Was there not just something in the news this week about allowing off label use, well guess it doesn’t apply here. The new ruling states the information provided has to be documented in medical journals in order to be distributed, but still it seems a bit gray. At any rate, for elderly patients Lilly bit the dust on this one, no details on how it was promoted for off label use. BD
FDA lets drugmakers advise doctors on unapproved or off label use
Eli Lilly was the picture of remorse on Thursday, when the pharmaceutical company admitted to the improper marketing of its antipsychotic drug Zyprexa, agreeing to pay more than $1.4 billion in settlements.
The Indianapolis-based company admitted guilt in a misdemeanor violation of the Food, Drug and Cosmetic Act for its improper marketing of Zyprexa to elderly patients with dementia during the period of September 1999 to March 2001.
Zyprexa is approved by the U.S. Food and Drug Administration as a treatment for schizophrenia in patients over 18. Lilly admitted to promoting the drug to elderly patients for off-label use as a treatment for dementia. The drug caused increased risk of death in this patient group. Zyprexa was approved in 1996 and will lose patent protection in 2011. It had annual sales of $4.7 billion in 2007.
Eli Lilly: Indy-based pharmaceutical company pleads guilty to promoting Zyprexa for unapproved uses; is slapped with $1.4 billion criminal fine, the largest ever placed on a U.S. company.
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Where is the money going as many victim claimants haven't been paid yet?
Something fishy going on here?
Conflict of interest.
Eli Lilly promotes sales of their #1 drug (Zyprexa $4.8 billion year) that can *cause* diabetes and then turn around and make billions selling more drugs to treat the diabetes.
Eli Lilly's # 1 cash cow Zyprexa has been overprescribed and linked to a ten times greater risk of causing type #2 diabetes and increased risk of heart attacks.
Daniel Haszard Zyprexa patient who got the diabetes from it.
Thank you for the update. Side effect today from what we think is helping us are scary indeed. Sometimes you wonder if some of the cures are worse than the problem.
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