A Lipitor marketing campaign illegally used misleading educational programs for doctors to boost sales of the drug, a former Pfizer executive claims. The Lipitor allegations against the drug maker are part of a whistleblower lawsuit filed in U.S. District Court for the Eastern District of New York in February 2004. The allegations raise serious questions about the way pharmaceutical companies use so-called “educational” programs to market drugs. Very often, such programs promote non-approved uses, overstate benefits, and downplay drug side effects.
Lipitor, known generically as Atorvastatin, is a member of the drug class known as statins. Lipitor was approved by the Food & Drug Administration for lowering cholesterol. Lipitor inhibits the rate-determining enzyme located in hepatic tissue that produces mevalonate, a small molecule used in the synthesis of cholesterol. This lowers the amount of cholesterol produced which in turn lowers the total amount of LDL – or bad -cholesterol. Lipitor is the world’s biggest-selling drug, with sales of $13.6 billion last year.
The Pfizer lawsuit was brought by Dr. Jesse Polansky, 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. Polansky claims he was fired by Pfizer after complaining of the company’s marketing practices. The lawsuit says that Lipitor educational programs were run by companies paid by Pfizer through “unrestricted educational grants.” Polansky claims that these programs promoted off-label use of Lipitor. According to the Wall Street Journal, in his suit, Dr. Polansky 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.
Drug companies are not allowed to market drugs based on such off-label uses, although doctors are allowed to prescribe medications any way they see fit. 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.
Concerns that drug companies like Pfizer use such “educational” programs to improperly market medications have been building for some time. Over the summer, a congressional committee convened a hearing over the issue. Just last month, the New York Times published a piece by Dr. Daniel Carlat, who recounted his experiences as a Wyeth-paid lecturer for the anti-depressant Effexor. According to Dr. Carlat, the Effexor information Wyeth instructed him to convey during visits to physician offices was often incomplete, downplayed risks, and was skewered to favor Effexor over other drugs. When Dr. Carlat, uncomfortable with the Wyeth-provided script, altered it to include more complete data on some of the drug’s risks, he was visited by a district manager, who expressed concern that the doctor was not exhibiting enough “enthusiasm” in his talks. Dr Carlat quit lecturing for Wyeth shortly after that episode.