Yet Another Drug Company Fined for Off-Label Marketing of Psych Medication

Since I started this blog way back in March of 2010, I have posted several times about big Pharma companies being fined for the off-label marketing of various psychiatric medications. Well, the hits just keep on coming.

The Consumerist was one of several news sources to recently report that: 

"New York Attorney General Eric Schneiderman announced the settlement Thursday resolving allegations that Bristol-Myers Squibb improperly marketed and promoted the drug Abilify.

Abilify — the brand name for the prescription drug aripiprazole – is a second-generation antipsychotic prescription drug, commonly, commonly referred to as “atypical antipsychotics,” that were originally used to treat schizophrenia.

According to the states’ complaint, which was also filed today, BMS engaged in off-label marketing, which is the promotion of drugs for uses that are not FDA-approved.

For example, the complaint claims that BMS improperly promoted Ability for pediatric use and for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease.

This, despite the fact that in 2006, Abilify received a “black box” warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.

Additionally, the complaint alleges that BMS violated state consumer protection laws by misrepresenting and minimizing the risks of the drug including metabolic and weight gain side effects and by misrepresenting the findings of scientific studies.

Under the proposed agreement, BMS is prohibited from promoting Ability from off-label uses; making false or misleading claims about the drug; compensating health care providers for attended promotional activities; using grant funds to promote Ability; and providing samples of the medication to health care providers who do not intend to use it for labeled purposes."

Bristol-Myers Squibb settled the claims with 43 states for a total of 19.5 million dollars. That sounds like a lot of money, but for big drug companies, it is actually a paltry sum. Fines like that are considered a cost of doing business

As readers know, I am rabidly against the use of antipsychotic medications in non-psychotic children, which is unfortunately becoming more and more common. However, I must admit I have negative feelings about that black box warning regarding the use of any (not just Abilify) antipsychotic medication in patients in nursing homes with advanced dementia due to Alzheimer's disease or other severe brain conditions. 

Things have gotten to the point where docs are afraid to prescribe these medications even in such patients who are actively psychotic with hallucinations and/or paranoid delusions, for which there are no other effective treatments.

Even in non-psychotic demented patients, antipsychotic meds are often the best agents for controlling assaultive behavior in this population. Unlike other sedatives, they do so while only minimally exacerbating memory and cognitive deficits in these people. Our society seems to want to pay nursing assistants only the minimum wage to take care of our impaired family members as they age. Long-term facilities are very expensive as it is. Not only that, but we under-staff them as well. While there may be psychosocial interventions which would reduce assaultive patients with dementia, we do not want to pay people to provide them.

Given those conditions, what is left? Medications, that's what. Do we really want to expose underpaid and overworked caretakers to dangerous aggressive behavior from patients who basically have no life anyway - just to prevent a tiny percentage of them from dying a little sooner due to the medications' cardiovascular side effects? Time to either pay up or shut up.