Lilly Fine for Zyprexa Off Label Marketing: $1.4B

When it came to fines paid for illegal marketing practices, the big drug companies had for some time been stuck in the mere hundreds of millions. Give Eli Lilly credit--they stole the lead with total fines of $1.4 billion for Zyprexa (olanzapine) marketing.

Specifically, the company tried to push its second-generation anti-psychotic drug well beyond its FDA-approved uses for schizophrenia and bipolar disorder. Perhaps the most extreme use detailed in these recent charges was a campaign to get docs to use Zyprexa as a--get this--sleeping pill, since sedation is a common side effect. Lilly reps were schooled in a "5 at 5" campaign, by which docs working in nursing homes were urged to prescribe a 5 milligram dose of the drug at 5 pm to assure a good night's sleep. This occurred well after Lilly knew of the drug's serious side effects, particularly obesity and an increased incidence of Type II diabetes. The settlement also cites Lilly's efforts to assure that the drug was heavily marketed to primary care physicians, despite the fact that relatively few primary care docs would be treating the major indications for which the drug was labelled.

As I alluded to in a previous post (http://brodyhooked.blogspot.com/2009/01/are-second-generation-antipsychotic.html), the basic problem here seems to have been the aggressive marketing of all the so-called "second generation" or "atypical" antipsychotics as extremely safe, free of the horrible side effects of tardive dyskinesia and the zombie-like state often seen with high-dose, continued use of the older antisychotics. There seems to be a two-step process. First you convince the medical community that a drug is extraordinarily free of side effects. Then you engage in "indication creep"-- since the drug is so safe, why not try it for patients who are less and less sick, or for patients who suffer from conditions less and less closely related to the major indications for the drug. In the case of Zyprexa, the creep was away from major psychosis and toward milder and milder mental health problems in the elderly, including depression, sleep disorders, and problem behavior such as wandering associated with dementia. In the case of the serotonin antidepressants, the creep took the form of prescribing antidepressants only in severe depression, to prescribing the drugs for any patients who had a bad hair day. Finally the research is done, very late in the day, revealing that the supposed absence of side effects was actually mythical (along with the mythical reports of the drugs' real efficacy), the creation of flawed research and aggressive marketing rather than pharmaceutical science.

Kmietowicz Z. Eli Lilly pays record $1.4bn for promoting off-label use of olanzapine. BMJ 2009, 338:b217. (Subscription required)