Steven E. Nissen MD, MACC

Steven E. Nissen MD is Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. In 2006-2007 he served as President of the American College of Cardiology (ACC), the professional society representing American cardiologists. Trustees.

His research has focused on application of intravascular ultrasound (IVUS) imaging to the assessment of progression and regression of coronary atherosclerosis.  Contributions to scientific literature include more than 350 journal articles and 60 book chapters. Dr. Nissen serves as Senior Consulting Editor for the Journal of the American College of Cardiology. He is co-author of a book for patients with heart disease, Heart411 released by Crown Books on January 31, 2012.

Dr. Nissen works closely with pharmaceutical companies on the development of new therapies for cardiovascular disease, but maintains a longstanding policy of requiring companies to donate all related honoraria directly to charity so that he receives neither income, nor a tax deduction.

He has also written extensively on the subject of drug safety. In 2001, he co-authored the first manuscript that raised concerns about the safety of rofecoxib (Vioxx™), which was withdrawn from the market 3 years later. In 2005, he re-analyzed data submitted to the Food and Drug Administration (FDA) to support approval of muraglitazar, a new agent to treat diabetes and lipid disorders, reporting that muraglitazar doubled the risk of major adverse cardiovascular outcomes. Despite a favorable recommendation by an Advisory Panel, the FDA subsequently halted approval. In 2007, he authored a manuscript that demonstrated that the widely used diabetes drug rosiglitazone (Avandia™) raised the risk of myocardial infarction, eventually leading in 2010 to withdrawal of the drug in Europe and severe restrictions in the US.

Dr. Nissen served as a member of the CardioRenal Advisory Panel of Food and Drug Administration (FDA) for 5 years, and Chairman the final year of his membership. He continues to serve as Advisor to several FDA committees as a “Special Government Employee”. In July 2008, while serving as guest member of the Endocrine and Metabolism Advisory Panel, he recommended a new approach for approval of diabetes drugs, which was ultimately adopted by the Agency in November 2008.

Dr. Nissen is also known for his role in public policy discussions, particularly in the area of drug safety. He has testified in both the Senate (Health Education and Labor Committee) and House of Representatives (Energy and Commerce Committee) on the need to reform the Food and Drug Administration (FDA). He was actively involved in discussions with Congress on the FDA Amendments Act of 2007 that added additional regulatory authority for the Agency.

In 2007, Time Magazine selected Dr. Nissen as one of the world’s 100 most influential people. He was selected for the Outstanding Scientist Award by the Cleveland Clinic in 2004. On 3 occasions, the Cardiovascular Medicine Fellows awarded him the Outstanding Teaching Award. He also received the distinguished Outstanding Contributions to Cardiovascular Research Award from the Gill Heart Institute of the University of Kentucky in 2004.

Dr. Nissen earned his medical degree from the University of Michigan School of Medicine in Ann Arbor.  He completed Internal Medicine internship and residency at the University of California, Davis in Sacramento, and Cardiology Fellowship at the University of Kentucky Medical Center in Lexington.