Drugs and the FDA: A New Book With Mikkael Sekeres

Recurring guest Mikkael A. Sekeres, MD, Professor of Medicine and Chief of the Division of Hematology, Sylvester Comprehensive Cancer Center, is today’s guest of honor to discuss and spotlight his just-published book: Drugs and the FDA: Safety, Efficacy, and the Public's Trust. Dr. Sekeres begins by sharing an anecdote of his experience on the FDA Oncologic Drugs Advisory Committee (ODAC) for Avastin as an inspiration to write the book. Then, he delves into the detailed process of becoming an ODAC member and how conflicts of interest are handled in the screening process, how personal experience bias (rather than data) may influence ODAC members to vote to approve a drug, financial compensation allotted to ODAC members, and how ODAC members balance science with humanity when considering drugs for approval. The conversation ends with a commentary on the good and bad of DTC advertising, the future of clinical trial phasing and designing, and a few other interesting discussion points.

Order Drugs and the FDA: Safety, Efficacy, and the Public's Trust.
https://www.amazon.com/Drugs-FDA-Safety-Efficacy-Publics/dp/0262047314

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