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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#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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