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Invited Commentary
Health Care Reform
November 23, 2009

Bringing the FDA's Information to Market: Comment on “Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data”

Arch Intern Med. 2009;169(21):1985-1987. doi:10.1001/archinternmed.2009.399

Here is a challenge: Imagine you are asked to turn a new prescription drug into a blockbuster. The drug is approved by the US Food and Drug Administration (FDA) to treat arthritis pain. That is good news because the arthritis market is huge. But you face some big challenges. First, there are several over-the-counter drugs available that treat pain equally well and at one-fiftieth of the cost. Your only comparative advantage is that your drug causes less gastrointestinal tract (GI) bleeding than other arthritis pain medicines. But this reduction is not very big and only applies to a very small slice (probably <5%) of the market—people at high risk for GI bleeding. And, oh yes, your drug may triple the chance of myocardial infarction.

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