The Body Hunters

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by Sonia Shah


  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

  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 studi
es 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

  Guess, Harry, 138

  Guidelines for the Conduct of Research Involving Human Subjects (NIH), 61

  Guinea Pig Zero (journal), 157

  guinea pigs. See test subjects

  Gulati, Rajiv, 131

  Gulhati, Chandra, 34, 115

  Haiti, 101, 135, 148

  Halsey, Neal, 93, 94

  Harrington, Mark, 169

  Harvard Medical School, 161

  Hashwani, S., 151

  Health and Human Services, U.S. Department of, 7, 157, 159

  health care: cost of, 60, 74, 82

  heart attacks, 47, 55, 59

  heart disease. See cardiovascular disease

  Heart Disease Weekly, 56

  Heller, Jean, 74

  hepatitis, 73, 116

  Herceptin, 4, 161

  Hilts, Philip, 18, 38, 78

  Hinduja Hospital (Mumbai, India), 120–21

  Hirsch, Laurence, 138

  HIV/AIDS: access to drugs for, 81–83, 94; conferences/meetings about, 89–90, 94, 95, 111; and conflicts of interest in clinical trials, 83–85; cost of drugs for, 79, 80, 81, 82–83, 89, 95, 99, 102, 105, 108, 110–11; denialism of, 100–111; emergence of, 100; and ethics, 133, 139–43; and globalization of clinical trials, 8, 13, 14, 15, 16; increase in research about, 76; and informed consent, 107, 109–10, 148, 149; isolation of cause of, 78; lack of subjects for trials for, 80; and megamarkets for drugs, 44; and outsourcing to India, 116; and placebo studies, 19–29, 31–35, 80, 87–91, 93–95, 97–98, 106, 107, 110, 111; and risk-benefit analysis, 166–70, 171; second rate treatments, 111; side effects of drugs for, 47; and substandard care, 77–99. See also nevirapine; nitazoxanide; VaxGen

  HIVNET 012 trial, 97–98, 108, 109–10, 139

  Ho, David, 92–93, 96

  Hoescht Marion Roussel, 48–50

  Hollinger, Mannfred, 100

  Hollis-Eden, 105, 106

  Hollis, Richard, 105, 106, 111

  homeless, 154–55

  Hopkins, Scott, 145–46

  Horrobin, David, 5

  Horton, Richard, 142

  hospitals: in India, 116. See also specific hospital

  Human, Delon, 133, 136–138

  human rights, 76, 91, 103, 110, 164, 168, 175

  Human Rights Watch, 168

  Hungary, 1

  hypertension, 8, 14, 44

  Ijsselmuiden, Carel, 10

  Immunitin (HE2000), 105–6, 107

  Imperial College (London, England), 154

  impotence: See also sildenafil (Viagra)

  incentives/money: for Indian clinical trials, 116–17; and informed consent, 149, 154–57, 158–61; for physicians, 158–60, 161, 173; and risk-benefit analysis, 171–74

  India: as British colony, 11; drug industry in, 114–15; ethics in, 112, 113, 114, 117–18, 120; generic manufacturers in, 111; and globalization of clinical trials, 7, 8, 9, 12, 14, 15, 119, 120–21, 126–30; HIV/AIDS in, 116; humans as test subjects in, 112–13; incentives/money in, 172–73; informed consent in, 151; licensing in, 114; medical schools in, 113–14; medical services in, 115–16; and nitazoxanide-placebo study, 34; outsourcing to, 112–31; and risk-benefit analysis, 171, 172–73

  Indian Council of Medical Research, 113

  Indian Medical Association, 114, 120

  Indiana Bible College, 155–56

  infant mortality, 12, 74

  infectious diseases, 72–73. See also specific disease

  informed consent, 144–63; barriers to, 150–52; and children, 146, 152, 158; and conflict of interest, 158–61; and deliberate misleading of subjects, 152, 158–62; and “don’t ask, don’t tell” atmosphere, 147; and ethics, 71, 137, 142, 143, 152, 153, 156–57; and HIV/AIDS, 107, 109–10, 148, 149; and humans as test subjects, 64, 71, 72, 75–76; as impossible standard, 162–63; and incentives/money, 149, 154–57, 158–60, 161; legis
lation about, 41; and main purpose of medical research, 176, 177; and methods for bridging gulf between investigators and patients, 150–51; as not voluntary, 148; and outsourcing to India, 113, 119–20; and oversight committees, 75; and physicians, 151–52; and placebo studies, 154, 156, 160–61; and therapy versus experimentation, 158–59, 161; in U.S., 153–57, 158, 159–60

  institutional review boards (IRBs), 75–76, 85, 117

  insulin: Boyer’s work on, 42–43

  International Military Tribunal (Nuremberg, Germany), 69–71

  International Monetary Fund (IMF), 12, 13, 25

  International Nursing Review, 151

  intravenous drug users, 140–42, 143, 167, 168

  invasive procedures, 8–9

  iron supplements, 148

  irregular heartbeats, 47

  Ivory Coast. See Côte d’Ivoire, 88

  Ivy, Andrew, 70–71, 72

  Jackson, Jay Brooks, 85–88, 97–99, 108, 109–10, 111, 139, 140–42, 171

  Japan, 69, 149

  Jesani, Amar, 117–18

  Jews, 68–69

  Johns Hopkins University, 88, 93, 96, 171

  Johnson, Traci, 155–56

  Journal of Infectious Diseases, 107

  Journal of Medical Ethics, 139

  Journal of the American Medical Association (JAMA), 57, 72

  Journal of the Medical Association of Thailand, 148

  Journal of the Royal Society of Medicine, 151

  journals: drug advertising in, 48. See also specific journal

  justice, 75, 76

  Kaninda, Anne-Valerie, 150

  Kano Infectious Disease Hospital (Nigeria), 146, 150, 172

  Kapadia, Farhad, 119, 120–21, 127, 131, 162

  Katz, Jay, 71

  Kelder, Indrek, 147–48

  Kelly, Paul S., 28, 29, 31, 32–33

  Kennedy, Donald, 165

  Kennedy, John F., 40

  Kenya, 12, 101–2, 149

  Koop, C. Everett, 159

  Koprowski, Hilary, 72

  Kramer, Larry, 78

  Krugman, Saul, 73

  Kumar, Vijai, 9

  Kusel, Elaine, 152

  kwashiorkor, 101

  labels: listing of ingredients on, 37

  Lallemant, Marc, 91, 93, 98, 111

  lamivudine (Epivir), 107

  Lancet (journal), 5, 94, 142

  Lasagna, Louis, 32

  Latin America, 7, 9, 12, 14, 134, 151–52. See also specific nation

  Latinos: as test subjects, 72

  Latvia, 9

  Lebanon, 127

  Lee, John C.M., 152

  Leff, Ben, 155, 156

  leprosy, 112

  letrozole (Femara), 113

  Levine, Robert, 132–33, 136

  Levy, Jean-Paul, 84

 

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