title: Enhancing patient autonomy through peer review to replace the FDA's rigorous approval process.
abstract: There may once have been a time when doctors unquestioningly accepted the government's declaration of a drug's effectiveness and when patients unquestioningly accepted the prescriptions of their doctors. That time has passed. Now, information--good and bad--showers from all directions on patients and physicians alike. A filter is needed, and peer review provides the best one. But who or what is this validated information for? Ethically, its primary purpose is to enable patients to make decisions consistent with their values. Providing vetted information in a form that is useful to patients requires an emphasis on comprehensible, comprehensive, trustworthy, verifiable, and transparent communication. The hypothetical comparative effectiveness case study in this month's Health Affairs does not appear to rise to the level that would be helpful to providers or patients.
authors.affiliation: Division of Bioethics, New York University Langone Medical Center, New York, NY, USA. Arthur.Caplan@nyumc.org
authors.forename: Arthur
authors.initials: A
authors.lastname: Caplan
mesh_terms: D017277:Drug Approval; D006801:Humans; D017712:Peer Review, Research; D026684:Personal Autonomy; D004364:Pharmaceutical Preparations; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations