Making the Case for Accelerated Withdrawal of Aducanumab

Peter Whitehouse^{1

2}, Sam Gandy^{3

4}, Vikas Saini⁵, Daniel R George⁶, Eric B Larson^{7

8}, G Caleb Alexander^{9

10}, Jerry Avorn¹¹, Shannon Brownlee¹², Cameron Camp¹³, Howard Chertkow^{14

15

16

17

18}, Adriane Fugh-Berman¹⁹, Rob Howard²⁰, Aaron Kesselheim^{21

22}, Kenneth M Langa^{23

24

25

26}, George Perry²⁷, Edo Richard^{28

29}, Lon Schneider³⁰

Affiliations

¹ Departments of Neurology, Psychiatry, Neuroscience, Cognitive Science, Organizational Behavior, and Design and Innovation, Case Western Reserve University, Cleveland, OH, USA.
² Professor of Medicine (Neurology), University of Toronto, Toronto, Ontario, Canada.
³ 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.
⁴ Research Administration and Division of Neurology, James J Peters VA Medical Center, Bronx, NY, USA.
⁵ Lown Institute, Needham, MA, USA.
⁶ Department of Humanities, Penn State College of Medicine, Hershey, PA, USA.
⁷ Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
⁸ Medicine and Health Services, University of Washington, Seattle, WA, USA.
⁹ Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹⁰ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹¹ Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
¹² Department of Policy and Management, George Washington University School of Public Health, Washington, DC, USA.
¹³ Director of Research and Development, Center for Applied Research in Dementia, Solon, OH, USA.
¹⁴ Cognitive Neurology and Innovation and Senior Scientist, Baycrest Academy for Research & Education at Baycrest Centre for Geriatric Care, Toronto, Ontario, Canada.
¹⁵ Kimel Centre for Brain Health and Wellness and Anne & Allan Bank Centre for Clinical ResearchTrials, Baycrest, Toronto, Ontario, Canada.
¹⁶ Canadian Consortium on Neurodegeneration in Aging, Canada.
¹⁷ Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada.
¹⁸ Neurology (Medicine), University of Toronto, Toronto, Ontario, Canada.
¹⁹ PharmedOut, Georgetown University Medical Center, Department of Pharmacology and Physiology, Washington, DC, USA.
²⁰ Old Age Psychiatry, Division of Psychiatry, University College London, UK.
²¹ Medicine, Harvard Medical School, Boston, MA, USA.
²² Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA, USA.
²³ Department of Internal Medicine, School of Medicine, University of Michigan, Ann Arbor, MI, USA.
²⁴ Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.
²⁵ Veterans Affairs Ann Arbor Center for Clinical Management Research, Ann Arbor, MI, USA.
²⁶ Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA.
²⁷ Department of Biology, University of Texas at San Antonio, San Antonio, TX, USA.
²⁸ Department of Neurology, Donders Institute for Brain, Behaviour and Cognition, Radboud University Medical Centre, Nijmegen, the Netherlands.
²⁹ Department of Public and Occupational Health, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
³⁰ Psychiatry and Neuroscience, Keck School of Medicine of USC, Psychiatry and The Behavioral Sciences, Los Angeles, CA, USA.

PMID: 35404287
DOI: 10.3233/JAD-220262

Making the Case for Accelerated Withdrawal of Aducanumab

Peter Whitehouse et al. J Alzheimers Dis. 2022.

. 2022;87(3):1003-1007.

doi: 10.3233/JAD-220262.

Authors

Affiliations

¹ Departments of Neurology, Psychiatry, Neuroscience, Cognitive Science, Organizational Behavior, and Design and Innovation, Case Western Reserve University, Cleveland, OH, USA.
² Professor of Medicine (Neurology), University of Toronto, Toronto, Ontario, Canada.
³ 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.
⁴ Research Administration and Division of Neurology, James J Peters VA Medical Center, Bronx, NY, USA.
⁵ Lown Institute, Needham, MA, USA.
⁶ Department of Humanities, Penn State College of Medicine, Hershey, PA, USA.
⁷ Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
⁸ Medicine and Health Services, University of Washington, Seattle, WA, USA.
⁹ Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹⁰ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹¹ Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
¹² Department of Policy and Management, George Washington University School of Public Health, Washington, DC, USA.
¹³ Director of Research and Development, Center for Applied Research in Dementia, Solon, OH, USA.
¹⁴ Cognitive Neurology and Innovation and Senior Scientist, Baycrest Academy for Research & Education at Baycrest Centre for Geriatric Care, Toronto, Ontario, Canada.
¹⁵ Kimel Centre for Brain Health and Wellness and Anne & Allan Bank Centre for Clinical ResearchTrials, Baycrest, Toronto, Ontario, Canada.
¹⁶ Canadian Consortium on Neurodegeneration in Aging, Canada.
¹⁷ Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada.
¹⁸ Neurology (Medicine), University of Toronto, Toronto, Ontario, Canada.
¹⁹ PharmedOut, Georgetown University Medical Center, Department of Pharmacology and Physiology, Washington, DC, USA.
²⁰ Old Age Psychiatry, Division of Psychiatry, University College London, UK.
²¹ Medicine, Harvard Medical School, Boston, MA, USA.
²² Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA, USA.
²³ Department of Internal Medicine, School of Medicine, University of Michigan, Ann Arbor, MI, USA.
²⁴ Institute for Social Research, University of Michigan, Ann Arbor, MI, USA.
²⁵ Veterans Affairs Ann Arbor Center for Clinical Management Research, Ann Arbor, MI, USA.
²⁶ Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI, USA.
²⁷ Department of Biology, University of Texas at San Antonio, San Antonio, TX, USA.
²⁸ Department of Neurology, Donders Institute for Brain, Behaviour and Cognition, Radboud University Medical Centre, Nijmegen, the Netherlands.
²⁹ Department of Public and Occupational Health, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
³⁰ Psychiatry and Neuroscience, Keck School of Medicine of USC, Psychiatry and The Behavioral Sciences, Los Angeles, CA, USA.

PMID: 35404287
DOI: 10.3233/JAD-220262

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.

Keywords: Aducanumab; Alzheimer’s disease; monoclonal antibody.

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Making the Case for Accelerated Withdrawal of Aducanumab

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Making the Case for Accelerated Withdrawal of Aducanumab

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