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
Go on to Still Here
(poem)
Return to 15 August 1999 Issue
Return to Newsletters
** Fair Use Notice**
This document may contain copyrighted material, use of which has not been
specifically authorized by the copyright owners. I believe that this
not-for-profit, educational use on the Web constitutes a fair use of the
copyrighted material (as provided for in section 107 of the US Copyright
Law). If you wish to use this copyrighted material for purposes of your
own that go beyond fair use, you must obtain permission from the copyright
owner.
