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Court Allows Eli Lilly To Bury Zyprexa Documents
By Evelyn Pringle (about the author) Page 1 of 4 page(s)
For OpEdNews: Evelyn Pringle - Writer
Information from the documents related to Lilly's antipsychotic drug, Zypexa, was highlighted two days in a row in front-page articles in the Times
The documents reveal the illegal marketing schemes used by Lilly to make Zyprexa its best-seller, which the company has managed to keep hidden for years by entering into out of court settlements in civil lawsuits which included confidentiality clauses and by getting judges to place the documents under protective orders to shield them from public view.
For instance, the documents under seal here are from a case where Lilly entered into an out-of-court settlement in June 2005, and agreed to pay $690 million to cover claims by about 8000 Zyprexa victims. But in order to get paid, the plaintiffs were required to sign a confidentiality clause and basically keep their mouths shut about Zyprexa from then on.
Its really comical the way Lilly keeps acting all indignant over the disclosure of these documents as if they contain brand new charges, when the company has been under federal and state investigations related to its off-label marketing of Zyprexa for several years already. The company is also facing Medicaid fraud charges in lawsuits all over the county.
In 1996, Zyprexa was approved for the treatment of adults with schizophrenia, and a few years later, it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.
Yet despite these extremely limited approved uses, Zyprexa went 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.
The documents provided to Times, span a decade and clearly show that the company promoted off-label the sale of Zyprexa for uses not approved by the FDA as being safe and effective. They also reveal that Lilly knew about Zyprexa's link to drastic weight gain and diabetes for years but failed to inform prescribing doctors and consumers.
In fact according to the Times, Lilly knowingly distributed false information to doctors about the risks as late as 2001. On December 21, 2006, the Times reported that the information provided to doctors about the blood-sugar risks of Zyprexa did not match data circulated inside the company after a review of Lilly's clinical trials.
The Times quotes a Lilly report from November, 1999, that shows that after examining 70 clinical trials, Lilly found that 16% of patients taking Zyprexa for a year had gained over 66 pounds. But instead of making these findings public, the company used data from a smaller group of trials that showed roughly 30% of Zypexa patients gained 22 pounds.
Mr Gottstein is not involved in the case in which the judge issued a protective order In re: Zyprexa Products Liability litigation, MDL No. 1596, United States District Court, Eastern District of New York (MDL 1596), "in any manner whatsoever," he says.
He is the leader of, "The Law Project for Psychiatric Rights (PsychRights), a public interest law firm devoted to the defense of people facing forced psychiatric drugging against their will.
Currently, Mr Gottstein represents an Alaskan patient and says the injunction will prevent him from using the Lilly documents to show that the side effects of Zyprexa are well-established by the company's own clinical trials and therefore, his client should not be forced to take such drugs against his will.
In Myers v Alaska Psychiatric Institute, 138 P.3d 238 (Alaska 2006), a case argued by Mr Gottstein last summer, the Alaska Supreme Court ruled that Alaska's forced drugging procedures were unconstitutional because they did not require the court to find such drugging to be in the person's best interests, and that there were no less restrictive
alternatives.
In order to present the evidence in the case he is handling now, Mr Gottstein is looking to the Alaskan courts to issue a ruling that says his client's right to avoid forced drugging outweighs Lilly's right to keep the information about risks hidden.
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