What makes placebo-controlled trials unethical?

Franklin G. Miller, Howard Brody

Research output: Contribution to journalArticle

164 Scopus citations

Abstract

The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm.

Original languageEnglish (US)
Pages (from-to)3-9
Number of pages7
JournalAmerican Journal of Bioethics
Volume2
Issue number2
DOIs
StatePublished - Mar 2002

Keywords

  • Clinical equipoise
  • Clinical trials versus treatment
  • Placebo-controlled clinical trials
  • Risk-benefit assessment
  • Scientific and clinical merit
  • Therapeutic obligation

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy

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