The Body Hunters (30 page)

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.

46
. See
www.ed.gov/rschstat/research/pubs/rigorousevid/guide_pg5.html
.

47
. Randomized controlled trials can be conducted with either placebo or “active” controls, and either way they correct for many difficulties in determining the effects of a medical intervention, not least the fact that ordinarily most minor sicknesses and conditions are “self-limiting”; that is, they go away on their own. In addition, chronic problems generally cycle up and down, becoming intense for a while, then lightening up, then becoming intense again. If an experimental drug or new medical intervention is judged solely by how it appears to affect patients, there is no way to account for this. If the patients rally, maybe the drug worked, or perhaps the condition simply improved on its own. Moerman,
Meaning, Medicine, and the “Placebo Effect
,” 12.

48
. Mannfred A. Hollinger,
Introduction to Pharmacology
(Philadelphia: Taylor & Francis, 1997), 205.

49
. Roy Porter,
The Greatest Benefit to Mankind: A Medical History of Humanity
(New York: W.W. Norton, 1997), 270.

50
. Jerry Avorn,
Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs
(New York: Alfred A. Knopf, 2004), 53.

51
. Paul Starr,
The Social Transformation of American Medicine: The Rise of a Sovereign Profession and the Making of a Vast Industry
(New York: Basic Books, 1982), 346; and Sarah Marie Lambert and Howard Markel, “Making History: Thomas Francis, Jr., MD, and the 1954 Salk Poliomyelitis Vaccine Field Trial,”
Archives of Pediatrics and Adolescent Medicine
, May 2000, 512.

52
. Marcia Meldrum, “‘A Calculated Risk': The Salk Polio Vaccine Field Trials of 1954,”
BMJ
, October 31, 1998, 1233–36.

53
. Lambert and Markel, “Making History,” 512.

54
. Anita Guerrini,
Experimenting with Humans and Animals: From Galen to Animal Rights
(Baltimore: Johns Hopkins University Press, 2003), 125; Meldrum, “‘A Calculated Risk.'”

55
. While politically palatable, the historical comparison would
certainly dilute the trial's rigor. However the comparison bore out, the results would be open to a range of fair criticism. If fewer vaccinated subjects contracted polio than unvaccinated ones, it could be because they had been less exposed to poliovirus because the weather was different, or perhaps were generally older and could fight off the virus more effectively, or maybe polio in the unvaccinated subjects had been diagnosed differently, and on and on. Since the two groups hadn't been tracked under precisely similar conditions, at the same time, or in the same place, results based on contrasting the groups would be like the proverbial comparison of apples to oranges: no one thing could explain why the two tasted so different. Meldrum, “‘A Calculated Risk.'”

56
. Louis Lasagna, “Placebos and Controlled Trials under Attack,”
European Journal of Clinical Pharmacology
15 (1979): 373–74; Pearce Wright, “Louis Lasagna,”
The Lancet
, October 25, 2003, 1423; Voice of America, “Science in the News: The Lives of Peter Safar and Louis Lasagna,” transcript, August 18, 2003.

57
. Robert Temple and Susan S. Ellenberg, “Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments,”
Annals of Internal Medicine
, September 19, 2000, 456–57.

58
. E-mail interview with Paul S. Kelly, January 26, 2005.

59
. Interview with Rosemary Soave, January 27, 2005.

60
. Robert I. Misbin, “Placebo-Controlled Trials in Type 2 Diabetes,”
Diabetes Care
24, no. 4 (2001): 768–74.

61
. E-mail correspondence from Joanna Hasegawa, January 25, 2003.

62
. E-mail correspondence from Robert Black, January 22, 2005.

63
. Most of the infectious diarrhea there stems from viruses, not parasites, with a small percentage caused by bacteria. Rehydration and antibiotics are “the only sensible therapy.” E-mail correspondence from Chandra Gulhati, January 25, 2005.

64
. R. Rodriguez-Garcia et al., “Effectiveness and Safety of Mebendazole Compared to Nitazoxanide in the Treatment of Giardia Lamblia in Children,”
Review Gastroenterology Mexico
, July/September 1999, 122–26; Cesar E. Davila-Gutierrez et al., “Nitazoxanide Compared with Quinfamide and Mebendazole in the Treatment of Helminthic Infections and Intestinal Protozoa in Children,”
American Journal of Tropical Medicine and Hygiene
66,
no. 3 (2002): 251–54; Uri Belkind-Valdovinos, “Evalucion de la nitazoxanida en dosis unica y por tres dias en parasitosis intestinal,”
Salud Publica de Mexico
, May/June 2004, 333–40.

65
. By February 2005 Kelly was in the process of asking the manufacturers for a quote in order to ascertain whether the University Teaching Hospital might be able to afford a supply of the drug. Interview with Paul S. Kelly, February 16, 2005.

 

1
. Press release, “Salix Pharmaceuticals Announces Positive Results of Rifaximin Study,” November 11, 2004.

2
. Globalization of Clinical Trials panel, Maximizing Clinical Efficiency Phases conference (Washington, DC, October 9, 2003).

3
. Philip J. Hilts,
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
(New York: Alfred A. Knopf, 2003), 23–25.

4
. Roy Porter,
The Greatest Benefit to Mankind: A Medical History of Humanity
(New York: W.W. Norton, 1997), 368, 663–64.

5
. Hilts,
Protecting America's Health
, 46, 53.

6
. Paul Ehrlich developed the concept of chemotherapy, synthesizing sulphanilamide in 1907. The drug didn't go into production until after Gerhard Domagk of I.G. Farbenindustrie refined the drug in 1932. Mannfred A. Hollinger,
Introduction to Pharmacology
(Philadelphia: Taylor & Francis, 1997), 207; Porter,
The Greatest Benefit to Mankind
, 452–54.

7
. Anita Guerrini,
Experimenting with Humans and Animals: From Galen to Animal Rights
(Baltimore: Johns Hopkins University Press, 2003), 111.

8
. Hilts,
Protecting America's Health
, 90; Hollinger,
Introduction to Pharmacology
, 300–301.

9
. Back in 1928 a compound produced by a soil mold—penicillin—had been found to have profound bacteria-killing properties. Penicillin didn't just slow bacterial cell growth, as sulfanilamide did—it killed the cells outright. Not only that, the compound attacked bacterial cells selectively, leaving mammalian
cells untouched and making even large doses of the drug theoretically safe for humans. The trouble was that the mold produced vanishingly small amounts of the compound, and even these quantities deteriorated fast. Producing enough stable penicillin to treat a single patient had proven so difficult for researchers at Oxford that they had resorted to recycling the chemical from the patient's urine; in the end, the team ran out of penicillin and the infected patient had perished. Hollinger,
Introduction to Pharmacology
, 134–35; Porter,
The Greatest Benefit to Mankind
, 456–57; Hilts,
Protecting America's Health
, 101–4.

10
. Laurie Garrett,
Betrayal of Trust: The Collapse of Global Public Health
(New York: Hyperion, 2000), 323.

11
. Ironically, at the time leading drug companies all refused to develop this promising drug into a more practical one, despite the entreaties of government officials. They considered the investment too risky, worrying that the life-saving drug might suddenly stop working, as had happened with sulfa drugs. Only after a government-sponsored project figured out how to increase the mold's yield of the drug by 120-fold did drug companies reluctantly agree to start producing penicillin. Hilts,
Protecting America's Health
, 102–3.