The Associated Press Friday, 20 September 1996
Robert Greene, Associated Press Writer

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

Doctors and other scientists are working to bridge the gap, from transplanting whole animal organs to genetically engineering animal tissue that the human body won't reject.

At the same time, researchers worry about how humans might react to animal-borne viruses and bacteria. Monkeys can spread the Ebola virus to humans, and primates carry simian immunodeficiency virus, closely related to the human AIDS virus. Scientists are exploring possible links between mad cow disease and Creutzfeld Jakob disease in humans.

The FDA guidelines offer a number of steps from the breeding of animals to the makeup of transplant teams to ensure that cross-species transplants are safe. Patients should be told of the risks to themselves, families and other close contacts, including sexual partners, according to the guidelines.

"There's a very real problem," said Dr. David Kessler, the FDA commissioner, noting that 3,000 people die a year from lack of available transplant organs.

"I think because of this problem we are willing to take some very real risks," he said. "But the watchword is caution. This needs to proceed scientifically and cautiously."

Although the guidelines are voluntary, Kessler emphasized that the agency already regulates animal-based products used in human medicine and will keep doing so.

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 transplant last year of baboon marrow into AIDS patient Jeff Getty of San Francisco.

Getty, 39, said he looks forward to reading the guidelines, wishes they could be more specific, but understands why they aren't -- the government still doesn't fully understand the risk and won't assume responsibility.

"How do we live our lives after we receive a transplant?" he said, adding that he received advice from his transplant team this summer.

"I was advised by one of the team doctors that is was OK for me to resume having casual contact and safe sex with my partner," he said. He said doctors found no baboon viruses in him.

A spokesman for People for the Ethical Treatment of Animals, an animal rights group based in Norfolk, Va., said the guidelines puts the government's seal on a wasteful and possibly dangerous practice.

Dan Mathews said the practice does not work, is cruel to animals, raises false hope in people, siphons scarce research dollars, and greatly increases the risk of new diseases.

"There's no shortage of available human organs," he said. "They're just being buried."

Research into so-called xenotransplants is widespread. Scientists are transplanting fetal pig cells to treat Parkinson's disease, genetically modified pig liver to counter human liver failure, pancreatic cells from pigs to treat human diabetes and fetal calf adrenal cells to ease the pain for people in the final stages of cancer.

For kidney patients, the need for sources other than humans is especially acute. More than 33,000 patients were awaiting kidney transplants in August.

"I think the viewpoint is that at some point in the next five years people are going to start to use xenotransplants, and I think the FDA wanted to be ahead of the curve," said Dr. Alan R. Hull, a Dallas nephrologist and medical professor and president of the National Kidney Foundation.

Among the guidelines, the FDA says surgical transplant teams should include a veterinarian and a doctor specializing in infectious diseases. The hospital or clinic should be associated with an accredited virology and microbiology laboratory.

Also, the proposals urge that samples of blood, cells and tissue from the animals and human recipients be saved for follow-up investigations. And the animals should be bred and reared in captivity from known stock and with close record-keeping and screening for known causes of infection.

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