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Coalition Seeking Xenotransplant Ban May Sue HHS for Failure to Respond to Legal Petition

An international coalition of public interest groups has given Health and Human Services (HHS) Secretary Donna Shalala legal notice that it will sue her agency if it does not respond to a legal petition filed last December asking for a ban on animal-to-human organ, cell and tissue transplants, (xenotransplants).

On December 10, 1998, the New York-based Campaign for Responsible Transplantation (CRT) filed a legal petition with HHS, signed by 55 scientists and concerned laypersons. The petition asked the agency to ban xenotransplantation because the technology could transmit deadly animal viruses to patients and non-patients alike. The petition also noted that HHS should have performed an environmental impact assessment before allowing the use of this risky new genetic engineering technology.

The deadline for HHS's response was June 10, 1999. Despite a May 26th letter sent to Shalala by CRT's lawyers, reminding her of the approaching deadline, HHS did not reply. No concrete answer was given, by phone or on paper, as to when a response would be issued.

On July 30, 1999, CRT's lawyers submitted another letter to Shalala, informing her that, failure to respond to the legal petition would be viewed as "constructive denial" and "failure to act" under the Administrative Procedures Act. The Act gives courts the power to "compel agency action unlawfully withheld and unreasonably delayed."

"We have lost our patience with HHS," says CRT Director Alix Fano. "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. We are giving HHS 14 more days to submit a response. If they stall again, we will consider litigation," says Fano.

Meanwhile, an anonymous source inside the Food and Drug Administration (FDA) told FDA Week (July 30, 1999) that HHS will set up a new committee to "oversee xenotransplant research, evaluate clinical and pre-clinical studies, and address controversial issues concerning xenotransplantation." This committee, which is to be funded by the National Institutes of Health, (taxpayers), will include members of the public. Information on the nomination of candidates for the committee will be published in the Federal Register.

The establishment of this committee, likely formed to move the technology forward, ironically comes at a time when the FDA has received hundreds of individual public comments, and thousands of pre-printed postcards, demanding a ban on xenotransplantation. These comments were submitted in response to recent FDA guidelines that instituted a de facto ban on nonhuman primate xenografts because of "significant infectious disease risk," but made no mention of the dangers posed by pigs - currently the source animals of choice.

In addition, a British advocacy group recently obtained undercover video footage showing "humanized" pigs bred for xenotransplants living in less than ideal conditions (call Michelle Thew at BUAV for more information at +44 0171 700 4888).

Transgenic animals are often born crippled, deformed, and sick, and are killed if they don't meet a company's quality specifications. The United States has no specific rules governing the development, use of, and welfare of transgenic animals, making it a haven for xenotransplantation breeding and experimentation programs.

"HHS has yet to address major concerns regarding the use of xenotransplantation," says Fano. "Yet the agency is going about its business, forming new committees designed to move this dangerous, costly and inhumane technology forward. We will persist until we get our reply, even if we have to sue HHS to get it," she says.