On 7 June 2021, aducanumab was granted accelerated approval for the treatment of Alzheimer disease (AD) by the FDA on the basis of amyloid-lowering effects considered reasonably likely to confer clinical benefit. This decision makes aducanumab the first new drug to be approved for the treatment of AD since 2003 and the first drug to ever be approved for modification of the course of AD. Many have questioned how scientific evidence, expert advice and the best interests of patients and families were considered in the approval decision. In this article, we argue that prior to approval, the FDA and Biogen’s shared interpretation of clinical trial data — that high-dose aducanumab was substantially clinically effective — avoided conventional scientific scrutiny, was prominently advanced by patient representative groups who had been major recipients of Biogen funds, and raised concerns that safeguards were insufficient to mitigate regulatory capture within the FDA. Here, we reflect on events leading to the FDA’s decision on 7 June 2021 and consider whether any lessons can be learned for the field.

2021 年 6 月 7 日，aducanumab 被 FDA 加速批准用于治疗阿尔茨海默病（AD），理由是其降低淀粉样蛋白的作用被认为有合理的可能带来临床益处。这一决定使 aducanumab 成为自 2003 年以来第一个被批准用于治疗 AD 的新药，也是第一个被批准用于改变 AD 病程的药物。许多人质疑在批准决定中如何考虑科学证据、专家建议以及患者和家属的最大利益。在这篇文章中，我们认为在批准之前，FDA 和 Biogen 对临床试验数据的共同解释——高剂量阿杜卡单抗在临床上是有效的——避免了传统的科学审查，曾是百健（Biogen）基金的主要接受者的患者代表团体大力推进，并引发了人们对保障措施不足以减轻 FDA 内部监管捕获的担忧。在这里，我们反思导致 FDA 于 2021 年 6 月 7 日做出决定的事件，并考虑是否可以从该领域吸取任何教训。