ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Saturday, September 21, 1996 TAG: 9609230064
SECTION: NATL/INTL PAGE: A3 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: ASSOCIATED PRESS
Responding to concerns about the risk of exposing people to animal-borne diseases, the government proposed guidelines Friday for transplanting animal organs and tissues into people.
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 human beings might react to animal-borne viruses and bacteria. Monkeys can spread the Ebola virus to human beings, 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.
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 human beings is especially acute. More than 33,000 patients were awaiting kidney transplants in August.
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