Dear Representative/Senator (insert
name):
RE: PLEASE BAN XENOTRANSPLANTATION AS
A HAZARD TO HUMAN HEALTH & SAFETY; AND CREATE A NATIONAL PROGRAM
TO PROMOTE HUMAN ORGAN DONATIONS
The FDA is currently reviewing
comments collected from Public Comments on Docket No. 99D-0557 on
"Public Health Issues Posed by the Use of Nonhuman Primate
Xenografts." While the FDA has implemented a ban on the
transplantation of vital organs, cells, and tissues from nonhuman
primates to humans due to "significant infectious disease risk," the
agency has either failed to admit or recognize the dangers posed by
transplants from other species.
Pigs, having become the species of
choice among the various companies vying for a piece of the billion
dollar animal organ market, pose an equally significant risk to
human health. Pigs carry a number of known as well as unknown
viruses that could "jump" from one species to another as a result of
xenografts. In 1996, virologists at the National Institute for
Medical Research in London discovered a pair of viruses called
porcine endogenous retrovirus-A and -B. Both of the viruses belong
to a family that includes the human immunodeficiency virus (HIV),
which causes AIDS and both can infect human cells. Pigs can also
harbor swine influenza, Australian paramyxovirus; a novel strain of
Hepatitis E, Japanese Encephalitis (JE), and the "Nipah" virus which
has already infected over 250 humans, killed 100, and led to the
slaughter of millions of pigs in Malaysia.
The human immune system is designed to
identify and reject foreign objects. Human-to-human transplants have
relied on immunosuppressive drugs to control rejection of
transplanted organs. Genetic differences make transplants from other
species particularly noticeable to the human immune system. Even
chimpanzees, our closest relatives, are six times as different from
us as we are from each other, and the risk of rejecting a baboon
organ is 25 times greater than for an unmatched human organ.
Xenograft researchers have developed increasingly powerful
immunosuppressive therapies to try to overcome this natural
reaction. Without exception these treatments create an immune
deficiency that leaves the already ill recipient vulnerable to fatal
infections.
As with any hazardous medical
procedure, xenograft recipients are required to sign an informed
consent agreement before undergoing the procedure, stating that the
patient understands the risk involved and the alternatives
available. It is doubtful that desperately ill patients are given
all the facts when considering xenograft procedures. In 1984,
doctors at Loma Linda University in California transplanted a baboon
heart into an infant born with serious heart defects. "Baby Fae"
died 20 days later. Afterwards, an independent review panel
determined that there were at least three other options-all more
promising than a xenograft-available to treat her condition. The
baby's mother, who was alone and virtually destitute, was never
informed of these options.
Xenografts divert precious resources
away from truly life-saving efforts to prevent and treat disease.
Each xenograft procedure costs between $250,000 and $300,000 to
perform. The University of Pittsburgh's experimental transplant
program receives more than $8 million each year in funding, largely
through federal grants from the National Institutes of Health.
Meanwhile, many promising new treatments for AIDS and other
life-threatening diseases go unexplored because of a lack of
funding. Ironically, national human organ donor procurement programs
receive less than half a million dollars annually.
PLEASE SUPPORT A NATIONAL PROGRAM TO
PROMOTE HUMAN ORGAN DONATIONS. Advocates of cross-species
transplants point to the dearth of human organ donors to justify
continued efforts in this field. Every year, thousands of Americans
are buried with organs that are suitable for donation, far exceeding
the 3,400 who die while on organ donor waiting lists. In fact, an
April 1998 General Accounting Office report on organ donation
revealed an untapped donor pool of 150,000 people annually which
leads many to believe that our government is not, as it claims,
doing all it can to increase organ donation.
In contrast, countries like Spain,
Austria, and Belgium have much higher donation rates than the U.S.
due in part to the fact that European organ donor policies assume
that every person is an organ donor unless otherwise specified. The
burden rests with individuals (or their families) if they do not
wish to donate their organs. Even within our current system,
patients have a better chance of long-term survival by waiting for a
last-minute human organ than by choosing a xenograft.
The Food and Drug Administration and
the National Institutes of Health's policy on xenografts has
essentially transformed planet earth into a giant experimental
laboratory in which every taxpayer will be forced to participate in
cruel, wasteful, and dangerous cross-species organ transplants. This
policy appears to be based not on science, but the potential profits
of the biomedical industry. If this policy were based on science,
the FDA and NIH would admit that the risks of infectious disease
posed by that of nonhuman primates and that of pigs are one in the
same, that every one of these previous experiments has failed, that
the tens of millions of dollars now wasted in the study of
xenografts would be better spent on truly life-saving efforts to
prevent and treat disease, and that they have failed to adequately
promote human organ donations.
I ask you to ensure that the
Department of Health and Human Services respond to public concerns
for human health and safety and ban xenotransplantation immediately.
I also ask you to do everything in your power to promote national
awareness of the importance of human organ donations.
Sincerely,
[Name]
