Billions of healthcare dollars may be being wasted on statin use in women, especially Pfizer’s popular Lipitor, for which the current regulatory regime does not create incentives to prevent such behavior, according to meta-analyses published online Sept. 5 in the Journal of Empirical Legal Studies.
Theodore Eisenberg and Martin T. Wells from Cornell Law School and University, respectively, in Ithaca, N.Y., performed meta-analyses of studies of cardio-protection of women and men by statins, including Lipitor (atorvastatin), and a legal analysis of advertising promoting Lipitor as preventing heart attacks.
The New York City-based Pfizer’s Lipitor had nearly $13 billion in sales in 2007, making it the best-selling drug in the world.
According to the researchers, the analyses do not support statin use to reduce heart attacks in women based on extrapolation from men, or approving or advertising statins as reducing heart attacks without qualification in a population that includes many women.
The researchers said the legal analyses raised the question of whether Lipitor's advertisements, which omit the drug’s slight increased risk for women, is consistent with the Food, Drug, and Cosmetics Act and related FDA regulations.
The investigators found that they were unable to find high-quality clinical evidence documenting reduced heart attack risk for women in a primary prevention context.
Based on their findings, Eisenberg and Wells found that FDA regulation should not preempt state law actions, which is currently challenging advertising that is not supported by FDA-approved labeling. They said that their findings suggest inadequate regulation of the world's best-selling drug, and they also counseled against the courts accepting the FDA’s claimed preemption of state law causes of action relating to warnings and safety.
The authors advise that courts evaluating preemption claims should consider actual agency performance as well as theoretical institutional competence.
“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 concluded.