Making the Case for Accelerated Withdrawal of Aducanumab

Peter Whitehouse, Departments of Neurology, Psychiatry, Neuroscience, Cognitive Science, Organizational Behavior, and Design and Innovation, Case Western Reserve University, Cleveland, OH, USA.
Sam Gandy, Departments of Neurology and Psychiatry, and The Mount Sinai Alzheimer's Disease Research Center, Icahn School of Medicine at Mount Sinai, New York NY, USA.
Vikas Saini, Lown Institute, Needham, MA, USA.
Daniel R. George, Department of Humanities, Penn State College of Medicine, Hershey, PA, USA.
Eric B. Larson, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
G Caleb Alexander, Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Jerry Avorn, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Shannon Brownlee, Department of Policy and Management, George Washington University School of Public Health, Washington, DC, USA.
Cameron Camp, Director of Research and Development, Center for Applied Research in Dementia, Solon, OH, USA.
Howard Chertkow, Cognitive Neurology and Innovation and Senior Scientist, Baycrest Academy for Research & Education at Baycrest Centre for Geriatric Care, Toronto, Ontario, Canada.
Adriane Fugh-Berman, PharmedOut, Georgetown University Medical Center, Department of Pharmacology and Physiology, Washington, DC, USA.
Rob Howard, Old Age Psychiatry, Division of Psychiatry, University College London, UK.
Aaron Kesselheim, Medicine, Harvard Medical School, Boston, MA, USA.
Kenneth M. Langa, Department of Internal Medicine, School of Medicine, University of Michigan, Ann Arbor, MI, USA.
George Perry, Department of Biology, University of Texas at San Antonio, San Antonio, TX, USA.
Edo Richard, Department of Neurology, Donders Institute for Brain, Behaviour and Cognition, Radboud University Medical Centre, Nijmegen, the Netherlands.
Lon Schneider, Psychiatry and Neuroscience, Keck School of Medicine of USC, Psychiatry and The Behavioral Sciences, Los Angeles, CA, USA.

Document Type

Journal Article

Publication Date

4-5-2022

Journal

Journal of Alzheimer's disease : JAD

DOI

10.3233/JAD-220262

Keywords

Aducanumab; Alzheimer’s disease; monoclonal antibody

Abstract

The controversial approval in June 2021 by the Food and Drug Administration (FDA) of aducanumab (marketed as Aduhelm), Biogen's monoclonal antibody for patients with Alzheimer's disease, raises significant concerns for the dementia field and drug approval process, considering its lack of adequate evidence for clinical efficacy, safety issues, and cost. On 15 December 2021, an international group of clinicians, basic science experts, psychological and social science researchers, lay people with lived experience of dementia, and advocates for public health met to discuss making a recommendation for whether aducanumab's approval should be withdrawn. Attendees considered arguments both in favor of and in opposition to withdrawal and voted unanimously to recommend that the FDA withdraw its approval for aducanumab and to support the Right Care Alliance's filing of a formal Citizen Petition to this effect.

Department

Health Policy and Management

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