The World Federation of Hemophilia is an international not-for-profit organization representing 95 member countries. It is dedicated to improving hemophilia care for the estimated 400,000 people around the world with hemophilia.
The World Federation of Hemophilia is very concerned about proposed expansion of screening policies to further exclude donors, ostensibly to reduce the theoretical risk of vCJD transmission by plasma products, without sound justification that the measures will increase the overall safety of people receiving these products.
Consider the following facts affecting the supply and safety of blood products today.
- The WFH’s most recent global survey shows that the majority of people with hemophilia (PWH) worldwide do not have access to recombinant products. These are available only in countries with an average GNP greater than $10,000.
- Safe plasma-derived concentrates therefore remain the lifeline for a majority of people with hemophilia. We estimate that this is likely to remain the case in the foreseeable future.
- A very large percentage of the plasma used for manufacturing these concentrates comes from the United States and Europe. Very few countries are able to collect plasma in sufficient quantity or of sufficient quality.
- The chief causes of death among 75% of PWH today are bleeding, HIV and hepatitis C (HCV). This is the result of lack of availability of plasma-derived products, or the use of unsafe plasma products which have not been viral inactivated.
- There is currently a worldwide shortage of plasma products for treating people with hemophilia. The shortage of recombinant products in Europe, North America and Japan threatens to have a serious impact on other parts of the world. Plasma- derived products that were once available in developing countries are now becoming scarce because developed countries have had to go back to using plasma products to make up for recombinant shortages.
Implementing policies that restrict donors from giving blood cause additional shortages in developing countries. Indeed, these restrictions, if adopted by all, may well cause shortages in developed countries as well if the recombinant product shortage continues.
Fewer available products in the developing world will lead to an increased number of deaths and disabilities because of:
- the unavailability of products to treat life-threatening bleeding episodes; and
- the replacement of safe products with unsafe local fresh frozen plasma and cryoprecipitate or by-products manufactured using lower quality plasma obtained from dubious sources.
Because of their tremendous worldwide impact, screening policies for donors that further reduce the global availability of plasma products should be based on sound scientific knowledge or judgment that the safety obtained by the new screening policies will outweigh the risk of more people dying from lack of treatment products.
In this instance, a theoretical risk of vCJD is being weighed against a real risk of shortages and this type of risk assessment is extremely difficult. The screening procedures currently in effect have tried to reasonably balance relative risk of shortage with the theoretical risk of vCJD.
However, further attempts to try to reduce the risk to absolute zero amplifies the real risk of death and blood-borne infections for 80% of the PWH living outside Europe and North America. Careful assessment of the expected gain in risk reduction in this situation is absolutely mandatory.
Line Robillard
Executive Director
June 28, 2001, Bethesda, Maryland
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This is intended to provide information only. The World Federation of Hemophilia does not engage in the practice of medicine and under no circumstances recommends particular treatment for specific individuals. In the case of vCJD and individual medical inquiries, the WFH suggests that further details should be sought from personal doctors or hemophilia centre staff.
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