HEALTH CARE REFORM
Bringing the FDA's Information to MarketComment on "Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data"
Steven Woloshin, MD, MS;
Lisa M. Schwartz, MD, MS
Arch Intern Med. 2009;169(21):1985-1987.
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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.
Do you think you could get physicians to prescribe your drug to over 20 million Americans? Could . . . [Full Text of this Article] THE VIOXX STORY
MAKING INFORMATION AVAILABLE
AUTHOR INFORMATION
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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
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Communicating Uncertainties About Prescription Drugs to the Public: A National Randomized Trial
Schwartz and Woloshin
Arch Intern Med 2011;171:1463-1468.
ABSTRACT
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It Is Time for Food and Drug Administration Reform
Guharoy
Arch Intern Med 2010;170:737-737.
FULL TEXT
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