Monday, December 20, 2010

Epidemic of Mania, Pharmaceutical Company Type (Bipolar Disorder P.C.) Claims Seventh Victim

Just as I thought I had heard the last about drug company mania mania, yet another example pops up.  Posts on this subject are starting to become a regular feature on this blog.  For the seventh time, the Justice Department has fined a pharmaceutical company for off-labeling marketing one of their drugs for a psychiatric indication for which there is no data, and once again the psychiatric indication is mania.  I hope these posts have not become monotonous.

This time the company is Elan pharmaceuticals and the drug - seemingly always an anticonvulsant or atypical antipsychotic - is the anti-seizure medication Zonegran.

According to the justice department press release at,  "Elan promoted the sale of Zonegran for a wide variety of improper off-label uses including mood stabilization for mania and bipolar disorder, migraine headaches, chronic daily headaches, eating disorders, obesity/weight loss and seizures in children under the age of 16.

Elan’s off-label marketing efforts targeted non-epilepsy prescribers and the company paid illegal kickbacks to physicians in an effort to persuade them to prescribe Zonegran for these off-label uses. Under the terms of the plea agreement, Elan has agreed to pay a criminal fine of $97,050,266 and plead to a misdemeanor violation of the Food Drug and Cosmetic Act. EPI will also forfeit $3.6 million in assets.

In addition, Elan has agreed to pay $102,890,517 to resolve civil allegations under the False Claims Act and related state statutes that the company illegally promoted Zonegran and caused false claims to be submitted to government health care programs for a variety of uses that were not medically accepted indications and therefore not covered by those programs."

The company was not accused of trying to expand their market by expanding the definition of bipolar disorder the way Eli Lilly did with their marketing for Zyprexa (see my March 22 post, The Zyprexa Documents).   However, would anyone be surprised if they had done this as well?  Any moody patient becomes fair game for a bipolar diagnosis.

Typically, the company "targeted non-epilepsy prescribers."  Translation: primary care doctors and perhaps psychiatrists. Apparently they are fairly easy targets to manipulate.

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