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(Circulation. 2006;113:2173-2176.)
© 2006 American Heart Association, Inc.

Editorial

Evaluating Drug Effects in the Post-Vioxx World

There Must Be a Better Way

Jerry Avorn, MD

From the Department of Medicine, Harvard Medical School, and Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Mass.

Correspondence to Jerry Avorn, MD, Division of Pharmacoepidemiology and Pharmacoeconomics, 1620 Tremont St, Suite 3030, Boston, MA 02120. E-mail javorn@partners.org

Key Words: Editorials • drugs • epidemiology • pharmacology • prevention

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
The drug approval process must determine efficacy validly, detect risks prudently, and do both in a timely and efficient way. Several high-profile medication withdrawals in recent years have refocused attention on the difficulty of the US healthcare system in meeting these goals. Rofecoxib (Vioxx, Merck) was taken off the market in September 2004 after 5 years of use by &20 million people, when its manufacturer reported that the drug doubles the risk of myocardial infarction or stroke. That experience, as well as other instances in which important side effects came to public attention long after a drug’s approval, has prompted discussion about how to repair the nation’s drug evaluation process. Some have proposed changing the degree of statistical certainty required for initial drug approval, with the hope that demanding a probability value of <0.0001 for efficacy (rather than the conventionally required 0.05) would slow down the approval process enough to increase the likelihood that adverse events would be detected. This idea is evaluated and rejected by Roth-Cline in the this issue of Circulation.¹ It is true that demanding unprecedentedly stringent tests for efficacy is a poor way to fix the nation’s drug safety problem, but not necessarily for the reasons Roth-Cline advances. A better solution will have to be based on a more comprehensive understanding of how the risks of new drugs are detected, evaluated, and addressed.

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The thalidomide tragedy of the early 1960s led to important reforms in the regulatory authority of the Food and . . . [Full Text of this Article]

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