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.