PRESS RELEASE
November 27, 2000
Contact: Alix Fano
Tel. (212) 579-3477
Anti-Xenotransplantation Coalition Files Lawsuit Against
FDA Claims Agency is Withholding Information on Clinical Trials, Hiding
Dangers
The Campaign for Responsible Transplantation (CRT, http://www.crt-online.org), 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.
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