The Second PhARMA Company Fined by DOJ in Just One Week

In my post of March 27, 2010, A Perfect Trifecta, I mentioned that a lot of psychiatrists seemed to be using an anti-epileptic drug called Topamax in patients whom they had diagnosed - often incorrectly - as having bipolar disorder.

It turns out that my observation was no accident. For the second time in just one week, the U.S. Department of Justice fined a pharmaceutical company for off-label marketing of drugs for psychiatric indications. Two Johnson & Johnson subsidiaries, pharmaceutical manufacturers Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., have agreed to pay $81 million to wrap up a probe of their Topamax promotions.

Just like with AstraZeneca, the companies did not admit guilt, and just like with AstraZeneca, the fine was a paltry sum compared to the money they made from the drug being misused. The drug has NO psychiatric indication at all.

According to settlement document posted on the Justice Department website, during the period from January 1, 2001 through December 31, 2003, the companies promoted the use of the drug for a variety of psychiatric conditions, including but not limited to bipolar disorder and drug and alcohol dependency.

According to the Justice Department press release, Ortho-McNeil paid doctors to come with sales reps on detailing calls and suggest unapproved uses for the drug. Doctors also were allegedly hired to speak at meetings and dinners about off-label Topamax use.

Five drug companies so far have been proven to have a vested interest in expanding the diagnosis of bipolar disorder for their own profit.