Former Pfizer Exec Sues Over Lipitor Marketing
17 CommentsBy Ed Silverman // February 11th, 2010 // 11:40 am
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. Six years ago, Polansky first filed such a suit, but the government decided not to intervene, and he has now updated some of his claims (background).
In painting the broader picture, Polansky charges Pfizer allegedly 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, Pfzier 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 and we await comment.
Marilyn Mann
A previous version of the complaint was dismissed with leave to amend.
http://www.kslaw.com/library/publication/HH060809_Opinion.pdf (memorandum and order granting Pfizer’s motion to dismiss, 5/22/09)
http://www.bloomberg.com/apps/news?pid=20601124&sid=aTeZesJxLJlg
elmore
Everything alleged for Lipitor should also be examined for a lot of other chronic diseases such as hypertension, especially those where a “pre” condition was invented or diagnostic criteria were revised (ie, expanded) or cut off levels for normal were lowered.
Justice in MI
First, this disclosure. I use Lipitor. And I am definitely within appropriate guidelines.
Still, every time I hear of a new study suggesting some additional benefit of any of the statins (beyond cardio issues), I wonder if there is not another study buried somewhere which shows precisely the opposite–that the manufacturer is aware of a potential risk directly related to the condition about which we hear the potential benefit.
It is obviously sad to be so cynical. But I believe there are enough instances where this turned out to be the case that it is not irrational to be so.
Codes R not us.
Whatever Jesse says in his claim is true. Not only for Lipitor but for most mega drugs.Bigpharma has learned long time ago, that by relentless pushing of their drugs they can increase the use way beyond what is really needed based on number of really sick people.This relentless pushing is more than pushing it for approved indication. If they did only that kind of pushing/selling they would never sell what they sell, for instance in case of Lipitor, in billions of $$. They need to go beyond approved indications and they do it all the time. Offlabel promotion is the most common, briberies of all kinds are also common (you Rx we pay you). The “education” of doctors mentioned is also an ingenious way to push their drugs beyond indications. They use so called key opinion leaders (top specialists who sold their services to big pharma, hired guns in other words) who under the “science” of it push company’s agenda and promote the drug beyond indications. This they can, for any specialist can make a claim of drug being effective in non-approved indication. He is a specialist after all. The drug Co can not by law, so they pay these mouthpieces to do it for them. The ways they push their drugs beyond the law, are limitless. Whenever they get caught and fined they invent new ones and the relentless promo goes on.We know most top bigpharma cos have been fined for different misconduct, offlabel being the most common. Recently Novartis got fined 185M with more to come. Lilly paid 1.6B for offlable promo of some drug. The list goes on and on. Would these fined cos stop as they promise and sign a pledge (while paying the fines)? Not a chance, they will just invent new and harder to prove ways. Bigpaharma or bigpharmafia, that is the question, Jimmy?
yobo
Let me first say this, drug companies like many of companies do, at times, try and strech the truth or present things in a missleading way. This complaint appears to be a rehash of the earlier dismissed one. The problem here is that in medicine there are no clear cut off points and variables that may lead to problems are just that, variables, that are difficult to quantify for an individual, but may be easier to do for a group. Thus the problem in this case, saying that maybe it is better to start Lipitor now because your lipids are so so or because your kidney disease appears to be worsening and Lipitor MAY help is very difficult to get a handle on for an individual. This is why the gov’t didn’t pursue the complaint the first time and probably won’t this time. The complaint does not outline clear cut abuse it brings forth the grey areas doctors face when treating. No doubt Pfizer exploited this, but it’s difficult to say this is criminal.
yobo
I just want clarify something, I am not defending bigpharma, I only commenting on this whistle blower case. (Don’r forget they stand a chance of hitting a huge payday as well and may exagerate their claims as well.) Also please read Codes R Not Us’ discussion above, it is right on the money! Bigpharma’s use of opinion leaders to promote a drug through the opinion leaders’ social networks is legendary. This stuff (doctors, drugs, and social networking) was first studied in the Midwest in the 1940s. As a matter of fact this study is legendary. Today, we see an acceleration of this as bigpharma themselves utilize social networks and encourage their opinion leaders to use them as well. What are these networks? — Facebook, Myspace, Twiter, websites, etc. Another big thing bigpharma does is invent new diseases to drive prescription volume. Examples are, impotence becoming erectile dysfunction, heartburn becoming GERD, moodiness become premenstrual dysphoric disorder, and check out psych’s bible Diagnostic and Statistical Manual of Mental Disorders 4 (DSM-IV) it is full if disorders that “in the day” used to be treated with a few beers with the boys or a glass of Chardinay with the girls plus a little bitching!
John
Yobo, I would comment on the “invention of new diseases” that chronic GERD was not invented by the pharmaceutical industry. A quick Pubmed search shows that publications describing the condition and using the term go back to the 1950’s, well before H-2 antagonists and proton pump inhibitors were conceived. In my own case, antacids provided no relief at all for pain that frequently brought tears to my eyes for hours. Did I mention that its a risk factor for esophageal cancer?
Whether impotence / erectile function is a disease or not, if renaming it reduces the stigma so more guys talk to their doctor, I don’t think its a bad thing. For the price of dinner at Denny’s, a lot of guys can make love to their wives again? Would you prefer that the R&D money have been spent on better displays for cell phones or maybe a 500 GB iPod?
As for disorders that “can be treated with a few beers with the boys +or a glass of chardonnay with the girls with a little bitching”, I really don’t know how to respond to that.
John
Just as an observation, I note that it has been nearly 8 hours since Yobo’s post.
The cries of outrage that we would see on this blog if a pharma employee had posted comments trivializing drug-induced sexual dysfunction, psychiatric disorders, pain, or increased cancer risk are notably absent.
Just something to think about….
Christopher
John, that your post coincides with Valentine’s Day weekend is not lost. And if dinner at Denny’s does it for some wives, well, fantastic. I suspect that an iPhone or a 500 gig iPod would be appreciated too.
Maybe one of Ed’s surveys is in order.
patrons99
I have a lot of patients taking Lipitor or some other statin to keep them within “guidelines”. But therein lies the problem. The lipid theory of atherogenesis is a foundation that is starting to show cracks. Statins beneficial effects may be due some mechanism other than their lipid lowering property. e.g. an anti-inflammatory mechanism. Another theory, the hemorheologic-hemodynamic theory of atherogenesis may play are much bigger role.
http://en.wikipedia.org/wiki/Atherosclerosis
Medical practice guidelines are, in effect, ghostwritten by pharma. They cannot be trusted. This places both patients and their physicians in a serious bind. The net effect of ghostwritten medical practice guidelines is direct injury to the public’s health and the federal healthcare fisc.
Perhaps a greater concern should be the myriad pleiotropic effects of the statins, e.g. their effect on Vitamin D3 and CoQ10 levels.
M Helm, MD
Patrons99,
Obviously (in pediatrics) I don’t have any patients on a statin. However, through my managed care work (and prior PhRMA time) the statins and beta blockers which prove to be most interesting and beneficial are also those with antioxidant and other apparent effects at the tissue level. I wonder if it is a case of serendipity that these antioxidant compounds just happen to lower levels of things we can measure (LDL or BP - assumed to be “bad” by association). I wonder the same about the effects of ACE Inhibitors which almost certainly offer very interesting and helpful effects for blood vessels and cardiac tissue. Most things which ultimately prove to be good and useful in medicine are “happy accidents,” and not all turn out to work the way we think they do.
What I wonder, and what hasn’t been adequately answered in my mind is this: If you treated a patient consistently with an antioxidant statin at a dose which would not necessarily get them to “goal,” and they actually took the med at least 75-80% of the time, would they gain the same survival benefit/CV event avoidance as if they “got to goal?” If the answer is “yes” why not treated everyone with risk factors at a 20 to 40mg dose of simsvastatin. I’ll bet that if someone studied CRP(or other non-specific inflammatory marker) levels prior to and after simvastatin (or atorvastatin) treatment there would be comparable reductions as seen with rosuvastatin. With an answer to that question, would it really matter what Pfizer’s marketing campaigns did? Of course they sought off-label use. However, any CV med is not used (or promoted) off-label to the extent that mental health medications are.
I still think Linus Pauling had the right idea - It is oxidation which kills us. And we also already know “Rust Never Sleeps.”
Thanks for reminding me that I forgot my Vit D last week.
patrons99
M Helm, M.D., I’ll bet that we could design some interesting prospective studies to undertake, if we didn’t have our daytime jobs. With an independent source of funding and no COIs to bias us, there would be no “sacred cow” dogma that should be considered untouchable.
M Helm, MD
Patrons99,
I’d like to collaborate on that venture! But isn’t this what we should expect from NIH (not to mention all the public money funding academic research)?
Prospective studies are definitely preferred, but I there may be some retrospective (health claims administration) data which would be useful to validate certain hypotheses. Some countries with universal coverage and robust claims data (or the US VA system which has the advantage of including clinical outcomes measures/lab results) might be able to answer some of these questions tomorrow. Maybe some folks already know these answers, they just haven’t gotten around to telling us.
We probably need to find a way to pay for “scientific liaisons” to bring our findings to practicing clinicians also…
Justice in MI
There _was_ a recent study (I think I recall seeing summary on Cardiobrief) which suggested that consistent statin dose for pt.’s situation (primary or seconday) was as beneficial as getting to a particular LDL goal.
BP Watch
Does this news surprise anybody? Anyone who has ever worked in Big Pharma knows that having a sense of right and wrong is frowned upon. You must leave your ethics behind because ethics and Big Pharma are like oil and water. the Big pharma mafia will do anything it can to make more money, driven by greed rather than caring for patients. However, until the CEOs and other top execs are prosecuted, convicted, fined and pay jail time, the status quo will continue. There is nothing to hold them back from their evil ways. If the companies are caught, they admit no wrongdoing, pay a minimal fine and laugh all the way to the bank.
Former SP
Vytorin marketing accusations can’t be far behind. One can only hope that Schering-Plough and Merck get dragged into court soon. Now that would be the old downer on the merger!
Codes R not us.
BP watch, has obviously watched the BIGPHARMAFIA (my name for it and I also call NOVAMAFIA AG, the company I worked for).Yes, anyone who worked for this biz in the last 25 years, has seen it all.It started in earnest some 25 years ago, when the BF wiseguys dacided to turn it into business as any other, where max+++ bottom line is the only measure of success. To acheive that they figured out what they must do.It called for them to go beyond the number of really sick and beyond the laws of the countries they operate in.That way they decided to sell their drugs to anyone who is willing to take them (by convincing doctors their drugs are useful in real and invented sicknesses) and to be successful in this they had to go beyond approved indications for their drugs, thus braking the laws of the host countries.The fact that this was planned, deliberate and approved by their top managements, tells you they do behave like mafia. In fact they are new mafia of the Organized Corporate Crime (OCC) that is real and doing well in our