The Wall Street Journal
Pfizer Is Sued Over Lipitor Marketing
By DAVID ARMSTRONG
December 20, 2007; Page B5
A former Pfizer Inc. official in a lawsuit accused the company of illegally boosting sales of its top-selling drug Lipitor through an elaborate campaign of misleading educational programs for doctors.
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.
The lawsuit was filed in U.S. District Court for the Eastern District of New York in February 2004. It was immediately sealed to allow federal prosecutors time to decide if they wanted to intervene in the case. In August, the government said it wouldn't intervene, lifting the seal. Pfizer was served a copy of the suit yesterday, according to Dr. Polansky's lawyer, Steve Berman of Hagens Berman Sobol Shapiro.
The failure of the government to intervene may signal that prosecutors are skeptical about the merits of the case. The government hasn't intervened in other cases which led to huge fines against drug companies. One example is another case involving Pfizer, this one for the off-label marketing of Neurontin.
Pfizer said, "We believe this case has no merit. 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 U.S. Food and Drug Administration."
Dr. Polansky was Pfizer's director of outcomes management strategies from 2001 to 2003, and his responsibilities included reviewing some of the marketing materials for Lipitor and other Pifzer products. He says he was fired by Pfizer after complaining about marketing he considered to be improper. Dr. 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 suit seeks compensation for Dr. Polansky as a whistleblower under laws that could give him a share of money recovered for any overpayments made by federal health-insurance programs.
Lipitor, a type of cholesterol treatment known as a statin, is the world's biggest-selling drug , with sales of $13.6 billion last year, according to IMS Health.
The allegations against Pfizer echo concern elsewhere that continuing medical-education programs for doctors are often sales pitches for "off-label" uses of drugs. A congressional committee this past summer said it was concerned there was little oversight of these programs -- where doctors are often wined and dined -- or enforcement when companies use them as marketing tools.
Pharmaceutical companies are prohibited from marketing drugs for indications other than what the FDA approves them for, although doctors aren't prohibited from prescribing them for unapproved uses. Independent educational programs can discuss off-label uses that aren't FDA approved. But Dr. Polansky's lawsuit charges that the Pfizer-funded programs weren't independent.
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 the marketing plan for the drug, citing an internal Pfizer marketing plan for Lipitor with a page titled "Medical Education Platform Supports the New Positioning."
Among other things, Dr. 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. 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, Dr. Polansky also said 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.
3 comments:
A recent newspaper artical by a Doctor said the idea cholesterol is with a total less than 200. But a reveiw of the Framingham Heart Study would reveal this to be very misleading. That study says the ideal cholesterol is with an HDL of 85 with a total all the way up to 300. The drug companies have brain washed doctors into prescribing statins where there is zero justification. I would like to send Dr. Polansky a plot I have prepared from the 1977 Framingham Study showing (Coronary Heart Disease Risk) versus Total Cholesterol, HDL, LDL with Trig of 100 and 200. This plot provides an excellent understanding of the mystery of cholesterol.
This kind of promotion beyond the approved label is as old as the bigpharma and is only one of the many illegal methods of promotion they have developed over years. However they all have one common characteristic and that is: They use perfectly legal methods of promotion and turn them into methods to promote illegal indications etc. In this case, they use what they call continuing education of physicians to promote Lipitor off-label by paying highly reputable (and bough hired guns for Pfizer) specialists/speakers to make these claims in the process of "education". They simply slip into their power point presentation that data that deals with off-label indication and present it as if it were completely legal and FDA approved one. It is that simple.
At the same time they have their sales forces "follow up" with those docs who attended the dinner talk, and reinforce the sales pitch at those docs offices. Very simple and effective and also hard to prove. Usually there is no paper trail and no witnesses. The spaker will not admitt he was paid and explicitly asked to present the off-lable data as real and approved.
I have seen this with Novartis for years. At one time we were even ordered (as sales reps) to review our speakers slides before they would go on with the talk, to make sure he has those needed and those that our Co issued them to use. Can you believe something like this? A pharma sales rep reviewing powerpoint presentation of a university professor before he does the talk. Hard isn;t it, but it happened. Personally I never asked any of my hired guns to let me do it. most likely they would have told me to.... and I would not blame them. However if they intended to do many talks for very nice honoraria they better do the talks as Rxed by the sponsoring company. Many did and many are still doing it every day for all companies all over the planet. Will be interesting to see what happens in this case.
Yes, I remeber it well at Novartis. We did it with Diovan, the ARB, big time at every opportunity. It started after VelHeft trial was presented at AHA convention in pre-Katrina NewOrleans. The trial was about proving that Diovan was effective in treatment of heart failure. It did not happen. The data was weak and non-conclussive. However we had a sub group of 400 patients that showed very good result in HF patients. But that was not enough to make the claim of Dio effectiveness in HF. Of course it would not stop Novartis' marketing people so they used well paid speakers to promote this off-label ind. to physicians, specialists and Gps at so called educational meetings. The reps did the same with fake detail aids and lit. It was brutal, I can tell you that. The Co never got caught and continued to do the same thing after few other poor trials did not show real effectiveness. Old story indeed.
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