State claims Lilly tried to blur Zyprexa-diabetes link

Anchorage Daily News
By LISA DEMER

Back in 2002, Eli Lilly and Co. came up with a $10 million effort to ramp up sales of its schizophrenia medicine, Zyprexa. They called it Project “BAD.”

Among other things, the company wanted to reduce the “negative aspect” of links between Zyprexa and diabetes in patients, jurors were told Monday in Anchorage Superior Court.

No one explained the name in court. “A project to overcome the bad,” Tommy Fibich, a lawyer representing the state, said later.

Lilly says “BAD” is an acronym. It stands for bipolar disorder, aripiprazole — the generic name of a new drug approved to compete with Zyprexa in 2002 — and diabetes, a Lilly spokeswoman said after court ended for the day.

The drug maker is defending itself against a lawsuit brought by the state of Alaska that claims it failed to warn of health problems linked to Zyprexa.

The trial is in its second week. If the state wins, there will be a new trial for damages. The state is seeking hundreds of millions of dollars to recover costs to Medicaid for treating these health problems, including diabetes, high blood sugar and significant weight gain. It contends that Lilly hid problems to protect sales of Zyprexa, which became the company’s best-selling drug.

Also Monday, a juror was excused from the trial because of a dental emergency. That leaves 12 jurors and one alternate for a case expected to last at least two more weeks.

Drug companies aren’t supposed to minimize the toxicity of medications, but that’s what Lilly was doing, a retired Food and Drug Administration medical officer, John Gueriguian, testified. An expert witness for the state, Gueriguian was on the witness stand a second day.

He revealed under cross-examination that he’s being paid $600 an hour. He said he didn’t yet know the total amount of his bill on this case.

Private lawyers from Texas, Minnesota and South Carolina are representing the state on a contingency basis — meaning they don’t get paid unless the state wins. The lawyers cover all their expenses, including expert fees.

Lilly failed to put enough information on the drug’s label warning until last year, though it had signs of trouble dating back to 1995, Gueriguian said under questioning by Fibich. By 2002, it should have put strong warnings on its label, he told jurors.

It did include some warning information about high blood sugar and diabetes as early as 2003, Gueriguian acknowledged under cross-examination by John Brennan, a lawyer for Lilly. That warning said problems had been reported for antipsychotic drugs including Zyprexa.

Brennan asked Gueriguian about studies that found Zyprexa was no worse than similar drugs Those studies were not well-designed and included too few subjects — and most were sponsored by Lilly, Gueriguian said.

Gueriguian bristled under cross-examination and at times had to be directed by Judge Mark Rindner to answer.

Lilly says it shared information with the FDA and didn’t try to hide problems with Zyprexa.

“There are some very difficult medical issues involved. There’s substantial disagreement in the medical community about those issues,” another Lilly lawyer, Andrew Rogoff, said after court ended for the day.

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2 Comments

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2 responses to “State claims Lilly tried to blur Zyprexa-diabetes link

  1. Pingback: State claims Lilly tried to blur Zyprexa-diabetes link | Diabetes Guide

  2. Ellen Liversidge

    In the Spring of 2003, three papers ran front page stories about Zyprexa and its connection to diabetes, hyperglycemia, and death. An inside source said that the FDA was embarrassed as, once again, they had required no warnings. And allegedly, Eli Lilly was afraid it alone would be fingered to place this warning. But, of course, in the end, the FDA protected Lilly and required all the atypical antipsyschotics to place this warning at the end of 2003, even though the culprit was Lilly and Lilly alone. See the Baltimore Sun, Wall St. Journal, and New York Times, March – April, 2003.

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