The FDA has opened an inquiry to determine if Eli Lilly manipulated the data it submitted for Zyprexa, a controversial antipsychotic that has been linked to rapid weight gain and diabetes. The agency has raised questions about a document Lilly generated in 2000 that outlined how patients taking Zyprexa in a clinical trial were three and a half times more likely to develop high blood sugar than patients in the control wing. But that document never made it to the FDA. Regulators instead received a report several months later that said that there was virtually no difference in blood sugar levels. A Lilly document said that the earlier--undelivered--report was checked for errors and that the later report was accurate. Zyprexa earns $4 billion a year, though U.S. sales have fallen dramatically as the controversy over the drug has developed.
- read the New York Times report on the FDA's inquiry
Related Articles:
Eli Lilly responds to Zyprexa claims. Report
Lilly to pay $500 million to settle Zyprexa diabetes claims. Report
Lilly accused of promoting off-label Zyprexa use. Report
NIH doctors slam Lilly's marketing tactics. Report