Live Longer World
Live Longer World
Aastha JS
FDA History and Breast Cancer Drug Controversy | Dr. Mikkael Sekeres
1 hour 5 minutes Posted Apr 24, 2024 at 6:09 pm.
Surprising finding about the FDA
Why did the FDA get established in 1938?
1962 turning point in the FDA & Thalidomide
Kennedy’s efficacy act on drugs approval
FDA’s accelerated approval; HIV & AIDS
Avastin breast cancer drug controversy
Why was Avastin trial contentious?
Genentech’s argument
Media reaction
FDA funded by big pharma
FDA vs. patient activist groups
Opioid crisis
Does the FDA go against advisory committee?
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Show notes
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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