Call for the Accelerated Withdrawal of Aducanumab

The following statement was drafted and approved by a group of internationally recognized experts in dementia research and treatment, and other health experts. We invite you to personally endorse this statement by adding your name at the bottom of this page. (press release)

CHAIR

Peter J. Whitehouse, M.D. Ph.D.
Professor, Case Western Reserve University and University of Toronto

CO-CHAIRS

Sam E. Gandy, M.D., Ph.D.
Professor of Neurology and of Psychiatry, Icahn School of Medicine at Mount Sinai

Vikas Saini, M.D., F.A.C.C
Chair, Right Care Alliance
President, Lown Institute

MEMBERS

G. Caleb Alexander, M.D., M.S.
Professor of Epidemiology and Medicine, Johns Hopkins Bloomberg School of Public Health

Jerry Avorn, M.D.
Professor of Medicine, Harvard Medical
Chief Emeritus, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

Shannon Brownlee, M.Sc.
Co-Chair, Right Care Alliance
Special Advisor to the President, Lown Institute
Lecturer, School of Public Health, George Washington University

Cameron Camp, Ph.D.
Director of Research and Development, Center for Applied Research in Dementia

Michael A. Carome, M.D.
Director, Health Research Group, Public Citizen

Howard Chertkow, M.D., F.R.C.P., F.C.A.H.S.
Chair in Cognitive Neurology and Innovation and Senior Scientist, Baycrest and Rotman Research Institute

Director, Kimel Centre for Brain Health and Wellness and Anne & Allan Bank Centre for Clinical Research Trials, Baycrest

Scientific Director, Canadian Consortium on Neurodegeneration in Aging

Adjunct Professor, Dept. of Neurology and Neurosurgery, McGill University Professor of Neurology (Medicine), University of Toronto

Adriane Fugh-Berman M.D.
Director, PharmedOut
Georgetown University Medical Center

Daniel R. George, Ph.D, M.Sc.
Associate Professor, Penn State College of Medicine

Robert J. Howard M.D. MRCPsych.
Professor of Old Age Psychiatry, Division of Psychiatry, Faculty of Brain Sciences, University College London

Edo Richard M.D. Ph.D.
Professor of Neurology, Radboud University Medical Center, Nijmegen and Amsterdam University Medical Center, The Netherlands

Aaron S. Kesselheim, M.D., J.D., M.P.H.
Professor of Medicine, Harvard Medical School

Kenneth M. Langa, MD, PhD
Cyrus Sturgis Professor of Medicine, University of Michigan

Eric B Larson, M.D., M.P.H.
Clinical Professor, Medicine and Health Services University of Washington

George Perry, Ph.D.
Editor-in-Chief, Journal of Alzheimer’s Disease
Professor & Semmes Distinguished University Chair in Neurobiology, University of Texas at San Antonio

Lon S. Schneider, M.D., M.S.
Della Martin Professor of Psychiatry and Neuroscience, Keck School of Medicine of USC

Call for the Accelerated Withdrawal of Aducanumab

Published: December 20, 2021

We call on the FDA to withdraw its marketing approval for Aduhelm (aducanumab) for the treatment of Alzheimer’s disease. An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval for these reasons:

  1. Aduhelm failed to demonstrate the prespecified necessary clinical benefit to patients and did not meet the FDA’s own 2019 guidance criteria for a regular approval. In two prematurely terminated trials, one showed no effect, while the other showed an effect that was not clinically meaningful.
  2. Aduhelm also did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression. It is not a reliable measure of patient benefit and should not replace clinical outcomes in drug approvals. The FDA’s claim that a reduction in amyloid plaque is “reasonably likely to predict” such a benefit is without foundation.
  3. Given the lack of evidence for clinical benefit, the risks of Aduhelm are unacceptable. This drug causes high rates of potentially dangerous side effects (disorientation, falling, brain swelling and bleeding) and a risk of death that is yet to be defined.

We are deeply concerned about the broader issues raised by the approval of this drug. The FDA’s acceptance of amyloid plaque PET scans instead of actual patient improvement for approving drugs for Alzheimer’s disease is not scientifically well-founded. In the absence of clear evidence of meaningful clinical benefit, the continued availability of Aduhelm is likely to lead to widespread overtreatment that will not improve the quality of life of patients, will expose them to unnecessary harms, and will consume extensive resources better spent on supportive services and public health measures to help people with this potentially devastating disease.

The FDA’s decision to approve Aduhelm is indefensible in both scientific and clinical terms. This drug should be withdrawn from the market immediately.

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Direct general inquiries to info@rightcarealliance.org and media inquiries to aaron@rightcarealliance.org.