Accelerated approval of aducanumab for mild Alzheimer's by the U.S. Food and Drug Administration on June 7, 2021, has generated substantial medical, scientific, and ethical controversy. That approval was contrary to the nearly unanimous judgment of the FDA's Advisory Committee that little reliable evidence existed of significant benefit, even though the drug did reduce β-amyloid. Three major ethical problems were created by this approval: (1) Medicare resources would be unjustly squandered, given the drug's $56,000 annual price and the 3.1 million older potential American patients needing the drug; (2) physicians will feel ethically compelled to provide the drug to desperate, insistent patients, given FDA approval and in spite of side effects of brain bleeds and brain swelling; (3) and false hopes are generated for patients. A needed corrective by the federal government would reduce reimbursement to the bare cost of producing the drug (plus only a modest profit) until a phase IV trial has been successfully completed.

中文翻译：

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阿尔茨海默氏症和 Aducanumab：不公正的利润和虚假的希望

美国食品和药物管理局于 2021 年 6 月 7 日加速批准 aducanumab 治疗轻度阿尔茨海默氏症，引发了大量医学、科学和伦理争议。该批准与 FDA 咨询委员会几乎一致的判断相反，即尽管该药物确实减少了 β-淀粉样蛋白，但几乎不存在显着益处的可靠证据。这一批准造成了三个主要的伦理问题：(1) 考虑到该药每年 56,000 美元的价格和 310 万需要该药的潜在美国老年患者，医疗保险资源将被不公正地挥霍；(2) 在获得 FDA 批准的情况下，尽管存在脑出血和脑肿胀的副作用，医生仍会感到在道德上被迫向绝望、坚持的患者提供药物；(3)给患者产生了虚假的希望。.