Title Drugs and the FDA : safety, efficacy, and the public's trust / Mikkael A. Sekeres

Published Cambridge, Massachusetts : The MIT Press, [2022] ©2022

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Description 1 online resource (xiii, 303 pages) : illustrations Contents This little drug came to market ... -- And finally, efficacy -- The moxie to do battle -- Trials and tribulations -- Starve a tumor, feed an industry -- A viral scourge -- Silence = death -- The FDA makes its case -- The Avastin decision -- Epilogue Summary 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 Bibliography Includes bibliographical references and index Notes Description based on online resource; title from digital title page (ProQuest Ebook Central, viewed on April 18, 2023) Subject United States. Food and Drug Administration. SUBJECT United States. Food and Drug Administration United States. Food and Drug Administration fast Subject Drug approval -- United States Breast -- Cancer -- Chemotherapy Administrative agencies -- United States Bevacizumab -- Therapeutic use Monoclonal antibodies -- Therapeutic use Drug Approval United States Government Agencies Bevacizumab -- therapeutic use Breast Neoplasms -- drug therapy Antibodies, Monoclonal, Humanized -- therapeutic use SOCIAL SCIENCE / Sociology / General. Monoclonal antibodies -- Therapeutic use Administrative agencies Breast -- Cancer -- Chemotherapy Drug approval SUBJECT United States https://id.nlm.nih.gov/mesh/D014481 Subject United States Form Electronic book ISBN 9780262371315 0262371316

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