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ethical issues by margaret a. clark

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Excerpted from "This Little Piggy Went to Market: The Xenotransplantation and Xenozoonose Debate" by Margaret A. Clark published in The Journal of Law, Medicine and Ethics 27:2:137-152. Copyright American Society of Law and Medicine, Incorporated, Summer 1999. Reprinted with permission.

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.

Animal rights

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. [61] "It seems that scientists are unclear and in profound disagreement among themselves as to where the lines should be drawn." [62]

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. [63] 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. [64]

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. [65]

Just as phylogenetic proximity is a measure of potential immune rejection, [66] 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 is? [67]

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. [68] 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 argument. [69]

"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. [70] 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. [71] 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 [72] 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 [73] 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 organs

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. [74]

Distribution of medical resources

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, [75] 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. [76] 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. [77]

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. [78]

If an individual loses "nature's lottery" by incurring a health condition that requires an organ transplant, and the "social lottery" [79] 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. [80]

Public assent

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." [81]

Living things as property

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. [82] 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. [83] 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." [84] 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. [85] 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." [86]

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. [87] 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." [88] 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." [89] 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." [90]

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. [91]

References

[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 chance?

[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, 1998).

[84.] Lowell v. Lewis, 15 F. Cas. 1018 (C.C.D. Mass. 1817) (No. 8568).

[85.] Id.

[86.] "'Morality' Aspect of Utility Requirement Can Bar Patent for Part-Human Inventions," Patent, Trademark and Copyright Journal News (BNA), at 555 (Apr. 9, 1998).

[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.

[89.] Id.

[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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