Pfizer Is Sued Over Lipitor

Pfizer Is Sued Over Lipitor Marketing
By DAVID ARMSTRONG
December 20, 2007; Page B5

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.

The lawsuit was filed in U.S. District Court for the Eastern District of New York in February 2004. It was immediately sealed to allow federal prosecutors time to decide if they wanted to intervene in the case. In August, the government said it wouldn't intervene, lifting the seal. Pfizer was served a copy of the suit yesterday, according to Dr. Polansky's lawyer, Steve Berman of Hagens Berman Sobol Shapiro.

The failure of the government to intervene may signal that prosecutors are skeptical about the merits of the case. The government hasn't intervened in other cases which led to huge fines against drug companies. One example is another case involving Pfizer, this one for the off-label marketing of Neurontin.

Pfizer said, "We believe this case has no merit. Furthermore, after reviewing the allegations in this complaint, the government declined to intervene in this action... . Pfizer does not condone the off-label promotion of our products. We believe that our sales and marketing practices are solely based on our prescription information as approved by the U.S. Food and Drug Administration."

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.