March 5 Cathy Shine Lecture: Do Government Agencies Protect Patients?
Failures in regulation and information dissemination by the FDA and medical licensing boards
Is there a role for regulatory agencies in creating an environment to improve the health of patients? Dr. Wolfe presents the case that, yes, some agencies have a role, but have dangerously failed to perform it adequately. A prime example is the FDA, which should be a more important source of patient protection, especially where it serves as gatekeeper for drugs and devices. Others include medical licensing boards, most of which have failed to take action against physicians who are practicing substandard medicine in their states. Dr. Wolfe offers powerful examples from his experiences monitoring and influencing the FDA and medical licensing boards, and discusses recommendations for improving their performance concerning patient safety.
Sidney M. Wolfe, MD, co-founded Public Citizen’s Health Research Group with Ralph Nader in 1971 and was its Director until June 2013, when he became its Senior Advisor. Under his leadership, the Group has published research on critical issues in health policy such as pharmaceutical safety and effectiveness, workplace safety, and human research subject protection, and advocated for transparency and accuracy in the development of policies affecting the health and safety of patients. Before moving to the Health Research Group, Dr. Wolfe, conducted research on aspects of blood-clotting at the National Institutes of Health. Since 1995 he has been an Adjunct Professor of Internal Medicine at the Case Western Reserve University School of Medicine and Senior Associate, Johns Hopkins University, School of Public Health. His received his medical degree from Case Western University and his internship and residency were in internal medicine. He is currently a member of the Society for General Internal Medicine and served on the FDA Drug Safety and Risk Management Advisory Committee from 2008 to 2012. He has published extensively in the medical and health policy literature and, since July 2013, has written a regular column for the British Medical Journal. His awards include receiving the 1990 MacArthur Foundation Fellowship.
Wednesday, March 5
Noon–1 p.m.
BUSM Instructional Building
72 East Concord St., Hiebert Lounge, 14th Floor
Free and open to the public, reception will follow
Sponsored by the Department of Health Law, Bioethics & Human Rights at BU School of Public Health.