
Director, Preventive Cardiology, THE UNIVERSITY OF CHICAGO
Member of the Healthcare Council
Michael Davidson, MD, FACC, is Executive Medical Director at Radiant Research, Director of Preventive Cardiology and Clinical Professor of Medicine at the University of Chicago Pritzker School of Medicine. In addition, he is Founder, President, and Chief Executive Officer of the Chicago Center for Clinical Research, currently part of Radiant Research. As an author and lecturer on lipid disorders, nutrition, and atherosclerosis, he has coordinated over 700 clinical trials in the areas of preventive cardiology and has published over 200 articles in medical journals, including the Journal of the American Medical Association, Journal of the American College of Cardiology, Circulation, and Atherosclerosis. His extensive research on statins, novel lipid-lowering drugs, and nonpharmacologic risk factor reduction has established him as a key opinion leader in this area. Dr. Davidson also served as President of the Midwest Lipid Association and Board Member of the National Lipid Association. (This is me - Update Profile)
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What are the potential ramification for Avandia following the FDA Advisory Committee?
July 25, 2007
FDA Advisory Committee on The Cardiovascular Ischemic/thrombotic Risks of Rosiglitzone | www.ncbi.nlm.nih.gov
It appears from the breifing documents that the FDA has concerns about the CV safety of Avandia. They appear to be less concerned about the CV safety of Actos but both drugs are associated with an increase risk of heart failure. It is unknown how the Advisory Committee will vote but based on the available information there is likely to be some labeling change for Avandia (possibly a black box for more than CHF) than could put it at significant commercial disadvantage to Actos or Januvia.
| Study Group Name | No. Members |
|---|---|
| Experts in the Leisure & Lodging Council | 4887 |
| Experts in the Automotive Council | 3422 |
| Non-Electrophysiologist Cardiologists (US) | 853 |
| Physicians who Treat Hypertension (US) | 792 |
| Physicians who Treat Hypercholesterolemia in the U.S. | 249 |