The Zyprexa Chronicles: Lilly's Legal Hypocrisy

Some of you may have noted that in recent coverage of the Zyprexa trial in Alaska that Lilly's outside attorney, Nina Gussack, has pointed out what she considers a discrepancy in Alaska's case. Namely, that the state alleges that Lilly failed to warn about risks inherent to the use of the drug while at the same time the state continues to use the drug. While one assumes a lawyer on the state's side will beat down that argument by countering that the drug is only risky for a certain percentage of patients, as it has later turned out, but that Lilly knew it was risky back before it properly warned users in the US.

Which brings me to a bit of hypocrisy in Gussack's approach. In April 2002, Japanese regulators ordered the company to slap warnings on its drugs in Japan, which the company did. Soon after, however, it argued in its own internal documents that the Japanese warning--with which they did not agree--had no affect on the safety of Zyprexa in America. (Yes, like the American and Japanese endocrine systems are so different.) In June of that year, the company rolled out an epic marketing program in which it sent its sales reps off to visit thousands of PCPs in America and convince them that in their practices they were regularly encountering women with agitation and mild depression and that these women showed the signs of bipolar disorder and would that doctor consider starting a patient such as that on Zyprexa today because Zyprexa, like, totally worked for that condition--the complex "mood patient." That sounds like the same kind of conflicted thinking they are accusing Alaska of.

Even weirder: At the time of the American PCP roll out, Zyprexa was only approved for acute mania use in bipolar disorder, and that would be bipolar disorder type 1 since bipolar disorder type 2 doesn't have mania as one of its dimensions. The women described in Lilly's campaign might have been bipolar disorder type 2, if that, but they were bipolar disorder type 1 and Lilly was using its bipolar disorder type 1 indication to roll on up on PCPs and get their patients knocked out on antipsychotics. One wonders how many of these women later developed diabetes and other maladies.

If that isn't ignoring its duty to warn given what had come down from Japan, then I don't know what would be. Kinda smells like off-label marketing to me as well.

Zyprexa documents relevant to this post:

April 15, 2002 Lilly memo on Japanese label changes

June 2002 Lilly Primary Care Sales Force Resource Guide

Zyprexa Frequent Areas of Concern from the Donna campaign