Xenotransplantation Critics File Motion in Federal Court
Group Says FDA is Withholding Documents on Side-Effects and Deaths
Download the motion (154KB, DOC format)
(Washington, DC) - The Campaign for Responsible Transplantation (CRT), a coalition of 90 public interest groups, has filed a motion in Federal District Court charging the Food and Drug Administration (FDA) with violating the Freedom of Information Act. The 45-page brief asks the Court to order the FDA to disclose thousands of pages of agency documents on clinical xenotransplant trials in which live animal cells, tissues, and organs (from pigs and baboons) have been implanted into humans.
"The FDA has fought the release of these records to us for almost two years," says CRT's Director Alix Fano. "There are about 32,000 pages of documents at issue here. FDA's lawyers have failed to justify why some or even portions of those pages can't be released, particularly given the serious public health risks involved," says Fano.
Leading virologists and FDA officials have acknowledged that xenotransplantation could transmit known and unknown animal viruses to patients, their families, health care workers, and the public at large, possibly triggering an AIDS-like pandemic. Despite these concerns, a hold on clinical trials was lifted in 1998 "without adequate public explanation," says Fano. Some 470 patients have been treated with xenotransplant products since 1992 - many were treated before the issuance of any guidelines - and over a dozen investigational new drug applications involving xenotransplantation are currently active.
Recent federal investigations into human gene therapy trials brought to light over 650 adverse event reports from 80 institutions, and eight patient deaths attributable to the experiments. CRT's brief reveals that by December 1997, one xeno trial sponsor, Diacrin, had already documented 232 adverse events in connection with clinical testing of its NeuroCell-PD product alone, which uses pig cells to treat Parkinson's Disease. In April 2000, the FDA halted a Diacrin stroke trial because two patients suffered side-effects after having pig cells injected into their brains. The precise number of adverse events in xenotransplant trials is unknown because FDA keeps that information secret. CRT's motion is a direct challenge to that policy of secrecy.
"We know from published sources that, since 1992, at least 16 patients have died during or after xenotransplant trials," says Fano. "Eight patients died in 1997 after having their blood "filtered" through pig livers at Cedars Sinai Medical Center in Los Angeles. A year later, another patient died at the Mayo Clinic in Rochester, Minnesota after undergoing a similar procedure. In all these cases, the patients' deaths were attributed to previous medical conditions and not to the xenotransplants themselves. But those deaths have been kept out of the public eye and the records need to be scrutinized. We think the FDA should release these documents and we hope the Court will agree," says Fano. CRT is represented by the Washington, DC public interest law firm, Meyer and Glitzenstein.
CRT's brief can be viewed at http://www.crt-online.org.