Ethical issues concerning xenotransplantation include animal rights, allocation
of resources, and distributive justice. In addition to obtaining consent for
xenotransplants from individual patients, consent is also necessary from the
populace, given the public health risks.
The genetic makeup of larger primates is about 98 percent identical to humans.
Opportunities exist to make medical breakthroughs by overcoming species' immune
barriers in ways that blur ethical boundaries. The British Medical
Journal recently published a letter on xenotransplantation from Neville
Goodman, a physician. He is outraged that expensive high technology treatments
like this are going forward at a time when political will is lacking to make
basic medical resources available in the third world. With indignation, he
quotes a researcher raising baboons for xenotransplant organs, who says her
baboons "are treated better than some people in third world countries," as if
proper treatment of the monkeys ends any ethical questions about
xenotransplantation.  "It seems that scientists are unclear and in
profound disagreement among themselves as to where the lines should be drawn."
Although some researchers prefer to work with primates, such as baboons or
chimpanzees, Jane Goodall makes a very compelling argument against using
chimpanzees in any laboratory research. Her observations of their social
behavior over a period of twenty-nine years prove their capacity not only for
emotional depth, but also for altruistic behavior.  Goodall shows that
capturing infant chimps by killing their mothers has contributed to their
endangered status, because young monkeys separated from their mothers do not
thrive or become prolific breeders. 
Respect for the rights of all beings is a tenet of the world's major religions,
and it gives the animal rights movement the support of serious long-standing
tradition. Daniel Rothman warns against taking the message of animal rights
advocates lightly. He points out that what is most deplorable is unnecessary,
frivolous use of animals that creates suffering. "The fear of being casual
with life," he says, "is a real one. Disrespect in one arena can breed
disrespect elsewhere." He asks whether a "lifeboat" argument (the choice of
lesser evils) can be used in defense of xenotransplants. 
Just as phylogenetic proximity is a measure of potential immune rejection, 
it also is a measure of how humans value other species. Is killing a primate
more serious than killing a pig? Is it about how human-like the species
Do humans have the right to use other species for their own (medical) purposes?
If so, what are the conditions or limits? Respect for living beings means not
treating them as a means to an end, an object. Immanuel Kant said this applied
to humans, but not to the rest of nature.  Environmentalists point out
that objectification and commodification of other life forms have caused us to
create the ecological conditions that imperil our own species.
A utilitarian ethic judges an action by effects on humans. A utilitarian would
argue that it is wrong to mistreat animals, because it can make them dangerous,
not because mistreatment is intrinsically wrong. By this kind of logic,
raising pigs for transplant organs might be criticized for its effect of
coarsening human sensibilities. This is essentially the old antivivisectionist
"Deep ecologists" would say humans are just one of many species, no more
intrinsically worthy of respect than any other. Human behavior vis-a-vis other
species might make them less worthy of respect.  Another perspective, from
Buddhism, is that of "dependent co-arising." It holds that there is no
independent self or separate existence of species. Humans must treat other
beings as they would treat themselves, because existence depends on and is
inseparable from the rest of the web of living beings.  If there ought to
be some reciprocity in our relations with nature, then xenotransplantation
bestows no boon to animals.
Raising animal populations for research and drug production has become more
sophisticated since the advent of recombinant DNA technology. Government
regulations currently protect laboratory animals, but how will they protect
genetically modified pharm cows, created to produce proteins in their milk for
research experiments (onco-mouse, knockout mice) or animals to be "harvested"
for their cells or organs? Animals that are used as a source for tissue and
cell transplant are regulated as biologicals, under FDA. Regulations on
animals in a research setting also apply. The 1996 PHS Guideline suggests that
existing regulations  should be followed for transplant animals, and that
transplant trials should be reviewed by animal care committees as well as
institutional review boards (IRBs).
In what way do these uses of animals raise new ethical issues? Is a threshold
crossed by raising larger mammals just to supply "spare pans" for humans? The
gift ethic  is supported by regulation in the United States. Scandals
surrounding human organ procurement argue for the preservation of this ethic.
Raising animals for their organs as a for-profit enterprise may raise
temptations to stretch this ethic. It appears that the breeding and raising of
animals for transplant purposes will require extensive monitoring to avoid
transmissible diseases as well as genetic or pharmacological alterations to
side-step various mechanisms of immune rejection. It is certain that the U.S.
Patent and Trademark Office (PTO) will receive more applications in this area,
and that the high hopes surrounding gene therapy startup companies will result
in new animal "products." Many will fail, but a few may be wildly successful
and profitable. With animal organ donors, a life may also be given for a life.
The moral import of this transaction should not be dismissed lightly just
because the donor is an animal.
Allocation of scarce resources is a very sensitive issue with human organ
donation, because there are never enough organs to meet needs. Much of the
raison d'etre for xenotransplantation is based on organ shortages. But even if
we accept the xenotransplantation and the technology is successful, allocation
issues still have to be worked out fairly, and not simply as an economic
commodity. A national structure of organ procurement and allocation, NOTA,
establishes priority rules and procedures. A reliable supply of organs could
increase U.S. annual expenditures for transplant surgeries, because more people
would get them. If costs rise, as might be expected, how will this affect
allocation, particularly to less-than-affluent patients? How will access to
human organs be affected? What ethical problems arise in allocation?
Justice and fairness require that society's burdens and benefits be borne
equally. Democracy requires that the medical professions, patients, and the
body politic have a voice. Physicians should not be forced to choose between
saving a life and distributing organs fairly. 
Health insurers and health maintenance organizations must weigh the efficacy
and costs of alternative treatments. In the case of kidney transplants, the
cost of maintaining a patient with renal failure on dialysis for years is less
than the cost of transplant surgery,  but the net cost in public health
care dollars is huge in either case. In Oregon, where health care rationing
has been developed to allocate public dollars as equitably as possible, organ
transplants are not covered for reimbursement. One commentator, at least, has
expressed skepticism that, despite the unacceptability of financial ability to
pay as a selection criterion, the realistic odds that equal access to
xenotransplantation can be achieved, given the potential expenditures that will
be necessary, are slim.  In 1996, for example, the average annual cost of
an allograft organ transplant per individual ranged from $ 118,845 for a lung
transplant to $ 19,195 for a kidney transplant. 
Why is the federal government funding an expensive and risky new technology
when it will benefit a few people and when one-third of the U.S. population,
mostly women and children, are uninsured and, hence, without any health care?
As Tristram Engelhardt puts it,
The debates concerning the allocation of treatment resources such as
transplantation recur and show no promise of abating. Some controversies
have a staying power because they spring from unavoidable moral and
conceptual puzzles. One cannot answer the question simply with scientific
data, but only by balancing values. Background values of equity, decency,
fairness, cost-benefit tradeoffs, individual rights and the limits of state
authority must be involved. 
If an individual loses "nature's lottery" by incurring a health condition that
requires an organ transplant, and the "social lottery"  by not having the
economic resources to pay for a transplant, can or should a social insurance
system redress this misfortune by spending common resources on transplants? Or
should the system spend the resources on universal preventive health care?
A sort of "global commons" argument exists: while big ticket technologies
carry large opportunity costs out of the public funds available for basic
services, administrators may choose to provide the higher ticket services in
order to stay competitive with other institutions that provide them, and thus
draw more prestige and patients. As in the global commons, each player
contributes to the dissipation of the common resource by behavior that is
rational to an individual, but not for the common good. 
The ethics of human transplants takes a new twist with xenotransplants, in that
the latter raises the serious possibility of diseases creating major public
health risks: "Xenotransplantation is a unique medical enterprise. It puts the
public at risk.... [and] it has to be the public that says, I do not accept
that risk, or I accept it." 
One effort to raise public awareness of ethical issues in biotechnology was the
recent patent application by researcher Stuart Newman and activist Jeremy
Rifkin. Claimed are three methods of creating human-animal chimeras. Genetic
material is moved from one species and placed into the embryo of another. 
Even though the inventors have stated that they have no intention of using the
patent to produce such chimeras, they list under possible applications of the
techniques the production of organs for transplant into humans. On the
surface, this patent does not differ from some patents already issued, such as
the "geep" (sheep-goat chimera) or implantation of human "early passage" and
embryonic stem cells into the embryos of another species.
However, Newman and Rifkin seek to drive a nail into the heart of biotechnology
by putting the morality of life patents at issue. As a way to challenge
biotechnology patent issues, the tactic is clever. It gives these
joint-inventors standing to have an "interference proceeding" declared by PTO
when any similar patents are filed.
They hit their mark, because PTO released a statement within days, declaring
that it would not allow patents on part-human inventions. PTO said that these
inventions might violate public policy and the morality aspects of the utility
requirement.  PTO's press release went on to cite an 1817 opinion by
Justice Story on the utility requirement, which excludes inventions "injurious
to the well being, good policy, or good morals of society."  Patent law
authority Donald Chisum raised issue with the public policy doctrine, noting
that, in fact, a patent approval can be withheld only if the invention has no
honest and moral purpose.  Nonetheless, two days later, PTO Commissioner
Bruce Lehman asserted his authority to determine the morality of an invention.
He said the press release was necessary to make it clear that "there will be no
patents on monsters, at least while I am commissioner." 
What is interesting is that PTO policy was issued when it was. Is PTO really
shocked by Newman and Rifkin's patent's subject matter? It is quite similar to
many patents already issued or in process. Chimeric techniques have been
around for several decades. In this case, researchers are attempting to use
them to overcome immune barrier problems in xenotransplantation.  Moving
human cells into donor animals or animal cells into humans has not raised red
flags at PTO before. Newman and Rifkin's application is different only in that
it calls a pig a pig, so to speak.
Rifkin and Newman's goal is to prevent the commercial exploitation of the
technology before it has had a full public airing of its ethical implications.
Rifkin has long been a critic of biotechnology; many industry representatives
and academics concede that this move may force a high profile public debate on
the issues. It may also buy time for researchers to clarify some of the risks
and necessary limits in applying the technology. PTO rejected this patent in
June 1999, but an appeal is being prepared.
Even biotechnology industry lawyers concede there is no legal consensus on
drawing a line on which life forms can and cannot be patented. In the past,
the Thirteenth Amendment to the U.S. Constitution, outlawing slavery, was
understood to bar human cell patents. Commenting on issues raised by Newman
and Rifkin's application, David Mickel, of the Biotechnology Industry
Organization, calls it a "grey area."  Researcher David Porteous, of the
UK Medical Research Council's Human Genetics unit, says, "Setting aside the
biological arguments, this is very much a mix of a legal and philosophical
discussion. It would certainly be a useful extension of the debate."  And
Jonathan Marks, professor of biology and anthropology at the University of
California/Berkeley says, "If this is what it takes to encourage geneticists to
think more about humanitarian issues, I am all for it." 
The European Patent Office, on the other hand, is considerably more sensitive
to ethical issues. The latest draft of its biotech patent policy specifically
excludes as "unpatentable" any inventions whose exploitation or publication
would be contrary to public policy or morality. These include: (1) procedures
for human cloning; (2) procedures for modifying the germ-line genetic identity
of human beings (alterations to genetic materials that are inheritable); (3)
changes to the genetic identity of animals that are likely to cause suffering
without substantial medical benefit to man or animal, and animals resulting
from such processes; (4) methods in which embryos are used; and (5) methods for
artificial production of human embryos containing the same genetic information
as another human being, dead or alive. 
[61.] N. Goodman, Letter, "This is Where I Start to Draw the Line," British
Medical Journal, 313 (1996): 696. Neville
Goodman says this:
shows how blinkered some human beings can be. The problem of viral
infection was seen as a risk--which might be worth taking 'in the quest to
end human suffering.' As if human suffering, in the global sense, has
anything to do with a lack of organs. It makes me uneasy to think that many
doctors do not seem to even think about these things. If they did, they
might at least modify their rhetoric and stop inflating the importance of
their interests. Id.
[62.] Note that the same sort of confusion and disagreement exists in later
discussion of life patenting and xenotransplant, about which the commissioner
of the Patent and Trademark Office has felt impelled to speak out on an
application of chimera xenografting processes made by antibiotech activists,
when technically and presumably morally equivalent patents have already been
approved. These include technology to get cows to produce in their mammary
glands the drug AAT (to treat cystic fibrosis); a xenograft process to move
human immune complements into pigs, thereby making pigs' organs less "foreign"
to human organ recipients' immune systems; a process to produce a blood-clot
regulator in goats; and one to make a tissue plasminogen activator.
[63.] See J. Goodall, "Ethical Concerns in the Use of Animals as Donors," in
Hardy, supra note 22, at 335-49.
[64.] See id. at 347.
[65.] See id.; and D.J. Rothman, "Xenograft: Social and Ethical Dimensions," in
Hardy, supra note 22, 321-33, at 333.
[66.] See Institute of Medicine, supra note 3, at 16.
[67.] See id. at 77, quoting philosopher James Walters. Walters's idea is that
"the highest moral status should be accorded those animals who are closest to
qualities that most humans possess ..." which enables man to "value beings in
terms of their
proximity or likeness to persons ... he thus holds that it may be more
justifiable to use anencephalic infants as organ sources than to use
chimpanzees." Id., citing James Walters, Remarks at Institute of Medicine
Meeting "Xenograft Transplantation: Science, Ethics and Public Policy,"
Bethesda (June 25-27, 1995).
[68.] See id. at 74. An extension of the rights approach would be to invest
other species with the same rights.
[69.] See Rothman, supra note 65, at 327-32. Daniel Rothman points out that
Victorian antivivisectionists feared that callous treatment of animals would
encourage inhuman treatment of the poor.
[70.] See G. Sessions and B. Devall, Deep Ecology (Salt Lake City:
Gibbes-Smith, 1986); G. Snyder, The Practice of the Wild (San Francisco: North
Point, 1990); R. Aitken, The Mind of Clover (San Francisco: North Point, 1984);
and J. Seed et al., Thinking like a Mountain: Towards a Council of All Beings
(Philadelphia: New Society, 1991).
[71.] See J. Macy, World as Lover, World as Self (Berkeley: Parallax Press,
1991): at 53-64. Joanne Macy writes:
The self is a metaphor. We can decide to limit it to our skin, our person,
our family, our organization, our species.... The obvious choice then, is
to extend our notions of self-interest. For example, it would not occur to
me to say to you, "Oh, don't cut off your leg. That would be an act of
violence." It wouldn't occur to me because your leg is part of your body.
Well, so are the trees in the Amazon rain basin. They are our external
lungs. And we are beginning to realize that the world is our body.
Id. at 189-92. Arne Naess, the Norwegian philosopher who coined the term "deep
ecology," puts it this way:
The extensive moralizing within the ecological movement, the false
impression that they are asked to make a sacrifice ... to show a nicer
moral standard ... but all of that would flow easily if the self were
widened and deepened so that the protection of nature was felt and
perceived as protection of our very selves.
Id. at 191. Thus, the Buddhist "Sangha," or fellowship, is extended into the
"Council of All Beings," in which, as Lawrence Tribe would have it, trees have
standing. Id. at 202.
[72.] See 61 Fed. Reg. 49,924-25 (Sept. 23, 1996). Section 3.2 of the
Guideline specifies that animals should be raised in accordance with the Guide
for the Care and Use of Laboratory Animals, which is a standard of the American
Association for the Accreditation of Laboratory Animal Care. No specific
mention is made about animal rights issues.
[73.] Human organs are not to be bought or sold. See National Organ Transplant
Act, 42 U.S.C. [sections] 273 (1984).
[74.] See Keyes, supra note 21, at 273-79. Don Keyes uses the retransplantation
decision to illustrate this last point: If the first organ graft fails, should
another scarce organ be used to replace it, or should another patient get a
[75.] See Institute of Medicine, supra note 3, at 54.
[76.] See R.W. Evans, "Xenotransplantation: A Panel Discussion of Some
Non-Clinical Issues," in Hardy, supra note 22, at 359-67.
[77.] See Institute of Medicine, supra note 3, at 81.
[78.] H.T. Engelhardt Jr., "Allocating Scarce Medical Resources and the
Availability of Organ Transplantation: Some Moral Presuppositions," in D.
Mathieu, ed., Organ Substitution Technology; Ethical, Legal and Public Policy
Issues (Boulder: Westview Press, 1988): 221-31, at 221-22.
[79.] See id. at 224-26.
[80.] See N. Daniels, "Justice and Big Ticket Technologies," in Mathieu, supra
note 78, at 211-220.
[81.] Transplant News, Feb. 13, 1998, available in 1998 Westlaw IAC-NEWS-C.
[82.] See D. Dickson, News, "Legal Fight Looms over Patent Bid on Human/Animal
Chimaeras," Nature, 392 (1998): 423-24.
[83.] See "Part-Human Inventions May Not Meet 'Morality' Requirement for
Patentability," Patent, Trademark and Copyright Law Daily (BNA), at d2 (Apr. 7,
[84.] Lowell v. Lewis, 15 F. Cas. 1018 (C.C.D. Mass. 1817) (No. 8568).
[86.] "'Morality' Aspect of Utility Requirement Can Bar Patent for Part-Human
Inventions," Patent, Trademark and Copyright Journal News (BNA), at 555 (Apr.
[87.] For a discussion about overcoming immune barriers, see Institute of
Medicine, supra note 3, at 26-38.
[88.] See Dickson, supra note 82, at 423.
[90.] Id. at 434.
[91.] See "European Parliament Approves Draft Biotech Patent Directive,"
Patent, Trademark and Copyright Law Daily
(BNA), at d3 (Aug. 28, 1997).
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