Furious Seasons

September 29, 2007

Bristol Myers Squibb To Pay Feds $515 Million Settlement

Late yesterday, the Department of Justice announced a settlement with BMS of allegations involving a range of drugs the company makes and markets, including Abilify. The company is paying $515 million. The allegations involving Abilify were these:

"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. The Food and Drug Administration has approved Abilify to treat adult schizophrenia and bi-polar disorder, but has not approved the use of Abilify for children and adolescents or for geriatric patients suffering from dementia-related psychosis. Indeed, the FDA has mandated that the package for Abilify carry a “black box” warning concerning its use in the treatment of dementia-related psychosis. 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."

Off-label marketing. Pushing an antipsychotic on kids and the elderly. So now two companies--Eli Lilly and BMS--have been busted for these kinds of activities. More are on the way, as various states allege similar types of activities in their lawsuits against AstraZeneca, maker of Seroquel, and Janssen/J&J, maker of Risperdal. Total industry payout from this and the Zyprexa settlements now comes to about $1.5 billion (not all of the $515 million settlement relates to Abilify).

Think about that when a doctor presses you or your child to take one of these drugs. Think about that when you read a website on bipolar disorder that acts as if these drugs have no problems. There's a reason these companies are settling these lawsuits.

More to come.

Posted by Philip Dawdy at September 29, 2007 12:36 PM

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Comments

My girlfriend took Abilify for Borderline Personality Disorder, and after seeing her on Seroquel, Zyprexa, etc. it certainly has a better side effect profile. There's minimal drowsiness and there's less weight gain (if any), although the risk of diabetes is still there. I think it interrupted her sleep to some extent, and, to be fair, she was taking it at a low dose (2.5 mg), so there might be greater side effects at higher doses. She's been off it for about six days, although she had a bit of an episode last night (the first in quite a while), so I don't know what she'll decide to do.

However, even if I don't hate Abilify quite as much as Philip does, there's really no excuse for this kind of marketing. The black box on Abilify notes that geriatric patients are 1.6 to 1.7 times as likely to die while taking the drug. I don't see how anyone could have authorized this kind of marketing knowing that they were effectively killing the elderly. I guess that as long as it's not their grandparents, they don't care.

Posted by: Simon at September 29, 2007 01:50 PM

There's a suicide infomercial in the New York Times Magazine from the Jed Foundation, a pharma front group:

http://nytimesshorts.feedroom.com/?fr_chl=d31ce0ff8aac169ff551065952377d8697886277

http://www.ahrp.org/cms/content/view/171/27/

Posted by: Sally at September 29, 2007 02:21 PM

It's not about hating a medication, it's about understanding the unethical promotion of the drug and awareness.Abilify-Increased Mortality in Elderly Patients with Dementia-Related Psychosis.

Abilify is known per psychiatrist circles as a med that induces mania in bipolar patients and in patients who are not bipolar. Just like the antidepressants, it is not what the medication was prescribed for, it is the outcome.[result,reaction]

This med was ramped up by a Psych in a inpatient setting per my 17 yr. old and her behaviors were so erratic, and dangerous within their own unit, that they left me a voicemail agreeing with my observations that the behavior was the same as "Luvox,Zoloft,Ativan...etc." they had to see it for themselves.

THEN we have an unaddressed issue here: Alzheimers patients that are commonly prescribed Abilify and Risperdal for agitation. [as well as Autistic kids].

Posted by: Stephany at September 29, 2007 08:03 PM

If the government gets the money, where does the money go? Does it actually get to people?

Posted by: Christina T at September 30, 2007 12:32 PM