Abbott Laboratories has pleaded guilty and agreed to pay $1.5 billion to resolve its criminal and civil liability stemming from its off-label promotion of Depakote, a drug that controls seizures.
The FDA had approved Depakote for three uses only: epileptic seizures, bipolar mania and migraine prevention. Abbott admitted to promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia.
From 1998 through 2006, the company admittedly used a special sales force to promote the drug in nursing homes for these off-label purposes. Additionally, from 2001 to 2006, Abbott marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use.
Abbott also funded two studies on the use of Depakote to treat schizophrenia. Both failed to meet the main study goals. When the second study did not result in statistically significant treatment differences between antipsychotic drugs used in combination with Depakote and antipsychotic drugs alone, Abbott waited almost two years to notify its sales force about the results. It then waited another two years to publish the results. During that time, the company continued to promote Depakote for the treatment of schizophrenia.
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The FDA had approved Depakote for three uses only: epileptic seizures, bipolar mania and migraine prevention. Abbott admitted to promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia.
From 1998 through 2006, the company admittedly used a special sales force to promote the drug in nursing homes for these off-label purposes. Additionally, from 2001 to 2006, Abbott marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use.
Abbott also funded two studies on the use of Depakote to treat schizophrenia. Both failed to meet the main study goals. When the second study did not result in statistically significant treatment differences between antipsychotic drugs used in combination with Depakote and antipsychotic drugs alone, Abbott waited almost two years to notify its sales force about the results. It then waited another two years to publish the results. During that time, the company continued to promote Depakote for the treatment of schizophrenia.
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