The Body Hunters (33 page)

34
. Guerrini,
Experimenting with Humans and Animals
, 123–28.

35
. Moreno,
Undue Risk
, 132–33, 154.

36
. Joel D. Howell and Rodney A. Hayward, “Writing Willow-brook, Reading Willowbrook,” in Goodman, McElligot, and Marks, eds.,
Useful Bodies
, 193.

37
. Reporter Geraldo Rivera exposed the appalling conditions at Willowbrook in a 1972 television program, ultimately leading to a class-action lawsuit. Shaila K. Dewan, “Recalling a Victory for the Disabled,”
New York Times
, May 3, 2000, 5; Margaret Engel, “Care for the Mentally Retarded: A Case History,”
Washington Post
, December 30, 1984.

38
. Merck later capitalized on Krugman's work by developing a hepatitis B vaccine, which they tested on their own executives. In a wry comment on Krugman's trials a Merck scientist joked in 1975 that the company had “picked the most worthless people we could find in the world who would be the least likely to sue.” If Merck hadn't, Krugman certainly had. Jon Cohen,
Shots in the Dark: The Wayward Search for an AIDS Vaccine
(New York: W.W. Norton, 2001), 79; David J. Rothman,
Strangers at the Bedside:
A History of How Law and Bioethics Transformed Medical Decision Making
(New York: Basic Books, 1991), 77.

39
. Guerrini,
Experimenting with Humans and Animals
, 139, citing Henry Beecher, “Ethics and Clinical Research,”
New England Journal of Medicine
264 (1966): 1354–60; Howell and Hayward, “Writing Willowbrook, Reading Willowbrook,” 192.

40
. Reverby, ed.,
Tuskegee's Truths
, 103.

41
. Elizabeth W. Etheridge, “Historical Perspectives: History of CDC,”
Morbidity and Mortality Weekly Report
, June 28, 1996, 526–30, at
www.cdc.gov/epo/mmwr/preview/mmwrhtml/00042732.htm
.

42
. Reverby, ed.,
Tuskegee's Truths
, 15, 26, 411.

43
. Ibid., 152–54.

44
. U.S. Bureau of Census, “National Health Expenditures—Summary, 1960 to 1999, and Projections, 2000 to 2010,”
Statistical Abstract of the U.S.: 2001
, Washington, DC, January 2002, 91.

45
. Paul Starr,
The Social Transformation of American Medicine: The Rise of a Sovereign Profession and the Making of a Vast Industry
(New York: Basic Books, 1982), 381–82, 409, citing “It's Time to Operate,”
Fortune
, January 1970, 79, and Ivan Illich,
Medical Nemesis: The Expropriation of Health
(New York: Pantheon, 1976).

46
. Some sections of the medical community, however, were not nearly so provoked. An editorial in the October 1972 issue of the
Southern Medical Journal
condemned the “irresponsible press”: “In complete disregard of their abysmal ignorance, members of the fourth estate bang out anything on their typewriters which will make headlines,” the editorial fumed. “If the men having latent syphilis . . . had been
forced
to take adequate treatment (60 or more weekly doses of a metal [mercury]), cardiovascular syphilis might have been avoided in most. In our free society, antisyphilitic treatment has never been forced. Since these men did not elect to obtain treatment available to them, the development of aortic disease lay at the subject's door and not in the Study's protocol.” Reverby, ed.,
Tuskegee's Truths
, 2, 177, 199; Vernal G. Cave, “Proper Uses and Abuses of the Health Care Delivery System for Minorities, with Special Reference to the Tuskegee Syphilis Study,”
Journal of the National Medical Association
67 (1975), reprinted in Reverby, ed.,
Tuskegee's Truths
, 399.

47
. Reverby, ed.,
Tuskegee's Truths
, 229; Garrett,
Betrayal of Trust
, 322

48
. Guerrini,
Experimenting with Humans and Animals
, 141–47.

49
. World Medical Association, “Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects,” available at
www.wma.net
.

50
. U.S. Food and Drug Administration,
Guidance for Industry: Acceptance of Foreign Clinical Studies
, March 2001; also
Code of Federal Regulations Title 21
, vol. 5, April 2005, 21CFR312.120; National Institutes of Health,
Guidelines for the Conduct of Research Involving Human Subjects
, August 2001.

 

1
. World Medical Association, “Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects,” available at
www.wma.net
.

2
. Laurie Garrett,
The Coming Plague: Newly Emerging Diseases in a World Out of Balance
(New York: Penguin Books, 1994), 302.

3
. Philip J. Hilts,
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
(New York: Alfred A. Knopf, 2003), 242.

4
. “As a profession, we doctors are not only determined, but also somewhat obsessed with primacy,” one commentator later noted, drily. “To the victors belongs more than mere mention in a medical textbook; discovering something first may be a medical investigator's best shot at immortality.” Howard Markel, “‘Who's on First?'—Medical Discoveries and Scientific Priority,”
New England Journal of Medicine
, December 30, 2004, 2792–93. See also Jon Cohen,
Shots in the Dark: The Wayward Search for an AIDS Vaccine
(New York: W.W. Norton, 2001), 18.

5
. Cohen,
Shots in the Dark
, 41.

6
. Mark Simpson, “Angry with a Capital A,”
The Guardian
, June 19, 1995, T42.

7
. Barnaby J. Feder, “Drug Expected to Spur Growth and Profit of Its Maker,”
Washington Post
, September 6, 1988; editorial, “AZT's Inhuman Cost,”
New York Times
, August 28, 1989, 16.

8
. Interview with Jay Brooks Jackson, October 10, 2003.

9
. Susan Okie, “Testing of New AIDS Drugs Beset by Conflicting Demands,”
Washington Post
, September 6, 1988.

10
. Richard Lynn and G. Harold Mehlman, “Why ACT UP Did What It Did,”
Washington Post
, June 2, 1990, A17.

11
. Okie, “Testing of New AIDS Drugs Beset by Conflicting Demands.”

12
. Jay Brooks Jackson et al., “HIVNET 012: A Phase III Placebo-Controlled Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates,” National Institute of Allergy and Infectious Disease IND#49,991 study protocol, June 5, 1997.

13
. Peter Lurie and Sidney Wolfe, “Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries,”
New England Journal of Medicine
, September 18, 1997.

14
. Interview with Peter Lurie, October 9, 2003.

15
. U.S. Public Health Service Task Force on the Use of Zidovudine to Reduce Perinatal HIV Transmission, “Recommendations of the U.S. Public Health Service Task Force on the Use of Zidovudine to Reduce Perinatal Human Immunodeficiency Virus,”
Morbidity and Mortality Weekly Report
, August 5, 1994, 1–20.

16
. See
www.fda.gov/ohrms/dockets/ac/03/transcripts/3932T1.htm
.

17
. See
www.fda.gov/oashi/aids/miles91.html
.

18
. Viramune (nevirapine) patient information, available at
www.viramune.com/PatientInfo/
.

19
. Brian Vastag, “Helsinki Discord? A Controversial Declaration,”
JAMA
, December 20, 2000, 2984.

20
. Donald G. McNeil, “Africans Outdo U.S. Patients in Following AIDS Therapy,”
New York Times
, September 3, 2003, 1.

21
. Ibid.

22
. Ira Flatow, “Talk of the Nation Science Friday: Medical Ethics, School Computers,” National Public Radio transcript, September 26, 1997.

23
. Elliot Marseille et al., “Cost Effectiveness of Single-Dose Nevirapine Regimen for Mothers and Babies to Decrease Vertical HIV-1 Transmission in Sub-Saharan Africa,”
The Lancet
,

September 4, 1999; letter from Neal Halsey to Harold Varmus, May 6, 1997.

24
. World Health Organization, “Recommendations from the Meeting on Mother-to-Infant Transmission of HIV by Use of Antiretrovirals,” Geneva, June 23–25, 1994; letter from Neal Halsey to Harold Varmus, May 6, 1997; Sheryl Gay Stolberg, “Placebo Use Is Suspended in Overseas AIDS Trials,”
New York Times
, February 19, 1998, 16.

25
. Peter Lurie et al., “Ethical, Behavioral, and Social Aspects of HIV Vaccine Trials in Developing Countries,”
JAMA
, January 26, 1994.

26
. Interview with Peter Lurie, October 9, 2003.

27
. Cohen,
Shots in the Dark
, 248.

28
. Ibid., 243, 161–65.

29
. Ibid., 261, 268–69.

30
. Ibid., 266.

31
. Ibid., 69.

32
. Peter Wehrwein and Kelly Morris, “HIV-1-Vaccine-Trial Go-Ahead Reawakens Ethics Debate,”
The Lancet
, June 13, 1998, 1789.

33
. Interview with Jay Brooks Jackson, October 10, 2003; Anne Bennett Swingle, “The Pathologist Who Struck Gold,”
Hopkins Medical News
, Spring/Summer 2001.

34
. Swingle, “The Pathologist Who Struck Gold.”

35
. Brooks Jackson et al., “HIVNET 012.”

36
. Ibid.

37
. Interview with Jay Brooks Jackson, October 10, 2003.

38
. Stefan Z. Wiktor et al., “Short-Course Oral Zidovudine for Prevention of Mother-to-Child Transmission of HIV-1 in Abidjan, Cote d'Ivoire: A Randomized Trial,”
The Lancet
, March 6, 1999, 781–85; Nathan Shaffer et al., “Short-Course Zidovudine for Perinatal HIV-1 Transmission in Bangkok, Thailand: A Randomized Controlled Trial,”
The Lancet
, March 6, 1999, 773.

39
. Catherine Wilfert et al., “Science, Ethics, and Future of Research into Maternal Infant Transmission of HIV-1,”
The Lancet
, March 6, 1999, 832.

40
. Interview with Peter Lurie, October 8, 2003.

41
. Esther Iverem, “The Silent Treatment,”
Washington Post
, February 22, 1997, H1.

42
. Interview with Peter Lurie, October 8, 2003.

43
. Lurie and Wolfe, “Unethical Trials of Interventions,” 853–56.

44
. Marcia Angell, “The Ethics of Clinical Research in the Third World,”
New England Journal of Medicine
, September 18, 1997, 847–49; Sheryl Gay Stolberg, “U.S. AIDS Research Abroad Sets Off Outcry over Ethics,”
New York Times
, September 18, 1997, A1.

45
. Jonathan Bor, “Editorial Writer Heard 'Round Medical World,”
Baltimore Sun
, October 26, 1997.

46
. Correspondence from Neal A. Holtzman to Sidney Wolfe, October 14, 1997.

47
. Flatow, “Talk of the Nation Science Friday.”

48
. Interview with Jonathan D. Moreno, March 21, 2005.

49
. Neal Halsey et al., “Ethics and International Research: Research Standards Are the Same Throughout the World; Medical Care Is Not,”
BMJ
, October 18, 1997.

50
. Wilfert et al., “Science, Ethics, and Future of Research,” 832–35.

51
. Shaffer et al., “Short-Course Zidovudine,” 773–79; Wiktor et al., “Short-Course Oral Zidovudine.”

52
. Jonathan Bor, “Ethics of AIDS Trials Is Debated,”
Baltimore Sun
, September 18, 1997.

53
. Wilfert et al., “Science, Ethics, and Future of Research,” 832–35.

54
. UNAIDS, “Ethical Considerations in HIV Preventive Vaccine Research, guidance document, May 2000, cited in World Medical Association, “Workgroup Report on the Revision of Paragraph 30 of the Declaration of Helsinki,” September 2003.

55
. Lurie joined Sidney Wolfe at Public Citizen. Marcia Angell was forced out of the editor's chair at the
New England Journal of Medicine
in 2000, amid “heated disagreements” over commercializing the journal. Michele Kurtz, “A Guiding Light at the New England Journal,”
Boston Globe
, July 6, 2004, D8.

56
. Cohen,
Shots in the Dark
, 276, 286, 348–49

57
. Ibid., 354.

58
. Interview with Peter Lurie, October 2003.

59
. Interview with Jay Brooks Jackson, October 10, 2003.

60
. Swingle, “The Pathologist Who Struck Gold.”