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 devil is always in the details," says Michael Loucks, a first assistant US Attorney in Boston who investigates off-label
marketing. "There are all kinds of questions that an investigator would ask. The same act can be criminal or non-criminal
depending on the purpose and the intent of the person doing it. The same principles of criminal law are true for all criminal
statutes, including off-label promotion. If the purpose in holding a conference is to promote the product off-label, for an
indication the company knows it doesn't have [FDA] approval for, and it's done in a variety of different ways, then the company
may have a problem."
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.