New rules proposed for animal-to-human transplants

September 20, 1996
Web posted at: 11:30 p.m. EDT

WASHINGTON (CNN) -- The Food and Drug Administration proposed strict guidelines Friday for transplanting organs from animals to humans.

The voluntary guidelines, which come years after some hospitals began experimenting with animal-to-human transplants, are needed because of a shortage of human donor organs, the FDA said.

"It's a judicious approach to balancing the need for transplants, but also minimizing the risk," FDA Commissioner Dr. David Kessler said. "It's a very cautious approach, because the risks are very real."

There is a significant shortage of human organs available for transplant. About 4,800 people a year donate them, while 48,000 people need them, and 3,000 people die waiting for them.

Doctors and other scientists are working to bridge the gap. They either transplant whole organs or genetically transform animal tissue that the human body won't reject. But researchers worry about how humans might react to animal-borne viruses and bacteria.

Some animal-to-human transplants have received widespread attention such as the transplant of a baboon heart into Baby Fae nearly 12 years ago, transplants of baboon livers at the University of Pittsburgh, and the transplant last year of baboon marrow into AIDS patient Jeff Getty of San Francisco.

The FDA proposal offers a number of guidelines from the breeding of animals to the makeup of transplant teams to ensure cross-species transplants.

Better screening

Among other measures, the guidelines call for screening donor animals for disease, saving tissue samples from both donor and recipient and establishing a national registry on transplant results. Patients should also be advised of the risks to themselves and those close to them.

Advocates say animal-to-human transplants, also called xenotransplants, are still so experimental that they won't help a lot of people immediately, but could over time.

But others are more skeptical. Animal-to-human transplants take money away from efforts to get more human donors, according to Steven Ragland of the Physicians Committee for Responsible Medicine.

"There is nothing safe about any animal-to-human transplants," Ragland said. "The human patient ultimately doesn't benefit. None has benefited in the past three decades of these ghastly experiments."

The FDA said it is proceeding cautiously. Its next step is to solicit public comments on the guidelines and make any necessary adjustments before putting them into effect, possibly early next year.

Correspondent Eugenia Halsey and The Associated Press contributed to this report.

Related stories:

• Activists clash over AIDS research vs. animal rights - June 16, 1996
• Baboon marrow transplant patient survives - Dec. 15, 1995
• Baboon bone marrow recipient 'feeling great' - December 15, 1995
• Experimental baboon-to-human AIDS transplant begins- Dec. 14, 1995

Related sites:

• Xenotransplant program from the University of Pittsburgh Medical Center
• Clinical History of Xenotransplantation from the University of Pittsburgh Medical Center
• Organ transplants from animals: examining the possibilities from the U.S. Food and Drug Administration
• Xenotransplantation: Risks, Clinical Potential, and Future Prospects from the Centers for Disease Control and Prevention

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