Rejection of Aducanumab (Aduhelm) by the Health Care Community: Lessons Learned and the Path Ahead

*Boston University School of Medicine and Public Health, Boston, MA

†Center for Drug Safety and Effectiveness

‡Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD

G.C.A. is past Chair and a current member of US Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Advisory Committee and he served on an FDA Advisory Committee on November 6, 2020, to discuss the case of aducanumab. He is also a co-founding Principal and equity holder in Monument Analytics, a health care consultancy whose clients include the life sciences industry as well as plaintiffs in opioid litigation and a past member of OptumRx’s National P&T Committee. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. H.B. declares no conflict of interest.

Correspondence to: G. Caleb Alexander, MD, MS, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street W6035, Baltimore, MD 21205. E-mail: [email protected].

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