by Sonia Shah
23. U.S. Department of Health and Human Services, Report of the Office of Inspector General: The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects, September 2001, iii.
24. “In an average year, we estimate that approximately 1,140 foreign clinical trials . . . are conducted under IND review and oversight. . . . [W]e can . . . estimate that 575 non-IND foreign trials are conducted annually for eventual submission to FDA for research or marketing applications.” From “Human Subject Protection; Foreign Clinical Studies Not Conducted under an Investigational New Drug Application,” Federal Register, June 10, 2004.
25. U.S. Department of Health and Human Services, Report of the Office of Inspector General: The Globalization of Clinical Trials, iii.
26. Marc Kaufman, “Clinical Trials of Drugs Fewer, Study Says,” Washington Post, May 4, 2005, A2.
27. Julie Schmit, “Costs, Regulations Move More Drug Tests Outside USA,” USA Today, May 16, 2005.
28. Pfizer press release, reprinted from “India Hub to Lead Pfizer’s Clinical Studies in Asia,” Times of India, October 3, 2003; “The Trial Trail,” Business India, March 3, 2003.
29. See www.quintiles.com/Corporate_Info/Regions/south_africa_and_india.
30. Interview with Bradley Logan, October 2003.
31. “Treating Study Volunteers as Customers,” CenterWatch Industry Reports, March 2003, 1, 4.
32. Yuri Raifeld and John Wurzlemann, Globalization of Clinical Trials panel, Maximizing Clinical Efficiency Phases conference (Washington, DC, October 9, 2003).
33. See www.quintiles.com/Corporate_Info/Regions/south_africa_and_india.
34. “Lifting India’s Barriers to Clinical Trials,” CenterWatch, August 2003.
35. Pfizer press release, October 3, 2003; “The Trial Trail.”
36. Jeetha D’silva, “AstraZeneca, Glaxo to Make India R&D Hub,” Economic Times, September 8, 2003.
37. “GSK Cuts Costs with More R&D Abroad, Electronic Data Capture,” Drug Industry Daily, November 6, 2004.
38. Tufts Center for the Study of Drug Development, “CROs Provide Gateway to Worldwide Clinical Trial Recruitment Efforts,” Impact Report, July/August 2003.
39. Ad for Neeman Medical International, from R&D Directions, July/August 2003.
40. “Success with Trials in Poland,” R&D Directions, July/August 2003, 28; Zheng-ming Chen, “Organizing Large Randomized Trials in China: Opportunities and Challenges,” Drug Information Journal 32 (1998): 1193S–1200S; Diego Glancszipigel, “Clinical Trials in Latin America,” Applied Clinical Trials, May 2003, 38; Sergei Varshavsky, “Discover Russia for Conducting Clinical Research,” Applied Clinical Trials, March 2002, 74; “A Billion Dollar Clinical Research Opportunity Lies in India,” BioSpectrum, August 19, 2003.
41. Interview with Carel Ijsselmuiden, September 4, 2003.
42. Malcolm Potts, “Thinking about Vaginal Microbicide Testing,” American Journal of Public Health 90, no. 2 (February 2000): 190.
43. Without quinine neither the British nor the French would have been able to colonize malarial Africa—while the natives could survive the disease, it stopped Europeans dead in their tracks more effectively than any resisting army. Porter, The Greatest Benefit to Mankind, 163–66, 230, 233, 465–66, 482.
44. Porter, The Greatest Benefit to Mankind, 237.
45. Meredith Fort, Mary Anne Mercer, and Oscar Gish, eds., Sickness and Wealth: The Corporate Assault on Global Health (Cambridge, MA: South End Press, 2004), 22.
46. London surgeon John Snow established that cholera spread via contaminated water in 1854; a British army surgeon proved that mosquitoes transmit malaria in 1897. Porter, The Greatest Benefit to Mankind, 412–13, 468–70.
47. Sheldon Watts, Epidemics and History: Disease, Power, and Imperialism (New Haven, CT: Yale University Press), 167–212.
48. A British army surgeon had discovered the wily parasite that causes malaria, lurking in the bellies of blood-thirsty mosquitoes back in 1897. Within a few decades, by draining the standing water pits where mosquitoes bred, screening windows so the bugs couldn’t get into bedrooms, and similar methods, malaria had been all but eradicated from much of the United States and northern Europe. The U.S. military had likewise eradicated malaria from tropical Panama, on account of their desire to build a canal through that country’s narrow jungle-covered isthmus.
But Western aid doctors, now led by the newly formed World Health Organization and tasked in 1948 with the business of “applying modern remedies” to all the countries of the world, did not seek to undertake such time-consuming and costly measures. By then, an “easy relief” from malaria had been discovered: the insecticide DDT. DDT was cheap and easy to apply, and had already saved the lives of millions of soldiers sent to the battlefield with a can of the stuff in hand. Practically indestructible, a spritz of DDT could kill adult mosquitoes as well as their off-spring, and its powdery residues would continue the carnage even years later. In 1955, the WHO boldly declared that if given sufficient quantities of DDT, it would eradicate malaria from the face of the planet.
Between 1958 and 1963, the United States generously funded the WHO’s anti-malaria campaign. The disease was successfully eradicated from southern Europe, and greatly lessened in India, Malaysia, and Sri Lanka. But as was clear from as early as the mid-1950s, malaria-carrying Anopheles mosquitoes could quickly become resistant to DDT, which was being vigorously applied not just by the WHO but by farmers everywhere, encouraged by Western officials overseeing the World Bank. In 1962, the toxic chemical’s environmental effects, from cancers and fish kills, were damningly indicted in Rachel Carson’s groundbreaking book Silent Spring. “Almost overnight,” remembers one entomologist, DDT became “‘the elixir of death.’” A year later Congress refused to allocate funds to the WHO program. After the plug was pulled on DDT, the denizens of malaria-ridden regions faced a massive return of the mosquitoes, this time shorn of their low-level immunity to malaria. Porter, The Greatest Benefit to Mankind, 468–91; “Development and Constitution of the W.H.O.,” Chronicle of the World Health Organization: 1947, vol. 1; Giancarlo Majori, “The Long Road to Malaria Eradication,” The Lancet, December 18, 1999; Susan W. Fisher, “Once-Admired Chemical DDT Has Instructive History,” Columbus Dispatch, June 11, 2000, 6B; Laurie Garrett, The Coming Plague: Newly Emerging Diseases in a World Out of Balance (New York: Penguin Books, 1994), 47–53.
49. Garrett, The Coming Plague, 42–46; Porter, The Greatest Benefit to Mankind, 472–91.
50. The bank’s drastic pronouncements quickly drowned out the suggestions of World Health Organization officials and even local governments’ health departments. In a single year, the bank could offer $2.5 billion for health care projects in indebted countries, making it—not the WHO nor local health officials—the developing world’s most influential authority on health policy. The entire annual budget of the World Health Organization, in contrast, dawdled around $900 million throughout the 1990s. Fort, Mercer, and Gish, eds., Sickness and Wealth, 128, 205.
51. Jim Yong Kim et al., eds., Dying for Growth: Global Inequality and the Health of the Poor (Monroe, ME: Common Courage Press, 2000), 93, 113, 143, citing Mebelo K.N. Mutukwa et al., “The Structural Adjustment Program in Zambia: Reflections from the Private Sector,” in Kapil Kapoor, ed., Africa’s Experience with Structural Adjustment, World Bank Discussion Paper 288, 1995, 73–87.
52. Sarah Sexton, “Trading Health Care Away? GATS, Public Services and Privatization,” Corner House Briefing 23, July 2001.
53. Kim et al., Dying for Growth, 158–65.
54. Similar “shock therapy” and “structural adjustment programs” transformed post-Soviet Russia, which in 1992 embarked on a risky plan to radically transform its state socialist system into a market-based capitalist economy. Formerly free public hospitals and clinics suddenly demanded exorbitant fees for their services to people newly out of work, bereft of housing and food subsidies previously supplied by the state, and faced with
skyrocketing inflation. By 1995, about half of all Russians had fallen into poverty, while a tiny fraction of the population made a killing. Russians were dying faster than they were replenishing their numbers with healthy babies, “a demographic pattern usually seen only in times of war, famine, or plague,” noted health economists Mark G. Field, David M. Kotz, and Gene Bukhman. Before the economic meltdown diphtheria had practically disappeared in Russia, with just 903 cases reported in 1989. By 1994, diphtheria had taken almost 40,000 Russians. The paternalistic, authoritarian Soviet TB control program—mandatory screening and months- and years-long exile for the infected in drafty sanatoriums—had effectively stifled tuberculosis, the caseload dropping by 5 percent to 7 percent every year. The program collapsed in the early 1990s, but little took its place save aging X-ray equipment and spotty drug supplies for the few who could pay for it. By 1998, no fewer than 2.5 million of Russia’s 148 million had fallen prey to the ancient scourge. Worse, almost a third of all tuberculosis victims in Russia’s prisons were beholden to a particularly nasty multidrug-resistant form. Kim et al., Dying for Growth, 158–65; Sarah Sexton, “Trading Health Care Away?”
55. By the end of the 1990s the AIDS pandemic and tuberculosis had effected a drastic turnabout in some African countries. A slow, steady march forward in life expectancy had been reversed. Kim et al., Dying for Growth, 5, 106–8.
56. Ibid., 208.
57. The company is now the largest employer on the continent of Africa. Sonia Shah, “Coke in Your Faucet?” The Progressive, August 2001, 29–30.
58. The business of penetrating new markets took on such import that Western officials willingly undermined public health protections in foreign countries if they appeared obstructive. In the mid-1990s, for example, U.S. State Department officials forced Guatemala to gut a widely praised law that had saved the lives of scores of infants. The law banned the use of images of chubby babies on infant-formula packaging, thus reducing the allure of a product that was too often reconstituted with dangerously contaminated water. When baby food manufacturer Gerber objected, state department officials threatened Guatemala with trade sanctions, and Guatemalan officials gutted the law, exempting Gerber and other baby-food importers from its strictures. “Prepared Statement of Lori Wallach, Global Trade Watch,” House Ways and Means Committee, Trade Subcommittee, Federal News Service, August 5, 1999; Gary Gardner and Brian Halweil, Underfed and Overfed: The Global Epidemic of Malnutrition, Worldwatch Institute Paper, March 2000, 33.
59. In Western countries the transition from the hardscrabble malnourishment of the hunting-gathering days to today’s drive-through, fast-food cornucopia had occurred over centuries, with the happy result that communities were able to control infectious diseases spread by poverty and hunger before facing the maladies of richly calorific diets, including diabetes, obesity, and heart disease. In developing countries no such time lag exists. In many countries, what nutrition experts call the “nutrition transition” is taking place within a single generation. Benjamin Caballero and Barry M. Popkin, eds., The Nutrition Transition: Diet and Disease in the Developing World (London: Academic Press, 2002), 140–41.
60. Joint WHO/FAO Expert Consultation, Diet, Nutrition, and the Prevention of Chronic Diseases (Geneva: World Health Organization, 2003).
61. Kim et al., Dying for Growth, 208.
62. Caballero and Popkin, eds., The Nutrition Transition, 165.
63. Ibid., 130, 160, 165, 183.
64. Sarah Boseley, “Clinton’s AIDS Plan Snubs Bush Plan,” The Guardian, April 7, 2004.
65. Robert Radtke, “India Must Steer a Middle Path on Generic Drugs,” Financial Times, March 24, 2005, 13.
66. Audrey R. Chapman et al., eds., Human Rights and Health: The Legacy of Apartheid (Washington, DC: American Association for the Advancement of Science, 1998), 20.
67. Interview with Marta Darder, November 13, 2003.
68. Porter, The Greatest Benefit to Mankind, 621.
69. Interview with Robin Pelteret, November 9, 2003.
70. This figure includes drug-trial funding from the Medical Research Council of South Africa and the Gates Foundation along with drug company contracts. The rationale is that the drug industry funds will subsidize public health–oriented research. Interview with Robin Pelteret, November 9, 2003.
2: The Placebo Control
1. Phillip J. Hilts, Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation (New York: Alfred A. Knopf, 2003), 225.
2. Ibid., 229.
3. Many Phase 3 failures are due to the fact that drug companies expect their drugs to be more effective than they are, and thus fail to enroll sufficient numbers of patients necessary to show their drug’s slim benefits. Karen Weiss, “Efficiency in Drug Development: Knowing the Agency’s Expectations to Create a Sound Development Plan,” Maximizing Clinical Efficiency Phases conference (Washington, DC, October 9, 2003).
4. Daniel Moerman, Meaning, Medicine, and the “Placebo Effect” (Cambridge: Cambridge University Press, 2002), 128.
5. Interview with Robert Temple, 2001.
6. Guy Boulton, “Scientist’s Patience Rewarded,” Tampa Tribune, August 10, 2004, 1.
7. Tim Radford, “Throwing the Microbe into the Bathwater,” The Guardian, February 22, 1989; Richard Dawood and Jeremy Skidmore, “The Treatment? There Isn’t One,” Daily Telegraph, August 23, 2003, 4; Antiviral Drug Advisory and Research Committee, Public Hearing NDA 20-871/Nitazoxanide, transcript, May 6, 1998; interview with Rosemary Soave, January 27, 2005.
8. Antiviral Drug Advisory and Research Committee, Public Hearing NDA 20-871/Nitazoxanide, 24.
9. Rosemary Soave, Antiviral Drug Advisory and Research Committee, Public Hearing NDA 20–871/Nitazoxanide.
10. O. Doumbo et al., “Nitazoxanide in the Treatment of Cryptosporidial Diarrhea and Other Intestinal Parasitic Infections Associated with Acquired Immunodeficiency Syndrome in Tropical Africa,” American Journal of Tropical Medicine and Hygiene, June 1997, 637–39.
11. Bob Dudley, Antiviral Drug Advisory and Research Committee, Public Hearing NDA 20-871/Nitazoxanide.
12. “AIDS patients sought for study with NTZ for cryptosporidiosis,” Journal of the International Association of Physicians in AIDS Care 3, no. 6 (June 1997): 48.
13. Antiviral Drug Advisory and Research Committee, Public Hearing NDA 20-871/Nitazoxanide.
14. Jon Cohen, Shots in the Dark: The Wayward Search for an AIDS Vaccine (New York: W.W. Norton, 2001), 288.
15. Andrew Carr et al., “Treatment of HIV-1-Associated Microsporidiosis and Cryptosporidiosis with Combination Antiretroviral Therapy,” The Lancet, January 24, 1998, 256–61.
16. Antiviral Drug Advisory and Research Committee, Public Hearing NDA 20-871/Nitazoxanide, 158.
17. Ibid.
18. Interview with Rosemary Soave, January 27, 2005.
19. Cynthia Sears, Antiviral Drug Advisory and Research Committee, Public Hearing NDA 20-871/Nitazoxanide.
20. Interview with Rosemary Soave, January 27, 2005.
21. Guy Boulton, “Scientist’s Patience Rewarded,” Tampa Tribune, August 10, 2004, 1.
22. Bill Schiller, “Africa’s Man of Peace Holds Court in Zambia,” Toronto Star, August 6, 1989, H1.
23. Lishala C. Situmbeko and Jack Jones Zulu, Zambia: Condemned to Debt, World Development Movement, April 2004, 6.
24. Schiller, “Africa’s Man of Peace Holds Court in Zambia.”
25. Situmbeko and Zulu, Zambia, 16–17.
26. Jon Jeter, “Less than $1 Means Family of 6 Can Eat,” Washington Post, February 19, 2002.
27. Situmbeko and Zulu, Zambia, 30.
28. Paul Peachey, “In Foreign Parts: We Could See Many Funerals Here, Warns Mayor as Zambia Stares into the Face of a Devastating Famine,” The Independent, July 29, 2002.
29. Situmbeko and Zulu, Zambia, 30.
30. Sharon LaFraniere, “AIDS Patients in Zambia Face Stark Choices,” New York Times, October 11, 2003, 1.
31. Mary Gordon, “Fighting AIDS in Zambia,” Toronto Star, January 18, 2004, F02.
32. Philip J. Hilts, “Out of Africa; Dispelling Myths about AIDS,” Washington Post, May 24, 1988, Z12.
33. Jonathan Manthorpe, “Kaunda Staring Down Barrel of Democracy,” Ottawa Citizen, July 28, 1991, F10.
34. Ruth SoRelle, “Seeking an Answer to AIDS,” Houston Chronicle, April 18, 1993, 10.
35. “Africa’s AIDS Pandemic,” Toronto Star, January 4, 2005, A13.
36. Oakland Ross, “AIDS Pledge ‘Opens Floodgates of Hope,’” Toronto Star, January 30, 2003, A09.
37. Child Health Research Project, Synopsis: Persistent Diarrhea Algorithm, Washington, DC, October 1997.
38. SoRelle, “Seeking an Answer to AIDS.”
39. Ibid.
40. Antiviral Drug Advisory and Research Committee, Public Hearing NDA 20-871/Nitazoxanide, 26.
41. Interview with Paul S. Kelly, January 26, 2005.
42. SoRelle, “Seeking an Answer to AIDS.”
43. Jean-Francois Rossignol et al., “Treatment of Diarrhea Caused by Cryptosporidium Parvum: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide,” Journal of Infectious Diseases 184, no. 1 (2001): 103–6; Jean-Francois Rossignol et al., “Treatment of Diarrhea Caused by Giardia Intestinalis and Entamoegba Histolytica or E. Dispar: A Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide,” Journal of Infectious Diseases 184, no. 3 (2001): 381–84; J. J. Ortiz et al., “Randomized Clinical Study of Nitazoxanide Compared to Metronidazole in the Treatment of Symptomatic Giardiasis in Children from Northern Peru,” Alimentary Pharmacology and Therapeutics 15 (2001): 1409–15.
44. Paul Kelly et al., “Albendazole Chemotherapy for Treatment of Diarrhoea in Patients with AIDS in Zambia: A Randomised Double Blind Controlled Trial,” BMJ 312 (1996): 1187–91.
45. The results showed that for HIV-infected children, the drug was no better than placebo. Beatrice Amadi et al., “Effect of Nitazoxanide on Morbidity and Mortality in Zambian Children with Cryptosporidiosis: A Randomized Controlled Trial,” The Lancet, November 2, 2002, 1375–80.
