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5-Animals: US Anti-Xenotransplantation Coalition files lawsuit against FDA

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TITLE:  Anti-Xenotransplantation Coalition files lawsuit against FDA
SOURCE: Campaign for Responsible Transplantation, Press Release
DATE:   November 27, 2000

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Anti-Xenotransplantation Coalition files lawsuit against FDA
Claims agency is withholding information on clinical trials, hiding dangers

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 

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.

Alix Fano
Tel. +1-212-579-3477

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