DISPUTE CONTINUES OVER ELI LILLY'S REPORTING OF ZYPREXA SIDE EFFECTS

Eli Lilly is countering a published report that claims the company's internal data showed a higher rate of diabetes in patients taking its antipsychotic medication Zyprexa than documented in the information provided to doctors.

The New York Times reported Dec. 21 on a company memo the newspaper said it obtained from James Gottstein, a lawyer representing mentally ill patients who have sued the state of Alaska for compelling patients to take psychiatric drugs against their will. According to the newspaper article, the February 2000 memo said that 3.6 percent of patients on Zyprexa (olanzapine) had treatment-emergent hyperglycemia (high blood sugar), compared with 1.05 percent of patients on the placebo.

But Eli Lilly said it did a "final, standard quality check of the data" afterward and "discovered that there were errors involving which patients were included or excluded in the analysis." The corrected analysis showed that 3.1 percent of Zyprexa patients developed possible hyperglycemia or diabetes, compared with 2.5 percent of placebo patients, and this information was what the company submitted to the FDA for a label change.

The newspaper article also cited a November 1999 internal company memo that it said showed, based on 70 clinical trials, that 16 percent of patients on Zyprexa put on more than 66 pounds after a year on the drug. The company, however, later told physicians that the results of a smaller group of trials showed a weight gain of 22 pounds in 30 percent of patients, according to the article.

Eli Lilly did not address this point directly in its response, saying "as part of its ongoing safety monitoring, Lilly, in 1999, undertook an examination of its Zyprexa clinical trial database to help us further understand whether a relationship between Zyprexa and diabetes exists. This database included, at the time, more than 75 clinical trials involving more than 5,000 patients."