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Newsletter - Animal Writes sm
15 August 1999 Issue

Animal-to-Human Organ Transplants:
Creating the Next AIDS
By Alix Fano, Director,
Campaign for Responsible Transplantation, New York, alixfano@mindspring.com

Allegedly motivated by the desire to solve the shortage of human organs and tissues for transplantation and alleviate human suffering, corporations such as Novartis and Baxter Health Care are breeding herds of transgenic pigs with human genes so their organs, cells and tissues can be harvested and transplanted into humans. But not all scientists believe that this is a good idea because Xenotransplantation could transfer deadly animal viruses to humans. Some virologists believe that Xenotransplantation will create a new AIDS-like epidemic. French virologist Calude Chastel believes that it will create a "new infectious Chernobyl."

Since 1905, some 80 humans have received whole organ "xenotransplants" from chimpanzees, baboons, pigs, goats and other animals, and all have died from infections and complications related to hyperacute rejection. Within the last 5 years, some 200 patients have been injected with fetal pig cells to allegedly treat the symptoms of epilepsy, diabetes, Parkinson's and Huntington's Disease, and to alleviate chronic pain associated with cancer. Hundreds of thousands of gruesome xenotransplant experiments between rats and chickens, pigs and dogs, and pigs and baboons, using various combinations of immunosuppressive drugs, have failed to tell us whether Xenotransplantation is either safe or effective; and limited human trials have not provided statistically significant information about safety or efficacy either. But biotech companies and researchers are determined to develop xenotransplants, regardless of the risk. In fact, they are counting on people to get sicker and sicker so that the demand for organs and tissues, specifically pig organs and tissues will continue to rise.

Pigs are being touted as the donor animals of choice because their organs are of similar size to humans and because, unlike baboons for example, they have been commercially bred and slaughtered for centuries. A conventional pig heart put into a human will turn black and stop beating in 15 minutes, but it is hoped that these "humanized" pig organs, which allegedly produce human proteins, will not be rejected, despite vast inter-species differences in anatomy, pathology, and metabolism. Novartis has pledged to spend $1 billion to develop xenotransplantation, and is simultaneously counting on the demand for pig organs and expensive anti-rejection drugs to rise. In a report entitled, "The Unrecognized Potential of Xenotransplantation," produced for Sandoz (the premier maker of anti-rejection drugs, now wholly owned by Novartis), the financial firm of Salomon Brothers predicts profits of $6 billion annually by the year 2010 for the xeno market. At a time when 45 million Americans lack basic health care (and attempts to increase human organ donations in the US have been skimpy at best), such an agenda seems grossly irresponsible. But it is even more irresponsible when one considers the risks posed by Xenotransplantation.

Prominent physicians and scientists in the U.S. and abroad have openly voiced their concerns about the risks of transferring infectious animal viruses to humans through xenotransplants. Virologists like Jonathan Allan of the Southwest Foundation for Biomedical Research in Texas say that, placing animal organs directly into humans circumvents all the natural barriers designed to prevent infection. Others, like Australian scientist Peter Collignon, say that xenotransplantation is the best way to create new epidemics.

The swine flu epidemic of 1918, which killed 20-40 million people worldwide, is a grim reminder of what happens when diseases jump the species barrier. The Ebola and Marburg viruses, and "mad cow disease" are evidence that animal viruses continue to infect humans. In December 1997, a laboratory worker at the Yerkes Regional Primate Research Center in Atlanta, died after she was splashed with body fluids from a rhesus monkey infected with the deadly herpes B virus. Several people were killed in Hong Kong last year by a flu that jumped from chickens to humans. This year, the novel Malaysian "Nipah" virus, which jumped from pigs to humans, infected 250+, killed 117, and led to the mass slaughter of some 1 million pigs. Experts admit that surveillance systems to guard against new and emerging infectious diseases are inadequate.

Yet xenotransplant researchers and biotechnology companies continue to imply that it would somehow be "safe" to use pigs as sources for organs, cells, and tissue in xenotransplants because, they say, humans have co-existed with, and eaten, pigs for centuries with allegedly no ill effects. But these statements ignore several important facts. Scientists acknowledge that "little or nothing is known about the pathogenic potential of endogenous retroviruses introduced directly into other species." The U.S. Department of Health and Human Services (HHS) has publicly acknowledged that xenotransplantation poses inherent disease risks to patients and non-patients alike. Humans with transplanted pig organs could realistically become viral time bombs, infecting scores of people with an animal virus, particularly if it were to become airborne.

It is known that pigs can carry bacterial, fungal, protozoal, helminth and viral pathogens. These cause a wide range of symptoms in humans, including fever and general malaise, sores on the face or feet, neurological disorders, meningitis, and death. All vertebrate species, including humans, harbor endogenous retroviruses, acquired during the course of evolution, some of which are capable of infecting other species. Pigs, like nonhuman primates, harbor endogenous retroviruses. It is estimated that hundreds of different endogenous retroviruses may be present in one animal.

Viruses infecting pigs that cannot be guaranteed to be absent from a xenograft include porcine retrovirus, porcine polyomavirus, porcine parvovirus, porcine circovirus, porcine cytomegalovirus, porcine reproductive and respiratory syndrome virus, influenza virus, porcine hepatitis E virus, and porcine herpesvirus.

The potential for transmission of porcine retroviruses to xenograft recipients is, therefore, a significant concern for xenotransplantation. Pigs harbor type C endogenous retroviruses. At least two infectious variants of porcine endogenous retroviruses, dubbed PERV-A and PERV-B, are widely distributed in different organs, cells and tissue (spleen, heart, kidney, liver, lung, thymus) of different breeds of pigs. These retroviruses are passed from mother to offspring and therefore cannot be eliminated by the conventional techniques used to generate "germ-free" animals. Furthermore, even "germ-free" pigs may be silent carriers of enteric organisms such as micrococci, streptococci D, and colibacillus; and contamination by as-yet unrecognized pathogens will always be possible. Veterinarian M.M. Swindle writes that "it will be impossible to provide complete individual animal screening in a timely fashion prior to performing a xenograft transplant." Consequently, all recipients of porcine cells, tissue, or organs would be exposed to PERVs and possibly other infectious organisms.

Pigs also carry prion proteins (associated with "mad cow disease") that could be transmitted to humans, and are likely to carry numerous viruses and infectious organisms that have yet to be identified.

Finally, the genetic modification, or "humanization,"of pigs could provide an opportunity for animal viruses to fool the human immune system and "hide" inside the human body. Retroviral infections from pigs could recombine with human endogenous retroviruses, leading to recombinant "superviruses." These could become preadapted for human infection and subsequent human-to-human transmission. Accurate screening for such viruses may be difficult. Xenotransplants could theoretically alter the human gene pool, by favoring the evolution of porcine-human chimeras (beings containing the genes of both pigs and humans).

Despite these disturbing issues, the U.S. Public Health Service and the World Health Organization are drafting voluntary guidelines for xenotransplantation procedures, the National Institutes of Health are using tax dollars to develop the technology, the Centers for Disease Control and Prevention is actively involved in policy development and risk analysis, and the Food and Drug Administration (FDA), which oversees the field, is approving clinical trials with animal tissues and organs.

What is Being Done to Stop Xenotransplants?

The Campaign for Responsible Transplantation (CRT) - now an international coalition of physicians, scientists, and 75 public interest groups representing over 2 million people - was formed in January 1998 out of concern that xenotransplantation was an irrational biotechnology that was being developed with public funds but without public consultation. On December 10, 1998, CRT filed a legal petition with HHS demanding a ban on xenotransplantation (www.crt-online.org).

The petition was signed by 55 scientists, physicians, veterinarians and concerned laypersons. HHS had until June 10th, 1999 to respond to the petition but did not. CRT is currently considering taking legal action to force HHS to respond, and will pursue legal means to ban xenotransplantation. The "CRT Legal Fund" has been established to that end. Funds are desperately needed to finance what will likely be a very tough battle and a potentially precedent-setting case. (Donations may be sent to CRT, PO Box 2751, New York, NY 10163-2751; please make checks payable to "MRMC.") CRT continues to be a thorn in HHS's side. On July 2nd, CRT submitted 20 pages of comments critical of recent FDA guidelines on xenotransplantation. CRT's grass-roots campaign generated hundreds of individual comments, and thousands of pre-printed postcards critical of the guidelines, which failed to address the dangers posed by the use of pigs in xenotransplants. CRT is distributing resource materials to journalists, scholars, scientists, legislators, advocacy groups, laypersons, and members of the press. CRT spokespersons grant radio interviews, speak to audiences, and submit Op-Eds and letters to the editor. CRT monitors scientific journals, newspapers, government databases, and the Internet, and attends public meetings on xenotransplantation, to track the development, financing, and regulation of the technology. Together we can stop xenotransplantation before it's too late. Here's what you can do to help.

What Can You Do?

* Write a letter to Donna Shalala demanding a ban on xenotransplantation. Send a c.c. to Dr. Phillip Noguchi of the FDA (see sample below)
* Sign CRT's on-line petition against xenotransplantation at www.crt-online.org. Circulate petitions in your community
* Help CRT's coalition grow. If you are the Director of a for-profit business or non-profit organization, a celebrity, or a religious leader, please fill out the form on CRT's website, or request one via mail
* Send a donation to CRT, PO Box 2751, New York, NY 10163-2751 (Please make checks payable to "MRMC"). If the contribution is for the CRT Legal Fund, specify that on the bottom left-hand corner of your check. All donations are tax-deductible to the fullest extent of the law
* Participate in the World Health Organization's electronic xenotransplantation discussion list. Voices of reason and protest are needed! Go to http://www.who.int/emc/diseases/zoo/meetings/xenodg.html# How to register
* Participate in CRT Action Alerts on CRT's website and ask to be added to CRT's mailing list
* Send us any news clips about xenotransplantation from your local paper
* Request anti-xenotransplant stickers from CRT
* Write a letter to the editor
* If you own a business, consider donating pro-bono services to CRT. Xeroxing, design, printing and legal services are always welcome
* Call your local radio or TV station, and encourage them to do a story on xenotransplantation. Suggest CRT as a resource
* Consider sponsoring a print ad in your local newspaper. Contact CRT for details
* Hold a fundraiser in your community for CRT and/or the CRT Legal Fund
* Medical and health care professionals who would like to support CRT's efforts should contact CRT to discuss ways they can participate in the campaign

(Sample Letter to Donna Shalala)

Date

Donna Shalala, Secretary
U.S. Department of Health and Human Services
200 Independence Ave., SW
Room 615F
Washington, DC 20201 Via Fax (202) 690-7203

Dear Secretary Shalala,

I am writing to demand an immediate ban on xenotransplantation. I believe 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 xenotransplant 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. Several questions have yet to be addressed by your agency. For example, 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? Who will be held accountable if a zoonotic virus spreads to the human population? Why aren't we allocating more resources towards population-based prevention programs that could drastically reduce the need for transplants of all kinds? Studies have shown that organ procurement agencies are not meeting their performance standards. Moreover, there are safer, more humane and cost-effective ways to solve the alleged human organ shortage that should be exhaustively explored by public health agencies before xenotransplantation is even considered. I believe that a technology as dangerous and problematic as xenotransplantation, should not be considered by responsible health authorities that are mandated to protect public health and prevent disease.

Sincerely,

Name
Address
City, State, Zip

c.c. Dr. Phillip Noguchi, Food and Drug Administration, HFM-515,
1401 Rockville Pike, Rockville, MD 20852-1448

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