Hi, I’m Aastha, and welcome to Live Longer World, where I write about practical longevity tips, with an emphasis on what I practice. Occasionally, I interview scientists in the aging field on their research and advances in biotechnology.
Today’s post is one such tangential interview on the FDA and drug development process.
My guest today is Dr. Mikkael Sekeres who is the author of the book Drugs and the FDA. He served as the chair of the Oncology Drugs Advisory Committee of the FDA, and was on the jury for the controversial trial of the breast cancer drug Avastin. We discuss:
The history of the FDA
The trial of Avastin which got FDA approval in 2008 and revoked in 2011
FDA's funding mechanisms
FDA ties to big pharma
What can be improved about the FDA and the criticisms it receives
Watch on YouTube. Listen on Spotify, or any other podcast platform. Find the links and timestamps below.
Follow me on X @aasthajs for more on longevity. Hope you enjoy the conversation!
All other platforms: here
Timestamps:
0:00 Surprising finding about the FDA
2:38 Why did the FDA get established in 1938?
11:48 1962 turning point in the FDA & Thalidomide
19:57 Kennedy’s efficacy act on drugs approval
25:40 FDA’s accelerated approval; HIV & AIDS
33:23 Avastin breast cancer drug controversy
41:13 Why was Avastin trial contentious?
45:23 Genentech’s argument
50:00 Media reaction
53:21 FDA funded by big pharma
56:39 FDA vs. patient activist groups
59:50 Opioid crisis
1:03:30 Does the FDA go against advisory committee?
FDA History and Breast Cancer Drug Controversy | Dr. Mikkael Sekeres