Drugs and the FDA: Safety, Efficacy, and the Public's Trust
Sekeres, Mikkael A.
- 出版商: MIT
- 出版日期: 2024-02-06
- 售價: $1,180
- 貴賓價: 9.5 折 $1,121
- 語言: 英文
- 頁數: 320
- 裝訂: Quality Paper - also called trade paper
- ISBN: 0262548399
- ISBN-13: 9780262548397
海外代購書籍(需單獨結帳)
相關主題
商品描述
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.
商品描述(中文翻譯)
美國食品藥品監督管理局(FDA)是如何在公共衛生危機和病患倡議的背景下形成的?這個故事以對乳癌藥物Avastin的爭議性聽證會為背景講述。食品藥品監督管理局對COVID-19疫苗和有爭議的阿茲海默症藥物Aduhelm的批准成為新聞焦點,但我們很少了解這個機構的工作方式。為什麼FDA是美國藥物安全和功效的最高權威?在《藥物與FDA》一書中,Mikkael Sekeres(一位領先的腫瘤學家,也是FDA癌症藥物諮詢委員會的前主席)講述了FDA如何成為全球最值得信賴的監管機構的故事。政府在一系列悲劇和健康危機以及病患倡議的推動下,才開始負責確保藥物和醫療器械的功效和安全性。在FDA成立之前,藥品製造商可以推銷任何藥劑,聲稱治療任何疾病,並在標籤上做出任何承諾。然而,在二十世紀期間,政府被迫採取行動,因為兒童被污染的白喉和天花疫苗中毒,一種早期抗生素含有防凍劑,一種用於懷孕晨吐的藥物導致嬰兒畸形,而愛滋病藥物的使用僅限於少數臨床試驗,而成千上萬的人死亡。Sekeres在爭議性的2011年乳癌藥物Avastin聽證會上擔任小組成員,描述了所有這些事件。他說,Avastin聽證會對FDA一個世紀的發展進行了考驗,展示了其制度的檢查和平衡如何運作或不運作。
作者簡介
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).
作者簡介(中文翻譯)
Mikkael A. Sekeres是邁阿密大學米勒醫學院Sylvester Comprehensive Cancer Center血液學部的醫學教授和主任,曾擔任美國食品藥品監督管理局腫瘤藥物諮詢委員會的主席。他是《紐約時報》Well專欄的定期撰稿人,也是《當血液崩潰時:白血病的人生教訓》(麻省理工學院出版社)的作者。