Authors: Sonia Shah
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.
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1
. Mannfred A. Hollinger,
Introduction to Pharmacology
(Philadelphia: Taylor & Francis, 1997), 9â10.
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, 54â67, 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
, 18â19, 43â54.
6
. Ibid., 25â34, 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, 763â67.
8
. Laurie Garrett,
The Coming Plague: Newly Emerging Diseases in a World Out of Balance
(New York: Penguin Books, 1994), 355â58.
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, 825â29.
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.
Â
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, 18â20.
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.”