The suit was filed by Jesse Polansky, a former director of outcomes management strategies at Pfizer. He alleged that Pfizer marketed Lipitor for patients with moderately high cholesterol when the FDA approval was only for high cholesterol patients. It was dismissed (with leave to amend) because he failed to identify any actual prescriptions filled due to Pfizer's alleged off-label promotion of Lipitor. (Such suits are difficult to prove because they require proof of prescriptions filled -- information which tends to be protected by doctor-patient confidentiality.)
Despite being dismissed, the suit raises some interesting allegations about how Pfizer influences health officials whose job it is to encourage us all to lower our cholesterol. In 2003, according to the suit, Pfizer funded the National Lipid Education Council, a continuing medical education group whose job was to educate doctors on cholesterol issues. CME is frequently criticized as a promotional tool for drug companies even though there are supposed to be firewalls between the companies that fund it and the content of the courses. Among the benefits of being a doctor on Pfizer's NLEP was, according to the suit:
... being selected by Pfizer as investigators on multimillion dollar research grants [plus an] honorarium, speaker fees, travel, entertainment, and having the opportunity to attend meetings and network with luminaries in the cardiovascular disease world.One of those trips was to the fancy-schmancy Ritz Carlton Half Moon Bay resort in California. Prices start at $355 per night. (And -- you guessed it! -- there's golf.)
Many of the NLEC ... faculty receive direct or indirect funding from Pfizer through travel, entertainment, honorarium, speaker fees, and other remuneration. Many of the faculty are also active participants in the NCEP, and are actively engaged in multi-million dollar Pfizer-funded clinical trials.
At the same time, the NIH maintained a cholesterol health group of its own, the National Cholesterol Education Program. The purpose of NCEP, according to its web site, is:
Through educational efforts directed at health professionals and the public, the NCEP aims to raise awareness and understanding about high blood cholesterol as a risk factor for CHD and the benefits of lowering cholesterol levels as a means of preventing CHD.But Polansky's suit says that the NIH's NCEP was staffed by many of the same people who were on Pfizer's NLEP:
As of 2003, there were a total of 14 members of the NCEP. The chairman of NCEP is a NLEC Steering Committee member and primary contributor to a recent Pfizer-funded Lipitor clinical trial. Seven of the NCEP members have participated in the Pfizer-funded NLEC.You can download Polansky's complaint against Pfizer here. It has a handy chart (pictured) that lists the crossover members between the two organizations. Polansky was fired by Pfizer after a February 2003 meeting he had with the company's Compliance Unit in which he complained that Lipitor was being marketed too aggressively.
Since Polansky's suit was filed, NLEC has changed its name. It's now the Committee on Cardiovascular and Metabolic Disease.