FDA History and Breast Cancer Drug Controversy | Dr. Mikkael Sekeres Live Longer World

Dr. Mikkael Sekeres is the author of the book The Drugs and 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


Episode Show Notes: https://livelongerworld.com/p/msekeres

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?


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DR. MIKKAEL SEKERES LINKS:
Website: https://www.mikkaelsekeres.com/
Twitter: https://twitter.com/MikkaelSekeres

Book: https://www.amazon.com/Drugs-FDA-Safety-Efficacy-Publics/dp/0262047314

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