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Assessing the Artificial Heart: The Clinical Moratorium Revisited

Published online by Cambridge University Press:  10 March 2009

Judith P. Swazey ,
Judith C. Watkins  and
Renée C. Fox
Judith P. Swazey
Affiliation:
The Acadia Institute
Judith C. Watkins
Affiliation:
The Acadia Institute
Renée C. Fox
Affiliation:
University of Pennsylvania
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Extract

Viewed in relation to the vast amount of clinical research in the United States, the number of total artificial heart (TAH) implants is so small as to be statistically invisible. And while the results of those implants to date may seem dubious in terms of the recipients' outcomes, theyare in fact very similar to those of many other innovative therapies when they are first tried ondesperately ill patients. Why, then, has the artificial heart been the object and subject of suchextraordinary interest and controversy? It has been the subject of special federal studies, reports, and hearings for 20 years; has been perceived and portrayed as a unique chapter in the annals of human experimentation and therapeutic innovation; has attracted medically unprecedented media attention; and, in the case of permanent implants, has received unusually exhaustive and restrictive regulatory supervision.

Type
Special Section: Transplantation and Artificial Organs
Information
International Journal of Technology Assessment in Health Care , Volume 2 , Issue 3 , July 1986 , pp. 387 - 410
Copyright
Copyright © Cambridge University Press 1986

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References

REFERENCES

1.American Medical Association, Judicial Council Statement. [Guidelines for experimental or clinical research on the artificial heart and animal organ transplants] American Medical News, 12 14, 1984.Google Scholar
2.Annas, G. J. Legal and ethical issues in artificial heart experimentation. Testimony presented before the Subcommittee on Investigations and Oversight, Committee on Science and Technology, U.S. House of Representatives, February 5, 1986.Google Scholar
3.Annas, G. J.No cheers for temporary artificial hearts. Hastings Center Report, 1985, 15, 27–28.CrossRefGoogle ScholarPubMed
4.Annas, G. J.The Phoenix heart: What we have to lose. Hastings Center Report, 1985, 15, 15–16.Google ScholarPubMed
5.Annas, G. J. Statement before the Food and Drug Circulatory System Advisory Panel Hearing on Artificial Heart Implants, December 20, 1985.Google Scholar
6.Annas, G. J., Glantz, L. H., & Katz, B. F.Informed consent to human experimentation: The subject's dilemma. Cambridge, MA: Ballinger, 1977.Google Scholar
7.Barber, B. & Fox, R. C.The case of the floppy-earred rabbits: An instance of serendipity gained and serendipity lost. American Journal of Sociology, 1958, 64, 128–36.CrossRefGoogle Scholar
8.Bernstein, B. J.The misguided quest for the artificial heart. Technology Review, 1984, 87, 12ff.Google ScholarPubMed
9.Brown, P. [Clinical Director, Humana Heart Institute.[ Personal interview, December 1985.Google Scholar
10.Buckley, M. J. [American College of Cardiology[ Testimony before the Food and Drug Circulatory System Advisory Panel Hearing on Artificial Heart Implants, December 20, 1985.Google Scholar
11.Carter, M. N.The business behind Barney Clark's heart. Money, 04 1983, 131–44.Google Scholar
12.Chapman, C. B. The Jarvik-7 blood pump; New hearts for old. 1985. Unpublished.Google Scholar
13.Cooley, D. A.Staged cardiac transplantation: Report of three cases. Heart Transplantation, 1982, 1, 145–153.Google Scholar
14.Cooley, D. A., Akutsu, T., Norman, J. C, et al. Total artificial heart in two-staged cardiac transplantation. Cardiovascular Diseases, Bulletin of the Texas Heart Institute, 1981, 8, 305–319.Google Scholar
15.Copeland, J. G. Total artificial heart as a bridge to heart transplantation. Testimony presented before the Subcommittee on Investigations and Oversight, Committee on Science and Technology, U.S. House of Representatives, February 5, 1985.Google Scholar
16.Cutler, E. & Beck, C.The present status of the surgical procedures in chronic valvular disease of the heart. Archives of Surgery, 1929, 18, 403–16.CrossRefGoogle Scholar
17.DeVries, W. C. The artificial heart. Presentation at conference on transplantation and artificial organs in Boston, Massachusetts, November 4–5, 1985.Google Scholar
18.DeVries, W. C. Personal interview. June 1983.Google Scholar
19.DeVries, W. C. Personal interview. December 1985.Google Scholar
20.DeVries, W. C. Statement to the Subcommittee on Investigations and Oversight, Committee on Science and Technology, U.S. House of Representatives, February 5, 1986.Google Scholar
21.DeVries, W. C. Testimony before the Food and Drug Circulatory System Advisory Panel Hearing on Artificial Heart Implants, December 20, 1985.Google Scholar
22.DeVries, W. C. & Symbion, Inc. Special patient consent for the implantation of the total artificial heart and related procedures. 1983. Unpublished.Google Scholar
23.Eichwald, E. J., Woolley, F. R., Cole, B., et al. Insertion of the artificial heart. IRB, 1981, 3,4–5.Google Scholar
24.Federal Register, Vol. 45, No. 13, Friday, January 18, 1980, 3732–3759, Medical Devices; Procedures for Investigational Device Exemptions. Amended, Federal Register, Vol. 45, No. 174, Friday, September 5, 1980, 58841–43.Google Scholar
25.Federal Register, Vol. 50, No. 204, Tuesday, October 22, 1985. Guidance for the Emergency Use of Unapproved Medical Devices; Availability.Google Scholar
26.Fields, A., Harasaki, H., Sands, D., et al. Infection in artificial blood pump implantation. Transactions of the American Society of Artificial Internal Organs, 1983, 29, 532–38.Google ScholarPubMed
27.Fineberg, H.Irresistible medical technologies: Weighing the costs and benefits. Technology Review, 1984, 87, 17ff.Google ScholarPubMed
28.Fox, R. C. “It's the same, but different”: A sociological perspective on the case of the Utah artificial heart. In Shaw, M. W. (ed.), After Barney Clark. Austin: University of Texas Press, 1983, 68–90.Google Scholar
29.Fox, R. C. & Swazey, J. P.The courage to fail. 2nd ed, revised. Chicago: The University of Chicago Press, 1978.Google Scholar
30.Fox, R. C., Swazey, J. P., & Cameron, E. M. Social and ethical problems in the treatment of end-stage renal disease patients. In Narins, R. G. (ed.), Controversies in nephrology and hypertension. New York: Churchill Livingstone, 1984, 45–70.Google Scholar
31.Glaser, R. J.The artificial heart-show business or science? (editorial) The Pharos, 1985, 48, 38.Google ScholarPubMed
32.Gore, Senator Albert Jr, Letter to Frank E. Young, Commissioner, Food and Drug Administration, February 5, 1986.Google Scholar
33.Gray, B. H. (ed.) The new health care for profit. Washington, DC: Institute of Medicine/National Academy Press, 1983.Google Scholar
34.Hastings, W. L., Aaron, J. L., Deneris, J., et al. A retrospective study of nine calves surviving five months on the pneumatic total artificial heart. Transactions of the American Society of Artificial Internal Organs, 1981, 27, 71–76.Google ScholarPubMed
35.Hazle, D. [Director of Public Relations, Humana Hospital Audubon] Personal interview. December, 1985.Google Scholar
36. The heart of the experiment (editorial). New York Times, January 7, 1985.Google Scholar
37.Jarvik, R. K.The total artificial heart. Scientific American, 1981, 249, 74–80.CrossRefGoogle Scholar
38.Jarvik, R. K. et al. Recent advances with the artificial heart (letter to the editor). New England Journal of Medicine, 1978, 298, 404–5.Google Scholar
39.Jones, David. [Chief Executive Officer, Humana Inc.] Personal interview. December, 1985.Google Scholar
40.Jonsen, A. R. The selection of patients. In Shaw, M. W. (ed.), After Barney Clark. Austin: University of Texas Press, 1983, 5–10.Google Scholar
41.Joyce, L. D., DeVries, W. C., Hastings, W. L., et al. Response of the human body to the first permanent implant of the Jarvik-7 total artificial heart. Transactions of the American Society of Artificial Internal Organs, 1983, 29, 81–87.Google Scholar
42.King, M.AMA officials criticize Humana heart project. Louisville Courier-Journal, 12 6, 1984, B1.Google Scholar
43.King, M.Experts question increased use of Jarvik-7 as temporary tool. Louisville Times, 02 12, 1986, A1.Google Scholar
44.Kolff, W. J.Artificial organs—forty years and beyond. Transactions of the American Society of Artificial Internal Organs, 1983, 29, 6–21.Google Scholar
45.Korcok, M.The business of ethics. Canadian Medical Association Journal, 1985, 132, 676–87.Google Scholar
46.McIntosh, C. L. Statement by [the] Chairman, Circulatory System Devices Advisory Panel, U.S. Food and Drug Administration, before the Subcommittee on Science and Technology, U.S. House of Representatives, February 5, 1986.Google Scholar
47.Mattox, K. L. [American College of Surgeons] Testimony before the Food and Drug Circulatory System Advisory Panel Hearing on Artificial Heart Implants, December 20, 1985.Google Scholar
48.Merz, B.Artificial hearts: An uneasy marriage of machinery and flesh. Medical World News, 05 27, 1985, 40–57.Google Scholar
49.Murray, K. D., Hughes, S., Bearnson, D., et al. Infection in total heart recipients. Transactions of the American Society of Artificial Internal Organs, 1983, 29, 539–45.Google Scholar
50.Murray, K. D. & Olsen, D. B.The Utah artificial heart: Success in the laboratory and its application to man. Journal of Contemporary Law, 1984, 1, 4–28.Google Scholar
51.National Heart, Lung, and Blood Institute, Working Group on Mechanical Circulatory Support. Artificial heart devices: Directions, needs, costs, societal and ethical issues. 05 1985.Google Scholar
52.National Institutes of Health. The totally implantable artificial heart: Economic, ethical, legal, medical, psychiatric, and social implications. Bethesda, MD: National Institutes of Health, 1973.Google Scholar
53.Nelson, M.Stout heart: Jarvik woman sits up, chats. USA Today, 01 1, 1986, 1.Google Scholar
54.Nosé, Y.The total artificial heart: From development to clinical trials (editorial). Artificial Organs, 1985, 9, 221.Google Scholar
55.Pennington, G. [Society of Thoracic Surgeons] Testimony before the Food and Drug Circulatory System Advisory Panel Hearing on Artificial Heart Implants, December 20, 1985.Google Scholar
56.Preston, T. A.The artificial heart controversy: Research, rationing, and regulation. Medical World News, 02 11, 1985, 37.Google ScholarPubMed
57.Reiser, S. J. The machine as means and end: The clinical introduction of the artificial heart. In Shaw, M. W. (ed.), After Barney Clark. Austin: University of Texas Press, 1983, 168–75.Google Scholar
58.Relman, A. S.The new medical-industrial complex. New England Journal of Medicine, 1980, 303, 963–70.Google Scholar
59.Relman, A. S.Privatizing artificial-heart research (letter to the editor). Wall Street Journal, 12 26, 1984.Google Scholar
60.Starr, P.The social transformation of American medicine. New York: Basic Books, 1983.Google Scholar
61.Strauss, M. J.The political history of the artificial heart. New England Journal of Medicine, 1984, 310, 332–36.Google Scholar
62.Swazey, J. P. & Fox, R. C. The clinical moratorium: A case study of mitral valve surgery. In Freund, P. A. (ed.), Experimentation with human subjects. New York: George Braziller, Inc., 1970, 315–57.Google Scholar
63.U. S. Congress, Office of Technology Assessment, Case study #9, The artificial heart: Costs, risks and benefits, prepared by Lubeck, D. P. & Bunker, J. P.. Washington, D.C.: Government Printing Office, 1982.Google Scholar
64. Valentine's Day holds special meaning for heart patients. Camden, NJ Courier Post, February 15, 1986.Google Scholar
65.Vinocur, B.Debating the value of artificial hearts. Boston Globe, 09 23, 1985.Google Scholar
66.Winsten, J. A.Science and the media: The boundaries of truth. Health Affairs, Spring 1985, 5–23.Google Scholar
67.Wolfe, S. M. Statement before the Food and Drug Circulatory System Advisory Panel Hearing on Artificial Heart Implants, December 20, 1985.Google Scholar
68.Woolley, R. [Chair, Artificial Heart Subcommittee, University of Utah Medical Center I.R.B.] Personal interview, June 1983.Google Scholar
69.Wrenn, M.-C.The artificial heart is here. Life, 09 1981, 29–33.Google Scholar