Coalition Releases Report:
(New York) � � The Food and Drug Administration (FDA) may be repeating mistakes it made while monitoring blood supplies during the AIDS crisis, according to the Campaign for Responsible Transplantation (CRT) � an international coalition of 80 public interest groups opposing animal-to-human organ, cell and tissue transplants (xenotransplants).
In a scathing 12-page critique released today, CRT used the words �inadequate� and �short-sighted� to describe FDA draft guidelines which seek to �defer� blood donations from xenotransplant patients and their �close contacts.�� CRT draws parallels to the 1980s, when FDA allowed thousands of people to receive HIV-tainted blood and blood products, resulting in thousands of cases of HIV infection and the deaths of over 10,000 hemophiliacs.
�FDA admits that xenotransplantation could spread known and unknown diseases to humans. It admits that, if these viruses got into the blood supply, it would be �disastrous,� says CRT�s Director Alix Fano.� �And yet the new blood guidelines prove that FDA has failed to correct problems which jeopardized its ability to protect the nation�s blood supply two decades ago.�
The problems were identified in a 1995 Institute of Medicine (IOM) report entitled HIV and the Blood Supply, and in several General Accounting Office reports including, Blood Supply: FDA Oversight and Remaining Issues of Safety (February 25, 1997).
In the 1980s the FDA, among other things, �accepted estimates that the risk of AIDS was low,� and chose the least aggressive options for reducing the probability of spreading the disease.� Today, FDA is:
�By allowing xenotransplantation, FDA is playing Russian Roulette with the public�s health.� Unless the technology is banned, the nation�s blood supply will never be safe,� says CRT�s Fano.