Anti-Xenotransplantation Coalition Denounces New Federal Guideline

(New York) - The Campaign for Responsible Transplantation (CRT), an international coalition of physicians, scientists, and 90 public interest groups, is denouncing a new 'Public Health Service [PHS] Guideline on Infectious Disease Issues in Xenotransplantation,' published May 26th.

"This guideline is so burdensome on so many levels that it invites human error," says CRT's Director, Alix Fano. "No guideline, however complex, will make cross-species transplants safe. Some of the measures outlined, such as storing tissue samples for future study, and establishing a national xenotransplant database, should have been set up long ago, before any clinical trials were approved. At this point, they will only serve to detect disease after the fact, and that's too late."

Today, PHS acknowledges, as it did in its 1996 draft xenotransplantation guideline, that viruses from animals used in cross-species transplants could infect patients, their offspring, health care workers, and the general public. But this time, the agency goes further by admitting that:

• "all xenotransplantation products pose a risk of infection and disease to humans,"
• "baboon endogenous retrovirus in human recipients of baboon [livers] has been documented,"
• "new viruses capable of infecting humans have been identified in pigs,"
• "all species pose infectious disease risks,"
• "[xenotransplant recipients] may represent a biohazard to healthy livestock."

"By making such statements and then recommending steps for how to move this technology forward, PHS is acting irrationally and blatantly disregarding the Precautionary Principle, adopted by over 130 governments as the basis for decision-making in the Cartagena Biosafety Protocol 2000," says Fano.

The PHS guideline also conveniently ignores issues of cost, liability, animal welfare and ethics.

For example, PHS recommends archiving blood and tissue samples and medical records from thousands of animals, patients, and health care workers (both living and dead) for 50 years. Who will pay for this? Where will this mountain of data be stored? What about fires, floods, power losses, hackers, and human error? Who will force patients to comply with the life-long monitoring schedules described in the guideline? Who will ensure that patients will "educate their close contacts" about the risk of infection, or will notify officials if they move, change their name or address? There is simply no legal mechanism to enforce compliance with the guideline.

Despite evidence of negligence and deception in recent gene therapy trials, the PHS trusts sponsors to design and monitor xenotransplant trials, tailor complex informed consent documents, educate workers, effectively screen source animals for viruses, maintain proper documentation, and reliably report crucial information about patient and animal health to federal agencies. There is no mention about who will be held responsible if a novel virus is unleashed upon society; and no emergency procedures to deal with an outbreak are proposed, even though the PHS acknowledges that "airborne transmission of infectious agents" is possible.

Who will decide how much animal suffering is justified? Up to 100 pig fetuses may be needed for a single transplantation of pig pancreatic islet cells into a diabetic patient. Each patient may need several transplants during the course of treatment. That's a lot of pigs for one person. The guideline endorses cloning to produce source animals, even though cloned animals suffer numerous health problems, and dozens of pigs may be killed to produce one clone.

PHS suggests that some animals from xenotransplant facilities may be considered "safe for human food use or as feed ingredients." If pigs are engineered with human genes to prevent rejection by the human body, wouldn't humans consuming these pigs, in a sense, become cannibals?

These and many other issues must be debated publicly before xenotransplantation goes forward.

PHS has blatantly lied in the current guideline by suggesting that Americans have neither endorsed nor rejected xenotransplantation. But documents obtained through the Freedom of Information Act by CRT reveal otherwise. In response to its 1996 draft guideline, PHS received over 160 comments: 115 against xenotransplantation, 29 in favor, and 19 neither for nor against, with 8 of these strongly opposing the use of nonhuman primates. Furthermore, the Food and Drug Administration received almost 6,000 postcards, and over 350 letters protesting its April 1999 guidelines on the use of nonhuman primates in xenotransplant trials.

"It is clear that the PHS has chosen to ignore the voices of opposition and caution," says Fano. "The agency has also completely ignored alternatives to xenotransplantation, including prevention of disease, increased human organ donation, and use of human tissue for transplant." Last week, for example, Canadian researchers announced that they successfully used human pancreatic islet cells to treat eight patients with Type 1 diabetes; others are growing human stem cells to treat neurological diseases like Parkinson's and Alzheimer's.

"At a time when almost 50 million Americans lack basic health care, our tax dollars should not be used to develop a dangerous, expensive, and unethical technology like xenotransplantation, especially when there are alternatives," says Fano. "Science can no longer exist in an ethical vacuum; it must respond to public needs and concerns. And the public must clearly demand accountability from the PHS, before it is too late."