Making the Case for Accelerated Withdrawal of Aducanumab

Author:

Whitehouse Peter12,Gandy Sam34,Saini Vikas5,George Daniel R.6,Larson Eric B.78,Alexander G. Caleb910,Avorn Jerry11,Brownlee Shannon12,Camp Cameron13,Chertkow Howard1415161718,Fugh-Berman Adriane19,Howard Rob20,Kesselheim Aaron2122,Langa Kenneth M.23242526,Perry George27,Richard Edo2829,Schneider Lon30

Affiliation:

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

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.

Publisher

IOS Press

Subject

Psychiatry and Mental health,Geriatrics and Gerontology,Clinical Psychology,General Medicine,General Neuroscience

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