Summary of CRT's Comments to the Food and Drug Administration Regarding Guidelines on "Public Health Issues Posed by the Use of Nonhuman Primate Xenografts"

Published in the Federal Register, April 6, 1999
Docket No. 99D-0557

To whom it may concern:

The Campaign for Responsible Transplantation (CRT) is an international coalition of physicians, scientists and 70 public interest groups representing 2 million people.

The FDA's guidelines on "Public Health Issues Posed by the Use of Nonhuman Primate Xenografts" are arbitrary and irresponsible due to their intentional exclusion of pigs as a species of concern for public health.

In its comments to the Docket No. 99D-0557, CRT has primarily discussed the risks posed by pigs as source animals for xenotransplants. CRT believes that the risk of transmitting nonhuman animal viruses to patients and non-patients through xenotransplants, whether from pigs, nonhuman primates, or other animals, though presently unquantifiable, is unacceptable. To disregard this risk to public health and dismiss it in favor of continuing clinical trials, is negligent and flies in the face of the Precautionary Principle. In addition to creating a potential public health nightmare, xenotransplantation would burden society with complex regulatory, administrative, financial, legal, social, ethical, and environmental problems that society should not have to deal with. Xenotransplantation imposes unacceptable suffering on highly intelligent, social, and sensitive animals such as pigs and baboons. The costs of xenotransplantation, in terms of animal and human suffering, do not outweigh its alleged benefits, which have yet to be demonstrated.

We have described a range of safer, more humane and cost-effective ways to solve the alleged human organ shortage. These options should be exhaustively explored by public health agencies before xenotransplantation is even considered. CRT believes, in any case, that a technology as fraught with problems as xenotransplantation, should not be considered by responsible health authorities.

At least two General Accounting Office reports, and several news reports, have raised doubts about the FDA's ability to protect the public health. It is doubtful that the FDA's regulatory record would magically improve, particularly since xenotransplantation presents an entirely new and difficult set of regulatory challenges.

The Department of Health and Human Services has, so far, not addressed liability issues vis-a-vis xenotransplantation, (i.e. regarding the handling of claims arising from injury, illness or death resulting from activities or procedures involving xenotransplantation),

Given the above, CRT demands that the FDA institute a formal ban on xenotransplantation, from all nonhuman species immediately.

Alix Fano, MA
Director
Submitted July 2, 1999

A copy of the full 20-page document is available from CRT upon request