Pfizer hit by whistleblower lawsuit on Lipitor
December 21, 2007 | Lisa Nainggolan

New York, NY - A former Pfizer employee is suing the company, asserting that the dismissal was prompted by his concerns about the marketing of its best-selling lipid-lowering drug, atorvastatin (Lipitor) [1]. Dr Jesse Polansky, who worked for the firm as director of outcomes management strategies from 2001 to 2003, is seeking compensation as a whistleblower, the Wall Street Journal reported yesterday.

Polansky claims Pfizer encouraged off-label use of atorvastatin via "unrestricted educational grants" to companies providing continuing medical education (CME) programs. Part of his job was to assess marketing materials, but when he objected to their content, his employment was terminated, says the article by David Armstrong.

Polansky filed the suit in the Eastern District of New York in February 2004, but it was sealed immediately to permit federal prosecutors time to consider whether or not they would intervene. In August of this year, they decided against this and the seal was lifted. Pfizer was served a copy of the lawsuit earlier this week by Polansky's lawyer.

"The failure of the government to intervene may signal that prosecutors are skeptical about the merits of this case," observes Armstrong.

Pfizer commented: "We believe this case has no merit. Furthermore, after reviewing the allegations in this complaint, the government has declined to intervene in this action. . . . Pfizer does not condone the off-label promotion of our products."

The article notes that off-label promotion of drugs by pharmaceutical companies is prohibited but that doctors are allowed to prescribe products for unapproved uses. Armstrong says that this summer, a congressional committee expressed concerns with regard to CME programs "where doctors are often wined and dined."

Polansky's suit claims that educational programs encouraged doctors to prescribe atorvastatin for people at moderate risk of coronary heart disease—an unapproved indication—and that they also included "deliberate misinformation promoting the idea that kidney-disease patients may need to be treated with statins."

Polansky is now a senior medical officer in a unit that investigates fraud and abuse at Medicare.

Source
  1. Armstrong D. Pfizer is sued over Lipitor marketing. Wall Street Journal, December 20, 2007. Available at: http://online.wsj.com.



Your comments
Pfizer hit by whistleblower lawsuit on Lipitor
# 1 of 4
December 21, 2007 02:51 (EST)
D Hackam
off label uses
This article surprised me. I thought atorvastatin was proven to reduce MI/stroke risk in moderate-risk primary prevention from trials like GREACE, CARDS, and ASCOT-LLA. Further, I have always considered chronic kidney disease to be a major near-coronary-risk equivalent (akin to diabetes), and subgroup analyses of RCTs have continuously confirmed this (eg the PPP). Lipitor is my first choice in this situation too - because it is not renally cleared to an appreciable extent. A little atorva 10 mg can go a long way in primary prevention!

Disclosures: none.
# 2 of 4
December 21, 2007 09:02 (EST)
Michael Cobble, M.D.
Whistles and Clowns
Well, I think that LDL therapy is indicated for patients with moderate risk if their LDL is over 130 and of course CKD is a high risk group. Fluvastatin (lescol) has some of the best data for people with kidney disease and is renally excreted but also metabolized in the kidney. We use all statins in kidney disease, although prefer rosuvastatin max dose 10 mg if gfr under 30.

This is too bad that PFE may have been overly creative in prmoting this product, but is that any surprise. We all know how PFE markets their products.

SPARCL interesting in atorva increasing hem stroke. mc
# 3 of 4
January 3, 2008 05:55 (EST)
Ray Duncan, PharmD.
Not Suprised...
I am not suprised that Pfizer was pushing for everything and all they could get considering that they seemed to know that Vytorin was on the way and Crestor was gaining speed. I was suprised clinically also that it is not indicated for Moderate, however, I believe that this may have been just prior to some of the referenced studies above making it to Lipitor's label.
Ray Duncan, PharmD, BCPS
# 4 of 4
January 6, 2008 03:58 (EST)
D Hackam
Lescol for kidney disease
Michael I must admit I rarely use this drug, although there may be some pharmacodynamic advantages, including lower muscle toxicty and absence of renal accumulation. I was impressed by the LIPS trial. However, my first choice in most situations is still atorvastatin, which was shown to reduce the risk of GFR decline in the TNT trial (with atorva 80 vs atorva 10 mg/d).
Ray, what you said makes sense. I would be interested to see the labelling updates.

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