Tuesday, November 11, 2008

SaBTO Summary of 1st Public Meeting – variant CJD and blood Tuesday 21st October 2008, 2pm-4pm

Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO)

Summary of 1st Public Meeting – variant CJD and blood

Tuesday 21st October 2008, 2pm-4pm

New King’s Beam House, London SE1


Mr John Forsythe – University of Edinburgh/SaBTO Chair

Mr Forsythe welcomed the audience, and outlined the background of SaBTO and the work of the committee. He explained that the committee feels that it is vital to share information used to make decisions and to invite comments from interested parties and the public. This explains the committee’s decision to hold an annual public meeting on selected topic.

1st Presentation: Introduction to variant CJD

Dr Hester Ward – National CJD Surveillance Unit/SaBTO vCJD expert

Dr Ward gave an introductory talk on the cause and epidemiology of variant CJD.

1. There are several different types of prion diseases in humans, which can be divided into idiopathic (e.g. sporadic CJD), acquired (e.g. variant CJD) and genetic (e.g. familial CJD). There is no evidence that sporadic CJD can be transmitted via transfusion.

2. Variant CJD emerged in 1996 with features distinct from those seen in sporadic CJD. It affects younger people, who survive longer, and there are also distinct clinical and neuropathological features.

3. 18 of those affected by vCJD are known to have been blood donors. 66 recipients of their blood have been identified, of whom 23 survive.

4. vCJD is infective in blood but there remain a large number of uncertainties. A self-sustaining secondary epidemic through blood transfusion may be possible.

5. Key to determining the size of a secondary epidemic is measuring how may people in the population may be carriers of vCJD (the ‘population prevalence’).

6. A study on stored appendix samples and one on tonsils have given estimates for carriers of between 1 in 1, 500 and 1 in 20, 000 of the UK population.

7. Possible further studies of this type could involve more appendix samples, a post-mortem archive or blood tests, which are not yet available but are in development.

2nd Presentation: Variant CJD and Blood: current safety measures and future options

Professor Marc Turner – University of Edinburgh and Scottish National Blood Transfusion Service/SaBTO Haematologist

Professor Turner gave a presentation on the issues around variant CJD and blood, the current safety measures in place, and options that may be considered in the future.

1. The prevalence of sub-clinical infection amongst the population of blood donors was discussed. The best estimate for incidence of further clinical cases is 70 .

2. This represents a discrepancy with the retrospective tonsil and appendix study data which indicates that the prevalence of sub-clinical infection of vCJD is 1/4000 (range 1/1000 to 1/20000). This suggests that up to 3,000 members of the UK population may be infected but remain sub clinical (symptom free) in the longer term.

3. It is known that in rodent models the potential level of peripheral infection is around 10 infectious doses per ml of blood (range 1-300 ID / ml).

4. These data taken together with the known transmission of variant CJD by blood suggest the possibility of an ongoing risk of transmission of variant CJD through blood, tissues and organs.

5. In the face of uncertainty, the best risk management approaches are those that give at least some control of risk over a wide range of plausible scenarios. In the context of variant CJD and blood, there are four potential approaches; donor selection, donor screening, component processing and minimising exposure.

6. Although a number of donor deferral criteria have been introduced both in the UK and internationally, they represent a relatively blunt risk management approach and can undermine the supply of blood and tissues.

7. A future test for vCJD may detect the presence of the abnormal protein in blood which would help to control the risk of secondary transmission , but will not give definitive information on the likelihood of development of clinical disease and will pose problems around sensitivity and specificity, validation and the management of those who have tested positive. There are particular concerns around the impact of a ‘poor’ test on donors and the blood supply.

8. Blood component processing is used to further reduce risk from transfusion. Red cells are re-suspended in optimal additive solution rather than plasma, and all red blood cells undergo leucodepletion. Using prion reduction filters to filter out prions from leucodepleted red blood cells may further reduce infectivity and these are currently under evaluation.

9. Risk reduction by reducing exposure to blood represents an immediately available, low cost measure that is relatively straightforward to implement.

3rd Presentation – A Patient’s Perspective

Mr Elwyn Nicol – SaBTO Patient Representative

Mr Nicol, explained that some 5 years ago he underwent a heart transplant, hence his interest in becoming the SaBTO patient representative.With no family connections or experience in, or background of, the medical profession. Mr Nicol represents the patient. He emphasised that his views are independent and well placed to express an opinion, based on his own experience.To lay members in this audience he confirmed that the well-being of patients, on this committee, seems paramount.There are 2.4m blood donors in the UK and it is claimed that the vCJD testing programmes being developed may be 99% effective. Mr Nicol said he considers that to be very good, but it could mean 1%, i.e. 24,000 donations or donors would be falsely told that they had tested positive for vCJD.

Until testing for vCJD in blood is 100% reliable, potentially 24000 blood donors, who 'do something special' without reward could be falsely told they have the disease every year. They could not know if they are truly threatened, not know if they will ever be able to get a life insurance policy, ever be able to get a mortgage or ever be able to buy a pension.
As a heavily transfused patient, Mr Nicol was and remains, content with the range of precautionary measures that exist. Until a 100% test exists Mr Nicol would prefer to rely on those existing measures rather than see potential distress and harm being caused to individual blood donors.

Those who will make the final decision have a very difficult choice to make – Nr Nicol said that we ask a lot from donors and asked if we can ask a society that their generosity be extended to submit to an unreliable test that could result in such anguish for so many?

Statements from family members of those affected by variant CJD

Two relatives of individuals affected by vCJD spoke.

Mr Peter Buckland spoke on behalf of his family. His son died after contracting vCJD from contaminated blood. Mr Buckland made the following points:

• The devastating effect of vCJD on the families of those affected was huge.

• The tragic consequences of the disease have been made more acute by a lack of information available to his family at the time from government institutions.

• The processes around management of vCJD should be open and honest, and those responsible should be prepared to explain their decisions.

• Delays in notifying those at risk of the disease did those who went on to develop vCJD a great disservice. Lives would have been led differently if the future implications had been made clear.

• An earlier notification would at the very least have allowed families to explore potential treatments for the disease in the early stages.

• Any test for vCJD should be made available. It is not acceptable that “at-risk” individuals be kept in the dark, however low that risk may be.

Ms Christine Lord is the mother of Andrew Black, who died from vCJD in 2007 aged 24, and made the following points:

• Those making the decisions around management of vCJD should be supervised by independent sources that are not government funded or backed.

• The terrible risk and legacy of vCJD that the UK population now face should lay clearly at the door of those who Ms Lord considers responsible for her son’s death. Ms Lord believes that if those ministers and officials in the 1980s and 1990s had not put profit before lives vCJD would have never existed and SaBTO would not be faced with the terrible dilemmas it now has to wrestle with.

• Testing should be made available as soon as it is developed. Ms Lord believes that it may not be in the Government’s best interest to make such a test available. The doubts about prevalence mean that the likely number of positives is not known; ministers may be reluctant to allow the wider public to be made aware of the true prevalence of vCJD in the population, particularly if the situation was worse than is currently forecast.

• Testing for vCJD should be a personal choice allowing people to live their lives accordingly. Ms Lord believes that officials in the 1980s and 1990s played god with the UK populations lives resulting in vCJD and too many innocent people dying needlessly and she is mindful that government may very well be playing god again by refusing the UK population the choice to test or not.

• As a mother who has lost her son to vCJD Ms Lord would take a test tomorrow and would like the opportunity to be able to do this in the near future.

• The devastation vCJD has wrecked on families, careers, futures and relationships cannot be described in mere words. As a bereaved mother, a qualified journalist and psychological counsellor Ms Lord is acutely aware of the huge impact and life scarring event that nursing a child through the most horrific disease has had on hundreds of family members and thousands of colleagues and friends. Ms Lord’s website is www.justice4andy.com.

Summary of questions/open forum

Q. What developments have there been since 2004 aimed at reducing the risk of vCJD transmission by blood transfusion?

SaBTO is considering other potential options for mitigating the risk of vCJD, including importation of red cells for the children, double-dose red cell collection, extension of platelet apheresis and importation of plasma for all recipients.Several manufacturers are developing filters aiming to remove prion protein from red cells for transfusion. One of these filters is CE marked which means that it can legally be used in the UK. This filter is under active assessment by the UK and Irish Blood Services. It is important that any new technology used to produce blood components is assessed to make sure that it is effective and will not cause any harm to patients. A pathway for assessing prion removal filters has been established by the UK Blood Services and endorsed by SaBTO. The Spongiform Encephalopathy Advisory Committee (SEAC) have advised that the UK Blood Services should obtain an independent assessment of the ability of these filters to remove prion protein. The first of these studies is well underway with early results expected to be reported in 2009. The UK Blood Services are also undertaking a clinical study of prion-filtered red cells in surgical patients and then transfusion dependent patients, designed to assess whether the filter results in an increase in adverse events to patients. These clinical studies were endorsed by SaBTO’s predecessor, the Advisory Committee on the Microbiological Safety of Blood, Tissues and Organs (MSBTO). SaBTO will review this subject further in spring/summer 2009 when data from the independent evaluation and clinical studies of prion-filters are likely to become available.

Q. What are the panel’s views on the potential for embryonic stem cells to be used to produce blood components for transfusion?

Although there has been considerable progress in this area, we still have a lot to learn about how the growth of stem cells is controlled, and also how to produce specific cell types from stem cells. There are significant challenges in being able to produce sufficient amounts of cells for transfusion or transplantation from stem cells and it is likely to be some years before such cells can be used clinically.

Q. How long is the incubation period for vCJD transmitted by blood transfusion?

We do not know, but in the 4 cases where vCJD infection is thought to have been transmitted by blood transfusion, the incubation period between receiving the implicated transfusion and development of symptoms of disease was 6-8 years in the 3 symptomatic cases. In animals, the incubation period following infection can be influenced by genetic factors and in other human prion diseases, such as Kuru, the incubation period can be up to 40 years. It is possible, therefore, that some people have been infected but have not yet (and maybe will never) develop clinical disease.

Q. When is a test for vCJD in blood likely to be available?

There is currently no validated diagnostic test that can be used to determine whether blood is infected with vCJD. Several companies are developing tests for vCJD in blood and are making good progress. As for prion removal filters the UK Blood Services have developed a pathway for assessing tests that may be applied to blood donors. We currently do not know how accurate these tests will prove to be. There are concerns around telling asymptomatic people, for example blood donors, that they may be infected with vCJD when the significance of the test result is uncertain, when it is unknown whether infection would necessarily result in disease, and when there is no proven treatment.The impact of a screening test on the blood and tissue supply could be profound depending on how accurate the test is due to the direct loss of donations due to false positive results and the indirect impact in deterring people from donating., In addition there would be a need to carry out lookback studies and both donors and past recipients may need to be designated as “at risk of vCJD for public health purposes” leading to significant impact on the wider NHS.It was noted that the development of a diagnostic test for vCJD was highly desirable for groups of patients who have been identified as ‘at risk from vCJD for public health purposes’. However, SaBTO’s remit is restricted to consideration of tests in the context of blood, tissue and organ donation.

Q. With regards to screening tests for vCJD in blood, what level of specificity and sensitivity do SaBTO regard as acceptable?

Currently the UK Blood Services screen blood for several viruses. Donors that have a positive result then undergo further testing with one or more confirmatory tests before being informed that they are positive. The acceptable performance of a vCJD screening test would depend, in part therefore, on whether a secondary screening test or confirmatory test was available.

Q. Why is blood labelled "Risk of adverse reaction/infection, including vCJD" but other infectious agents such as HIV not included on the label? Why is plasma that is imported not labelled the same way?

The labelling of blood components has been changed to bring it in line with labelling of tissue products. Other infectious agents such as HIV do not appear on the label as blood donations are currently tested for these; there is no screening test for vCJD available. Plasma is imported from a country with low risk of vCJD and therefore not labelled in the same way as blood components from the UK. SaBTO are currently examining the possibility of recommending full written informed consent for transfusion, which would include information on the risks involved and whether there are any suitable alternatives.

Q. Why aren’t platelets imported? Is importation of red cells feasible?

Plasma components have a 2 year shelf-life and can be transported frozen. Platelets have a shelf-life of 5 days and must also be transported and stored in a very specific way to preserve them. It would therefore be highly unlikely that sufficient platelets could be imported from outside the UK with these limitations. NHS Blood & Transplant are currently conducting a feasibility study to assess options for importing red cells. Importing red cells for all patients in the UK will not be possible (over 2 million units of red cells per year are required). It may be possible to import red cells for selected patient groups, for example for children. Importation of special red cell products with a short-shelf life of 5 days or less is not likely to be feasible however. It is important to also consider other risks that may be increased in possible source countries, such as viral risk, since systems are not available to treat red cells to kill viruses.
Q. If a test for vCJD is available, should it be used to screen egg and sperm donors?

So far SaBTO have only considered the possible use of a vCJD screening test for blood donors. In due course the committee will also have to consider the application of such a test to donors of tissues, organs and gametes.

Q. Would prion filtration prevent the need to import red cells? And unlike screening for vCJD, prion-filtration would not have any negative impact on the donor.

Prion-filtration or importation of red cells would reduce the cost-effectiveness of the other. SaBTO are considering a number of possible options to reduce the risk of vCJD transmission by blood. The cost-effectiveness and advantages/disadvantages of each option have been considered at the April and July 2008 meetings of SaBTO. The committee will be considering these measures further in 2009 when further data on prion filtration and testing are available.

Q. Has there been a case of vCJD transmission by blood transfusion of leucocyte depleted blood?

No. So far all 4 possible transmissions of infected prion protein have all been from non-leucocyte depleted red cells and there have been no known infections from blood since this time. Leucocyte depletion was implemented in the UK in 1998/1999. Animal studies suggest that leucocyte depletion only removes about 40-50% of infectivity in blood. We also do not know what the maximum period of incubation between transfusion of infected blood and development of vCJD could be, and therefore leucocyte-depleted blood could be capable of transmitting infection but there may not have been sufficient time for any of the recipients to develop clinical disease as yet.

Q. Have SaBTO sought advice from the Association of British Insurers regarding vCJD tests?
The Association of British Insurers have been consulted previously with regard to patients who have developed CJD following treatment with growth hormones. Their response indicated that such recipients would not have any issues relating to insurance policies. SaBTO will obtain further information from the Association of British Insurers when more information is available on the performance of vCJD screening tests.

Q. SaBTO requested a feasibility study on the use of double-dose red cells at their July meeting. When will this be available?

NHS Blood & Transplant have been asked to perform a feasibility study on the use of double dose red cells for selected patient groups. This will be presented to the committee in Spring 2009 along side other options for risk-reduction of vCJD by transfusion.

Q. Why does SaBTO still use estimates of prevalence from the Hilton study published in 2004 and not the later National Anonymised Tonsil Archive (NATA) study?

This has been reviewed by the Spongiform Encephalopathy Advisory Committee (SEAC) not SaBTO. The Hilton study was on both appendices and tonsils (but mainly appendices). There are differences between the studies in terms of the tissue studied, the period in time the study was performed since the initial BSE epidemic and the sensitivity of test methods used. SEAC therefore do not consider it to be appropriate to combine data from the two studies. The estimates of prevalence from the two studies are currently consistent with each other, and the confidence intervals of the NATA study are within those of the Hilton study.

At the end of the meeting it was generally agreed that this exercise had been very useful – both to spread important information on this issue and also to open dialogue with all those involved. SaBTO intend to hold a similar public meeting next year.


Worries over test for mad cow disease

Published: Tuesday, 21-Oct-2008 Printer Friendly Email to a Friend

Disease/Infection News

A new test to screen blood for the incurable human form of mad cow disease could be available within 18 months, but it has raised concerns. The breakthrough blood test which will be able to diagnose variant Creutzfeldt-Jakob diseases (vCJD), is currently undergoing clinical trials but experts are worried it will reduce the number of people prepared to donate blood - research suggests 1 in every 4,000 people might harbour vCJD in their blood, though 95% of them may never actually develop the full blown disease.

Variant CJD is a rare and fatal human neurodegenerative condition and is a Transmissible Spongiform Encephalopathy (TSE) or prion disease - because of the characteristic spongy degeneration of the brain - it is strongly linked to exposure, probably through food, to a TSE of cattle called Bovine Spongiform Encephalopathy (BSE).

In the early stages patients usually experience psychiatric symptoms such as depression or, less often, a schizophrenia-like psychosis.

Unusual sensory symptoms, such as "stickiness" of the skin, have been experienced by half of the cases early in the illness and neurological signs, including unsteadiness, difficulty walking and involuntary movements, which develop as the illness progresses; by the time of death, patients become completely immobile and mute.

There are at present no available, completely reliable diagnostic tests for use before the onset of clinical symptoms, but magnetic resonance scans, tonsillar biopsy and cerebrospinal fluid tests are useful for detection.

The highest incidence of vCJD is in the UK, the country with the largest potential exposure to BSE. A statutory ban on the feeding of protein derived from ruminants (e.g. cattle, sheep and goats) to any ruminant exists.

The use in the food chain of bovine offals thought to pose a potential risk to humans was also banned in the UK in 1989.

According to advisers to the British government, though the test is undoubtedly a significant step towards eliminating the incurable disease and preventing it from becoming endemic in society, it could result in a reduction in the number of blood donors and there are also fears it could increase insurance premiums.

Experts suspect that donors will be reluctant to give blood if they risk being told that they have the possibility of developing the disease which causes a horrible and agonising death.

Dr. John Forsythe, chair of the Advisory Committee on the Safety of Blood Tissues and Organs (SABTO) and a transplant surgeon at the Royal Infirmary of Edinburgh says the test does have significant downsides, despite concerns that the disease could become widespread in the UK.

However only 4 of the 167 people who have died from vCJD contacted it through infected blood - but the knowledge of having the disease would be terrifying prospect.

The problem is compounded because around 1% of the positive tests could be wrong and with two million people donating blood every year in Britain that could amount to 250 people being told they had the infection, and up to four of them being falsely diagnosed.

Experts say from both a legal and ethical standpoint, those incubating the disease would have to be told even though only a few could develop it fully.

In 2004 vCJD had an impact on blood supplies when the number of blood donors dropped by 52,000 when those who had received blood transfusions in the previous two decades was banned from donating blood.

Currently donated blood is screened for HIV, syphilis and hepatitis B and C, but because vCJD is neither curable or treatable, many donors may prefer to not know they could develop the progressive and fatal degenerative brain disease.

Presently vCJD is tested for by performing post mortem biopsies on the brain.




The Spongiform Encephalopathy Advisory Committee held its 101st meeting in London on 15th October 2008, and discussed the following:

CURRENT ISSUES SEAC was informed about:

. A mother and son in Spain who had died of variant Creutzfeldt-Jakob Disease (vCJD). This is the first recorded instance of more than one case of vCJD within one family. Both the mother and son lived in a region of Spain with a history of BSE and had frequently shared meals of cattle brain. As no other risk factor has been identified, it seems most likely that both infections were acquired from dietary exposure.

. Results of tests on a single goat from a culled UK dairy herd with a large classical scrapie outbreak. On the basis of the results the presence of Bovine Spongiform Encephalopathy (BSE) cannot be excluded. Further testing by mouse bioassays, which may take at least two, if not more, years to complete, is required to make a definitive diagnosis.


SEAC was updated by the Health Protection Agency (HPA) about the progress of the National Anonymous Tonsil Archive (NATA), a proposed second retrospective survey of 30 000 stored appendix samples and a proposed post mortem tissue archive. These studies would provide data to estimate the prevalence of subclinical vCJD (vCJD infections that have yet to develop, or may never develop, into clinical disease).

Around 62 500 tonsil samples collected by NATA have been tested with no positive samples found. An application for the second retrospective survey of appendix samples is currently under consideration by a Research Ethics Committee. SEAC learned that the establishment of a post mortem tissue archive, which is dependent on the collection of samples from Coroners' autopsies, does not have the support of Coroners needed to take it forward. SEAC is extremely disappointed about the lack of support from Coroners for the post mortem tissue archive. As SEAC has repeatedly stated, the archive is key to obtaining better estimates of the prevalence of subclinical vCJD. These estimates are vital to make meaningful assessments of the risks to public health from vCJD and of the effectiveness of current, and the need for further, very costly public health protection measures. SEAC acknowledged the strenuous efforts made by the HPA, the Department of Health (DH) and National Health Service Blood and Tissue to devise a system to collect samples that would have the least impact on the work of Coroners. SEAC remains strongly in favour of establishing the archive.

snip... see;



SEAC discussed with Dr Pierluigi Gambetti (US National Prion Disease Pathology Surveillance Center) his recently published report5 on the identification in the United States of America of a new human prion disease. SEAC agreed that there is considerable work to be done to characterise fully this new disease, its cause and whether it is infectious or not. As preliminary unpublished data were also presented, this issue was discussed in a reserved business session in accordance with the SEAC Code of Practice.


SEAC considered preliminary results provided by the HPA and National CJD Surveillance Unit from tests on eye tissue (sclera) from a vCJD case. The results suggest the presence of infectivity and, in contrast with previous testing of samples from other vCJD cases, abnormal prion protein in this tissue. However, as the sclera is very difficult to remove from surrounding eye tissues, which are themselves known to carry vCJD infectivity, the findings may have arisen as a result of contamination at autopsy. Nevertheless, even if the data are reliable, they indicate that there may only be a relatively low level of infectivity present in sclera. As preliminary unpublished data were considered, this issue was discussed in a reserved business session in accordance with the SEAC Code of Practice.

5 Gambetti et al. (2008) A novel human disease with abnormal prion protein sensitive to protease. Ann. Neurol. 63, 697-708. 5 © SEAC 2008





5.5 There is now convincing evidence of human to human transmission of vCJD via blood transfusion with 3 clinical cases of the disease and one of sub-clinical infection believed to have been transmitted via this route. However, in humans little is known about the level, distribution and temporal development of infectivity in blood. Estimates of prevalence of asymptomatic infection in the UK population remain uncertain, as does the susceptibility of recipients to infection. 5.6 To assess the cost-effectiveness of future measures to reduce the risk of vCJD by blood components 8 scenarios relating to prevalence, susceptibility and infectivity were modelled: a prevalence of 1:20,000 (LOW) and1:4000 (HIGH), infectivity of 0.1 ID/ml (LOW) and 30 ID/ml (HIGH), and susceptibility of recipients to development of clinical disease of 10% (LOW) and 100% (HIGH). It was noted that the high susceptibility scenario is not consistent with the observed number of clinical cases. It was noted that SEAC reviewed data available to date from The National Anonymised Tonsil Archive (NATA) Study at their meeting on 25th April 2008 and has not revised its estimate of prevalence of sub-clinical infection as a result.


these minutes are not available yet ;

1st Public Meeting of SaBTO (Advisory Committee on the Safety of Blood, Tissues and Organs)

Tuesday 21st October 2008, 2pm-4pm


vCJD case study highlights blood transfusion risk Friday 8th December 2006


Public release date: 29-Aug-2008

Contact: Tara Womersley mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000179/!x-usc:mailto:tara.womersley@ed.ac.uk 44-131-650-9836 University of Edinburgh

Study confirms vCJD could be transmitted by blood transfusion A 9-year study in sheep has added to the evidence that vCJD can be transmitted through blood transfusion in humans The findings underline the importance of precautions against vCJD transmission, such as the Government decision in 2004 to ban blood donations from anyone who had received a blood transfusion since 1980.

The study published in Blood, the journal of the American Society of Hematology, looked at BSE transmission between sheep through infected blood with the aim of quantifying how vCJD - the human form of BSE - could be spread through transfusions.

Researchers (Fiona Houston, Nora Hunter and colleagues) at the Neuropathogenesis Unit at the Institute of Animal Health, which is now part of The Roslin Institute, University of Edinburgh, found that the likelihood of BSE being transmitted between sheep through transfusion of infected sheep blood was 36 per cent, with rates of 43 per cent found for scrapie.

Fiona Houston, now at the University of Glasgow, who led the research, said: "It is apparent that the stage of disease incubation in infected donors played a large role in the likelihood of transmission. The longer that BSE or scrapie had been carried by donors, the greater the likelihood of the disease being transmitted with transfusions of infected blood."

While cases of vCJD are tailing off there are concerns that up to 4,000 people could be carrying the disease in the UK, which could then be transmitted through infected blood causing further infections.

Scientists are working to develop a test for vCJD that can be used before symptoms develop and a filter is also being trialled to remove prions – infective proteins – from donated blood.

Dr Houston said: "The study shows that, for sheep infected with BSE or scrapie, transmission rates via blood transfusion can be high, particularly when donors are in the later stages of infection. This suggests that blood transfusion represents an efficient route of transmission for these diseases and justifies the current control measures put in place to safeguard human blood supplies.

"While it may not correlate directly to what happens in the human population, due to factors such as species differences in genetic susceptibility to disease, it provides greater insight into the role of how vCJD may be carried through infected blood. By understanding how vCJD can be transmitted through blood transfusions, we can ensure the most effective control measures to minimise human to human infection."

BSE is one of a group of rare neurodegenerative disorders called transmissible spongiform encephalopathies (TSEs), which include scrapie and vCJD. Of 22 sheep that received BSE infected blood, eight showed evidence of infection. Nine out of 21 sheep receiving scrapie-infected blood developed the disease.

To date 167 cases of vCJD have been recorded in the United Kingdom, of which three patients are thought to have received vCJD through infected blood.

### Tara Womersley, Press and PR office, University of Edinburgh, Tel 0131 650 9836 or 07791 355 804 Email: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000179/!x-usc:mailto:Tara.womersley@ed.ac.uk

The University of Edinburgh is a charitable body, registered in Scotland, with registration number SC005336.



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.



----- Original Message -----
From: Terry S. Singeltary Sr.
To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000179/!x-usc:mailto:FREAS@CBER.FDA.GOVCc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000179/!x-usc:mailto:william.freas@fda.hhs.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000179/!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 [TSSSUBMISSION]

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 ;


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


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 ;

PRODUCTSource Plasma, Recall # B-0054-7CODEUnits: 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, 04MMNC1578RECALLING FIRM/MANUFACTURERBioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004.Firm initiated recall is complete.REASONBlood products, collected from a donor who was at increased risk for newvariant Creutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE89 unitsDISTRIBUTIONCA and AustriaEND OF ENFORCEMENT REPORT FOR October 25, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.htmlUSA FDA MAD COW BLOOD HUMANS RECALL (these are dime a dozen)RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II______________________________PRODUCTSource Plasma, Recall # B-1708-6CODEUnits: 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 05MIND2962RECALLING FIRM/MANUFACTURERBioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005.Firm initiated recall is complete.REASONBlood products, collected from unsuitable donors based on risk factors forCreutzfeldt-Jakob Disease (CJD), were distributed.VOLUME OF PRODUCT IN COMMERCE80 unitsDISTRIBUTIONCA, NC, and MD______________________________PRODUCTa) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;b) Fresh Frozen Plasma, Recall # B-1715-6;c) Platelets, Recall # B-1716-6CODEa), b), and c) Unit: 2443732RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by letters datedNovember 11, 2003 and December 18, 2003. Firm initiated recall is complete.REASONBlood products, co lected from a donor who was at increased risk for newvariant Creutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONTX and WIEND OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.htmlPRODUCTFresh Frozen Plasma, Recall # B-1751-6CODEUnit: 4936623RECALLING FIRM/MANUFACTURERGulf Coast Regional Blood Center, Houston, TX, by facsimile dated September16, 2005. Firm initiated recall is complete.REASONBlood product, which was collected from an unsuitable donor based on riskfactors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONTXEND OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006###http://ww .fda.gov/bbs/topics/enforce/2006/ENF00968.htmlMon Aug 7, 2006 10:2471.248.132.189PRODUCTa) Red Blood Cells, Recall # B-1587-6;b) Cryoprecipitated AHF, Recall # B-1588-6;c) Recovered Plasma, Recal # B-1589-6CODEa), b) and c) Unit: 2016719RECALLING FIRM/MANUFACTURERWalter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile onMarch 13, 2003. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONGA and Germany______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;b) Fresh Frozen Plasma, Recall # B-1591-6CODEa) and b) Unit: 2443595RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June30, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;b) Fresh Frozen Plasma, Recall # B-1593-6CODEa) and b) Unit: 2545596RECALLING FIRM/MANUFACTURERSouth Texas Blood and Tissue Center, San Antonio, TX, by facsimile onDecember 14, 2004 and January 3, 2005. Firm initiated recall is complete.REASONBlood products, which were collected from a donor who may be at increasedrisk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONTX______________________________http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html





Friday, October 24, 2008

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


Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0006.1 Public Submission Title Attachment to Singletary comment





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