Coalition Asks U.S. to Follow Europe's Lead by Banning Animal Organ Transplants

Formal Legal Petition Demanding Ban Currently Before U.S. Health Agency

Experts Link Cross-Species Mixing to Viral Epidemics

Parliamentarians from 40 European countries unanimously voted to recommend a world-wide ban on animal-to-human organ transplants (xenotransplants) last week, citing unanswered questions about the risks of transferring animal viruses to the public, and the lack of acceptable guidelines to govern the practice.

"The Council of Europe's vote gives added weight to our campaign here in the U.S.," said Alix Fano, spokesperson for the Campaign for Responsible Transplantation (CRT). "This should be a wake-up call for our public health authorities. We want the Department of Health and Human Services (HHS) to follow Europe's lead and start putting public health before industry profits. We want a ban on these dangerous procedures now," said Fano.

On December 10, 1998, CRT filed a legal petition with HHS demanding a ban on xenotransplants in the interest of public health. HHS has until June 10, 1999 to respond. The petition was signed by 55 scientists, physicians, veterinarians and concerned laypersons. CRT has also collected thousands of signatures on a non-legal petition, supporting a ban on xenotransplants.

The U.S. Food and Drug Administration has continued to approve clinical trials using animal cells, tissues and organs despite the coalition's request, such as pig liver cells to "filter" the blood of acutely ill patients awaiting human organs. "These procedures have been carried out across the country, and that is unacceptable in light of expert warnings of potential viral epidemics," said Fano.

Scientists have expressed concerns that, xenotransplantation techniques using animal cells are no safer than whole organ transplants, because viruses may still be transmitted to the patient, and the general population. Pigs carry numerous bacterial, fungal, and viral pathogens that can cause disease in humans. New infections could have long incubation periods, and may not be detected until they have been transmitted to other individuals.

In its official recommendation (#1399 (1999) (1)), the Parliamentary Assembly of the Council of Europe (CoE) in Strasbourg stated, and HHS has acknowledged, that: "[t]he transmission of animal retroviruses and prions into humans through xenotransplants may cause diseases, which if transmitted to other humans, may cause major pandemics." Furthermore "[t]here are considerable scientific, medical, ethical, social and legal problems that should be answered before clinical xenotransplantations proceed."

The Council's vote is timely in light of a new study by researchers at the University of Alabama, Birmingham, suggesting that AIDS was the result of cross-species transmission between chimpanzees and humans. AIDS now infects 35 million people wordwide. British virologist Robin Weiss said this new study has "heightened concern that retroviruses might also cross to humans from more distant species, such as pigs, if their tissues [and organs] were used for xenotransplantation."

The Council's recommendation "for the rapid introduction in all member states of a legally binding moratorium on all clinical xenotransplantations," will now go before the Council of Ministers (the executive branch of the CoE) for consideration. Ministers must present the CoE's proposal to their individual governments as a precursor to binding legislation. This process may take months.

European governments are certain to face intense lobbying from xenotransplant proponents, who will likely use statistics and emotion to make their case. Some 3000 transplant patients die each year in the U.S., and over 60,000 are on waiting lists for organs because of the alleged chronic shortage of human organs. This shortage, proponents say, could be alleviated through the use of pig, and possibly primate, organs and tissues.

But a U.S. General Accounting Office (GAO) report (April 1998), entitled "Organ Donation: Assessing Performance of Organ Procurement Organizations," reveals a potential organ donor pool of 150,000 people. This is in stark contrast to previous estimates of 5,000 to 29,000 people annually.

The Health Care Finance Administration (HCFA), which sets performance standards for the 63 Organ Procurement Organizations (OPOs) operating in the U.S., has acknowledged that its current standard does not accurately assess OPOs' ability to meet the goal of acquiring all usable organs. OPOs are legally required to conduct and participate in systematic efforts to acquire all usable organs from potential donors.

"If the revised GAO estimate of 150,000 potential organ donors is accurate, and if these organs are secured, it could solve the national organ shortage, and completely eliminate the need for animal organ transplants," said CRT spokesperson Fano.

Furthermore, in its legal petition, CRT presented evidence that population-based preventive medicine, if implemented on a grand scale, could drastically reduce the demand for transplants of all kinds.

CRT, an international coalition of 70 organizations representing over 2 million people, was launched on January 20, 1998 out of concern over the rush to commercialize xenotransplantation. Some of CRT's members include Committee for Children (US), Doctors for the Environment (Switzerland), Doctors and Lawyers for Responsible Medicine (UK), Farming and Livestock Concern (UK), Greenpeace (Switzerland), International Center for Technology Assessment (US), The Jane Goodall Institute (US), The Loka Institute (US), Mothers for Natural Law (US), Natural Health Society of Australia, New Mexico Center for Chronic Disorders, NoGen (Holland), Physicians Committee for Responsible Medicine (US),What Doctors Don't Tell You (UK), and numerous animal protection organizations.