A former Pfizer Inc. official in a lawsuit accused the company of illegally boosting sales of its top-selling drug Lipitor through an elaborate campaign of misleading educational programs for doctors.
Jesse Polansky, claims that the educational campaign was a key part of a marketing strategy that "led thousands of physicians to prescribe Lipitor for millions of patients who did not need medication" and could be harmed by overly aggressive treatment. Dr. Polansky was Pfizer's director of outcomes management strategies from 2001 to 2003, and his responsibilities included reviewing some of the marketing materials for Lipitor and other Pifzer products. He says he was fired by Pfizer after complaining about marketing he considered to be improper. Dr. Polansky now works as the senior medical officer for Medicare in a unit that investigates fraud and abuse at the big government health insurer.
The suit seeks compensation for Dr. Polansky as a whistleblower under laws that could give him a share of money recovered for any overpayments made by federal health-insurance programs. Lipitor, a type of cholesterol treatment known as a statin, is the world's biggest-selling drug, with sales of $13.6 billion last year, according to IMS Health. The allegations against Pfizer echo concern elsewhere that continuing medical-education programs for doctors are often sales pitches for "off-label" uses of drugs. A congressional committee this past summer said it was concerned there was little oversight of these programs -- where doctors are often wined and dined -- or enforcement when companies use them as marketing tools.
Pharmaceutical companies are prohibited from marketing drugs for indications other than what the FDA approves them for, although doctors aren't prohibited from prescribing them for unapproved uses. Independent educational programs can discuss off-label uses that aren't FDA approved. But Dr. Polansky's lawsuit charges that the Pfizer-funded programs weren't independent. The Lipitor educational programs were run by companies paid by Pfizer through "unrestricted educational grants," the lawsuit says. It alleges that the educational programs were integrated into the marketing plan for the drug, citing an internal Pfizer marketing plan for Lipitor with a page titled "Medical Education Platform Supports the New Positioning." Among other things, Dr. Polansky says Pfizer wanted to extend Lipitor use beyond the indications found on the drug's label by targeting people at moderate risk of developing heart disease or having a heart attack. He said the educational programs for doctors deliberately misrepresented the drug's label to encourage Lipitor therapy for people in the moderate-risk category who didn't need the drug. In his suit, Dr. Polansky also said the Pfizer programs included deliberate misinformation promoting the idea that kidney-disease patients may need to be treated with statins. While kidney disease is recognized by some doctors as a risk for heart disease, it isn't part of the federal guidelines that factor into Lipitor's approved use.
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