Placebo orthodoxy and the double standard of care in multinational clinical research.

Maya J Goldenberg
Author Information
  1. Maya J Goldenberg: Department of Philosophy, University of Guelph, Guelph, ON, N1G 2W1, Canada, mgolden@uoguelph.ca.

Abstract

It has been almost 20 years since the field of bioethics was galvanized by a controversial series of multinational AZT trials employing placebo controls on pregnant HIV-positive women in the developing world even though a standard of care existed in the sponsor countries. The trove of ethical investigations that followed was thoughtful and challenging, yet an important and problematic methodological assumption was left unexplored. In this article, I revisit the famous "double standard of care" case study in order to offer novel consideration of the placebo orthodoxy that underlies much of the ethical debate. This majority view found in medical research is that placebo-controlled trials are methodologically superior to comparative trials that use active controls. I challenge this orthodoxy and argue that lives were unnecessarily lost in these trials as a result. Furthermore, current HIV research on vaccines and microbicides is now poised to repeat the error of subscribing to the placebo orthodoxy.

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MeSH Term

Anti-HIV Agents
Controlled Clinical Trials as Topic
Developed Countries
Developing Countries
Female
HIV Infections
Healthcare Disparities
Humans
Infectious Disease Transmission, Vertical
Informed Consent
International Cooperation
Placebos
Pregnancy
Pregnancy Complications, Infectious
Research Design
Social Justice
Standard of Care
Zidovudine

Chemicals

Anti-HIV Agents
Placebos
Zidovudine

Word Cloud

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