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Anti-Xenotransplantation Coalition Files Lawsuit Against FDA
Claims Agency is Withholding Information on Clinical Trials, Hiding Dangers

November 27, 2000

Download the CRT lawsuit in PDF format.

The Campaign for Responsible Transplantation (CRT), a coalition of 90 public interest groups, filed a lawsuit in Federal District Court today to obtain records from the Food and Drug Administration (FDA) on clinical trials in which animal cells, tissue, and organs have been implanted into humans.

CRT's lawsuit charges that the FDA repeatedly ignored its requests for information, initially filed back in March 2000, and ultimately violated the Freedom of Information Act (FOIA) by improperly withholding records.

The FOIA requires federal agencies to release documents to the public upon request, unless specific statutory exemptions apply. In its lawsuit, CRT explains that the records it requested should not be exempt from disclosure since trial sponsors have themselves divulged details about the human experiments to the media and the public through press releases, the Internet, and presentations at FDA-sponsored public meetings.

"We know, through articles in scientific journals and magazines like The New England Journal of Medicine, Transplantation, New Scientist and others, that since the early 1990s, over a dozen patients have died, and countless others have experienced adverse side-effects in xenotransplant experiments using body parts from genetically altered pigs and/or baboons," says CRT's Director Alix Fano. "This is not the rosy picture of xenotransplantation portrayed in newspapers and TV programs. We believe the public has a right to all the facts; apparently, FDA doesn't," says Fano.

Biotechnology companies and government health officials are promoting xenotransplantation as a panacea for the perceived human organ and tissue shortage despite mounting concerns about safety. The FDA, which has approved over a dozen clinical xenotransplant trials, has admitted that the technology could facilitate the transmission of known or as yet unrecognized animal viruses to patients and the general public. Indeed, last October, baboon Cytomegalovirus was detected in stored blood and tissue samples of a baboon liver recipient who died in 1992.

When viewed within the context of emerging infectious diseases like nvCJD ("mad cow disease"), AIDS (which some scientists believe originated in chimpanzees), a growing catalogue of new pig viruses, and recent gene therapy fiascos in which patients died and side-effects were covered up, the U.S.'s enthusiasm for using genetically altered pigs as organ factories is disturbing.

"We believe there has been a pattern of secrecy within the FDA and other federal agencies with respect to xenotransplantation," says Fano. "The purpose of CRT's lawsuit is to break through the wall of secrecy so that the public interest can be served." The lawsuit is being handled by the Washington, DC public interest law firm, Meyer & Glitzenstein.