THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Saturday, September 21, 1996 TAG: 9609210299
SECTION: FRONT PAGE: A3 EDITION: FINAL
SOURCE: FROM WIRE REPORTS
LENGTH: 92 lines
Federal health officials Friday proposed new guidelines for transplants of animal organs and tissues into humans, responding to concerns about their potential for causing outbreaks of new and previously known diseases.
The guidelines ``aim to walk a tightrope'' in protecting public health while not impeding promising research efforts to find new ways to alleviate the shortage of human donor organs and tissues, Dr. David A. Kessler, the commissioner of food and drugs, said in an interview.
A Norfolk-based animal rights group, meanwhile, criticized the proposed guidelines as a wasteful and potentially dangerous process.
The need for the guidelines reflects recent successes with human transplants. About 48,000 Americans are on waiting lists for human organ transplants and about 3,000 die each year because they cannot receive a transplant in time.
The success, in turn, has led immunologists and surgeons to renew efforts to overcome the immune reaction by which humans naturally reject animal tissue.
The guidelines for cross-species transplants were developed by the Food and Drug Administration, National Institutes of Health, and the Centers for Disease Control and Prevention, and are generally in accord with versions presented at several earlier scientific meetings. The guidelines are being published in the Federal Register and the public will have 90 days to review them and comment.
The guidelines for the use of animal tissues in humans, which is known as xenotransplantation, will cover all forms of xenotransplants, including cells, tissues and organs. They will take into account points raised in published reports from American and British scientific organizations and the often harsh debate over possible hazards discussed in recent years.
Proponents say xenotransplants hold promise for a wide range of diseases.
In a widely publicized case last year, an AIDS patient, Jeff Getty, received bone marrow cells from a baboon in an experiment in San Francisco in hope that the baboon's cells, which are resistant to infection with the AIDS virus, would improve his health. Although the baboon cells did not take hold in Getty, he is thriving and his doctors are at a loss to explain why.
Among other potential uses of xenotransplants are these:
Insulin-producing pancreatic cells from pigs for diabetics.
Fetal pig cells for treating Parkinson's disease.
A genetically modified pig liver for treating the most severe form of liver failure.
Implanting cells from the adrenal glands of fetal calves to relieve pain in the late stages of cancer.
``We must realize up front that we are dealing with many unknowns'' in xenotransplantation, Kessler said. ``There are very real risks and the watchword of the guidelines is caution.''
The guidelines recommend but do not require creation of a national registry to provide information to help identify xenotransplant-associated health problems and to aid in epidemiologic and public health investigations.
Federal officials are calling for researchers conducting xenotransplants to document an animal's breeding history and to take appropriate safety measures to screen animals before using their tissues to reduce the chances of cross-species transmission of animal diseases. The guidelines call for local review boards to assess infectious disease risks at each institution carrying out such research.
Health officials also call for preserving serums, white blood cells and other biological samples from the source animal and transplant recipient for potential public health investigations. Kessler said each institution that carries out xenotransplants would be required to store such samples indefinitely.
Keeping such material will allow scientists to apply what they learn in coming years to old samples. After scientists discovered the AIDS virus, for example, they could test samples kept frozen for many years to determine whether the infection was present in the past.
Although doctors have mapped the spectrum of infectious agents transmitted from human transplants, they do not know the full range of those potentially transmitted by xenografts.
Also, some infectious agents may not produce clinically recognizable disease until many years after they enter a human, and infectious agents that produce minimal symptoms in animals may cause severe illness, even death, in humans. Microbes may change form when transmitted from a natural host into a new species.
A spokesman for People for the Ethical Treatment of Animals, an animal rights group based in Norfolk, said the guidelines put 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.'' MEMO: This story was compiled from reports by The New York Times and The
Associated Press.
KEYWORDS: FDA ANIMAL TRANSPLANTS GUIDELINES by CNB