The Body Hunters
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21. “South Africa: Rath Foundation Conduct Illegal Experiments,” Africa News, September 5, 2005.
22. Niels Lynoe et al., “Obtaining Informed Consent in Bangladesh,” New England Journal of Medicine, February 8, 2001, 460–61.
23. Kass and Hyder, “Attitudes and Experiences,” B-28.
24. Ibid., B-27.
25. Mary Pat Flaherty et al., “Life by Luck of the Draw,” Washington Post, December 22, 2000, A1.
26. East African Standard, “Kenya: Rarieda Guinea Pigs Insist They Were Tricked into Joining Study,” Africa News, January 26, 2004.
27. Sergei Varshavsky, “Discover Russia for Conducting Clinical Research,” Applied Clinical Trials, March 2002, 74–80.
28. “Jump Starting Clinical Trials in China,” CenterWatch, July 2002.
29. Interview with Anne-Valerie Kaninda, 2001.
30. See, for example, Jared Diamond, Guns, Germs, and Steel: The Fates of Human Societies (New York: W.W. Norton, 1997), 117–22.
31. Daniel W. Fitzgerald et al., “Comprehension During Informed Consent in a Less-Developed Country,” The Lancet, October 26, 2002, 1301–2.
32. National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, vol. 1, April 2001, 41.
33. Interview with Jonathan D. Moreno, March 22, 2005.
34. M. Upvall et al., “Negotiating the Informed-Consent Process in Developing Countries: A Comparison of Swaziland and Pakistan,” International Nursing Review 48, no. 3 (2001): 188–92.
35. National Bioethics Advisory Commission, Ethical and Policy Issues in International Research, vol. 1, 48.
36. Kass and Hyder, “Attitudes and Experiences,” B-27.
37. Ibid., B-28.
38. A.K. Sanwal et al., “Informed Consent in Indian Patients,” Journal of the Royal Society of Medicine, April 1996, 196–98.
39. LaFraniere et al., “The Dilemma.”
40. John C.M. Lee, “Clinical Research in China,” Drug Information Journal 32 (1998): 1265S–73S.
41. Interview with Robert Temple, September 2003.
42. Pfizer correspondence with the Washington Post on Clinical Trials Series, available at www.pfizer.com/pfizerinc/about/press/trovanq&a.html.
43. Interview with Elaine Kusel, 2001.
44. Pfizer correspondence with the Washington Post on Clinical Trial Series; H. Veeken et al., “Priority During a Meningitis Epidemic: Vaccination or Treatment?” Bulletin of the World Health Organization, March 1998, 2.
45. Interview with Larry Baraff, 2001.
46. Interview with Solomon Benatar, November 10, 2003.
47. Joe Stephens, “Doctors Say Drug Trials’ Approval Was Backdated,” Washington Post, January 16, 2001, A1.
48. Pfizer correspondence with the Washington Post on Clinical Trial Series.
49. In the end, more than two hundred thousand Africans fell ill with meningitis, and despite the efforts of aid doctors who treated tens of thousands in Kano alone, twenty thousand died. Nobody would have known anything about the experiment in Kano had a Washington Post reporter not somehow gotten wind of it. The FDA later curtailed the use of Trovan when reports of liver damage surfaced. Joe Stephens, “Where Profits and Lives Hang in the Balance,” Washington Post, December 17, 2000; Pfizer correspondence with the Washington Post on Clinical Trial Series.
50. Advisory Committee on Human Radiation Experiments, “History of Prison Research Regulation,” Final Report, at tis.eh.doe.gov/ohre/roadmap/achre/chap9_4.html.
51. Daniel Moerman, Meaning, Medicine, and the “Placebo Effect” (Cambridge: Cambridge University Press, 2002), 128.
52. Advisory Committee on Human Radiation Experiments, “History of Prison Research Regulation,” citing Stephen Gettinger and Kevin Krajick, “The Demise of Prison Medical Research,” Corrections Magazine, December 1979, 12.
53. Neal Dickert and Christine Grady, “What’s the Price of a Research Subject? Approaches to Payment for Research Participation,” New England Journal of Medicine, July 15, 1999, 198–203.
54. Andrew Pollack, “In Drug Research, the Guinea Pigs of Choice Are, Well, Human,” New York Times, August 4, 2004.
55. Interview with Ben Leff, August 25, 2003.
56. See www.indianabiblecollege.org/employment.htm.
57. See www.lillyclinic.com.
58. See www.lillyclinic.com/about/tour.htm.
59. “Test Subjects Call Lilly Screening Process Inadequate,” Associated Press, March 4, 2004; Tom Murphy, “Clinical Trials Face Volunteer Challenges; Lilly Bucks National Trend, Reports No Enrollment Woes,” Indianapolis Business Journal, July 19, 2004; “FDA Clears Lilly Drug in Suicide During Clinical Trial,” Associated Press, August 12, 2004.
60. Elizabeth Shogren, “FDA Sat on Report Linking Suicide, Drugs,” Los Angeles Times, April 6, 2004.
61. Deanna Wrenn, “Lilly Alters Procedure in Drug Test in Response to Suicide,” Associated Press, March 5, 2004.
62. Carol Druga, “Woman Who Committed Suicide During Lilly Drug Study Was Trying to Earn Money for College,” Associated Press, February 12, 2004.
63. “Participant in Drug Trial Found Dead of Suicide in Eli Lilly Lab,” Associated Press, February 10, 2004.
64. “FDA Clears Lilly Drug in Suicide During Clinical Trial,” Associated Press, August 12, 2004; Reuters, “Antidepressant by Eli Lilly Is Approved for Diabetics,” New York Times, September 8, 2004; Shankar Vedantam, “Depression Drugs to Carry a Warning; FDA Orders Notice of Risks for Youths,” Washington Post, October 16, 2004, A1; “Antidepressant Tied to Attempted Suicides,” New York Times, July 2, 2005, 9.
65. Interview with Ben Leff, August 25, 2003.
66. Dickert and Grady, “What’s the Price of a Research Subject?”
67. Department of Health and Human Services Office of Inspector General, Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research, June 2000, 26.
68. Interview with Anamika Jithoo, November 2003.
69. Robert Helms, ed., Guinea Pig Zero: An Anthology of the Journal for Human Research Subjects (New Orleans, LA: Garrett County Press, 2002), 16.
70. Ibid., 40–43.
71. Department of Health and Human Services Office of Inspector General, Recruiting Human Subjects.
72. Ibid., 17.
73. Thomas Bodenheimer, “Uneasy Alliance—Clinical Investigators and the Pharmaceutical Industry,” New England Journal of Medicine, May 18, 2000, 1539–44.
74. Department of Health and Human Services Office of Inspector General, Recruiting Human Subjects, 18.
75. Ibid.
76. Holcomb B. Noble, “Hailed as a Surgeon General, Koop Is Faulted on Web Ethics,” New York Times, September 5, 1999, 1.
77. Nick Smith, “The Strains of Pharming It Out,” Scrip, July/August 2002, 32.
78. Interview with Ken Getz, October 2003.
79. See www.threewire.com/Inside/About.htm.
80. See www.clinicalsolutionsonline.com/.
81. Robert Whitaker, “Lure of Riches Fuels Testing,” Boston Globe, November 17, 1998.
82. Michael D. Lemonick and Andrew Goldstein, “At Your Own Risk: Some Patients Join Clinical Trials Out of Desperation, Others to Help Medicine Advance. Who Is to Blame if They Get Sick—Or Even Die?” Time, April 22, 2002.
83. National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, vol. 1, 3–4.
84. Lemonick and Goldstein, “At Your Own Risk.”
85. Christopher K. Daugherty, “Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective,” Journal of Clinical Oncology, May 1999, 1601–17.
86. David F. Horrobin, “Are Large Clinical Trials in Rapidly Lethal Diseases Usually Unethical?” The Lancet, February 22, 2003, 695–97.
87. Paul Root Wolpe, “Not Just How, but Whether: Revisiting Hans Jonas,” American Journal of Bioethics, Fall 2003, vii–viii.
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88. David A. Stone et al., “Patient Expectations in Placebo-Controlled Randomized Clinical Trials,” Journal of Evaluation in Clinical Practice 11, no. 1 (2005): 77–84.
89. Franklin G. Miller and Donald L. Rosenstein, “The Therapeutic Orientation to Clinical Trials,” New England Journal of Medicine, April 3, 2003, 1383–86.
90. Department of Health and Human Services Office of Inspector General, Recruiting Human Subjects.
91.Horrobin, “Are Large Clinical Trials in Rapidly Lethal Diseases Usually Unethical?”
92. Post on Breast Cancer Action Nova Scotia discussion group, at bca.ns.ca/indice/2003/65index.cgi/noframes/read/249686.
93. Moerman, Meaning, Medicine, and the “Placebo Effect,” 105–6.
94. Ibid., 41.
95. Interview with Dr. Farhad Kapadia, November 29, 2003.
96. “The Use of Innovative Strategies in Patient Recruitment: Best Practices and Success Stories from Pharma and Biotech,” panel discussion, Maximizing Clinical Efficiency Phases, Washington, DC, October 8–10, 2003.
97. Interview with Larry J. Baraff, January 10, 2002.
98. Robert I. Misbin, “Placebo-Controlled Trials in Type 2 Diabetes,” Diabetes Care 24, no. 4 (2001): 768–74.
99. Interview with Jonathan D. Moreno, March 22, 2005.
100. Adrian Michaels, “Pfizer Suit Adds to Pressure on Industry,” Financial Times, September 3, 2001, 8; Reuters, “Case over Pfizer Clinical Trial in Nigeria Is Reopened,” New York Times, October 14, 2003, 4.
10: Tipping the Scales
1. Anne Bennett Swingle, “The Pathologist Who Struck Gold,” Hopkins Medical News, Spring/Summer 2001.
2. “President Nixon, you can cure cancer,” philanthropist Mary Lasker and her allies boldly claimed in a New York Times advertisement. “We lack only the will and the kind of money . . . that went into putting a man on the moon.” Gary Cohen and Shannon Brownlee, “Mary and Her ‘Little Lambs’ Launch a War,” U.S. News & World Report, February 5, 1996, 76; U.S. Bureau of Census, “Deaths by Major Causes: 1960 to 2001,” Statistical Abstract of the United States, 2003, Washington, DC, January 2003, 91.
3. Roy Porter, The Greatest Benefit to Mankind: A Medical History of Humanity (New York: W.W. Norton, 1997), 580.
4. Abigail Trafford, “Fanfare Fades in the Fight Against Cancer,” U.S. News & World Report, June 19, 1978, 63.
5. Interview with Ruth Faden, 2001.
6. Anne-Emannuelle Bim, “Gates’ Grandest Challenge: Transcending Technology as Public Health Ideology,” The Lancet, March 11, 2005.
7. Interview with Dr. Solomon Benatar, November 10, 2003.
8. FDA News, “CDC Revises Guidelines for Expanded Use of Preventive HIV Regimens,” Drug Daily Bulletin, January 31, 2005.
9. Sabin Russell, “Antiviral Drug Used to Treat AIDS to Be Tested as Vaccine,” San Francisco Chronicle, December 1, 2004.
10. National Center for HIV, STD, and TB Prevention, Divisions of HIV/AIDS Prevention, CDC Trials of Daily Oral Tenofovir for Preventing HIV Infection, Centers for Disease Control, February 17, 2005.
11. Ibid.
12. “Daily Tenofovir DF to Prevent HIV Infection among Sex Workers in Cambodia,” clinical trial listing, clinicaltrials.gov.
13. Family Health International, “FHI Oral Tenofovir Study,” available at www.fhi.org.
14. Human Rights Watch, Not Enough Graves: Thailand’s War on Drugs, HIV/AIDS and Violations of Human Rights, July 2004, cited in Thai AIDS Treatment Action Group et al. press release, “Thai Activists Speak Out on Tenofovir Trial in IDUs,” December 8, 2004, and “Thailand’s ‘War on Drugs’ Had Unexpected Consequences, New Study Says,” Associated Press, March 30, 2005.
15. Sabin Russell, “Prostitutes Protest AIDS-Drug Test, Bay Area Company Hit with Charges of Exploitation,” San Francisco Chronicle, July 14, 2004; Marilyn Chase and Guatam Naik, “Key AIDS Study in Cambodia Now in Jeopardy,” Wall Street Journal, August 12, 2004, B1.
16. ACT UP Paris and Asian Pacific Network of Sex Workers press release, “Gilead Organizes the Infection of Sex Workers,” July 15, 2004.
17. Chase and Naik, “Key AIDS Study in Cambodia.”
18. “Cambodia’s Premier Halts Planned Trials of AIDS Drug,” Associated Press, August 11, 2004.
19. Thai AIDS Treatment Action Group et al. press release, “Thai Activists Speak Out on Tenofovir Trials in IDUs.”
20. ACT UP Paris press release, “The Cameroonian Government Must Condemn Unethical Trials, and Not People Living with HIV/AIDS,” January 25, 2005.
21. Jon Cohen, “Cameroon Suspends AIDS Study,” Science, February 4, 2005.
22. Andrew Jack and Michael Peel, “AIDS Study Runs into Trouble in Nigeria,” Financial Times, March 15, 2005, 12.
23. Cohen, “Cameroon Suspends AIDS Study.”
24. “A Public Statement from the Global Campaign for Microbicides and the AIDS Vaccine Advocacy Coalition on the Impact of Stopping Tenofovir Trials in Cambodia and Cameroon,” February 18, 2005.
25. Chase and Naik, “Key AIDS Study in Cambodia.”
26. Andrew Jack, “Mission to Save AIDS Drug Trial from Ethical Whirlpool,” Financial Times, February 23, 2005, 24.
27. Interview with Mitchell Warren, March 24, 2005.
28. Cohen, “Cameroon Suspends AIDS Study.”
29. Sabin Russell, “Prostitutes Protest AIDS-Drug Test.”
30. Center for HIV Identification, Prevention, and Treatment Services, “Anticipating the Efficacy of HIV Preexposure Prophylaxis (PrEP) and the Needs of At-Risk Californians,” November 2004.
31. Shambavi Subbarao et al., “Chemoprophylaxis with Oral Tenofovir Disoproxil Fumarate (TDF) Delays but Does Not Prevent Infection in Rhesus Macaques Given Repeated Rectal Challenges of SHIV,” Conference on Retroviruses and Opportunistic Infections, Boston, February 22–25, 2005.
32. AIDS Vaccine Advocacy Coalition, “Will a Pill a Day Prevent HIV? Anticipating the Results of the Tenofovir ‘PREP’ Trials,” March 2005, 1.
33. Interview with John Wurzlemann, October 9, 2003.
34. Interview with Jay Brooks Jackson, October 10, 2003.
35. Seth Berkley, “Thorny Issues in the Ethics of AIDS Vaccine Trials,” The Lancet, September 20, 2003, 992.
36. Interview with Nadeem Rais, November 25, 2003.
37. TROUT Review Group, “How Do the Outcomes of Patients Treated with Randomized Control Trials Compare with Those of Similar Patients Treated Outside These Trials?” available at hiru.mcmaster.ca/ebm/trout.
38. Interview with Arthur Ammann, 2001.
39. Interview with Macé Schuurmans, November 13, 2003.
40. Pfizer correspondence with the Washington Post on Clinical Trials Series, available at www.pfizer.com/pfizerinc/about/press/trovanq&a.html.
41. Joe Stephens, “Where Profits and Lives Hang in Balance: Finding an Abundance of Subjects and Lack of Oversight Abroad, Big Drug Companies Test Offshore to Speed Products to Market,” Washington Post, December 17, 2000.
42. Interview with Macé Schuurmans, November 13, 2003.
43. Interview with Yash Lokhandwala, November 28, 2003.
44. E-mail correspondence with Mary Ngoma, January 24, 2005.
45. Interview with Yash Lokhandwala, November 28, 2003.
46. Interview with Solomon Benatar, November 11, 2003.
47. Interview with Leslie London, November 11, 2003.
Conclusion
1. Interview with Solomon Benatar, November 11, 2003.
Acknowledgments
Thanks first to Mark, Zakir, and Kush Bulmer, who supported me throughout the writing of this book. Hasmukh Shah, MD; Hansa Shah, MD; David Bulmer, MD; and Carolyn Bulmer provided much-needed encouragement and translation. Peter Lurie, MD; Anthony Arnove; Andy Hsiao; Esther Kaplan; and Gregg Weinberg, among others, helped develop the ideas in this book. Grateful thanks also to Gita and Babulin Shah in Mumbai and to Martin and Jessica McEwan in South Africa, as well as the many clinicians, investigators, ethicists
, activists, and patients who shared their stories with me.
Index
Abdullah v. Pfizer, 163
Abidjan, Côte d’Ivoire: HIV/AIDS conference in, 89–90, 94
Abraham, Edward, 129
academic research, 43–44, 57–60, 68, 171
access to drugs, posttrial, 137, 138, 170–71, 176
accountability: of drug industry, 176–78
acid reflux, 60
ACT UP, 80, 168
ACTG 076, and HIV/AIDS, 80–81, 82, 83, 86, 88, 89, 90
ADDRESS trial (Administration of Drotrecogin Alfa [Activated] in Early Severe Sepsis), 127–31
advertising, drug, 39, 45–46, 48–53, 55, 56–57, 61, 125–26, 128
Africa: and globalization of clinical trials, 7, 10–11, 13, 14; HIV/AIDS in, 82, 87, 90, 92, 93, 95, 167; and informed consent, 153; meningitis in, 144–46; and risk-benefit analysis, 167. See also specific nation
African Americans: as test subjects, 63, 64–67, 74–75, 77, 90, 94; rights of, 74. See also Tuskegee Syphilis Study
African National Congress (ANC), 101, 102–3
Agency for International Development, U.S., 82
AIDS. See HIV/AIDS
AIDS Clinical Trials Group (ACTG), 79, 80, 86–87
AIDS Vaccine Advocacy Coalition, 169, 170
albendazole, 29
Alinia. See nitazoxanide
Allegra. See fexofenadine
allergies, 133–34. See also specific drug
AMA Drug Evaluations, 56
American Heart Association (AHA), 59
American Journal of Bioethics, 162
American Medical Association (AMA), 42, 66, 71
Ammann, Arthur, 171–72
amphotericin B, 58
Angell, Marcia, 53, 58, 92, 93, 132
antibiotics, 38, 128, 145. See also trovafloxacin (Trovan)
antidepressants, 53
antihistamines, 49–50, 55. See also specific drug
antiretroviral drugs: and ethics, 139, 140, 141, 142; for HIV/AIDS, 22–29, 78–99, 102, 104, 105, 106, 107–8, 110–11; and placebo studies, 22–29; and risk-benefit analysis, 166–67, 171