MRC Integrative Epidemiology Unit (IEU) Seminar Series

Title: Tales of drug safety and advances in regulatory science at the US Food and Drug Administration 

Abstract: Serious drug safety problems sometimes precipitate new federal legislation.  This talk focuses on three drug safety stories in the early 21^st century:  cerivastatin and the risk of rhabodmyolysis; the use of surrogate endpoints in the approval of drugs to treat risk factors such as high blood pressure, cholesterol, and glucose; and rofecoxib and the risk of myocardial infarction.  This last one was the occasion of a Senate hearing, an Institute of Medicine Report, the FDA Amendments Act of 2007, and the adoption by the FDA of the lifecycle approach to managing the risk-benefit profile of approved mediations during their market life.  The essential tension is the balance between the speed of approval and the quality of information.  Unexpected safety problems remain invisible without vigilance.  Science-based regulation is essential to promote the health of the public.   

Biography: 

Bruce M. Psaty, MD, PhD is a Professor of Medicine, Epidemiology, and Health Services; Co-Director of the Cardiovascular Health Research Unit at the University of Washington; an Investigator at Kaiser Permanente Washington Health Research Institute; and a general internist at Harborview Medical Center, Seattle, WA.  He received his MD and PhD in English language and literature from Indiana University and his MPH in epidemiology from the University of Washington.  His research interests include cardiovascular epidemiology, epidemiological methods, myocardial infarction, stroke, hypertension, diabetes, drug safety, pharmacoepidemiology, genetics, genomics, and pharmacogenetics.

All welcome