In a recent interview former Food and Drug Administration (FDA) advisor turned whistleblower exposed how the FDA approves harmful drugs.
Dr. Aaron S. Kesselheim, MPH, began advising the Food and Drug Administration (FDA) in 2015, and then joined one of its advisory panels as a permanent member in 2019.
At that time, he was ready to use the skills he’d acquired in a successful medical career to help guide the agency he much respected.
But then, the FDA approved a drug called aducanumab (Aduhelm) to treat Alzheimer’s disease despite the advisory committee’s almost unanimous recommendation against that, which was based on a lack of evidence of success in treatment.
Kesselheim was concerned enough about the approval to resign from his important post. Since that resignation, Kesselheim has drawn public praise and written a New York Times opinion column on the topic.
It appears his and two other panel member’s departure was a factor in the decision by two House committees to hold hearings on the approval of Aduhelm.
Healthline sat down with Kesselheim earlier this week to talk about that decision, the FDA, and how he feels it could better serve the public.
Tell me about becoming an FDA adviser in 2015 and an advisory board member in 2019. Was it exciting for you? Did it make you feel like you could make a difference?
Kesselheim: Yes, sure. A lot of the research I do relates to FDA decision making and its impacts on drug availability. I had met and collaborated with a lot of the FDA scientists before, so it wasn’t my first interaction with the FDA.
Back in 2015, they invited me to join the FDA Peripheral and Central Nervous System Advisory Committee. I was aware of the important role they play, and I was really honored to be asked. Then in 2019, I was asked to be a permanent member, and my role was to go until 2023.
But yes, I think being asked is a nice honor. Advisory committees are supposed to have an important role in helping work through some of the more controversial decisions and products that the FDA deals with.