Death, Drugs, & Corruption at the FDA - Dr. Mikkael Sekeres, University of Miami

What happens when the FDA approves a drug that doesn't work? Say
it gets accelerated approval from the regulatory body, but
further clinical trials demonstrate a lack of efficacy. Normally,
the agency requests that the company take their drug off the
market, the company does so, and so the wheel turns. But when
post-approval clinical trials showed that Genentech's blockbuster
breast cancer drug Avastin was killing women, the company broke
with more than a century of tradition, and declined to take their
drug off the market. We talk with Miami University's Mikkael
Sekeres about his experience sitting on the jury for the trial
that denied Genentech's right to keep selling Avastin to breast
cancer patients, regulatory capture, care for the dying,
gamesmanship at the FDA and much, much more.

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the FDA: https://amzn.to/3QuIiUk

#medicine #fda #cancer
                        


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PODCAST INFO:  Anastasia completed her PhD studying
bioelectricity at Columbia University. When not talking to
brilliant people or making movies, she spends her time painting,
reading, and guiding backcountry excursions. Michael Shilo also
did his PhD at Columbia studying the elastic properties of
molecular water. When he's not in the film studio, he's exploring
sound in music. They are both freelance professors at various
universities.   

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