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Anti-Xenotransplantation Coalition Threatens Suit Against HHS

Westport, Aug. 05 (Reuters Health)

A coalition seeking a ban on xenotransplantation is threatening to sue the US Department of Health and Human Services for failure to respond to a legal petition.

According to the New York-based Campaign for Responsible Transplantation, it sent a legal petition to HHS in December 1998 asking for a ban on the animal-to-human technology because of the risks it entails. The petition was signed by 55 scientists and laypersons.

The Campaign for Responsible Transplantation gave HHS until June 10, 1999 to respond to the legal petition, but it has yet to respond, Campaign Director Alix Fano told Reuters Health. She said that HHS has ignored the group's concerns and that they informed HHS through a letter sent on July 30 that it has 2 more weeks to respond before they file a suit for "failure to act" under the Administrative Procedures Act.

Fano said that the campaign is seeking the ban on xenotransplantation due to the risks of animal viruses being passed on to humans. She said that the technology is also problematic from a social and economic standpoint.

She said that xenotransplantation is more expensive than human-to-human transplantations. In addition, Fano said that no cost-benefit analysis has been done by the government to determine if such animal-to-human transplants are necessary.

She said that recipients who become infected with a virus through such techniques would need to be quarantined, which would cost an additional, undetermined amount of money. Fano also pointed to the environmental pollution issues that would need to be addressed and have not been addressed by HHS.

According to Fano, HHS should be addressing the problem of getting more people to donate organs rather than encouraging the development of xenotransplant techniques.

Fano said, "We have given the agency ample time to respond to our petition, and several opportunities to tell us when they expect to reply. They are obviously stalling and that is unacceptable in light of the public health risks posed by xenotransplantation."

The campaign noted in a statement that sources within the Food and Drug Administration have said that HHS intended to set up a new committee to oversee xenotransplantation research.

A HHS spokesperson told Reuters Health that she could not comment specifically on the campaign's petition, but the agency ". . . wants to be as responsible as possible in addressing the campaign's concerns and is in the process of forming a response to the petition."

- Westport Newsroom 203.319.2700