"He Knows That Machine Is His Mortality": Old and new social and cultural patterns in the clinical trial of the AbioCor artificial heart

Perspectives in Biology and Medicine

Volumn 47, Issue 1, 2004, Pages 74-99

  Fox, Renée C ^a,c   Swazey, Judith P ^b  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b Acadia Institute   (United States)

^c The Wellington #1104 ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTIFICIAL HEART; CLINICAL TRIAL; CULTURAL ANTHROPOLOGY; FAMILY; HEART TRANSPLANTATION; HUMAN; LAW SUIT; PATIENT INFORMATION; PRIORITY JOURNAL; RECIPIENT; REVIEW; SOCIOLOGY; UNITED STATES;

ANALYTICAL APPROACH; BIOMEDICAL AND BEHAVIORAL RESEARCH; HEALTH CARE AND PUBLIC HEALTH;

ATTITUDE TO HEALTH; CLINICAL TRIALS; COMMERCE; CONSENT FORMS; CULTURE; FINANCING, GOVERNMENT; HEART, ARTIFICIAL; HUMANS; IMPLANTS, EXPERIMENTAL; MALE; NATIONAL INSTITUTES OF HEALTH (U.S.); OUTCOME ASSESSMENT (HEALTH CARE); PATIENT DISCHARGE; TERMINALLY ILL; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 1642456555     PISSN: 00315982     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (74)

1. Abiomed. n.d. Informed consent to participate in AbioCor™ implantable replacement heart clinical trial.
2. Abiomed. 2001a. The AbioCor™ clinical trial. Fact sheet, June 25.
3. Abiomed. 2001b. Second patient receives AbioCor implantable replacement heart. News release, Sept. 13.
4. Abiomed. 2001c. Abiomed CEO explains information policy for initial human trial of AbioCor replacement heart. News release, Aug. 6. http://www.abiomed.com/invest/ press/060801 (accessed Aug. 22, 2001).
5. Abiomed. 2002a. Abiomed announces results for fiscal quarter and year ended March 31, 2002. News release, May 16. http://www.abiomed.com/invest/press/ 160502 (accessed Aug. 18, 2002).
6. Abiomed. 2002b. Abiomed ISO certification received for AbioCor implantable replacement heart. Patient enrollment in clinical trial set to resume. News release, March 6. http://www.abiomed.com/invest/press/03/06/02. html (accessed March 10, 2002).
7. Abiomed. 2002c. Abiomed updates clinical trial progress and schedule at Banc America Securities Healthcare Conference. April 3. http://www.abiomed.com/ invest/press/ 030402 (accessed April 4, 2002).
8. Abiomed 2003a. Abiomed provides information on plans for U.S. market entry with AbioCor and Heart Assist product line enhancement. New release, March 25. http:// www.abiomed.com/invest/press/032053.html (accessed May 1, 2003).
9. Abiomed. 2003b. Abiomed provides update on AbioCor trial enrollment. Tenth patient implanted at Texas Heart Institute. Periodic announcements to replace individual patient reports. News release March 10. http://www.abiomed. com/invest/press/ 031003b.html (accessed March 11, 2003).
10. Abiomed. 2003c. Tom Christerson, pioneer AbioCor patient, dies in Louisville. News release, Feb. 7. http://www.abiomed.com/invest/press/020703. html (accessed Feb. 8, 2003).
11. Altman, L. K. 2001. Manufacturer of artificial heart forbids doctors to talk about patient's condition. NY Times, July 13.
12. Anderson, P. 2002. Personal communication, Oct. 21.
13. Annas, G. J. 1986. Death and the magic machine: informed consent to the artificial heart. Western New Engl Law Rev 9:89-112.
14. Annas, G. J. 2001. The unknowns of the mechanical heart. Op-Ed. NY Times, Aug. 23.
15. Applebaum, P. S., et al. 1987. False hopes and best data: consent to research and the therapeutic misconception. 1987. Hastings Cent Rep 17(2):20-24.
16. Associated Press. 2003a. Doctors had discussed replacing patient's artificial heart. Man declines attempt to replace device. Feb. 11. http://thebostonchannel.com/health/ 1970154/detail.html (accessed Feb. 13, 2003).
17. Associated Press. 2003b. Widow agrees to settle suit over device used to test heart. NY Times, June 17.
18. Burling, S. 2001. A heartening experience in Philadelphia. Philadelphia Inquirer, Dec 7. http://inq.philly.com/content/inquirer/2001/12/07.htm.
19. Burling, S. 2002a. Heart teams still upbeat on AbioCor. Philadelphia Inquirer, Aug. 29. http://www.philly.com.htm.
20. Burling, S. 2002b. Life, but at what cost? Philadelphia Inquirer, Sept. 29. http://www.philly. com/mld/philly/living/health/4170905.htm.
21. Burling, S. 2002c. Mechanical-heart patient comes to regret his life-saving choice. Philadelphia Inquirer, July 19. http://inq.philly.com/ content/inquirer/2002/07/19.htm.
22. Burling, S. 2002d. Widow sues artificial heart maker. Philadelphia Inquirer, Oct. 17. http:// www.philly.com/mld/philly/news/local/4301284.htm.
23. CBS News. 2003. Pulse of an artificial heart. Feb. 13. http://www.cbsnews.com/stories/ 2003/02/13/earlyshow/series/health/heartscore (accessed Feb. 17, 2003).
24. Culliton, B. 1988. Politics of the heart. Science 241 (July 15):283.
25. Ditlea, S. 2002. The trials of an artificial heart. Sci Am (July):61-69.
26. Fox, R. C. 1974. Experiment perilous. Philadelphia: Univ. of Pennsylvania Press.
27. Fox, R. C. 1984. "It's the same but different": A sociological perspective on the case of the Utah artificial heart. In After Barney Clark, ed. M. W. Shaw, 68-90. Austin: Univ. of Texas Press.
28. Fox, R. C., and J. P. Swazey. 1992. Spare parts: Organ replacement in American society. New York: Oxford Univ. Press.
29. Fox, R. C., and J. P. Swazey. 2002. The courage to fail. A social view of organ transplants and dialysis. New Brunswick, NJ: Transaction Publishers.
30. Gil, G. 2001. Friends, family honor pioneer Tools. Louisville Courier-Journal, Dec. 8. http://www.courier-journal.com/localnews/2001/12/08. htm.
31. Gil, G. 2002a. AbioCor to be altered slightly: Blood clots found in artificial hearts. Louisville Courier-Journal, Jan. 24. http://www.courier- journal.com/localnews/2002/01/ 24.htm.
32. Gil, G. 2002b. Clots prompt new criteria for AbioCor: Maker of artificial heart more selective about recipients. Louisville Courier-Journal, Sept. 6. http://www.courier-journal.com/localnews/2002/09/06.htm.
33. Gil, G. 2002c. Heart patient happy at home: AbioCor recipient slowly regaining strength. Louisville Courier-Journal, June 27. http://www.courier- journal.com/localnews/2002/ 06/27.htm.
34. Gil, G. 2003a. Abiomed knew of membrane problem: Christerson, others decided against new heart. Louisville Courier-Journal, Feb. 11. http://www.courier-journal.com/local-news/2003/02/11.htm.
35. Gil, G. 2003b. Death of Christerson shines light on bioethics: Heart experiment's end was a right-to-die choice. Louisville Courier-Journal, Feb. 9. http://www.courier-journal. com/localnews/2003/02/09.htm.
36. Gil, G. 2003c. Lexington recipient of AbioCor heart dies: Propps enjoyed life to the nth degree. Louisville Courier-Journal, March 19. http://www.courier-journal.com/local-news/2003/03/19.htm (accessed March 22, 2003).
37. Gil, G. 2003d. Maker of AbioCor targets strokes. Louisville Courier-Journal, Aug. 9. http:// www.courier-journal.com/ky/met-front- heart08090 (accessed Aug. 12, 2003).
38. Gil, G. 2003e. Tenth recipient of AbioCor artificial heart is dead, Houston hospital says. Louisville Courier-Journal, July 17. http://www.courier- journal.com/localnews/2003/ 07/17.htm (accessed July 18, 2003).
39. Gil, G., and S. Shipley. 2002. Home is where his heart is now: AbioCor patient returns to Central City. Louisville Courier-Journal, April 17. http://www.courier-journal.com/ localnews/2002/04/17.htm.
40. Hahnemann University Hospital. 2002. Fifth artificial heart patient dies: Philadelphia heart "hero" succumbs at Hahnemann University Hospital. News briefing, Aug. 26.
41. Highland, D. 2003. Heart patient laid to rest. Louisville Courier-Journal, Feb. 12. http:// www.courier-journal.com/localnews/htm.
42. Jewish Hospital. 2003a. AbioCor artificial heart patient passes away. News release, March 18. http://www.jewishhospital.org/FullRelease.asp (accessed March 21, 2003).
43. Jewish Hospital. 2003b. AbioCor heart implanted at Jewish Hospital. News release, Jan. 8. http://www.jewishhospital.org/FullRelease.asp (accessed Jan. 12, 2003).
44. Jewish Hospital 2003c. Artificial heart patient passes away. News release, Apr. 18. http:// www.jewishhospital.org/FullRelease.asp (accessed Apr. 19, 2003).
45. Jewish Hospital. 2003d. Jewish Hospital/University of Louisville team implants AbioCor. News release, Jan. 23. http://www.jewishhospital.org/ FullRelease.asp (accessed Jan. 26, 2003).
46. Jewish Hospital. 2003e. Tom Christerson, world's second artificial heart patient, passes away. News release, Feb. 7. http://www.jewishhospital.org/ FullRelease.asp (accessed Feb. 8, 2003).
47. Kaukas, D. 2001a. Implant team offers glimpses of pioneering heart patient. Louisville Courier-Journal, Aug. 30. http://www.courier-journal.com/ localnews/htm.
48. Kaukas, D. 2001b. Patient "resting comfortably" after implant: Long-term outlook not yet clear after medical milestone. Louisville Courier-Journal, July 4. http://www.courier-journal.com/localnews/2001/07/04. htm.
49. Krasner, J. 2002. Abiomed will slow artificial heart trials. Boston Globe, April 4.
50. Krasner, J., and Mishra, R. 2002. Abiomed in race against time to prove artificial heart's promise. Boston Globe, Sept. 13.
51. Lovan, D. T. 2003. Tom Christerson, AbioCor's longest-living recipient, remembered in funeral service. Louisville Courier-Journal, Feb. 11. http://www.courier-journal.com/ localnews/2003/02/11/update_hart.html.
52. McCarthy, P. M., and W. A. Smith. 2002. Mechanical circulatory support: A long and winding road. Science 295(5557):998-99.
53. Mestel, R. 2001. Patient dies nearly 5 months after getting mechanical heart. Los Angeles Times, Dec. 1. http://www.latimes.com/templates/misc/1dec01.
54. Miller, F. G., and D. L. Rosenstein. The therapeutic orientation in clinical trials. N. Engl J Med 384 (Apr. 3):1383-86.
55. Mishra, R., and G. Cook. 2002. Flaw in artificial heart is cited in strokes. Boston Globe, Jan. 24.
56. Moore, F. D. 1968. Medical responsibility for the prolongation of life. JAMA 206:384-86.
57. Moore, J. 2002. The AbioCor artificial heart: One year later. Cardiol Today, Sept. http:// www.cardiologytoday.com/200209/abiocor.asp.
58. New York Times. 1988. Dracula of medical technology. Editorial. May 21.
59. Pope, J. Artificial heart company insists trial will go on.2003. Miami Herald, Feb. 13. http://www.miami.com/mld/miamiherald/businesss/5176127.htm.
60. Quinn v. Abiomed et al., Philadelphia Co., No. 001524 (Ct. Common Pleas, 2002).
61. Reuters Health. 2001. Second artificial heart patient progressing slowly. Nov. 7. http:// Transplantation.medscape.com/reuters/prof/2001/11.07.html.
62. Rowland, R., and D. Goldschmidt. 2002. Artificial heart one year later. http://www. CNN.com/Health/03/07/02.htm (accessed July 5, 2002).
63. Schreiner, B. 2003. Analysts more upbeat after resumption of AbioCor implants. Louisville Courier-Journal, Jan. 9. http://www.courier-journal.com/ localnews/2003/01/09/ update_abiocor.html.
64. Starr, P. 1982. The social transformation of American medicine. New York: Basic Books.
65. Stolberg, S. G. 2002. On medicine's frontier: the last journey of James Quinn. NY Times, Oct. 8. http://www.nytimes.com/2002/10/08/health/anatomy 08HEAR.htm.
66. Tangonan, S. 2002. Progress in the C-A-R-D-S for heart "hero." Louisville Courier-Journal, March 3. http://www.courier-journal.com/localnews/ 2002/03/03.htm.
67. Tangonan, S. 2003. Eighth AbioCor heart recipient dies 101 days after surgery: Veteran is praised for spirit, humor at Jewish Hospital. Louisville Courier-Journal, Apr. 19. http:// www.courier-journal.com/localnews/2002/04/193. htm (accessed Apr. 20, 2003).
68. Texas Heart Institute. 2002. World's third recipient of AbioCor™ artificial heart is born risk taker, continues steady recovery. News release, Jan. 16. http://www.texasheartinstitute.org/abio1_02.html (accessed Feb. 17, 2002).
69. Vennochi, J. 2001. From the heart, disturbing questions. 2001. Boston Globe, July 6.
70. Wilson, R. 2003. When should a scholar's notes be confidential? Chronicle Higher Ed (May 16):A10-A12.
71. Wolfson, A. 2001. AbioCor maker is driven to sustain life. Louisville Courier-Journal, Nov. 25. http://www.courier-journal.com/localnews/2001/11/ 25htm.
72. Wolfson, A. 2002. Artificial-heart maker slows pace of implants. Louisville Courier-Journal, April 4. http://www.courier-journal.com/localnews/ 2002/04/04.htm.
73. Woolhouse, M. 2002. AbioCor heart patient back home after surgery. Louisville Courier-Journal, Aug. 16. http://www.courier-journal.eom/localnews/ 2002/8/16/5htm.
74. Yetter, D. 2003. Sadness grips Christerson's home town. Louisville Courier-Journal, Feb. 9.