Public Release:  Top-selling prescription drug mismarketed to women

Wiley

Ithaca, N.Y. - September 17, 2008 - Lipitor has been the top-selling drug in the world and has accounted for over $12 billion in annual sales. It has been prescribed to both men and women to lower cholesterol and reduce the risk of heart attack and stroke in patients with common risk factors for heart disease. However, a new study appearing in the Journal of Empirical Legal Studies was unable to find high quality clinical evidence documenting reduced heart attack risk for women in a primary prevention context. Furthermore, advertising omits label information relevant to women.

Theodore Eisenberg of Cornell Law School and Martin T. Wells of Cornell University assembled studies for a meta analysis of drugs' effects on cardiovascular risk, taking into account all relevant studies reporting risks for both men and women.

Not one of the studies that included women with a mixture of risk factors for heart attacks provided statistically significant support for prescribing Lipitor or other statins to protect against cardiovascular problems. Pfizer's claims of clinical proof that Lipitor reduces risk of heart attack in patients with multiple risk factors for heart disease does not appear to be scientifically supported for large segments of the female population.

In addition, Lipitor's advertising repeatedly fails to report that clinical trials were statistically significant for men but not for women. Unqualified advertising claims of protection against heart attacks may therefore be misleading. Pfizer's advertising also does not disclose critical portions of the Lipitor FDA-approved label, which acknowledges the absence of evidence with respect to women.

"Our findings indicate that each year, reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks but that scientific evidence supporting their hope does not exist," the authors conclude.

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This study is published in the September 2008 issue of the Journal of Empirical Legal Studies. Media wishing to receive a PDF of this article may contact journalnews@bos.blackwellpublishing.net.

Theodore Eisenberg is affiliated with Cornell Law School and can be reached for questions at ted-eisenberg@lawschool.cornell.edu.

Journal of Empirical Legal Studies (JELS) fills a gap in the legal and social science literature that has often left scholars, lawyers, and policymakers without basic knowledge of legal systems. Always timely and provocative, studies published in JELS have been covered in leading news outlets such as the New York Times, the Wall Street Journal, the Economist, Forbes Magazine, the Financial Times, and USA Today.

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