Research Ethics and Policy Series (REPS) | Jason Karlawish, MD

What just happened? The strange tale of the FDA’s approval of aducanumab for the treatment of Alzheimer’s disease

Jason Karlawish, MD
Professor of Medicine, Medical Ethics and Health Policy, and Neurology              
Co-Director, Penn Memory Center               
Director, Outreach and Recruitment Core, Research Education Component of the Penn Alzheimer’s Disease Research Center     

Monday, October 4, 12:00-1:00p Eastern
Via Zoom. Register in advance: 
https://upenn.zoom.us/meeting/register/tJIvdOqqpzMsEtR8ZdMLhHCPr963XXEYQEVf
The meeting link will be provided automatically upon registration.

Abstract: On the morning of June 7, 2021, the idea of using a positron emission tomography (PET) measure of beta-amyloid as a surrogate for the care of patients with Alzheimer disease was an important hypothesis in need of more research. By the evening of June 7, it was clinical practice.

This revolution in care was the aftermath of not a scientific breakthrough but the imperious decision of a divided Food and Drug Administration (FDA). The FDA had approved Biogen’s drug aducanumab for the treatment of Alzheimer disease. The agency argued that the drug’s ability to reduce beta-amyloid is an adequate surrogate for clinical benefit. Jason Karlawish will discuss why this controversial decision continues to reverberate throughout the American health care system. It has exposed enduring controversies in developing treatments for brain diseases, the steady breakdown in processes at FDA, the need to revisit why we even have an FDA, and how, in America, a disease does not fully exist until it has a business model.

For more information, please contact Mary.Pham@pennmedicine.upenn.edu.