Skip to main content
SpringerLink
Log in

Use and abuse of empirical knowledge in contemporary bioethics

  • Published:
Medicine, Health Care and Philosophy Aims and scope Submit manuscript

Abstract

In 1997 a debate broke out about the ethical acceptability of using placebo as a comparative alternative to establishe effective treatment in trials conducted in developing countries for the purpose of preventing perinatal HIV-transmission. The debate has now been going on for more than five years. In spite of extensive and numerous attempts at resolving the controversy, the case seems far from being settled. The aim of this paper is to provide an updated account of the debate, by identifying empirical arguments employed in the controversy and by critically assessing their use in the debate. A notion of resolution of moral conflicts will be introduced that makes it possible to give a more positive verdict on the moral results of this controversy. Finally, the procedural problem of safe-guarding the selection of empirical arguments against undue forms of normative bias will be addressed.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  • Angell, M.: 1997, ‘The Ethics of Clinical Research in the Third World' (Editorial), New England Journal of Medicine 337(12), 847–849.

    Article  PubMed  Google Scholar 

  • Angell, M.: 2000, ‘Investigators' Responsibilities for Human Subjects in Developing Countries’ (Editorial), New England Journal of Medicine 342, 967–969.

    Article  PubMed  Google Scholar 

  • Benatar, S.R.: 2000, ‘Justice and International Research: A Response to Reidar K. Lie’, in: R.J. Levine, S. Gorovitz and J. Gallagher (eds.), Biomedical Research Ethics: Updating International Guidelines. A Consultation. Geneva, pp. 41–50.

  • Brennan, T.A.: 1994, Letter to Gilbert Meier, NIH Division of Research Ethics, December 28.

  • Brody, B.A.: 1997, ‘When Are Placebo-Controlled Trials No Longer Appropriate?’, Controlled Clinical Trials 18, 602–612.

    Article  PubMed  Google Scholar 

  • Christakis, N.A.: 1988, ‘The Ethical Design of an AIDS Vaccine Trial in Africa’, Hastings Center Report 18(3), 31–37.

    Google Scholar 

  • Cochrane, J.: 2000, ‘Narrowing the Gap: Access to HIV Treatments in Developing Countries. A Pharmaceutical Company's Perspective’, Journal of Medical Ethics 26, 47–50.

    Article  PubMed  Google Scholar 

  • Cohen, F.: 1995, ‘Bringing AZT to poor countries’, Science 269, 624–626.

    PubMed  Google Scholar 

  • Council for International Organisations of Medical Sciences (CIOMS): 1993, International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS.

    Google Scholar 

  • Council for International Organisations of Medical Sciences (CIOMS): 2002, International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS.

    Google Scholar 

  • Connor, EM., RS. Sperling and R. Gelbert et al.: 1994, ‘Reduction of Maternal-infant Transmission of Human Immunodeficiency Virus Type 1 with Zidovudine Treatment’, New England Journal of Medicine 331, 1173–1180.

    Article  PubMed  Google Scholar 

  • Crouch, R.A. and J.D. Arras: 1998, ‘AZT Trials and Tribulations’, Hastings Center Report 28(6), 26–34.

    PubMed  Google Scholar 

  • Ekunwe, E.O.: 1984, ‘Informed Consent in the Developing World', Hastings Center Report 14(3), 23.

    Google Scholar 

  • Emanuel, E.J.: 1998, ‘A World of Research Subjects’, Hastings Center Report, 28(6), 25.

    Google Scholar 

  • Emanuel, E.J. and F.K. Miller: 2001, ‘The Ethics of Placebo-Controlled Trials — A Middle Ground', New England Journal of Medicine 345(12), 915–919.

    Article  PubMed  Google Scholar 

  • Enserink, M.: 2000, ‘Helsinki's New Clinical Rules: Fewer Placebos, More Disclosure’, Science 290, 418–419.

    Article  PubMed  Google Scholar 

  • de Fonseca, Q. and R.K. Lie: 1995, ‘Informed Consent to Preventive AIDS Vaccine Trials in Brazil’, AIDS & Public Policy Journal 10, 22–26.

    Google Scholar 

  • de Zulueta, P.: 2001, ‘Randomised Placebo-controlled Trials and HIV-infected Pregnant Women in Developing Countries. Ethical Imperialism or Unethical Exploitations?’, Bioethics 15(4), 289–311.

    Article  PubMed  Google Scholar 

  • del Río, C.: (1998), ‘Is Ethical Research Feasible in Developed and Developing Countries?’, Bioethics 12(4), 328–330.

    Article  PubMed  Google Scholar 

  • Freedman, B.: 1987, ‘Equipoise and the Ethics of Clinical Research’, New England Journal of Medicine 317, 141–145.

    PubMed  Google Scholar 

  • Gifford, F.: 2000, ‘Freedman's “Clinical Equipoise” and “Sliding-Scale All-Dimensions-Considered Equipoise”’, The Journal of Medicine and Philosophy 25(4), 99–426.

    Article  Google Scholar 

  • Gilson, L., R. Mkanje, H. Grosskurth and F. Mosha et al.: 1998, ‘Costeffectiveness of Improved Treatment Services for Sexually Transmitted Diseases in Preventing HIV-1 Infection in Mwanza Region, Tanzania’, The Lancet 350, 1805–1809.

    Article  Google Scholar 

  • Glantz, L.H., G.J. Annas, M.A. Grodin and W.K. Mariner: 1998, ‘Research in Developing Countries. Taking “Benefit” Seriously’, Hastings Center Report 28(6), 38–42.

    PubMed  Google Scholar 

  • Grady, C.: 1998, ‘Science in the Service of Healing’, Hastings Center Report 28(6), 34–38.

    Google Scholar 

  • Ijsselmuiden, C.B. and R.R. Faden: 1992, ‘Research and Informed Consent in Africa. Another Look’, New England Journal of Medicine 326, 830–833.

    PubMed  Google Scholar 

  • Kumara, L. and C. Watts: 1998, ‘Costeffectiveness Estimates of the Mwanza Sexually Transmitted Diseases Intervention’, The Lancet 351, 989.

    Google Scholar 

  • Lallemant, M., S. Le Coeur and K. McIntosh et al.: 1995, ‘AZT Trial in Thailand', Science 270, 899–900.

    PubMed  Google Scholar 

  • Lallemant, M., K. McIntosh and G. Jourdain et al.: 1998, ‘Ethics of Placebo-Controlled Trials of Zidovudine to Prevent the Perinatal Transmission of HIV in the Third World', New England Journal of Medicine 338(12), 839–840.

    Google Scholar 

  • Levine, C.: 1998, ‘Placebos and HIV. Lessons Learned', Hastings Center Report, 28(6), 43–48.

    PubMed  Google Scholar 

  • Levine, R.J.: 2000, ‘Revision of the CIOMS International Guidelines: A Progress Report’, in: R.J. Levine, S. Gorovitz and J. Gallagher (eds.), Biomedical Research Ethics: Updating International Guidelines. A Consultation. Geneva, pp. 4–15.

  • Lie, R.K.:1998, ‘Ethics of Placebo-controlled Trials in Developing Countries’, Bioethics 12(4), 307–311.

    Google Scholar 

  • Lie, R.K.: 2000, ‘Justice and International Rresearch’, in: R.J. Levine, S. Gorovitz and J. Gallagher (eds.), Biomedical Research Ethics: Updating International Guidelines. A Consultation. Geneva, pp. 27–39.

  • Lie, R.K.: 2002, ‘The HIV Perinatal Transmission Studies’, in: R.K. Lie. and P.T. Schotsmans (eds.), Healthy Thoughts. European Perspectives on Health Care Ethics. Leuven: Peeters, pp. 189–206.

    Google Scholar 

  • London, A.J.: 2001, ‘Equipoise and International Humansubjects Research’, Bioethics 15(4), 312–331.

    Article  PubMed  Google Scholar 

  • Lurie, P. and S.M. Wolfe: 1997, ‘Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries’, New England Journal of Medicine 337(12), 853–856.

    Article  PubMed  Google Scholar 

  • Nowak, R.: 1995, ‘Staging Ethical AIDS Trials in Africa’, Science 269, 1332–1335.

    PubMed  Google Scholar 

  • Phanuphak, P.: 1998, ‘Ethical Issues in Studies in Thailand of the Vertical Transmissions of HIV’, New England Journal of Medicine 338(12), 834–835.

    Article  PubMed  Google Scholar 

  • Resnik, B.: 1998, ‘The Ethics of HIV Research in Developing Countries’, Bioethics 12(4), 286–306.

    Article  PubMed  Google Scholar 

  • Ridge, D. and J. Arachne: 1997, ‘From Pharmaceuticals to Alternative Treatments for HIV/AIDS: What is the Potential?’, Health Care Analysis 5, 275–282.

    Article  PubMed  Google Scholar 

  • Rothman, D.J.: 2000, ‘The Shame of Medical Research’, The New York Review, November 30.

  • Rothman, D.J.: 2001, ‘Medical Morals: An Exchange’, The New York Review, March 8.

  • Rothman, D.J.: 2001, ‘The Shame of Medical Research: An Exchange’, The New York Review, May 17.

  • Rothman, K.J. and K.B. Michels: 2000, ‘For and Against. Declaration of Helsinki Should be Strengthened', British Medical Journal 321(12), 442–445.

    PubMed  Google Scholar 

  • Schüklenk, U.: 1998, ‘Unethical Perinatal HIV Transmission Trials Establish Bad Precedent’, Bioethics 12(4), 312–319.

    Article  PubMed  Google Scholar 

  • Shapiro, H.T. and E.M. Meslin: 2001, ‘Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries’, New England Journal of Medicine, 345(2), 139–142.

    Article  PubMed  Google Scholar 

  • Sperling, R.S., D.E. Shapiro and R.W. Coombs et al.: 1996, ‘Maternal Viral Load, Zidovudine Treatment, and the Risk of Transmission of Human Immunodeficiency Virus Type 1 from Mother to Infant’, New England Journal of Medicine 335, 1621–1629.

    Article  PubMed  Google Scholar 

  • Steinbrook, R.: 2002, ‘Preventing HIV Infection in Children’, New England Journal of Medicine 346(24), 1842–1843.

    Article  PubMed  Google Scholar 

  • Steinbrook, R.: 2002, ‘Beyond Barcelona — The Global Responses to HIV’, New England Journal of Medicine 347(8), 553–554.

    Article  PubMed  Google Scholar 

  • Thomas, J.: 1998, ‘Ethical Challenges of HIV Clinical Trials in Developing Countries’, Bioethics 12(4), 320–327.

    Article  PubMed  Google Scholar 

  • Tranøy, K.E.: 1998, Det åpne sinn. Moral og etikk mot et nytt årtusen [The Open Mind. Moral and Ethics in a New Millennium]. Oslo: Universitetsforlaget.

    Google Scholar 

  • Varmus, H. and D. Satcher: 1997, ‘Ethical Complexities of Conducting Research in Developing Countries’, New England Journal of Medicine 337, 1000–1005.

    Article  PubMed  Google Scholar 

  • Weijer, C.: 2000, ‘Ethical Challenges of the Randomized Controlled Trial’, in: R.J. Levine, S. Gorovitz and J. Gallagher (eds.), Biomedical Research Ethics: Updating International Guidelines. A consultation. Geneva, pp. 57–91.

  • Weijer, C. and J.A. Anderson: 2001, ‘The Ethics Wars. Disputes over International Research’, Hastings Center Report 31(3), 18–20.

    PubMed  Google Scholar 

  • Whalen, C.C., J.L. Johnson and A. Okwera et al.: 1997, ‘A Trial of Three Regimens to Prevent Tuberculosis in Ugandan Adults Infected with the Human Immunodeficiency Virus’, New England Journal of Medicine 337, 801–808.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Center for Medical Ethics, University of Oslo, Box 1130, Blindern, 0318, Oslo, Norway

    Jan Helge Solbakk

Authors
  1. Jan Helge Solbakk
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Solbakk, J.H. Use and abuse of empirical knowledge in contemporary bioethics. Med Health Care Philos 7, 5–16 (2004). https://doi.org/10.1023/B:MHEP.0000021845.28818.e2

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1023/B:MHEP.0000021845.28818.e2

Search

Navigation