Description
Book Synopsis: How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin.
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 US 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. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works—or doesn't work.
Details
Discover the untold story of the FDA and its role in ensuring the safety and efficacy of drugs and medical devices. In "Drugs and the FDA: Safety, Efficacy, and the Public's Trust," Mikkael Sekeres, a leading oncologist and former chair of the FDA's cancer drug advisory committee, takes you on a journey through the agency's history. From the tragedies and health crises that sparked its establishment to the challenges it faces today, this book reveals how the FDA became the trusted regulatory authority it is today.
In an era of COVID-19 vaccines and controversial drugs like Aduhelm, understanding the work of the FDA is more important than ever. Why is the FDA the ultimate authority on a drug's safety and efficacy? Through meticulous research and insider knowledge, Sekeres explains why the FDA has become the gold standard in drug regulation. With their commitment to patient safety and rigorous testing protocols, the FDA ensures that every product approved is of the highest quality.
Before the FDA existed, the pharmaceutical industry was a wild west, with no regulations to protect consumers. Drug makers could make outrageous claims and sell ineffective or even dangerous products. But through a series of tragic incidents and the voices of patient advocates, the government recognized the need for intervention. "Drugs and the FDA" chronicles these events, including cases where children were harmed by contaminated vaccines and drugs caused irreparable damage. It's a powerful reminder of why the FDA's work is crucial for public health.
Join Mikkael Sekeres as he recounts his own experiences as a panel member during the 2011 hearings on the breast cancer drug Avastin. These hearings served as a litmus test for the FDA's century-long evolution, showcasing the effectiveness of its system of checks and balances. Through this gripping account, you'll gain a deeper understanding of the FDA's crucial role in safeguarding the well-being of the public.
Are you ready to delve into the captivating world of the FDA? Gain valuable insights and a newfound appreciation for the regulatory agency that ensures your safety. Get your copy of "Drugs and the FDA: Safety, Efficacy, and the Public's Trust" now!
Click here to order your copy today!
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