An amended whistleblower suit alleges that pharmaceutical company Pfizer unlawfully marketed Lipitor to the public for more than seven years and deliberately misrepresented U.S. guidelines, including those issued by the National Institutes of Health.
Lipitor, a statin, is indicated for use by the FDA for persons with “evaluated levels of low-density lipoprotein (LDL), so-called bad cholesterol.”
According to court documents, Jesse Polansky, MD, former director of Pfizer's Outcomes Management Strategies and medical director for its marketing team review committee, has accused New York City-based Pfizer of prescribing Lipitor, to “millions of patients for whom drug therapy is not recommended, and for whom the medication could be dangerous.”
The plaintiff accuses Pfizer of misrepresenting the guidelines set forth by the National Institutes of Health, National Heart, Lung and Blood Institute, the National Cholesterol Education Program (NCEP) and the Adult Treatment Plan III.
According to the guidelines, 100 million Americans have elevated cholesterol requiring lifestyle modifications or drug therapy, however, only 36.5 million of those are approved for drug therapy. According to the court documents, more than 26 million Americans have been prescribed Lipitor to treat high blood pressure.
Of the 17.4 million patients with elevated cholesterol, only 2.8 million were indicated for drug therapy, based on the court documents. “Pfizer realized that by off-label marketing to the balance of “moderate risk” patients, it could increase its revenues by billions of dollars,” the plaintiff charged.
As a result of marketing Lipitor to these patients, annual sales increased 126 percent, from $5.4 billion in 2000 to $12.2 billion in 2005. According to the documents, Lipitor sales exceeded $13 billion in 2006.
Polansky alleges that these overabundant prescriptions were funded by government healthcare plans including federal programs, state programs such as Medicaid, pharmacy benefit managers, HMOs and others. He also claimed that Pfizer created “false” and “misleading” promotional materials to market the drug.
The documents allege that Pfizer “never applied to the FDA for approval of off-guideline use of Lipitor, uses outside the scope of the NCEP guidelines.”
Under the filing of this False Claims Act, Polansky seeks to recover damages and civil penalties stemming from the false marketing claims.