The Body Hunters (39 page)

Clinical Solutions,
159

clinical trials: breadth of data about,
75
; conflicts of interest in,
83–85
; cost of,
4
,
5
,
8
,
9
,
47
,
96
; decline in U.S.–based,
7
; duration of,
4
,
47
; emergence of controlled,
6
; exclusion of pregnant women from,
41–42
; globalization of,
1–17
,
76
,
133
,
135–36
; guidelines for conducting in India,
113
; Indian incentives for industry-sponsored,
116–17
; legal codification of,
6
; public mistrust of,
4
,
154
; purpose of,
36–37
,
174–78
; reluctance of Americans to participate in,
3–5
,
9
; size and scope of,
41
,
161
; as time-consuming,
46
.
See also specific topic

clinics: incentives/money for,
158–59
,
172–73
; and risk-benefit analysis,
172–73

Clinton (Bill) administration,
102

Coca-Cola,
13
,
15

Cohen, Jon,
84
,
85

concentration camps,
69–71
,
77

conflict of interest,
18–19
,
137
,
158–61

Contergan.
See
thalidomide

continuing medical education,
55
,
56

contraceptives,
112
,
148

contract research organizations (CROs): emergence of,
6–7
; and globalization of clinical trials,
7
,
8
,
9
,
127
; and HIV/AIDS,
104
; and informed consent,
149
,
158–59
,
162
; and outsourcing to India,
117
; pool of potential subjects used by,
7
; reputation of,
36
; and risk-benefit analysis,
170
,
171

Coovadia, Hoosen,
82

Coovadia, Jerry,
94

Côte d'Ivoire,
88

Council for International Organization of Medical Sciences,
139

Covance,
6
,
9

Crestor.
See
rosuvastatin

Critical Care Medicine
(journal),
128

Croatia,
9
,
127

CROs.
See
contract research organizations

cryptosporidiosis.
See
nitazoxanide

CT scans,
9

Cymbalta.
See
duloxetine

Daily International Pharma Alert
,
116

Darder, Marta,
16–17

Declaration of Helsinki (1975),
75–76
,
77
,
92
,
132–34
,
135
,
136–39
,
140
,
146
,
168

Deeb, Mirryena,
102

DeMets, David L.,
46–47

dengue fever,
12

DeRosia, Dennis,
4

desloratadine (Clarinex),
60

diabetes,
8
,
14
,
33
,
118

Diamond, Aaron,
96

diarrhea,
116

Dickert, Neal,
157

DiGiorgio, Mark,
50

doctors.
See
physicians

Dole, Bob,
51

dosage, drug,
55–56

double-blind studies,
30

double standard,
132–43

DPT immunizations,
12

drotrecogin alfa (Xigris)
120–31

drug industry: accountability in,
176–78
; growth of,
36–61
; and independence of academic researchers,
57–60
; in India,
114–15
; multinational,
3
,
14–15
,
115
,
116
,
118
; physicians as checks on,
50–51
; pressure on physicians by,
55–57
; problems faced by,
3
; profits of,
39
,
79
,
120
,
176
; public confidence in,
178
; regulation of,
36–38
,
39
,
40–41
,
42
,
48
,
75
,
76
; reputation of,
37
,
38
,
39–41
,
42
; as special interest,
178
.
See also specific corporation or topic

Drug Information Association,
136–37

drugs: access to,
137
,
138
,
170–71
,
176
; adverse reactions to,
61
; cost of,
74
,
122–23
,
127
,
131
,
169
; essential,
60
,
141
; fake/substandard,
115
; illicit marketing of,
115
; pricing of,
38–39
; side effects of,
47
,
48–50
,
115
; withdrawal of approved,
42
,
48
.
See also specific drug

duloxetine (Cymbalta),
155–56

DuPont, Herbert,
27–28

Eastern Europe,
1–2
,
7
.
See also specific nation

effectiveness, drug,
41
,
46
,
50
,
56

Egypt,
28
,
33
,
127

Eichacker, Peter Q.,
126

Eli Lilly: blockbuster drugs from,
45
; and duloxetine (Cymbalta),
155–56
; incentives/money paid by,
155–56
; and informed consent,
155–56
; and outsourcing to India,
116
,
118
,
120–21
,
126–31
; prisoner studies of,
154
; problems faced by,
3
; and fluoxetine (Prozac),
45
,
53
,
121
; reputation of,
37
; and drotrecogin alfa (Xigris),
120–31

emtricitabine (Emtriva)
107–8

Emtriva.
See
emtricitabine

encainide,
47

Enkaid.
See
encainide

Epivir.
See
lamivudine

erectile dysfunction (ED),
51–53
,
60–61
,
118

esomeprazole (Nexium),
60

Estonia,
9
,
147–48

ethics: and accountability in drug industry,
178
; calibrating codes of,
132–43
; and double standard for poor subjects,
132–43
; and globalization of clinical trials,
133
,
135–36
; and HIV/AIDS,
91
,
93
,
95
,
96
; and informed consent,
71
,
137
,
142
,
143
,
152
,
153
,
156–58
; as limitation on clinical studies,
175
; and main purpose of medical research,
177
; and outsourcing to India,
112
,
113
,
114
,
117–18
,
120
; and placebo studies,
18–19
,
133
,
134
,
137
,
139
,
141
; and principles governing clinical trials,
70–76
; and risk-benefit analysis,
173–74
; and substandard care,
132
,
140–41
.
See also
“Declaration of Helsinki” (1975)
;
Nuremberg Code

European Group on Ethics in Science and New Technologies,
139

experimentation: in ancient times,
5–6
; depersonalization of,
178
; therapy differentiated from,
158–59
,
161
.
See also
clinical trials

Eyetech,
5

Faden, Ruth,
132
,
165

fast food,
13

Fauci, Anthony,
84

Femara.
See
letrozole

Fernald School (Massachusetts): children as test subjects in,
67–68

fertility,
113

fexofenadine (Allegra)
49–50

flecainide (Tambocor),
47

Fleming, Thomas R.,
46–47

fluconazole,
58

fluoxetine (Prozac),
45
,
53
,
121
,
155

Food and Drug Administration (FDA), U.S.: and accountability in drug industry,
177–78
; and advertising,
48–50
; approval of foreign investigators by,
7
; compassionate use program of,
21
; criticisms of,
46
; and Declaration of Helsinki,
133–34
,
135
; and ethics,
132
,
133–34
,
135
,
137
; flexibility for approval by,
46–47
; and globalization of clinical trials,
3
,
7
; and HIV/AIDS,
78
,
81
,
106
,
109–10
; increase in applications to,
43
; and informed consent,
156–57
,
162–63
; and legislation of 1962,
41
; and main purpose of clinical trials,
176
; and “me-too” drugs,
53
,
55
,
60
; and outsourcing to India,
113
,
119
; placebo-controlled studies as preferred by,
32
; and risk-benefit analysis,
171
; safety and effectiveness proof for approval by,
41
; standards/guidelines of,
3
,
58
,
133–34
,
135
,
176
,
177–78
; streamlining of review process by,
44
,
47–48
; and weakening of regulations,
46
; withdrawal of drugs approved by,
42
,
48
.
See also specific person or drug

Food and Drug Act (1906),
37

Food and Drug Act (1962),
40–41
,
42
,
154

Food, Drug and Cosmetic Act (1938),
38

foreign investigators: FDA approval of,
7

Fost, Norman,
94

Framingham Heart Study,
45

France,
130

Francis, Don,
85
,
96

Fromell, Greg,
6

Furberg, Curt,
59

Gallo, Robert,
82
,
101

Garrett, Laurie,
12
,
78

Gates (Bill and Melinda) Foundation,
165–66
,
167

Gay Men's Health Crisis,
142

Gazi, Costa,
102

Gelles, Jonathan,
79

Gelsinger, Jesse,
160

Genentech,
4
,
43
,
83–84
,
105
,
161

generic drugs,
44
,
102
,
111
,
116
,
123

genetics revolution,
42
,
57

Germany,
69–71
,
73
,
77
,
130

Ghana,
12
,
167

Gilead Sciences,
107–8
,
167–70

Gish, Oscar,
11

GlaxoSmithKline,
8
,
9
,
115
,
116
,
118
,
137
,
154
.
See also
AZT

Global Campaign for Microbicides,
169

globalization: of clinical trials,
1–17
,
76
,
133
,
135–36

gonorrhea,
67

Gore, Al,
98

government experiments: and humans as test subjects,
67–72
.
See also specific government

gp120 vaccine,
83–84
,
85
,
96

Grady, Christine,
157

Groote Schur Hospital (Cape Town, South Africa),
17
,
101

Guerrini, Anita,
70