It seems like just when I get finish with a post about yet another drug company getting in trouble for off-labeling marketing of a drug that is used in bipolar disorder, another company adds itself to the list. This time, it is Abbott Laboratories, maker of the second-line drug for mania prophylaxis, Depakote. Depakote is effective for mania prophylaxis, although probably not as effective as lithium. Still, drug companies just refuse to satisfy themselves with honest marketing of an effective drug.
ABC World News (5/7) reported, "Tonight one of the largest drug companies, Abbott Laboratories has agreed to a staggering settlement" with the US Justice Department. "Today $1.6 billion in criminal and civil fines for improperly marketing the anti-seizure drug Depakote in nursing homes. The company convinced the nursing homes to use the drug to treat aggression in dementia patients, despite the lack of credible evidence that the drug was effective for that use." This fine included $700 million in criminal penalties. The AP (5/8) reported, "At a news conference at the Justice Department, US Attorney Timothy Heaphy said that the top levels of Abbott carried out a strategy of systematically marketing the drug for purposes other than what federal regulators had allowed. The illegal conduct was not the product of 'some rogue sales representatives,' said Heaphy, the US attorney for the western district of Virginia. He said the company engaged in the strategy from 1998 to at least 2006." Other off label (non FDA-approved) indications for which the drug was marketed included schizophrenia and autism. For a while, it seemed to me that every time I saw a hospital report about a patient diagnosed with schizophrenia, they had been treated with Depakote along with the usual anti-psychotic medication. As far as I could tell, it added nothing to the treatment of delusions and hallucinations other than some extra sedation. I never understood the rationale for this practice. Now it's clear.Abbott's off-label marketing efforts were directed at nursing-home directors, geriatric doctors, and other long-term care providers in addition to psychiatrists. The company also gave doctors illegal kickbacks to talk up off-label uses so that sales of depakote would increase.