IN THIS issue of the ARCHIVES, Kahn et al1 summarize the findings of their analysis of primary and supervisory review documents and memoranda, authored by Food and Drug Administration clinical and statistical staff, that were obtained under the Freedom of Information Act from the files of 7 antidepressant New Drug Applications approved between 1987 and 1997. The authors undertook their analysis in an effort to determine whether there was any evidence within the agency's reviews of the comprehensive reports that drug sponsors make to the Food and Drug Administration to support the suspicion/belief, widely prevalent among those who question the ethical propriety of placebo-controlled trials, that patient-subjects randomized to placebo are at greater risk of injury and/or suffer greater substantive discomfort than those assigned to other experimental treatment conditions.
Leber P. Placebo ControlsNo News Is Good News. Arch Gen Psychiatry. 2000;57(4):319-320. doi:10.1001/archpsyc.57.4.319