The price drug companies pay for illegally marketing drugs for off-label (tnat is, non-FDA-approved) uses just got higher. Such off-label pushing has been a growing problem the past few years, as drug companies sought to expand the use and thus the profit from established drugs. Doctors are free to prescribe drugs for off-label uses -- but companies aren't allowed to recommend or urge such use, as such use hasn't, by definition, been vetted at the FDA and so should be a doctor call, not the drug companies. Nevertheless, companies have indulged heavily in the practice.
This fine might be heavy enough to seriously discrouage it. The fine is over a third of what the total sales of the reported $3.5B the drug (Zyprexa) generated. Not clear to me if anyone knows what portion of that $3.5 came from off-label use. But it seems doubtful it was $1.4B, which is what they're paying to settle the case.
The AP, the Wall Street Journal, Furious Seasons, and In the Pipeline all report or comment on it.
I'll comment in another post on how this story reflects an interesting, and I would say promising, intersection of the powers of the mainstream and new (blogging) press.
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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.
Zyprexa Claims being Stonewalled.
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.