Xenotransplantation: Ethics and economics

Food and Drug Law Journal

Volumn 53, Issue 2, 1998, Pages 353-384

  Kress, Jack M ^a,b  

^a U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

^b US Court of Federal Claims ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANIMAL EXPERIMENT; ANIMAL WELFARE; CLINICAL PROTOCOL; ECONOMIC ASPECT; EMOTION; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HEALTH CARE POLICY; HUMAN EXPERIMENT; INFECTION; LEGAL ASPECT; MEDICAL ETHICS; PUBLIC HEALTH; REVIEW; XENOTRANSPLANTATION;

ANIMAL RIGHTS; ANIMALS; ECONOMICS, MEDICAL; ETHICS, MEDICAL; HUMAN EXPERIMENTATION; HUMANS; LEGISLATION, MEDICAL; TRANSPLANTATION, HETEROLOGOUS; UNITED STATES; ZOONOSES;

EID: 0031867236     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (127)

1. Pub. L. No. 98-507, § 301, 98 Stat. 2339 (codified as amended at 42 U.S.C. § 273 et seq. (1994)).
2. Draft Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation, 61 Fed. Reg. 49,919 (Sept. 23, 1996) [hereinafter Draft PHS Guideline]. See also 61 Fed. Reg. 19,722 (May 2, 1996) (DHHS final rules governing performance standards for organ procurement organizations).
3. Draft Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation, 61 Fed. Reg. 49,919 (Sept. 23, 1996) [hereinafter Draft PHS Guideline]. See also 61 Fed. Reg. 19,722 (May 2, 1996) (DHHS final rules governing performance standards for organ procurement organizations).
4. DHHS Conference, "Developing U.S. Public Health Policy in Xenotransplantation," Bethesda, MD (Jan. 21-22, 1998) [hereinafter DHHS Conference].
5. DHHS Conference, "Developing U.S. Public Health Policy in Xenotransplantation," Bethesda, MD (Jan. 21-22, 1998) [hereinafter DHHS Conference].
6. Strictly speaking, only the first of these three examples is a xenograft; the other two are products of animal origin, but no graft is involved. In any event, the primary rationale that FDA scientists give for excluding all of these products is that they are thought to represent a very low level of risk; they often are highly processed with viral removal steps or fixation procedures that are believed to inactivate most infectious disease threats, and they have been used and monitored without incident for long periods of time.
7. Figures provided by the United Network for Organ Sharing (UNOS), Richmond, VA; National Kidney Foundation, Southeastern Institute of Research, Richmond, VA.
8. Figures provided by the United Network for Organ Sharing (UNOS), Richmond, VA; National Kidney Foundation, Southeastern Institute of Research, Richmond, VA.
9. See Christina L. Kaufman, Barbara A. Gaines & Suzanne T. Ildstad, Xenotransplantation, 13 ANNUAL REV. OF IMMUNOLOGY 339 (1995).
10. FDA's informed consent regulations are found in 21 C.F.R. pt. 50 (1997), See also 45 C.F.R. pt. 46 (1997).
11. Sam Loewenberg, Who Gets the Organs?, LEGAL TIMES, Mar. 16, 1998, at 4.
12. Rick Weiss, New Rules for Organ Waiting Lists, WASH. POST, Mar. 27, 1998, at A16.
13. See Pub. L. No. 98-507, 98 Stat. 2339. Then-Representative Albert Gore hailed this feature as involving a "true compromise" that would "save many thousands of lives." 136 CONG. REC. H11087-88 (daily ed. Oct. 3, 1984) (statement of Rep. Gore).
14. See 63 Fed. Reg. 16,293, 16,297 (Apr. 2, 1998).
15. Weiss, supra note 10, at A16.
16. INSTITUTE OF MED. COMM. ON XENOGRAFT TRANSPLANTATION, XENOTRANSPLANTATION: SCIENCE, ETHICS AND PUBLIC POLICY 2 (Nat'l Acad. Press 1996) [hereinafter IOM COMM.].
17. 8A U.L.A. 63 (1993).
18. Pub. L. No. 98-507, 98 Stat. 2339 (1984) (codified at 42 U.S.C. §§ 274-274e (1994)).
19. ARTHUR L. CAPLAN, IF I WERE A RICH MAN, COULD I BUY A PANCREAS? (Indiana Univ. Press 1992).
20. Richard A. Epstein, Organ Transplants: Is Relying on Altruism Costing Lives?', 4 AM. ENTERPRISE 50 (1993). See also Gregory S. Crespi, Overcoming the Legal Obstacles to the Creation of a Futures Market in Bodily Organs, 55 OHIO ST. L.J. 1 (1994). But see Gloria S. Banks, Legal and Ethical Safeguards: Protection of Society's Most Valuable Participant in a Commercialized Organ Transplantation System, 21 AM. J. L. & MED. 45 (1995).
21. Richard A. Epstein, Organ Transplants: Is Relying on Altruism Costing Lives?', 4 AM. ENTERPRISE 50 (1993). See also Gregory S. Crespi, Overcoming the Legal Obstacles to the Creation of a Futures Market in Bodily Organs, 55 OHIO ST. L.J. 1 (1994). But see Gloria S. Banks, Legal and Ethical Safeguards: Protection of Society's Most Valuable Participant in a Commercialized Organ Transplantation System, 21 AM. J. L. & MED. 45 (1995).
22. Richard A. Epstein, Organ Transplants: Is Relying on Altruism Costing Lives?', 4 AM. ENTERPRISE 50 (1993). See also Gregory S. Crespi, Overcoming the Legal Obstacles to the Creation of a Futures Market in Bodily Organs, 55 OHIO ST. L.J. 1 (1994). But see Gloria S. Banks, Legal and Ethical Safeguards: Protection of Society's Most Valuable Participant in a Commercialized Organ Transplantation System, 21 AM. J. L. & MED. 45 (1995).
23. IOM COMM., supra note 14, at 66, See also CAPLAN, supra note 17, at 161.
24. See generally DAVID BARNES & LYNN STOUT, CASES AND MATERIALS ON LAW AND ECONOMICS (West 1993).
25. H.B. 1670, 89th Gen. Assembly (Mo. 1998).
26. See Organ Transplants Via Death Row, WASH. POST, Mar. 16, 1998, at A15. Although this article does not make the point, it should be plain that, as with the organ "donation" situation in China, the notion of free and informed consent on the part of a death-row inmate is fairly ludicrous.
27. David J. Rothman, The International Organ Traffic, N.Y. REV. OF BOOKS, Mar. 26, 1998, at 14. Professor Rothman points out that China has been in the vanguard of such efforts: "In 1984, immediately after cyclosporine became available, the government [secretly] issued a document entitled 'Rules Concerning the Utilization of Corpses or Organs from the Corpses of Executed Prisoners.'" See also Erik Eckholm, A Gruesome Trade: Human Organs From China, N.Y. TIMES, Feb. 25, 1998, at A26. There is irony in the fact that China, the last major self-proclaimed bastion of communism, precisely ti its executions - estimated at well over 4000 a year - to meet market supply needs; prospective transplant recipients arrive for surgery at the appointed time, and a fresh organ becomes immediately available
28. David J. Rothman, The International Organ Traffic, N.Y. REV. OF BOOKS, Mar. 26, 1998, at 14. Professor Rothman points out that China has been in the vanguard of such efforts: "In 1984, immediately after cyclosporine became available, the government [secretly] issued a document entitled 'Rules Concerning the Utilization of Corpses or Organs from the Corpses of Executed Prisoners.'" See also Erik Eckholm, A Gruesome Trade: Human Organs From China, N.Y. TIMES, Feb. 25, 1998, at A26. There is irony in the fact that China, the last major self-proclaimed bastion of communism, precisely ti its executions - estimated at well over 4000 a year - to meet market supply needs; prospective transplant recipients arrive for surgery at the appointed time, and a fresh organ becomes immediately available
29. Animal rights activists likely see it as condign punishment that those who indulge themselves in copious quantities of such animal products as meat and cheese are the same individuals most likely to become candidates for heart transplantation.
30. In December 1997, HCFA issued a notice of proposed rulemaking, related to Medicare conditions of participation for hospitals, that was aimed at increasing the frequency at which potential donors are reported to the cognizant Organ Procurement Organizations, which also are regulated by HCFA. See 62 Fed. Reg. 66,726 (Dec. 19, 1997). At about the same time, Vice President Albert Gore and DHHS Secretary Donna Shalala announced a "National Organ and Tissue Donation Initiative" based on an array of proposed public/private partnerships, with information available at a newly-established Website. See Organ Donation (visited May 19, 1998) 〈http://www.organdonor.gov〉.
31. Figures provided by UNOS, Richmond, VA. See also CAPLAN, supra note 17, at 152-53, 159-60, 262-63. The comparable figures in the United Kingdom (UK) indicate that 70% of the public favor transplantation, but only 25% carry donor cards. NUFFIELD COUNCIL ON BIOETHICS, ANIMAL-TO-HUMAN TRANSPLANTS: THE ETHICS OF XENOTRANSPLANTATTON 15 (1996) [hereinafter NUFFIELD COUNCIL].
32. See, e.g., Donald M. Bruce, Society, Religion, and Technology Project of the Church of Scotland, Website (1996) 〈http://webzone1.co.uk/www/srtproject/srtpage3.htm〉.
33. See, e.g., Rabbi Dr. Moses Tendler, Yeshiva University Professor of Talmud, The Ethics of Organ Donations, (Dec. 4, 1995), speech at Odie Conference Center, Aidekman Campus, Whippany, NJ, summary available at 〈http://www.transweb.org/reference/articles/donation/ rabbi_tendler_html〉. In Israel, cadaveric organs rarely are retrieved, however, because Orthodox law retains heart failure as the exclusive definition of death. Although most Israeli religious leaders have sanctioned allotransplantation as a last resort life-saving measure, there have been few statements on xenotransplantation.
34. Given that end-stage renal disease is increasing more rapidly among this group than in any other racial category, it is particularly unfortunate that this view prevails. M. Roy First, Xenotransplantation: Social, Ethical, Religious, and Political Issues, 51 KIDNEY INT'L 5 (1997).
35. A number of sociological, anthropological, and theological essays on this subject are collected in STUART J. YOUNGNER, RENEE C. FOX & LAURENCE J. O'CONNELL, ORGAN TRANSPLANTATION: MEANINGS AND REALITIES (Univ. of Wisc. Press 1996).
36. In 1996, the District of Columbia passed a statute - the only one like it in the nation to this point - that permits surgeons to make preliminary transplantation decisions withoutthe prior consent (of the family or individual) of a person declared dead. D.C. CODE ANN. § 2-1509 (Supp. 1997).
37. Although not applicable everywhere, the Uniform Determination of Death Act does define death as "either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem," Uniform Determination of Death Act, § 1, 12 U.L.A. 340 (Supp. 1996). See also Guidelines Are Urged in Using Organs of Heart-Dead Patients, N.Y. TIMES, Dec. 21, 1997, at 38.
38. Rick Weiss, Science on the Ethical Frontier: Harvesting Organs to Transplant, WASH. POST, Nov. 24, 1997, at A16.
39. See Paul A. Byrne, Joseph C. Evers & Richard G. Nilges, Anencephaly - Organ Transplantation?, 9 ISSUES L. & MED. 1 (1993).
40. Rick Weiss, Some Hospitals Use Questionable Methods to Get Organs for Transplants, Panel Says, WASH. POST, Dec. 19, 1997, at A27.
41. S. Beddard & D. Lyons, The Science and Ethics of Xenotransplantation: A Report of Uncaged Campaigns 38 (undated pamphlet); S. Deehan, THE TIMES (LONDON), Jan. 21, 1997, at 37.
42. S. Beddard & D. Lyons, The Science and Ethics of Xenotransplantation: A Report of Uncaged Campaigns 38 (undated pamphlet); S. Deehan, THE TIMES (LONDON), Jan. 21, 1997, at 37.
43. Beddard & Lyons, supra note 36, at 42. See also Alan H. Berger, Xenotransplantation: The Ethics, the Science, the Risks, paper delivered at Animal Care and Use Conference, Boston, MA 5 (Mar. 15, 1996).
44. Rothman, supra note 23, at 15.
45. IOM COMM., supra note 14, at 79.
46. Id.
47. Figures provided by HCFA staff, based on assumptions provided by author.
48. Loewenberg, supra note 9, at 4.
49. NUFFIELD COUNCIL, supra note 26. At the DHHS Conference, Clare Witt of the World Health Organization (WHO) described transplantations in Japan, Indonesia, the Philippines, Thailand, Malaysia, Hong Kong, and Singapore, She noted that the 1997 average cost of a kidney transplant operation in these nations was $15,785. See DHHS Conference, supra note 3.
50. NUFFIELD COUNCIL, supra note 26. At the DHHS Conference, Clare Witt of the World Health Organization (WHO) described transplantations in Japan, Indonesia, the Philippines, Thailand, Malaysia, Hong Kong, and Singapore, She noted that the 1997 average cost of a kidney transplant operation in these nations was $15,785. See DHHS Conference, supra note 3.
51. NUFFIELD COUNCIL, supra note 26.
52. For more information on the Baby Fae story, see L.L. Bailey, S.L. Neihsen-Cannarella et al., Baboon to Human Cardiac Xenotransplantation in a Neonate, 254 JAMA 3321 (1985); THOMAS SCULLY & CELIA SCULLY, PLAYING GOD (Simon & Schuster 1987).
53. For more information on the Baby Fae story, see L.L. Bailey, S.L. Neihsen-Cannarella et al., Baboon to Human Cardiac Xenotransplantation in a Neonate, 254 JAMA 3321 (1985); THOMAS SCULLY & CELIA SCULLY, PLAYING GOD (Simon & Schuster 1987).
54. But see supra notes 22-23 and accompanying text (discussion concerning the Chinese scheduling of executions).
55. Relevant investigational new drug (IND) regulations are found in 21 C.F.R. pt. 312.
56. ALIX FANO, MURRAY J. COHEN, MARJORIE CRAMER, RAY GREEK & STEPHEN R. KAUFMAN, OF PIGS, PRIMATES AND PLAGUES 1 (Med. Research Modernization Comm. 1996).
57. IOM COMM., supra note 14, at 22.
58. VOGUE, Sept. 1989, at 87. Ms. Newkirk also has declared, "Animal liberationists do not separate out the human animal. A rat is a pig is a dog is a boy." See Katie McCabe, Who Will Live, Who Will Die?, WASHINGTONIAN, Aug. 1986, at 114.
59. VOGUE, Sept. 1989, at 87. Ms. Newkirk also has declared, "Animal liberationists do not separate out the human animal. A rat is a pig is a dog is a boy." See Katie McCabe, Who Will Live, Who Will Die?, WASHINGTONIAN, Aug. 1986, at 114.
60. If the animal is raised and fed in captivity for a long period with no other purpose in mind than this result, that process might be referred to, in another context, as premeditated (or perhaps premedicated) murder.
61. Gen. 1:26.
62. For a general discussion, see SUNNI BLOYD, ANIMAL RIGHTS (Lucent Books 1990). The "bible" of the animal rights movement is PETER SINGER, ANIMAL LIBERATION: A NEW ETHIC FOR OUR TREATMENT OF ANIMALS (2d ed. Pimlico 1995). See also IN DEFENSE OF ANIMALS (Peter Singer ed., Basil Blackwell 1985). An opposing perspective is provided in pamphlets offered by the Americans for Medical Progress Educational Foundation, Alexandria, VA.
63. For a general discussion, see SUNNI BLOYD, ANIMAL RIGHTS (Lucent Books 1990). The "bible" of the animal rights movement is PETER SINGER, ANIMAL LIBERATION: A NEW ETHIC FOR OUR TREATMENT OF ANIMALS (2d ed. Pimlico 1995). See also IN DEFENSE OF ANIMALS (Peter Singer ed., Basil Blackwell 1985). An opposing perspective is provided in pamphlets offered by the Americans for Medical Progress Educational Foundation, Alexandria, VA.
64. For a general discussion, see SUNNI BLOYD, ANIMAL RIGHTS (Lucent Books 1990). The "bible" of the animal rights movement is PETER SINGER, ANIMAL LIBERATION: A NEW ETHIC FOR OUR TREATMENT OF ANIMALS (2d ed. Pimlico 1995). See also IN DEFENSE OF ANIMALS (Peter Singer ed., Basil Blackwell 1985). An opposing perspective is provided in pamphlets offered by the Americans for Medical Progress Educational Foundation, Alexandria, VA.
65. The legislation that embodies this consensus and governs the treatment of research animals includes the Animal Welfare Act, Pub. L. No. 89-544, 80 Stat. 350 (1966) (as amended by Pub. L. No. 91-579, 84 Stat. 1560 (1970); Pub. L, No. 94-279, 90 Stat. 417 (1976); Pub. L. No. 99-198, tit. XVII, 99. Stat. 1650 (1985) (codified at 7 U.S.C. ch. 54, §§ 2131 et seq. (1994) and 9 C.F.R. (1997) (administered by the U.S. Department of Agriculture). Criteria for appropriate animal care, treatment, and experimental practices are established by the American Association for Accreditation of Laboratory Animal Care, and outlined in INSTITUTE OF LABORATORY ANIMAL RESOURCES, NATIONAL ACADEMY OF SCIENCES, GUIDE FOR THE CARE AND USE OF LABORATORY ANIMALS (NIH Pub. No. 86-23).
66. "Speciesism" is a term animal rights activists have coined to describe partiality and prejudice in favor of humans over nonhumans, a view that they assert is as morally corrupt as racism and sexism.
67. For a fuller, extended discussion of this issue from a philosophical standpoint, see generally MICHAEL ALLEN FOX, THE CASE FOR ANIMAL EXPERIMENTATION: AN EVOLUTIONARY AND ETHICAL PERSPECTIVE (Univ. of Cal. Press 1986).
68. Ernest D. Prentice, Ira J. Fox, Robert S. Dixon, Dean L. Antonson & Terence A. Lawson, Justifiable Clinical Research or Medical Adventurism?: The Ethics of Xenotransplantation, paper delivered at conference on "Current Issues and New Frontiers in Animal Research," San Antonio, Texas (Dec. 8-9, 1994). At the DHHS Conference, supra note 3, Clare Witt, presenting WHO statistics, noted these variations and mentioned that Shinto adherents in Japan oppose removal of organs from the dead because that would disturb the spirit of the dead. Some African delegates to WHO had expressed similar concerns. The New Zealand delegate to the DHHS Conference explained that his country's laws required multicultural agreement in this regard, so the view held by the Maoris in his country similarly has limited allotransplantation there. Colleagues at the Indian Health Service have informed the author that many American Indian tribes observe a similar taboo.
69. Ernest D. Prentice, Ira J. Fox, Robert S. Dixon, Dean L. Antonson & Terence A. Lawson, Justifiable Clinical Research or Medical Adventurism?: The Ethics of Xenotransplantation, paper delivered at conference on "Current Issues and New Frontiers in Animal Research," San Antonio, Texas (Dec. 8-9, 1994). At the DHHS Conference, supra note 3, Clare Witt, presenting WHO statistics, noted these variations and mentioned that Shinto adherents in Japan oppose removal of organs from the dead because that would disturb the spirit of the dead. Some African delegates to WHO had expressed similar concerns. The New Zealand delegate to the DHHS Conference explained that his country's laws required multicultural agreement in this regard, so the view held by the Maoris in his country similarly has limited allotransplantation there. Colleagues at the Indian Health Service have informed the author that many American Indian tribes observe a similar taboo.
70. NUFFIELD COUNCIL, supra note 26, at 52.
71. Id. at 54. The primary rationale offered by members of the Nuffield Council was their analysis of the relatively high risk of cross-species infection between primates, compared to the very low risk of infectious organisms being transmitted from domesticated pigs, which would be raised in isolation and therefore would be essentially pathogen-free.
72. Despite their phylogenic proximity to humans, chimpanzees are an endangered species. Baboons have relatively small numbers in captivity, have a long gestation period, and tend to give birth to only one offspring at a time. Pigs have a long and relatively safe history with regard to pathogens, exist in large numbers, give birth to multiple offspring after a relatively short gestation period, have organs that grow to a size comparable to that of a human's, and are an animal that many people already accept as a food source.
73. See, e.g., the Old Testament prohibition at Lev. 19:19.
74. First, supra note 29, at 46. The Nuffield Council reported, however, that the Union of Muslim Organizations of England and Ireland recommended that porcine organs not be used. See NUFFIELD COUNCIL, supra note 26, at 44.
75. Draft PHS Guideline, 61 Fed. Reg. at 49,923-26.
76. NUFFIELD COUNCIL, supra note 26, at 88.
77. In this regard, the remarks of literary critic Leslie Fiedler are interesting, as he suggests that it is not fear of failure but rather a fear of success in prolonging life through these unnatural methods - thus bringing about a Faustian damnation - that is most responsible for public ambivalence toward transplantation. See Leslie A. Fiedler, Why Organ Transplant Programs Do Not Succeed, in YOUNGNER ET AL., supra note 30, at 56.
78. Suzanne D. Fullbrook & M.B. Wilkinson, Animal to Human Transplants: The Ethics of Xenotransplanlation (Pt. 1), 6 BRITISH J. OF THEATRE NURSING 32 (May 1996).
79. IOM COMM., supra note 14, at 16. See also NUFFIELD COUNCIL, supra note 26, at 101-05.
80. The well-publicized case of Jeff Getty provides an illustration. An AIDS patient in the final stages of the disease, Mr. Getty petitioned FDA for permission to receive bone marrow from a baboon, followed by radiation treatment. After he received approval from IRBs at both the University of Pittsburgh and the University of California, San Francisco, FDA allowed the procedure to go forward. Mr. Getty's subsequent improvement in health was attributed to the radiation treatment rather than the xenotransplant, however, because the baboon marrow failed to engraft. Thus, in a reversal of the old saw, the operation was a failure, but the patient lived. See Frank Morgan, Comment: Babe the Magnificent Organ Donor? The Perils and Promises Surrounding Xenotransplantation, 14 J. CONTEMP. HEALTH L. & POL'Y 127 (1997).
81. 62 Fed. Reg. 49,946 (Sept. 24, 1997).
82. 447 U.S. 303, 206 USPQ 193 (1980). Chakrabarty modified an existing bacterial strain by inserting new DNA into a bacterial cell, giving the organism the ability to break down various components of crude oil, thus allowing for faster cleanup of oil spills. He had thus "produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility." Id. at 310.
83. See in re Hibbard, 227 USPQ 443 (PTO Bd. App. & Int. 1985).
84. Commissioner of Patents, Nonnaturally Occurring Non-Human Animals Are Patentable Under Section 101, 33 PATENT TRADEMARK & COPYRIGHT J. (BNA) 664 (1987). For an extensive discussion, see Rebecca S. Eisenberg, Proprietary Rights and the Norms of Science in Biotechnology Research, 97 YALE L.J. 177 (1987). The Chakrabarty majority maintained that patents involving living organisms were nothing new, pointing out that, in 1873, the U.S. Patent Office had granted Louis Pasteur a patent on "yeast, free from organic germs of disease, as an article of manufacture." Chakrabarty, 447 U.S. at 314 n.9.
85. Commissioner of Patents, Nonnaturally Occurring Non-Human Animals Are Patentable Under Section 101, 33 PATENT TRADEMARK & COPYRIGHT J. (BNA) 664 (1987). For an extensive discussion, see Rebecca S. Eisenberg, Proprietary Rights and the Norms of Science in Biotechnology Research, 97 YALE L.J. 177 (1987). The Chakrabarty majority maintained that patents involving living organisms were nothing new, pointing out that, in 1873, the U.S. Patent Office had granted Louis Pasteur a patent on "yeast, free from organic germs of disease, as an article of manufacture." Chakrabarty, 447 U.S. at 314 n.9.
86. "Oncomouse" is the name given a transgenic mouse that carries human cancer genes. On April 12, 1988, U.S. Patent No. 4736866 was granted to Harvard University amidst a furorasto the legitimacy of the concept of patenting an animal. The fight continues. Basing its stance on a clause in the European Patent Convention that forbids patents on "inventions considered to be contrary to public morality," a German group, Kein Patent auf Leben (No Patents on Life), has led opposition to Harvard obtaining the first European-wide patent on an animal. See Alison Abbott, Oncomouse Hearing Ends Up in Confusion, 378 NATURE 427 (1995). In the United States, courts have held that "living" inventions are patent-eligible subject matter and not against public order and morality. See, e.g., Animal Legal Defense Fund v.Quigg, 932 F.2d 920, 18 USPQ2d 1677 (Fed. Cir. 1991). See generally HAROLD C. WEGNER, PATENT LAW IN BIOTECHNOLOGY, CHEMICALS & PHARMACEUTICALS §§ 102-03 (2d ed. 1994).
87. "Oncomouse" is the name given a transgenic mouse that carries human cancer genes. On April 12, 1988, U.S. Patent No. 4736866 was granted to Harvard University amidst a furorasto the legitimacy of the concept of patenting an animal. The fight continues. Basing its stance on a clause in the European Patent Convention that forbids patents on "inventions considered to be contrary to public morality," a German group, Kein Patent auf Leben (No Patents on Life), has led opposition to Harvard obtaining the first European-wide patent on an animal. See Alison Abbott, Oncomouse Hearing Ends Up in Confusion, 378 NATURE 427 (1995). In the United States, courts have held that "living" inventions are patent-eligible subject matter and not against public order and morality. See, e.g., Animal Legal Defense Fund v.Quigg, 932 F.2d 920, 18 USPQ2d 1677 (Fed. Cir. 1991). See generally HAROLD C. WEGNER, PATENT LAW IN BIOTECHNOLOGY, CHEMICALS & PHARMACEUTICALS §§ 102-03 (2d ed. 1994).
88. See generally Principles of Ethical Conduct for Government Officers and Employees, Exec. Order No. 12,674 (Apr. 12, 1989) (as modified by Exec. Order No. 12,731); Standards of Ethical Conduct for Employees of the Executive Branch, 5 C.F.R. § 2635 (1993) [hereinafter Standards of Conduct].
89. See Henry Thomas Stelfox, Grace Chua, Keith O'Rourk & Allan S. Detsky, Conflict of Interest in the Debate Over Calcium-Channel Antagonists, 338 NEW ENG. J. MED. 101 (1998). See also Elyse Tanouye, Does Corporate Funding Influence Research?, WALL ST. J., Jan. 8, 1998, at B1.
90. See Henry Thomas Stelfox, Grace Chua, Keith O'Rourk & Allan S. Detsky, Conflict of Interest in the Debate Over Calcium-Channel Antagonists, 338 NEW ENG. J. MED. 101 (1998). See also Elyse Tanouye, Does Corporate Funding Influence Research?, WALL ST. J., Jan. 8, 1998, at B1.
91. Stelfox et al., supra note 75, at 104.
92. See Proposed Final Rule, Financial Disclosure by Clinical Investigators, 63 Fed. Reg. 5233 (Feb. 2, 1998).
93. INSTITUTE OF MEDICINE, FOOD AND DRUG ADMINISTRATION ADVISORY COMMITTEES (Nat' Acad. Press 1992). It should be noted that the Standards of Conduct arguably remove nonfinancial bias considerations from the review of federal ethics officials by stating, "Nothing in this section shall be construed to suggest that an employee should not participate in a matter because of his political, religious or moral views." 5 C.F.R. § 2635.502(b)(1)(v).
94. The author, in his capacity as the DHHS Designated Agency Ethics Official, occasionally has recommended that remedies such as nonvoting status, or recusal from certain discussions, would be appropriate for members of some FDA advisory committees when such issues were implicated, because the usual formal waiver process is inapplicable where nonfinancial conflicts of interest are involved.
95. Pub. L. No. 89-487, 80 Stat. 250 (1966), as amended 5 U.S.C. § 552 (1994).
96. Pub. L. No. 94-40, 90 Stat. 1241 (1976).
97. Pub. L. No. 92-463, 86 Stat. 776 (1972) (codified at 5 US.C. App.).
98. See FANO ET AL., supra note 48, at 2. See also Tim Harper, Mixed International Response to Tainted Blood HIV, AIDS Cases Do Win Financial Aid, TORONTO STAR, Feb. 2, 1998, at A14.
99. The principal statute governing the jurisdiction of the U.S. Court of Federal Claims is the Tucker Act, ch. 359, 24 Stat. 505 (1887) (codified as amended at 28 U.S.C § 1491 (1994)). Pursuant to this statute, the court possesses jurisdiction to entertain any suit for money against the United States that does not sound in tort and that is founded on 1) the Constitution, 2) an act of Congress, 3) an Executive Order, 4) a regulation of an Executive Department, or 5) any express or implied-in-fact contract with the United States. The DHHS regulations on xenotransplantation likely would provide sufficient jurisdiction.
100. Pub. L. No. 99-660, 100 Stat. 3743 (codified at 42 U.S.C. §§ 300aa-1 et seq.).
101. DHHS Conference, supra note 3.
102. See, e.g., Beate G. Exner, Michael Neipp & Suzanne T. Ildstad, Baboon Bone Marrow in Man, Paper Distributed by the Institute for Cellular Therapeutics, Allegheny University of the Health Sciences, Philadelphia, PA (1997).
103. See Louise E. Chapman et al., Xenotransplantation and Xenogeneic Interactions, 333 NEW ENG. J. MED. 1948 (1995).
104. See Jonathan S. Allan, Are Transplants From Animals Too Risky?, WASH. POST, June 17, 1997, at 2; P.J. Kanki et al., Seriologic Identification and Characterization of a Macaque T-Lymphotropic Retrovirus Closely Related to HTLV-III, 228 SCI. 1199 (1985); J. Harvey et al., "An Assessment of Several Alternative Species as Donors for Xenotransplantation," paper distributed at DHHS Conference, supra note 3, at 25 ("To this date, the debate continues and the answer remains unclear. Whether the true origin of HIV/AIDS will ever be determined remains an enigma . . . .").
105. See Jonathan S. Allan, Are Transplants From Animals Too Risky?, WASH. POST, June 17, 1997, at 2; P.J. Kanki et al., Seriologic Identification and Characterization of a Macaque T-Lymphotropic Retrovirus Closely Related to HTLV-III, 228 SCI. 1199 (1985); J. Harvey et al., "An Assessment of Several Alternative Species as Donors for Xenotransplantation," paper distributed at DHHS Conference, supra note 3, at 25 ("To this date, the debate continues and the answer remains unclear. Whether the true origin of HIV/AIDS will ever be determined remains an enigma . . . .").
106. See Jonathan S. Allan, Are Transplants From Animals Too Risky?, WASH. POST, June 17, 1997, at 2; P.J. Kanki et al., Seriologic Identification and Characterization of a Macaque T-Lymphotropic Retrovirus Closely Related to HTLV-III, 228 SCI. 1199 (1985); J. Harvey et al., "An Assessment of Several Alternative Species as Donors for Xenotransplantation," paper distributed at DHHS Conference, supra note 3, at 25 ("To this date, the debate continues and the answer remains unclear. Whether the true origin of HIV/AIDS will ever be determined remains an enigma . . . .").
107. NATIONAL RESEARCH COUNCIL, MAPPING AND SEQUENCING THE HUMAN GENOME (Nat'l Acad. Press 1988).
108. FDA's IRB regulations are found at 21 C.F.R. pt. 56.
109. Suzanne Fullbrook & M.B. Wilkinson, Animal to Human Transplants: The Ethics of Xenotransplantation (Pt. 2), 6 BRITISH J. OF THEATRE NURSING 13 (June 1996).
110. Informed Consent Procedure Adequate for Baby Fae: NIH, AM. MED. NEWS, Mar. 29, 1985, at 17.
111. NUFFIELD COUNCIL, supra note 26, at 112.
112. Harold Y. Vanderpool, Four Neglected Ethical Issues in Clinical Trials with Xenotransplants, paper delivered at DHHS Conference, supra note 3.
113. Statement at DHHS Conference, supra note 3.
114. Ch. 288, 37 Stat. 309 (1912) (codified at 42 U-.S-.C. §§ 201-299).
115. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (as amended 21 U.S.C. § 301 et seq. (1994)).
116. FDA currently regulates human somatic cell therapies, 58 Fed. Reg. 53,248 (Oct. 14, 1993), and human tissue for transplantation, 21 C.F.R. pt 1270. In October 1997, one U.S. District Court implicitly accepted FDA's jurisdiction under the PHS Act. United States v. Loran Med. Systems, No. CV 96-4283 SVW (D.D.C. Oct. 17, 1997).
117. Steven Benowitz, Many Scientists Contesting Xenotransplant Guidelines, 11 THE SCIENTIST 1 (1997).
118. Statement at DHHS Conference, supra note 3.
119. The French delegate to the DHHS conference reported that, on January 14, 1998, the French Parliament passed a law that took virtually the same position.
120. Statement at DHHS Conference, supra note 3.
121. F.H. Bach et al., Uncertainty in Xenotransplantation: Individual Benefit Versus Collective Risk, 4 NATURE MED. 141 (1998). It should be noted, however, that named co-author Dr. Fishman has since retracted his authorship of this article.
122. Statement at DHHS Conference, supra note 3.
123. Chapman et al., supra note 88.
124. Statement at DHHS Conference, supra note 3.
125. Statement at DHHS Conference, supra note 3.
126. Statement at DHHS Conference, supra note 3.
127. WORLD HEALTH ORGANIZATION, REPORT OF WHO CONSULTATION ON XENOTRANSPLANTATION (WHO/EMC/ ZOO/98.2) Geneva, Switzerland (Oct. 28-30, 1997).