Drugs and the FDA

Safety, Efficacy, and the Public's Trust

By: Mikkael A. Sekeres

Narrated by: Mike Lenz

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.

©2022 Mikkael A. Sekeres (P)2023 Tantor

Metastic

As a cancer doc interested in drug development the book has good content and narrative. Why can’t the reader pronounce METASTATIC in a book like this and keep saying METASTIC

Good lord - where is the editing on something so simple and central to the book

What is “metastic”?

Very good overview of fda drug approval, but the reader says “metastic” instead of metastatic. Metastic is not a word.

Great book but reading of professional word needs improve

It is a Great book but reading of professional word needs improvement such as ‘metastatic’.