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Previous Volume 352:2553-2555 June 16, 2005 Number 24 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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To the Editor: Okie's Perspective article (March 17 issue)¹ on the Food and Drug Administration (FDA) covers important ground but misses a key issue. No drug is absolutely safe; drug safety is always assessed in relation to the disease being treated. We tolerate greater risk from beneficial therapy when the alternatives are bad.

Risk–benefit analysis requires us to define the target population for the drug. Clinical trials are the best way to define this population. Direct-to-consumer marketing campaigns, on which drug companies spend billions of dollars, circumvent this process and often encourage patients to demand prescription drugs inappropriately. Rofecoxib (Vioxx) . . . [Full Text of this Article]

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