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.