URL: http://www.nature.com/cgi-taf/DynaPage.taf?file=/nature/journal/v408/n6813/full/408630b0_fs.html
Date accessed: 31 January 2001
Nature 408, 630 (2000) © Macmillan Publishers Ltd.
07 December 2000
PAUL SMAGLIK [WASHINGTON]
Contained: data on adverse events in animal transplant studies have
not been freely released. The Campaign for Responsible Transplantation, which filed the lawsuit, says
adverse events from xenotransplantation have been reported in journals and at
public meetings hosted by the FDA, but the agency has refused to release all the
data from these trials. An FDA spokesperson declined to comment on the lawsuit. The campaign group compares the work's secrecy to that which surrounded gene
therapy until the death of a patient, Jesse Gelsinger, during clinical trials at
the University of Pennsylvania last year. Alix Fano, director of the group, says
that it wants xenotransplantation research to be as open as gene-therapy trials
now are. "This is a new form of biotech — it's akin to the gene-therapy
trials where a lot of side effects went unreported," she says. Fano estimates that there are around a dozen xenotransplantation trials under
way in the United States. The precise number is unknown, she says, because the
FDA does not disclose it. The trials began more than 30 years ago, with about 12
transplants of chimpanzee organs. More recent experiments have studied the
transplantation of cells, rather than complete organs. LeRoy Walters, director of the Kennedy Institute of Ethics at Georgetown
University in Washington DC, supports the idea that data from medical research
should be more freely available. "I would like to see a public registry of
all clinical trials across the board," he says. The lawsuit reflects the tension between the industrial sponsors of research,
who want to keep the results of clinical trials private, and some public-health
advocates, who want more openness. That tension increased last autumn following
Gelsinger's death, which set in motion a chain of events that resulted in a
publicly accessible database of gene-therapy clinical trials. Drug companies say that the release of information from clinical trials can
threaten their competitiveness. But campaigners and bioethicists argue that both
gene therapy and xenotransplantation differ so much from conventional medicine
that more transparency is needed. Gene therapy, they say, runs the risk of germline gene transfer, where
genetic changes are passed unintentionally to the patient's children. With
xenotransplantation, critics worry that retroviruses might pass from animals to
humans.
Opponents of xenotransplantation research have begun a lawsuit against the US
Food and Drug Administration (FDA), demanding that more information be made
public about experiments in which humans receive transplants of animal tissue.
AP
Category: 30. Xenotransplantation