How did Pfizer market to doctors?

Pfizer targeted physicians "with outreach programs, speaker events, sales calls, and computer software to mislead doctors about the FDA-approved uses of Lipitor," Eisenhofer alleges in the complaint. "For example, Pfizer's Lipitor 2002 US Operating Plan (Operating Plan) laid out the Company's illegal scheme." According to that document, plaintiffs claim, Pfizer's primary concern when communicating to healthcare professionals about Lipitor was to hammer home Pfizer's "Get to Goal Message."

Pfizer is likely to maintain that the meetings and events for doctors were simply education programs, and that much of the information relies on studies that show benefit to patients. Presenting a third-party study is legal, provided that the company's motive is pure.

The plaintiffs accuse Pfizer of improperly utilizing third parties to promote its "fraudulent scheme." How did that work?

The plaintiffs maintain that Pfizer "fully funded" the Emerging Science in Lipid Management (ESLM) and the National Lipid Education Council (NLEC) "to fraudulently promote the off-label use of Lipitor. (NLEC changed its name in 2006 to the Committee on Cardiovascular and Metabolic Disease.)

These organizations produce and distribute a variety of continuing medical education programs that "repeatedly distorted the line between on and off-label use of Lipitor,"according to the complaint.

"I believe they are allowed to distribute third party materials," Eisenhofer says. "But I don't think they can go and pay somebody to create information, publicize it, and then claim that it is the work of third parties. This is what we are accusing them of doing."

Dr. Antonio M. Gotto , the dean of Weill Cornell Medical College, is chair of both ESLM and NLEC. He says ESLM is fully funded by Pfizer, but that Abbott and Reliant, among others, also fund NLEC, all by unrestricted educational grants. Gotto denies that either organization promotes the use of Lipitor beyond the treatment guidelines.

" Pfizer is a big target because Lipitor is the number-one selling drug in the world," Gotto says. "These are primarily insurance companies that are connected with the Teamsters union, and so they see this as an opportunity to try to recover some money that was spent on providing medication for their [members]."

If the suit goes forward, Gotto says he will be ready to testify. "I would be happy to defend in court the material in our publications with regard to educating physicians about the proper use of statins in lipid management, and how they are entirely consistent with the guidelines."

What the Lipitor Label Says

The Lipitor label incorporates the ATP III (Adult Treatment Panel III) prescribing guidelines, which can be found in the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults.

The guidelines recommend drug therapy at certain LDL cholesterol (LDL-C) levels based on the number of coronary heart disease (CHD) risk factors a patient has. The more risk factors, the lower the cholesterol level at which drug therapy begins. But for patients with two or more risk factors, the label also uses the percentage risk of developing CHD in the next 10 years to determine the LDL-C level at which drug therapy starts. If risk is less than 10 percent, drug therapy starts at 160 mg/dL. If it's greater than 10 percent but less than 20 percent, therapy starts at 130 mg/dL.