In this paper, I evaluate the ethical implications of the FDA’s move to en-courage randomized, double-blinded, sham-controlled trials for Class III devices when such studies are possible. In Part I, I describe the placebo effect and how researchers control for it. In Part II, I describe the results of studies of medical procedures and devices that have used a sham control. In Part III, I de-scribe the ethical concerns surrounding the use of sham surgeries to study medical devices. In Part IV, I argue for the use of randomized, double-blinded, sham-controlled device trials, and propose an ethical framework for these studies.
Comment,
Yale Law School, J.D. expected 2016; University of Arizona, Ph.D. in Sociology 2012. This Comment benefited from conversations with, and feedback from, Aaron Kesselheim. I am also indebted to Cindy Cain, the first reviewer of all my scholarship, for her insightful comments on this work. Finally, special thanks to the editorial staff of Yale Law & Policy Review for their helpful feedback and editing.
