HIQA says vCJD blood filter not justified
[Posted: Wed 27/07/2011 http://www.irishhealth.com/]
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.
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.
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.
It said the prion filters appeared to be safe and would remove almost all the residual risk of vCJD from blood for transfusion.
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.
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.
HIQA said in arriving at its recommendation about prion filters, it noted the 'substantial undertainty around the risk of vCJD in Ireland.'
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.
Dr Patricia Harrington of HIQA said the cost of implementing universal prion filtration was high compared to the likely benefits.
HIQA has submitted its recommendation on prion filters to the Minister for Health for consideration.
http://www.irishhealth.com/article.html?id=19541
SEE UPDATE ;
HIQA publishes assessment of vCJD filter technology
Date of publication: Wednesday, July 27, 2011
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.
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.
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.
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.
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."
The Board of the Authority has approved the HTA report and it has been submitted to the Minister for Health for his consideration.
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."
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'.
Further Information:
Marty Whelan Head of Communications and Stakeholder Engagement Directorate 01 8147481 / 086 2447623 or email mwhelan@hiqa.ie
Notes to the Editor:
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.
http://www.hiqa.ie/press-release/2011-07-27-hiqa-publishes-assessment-vcjd-filter-technology-0
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.
http://www.hiqa.ie/system/files/HTA-Prion-Filtration.pdf
TSS
tell that to the victims of the nvCJD, there families and friends. ...TSS
----- Original Message -----
From: Emery, Bryan (CBER)
To: 'Terry S. Singeltary Sr.'
Cc: Emery, Bryan (CBER)
Sent: Friday, July 22, 2011 9:47 AM
Subject: RE: TSEAC Meeting August 1, 2011 donor deferral Saudi Arabia vCJD risk blood and blood products
Hi Mr. Singeltary,
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.
thanks for your public participation
LCDR Bryan Emery
--------------------------------------------------------------------------------
From: Terry S. Singeltary Sr. [mailto:flounder9@verizon.net]
Sent: Wednesday, June 29, 2011 3:54 PM
To: Emery, Bryan (CBER)
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
Subject: TSEAC Meeting August 1, 2011 donor deferral Saudi Arabia vCJD risk blood and blood products
Meeting of the Transmissible Spongiform Encephalopathies Advisory Committee
Center Date Time Location
CBER August 1, 2011 9:00 a.m. - 4:30 p.m.
Hilton Washington DC/North, 620 Perry Pkwy., Gaithersburg, MD
Agenda
snip...end...TSS
Wednesday, June 29, 2011
TSEAC Meeting August 1, 2011 donor deferral Saudi Arabia vCJD risk blood and blood products
http://tseac.blogspot.com/2011/06/tseac-meeting-august-1-2011-donor.html
Bio.108: Transmission of Prion Disease by Multiple, Clinically-Relevant Blood Components Following a Single Blood Transfusion
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
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
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.
PPPM.18: Induction of Ab Amyloidogenesis In Vivo by Blood Transfusion
Rodrigo Morales,1,† Claudia Duran-Aniotz,1, 2 Akihiko Urayama,1 Lisbell Estrada,3 Diego Morales-Scheihing1, 2 and Claudio Soto1
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
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.
http://www.prion2011.ca/files/PRION_2011_-_Posters_(May_5-11).pdf
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]
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.
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]
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.
http://www.publications.parliament.uk/pa/cm201011/cmhansrd/cm110509/text/110509w0004.htm#11050951000005
SEE FULL TEXT ;
Wednesday, May 11, 2011
House of Commons CJD May 2011 UPDATE
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:
http://transmissiblespongiformencephalopathy.blogspot.com/2011/05/house-of-commons-cjd-may-2011-update.html
Tuesday, July 26, 2011
Irhad Rizvo Durakovic has lost his fight to nvCJD R.I.P.
http://creutzfeldt-jakob-disease.blogspot.com/2011/07/irhad-rizvo-durakovic-has-lost-his.html
http://transmissiblespongiformencephalopathy.blogspot.com/
http://vcjdtransfusion.blogspot.com/
http://creutzfeldt-jakob-disease.blogspot.com/
http://www.wellsphere.com/cjd-article/large-scale-immunohistochemical-examination-for-lymphoreticular-prion-protein-in-tonsil-specimens-collected-in-britain/1242673
TSS
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