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? CONNECT WITH AASTHA, LIVE LONGER WORLD: Twitter: https://twitter.com/aasthajs Newsletter: https://livelongerworld.com/ Instagram: https://www.instagram.com/aasthajs/ Airchat: https://www.getairchat.com/aasthajs 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 If you enjoyed the episode, please share it and leave a rating. Best, Aastha.
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