Lilly & Zyprexa – Glaxo & Seroxat?

I notice that Phil Dawdy at Furious Seasons has an update on the Zyprexa story. I’ve written about Zyprexa before but Phil is the Daddy on this one.

In March 2007, I wondered “how does a drug such as Zyprexa, that was approved for the treatment of adults with schizophrenia, and a few years later, was approved for short-term treatment of adults with manic episodes associated with bipolar disorder, become such a HUGE selling medicine?

“Despite its extremely limited original approved uses, Zyprexa has gone on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly’s best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.”

This from Furious Seasons:

Late last week, US District Court Judge Jack Weinstein shot off his mouth in an opinion he filed in the midst of a merry-goround of opinions being filed as various Zyprexa cases under his purview are shaped up to march toward trial or settlement. Recently, Weinstein pressed Eli Lilly to settle all outstanding Zyprexa claims and various estimates put that figure at over $7 billion. Even at a payout of $7 billion, Lilly will be ahead on the deal. [Lilly has already settled about $1.3 billion in claims over its handling of Zyprexa].

Anyway, the judge let the FDA have it right in the kisser over Zyprexa, which, as most of you know, has been linked to thousands of cases of diabetes, hyperglycemia, massive weight gain, deaths and other problems:

“Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa.”

Weinstein’s opinion is well-supported by the facts and he had more to say about the FDA in his opinion, which you can read  here (pdf file). As he notes elsewhere in the opinion, the drug regulators in other countries were not fooled by Lilly’s various smokescreens, but the FDA was.

He also went after Lilly:

“Lilly’s alleged lack of transparency, failure to warn, and deceptive or illegal marketing practices are but some of the factors that a juror could find led to this litigation….Lilly exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers, in order to support an excessive price. Evidence of defendant’s alleged failure to disclose its products’ side effects, its violation of obligations of transparency, and its deliberate encouragement of off-label use, permits-but just barely-a jury finding of liability under RICO.” [RICO is the federal Racketeer Influenced and Corrupt Organizations statute that was designed to prosecute various mafia families. That acronym coming out of the judge’s pen should have Lilly running for its settlement checkbook].

What strikes me about the the Judge’s opinion in this matter is that it could so easily have been written about Glaxo and Seroxat:

“… lack of transparency, failure to warn, and deceptive or illegal marketing practices… exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers… violation of obligations of transparency… deliberate encouragement of off-label use…”

And in the same way that the FDA has “failed consumers”, so in the UK we see the MHRA has done the same.

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