Hostname: page-component-8448b6f56d-wq2xx Total loading time: 0 Render date: 2024-04-23T15:40:31.369Z Has data issue: false hasContentIssue false
  • English
  • Français

The Balm of Gilead: Is the Provision of Treatment to Those Who Seroconvert in HIV Prevention Trials a Matter of Moral Obligation or Moral Negotiation?

Published online by Cambridge University Press:  01 January 2021

Charles Weijer  and
Guy J. LeBlanc
Get access Rights & Permissions [Opens in a new window]

Extract

Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?

(Jeremiah 8:22)

In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health (NIH), U.S. Centers for Disease Control and Prevention (CDC), and the Bill and Melinda Gates Foundation (Gates Foundation) testing the safety and efficacy of tenofovir (Viread), an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 34 , Issue 4 , Winter 2006 , pp. 793 - 808
Copyright
Copyright © American Society of Law, Medicine and Ethics 2006

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Family Health International, FHI Oral Tenofovir Study. Available at <http://www.fhi.org/en/RH/Pubs/Briefs/fhitdfstudy,htm> (last visited August 10, 2006).+(last+visited+August+10,+2006).>Google Scholar
Press Release, Gilead Sciences and Aspen Pharmacare Sign Letter of Intent to Establish Non-Exclusive Licensing and Distribution Agreement for Antiretrovirals Truvada and Viread in Developing World Countries. Available at <http://www.gilead.com/wt/sec/pr_700521> (last visited August 10, 2006).+(last+visited+August+10,+2006).>Google Scholar
Chase, M. and Naik, G., “Key AIDS Study in Cambodia Now in Jeopardy,” The Wall Street Journal, August 12, 2004, at B1.Google Scholar
Anonymous, “Cambodia Halts AIDS Drug Testing,” Morning Star, August 12, 2004, at 3.Google Scholar
Anonymous, “The Trials of Tenofovir Trials,” The Lancet 365 (2005): at 1111.CrossRefGoogle Scholar
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington: DHEW Publication (OS) 78–0012, 1978).Google Scholar
Weijer, C. and Miller, P. B., “When are Research Risks Reasonable in Relation to Anticipated Benefits?” Nature Medicine 10 (2004): 570–573.CrossRefGoogle Scholar
Weijer, C., “Protecting Communities in Research: Philosophical and Pragmatic Challenges,” Cambridge Quarterly of Healthcare Ethics 8 (1999): 501–513.CrossRefGoogle Scholar
Weijer, C. and Emanuel, E. J., “Protecting Communities in Biomedical Research,” Science 289 (2000): 1142–1144.CrossRefGoogle Scholar
45 CFR 46.Google Scholar
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Compensation for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects. Volume 1: Report (Washington, DC: U.S. Government Printing Office, 1982): at 53.Google Scholar
Childress, J. F., “Compensating Injured Research Subjects: The Moral Argument,” Hastings Center Report 6, no.6 (1976): 21–27, at 24.CrossRefGoogle Scholar
Health Education and Welfare Secretary's Task Force, Compensation of Injured Research Subjects (Washington, DC: DHEW, 1977).Google Scholar
Id., at VI-9.Google Scholar
Childress, supra note 12, at 26.Google Scholar
Black, H. C., Black's Law Dictionary (St. Paul, MN: West Publishing Co., 1990): at 1225.Google Scholar
Schuklenk, U. Ashcroft, R., “International Research Ethics,” Bioethics 14 (2000): 158–172, at 168.CrossRefGoogle Scholar
Slack, C. Stobie, M. Milford, C. Lindegger, G. Wassenaar, D. Strode, A. Ijsselmuiden, C, “Provision of HIV Treatment in HIV Prevention Trials: A Developing Country Perspective,” Social Science & Medicine 60 (2005): 1197–1208.CrossRefGoogle Scholar
Slack, et al., supra note 18, at 1199.Google Scholar
Id.Google Scholar
Id.Google Scholar
Levine, R. J., Ethics and Regulation of Clinical Research (New Haven, CT: Yale University Press, 1988): at 155.Google ScholarPubMed
Nuffield Council on Bioethics, The Ethics of Research Related to Health Care in Developing Countries (London: Nuffield Council on Bioethics, 2002): at 153–154. Also available at <http://www.nuffeldbioethics.org/go/ourwork/developingcountries/introduction> (last visited August 10, 2006).+(last+visited+August+10,+2006).>Google Scholar
Id., at 96. See also page 139.Google Scholar
Medical Research Council of South Africa, Guidelines on Ethics for Medical Research: HIV Preventive Vaccine Research (Johannesburg: Medical Research Council of South Africa, 2003): at 31. Also available at <http://sahealthinfo.org/ethics/book5.htm> (last visited August 10, 2006).+(last+visited+August+10,+2006).>Google Scholar
WHO-UNAIDS Report, Treating People with Intercurrent Infection in HIV Prevention Trials: Report from a WHO/UNAIDS Consultation, Geneva July 17–18, 2003. AIDS 18 (2004): W1–W12.CrossRefGoogle Scholar
Fitzgerald, D. W. Pape, J. W. Wasserheit, J. N. Counts, G. W., and Corey, L., “Provision of Treatment in HIV-1 Vaccine Trials in Developing Countries,” The Lancet 362, no. 9388 (2003): 993–4, at 993.CrossRefGoogle Scholar
Id.Google Scholar
Macklin, R., Double Standards in Medical Research in Developing Countries (Cambridge: Cambridge University Press, 2004): at 252–253.CrossRefGoogle Scholar
Supra note 27.Google Scholar
Supra note 26.Google Scholar
Id., at 4. Compare with Macklin, supra note 29, at 254: “Instead, the justification [for providing treatment] lies partly in another principle of research ethics: maximize benefits and minimize harms to subjects. Granted, that principle is usually interpreted to refer to the benefits and harms that flow directly from the research maneuvers themselves. But there is no reason why the principle of beneficence cannot also apply more broadly to care and treatment provided to research subjects.”Google Scholar
Weijer, and Miller, supra note 7.Google Scholar
Bass, E., “Ethics, Antiretrovirals, and Prevention Trials: An Online Debate,” IAVI Report 7, no. 3 (2003), available at <http://www.iavireport.org/Issues/0104/EthicsAntiretroviralsandPreventionTrials.asp> (last visited August 10, 2006).Google Scholar
Id.Google Scholar
Supra note 26. Compare with R. Macklin, “Ethics and Equity in Access to HIV Treatment – 3 by 5 Initiative,” Background paper for the consultation on ethics and equitable access to treatment and care for HIV/AIDS, Geneva, 2004: “Justice as reciprocity calls for providing something in return for contributions that people have made. One example might be individuals who have participated in HIV-related research: participants in AIDS treatment trials, and those in epidemiologic or preventive vaccine trials discovered to be HIV positive. These people undertook the risks or inconvenience of serving as research subjects without a guarantee of receiving any direct beneft.”Google Scholar
Bass, supra note 34.Google Scholar
Id.Google Scholar
Supra note 26, at 4. Compare with Macklin, supra note 29, at 254: “[J]ustice as equality rejects both geographical location and economic status as a basis for determining what justice requires. Since research in today's world is a global enterprise, justice in international research calls for treating subjects equally whether they live in Boston or Botswana, Utah or Uganda.”Google Scholar
Slack, et al., supra note 18, at 1204.Google Scholar
Shapiro, K. and Benatar, S. R., “HIV Prevention Research and Global Inequality: Steps Towards Improved Standards of Care,” Journal of Medical Ethics 31 (2005): 39–47.CrossRefGoogle Scholar
Id., at 40.Google Scholar
Id.Google Scholar
Id., at 42.Google Scholar
Miller, P. B. and Weijer, C., “Fiduciary Obligations in Clinical Research,” Journal of Law, Medicine & Ethics 34 (2006): 424–440.CrossRefGoogle Scholar
Weijer, supra note 8.Google Scholar
Weijer, and Emanuel, supra note 9.Google Scholar
Weijer, C. Goldsand, G., and Emanuel, E. J., “Protecting Communities in Research: Current Guidelines and Limits of Extrapolation,” Nature Genetics 23 (1999): 275–280.CrossRefGoogle Scholar
Council for International Organizations of Medical Sciences, International Ethics Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 2002): Guideline 10.Google Scholar
Joint United Nations Programme on HIV/AIDS, Ethical Considerations in HIV Preventive Vaccine Research (Geneva: UNAIDS, 2000): Guidance point 5.Google Scholar
U.S. National Bioethics Advisory Commission, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, vol. 1 (Bethesda, Maryland: National Bioethics Advisory Commission, 2001): Recommendation 2.3.Google Scholar
Wellcome Trust, Research Involving People Living in Developing Countries: Position Statement and Guidance Notes for Applicants, 2005, available at <http://www.wellcome.ac.uk/doc_wtd015295.html> (last visited August 10, 2006).+(last+visited+August+10,+2006).>Google Scholar
UNAIDS, supra note 50, guidance point 16.Google Scholar
Nuffield Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries: A Follow-up Discussion Paper (London: Nuffield Council on Bioethics, 2005): at 32. Available at <http://www.nuffeldbioethics.org/go/ourwork/developingcountries/publication_169.tml> (last visited August 10, 2006).+(last+visited+August+10,+2006).>Google Scholar
The Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries, “Moral Standards for Research in Developing: From ‘Reasonable Availability’ to ‘Fair Benefits’,” Hastings Center Report 34, no. 3 (2004): 17–27.Google Scholar
Supra note 55, at 20.Google Scholar
Supra note 55, at 23.Google Scholar
Supra note 26, at 4.Google Scholar