FDA reviews withheld Eli Lilly data

The New York Times reported that the FDA is examining an Eli Lilly document from February 2000 that showed patients taking Zyprexa in a clinical trial were three and a half times as likely to develop high blood sugar as a placebo, and therefore have a higher risk of developing diabetes. Later, Eli Lilly provided data to the agency that showed almost no difference in blood sugar between patients who took Zyprexa and those on placebo.

Eli Lilly has defended its position and claims the document was a preliminary analysis and a final examination of the data revealed that this analysis was incorrect. The company said it is working closely with the agency to resolve the issue.