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Abstract Details

Activity Number: 460
Type: Topic Contributed
Date/Time: Wednesday, August 1, 2012 : 8:30 AM to 10:20 AM
Sponsor: ENAR
Abstract - #303977
Title: The Recent Controversy Involving GLP-1--Based Therapies for Type 2 Diabetes: Statistical and Epidemiologic Issues in Post-Marketing Database Studies
Author(s): Michael Elashoff*+ and Cynthia Girman*+ and George Rochester*+ and William DuMouchel*+
Companies: University of California at Los Angeles/CardioDX and Merck Research Laboratories and FDA and Oracle Health Sciences Global Business Unit
Address: 2500 Faber Place, Palo Alto, CA, 94303, Merck Research Laboratories, North Wales, , 10903 New Hampshire Ave , Silver Spring, MD, 20993-0002 , USA Oracle Health Sciences Global Business Unit, Tucson, ,
Keywords: Post-marketing studies ; Large Database ; AERS ; Drug safety ; Drug Development ; Epidemiology
Abstract:

This panel considers the use of large databases, including the FDA Adverse Event Reporting System (AERS) to infer associations between adverse events and therapeutic interventions, with specific reference to a report of elevated risk of pancreatitis, pancreatic and thyroid cancer in type 2 diabetic patients receiving GLP-1 based therapies (Elashoff et al. 2011. Gastroenterology 141: 150-156). This paper was intensely criticized with specific concerns including bias in the estimated association due to the voluntary nature of the submitted reports, increased reporting rate following a medical alert of labeling change by the FDA, and lack of information about potential confounders. Global questions are raised by this study. For a drug approved after rigorous safety evaluations, what level of evidence of adverse risk is sufficiently strong to warrant publication in a high-profile journal? How do we interpret results from AERS and other large-scale post-marketing studies? This panel will discuss the tension between the need to report risks that may have been overlooked in a drug's development, and the possible damage that may occur if the reported risk is a spurious finding.


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