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A Counterpoint

Brian L. Strom, MD, MPH

JAMA. 2004;292:2643-2646. Published online November 22, 2004 (doi:10.1001/jama.292.21.2643)

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Health care practitioners and patients seek safe and effective drugs. However, no drug is completely safe; all drugs have toxic effects that must be balanced with their benefits in deciding whether they should be marketed or used in any given person. To inform such decisions, the United States relies on a drug approval system whereby preclinical studies precede 3 phases of clinical studies. Collectively, these usually include 500 to 3000 exposed patients and 2 or more confirmatory trials, demonstrating before marketing that a drug is effective and reasonably safe for its recommended use.¹ Thus, adverse reactions occurring in 1% or more of exposed patients are usually well described upon marketing. However, rarer adverse reactions are not well characterized until after marketing.² This reflects a deliberate societal decision to balance delays in access to new drugs with delays in information about rare adverse reactions. To provide . . . [Full Text of this Article]

Spontaneous Reporting System



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