Eli Lilly and The New York Times: The Alaska Trial

March 6, 2008

Eli Lilly and its Zyprexa legal woes have hit the road. The Indianapolis-based company and its lawyers are in Alaska, defending against charges of improper marketing of its aforementioned blockbuster schizophrenia drug.

The State of Alaska has filed suit against Eli Lilly, contending that the drugmaker inappropriately downplayed Zyprexa’s health risks and should now be held responsible for the medical expenses of in-state Medicaid patients who contracted diabetes or other ailments after taking the drug. Many will be keenly watching this trial. Eight other states have filed similar suits and as many as 30 others are reportedly considering doing so. Opening statements were made yesterday.

This blog marks the third or fourth time I’ve written on the topic. I’m beginning to think that few outside Eli Lilly are as engrossed in the details as me and The New York Times, which has also written extensively about it. The newsworthiness of this major legal battle explains the Times‘ ongoing interest; my own stems from the broader crisis communications lessons to be learned from Eli Lilly’s handling of this matter.

While the Times did an admirable job of covering the trial’s opening arguments and setting the legal stage, I must question its reporting in that same article about Eli Lilly being investigated for “off-label” marketing of this drug – a serious no-no in the pharma world. While the reference to those charges was unquestionably relevant, the Times neglected to inform readers that the State of Alaska’s lawsuit had also alleged off-label marketing tactics, but that the presiding judge had already thrown out the claim. While I don’t know whether the dismissal was due to a lack of corroborating evidence or perhaps simply a technical glitch – the Times should have at least given the full story.

As an aside, I can’t help but note the irony of Alaska prosecutor Scott Allen reportedly characterizing Eli Lilly’s alleged conduct as being “reprehensible”. That is the same word that senior federal district Judge Jack B. Weinstein used to characterize the information-gathering tactics of Alex Berenson, the Times reporter who has been following this story for the paper.

Up until today, I had been largely mistrustful of the Times‘ Zyprexa reporting because of the alleged ethical shortcuts the newspaper had taken in obtaining the story. I refused, naively, to accept that Zyprexa, an FDA-approved pharmaceutical, could be as horrific a drug as the Times portrayed it to be. I figured that that Lilly’s communications team was simply doing a very poor job at damage control, woefully mismanaging the escalating PR crisis. The anecdotal evidence that Lilly’s outside attorneys are also actively engaged in Lilly’s media relations efforts only reaffirmed my belief.

But I admit my stance has changed now that I’ve read the initial comments made during the opening statement made by Nina Gussack of the Philadelphia-based law firm Pepper Hamilton, which represents Eli Lilly. In a nutshell, she defended the company by saying that Zyprexa’s benefits outweigh the risks and noted that Alaska’s Medicaid program continues to pay for Zyprexa.

While this cost-vs.-benefit approach is hardly a novel one, it just doesn’t sit well. I understand, of course, that there are inherent health risks with virtually any drug and that, despite the threat of possible side effects, informed patients often decide to take that gamble each and every day, starting new drug regiments to cure what ails them. I also understand that there are times when doctors have to make that decision for them, such as in emergency rooms, where the patient’s life is at risk and giving consent is not possible.

What I find morally repugnant, however, is the thought of doctors prescribing drugs that potentially cause life-threatening illnesses to patients who are unable to give their informed consent when other, less risky drug therapies are available. Is schizophrenia the more pressing health concern than diabetes or vice versa? Who gets to make that call? What about the myriad health complications that are shown to be associated with obesity in general? How do we factor them in to the prescribe-or-not-prescribe decision process?

After reading about yesterday’s Eli Lilly assertions, it is now clear to me why the company has hid behind its attorneys rather than aggressively, publicly address the allegations repeatedly raised by the Times. The “benefits outweigh the costs” rationale is a rather weak one to flog in the face of a mounting public backlash. Then again, the public comments they did make – that the Times had repeatedly taken evidence “out of context” – is hardly reassuring to investors, patients, doctors, and everyone else for that matter. As I’ve noted before, the “out of context” defense is rarely a credible one.

While I don’t think that the ends justify the means with respect to how the Times obtained some of its information for its ongoing Zyprexa coverage, I do admit that I’m grateful that much of it has come to light. Something tells me that Eli Lilly and the prescribing doctors who fell for its sales reps’ spiel are much less so.