Friday Sept. 9
Waterhouse Room, Gordon Hall 106
Harvard Medical School
25 Shattuck Street
Boston, MA 02115
Register for this event
A light lunch will be served.
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There is a growing push to incorporate patient voices more directly at the FDA in decisionmaking about investigational drugs, but what are the optimal parameters of patients'
To address these and other questions, we will consider two recent cases: flibanserin (the "female Viagra") for hypoactive sexual desire disorder in women and eteplirsen for Duchenne muscular dystrophy. In both cases, patients had a substantial voice in the data collection and FDA review processes, leading to controversial outcomes.
Diana Zuckerman, PhD
President, National Center for Health Research
Walid Gellad, MD, MPH
Assoc. Prof. of Medicine, University of Pittsburgh & Pittsburgh VA Medical Center
Aaron S. Kesselheim, MD, JD, MPH
Assoc. Prof. of Medicine, Brigham and Women's Hospital & Harvard Medical School
The Health Policy and Bioethics Consortia are hosted by the Harvard Medical School Center for Bioethics and organized by the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women's Hospital, in collaboration with the Harvard Law School Petrie-Flom Center and the Harvard Program in Therapeutic Science. This new monthly series convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations. Support provided by the Oswald DeN. Cammann Fund at Harvard University.