The Ethics of Placebo-Controlled Trials

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Abstract
Emanuel and Miller (Sept. 20 issue)1 characterize the current debate about placebo-controlled trials as a debate between two orthodoxies: placebo orthodoxy and active-control orthodoxy. We used the term “placebo orthodoxy” to describe the widely held but incorrect view that the use of a placebo control is always better than the use of an active control.2,3 Labeling our position “active-control orthodoxy” wrongly suggests that we believe that “if an effective therapy exists, the use of a placebo should be prohibited” in all cases.1 We do, however, represent a clinical-equipoise orthodoxy in believing that therapeutic interventions in research must be consistent with physicians' duty of care to patients.4 Mounting a trial requires genuine disagreement among expert practitioners as to the preferred treatment.4 If expert clinicians hold, as we believe they do, that not treating baldness or headaches is consistent with competent medical practice, then a placebo control is permissible. No competent clinician believes that withholding treatment from a severely depressed or schizophrenic patient is acceptable, and hence placebo-controlled trials in such cases are unethical.5

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