Xenotransplantation clinical trials killed dozens and caused hundreds of adverse events.
The US Food and Drug Administration (FDA) is accused of withholding thousands of documents on side effects and deaths relating to xenotransplantation. The charge of violating the Freedom of Information Act was brought this week in Washington by the Campaign for Responsible Transplantation (CRT). The group represents 90 public interest bodies.
"The FDA has fought the release of these papers for two years" said Alix Fano, director of CRT, "there are about 32,000 pages of documents at issue here". A 45-page brief was lodged with the Federal District Court ordering the FDAs disclosure of documents on clinical xenotransplantation trials in which live animal cells, tissues and organs originating from pigs and baboons have been transplanted into humans. Despite federal investigations into human gene therapy, which uncovered over 650 adverse event reports and eight patient deaths from eighty institutions, suspension on clinical trials was lifted in 1998.
CRT brief exposes Diacrin, a xenotransplantation sponsor, whose clinical testing of a NeuroCell PD product involved using pig cells to treat Parkinsons, yielded 232 adverse events in 1997. In 2000 their trials to treat stroke victims had to be halted (by the FDA) when two patients suffered adverse reactions after having pig cells injected into their brains.
CRT cites 16 patient deaths during or after xenotransplant trials since 1992 and in all cases, death was attributed to "previous medical conditions". Eight patients died in 1997 after having their blood filtered through pig livers at Cedars Sinai Medical Center in L.A.
There are other risks to the patients, their families, heath workers and the public at large. Eminent scientists agree that xenotransplantation could transmit known and unknown viruses from animals to humans with devastating consequences.
Article first published February 2002