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To the Editor: While I generally agree with the advocacy position taken by Mr Moore and colleagues¹ that more resources be committed to the postmarketing surveillance of adverse drug events (ADEs) occurring with the use of marketed medications and other treatments, most of their suggestions are based on hyperbole and not on an appreciation of the principles or difficulties of surveillance. Consider their suggestion that the Food and Drug Administration (FDA) enumerate or estimate drug-induced disease and deaths much as the National Highway Transportation Safety Administration and Federal Aviation Administration (FAA) track motor vehicle and airplane crashes and deaths. Although this sounds rational and easy, it is unclear exactly how a drug-induced clinical event should be defined, especially since most events of interest are not particularly specific to a single drug or population. Whereas judging a death in an automobile crash as being caused by the crash is correct almost . . . [Full Text of this Article]

Thomas J. Moore
George Washington University School of Public Health and Health Services
Washington, DC

Bruce M. Psaty, MD, PhD
University of Washington School of Medicine
Seattle

Curt D. Furberg, MD, PhD
Wake Forest University School of Medicine
Winston-Salem, NC

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