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阿杜卡奴单抗治疗阿尔茨海默病中被忽视的代表性不足人群:伦理评论

Under-Represented Populations Left Out of Alzheimer's Disease Treatment with Aducanumab: Commentary on Ethics.

作者信息

Padala Sanjana P, Yarns Brandon C

机构信息

Vanderbilt University, College of Arts and Sciences/Medicine, Health and Society, Nashville, TN, USA.

Department of Psychiatry/Mental Health, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.

出版信息

J Alzheimers Dis Rep. 2022 Jun 22;6(1):345-348. doi: 10.3233/ADR-220023. eCollection 2022.

Abstract

Despite controversy about the efficacy and safety of aducanumab, the FDA's fast-tracking of this medicine is truly historic. However, structural problems leading to socioeconomic disparities and systemic racism in science, healthcare, and society have left out under-represented populations. This perspective outlines the racial and socioeconomic health disparities in aducanumab treatment: 1) Disparities in the risk of Alzheimer's disease (AD), 2) Limited participation from under-represented groups in AD trials raising concerns about the generalizability of the results, 3) Questionable applicability of the amyloid hypothesis in groups under-represented in AD research, and 4) Aducanumab's initial sticker price that unfairly singled out those with lower socioeconomic backgrounds. Potential solutions are discussed.

摘要

尽管对于阿杜卡单抗的疗效和安全性存在争议,但美国食品药品监督管理局(FDA)对这种药物的快速审批确实具有历史意义。然而,科学、医疗保健和社会中导致社会经济差距和系统性种族主义的结构性问题使得代表性不足的人群被排除在外。这一观点概述了阿杜卡单抗治疗中存在的种族和社会经济健康差距:1)阿尔茨海默病(AD)风险的差异;2)代表性不足的群体在AD试验中的参与有限,这引发了对结果普遍性的担忧;3)淀粉样蛋白假说在AD研究中代表性不足的群体中的适用性存疑;4)阿杜卡单抗的初始标价不公平地针对了社会经济背景较低的人群。文中还讨论了潜在的解决方案。

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