Overview

Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate United States authority on a drug's safety and efficacy? In Drugs and the FDA, Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member.

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Mikkael A. Sekeres is director of the Leukemia Program at the Cleveland Clinic, where he is also professor of medicine and vice chair for clinical research at the Taussig Cancer Institute. He writes regularly for the Well section of the New York Times. Mike Lenz has been an audiobook narrator and voice actor for more than fourteen years. Having narrated titles in genres ranging from fiction, entertainment, science, and children's literature to Christian, business, self-help, and history, Mike loves bringing nonfiction and fiction stories to life with his engaging, confident, and trustworthy voice. Mike's broad background includes voicing commercials, eLearning projects, real estate videos, corporate and web-based videos, and brand imaging, appearing in regional and national television commercials as an on-camera talent, and serving as the mayor of his hometown of Saratoga Springs, New York. Mike is also a Voice Arts Award-nominated podcast producer as well as an author. He is a frequent speaker at learning and voice-over conferences. Mike currently lives in Saratoga Springs, New York, with his wife and four children.

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