Dr. Jason Karlawish gave a lecture for the Research Ethics and Policy Series hosted by Perelman School of Medicine and the Penn Department of Medical Ethics and Health Policy.

Talk description:

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. Dr. 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.