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By Herb Newborg

Pfizer Crimes Result in Millions of Unwarranted Prescriptions
New whistleblower lawsuit accuses Pfizer of illegally scheming to boost Lipitor sales through multiple illegal activities.

A former Pfizer executive has accused the drugmaker of illegally boosting Lipitor sales 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.

The whistleblower lawsuit accuses Pfizer of illegally scheming to boost Lipitor sales by misrepresenting product labeling and federal cholesterol guidelines; using misleading educational programs for doctors, and unlawful sampling kickback schemes, among other things, that resulted in off-label marketing that allegedly defrauded Medicaid and Medicare.

Jesse Polansky, who was director of outcomes management from April 2001 until July 2003, claims “thousands of physicians have prescribed Lipitor to millions of patients for whom drug therapy is not recommended, and for whom the medication could be dangerous. Millions of those improper prescriptions were ultimately paid for by various government healthcare plans” according to the lawsuit, which was filed in federal court in New York.

In painting the broader picture, Polansky charges Pfizer disregarded distinctions in the National Cholesterol Education Program (NCEP) guidelines, which approved drug therapy for about 36.5 million Americans. However, the largest subset are ‘moderate risk’ patients, those with two or more risk factors and less than 10 percent risk of heart attack. Of those, 14.6 million need only therapeutic lifestyle changes, while drugs are recommended only for the remaining 2.8 million. By off-label marketing to the rest, the suit charges, Pfizer realized “it could increase revenues by billions of dollars.”

Pfizer accomplished this, according to the suit, by repeatedly and deliberately blurring distinctions between patient groups established in the NCEP guidelines in slide presentations and other materials used for continuing medical education programs; information distributed at health fair and screening programs; material provided by sales reps; on its Lipitor web site; and with inaccurate cardiac risk calculators used by physicians. In doing so, Pfizer was able to “classify falsely many moderate risk patients as moderately high risk, making them eligible” for Lipitor prescriptions.

The suit also claims Pfizer tried to widen the Lipitor market by targeting patients with hypertension and “misrepresented the design and findings” of a company-funded trial called ASCOT, in which drugmaker “falsely claimed” that all hypertensive patients benefit from taking Lipitor. “Not only did the Ascot trial not result in such a finding but the ASCOT trial was only designed to address the role of Lipitor in hypertensive patients who had at least three additional cardiac risk factors,” the suit charges.

Another charge: Pfizer used reps and CME to misrepresent guidelines and limit distribution of unfavorable studies to promote off-label Lipitor use for patients with chronic kidney disease, including those with end-stage renal disease, which represents a substantial potential market. Pfizer promoted the idea that CKD is the same equivalent risk as coronary heart disease, according to NCEP guidelines, but “this is false,” the suit states. “Lipitor does not have an FDA-approved indication for more aggressive treatment to slow the deterioration of kidney function in patients with CKD.

The lawsuit goes on to reiterate how Pfizer attempted to educate physicians about Lipitor through the National Lipid Education Council, which included many members with ties to the drugmakers. And Pfizer allegedly limited distribution of samples of entry level doses - 10mg or 20 mg - so docs would write more prescriptions for higher doses, which are more expensive and don’t face generic competition.

Pfizer has previously denied the charges.