Micro-Macro; FDA-EMA: On Developing Diabetes Drugs

• Activity Number: 328
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Janet Wittes*+
• Companies: Statistics Collaborative, Inc.
• Keywords: diabetes ; FDA ; JAMA ; statisticians in industry ; diabetes ; FDA ; JAMA ; statisticians in industry

Abstract

The fall-out from the rosiglitazone meta-analysis and ACCORD has affected treatment of diabetes, regulatory pathways to drug approval for diabetes, and the response of least one medical journal (JAMA) to reviewing papers from industy. One would have thought that the approach to preventing microvascular disease (eg, retinopathy) in Type II diabetes (ie, strict control of glucose) would reduce macrovascular disease (eg, heart attack)as well. But the meta-analysis and ACCORD studies suggest the opposite. Those studies have led the FDA to issue a new guidance for new diabetes drugs; this guidance differs materially from the EMA's guidelines. Moreover, statisticians in industry - even those not remotely involved in the diabetes story - find themselves the object of suspicion. This talk describes the story leading to the current morass and makes suggestions for the future.