Against Evidential Pluralism in Pharmaceutical Regulation

Abstract

We examine arguments regarding the use of mechanistic evidence in assessing treatment efficacy and find that advocates and critics of EBM+ have largely been talking past each other due to a difference in focus. We explore aducanumab for the treatment of Alzheimer’s disease as a case which may speak to the role of EBM+ in pharmaceutical regulation. The case suggests the debate may be more fruitful if philosophers confine debates to particular domains of medicine and weigh in prospectively instead of relying on historical cases where outcomes are known and which are susceptible to hindsight bias.