Monday, June 8, 2009

Lilly's Off-Label Marketing of Zyprexa--It's Marketing, not Education

At this late juncture, there are still three people in the US who believe the old shibboleth of the pharmapologists, that what doctors hear from drug reps is "education, not marketing." After they read this post, two of the three will finally change their minds. The third is a hopeless case and needs to be put on Zyprexa.

Glen Spielmans, a psychologist at Metropolitan State University, St. Paul, is author of a paper currently posted ahead of publication on the Social Science & Medicine journal website (subscription required). He replies on internal company papers released through legal action to document the marketing scheme pursued by Eli Lilly in trying to get physicians, especially in primary care, to prescribe Zyprexa (olanzapine) liberally and far in excess of the labelled indications. As he points out, these off-label marketing schemes eventually netted Lilly a $1.4B fine, the largest corporate criminal fine in US history.

Lilly had high hopes for Zyprexa, at one point anticipating that annual sales could reach $10B. There were only two problems with their miracle drug. First, it did not work very well for many of the off-label uses for which it was tested, such as behavioral problems in dementia and mood disorders. For that matter, the original claims that Zyprexa, as a "second generation" antipsychotic, really worked any better than the old first generation drugs for any of the labeled indications (psychosis), were never well documented and recently have been largely debunked. Second, the claims of a wonderful safety record were undermined when it was finally revealed that the drug causes serious metabolic disruptions and weight gain in many patients, sufficient to cause the onset of diabetes in some.

Lilly targeted much of its off-label marketing at primary docs, knowing that they saw a large number of patients who are basically unfulfilled and unhappy, but who may not have a diagnosable mental disorder according to strict psychiatric criteria. The company prepared a number of patient vignettes its speakers and reps could present to docs. Each vignette was of a patient who had some mental symptoms, but was clearly not psychotic. Each was designed to suggest to the doc that a lot of patients who came though the door must have undiagnosed, serious mental disorders, for which she could both safely and effectively prescribe Zyprexa.

For example, consider "Donna," a mid-30s single mom, who on one visit complains of feeling anxious, irritable, sleeping more than usual, and having trouble concentrating. It's pointed out to the doc that several appointments earlier, "Donna" had been elated and talkative and reported little need for sleep. Though the severity of symptoms depicted in "Donna's" case falls far short of the official criteria for diagnosing bipolar disorder, the point of the vignette was to convince the doc that "Donna" had a significant, complicated mood disorder that could be successfull treated in the primary care setting with Zyprexa--with no need to refer to a psychiatrist for a formal diagnosis, presumably.

Without boring you with a lot more detail, I would suggest that there is only one possible conclusion a person could come to on reading the evidence that Spielmans has compiled from the legal record. None of this had anything vaguely to do with science or education. It most certainly has nothing at all to do with improving patient care. All of it had to do with selling a drug.

Why is any of this even worth mentioning, since by now we have heard this same sorry story so many times? A couple of weeks ago, Kris Hundley, reporter for the St. Petersburg Times, briefed us on a batch of internal company memos recently released in an Orlando court ( This time the company was AstraZeneca and the drug was Seroquel, another newer antipsychotic which also causes weight gain and diabetes. The AstraZeneca documents show a similar pattern of pushing off-label use and hiding unpleasant findings about side effects or lack of effectiveness from docs. But the most notable passage in Hundley's article was:

AstraZeneca marketers were jealous of what they saw as competitor Lilly's ability to cast questionable study results in a positive light. "They (Lilly) are able to spin the same data in many different ways through an effective publications team," according to a 2003 memo. "Negative data usually remains well hidden."

Way to go, Lilly--AstraZeneca admits that you were the leaders in the race to the bottom.

Spielmans GI. The promotion of olanzapine in primary care: an examination of internal industry documents. Social Science & Medicine 2009 (e-pub ahead of print; doi:10.1016/j.socscimed.2009.05.001).

Hundley K. Memos: results hidden to peddle antipsychotic. St. Petersburg (FL) Times, May 20, 2009.

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