Group Sues FDA for Information on Xenotransplantation Trials
A nonprofit coalition of 90 public interest groups filed suit against the Food and Drug Administration on November 27 to compel the FDA to release information regarding clinical trials related to xenotransplantation.
The New York-based Campaign for Responsible Transplantation (CRT) said in its suit that it had written to the FDA on March 9 requesting "all FDA records concerning applications for approval to conduct clinical trails in humans that involve xenotransplantation, and all information concerning currently ongoing and concluded clinical trials involving xenotransplantation." CRT said that because the FDA has not complied, the coalition is seeking the information under the Freedom of Information Act. The suit was filed in the United States District Court for the District of Columbia.
CRT was launched in January 1998. The lawsuit describes the group as "dedicated to education and dissemination of information concerning the health risks and ethical and policy considerations of xenotransplantation."
In a press release, CRT charged that although the FDA has not released information on clinical trials regarding xenotransplantation, scientific journals and magazines over the past decade have chronicled more than a dozen related deaths and that "countless others have experienced adverse side-effects in xenotransplant experiments using body parts from genetically altered pigs and/or baboons."
For Your Information:
CRT's homepage is at www.crt-online.org. The press release
is posted at www.crt-online.org/112700.html, where
the lawsuit can be downloaded.
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