Regulation with placebo effects

Duke Law J. 2008 Dec;58(3):411-72..

Abstract

A growing scientific literature supports the existence of placebo effects from a wide range of health interventions and for a range of medical conditions. This Article reviews this literature, examines the implications for law and policy, and suggests future areas for research on placebo effects. In particular, it makes the case for altering the drug approval process to account for, if not credit, placebo effects. It recommends that evidence of placebo effects be permitted as a defense in cases alleging violations of informed consent or false advertising. Finally, it finds that tort law already has doctrines such as joint and several liability to account for placebo effects. Future research on placebo effects should focus on whether awareness of placebo effects can disable these effects and whether subjects can control their own placebo effects.

MeSH terms

  • Bias
  • Clinical Trials as Topic / legislation & jurisprudence*
  • Consumer Advocacy / legislation & jurisprudence
  • Drug Approval / legislation & jurisprudence*
  • Fraud / legislation & jurisprudence
  • Humans
  • Informed Consent / legislation & jurisprudence
  • Legislation, Drug*
  • Liability, Legal
  • Malpractice / legislation & jurisprudence
  • Placebo Effect*
  • United States
  • United States Food and Drug Administration