Institute of the History of Medicine The Johns Hopkins University
Pharmacoepidemiology is a historical science whose own history is rooted in a series of real-world controversies over what constitutes evidence and who should bear the burden of proof when patients are harmed by novel drugs. While the stakes, stakeholders, and methods of pharmacoepidemiological research have changed substantially from the regional sulfanilamide disasters of 1938, to the global Thalidomide controversy of 1961, and the Vioxx and Avandia scandals that framed the early 21st century, the field has always had to contend with a background skepticism over what kinds of evidence was needed to truly prove harm or safety, benefit or cost-effectiveness of a given medication against the many uncertain variables of real world data. This plenary session will focus on challenges which the field of pharmacoepidemiology has faced, currently faces, and will continue to face in connecting robust evidence with timely regulatory action in an uncertain world. Attendees will gain insights into the stakes and stakeholders, ethical and evidentiary challenges of a field not yet 100 years old, with an eye towards how evidentiary standards continue to change in the dynamism of the present.
