FDA official testifies in schizophrenia drug case

Posted: Sunday, March 09, 2008

ANCHORAGE - A retired medical officer with the federal Food and Drug Administration testified that drug maker Eli Lilly & Co. downplayed the health risks of its schizophrenia drug Zyprexa to make more money.

John Gueriguian appeared in Anchorage Superior Court on behalf of the state of Alaska, which is suing Lilly over the drug. The state contends that it needs to recover costs to its Medicaid system for serious health problems caused by Zyprexa.

"Simply put, it's putting profit over the concern of the consumer," Gueriguian told the jury.

Gueriguian worked at the FDA for 20 years and is now a consultant. He fiercely opposed approval of the diabetes drug Rezulin, made by Warner-Lambert. It got on the market anyway only to be withdrawn after dozens of deaths and reports of liver toxicity.

Lawyers working for the state hired him to analyze Lilly documents and e-mails.

Lilly attorney John Brenner told reporters the company turned over its data to the FDA, which approved the drug in 1996.

"We didn't hide anything," Brenner said. "There's an ongoing debate being played out in the medical community."

Alaska is one of nine states suing Lilly over Zyprexa and the first to go to trial.

Zyprexa remains on the market in the United States and more than 80 other countries. Global sales of the drug approached $4.8 billion last year.

Internal e-mails revealed during the trial showed that at least a few Lilly employees were aware of concerns over the drug leading to diabetes.

One employee wrote that consultants were concerned over the company's handling of the issue.

"I do believe they made a very strong point that unless we come clean on this, it could get much more serious than we might anticipate," Thomas Brodie wrote in an Oct. 9, 2000, e-mail to others at Lilly.

The next day, another Lilly employee responded that the real concern seemed to be about weight gain, and that the consultants wanted the company to "aggressively face the issue" and work with doctors to help them manage patients' weight.

Marni Lemons, a Lilly spokeswoman, said Friday that the state's lawyers are focusing on a few misleading or poorly worded documents out of millions of pages of records.

The trial resumes Monday.



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