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Analysis: Pfizer Slapped With RICO Lawsuit
Is Pfizer in bed with the Mafia?  I think not.  However, a union welfare fund based in Tony Soprano’s home state of New Jersey has slapped Pfizer with a RICO lawsuit.  In the lawsuit, the union alleges that Pfizer marketed its cholesterol medication to people who did not need it.  According to Lipitor’s prescription label, people at low risk of coronary heart disease and with a cholesterol level of 160 mg/dL or below should not receive the medication.  The union charges that Pfizer marketed Lipitor to people at low risk of coronary disease and with cholesterol levels below 160 mg/dL.  According to attorney Geoffrey Jarvis, who is representing the plaintiffs:

“[Pfizer] would make presentations to doctors and try to take the focus off the guidelines . . . and promote what they call the get-to-goal message. That was their mantra. The goal for everyone, even the patients who are low risk, was cholesterol of 130.  So what they suggested was that if you’re above 130, you should get to goal. But that’s not what the guidelines call for. They say that if you are above 160, and it’s called for, then we try to treat you to make sure you are at 130. What Pfizer is trying to do is promote this get-to-goal message for everybody. They want to cloud the message that if you are above 160 you take [Lipitor], and if you are below 160 you don’t.”

The Implications

This lawsuit has interesting implications, not just for Pfizer, but for all pharmaceutical companies in the cardiovascular arena.  It is standard practice for physicians to encourage people with heart disease to attempt to exceed recommended goals.  For example, even though guidelines and drug labels do not call for the use of anti-hypertensive medications for people with blood pressures below 140/90 mmHg some physicians are prescribing them.  (140/90 mmHg is the blood pressure level people are considered to have hypertension.)   They take a person’s background, weight and other risk factors into account when making a decision to prescribe a medication. 

The complicating factor is that physicians often don’t believe that therapeutic lifestyle modifications (exercise, diet) will work.  That’s why they turn to a drug to help people meet or exceed recommended goals.  And, while drug companies are careful to say that a medication should not be prescribed for an off-label use, they do encourage physicians to do whatever they can to lower people’s heart disease risk, as Pfizer did. 

Jarvis recognizes that physicians, not drug companies, have the ultimate say in what a patient receives.  However, he argues: 

“The complaint makes [it clear that physicians have the right to prescribe whatever they want.].  But, does that mean that somebody else has to pay for it? Here, the concern is what kind of system we want to have to maintain the doctor’s discretion. Should people, to get their Lipitor prescription, have to turn in all of their medical records to the insurance company to get it approved? We don’t want that system. But we would like, at least as a prophylactic measure, to prevent the drug companies from advertising the drug to the physicians. To prevent them from trying to get doctors to prescribe it to people who it’s not appropriate for.”

Jarvis’ argument is worth repeating because it very important.  He wants to prevent pharmaceutical companies from advertising Lipitor to physicians.  This goes back to an old debate regulators, physicians and others have been having about pharmaceutical company marketing practices.  Should pharmaceutical companies be allowed to show physicians data that is not “on-label?”

This lawsuit is worth watching for a host of reasons, including free speech and physician autonomy.  I’ll be watching to see how it plays out.

(Via Pharmaceutical Executive)

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