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Final Draft 07 Feb
Statement before the Transmissible Spongiform Encephalopathy
G. Michael Fitzpatrick, Chief Operating Officer
Founded in 1962, America’s Blood Centers is North America’s largest network of independent non-profit, community blood centers. Seventy-six blood centers operate more than 600 collection sites in 45 U.S. states and Québec, Canada, and provide nearly half of the United States, and nearly one-quarter of Canada’s volunteer donor blood supply. These centers serve more than 150 million people and provide blood products (over 7 million collections annually) and services to more than 3,300 hospitals. US based ABC members are licensed and regulated by the U.S. Food & Drug Administration.
FDA announced donor deferral criteria to reduce the risk of transfusion associated vCJD in August of 1999 (five years ago) based on the application of the Precautionary Principle and the hypothesis that the prion responsible for vCJD could be transmitted by transfusion. At the October 2004 meeting, the committee reviewed two cases of vCJD that have been associated with the transfusion of blood from individuals who later died from vCJD, and did not recommend additional deferral actions.
Today FDA asks this committee to review the issue again and asks whether individuals who received a blood transfusion in Europe should be deferred as blood donors. The rationale for timing this discussion is not clear to us as we prepare these remarks. The number of BSE cases has declined. The incidence of vCJD has declined since the peak in 1999. The total number of vCJD cases around the world, about 160, remains small. Only four new cases of vCJD were diagnosed in the UK in 2004, down from a peak of 29 in 1999. No recipient of plasma derived coagulation factors in the UK has developed vCJD, despite the fact that most of them are exposed to thousands of donors
If we review the model used by FDA to decide on the scope of geographical deferrals for people that lived in the UK and the rest of Europe, it was predicated on balancing proportionate risk reduction with donor losses, and predicted a statistically derived 90% diminution of while deferring about 2-3% of the individuals who were already donating. The recommendation to defer all European transfusion recipients in order to decrease the almost unquantifiable residual risk provides is what amounts to an immeasurable contribution that would be statistically insignificant.
While most ABC blood centers can absorb the minimal donor loss associated with deferral for transfusion in the rest of Europe, we are concerned about standing at the top of a slippery slope of broader deferrals for a history of transfusion that will cost us as many as 5% of our donors. This is an unnecessary donor loss and unreasonable stigmatization of volunteer blood donors. It also sends recipients a mixed message, ABC, ARC, AABB and the FDA have frequently said over the past few years that the blood supply is safer than ever, yet FDA now is considering sending the message to recipients that the act of accepting a life-saving, SAFE, transfusion would defer the recipient from ever passing on this life-saving gift by becoming a regular blood donor. Blood recipients have become some of the best donor recruiters in the nation and regularly donate themselves. If deferred for no known/real risk they will have survived their illness through transfusion to now live under a cloud of doubt, wondering if the blood they received was safe and when and if they will begin to show signs of vCJD or some other unknown disease that is preventing them from being a donor. This is an unwarranted stigmatization of a recipient.
We want to note a specific comment about geographical deferrals made in the briefing document. The document states that “Post-donation information related to geographic exposures continues to comprise a high proportion of biological product deviation submitted to FDA, indicating that improvements in donor eligibility determinations are still needed”. In our opinion, post-donation calls are a success, not a failure, of the screening process. Donors go home, think about the questions, look at their passports and travel diaries and call back with more precise information. They want to do the right thing!
Immense resources (people, dollars and the good will of our donors) continue to be used to update deferral questions, screen and defer donors, and respond to questions from deferred donors and their friends. These resources could be better utilized in cGMP compliance and developing new screening techniques, better procedures, and recruitment of new donors. Deferral of transfusion recipients will not reduce the presumptive risk of transmission of vCJD by transfusion in any measurable way.
We again ask that FDA initiate discussions of what would constitute an exit strategy. The questions that need to be answered are: What requirements should be fulfilled before discontinuance of part or all vCJD deferrals? For instance, would we consider discontinuing the UK deferrals a certain number of years after implementation of recognized safety measures? Could we decide that former U.S. military and dependents have had less exposure than originally thought to the vCJD agent and should be deferred for a shorter period of time? Could we discuss the possibility of removing European countries which havehad no human cases of vCJD (all but France and Italy) from the deferral criteria?
Thank you for the opportunity to address the committee and we hope to be able to work with the FDA in the future on determining an appropriate exit strategy.