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