The Body Hunters (38 page)

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.

 

1
. Interview with Solomon Benatar, November 11, 2003.

 

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.

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

APACHE II (Acute Physiology and Chronic Health Evaluation),
124–25
,
127

Applied Clinical Trials
(journal),
149

Argentina,
12
,
127

arthritis,
58

Asia: and globalization of clinical trials,
7
,
9
,
10–11
,
12
; HIV/AIDS in,
82
,
92
,
167
; and risk-benefit analysis,
167
.
See also specific nation

Association for Consumers' Action on Safety and Health,
113

asthma,
14

AstraZeneca,
9
,
55
,
56
,
60
,
137

Atomic Energy Commission,
67–68

atorvastatin (Lipitor),
53

Australia,
22
,
40
,
68–69

Avorn, Jerry,
31

Ayers, Marc,
20
,
21

AZT (Retrovir).
See
zidovudine

bacterial infections,
38

Bahlman, Bill,
22

Bal, Arun,
113

Bangladesh,
148

Baraff, Larry,
152–53
,
162

Bayer,
37
,
55
,
56

Bayh-Dole Act,
43

Baycol.
See
cerivastatin

Beckerman, Karen,
140

Beecher, Henry K.,
73

Belgian Congo,
72

Belmont Report,
75
,
76
,
154

Benatar, Solomon,
153
,
166
,
173–74
,
175–76

Berkley, Seth,
171

Bernard, Claude,
62–63

Bernard, Gordon,
123
,
126

“best proven” methods,
77
,
97–98
,
133
,
138
,
141
,
153
,
168

Biggar, Robert,
101

biotech revolution,
42

birth defects,
41–42
.
See also
thalidomide (Contergan)

Black, Robert,
34

blockbuster drugs,
45
,
46–47
,
51–53
,
61
.
See also specific drug

blood pressure,
47
,
59

Bodenheimer, Thomas,
6
,
158

Boehringer Ingelheim,
15
,
86
,
108
,
109
,
156–57

Botswana,
111
,
167

Boyd, Mark,
64

Boyer, Herbert,
42–43

Brazil,
9
,
11
,
15
,
127
,
148

breast cancer,
1
,
161

Bristol-Myers Squibb,
47
,
53
,
152
,
154

British Medical Journal
,
114
,
128
,
138

Bulgaria,
9

buprenorphine (Subutex),
141

Buxton, Peter J.,
74

calcium channel blockers,
59

Cambodia,
166–67
,
168

Cameroon,
167
,
168
,
169

Canada,
130

cancer: failure in research about,
5
; and globalization of clinical trials,
5
,
8
; and humans as test subjects,
73
; and informed consent,
160
,
161
; reluctance of Americans to participate in trials for,
4
,
5
; and risk-benefit analysis,
165
; “war” on,
165
.
See also type of cancer

cardiovascular disease,
1
,
8
,
14
,
41
,
44
,
45
,
165

ceftriaxone (Rocephin),
146
,
152

Center for AIDS Prevention Studies,
89
,
95

Centers for Disease Control (CDC): and HIV/AIDS,
78
,
81
,
88
,
89
,
90–91
,
94
,
95
,
97
,
111
; and humans as test subjects,
73–74
; and risk-benefit analysis,
167
,
168
,
170

Centers for Medicare and Medicaid,
126

CenterWatch,
3
,
8
,
118
,
149

Centocor,
121–22

Centoxin,
121–22

cerebrovascular diseases,
165

cerivastatin (Baycol),
53
,
55

cervical cancer,
1

cetirizine (Zyrtec)
50

Chemie Grunenthal,
39
,
40

children: and ethics,
134
; and HIV/AIDS,
26–29
,
32–33
,
34
,
85
,
93–94
,
101
; as test subjects,
67–68
,
72
,
73
,
77
; in India,
116
; and informed consent,
146
,
152
,
157
,
163
; lung-impaired,
134
; and meningitis,
144–46
,
152
,
163
; in Nigeria,
144–46
,
152
,
163
; and nitazoxanide-placebo study,
26–29
,
32–33
,
34
; sulfa deaths of,
38
; in Zambia,
26–29
,
32–33
,
34
.
See also
pregnant women

Chile,
9
,
127

China,
14
,
69
,
117
,
140–43
,
149
,
152

Chiron,
116

chloramphenicol,
146

cholera,
12
,
69
,
145

cholesterol,
45
,
47
,
53
,
55

Chotchatmala, Wivat,
149

Chowpatty Medical Centre (CMC) (India),
118–19

cimetidine (Tagamet),
45

Cipla,
15

Clarinex.
See
desloratadine

Claritin.
See
loratadine

Clark, Taliaferro,
64