On episode 150, we welcome Dr. Mikkael Sekeres to discuss the social and political climate that fostered the necessity to create the FDA, medical charlatans and the history of pseudo-medicine, the necessity of clinical trials for creating safe and effective medications, why anecdotal evidence isn’t equivalent to scientific validation, the FDA’s decision to remove the breast cancer indication for the drug Avastin and Genentech’s decision to fight it, Mikkael’s personal experience during that hearing while a member of the jury, the public’s distrust of the FDA and where it stems from, Genentech spin-doctoring data to make their case for the safety and efficacy of Avastin, why mostly harmful medications should be removed from circulation if proven so, and how the FDA decides on which drugs to approve and which ones to recommend removing.

Dr. Mikkael A. Sekeres is Professor of Medicine and Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, and former Chair of the Oncologic Drugs Advisory Committee of the FDA. He is the author or co-author of over 400 manuscripts and 650 abstracts published in leading journals such as NEJM, Blood, Journal of Clinical Oncology, Nature Genetics, Cancer Cell, Journal of the National Cancer Institute, Journal of Clinical Investigation, PLoS One, and Leukemia. A regular contributor to the Well section of the New York Times, has authored 8 books, including When Blood Breaks Down: Life Lessons from Leukemia and his newest book, available now, is called Drugs and the FDA: Safety, Efficacy, and the Public’s Trust.

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