Why Is The Zyprexa Judge Smiling?

2 Comments

jack-weinstein1Perhaps Jack Weinstein recognizes the irony in a passage buried in his voluminous draft discussion, which he issued last week in hopes of corralling Lilly to settle massive product-liability litigation brought by insurers and others who claim the drugmaker hid serious side effects, and that the antipsychotic was overpriced and improperly marketed.

In February 2007, the federal judge labeled a reporter for The New York Times ‘reprehensible’ for participating in what he called an illegal conspiracy to leak and publish sealed court documents about Zyprexa risks and marketing in a series of articles in late 2006. The episode angered patient and free-speech advocates, who contended that Weinstein’s decision to keep the documents confidential, even after many circulated on the Internet, was not only a First Amendment issue but violated public health.

Yet in a section of his draft discussion, beginning on page 137 and running just a few pages, Weinstein notes that disclosure of the sealed info prompted the FDA to press Lilly for additional info before proceeding with the drugmaker’s request to approve Symbyax, a combination of Zyprexa and its Prozac antidepressant. “In March 2007, the FDA raised additional data about weight gain and hyperglycemia and suggested that Lilly has not been forthcoming with additional data,” he wrote.

Weinstein then briefly recaps the agency’s subsequent efforts to ferret out the side effect info, and even cites FDA correspondence to Lilly in which the agency writes that “we lack important safety information needed to adequately update the labeling with all relevant risk information.” The labeling refers to Zyprexa, not just Symbyax, by the way. In other words, Weinstein does seem to acknowledge the sealed documents were deemed important by the agency overseeing public health.

Of course, Weinstein agreed to seal the documents, which made him the target of free speech and patient advocates, although such arrangements are usually made at the behest of lawyers for plaintiffs and defendants in the presumed interest of speeding along the litigation. Lilly, in particular, fought doggedly to have the documents remain sealed. Nonetheless, Weinstein’s own summary is a reminder that, without the leak, the risk info that so interested the FDA would have remained under wraps.

And what of the three conspirators?

The reprehensible Times reporter, Alex Berenson, is believed to be working on a novel. The former expert witness for plaintiffs’ lawyers, David Egilman, who is an associate professor at Brown University, settled with Lilly, although never admitted to doing anything illegal. And the final conspirator, Jim Gottstein, who runs a non-profit in Alaska against forced drugging, is fighting an injunction in which Weinstein accused him of violating a court order.

Jump to comments

Share

Comments

  1. Thanks, Ed! This is an utterly fascinating document in terms of what it describes both re: internal Lilly communications and between the company and FDA.

    I have only gone through a bit of it so far, but the following impress me:

    - Explicit reference to the Rezulin as not a model to follow, as noted by some at Lilly.

    - Divisions within the company about whether to be “aggressively” [their word] forthcoming about Zyprexa and weight gain/hyperglycemia, or the contrary.

    - The ongoing label struggle related to above, parsing every word and nuance in a wrestling match with some at FDA. FDA comes through as relatively vigilant, at least in the part I read, although the process goes on and on, as we’ve learned in other circumstances.

    - Still unclear to me whether FDAAA, in practice, would actually empower FDA to declare label and that’s that. I assume appeals, etc. would still provide the possibility of lengthy “negotiations.” Are there relevant time-limits in FDAAA, anyone know?

  2. It’s Lilly’s own fault they have LIED over & over

    I have sent 5 certified letters to Eli Lilly operatives including their Pepper and Hamilton law firm as far back as 2.5 years ago,asking to be included in their ‘promised’ $1.2 billion settlement.

    I signed releases for them to contact my Doctor for my medical records,at my last Doctor’s visit he informed me that he has never been contacted,(going on two years now).
    That’s right Lilly has something like 250 lawyers and they don’t even try to contest my claim? I have made thousands of pages denouncing their Zyprexa.

    This is disappointing to learn that they are stonewalling my case,I repeat they have NOT even contacted my doctor!
    I am not the only one either!

Leave a Comment

Subscribe

RSS Feed

Comments feed for this post only.

Clear

Clear

© 2007- 2008 Newark Morning Ledger Co.  All Rights Reserved.

Thanks for trying out the new Pharmalot printing tools. If you're got any suggestions for how we can help you print better, please let us know by clicking on the contact link at http://www.pharmalot.com/

-->