The Body Hunters (37 page)

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.

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.

 

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.