The Body Hunters
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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.”
61. Johns Hopkins Medical Institutions Office of Communications and Public Affairs press release, “Brooks Jackson Named New Director of Hopkins Pathology,” September 28, 2001.
62. Marc Lallemant et al., correspondence, “Ethics of Placebo-Controlled Trials of Zidovudine to Prevent the Perinatal Transmission of HIV in the Third World,” New England Journal of Medicine, March 19, 1998; Marc Lallemant et al., “A Trial of Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of Human Immunodeficiency Virus Type 1,” New England Journal of Medicine, October 5, 2000.
63. Elliot Marseille et al., “Cost Effectiveness of Single-Dose Nevirapine Regimen”; Adriana M. Campa et al., correspondence, “HIVNET Nevirapine Trials,” The Lancet, November 20, 1999.
6: South Africa: Drug Trials and AIDS Denialism
1. Mannfred A. Hollinger, Introduction to Pharmacology (Philadelphia: Taylor & Francis, 1997), 9–10.
2. Audrey R. Chapman and Leonard S. Rubenstein, eds., Human Rights and Health: The Legacy of Apartheid (Washington, DC: American Association for the Advancement of Science, 1998), 17.
3. Samantha Power, “The AIDS Rebel,” New Yorker, May 19, 2003, 54–67, 59.
4. Roy Porter, The Greatest Benefit to Mankind: A Medical History of Humanity (New York: W.W. Norton, 1997), 621.
5. Chapman and Rubenstein, eds., Human Rights and Health, 18–19, 43–54.
6. Ibid., 25–34, 40, 42, 109.
7. R.J. Biggar et al., “Regional Variation in Prevalence of Antibody Against Human T-Lymphotropic Virus Types I and III in Kenya, East Africa,” International Journal of Cancer, June 15, 1985, 763–67.
8. Laurie Garrett, The Coming Plague: Newly Emerging Diseases in a World Out of Balance (New York: Penguin Books, 1994), 355–58.
9. Paul Farmer, Infections and Inequalities: The Modern Plagues (Los Angeles: University of California Press, 1999), 122.
10. Lawrence K. Altman, “Linking AIDS to Africa Provokes Bitter Debate,” New York Times, November 21, 1985, A1.
11. Power, “The AIDS Rebel.”
12. Interview with Costa Gazi, September 11, 2003.
13. Chris McGreal, “Dying for Drugs: South Africa’s Sick Wait for Judgment Day: Multinationals Go to Court Today over a Law Aimed at Cutting the Cost of Medicines,” The Guardian, March 5, 2001, 16.
14. Tom Cohen, “Claims of Breakthrough in AIDS Treatment Questioned,” Associated Press, January 22, 1997; Power, “The AIDS Rebel.”
15. “National Party Urges Sacking of Health Minister over AIDS Drug Issue,” BBC Summary of World Broadcasts, February 7, 1997; Jack Lundin, “Nothing to Write Home About: Virodene,” Financial Mail (South Africa), April 24, 1998.
16. Power, “The AIDS Rebel.”
17. Chapman and Rubenstein, eds., Human Rights and Health, 78.
18. Interview with Costa Gazi, September 11, 2003; Power, “The AIDS Rebel.”
19. The Anglo American program was plagued by delays and criticisms from union and AIDS activists. At first, workers feared the company would discriminate against them if they tested positive for HIV. “The mining industry has been very brutal and you can’t expect confidence and trust that workers will not face dismissal if they test positive with HIV,” said Welcome Mboniso, a miners union representative. Hundreds of workers die every year in mine accidents, he said. “It’s already a killer industry.” By 2005, Anglo American was providing free antiretroviral therapy to 2,000 of its employees in sub-Saharan Africa. Terry Macalister, “They Dare Not Speak Its Name,” The Guardian, October 9, 2003; Lauren Mills, “Hope Amid an Appalling Epidemic,” Financial Times, July 29, 2005; www.unaids.org/en/geographical+area/by+country/south+africa.asp.
20. “New Report Estimates HIV/AIDS Drug Market Will Triple in Value from $5 Billion in Annual Sales to $13 Billion in 2007,” HIVandhepatitis.com, July 23, 2001.
21. Interview with Keymanthri Moodley, November 11, 2003.
22. Interview with Simon Yaxley, January 2002.
23. Interview with Caroline Loew, January 2002.
24. Penni Crabtree, “Tragedy Gave Boost to San Diego Biotech Firm’s Push for Drug Approval,” San Diego Union-Tribune, May 16, 2002.
25. “Hollis Eden Pharmaceuticals: Richard Hollis,” San Diego Magazine, February 2001, 134.
26. Simon Barber, “US Aids Drug to Be Tested on SA Subjects,” Business Day, October 2, 1998, 1.
27. John S. James, “HE2000 Begins Clinical Trials,” The Body, June 4, 1999.
28. Crabtree, “Tragedy Gave Boost.”
29. Public Citizen press release, “Company Loses Second Bid to Silence Stockholder Who Posted Critical Comments on Web,” October 26, 2001.
30. Crabtree, “Tragedy Gave Boost.”
31. Joseph Radford, “Combating HIV,” Corporate Africa, Summer 2001.
32. Interview with Bob Marsella, September 10, 2003.
33. Hollis-Eden Pharmaceuticals Annual Report 2004, 4.
34. Interview with Keymanthri Moodley, November 11, 2003.
35. Andrew Pollack, “U.S. Approves New Once-a-Day AIDS Drug from Glaxo Rival,” New York Times, July 3, 2003.
36. “Sixth Patient Dies in Suspended AIDS Trials,” South African Press Association, April 23, 2000; “Might Be Impossible to Say if Nevirapine Killed 5 Women,” South African Press Association, April 10, 2000; “Lack of AIDS Drugs for Poor Makes SA Ripe for Exploitation: Gazi,” South African Press Association, April 24, 2000.
37. Interview with Costa Gazi, September 11, 2003.
38. “Sixth Patient Dies in Suspended AIDS Trials,” South African Press Association; “Might Be Impossible to Say if Nevirapine Killed 5 Women,” South African Press Association; “Lack of AIDS Drugs for Poor Makes SA Ripe for Exploitation,” South African Press Association.
39. Ian Sanne et al., “Severe Hepatotoxicity Associated with Nevirapine Use in HIV-Infected Subjects,” Journal of Infectious Diseases, March 15, 2005, 825–29.
40. Treatment Action Campaign press release, “MCC Decision to Deregister Nevirapine for Mother-to-Child Transmission Prevention Is Disturbing and Confusing,” July 31, 2003.
41. Power, “The AIDS Rebel.”
42. Mike Cohen, “South African Government Launches New Attack on Drug Companies,” Associated Press, April 5, 2000.
43. “BI Offers Free Viramune to Developing Countries,” Pharma Marketletter, July 7, 2000.
44. “Leave Them Be,” The Economist, April 6, 2002.
45. Interview with Bob Marsella, September 19, 2003.
46. Adele Baleta, “South African Court Again Tells Government to Increase Access to AIDS Drug,” The Lancet, March 30, 2002, 1132.
47. Interview with Jay Brooks Jackson, October 10, 2003.
48. The National Institute of Allergy and Infectious Diseases shut the site down and commenced a lengthy, fifteen-month-long audit. According to a review by NIAID, “certain aspects of the collection of primary data may not conform to FDA regulatory requirements.” National Institute of Allergy and Infectious Diseases press release, “Review of HIVNET 012,” March 22, 2002; National Institute of Allergy and Infectious Diseases Division of AIDS, HIVNET 012 Monitoring Report, March 2003, 10, 46, 49; John Solomon, “Top U.S. Officials Warned of Concerns Before AIDS Drug Sent to Africa,” Associated Press, December 13, 2004.
49. Henry J. Kaiser Family Foundation, “South African Medicines Control Council Calls for Alternate Nevirapine Efficacy Data in 90 Days, Could Ban Use of Drug,” August 1, 2003.
50. Treatment Action Campaign, “MCC Decision to Deregister Nevirapine”; “Nevirapine Deadline Extended to 6 Months,” Cape Argus, September 16, 2003.
51. “Outrage as Medicines Control Council Rejects Results of Nevirapine Trials,” South African Medical Association News, July 30, 2003.
52. “Manto Defends Herbal Research in the Fight Against Aids,” South African Broadcasting Corporation, July 24, 2003.
53. Power, “The AIDS Rebel.”
54. Jeremy Laurance, “The Bombay Copycats Who Sold Treatment for $1 a Day,” The Independent, April 20, 2001, 17.
55. Robert Radtke, “India Must Steer a Middle Path on Generic Drugs,” Financial Times, March 24, 2005, 13.
56. David Pilling, “Activists Jubilant in S Africa Drugs Case,” Financial Times, April 20, 2001, 9.
57. “Government Makes Dramatic AIDS Pledge,” The Star, August 7, 2003, 1. The battle to tackle AIDS in South Africa had hardly been won: according to a June 2005 World Health Organization report, just 104,600 of more than 800,000 South Africans in need of antiretroviral therapy had access to it. See www.who.int/3by5/support/june2005_zaf.pdf.
58. Donald G. McNeil, “Africans Outdo U.S. Patients in Following AIDS Therapy,” New York Times, September 3, 2003, 1.
7: Outsourcing to India: The One Billion Body Politic
1. Alix M. Freedman, “Population Bomb: Two Americans Export Chemical Sterilizations to the Third World,” Wall Street Journal, June 18, 1998, A1.
2. Sanjay Kumar, “Sterilization by Quinacrine Comes under Fire in India,” The Lancet, May 17, 1997.
3. Laxmi Murthy, “Contraceptive Research: Need for a Paradigm Shift,” One India, One People, July 2001, 18–20.
4. M.D. Gupte and D.K. Sampath, “Ethical Issues Considered in Tamil Nadu Leprosy Vaccine Trial,” Indian Journal of Medical Ethics, January/March 2000.
5. Amit Sen Gupta, “Research on Hire,” Indian Journal of Medical Ethics, October/December 2001.
6. Ganapati Mudur, “Johns Hopkins Admits Scientist Used Indian Patients as Guinea Pigs,” BMJ, November 24, 2001, 1204.
7. Chandra Gulhati, “Illegal Trials on Letrozole: Hundreds of Women Used as Guinea Pigs,” Monthly Index of Medical Specialties India, December 2003.
8. Jeetha D’Silva and Vikram Doctor, “Clinical Trials in Dock as Guinea Pigs Fail the Test,” Economic Times, March 11, 2004.
9. Interview with Amar Jesani, November 25, 2003.
10. Shabnam Minwalla, “Many Doctors Rely on Skewed Data,” Times of India, September 18, 2003.
11. “UN Raps India for Missing Literacy Deadline,” Hindustan Times, November 9, 2005.
12. Ganapati Mudur, “Inadequate Regulations Undermine India’s Health Care,” BMJ, January 17, 2004, 124.
13. Manidipa Mukherjee, “In the Dock,” Humanscape, March 1997, 29.
14. Interview with Amar Jesani, November 25, 2003.
15. P.K. Sarkar, “A Rational Drug Policy,” Indian Journal of Medical Ethics, January/March 2004.
16. Nobhojit Roy, “Who Rules the Great Indian Drug Bazaar?” Indian Journal of Medical Ethics, January/March 2004.
17. Poornima Joshi, “The Cost of Falling Ill,” Hindustan Times, March 18, 2001.
18. Monobina Gupta, “Tuberculosis Drugs Head Spurious List,” The Telegraph (Calcutta), August 4, 2003.
; 19. Arindam Mukherjee, “Pills That Kill,” Outlook, September 22, 2003, 52.
20. Daniel Pearl and Steve Stecklow, “Drug Firms’ Incentives Fuel Abuse by Pharmacists,” Indian Express, August 17, 2001, reprinted from Wall Street Journal.
21. Chandra Gulhati, “Irrational Fixed-Dose Combinations: A Sordid Story of Profits Before Patients,” Indian Journal of Medical Ethics, January/March 2003.
22. Mukherjee, “Pills That Kill.”
23. Chandra Gulhati, “Illegal, Unethical Promotion Hits New Highs,” Monthly Index of Medical Specialties India, posted to e-drug list, April 1, 2004.
24. S.M. Moazzem Hossain, “Community Development and Its Impact on Health: South Asian Experience,” BMJ, April 3, 2004, 830–31.
25. Anita K.M. Zaidi et al., “Burden of Infectious Diseases in South Asia,” BMJ, April 3, 2004, 811.
26. Ganapati Mudur, “Hospitals in India Woo Foreign Patients,” BMJ, June 5, 2004, 1338.
27. FDA News, “New Indian Patent Law Heralds Multinationals’ Return,” Daily International Pharma Alert, January 31, 2005.
28. FDA News, “Drug Majors Anticipate Final Approval for India’s Patent Reform,” Daily International Pharma Alert, January 25, 2005.
29. James Love, “Options to Traditional Patents,” Financial Express, April 6, 2005.
30. Narayan Kulkarni, “The Trials Leader,” Biospectrum, June 10, 2003.
31. Interview with Ken Getz, October 2003.
32. “Lifting India’s Barriers to Clinical Trials,” CenterWatch, August 2003, 1.
33. D’Silva and Doctor, “Clinical Trials in Dock.”
34. Sandhya Srinivasan, “Discussion on Biomedical Research on Humans in India: A Short Review,” Achutha Menon Centre for Health Science Studies and Sree Chitra Tirunal Institute for Medical Sciences and Technology, October 2000, 14.
35. D’Silva and Doctor, “Clinical Trials in Dock.”
36. “Lifting India’s Barriers to Clinical Trials,” CenterWatch, 6.
37. Atul Gawande, “Dispatch from India,” New England Journal of Medicine, December 18, 2003, 2383–86.
38. Interview with Nadeem Rais, November 25, 2003.