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Abstract Details
Activity Number:
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460
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 1, 2012 : 8:30 AM to 10:20 AM
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Sponsor:
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ENAR
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Abstract - #303977 |
Title:
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The Recent Controversy Involving GLP-1--Based Therapies for Type 2 Diabetes: Statistical and Epidemiologic Issues in Post-Marketing Database Studies
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Author(s):
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Michael Elashoff*+ and Cynthia Girman*+ and George Rochester*+ and William DuMouchel*+
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Companies:
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University of California at Los Angeles/CardioDX and Merck Research Laboratories and FDA and Oracle Health Sciences Global Business Unit
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Address:
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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, ,
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Keywords:
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Post-marketing studies ;
Large Database ;
AERS ;
Drug safety ;
Drug Development ;
Epidemiology
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Abstract:
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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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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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