Doctors statement on Aduhelm

Crushed

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 This drug should be withdrawn from the market immediately.

among the signers
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

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

  

Donr

I hope that the FDA will read letters like this.