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Report shows discrepancies in Lilly's Zyprexa data

Dec 21, 2006 | AP

Eli Lilly and Co. didn't tell doctors the extent of Zyprexa's blood-sugar risks for at least a year even as it considered changing the top-selling drug's prescription label to include more information about its potential to raise sugar levels, a report says.

The New York Times reported Thursday that Indianapolis-based Lilly originally showed that patients taking the anti-schizophrenia drug were 3.5 times as likely to experience high blood sugar as those taking a placebo. The data were reported in a February 2000 memo sent to top Lilly scientists, which was provided to The Times by an Alaska lawyer who represents mentally ill patients.

Until late 2001, however, Lilly told doctors that patients taking Zyprexa were only slightly more likely to suffer high blood sugar as those taking a placebo, The Times said.

Doctors and regulatory agencies have long questioned whether the drug causes weight gain and high blood sugar, key risk factors for diabetes.

In a statement released Thursday, Lilly said the newspaper's report on Zyprexa is misleading because the documents cited in the story contained "preliminary" data about an analysis of the drug's effects on patients.

"The data referenced in The New York Times article is the preliminary analysis not the final accurate analysis that was shared with the FDA - and is therefore very misleading," according to the statement.

Lilly said the documents cited by The Times are among 11 million the company provided the attorney and "do not represent an accurate view of company strategy or conduct."

After the February 2000 memo, Lilly said it re-examined its clinical trial results and found errors in its "final, standard quality check of the data."

The 2000 memo also indicates Lilly considered changing Zyprexa's prescription label to provide doctors with more information about the drug's potential to raise blood-sugar levels. The labels never were changed.

Zyprexa, which was introduced in 1996, is Lilly's top seller, with $4.2 billion in sales in 2005.

Lilly last year agreed to pay $700 million to settle about 8,000 claims from people who contended Zyprexa labels failed to provide adequate warning that the drug could put patients more at risk for developing diabetes. Other claims are pending.

The company maintains, however, that no link between Zyprexa and diabetes has ever been proven.

Memos obtained by The Times also showed that 16 percent of patients taking Zyprexa for a year gained more than 66 pounds. Lilly instead disclosed that about 30 percent of patients in smaller trials gained an average of 22 pounds, The Times said.

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