The Body Hunters (36 page)

6
. Brian Vastag, “Helsinki Discord? A Controversial Declaration,”
JAMA
, December 20, 2000, 2984; Okie, “Health Officials Debate Ethics of Placebo Use.”

7
. FDA Division of Pulmonary and Allergy Drug Products, “Use of Placebo-Controls in Life Threatening Diseases: Is the Developing World the Answer?”
Scientific Rounds
, January 24, 2001.

8
. Interview with Robert Temple, 2001.

9
. U.S. Food and Drug Administration,
Guidance for Industry.

10
. E.M. Meslin, “Memorandum to the National Bioethics Advisory Commission. Materials Relating to Public Comments: International Report,” November 21, 2000, cited in Public Citizen, “Letter to the National Bioethics Advisory Commission Criticizing Their Draft Report on Ethics of Research in Developing Countries,” HRG Publication #1550, December 6, 2000, available at
www.citizen.org/publications/release.cfm?ID=6751#N_2_
.

11
. Nancy Kass and Adnan A. Hyder, “Attitudes and Experiences of U.S. and Developing Country Investigators Regarding U.S. Human Subjects Regulation,” commissioned paper, in National Bioethics Advisory Commission,
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries
, Washington, DC, May 2001.

12
. A.A. Hyder et al., “Ethical Review of Health Research: A Perspective from Developing Country Researchers,”
Journal of Medical Ethics
, February 2004, 68–72.

13
. National Bioethics Advisory Commission, Recommendation 4.1 and 4.2,
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries
, April 2001, cited in WMA Workgroup, September 2003.

14
. Okie, “Health Officials Debate Ethics of Placebo Use.”

15
. Bernhard Huitfeldt et al., “Choice of Control in Clinical Trials—Issues and Implications of ICH-E10,”
Drug Information Journal
, October/December 2001, 1147–56.

16
. “Declaration of Helsinki Placebo Rule Being Reconsidered,” July 10, 2001, article provided by Dr. Ruth Macklin.

17
. Interview with Delon Human, 2001.

18
. See
www.wma.net/e/policy/17-c_e.html
.

19
. Letter from Public Citizen to Delon Human, World Medical Association, August 28, 2003.

20
. Laurence Hirsch and Harry Guess, “Some Clauses Will
Hinder Development of New Drugs and Vaccines,”
BMJ
323 (December 2001): 1417.

21
. Pharmaceutical Research and Manufacturers Association discussion paper, June 2001, cited in World Medical Association, “Documentation for the Preparation of Note of Clarification on Paragraph 30 of the Revised Declaration of Helsinki,” September 2003.

22
. Some have interpreted the clarification to Paragraph 30 as an affirmation of the requirement that study drugs be provided after trials end. The clarification reads, “The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic, and therapeutic procedures identified as beneficial in the study or access to other appropriate care. Posttrial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review.” The ambiguity as to whether study drugs must be provided or must simply be identified and described to ethics committees “depends on what ‘it' means,” one bystander noted. See World Medical Association, “Workgroup Report on the Revision of Paragraph 30 of the Declaration of Helsinki,” September 2003; World Medical Association, “Declaration of Helsinki,” at
www.wma.net
; interview with Peter Lurie, March 22, 2005.

23
. R.K. Lie et al., “The Standard of Care Debate: The Declaration of Helsinki Versus the International Consensus Opinion,”
Journal of Medical Ethics
30 (2004): 190–99.

24
. Karen Palmore Beckerman, “Long-Term Findings of HIVNET 012: The Next Steps,”
The Lancet
, September 13, 2003.

25
. Interview with Jay Brooks Jackson, October 10, 2003.

26
. S.H. Eshleman et al., “Selection and Fading of Resistance Mutations in Women and Infants Receiving Nevirapine to Prevent HIV-1 Vertical Transmission (HIVNET 012),”
AIDS
15 (2001): 1951–57.

27
. Beckerman, “Long-Term Findings of HIVNET 012.”

28
. “South Africa Ends Nevirapine Monotherapy in HIV PMTCT, Due to Resistance Issues,”
Pharma Marketletter
, July 14, 2004.

29
. “China Begins Legalizing Methadone as Part of Effort to Prevent HIV Transmission among Injection Drug Users,”
Kaiser Daily HIV/AIDS Report
, August 12, 2004.

30
. Anne Bennett Swingle, “The Pathologist Who Struck Gold,”
Hopkins Medical News
, Spring/Summer 2001.

31
. Interview with Jay Brooks Jackson, October 10, 2003.

32
. Swingle, “The Pathologist Who Struck Gold.”

33
. Nadeeja Koralage, “China to Offer Free HIV Testing and Treatment,”
BMJ
, April 24, 2004.

34
. Letter from International AIDS Society to Secretary of the Expert Committee on the Selection and Use of Essential Medicines Policy, World Health Organization, January 14, 2005.

35
. John G. McNeil et al., “HIV Vaccine Trial Justified,”
Science
, February 13, 2004, 961.

36
. Jon Cohen, “Disappointing Data Scuttle Plans for Large-Scale AIDS Vaccine Trial,”
Science
, March 1, 2002, 1616.

37
. “Thailand Going Through 3rd Phase of Developing AIDS Vaccine,”
Global News Wire—Africa Asia Intelligence Wire
, February 28, 2005.

38
. Richard Horton, “AIDS: The Elusive Vaccine,”
New York Review of Books
, September 23, 2004.

39
. Agence France Presse, “Experts Call for World's Largest HIV Vaccine Trial to Be Scrapped,” Channel NewsAsia, July 15, 2004.

40
. Interview with Robert Temple, September 2003.

 

1
. Interview with Sten Vermund, 2001; World Health Organization,
Control of Epidemic Menigococcal Disease: WHO Practical Guidelines
, 2d ed., 6–12.

2
. World Health Organization, “Disease Outbreaks Reported: Meningococcal Meningitis in Nigeria,” March 6, 1996.

3
. Interview with Anne-Valerie Kaninda, 2001.

4
. See FDA review, at
www.fda.gov/cder/foi/nda/97/020760a.htm
.

5
. Interview with Anne-Valerie Kaninda, 2001; Roche Pharmaceuticals, “Rocephin (Ceftriaxone Sodium) for Injection” product information; Centers for Disease Control, “Meningococcal Disease Among College Students: ACIP Modifies Recommendations for Meningitis Vaccination,” October 20, 1999.

6
. World Health Organization,
Control of Epidemic Meningococcal Disease
, 22–23; correspondence with Maria Santamaria, 2001.

7
.
Juan Walterspiel, MD v. Pfizer, Inc.
, Civil Action No. 3:98cv917, U.S. District Court, District of Connecticut, July 26, 1998, 3–4, 6, 9–10, 20;
Abdullahi v. Pfizer
, 51–52.

8
.
Walterspiel, MD v. Pfizer, Inc.
, 10.

9
. Ibid., 14.

10
. Joe Stephens, “Where Profits and Lives Hang in Balance: Finding an Abundance of Subjects and Lack of Oversight Abroad, Big Drug Companies Test Offshore to Speed Products to Market,”
Washington Post
, December 17, 2000, A1.

11
. H. Veeken et al., “Priority During a Meningitis Epidemic: Vaccination or Treatment?”
Bulletin of the World Health Organization
, March 1998, 135.

12
. Marie Doona and J. Bernard Walsh, “Use of Chloramphenicol as Topical Eye Medication: Time to Cry Halt? Bone Marrow Aplasia Also Occurs with Ocular Use,”
BMJ
, May 13, 1995, 1217.

13
. Stephens, “Where Profits and Lives Hang in Balance”; “Roche Unit's Drug Is Approved,”
Wall Street Journal
, August 31, 1993, A4.

14
. Nancy Kass and Adnan A. Hyder, “Attitudes and Experiences of U.S. and Developing Country Investigators Regarding U.S. Human Subjects Regulations,” commissioned paper, National Bioethics Advisory Commission,
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries
, vol. 2, May 2001, B-9.

15
. Ibid., B-5

16
. Sharon LaFraniere et al., “The Dilemma: Submit or Suffer,”
Washington Post
, December 19, 2000, A1.

17
. P. Pitisuttithum et al., “Risk Behaviors and Comprehension among Intravenous Drug Users Volunteered for HIV Vaccine Trial,”
Journal of the Medical Association of Thailand
, January 1997, 80.

18
. Daniel W. Fitzgerald et al., “Comprehension During Informed Consent in a Less-Developed Country,”
The Lancet
, October 26, 2002, 1301–2.

19
. E. Hardy et al.,
Informed Consent and Fertility Regulation in Brazil, Final Report
, 1998, unpublished, cited in Kass and Hyder, “Attitudes and Experiences,” 48.

20
. Q.A. Karim et al., “Informed Consent for HIV Testing in a South African Hospital: Is It Truly Informed and Truly Voluntary?”
American Journal of Public Health
, April 1, 1998, 637–40.

21
. “South Africa: Rath Foundation Conduct Illegal Experiments,”
Africa News
, September 5, 2005.

22
. Niels Lynoe et al., “Obtaining Informed Consent in Bangladesh,”
New England Journal of Medicine
, February 8, 2001, 460–61.

23
. Kass and Hyder, “Attitudes and Experiences,” B-28.

24
. Ibid., B-27.

25
. Mary Pat Flaherty et al., “Life by Luck of the Draw,”
Washington Post
, December 22, 2000, A1.

26
. East African Standard, “Kenya: Rarieda Guinea Pigs Insist They Were Tricked into Joining Study,”
Africa News
, January 26, 2004.

27
. Sergei Varshavsky, “Discover Russia for Conducting Clinical Research,”
Applied Clinical Trials
, March 2002, 74–80.

28
. “Jump Starting Clinical Trials in China,”
CenterWatch
, July 2002.

29
. Interview with Anne-Valerie Kaninda, 2001.

30
. See, for example, Jared Diamond,
Guns, Germs, and Steel: The Fates of Human Societies
(New York: W.W. Norton, 1997), 117–22.

31
. Daniel W. Fitzgerald et al., “Comprehension During
Informed Consent in a Less-Developed Country,”
The Lancet
, October 26, 2002, 1301–2.

32
. National Bioethics Advisory Commission,
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries
, vol. 1, April 2001, 41.

33
. Interview with Jonathan D. Moreno, March 22, 2005.

34
. M. Upvall et al., “Negotiating the Informed-Consent Process in Developing Countries: A Comparison of Swaziland and Pakistan,”
International Nursing Review
48, no. 3 (2001): 188–92.

35
. National Bioethics Advisory Commission,
Ethical and Policy Issues in International Research
, vol. 1, 48.

36
. Kass and Hyder, “Attitudes and Experiences,” B-27.

37
. Ibid., B-28.

38
. A.K. Sanwal et al., “Informed Consent in Indian Patients,”
Journal of the Royal Society of Medicine
, April 1996, 196–98.

39
. LaFraniere et al., “The Dilemma.”

40
. John C.M. Lee, “Clinical Research in China,”
Drug Information Journal
32 (1998): 1265S–73S.

41
. Interview with Robert Temple, September 2003.

42
. Pfizer correspondence with the
Washington Post
on Clinical Trials Series, available at
www.pfizer.com/pfizerinc/about/press/trovanq&a.html
.

43
. Interview with Elaine Kusel, 2001.

44
. Pfizer correspondence with the
Washington Post
on Clinical Trial Series; H. Veeken et al., “Priority During a Meningitis Epidemic: Vaccination or Treatment?”
Bulletin of the World Health Organization
, March 1998, 2.

45
. Interview with Larry Baraff, 2001.

46
. Interview with Solomon Benatar, November 10, 2003.

47
. Joe Stephens, “Doctors Say Drug Trials' Approval Was Backdated,”
Washington Post
, January 16, 2001, A1.