Study: Lilly Marketed Zyprexa Off-Label For Bipolar Disorder

A new study is out in the journal Social Science & Medicine examining how Eli Lilly marketed Zyprexa, its controversial atypical antipsychotic, in primary care settings (meaning to non-psychiatrists). The paper's author, a psychology prof at Metropolitan State University in Minnesota named Glen Spielmans, relied heavily upon the Zyprexa documents hosted on this site for his trail of evidence. As far as I know, his paper is the first published academic study of how Lilly marketed the drug far outside of its approved indications (schizophrenia and mania) in the first half of this decade.

Longtime readers will remember that I first wrote about Lilly's marketing of Zyprexa for bipolar disorder type 2, for which it did not have marketing approval, and for agitation and mild depression, for which the company also had no approvals, in February 2007. I'm glad that Spielmans took up this matter and the entire history of Lilly's PCP marketing campaign, as he adds a lot of depth and texture to the story. I also understand that attorneys for Elsevier, the journal's publisher, lawyered the hell out of his paper, a highly unusual move in academic publishing, in order to keep from running afoul of Lilly's legal team.

It's an excellent paper and I encourage you to all give it a read. In addition, I appreciate the acknowledgment Spielmans gives me at the end of the paper.

My favorite part of the paper comes here:

"The relatively mild symptoms marketed by Lilly as components of ‘complicated mood’ (anxiety, irritability, disturbed sleep, and mood swings) are ill-defined and, to some extent, are likely to be experienced by a large number of people. Labeling this constellation of ill-defined and likely common symptoms as indicative of a mental condition is suggestive of ‘disease mongering’ a term referencing the effort of pharmaceutical companies to broaden the market by convincing patients (and physicians) that a large number of people are suffering from a (usually relatively mild) illness which would benefit from pharmaceutical intervention. In trade journals, pharmaceutical industry insiders have plainly stated that expanding the market for their products via 'condition branding' (an industry term analogous to ‘disease mongering’) is a highly useful tool in the marketing arsenal. Indeed, the current corpus of internal documents hints that, in addition to marketing olanzapine, sales representatives were also marketing the expanded boundaries of bipolar disorder. No longer was bipolar disorder a relatively uncommon condition relegated to treatment by psychiatrists, it was to be marketed as a common illness with a broad spectrum of severity that warranted treatment in primary care. Despite an expanded treatment market, there is a paucity of controlled clinical trial data regarding the benefits and risks of treating adults with mild symptoms of bipolar disorder/complicated mood with ‘mood stabilizers’ or atypical antipsychotics such as olanzapine."

Condition branding is such a delightful term. Too bad it creates so many artificial realities at such high costs for so many people.

Lilly should be counting its lucky stars after reading this paper because it's clear that the company off-label marketed for bipolar disorder type 2 and for agitation and mild depression, but was only rung up by the feds and about 30 states for off-label marketing for dementia. As I've said before, its $1.42 billion settlement earlier this year with the feds and states allowed Lilly to get off cheaply, albeit with a criminal misdemeanor plea.

To date, Lilly has settled about $2.7 billion in claims concerning its handling of Zyprexa--and there's likely more to go.

By the way, Zyprexa is the subject of 22,191 adverse events reports in the FDA's adverse events database as of the end of 2008, including 3,442 reports where the outcome was death.