The Body Hunters (41 page)

Manthorpe, Jonathan,
26

March of Dimes,
31
,
32

marketing
See
advertising, drug

Massachusetts General Hospital,
72

Massachusetts Male Aging Study,
51

Massengill,
38

Mbeki, Thabo,
103–4
,
108

McClellan, Mark,
3
,
60

McDonald's,
13

MDS Pharma,
105

“me-too” drugs,
53–54
,
55–56
,
60
,
61
,
133
,
134
,
137
,
177
,
178

measles,
101
,
116
,
145

Médecins Sans Frontières,
144
,
169

media: and Psaty studies,
59

medical boards,
56

medical research: cost of,
53
; limitations on,
175
; main purpose of,
175–78
; “side effects” of,
175
,
176
; tenets of,
30
.
See also
clinical trials

medical schools: in India,
113–14

medical services: in India,
115–16

medical techniques: cost of,
74

medicine: advances in,
11
; arrogance of,
74–75
; faith in,
74
; inferiority of American,
74

medicines: as social goods,
178

Medicines Act (South Africa, 1997),
102

melanoma,
160

meningitis,
144–46
,
150
,
152–53

mental illness,
8

Merck,
3
,
37
,
45
,
46
,
53
,
116
,
137

methadone,
141

Mevacor.
See
lovastatin

Mexico,
9
,
20
,
34
,
127

Middle East,
14

Mitchell, Allen A.,
42

Moi, Daniel arap,
101–2

Moodley, Keymanthri,
107

Moore, John P.,
96
,
142

Moreno, Jonathan D.,
67
,
68
,
94
,
150–51
,
163

Morocco,
135

MRIs,
9

Mulago Hospital (Kampala, Uganda),
86
,
87
,
109–10

multinational drug corporations.
See
drug industry
;
specific corporation

Munford, Robert S.,
126

Myers, Maureen,
79

National Bioethics Advisory Commission (NBAC),
135–36
,
139
,
147
,
148
,
149
,
151
,
164–65

National Cancer Institute,
79

National Heart, Blood, and Lung Institute,
59

National Institute of Allergy and Infectious Diseases,
84
,
88

National Institutes of Health (NIH): budget of,
38
; and ethics,
135–36
,
141
,
142
; functions of,
38
;
Guidelines for the Conduct of Research Involving Human Subjects
of,
61
; and HIV/AIDS,
21–22
,
23
,
31
,
78
,
84
,
85
,
87
,
93
,
95
,
96
,
98
,
101
; and independence of academic researchers,
57
; and nitazoxanide-placebo study,
21–22
,
23
,
31
; and risk-benefit analysis,
167
; as source of funding,
47
,
51
,
57

National Research Act (1974),
75

National Research Council,
42

Native Americans: as test subjects,
72

Neeman Medical International,
9

nevirapine (Viramune),
86
,
87
,
97–99
,
104
,
107
,
108
,
109
,
110
,
139–142
,
166

New England Journal of Medicine
: and ethics questions,
73
,
92
,
157
; and humans as test subjects,
73
; and informed consent,
158
; and marketing of drugs,
53
,
57
,
58
,
60
; and “me-too” drugs,
53
; and Psaty's study,
60
; and reputation of clinical research,
36
; and safety and effectiveness of drugs,
42
; and sepsis studies,
121–22
,
124
,
125
,
126
,
127
,
130

Nexium.
See
esomeprazole

Ngoma, Mary,
173

Nigeria: HIV/AIDS in,
167
,
168
,
172
; informed consent in,
152
,
153
,
163
; lack of health care in,
12
; meningitis in,
144–46
,
152
,
153
,
163
; and risk-benefit analysis,
167
,
168
,
172

nitazoxanide (Alinia),
19–35
,
173

Nixon, Richard M.,
165

nongovernmental organizations (NGOs),
108
,
169
.
See also specific organization

non-treatment studies: and humans as test subjects,
63–67

nonnucleoside reverse transcriptase inhibitors,
81

North Africa,
14

Novartis,
116
,
118

novobiocin,
42

Nuclear Regulatory Commission,
67–68

Nuremberg Code,
71–72
,
73
,
154
,
163

nurses: and risk-benefit analysis,
173

omeprazole (Prilosec),
60

OneWorld Health,
34

Otieno, Lucas Oyombe,
149

oversight committees,
75–76
.
See also
institutional review boards (IRBs)

Pakistan,
151

Pan Africanist Congress Party,
107

Pappworth, Maurice,
73

parasitic infections,
20–35

Pasteur, Louis,
11

patents,
43–44
,
116
,
121

patients: as test subjects,
68
; mistaken beliefs of,
160–61
; rights of,
114
.
See also
informed consent

pegaptanib (Macugen),
5

Pelteret, Robin M.,
17

penicillin,
38
,
66

Peru,
11
,
28
,
33

Petrimae, Irme,
148

Pfizer: advertising by,
51
; and ethics,
137
; and fluconazole,
58
; and globalization of clinical trials,
5
,
8
,
9
; and incentives/money,
172
; and informed consent,
150
,
152
,
153
,
154
,
163
; and Lipitor,
54
; Nigerian lawsuit against,
163
; and outsourcing to India,
116
,
118
; problems faced by,
3
; and Psaty studies,
59
; and risk-benefit analysis,
172
; and trovafloxacin (Trovan),
145–46
,
150
,
152
,
153
,
163
,
172
; and sildenafil (Viagra),
51–53

Pharmaceutical Executive
magazine,
36
,
59

Pharmaceutical Research and Manufacturers of America (PhRMA),
102
,
105
,
132
,
136
,
137
,
138

pharmacists: and outsourcing to India,
115

Phase 1 trials,
3
,
19
,
156
,
160

Phase 2 trials,
3
,
157–58
,
167

Phase 3 trials,
3
,
19
,
117
,
157–58
,
167

Philippines,
9
,
127

phocomelia,
40

physicians: as checks on drug companies,
50–51
; conflict of interest of,
18–19
,
158
; and CROs,
7
; incentives/money for,
158–60
,
161
,
173
; and informed consent,
151–52
,
158–60
; as investigators,
158
,
161
; licensing of,
114
; marketing of drugs by,
56–57
; and placebo studies,
18–19
; policing of conduct in India,
114
; pressures on,
55–57
,
158–60
; and risk-benefit analysis,
173
; and thalidomide,
40

Physicians' Desk Reference
,
55–56

Physicians for Human Rights,
103

placebo effect,
32

placebo studies,
18–35
; and duloxetine (Cymbalta),
156
; and ethics,
18–19
,
133
,
134
,
137
,
139
,
141
; and HIV/AIDS,
19–29
,
31–35
,
80
,
87–91
,
93–95
,
97–98
,
106
,
107
,
110
,
111
; and informed consent,
154
,
156
,
160–61
; legislation about,
41
; and

megamarkets for drugs,
44
; and RCTs,
30–32
; and risk-benefit analysis,
167
,
168
,
173
; and sepsis trials,
112
,
121–22
,
123
,
124
,
125
,
126–30

plague,
69
,
114

pneumonia,
116
,
145

Poland,
1
,
2
,
9

polio,
4
,
12
,
31–32
,
66
,
72
,
116

politics: and controlled trials,
31–32

Polk State School (Pennsylvania),
72

Porter, Roy,
10–11
,
63

postmarketing “trials,”
56–57

posttrial period: access to drug in,
137
,
138
,
170–71
,
176

Potkar, Chandrashekhar,
118

Potts, Malcolm,
10

Pravachol.
See
pravastatin

pravastatin (Pravachol),
53

pregnant women: and ethics,
133
,
139
,
140
; exclusion from clinical trials of,
41–42
; and HIV/AIDS,
79–83
,
87–92
,
94–95
,
97–99
,
104
,
108
,
109
,
111
,
133
,
139
,
140
,
166–67
; and risk-benefit analysis,
166–67

Prescription Drug User's Fee Act (1992),
47–48

Prilosec.
See
omeprazole

prisoners,
6
,
67
,
69–71
,
72
,
77
,
154

protease inhibitors,
81

PROWESS trial (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis),
123–25
,
126
,
127
,
129
,
130

Prozac.
See
fluoxetine

Psaty, Bruce,
59–60

Public Citizen,
92
,
134

Public Health Service, U.S.,
63
,
64–65
,
66
,
67
,
70
,
73–74
,
81

quinacrine,
112