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

Live Longer World podcast #28

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?

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Conversations with longevity scientists, entrepreneurs and other advocates transforming the field of longevity science and the science behind aging.
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Aastha Jain Simes