AZT trials and tribulations

Hasting Center Report

Volumn 28, Issue 6, 1998, Pages 26-34

  Crouch, Robert A ^a   Arras, John D ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; PLACEBO; ZIDOVUDINE;

ANALYTICAL APPROACH; BIOMEDICAL AND BEHAVIORAL RESEARCH; CENTERS FOR DISEASE CONTROL AND PREVENTION; CLINICAL TRIAL; CONTROL GROUP; DEVELOPING COUNTRY; DISEASE TRANSMISSION; FEMALE; HEALTH CARE AND PUBLIC HEALTH; HUMAN; HUMAN EXPERIMENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INTERNATIONAL COOPERATION; MEDICAL ETHICS; MORALITY; PATIENT ADVOCACY; PREGNANCY; PREGNANCY COMPLICATION; PREGNANT WOMAN; PUBLIC HEALTH SERVICE; RESEARCH SUBJECT; RESOURCE ALLOCATION; REVIEW; THAILAND; UNITED STATES;

ANALYTICAL APPROACH; BIOMEDICAL AND BEHAVIORAL RESEARCH; CENTERS FOR DISEASE CONTROL AND PREVENTION; HEALTH CARE AND PUBLIC HEALTH;

ANTI-HIV AGENTS; CENTERS FOR DISEASE CONTROL AND PREVENTION (U.S.); CLINICAL TRIALS; CONTROL GROUPS; DEVELOPING COUNTRIES; DISEASE TRANSMISSION, VERTICAL; ETHICS, MEDICAL; FEMALE; HIV INFECTIONS; HUMANS; INTERNATIONALITY; MORAL OBLIGATIONS; PATIENT ADVOCACY; PLACEBOS; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANT WOMEN; RESEARCH SUBJECTS; RESOURCE ALLOCATION; THAILAND; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED STATES; ZIDOVUDINE;

EID: 0032197089     PISSN: 00930334     EISSN: None     Source Type: Journal    
DOI: 10.2307/3528266     Document Type: Article

References (40)

1. Centers for Disease Control and Prevention, "Administration of Zidovudine During Late Pregnancy and Delivery to Prevent Perinatal HIV Transmission-Thailand, 1996-1998," Morbidity & Mortality Weekly Report 47, no. 8 (1998): 151-54.
2. Edward M. Connor, Rhoda S. Sperling, Richard Gelber et al., "Reduction of Maternal-Infant Transmission of Human Immunodeficiency Virus Type 1 with Zidovudine Treatment," NEJM 331 (1994): 1173-80, at 1174.
3. Department of Health and Human Services, The Conduct of Clinical Trials of Maternal-Infant Transmission of HIV Supported by the United States Department of Health and Human Services in Developing Countries (Washington, D.C.: DHHS, July 1997). The United Nations has recently changed its recommendations concerning breastfeeding.
4. See Lawrence K. Altman, "AIDS Brings a Shift on Breast-Feeding," New York Times, 26 July 1998.
5. World Health Organization, Recommendations from the Meeting on Mother-to-Infant Transmission of HIV by Use of Antiretrovirals, Geneva, 23-25 June 1994.
6. Harold Varmus and David Satcher, "Ethical Complexities of Conducting Research in Developing Countries," NEJM 337 (1997): 1003-1005.
7. Department of Health and Human Services, The Conduct of Clinical Trials.
8. Peter Lurie and Sidney M. Wolfe, "Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries," NEJM 337 (1997): 853-56, at 854.
9. Lurie and Wolfe, "Unethical Trials"; Sidney M. Wolfe and Peter Lurie, letter to Donna Shalala, Secretary of Health and Human Services, 23 October 1997.
10. Wolfe and Lurie, letter to Donna Shalala; Marcia Angell, "The Ethics of Clinical Research in the Third World," NEJM 337 (1997): 847-49.
11. Lurie and Wolfe, "Unethical Trials," p. 855.
12. Benjamin Freedman, "Equipoise and the Ethics of Clinical Research," NEJM 317 (1987): 141-45.
13. Benjamin Freedman, "Placebo-Controlled Trials and the Logic of Clinical Purpose," IRB: A Review of Human Subjects Research 12, no. 6 (1990): 1-6, at 5.
14. The yearly per capita health care expenditure (in U.S. dollars) within the developing world has been estimated by the World Bank to range from a low of $11 in China to a high of S105 in Latin America and the Caribbean, with $24 (mean) being available to those living in the countries of sub-Saharan Africa, the proposed location for several trials. As a point of reference, the same figure for the United States is $3,516. See, Bengt Jönsson and Philip Musgrove, "Government Financing of Health Care," in Innovations in Health Care Financing: Proceedings of a World Bank Conference, March 10-11, 1997, World Bank Discussion Paper No. 365, ed. George J. Schieber (Washington, D.C.: The World Bank), pp. 39-64, at 46.
15. Varmus and Satcher, "Ethical Complexities."
16. Alan F. Fleming, "Tropical Obstetrics and Gynecology 1. Anemia in Pregnancy in Tropical Africa," Transactions of the Royal Society of Tropical Medicine & Hygiene 83, no. 4 (1989): 441-48;
17. Danstan Bagenda and Philippa Musoke-Mudido, "A Reaction: We're Trying to Help Our Sickest People, Not Exploit Them," Washington Post, 28 September 1997.
18. Mary Glenn Fowler and Lynne Mofenson, "Progress in Prevention of Perinatal HIV-1," Acta Paediatrica 421, Suppl. (1997): 97-103;
19. Richard D. Semba, "Overview of the Potential Role of Vitamin A in Mother-to-Child Transmission of HIV-1," Acta Paediatrica 421, Suppl. (1997): 107-12.
20. Gabriella Scarlatti, "Paediatric HIV Infection," The Lancet 348 (1996): 863-68;
21. Martha F. Rogers and Harold W. Jaffe, "Reducing the Risk of Maternal-Infant Transmission of HIV: A Door Is Opened," NEJM 331 (1994): 1222-23.
22. The Working Group on Mother-to-Child Transmission of HIV, "Rates of Mother-to-Child Transmission of HIV-1 in Africa, America, and Europe: Results from 13 Perinatal Studies," Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 8, no. 5 (1995): 506-10;
23. Robert W. Ryder and Frieda Behets, "Reasons for the Wide Variation in Reported Rates of Mother-to-Child Transmission of HIV-1," AIDS 8, no.10 (1994): 1495-97.
24. Influential examples of this approach to health care justice, which encompasses a spectrum of more or less egalitarian options, include: Norman Daniels, Am I My Parents' Keeper? (New York: Oxford University Press, 1987);
25. Ronald Dworkin, "Will Clinton's Plan be Fair?" New York Review of Books (13 January 1994): 20-25;
26. Paul Menzel, Strong Medicine (New York: Oxford University Press, 1990).
27. Judith N. Shklar, The Faces of Injustice (New Haven: Yale University Press, 1990), p. 15.
28. In Uganda, the government spends $2.50 per capita per year on health care and $15 per capita per year on debt servicing. See Dorothy E. Logie and Solomon R. Benatar, "Africa in the 21st Century: Can Despair be Turned to Hope?" British Medical Journal 315 (1997): 1444-46.
29. E.C.O. Edi-Osagie and N.E. Edi-Osagie, "Placebo Trials Are Unethical for Established, Untested Treatments," British Medical Journal 316 (1998): 625-26, at 625.
30. George J. Annas and Michael A. Grodin, "Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa," American Journal of Public Health 88, no. 4 (1998): 560-63.
31. Annas and Grodin, "Human Rights."
32. For example, Glaxo Wellcome, the manufacturers of AZT, announced in March 1998 that they would substantially reduce the price of AZT in order to make it more available to developing countries in their battle against vertical HIV transmission. See UNAIDS Press Release, "UNAIDS Statement Commending Glaxo Wellcome for Reducing Cost of AZT for Pregnant Women with HIV in Developing World," http://www.us.unaids.org/high-band/press/glaxo.html.
33. Elliot Marseille, James G. Kahn, and Joseph Saba, "Cost-Effectiveness of Antiviral Drug Therapy to Reduce Mother-to-Child HIV Transmission in sub-Saharan Africa," AIDS 12, no. 8 (1998): 939-48. The CDC/ Thailand protocol might nevertheless still be defended on the ground that its demonstration of the effectiveness of a $50 dose of AZT could prove decisive in convincing the drug company to lower its prices. This fact speaks in favor of a more flexible attitude toward the ethical preconditions of such trials. It is worth remembering that the initial measles vaccine originally cost $50 but can now be purchased for $1.
34. Elizabeth Glaser Pediatric AIDS Foundation and the Emory/Atlanta Center for AIDS Research, Science, Ethics and the Future of Research into Maternal Infant Transmission of Human Immunodeficiency Virus-Drafi Document, Atlanta, 26 August 1998.
35. Similar recommendations are found in A. van Vliet and J. van Roosmalen, "Worldwide Prevention of Vertical Human Immunodeficiency Virus (HIV) Transmission," Obstetrical and Gynecological Survey 52, no. 5 (1997): 301-309.
36. Richard D. Semba, Paolo G. Miotti, John D. Chiphangwi et al., "Maternal Vitamin A Deficiency and Mother-to-Child Transmission of HIV-1," The Lancet 343 (1994): 1593-97.
37. Semba, "Overview of the Potential Role of Vitamin A."
38. Semba, "Overview of the Potential Role of Vitamin A."
39. Centers for Disease Control and Prevention, "Administration of Zidovudine," p. 153.
40. Charles Weijer and Carl Elliott, "Down with Placebolatry," New Scientist 149 (1996): 47. The term "placebolatry" is Benjamin Freedman's.