Xenotransplantation Guidelines Out Soon By Therese M. Droste BETHESDA (Reuters) -- On Thursday, the second day of the conference on Developing US Public Health Service Policy in Xenotransplantation, experts continued their debate on the issues surrounding use of animal organs in the treatment of humans. Dr. Harold Y. Vanderpool of the University of Texas Medical Branch at Galveston said transplantation of animal organs and tissues into human subjects calls for examining four critical ethical issues. "These are not daunting issues" but they must be addressed, Vanderpool said. First, scientists must consider judgments regarding permissible harm-benefit thresholds for the initiation of clinical trials involving human subjects. It encompasses three factors that must be played off one another: scientific-medical feasibility, clinical urgency, and the potential of scientific discovery, Vanderpool said. Second, it's necessary to secure informed consent from third-party groups such as medical personnel and patients' close contacts, Vanderpool said. This will protect researchers and medical institutions from lawsuits from medical personnel and close contacts of patients who might claim that they were never told about the risks they might run from dealing with patients who have received animal organs. Third, there are serious difficulties in securing informed consent from research subjects, Vanderpool said. Some subjects for xenotransplantation are sick and desperate to extend their lives, "but they still must understand the complex concerns" surrounding xenotransplantation, he said. And fourth, there are problems regarding who approves and oversees clinical trials, Vanderpool added. Dr. Leroy Walters of Georgetown University provided several elements to help devise xenotransplantation policy: -- Conduct regular public discussion and review of xenotransplantation protocols that typify the major lines of current research or that raise issues; -- Publicly list all clinical studies of xenotransplantation into humans, without regard to the funding sources; -- Run a registry tracking all volunteers in early xenotransplantation studies. "The question will be... whether or not the registry should also include and track members of immediate families," Walters said; -- Have an annual accounting of the number of animals used by a species for transplants into human beings; -- Have an annual assessment based on a global literature review of the public health risks associated with xenotransplantation; -- And have an external review at the end of the first five years and every two years thereafter of whether a special oversight system continues to be needed for this innovative field, Walters said. Developing public policy for xenotransplantation is controversial due to potential dangers to public health, especially the potential risk of animal viruses mutating into forms that can infect humans. Such risks are enunciated in the February 1 issue of Nature Medicine, in which Dr. Fritz Bach of Beth Israel Deaconess and Harvard University in Boston, Massachusetts, calls for a "moratorium" on xenotransplantation on humans. Bach told Reuters that it's necessary to get public input on xenotransplantation by way of a broad-based national committee that will educate the public of the viral and other risks of xenotransplantation. Such a committee could be put together by the President or Congress, he said. The moratorium, Bach said, "could be lifted the first time the committee meets, if that's what they decide," but that it's crucial for the public to be involved. He stressed that the moratorium need not impact either xenotransplantation research or its funding. Dr. Louisa Chapman of the Centers for Disease Control and Prevention said that revisions to the xenotransplantation guidelines, first published in the December 1996 Federal Register, will be completed in the first half of 1998.
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