Drugs and the FDA

Safety, Efficacy, and the Public's Trust

Mikkael A. Sekeres

$49.99

Paperback

Not in-store but you can order this
How long will it take?

Availability Information

We source books from suppliers in Australia and overseas. For books we don't currently have in stock, the time it takes to get them from our suppliers can vary widely - from a few days to a few months - so we check each book with each supplier to determine the expected time it will take to be supplied to us.

We then advise you accordingly. If the time taken to get any book is too long for you, you can let us know and we will cancel or adjust your order, and refund as required.

To find out the anticipated arrival time for specific items prior to ordering, please contact us by phone or email:

Phone +61 2 9264 3111, or 1800 4 BOOKS (1800 4 26657) if outside Sydney:
option 1 Abbey's Bookshop (Crime, History, Science, Kids & more) • info@abbeys.com.au
option 2 Language Book Centre (ESL & Foreign Languages) • language@abbeys.com.au
option 3 Galaxy Bookshop (Sci-fi, Fantasy, Romance, Graphic Novels) • sf@galaxybooks.com.au

QTY:

English

MIT Press
06 February 2024

Medical & healthcare law

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.

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.

By: Mikkael A. Sekeres
Imprint: MIT Press
Country of Publication: United States
Dimensions: Height: 229mm, Width: 152mm,
Weight: 369g
ISBN: 9780262548397
ISBN 10: 0262548399
Pages: 320
Publication Date: 06 February 2024
Audience: General/trade , ELT Advanced
Format: Paperback
Publisher's Status: Active

Preface ix 1 This Little Drug Came to Market... 1 2 And Finally, Efficacy 29 3 The Moxie to Do Battle 53 4 Trials and Tribulations 77 5 Starve a Tumor, Feed an Industry 107 6 A Viral Scourge 131 7 Silence = Death 155 8 The FDA Makes Its Case 185 9 The Avastin Decision 215 Epilogue 247 Acknowledgments 259 Appendix 261 Notes 267 Index 299

Mikkael A. Sekeres is Professor of Medicine and Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, and former Chair of the Oncologic Drugs Advisory Committee of the FDA. A regular contributor to the Well section of the New York Times, he is the author of When Blood Breaks Down- Life Lessons from Leukemia (MIT Press).

Reviews for Drugs and the FDA: Safety, Efficacy, and the Public's Trust

"""It's a physician's-eye-view on the products that fill our medicine cabinets, but Sekeres includes patients in the mix, too. A public that, in his words, 'revolts, protesting loudly enough to be heard, to provoke change' is the true driver of this engaging book."" --Erin Blakemore, The Washington Post ""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."" --Bill of Health, Harvard Law School"