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Anti-Xenotransplantation Coalition Releases Report:
�FDA�s Proposed Blood Policy Could Lead to New AIDS�

(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:

  • Downplaying the risks of infection from animal viruses, like the porcine endogenous retroviruses
  • Has no system in place, such as a name-based registry, to track and monitor all xenotransplant patients and their contacts, meaning that some of these individuals may have already donated blood
  • Has no system in place to determine whether previous guidelines (which also recommended blood bans from patients) are being followed
  • Has no system in place to determine how or whether companies are tracking patients treated with their xenotransplant products
  • Has not specified how hospitals � already overwhelmed and underbudgeted - are to implement this new blood guideline, to prevent blood donations from potentially infected individuals
  • Has not identified a plan to educate the public about this new threat to the blood supply
  • Is not prepared for a public health emergency caused by latent or unknown animal viruses.

�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.

Copies of CRT�s critique are available via fax, e-mail, snail mail, and for download.