Advocacy Group Sues FDA, Claims Agency is Withholding Risks of Xenotransplantation

WASHINGTON (Reuters Health) – The Campaign for Responsible Transplantation (CRT) on Monday has asked a federal district court to compel the US Food and Drug Administration (FDA) to release records detailing the potential risks of xenotransplantation that CRT officials claim the agency has but is concealing.

“We want the court to rule that the FDA violated the Freedom of Information Act (FOIA) by withholding Äxenotransplantation clinical trial dataÅ,” CRT spokeswoman Alix Fano told Reuters Health.

The group’s lawsuit, filed in the Federal District Court for the District of Columbia, alleges that the FDA “repeatedly ignored ÄCRT’sÅ requests” for information on clinical trials in which animal cells, tissue and organs are transplanted into humans for therapeutic purposes.

According to Fano, the coalition’s initial March 9 document request filed with the FDA included “voluminous” documents that contained reprints from scientific journals, press releases, public meeting transcripts and Internet Websites. These documents, she alleges, illustrate that sponsors have shown little reluctance to disclose to the public details of their xenotransplantation trials.

CRT hopes to persuade the court that such data should not be exempt from the group’s FOIA request.

Before filing the suit, CRT followed up its information request with two unsuccessful appeals and was informed by an FOIA official via telephone that “it could take years before we get to this,” Fano noted.

Based on articles in peer-reviewed medical journals, including the New England Journal of Medicine, more than 12 patients have died and numerous others have suffered serious side effects in the past 10 years after receiving tissue or organs from pigs and baboons, Fano claims.

CRT, which is headquartered in New York, cited a case last October in which a baboon Cytomegalovirus was identified in stored blood and tissue samples taken from the recipient of a baboon liver who died in 1992.

“This is not the rosy picture of xenotransplantation portrayed in newspapers and TV programs,” she said. “We believe the public has a right to all the facts; apparently FDA doesn’t.”

Although an FDA official contacted by Reuters Health declined to comment specifically on the pending lawsuit, she noted that the agency routinely responds to various groups regarding “why we do what we do.” The official also noted that the FDA’s policy on xenotransplantation is “well dealt with” in the recently issued public health service guidelines.