2 janvier, 2008 19:56
Whistleblower Sues Pfizer Over Deceptive Lipitor Marketing Categories
A former Pfizer employee has sued the pharmaceutical giant alleging that the sales of Lipitor, a cholesterol lowering drug, were hugely inflated by a deceptive 'educational' campaign that induced medical doctors to prescribe the drug to patients who didn't need it.
According to the Wall Street Journal, which
reports on the legal case, 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 whistleblower's lawsuit was filed in U.S. District Court for the Eastern District of New York in February 2004 but was sealed to allow government prosecutors time to consider whether they wanted to join in. The government has declined to intervene which led to the unsealing of the case earlier this year.
Whistleblower sues Pfizer -
Image: Pharmalot.
Pfizer says "we believe the case has no merit" and points to the government's refusal to join the action. Polansky claims he was fired by Pfizer after complaining about improper marketing practices. Dr. Polansky now works as the senior medical officer for Medicare in a unit that investigates fraud and abuse at the government health insurer.
Lipitor is a super blockbuster drug - it generated more than 13 billion dollars in sales for Pfizer last year. But it also is a very controversial drug. Lower cholesterol counts are not equal to prevented heart attacks, a fact that is never mentioned in the 'educational' campaigns Pfizer is running to increase the sales of its drugs. The Wall Street Journal puts it like this:
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."
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Cholesterol lowering drugs: side effects
Another very controversial side of the drug are its severe 'side effects'. Statins or cholesterol lowering drugs, of which Lipitor is the most prominent example, are interfering with the human liver's ability to manufacture cholesterol which, far from being the bugbear we are made to believe it is, has hugely important functions in our bodies' metabolism.
Dr. Duane Graveline says in his
Critical Review of Statins:There is no doubt that the present notoriety of cholesterol has all but obscured its physiological importance and necessity in our bodies. Cholesterol is not only the most common organic molecule in our brain, it is also distributed intimately throughout our entire body.
It is an essential constituent of the membrane surrounding every cell. The presence of cholesterol in this fatty double layer of the cell wall adjusts the fluid level and rigidity of this membrane to the proper value for both cell stability and function.
Additionally, cholesterol is metabolized into other essential body steroids known as the steroid hormones and is therefore the sole source for the formation of the very powerful chemicals in our body that determine our sexuality, control the reproductive process and make possible our very existence.
Since cholesterol is a very important molecule for proper brain function, it seems no wonder that lowering cholesterol through drugs like Lipitor has been associated with
neurological side effects such as Amyotrophic Lateral Sclerosis and Alzheimer's disease.The fact that cholesterol is an essential component of cell membranes may explain why many people taking Lipitor and other cholesterol lowering drugs suffer sometimes excruciating
muscle pains that, more often than not, prescribing physicians have not been told about and thus simply discount when the patient complains about them.The reality of these painful effects is documented by the comments readers posted on two earlier articles on this site:
Lipitor - The Human Cost and Lipitor: Side Effects and Natural Remedy. The stories of these numerous readers collected as spontaneous comments to these two articles should give anyone pause to think before taking cholesterol lowering drugs, but more than that - they should induce the FDA and other health authorities to take a more critical approach to the widely accepted "everybody knows" that cutting cholesterol levels is a desirable preventive health intervention and that everyone with even slightly elevated cholesterol should be put on statin drugs.
