURT OF THE UNITED STATES<br />
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Syllabus<br />
<br />
BRUESEWITZ ET AL. v. WYETH LLC, FKA WYETH, INC., ET AL.<br />
<br />
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT<br />
<br />
No. 09–152. Argued October 12, 2010—Decided February 22, 2011<br />
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The National Childhood Vaccine Injury Act of 1986 (NCVIA or Act) created a no-fault compensation program to stabilize a vaccine market adversely affected by an increase in vaccine-related tort litigation and to facilitate compensation to claimants who found pursuing legitimate vaccine-inflicted injuries too costly and difficult. The Act provides that a party alleging a vaccine-related injury may file a petition for compensation in the Court of Federal Claims, naming the Health and Human Services Secretary as the respondent; that the court must resolve the case by a specified deadline; and that the claimant can then decide whether to accept the court’s judgment or reject it and seek tort relief from the vaccine manufacturer. Awards are paid out of a fund created by an excise tax on each vaccine dose. As a quid pro quo, manufacturers enjoy significant tort-liability protections. Most importantly, the Act eliminates manufacturer liability for a vaccine’s unavoidable, adverse side effects. Hannah Bruesewitz’s parents filed a vaccine-injury petition in the Court of Federal Claims, claiming that Hannah became disabled after receiving a diphtheria, tetanus, and pertussis (DTP) vaccine manufactured by Lederle Laboratories (now owned by respondent Wyeth). After that court denied their claim, they elected to reject the unfavorable judgment and filed suit in Pennsylvania state court, alleging, inter alia, that the defective design of Lederle’s DTP vaccine caused Hannah’s disabilities, and that Lederle was subject to strictliability and liability for negligent design under Pennsylvania common law. Wyeth removed the suit to the Federal District Court. It granted Wyeth summary judgment, holding that the relevant Pennsylvania law was preempted by 42 U. S. C. §300aa–22(b)(1), which 2 BRUESEWITZ v. WYETH LLC<br />
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Syllabus<br />
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provides that "[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings." The Third Circuit affirmed.<br />
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Held: The NCVIA preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine’s side effects. Pp. 7–19.<br />
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(a) Section 300aa–22(b)(1)’s text suggests that a vaccine’s design is not open to question in a tort action. If a manufacturer could be held liable for failure to use a different design, the "even though" clause would do no work. A vaccine side effect could always have been avoidable by use of a different vaccine not containing the harmful element. The language of the provision thus suggests the design is not subject to question in a tort action. What the statute establishes as a complete defense must be unavoidability (given safe manufacture and warning) with respect to the particular design. This conclusion is supported by the fact that, although products-liability law establishes three grounds for liability—defective manufacture, inadequate directions or warnings, and defective design—the Act mentions only manufacture and warnings. It thus seems that the Act’s failure to mention design-defect liability is "by deliberate choice, not in advertence." Barnhart v. Peabody Coal Co., 537 U. S. 149, 168. Pp. 7–8.<br />
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(b) Contrary to petitioners’ argument, there is no reason to believe that §300aa–22(b)(1)’s term "unavoidable" is a term of art incorporating Restatement (Second) of Torts §402A, Comment k, which exempts from strict liability rules "unavoidably unsafe products." "Unavoidable" is hardly a rarely used word, and cases interpreting comment k attach special significance only to the term "unavoidably unsafeproducts," not the word "unavoidable" standing alone. Moreover, reading the phrase "side effects that were unavoidable" to exempt injuries caused by flawed design would require treating "even though"as a coordinating conjunction linking independent ideas when it is a concessive, subordinating conjunction conveying that one clause weakens or qualifies the other. The canon against superfluity does not undermine this Court’s interpretation because petitioners’ competing interpretation has superfluity problems of its own. Pp. 8–12.<br />
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(c) The structure of the NCVIA and of vaccine regulation in general reinforces what §300aa–22(b)(1)’s text suggests. Design defects do not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process. This lack of guidance for design defects, combined with<br />
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3 Cite as: 562 U. S. ____ (2011) Syllabus<br />
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the extensive guidance for the two liability grounds specifically mentioned in the Act, strongly suggests that design defects were not mentioned because they are not a basis for liability. The Act’s mandates lead to the same conclusion. It provides for federal agency improvement of vaccine design and for federally prescribed compensation,which are other means for achieving the two beneficial effects of design-defect torts—prompting the development of improved designs, and providing compensation for inflicted injuries. The Act’s structural quid pro quo also leads to the same conclusion. The vaccine manufacturers fund an informal, efficient compensation program for vaccine injuries in exchange for avoiding costly tort litigation and the occasional disproportionate jury verdict. Taxing their product to fund the compensation program, while leaving their liability for design defect virtually unaltered, would hardly coax them back into the market. Pp. 13–16.<br />
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561 F. 3d 233, affirmed.<br />
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SCALIA, J., delivered the opinion of the Court, in which ROBERTS,<br />
<br />
C. J., and KENNEDY, THOMAS, BREYER, and ALITO, JJ., joined. BREYER, J., filed a concurring opinion. SOTOMAYOR, J., filed a dissenting opinion, in which GINSBURG, J., joined. KAGAN, J., took no part in the consideration or decision of the case. _________________ _________________ 1 Cite as: 562 U. S. ____ (2011)<br />
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Opinion of the Court<br />
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NOTICE: This opinion is subject to formal revision before publication in thepreliminary print of the United States Reports. Readers are requested tonotify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in orderthat corrections may be made before the preliminary print goes to press.<br />
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SUPREME COURT OF THE UNITED STATES<br />
<br />
No. 09–152<br />
<br />
RUSSELL BRUESEWITZ, ET AL., PETITIONERS v. WYETH LLC, FKA WYETH, INC., FKA WYETHLABORATORIES, ET AL.<br />
<br />
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OFAPPEALS FOR THE THIRD CIRCUIT<br />
<br />
[February 22, 2011]<br />
<br />
JUSTICE SCALIA delivered the opinion of the Court.<br />
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We consider whether a preemption provision enacted inthe National Childhood Vaccine Injury Act of 1986(NCVIA)1 bars state-law design-defect claims againstvaccine manufacturers. .....<br />
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snip...please see full text ;<br />
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<a href="http://www.supremecourt.gov/opinions/10pdf/09-152.pdf">http://www.supremecourt.gov/opinions/10pdf/09-152.pdf</a><br />
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Is polio still a disease seen in the United States? The last cases of naturally occurring paralytic polio in the United States were in 1979, when an outbreak occurred among the Amish in several Midwestern states. From 1980 through 1999, there were 152 confirmed cases of paralytic polio cases reported. Of the 152 cases, eight cases were acquired outside the United States and imported. The last imported case caused by wild poliovirus into the United States was reported in 1993.<br />
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The remaining 144 cases were vaccine-associated paralytic polio (VAPP) caused by live oral polio vaccine (OPV).<br />
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<a href="http://www.cdc.gov/vaccines/vpd-vac/polio/dis-faqs.htm">http://www.cdc.gov/vaccines/vpd-vac/polio/dis-faqs.htm</a><br />
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How do Democrats and Republicans stand on tort reform issues?<br />
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"Tort Reform" is a very partisan issue. At both the state and national levels, Republicans overwhelmingly support tort reform and Democrats oppose it. The trial lawyer associations which represent plaintiff lawyers are major contributors to the Democrats. Insurance and medical interests contribute heavily to Republicans. In fact, the tort reform debate can be considered as an aspect of the overall political dynamic involving distribution of the nation's wealth. The most contentious issues involve medical malpractice and product liability. The result of settlements and verdicts of these cases is a transfer of wealth from groups which tend to be wealthy to victims and their lawyers. Virtually all the reform proposals ultimately attempt to limit the amount of funds which are distributed in this fashion.<br />
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<a href="http://www.newsbatch.com/tort.htm">http://www.newsbatch.com/tort.htm</a><br />
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February 18, 2011 It’s Time to Call Tort Reform What it Really Is Standing Up Against Corporate Tyranny<br />
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Jacob Diesselhorst, Nix Law Group, PLLC, Edmond, Oklahoma<br />
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I love Oklahoma. I love the people of Oklahoma, all of them. The hard-working men and woman, the elderly-who have paved the way for us and the children-who we are grooming to carry on the legacy for our state’s future.<br />
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I love the idea of democracy and freedom. This great country of ours’ was founded based on principles…certain unalienable rights that are bestowed upon all of us– The principle that us all, whether white or black, rich or poor, republican or democrat, should be treated equally and be allowed to play on a level playing field. In turn, our political system, the 3 branches of government, should continue to exemplify this ideal and support our efforts to uphold it. Unfortunately, politics in Oklahoma has deteriorated into a power struggle for control of money and resources as opposed to an effort to embody the principles of freedom, equality and justice.<br />
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Like many of us, I am disgusted by the ugly politics and lack of civility that has invaded government. Party lines are now clearly drawn, as both sides teeter for control of a system that is now broken due to the power of special interests. Special interests have infested our politics to the point now there is no way to differentiate between two. Oklahoma politics are no different. Money talks.<br />
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The Chamber, big business, big insurance and big oil have a tight grip on this State and the brass of the current leadership of the Oklahoma Republican party. Don’t take my word for it? Let the evidence speak for itself. Look at the campaign finance reports for Oklahoma’s current GOP leadership, they read like a who’s who of Oklahoma’s business community, the super-rich and the PACS (Political Action Committees) formed by the special interests that now dictate Oklahoma politics.<br />
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Unfortunately, this influence of the money and power of big business and corporations has infected Republican leadership and convinced them to pursue policy changes that do nothing to protect or assist the general public, but act only to further enrich and empower the voracious and self-serving interests of Corporations and Insurance Companies. One disturbing example of special interests’ invasion into democracy is taking place in Oklahoma right now—with the efforts of a chosen few to force more so-called “tort reform” on the people of Oklahoma.<br />
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Tort Reform (as it is called) is the effort by the Big Business wing of the Republican party (at the direction of the corporations who fund their political campaigns and reelections) to invade the sanctity of the judicial branch and legislate in the court room by taking away the autonomy of the civil jury and dictating how juries must decide cases and what evidence is and is not allowed to come in to evidence at trial.<br />
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•Politicans want to place an arbitrary, one-size-fits all hard cap of $250k on the amount of damages a civil jury can award a catstrophically injured Oklahoman for the rest of his or her lifetime no matter how severe the injuries and no matter how disgusting, reckless and wanton the conduct of the negligent Defendant.<br />
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•GOP Idealogs claim hard caps “deter frivolous lawsuits.” This is a BLATANT LIE. Frivolous lawsuits never see the light of day in Oklahoma. Numerous laws already in place require Expert Reports before lawsuits can be filed. Moreover, Hard Caps do nothing to prevent minor injury lawsuits from being filed. What arbitratry hard caps do cause—is for people with legitimate, long term catstrophic injuries (a brain injured child or a blinded teenager or a badly burned stay-at-home mom or a nursing home resident who is beaten to death and raped in his nursing home by a bad employee) from obtaining full and fair compensation for their injuries.<br />
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•Non-economic damages are meant to serve as a deterence to Corporations and individual and ensure that our highways, schools, airports, public transportaion, workplaces, products, etc.) are SAFE. CAPS ELIMINATE THIS DETERENCE and actually give corporations, bad doctors, bad nurses, truck drivers, etc. a free license to run amuck in our state with no fear of every being punished above 250k. (which is like a parking ticket to many multi-million dollar businesses, corporations and insurance companies)<br />
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•Further, Policitians want to tip the scales of justice in favor of negligent defendants by giving a negligent tortfeasor’s insurance company and CREDIT for any collateral source of insurance an injured Oklahoman has in awarding damages.<br />
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•In other words, if you are horribly injured in a trucking accident and have $150k in medical bills–the jury gets to know your health insurance company paid part of the bills, that part was written off and that part came out of your pocket. Meanwhile, the fact that the negligent trucking company, hospital, oil and gas company etc. has millions of dollars in liability insurance will remain hidden from the jury.<br />
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•Even more disturbing, if you had the forsight to purcahse disability insurance or life insurance (in the case of a wrongful death case)–the negligent corporation’s liability insurance company will also get a credit for that insurance money (even though it is from another seperate insurance company). In other words, everyone benefits in this equation (the insurance companies and negligent defendants) EXCEPT THE ONE WHO SHOULD—THE CATASTROPHICALY INJURED OKLAHOMAN.<br />
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Our civil justice system is built on a principle of a balance of power and a weighing of the evidence to determine fault, liability and damages. The scales of justice illustrate this ideal. Our court system has successfully existed for hundreds of years built around the JURY. The Jury being a group of citizens like you and me who are entrusted to hear the evidence of a particular case and work together to render a fair and reasoned verdict. Now, however, politicians, not jurors, will decide the amount of damages to award in civil cases involving human injury and death by forcing upon a one-size fits all law that caps the maximum damages at $250,000.00 and decreases any economic damages awarded (medical bills, future medical bills, disability, loss of earnings, etc.) by the amounts of any collateral source of compensation that exists to pay part of them.<br />
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In other words, “tort reform” serves to cripple the very purpose of the jury system—to leave it to the people to decide the damages to render against a defendant who has been found to be negligent, reckless or wanton in its conduct and, as a result, caused harm to another person—by taking away the right of jurors (OKLAHOMA CITIZENS) to fairly decide legal disputes.<br />
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I for one stand with the people of Oklahoma and their constitutional right to a fair jury trial by the people…not politicians. With “tort reform”—Special Interests are completing the trifecta of infecting all 3 branches of government with their greed and self-serving influence. Meanwhile, the citizens of Oklahoma stand by, unknowlingly, while their rights are taken away by corrupt politicans whose only motivation is to satisfy their biggest campaign donors (i.e., BIG BUSINESS/BIG INSURANCE) so they can hope to get relected.<br />
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Sad but true.<br />
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Politics as usual in this State cannot be allowed to continue. The very rights to which each of us is entitled now hang in the balance.<br />
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David Farnbauch at 7:55 am. (General)<br />
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<a href="http://www.sweeneylawfirm.com/blog/its-time-to-call-tort-reform-what-it-really-is.htm">http://www.sweeneylawfirm.com/blog/its-time-to-call-tort-reform-what-it-really-is.htm</a><br />
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Wisconsin May Cap Punitive Damages At $200000 | Tort Reform ...Jan 14, 2011 ... GOP caps punitive damages in tort reform bill - WBAY-TV Green Bay-Fox ... Whenever the Republican party issues their issues platform, they're always for the death ... 2011 Looking Like A Bad Year For Civil Justice (JL) ...<br />
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<a href="http://www.tortdeform.com/.../2011/.../wisconsin_may_cap_punitive_dam.html">www.tortdeform.com/.../2011/.../wisconsin_may_cap_punitive_dam.html</a><br />
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Justinian Lane Wisconsin May Cap Punitive Damages At $200,000 Continuing the “2011 will be a bad year for civil justice” theme:<br />
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The Senate judiciary committee voted 3-2 on Friday to cap punitive damages at $200,000 or twice the amount of compensatory damages, whichever is greater. Current state law does not lay out any caps on punitive damages.<br />
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Source: Wis. GOP caps punitive damages in tort reform bill - WBAY-TV Green Bay-Fox Cities-Northeast Wisconsin News<br />
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Capping punitive damages at $200k will only encourage corporations to sell profitable but defective products. If it weren’t for punitive damage awards well in excess of $200k, Johns Manville might still be pumping out asbestos products.<br />
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I don’t understand Republican ideology. On one hand, most of them support the death penalty. But on the other hand, they don’t like punitive damages. How can you rationalize putting a man to death for committing a crime, but not allowing the family of his victims to take more than $200k?<br />
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<a href="http://www.tortdeform.com/archives/2011/01/wisconsin_may_cap_punitive_dam.html">http://www.tortdeform.com/archives/2011/01/wisconsin_may_cap_punitive_dam.html</a><br />
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<a href="http://www.wisbar.org/AM/Template.cfm?Section=News&Template=/CM/ContentDisplay.cfm&ContentID=99772">http://www.wisbar.org/AM/Template.cfm?Section=News&Template=/CM/ContentDisplay.cfm&ContentID=99772</a><br />
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Archives for February 2011 ><br />
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Arbitrary Damage Caps Reward Negligent and Wrongful Actors and Punish the Innocent Citizens of Oklahoma<br />
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Posted by Jacob Diesselhorst on February 17, 2011<br />
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In 2009 (less than 2 years ago), Oklahoma passed what the then-newly-annointed Republican Majority Senate and House Leadership coined "Landmark Comprehensive Lawsuit Reform."<br />
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Per the Oklahoma GOP's own Press Release of May 11, 2009--<br />
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“ The agreement is multi-faceted, including several key components of reform which will improve health care access to all Oklahomans, as well as assuring small business’ health and viability in the state.<br />
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”“I’m very pleased with the agreement,” said Glen Coffee (the then Republican Senate Majority Leader and now, somehow, Secretary of State (We will save that for another day). In May 2009, Coffee proclaimed “Republicans have promised reform of the legal system, the people expect us to deliver, and we have in fact delivered. The spirit of cooperation exhibited by all parties in this negotiation was gratifying, and is indicative of what can be done when people negotiate in good faith toward a mutually beneficial goal,” Coffee continued. “We look forward to sending this historic reform to Governor Henry to ratify the hard work all the parties have accomplished for the state.”<br />
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Current House Speaker Benge (who is now acting like 2009 never happened in pushing the GOP's new Corporate Welfare and Lawsuit Immunity laws) said back in 2009 about the then passed broadsweeping lawsuit reform:<br />
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“We have said since the beginning of session that lawsuit reform was one of our top priorities, and this agreement represents a huge victory for the people of Oklahoma today. All interested parties have worked together to make this deal a reality and I am proud of the collaboration that has occurred. This legislation will ensure access to the courts for all who have legitimate claims, but will also bring some certainty to a system that has recently become a hindrance to economic development in our state. I look forward to Gov. Henry signing this bill.”<br />
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”Dan Sullivan, a prominent lawyer for insurance companies and large corporations in Oklahoma and GOP Representative from Tulsa, also said in 2009:<br />
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“This agreement provides additional protections to the medical and business community from frivolous suits while protecting the right to a trial by a jury of their peers for those that are truly injured.<br />
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”HOW SOON WE FORGET. Now, the Oklahoma GOP Big Business Republicans, drunk with power in Oklahoma, having swept their way into the Governor's office and total, unfettered control of Oklahoma, plans to tip the scales of justice completely over in favor of negligent and reckless defendant tort feasors by passing the most broadsweeping and unconstitional civil justice changes in modern US History. These laws should not and in fact do not appeal to social minded and reasonable Conservative Oklahomans. See Example 1 and Example 2.<br />
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The Oklahoma GOP is slithering these bills through at the Capital with very little fanfare and Oklahoma is just sitting back while the bandits are making away with the take. In fact, Most Oklahomans do not know about these additional draconian changes and clearly do not know that not a single one of the "reforms" the GOP are now proposing favor individual Oklahomans- they all favor negligent and reckless civil defendants.<br />
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ARBITRARY $250K DAMAGE CAPS THAT RESTRICT JURY AWARDS NO MATTER HOW BAD A DEFENDANT ACTS AND HOW HORRIBLY AND PERMANENTLY AN INNOCENT OKLAHOMAN IS INJURED OR MAIMED = NO ACCOUNTABILITY.<br />
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And who bears the burden of this Corporate Bailout/Corporate Welfare?---regular Oklahomans- You, me, our kids, our parents, especially the must vulnerable of all:<br />
<br />
•children •the elderly •stay at home moms ' •lower wage earners like pastors, fireman, police officers, teachers, etc. According to the Oklahoma GOP, The most damages a jury can ever award these type of Oklahomans, no matter how catastrophic and long-term their injuries may be, is only 250k. 90% of Oklahomans would never support this type of law--yet it will likely sail through the on the backs of the politicians the Chamber put in place, right onto the desk of Mary Failing who will not even read it before she signs it.<br />
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After these horrific and unconstitutional bills become law, Oklahomans who have LEGITIMATE CIVIL CASES and whose only avenue for justice is the COURTHOUSE, will be the one's left out in the cold with no way to get JUSTICE for their loss of quality of life---pain and suffering, disability, inability to earn a living, etc.<br />
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The Oklahoma GOP's new, so-called "Tort Reform" rewards negligent corporations cutting corners for profits, bad nursing homes, foreign produce manufacturers like drug companies and medical device companies, bad doctors, unsafe truck drivers, drunk drivers, texting drivers etc. and their multi-billion dollar Insurance Company allies. All this at the expense of your constitutional right to a non-biased and fair trial by jury of your peers- Oklahoma citizens.<br />
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How about we let Oklahoma juries sort out legitimate civil disputes and not well-greased and bought-and-paid-for politicians (who talk out of both sides of their mouths depending on what year it is) and whose only interests they apparently protect are those of the corporate donors who got them elected and will keep them in office.<br />
<br />
Tags:anthony sykes, lawsuit reform, mary fallin, nix law group, oklahoma law, rob johnson, tort reform<br />
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<a href="http://www.oklahomainjurylawadvocate.com/2011/02/">http://www.oklahomainjurylawadvocate.com/2011/02/</a><br />
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Sunday, January 30, 2011<br />
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Vaccines and Transmissible Spongiform Encephalopathy the Prion Disease, what if ?<br />
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COMMERCIAL IN CONFIDENCE<br />
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/vaccines-and-transmissible-spongiform.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/vaccines-and-transmissible-spongiform.html</a><br />
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<a href="http://www.whale.to/v/singeltary.html">http://www.whale.to/v/singeltary.html</a><br />
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<a href="http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html">http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html</a><br />
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please note ;<br />
<br />
PPo2-26:<br />
<br />
Transmission of Classical and Atypical (L-type) Bovine Spongiform Encephalopathy (BSE) Prions to Cynomolgus macaques<br />
<br />
Fumiko Ono,1 Yoshio Yamakawa,2 Minoru Tobiume,3 Yuko Sato,3 Harutaka Katano,3 Kenichi Hagiwara,2 Iori Itagaki,1 Akio Hiyaoka,1 Katuhiko Komatuzaki,1 Yasunori Emoto,1 Hiroaki Shibata,4 Yuichi Murayama,5 Keiji Terao,4 Yasuhiro Yasutomi4 and Tetsutaro Sata3<br />
<br />
1The Corporation for Production and Research of Laboratory Primates; Tsukuba City, Japan; 2Departments of Cell Biology and Biochemistry; and 3Pathology; National Institute of Infectious Diseases; Tokyo, Japan; 4Tsukuba Primate Research Center; National Institute of Biomedical Innovation; Tsukuba City, Japan; 5Prion Disease Research Team; National Institute of Animal Health; Tsukuba City, Japan<br />
<br />
Key words: L-type BSE, cBSE, cynomolgus macaques, transmission<br />
<br />
BSE prion derived from classical BSE (cBSE) or L-type BSE was characterized by inoculation into the brain of cynomolgus macaques. The neurologic manifestation was developed in all cynomolgus macaques at 27–43 months after intracerebral inoculation of brain homogenate from cBSE-affected cattle (BSE JP/6). Second transmission of cBSE from macaque to macaque shortened incubation period to 13–18 months. cBSE-affected macaques showed the similar clinical signs including hyperekplexia, tremor and paralysis in both primary and second transmission.<br />
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Two macaques were intracerebrally inoculated brain homogenate from the L-type BSE-affected cattle (BSE JP/24). The incubation periods were 19–20 months in primary transmission.<br />
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The clinical course of the L-type BSE-affected macaques differed from that in cBSE-affected macaques in the points of severe myoclonus without hyperekplexia. The glycoform profile of PrPSc detected in macaque CNS was consistent with original pattern of either cBSE or L-typeBSE PrPSc, respectively. Although severe spongiform change in the brain was remarkable in all BSE-affected macaques, severe spongiform spread widely in cerebral cortex in L-type BSE-affected macaques. Heavy accumulation of PrPSc surrounded by vacuola formed florid plaques in cerebral cortex of cBSE-affected macaques. Deposit of PrPSc in L-type BSE-affected macaque was weak and diffuse synaptic pattern in cerebrum, but large PrPSc plaques were evident at cerebellum. MRI analysis, T2, T1, DW and flair sequences, at the time of autopsy revealed that brain atrophy and dilatation of cerebral ventricles were significantly severe in L-type BSE-affected macaques. These results suggest that L-type BSE is more virulent strain to primates comparing to cBSE.<br />
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<a href="http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099">http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099</a><br />
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Saturday, January 29, 2011<br />
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Atypical L-Type Bovine Spongiform Encephalopathy (L-BSE) Transmission to Cynomolgus Macaques, a Non-Human Primate<br />
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Jpn. J. Infect. Dis., 64 (1), 81-84, 2011<br />
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<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html</a><br />
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Wednesday, February 16, 2011 IN CONFIDENCE SCRAPIE TRANSMISSION TO CHIMPANZEES<br />
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IN CONFIDENCE<br />
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<a href="http://scrapie-usa.blogspot.com/2011/02/in-confidence-scrapie-transmission-to.html">http://scrapie-usa.blogspot.com/2011/02/in-confidence-scrapie-transmission-to.html</a><br />
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Vaccines and Transmissible Spongiform Encephalopathy the Prion Disease, what if ?<br />
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COMMERCIAL IN CONFIDENCE<br />
<br />
3.2 Minute 5.3 - 5.4 Bovine Spongiform Encephalopathy<br />
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It was reported that some replies had been received from Companies using pituitary glands in their products. Copies of the BSE document had also been sent to DHSS and NIBSC.<br />
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and then another 3 + pages of blank space. ...TSS<br />
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<a href="http://collections.europarchive.org/tna/20080102164813/http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf">http://collections.europarchive.org/tna/20080102164813/http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf</a><br />
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COMMERCIAL IN CONFIDENCE<br />
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BSE - CURRENT POSITION WITH VETERINARY LICENCED PRODUCTS (MA.1968)<br />
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There are three areas of particular concern, vaccines (including emergency vaccines), pharmaceuticals which are covered by MA licences and unlicenses hormonal products produced under exemptions claimed under (Section 9(2) Medicines Act).<br />
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1) Vaccines<br />
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<a href="http://collections.europarchive.org/tna/20080103033809/http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf">http://collections.europarchive.org/tna/20080103033809/http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf</a><br />
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NOT FOR PUBLICATION<br />
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another 6 pages of blank space. ...TSS<br />
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<a href="http://collections.europarchive.org/tna/20080103032658/http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf">http://collections.europarchive.org/tna/20080103032658/http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf</a><br />
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<a href="http://collections.europarchive.org/tna/20080103032631/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf">http://collections.europarchive.org/tna/20080103032631/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf</a><br />
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<a href="http://collections.europarchive.org/tna/20080103033926/http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf">http://collections.europarchive.org/tna/20080103033926/http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf</a><br />
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COMMERCIAL IN CONFIDENCE<br />
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<a href="http://collections.europarchive.org/tna/20080103034137/http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf">http://collections.europarchive.org/tna/20080103034137/http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf</a><br />
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COMMERCIAL IN CONFIDENCE<br />
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Medicines Act - Veterinary Products Committee<br />
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<a href="http://collections.europarchive.org/tna/20080103034140/http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf">http://collections.europarchive.org/tna/20080103034140/http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf</a><br />
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COMMERCIAL IN CONFIDENCE<br />
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NOT FOR PUBLICATION<br />
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COMMITTEE ON SAFETY OF MEDICINES<br />
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another 6 pages or so that are blank. ...TSS<br />
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<a href="http://collections.europarchive.org/tna/20080102185137/http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf">http://collections.europarchive.org/tna/20080102185137/http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf</a><br />
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<a href="http://collections.europarchive.org/tna/20080102184613/http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf">http://collections.europarchive.org/tna/20080102184613/http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf</a><br />
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COMMERCIAL IN CONFIDENCE<br />
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NOT FOR PUBLICATION<br />
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COMMITTEE ON SAFETY OF MEDICINES<br />
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WORKING PARTY ON BOVINE SPONGIFORM ENCEPHALOPATHY<br />
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7.2.1. Products with bovine brain/lymphoid tissue as ingredients and administered by injection...[111]<br />
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7.2.2 Products with bovine ingredients (other than brain/lymphoid tissue) and administered by injection...[135]<br />
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7.2.3 Tissue implants, open wound dressings, surgical materials, dental and opthalmic products with bovine ingredients...[27]<br />
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7.2.4. Products with bovine ingredients and administered topically...[5]<br />
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7.2.5 Products with bovine ingredients and administered orally...[9]<br />
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7.2.6 Products with other animal/insect/bird ingredients and administered:<br />
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a. by injection a: 117<br />
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b. by topically b: 6<br />
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c. orally c: 8<br />
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7.2.7 Products with materials produced from animal material by chemical processes, eg stearic acid, gelatin and lanolin...[156]<br />
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With two exceptions, the replies to date have not given any immediate cause for concern, although 176 products do not conform to the CSM/VPC guidelines.<br />
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8. The first exception was from which gave very limited information about a very large number of homoepathic medicines with material obtained from cattle and a number with material from the brain. Of these, 53 were injectable products of which 20 were derived from cattle brain. A list of these products is attached as Appendix 1 to Annex D. The second exception relates to the product, 'Surgical Catgut', which is sourced from UK bovine intestines and will contain lymphoid material...<br />
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see full text ;<br />
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<a href="http://collections.europarchive.org/tna/20080102164420/http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf">http://collections.europarchive.org/tna/20080102164420/http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf</a><br />
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COMMERCIAL IN CONFIDENCE<br />
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<a href="http://collections.europarchive.org/tna/20080102164744/http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf">http://collections.europarchive.org/tna/20080102164744/http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf</a><br />
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MANAGEMENT IN CONFIDENCE<br />
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CERTIFIED BSE-FREE HERDS FOR SOURCE OF MATERIAL FOR BIOLOGICAL PRODUCTS<br />
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<a href="http://collections.europarchive.org/tna/20080102184729/http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf">http://collections.europarchive.org/tna/20080102184729/http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf</a><br />
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<br />
Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001<br />
<br />
Date: Tue, 9 Jan 2001 16:49:00 -0800<br />
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From: "Terry S. Singeltary Sr." <flounder@wt.net><br />
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Reply-To: Bovine Spongiform Encephalopathy <bse-l@uni-karlsruhe.de><br />
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To: BSE-L@uni-karlsruhe.de<br />
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[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.<br />
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[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?<br />
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[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]<br />
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[host Richard] could you repeat the question?<br />
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[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?<br />
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[not sure whom ask this] what group are you with?<br />
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[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.<br />
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[not sure who is speaking] could you please disconnect Mr. Singeltary<br />
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[TSS] you are not going to answer my question?<br />
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[not sure whom speaking] NO<br />
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from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;<br />
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[unknown woman] what group are you with?<br />
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[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?<br />
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at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.<br />
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<br />
snip...full text ;<br />
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<br />
<a href="http://bse-atypical.blogspot.com/2010/01/14th-international-congress-on.html">http://bse-atypical.blogspot.com/2010/01/14th-international-congress-on.html</a><br />
<br />
<br />
<br />
<br />
The documents below were provided by Terry S. Singeltary Sr on 8 May 2000.<br />
<br />
They are optically character read (scanned into computer) and so may contain typos and unreadable parts.<br />
<br />
TIP740203/l 0424 CONFIDENTIAL<br />
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snip...<br />
<br />
The responses by the companies were presented by Ms Turner and were categorised by MCA standards, the products that were discussed were all low volume usage products eg sutures, heart valves.<br />
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8. As the responses included some materials of human origin it was decided that more information should be sought about CJD. There had been 2 recent deaths reported associated with human growth hormone. These were being investigated.<br />
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snip...<br />
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<a href="http://www.mad-cow.org/00/may00_news.html#aaa">http://www.mad-cow.org/00/may00_news.html#aaa</a><br />
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<br />
<br />
5.3.3 The greatest risk, in theory, would be from parenteral injection of material derived from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation which are prepared from bovine tissues, or which utilise bovine serum albumin or similar agents in their manufacture, might also be capable of transmitting infectious agents. All medicinal products are licensed under the Medicines Act by the Licensing Authority following guidance, for example from the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials (CDSM) and their subcommittees. The Licensing Authority have been alerted to potential concern about BSE in medicinal products and will ensure that scrutiny of source materials and manufacturing processes now takes account of BSE agent.<br />
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<br />
<br />
see all 76 pages ;<br />
<br />
<br />
<a href="http://collections.europarchive.org/tna/20080102132706/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf">http://collections.europarchive.org/tna/20080102132706/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf</a><br />
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<br />
<br />
EXPORT OF BRITISH BIOLOGICAL PHARMACEUTICALS...<br />
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snip...please see full text ;<br />
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Sunday, January 30, 2011<br />
<br />
Vaccines and Transmissible Spongiform Encephalopathy the Prion Disease, what if ?<br />
<br />
COMMERCIAL IN CONFIDENCE<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/vaccines-and-transmissible-spongiform.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/vaccines-and-transmissible-spongiform.html</a><br />
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<br />
TSS<br />
<br />
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<br />
Saturday, February 26, 2011 <br />
<br />
Supreme Court Protects Vaccine Manufacturers, Not Injured Children there from Bruesewitz vs Wyeth<br />
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<br />
http://vcjdtransfusion.blogspot.com/2011/02/supreme-court-protects-vaccine.htmlTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-31965860040992716852011-02-24T13:54:00.000-08:002011-02-24T13:54:13.783-08:00The risk of variant Creutzfeldt-Jakob disease among UK patients with bleeding disorders, known to have received potentially contaminated plasma productsThe risk of variant Creutzfeldt-Jakob disease among UK patients with bleeding disorders, known to have received potentially contaminated plasma products<br />
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S. M. A. ZAMAN1, F. G. H. HILL2,9, B. PALMER3, C. M. MILLAR4,9, A. BONE1, A. M. MOLESWORTH1, N. CONNOR1, C. A. LEE5, G. DOLAN6, J. T. WILDE7,9, O. N. GILL1, M. MAKRIS8,9<br />
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<br />
Article first published online: 23 FEB 2011<br />
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<br />
DOI: 10.1111/j.1365-2516.2011.02508.x<br />
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© 2011 Blackwell Publishing Ltd<br />
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Keywords: haemophilia; inherited bleeding disorders; risk assessment; UK plasma products; variant Creutzfeldt-Jakob disease<br />
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Summary. The risk of variant Creutzfeldt-Jakob disease (vCJD) from potentially infected plasma products remains unquantified. This risk has been assessed for 787 UK patients with an inherited bleeding disorder prospectively followed-up for 10–20 years through the UK Haemophilia Centre Doctors’ Organisation (UKHCDO) Surveillance Study. These patients had been treated with any of 25 ‘implicated’ clotting factor batches from 1987 to 1999, which included in their manufacture, plasma from eight donors who subsequently developed clinical vCJD. Variant CJD infectivity of these batches was estimated using plasma fraction infectivity estimates and batch-manufacturing data. Total potential vCJD infectivity received by each patient has been estimated by cumulating estimated infectivity from all doses received during their lifetime. Of 787 patients, 604 (77%) were followed-up for over 13 years following exposure to an implicated batch. For these 604 patients, the estimated vCJD risk is =1% for 595, =50% for 164 and 100% for 51. This is additional to background UK population risk due to dietary exposure. Of 604 patients, 94 (16%) received implicated batches linked to donors who developed clinical vCJD within 6 months of their donations. One hundred and fifty-one (25%) had received their first dose when under 10 years of age. By 1st January 2009, none of these patients had developed clinical vCJD. The absence of clinical vCJD cases in this cohort to date suggests that either plasma fraction infectivity estimates are overly precautionary, or the incubation period is longer for this cohort than for implicated cellular blood product recipients. Further follow-up of this cohort is needed.<br />
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<br />
<a href="http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2516.2011.02508.x/abstract">http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2516.2011.02508.x/abstract</a><br />
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<br />
Atypical BSE (BASE) Transmitted from Asymptomatic Aging Cattle to a Primate<br />
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Emmanuel E. Comoy1*, Cristina Casalone2, Nathalie Lescoutra-Etchegaray1, Gianluigi Zanusso3, Sophie Freire1, Dominique Marcé1, Frédéric Auvré1, Marie-Magdeleine Ruchoux1, Sergio Ferrari3, Salvatore Monaco3, Nicole Salès4, Maria Caramelli2, Philippe Leboulch1,5, Paul Brown1, Corinne I. Lasmézas4, Jean-Philippe Deslys1<br />
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1 Institute of Emerging Diseases and Innovative Therapies, CEA, Fontenay-aux-Roses, France, 2 Istituto Zooprofilattico Sperimentale del Piemonte, Turin, Italy, 3 Policlinico G.B. Rossi, Verona, Italy, 4 Scripps Florida, Jupiter, Florida, United States of America, 5 Genetics Division, Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America<br />
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<br />
Abstract<br />
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<br />
<br />
Background Human variant Creutzfeldt-Jakob Disease (vCJD) results from foodborne transmission of prions from slaughtered cattle with classical Bovine Spongiform Encephalopathy (cBSE). Atypical forms of BSE, which remain mostly asymptomatic in aging cattle, were recently identified at slaughterhouses throughout Europe and North America, raising a question about human susceptibility to these new prion strains.<br />
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Methodology/Principal<br />
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Findings Brain homogenates from cattle with classical BSE and atypical (BASE) infections were inoculated intracerebrally into cynomolgus monkeys (Macacca fascicularis), a non-human primate model previously demonstrated to be susceptible to the original strain of cBSE. The resulting diseases were compared in terms of clinical signs, histology and biochemistry of the abnormal prion protein (PrPres). The single monkey infected with BASE had a shorter survival, and a different clinical evolution, histopathology, and prion protein (PrPres) pattern than was observed for either classical BSE or vCJD-inoculated animals. Also, the biochemical signature of PrPres in the BASE-inoculated animal was found to have a higher proteinase K sensitivity of the octa-repeat region. We found the same biochemical signature in three of four human patients with sporadic CJD and an MM type 2 PrP genotype who lived in the same country as the infected bovine.<br />
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Conclusion/Significance<br />
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Our results point to a possibly higher degree of pathogenicity of BASE than classical BSE in primates and also raise a question about a possible link to one uncommon subset of cases of apparently sporadic CJD. Thus, despite the waning epidemic of classical BSE, the occurrence of atypical strains should temper the urge to relax measures currently in place to protect public health from accidental contamination by BSE-contaminated products.<br />
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Citation: Comoy EE, Casalone C, Lescoutra-Etchegaray N, Zanusso G, Freire S, et al. (2008) Atypical BSE (BASE) Transmitted from Asymptomatic Aging Cattle to a Primate. PLoS ONE 3(8): e3017. doi:10.1371/journal.pone.0003017<br />
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Editor: Neil Mabbott, University of Edinburgh, United Kingdom<br />
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Received: April 24, 2008; Accepted: August 1, 2008; Published: August 20, 2008<br />
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Copyright: © 2008 Comoy et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.<br />
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Funding: This work has been supported by the Network of Excellence NeuroPrion.<br />
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Competing interests: CEA owns a patent covering the BSE diagnostic tests commercialized by the company Bio-Rad.<br />
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* E-mail: <a href="mailto:emmanuel.comoy@cea.fr">emmanuel.comoy@cea.fr</a><br />
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<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0003017">http://www.plosone.org/article/info:doi/10.1371/journal.pone.0003017</a><br />
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Session I - Prions: Structure, Strain and Detection (II)<br />
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Searching for BASE Strain Signature in Sporadic Creutzfedlt-Jakob Disease<br />
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<br />
Gianluigi Zanusso<br />
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Department of Neurological and Visual Sciences, Section of Clinical Neurology University of Verona, Verona, Italy.<br />
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Bovine amyloidotic spongiform encephalopathy (BASE) is a newly recognized form of bovine prion disease, which was originally detected in Italy in 2004 as an effect of active surveillance. BASE or BSE L-type (L is referred to the lower electrophoretic PrPSc migration than classical BSE) has now been reported in several countries, including Japan. All field cases of BASE were older than 8 years and neurologically normal at the time of slaughtered. By experimental transmission, we defined the disease phenotype of cattle BASE, which is quite distinct from that seen in typical BSE and characterized by mental dullness and amyotrophy. Surprisingly, following intraspecies and interspecies transmission the incubation period of BASE was shorter than BSE. The relatively easy transmission of BASE isolate as well as the molecular similarity with sporadic Creutzfeldt-Jakob disease (sCJD) have raised concern regarding its potential passage to humans. Tg humanized mice Met/Met at codon 129 challenged with both BSE and BASE isolates, showed a resistance to BSE but a susceptibility to BASE at a 60% rate; in addition, BASE-inoculated Cynomolgus (129 Met/Met) had shorter incubation periods than BSE-inoculated primates. In this study we compared the biochemical properties of PrPSc in Cynomolgus and in TgHu Met/Met mice challenged with BSE and BASE strains, by conventional SDS-PAGE analysis and 2D separation. The results obtained disclose distinct conformational changes in PrPSc, which are dependent on the inoculated host but not on the codon 129 genotype.<br />
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This work was supported by Neuroprion contract n. FOOD CT 2004 -506579 (NOE)<br />
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<a href="http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf">http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf</a><br />
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P02.35<br />
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Molecular Features of the Protease-resistant Prion Protein (PrPres) in H-type BSE<br />
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Biacabe, A-G1; Jacobs, JG2; Gavier-Widén, D3; Vulin, J1; Langeveld, JPM2; Baron, TGM1 1AFSSA, France; 2CIDC-Lelystad, Netherlands; 3SVA, Sweden<br />
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Western blot analyses of PrPres accumulating in the brain of BSE-infected cattle have demonstrated 3 different molecular phenotypes regarding to the apparent molecular masses and glycoform ratios of PrPres bands. We initially described isolates (H-type BSE) essentially characterized by higher PrPres molecular mass and decreased levels of the diglycosylated PrPres band, in contrast to the classical type of BSE. This type is also distinct from another BSE phenotype named L-type BSE, or also BASE (for Bovine Amyloid Spongiform Encephalopathy), mainly characterized by a low representation of the diglycosylated PrPres band as well as a lower PrPres molecular mass. Retrospective molecular studies in France of all available BSE cases older than 8 years old and of part of the other cases identified since the beginning of the exhaustive surveillance of the disease in 20001 allowed to identify 7 H-type BSE cases, among 594 BSE cases that could be classified as classical, L- or H-type BSE. By Western blot analysis of H-type PrPres, we described a remarkable specific feature with antibodies raised against the C-terminal region of PrP that demonstrated the existence of a more C-terminal cleaved form of PrPres (named PrPres#2 ), in addition to the usual PrPres form (PrPres #1). In the unglycosylated form, PrPres #2 migrates at about 14 kDa, compared to 20 kDa for PrPres #1. The proportion of the PrPres#2 in cattle seems to by higher compared to the PrPres#1. Furthermore another PK-resistant fragment at about 7 kDa was detected by some more N-terminal antibodies and presumed to be the result of cleavages of both N- and C-terminal parts of PrP. These singular features were maintained after transmission of the disease to C57Bl/6 mice. The identification of these two additional PrPres fragments (PrPres #2 and 7kDa band) reminds features reported respectively in sporadic Creutzfeldt-Jakob disease and in Gerstmann-Sträussler-Scheinker (GSS) syndrome in humans.<br />
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<a href="http://www.neuroprion.com/pdf_docs/conferences/prion2007/abstract_book.pdf">http://www.neuroprion.com/pdf_docs/conferences/prion2007/abstract_book.pdf</a><br />
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P26 TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN HUMANIZED MOUSE MODELS<br />
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Liuting Qing1, Fusong Chen1, Michael Payne1, Wenquan Zou1, Cristina Casalone2, Martin Groschup3, Miroslaw Polak4, Maria Caramelli2, Pierluigi Gambetti1, Juergen Richt5*, and Qingzhong Kong1 1Department of Pathology, Case Western Reserve University, Cleveland, OH 44106, USA; 2CEA, Istituto Zooprofilattico Sperimentale, Italy; 3Friedrich-Loeffler-Institut, Germany; 4National Veterinary Research Institute, Poland; 5Kansas State University, Diagnostic Medicine/Pathobiology Department, Manhattan, KS 66506, USA. *Previous address: USDA National Animal Disease Center, Ames, IA 50010, USA<br />
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Classical BSE is a world-wide prion disease in cattle, and the classical BSE strain (BSE-C) has led to over 200 cases of clinical human infection (variant CJD). Two atypical BSE strains, BSE-L (also named BASE) and BSE-H, have been discovered in three continents since 2004. The first case of naturally occurring BSE with mutated bovine PrP gene (termed BSE-M) was also found in 2006 in the USA. The transmissibility and phenotypes of these atypical BSE strains/isolates in humans were unknown. We have inoculated humanized transgenic mice with classical and atypical BSE strains (BSE-C, BSE-L, BSE-H) and the BSE-M isolate. We have found that the atypical BSE-L strain is much more virulent than the classical BSE-C. The atypical BSE-H strain is also transmissible in the humanized transgenic mice with distinct phenotype, but no transmission has been observed for the BSE-M isolate so far.<br />
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III International Symposium on THE NEW PRION BIOLOGY: BASIC SCIENCE, DIAGNOSIS AND THERAPY 2 - 4 APRIL 2009, VENEZIA (ITALY)<br />
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<a href="http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf">http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf</a><br />
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PRION 2010<br />
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International Prion Congress: From agent to disease September 8–11, 2010 Salzburg, Austria<br />
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PPo3-11:<br />
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Blood Transmission Experiments in Primates: Squirrel Monkeys (the Baxter Study)<br />
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Paul Brown, James Ironside, Susan Gibson, Robert G. Will, Thomas R. Kreil and Christian Abee<br />
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Plasma and buffy coat samples from 2 sCJD and 3 vCJD cases were inoculated i.c. and i.v. into a total of 21 squirrel monkeys. Pooled brain from the 3 vCJD patients titered 106 LD50/g (i.c.). Whole blood from each of 4 monkeys inoculated with 10% vCJD brain homogenate was transfused i.v. to individual recipient monkeys at approximately 3-month intervals during the incubation and clinical stages of disease in the donor animals. Plasma, RBC’s, platelets, and purified leukocytes from 6 chimpanzees infected with either human sCJD or GSS were inoculated i.c. and i.v. into 12 monkeys. In the entire group of monkeys inoculated with blood or blood components, only a single neuropathologically-verified transmission occurred within a 5-year observation period, in an animal inoculated with leukocytes from a pair of GSS-infected chimpanzee.<br />
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Conclusions. In a primate model highly susceptible to TSE (the squirrel monkey), infectivity was not detected (<10 i.c. LD50/ml) in plasma or buffy coat from 2 sCJD and 3 vCJD patients, or in whole blood from 1st passage vCJD in monkeys. We did, however, detect infectivity in one monkey inoculated with purified leukocytes from chimpanzee-passaged GSS, and observed what appeared to be a ‘triggering’ of symptomatic disease by physiological stress in chimpanzees subjected to plasmapheresis under general anaesthesia.<br />
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PPo4-20:<br />
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All Clinically Relevant Components, from Prion Infected Blood Donors, can Cause Disease Following a Single Transfusion<br />
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Sandra McCutcheon,1 Fiona E. Houston,2 Anthony R. Alejo-Blanco,1 Christopher de Wolf,1 Boon Chin Tan,1 Anthony Smith,3 Nora Hunter,1 Valerie S. Hornsey,4 Ian R. MacGregor,4 Christopher V. Prowse,4 Marc Turner5 and Jean C. Manson1<br />
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1The Roslin Institute; Roslin, Edinburgh UK; 2The University of Glasgow; Glasgow, UK; 3The Institute for Animal Health; Compton, Berkshire UK; 4National Science Laboratory; Scottish National Blood Transfusion Service (SNBTS); Edinburgh, UK; 5University of Edinburgh and SNBTS; Edinburgh, UK<br />
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Key words: blood, prion, BSE, transfusion<br />
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Introduction. To date, there have been over 220 cases of vCJD worldwide, likely acquired directly from bovine sources. There is concern that human to human transmission from individuals sub-clinically infected with vCJD may amplify/prolong a vCJD epidemic. The area of greatest concern in this respect is blood transfusion, of which there have been several reported cases. Here we examined which blood components are likely to pose the greatest risk of transmitting vCJD via blood transfusion using our sheep BSE model.<br />
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Results. 67% of donors have been confirmed as having BSE. We have recorded 25 positive transmissions of BSE following transfusion of non-leucodepleted blood components and 2 transmissions resulting from the transfusion of leucoreduced red cells and leucoreduced plasma.<br />
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Conclusion. We show that all components, prepared to the same criteria as used in human medicine, contain sufficient levels of infectivity to cause disease in recipients following a single blood transfusion. Leucoreduction of plasma and red cell concentrates does not remove infectivity. These data indicate the importance of devising appropriate control measures to minimise the risk of human to human transmission of vCJD by blood transfusion. Department of Health, UK (007/0162).<br />
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Methods. Sheep were orally infected with bovine BSE brain homogenate. We collected two full-sized donations of whole blood, before the onset of clinical signs. The following components were transfused into naive recipients: whole blood, red cell concentrates buffy coat, plasma and platelet units. We also transfused leucoreduced plasma, platelets and red cells. We collected a unit of whole blood from selected primary recipients for transfusion into secondary recipients.<br />
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PPo4-21:<br />
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The Risk of Variant Creutzfeldt-Jakob Disease (vCJD) Among UK Patients with Bleeding Disorders, Known to Have Received Clotting Factors Linked to Donors who Subsequently Developed vCJD<br />
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Syed M.A. Zaman,1 Nicky Connor,1 Noel Gill,1 Carolyn M. Millar,2,6 Mike Makris,3,6 Benedict Palmer4 and Frank G.H. Hill5,6<br />
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1CJD Section, Health Protection Agency Centre for Infections; London, UK; 2Department of Haematology; Imperial College; London, UK; 3University of Sheffield; Royal Hallamshire Hospital; Sheffield, UK; 4National Haemophilia Database; Manchester, UK; 5The Children’s Hospital NHS Foundation Trust; Birmingham, UK; 6Members of the Transfusion Transmitted Infection Working Party of the UK; Haemophilia Centre Doctors’ Organisation (UKHCDO); Sheffield, South Yorkshire UK<br />
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The risk of Creutzfeldt-Jakob Disease (vCJD) from potentially infected plasma products remains un-quantified. This risk has been assessed for 787 UK bleeding disorder patients prospectively followed-up for 10–20 years through the UK Haemophilia Centre Doctors’ Organisation (UKHCDO) Surveillance Study. These patients were treated with any of 25 ‘implicated’ clotting factor batches from 1987–1999, which included in their manufacture plasma from eight donors who subsequently developed vCJD. VCJD infectivity of these batches was estimated using plasma fraction infectivity estimates and batch manufacturing data. The quantity of implicated batches received by these patients was obtained. Total vCJD infectivity received by each patient has been estimated by cumulating infectivity from all doses received in their lifetime. Of 787 patients, 604 (77%) were followed-up for over 13 years since exposure to an implicated batch. By end 2008, none of these patients had developed vCJD. For these 604 patients, the estimated vCJD risk is <1% for 595, <50% for 164, and 100% for 51. This is additional to the background UK population risk due to dietary exposure. Of 604 patients, 94 (16%) received implicated batches linked to donors who developed vCJD within six months of their donations. 151 (25%) had received their first dose under 10 years of age. The absence of clinical vCJD cases in this cohort to date suggests that either plasma fraction infectivity estimates are overly precautionary, or the incubation period is longer for this cohort than for implicated cellular blood product recipients. Further follow up of this cohort is needed to answer these questions.<br />
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<a href="http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099">http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099</a><br />
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FC5.1.1<br />
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Transmission Results in Squirrel Monkeys Inoculated with Human sCJD, vCJD, and GSS Blood Specimens: the Baxter Study<br />
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Brown, P1; Gibson, S2; Williams, L3; Ironside, J4; Will, R4; Kreil, T5; Abee, C3 1Fondation Alliance BioSecure, France; 2University of South Alabama, USA; 3University of Texas MD Anderson Cancer Center, USA; 4Western General Hospital, UK; 5Baxter BioSience, Austria<br />
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Background: Rodent and sheep models of Transmissible Spongiform Encephalopathy (TSE) have documented blood infectivity in both the pre-clinical and clinical phases of disease. Results in a (presumably more appropriate) non-human primate model have not been reported.<br />
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Objective: To determine if blood components (red cells, white cells, platelets, and plasma) from various forms of human TSE are infectious.<br />
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Methods: Blood components were inoculated intra-cerebrally (0.1 ml) and intravenously (0.5 ml) into squirrel monkeys from 2 patients with sporadic Creutzfeldt- Jakob disease (sCJD) and 3 patients with variant Creutzfeldt-Jakob disease (vCJD). Additional monkeys were inoculated with buffy coat or plasma samples from chimpanzees infected with either sCJD or Gerstmann-Sträussler-Scheinker disease (GSS). Animals were monitored for a period of 5 years, and all dying or sacrificed animals had post-mortem neuropathological examinations and Western blots to determine the presence or absence of the misfolded prion protein (PrPTSE).<br />
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Results: No transmissions occurred in any of the animals inoculated with blood components from patients with sporadic or variant CJD. All donor chimpanzees (sCJD and GSS) became symptomatic within 6 weeks of their pre-clinical phase plasmapheresis, several months earlier than the expected onset of illness. One monkey inoculated with purified leukocytes from a pre-clinical GSS chimpanzee developed disease after 36 months.<br />
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Conclusion: No infectivity was found in small volumes of blood components from 4 patients with sporadic CJD and 3 patients with variant CJD. ***However, a single transmission from a chimpanzee-passaged strain of GSS shows that infectivity may be present in leukocytes, and the shock of general anaesthesia and plasmspheresis appears to have triggered the onset of illness in pre-clinical donor chimpanzees.<br />
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FC5.1.2<br />
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Interim Transmission Results in Cynomolgus Macaques Inoculated with BSE and vCJD Blood Specimens<br />
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Lasmezas, C1; Lescoutra, N2; Comoy, E2; Holznagel, E3; Loewer, J3; Motzkus, D4; Hunsmann, G4; Ingrosso, L5; Bierke, P6; Pocchiari, M5; Ironside, J7; Will, R7; Deslys, JP2 1Scripps Florida, Infectology, USA; 2CEA, France; 3PEI, Germany; 4DPZ, Germany; 5Istituto Superiore di Sanita, Italy; 6SMI, Sweden; 7CJD Surveillance Unit, UK<br />
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BSE and vCJD transmitted to cynomolgus macaques reproduce many features of human vCJD, including clinical symptoms, neuropathological hallmarks of vCJD, PrPres electrophoretical pattern and, most importantly, the wide distribution of infectivity in peripheral organs. The latter characteristic distinguishes vCJD from sCJD in both humans and cynomolgus macaques, and prompted us to use this non-human primate model for further investigations of vCJD and its risk for human health. The occurrence of four vCJD infections in humans transfused with blood from patients who later developed vCJD has raised concern about blood transfusion safety in countries with vCJD. In this collaborative European study, we investigated the infectivity of blood components and whole blood administered by intracerebral (ic) and intravenous (iv) routes. Buffy-coat and whole blood was inoculated by ic and iv route, respectively, from two vCJD patients and from two clinical vCJD-inoculated macaques. Transfusions were also performed from whole blood and blood leucodepleted according to hospital practice standards from two clinical BSE inoculated macaques. Blood infectivity during the preclinical phase is being examined in orally infected macaques. Whole blood was collected and transfused from one such animal two years after oral challenge, whereas buffy-coat and plasma from two animals at 2 and 4.5 years post-challenge, respectively, have been inoculated by the ic route. This is an ongoing study in which recipient animals continue to be observed at various times post-inoculation. So far, we have had one positive transmission in one animal transfused 65 months earlier with 40 ml of whole blood from a vCJD macaque (the characteristics of the disease in this animal will be shown in a separate poster by E. Comoy). This positive transmission reproduces transfusion transmission of vCJD in humans, with an incubation of 5.5 years compatible with incubation periods observed in humans.<br />
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<a href="http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf">http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf</a><br />
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Saturday, September 5, 2009<br />
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TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS<br />
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snip...<br />
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But the first thing is our own study, and as I mentioned, it's a Baxter primate study, and those are the major participants. And the goal was twofold, and here is the first one: to see whether CJD, either sporadic or familial -- actually it turns out to be the familial CJD is incorrect. It really should be the Fukuoka strain of Gerstmann-Straussler-Scheinker disease. So it's really GSS instead of familial CJD -- when passaged through chimps into squirrel monkeys using purified blood components, very pure blood components.<br />
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So this addresses the question that was raised just recently about whether or not red cell infectivity that's been found in rodents is really in the red cells or is it contaminated.<br />
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We prepared these samples with exquisite care, and they are ultra-ultra-ultra purified. There's virtually no contamination of any of the components that we looked at ? platelets, red cells, plasma, white cells -- with any other component.<br />
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These are a sort of new set of slides, and what I've tried to do is make them less complicated and more clear, but I'm afraid I haven't included the build. So you'll just have to try and follow what I explain with this little red pointer.<br />
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There were three initial patients. Two of them had sporadic CJD. One of them had Gerstmann-Straussler-Scheinker syndrome. Brain tissue from each individual patient was inoculated intracerebrally into a pair of chimpanzees. All right?<br />
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From those chimps, either plasma or ultra purified -- in fact, everything is ultra-purified. I'll just talk about purified plasma, purified white cells -- were inoculated intracerebrally and intravenously to get the maximum amount of infective load into a pair of squirrel monkeys.<br />
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The same thing was done for each of these three sets. This monkey died from non-CJD causes at 34 months post inoculation.<br />
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Let me go back for a second. I didn't point out the fact that these were not sacrificed at this point. These chimpanzees were apheresed at 27 weeks when they were still asymptomatic. In this instance, we apheresed them terminally when they were symptomatic.<br />
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And before I forget, I want to mention just a little sidelight of this. Chimpanzees in our experience -- and I think we may be the only people that have ever inoculated chimpanzees, and that's no longer a possibility, so this was 20, 30 years ago -- the shortest incubation period of any chimpanzee that we have ever seen with direct intracerebral inoculation is 13 months.<br />
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So we chose 27 weeks, which is about seven months, and incidentally typically the incubation period is more like 16 or 18 months. The shortest was 13 months. We chose the 27th week, which is about six and a half months, thinking that this would be about halfway through the incubation period, which we wanted to check for the presence or absence of infectivity.<br />
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But within four weeks after the apheresis, which was conducted under general anesthesia for three or four hours apiece, every single one of the six chimpanzees became symptomatic. That is another experiment that I would love to conclude, perhaps because this is simply not heard of, and it very much smells like we triggered clinical illness. We didn't trigger the disease, but it certainly looks like we triggered symptomatic disease at a point that was much earlier than one would have possibly expected.<br />
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Maybe it will never be done because it would probably open the floodgates of litigation. There's no end of little things that you can find out from CJD patients after the fact. For example, the neighbor's dog comes over, barks at a patient, makes him fall down, and three weeks later he gets CJD. So you have a lawsuit against the neighbor.<br />
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I mean, this is not an unheard of matter, but I do think that physical stress in the form of anesthesia and four hours of whatever goes on with anesthesia, low blood pressure, sometimes a little hypoxemia looks like it's a bad thing.<br />
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So here we have the 31st week. All of the chimps are symptomatic, and here what we did was in order to make the most use of the fewest monkeys, which is always a problem in primate research, we took these same three patients and these six chimps. Only now we pooled these components; that is to say, we pooled the plasma from all six chimps. We pooled ultra-purified white cells from all six chimps because here we wanted to see whether or not we could distinguish a difference between intracerebral route of infection and intravenous route of infection.<br />
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With respect to platelets and red blood cells, we did not follow that. We inoculated both intracerebral and intravenously, as we had done earlier because nobody has any information on whether or not platelets and red cells are infectious, and so we wanted again to get the maximum.<br />
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This is an IV versus IC goal. This one, again, is just getting the maximum load in to see whether there is, in fact, any infectivity in pure platelets, in pure red cells.<br />
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And of all of the above, the only transmission of disease related to the inoculation was in a squirrel monkey that received pure leukocytes from the presymptomatic apheresis. So that goes some way to address the question as to whether or not it's a matter of contamination. To date the red cells have not been -- the monkeys that receive red cells have not been observed for more than a year because that was a later experiment.<br />
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So we still can't say about red cells, but we're about four and a half years down the road now, and we have a single transmission from purified leukocytes, nothing from plasma and nothing from platelets.<br />
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That was the first part of the experiment. The second part was undertaken with the cooperation of Bob Will and others supplying material to us. These were a couple of human, sporadic cases of CJD and three variant cases of CJD from which we obtained buffy coat and plasma separated in a normal way. That is, these are not purified components.<br />
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The two cases of sporadic CJD, the plasma was pooled from both patients. The buffy coat was pooled from both patients, and then inoculated intracerebrally and intravenously into three squirrel monkeys each. This is a non-CJD death five years after inoculation. The other animals are still alive.<br />
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For variant CJD we decided not to pool. It was more important to eliminate the possibility that there was just a little bit of infectivity in one patient that would have been diluted to extinction, if you like, by mixing them if it were to so occur with two patients, for example, who did not have infectivity. So each one of these was done individually, but the principle was the same: plasma and buffy coat for each patient was inoculated into either two or three squirrel monkeys. This is, again, a non-CJD related death.<br />
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In addition to that, we inoculated rain as a positive control from the two sporadic disease cases of human -- from the two human sporadic cases at ten to the minus one and ten to the minus three dilutions. We have done this many, many times in the past with other sporadic patients. So we knew what to expect, and we got exactly what we did expect, namely, after an incubation period not quite two years, all four monkeys developed disease at this dilution and at the minus three dilution, not a whole lot of difference between the two.<br />
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<br />
<br />
Now, these are the crucial monkeys because each one of these monkeys every three to four months was bled and the blood transfused into a new healthy monkey, but the same monkey all the time. So this monkey, for example, would have received in the course of 21 months about six different transfusions of blood from this monkey into this monkey, similarly with this pair, this pair, and this pair. So you can call these buddies. This is sort of the term that was used. These monkeys are still alive.<br />
<br />
<br />
<br />
In the same way, the three human variant CJD specimens, brain, were inoculated into four monkeys, and again, each one of these monkeys has been repeatedly bled at three to four month intervals and that blood transfused into a squirrel monkey, the same one each time. Ideally we would love to have taken bleeding at three months and inoculated a monkey and then let him go, watch him, and then done the same thing at six months. It would have increased the number of monkeys eightfold and just unacceptably expensive. So we did the best we could.<br />
<br />
<br />
<br />
That, again, is a non-CJD death, as is this.<br />
<br />
<br />
<br />
This was of interest mainly to show that the titer of infectivity in brain from variant CJD is just about the same as it from sporadic. We didn't do a minus five and a minus seven in sporadic because we have an enormous experience already with sporadic disease in squirrel monkeys, and we know that this is exactly what happens. It disappears at about ten to the minus five. So the brain titer in monkeys receiving human vCJD is identical to the brain titer in monkeys that have been inoculated with sporadic CJD.<br />
<br />
<br />
<br />
That's the experiment. All of the monkeys in aqua are still alive. They are approaching a five-year observation period, and I think the termination of this experiment will now need to be discussed very seriously in view of a probable six-year incubation period in the U.K. case. The original plan was to terminate the experiment after five years of observation with the understanding that ideally you would keep these animals for their entire life span, which is what we used to do when had unlimited space, money, and facilities. We can't do that anymore.<br />
<br />
<br />
<br />
It's not cheap, but I think in view of the U.K. case, it will be very important to think very seriously about allowing at least these buddies and the buddies from the sporadic CJD to go on for several more years because although you might think that the U.K. case has made experimental work redundant, in point of fact, anything that bears on the risk of this disease in humans is worthwhile knowing, and one of the things we don't know is frequency of infection. We don't know whether this case in the U.K. is going to be unique and never happen again or whether all 13 or 14 patients have received blood components are ultimately going to die. Let's hope not.<br />
<br />
<br />
<br />
The French primate study is primarily directed now by Corinne Lasmezas. As you know, the late Dominique Dromont was the original, originally initiated this work, and they have very active primate laboratory in France, and I'm only going to show two very simple slides to summarize what they did.<br />
<br />
<br />
<br />
The first one is simply to show you the basis of their statement that the IV route of infection looks to be pretty efficient because we all know that the intracerebral route of infection is the most efficient, and if you look at this where they inoculated the same infective load either intracerebrally or intravenously, the incubation periods were not substantially different, which suggests but doesn't prove, but doesn't prove that the route of infection is pretty efficient.<br />
<br />
<br />
<br />
Lower doses of brain material given IV did extend the incubation period and presumably it's because of the usual dose response phenomenon that you see in any infectious disease.<br />
<br />
<br />
<br />
With a whopping dose of brain orally, the incubation period was even lower. Again, just one more example of inefficiency of the route of infection and the necessity to use more infective material to get transmissions.<br />
<br />
<br />
<br />
And they also have blood inoculated IV which is on test, and the final slide or at least the penultimate slide shows you what they have on test and the time of observation, that taken human vCJD and like us inoculated buffy coat, they've also inoculated whole blood which we did not do.<br />
<br />
<br />
<br />
So to a great extent their studies are complementary to ours and makes it all worthwhile.<br />
<br />
<br />
<br />
We have about -- oh, I don't know -- a one to two-year lead time on the French, but they're still getting into pretty good observation periods. Here's three-plus years.<br />
<br />
<br />
<br />
They have variant CJD adapted to the macaque. That is to say this one was passaged in macaque monkeys, the cynomolgus, and they did the same thing. Again, we're talking about a study here in which like ours there are no transmissions. I mean, we have that one transmission from leukocytes, and that's it.<br />
<br />
<br />
<br />
Here is a BSE adapted to the macaque. Whole blood, and then they chose to inoculate leukodepleted whole blood, in both instances IV. Here they are out to five years without a transmission.<br />
<br />
<br />
<br />
And then finally oral dosing of the macaque, which had been infected with -- which was infected with BSE, but a macaque passaged BSE, whole blood buffy coat and plasma, all by the IC route, and they're out to three years.<br />
<br />
<br />
<br />
So with the single exception of the leukocyte transmission from our chimp that was inoculated with a sporadic case of CJD or -- excuse me -- with a GSS, Gerstmann-Straussler, in neither our study nor the French study, which are not yet completed have we yet seen a transmission.<br />
<br />
<br />
<br />
And I will just close with a little cartoon that appeared in the Washington Post that I modified slightly lest you get too wound up with these questions of the risk from blood. This should be a "corrective."<br />
<br />
<br />
<br />
(Laughter.)<br />
<br />
<br />
<br />
DR. BROWN: Thanks.<br />
<br />
<br />
<br />
Questions?<br />
<br />
<br />
<br />
CHAIRPERSON PRIOLA: Yes. Any questions for Dr. Brown? Dr. Linden.<br />
<br />
<br />
<br />
DR. LINDEN: I just want to make sure I understand your study design correctly. When you mention the monkeys that have the IV and IC inoculations, the individual monkeys had both or --<br />
<br />
<br />
<br />
DR. BROWN: Yes, yes, yes. That's exactly right.<br />
<br />
<br />
<br />
DR. LINDEN: So an individual monkey had both of those as opposed to some monkeys had one and some had the other?<br />
<br />
<br />
<br />
DR. BROWN: Correct, correct. Where IC and IV are put down together was IC plus IV into a given monkey.<br />
<br />
<br />
<br />
DR. LINDEN: Into a given monkey. Okay.<br />
<br />
<br />
<br />
And the IC inoculations, where were those given?<br />
<br />
<br />
<br />
DR. BROWN: Right parietal cortex, Southern Alabama.<br />
<br />
<br />
<br />
(Laughter.)<br />
<br />
<br />
<br />
DR. BROWN: Oh, it can't be that clear. Yeah, here, Pierluigi.<br />
<br />
<br />
<br />
CHAIRPERSON PRIOLA: Dr. Epstein.<br />
<br />
<br />
<br />
DR. BROWN: Pierluigi always damns me with feint praise. He always says that's a very interesting study, but. I'm waiting for that, Pierluigi.<br />
<br />
<br />
<br />
I think Jay Epstein --<br />
<br />
<br />
<br />
DR. GAMBETTI: I will say that there's an interesting study and will say, but I just --<br />
<br />
<br />
<br />
(Laughter.)<br />
<br />
<br />
<br />
DR. GAMBETTI: -- I just point of review. You talk about a point of information. You say that -- you mention GSS, I guess, and the what, Fukuowa (phonetic) --<br />
<br />
<br />
<br />
DR. BROWN: Yes, Fukuoka 1.<br />
<br />
<br />
<br />
DR. GAMBETTI: Fukuowa, and is that from the 102, if I remember correctly, of the --<br />
<br />
<br />
<br />
DR. BROWN: Yes, that is correct.<br />
<br />
<br />
<br />
DR. GAMBETTI: Because that is the only one that also --<br />
<br />
<br />
<br />
DR. BROWN: No, it's not 102. It's 101. It's the standard. It's a classical GSS. Oh, excuse me. You're right. One, oh, two is classical GSS. It's been so long since I've done genetics. You're right.<br />
<br />
<br />
<br />
DR. GAMBETTI: Because that is the only one I know, I think, that I can remember that has both the seven kv fragment that is characteristic of GSS, but also the PrPsc 2730. So in a sense, it can be stretching a little bit compared to the sporadic CJD.<br />
<br />
<br />
<br />
DR. BROWN: Yeah, I think that's right. That's why I want to be sure that I made you aware on the very first slide that that was not accurate, that it truly was GSS.<br />
<br />
<br />
<br />
There's a GSS strain that has been adapted to mice, and it's a hot strain, and therefore, it may not be translatable to sporadic disease, correct. All we can say for sure is that it is a human TSE, and it is not variant. I think that's about it.<br />
<br />
<br />
<br />
DR. GAMBETTI: I agree, but this is also not perhaps the best --<br />
<br />
<br />
<br />
DR. BROWN: No, it is not the best. We understand --<br />
<br />
<br />
<br />
DR. GAMBETTI: -- of GSS either.<br />
<br />
<br />
<br />
DR. BROWN: Yeah. If we had to do it over again, we'd look around for a -- well, I don't know. We'd probably do it the same way because we have two sporadics already on test they haven't transmitted, and so you can take your pick of what you want to pay attention to.<br />
<br />
<br />
<br />
Jay?<br />
<br />
<br />
<br />
DR. EPSTEIN: Yes, Paul. Could you just comment? If I understood you correctly, when you did the pooled apheresis plasma from the six chimps when they were symptomatic at 31 weeks, you also put leukocytes into squirrel monkeys in that case separately IV and IC, but in that instance you have not seen an infection come down in squirrel monkey, and the question is whether it's puzzling that you got transmission from the 27-week asymptomatic sampling, whereas you did not see transmission from the 31-week sampling in symptomatic animals.<br />
<br />
<br />
<br />
DR. BROWN: Yes, I think there are two or three possible explanations, and I don't know if any of them are important. The pre-symptomatic animal was almost symptomatic as it turned out so that we were pretty close to the period at which symptoms would being, and whether you can, you know, make much money on saying one was incubation period and the other was symptomatic in this particular case because both bleedings were so close together. That's one possibility.<br />
<br />
<br />
<br />
The other possibility is we're dealing with a very irregular phenomenon and you're not surprised at all by surprises, so to speak so that a single animal, you could see it almost anywhere.<br />
<br />
<br />
<br />
The third is that we, in fact, did just what I suggested we didn't want to do for the preclinical, namely, by pooling we got under the threshold. See?<br />
<br />
<br />
<br />
You can again take that for what it's worth. It is a possible explanation, and again, until we know what the levels of infectivity are and whether by pooling we get under the threshold of transmission, we simply cannot make pronouncements.<br />
<br />
<br />
<br />
CHAIRPERSON PRIOLA: Dr. DeArmond.<br />
<br />
<br />
<br />
DR. DeARMOND: Yeah, it was very interesting data, but the --<br />
<br />
<br />
<br />
(Laughter.)<br />
<br />
<br />
<br />
DR. BROWN: I just love it. Go ahead.<br />
<br />
<br />
<br />
DR. DeARMOND: Two comments. The first one was that the GSS cases, as I remember from reading your publications -- I think Gibbs was involved with them -- when you transmitted the GSS into animals, into monkeys, perhaps I think it was chimps, the transmission was more typical of CJD rather than GSS. There were no amyloid plaques. It was vacuolar degeneration so that you may be transmitting a peculiar form, as I criticized once in Bali and then you jumped all over me about.<br />
<br />
<br />
<br />
DR. BROWN: I may do it again.<br />
<br />
<br />
<br />
DR. DeARMOND: Calling me a bigot and some other few things like that.<br />
<br />
<br />
<br />
(Laughter.)<br />
<br />
<br />
<br />
DR. BROWN: Surely not. I wouldn't have said that.<br />
<br />
<br />
<br />
DR. DeARMOND: So there could be something strange about that particular --<br />
<br />
<br />
<br />
DR. BROWN: Yeah. I think you and Pierluigi are on the same page here. This may be an unusual strain from a number of points of view.<br />
<br />
<br />
<br />
DR. DeARMOND: The other question though has to do with species barrier because the data you're showing is kind of very reassuring to us that it's hard to transmit from blood, but the data from the sheep and from the hamsters and some of the work, I think, that has been done by others, that it's easy in some other animals to transmit, hamster to hamster, mouse to mouse.<br />
<br />
<br />
<br />
Could you comment on the --<br />
<br />
<br />
<br />
DR. BROWN: That's exactly why we went to primates. That's exactly it, because a primate is closer to a human than a mouse is, and that's just common sense.<br />
<br />
<br />
<br />
And so to try and get a little closer to the human situation and not totally depend on rodents for transferrable data, that is why you would use a primate. Otherwise you wouldn't use them. They're too expensive and they cause grief to animal care study people and protocol makers and the whole thing.<br />
<br />
<br />
<br />
Primate studies are a real pain.<br />
<br />
<br />
<br />
DR. DeARMOND: But right now it's inconclusive and you need more time on it.<br />
<br />
<br />
<br />
DR. BROWN: I believe that's true. I think if we cut it off at six years you could still say it was inconclusive, and cutting it off at all will be to some degree inconclusive, and that's just the way it is.<br />
<br />
<br />
<br />
DR. DeARMOND: So what has to be done? Who do you have to convince, or who do we all have to convince to keep that going?<br />
<br />
<br />
<br />
DR. BROWN: Thomas?<br />
<br />
<br />
<br />
Without trying to be flip at all, the people that would be the first people to try to convince would be the funders of the original study. If that fails, and it might for purely practical reasons of finance, then we will have to look elsewhere because I really don't want to see those animals sacrificed, not those eight buddies. Those are crucial animals, and they don't cost a whole lot to maintain. You can maintain eight -- well, they cost a lot from my point of view, but 15 to $20,000 a year would keep them going year after year.<br />
<br />
<br />
<br />
CHAIRPERSON PRIOLA: Dr. Johnson.<br />
<br />
<br />
<br />
DR. JOHNSON: Yeah, Paul, I'm intrigued as you are by the shortening of the incubation period. Have you in all of the other years of handling these animals when they were transfused, when they were flown out to Louisiana at night -- a lot of the stressful things have happened to some of these chimps. Have you ever noticed that before or is this a new observation?<br />
<br />
<br />
<br />
DR. BROWN: Brand new.<br />
<br />
<br />
<br />
MR. JOHNSON: Brand new. Okay.<br />
<br />
<br />
<br />
CHAIRPERSON PRIOLA: Bob, did you want to say something? Dr. Rohwer.<br />
<br />
<br />
<br />
DR. ROHWER: The Frederick fire, wasn't that correlated with a lot of --<br />
<br />
<br />
<br />
DR. BROWN: Not that I k now of, but you may --<br />
<br />
<br />
<br />
DR. ROHWER: Well, that occurred shortly after I came to NIH, and what I remember is that there were a whole bunch of conversions that occurred within the few months following the fire. That was fire that occurred adjacent to the NINDS facility, but in order to protect it, they moved the monkeys out onto the tarmac because they weren't sure it wouldn't burn as well.<br />
<br />
<br />
<br />
DR. BROWN: Well, if you're right, then it's not brand new, but I mean, I'm not sure how we'll ever know because if I call Carlton and ask him, I'm not sure but what I would trust the answer that he gives me, short of records.<br />
<br />
<br />
<br />
You know, Carlot is a very enthusiastic person, and he might say, "Oh, yeah, my God, the whole floor died within three days," but I would want to verify that.<br />
<br />
<br />
<br />
On the other hand, it may be verifiable. There possibly are records that are still extant.<br />
<br />
<br />
<br />
DR. ROHWER: Actually I thought I heard the story from you.<br />
<br />
<br />
<br />
(Laughter.)<br />
<br />
<br />
<br />
DR. BROWN: You didn't because it's brand new for me. I mean, either that or I'm on the way<br />
<br />
<br />
<br />
(Laughter.)<br />
<br />
<br />
<br />
CHAIRPERSON PRIOLA: Dr. Bracey.<br />
<br />
<br />
<br />
DR. BRACEY: I was wondering if some of the variability in terms of the intravenous infection route may be related to intraspecies barriers, that is, the genetic differences, the way the cells, the white leukocytes are processed, whether or not microchimerism is established, et cetera.<br />
<br />
<br />
<br />
DR. BROWN: I don't think that processing is at fault, but the question, the point that you raise is a very good one, and needless to say, we have material with which we can analyze genetically all of the animals, and should it turn out that we get, for example, -- I don't know -- a transmission in one variant monkey and no transmissions in another and a transmission in three sporadic monkeys, we will at that point genetically analyze every single animal that has been used in this study, but we wanted to wait until we could see what would be most useful to analyze.<br />
<br />
<br />
<br />
but the material is there, and if need be, we'll do it.<br />
<br />
<br />
<br />
CHAIRPERSON PRIOLA: Okay. Thank you very much, Dr. Brown.<br />
<br />
<br />
<br />
I think we'll move on to the open public hearing section of the morning.<br />
<br />
<br />
<br />
snip...<br />
<br />
<br />
<br />
<a href="http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4019t1.DOC">http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4019t1.DOC</a><br />
<br />
<br />
<br />
<br />
snip...<br />
<br />
<br />
<br />
see full text ;<br />
<br />
<br />
<br />
<br />
<a href="http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html">http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html</a><br />
<br />
<br />
<br />
<br />
<br />
Thursday, August 12, 2010<br />
<br />
<br />
<br />
USA Blood products, collected from a donor who was at risk for vCJD, were distributed July-August 2010<br />
<br />
<br />
<a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html</a><br />
<br />
<br />
<br />
<br />
<br />
Sunday, August 01, 2010<br />
<br />
<br />
<br />
Blood product, collected from a donors possibly at increased risk for vCJD only, was distributed USA JULY 2010<br />
<br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html">http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html</a><br />
<br />
<br />
<br />
<br />
<br />
14th ICID International Scientific Exchange Brochure -<br />
<br />
<br />
<br />
Final Abstract Number: ISE.114<br />
<br />
<br />
<br />
Session: International Scientific Exchange<br />
<br />
<br />
<br />
Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America update October 2009<br />
<br />
<br />
<br />
T. Singeltary<br />
<br />
<br />
<br />
Bacliff, TX, USA<br />
<br />
<br />
<br />
Background:<br />
<br />
<br />
<br />
An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and fed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.<br />
<br />
<br />
<br />
Methods:<br />
<br />
<br />
<br />
12 years independent research of available data<br />
<br />
<br />
<br />
Results:<br />
<br />
<br />
<br />
I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.<br />
<br />
<br />
<br />
Conclusion:<br />
<br />
<br />
<br />
I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.<br />
<br />
<br />
<br />
page 114 ;<br />
<br />
<br />
<br />
<br />
<a href="http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf">http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf</a><br />
<br />
<br />
<br />
<br />
<br />
International Society for Infectious Diseases Web: <a href="http://www.isid.org/">http://www.isid.org/</a><br />
<br />
<br />
<br />
please see full text ;<br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/">http://transmissiblespongiformencephalopathy.blogspot.com/</a><br />
<br />
<br />
<br />
<br />
<br />
Wednesday, September 08, 2010<br />
<br />
<br />
<br />
Emerging Infectious Diseases: CJD, BSE, SCRAPIE, CWD, PRION, TSE Evaluation to Implementation for Transfusion and Transplantation September 2010<br />
<br />
<br />
<br />
<a href="http://vcjdtransfusion.blogspot.com/2010/09/emerging-infectious-diseases-cjd-bse.html">http://vcjdtransfusion.blogspot.com/2010/09/emerging-infectious-diseases-cjd-bse.html</a><br />
<br />
<br />
<br />
<br />
Wednesday, February 2, 2011<br />
<br />
Detection of prion infection in variant Creutzfeldt-Jakob disease: a blood-based assay<br />
<br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/02/detection-of-prion-infection-in-variant.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/02/detection-of-prion-infection-in-variant.html</a><br />
<br />
<br />
<br />
<br />
Monday, February 7, 2011<br />
<br />
<br />
<br />
FDA's Currently-Recommended Policies to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products 2011 ???<br />
<br />
<br />
<br />
<br />
<a href="http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html">http://tseac.blogspot.com/2011/02/fdas-currently-recommended-policies-to.html</a><br />
<br />
<br />
<br />
<br />
<br />
Monday, September 13, 2010<br />
<br />
<br />
<br />
atypical BSE strains and sporadic CJD strains, is there a connection and why shouldn't there be $<br />
<br />
<br />
<br />
<a href="http://bse-atypical.blogspot.com/2010/09/atypical-bse-strains-and-sporadic-cjd.html">http://bse-atypical.blogspot.com/2010/09/atypical-bse-strains-and-sporadic-cjd.html</a><br />
<br />
<br />
<br />
<br />
Saturday, January 29, 2011<br />
<br />
Atypical L-Type Bovine Spongiform Encephalopathy (L-BSE) Transmission to Cynomolgus Macaques, a Non-Human Primate<br />
<br />
<br />
<br />
Jpn. J. Infect. Dis., 64 (1), 81-84, 2011<br />
<br />
<br />
<br />
<a href="http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html">http://transmissiblespongiformencephalopathy.blogspot.com/2011/01/atypical-l-type-bovine-spongiform.html</a><br />
<br />
<br />
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Tuesday, September 14, 2010<br />
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Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)<br />
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<a href="http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html">http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html</a><br />
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Sunday, May 10, 2009<br />
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Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)<br />
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TO : william.freas@fda.hhs.gov <william.freas@fda.hhs.gov><br />
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May 8, 2009<br />
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Greetings again Dr. Freas, TSEAC et al,<br />
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I would kindly, once again, wish to comment at this meeting about the urgent actions that need to be taken asap, to the Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009. Due to my disability from my neck injury, I will not be attending this meeting either, however I hope for my submission to be read and submitted. ...<br />
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IN reply to ;<br />
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<a href="http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html">http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html</a><br />
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Friday, February 11, 2011<br />
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Creutzfeldt-Jakob disease (CJD) biannual update (2010/1) Emerging infections/CJD<br />
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<a href="http://creutzfeldt-jakob-disease.blogspot.com/2011/02/creutzfeldt-jakob-disease-cjd-biannual.html">http://creutzfeldt-jakob-disease.blogspot.com/2011/02/creutzfeldt-jakob-disease-cjd-biannual.html</a><br />
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TSSTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-3044438096548802122010-09-28T08:09:00.000-07:002010-09-28T08:16:51.935-07:00Variant CJD: where has it gone, or has it?Pract Neurol 2010; 10: 250–251<br /><br />Variant CJD: where has it gone, or has it?<br /><br />Bob Will<br /><br />The feared large scale epidemic of variant Creutzfeldt–Jakob disease (vCJD) has thankfully not materialised. The number of cases identifi ed annually in the UK has been in decline since 1999 although there could still be a tail to the outbreak lasting for many years (fi gure). Internationally, the trend in the number of vCJD cases is also in decline and bovine spongiform encephalopathy (BSE) is now a rare disease, even in the UK. One explanation is that the measures introduced to control these diseases were effective; indeed, it is of interest that, to date, no case of vCJD in the UK was born after 1989 when the specifi ed bovine offal ban was introduced whereas there have been three cases born after this date in other European countries where legislative measures to minimise human exposure to BSE were introduced some years later. However, BSE and vCJD control measures are very costly and there will be pressure in the coming years to withdraw or amend relevant legislation and guidance. An important question is whether there are continuing realistic concerns about public health in relation to vCJD and not simply, as has been suggested in the press, scaremongering by some researchers keen to maintain funding.<br /><br />All probable and definite cases of vCJD internationally, in which genetic testing has been carried out (199/219), have been methionine (MM) homozygous at codon 129 of the prion protein gene. This is clearly a susceptibility factor for the development of clinical disease. However, two out of three prion protein positive appendices in a screening study of 12 674 routine appendix specimens were valine/valine (VV), and a clinically unaffected recipient of a vCJD implicated blood transfusion with disease associated prion protein in their spleen was a heterozygote (MV). This implies that there may be a population of individuals who are subclinically infected but who may never develop clinical disease within their lifespan, perhaps explaining, in part, the mismatch between the extensive human exposure to BSE in the food chain and the relatively limited number of clinical cases so far observed.<br /><br />This has important implications for the risk of secondary transmission from person to person—for example, through contaminated surgical instruments or blood transfusion. According to one estimate, extrapolating from the estimated prevalence of subclinical infection, 1 in 10 000 blood donations have been derived from individuals who are infected with vCJD. The fact of transfusion transmission of vCJD is now established with three cases of vCJD developing symptoms 5–8 years after having received a blood transfusion from people who donated the blood 1.5–3.5 years before themselves developing the condition (in addition to the subclinical infection referred to above).1 Concerns have been heightened by the discovery of disease associated prion protein in the spleen of a person with haemophilia who had received factor VIII derived from a pool containing a vCJD donation.2 Furthermore, there is a signifi cant population who have been exposed to plasma products potentially contaminated with the vCJD agent but, to date, there is no evidence that clinical cases of vCJD have been caused by exposure to such treatments. One unresolved question is why there have not been more cases of vCJD linked to blood transfusion or plasma products and there is a pressing need to obtain more precise information on the prevalence of infection in the general population.<br /><br />The recent identifi cation of a possible clinical case of vCJD in an individual with an MV genotype3 reinforces the long held concern that there may be further waves of vCJD cases in individuals with a non-MM codon 129 genotype. Mathematical models suggest that the number of MV and VV cases will be limited and not exceed the primary MM outbreak, but predicting infectious outbreaks is an imprecise science, as may be inferred from the recent swine fl u epidemic which never materialised, at least not to the extent predicted. The adage that ‘Essentially, all models are wrong but some are useful’ (George Edwin Pelham Box, 2007), reinforces the need for caution in predicting the future course of the vCJD outbreak. There is also the possibility that the phenotype of vCJD may be infl uenced by the genetic background. It is reassuring therefore that the recent possible MV case was identifi ed on the basis of the clinical features as this may indicate that any further such cases will also be recognised as vCJD.<br /><br />However, there is clearly still a continuing need to look for new phenotypes of human prion disease. Novel forms of animal prion diseases have been identifi ed in recent years, including atypical scrapie and the rare H and L forms of atypical BSE, probably as a result of the extensive abattoir testing of animal populations. Atypical BSE has been transmitted to a range of laboratory animals, and in a primate model the incubation period was shorter than with conventional BSE and the clinical and pathological phenotype different.4<br /><br />The incubation period in human prion disease can extend to decades and there are continuing concerns and uncertainties that indicate that there are good reasons to continue research and surveillance in vCJD, despite the clear decline in the primary outbreak of vCJD.<br /><br />Competing interests BW holds research grants in relation to CJD research and surveillance. Provenance and peer review Commissioned; not externally peer reviewed.<br /><br />REFERENCES<br /><br />1. Hewitt PE, Llewelyn CA, Mackenzie J, et al. Creutzfeldt–Jakob disease and blood transfusion: results of the UK Transfusion Medicine Epidemiological Review study. Vox Sang 2006;91:221–30.<br /><br />2. Peden A, McCardle L, Head MW, et al. Variant CJD infection in the spleen of a neurologically asymptomatic UK adult patient with haemophilia. Haemophilia 2010;16:296–304.<br /><br />3. Kaski D, Mead S, Hyare H, et al. Variant CJD in an individual heterozygous for PRNP codon 129. Lancet 2009;374:2128.<br /><br />4. Comoy EE, Casalone C, Lescoutra-Etchegaray N, et al. Atypical BSE (BASE) transmitted from asymptomatic aging cattle to a primate. PLoS One 2008;3:e3017.<br /><br /><br /><a href="http://pn.bmj.com/content/10/5/250.extract">http://pn.bmj.com/content/10/5/250.extract</a><br /><br /><br /><br /><br />Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America<br /><br />14th ICID International Scientific Exchange Brochure -<br /><br />Final Abstract Number: ISE.114<br /><br />Session: International Scientific Exchange<br /><br />Transmissible Spongiform encephalopathy (TSE) animal and human TSE in North America<br /><br />update October 2009<br /><br />T. Singeltary<br /><br />Bacliff, TX, USA<br /><br />Background:<br /><br />An update on atypical BSE and other TSE in North America. Please remember, the typical U.K. c-BSE, the atypical l-BSE (BASE), and h-BSE have all been documented in North America, along with the typical scrapie's, and atypical Nor-98 Scrapie, and to date, 2 different strains of CWD, and also TME. All these TSE in different species have been rendered and fed to food producing animals for humans and animals in North America (TSE in cats and dogs ?), and that the trading of these TSEs via animals and products via the USA and Canada has been immense over the years, decades.<br /><br />Methods:<br /><br />12 years independent research of available data<br /><br />Results:<br /><br />I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc.<br /><br />Conclusion:<br /><br />I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. Restricting the reporting of CJD and or any human TSE is NOT scientific. Iatrogenic CJD knows NO age group, TSE knows no boundaries. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route.<br /><br />page 114 ;<br /><br /><br /><a href="http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf">http://ww2.isid.org/Downloads/14th_ICID_ISE_Abstracts.pdf</a><br /><br /><br />International Society for Infectious Diseases Web: <a href="http://www.isid.org/">http://www.isid.org/</a><br /><br /><br /><br />please see full text ;<br /><br /><a href="http://transmissiblespongiformencephalopathy.blogspot.com/">http://transmissiblespongiformencephalopathy.blogspot.com/</a><br /><br /><br /><br />To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures.<br /><br /><br /><a href="http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2">http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2</a><br /><br /><br /><br />please see full text ;<br /><br />Wednesday, March 31, 2010<br /><br />Atypical BSE in Cattle<br /><br /><br /><a href="http://bse-atypical.blogspot.com/2010/03/atypical-bse-in-cattle-position-post.html">http://bse-atypical.blogspot.com/2010/03/atypical-bse-in-cattle-position-post.html</a><br /><br /><br /><br />let's take a closer look at this new prionpathy or prionopathy, and then let's look at the g-h-BSEalabama mad cow.<br /><br />This new prionopathy in humans? the genetic makeup is IDENTICAL to the g-h-BSEalabama mad cow, the only _documented_ mad cow in the world to date like this, ......wait, it get's better. this new prionpathy is killing young and old humans, with LONG DURATION from onset of symptoms to death, and the symptoms are very similar to nvCJD victims, OH, and the plaques are very similar in some cases too, bbbut, it's not related to the g-h-BSEalabama cow, WAIT NOW, it gets even better, the new human prionpathy that they claim is a genetic TSE, has no relation to any gene mutation in that family. daaa, ya think it could be related to that mad cow with the same genetic make-up ??? there were literally tons and tons of banned mad cow protein in Alabama in commerce, and none of it transmitted to cows, and the cows to humans there from ??? r i g h t $$$<br /><br />ALABAMA MAD COW g-h-BSEalabama<br /><br />In this study, we identified a novel mutation in the bovine prion protein gene (Prnp), called E211K, of a confirmed BSE positive cow from Alabama, United States of America. This mutation is identical to the E200K pathogenic mutation found in humans with a genetic form of CJD. This finding represents the first report of a confirmed case of BSE with a potential pathogenic mutation within the bovine Prnp gene. We hypothesize that the bovine Prnp E211K mutation most likely has caused BSE in "the approximately 10-year-old cow" carrying the E221K mutation.<br /><br /><br /><br /><a href="http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1000156">http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1000156</a><br /><br /><br /><a href="http://www.plospathogens.org/article/fetchObjectAttachment.action?uri=info%3Adoi%2F10.1371%2Fjournal.ppat.1000156&representation=PDF">http://www.plospathogens.org/article/fetchObjectAttachment.action?uri=info%3Adoi%2F10.1371%2Fjournal.ppat.1000156&representation=PDF</a><br /><br /><br /><br />Saturday, August 14, 2010<br /><br />BSE Case Associated with Prion Protein Gene Mutation (g-h-BSEalabama) and VPSPr PRIONPATHY<br /><br />(see mad cow feed in COMMERCE IN ALABAMA...TSS)<br /><br /><br /><a href="http://prionpathy.blogspot.com/2010/08/bse-case-associated-with-prion-protein.html">http://prionpathy.blogspot.com/2010/08/bse-case-associated-with-prion-protein.html</a><br /><br /><br /><br />2009 UPDATE ON ALABAMA AND TEXAS MAD COWS 2005 and 2006<br /><br /><br /><a href="http://bse-atypical.blogspot.com/2006/08/bse-atypical-texas-and-alabama-update.html">http://bse-atypical.blogspot.com/2006/08/bse-atypical-texas-and-alabama-update.html</a><br /><br /><br /><br />Monday, October 19, 2009<br /><br />Atypical BSE, BSE, and other human and animal TSE in North America Update October 2009<br /><br /><br /><a href="http://bse-atypical.blogspot.com/2009/10/atypical-bse-bse-and-other-human-and.html">http://bse-atypical.blogspot.com/2009/10/atypical-bse-bse-and-other-human-and.html</a><br /><br /><br /><br />Tuesday, September 14, 2010<br /><br />Feed Safety and BSE/Ruminant Feed Ban Support Project (U18)<br /><br /><br /><a href="http://madcowfeed.blogspot.com/2010/09/feed-safety-and-bseruminant-feed-ban.html">http://madcowfeed.blogspot.com/2010/09/feed-safety-and-bseruminant-feed-ban.html</a><br /><br /><br /><br />Tuesday, August 03, 2010<br /><br />Variably protease-sensitive prionopathy: A new sporadic disease of the prion protein<br /><br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/08/variably-protease-sensitive-prionopathy.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/08/variably-protease-sensitive-prionopathy.html</a><br /><br /><br /><br />Monday, August 9, 2010<br /><br />Variably protease-sensitive prionopathy: A new sporadic disease of the prion protein or just more PRIONBALONEY ?<br /><br /><br /><a href="http://prionunitusaupdate2008.blogspot.com/2010/08/variably-protease-sensitive-prionopathy.html">http://prionunitusaupdate2008.blogspot.com/2010/08/variably-protease-sensitive-prionopathy.html</a><br /><br /><br /><br />***+++***<br /><br /><br />Thursday, July 10, 2008<br /><br />A Novel Human Disease with Abnormal Prion Protein Sensitive to Protease update July 10, 2008 Friday, June 20, 2008<br /><br /><br /><a href="http://cjdmadcowbaseoct2007.blogspot.com/2008/07/novel-human-disease-with-abnormal-prion.html">http://cjdmadcowbaseoct2007.blogspot.com/2008/07/novel-human-disease-with-abnormal-prion.html</a><br /><br /><br /><br />CJD TEXAS 38 YEAR OLD FEMALE WORKED SLAUGHTERING CATTLE EXPOSED TO BRAIN AND SPINAL CORD MATTER<br /><br /><br />>>> Up until about 6 years ago, the pt worked at Tyson foods where she worked on the assembly line, slaughtering cattle and preparing them for packaging. She was exposed to brain and spinal cord matter when she would euthanize the cattle. <<<<br /><br /><br />Irma Linda Andablo CJD Victim, she died at 38 years old on February 6, 2010 in Mesquite Texas<br /><br />Irma Linda Andablo CJD Victim, she died at 38 years old on February 6, 2010 in Mesquite Texas. She left 6 Kids and a Husband.The Purpose of this web is to give information in Spanish to the Hispanic community, and to all the community who want's information about this terrible disease.-<br /><br />Physician Discharge Summary, Parkland Hospital, Dallas Texas<br /><br />Admit Date: 12/29/2009<br /><br />Discharge Date: 1/20/2010<br /><br />Attending Provider: Greenberg, Benjamin Morris;<br /><br />General Neurology Team: General Neurology Team<br /><br />Linda was a Hispanic female with no past medical history presents with 14 months of incresing/progressive altered mental status, generalized weakness, inability to walk, loss of appetite, inability to speak, tremor and bowel/blader incontinence. She was, in her usual state of health up until February, 2009, when her husbans notes that she began forgetting things like names and short term memories. He also noticed mild/vague personality changes such as increased aggression. In March, she was involved in a hit and run MVA,although she was not injured. The police tracked her down and ticketed her. At that time, her son deployed to Iraq with the Army and her husband assumed her mentation changes were due to stress over these two events. Also in March, she began to have weakness in her legs, making it difficult to walk. Over the next few months, her mentation and personality changes worsened, getting to a point where she could no longer recognized her children. She was eating less and less. She was losing more weight. In the last 2-3 months, she reached the point where she could not walk without an assist, then 1 month ago, she stopped talking, only making grunting/aggressive sounds when anyone came near her. She also became both bowel and bladder incontinent, having to wear diapers. Her '"tremor'" and body jerks worsened and her hands assumed a sort of permanent grip position, leading her family to put tennis balls in her hands to protect her fingers. The husband says that they have lived in Nebraska for the past 21 years. They had seen a doctor there during the summer time who prescribed her Seroquel and Lexapro, Thinking these were sx of a mood disorder. However, the medications did not help and she continued to deteriorate clinically. Up until about 6 years ago, the pt worked at Tyson foods where she worked on the assembly line, slaughtering cattle and preparing them for packaging. She was exposed to brain and spinal cord matter when she would euthanize the cattle. The husband says that he does not know any fellow workers with a similar illness. He also says that she did not have any preceeding illness or travel.<br /><br /><br /><a href="http://www.recordandoalinda.com/index.php?option=com_content&view=article&id=19:cjd-english-info&catid=9:cjd-ingles&Itemid=8">http://www.recordandoalinda.com/index.php?option=com_content&view=article&id=19:cjd-english-info&catid=9:cjd-ingles&Itemid=8</a><br /><br /><br /><br />Terry S. Singeltary Sr. has added the following comment: "According to the World Health Organisation, the future public health threat of vCJD in the UK and Europe and potentially the rest of the world is of concern and currently unquantifiable. However, the possibility of a significant and geographically diverse vCJD epidemic occurring over the next few decades cannot be dismissed <http:>.<br /><br />The key word here is diverse. What does diverse mean?<br /><br />If USA scrapie transmitted to USA bovine does not produce pathology as the UK c-BSE, then why would CJD from there look like UK vCJD?"<br /><br />SEE FULL TEXT ;<br /><br /><br /><a href="http://www.promedmail.org/pls/apex/f?p=2400:1001:568933508083034::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,82101">http://www.promedmail.org/pls/apex/f?p=2400:1001:568933508083034::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,82101</a><br /><br /><br /><br />.57 The experiment which might have determined whether BSE and scrapie were caused by the same agent (ie, the feeding of natural scrapie to cattle) was never undertaken in the UK. It was, however, performed in the USA in 1979, when it was shown that cattle inoculated with the scrapie agent endemic in the flock of Suffolk sheep at the United States Department of Agriculture in Mission, Texas, developed a TSE quite unlike BSE. 32 The findings of the initial transmission, though not of the clinical or neurohistological examination, were communicated in October 1988 to Dr Watson, Director of the CVL, following a visit by Dr Wrathall, one of the project leaders in the Pathology Department of the CVL, to the United States Department of Agriculture. 33 The results were not published at this point, since the attempted transmission to mice from the experimental cow brain had been inconclusive. The results of the clinical and histological differences between scrapie-affected sheep and cattle were published in 1995. Similar studies in which cattle were inoculated intracerebrally with scrapie inocula derived from a number of scrapie-affected sheep of different breeds and from different States, were carried out at the US National Animal Disease Centre. 34 The results, published in 1994, showed that this source of scrapie agent, though pathogenic for cattle, did not produce the same clinical signs of brain lesions characteristic of BSE.<br /><br />32 Clark, W., Hourrigan, J. and Hadlow, W. (1995) Encephalopathy in Cattle Experimentally Infected with the Scrapie Agent, American Journal of Veterinary Research, 56, 606-12<br /><br />33 YB88/10.00/1.1<br /><br /><br /><a href="http://web.archive.org/web/20040823105233/www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf">http://web.archive.org/web/20040823105233/www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf</a><br /><br /><br /><br /><br />Monday, August 9, 2010<br /><br />National Prion Disease Pathology Surveillance Center Cases Examined (July 31, 2010)<br /><br />(please watch and listen to the video and the scientist speaking about atypical BSE and sporadic CJD and listen to Professor Aguzzi)<br /><br /><br /><a href="http://prionunitusaupdate2008.blogspot.com/2010/08/national-prion-disease-pathology.html">http://prionunitusaupdate2008.blogspot.com/2010/08/national-prion-disease-pathology.html</a><br /><br /><br /><br />Tuesday, September 14, 2010<br /><br />Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)<br /><br /><br /><a href="http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html">http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html</a><br /><br /><br /><br />Friday, September 24, 2010<br /><br />USA Blood products, collected from a donor who was at risk for vCJD, were distributed SEPTEMBER 2010<br /><br /><br /><a href="http://vcjdtransfusion.blogspot.com/2010/09/usa-blood-products-collected-from-donor.html">http://vcjdtransfusion.blogspot.com/2010/09/usa-blood-products-collected-from-donor.html</a><br /><br /><br /><br />Wednesday, September 08, 2010<br /><br />Emerging Infectious Diseases: CJD, BSE, SCRAPIE, CWD, PRION, TSE Evaluation to Implementation for Transfusion and Transplantation September 2010<br /><br /><br /><a href="http://vcjdtransfusion.blogspot.com/2010/09/emerging-infectious-diseases-cjd-bse.html">http://vcjdtransfusion.blogspot.com/2010/09/emerging-infectious-diseases-cjd-bse.html</a><br /><br /><br /><br /><br />layperson<br /><br /><br />Terry S. Singeltary Sr.<br />P.O. Box 42<br />Bacliff, Texas USA 77518<br />flounder9@verizon.netTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-62708114758822632452010-09-24T19:04:00.000-07:002010-09-24T19:10:52.451-07:00USA Blood products, collected from a donor who was at risk for vCJD, were distributed SEPTEMBER 2010USA Blood products, collected from a donor who was at risk for vCJD, were distributed SEPTEMBER 2010<br /><br /><br /><br />PRODUCT<br />Red Blood Cells. Recall # B-2300-10<br />CODE<br />Unit: W001607702825<br />RECALLING FIRM/MANUFACTURER<br />Recalling Firm: Department of the Air Force, Wright Patterson AFB, OH, by letter dated April 8, 2008.<br />Manufacturer: Depart of Air Force 88th Medical Group SGQC WPAFB, Wright Patterson AFB, OH. Firm initiated recall is complete.<br />REASON<br />Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.<br />VOLUME OF PRODUCT IN COMMERCE<br />1 unit<br />DISTRIBUTION<br />Japan<br /><br />___________________________________<br /><br /><br /><br />PRODUCT<br />Recovered Plasma. Recall # B-2302-10<br />CODE<br />Units: R08951; P90041; P90041<br />RECALLING FIRM/MANUFACTURER<br />Blood Center of Northcentral Wisconsin, Inc., Wausau, WI, by fax on January 2, 2007. Firm initiated recall is complete.<br />REASON<br />Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br />VOLUME OF PRODUCT IN COMMERCE<br />3 units<br />DISTRIBUTION<br />NY<br /><br />___________________________________<br /><br /><br />PRODUCT<br />1) Red Blood Cells Leukocytes Reduced. Recall # B-2338-10;<br />2) Plasma Frozen. Recall # B-2339-10<br />CODE<br />1) and 2) Unit: 5039861<br />RECALLING FIRM/MANUFACTURER<br />Community Blood Center, Inc., Appleton, WI, by letter dated September 21, 2007 or by electronic notification on September 21, 2007. Firm initiated recall is complete.<br />REASON<br />Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br />VOLUME OF PRODUCT IN COMMERCE<br />2 units<br />DISTRIBUTION<br />WI, Switzerland<br /><br />___________________________________<br /><br /><br />END OF ENFORCEMENT REPORT FOR SEPTEMBER 22, 2010<br /><br /><br /><br /><a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm227078.htm">http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm227078.htm</a><br /><br /><br /><br /><br />PRODUCT<br /><br />1) Cryoprecipitated AHF, Pooled. Recall # B-2155-10;<br /><br />2) Recovered Plasma. Recall # B-2156-10<br /><br />CODE<br /><br />1) Unit: W036309907231;<br /><br />2) Unit: W036309616077<br /><br />RECALLING FIRM/MANUFACTURER<br /><br />BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax and internet on May 5, 2010 and May 13, 2010. Firm initiated recall is complete.<br /><br />REASON<br /><br />Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br /><br />VOLUME OF PRODUCT IN COMMERCE<br /><br />2 units<br /><br />DISTRIBUTION<br /><br />TX, Switzerland<br /><br /><br /><br />___________________________________<br /><br /><br />PRODUCT<br /><br />Red Blood Cells Leukocytes Reduced. Recall # B-2157-10<br /><br />CODE<br /><br />Unit: 6371718<br /><br />RECALLING FIRM/MANUFACTURER<br /><br />South Texas Blood & Tissue Center, San Antonio, TX, by telephone on January 23, 2010 and by fax on January 25, 2010. Firm initiated recall is complete.<br /><br />REASON<br /><br />Blood product, collected from a donor who failed to answer questions regarding risk for vCJD, was distributed.<br /><br />VOLUME OF PRODUCT IN COMMERCE<br /><br />1 unit<br /><br />DISTRIBUTION<br /><br />TX<br /><br />___________________________________<br /><br /><br />PRODUCT<br /><br />Source Plasma. Recall # B-2212-10<br /><br />CODE<br /><br />Units: 09FMOG6851; 09FMOG3410; 09FMOG2756; 09FMOG1418; 09FMOF6640; 09FMOF2642; 09FMOF1554; 09FMOD7746; 09FMOF0063; 09FMOF7599<br /><br />RECALLING FIRM/MANUFACTURER<br /><br />BioLife Plasma Service LP, Springfield, MO, by fax on April 1, 2010. Firm initiated recall is complete.<br /><br />REASON<br /><br />Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br /><br />VOLUME OF PRODUCT IN COMMERCE<br /><br />10 units<br /><br />DISTRIBUTION<br /><br />CA<br /><br />___________________________________<br /><br /><br />PRODUCT<br /><br />1) Red Blood Cells Leukocytes Reduced. Recall # B-2213-10;<br /><br />2) Recovered Plasma. Recall # B-2214<br /><br />CODE<br /><br />1) and 2) Unit: 6325245<br /><br />RECALLING FIRM/MANUFACTURER<br /><br />South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on February 8, 2010. Firm initiated recall is complete.<br /><br />REASON<br /><br />Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br /><br />VOLUME OF PRODUCT IN COMMERCE<br /><br />2 units<br /><br />DISTRIBUTION<br /><br />FL, TX<br /><br />___________________________________<br /><br /><br />END OF ENFORCEMENT REPORT FOR SEPTEMBER 15, 2010<br /><br /><br /><a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm225990.htm">http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm225990.htm</a><br /><br /><br /><br />PRODUCT<br />Source Plasma. Recall # B-2056-10<br />CODE<br />Units: FD0500537, FD0502880, FD0503259, FD0509894, FD0515518, FD0516063, FD0517957, FD0518606, FD0522255, FD0523346, FD0523544, FD0524204, FD0524698, FD0525142, FD0525845, FD0526653, FD0526878, FD0527579, FD0527845, FD0528519, FD0528827, FD0529544, FD0529761, FD0530471, FD0530712, FD0531425, FD0531801, FD0532483, FD0532869, FD0537501, FD0537687, FD0538370, FD0543210, FD0546250, FD0546632, FD0547328, FD0547832, FD0548286, FD0548743, FD0549325, FD0549840, FD0550427, FD0551448, FD0551572, FD0552307, FD0553173, FD0553418, FD0554063, FD0554834, FD0555041, FD0559685, FD0560235, FD0560592, FD0561168, FD0561786, FD0562212, FD0562883, FD0563248, FD0564435, FD0564723, FD0565467, FD0565880, FD0566540, FD0567053, FD0567723, FD0567965, FD0568941, FD0569180, FD0570057, FD0571177, FD0571477, FD0572411, FD0572818, FD0573582, FD0573871, FD0574531, FD0576955, FD0577140, FD0579983, FD0580403, FD0581156, FD0581623, FD0582680, FD0583090, FD0584073, FD0584500, FD0585410, FD0586089, FD0586790, FD0587500, FD0588791, FD0589023, FD0590248, FD0590600, FD0591592, FD0592445, FD0593277, FD0593712, FD0594626, FD0595049, FD0596132, FD0596519, FD0597701, FD0598681, FD0599198, FD0600210, FD0600690, FD0601755, FD0602401, FD0603415, FD0603985, FD0605122, FD0608608, FD0609074, FD0609979, FD0610508, FD0611469, FD0612006, FD0612905<br />RECALLING FIRM/MANUFACTURER<br />DCI Biologicals LLC, Farmington, NM, by facsimile on September 26, 2009 and electronic mail dated January 15, 2010. Firm initiated recall is complete.<br />REASON<br />Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br />VOLUME OF PRODUCT IN COMMERCE<br />119 units<br />DISTRIBUTION<br />NY, UK<br /><br />___________________________________<br /><br /><br /><br />END OF ENFORCEMENT REPORT FOR SEPTEMBER 8, 2010<br /><br /><br /><a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm225223.htm">http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm225223.htm</a><br /><br /><br /><br /><br />PRODUCT<br />Source Plasma. Recall # B-2134-10<br />CODE<br />Units: 3910020431, 3910019695, 3910018715, 3910018227, 3910017100, 3910016675, 3910015596, 3910015120, 3910014175, 3910013575, 3910012934, 3910012281, 3910010102, 3910009899, 3910007715, 3910007430<br />RECALLING FIRM/MANUFACTURER<br />Talecris Plasma Resources, Inc., N Las Vegas, NV, by fax on July 17, 2009. Firm initiated recall is complete.<br />REASON<br />Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br />VOLUME OF PRODUCT IN COMMERCE<br />16 units<br />DISTRIBUTION<br />NC<br /><br />___________________________________<br /><br /><br /><br />PRODUCT<br />1) Red Blood Cells. Recall # B-2215-10;<br />2) Fresh Frozen Plasma. Recall # B-2216-10<br />CODE<br />1) and 2) Unit: 0951592<br />RECALLING FIRM/MANUFACTURER<br />Memorial Blood Centers, Saint Paul, MN, by letter on November 5, 2008. Firm initiated recall is complete.<br />REASON<br />Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.<br />VOLUME OF PRODUCT IN COMMERCE<br />2 units<br />DISTRIBUTION<br />MN<br /><br />___________________________________<br /><br /><br />PRODUCT<br />Recovered Plasma. Recall # B-2217-10<br />CODE<br />Unit: 0951592<br />RECALLING FIRM/MANUFACTURER<br />Memorial Blood Centers, Saint Paul, MN, by letter on November 5, 2008. Firm initiated recall is complete.<br />REASON<br />Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.<br />VOLUME OF PRODUCT IN COMMERCE<br />1 unit<br />DISTRIBUTION<br />MN<br /><br />___________________________________<br /><br /><br /><br />END OF ENFORCEMENT REPORT FOR SEPTEMBER 1, 2010<br /><br /><br /><a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm224723.htm">http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm224723.htm</a><br /><br /><br /><br /><br />Tuesday, September 14, 2010<br /><br /><br />Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting October 28 and 29, 2010 (COMMENT SUBMISSION)<br /><br /><br /><a href="http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html">http://tseac.blogspot.com/2010/09/transmissible-spongiform_14.html</a><br /><br /><br /><br />Hi Terry,<br /><br />Thank you for your comments related to the Transmissible Spongiform Encephalopathy's Advisory Committee meeting on October 28-29, 2010.<br /><br />Your comments will be provided to the Committee.<br /><br />Thanks<br /><br />XXXX<br /><br /><br />Wednesday, September 08, 2010<br /><br />Emerging Infectious Diseases: CJD, BSE, SCRAPIE, CWD, PRION, TSE Evaluation to Implementation for Transfusion and Transplantation September 2010<br /><br /><br /><a href="http://vcjdtransfusion.blogspot.com/2010/09/emerging-infectious-diseases-cjd-bse.html">http://vcjdtransfusion.blogspot.com/2010/09/emerging-infectious-diseases-cjd-bse.html</a><br /><br /><br /><br />Saturday, July 17, 2010<br /><br />Variant Creutzfeldt-Jakob disease Ironside JW., Haemophilia.<br /><br />2010 Jul;16 Suppl 5:175-80 REVIEW ARTICLE<br /><br /><br /><a href="http://vcjdtransfusion.blogspot.com/2010/07/variant-creutzfeldtjakob-disease.html">http://vcjdtransfusion.blogspot.com/2010/07/variant-creutzfeldtjakob-disease.html</a><br /><br /><br /><br /><br />Monday, August 9, 2010<br /><br /><br />National Prion Disease Pathology Surveillance Center Cases Examined (July 31, 2010)<br /><br /><br />(please watch this damning video at the bottom of this url...tss)<br /><br /><br /><br /><a href="http://prionunitusaupdate2008.blogspot.com/2010/08/national-prion-disease-pathology.html">http://prionunitusaupdate2008.blogspot.com/2010/08/national-prion-disease-pathology.html</a><br /><br /><br /><br /><br />TSSTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0tag:blogger.com,1999:blog-38660275.post-67895278201267848172010-09-08T14:33:00.000-07:002010-09-08T15:29:26.967-07:00Emerging Infectious Diseases: CJD, BSE, SCRAPIE, CWD, PRION, TSE Evaluation to Implementation for Transfusion and Transplantation September 2010Emerging Infectious Diseases: CJD, BSE, SCRAPIE, CWD, PRION, TSE Evaluation to Implementation for Transfusion and Transplantation September 2010<br /><br />February 22, 2010: Vaccines and Related Biological Products Advisory Committee Transcripts (PDF - 193KB) Posted: 7/21/2010<br /><br />snip...<br /><br />Now let me just review quickly the status of bovine spongiform encephalopathy which has been the first of the animal diseases, clearly transmissible to human beings. The first case was diagnosed in 1986. Presumably animals were infected probably five or six years earlier. Feed ban, the first of several feed bans was imposed in the United Kingdom in 1990.<br /><br />In 1988, the disease peaked among cattle. There were something over 37,000 cases a year in the U.K., in 1992 declined thereafter. Last year in the U.K. only 12 cases were seen.<br /><br />There are 24 other countries that have had BSE, world total more than 187,000 cases diagnosed, reports there must have been many more that were not diagnosed.<br /><br />280<br /><br />We have had in the United States three cases. One came in from Canada, diagnosed in 2003, one in 2006, and one in 2007. Canada has now had 18 recognized cases. So far as I know, all of those cases in Canada in the western part of the country.<br /><br />There are only six cases that have high prevalence of BSE. And I -- but a number of other cases, there's -- and other countries, they are still seeing cases. Twelve countries have reported no cases since 2008 including the United States. But, unfortunately, last year there were 14 countries, and two have subsequently fallen off the list, Denmark and the Czech Republic. The point is that this disease is still around, and it's not clear when it will finally be eradicated.<br /><br />In addition, the United Kingdom shows widespread exports of meat and bone meal, the presumed vector of this infection, sold all over the world including the United States. But large amounts where sold into the former Soviet Union and the Southeast Asia. They have reported no cases, but we wonder if their surveillance systems are very robust. And in any case, we must still consider this potentially a worldwide infection of cattle, fortunately<br /><br />281<br /><br />coming under control in Western Europe and we hope in North America as well.<br /><br />The World Organization for Animal Health, the OIE, has started to a system of BSE risk categorization. Two categories of interest, one negligible BSE risk, and the other controlled BSE risk. I won't go through the details of their criteria. There are in the slide; there are 11 negligible risk countries including Australia, New Zealand, some countries of northern Europe and South America; 32 controlled risk countries including the USA.<br /><br />I must say I am a little uncomfortable categorizing the USA risk together with those of the U.K., Portugal, and Spain. But, so far as I know, the USDA has accepted their classification. It hasn't, not at least publicly, challenged them. The concern with BSE is that it is -- has transmitted disease to human beings, variant CJD, first described in the medical literature in 1996. The first teenager became ill probably in 1994, very different from sporadic CJD in its epidemiology. Much younger kids in their teens have been found with it in mean age 29 years or slightly shorter duration, some differences in clinical presentation and there are<br /><br />282<br /><br />differences in the pathology.<br /><br />Perhaps 15 percent of patients with Creutzfeldt-Jakob disease have amyloid plaques. All the patients with variant CJD have had amyloid plaques, often -- sorry always surrounded, at least some of them with these haloes or vacuoles called florid or flower like plaques. And their accumulations in variant CJD of prion protein in lymphoid tissues visible under the light microscope. And no one has to work very hard to find prion protein, never seen by you know, histo-chemistry in sporadic CJD. So it's a different looking disease.<br /><br />As Sue summarized for you earlier today, there are now, I have got 218 cases of variant CJD, 172 of them in the United Kingdom, 46 outside the United Kingdom. Some of them were clearly acquired in the United Kingdom. We've had three cases in the United States, two of whom were long-time residents of the United Kingdom and one a long-term resident of Saudi Arabia; one case in Canada, also a long-time resident of the United Kingdom.<br /><br />Deaths in the United Kingdom peaked about eight years after the peak of BSE diagnosed in cattle. One could use that to approximate a possible incubation<br /><br />283<br /><br />period. Sue has already reported to you the four transfusion transmitted cases which were, what, on occasion are our concern in this group. And, as most of you know, in February of last year the United Kingdom reported a case of what appeared to be a pre-clinical infection in an elderly man who was a -- had hemophilia and had been receiving treatments with a plasma derived factor, factor 8.<br /><br />One of the donors to the factor 8 he received was identified with variant CJD although an epidemiological study in the United Kingdom suggested that at least given some assumptions of prevalence, he might have been equally likely to have been infected from one of the non-implicated batches. Of course, it is not possible to know. The incubation periods are important because that lets us make some projections about how long someone might be carrying a transmissible agent in blood. To me, one of the most informative cases is a case in Japan, who spent only 24 days in the United Kingdom and three days in France, 12 years before returning Japan. Japan has some small amount of BSE on its own but the most probable<br /><br />284<br /><br />source of his infection was the United Kingdom and it gives you a 12-year incubation period.<br /><br />And the few other people who came down after exposures in the United Kingdom, their exposures were much longer so it's harder to calculate an incubation period. But they fall into that approximate range. The transfusions transmitted cases had somewhat shorter incubation period, anywhere from 6.3 to 8.5 years and the plasma derivative associated case, you can't see it on this projection, but it is 11 years if the implicated donor was, in fact, the source.<br /><br />Steve Anderson and Hong Yang have done distributions of the likely incubation periods of persons with the methionine homonzygous and other genotypes. And the disturbing thing is it's certainly possible that there are going to be long tails to the number of people incubating variant CJD. And at the end of last year, Cosky (phonetic) and colleagues described typical variant CJD in a person heterozygous for methionine and valium at codon 129. Now we know that people with all genotypes presumably can be expected to come down with infection.<br /><br />We hope that the peak will be much smaller in<br /><br />285<br /><br />people with heterozygous genotype who make up about 50 percent of the population in the United Kingdom and probably about the same here. But if it is going to be like sporadic CJD, incubation periods may well exceed 35 years and even 40 years. And those folks are out there and we don't know how many of them are -- will have agent in blood or how long it will last or how much there would be.<br /><br />I want to mention this because from a public health point of view keeping the cattle herd free of disease is probably the single most important thing that we can do. And in the context of the United States, the single most important measure taken is to prevent the feeding of contaminated material to a cattle, a feed ban line to affect here removing most mammalian proteins from cattle feed in 1997. And that was expanded in 2008, went into implementation last year to keep the highest risk material, that is brain and spinal cord of animals, over the age of 30 months from rendering for feeding to any kind of farm animals to prevent -- or pet food also to prevent cross-contamination on farms which was a problem<br /><br />286<br /><br />in the United Kingdom.<br /><br />There won't be time to talk about it, but there has been considerably more trouble with dura mater allograft which has infected over 150 recipients. Corneas have infected a couple of people with Creutzfeldt-Jakob disease and neuro surgical instruments. We have been over the both the blood red blood cells -- by the way, all four of the transfusion transmitted cases were in non-nuclear reduced to red cell concentrates. However, I think the plasma derivative case suggests that that is not going to be enough to remove risk to a safe level.<br /><br />The general methods for managing risks we have already discussed. Risk can be accepted, reduced by restricting use of product or screening or manufacturing processes. And the FDA is particularly concerned with validating screening tests and validating methods that purport to remove infected material from final products. That's not just blood products; that's all biological products.<br /><br />In January of 2007, the agency published a proposed medical products rule. I won't go into it except to express my own personal concern about fetal bovine<br /><br />287<br /><br />serum because fetal bovine serum comes from the carcasses of gravid older cows which means that their nervous systems are at greater likelihood, if there is any BSE left in the country, of getting into the product and fetal calf serum is so widely used in vaccines and other biological products.<br /><br />I have given you a timeline of the history of TSEs and FDA blood safety policies merged. Really the history of really begins in 1978 when Elias and Laura Manuelidis first detected CJD agent in blood of experimentally infected guinea pigs. This was confirmed in 1983 and in the 1983, the FDA issued its first guidance of recommending withdrawal of CJD implicated blood components when a donor had subsequently come down with CJD. I won't go into details, but as most of you know those deferral recommendations were made progressively more stringent over the years.<br /><br />What do we know about the infection agent in the blood? Almost everything we know we have learned from the work of Bob Rohwer, originally with Paul Brown, later with Luisa Gregori, some work of Paul Brown with Larisa Cervenakova. In experimentally infected hamsters, the<br /><br />288<br /><br />infectivity is first detectable in blood about 50 percent of the way through incubation period and the amounts detected continued to rise progressively until the animal becomes ill and has to be terminated.<br /><br />But the amounts are very low. They almost never exceed 10 infectious doses per milliliter which is plenty to infect a recipient, but makes it very difficult to detect because of sampling problems. It makes it very difficult to detect the infectious agent.<br /><br />In the blood, infectivity can be found in all components. But the components that seem to be intrinsically infected are the nucleated cells and the plasma. Considerable amount of infectivity appears to be intrinsic to the plasma which, of course, contaminates all the other components.<br /><br />General methods to reducing the risk -- reduce the risk of exposure to the BSE agent through diet and that is what we try to do with the geographic deferrals or other exposures, deferring for use of U.K. bovine insulin, no longer marketed in this country, reduce the risk that the donor was exposed to vCJD of human origin and that means nobody transfused in U.K. after 1980. In 2005-2006,<br /><br />289<br /><br />we proposed modifying that to defer for transfusion in France. There has also been some consideration, at least in the U.K., of deferring people who had risk surgical procedures. We haven't done that.<br /><br />I won't go through the 2002 deferral guidance which is as most of you know still in force. The proposed modification, we hope, will be finalized this year. It's a striking difference between what's been seen with recipients of implicated transfusions in the United Kingdom and those receiving implicated sporadic CJD transfusions in the United States, described last year by Carrie Dorsey and colleagues from the American Red Cross building on work that was started, I believe, by Marion Sullivan supported by the CDC.<br /><br />Out of the 26 recipients of labile components of receiving transfusion in the United Kingdom, four of them have already come down with variant CJD whereas 144 recipients have implicated components in the United States. Nobody has been recognized with CJD.<br /><br />Now the intensity of surveillance is not as good here. A lot of the patients did not get autopsies and some of the recipients received blood collected more than<br /><br />290<br /><br />five before onset. And then so it is not clear that all the donors would have had agent in their blood. But it is reassuring as far as it goes. Is it sufficiently reassuring to change FDA's guidance? It hasn't yet.<br /><br />Mark Walderhaug showed you this sensitivity analysis performed by Steve Anderson and Hong Yang showing that for plasma derivatives the reduction of infectivity by manufacturing is the single most important factor in reducing the risk. And based on this, the division of hematology has entertained requests or has solicited efforts to validate those steps being used to manufacture various plasma, plasma derivatives and has entertained requests for label claims.<br /><br />The model for concluding that a method for reducing infectivity is effective was taken from what is done with viruses. For viruses, a process has to -- in order to have a claim has to have at least two effective orthogonal steps to remove or inactivate virus. Each step should drop at least four logs. One of the steps should inactivate the virus. There should be mass balance that you should know where all of the virus that disappeared went, and you should be able to inactivate or remove at<br /><br />291<br /><br />least three logs more than the amount that you think might be present in a worst case.<br /><br />Of course, we can't do that for spongiform encephalopathies, but we have seen some clearance data presented, first to reiterate that PrPTSE clearance would be acceptable only as a preliminary assessment of probable effectiveness. That is if you do clearance study and you can't get rid of all the abnormal PrPTSE, then you might not want to waste time with that method of removal so that infectivity still required -- demonstration of removal of infectivity still requires bioassays in animals and, of course, it's infectivity that is the actual adverse event of concern.<br /><br />Our pilot studies with our U.S. licensed plasma-derived factor VIII have all showed substantial clearance of model TSE agents of at least four logs and the product used in the United Kingdom is not licensed in this country. Five products have been granted label claims. Unfortunately, none of those was based on an inactivation step, they were all removal steps of greater concern because, of course, that agent if it is not inactivated, is still available on the filters to infect a subsequent<br /><br />292<br /><br />product if not discarded. And no claim of complete elimination of a TSE agent has been allowed.<br /><br />It would be very good if we could do Andy Morton test. And you may recall that in 2006 we had a whole session of TSE advisory committee of tests that were in development. The desirable property is that they should be suitable to test individual donations, high throughput, highly analytical sensitivity that is to detect very low concentrations of PrPTSE and all of them that I am aware of are based on -- test and developmental based on the detection of abnormal PRP. They should have reasonable clinical sensitivity. We wouldn't require that every single infected donor be detected. I don't know how you determine that in the first place, but it should be able to eliminate a reasonable number of infected donors from the donor pool.<br /><br />And it should to have a high specificity that is the inability to discriminate PrPTSE from other proteins yielding a low false-positive rate. And that's a problem. Luisa Gregori summarized at our last TSE meeting all the proteins that are present in human plasma, all of them in great excess to what one would expect for PrPTSE. The<br /><br />293<br /><br />greatest problem is that there is perhaps ten to the fifth more normal PRP circulating in plasma than what you would expect based on the same -- based on the ratio determined from normal PRP to abnormal PRP in brain, you can predict, what if the ratio stays the same which we don't know, but what it would be in plasma and the PrPTSE would be present in an excess of a hundred thousand fold.<br /><br />That's important because if you don't get rid of all the normal PRP, or if it is alive and it is supposed to be specific detects even a little bit of the normal PRP, there goes your specificity. And, in fact, nobody has successfully validated one of the tests yet.<br /><br />Analytical studies, the U.K. has actually a committee that set up an algorithm for what it's going to take to get a test approved in the United Kingdom. There should be convincing analytical studies followed by spiking studies with blinded panels of human plasmas spiked with TSE infected brain tissues. If it does well on that, then with spleen tissue which is supposed to more like blood. Then the test should be able to detect endogenously infected blood from available animal models.<br /><br />It would be even better if endogenously vCJD<br /><br />294<br /><br />infected nonhuman primate blood could be detected because then exactly the same reagents that are proposed for human use could be used, which of course you can't do with rodents because of the failure of cross-reactivity. And it would nice to have a well characterized human vCJD blood reference material, but not even the U.K. has that.<br /><br />I won't dwell on it, but there are a number of companies have advertised that they had promising tests and development. We had eight or perhaps it was nine presented in 2006, all except two or three have fallen silent now without bringing a test to market.<br /><br />Luisa did a web search for the June meeting of last year and found that four other companies were still trying to develop a useful antemortem human blood test. The -- one of the companies, Amorfix, was reporting a specificity study using 10,000 reactive blood donors. Out of 10,000 tested -- six positives out of 10,000 tested in France. It might have been a little reassuring if they used a country that hadn't had 25 cases of variant Creutzfeldt-Jakob disease but that's what they had.<br /><br />Two of the tests were based on an apparent amplification of abnormal protein. One of them used an<br /><br />295<br /><br />interesting palindromic peptide. They have fallen silent now. The other one, Amprion, is using a very interesting technique called Protein Misfolding Cyclical Amplification. And the basic principle seems to work that as you take a very small amount of abnormal prion protein, abnormal brain tissue, do repeated sonications and the amount of protein increases to a level detectable by Western blot.<br /><br />To my knowledge, this method has not been subjected to the traditional kind of analysis, comparative analysis side by side with blinded replica, unknown dilutions in plasma or serum compared with other detection methods. The developer of the method is going to be speaking at the FDA on the 26th of May. Perhaps he will have more information to share with us. You are all welcome. Well, not all of you, the room isn't that big. But some of you are welcome there, are welcome to come. We had mentioned that there is an absence of -- we have given up on human reference materials. They are just not going to be available but Corinne Lasmezas and colleagues have a very interesting model of infection of cynomolgus macaques with variant CJD agent. The infectivity is present in blood and Luisa Gregori is<br /><br />296<br /><br />leading a new effort in the FDA. We finally have approvals and funding and the inoculum and she is going to be infecting cynomolgus macaques and collecting blood at intervals through symptomatic disease.<br /><br />What we don't have is a well validated sensitive mouse assay because we certainly can't assay for infectivity in other cynomolgus monkeys which would have been the classical way to try to do it. I won't mention this, but she is also working on the use of urine as an alternative test material because in rodents infectivity can be detected in urine. But that's not been done in human urine, but it's very little -- very little investigation has been done with human urine. And in any case, it probably it isn't going to be a suitable donor screening testing in any case.<br /><br />I share with Sue some sense of enthusiasm for the possibility of blood filters. There are two of them that have been described publicly. We think there may be others in development. The MacoPharma/Prometic: P-Capt Prion Reduction Filter and then the Pall Corporation has a filter. The U.K. Advisory Committee on Safety of Blood, Tissues, and Organs some months ago recommended using a --<br /><br />297<br /><br />one of the filters with leuco reduction to treat blood for recipients in the U.K. under the age of 13.<br /><br />But the filters are not available in the United States. And of course, here the risk-cost benefit ratio would be quite different from the U.K. because our prevalence is presumably much lower than it is in the U.K.<br /><br />So to conclude we agree that ante-mortem assays for PrPTSE in blood and tissue donors would be useful. We encourage them; we don't have any available yet. I don't believe that any national authority has approved a test for practical use. There is no proof of concept that PrPTSE is even present in plasma and no test in development to my knowledge has convincingly identified vCJD infected or any other TSE infected human blood. There are some intriguing reports about animals.<br /><br />There are unresolved issues regarding tests for TSE in blood. There are no TSE blood reference materials, human or nonhuman nor primate blood reference materials available. There has been no confirmatory assay described. And as for other infections of low prevalence, any analytically good but imperfect screening test, any such test would have a very low positive predictive value<br /><br />298<br /><br />which means that most of the positives would be false positives leading to continuing significant donor deferrals and exceptionally difficult donor counseling.<br /><br />PrP-removal filters have already been recommended in the U.K. but they are not available in the United States. The continued deferral of donors at increased risk for vCJD both food borne and blood borne seems reasonable. It's a low tech approach. It's probably been effective in reducing the risk of transfusion transmitted vCJD here. Of our three vCJD patients identified, two of them -- none of them was a blood donor but had they tried, two of them would have been deferred, the third would not.<br /><br />It probably causes less emotional distress to be deferred for geographical reason than to get a false positive test result. But the default policy, we acknowledge, is extremely wasteful because it's deferring many otherwise suitable donors. We should probably continue deferring donors transfused in countries with possible high prevalence of preclinical variant CJD, currently the U.K. and France.<br /><br />But the good news to me is that the need for<br /><br />299<br /><br />donor deferrals and for testing and filtering would -- should decline as more countries implement effective anti-BSE food and animal feed precautions. And with that, I close. Sorry, if I ran a little bit over.<br /><br />(Applause)<br /><br />Q & A<br /><br />DR. ALTER: Are there any questions? I think everybody wants -- Steve?<br /><br />STEVE: Yeah, I have one quick one. I noticed from the slides on the actual FDA deferral policies from the guidance in 2002 that, if I read them correctly, the exclusion -- deferral criteria for visiting the U.K. are time limited, 1980 to 1996, but the criteria for visiting France or the rest of Europe are to the present. And I wonder if you have thought about reexamining whether to the present is still indicative given the low rates of vCJD these days?<br /><br />DR. ASHER: Yes. We have thought about it. And I can only speak for myself but we have thought about it a lot. There are certain problems in Europe. We had a<br /><br />300<br /><br />discussion of food protections in the European Union at the June meeting. And the problem is deciding when which country implemented the same level of food protection that we have considered acceptable in the United Kingdom. But in principle, you are absolutely, you are -- also the cross border exchange in food is greater in continental Europe than it is in spite of the Eurostar Britain is still separated geographically from the rest of -- it's a great train by the way to recommend, but at any rate there are certain difficulties in drawing a bright line between countries.<br /><br />And I'm -- we didn't get a great deal of assistance from the European Union. Their feeling is they have the directives in place and every country is supposed to be following those directives, and therefore we should assume that they are following those directives and maybe we should. But, in principle, I think that you are absolutely right. When other countries reach the level of food chain protections we have considered acceptable, in the U.K. I can't see any reason for considering that risk to be any greater than that in the U.K. The problem is making the decision country by country.<br /><br />301<br /><br />DR. ALTER: Okay. Well, we are little bit behind. We can all try to get --- (tape interruption.)<br /><br />SESSION 3: ROUNDTABLE DISCUSSION<br /><br />February 22, 2010: Vaccines and Related Biological Products Advisory Committee Transcripts (PDF - 193KB) Posted: 7/21/2010<br /><br />Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety Public Workshop Transcript - Day 1 (PDF - 572KB)<br /><br />Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety Public Workshop Transcript - Day 2 (PDF - 496KB)<br /><br /><br /><br /><a href="http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM214030.pdf">http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM214030.pdf</a><br /><br /><br /><br /><br /><a href="http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM214031.pdf">http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM214031.pdf</a><br /><br /><br /><br /><br /><br />PRION 2010<br /><br />International Prion Congress: From agent to disease September 8–11, 2010 Salzburg, Austria<br /><br /><br />PPo3-11:<br /><br />Blood Transmission Experiments in Primates: Squirrel Monkeys (the Baxter Study)<br /><br />Paul Brown, James Ironside, Susan Gibson, Robert G. Will, Thomas R. Kreil and Christian Abee<br /><br />Plasma and buffy coat samples from 2 sCJD and 3 vCJD cases were inoculated i.c. and i.v. into a total of 21 squirrel monkeys. Pooled brain from the 3 vCJD patients titered 106 LD50/g (i.c.). Whole blood from each of 4 monkeys inoculated with 10% vCJD brain homogenate was transfused i.v. to individual recipient monkeys at approximately 3-month intervals during the incubation and clinical stages of disease in the donor animals. Plasma, RBC’s, platelets, and purified leukocytes from 6 chimpanzees infected with either human sCJD or GSS were inoculated i.c. and i.v. into 12 monkeys. In the entire group of monkeys inoculated with blood or blood components, only a single neuropathologically-verified transmission occurred within a 5-year observation period, in an animal inoculated with leukocytes from a pair of GSS-infected chimpanzee.<br /><br />Conclusions. In a primate model highly susceptible to TSE (the squirrel monkey), infectivity was not detected (<10>92%. Due to limited data and knowledge of vCJD, the model estimates are uncertain. This analysis identifies critical data gaps in understanding the risk of TTvC, and provides a tool to inform regulatory decision-making.<br /><br /><br /><br /><br />PPo4-20:<br /><br />All Clinically Relevant Components, from Prion Infected Blood Donors, can Cause Disease Following a Single Transfusion<br /><br />Sandra McCutcheon,1 Fiona E. Houston,2 Anthony R. Alejo-Blanco,1 Christopher de Wolf,1 Boon Chin Tan,1 Anthony Smith,3 Nora Hunter,1 Valerie S. Hornsey,4 Ian R. MacGregor,4 Christopher V. Prowse,4 Marc Turner5 and Jean C. Manson1 1The Roslin Institute; Roslin, Edinburgh UK; 2The University of Glasgow; Glasgow, UK; 3The Institute for Animal Health; Compton, Berkshire UK; 4National Science Laboratory; Scottish National Blood Transfusion Service (SNBTS); Edinburgh, UK; 5University of Edinburgh and SNBTS; Edinburgh, UK<br /><br />Key words: blood, prion, BSE, transfusion<br /><br />Introduction. To date, there have been over 220 cases of vCJD worldwide, likely acquired directly from bovine sources. There is concern that human to human transmission from individuals sub-clinically infected with vCJD may amplify/prolong a vCJD epidemic. The area of greatest concern in this respect is blood transfusion, of which there have been several reported cases. Here we examined which blood components are likely to pose the greatest risk of transmitting vCJD via blood transfusion using our sheep BSE model.<br /><br />Results. 67% of donors have been confirmed as having BSE. We have recorded 25 positive transmissions of BSE following transfusion of non-leucodepleted blood components and 2 transmissions resulting from the transfusion of leucoreduced red cells and leucoreduced plasma.<br /><br />Conclusion. We show that all components, prepared to the same criteria as used in human medicine, contain sufficient levels of infectivity to cause disease in recipients following a single blood transfusion. Leucoreduction of plasma and red cell concentrates does not remove infectivity. These data indicate the importance of devising appropriate control measures to minimise the risk of human to human transmission of vCJD by blood transfusion. Department of Health, UK (007/0162).<br /><br />Methods. Sheep were orally infected with bovine BSE brain homogenate. We collected two full-sized donations of whole blood, before the onset of clinical signs. The following components were transfused into naive recipients: whole blood, red cell concentrates buffy coat, plasma and platelet units. We also transfused leucoreduced plasma, platelets and red cells. We collected a unit of whole blood from selected primary recipients for transfusion into secondary recipients.<br /><br /><br /><br /><br />PPo4-21:<br /><br />The Risk of Variant Creutzfeldt-Jakob Disease (vCJD) Among UK Patients with Bleeding Disorders, Known to Have Received Clotting Factors Linked to Donors who Subsequently Developed vCJD<br /><br />Syed M.A. Zaman,1 Nicky Connor,1 Noel Gill,1 Carolyn M. Millar,2,6 Mike Makris,3,6 Benedict Palmer4 and Frank G.H. Hill5,6 1CJD Section, Health Protection Agency Centre for Infections; London, UK; 2Department of Haematology; Imperial College; London, UK; 3University of Sheffield; Royal Hallamshire Hospital; Sheffield, UK; 4National Haemophilia Database; Manchester, UK; 5The Children’s Hospital NHS Foundation Trust; Birmingham, UK; 6Members of the Transfusion Transmitted Infection Working Party of the UK; Haemophilia Centre Doctors’ Organisation (UKHCDO); Sheffield, South Yorkshire UK<br /><br />The risk of Creutzfeldt-Jakob Disease (vCJD) from potentially infected plasma products remains un-quantified. This risk has been assessed for 787 UK bleeding disorder patients prospectively followed-up for 10–20 years through the UK Haemophilia Centre Doctors’ Organisation (UKHCDO) Surveillance Study. These patients were treated with any of 25 ‘implicated’ clotting factor batches from 1987–1999, which included in their manufacture plasma from eight donors who subsequently developed vCJD. VCJD infectivity of these batches was estimated using plasma fraction infectivity estimates and batch manufacturing data. The quantity of implicated batches received by these patients was obtained. Total vCJD infectivity received by each patient has been estimated by cumulating infectivity from all doses received in their lifetime. Of 787 patients, 604 (77%) were followed-up for over 13 years since exposure to an implicated batch. By end 2008, none of these patients had developed vCJD. For these 604 patients, the estimated vCJD risk is <1% <br /><br /><br /><br /><a href="http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099">http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099</a><br /><br /><br /><br />some additional interesting studies.<br /><br /><br />O.10.5<br /><br /><br />A novel human prion disease affecting subjects with the three prion protein codon 129 genotypes: could it be the sporadic form of Gerstmann-Straussler?<br /><br /><br />Pierluigi Gambetti Case Western Reserve University, USA<br /><br /><br />Background: We recently described a novel prion disease, named protease-sensitive prionopathy or PSPr, characterized by the presence of an abnormal prion protein (PrP) that was 60 fold less protease resistant than that of sporadic Creutzfeldt-Jakob disease (sCJD) and on immunoblot generated a distinct ladder-like profile. All affected subjects where homozygous for valine at codon 129 (VV) and had no mutation in the PrP gene.<br /><br /><br />Methods: We have characterized several new cases in our surveillance and received from Europe.<br /><br /><br />Results: 1) A disease overall similar to that reported in the 129VV subjects also affects subjects that are methionine/valine heterozygous (MV) and methionine homozygous (MM) at codon 129 and have no PrP gene mutation; 2) The clinical and histopathological features of the new MV and MM PSPr cases are similar but distinguishable from those of the original VV cases; 3) The electrophoretic profiles generated by the abnormal PrP isoforms associated with the MV and MM cases are similar to VV cases but show increasing levels of proteaseresistance; 3) abnormal tau is present in all three genotypic forms of PSPr with features apparently similar to those of primary tauopathies placing PSPr at the intersection of tauopathies and prion diseases. Discussion: Will focus on: 1) the features of the abnormal PrP in the newly discovered 129MV and 129MM PSPr; 2) the effect of the 129 polymorphism on PSPr compared to that on sCJD; 3) the relationship of PSPr with tauopathies; 4) whether PSPr now with the three 129 genotypic forms is the long sought sporadic form of GSS.<br /><br /><br />(Supported by NIH AG-14359, NS052319, CDC UR8/CCU515004).<br /><br /><br /><a href="http://www.neuroprion.org/resources/pdf_docs/conferences/prion2009/prion2009_bookofabstracts.pdf">http://www.neuroprion.org/resources/pdf_docs/conferences/prion2009/prion2009_bookofabstracts.pdf</a><br /><br /><br /><br />I ask Professor Kong ;<br /><br /><br />Thursday, December 04, 2008 3:37 PM<br />Subject: RE: re--Chronic Wating Disease (CWD) and Bovine Spongiform Encephalopathies (BSE): Public Health Risk Assessment<br /><br /><br />''IS the h-BSE more virulent than typical BSE as well, or the same as cBSE, or less virulent than cBSE? just curious.....''<br /><br /><br />Professor Kong reply ;<br /><br /><br />.....snip<br /><br /><br />''As to the H-BSE, we do not have sufficient data to say one way or another, but we have found that H-BSE can infect humans. I hope we could publish these data once the study is complete. Thanks for your interest.''<br /><br /><br />Best regards,<br /><br /><br />Qingzhong Kong,<br /><br /><br />PhD Associate Professor Department of Pathology Case Western Reserve University Cleveland, OH 44106 USA<br /><br />END...TSS<br /><br /><br />P26<br /><br /><br />TRANSMISSION OF ATYPICAL BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) IN HUMANIZED MOUSE MODELS<br /><br /><br />Liuting Qing1, Fusong Chen1, Michael Payne1, Wenquan Zou1, Cristina Casalone2, Martin Groschup3, Miroslaw Polak4, Maria Caramelli2, Pierluigi Gambetti1, Juergen Richt5*, and Qingzhong Kong1 1Department of Pathology, Case Western Reserve University, Cleveland, OH 44106, USA; 2CEA, Istituto Zooprofilattico Sperimentale, Italy; 3Friedrich-Loeffler-Institut, Germany; 4National Veterinary Research Institute, Poland; 5Kansas State University, Diagnostic Medicine/Pathobiology Department, Manhattan, KS 66506, USA. *Previous address: USDA National Animal Disease Center, Ames, IA 50010, USA<br /><br /><br />Classical BSE is a world-wide prion disease in cattle, and the classical BSE strain (BSE-C) has led to over 200 cases of clinical human infection (variant CJD). Two atypical BSE strains, BSE-L (also named BASE) and BSE-H, have been discovered in three continents since 2004. The first case of naturally occurring BSE with mutated bovine PrP gene (termed BSE-M) was also found in 2006 in the USA. The transmissibility and phenotypes of these atypical BSE strains/isolates in humans were unknown. We have inoculated humanized transgenic mice with classical and atypical BSE strains (BSE-C, BSE-L, BSE-H) and the BSE-M isolate. We have found that the atypical BSE-L strain is much more virulent than the classical BSE-C. The atypical BSE-H strain is also transmissible in the humanized transgenic mice with distinct phenotype, but no transmission has been observed for the BSE-M isolate so far.<br /><br /><br />III International Symposium on THE NEW PRION BIOLOGY: BASIC SCIENCE, DIAGNOSIS AND THERAPY 2 - 4 APRIL 2009, VENEZIA (ITALY)<br /><br /><br /><a href="http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf">http://www.istitutoveneto.it/prion_09/Abstracts_09.pdf</a><br /><br /><br /><br />P02.35<br /><br /><br />Molecular Features of the Protease-resistant Prion Protein (PrPres) in H-type BSE<br /><br /><br />Biacabe, A-G1; Jacobs, JG2; Gavier-Widén, D3; Vulin, J1; Langeveld, JPM2; Baron, TGM1 1AFSSA, France; 2CIDC-Lelystad, Netherlands; 3SVA, Sweden<br /><br /><br />Western blot analyses of PrPres accumulating in the brain of BSE-infected cattle have demonstrated 3 different molecular phenotypes regarding to the apparent molecular masses and glycoform ratios of PrPres bands. We initially described isolates (H-type BSE) essentially characterized by higher PrPres molecular mass and decreased levels of the diglycosylated PrPres band, in contrast to the classical type of BSE. This type is also distinct from another BSE phenotype named L-type BSE, or also BASE (for Bovine Amyloid Spongiform Encephalopathy), mainly characterized by a low representation of the diglycosylated PrPres band as well as a lower PrPres molecular mass. Retrospective molecular studies in France of all available BSE cases older than 8 years old and of part of the other cases identified since the beginning of the exhaustive surveillance of the disease in 20001 allowed to identify 7 H-type BSE cases, among 594 BSE cases that could be classified as classical, L- or H-type BSE. By Western blot analysis of H-type PrPres, we described a remarkable specific feature with antibodies raised against the C-terminal region of PrP that demonstrated the existence of a more C-terminal cleaved form of PrPres (named PrPres#2 ), in addition to the usual PrPres form (PrPres #1). In the unglycosylated form, PrPres #2 migrates at about 14 kDa, compared to 20 kDa for PrPres #1. The proportion of the PrPres#2 in cattle seems to by higher compared to the PrPres#1. Furthermore another PK-resistant fragment at about 7 kDa was detected by some more N-terminal antibodies and presumed to be the result of cleavages of both N- and C-terminal parts of PrP. These singular features were maintained after transmission of the disease to C57Bl/6 mice. The identification of these two additional PrPres fragments (PrPres #2 and 7kDa band) reminds features reported respectively in sporadic Creutzfeldt-Jakob disease and in Gerstmann-Sträussler-Scheinker (GSS) syndrome in humans.<br /><br /><br /><a href="http://www.neuroprion.com/pdf_docs/conferences/prion2007/abstract_book.pdf">http://www.neuroprion.com/pdf_docs/conferences/prion2007/abstract_book.pdf</a><br /><br /><br /><br />MORE from this years PRION 2010 International Prion Congress: From agent to disease September 8–11, 2010 Salzburg, Austria<br /><br /><br />PPo2-17:<br /><br /><br />Atypical H-type BSE Infection in Bovine-PrP Transgenic Mice Let to the Emergence of Classical BSE Strain Features<br /><br /><br />Juan Carlos Espinosa,1 Olivier Andréoletti,2 Caroline Lacroux,2 Irene Prieto,1 Patricia Lorenzo,1 Magdalena Larska,1 Thierry Baron3 and Juan María Torres1 1Centro de Investigación en Sanidad Animal; INIA; Valdeolmos, Madrid Spain; 2UMR INRA-ENVT 1225; Interactions Hôte Agent Pathogène; Ecole Nationale Vétérinaire de; Toulouse, France; 3Agence Francaise de Sécurité Sanitaire des Aliments; Lyon Cedex, France<br /><br /><br />Key words: atypical BSE, PrPres, prion strain, prion transmission<br /><br /><br />Until identification of atypical cases of Bovine Spongiform Encephalopathy (BSE) in several countries it was assumed that BSE in cattle consisted of only a unique and biologically homogeneous strain type that caused BSE epidemic in Europe. Currently, beside the classical BSE strain associated to most described cases, atypical BSE cases are identified as H- or L-type based on the differences in the western blot profiles of abnormal protease-resistant prion protein (PrPres) according to the apparent molecular mass of its unglycosilated band. In the present study, we characterized five atypical BSE-H isolates by analyzing their molecular and neuropathological properties after transmission in transgenic mice expressing homologous bovine prion protein (PrP). The results showed that most of the inoculated animals conserved the atypical BSE-H strain features. However, a number of animals inoculated with two of these isolates showed prion strain features resembling those of classical BSE in this mouse model. On each case, the strain characteristics were preserved after subsequent passage in the same mice. These data suggest that atypical BSE-H prions, can acquire epidemic BSE-like properties during propagation in a homologous bovine PrP context. Beside a new view on BSE strains diversification, our observations support the hypothesis that atypical BSE-H, which could be a sporadic form of prion disease in cattle, may be at the origin of the foodborne BSE epizooty.<br /><br /><br /><br />PPo3-9:<br /><br /><br />Potential of Cell Substrates used for Production of Biologics to Propagate Transmissible Spongiform Encephalopathy (TSE) Agents: 5-year Update<br /><br /><br />P. Piccardo,1,* L. Cervenakova,2 I. Vasilyeva,2 O. Yakovleva,2 I. Bacik,1 J. Cervenak,1 L. Gregori,1 K. Pomeroy,1 L. Kurillova,1 C. McKenzie2 and D.M. Asher1 1Laboratory of Bacterial and TSE Agents; CBER; FDA; USA; 2J. Holland Laboratory; American Red Cross; USA *Presenting Author<br /><br /><br />Key words: cell culture, animal models, biologics, prion, TSE-agent<br /><br /><br />Background. TSE agents have contaminated human-tissue-derived therapeutics and animal vaccines. Many biologics are prepared in cell cultures. Although most cultures studied resisted infection with TSE agents, a few were susceptible.<br /><br /><br />Objectives. We are investigating susceptibility of several cell lines to infection with TSE agents. Results. We studied Vero, CHO, MDCK, HEK-393 and WI-38 cells. We also studied SH-SY5Y cells overexpressing wild-type PrP and mutant PrPs. Cells exposed to TSE agents were serially propagated for 30 passages and samples tested for TSE-associated PrP (PrPTSE) and infectivity by intracerebral inoculation into transgenic mice and squirrel monkeys (BSE-exposed cells only). No exposed cell substrate has transmitted TSE to mice or monkeys to date. No PrPTSE was found in any exposed cells after 30 passages. Known susceptible murine cells exposed to mouse-adapted scrapie agent as positive controls accumulated PrPTSE. Three monkeys inoculated with BSE reference material have developed TSE to date.<br /><br /><br />Discussion. To date, no candidate cell substrate exposed to 3 TSE agents accumulated PrPTSE or propagated a TSE agent. Squirrel monkeys provide a new model to study BSE pathogenesis.<br /><br /><br />Methods. We inoculated brain suspensions containing agents of bovine spongiform encephalopathy (BSE), variant Creutzfeldt-Jakob disease (vCJD) or sporadic CJD into several cell lines important in manufacture of biologics. Serial dilutions of the BSE reference material used as inoculum were also inoculated into mice and squirrel monkeys.<br /><br />The findings and conclusions in this article have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Administration determination or policy. Acknowledgements Support. NIAID-NIH AI-4893-02/FDA 224-05-1307<br /><br /><br /><br />PPo2-27:<br /><br /><br />Generation of a Novel form of Human PrPSc by Inter-species Transmission of Cervid Prions<br /><br /><br />Marcelo A. Barria,1 Glenn C. Telling,2 Pierluigi Gambetti,3 James A. Mastrianni4 and Claudio Soto1 1Mitchell Center for Alzheimer’s disease and related Brain disorders; Dept of Neurology; University of Texas Houston Medical School; Houston, TX USA; 2Dept of Microbiology, Immunology & Molecular Genetics and Neurology; Sanders Brown Center on Aging; University of Kentucky Medical Center; Lexington, KY USA; 3Institute of Pathology; Case western Reserve University; Cleveland, OH USA; 4Dept of Neurology; University of Chicago; Chicago, IL USA<br /><br /><br />Prion diseases are infectious neurodegenerative disorders affecting humans and animals that result from the conversion of normal prion protein (PrPC) into the misfolded and infectious prion (PrPSc). Chronic wasting disease (CWD) of cervids is a prion disorder of increasing prevalence within the United States that affects a large population of wild and captive deer and elk. CWD is highly contagious and its origin, mechanism of transmission and exact prevalence are currently unclear. The risk of transmission of CWD to humans is unknown. Defining that risk is of utmost importance, considering that people have been infected by animal prions, resulting in new fatal diseases. To study the possibility that human PrPC can be converted into the infectious form by CWD PrPSc we performed experiments using the Protein Misfolding Cyclic Amplification (PMCA) technique, which mimic in vitro the process of prion replication. Our results show that cervid PrPSc can induce the pathological conversion of human PrPC, but only after the CWD prion strain has been stabilized by successive passages in vitro or in vivo. Interestingly, this newly generated human PrPSc exhibits a distinct biochemical pattern that differs from any of the currently known forms of human PrPSc, indicating that it corresponds to a novel human prion strain. Our findings suggest that CWD prions have the capability to infect humans, and that this ability depends on CWD strain adaptation, implying that the risk for human health progressively increases with the spread of CWD among cervids.<br /><br /><br />PPo3-7:<br /><br /><br />Prion Transmission from Cervids to Humans is Strain-dependent<br /><br /><br />Qingzhong Kong, Shenghai Huang,*Fusong Chen, Michael Payne, Pierluigi Gambetti and Liuting Qing Department of Pathology; Case western Reserve University; Cleveland, OH USA *Current address: Nursing Informatics; Memorial Sloan-Kettering Cancer Center; New York, NY USA<br /><br /><br />Key words: CWD, strain, human transmission<br /><br /><br />Chronic wasting disease (CWD) is a widespread prion disease in cervids (deer and elk) in North America where significant human exposure to CWD is likely and zoonotic transmission of CWD is a concern. Current evidence indicates a strong barrier for transmission of the classical CWD strain to humans with the PrP-129MM genotype. A few recent reports suggest the presence of two or more CWD strains. What remain unknown is whether individuals with the PrP-129VV/MV genotypes are also resistant to the classical CWD strain and whether humans are resistant to all natural or adapted cervid prion strains. Here we report that a human prion strain that had adopted the cervid prion protein (PrP) sequence through passage in cervidized transgenic mice efficiently infected transgenic mice expressing human PrP, indicating that the species barrier from cervid to humans is prion strain-dependent and humans can be vulnerable to novel cervid prion strains. Preliminary results on CWD transmission in transgenic mice expressing human PrP-129V will also be discussed.<br /><br />Acknowledgement Supported by NINDS NS052319 and NIA AG14359.<br /><br /><br /><a href="http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099">http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099</a><br /><br /><br /><br /><br />Greetings Everyone !<br /><br /><br />Confucius ponders, IS GSS and the g-h-BSEalabama mad cow case, the birth of nvCJD-like disease from cattle to humans in the USA ???<br /><br /><br />Could it be from the ever growing cases of the Nor-98 atypical scrapie in the USA, with 6 cases documented already this year ???<br /><br /><br />Could it be possible from one of the CWD strains here in the USA ???<br /><br /><br />ARE GAMBETTI'S INFAMOUS 2ND 10+ AND GROWING, simply USA MAD COW strain in humans ???<br /><br /><br />WHY not, if US sheep scrapie transmitted to US cattle did not produce a c-BSE (UK type), then why would it produce an nvCJD strain in humans ???<br /><br /><br />THE ever growing strains of TSE in humans and animals, and classification there from, does not compute. now we are seeing atypical h-BSE cases, and atypical l-BSE cases, atypical human TSE cases that look like these atypical BSE cases, so why in the name of science is all this not acceptable to conclude that these atypical human TSE are a by-product of these atypical animal TSE $$$ and how can it be that the science that concluded IRONSIDES 1st 10+ in 1995, does not correspond with Gambetti's 2nd 10+, in that Gambetti's 2nd 10+ is not a cause from anything, just a happenstance of bad luck on a funked out twisted protein that spontaneously twist to a bad protein on it's own, or, it is familial CJD, but not related to any common family mutation, like sporadic FFI or sporadic GSS $$$ this does not compute either. JUST HOW long can Gambetti et al hold off on a final analysis of the ever growing numbers of human TSE in the USA $$$<br /><br /><br />National Prion Disease Pathology Surveillance Center Cases Examined1 (July 31, 2010)<br /><br /><br />5 Includes<br /><br />16 cases in which the diagnosis is pending, and 18 inconclusive cases;<br /><br />6 Includes 21 (19 from 2010) cases with type determination pending in which the diagnosis of vCJD has been excluded.<br /><br /><br /><a href="http://www.cjdsurveillance.com/pdf/case-table.pdf">http://www.cjdsurveillance.com/pdf/case-table.pdf</a><br /><br /><br /><br />CAN the blood from these atypical CJD cases transmit TSE prions ???<br /><br /><br />WHAT if these strange atypical case of human TSE in the USA are from USA cattle, deer, elk, sheep, goat, will blood products transmit, and why wouldn't they ???<br /><br /><br />Have there been extensive transmission studies done with blood and all it's products there from ???<br /><br /><br />WHAT about vaccines ???<br /><br /><br />>>> Results. We studied Vero, CHO, MDCK, HEK-393 and WI-38 cells. We also studied SH-SY5Y cells overexpressing wild-type PrP and mutant PrPs. Cells exposed to TSE agents were serially propagated for 30 passages and samples tested for TSE-associated PrP (PrPTSE) and infectivity by intracerebral inoculation into transgenic mice and squirrel monkeys (BSE-exposed cells only). No exposed cell substrate has transmitted TSE to mice or monkeys to date. No PrPTSE was found in any exposed cells after 30 passages. Known susceptible murine cells exposed to mouse-adapted scrapie agent as positive controls accumulated PrPTSE. Three monkeys inoculated with BSE reference material have developed TSE to date. <<< ???<br /><br /><br />Thursday, August 12, 2010<br /><br /><br />USA Blood products, collected from a donor who was at risk for vCJD, were distributed July-August 2010<br /><br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/08/usa-blood-products-collected-from-donor.html</a><br /><br /><br />Sunday, August 01, 2010<br /><br /><br />Blood product, collected from a donors possibly at increased risk for vCJD only, was distributed USA JULY 2010<br /><br /><br /><a href="http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html">http://vcjdtransfusion.blogspot.com/2010/08/blood-product-collected-from-donors.html</a><br /><br /><br /><br />FC5.1.1<br /><br /><br />Transmission Results in Squirrel Monkeys Inoculated with Human sCJD, vCJD, and GSS Blood Specimens: the Baxter Study<br /><br /><br />Brown, P1; Gibson, S2; Williams, L3; Ironside, J4; Will, R4; Kreil, T5; Abee, C3 1Fondation Alliance BioSecure, France; 2University of South Alabama, USA; 3University of Texas MD Anderson Cancer Center, USA; 4Western General Hospital, UK; 5Baxter BioSience, Austria<br /><br /><br />Background: Rodent and sheep models of Transmissible Spongiform Encephalopathy (TSE) have documented blood infectivity in both the pre-clinical and clinical phases of disease. Results in a (presumably more appropriate) non-human primate model have not been reported.<br /><br /><br />Objective: To determine if blood components (red cells, white cells, platelets, and plasma) from various forms of human TSE are infectious.<br /><br /><br />Methods: Blood components were inoculated intra-cerebrally (0.1 ml) and intravenously (0.5 ml) into squirrel monkeys from 2 patients with sporadic Creutzfeldt- Jakob disease (sCJD) and 3 patients with variant Creutzfeldt-Jakob disease (vCJD). Additional monkeys were inoculated with buffy coat or plasma samples from chimpanzees infected with either sCJD or Gerstmann-Sträussler-Scheinker disease (GSS). Animals were monitored for a period of 5 years, and all dying or sacrificed animals had post-mortem neuropathological examinations and Western blots to determine the presence or absence of the misfolded ‘prion’ protein (PrPTSE).<br /><br /><br />Results: No transmissions occurred in any of the animals inoculated with blood components from patients with sporadic or variant CJD. All donor chimpanzees (sCJD and GSS) became symptomatic within 6 weeks of their pre-clinical phase plasmapheresis, several months earlier than the expected onset of illness. One monkey inoculated with purified leukocytes from a pre-clinical GSS chimpanzee developed disease after 36 months.<br /><br /><br />Conclusion: No infectivity was found in small volumes of blood components from 4 patients with sporadic CJD and 3 patients with variant CJD. ***However, a single transmission from a chimpanzee-passaged strain of GSS shows that infectivity may be present in leukocytes, and the ‘shock’ of general anaesthesia and plasmspheresis appears to have triggered the onset of illness in pre-clinical donor chimpanzees.<br /><br /><br /><br />FC5.1.2<br /><br /><br />Interim Transmission Results in Cynomolgus Macaques Inoculated with BSE and vCJD Blood Specimens<br /><br /><br />Lasmezas, C1; Lescoutra, N2; Comoy, E2; Holznagel, E3; Loewer, J3; Motzkus, D4; Hunsmann, G4; Ingrosso, L5; Bierke, P6; Pocchiari, M5; Ironside, J7; Will, R7; Deslys, JP2 1Scripps Florida, Infectology, USA; 2CEA, France; 3PEI, Germany; 4DPZ, Germany; 5Istituto Superiore di Sanita, Italy; 6SMI, Sweden; 7CJD Surveillance Unit, UK<br /><br /><br />BSE and vCJD transmitted to cynomolgus macaques reproduce many features of human vCJD, including clinical symptoms, neuropathological hallmarks of vCJD, PrPres electrophoretical pattern and, most importantly, the wide distribution of infectivity in peripheral organs. The latter characteristic distinguishes vCJD from sCJD in both humans and cynomolgus macaques, and prompted us to use this non-human primate model for further investigations of vCJD and its risk for human health. The occurrence of four vCJD infections in humans transfused with blood from patients who later developed vCJD has raised concern about blood transfusion safety in countries with vCJD. In this collaborative European study, we investigated the infectivity of blood components and whole blood administered by intracerebral (ic) and intravenous (iv) routes. Buffy-coat and whole blood was inoculated by ic and iv route, respectively, from two vCJD patients and from two clinical vCJD-inoculated macaques. Transfusions were also performed from whole blood and blood leucodepleted according to hospital practice standards from two clinical BSE inoculated macaques. Blood infectivity during the preclinical phase is being examined in orally infected macaques. Whole blood was collected and transfused from one such animal two years after oral challenge, whereas buffy-coat and plasma from two animals at 2 and 4.5 years post-challenge, respectively, have been inoculated by the ic route. This is an ongoing study in which recipient animals continue to be observed at various times post-inoculation. So far, we have had one positive transmission in one animal transfused 65 months earlier with 40 ml of whole blood from a vCJD macaque (the characteristics of the disease in this animal will be shown in a separate poster by E. Comoy). This positive transmission reproduces transfusion transmission of vCJD in humans, with an incubation of 5.5 years compatible with incubation periods observed in humans.<br /><br /><br /><a href="http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf">http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf</a><br /><br /><br /><br />Saturday, September 5, 2009<br /><br /><br />TSEAC MEETING FEBRUARY 12, 2004 THE BAXTER STUDY GSS<br /><br /><br /><a href="http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html">http://tseac.blogspot.com/2009/09/tseac-meeting-february-12-2004-baxter.html</a><br /><br /><br /><br />Thursday, July 08, 2010<br /><br />Nosocomial transmission of sporadic Creutzfeldt-Jakob disease: results from a risk-based assessment of surgical interventions Public release date: 8-Jul-2010<br /><br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/07/nosocomial-transmission-of-sporadic.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/07/nosocomial-transmission-of-sporadic.html</a><br /><br /><br /><br />National Prion Disease Pathology Surveillance Center Cases Examined1 (July 31, 2010)<br /><br /><br />(please see video at the bottom of this url...tss)<br /><br /><br /><a href="http://prionunitusaupdate2008.blogspot.com/2010/08/national-prion-disease-pathology.html">http://prionunitusaupdate2008.blogspot.com/2010/08/national-prion-disease-pathology.html</a><br /><br /><br /><br />Sunday, July 11, 2010<br /><br /><br />CJD or prion disease 2 CASES McLennan County Texas population 230,213 both cases in their 40s<br /><br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/07/cjd-2-cases-mclennan-county-texas.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/07/cjd-2-cases-mclennan-county-texas.html</a><br /><br /><br /><br />Thursday, July 08, 2010 GLOBAL CLUSTERS OF CREUTZFELDT JAKOB DISEASE - A REVIEW 2010<br /><br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/07/global-clusters-of-creutzfeldt-jakob.html</a><br /><br /><br /><br />Tuesday, August 03, 2010<br /><br /><br />Variably protease-sensitive prionopathy: A new sporadic disease of the prion protein<br /><br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/08/variably-protease-sensitive-prionopathy.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/08/variably-protease-sensitive-prionopathy.html</a><br /><br /><br /><br />Monday, August 9, 2010<br /><br /><br />Variably protease-sensitive prionopathy: A new sporadic disease of the prion protein or just more Prionbaloney ?<br /><br /><br /><a href="http://prionunitusaupdate2008.blogspot.com/2010/08/variably-protease-sensitive-prionopathy.html">http://prionunitusaupdate2008.blogspot.com/2010/08/variably-protease-sensitive-prionopathy.html</a><br /><br /><br /><br />Friday, November 30, 2007<br /><br /><br />CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION<br /><br /><br /><a href="http://cjdquestionnaire.blogspot.com/">http://cjdquestionnaire.blogspot.com/</a><br /><br /><br /><br /><br />ALABAMA MAD COW g-h-BSEalabama<br /><br /><br />In this study, we identified a novel mutation in the bovine prion protein gene (Prnp), called E211K, of a confirmed BSE positive cow from Alabama, United States of America. This mutation is identical to the E200K pathogenic mutation found in humans with a genetic form of CJD. This finding represents the first report of a confirmed case of BSE with a potential pathogenic mutation within the bovine Prnp gene. We hypothesize that the bovine Prnp E211K mutation most likely has caused BSE in "the approximately 10-year-old cow" carrying the E221K mutation.<br /><br /><br /><a href="http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1000156">http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1000156</a><br /><br /><br /><a href="http://www.plospathogens.org/article/fetchObjectAttachment.action?uri=info%3Adoi%2F10.1371%2Fjournal.ppat.1000156&representation=PDF">http://www.plospathogens.org/article/fetchObjectAttachment.action?uri=info%3Adoi%2F10.1371%2Fjournal.ppat.1000156&representation=PDF</a><br /><br /><br /><br />let's take a closer look at this new prionpathy or prionopathy, and then let's look at the g-h-BSEalabama mad cow.<br /><br /><br />This new prionopathy in humans? the genetic makeup is IDENTICAL to the g-h-BSEalabama mad cow, the only _documented_ mad cow in the world to date like this, ......wait, it get's better. this new prionpathy is killing young and old humans, with LONG DURATION from onset of symptoms to death, and the symptoms are very similar to nvCJD victims, OH, and the plaques are very similar in some cases too, bbbut, it's not related to the g-h-BSEalabama cow, WAIT NOW, it gets even better, the new human prionpathy that they claim is a genetic TSE, has no relation to any gene mutation in that family. daaa, ya think it could be related to that mad cow with the same genetic make-up ??? there were literally tons and tons of banned mad cow protein in Alabama in commerce, and none of it transmitted to cows, and the cows to humans there from ??? r i g h t $$$<br /><br /><br /><br />Saturday, August 14, 2010<br /><br /><br />BSE Case Associated with Prion Protein Gene Mutation (g-h-BSEalabama) and VPSPr PRIONPATHY (see mad cow feed in COMMERCE IN ALABAMA...TSS)<br /><br /><br /><a href="http://prionpathy.blogspot.com/2010/08/bse-case-associated-with-prion-protein.html">http://prionpathy.blogspot.com/2010/08/bse-case-associated-with-prion-protein.html</a><br /><br /><br /><br />Wednesday, March 31, 2010<br /><br /><br />Atypical BSE in Cattle To date the OIE/WAHO assumes that the human and animal health standards set out in the BSE chapter for classical BSE (C-Type) applies to all forms of BSE which include the H-type and L-type atypical forms. This assumption is scientifically not completely justified and accumulating evidence suggests that this may in fact not be the case. Molecular characterization and the spatial distribution pattern of histopathologic lesions and immunohistochemistry (IHC) signals are used to identify and characterize atypical BSE. Both the L-type and H-type atypical cases display significant differences in the conformation and spatial accumulation of the disease associated prion protein (PrPSc) in brains of afflicted cattle. Transmission studies in bovine transgenic and wild type mouse models support that the atypical BSE types might be unique strains because they have different incubation times and lesion profiles when compared to C-type BSE. When L-type BSE was inoculated into ovine transgenic mice and Syrian hamster the resulting molecular fingerprint had changed, either in the first or a subsequent passage, from L-type into C-type BSE. In addition, non-human primates are specifically susceptible for atypical BSE as demonstrated by an approximately 50% shortened incubation time for L-type BSE as compared to C-type. Considering the current scientific information available, it cannot be assumed that these different BSE types pose the same human health risks as C-type BSE or that these risks are mitigated by the same protective measures. This study will contribute to a correct definition of specified risk material (SRM) in atypical BSE. The incumbent of this position will develop new and transfer existing, ultra-sensitive methods for the detection of atypical BSE in tissue of experimentally infected cattle.<br /><br /><br /><a href="http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2">http://www.prionetcanada.ca/detail.aspx?menu=5&dt=293380&app=93&cat1=387&tp=20&lk=no&cat2</a><br /><br /><br /><br />CJD TEXAS 38 YEAR OLD FEMALE WORKED SLAUGHTERING CATTLE EXPOSED TO BRAIN AND SPINAL CORD MATTER<br /><br /><br /><br /><br />>>>Up until about 6 years ago, the pt worked at Tyson foods where she worked on the assembly line, slaughtering cattle and preparing them for packaging. She was exposed to brain and spinal cord matter when she would euthanize the cattle. <<<<br /><br /><br /><br />Irma Linda Andablo CJD Victim, she died at 38 years old on February 6, 2010 in Mesquite Texas<br /><br /><br />Irma Linda Andablo CJD Victim, she died at 38 years old on February 6, 2010 in Mesquite Texas. She left 6 Kids and a Husband. The Purpose of this web is to give information in Spanish to the Hispanic community, and to all the community who want's information about this terrible disease.-<br /><br /><br />Physician Discharge Summary, Parkland Hospital, Dallas Texas<br /><br /><br />Admit Date: 12/29/2009<br /><br /><br />Discharge Date: 1/20/2010<br /><br /><br />Attending Provider: Greenberg, Benjamin Morris;<br /><br /><br />General Neurology Team: General Neurology Team<br /><br /><br />Linda was a Hispanic female with no past medical history presents with 14 months of incresing/progressive altered mental status, generalized weakness, inability to walk, loss of appetite, inability to speak, tremor and bowel/blader incontinence. She was, in her usual state of health up until February, 2009, when her husbans notes that she began forgetting things like names and short term memories. He also noticed mild/vague personality changes such as increased aggression. In March, she was involved in a hit and run MVA,although she was not injured. The police tracked her down and ticketed her. At that time, her son deployed to Iraq with the Army and her husband assumed her mentation changes were due to stress over these two events. Also in March, she began to have weakness in her legs, making it difficult to walk. Over the next few months, her mentation and personality changes worsened, getting to a point where she could no longer recognized her children. She was eating less and less. She was losing more weight. In the last 2-3 months, she reached the point where she could not walk without an assist, then 1 month ago, she stopped talking, only making grunting/aggressive sounds when anyone came near her. She also became both bowel and bladder incontinent, having to wear diapers. Her '"tremor'" and body jerks worsened and her hands assumed a sort of permanent grip position, leading her family to put tennis balls in her hands to protect her fingers. The husband says that they have lived in Nebraska for the past 21 years. They had seen a doctor there during the summer time who prescribed her Seroquel and Lexapro, Thinking these were sx of a mood disorder. However, the medications did not help and she continued to deteriorate clinically. Up until about 6 years ago, the pt worked at Tyson foods where she worked on the assembly line, slaughtering cattle and preparing them for packaging. She was exposed to brain and spinal cord matter when she would euthanize the cattle. The husband says that he does not know any fellow workers with a similar illness. He also says that she did not have any preceeding illness or travel.<br /><br /><br /><a href="http://www.recordandoalinda.com/index.php?option=com_content&view=article&id=19:cjd-english-info&catid=9:cjd-ingles&Itemid=8">http://www.recordandoalinda.com/index.php?option=com_content&view=article&id=19:cjd-english-info&catid=9:cjd-ingles&Itemid=8</a><br /><br /><br />Our condolences go out to the family and friends of Irma Linda Andablo, and a great big Thank You for this report from the family and the hospital. WE, the public would never have known about this case other wise. Thank you ! ...TSS<br /><br /><br /><br />>>>Up until about 6 years ago, the pt worked at Tyson foods where she worked on the assembly line, slaughtering cattle and preparing them for packaging. She was exposed to brain and spinal cord matter when she would euthanize the cattle. <<<<br /><br /><br />Monday, March 29, 2010<br /><br />Irma Linda Andablo CJD Victim, she died at 38 years old on February 6, 2010 in Mesquite Texas<br /><br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/03/irma-linda-andablo-cjd-victim-she-died.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/03/irma-linda-andablo-cjd-victim-she-died.html</a><br /><br /><br />CJD TEXAS 38 YEAR OLD FEMALE WORKED SLAUGHTERING CATTLE EXPOSED TO BRAIN AND SPINAL CORD MATTER<br /><br /><br /><a href="http://cjdtexas.blogspot.com/2010/03/cjd-texas-38-year-old-female-worked.html">http://cjdtexas.blogspot.com/2010/03/cjd-texas-38-year-old-female-worked.html</a><br /><br /><br /><br /><br />Terry S. Singeltary Sr. has added the following comment: "According to the World Health Organisation, the future public health threat of vCJD in the UK and Europe and potentially the rest of the world is of concern and currently unquantifiable. However, the possibility of a significant and geographically diverse vCJD epidemic occurring over the next few decades cannot be dismissed <http:>.<br /><br /><br />The key word here is diverse. What does diverse mean?<br /><br />If USA scrapie transmitted to USA bovine does not produce pathology as the UK c-BSE, then why would CJD from there look like UK vCJD?"<br /><br />SEE FULL TEXT ;<br /><br /><br /><a href="http://www.promedmail.org/pls/apex/f?p=2400:1001:568933508083034::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,82101">http://www.promedmail.org/pls/apex/f?p=2400:1001:568933508083034::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,82101</a><br /><br /><br /><br />.57 The experiment which might have determined whether BSE and scrapie were caused by the same agent (ie, the feeding of natural scrapie to cattle) was never undertaken in the UK. It was, however, performed in the USA in 1979, when it was shown that cattle inoculated with the scrapie agent endemic in the flock of Suffolk sheep at the United States Department of Agriculture in Mission, Texas, developed a TSE quite unlike BSE. 32 The findings of the initial transmission, though not of the clinical or neurohistological examination, were communicated in October 1988 to Dr Watson, Director of the CVL, following a visit by Dr Wrathall, one of the project leaders in the Pathology Department of the CVL, to the United States Department of Agriculture. 33 The results were not published at this point, since the attempted transmission to mice from the experimental cow brain had been inconclusive. The results of the clinical and histological differences between scrapie-affected sheep and cattle were published in 1995. Similar studies in which cattle were inoculated intracerebrally with scrapie inocula derived from a number of scrapie-affected sheep of different breeds and from different States, were carried out at the US National Animal Disease Centre. 34 The results, published in 1994, showed that this source of scrapie agent, though pathogenic for cattle, did not produce the same clinical signs of brain lesions characteristic of BSE.<br /><br />32 Clark, W., Hourrigan, J. and Hadlow, W. (1995) Encephalopathy in Cattle Experimentally Infected with the Scrapie Agent, American Journal of Veterinary Research, 56, 606-12<br /><br />33 YB88/10.00/1.1<br /><br /><a href="http://web.archive.org/web/20040823105233/www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf">http://web.archive.org/web/20040823105233/www.bseinquiry.gov.uk/files/yb/1988/10/00001001.pdf</a><br /><br /><br /><br />34 Cutlip, R., Miller, J., Race, R., Jenny, A., Katz, J., Lehmkuhl, H., Debey, B. and Robinson, M. (1994) Intracerebral Transmission of Scrapie to Cattle, Journal of Infectious Diseases, 169, 814-20<br /><br /><br /><br /><br />Friday, August 27, 2010<br /><br />NEW ATYPICAL NOR-98 SCRAPIE CASE DETECTED IDAHO NOW 5 CASES DOCUMENTED 2010<br /><br /><a href="http://nor-98.blogspot.com/2010/08/new-atypical-nor-98-scrapie-case.html">http://nor-98.blogspot.com/2010/08/new-atypical-nor-98-scrapie-case.html</a><br /><br /><br /><br /><br /><br />PR-26<br /><br /><br />NOR98 SHOWS MOLECULAR FEATURES REMINISCENT OF GSS<br /><br /><br />R. Nonno1, E. Esposito1, G. Vaccari1, E. Bandino2, M. Conte1, B. Chiappini1, S. Marcon1, M. Di Bari1, S.L. Benestad3, U. Agrimi1 1 Istituto Superiore di Sanità, Department of Food Safety and Veterinary Public Health, Rome, Italy (romolo.nonno@iss.it); 2 Istituto Zooprofilattico della Sardegna, Sassari, Italy; 3 National Veterinary Institute, Department of Pathology, Oslo, Norway<br /><br />Molecular variants of PrPSc are being increasingly investigated in sheep scrapie and are generally referred to as "atypical" scrapie, as opposed to "classical scrapie". Among the atypical group, Nor98 seems to be the best identified. We studied the molecular properties of Italian and Norwegian Nor98 samples by WB analysis of brain homogenates, either untreated, digested with different concentrations of proteinase K, or subjected to enzymatic deglycosylation. The identity of PrP fragments was inferred by means of antibodies spanning the full PrP sequence. We found that undigested brain homogenates contain a Nor98-specific PrP fragment migrating at 11 kDa (PrP11), truncated at both the C-terminus and the N-terminus, and not N-glycosylated. After mild PK digestion, Nor98 displayed full-length PrP (FL-PrP) and N-glycosylated C-terminal fragments (CTF), along with increased levels of PrP11. Proteinase K digestion curves (0,006-6,4 mg/ml) showed that FL-PrP and CTF are mainly digested above 0,01 mg/ml, while PrP11 is not entirely digested even at the highest concentrations, similarly to PrP27-30 associated with classical scrapie. Above 0,2 mg/ml PK, most Nor98 samples showed only PrP11 and a fragment of 17 kDa with the same properties of PrP11, that was tentatively identified as a dimer of PrP11. Detergent solubility studies showed that PrP11 is insoluble in 2% sodium laurylsorcosine and is mainly produced from detergentsoluble, full-length PrPSc. Furthermore, among Italian scrapie isolates, we found that a sample with molecular and pathological properties consistent with Nor98 showed plaque-like deposits of PrPSc in the thalamus when the brain was analysed by PrPSc immunohistochemistry. Taken together, our results show that the distinctive pathological feature of Nor98 is a PrP fragment spanning amino acids ~ 90-155. This fragment is produced by successive N-terminal and C-terminal cleavages from a full-length and largely detergent-soluble PrPSc, is produced in vivo and is extremely resistant to PK digestion.<br /><br />*** Intriguingly, these conclusions suggest that some pathological features of Nor98 are reminiscent of Gerstmann-Sträussler-Scheinker disease.<br /><br />119<br /><br /><a href="http://www.neuroprion.com/pdf_docs/conferences/prion2006/abstract_book.pdf">http://www.neuroprion.com/pdf_docs/conferences/prion2006/abstract_book.pdf</a><br /><br /><br /><br /><br /><br />Sunday, May 18, 2008<br /><br /><br />MAD COW DISEASE BSE CJD CHILDREN VACCINES Sunday, May 18, 2008<br /><br />MAD COW DISEASE BSE CJD CHILDREN VACCINES<br /><br />TIP740203/l 0424 CONFIDENTIAL<br /><br /><br /><a href="http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html">http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html</a><br /><br /><br /><br /><br /><br />Monday, December 14, 2009<br /><br />Similarities between Forms of Sheep Scrapie and Creutzfeldt-Jakob Disease Are Encoded by Distinct Prion Types<br /><br /><br /><a href="http://nor-98.blogspot.com/2009/12/similarities-between-forms-of-sheep.html">http://nor-98.blogspot.com/2009/12/similarities-between-forms-of-sheep.html</a><br /><br /><br /><br /><br /><a href="http://nor-98.blogspot.com/2010/08/scrapie-canada-update-current-as-of.html">http://nor-98.blogspot.com/2010/08/scrapie-canada-update-current-as-of.html</a><br /><br /><br /><br /><br />PPo2-27:<br /><br />Generation of a Novel form of Human PrPSc by Inter-species Transmission of Cervid Prions<br /><br />Marcelo A. Barria,1 Glenn C. Telling,2 Pierluigi Gambetti,3 James A. Mastrianni4 and Claudio Soto1 1Mitchell Center for Alzheimer’s disease and related Brain disorders; Dept of Neurology; University of Texas Houston Medical School; Houston, TX USA; 2Dept of Microbiology, Immunology & Molecular Genetics and Neurology; Sanders Brown Center on Aging; University of Kentucky Medical Center; Lexington, KY USA; 3Institute of Pathology; Case western Reserve University; Cleveland, OH USA; 4Dept of Neurology; University of Chicago; Chicago, IL USA<br /><br />Prion diseases are infectious neurodegenerative disorders affecting humans and animals that result from the conversion of normal prion protein (PrPC) into the misfolded and infectious prion (PrPSc). Chronic wasting disease (CWD) of cervids is a prion disorder of increasing prevalence within the United States that affects a large population of wild and captive deer and elk. CWD is highly contagious and its origin, mechanism of transmission and exact prevalence are currently unclear. The risk of transmission of CWD to humans is unknown. Defining that risk is of utmost importance, considering that people have been infected by animal prions, resulting in new fatal diseases. To study the possibility that human PrPC can be converted into the infectious form by CWD PrPSc we performed experiments using the Protein Misfolding Cyclic Amplification (PMCA) technique, which mimic in vitro the process of prion replication. Our results show that cervid PrPSc can induce the pathological conversion of human PrPC, but only after the CWD prion strain has been stabilized by successive passages in vitro or in vivo. Interestingly, this newly generated human PrPSc exhibits a distinct biochemical pattern that differs from any of the currently known forms of human PrPSc, indicating that it corresponds to a novel human prion strain. Our findings suggest that CWD prions have the capability to infect humans, and that this ability depends on CWD strain adaptation, implying that the risk for human health progressively increases with the spread of CWD among cervids.<br /><br /><br /><br />PPo3-7:<br /><br />Prion Transmission from Cervids to Humans is Strain-dependent<br /><br />Qingzhong Kong, Shenghai Huang,*Fusong Chen, Michael Payne, Pierluigi Gambetti and Liuting Qing Department of Pathology; Case western Reserve University; Cleveland, OH USA *Current address: Nursing Informatics; Memorial Sloan-Kettering Cancer Center; New York, NY USA<br /><br />Key words: CWD, strain, human transmission<br /><br />Chronic wasting disease (CWD) is a widespread prion disease in cervids (deer and elk) in North America where significant human exposure to CWD is likely and zoonotic transmission of CWD is a concern. Current evidence indicates a strong barrier for transmission of the classical CWD strain to humans with the PrP-129MM genotype. A few recent reports suggest the presence of two or more CWD strains. What remain unknown is whether individuals with the PrP-129VV/MV genotypes are also resistant to the classical CWD strain and whether humans are resistant to all natural or adapted cervid prion strains. Here we report that a human prion strain that had adopted the cervid prion protein (PrP) sequence through passage in cervidized transgenic mice efficiently infected transgenic mice expressing human PrP, indicating that the species barrier from cervid to humans is prion strain-dependent and humans can be vulnerable to novel cervid prion strains. Preliminary results on CWD transmission in transgenic mice expressing human PrP-129V will also be discussed.<br /><br />Acknowledgement Supported by NINDS NS052319 and NIA AG14359.<br /><br /><br /><br /><a href="http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099">http://www.prion2010.org/bilder/prion_2010_program_latest_w_posters_4_.pdf?139&PHPSESSID=a30a38202cfec579000b77af81be3099</a><br /><br /><br /><br /><br /><br /><a href="http://chronic-wasting-disease.blogspot.com/2010/07/comments-sought-on-revised-plan-to.html">http://chronic-wasting-disease.blogspot.com/2010/07/comments-sought-on-revised-plan-to.html</a><br /><br /><br /><br /><br /><br /><a href="http://chronic-wasting-disease.blogspot.com/2009/09/experimental-oral-transmission-of.html">http://chronic-wasting-disease.blogspot.com/2009/09/experimental-oral-transmission-of.html</a><br /><br /><br /><br /><br /><br /><a href="http://chronic-wasting-disease.blogspot.com/2009/08/susceptibilities-of-nonhuman-primates.html">http://chronic-wasting-disease.blogspot.com/2009/08/susceptibilities-of-nonhuman-primates.html</a><br /><br /><br /><br /><br /><br /><a href="http://chronic-wasting-disease.blogspot.com/">http://chronic-wasting-disease.blogspot.com/</a><br /><br /><br /><br /><br /><br />Wednesday, September 08, 2010<br /><br />CWD PRION CONGRESS SEPTEMBER 8-11 2010<br /><br /><br /><a href="http://chronic-wasting-disease.blogspot.com/2010/09/cwd-prion-2010.html">http://chronic-wasting-disease.blogspot.com/2010/09/cwd-prion-2010.html</a><br /><br /><br /><br /><br /><br />Sunday, September 6, 2009<br /><br />MAD COW USA 1997 SECRET VIDEO<br /><br /><br /><a href="http://madcowusda.blogspot.com/2009/09/mad-cow-usa-1997-video.html">http://madcowusda.blogspot.com/2009/09/mad-cow-usa-1997-video.html</a><br /><br /><br /><br /><br /><br />U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ? see video at bottom<br /><br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html">http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html</a><br /><br /><br /><br /><br /><br />Rural and Regional Affairs and Transport References Committee The possible impacts and consequences for public health, trade and agriculture of the Government’s decision to relax import restrictions on beef Final report June 2010<br /><br />2.65 At its hearing on 14 May 2010, the committee heard evidence from Dr Alan Fahey who has recently submitted a thesis on the clinical neuropsychiatric, epidemiological and diagnostic features of Creutzfeldt-Jakob disease.48 Dr Fahey told the committee of his concerns regarding the lengthy incubation period for transmissible spongiform encephalopathies, the inadequacy of current tests and the limited nature of our current understanding of this group of diseases.49<br /><br />2.66 Dr Fahey also told the committee that in the last two years a link has been established between forms of atypical CJD and atypical BSE. Dr Fahey said that: They now believe that those atypical BSEs overseas are in fact causing sporadic Creutzfeldt-Jakob disease. They were not sure if it was due to mad sheep disease or a different form. If you look in the textbooks it looks like this is just arising by itself. But in my research I have a summary of a document which states that there has never been any proof that sporadic Creutzfeldt-Jakob disease has arisen de novo—has arisen of itself. There is no proof of that. The recent research is that in fact it is due to atypical forms of mad cow disease which have been found across Europe, have been found in America and have been found in Asia. These atypical forms of mad cow disease typically have even longer incubation periods than the classical mad cow disease.50<br /><br /><a href="http://www.aph.gov.au/senate/committee/rrat_ctte/mad_cows/report/report.pdf">http://www.aph.gov.au/senate/committee/rrat_ctte/mad_cows/report/report.pdf</a><br /><br /><br /><br /><br /><br />Wednesday, August 11, 2010<br /><br />Heterozygosity at Polymorphic Codon 219 in Variant Creutzfeldt-Jakob Disease<br /><br />Vol. 67 No. 8, August 2010<br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2010/08/heterozygosity-at-polymorphic-codon-219.html">http://creutzfeldt-jakob-disease.blogspot.com/2010/08/heterozygosity-at-polymorphic-codon-219.html</a><br /><br /><br /><br /><br />Saturday, January 2, 2010<br /><br />Human Prion Diseases in the United States January 1, 2010 ***FINAL***<br /><br /><a href="http://prionunitusaupdate2008.blogspot.com/2010/01/human-prion-diseases-in-united-states.html">http://prionunitusaupdate2008.blogspot.com/2010/01/human-prion-diseases-in-united-states.html</a><br /><br /><br /><br /><br /><br />my comments to PLosone here ;<br /><br /><br /><br /><a href="http://www.plosone.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd&root=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd">http://www.plosone.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd&root=info%3Adoi%2F10.1371%2Fannotation%2F04ce2b24-613d-46e6-9802-4131e2bfa6fd</a><br /><br /><br /><br /><br /><br />Title:<br /><br />HUMAN and ANIMAL TSE Classifications i.e. mad cow disease and the UKBSEnvCJD only theory<br /><br /><br /><br /><a href="http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648027c28e&disposition=attachment&contentType=pdf">http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648027c28e&disposition=attachment&contentType=pdf</a><br /><br /><br /><br /><a href="http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html">http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html</a><br /><br /><br /><br /><br /><br />Saturday, June 13, 2009<br /><br />Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009<br /><br /><br /><br /><a href="http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html">http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html</a><br /><br /><br /><br /><br />From: Terry S. Singeltary Sr.<br /><br />To: FREAS@CBER.FDA.GOV<br /><br />Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov<br /><br />Sent: Friday, December 01, 2006 2:59 PM<br /><br />Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION PART III]<br /><br />page 1 starts on page 13, then come back to page 1 to finish.....tss<br /><br /><br /><br /><a href="http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8">http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8</a><br /><br /><br /><br /><br />PDF]Freas, William TSS SUBMISSION<br /><br />File Format: PDF/Adobe Acrobat -<br /><br />Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary<br /><br />Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...<br /><br /><br /><br /><a href="http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf">http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf</a><br /><br /><br /><br /><br />VACCINES AND TSE I.E. PRION DISEASE AKA MAD COW TYPE DISEASE CONFIDENTIAL<br /><br />NOW, the vaccine TSE issue ;<br /><br />NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE<br /><br />snip...<br /><br />I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use.<br /><br />snip...<br /><br />The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out...<br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102174454/http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf">http://collections.europarchive.org/tna/20080102174454/http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf</a><br /><br /><br /><br /><br />B.S.E. and Veterinary Medicines<br /><br />Thank you very much indeed for your letter of the 26th of January outlining to me the various steps that are proposing to take in order to reduce the risk from B.S.E. in veterinary medicines. It is, as you say, and extremely difficult problem. ....<br /><br /><br /><a href="http://web.archive.org/web/20030526124448/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf">http://web.archive.org/web/20030526124448/http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf</a><br /><br /><br /><br /><br />Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103002832/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf">http://collections.europarchive.org/tna/20080103002832/http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf</a><br /><br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102155758/http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf">http://collections.europarchive.org/tna/20080102155758/http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf</a><br /><br /><br /><br /><br />(It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.)<br /><br />PITUITARY EXTRACT<br /><br />This was used to help cows super ovulate. This tissue was considered to be of greatest risk of containing BSE and consequently transmitting the disease.<br /><br />BEEF BRAIN AND BRAIN INFUSION BROTHS<br /><br />Considered to be of great risk.<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164725/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf">http://collections.europarchive.org/tna/20080102164725/http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf</a><br /><br /><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br />MEDICINES ACT - VETERINARY PRODUCTS COMMITTEE<br /><br />5 BLANK PAGES. ...TSS<br /><br />7. Any Other Business<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164736/http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf">http://collections.europarchive.org/tna/20080102164736/http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf</a><br /><br /><br /><br /><br />TWA LITTLE STATEMENT 331<br /><br />8 June 1988 Internal CVL meeting to discuss the implications of BSE to Biologicals Products containing bovine extracted material (Annex 6). (YB 88/06.08/11.1-11.2) Following a detailed review of situation the following recommendations were made:<br /><br />1. Specific concern over use of pituitary gland products by veterinary surgeons and companies. Paper to be produced for Tolworth (Veterinary Medicines Division).<br /><br />2. Urgent review of all products both immunological and pharmaceutical for possible inclusion of ingredients of bovine origin.<br /><br />3. Draft guidelines to be presented in full to the National Office of Animal Health (NOAH), the trade body representing the Veterinary Medicines part of the pharmaceutical industry, at next meeting on 11 July 1988<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102163939/http://www.bseinquiry.gov.uk/files/ws/s331.pdf">http://collections.europarchive.org/tna/20080102163939/http://www.bseinquiry.gov.uk/files/ws/s331.pdf</a><br /><br /><br /><br /><br />TWA LITTLE minute<br /><br />2. We have identified one problem over where we are unable to act and this is the use of gonadotrophins in embryo transfer work. Some veterinary surgeons are quite legally using this exemption from the Medicines Act contained in Section 9(2) to prepare gonadotrophins from pituitary glands from various species, including cattle. These hormones are used to stimulate superovulation in donor cows.<br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164806/http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf">http://collections.europarchive.org/tna/20080102164806/http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf</a><br /><br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164811/http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf">http://collections.europarchive.org/tna/20080102164811/http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf</a><br /><br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103031215/http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf">http://collections.europarchive.org/tna/20080103031215/http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf</a><br /><br /><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br />3.2 Minute 5.3 - 5.4 Bovine Spongiform Encephalopathy<br /><br />It was reported that some replies had been received from Companies using pituitary glands in their products. Copies of the BSE document had also been sent to DHSS and NIBSC.<br /><br />and then another 3 + pages of blank space. ...TSS<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102164813/http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf">http://collections.europarchive.org/tna/20080102164813/http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf</a><br /><br /><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br />BSE - CURRENT POSITION WITH VETERINARY LICENCED PRODUCTS (MA.1968)<br /><br />There are three areas of particular concern, vaccines (including emergency vaccines), pharmaceuticals which are covered by MA licences and unlicenses hormonal products produced under exemptions claimed under (Section 9(2) Medicines Act).<br /><br />1) Vaccines<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103033809/http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf">http://collections.europarchive.org/tna/20080103033809/http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf</a><br /><br /><br /><br /><br />NOT FOR PUBLICATION<br /><br />another 6 pages of blank space. ...TSS<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103032658/http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf">http://collections.europarchive.org/tna/20080103032658/http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf</a><br /><br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103032631/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf">http://collections.europarchive.org/tna/20080103032631/http://www.bseinquiry.gov.uk/files/yb/1988/11/04003001.pdf</a><br /><br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103033926/http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf">http://collections.europarchive.org/tna/20080103033926/http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf</a><br /><br /><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080103034137/http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf">http://collections.europarchive.org/tna/20080103034137/http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf</a><br /><br /><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br />Medicines Act - Veterinary Products Committee<br /><br /><a href="http://collections.europarchive.org/tna/20080103034140/http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf">http://collections.europarchive.org/tna/20080103034140/http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf</a><br /><br /><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br /><a href="http://collections.europarchive.org/tna/20080102164744/http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf">http://collections.europarchive.org/tna/20080102164744/http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf</a><br /><br /><br /><br /><br />MANAGEMENT IN CONFIDENCE<br /><br />CERTIFIED BSE-FREE HERDS FOR SOURCE OF MATERIAL FOR BIOLOGICAL PRODUCTS<br /><br /><a href="http://collections.europarchive.org/tna/20080102184729/http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf">http://collections.europarchive.org/tna/20080102184729/http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf</a><br /><br /><br /><br /><br />Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001<br /><br />Date: Tue, 9 Jan 2001 16:49:00 -0800<br /><br />From: "Terry S. Singeltary Sr." <flounder@wt.net><br /><br />Reply-To: Bovine Spongiform Encephalopathy <bse-l@uni-karlsruhe.de><br /><br />To: BSE-L@uni-karlsruhe.de<br /><br />[host Richard Barns] and now a question from Terry S. Singeltary of CJD Watch.<br /><br />[TSS] yes, thank you, U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?<br /><br />[no answer, you could hear in the back ground, mumbling and 'we can't. have him ask the question again.]<br /><br />[host Richard] could you repeat the question?<br /><br />[TSS] U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds?<br /><br />[not sure whom ask this] what group are you with?<br /><br />[TSS] CJD Watch, my Mom died from hvCJD and we are tracking CJD world-wide.<br /><br />[not sure who is speaking] could you please disconnect Mr. Singeltary<br /><br />[TSS] you are not going to answer my question?<br /><br />[not sure whom speaking] NO<br /><br />from this point, i was still connected, got to listen and tape the whole conference. at one point someone came on, a woman, and ask again;<br /><br />[unknown woman] what group are you with?<br /><br />[TSS] CJD Watch and my Mom died from hvCJD we are trying to tract down CJD and other human TSE's world wide. i was invited to sit in on this from someone inside the USDA/APHIS and that is why i am here. do you intend on banning me from this conference now?<br /><br />at this point the conference was turned back up, and i got to finish listening. They never answered or even addressed my one question, or even addressed the issue. BUT, i will try and give you a run-down for now, of the conference.<br /><br />snip...full text ;<br /><br /><br /><a href="http://bse-atypical.blogspot.com/2010/01/14th-international-congress-on.html">http://bse-atypical.blogspot.com/2010/01/14th-international-congress-on.html</a><br /><br /><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br />NOT FOR PUBLICATION<br /><br />COMMITTEE ON SAFETY OF MEDICINES<br /><br />another 6 pages or so that are blank. ...TSS<br /><br /><a href="http://collections.europarchive.org/tna/20080102185137/http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf">http://collections.europarchive.org/tna/20080102185137/http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf</a><br /><br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102184613/http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf">http://collections.europarchive.org/tna/20080102184613/http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf</a><br /><br /><br /><br /><br />COMMERCIAL IN CONFIDENCE<br /><br />NOT FOR PUBLICATION<br /><br />COMMITTEE ON SAFETY OF MEDICINES<br /><br />WORKING PARTY ON BOVINE SPONGIFORM ENCEPHALOPATHY<br /><br />7.2.1. Products with bovine brain/lymphoid tissue as ingredients and administered by injection...[111]<br /><br />7.2.2 Products with bovine ingredients (other than brain/lymphoid tissue) and administered by injection...[135]<br /><br />7.2.3 Tissue implants, open wound dressings, surgical materials, dental and opthalmic products with bovine ingredients...[27]<br /><br />7.2.4. Products with bovine ingredients and administered topically...[5]<br /><br />7.2.5 Products with bovine ingredients and administered orally...[9]<br /><br />7.2.6 Products with other animal/insect/bird ingredients and administered:<br /><br />a. by injection a: 117<br /><br />b. by topically b: 6<br /><br />c. orally c: 8<br /><br />7.2.7 Products with materials produced from animal material by chemical processes, eg stearic acid, gelatin and lanolin...[156]<br /><br />With two exceptions, the replies to date have not given any immediate cause for concern, although 176 products do not conform to the CSM/VPC guidelines.<br /><br />8. The first exception was from which gave very limited information about a very large number of homoepathic medicines with material obtained from cattle and a number with material from the brain. Of these, 53 were injectable products of which 20 were derived from cattle brain. A list of these products is attached as Appendix 1 to Annex D. The second exception relates to the product, 'Surgical Catgut', which is sourced from UK bovine intestines and will contain lymphoid material...<br /><br />see full text ;<br /><br /><a href="http://collections.europarchive.org/tna/20080102164420/http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf">http://collections.europarchive.org/tna/20080102164420/http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf</a><br /><br /><br /><br /><br />please see ;<br /><br />Sunday, December 16, 2007<br /><br />Risk factors for sporadic Creutzfeldt-Jakob disease<br /><br />Increased risk was not associated with surgical categories chosen a priori but was confined to the residual category other surgery, in which the increase in risk appeared most marked for three subcategories: skin stitches, nose/throat operations, and removal of growths/cysts/moles.<br /><br />snip...<br /><br />which the increase in risk appeared most marked for three subcategories:<br /><br />skin stitches, nose/throat operations, and removal of growths/cysts/moles.<br /><br />10 January 1990<br /><br />Other US BSE risks: the imported products picture<br /><br />24 Jul 00 Trade Statistics: UK to US<br /><br />Compiled by Terry S.Singeltary Sr of Bacliff, Texas<br /><br />[Opinion (webmaster): The US has focused for years on tracing, containing, and eradicating live animal imports from the UK or other countries with acknowledged BSE like Belgium, including some 499 cattle and the Vermont sheep. This strategy does not acknowledge imports of rendered bovine products from England during the BSE period nor secondary products such as surgical catgut, which is to say surgical cowgut, or dairy cattle embryos, vaccines for veterinarian and human medicines. What has become of these?<br /><br />Mr. Singeltary, who lost his mother to CJD of unexplained origin a few years back and went on to became a well-known TSE activist, has tracked down voluminous pertinent import data through correspondence with UK officials and searches of government web sites. Imports of such products are frequently cited by Europeans in rating BSE risks in the US and in shutting out US exports.<br /><br />Many people's eyes glaze over when reviewing reams of sometimes older trade statistics. There is no proof that any of the imported products was contaminated with BSE nor if so, any evidence that any BSE product lead to infection in US livestock, surgical patients, or what not. Nonetheless, the data obtained by Mr. Singeltary establish that an appalling variety and tonnage of products that were imported by the US from the UK and othr BSE-affected countries during the peak of the BSE epidemic years.]<br /><br />10 January 1990<br /><br />NOT FOR PUBLICATION<br /><br />COMMITTEE ON SAFETY OF MEDICINES<br /><br />WORKING PARTY ON BOVINE SPONGIFORM ENCEPHALOPATHY<br /><br />SURGICAL CATGUT SUTURES<br /><br />2.1 At the first meeting of the Working Party on Bovine Spongiform Encephalopathy on 6 September 1989, detailed consideration was given to XXXXX Surgical Catgut. This arose from the Company's response to the Letter to License Holders, indicating that the bovine small intestine source material was derived from UK cattle, unlike 8 other licensed catgut sutures. In contrast XXXXX Surgical Catgut was stated to hold over 90% share of the market for catgut sutures, and to constitute approximately 83% of all sutures used in U.K.<br /><br />IMPORTS OF SUTURES FROM THE KNOWN BSE COUNTRY;<br /><br />3006.10.0000: STERILE SURGICAL CATGUT, SIMILAR STERILE SUTURE MATERIALS AND STERILETISSUE ADHESIVES FOR SURGICAL WOUND CLOSURE; AND SIMILAR STERILE MATERIAL<br /><br />U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)<br /><br /><--- Dec 1998 ---> <--- 1998 YTD ---><br /><br />Country Quantity Value Quantity Value<br /><br />===================================================<br /><br />WORLD TOTAL . . . . . . . 10,801 3,116 143,058 40,068<br /><br />Belgium . . . . . . . . . --- --- 107 14<br /><br />France . . . . . . . . . 81 49 2,727 1,132<br /><br />Switzerland . . . . . . . --- --- 1,357 1,693<br /><br />United Kingdom . . . . . 1,188 242 35,001 5,564<br /><br /><br /><a href="http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh">http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh</a><br /><br /><br /><br /><br />see url now available at ;<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102182449/http://www.bseinquiry.gov.uk/files/yb/1990/01/10008001.pdf">http://collections.europarchive.org/tna/20080102182449/http://www.bseinquiry.gov.uk/files/yb/1990/01/10008001.pdf</a><br /><br /><br /><br /><br />Part II<br /><br />2.1 Bovine Small Intestine<br /><br />This is the largest single category, comprising 9 product licenses for surgical catgut, held by 3 Companies ;<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102182349/http://www.bseinquiry.gov.uk/files/yb/1990/01/10010001.pdf">http://collections.europarchive.org/tna/20080102182349/http://www.bseinquiry.gov.uk/files/yb/1990/01/10010001.pdf</a><br /><br /><br /><br /><br />2.2 Skin<br /><br />Bovine dermal collagen is present in 2 products for correction of tissue contour deformities by injection and 4 implantable haemostates.<br /><br />Source USA, USA, W Germany, W. Germany, France. ...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102182349/http://www.bseinquiry.gov.uk/files/yb/1990/01/10010001.pdf">http://collections.europarchive.org/tna/20080102182349/http://www.bseinquiry.gov.uk/files/yb/1990/01/10010001.pdf</a><br /><br /><br /><br /><br />UPDATE ON SURGICAL CATGUT<br /><br />MAY 1990<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102222354/http://www.bseinquiry.gov.uk/files/yb/1990/05/00011001.pdf">http://collections.europarchive.org/tna/20080102222354/http://www.bseinquiry.gov.uk/files/yb/1990/05/00011001.pdf</a><br /><br /><br /><br /><br />40,000 human heart valves a year from BSE herds<br /><br />Sun, 3 Sep 2000.<br /><br />Unpublished Inquiry documents obtained by CJD activist Terry S. Singeltary Sr. of Bacliff, Texas<br /><br /><br /><a href="http://www.mad-cow.org/00/sep00_news.html#hhh">http://www.mad-cow.org/00/sep00_news.html#hhh</a><br /><br /><br /><br /><br />The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.<br /><br />TIP740203/l 0424 CONFIDENTIAL<br /><br />snip...<br /><br />The responses by the companies were presented by Ms Turner and were categorised by MCA standards, the products that were discussed were all low volume usage products eg sutures, heart valves.<br /><br />8. As the responses included some materials of human origin it was decided that more information should be sought about CJD. There had been 2 recent deaths reported associated with human growth hormone. These were being investigated.<br /><br />snip...<br /><br /><br /><a href="http://www.mad-cow.org/00/may00_news.html#aaa">http://www.mad-cow.org/00/may00_news.html#aaa</a><br /><br /><br /><br /><br />5.3.3 The greatest risk, in theory, would be from parenteral injection of material derived from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation which are prepared from bovine tissues, or which utilise bovine serum albumin or similar agents in their manufacture, might also be capable of transmitting infectious agents. All medicinal products are licensed under the Medicines Act by the Licensing Authority following guidance, for example from the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials (CDSM) and their subcommittees. The Licensing Authority have been alerted to potential concern about BSE in medicinal products and will ensure that scrutiny of source materials and manufacturing processes now takes account of BSE agent.<br /><br />see all 76 pages ;<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102132706/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf">http://collections.europarchive.org/tna/20080102132706/http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf</a><br /><br /><br /><br /><br />EXPORT OF BRITISH BIOLOGICAL PHARMACEUTICALS<br /><br />1. Please see the attached note of a recent meeting in Brussels. For Dr. Purford should read Dr. Purves (I think). If the Germans get their way, and it looks as if they might, because of worries about BSE we could end up with a ban on certain bovine materials being exported from the UK for pharmaceutical manufacture. Thse materials include cell cultures of bovine origin (? and also any cultures which have been fed bovine nutrient material), bovine serum, and fetal calf serum.<br /><br />2. Whilst export of these raw materials may be very limited, it is only a small step to include in this export ban any finished product made from such materials. This would include virtually all biologicals and vaccines. This could have very serious effects on the export trade of British Manufacturers of biologicals because even where they source their bovine ingredients outside the UK it might be impossible or at least very difficult to bypass any export ban.<br /><br />3. Our own line is that we have not used regulations to restrict the use of British bovine material for non-food use, although certain offals cannot be used for human consumption. ...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102220244/http://www.bseinquiry.gov.uk/files/yb/1990/03/13002001.pdf">http://collections.europarchive.org/tna/20080102220244/http://www.bseinquiry.gov.uk/files/yb/1990/03/13002001.pdf</a><br /><br /><br /><br /><br />Export of British 'Biological' Pharmaceuticals<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102220202/http://www.bseinquiry.gov.uk/files/yb/1990/03/13008001.pdf">http://collections.europarchive.org/tna/20080102220202/http://www.bseinquiry.gov.uk/files/yb/1990/03/13008001.pdf</a><br /><br /><br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102215829/http://www.bseinquiry.gov.uk/files/yb/1990/03/13009001.pdf">http://collections.europarchive.org/tna/20080102215829/http://www.bseinquiry.gov.uk/files/yb/1990/03/13009001.pdf</a><br /><br /><br /><br /><br />No papers were presented by our American guests and none covered the subject of pharmaceuticals. ...<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102220453/http://www.bseinquiry.gov.uk/files/yb/1990/04/02002001.pdf">http://collections.europarchive.org/tna/20080102220453/http://www.bseinquiry.gov.uk/files/yb/1990/04/02002001.pdf</a><br /><br /><br /><br /><br />STANDING COMMITTEE MEETING ON BSE<br /><br />Thanks for your note. I am disappointed not to have been informed about this meeting in advance and am surprised that Dr. Tyrrell was not involved either. I find it insulting to be told the proceedings were in confidence and find your excuse about only hosting the meeting unconvincing.<br /><br /><br /><a href="http://collections.europarchive.org/tna/20080102220555/http://www.bseinquiry.gov.uk/files/yb/1990/04/06002001.pdf">http://collections.europarchive.org/tna/20080102220555/http://www.bseinquiry.gov.uk/files/yb/1990/04/06002001.pdf</a><br /><br /><br /><br /><br />The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.<br /><br />TIP740203/l 0424 CONFIDENTIAL<br /><br />Mr Cunningham CMP3 From: D O Hagger MBI Dr Salisbury MED/IMCD3 Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989 Mr Dudley PD/AD4<br /><br />snip...<br /><br />89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g<br /><br />From: Dr H Pickles Med SEB/B Date: 3 July 1989<br /><br />CATTLE BY-PRODUCTS AND BSE<br /><br />I was interested to see the list of by-products sent to the HSE. Those of particular concern included:<br /><br />* small intestines: sutures (I thought the source was ovine but you are checking this)<br /><br />* spinal cord: pharmaceuticals<br /><br />* thymus: pharmaceuticals<br /><br />Are you able to give me more information on which UK manufacturers use these materials? Our proposed ban on bovine offal for human consumption would not affect these uses, I assume.<br /><br />snip...see full text ;<br /><br /><br /><a href="http://www.mad-cow.org/00/may00_news.html">http://www.mad-cow.org/00/may00_news.html</a><br /><br /><br /><br /><br /><a href="http://www.javno.com/en/world/clanak.php?id=32047">http://www.javno.com/en/world/clanak.php?id=32047</a><br /><br /><br /><br /><br /><a href="http://creutzfeldt-jakob-disease.blogspot.com/2007/12/risk-factors-for-sporadic-creutzfeldt.html">http://creutzfeldt-jakob-disease.blogspot.com/2007/12/risk-factors-for-sporadic-creutzfeldt.html</a><br /><br /><br /><br /><br /><a href="http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html">http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html</a><br /><br /><br /><br /><br />Research Lead: Dr. David Westaway, University of Alberta<br /><br />Project: "Extending the spectrum of Prionopathies to Amyotrophic Lateral Sclerosis and Autism"<br /><br />This project proposes to link the chemistry of the prion protein to the new territory of other nervous system diseases, such as ALS (Lou Gehrig's disease) and the socialization disorder autism-diseases which are at least one thousand times more common than prion diseases. It is believed that a different type or prion protein may operate in other types of brain diseases, which could lead to new ways of thinking about incurable disorders. The project will create changes in the amounts of the various forms of the new membrane protein, and then perform an array of analyses on the behavior and nervous system transmission of laboratory mice. Nervous transmission by electrical impulse can be measured in isolated brain cells, a system that is also convenient to study the effect of stress by adding small amounts of toxins to the fluids bathing the cultures. By these means, the project aims to extend the boundaries of what is considered "prion disease."<br /><br />Funding: $520,500<br /><br /><br /><a href="http://www.prioninstitute.ca/index.php?page=webpages&menucat=42&id=26&action=displaypage&side=1">http://www.prioninstitute.ca/index.php?page=webpages&menucat=42&id=26&action=displaypage&side=1</a><br /><br /><br /><br /><br />Unfolding the Prion Mystery Building and Growing Research Expertise in Alberta Year 4 2008-2009 Annual Report<br /><br />Dr. David Westaway, University of Alberta Extending the spectrum of prionopathies to amyotrophic lateral sclerosis (ALS) and autism Dr. Westaway’s study aims to extend the boundaries of what is considered prion disease. His project takes the chemistry of the prion protein into the territory of nervous system diseases such as ALS (Lou Gehrig’s disease) and socialization disorder diseases such as autism. These brain diseases are at least 1,000 times more common than diseases currently accepted as prion related. Dr. Westaway hypothesizes that a different type of protein misfolding may operate in brain diseases such as Lou Gehrig’s and autism. This type of protein misfolding may occur in response to stresses in the brain. Unlike misfolded prions, other misfolded proteins may be noninfectious and not viable outside of the affected animal. Dr. Westaway’s research team will investigate these hypotheses by inducing changes in the brain cells of laboratory mice, measuring the resulting electrical impulses in the animals’ nervous systems and analyzing the effect on behaviour. Because nervous transmission by electrical impulse can be measured in isolated brain cells, adding small amounts of toxins to the fluids bathing the cell cultures will make it possible to study the effect of stress. The results could lead to new ways of thinking about nervous system disorders.<br /><br /><br /><a href="http://www.prioninstitute.ca/forms/WEBSITE%20AR.pdf">http://www.prioninstitute.ca/forms/WEBSITE%20AR.pdf</a><br /><br /><br /><br /><br />Wednesday, February 3, 2010<br /><br />Import Alert 62-07 Sygen Injectable (Bovine-Extracted GMI Monosialoganglioside) manufactured from bovine brain starting material<br /><br /><br /><a href="http://bseusa.blogspot.com/2010/02/import-alert-62-07-sygen-injectable.html">http://bseusa.blogspot.com/2010/02/import-alert-62-07-sygen-injectable.html</a><br /><br /><br /><br /><br />Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 flounder@verizon.netTerry S. Singeltary Sr.http://www.blogger.com/profile/06986622967539963260noreply@blogger.com0