FDA Failed to Justify Withholding Xenotransplantation Information From Public, Court Rules

Court Gives FDA Until November 10, 2002 to Prove Secrecy Concerning Xenotransplantation is Legal

(Washington) – The United States District Court for the District of Columbia, Judge Ricardo M. Urbina, ruled Tuesday that the Food and Drug Administration (FDA) failed to prove that it could withhold approximately 27,000 records concerning xenotransplantation clinical trials from the Campaign for Responsible Transplantation (CRT).

CRT, a New York-based coalition of 90 public interest groups, believes that cross-species or xenotransplants should be banned because of the risk of infecting patients and the general public with viruses from genetically altered pigs – biotechnology companies’ source animals of choice.

The Court held that the FDA fai8led to justify its decision to withhold the records in question under the Freedom of Information ACT (FOIA) because the agency did not describe them in sufficient detail, or prove that they could lawfully be withheld.

“We are very pleased with the judge’s decision,” says CRT’s Director Alix Fano. “It proves, in this phase of litigation, that the FDA has failed to meet its obligation for public disclosure under FOIA. We look forward to discovering why the FDA is being so protective of the documents in its possession,” she says.

The FDA claimed that thousands of records could lawfully be withheld as “trade secret” and/or “confidential commercial information;” but the Court concluded that the FDA needed to make an either/or distinction, rather than use a blanket rationale for withholding the information, leaving CRT to guess which claim applied. The Court called the distinction “crucial.”

In addition, the Court determined that the agency’s contention that thousands of record could be withheld because they would reveal internal FDA discussions about the regulation of xenotransplantation were “vague” and “conclusory”.

The Court has given the FDA until November 10, 2002, to make a final attempt to prove its justification for withholding the records at issue. The FDA was ordered to supply additional documents and affidavits in its defense, and both parties were ordered to resume settlement talks.

CRT originally filed a FOIA request in March 2000 to obtain information on clinical xenotransplantation trials, with the aim of gathering data on side-effects, possible human infections, and deaths in such trials. After the FDA repeatedly ignored its request for information, CRT filed suite in November 2000 charging that the agency violated the FOIA. The law requires federal agencies to release documents to the public upon request, barring specific statutory exemptions. In its lawsuit, CRT explained that the records it request should not be exempt from disclosure since trial sponsors have themselves divulged details about their human experiments to the media and the public through press releases, the Internet and presentations at FDA-sponsored public meetings. But in March 2001, six biotechnology companies (Diacrin, Genzyme, Diacrin/Genzyme, Circe Biomedical, Nextran, and Novartis) intervened in the litigation between CRT and the FDA, to limit or prevent disclosure of documents to CRT.

“We know, through articles in scientific journals and magazines, that since the early 1990’s over a dozen patients have died in xenotransplant experiments,” says Fano. Some 232 adverse events occurred during the testing of one product, Diacrin’s NeuroCell, which used pig cells in Parkinson’s treatments. “This is not the rosy picture of xenotransplantation portrayed by its proponents.”

Companies and government health officials are promoting xenotransplantation as a panacea for the human organ and tissue shortage despite mounting concerns about risk and the availability of safer options. The FDA, which has approved over a dozen clinical xenotransplant trials, has admitted that the technology is dangerous. Given a growing catalogue of new killer pig viruses, AIDS, “mad cow disease,” and recent gene therapy fiascos in which patients died and side-effects were covered up, CRT finds the U.S.’s enthusiasm for xenotransplantation disturbing.

CRT is represented by the Washington, DC public interest law firm, Meyer & Glitzenstein.