Lewis, Stephen, 26–27
licensing: of physicians, 114
Lieberman, Jeffrey, 57–58
life-enhancing drugs, 53
life expectancy, 12, 14, 74
lifestyle drugs, 45–46, 60–61
Lipitor. See atorvastatin
Lipsky, Janice, 52
Loew, Caroline, 136, 137
Logan, Bradley, 8
Lokhandwala, Yash, 172, 173
London, Leslie, 174
loratadine (Claritin) 49–50, 55, 60
Loudon, James, 149
lovastatin (Mevacor), 45, 53–54
lung disease, 14, 134
Lung Institute (Cape Town, South Africa), 16–17
Lurie, Mark, 93
Lurie, Peter, 88–91, 92, 93, 94, 95, 97, 132, 134, 137–38, 139
Macugen. See pegaptanib
“magic bullet” drugs: emergence of, 38
malaria: and globalization of clinical trials, 12, 14; and humans as test subjects, 64, 67, 68–69, 70–71, 72; and informed consent, 149; medicines for, 11; and megamarkets for drugs, 44; and risk-benefit analysis, 167, 169
Malaysia, 9
Mali, 21
Mandela, Nelson, 103, 106
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 perio
d: 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
Quinn, Tom, 82
Quintiles Transnational, 6–7, 8, 9, 105–6, 159
racism, 74–75, 90, 94, 100–111. See also African Americans
radioactive materials, 67–68, 72
Raifeld, Yuri, 9
Rais, Nadeem, 118–19, 171
Raj, Arul, 120
Ranbaxy, 15
randomized controlled trials (RCTs): as basis for clinical experimentation, 41; double-blind, 30; and FDA regulations, 58; and HIV/AIDS, 81; and independence of academic researchers, 58; for loratadine (Claritin), 55; and outsourcing to India, 119, 120; and placebo effect, 32; and politics, 31–32; requirements for, 41; and risk-benefit analysis, 171–72; as tenet of medical research, 30; choice of control in, 31. See also specific study
Raymond, Betsy, 146
Reagan (Ronald) administration, 78
regulation: and outsourcing to India, 113, 114–15. See also specific agency or organization
Retrovir. See zidovudine (AZT)
Reverby, Susan, 65
Richardson-Merrell, 39–40
risk-benefit analysis, 164–74; and access to study drug after trial ends, 170–71; for effectiveness, 51; and ethics, 173–74; and faith in benefits of medicine, 165–66; and growth of drug industry, 61; and HIV/AIDS, 85; and humans as test subjects, 71–73, 75; and incentives/money, 171–74; and minimizing of risks, 164–66; and oversight committees, 75
Robbins, Fred, 86
Rocephin. See ceftriaxone
Roche (drug company), 146
Roche, Ellen, 160
Rockefeller Foundation, 64
Romania, 9, 127
Romark Laboratories: nitazoxanide-placebo study by, 20–35
Roosevelt, Franklin D., 66
Rossignol, Jean-François, 20, 21, 24
rosuvastatin (Crestor), 53, 54, 55
Ruff, Andrea, 93
Russia, 7, 8–9, 127, 149
safety, drug, 41, 46
Salk, Jonas, 4, 31–32, 72
Sanghatana, Stree Shakti, 112
Sanne, Ian, 107
Saudi Arabia, 127
Schering-Plough, 36, 48–50, 55
schizophrenia, 159
Schuurmans, Macé, 172
Scientific American (journal), 154
Scrip (journal), 4
Sears, Cynthia, 24
Seda, Andrew Okal, 149
Seldane. See terfenadine
selective serotonin reuptake inhibitors (SSRI), 155–56
senior citizens: spending on drugs by, 44–45
sepsis, 121–31
Shahani, Ranjit, 118
sildenafil (Viagra), 51–53, 60–61, 129
Silliman, Nancy, 23
simvastatin (Zocor), 53
Singapore, 127
Slovak Republic, 127
Slovenia, 127
smallpox, 12
Soave, Rosemary, 23, 24, 29, 33
soldiers: as test subjects, 68–69
Sommer, Alfred, 92–93, 94, 95, 111
South Africa: ADDRESS trial in, 127; and globalization of clinical trials, 7, 8, 9, 15–17; HIV/AIDS in, 100–111, 140, 148; and informed consent, 148; and risk-benefit analysis, 172
South African Medical and Dental Council, 101, 103
South African Press Association, 103
Srinivasan, Sandhya, 117
state health departments: and placebo studies, 31–32
statins, 54–56, 60
steroids, 123, 128, 129, 131
The Story of Louis Pasteur (film), 66
students: and informed consent, 154–56
Subutex. See buprenorphine
substandard care: and ethics, 132, 140–41; and HIV/AIDS, 77–99
Suffredini, Anthony, 126
suicide, 155–56
sulfanilamide, 38
Sullivan, Andrew, 22
surrogate end point, 46, 47
Swaziland, 151
Switzerland, 172
syphilis: and humans as test subjects, 63–67, 73–75, 77, 90, 94; penicillin as treatment for, 38
Syphilis Study, Tuskegee. See Tuskegee Syphilis Study
Tagamet. See cimetidine
Tambocor. See flecainide
taxes: and outsourcing to India, 117
television: drug advertising on, 48–50, 51–52
Temple, Robert, 18, 19, 30, 31, 32, 33, 50, 134, 136–37, 143, 152, 170
tenofovir (Viread), 167–70
terfenadine (Seldane), 48–49
test subjects: humans as, 62–76, 77, 90, 94, 108, 112–13
Thailand: ADDRESS trial in, 127; and globalization of clinical trials, 9; HIV/AIDS in, 84–85, 88, 91, 94, 96, 97, 142–43, 148, 149, 166–67, 168; and informed consent, 148, 149; intravenous drug users in, 167, 168; and risk-benefit analysis, 166–67, 168
thalidomide, 39–41
therapy: experimentation as differentiated from, 158–59, 161
ThreeWire, 159
3M, 47
Tiefer, Leonore, 52
tobacco, 13, 14
trade shows, 9–10
treatment: necessity of, 50–55
Treatment Action Group, 142, 169
trovafloxacin (Trovan), 145–46, 150, 152, 153, 163, 172
Trovan. See trovafloxacin.
tuberculosis, 14, 38, 44, 116
Turkey, 135
Tuskegee Syphilis Study, 4, 66, 67, 70, 73–75, 77, 90, 94, 132, 154
typhoid, 69, 73, 101
Uganda, 86, 87, 88, 97–98, 99, 101, 109–10, 111, 135
UNAIDS, 90–91, 93, 95, 139
UNICEF, 26, 144
United Nations’s Joint Programme on HIV/AIDS, 90–91
United States: government sponsored studies in, 69–71, 72, 149, 154; informed consent in, 153–57, 158, 159–60
university hospitals, 68, 158
University of California, 68
University of Cape Town (South Africa), 17
University of Chicago, 68, 155
University of Oklahoma, 160
University of Rochester Hospital, 68
University of South Florida, 160
University of Stellenbosch, 104, 172
University Teaching Hospital (Lusaka, Zambia), 26–29, 32–33, 34, 35, 173
Upjohn, 42
Upvall, M., 151
uranium, 72
VaxGen, 85, 96, 142, 149
venereal disease, 63–65. See also gonorrhea; syphilis
venograms, 8–9
Viagra. See sildenafal
Vick Chemical, 39
Viramune. See nevirapine
Viread. See tenofovir
Virodene, 103
vitamin A supplements, 93–94
Walterspiel, Juan, 145–46
Ward, Nicholas, 123
Warren, H. Shaw, 126
Warren, Mitchell, 169
WebMD, 129
Weschler, Jill, 36
Wilfert, Catherine, 92–93
Willowbrook State School (New York), 73, 77
Wolfe, Sidney, 36, 92
women: an
d HIV/AIDS, 148, 167; and informed consent, 148; and outsourcing to India, 112, 113, 119–20; and risk-benefit analysis, 167. See also pregnant women
World Bank, 12, 13, 25, 89, 92, 116
World Health Organization (WHO), 12, 14, 60, 82–83, 84, 115, 141–42, 144, 145, 146
World Medical Association (WMA), 75–76, 132–33, 136–37, 138–39. See also Declaration of Helsinki
World Trade Organization (WTO), 15, 116
World War II, 11–12, 67–72, 147
Wrentham State School (Massachusetts): children as test subjects in, 67–68
Wrigley Gums, 52
Wurzlemann, John, 1–2, 3, 8, 9, 36, 127, 170, 173
Wyeth, 8
Xigris. See drotrecogin alfa
Yale University, 154
Yaxley, Simon, 105
Zagury, Daniel, 85
Zaire, 12, 85
Zambia, 12, 25–29, 30, 32–33, 34, 173
zidovudine (AZT, Retrovir): and ethics, 139; and HIV/AIDS, 78–83, 86, 87, 88, 90, 91, 94, 95, 97, 98, 104; and risk-benefit analysis, 166
Zocor. See simvastatin
Zyrtec. See cetirizine