Aaron Kesselheim, MD, JD, MPH is Assistant Professor of Medicine at Harvard. His project is "Access to drugs and devices that have limited supporting data: ethical implications for patients and physicians." The FDA faces increasing pressure to approve promising new drugs and medical devices for conditions with no effective treatment in an expeditious manner, even if the detailed evidence of efficacy and safety is not available. Dr. Kesselheim will study the experience with orphan drugs and expanded access programs as a way to analyze how to balance unclear efficacy and unknown risks. In addition to this topic, Dr. Kesselheim has also carried out research on other research ethics issues and on conflicts of interest in medicine.