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.