Drugs and the FDA
Safety, Efficacy, and the Public's Trust
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, throughout the twentieth century, the government was forced to take increasing 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.
“In this fast-paced and suspenseful book, Sekeres provides an insider's view of one of the biggest drug controversies of our time, expertly weaving the history of the FDA with the decisions it makes today.”
Siddhartha Mukherjee, Pulitzer prize winning author of The Emperor of All Maladies: A Biography of Cancer
“A deft and gripping tale! You'll never look at a medicine bottle the same way again.”
Danielle Ofri, author of When We Do Harm
“A thought-provoking book that confronts readers with all of these difficult questions while keeping them glued to their seats through Sekeres's skillful and self-reflective retelling of the Avastin hearings.”
Harvard Law Bill of Health Blog