Lawsuit Claims Pfizer Deceived Doctors Into Prescribing Its Cholesterol Drug Lipitor
Jesse Polansky, a former director of outcomes management at Pfizer (PFE) from 2001 until 2003, has re-filed his whistleblower lawsuit regarding the cholesterol drug Lipitor, the best-selling prescription substance in the world and the backbone of the company.
BNET readers will remember that it was an earlier version of Polansky's suit which alleged half the members of the National Institutes of Health's National Cholesterol Education Program -- which sets cholesterol drug prescribing guidelines -- were also members of the Pfizer-funded National Lipid Education Council.
The latest version restates his claim in more detail, which is that only 36.6 million Americans require drug treatment for cholesterol but because Pfizer fraudulently promoted Lipitor for people with moderate or mild cholesterol problems an additional 14.6 million patients ended up on the drug. Here are some highlights from the new suit:
Pfizer allegedly copied Neurontin playbook Pfizer acquired both the anti-seizure drug Neurontin and Lipitor from Parke-Davis. Pfizer later paid a $430 million settlement for the off-label marketing of Neurontin as a painkiller. Polansky says:
...its off-label marketing practices regarding Lipitor largely mirror those of NeurontinLipitor offers "Absolution" Polansky alleges that Pfizer believed patients felt guilty when diet and exercise did not improve their health. So the company's marketing 2002 marketing plan would offer patients "absolution" from this guilt:
"Absolution â€" Idea that we need to absolve them of this before we can get them interested in using Lipitor." This, Pfizer stated [in the plan], is the "Key to reaching the consumer."Software allegedly rigged Pfizer distributed a program to doctors called the "Lipid Goal Manager" which was rigged so that it calculated patients with certain cholesterol indicators as in need of treatment when they were not. "Pfizer's knowledge of the inaccurate risk calculator embedded in the software is evident in the software engineering," the suit states. A patient with a 10-year risk classification of just 6 percent would see a result of an 11 percent risk if their details were punched into the Pfizer software, the suit claims.
Side effects? What side effects? A sales rep quoted in the suit says she was instructed to pretend that there were no significant side effects with the drug:
... when confronted by physicians about side effects in their patients, she was directed to say "Wow, you are really seeing that? You are the only doctor - you're the first physician that is telling me that."Karen Katen's pyramid of doom The suit alleges that in a June 17, 2003, analyst meeting, Karen Katen, Pfizer's former president, presented a slide that showed a pyramid of 64 million Americans in a "platform for growth," i.e., potential patients for Lipitor. The suit claims, "According to the Guidelines, there are approximately [only] 37 million Americans eligible to use statins."
Samples on top of samples Polansky alleges that some doctors were so heavily visited by sales reps -- two reps visiting every week for some -- that their sample cabinets groaned under the weight of free Lipitor. One doctor, William N. Ginn of West Milton, Ohio, had eight sample cabinets, the suit claims, six of which contained Lipitor.
Hat tip to Pharmalot.