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.
This study is published in the September 2008 issue of the Journal of Empirical Legal Studies.
As many of you already know, I am not a big fan of Lipitor or other statins, such as Crestor, Pravachol, Zocor, Mevacor and Lescol. Their use in prevention of heart disease leaves a lot to be desired. While not being a fan of statin drugs, I still am a fan of the pharmaceutical industry, just as I am a fan of the vitamin and neutraceutical industries, as long as their claims are valid and marketed truthfully.
I hope I am wrong, but this article from the Journal of Empirical Legal Studies may be a trial balloon for legal trouble for the pharmaceutical industry. We may soon see health insurers, Medicare and State Medicaid filing lawsuits worth billions of dollars to recover money spent on alleged false claims for Lipitor.