On Friday, the U.S. Department of Justice announced a landmark
over one-half billion dollar settlement with Bristol-Myers Squibb based, in part, on their marketing of Abilify, a fairly commonly prescribed antipsychotic used in the treatment of schizophrenia and bipolar disorder. It was a settlement a long time in coming, announced originally in December 2006.

Not surprisingly, BMS had little to say about the announcement. The original December 2006 announcement gave some idea of what the settlement would entail, at least from a dollar perspective. But the DOJ press release goes into the juicy details that BMS has been mum about.

So this puts a formal end to the investigation, and BMS is merely $515 million poorer. Although I’m not sure I’d use the word “poor” to ever describe a company that brings in nearly $18 billion in 2006 revenues ($1.6 billion in profit), making it the 6th largest pharmaceutical in the world. That means they had to give up a third of their profits for 2006. Luckily they still made a billion for their efforts.

Abilify is recommended by most of our members who take it and have rated it, and appears to be fairly well-tolerated among the antipsychotics. That’s why these allegations are all the more difficult to understand. If Abilify is a good drug for bipolar and schizophrenia, which we believe it is, why the need for all of the off-label sales tactics?

The allegations related to Abilify were:

Second, the Government alleged that, from 2002 through the end of 2005, BMS knowingly promoted the sale and use of Abilify, an atypical antipsychotic drug, for pediatric use and to treat dementia-related psychosis, both “off-label” uses.[...] Nonetheless, BMS directed its sales force to call on child psychiatrists and other pediatric specialists, and the sales force then urged physicians and others providers to prescribe Abilify for pediatric patients. BMS also created a specialized long term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder.

Honestly, I’m not sure how a company of this magnitude could, for 3 years!, think that this kind of behavior was “okay” and not going to come under scrutiny. It is exactly this kind of unfortunate behavior that paints the entire pharmaceutical industry with a singular, often-negative brush.

Will this have a chilling effect on both BMS and the rest of the industry from engaging in these kinds of practices in the future? Gosh, one would hope. Because if a half-billion dollars isn’t going to make a statement, I’m not sure what will.

Dr. John Grohol is the CEO and founder of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues -- as well as the intersection of technology and human behavior -- since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.

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    Last reviewed: By John M. Grohol, Psy.D. on 1 Oct 2007
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