Pfizer Sued By Former Exec Over Lipitor Marketing
9 CommentsBy Ed Silverman // December 20th, 2007 // 7:58 am
A former Pfizer exec accused the drugmaker of illegally boosting Lipitor sales through an elaborate campaign of misleading educational programs for docs, The Wall Street Journal reports. Jesse Polansky, claims that the educational campaign was a key part of a marketing strategy that “led thousands of physicians to prescribe Lipitor for millions of patients who did not need medication” and could be harmed by overly aggressive treatment.
His lawsuit was filed in federal court in New York in February 2004, but was sealed while prosecutors decided whether to join the case. In August, the government decided to pass, lifting the seal, the Journal writes, adding that, Polanksy’s lawyer says Pfizer was served a copy of the suit yesterday. The failure of the government to intervene may signal that prosecutors are skeptical about the merits.
Polansky was director of outcomes management strategies from 2001 to 2003, and his responsibilities included reviewing some marketing materials for Lipitor and other products. The journal writes that he claims he was fired by Pfizer after complaining about marketing he considered improper. Polansky now works as the senior medical officer for Medicare in a unit that investigates fraud and abuse at the big government health insurer, the paper adds.
The suit seeks compensation for Polansky as a whistleblower under laws that could give him a share of money recovered for any overpayments made by federal health-insurance programs. “We believe this case has no merit,” the drugmaker tells the paper.
UPDATE: Here is Polansky’s lawsuit.
“Furthermore, after reviewing the allegations in this complaint, the government declined to intervene in this action…Pfizer does not condone the off-label promotion of our products. We believe that our sales and marketing practices are solely based on our prescription information as approved by the US Food and Drug Administration.”
The Lipitor educational programs were run by companies paid by Pfizer through “unrestricted educational grants,” the lawsuit says. It alleges that the educational programs were integrated into Lipitor marketing, citing an internal Pfizer plan for Lipitor with a page titled “Medical Education Platform Supports the New Positioning,” according to the Journal.
Among other things, Polansky says Pfizer wanted to extend Lipitor use beyond the indications found on the drug’s label by targeting people at moderate risk of developing heart disease or having a heart attack, the Journal reports. He said the educational programs for doctors deliberately misrepresented the drug’s label to encourage Lipitor therapy for people in the moderate-risk category who didn’t need the drug.
In his suit, Polansky also charged the Pfizer programs included deliberate misinformation promoting the idea that kidney-disease patients may need to be treated with statins. While kidney disease is recognized by some doctors as a risk for heart disease, it isn’t part of the federal guidelines that factor into Lipitor’s approved use, the Journal points out.
Source: The Wall Street Journal
BP Watch
Not a surprise that Pfizer once again alledgedly joins the ranks of the most unethical Big Pharma companies. They can now join the group of the companies that have been accused many times of marketing and selling inappropriately as well as firing one of their honest employees that simply tried to do the right thing. I believe that the list is topped by Schering-Plough and Novartis, but followed closely by Lilly, JNJ, GSK, Wyeth and Sanofi-Aventis.
These activities in a healthcare industry are deplorable. The Big pharma companies keep doing what they want, promoting inappropriately and off-lable, skirting around the laws, destroying evidence, blatently lying when called to testify, and laughing all the way to the bank. In the meantime, the honest employees who seek to do what’s right lose their jobs, are ostracized and blackballed, have their careers ruined and struggle to find a job where they will be out of the reach of their previous employer. They suffer all of this because they have ethics and integrity.
This will never change unless the FDA, OIG, Congress and others in DC call them to task for their disgusting acts and make them really pay for what they’ve done. The top execs may end up in hell, but even that won’t be enough punishment for the lives they’ve ruined.
BP Watch
Previous SP
BP Watch,
I completely agree with you. My previous company was one of the absolute worst I’ve ever seen. In my mind, their “turnaround” was fueled by more corrupt activities than I’ve ever seen. In addition, I believe that the corrupt tradition of their top executives has been carried from company, to company, and they always manage to escape by running away from accountability at the last minute.
I hope they all burn, burn, burn on earth and in the afterlife. Better yet, let’s make them take phen/fen, human growth hormone, and vytorin all at the same time and see how they make it through. I think that where they should end up is in a 8′ x 8′ concrete room at the nearest Federal facility, but I seriously doubt that it will ever happen.
Previous SP
TOdd
Were they promoting something besides the updated NCEP guidelines? I believe the data does show the lower the better, but it is likely not FDA approved….. I guess this goes back to the off-label promotion (kind of). But if you are reinforcing what the ACC/AHA is advocating I find it hard to blame Pfizer. I do not disagree they do some shady things, but am not sure if this is one of them. I would like to know what they were saying, was it a grey area that did show benefit to patients or were they making up the data.
From what I read — they were basically disseminating independently developed guidelines. You know, the ones available at the ACC/AHA website.
Do you think docs here an off-label pitch for a drug from the rep and immediately adopt it to their practice? It isn’t quite that easy. Docs are a little smarter than you give credit to. But the guidelines provided good info that all docs should have.
Atlex
BP,
First, and formost, for those of you with low reading comprehension or a built-in bias, this is an accusation and not a conviction. In fact, federal investigated for 3 and a half years before determining that the case didn’t merit their backing. That doesn’t mean that there’s no case, but it sure casts suspicion on the accusations.
Second, since the pharma industry is the most regulated in the country (and probably the world), the chances of violating laws and regulations are quite high even when every attempt is made to stay on the legal side of very hazy lines. I’m not saying that evey pharma is ethical or that every individual within highly ethical pharmas acts in an ethical manner all of the time. What I am saying is that with few exceptions, major pharmas spend an inordinant amount of time and money making every effort to ensure the legality of their sales and marketing efforts.
Atlex
TOdd
AMEN, thanks for saving me some more typing Atlex. So a disgruntled employee is looking for millions in a federal lawsuit, the gov’t didn’t even hold out their hand looking for $$$$. Nice try for the whistleblower goldmine. I actually can’t wait until my company tries something off, as every whistleblower seems to be set for life (except this guy). I think there are plenty of people thinking like that so companies are extra careful.
henry
the feds spent 3 plus years investigating what we the general public know already, they should be fired, waste of our tax dollars.
Big Pharma is regulated…. plenty of CFRs to read, but who enforces these regulations? please inform me if you know.
For one disgruntled fired employee who is brave enough to file a lawsuit there are 1,000’s of disgruntled pharma employees who would like to blow the whistle even louder but can’t for many reasons.
Good for him… they will settle.
TOdd
There are dollars out there if they do blow the whistle on something legitimate - 25% of the hundred of million dollar FDA fine.
Again I ask the question — were they just talking and presenting the leading recommendations from the American College of Cardiology(ACC) and American Heart Association (AHA). Actually a service to practicing physicians that might have missed this important new information
Also, doesn’t everyone in the world hear about off-label uses of drugs when nightly news picks up the AP story. Haven’t we all heard about statins for Dementia? Pretty sure that isn’t labeled (or well substantiated for that matter). I don’t think Pfizer put out that press release.
Henry, good luck finding a backbone.
Chris
3 year of elapsed time does not equal ‘3 years of govt investigation’.
Judy
http://www.spacedoc.net