How Good Is “Good Enough”? The Case for Varying Standards of Evidence According to Need for New Interventions in HIV Prevention
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
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American Journal of Bioethics 12 (6):21-30 (2012)
In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it.
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References found in this work BETA
Franklin G. Miller & Howard Brody (2003). A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials. Hastings Center Report 33 (3):19-28.
Alex John London & Kevin J. S. Zollman (2010). Research at the Auction Block: Problems for the Fair Benefits Approach to International Research. Hastings Center Report 40 (4):34-45.
Ruth Macklin (1999). Against Relativism: Cultural Diversity and the Search for Ethical Universals in Medicine. Oxford University Press.
Ruth Macklin (2001). After Helsinki: Unresolved Issues in International Research. Kennedy Institute of Ethics Journal 11 (1):17-36.
Richard Ashcroft (1999). Equipoise, Knowledge and Ethics in Clinical Research and Practice. Bioethics 13 (3-4):314-326.
Citations of this work BETA
Bridget Haire (2015). It’s Time: The Case for PrEP as an Active Comparator in HIV Biomedical Prevention Trials. Journal of Bioethical Inquiry 12 (2):239-249.
Bridget Haire & John M. Kaldor (2013). Ethics of ARV Based Prevention: Treatment‐as‐Prevention and PrEP. Developing World Bioethics 13 (2):63-69.
Sarah J. L. Edwards, Sapfo Lignou & Elizabeth Oduwo (2012). Evidence of Efficacy and Human Right to Health. American Journal of Bioethics 12 (6):35-37.
Quarraisha Abdool Karim & Ronald Bayer (2013). Anti‐Retrovirals for Treatment and Prevention – Time for New Paradigms in Our Response to the HIV/AIDS Epidemic? Developing World Bioethics 13 (2):ii-iii.
Bridget Haire, Morenike Oluwatoyin Folayan, Catherine Hankins, Jeremy Sugarman, Sheena McCormack, Gita Ramjee & Mitchell Warren (2013). Ethical Considerations in Determining Standard of Prevention Packages for HIV Prevention Trials: Examining PrEP. Developing World Bioethics 13 (2):87-94.
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