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My mother was murdered by what I call corporate and political homicide i.e. FOR PROFIT! she died from a rare phenotype of CJD i.e. the Heidenhain Variant of Creutzfeldt Jakob Disease i.e. sporadic, simply meaning from unknown route and source. I have simply been trying to validate her death DOD 12/14/97 with the truth. There is a route, and there is a source. There are many here in the USA. WE must make CJD and all human TSE, of all age groups 'reportable' Nationally and Internationally, with a written CJD questionnaire asking real questions pertaining to route and source of this agent. Friendly fire has the potential to play a huge role in the continued transmission of this agent via the medical, dental, and surgical arena. We must not flounder any longer. ...TSS

Sunday, February 15, 2009

Scientists warn of first ever case of human mad cow disease from blood plasma

Scientists warn of first ever case of human mad cow disease from blood plasma

The first case of a person being infected with the human form of mad cow disease after receiving contaminated blood plasma has been identified by scientists.

By Patrick Hennessy and Laura Donnelly Last Updated: 11:10AM GMT 15 Feb 2009

Scientists fear there could be a second wave of the human variant of mad cow disease, which was caused by cattle being fed the remains of other cattle in the 1980s Photo: EPA The man was one of thousands of haemophiliacs who received blood plasma transfusions in the years before strict controls were brought in to eliminate the spread of variant Creutzfeldt-Jakob disease (vCJD).

Until now, scientists had maintained that the 4,000 people who may have received plasma from infected donors were at very low risk of developing the fatal brain disease. Warnings were issued to them as a "highly precautionary measure".

But the Health Protection Agency is expected to announce on Tuesday that an elderly man, who died from other causes, contracted vCJD from plasma.

Although vCJD has been transmitted by blood donations in the past, leading to three deaths, no cases of infection had ever been linked to plasma, which is used to clot blood. Scientists had believed the processing and dilution of the product before it is injected into patients significantly reduced the risks.

BSE expert Professor Hugh Pennington, Emeritus Professor of Bacteriology at Aberdeen University said the findings would have "significant implications" for thousands of people who had been given plasma before the dangers were suspected.

"This looks like pretty grim news for a group of people who have been through fire and water for so long; they have already had increased exposure to hepatitis B and HIV," he said.

Warnings were sent to 4,000 haemophiliacs, and patients suffering from other rare blood conditions in 2004 to warn them that they had had received transfusions from 200 batches of blood products at risk of contamination with vCJD. The plasma was collected from nine people who went on to develop the brain-wasting disease.

All 4,000 were advised not to give blood or donate organs and to warn doctors and dentists that they had been put at risk by the use of plasma.

To date, 164 people have died from vCJD in Britain, with most cases linked to eating meat infected with bovine spongiform encephalopathy.

Prof Pennington said details of the way the new link had been detected would be crucial in determining further investigations.

"There is a lot more we still need to know. The fact that this person is elderly, when most of the deaths from vCJD have been young people, and that they died from another cause, is another area for research," he said, suggesting that it might mean that the disease progressed more slowly in some people.

He said restrictions over blood donation, which mean anyone who has had a transfusion cannot donate, and that all plasma is now taken from stocks in the United States, meant the risks to those receiving blood or plasma now were "vanishingly low".

The brain-wasting disease vCJD was first detected in the mid 1990s. Most vCJD patients have been infected after eating BSE contaminated meat. The number of deaths peaked in 2000, when there were 28 deaths. That number has dropped to about five cases a year since 2005.

The epidemic of BSE in the 1980s and 1990s was caused by cattle being fed the remains of other cattle in the form of meat and bone meal, causing an infectious agent to spread.

More than 4 million cattle were slaughtered after almost 200,000 were infected with the fatal neurodegenerative disease.

Scientists recently warned that Britain could see a second wave of the vCJD, affecting as many as 300 people, after discovering that genetic differences can affect how long it takes a person to incubate the disease.





http://www.telegraph.co.uk/health/4624348/Scientists-warn-of-first-ever-case-of-human-mad-cow-disease-from-blood-plasma.html





Title a bit misleading, should have probably read something like ;



>>>Scientists warn of first ever DOCUMENTED case of human mad cow disease from blood plasma<<<


WITH the many strains or phenotypes of the sporadic CJD's, plus, the NEW TSE announced last year by Gambetti et al here in the USA, it would seem prudent to a look back at all TSE suspect donors, considering the terribly poor BSE surveillance system in the USA, and especially since all strains of BSE have been documented in North America i.e. the typical UK c-BSE strain, the H and L atypical BSE strain in Canada, and the TWO cases of H type cases in Texas and Alabama, plus the one typical c-BSE imported case in Washington. anyone that does not think the L-BSE strain is in not in the USA, considering for one thing, the infamous 'enhanced june 2004 bse surveillance' was flawed from the beginning, before it was shut down just about completely, well they would only be dreaming in my opinion. considering all these factors, there is a high likelihood, also in my opinion, that the USA blood supply has been tainted with TSE for some time. let's take another _look back_ at the nvCJD ONLY blood recalls in the USA ; AMERICAN RED CROSS AND CDC BLOOD DONOR "LOOK BACK" STUDY Due to the recent discovery of two cases of vCJD blood transfusion transmission in the U.K. the American Red Cross, at the October 14 FDA TSEAC meeting, announced an acceleration of their "Look Back" study implemented in 1995. In this study all blood and blood products donated to the American Red Cross by a person who subsequently died of CJD will be traced. This "Look Back" study is a very important one for all of our families of CJD patients, past and present. If your loved one was a blood donor or a blood recipient and you wish to participate please contact one of the names listed below. As the wife of a regular blood donor who died of CJD in 2000 I am relieved to know that this study is being given high priority by the ARC and the CDC. I know we all certainly hope that sCJD is not a vector, however, we won't know unless this research is conducted. The recipients of any whole blood or blood product donated by a person who subsequently died of CJD will NOT be notified unless medically appropriate notification and counseling is deemed necessary by the health care provider. Contact Information: Kerri Dorsey, MPH 301-738-0592 E-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:dorseyke@usa.redcross.org

Shimian Zou, PhD 301-738-0644 E-mail: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:zous@usa.redcross.org


SEE CJD VOICE ;

10/24/2004 AMERICAN RED CROSS AND CDC : BLOOD DONOR “LOOK BACK” STUDY




http://creativegumbo.net/cjdvoice/newsflash.htm





Thursday, December 04, 2008 2:37 PM

"we have found that H-BSE can infect humans."

personal communication with Professor Kong. ...TSS



see full text ;





http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html






Quick Summary for the Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) Oct 14, 2004



In the afternoon open public hearing Peter L. Page, MD, from the American Red Cross presented their “CJD Lookback Study”; Michael Fitzpatrick, PhD, of America’s Blood Centers requested FDA consider an “exit strategy” for CJD deferrals. Other presentations and comments were made by: Robert Rohwer, PhD, VA Hospital Baltimore; Merlyn Sayers, MD, PhD, Carter Blood Care; Jonathan Goldsmith, MD, Immune Deficiency Foundation and David Cavenaugh, Committee of Ten Thousand. Three written submissions to the meeting record were received including a copy of a letter from a woman in the UK to her husband’s consultant regarding vCJD and questions from her for this meeting, an e-mail from Terry Singletary and an e-mail from Barbara Sachau. The major topic of the meeting was a discussion entitled, “Consideration of Current FDA-Recommended Safeguards to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products”. In preparation for discussion of this topic the Committee listened to the following presentations:


snip...




http://www.fda.gov/OHRMS/DOCKETS/ac/04/minutes/2004-4075M1_Summary%20minutes.pdf






From: Terry S. Singeltary Sr.

To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:FREAS@CBER.FDA.GOV

Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:william.freas@fda.hhs.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:rosanna.harvey@fda.hhs.gov


Sent: Friday, December 01, 2006 2:59 PM

Subject: Re: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION



----- Original Message -----

From: Terry S. Singeltary Sr.

To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:FREAS@CBER.FDA.GOV

Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:william.freas@fda.hhs.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:rosanna.harvey@fda.hhs.gov

Sent: Wednesday, November 29, 2006 1:24 PM Subject: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION]

November 29, 2006

Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al,


a kind and warm Holiday Greetings to you all.


i kindly wish to submit the following to the TSE advisory committee for the meeting December 15, 2006, about the assessment for potential exposure to vCJD in human plasma-derived antihemophilic factor (FVIII) products manufactured from U.S. plasma donors and related communication material ;



http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-20251.htm




i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;



http://www.newsday.com/news/health/ats-ap_health14nov27,0,7955259.story?coll=ny-leadhealthnews-headlines




however, i seem to disagree. from my primitive ciphering, i see it another way. this is a huge catastrophic risk. 3 in 160 is 1.9%. so call that 2% which is 1 in 50 or twenty per thousand or 20,000 per million. also, what about the mixed genotypes/mixed susceptibility? what about the silent carriers that donated tainted blood? what about the sporadic CJDs of UNKNOWN strain or phenotype? this risk assessment is just more BSe to me. Just another in a long line of industry fed crap. i pray that my assessment is the one that is wrong. but it is THEY who roll the dice with your life. It is THEY who refuse to regulate an industry that has run amok. just from a recall aspect of potentially tainted blood, and these are just recent recalls ;

PRODUCT Source Plasma, Recall # B-0054-7 CODE Units: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891, 03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969, 03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588, 03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228, 03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628, 03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707, 03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189, 03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979, 03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707, 04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719, 04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816, 04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063, 04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485, 04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930, 04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578 RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 89 units DISTRIBUTION CA and Austria

END OF ENFORCEMENT REPORT FOR October 25, 2006

###



http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.html




USA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ______________________________ PRODUCT Source Plasma, Recall # B-1708-6 CODE Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140, MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855, MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136, MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343, 04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504, 05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874, 05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236, 05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336, 05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907, 05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277, 05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355, 05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892, 05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962 RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005. Firm initiated recall is complete. REASON Blood products, collected from unsuitable donors based on risk factors for Creutzfeldt-Jakob Disease (CJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 80 units DISTRIBUTION CA, NC, and MD

______________________________

PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6; b) Fresh Frozen Plasma, Recall # B-1715-6; c) Platelets, Recall # B-1716-6 CODE a), b), and c) Unit: 2443732 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by letters dated November 11, 2003 and December 18, 2003. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION TX and WI

END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006

###



http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.html




PRODUCT Fresh Frozen Plasma, Recall # B-1751-6 CODE Unit: 4936623 RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated September 16, 2005. Firm initiated recall is complete. REASON Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION TX

END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006

###



http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html



Mon Aug 7, 2006 10:24 71.248.132.189

PRODUCT a) Red Blood Cells, Recall # B-1587-6; b) Cryoprecipitated AHF, Recall # B-1588-6; c) Recovered Plasma, Recal # B-1589-6 CODE a), b) and c) Unit: 2016719 RECALLING FIRM/MANUFACTURER Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on March 13, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION GA and Germany

______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6; b) Fresh Frozen Plasma, Recall # B-1591-6 CODE a) and b) Unit: 2443595 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 30, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX

______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6; b) Fresh Frozen Plasma, Recall # B-1593-6 CODE a) and b) Unit: 2545596 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 14, 2004 and January 3, 2005. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX

______________________________



http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html




PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6; b) Fresh Frozen Plasma, Recall # B-1551-6 CODE a) and b) Unit 2395371 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6; b) Platelets, Recall # B-1553-6; c) Fresh Frozen Plasma, Recall # B-1554-6 CODE a), b) and c) Unit 2438702 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION TX

______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6; b) Fresh Frozen Plasma, Recall # B-1556-6 CODE a) and b) Unit 2454970 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX

______________________________ PRODUCT a) Red Blood Cells, Recall # B-1494-6 b) Cryoprecipitated AHF, Recall # B-1495-6 CODE a) and b) Unit 5013100 RECALLING FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May 17, 2005. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION GA

______________________________ PRODUCT Source Plasma, Recall # B-1450-6 CODE Unit numbers ST0824313 and ST0824764 RECALLING FIRM/MANUFACTURER Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION UK

______________________________ PRODUCT Plasma Frozen, Recall # B-1422-6; Recovered Plasma, Recall # B-1423-6 CODE a) Unit 03E42218; b) Unit 03E38153 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail or letter on February 20 or 21, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION GA and Switzerland

______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6; b) Recovered Plasma, Recall # B-1375-6 CODE a) and b) unit 2453906 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX and Austria

______________________________ PRODUCT Source Plasma. Recall # B-1295-6 CODE Units: NG0046551, NG0045950 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002, Firm initiated recall is complete. REASON Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION KY

______________________________ PRODUCT Source Plasma. Recall # B-1296-6 CODE Unit: NG 0044520 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 12, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION KY

______________________________ PRODUCT Source Plasma. Recall # B-1297-6 CODE Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020, NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 13 units DISTRIBUTION KY

______________________________ PRODUCT Source Plasma, Recall # B-1298-6 CODE Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG 0042525, NG 0042341 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units DISTRIBUTION KY

______________________________ PRODUCT Recovered Plasma, Recall # B-1299-6 CODE Unit: 4357117 RECALLING FIRM/MANUFACTURER Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete. REASON Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Germany

END OF ENFORCEMENT REPORT FOR July 12, 2006

###



http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html




CJD WATCH MESSAGE BOARD TSS


FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY Fri Jul 7, 2006 09:37 70.110.83.160

FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY

PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6; b) Platelets, Recall # B-1380-6; c) Fresh Frozen Plasma, Recall # 1381-6; d) Recovered Plasma, Recall # B-1382-6 CODE a) Unit numbers: 2343106, 2377779, and 2403533; b) and c) Unit numbers: 2377779; d) Unit numbers: 2343106 and 2403533 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 12, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units DISTRIBUTION TX and Austria ______________________________

PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6; b) Recovered Plasma, Recall # B-1468-6 CODE a) and b) Unit numbers: 2329380 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX and Switzerland

______________________________

PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6; b) Cryoprecipitated AHF, Recall # B-1480-6; c) Recovered Plasma, Recall # B-1481-6 CODE a), b), and c) Unit numbers: 2383280 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 23 and 29, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION TX and Switzerland

______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6; b) Fresh Frozen Plasma, Recall # B-1483-6 CODE a) and b) Unit number: 2501452 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 5, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX and NY

______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6; b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6; c) Recovered Plasma, Recall # B-1486-6 CODE a) and c) Unit number: 2554077; b) Unit number: 2415708 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 13, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION TX and Austria

_____________________________________

END OF ENFORCEMENT REPORT FOR July 5, 2006

###



http://www.fda.gov/bbs/topics/enforce/2006/ENF00959.html




Greetings again Dr. Freas et al at FDA,

WITH new atypical TSE in the bovine, in the sheep, goat, and humans, and the fact that the new BASE TSE in cattle being very very similar to sporadic CJD, rather than the nvCJD, the fact that now science showing the TSE agent of the atypical cattle in Japan showing infectivity other than CNS tissue, the fact that the latest Texas mad cow and the recent Alabama mad cow both being of the atypical strain, it would seem prudent to include all human TSE in the blood ban, in my opinion. with sporadic CJD, you have many strains and or phenotypes, some of which are 'UNKNOWN', so we do not know how this will transmit, what tissues are infectious and or if blood transmits. that's the bottom line, however it has been reported that the BASE is more virulent to humans. With this, and the fact that sporadic CJD has tripled in the past few years or so, i see it as being prudent to take serious and immediate action ;

PERSPECTIVE

On the Question of Sporadic or Atypical Bovine Spongiform Encephalopathy and Creutzfeldt-Jakob Disease

Paul Brown,* Lisa M. McShane,† Gianluigi Zanusso,‡ and Linda Detwiler§

Strategies to investigate the possible existence of sporadic bovine spongiform encephalopathy (BSE) require systematic testing programs to identify cases in countries considered to have little or no risk for orally acquired disease, or to detect a stable occurrence of atypical cases in countries in which orally acquired disease is disappearing. To achieve 95% statistical confidence that the prevalence of sporadic BSE is no greater than 1 per million (i.e., the annual incidence of sporadic Creutzfeldt-Jakob disease [CJD] in humans) would require negative tests in 3 million randomly selected older cattle. A link between BSE and sporadic CJD has been suggested on the basis of laboratory studies but is unsupported by epidemiologic observation. Such a link might yet be established by the discovery of a specific molecular marker or of particular combinations of trends over time of typical and atypical BSE and various subtypes of sporadic CJD, as their numbers are influenced by a continuation of current public health measures that exclude high-risk bovine tissues from the animal and human food chains. ......

PLEASE READ FULL TEXT ;



http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm?s_cid=eid06_0965_e




CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006

The U.S. Department of Agriculture was quick to assure the public earlier this week that the third case of mad cow disease did not pose a risk to them, but what federal officials have not acknowledged is that this latest case indicates the deadly disease has been circulating in U.S. herds for at least a decade.

The second case, which was detected last year in a Texas cow and which USDA officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a picture of the disease having been here for 10 years or so, since it is thought that cows usually contract the disease from contaminated feed they consume as calves. The concern is that humans can contract a fatal, incurable, brain-wasting illness from consuming beef products contaminated with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that."

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.

USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end

http://www.upi.com/


*** Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain



http://www.usda.gov/oig/webdocs/50601-10-KC.pdf




Prion infections, blood and transfusions

Adriano Aguzzi* and Markus Glatzel

Prion infections lead to invariably fatal diseases of the CNS, including Creutzfeldt-Jakob disease (CJD) in humans, bovine spongiform encephalopathy (BSE), and scrapie in sheep. There have been hundreds of instances in which prions have been transmitted iatrogenically among humans, usually through neurosurgical procedures or administration of pituitary tissue extracts. Prions have not generally been regarded as bloodborne infectious agents, and case-control studies have failed to identify CJD in transfusion recipients. Previous understanding was, however, questioned by reports of prion infections in three recipients of blood donated by individuals who subsequently developed variant CJD. On reflection, hematogenic prion transmission does not come as a surprise, as involvement of extracerebral compartments such as lymphoid organs and skeletal muscle is common in most prion infections, and prions have been recovered from the blood of rodents and sheep. Novel diagnostic strategies, which might include the use of surrogate markers of prion infection, along with prion removal strategies, might help to control the risk of iatrogenic prion spread through blood transfusions. ...

snip...

Last, despite all epidemiological evidence to the contrary, patients who are methionine/valine heterozygous at codon 129 of the PRNP gene are susceptible to infection with vCJD prions, which raises several important questions. Is the virulence of BSE prions enhanced when passaged from human to human, as opposed to the original bovine to human situation? Passaging experiments of scrapie infectivity between mice and hamsters indicate that this scenario is highly plausible.6 Even more importantly, can vCJD infection of heterozygous individuals establish a permanent subclinical carrier state? Although this situation might constitute a best-case scenario for the infected individuals, it could be disastrous from an epidemiological viewpoint, as it might lead to an unrecognized and possibly self-sustaining epidemic. ...

snip... full text ;

JUNE 2006 VOL 2 NO 6 AGUZZI AND GLATZEL NATURE CLINICAL PRACTICE NEUROLOGY 329



www.nature.com/clinicalpractice/neuro




FDA Fines American Red Cross $4.2 Million (BLOOD CJD) Fri Sep 8, 2006 20:01 71.248.154.242

FDA Statement FOR IMMEDIATE RELEASE Statement September 8, 2006 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Fines American Red Cross $4.2 Million for Failure to Meet Established Blood Safety Laws



http://www.fda.gov/cber/talkpapers.htm#arc




snip...

One way the Red Cross erred was by failing to ask donors about travel history that could increase the chances of having malaria or the human version of mad cow disease, FDA officials said.

snip...




http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-09-08T224834Z_01_N08403053_RTRIDST_0_HEALTH-REDCROSS-DC.XML




http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-09-08T224834Z_01_N08403053_RTRIDST_0_HEALTH-REDCROSS-DC.XML&pageNumber=1&imageid=&cap=&sz=13&WTModLoc=NewsArt-C1-ArticlePage1




Greetings again Dr. Freas et al at FDA,

THIS was like closing the barn door after the mad cows got loose. not only the red cross, but the FDA has failed the public in protecting them from the TSE aka mad cow agent. TSE agent i.e. bse, base, cwd, scrapie, tme, and any sub strains thereof. we do not know if these strains will or have transmitted to humans as subclinical TSE or clinical disease, and we do not know if they have or will transmit second, third, forth passage via friendly fire i.e. multiple potential routes via medical, surgical, pharmaceutical etc.

IF you remember correctly Dr. Freas et al, i called this long ago, almost 6 years ago ;

To: Freas, William
From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Monday, January 08,200l 3:03 PM
To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:freas@CBS5055530.CBER.FDA.GOV

Subject: CJDIBSE (aka madcow) Human/Animal TSE's--U.S.--Submission To Scientific Advisors and Consultants Staff January 2001 Meeting (short version)


Greetings again Dr. Freas and Committee Members,


I wish to submit the following information to the Scientific Advisors and Consultants Staff 2001 Advisory Committee (short version). I understand the reason of having to shorten my submission, but only hope that you add it to a copy of the long version, for members to take and read at their pleasure, (if cost is problem, bill me, address below). So when they realize some time in the near future of the 'real' risks i speak of from human/animal TSEs and blood/surgical products. I cannot explain the 'real' risk of this in 5 or 10 minutes at some meeting, but will attempt here:

remember AIDS/HIV, 'no problem to heterosexuals in the U.S.? no need to go into that, you know of this blunder:

DO NOT make these same stupid mistakes again with human/animal TSE's aka MADCOW DISEASE.

I lost my Mom to hvCJD, and my neighbor lost his Mother to sCJD as well (both cases confirmed). I have seen many deaths, from many diseases. I have never seen anything as CJD, I still see my Mom laying helpless, jerking tremendously, and screaming "God, what's wrong with me, why can't I stop this". I still see this, and will never forget. Approximately 10 weeks from 1st of symptoms to death. This is what drives me. I have learned more in 3 years about not only human/animal TSE's but the cattle/rendering/feeding industry/government than i ever wished to. I think you are all aware of CJD vs vCJD, but i don't think you all know the facts of human/animal TSE's as a whole, they are all very very similar, and are all tied to the same thing, GREED and MAN.

I am beginning to think that the endless attempt to track down and ban, potential victims from known BSE Countries from giving blood will be futile. You would have to ban everyone on the Globe eventually? AS well, I think we MUST ACT SWIFTLY to find blood test for TSE's, whether it be blood test, urine test, eyelid test, anything at whatever cost, we need a test FAST.

DO NOT let the incubation time period of these TSEs fool you. To think of Scrapie as the prime agent to compare CJD, but yet overlook the Louping-ill vaccine event in 1930's of which 1000's of sheep where infected by scrapie from a vaccine made of scrapie infected sheep brains, would be foolish. I acquired this full text version of the event which was recorded in the Annual Congress of 1946 National Vet. Med. Ass. of Great Britain and Ireland. From the BVA and the URL is posted in my (long version).

U.S.A. should make all human/animal TSE's notifiable at all ages, with requirements for a thorough surveillance and post-mortem examinations free of charge, if you are serious about eradicating this horrible disease in man and animal. There is histopathology reports describing "florid plaques" in CJD victims in the USA and some of these victims are getting younger. I have copies of such autopsies, there has to be more. PLUS, sub-clinical human TSE's will most definitely be a problem.

THEN think of vaccineCJD in children and the bovine tissues used in the manufacturing process, think of the FACT that this agent surviving 6OO*C. PNAS -- Brown et al. 97 (7): 3418 scrapie agent live at 600*C Then think of the CONFIDENTIAL documents of what was known of human/animal TSE and vaccines in the mid to late 8Os, it was all about depletion of stock, to hell with the kids, BUT yet they knew. To think of the recall and worry of TSE's from the polio vaccine, (one taken orally i think?), but yet neglect to act on the other potential TSE vaccines (inoculations, the most effective mode to transmit TSEs) of which thousands of doses were kept and used, to deplete stockpile, again would be foolish. --Oral polio; up to 1988, foetal calf serum was used from UK and New Zealand (pooled); since 1988 foetal calf serum only from New Zealand. Large stocks are held. --Rubella; bulk was made before 1979 from foetal calf serum from UK and New Zealand. None has been made as there are some 15 years stock. --Diphtheria; UK bovine beef muscle and ox heart is used but since the end of 1988 this has been sourced from Eire. There are 1,250 litres of stock. --Tetanus; this involves bovine material from the UK mainly Scottish. There are 21,000 litres of stock. --Pertussis; uses bovine material from the UK. There are 63,000 litres of stock. --They consider that to switch to a non-UK source will take a minimum of 6-18 months and to switch to a non-bovine source will take a minimum of five years. 3. XXXXXXXXXXX have measles, mumps, MMR, rubella vaccines. These are sourced from the USA and the company believes that US material only is used. 89/2.14/2.1 ============ BSE3/1 0251 4. XXXXXXXXXXX have a measles vaccine using bovine serum from the UK. there are 440,000 units of stock. They have also got MMR using bovine serum from the UK. 5. XXXXXXXXXXX have influenza, rubella, measles,' MMR vaccines likely to be used in children. Of those they think that only MMR contains bovine material which is probably a French origin. 6. XXXXXXXXXXX have diphtheria/tetanus and potasses on clinical trial. These use veal material, some of which has come from the UK and has been ade by XXXXXXXXXXX (see above). I have documents of imports from known BSE Countries, of ferments, whole blood, antiallergenic preparations, human blood plasma, normal human blood sera, human immune blood sera, fetal bovine serum, and other blood fractions not elsewhere specified or included, imported glands, catgut, vaccines for both human/animal, as late as 1998.

Let us not forget about PITUITARY EXTRACT. 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. ANNEX 6: MEETING HELD ON 8 JUNE 1988 TO DISCUSS THE IMPLICATIONS OF BSE TO BIOLOGICAL PRODUCTS CONTAINING BOVINE - EXTRACTED MATERIAL How much of this was used in the U.S.? Please do not keep making the same mistakes. 'Absence of evidence is not evidence of absence'.

What are the U.S. rules for importing and manufacturing vaccines, medicines and medical devices? Does the U.S.A. allow sourcing of raw material of ruminants from the U.S.A.?

U.S. cattle, what kind of guarantee can you give for serum or tissue donor herds.?

The U.S. rendering system would easily amplify T.S.E.'s: Have we increased the stability of the system (improved heat treatments) since the EU SSC report on the U.S.A. was published in july 2000?

What is done to avoid cross-contaminations in the U.S.A.? How can the U.S. control absence of cross-contaminations of animal TSE's when pig and horse MBM and even deer and elk are allowed in ruminant feed, as well as bovine blood?

I sadly think of the rendering and feeding policy before the Aug. 4, 1997 'partial' feed ban, where anything went, from the city police horse, to the circus elephant, i will not mention all the scrapie infected sheep. I am surprised that we have not included man 'aka soyent green'. It is a disgusting industry and nothing more than greed fuels it. When will the U.S.. start real surveillance of the U.S. bovine population (not passive, this will not work)?

When will U.S. start removing SRMs? Have they stopped the use of pneumatic stunners in the U.S.?

If so, will we stop it in all U.S. abattoirs or only in those abattoirs exporting to Europe? If not, WHY NOT?

same questions for removal of SRM in the U.S.A., or just for export? If not, WHY NOT?

How do we now sterilize surgical/dental instruments in the U.S.A.? Where have we been sourcing surgical catgut?
(i have copies of imports to U.S., and it would floor you)

When will re-usable surgical instruments be banned?

'Unregulated "foods" such as 'nutritional supplements' containing various extracts from ruminants, whether imported or derived from US cattle/sheep/cervids ("antler velvet" extracts!) should be forbidden or at least very seriously regulated. (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'). What is the use of banning blood or tissue donors from Germany, France, etc... when the U.S.A. continues exposing cattle, sheep and people to SRM, refuses to have a serious feed ban, refuses to do systematic BSE-surveillance?

The FDA should feel responsible for the safety of what people eat. prohibit the most dangerous foods, not only prohibit a few more donors, the FDA should be responsible for the safe sourcing of medical devices, not only rely on banning donors "from Europe", The 'real' risks are here in the U.S. as well, and have been for some time. We must not forget the studies that have proven infectivity in blood from TSE's.

The Lancet, November 9, 1985 " Sir, --Professor Manuelidis and his colleagues (Ott 19, p896) report transmission to animals of Creutzfeldt-Jakob disease (CJD) from the buffy coat from two patients. We also transmitted the disease from , whole blood samples of a patient (and of mice) infected with CJD.l Brain, Cornea, and urine from this patient were also infectious, and the clinicopathological findings2 are summarised as follows. snip...

full text ;



http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf




Greetings again Dr. Freas et al at FDA,

NOW, here we are in 2006, worried and still fumbling around with what should have been done long, long ago ;


snip...


ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)

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.

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. ...

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518

snip... see full text 48 pages, 1st page starts on page 13. ...TSS




http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8






-------- Original Message --------
Subject: Docket #03-025IF -- Docket #03-038IF -- Docket #01-033DF -- SUBMISSIONS -- USDA ISSUES NEW REGULATIONS TO ADDRESS BSE
Date: Thu, 08 Jan 2004 15:33:20 -0600 From: "Terry S. Singeltary Sr."
To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:fdadockets@oc.fda.gov
CC: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:Freas@cber.FDA.gov


Greetings FDA,

I would kindly like to make a submission to Federal Docket Docket #03-025IF -- Docket #03-038IF and Docket #01-033DF -- TSS SUBMISSIONS -- USDA ISSUES NEW REGULATIONS TO ADDRESS BSE



snip...


ONE FINAL COMMENT PLEASE, on the use of bovine blood (especially from downers) in milk replacers for calves. As the name implies, milk replacer is used in lieu of mother's milk. It contains a variety of ingredients, including whey (a dairy byproduct of cheese making), vitamins, minerals, medications, animal fats, and, in many replacers, cow and pig blood. I am _deeply_ concerned with this continued practice;

STUDY DESIGN AND METHODS: BSE was passaged through macaque monkeys and

then adapted to the prosimian microcebe (Microcebus murinus ). Brain

homogenate and buffy coat from an affected microcebe were separately

inoculated intracerebrally into three healthy microcebes (two animals

received brain and one received buffy coat).

RESULTS: All three inoculated microcebes became ill after incubation

periods of 16 to 18 months. Clinical, histopathologic, and

immunocytologic features were similar in each of the recipients.

CONCLUSION: Buffy coat from a symptomatic microcebe infected 17 months

earlier with BSE contained the infectious agent. This observation

represents the first documented transmission of BSE from the blood of an

experimentally infected primate, which in view of rodent buffy coat

infectivity precedents and the known host range of BSE is neither

unexpected nor cause for alarm.



http://www.blackwell-synergy.com/servlet/useragent?func=synergy&synergyAction=showAbstract&doi=10.1046/j.1537-2995.2002.00098.x




Transmission of prion diseases by blood transfusion

1 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 1 Institute for Animal Health, Neuropathogenesis Unit, West Mains Road, Edinburgh EH9 3JF, UK 2 Institute for Animal Health, Compton, Newbury, Berkshire RG20 7NN, UK Author for correspondence: Nora Hunter. Fax +44 131 668 3872. e-mail mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:nora.hunter@bbsrc.ac.uk Received 16 May 2002; Accepted 9 July 2002 This article is now available in the November 2002 print issue of JGV (vol. 83, 2897–2905). The complete issue of the journal may be seen in electronic form on JGV Online (http://vir.sgmjournals.org). 0001-8580 © 2002 SGM Abstract 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 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. Introduction Creutzfeldt–Jakob disease (CJD) is one of a group of related diseases...

snip...

14 Discussion With this report we have confirmed and extended our initial observation of a single case of BSE following transfusion of blood from a BSE-infected sheep and have provided the first conclusive evidence of significant levels of infectivity in blood in a naturally occurring TSE (scrapie). The experiment may take up to 5 years to complete; however, so far we have clear evidence of disease transmission by the blood transfusion route in 2 of 24 sheep (8 %) with BSE and 4 of 21 sheep (19 %) with scrapie, with two additional animals showing clinical signs in the BSE group. If the clinically suspect BSE-transfused sheep progress as expected, this would bring the transmission rate for BSE up to 17 %, comparable with the scrapie rate. Positive transmissions have occurred not only with samples taken from sheep at the clinical phase of disease but also with those from apparently healthy donors as early as halfway through the incubation period (Fig. 1, lane 9; no PrPSc detection in the brain of donor J2746). Each TSE is transmitting to its appropriate susceptible genotype (AXQ/AXQ for BSE and VRQ/VRQ for scrapie) and Western blot/glycoform analyses support the conclusion that donors and recipients are infected with the same strains of BSE and scrapie. Our negative controls remain healthy, although still at relatively early stages post-transfusion and our positive controls are developing clinical signs at around, or greater than, 600 days post-challenge, showing incubation periods very similar to the transfusion cases. Whole blood transfusion (400–450 ml) cases are presenting incubation periods of around 600 days, which is very similar to those resulting from i.v. injection of 0.2 g BSE cattle brain homogenate. The transfusions might be expected to be more efficient because they are a sheepto- sheep transmission with no species barrier, which contrasts with the i.v. brain infections, which is a cattle-to-sheep transmission. A full titration of the inoculum used in the cattle BSE brain i.v. controls is under way in mice but is incomplete at the time of writing. Accurate estimation of the levels of infectivity in blood will require i.v. titration in sheep; however, the results presented here suggest that they are significantly higher than suspected previously. Another important consideration is the distribution of infectivity among different blood components. Perhaps surprisingly, most positive transmissions so far have followed transfusion of whole blood rather than buffy coat, whereas previous studies have tended to find infectivity concentrated in the buffy coat fraction. As we now have a clinical case of scrapie resulting from transfusion of buffy coat, it is clear that, in our model, infectivity is also carried by the cells in this fraction. However, these preliminary results suggest that infectivity is not confined to the buffy coat fraction and that there may also be significant levels of infectivity in the plasma and/or red cell fractions. 15 The presence of infectivity in blood suggests that it should be possible to detect PrPSc or other surrogates of infectivity by alternative methods, with obvious benefits for development of ante-mortem diagnostic tests. Early reports of the use of capillary electrophoresis to detect PrPSc in the blood of scrapie-infected sheep showed some promise (Schmerr et al., 1997); however, a recent study could not detect PrPSc in peripheral blood leucocytes of scrapie-infected sheep using immunocytochemistry (Herrmann et al., 2002). PrPC is known to be expressed only on peripheral blood mononuclear cells in sheep, in contrast to humans where it is also found on platelets and, at low levels, on erythrocytes (Barclay et al., 2002; Herrmann et al., 2001; Holada et al., 1998). Since tissues that express PrPC do not always equate with areas that accumulate PrPSc and infectivity during disease, the distribution of infectivity in blood fractions of different species clearly merits more detailed analysis. Immunocytochemical detection of PrPSc in peripheral tissues of two of the BSE transfusion cases has shown a greatly reduced involvement of lymphoid tissues, including tonsil, in the peripheral pathogenesis compared with NPU Cheviot sheep orally infected with BSE or natural scrapie (Foster et al., 2001a). A recent report has shown that a proportion of Romney sheep in the late pre-clinical stages of infection with BSE following oral dosing (22 months post-infection) have PrPSc deposits in the CNS in the absence of any detectable involvement of peripheral lymphoid tissues (Jeffrey et al., 2001). This study also noted the relatively late and variable onset of PrPSc accumulation in the lymphoid tissues of BSE-infected sheep. A more detailed study of BSE and scrapie transfusion cases, and positive controls, will be undertaken to determine whether lack of involvement of the LRS is a consistent feature in animals infected by the i.v. route; the results will be published at a later date. If our preliminary observations are confirmed, there may be implications for human patients with the misfortune to have received blood products from vCJD cases, because a negative tonsil biopsy as a means of reassurance might very well be unreliable. On the other hand, it also may mean that if a human patient became infected with vCJD by the i.v. route, then the peripheral tissues and blood of this secondary case may not themselves be highly infectious. In conclusion, our results so far indicate that, with more than 10 % of transfusions resulting in disease in the recipients, blood transfusion represents an appreciable risk for transmission of TSEs in sheep and, by extension, of vCJD in human beings. The relatively short and consistent incubation periods seen in positive cases suggests that levels of infectivity in the blood may be higher than suspected previously, even in the pre-clinical stages of infection, and/or that transmission by the i.v. route is highly efficient. From these preliminary results, it would appear that measures taken to safeguard the blood supply in the UK are fully justified. However, further work, in particular a thorough investigation of the distribution of infectivity in different blood fractions, is required before a reliable estimate of the risks associated with contaminated blood products can be made. Acknowledgements The authors are indebted to the UK Department of Health, European Union and DEFRA for their financial contribution to this study.

Nora Hunter,1 James Foster,1 Angela Chong,1 Sandra McCutcheon,2 David

Parnham,1 Samantha Eaton,1 Calum MacKenzie1 and Fiona Houston2

see full text;



http://www.socgenmicrobiol.org.uk/JGVDirect/18580/18580ft.pdf




I have been concerned about transmission of TSEs to human/animals for some time;



http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm




PDF]Freas, William TSS SUBMISSION File Format: PDF/Adobe Acrobat - Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...



http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf




PLUS, now we have this factor to consider;


vCJD: Blood Transfusion Incident

3.58 p.m.

Lord Warner: My Lords, with permission, I wish to repeat a Statement made by my right honourable friend the Secretary of State for Health in another place. The Statement is as follows:

"With permission, Mr Speaker, I wish to make a Statement about a blood transfusion incident involving variant Creutzfeldt-Jakob Disease (vCJD). It may assist the House if I begin by setting out the basic facts before discussing the implications.

"In March 1996, a blood donor, who was at the time free of the signs of variant CJD, donated blood to the National Blood Service. Shortly after that, the donated blood was transfused into a patient who underwent surgery for a serious illness. In

17 Dec 2003 : Column 1170

continuing my description of the events to the House, I will from now on refer to those individuals as the 'donor' and the 'recipient' of the blood.

"The donor showed no signs of variant CJD at the time the blood was given, but developed the disease three years later—that is, in 1999—and died from it. The recipient of the blood died in the autumn of this year.

Initial post-mortem examination of the recipient of the blood showed changes in the brain indicative of CJD. Further examinations and tests of this patient's brain confirmed the diagnosis of variant CJD. The link between the donor and the recipient was first reported to officials in my department on 9th December 2003 at which time the diagnosis of variant CJD in the recipient was still being confirmed.

"I was first alerted to the developments on Friday 12th December and was briefed by the Chief Medical Officer on Monday and Tuesday this week. Today I am bringing this information to the House at the earliest opportunity. I have given and will give the minimal clinical details of the recipient, because the family has indicated that it wishes to have its privacy respected.

"In the light of the facts I have outlined, it is therefore possible that the disease was transmitted from donor to recipient by blood transfusion in circumstances where the blood of the donor was infectious three years before the donor developed variant CJD and where the recipient developed variant CJD after a six and a half year incubation period. This is a possibility, not a proven causal connection, because it is also possible that both individuals separately acquired variant CJD by eating BSE-infected meat or meat products....

snip...full text



http://www.publications.parliament.uk/pa/ld199697/ldhansrd/pdvn/lds03/text/31217-09.htm




WE must not forget the old findings from Manuelidis et al, TATEISHI et al, Hunter et al,

1: Science. 1978 Jun 2;200(4345):1069-71.

Viremia in experimental Creutzfeldt-Jakob disease.

Manuelidis EE, Gorgacs EJ, Manuelidis L.

Inoculation of the buffy coat of blood from guinea pigs infected with Creutzfeldt-Jakob disease resulted in passage of this disease to recipient animals. This demonstrates that there is a viremia in experimental Creutzfeldt-Jakob disease. These findings suggest that the hematogenous route may be implicated in the human infection and that the disease may possibly be transmitted by blood transfusions.

PMID: 349691 [PubMed - indexed for MEDLINE]




http://www.ncbi.nlm.nih.gov/entrez/quer





snip... full text ;





https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument






Subject: USA FDA BLOOD RECALL nvCJD aka mad cow disease From: "Terry S. Singeltary Sr." <[log in to unmask]> Reply-To: SAFETY <[log in to unmask]> Date: Mon, 9 Oct 2006 16:47:14 -0500 Content-Type: text/plain Parts/Attachments: text/plain (699 lines)

USA FDA BLOOD RECALL nvCJD aka mad cow disease

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ______________________________ PRODUCT Source Plasma, Recall # B-1708-6 CODE Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140, MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855, MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136, MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343, 04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504, 05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874, 05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236, 05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336, 05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907, 05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277, 05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355, 05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892, 05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962 RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005. Firm initiated recall is complete. REASON Blood products, collected from unsuitable donors based on risk factors for Creutzfeldt-Jakob Disease (CJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 80 units DISTRIBUTION CA, NC, and MD

______________________________





http://list.uvm.edu/cgi-bin/wa?A2=ind0610B&L=SAFETY&P=14990





A case-control study of sporadic Creutzfeldt-Jakob disease in Switzerland: analysis of potential risk factors with regard to an increased CJD incidence in the years 2001-2004




http://creutzfeldt-jakob-disease.blogspot.com/2009/02/case-control-study-of-sporadic.html





Thursday, January 29, 2009

Medical Procedures and Risk for Sporadic Creutzfeldt-Jakob Disease, Japan, 1999-2008 (WARNING TO Neurosurgeons and Ophthalmologists) Volume 15, Number 2-February 2009 Research




http://creutzfeldt-jakob-disease.blogspot.com/2009/01/medical-procedures-and-risk-for.html





Thursday, November 27, 2008

Prion diseases are efficiently transmitted by blood transfusion in sheep
TRANSFUSION MEDICINE




http://vcjdblood.blogspot.com/2008/11/prion-diseases-are-efficiently.html




vCJD case study highlights blood transfusion risk



http://vcjdblood.blogspot.com/





Номер архива
20061208.3468
День публикации
08-ДЕК-2006
Тема
PRO/AH/EDR> CJD (new var.), blood transfusion riskCJD (NEW VARIANT), BLOOD TRANSFUSION RISK





http://apex.oracle.com/pls/otn/f?p=2400:1202:5490148654931058710::NO::F2400_P1202_CHECK_DISPLAY,F2400_P1202_PUB_MAIL_ID:X,35445





http://www.promedmail.org/pls/otn/f?p=2400:1202:9557296506089968094::NO::F2400_P1202_CHECK_DISPLAY,F2400_P1202_PUB_MAIL_ID:X,28585





4th CASE VCJD VIA BLOOD TRANSFUSION, BSE, BASE, AND SPORADIC CJDBy Terry S Singeltary

Bacliff, Texas USA Jan 24, 07




http://www.bloodindex.org/view_news_zone.php?id=206




From: Terry S. Singeltary Sr. (216-119-130-97.ipset10.wt.net)

Subject: Other Transmission Studies of CJD from Blood and Urine Into Mice...

Date: September 18, 2000 at 2:01 pm PST




http://www.whale.to/v/singeltary4.html





From: TSS (216-119-138-163.ipset18.wt.net)

Subject: RE--CJD&CHILDREN-- could the 'v' in vCJD simply mean vaccineCJD?

Date: September 10, 2000 at 8:47 am PST



http://www.whale.to/v/singeltary7.html





Subject: Louping-ill vaccine documents from November 23rd, 1946

Date: Sat, 9 Sep 2000 17:44:57 -0700

From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy

To: BSE-L@uni-karlsruhe.de


######### Bovine Spongiform Encephalopathy #########


THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946

NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND

ANNUAL CONGRESS, 1946




http://www.whale.to/v/singeltary.html




Friday, October 24, 2008

CBER 2007 Annual Report Assessing the Potential Risk of variant Creutzfeldt-Jakob Disease from Blood Products



http://creutzfeldt-jakob-disease.blogspot.com/2008/10/cber-2007-annual-report-assessing.html




Tuesday, November 11, 2008SaBTO Summary of 1st Public Meeting - variant CJD and blood

Tuesday 21st October 2008, 2pm-4pm




http://vcjdblood.blogspot.com/2008/11/sabto-summary-of-1st-public-meeting.html




ONE HUNDRED AND FIRST MEETING OF THE SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEEOct 23, 2008 at 9:00 AM




http://seac992007.blogspot.com/2008/10/one-hundred-and-first-meeting-of_23.html




http://flounder068.vox.com/library/post/one-hundred-and-first-meeting-of-the-spongiform-encephalopathy-advisory-committee.html





vCJD case study highlights blood transfusion risk



http://vcjdblood.blogspot.com/




Owens, Julie
From: Terry S. Singeltary Sr. [flounder9@verizon.net]
Sent: Monday, July 24, 2006 1:09 PM
To: FSIS RegulationsCommentsSubject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)Page 1 of 988/3/2006


Greetings FSIS,


I would kindly like to comment on the following ;


[Federal Register: July 12, 2006 (Volume 71, Number 133)][Notices][Page 39282-39283]From the Federal Register Online via GPO Access [wais.access.gpo.gov][DOCID:fr12jy06-35]


-----------------------------------------------------------------------


DEPARTMENT OF AGRICULTURE


Food Safety and Inspection Service[Docket No. FSIS-2006-0011]Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)Update; Notice of Availability and Technical Meeting




http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf





PEER REVIEW

October 31, 2002

Review of the Evaluation of the Potential for Bovine SpongiformEncephalopathy in the United StatesConducted 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




http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf





HARVARD BSE RISK ASSESSMENT


RESPONSE TO COMMENTS FROM TERRY S. SINGELTARY SR.


Comment #1: SINCE the first Harvard BSE Risk Assessment was so flawed and fraught with error after the PEER REVIEW assessment assessed this fact, how do you plan on stopping this from happening again, will there be another peer review with top TSE Scientists, an impartial jury so-to-speak, to assess this new and updated Harvard BSE/TSE risk assessment and will this assessment include the Atypical TSE and SRM issues?


Response: The original (October 2003) and the revised (October 2005) Harvard BSE risk assessments underwent external peer review. Subsequently, revisions were made to the analysis. In the most recent review, the most significant revisions have been: 1) the addition of explicit modeling of the poultry litter pathway for the potential recycling of bovine protein into cattle feed; and 2) a decrease in the assumed effectiveness of ante mortem inspection in the identification of animals with BSE.


Comment #2: WITH A RECENT NATION WIDE MAD COW FEED BAN RECALL in the past few months that consisted of some 10,878.06 TONS, then another Mad Cow feed ban warning letter in May, IT should seem prudent to ask why our feed bans continue to fail in 2006, and continue to fail today?


Response: This question about feed bans is a matter for policy. As such, it is not addressed in this response.


Comment #3: WHY still now only partial ruminant feed ban, with the fact that now we seem to have 3 cases of nvCJD to humans i.e. human bovineTSE that were responsible from blood, and the fact the last 2 mad cows documented in the USA were that of an Atypical strain, would it not seem prudent to remove blood as well from ruminant feed? WOULD it not seem prudent to improve and expand the SRM list now? as per your own thinking; If transmission occurs, tissue distribution comparisons will be made between cattle infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in tissue distribution could require new regulations regarding specific risk material (SRM) removal.


Response: This comment pertains to policy. As such, it is not addressed here.


Comment #4: WHAT does USDA/FDA ET AL intend to do about the risks of atypical BSE/TSE in cattle now that infectivity shows in tissue samples other than CNS in Japan, the fact now that the last Texas mad cow and that last mad cow in Alabama were indeed of the atypical strain, the fact that the studies long ago in Mission, Texas of USA sheep scrapie transmission to the USA bovine, which proved an 'atypical tse' in the USA bovine, the fact also that USDA/FDA are still floundering on the last SRM regulations, but with the BASE strain now in cattle that is not similar to nvCJD, but very similar to the sporadic CJD, and sporadic CJD has tripled in the last few years in the USA. WHAT do you plan to do to protect human health from these atypical strains of TSE, in relations to SRMs ? - 19 -


Response: The BSE risk assessment simulation model characterizes the disease history of BSE, including the agent’s spread within the body of the animal over time. It also quantifies the agent’s persistence during the feed manufacture process, and ultimately the agent’s ability to cause disease in other exposed animals. There is no definitive evidence that these properties differ substantially for atypical BSE strains, compared to the typical BSE agent.


Comment #5: THE 2004 Enhanced BSE surveillance program, that tested all those cows, but then we found just how terribly flawed the program was, from testing protocols, to testing the most likely to have BSE i.e. high risk, to the geographical distribution of the testing and high risk areas, to letting the tissue samples of one mad cow sit on a shelf for 7+ months and then having to have an act of Congress to ever get that cow finally confirmed, to that other Texas mad cow they decided to not even bother testing at all, just rendered that very suspect cow, too suspect to test evidently, back to that Alabama mad cow that they could only give a guess as to age with dentition where we all know that the age of that cow was so close to 10 years it could have been 9 years 7 months to 10 years 3 months, thus possibly being an BAPB i.e. USA 'born after partial ban', to all those rabies suspect cows that did not have rabies, and DID NOT get tested for BSE/TSE in that June 2004 enhanced surveillance program, even though the common lay person knows the suspect rabies negative cows are suppose to be BSE/TSE tested, how does one correct all these blatant failures and will they be corrected?


Response: This comment pertains to policy. As such, it is not addressed here.


Comment #6: WHAT happened to the test results and MOUSE BIO-ASSAYS of those imported sheep from Belgium that were confiscated and slaughtered from the Faillace's, what sort of TSE did these animals have?


Response: It is not clear how the test results referred to in this comment are relevant to the Harvard BSE Risk Assessment Update. Sheep were not considered in the risk assessment.


Comment #7: WHY is it that the Farm of the Mad Sheep of Mad River Valley were quarantined for 5 years, but none of these farms from Texas and Alabama with Atypical TSE in the Bovine, they have not been quarantined for 5 years, why not, with the real risk of BSE to sheep, whom is to say this was not BSE ?


Response: This comment pertains to policy. As such, it is not addressed here.





http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf






Monday, September 1, 2008

RE-FOIA OF DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E. (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES [No. 00-072-1]

September 1, 2008




http://foiamadsheepmadrivervalley.blogspot.com/2008/09/re-foia-of-declaration-of-extraordinary.html




Plasma & Serum Proteins Receive Continued FDA Approval 4/25/2008 APC, Inc. is pleased to advise our customers and industry partners that as anticipated, the Food and Drug Administration (FDA) will continue to allow the use of bovine blood, plasma and serum proteins in ruminant feeds. In April 2008 FDA announced the publication of its Final Rule for 21 CFR Part 589.2001 - Substances Prohibited From Use in Animal Food or Feed. FDA specifically stated in their opinion that, "FDA is not prohibiting the use of blood and blood products in animal feed because we believe such a prohibition would do very little to reduce the risk of BSE transmission." Known as a leader in developing nutritional products for the swine industry, where 95% of pig starter diets in the United States contain functional proteins, APC has more recently developed their line of colostrum replacers, supplements, feed additives and milk replacer ingredients for calves. Products include plasma, serum and immunoglobulin concentrate based Acquire®, Lifeline®, Gammulin® and Nutrapro® used to optimize the health and performance of calves. To view the full report for Final Rule 21 CFR Part 589.2001 visit:



http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2002-N-0031-nfr.pdf



To view the complete Feed Rule 21 CFR Part 589 visit:



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=589&showFR=1




TRANSFUSION MEDICINE

Prion diseases are efficiently transmitted by blood transfusion in sheep

Fiona Houston1, Sandra McCutcheon1, Wilfred Goldmann2, Angela Chong2, James Foster2, Silvia Sisó3, Lorenzo González3, Martin Jeffrey3, and Nora Hunter2 1 Neuropathogenesis Division, Roslin Institute, Compton, United Kingdom; 2 Neuropathogenesis Division, Roslin Institute, University of Edinburgh, Edinburgh, United Kingdom; and 3 Lasswade Laboratory, Veterinary Laboratories Agency, Penicuik, United Kingdom

The emergence of variant Creutzfeld-Jakob disease, following on from the bovine spongiform encephalopathy (BSE) epidemic, led to concerns about the potential risk of iatrogenic transmission of disease by blood transfusion and the introduction of costly control measures to protect blood supplies. We previously reported preliminary data demonstrating the transmission of BSE and natural scrapie by blood transfusion in sheep. The final results of this experiment, reported here, give unexpectedly high transmission rates by transfusion of 36% for BSE and 43% for scrapie. A proportion of BSE-infected tranfusion recipients (3 of 8) survived for up to 7 years without showing clinical signs of disease. The majority of transmissions resulted from blood collected from donors at more than 50% of the estimated incubation period. The high transmission rates and relatively short and consistent incubation periods in clinically positive recipients suggest that infectivity titers in blood were substantial and/or that blood transfusion is an efficient method of transmission. This experiment has established the value of using sheep as a model for studying transmission of variant Creutzfeld-Jakob disease by blood products in humans.



http://bloodjournal.hematologylibrary.org/cgi/content/abstract/112/12/4739?ct




snip... full text ;

Friday, November 21, 2008Plasma & Serum Proteins Receive Continued FDA Approval




http://madcowfeed.blogspot.com/2008/11/plasma-serum-proteins-receive-continued.htmlhttp://madcowfeed.blogspot.com/




Thursday, November 27, 2008Prion diseases are efficiently transmitted by blood transfusion in sheep




http://vcjdblood.blogspot.com/2008/11/prion-diseases-are-efficiently.html




In 2007, in one weekly enforcement report, the fda recalled 10,000,000+ pounds of BANNED MAD COW FEED, 'in commerce', and i can tell you that most of it was fed out ;

10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007

Date: March 21, 2007 at 2:27 pm PST

REASON

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. VOLUME OF PRODUCT IN COMMERCE 42,090 lbs. DISTRIBUTION WI

REASON

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. VOLUME OF PRODUCT IN COMMERCE 9,997,976 lbs. DISTRIBUTION ID and NV

END OF ENFORCEMENT REPORT FOR MARCH 21, 2007



http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html





Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, TN, AND WV Date: September 6, 2006 at 7:58 am PST

snip... see listings and references of enormous amounts of banned mad cow protein 'in commerce' in 2006 and 2005 ;

see full text ;

Friday, April 25, 2008

Substances Prohibited From Use in Animal Food or Feed [Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46



http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html





SPECIFIED RISK MATERIALS



http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html





November 25, 2008Update On Feed Enforcement Activities To Limit The Spread Of BSE




http://madcowfeed.blogspot.com/2008/11/november-2008-update-on-feed.html





Wednesday, February 11, 2009 Atypical BSE North America Update February 2009


Greetings,

Considering that Mad Cow disease of all documented phenotypes, either the c-BSE, or the atypical h-BSE and or the l-BSE, ALL of which have been documented in North America, how many more, who knows, but they seem to be throwing all there marbles in the pot now by calling the h-type BSE 'familial'. what happens if we come up with another strain ? kinda like the sporadic FFI, that's not familial, what's that all about ? considering the many different strains of the typical scrapie 20+, and then the atypical Nor-98 Scrapie, which the USA has documented 6 cases the last i heard, and the thought of more than one strain of CWD in deer and elk, where will the next year, 4 years, 8 years, and beyond take us in the world of human and animal Transmissible Spongiform Encephalopathy and 'sound science' in the USA ? WILL the New Administration see the enfamous enhanced bse surveillance program of 2004 for what it was, a fraud, and have a 'redo' ? WE can hope i suppose. ...TSS


Both of the BSE cases ascertained in the US native-born cattle were atypical cases (H-type), which contributed to the initial ambiguity of the diagnosis. 174, 185 In Canada, there have been 2 atypical BSE cases in addition to the 14 cases of the classic UK strain of BSE2: one was the H-type, and the other was of the L-type.198


snip...end


source :


Enhanced Abstract Journal of the American Veterinary Medical Association January 1, 2009, Vol. 234, No. 1, Pages 59-72

Bovine spongiform encephalopathy

Jane L. Harman, DVM, PhD; Christopher J. Silva, PhD



http://avmajournals.avma.org/doi/ref/10.2460/javma.234.1.59





Thursday, December 04, 2008 2:37 PM

"we have found that H-BSE can infect humans."

personal communication with Professor Kong. ...TSS

see full text ;




http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html





Sunday, December 28, 2008

MAD COW DISEASE USA DECEMBER 28, 2008 an 8 year review of a failed and flawed policy




http://bse-atypical.blogspot.com/2008/12/mad-cow-disease-usa-december-28-2008-8.html





Wednesday, August 20, 2008

Bovine Spongiform Encephalopathy Mad Cow Disease typical and atypical strains, was there a cover-up ?

August 20, 2008



http://bse-atypical.blogspot.com/2008/08/bovine-spongiform-encephalopathy-mad.html





Monday, May 19, 2008 SPORADIC CJD IN FARMERS, FARMERS WIVES, FROM FARMS WITH BSE HERD AND ABATTOIRS



http://bseinquiry.blogspot.com/2008/05/sporadic-cjd-in-farmers-farmers-wives.html




http://bseinquiry.blogspot.com/





A New Prionopathy OR more of the same old BSe and sporadic CJD




http://creutzfeldt-jakob-disease.blogspot.com/2008/08/new-prionopathy-or-more-of-same-old-bse.html




Communicated by: Terry S. Singeltary Sr. [In submitting these data, Terry S. Singeltary Sr. draws attention to the steady increase in the "type unknown" category, which, according to their definition, comprises cases in which vCJD could be excluded. The total of 26 cases for the current year (2007) is disturbing, possibly symptomatic of the circulation of novel agents. Characterization of these agents should be given a high priority. - Mod.CP]




http://pro-med.blogspot.com/2007/11/proahedr-prion-disease-update-2007-07.html




http://www.promedmail.org/pls/askus/f?p=2400:1001:6833194127530602005::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1010,39963




There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection. He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.




http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm




http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf




sporadic Fatal Familial Insomnia




http://sporadicffi.blogspot.com/




JOURNAL OF NEUROLOGY MARCH 26, 2003


RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States

Email Terry S. Singeltary: flounder9@verizon.net


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?




http://www.neurology.org/cgi/eletters/60/2/176#535




THE PATHOLOGICAL PROTEIN

Hardcover, 304 pages plus photos and illustrations. ISBN 0-387-95508-9

June 2003

BY Philip Yam CHAPTER 14 LAYING ODDS


Answering critics like Terry Singeltary, who feels that the U.S. under- counts CJD, Schonberger conceded that the current surveillance system has errors but stated that most of the errors will be confined to the older population.



http://www.thepathologicalprotein.com/




Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA

Diagnosis and Reporting of Creutzfeldt-Jakob Disease To the Editor:


In their Research Letter, 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. Terry S. Singeltary, Sr Bacliff, Tex 1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States: 1979-1998. JAMA. 2000;284:2322-2323.


FREE FULL TEXT




http://jama.ama-assn.org/cgi/content/extract/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=singeltary&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT




http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=singeltary&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT




2 January 2000 British Medical Journal U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well




http://www.bmj.com/cgi/eletters/320/7226/8/b#6117




15 November 1999 British Medical Journal vCJD in the USA * BSE in U.S.




http://www.bmj.com/cgi/eletters/319/7220/1312/b#5406




Creutzfeldt Jakob Disease




http://creutzfeldt-jakob-disease.blogspot.com/




USA PRION UNIT BLOG




http://prionunitusaupdate2008.blogspot.com/




Sunday, April 20, 2008 Progress Report from the National Prion Disease Pathology Surveillance Center April 3, 2008 Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD. see full text ;




http://prionunitusaupdate2008.blogspot.com/2008/04/progress-report-from-national-prion.html





CJD TEXAS (cjd clusters)




http://cjdtexas.blogspot.com/




USA WRITTEN CJD QUESTIONNAIRE ???




http://cjdquestionnaire.blogspot.com/




Attending Dr.: Date / Time Admitted : 12/14/97 1228 UTMB University of Texas Medical Branch Galveston, Texas 77555-0543 (409) 772-1238 Fax (409) 772-5683 Pathology Report FINAL AUTOPSY DIAGNOSIS Autopsy' Office (409)772-2858 FINAL AUTOPSY DIAGNOSIS I. Brain: Creutzfeldt-Jakob disease, Heidenhain variant.




http://creutzfeldt-jakob-disease.blogspot.com/2008/07/heidenhain-variant-creutzfeldt-jakob.html




2007


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.



http://www.cjdfoundation.org/fact.html




Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518

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posted by Terry S. Singeltary Sr. | 11:43 AM

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