FDA Probes Lilly Over Zyprexa Data

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For those who thought the Zyprexa scandal had blown over, a new report puts such notions to rest. The FDA is examining whether Eli Lilly & Company provided it with accurate data about the weight gain and diabetes. side effects.

The FDA has questions about a Lilly document from February 2000 in which the drugmaker found that patients taking Zyprexa in clinical trials were three and a half times as likely to develop high blood sugar as those who did not take the drug.

That document was not submitted to the agency. But a few months later, Lilly provided data to the FDA that showed almost no difference in blood sugar between patients who took Zyprexa and those who did not. The agency hasn’t decided whether to take any action against Lilly.

“The FDA continues to explore the concerns raised recently regarding information provided to the FDA on Zyprexa’s safety,” Mitchell Mathis, a deputy director in the psychiatry division of the agency’s center for drug evaluation and research, tells The New York Times.

A Lilly spokesman, Phil Belt, says the company had rechecked its database and found errors in the original statistics, but that the data submitted later was accurate. But the 2000 document said that its figures had already been checked for error.

The discrepancy between Lilly’s initial data and what it later submitted came at a time when Zyprexa’s sales were soaring, even as some doctors and foreign regulatory agencies were questioning the drug’s safety.

The FDA has never concluded that Zyprexa causes diabetes more than other widely used psychiatric drugs, although the American Diabetes Association has. Zyprexa remains Lilly’s top-selling drug, with $4 billion in worldwide annual sales. But scrips in the US have fallen nearly 50 percent since 2003 amid the safety concerns.

The document from 2000 and others were provided to The Times by Jim Gottstein, a lawyer in Alaska who represents mentally ill people he says are forced to take psychiatric medications against their will.

Those documents were published last December, leading a federal judge to accuse Gottstein; an expert witness for plaintiffs’ lawyers, David Egilman, and Times reporter Alex Berenson of conspiring to circumvent a court order preventing disclosure of confidential material filed in a class-action suit against Lilly.

Besides the FDA inquiry, Lilly is facing federal and state investigations into the way it marketed and promoted Zyprexa. The company has already agreed to pay $1.2 billion to settle 28,500 lawsuits from people who contend that they developed diabetes or other diseases after taking the drug. At least 1,200 more lawsuits are pending.

The rest of the story is here (registration required).[tags]Eli Lilly, Zyprexa[/tags]

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