Just two weeks ago, Eli Lilly and Company, (LLY) agreed to pay nearly $1.415 billion in fines for "off-label promotion" of the drug Zyprexa, a drug used to treat various conditions related to psychotic disorders, such schizophrenia and acute manic episodes. Not content with these revenues, LLY promoted the drug as a treatment for dementia, including Alzheimer's dementia in elderly people.
The sum includes a criminal fine of $515 million, which the Justice Department called "largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution." The company will also pay up to $800 million in a civil settlement with the federal government and the states, and forfeit $100 million in assets. Commenting on this large fine, LLY stated that it plead guilty to one misdemeanor charge and "disagrees with and does not admit to the civil allegations."
Contrast this whole process to LLY's challenges in 1982. A LLY drug Oraflex was withdrawn from the market only one month after the FDA approved because a British medical journal documented five cases of death due to jaundice in patients. The FDA accused LLY of suppressing unfavorable research findings. In 1985, the Oraflex controversy culminated when the U.S. Justice Department filed criminal charges against LLY. The Justice Department accused LLY of failing to inform the government about four deaths and six illnesses related to Oraflex. LLY pleaded guilty to 25 criminal counts, which resulted in a $25,000 fine. All counts were misdemeanors; there was no charge against LLY of intentional deception.
Oraflex was a case with documented deaths, accusations of suppressed research, numerous charges and an admission of guilt, resulting in a $25,000 fine. Zyprexa was promoted aggressively for unapproved uses, one charge and no admission of civil guilt, resulting in a $1.4 billion fine. Was the issue of "intentional deception" such a distinguising factor between the size of these fines? Or have the times really changed that much?
Wednesday, January 28, 2009
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