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Civitas home page Summer/99 issue of CivAb
FDA HAS NOT BANNED PIG-TO-HUMAN TRANSPLANTS
AND NEEDS TO HEAR FROM YOU - Alix Fano, Director CRT
On April 6, 1999, the Food and Drug Administration (FDA) published an "industry guidance" in the Federal Register on "Public Health Issues Posed by the Use of Nonhuman Primate Xenografts." This "guidance" instituted a de facto ban on live organ, cell, and tissue transplants from nonhuman primates because they would expose the public to "significant infectious disease risk". But the FDA guidelines failed to address the dangers posed by transplanting organs from non-primate species.
Genetically-altered pigs are being considered as the primary source for xenotransplants despite the existence of over 25 diseases in pigs that can infect humans. New pig viruses continue to be discovered daily. The deadly Malaysian "Nipah" virus infected over 250 humans, killed 100, and led to the mass slaughter of some one million pigs.
The FDA must be flooded with your letters and postcards now. The deadline for comments is July 6, 1999. Here are some key points to make:
Pigs are not any safer than nonhuman primates: witness swine influenza, the Porcine Endogenous Retroviruses (PERVS), the Australian paramyxovirus, a novel strain of Hepatitis E found in US pig herds, and the new Malaysian "Nipah" virus that has devastated humans and pigs alike. PERVS, present throughout the pig genome, have infected human cells in vitro. The influenza virus of 1918, which resembled a common swine flu virus, killed more people in modern history than any other epidemic including AIDS and the Black Plague.
Remind the FDA that it violated the national Environmental Policy Act by failing to perform an environmental impact statement before allowing clinical xenotransplantation experiments.
Xenotransplantation is receiving substantial public (and private) financing without adequate public debate. Tell the FDA that you do not want your tax dollars used to develop xenotransplantation.
There are safer, more cost-effective, and humane alternatives to xenotransplantation that are not being explored by regulatory authorities. These include investing heavily in preventive medicine programs to reduce the need for transplants of all kinds, and increasing the pool of human organs as many European countries have successfully done through legislative schemes.
Demand that the Department of Health and Human Services ban xenotransplantation from all nonhuman species immediately.
Some questions you may wish to ask the FDA:
Who will pay the hidden costs of breeding, housing, feeding, medicating, screening, transporting, rendering, and disposing of the waste and remains of herds of transgenic pigs?
Can we justify raising more pigs for human use at a time when the Environmental Protection Agency is placing new restrictions on livestock pollution?
Given that over 45 million Americans lack basic health care, can we spend hundreds of thousands of dollars on operations that promise to be more expensive than standard allotransplants?
Xenograft recipients and their close contacts would require life-long monitoring for signs of infection; the FDA wants to establish a multi-million dollar registry and archive to house blood and tissue from source animals and patients for at least 50 years at taxpayer expense. Is this fair?
Who will be held accountable if a zoonotic virus spreads to the human population?
Why do European countries like Spain, Austria and Belgium have much higher organ donation rates that the U.S.?
Given the acknowledged danger xenotransplantation poses to individual patients and society at large, does the technology deserve continued public support?
Send comments, including Docket number by July 6, 1999 to:
Docket No. 99D-0557
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville MD 20852
Pre-printed postcards are available @ $3 for 50, $10 for 100; $15 for 250; $20 for 500, $30 for 1000. CRT is in need of funds to carry on this critical campaign. Please make checks payable to MRMC and send to
CRT
PO Box 2751
New York NY 10163-2751
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