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December 20, 2021
Alzheimer’s experts call for accelerated withdrawal of Aduhelm; formal petition for removal begins
Approval described as “indefensible in both scientific and clinical terms.”
A group of health professionals, most of them internationally recognized experts in Alzheimer’s disease research and treatment, have issued a formal statement calling on the U.S. Food and Drug Administration to withdraw approval of the drug aducanumab. The FDA approved the use of aducanumab, marketed by Biogen as Aduhelm, for treatment of Alzheimer’s disease in June 2021.
Reasons for concern cited in the statement include insufficient evidence from trials, the inappropriate use of amyloid plaque reduction as a surrogate marker, and dangerous side effects like brain swelling and bleeding.
The statement was drafted and approved at a meeting held last week and has now been posted online. It is endorsed by 17 of the 18 attendees, including Aaron Kesselheim, MD, one of the three FDA advisory committee members that resigned when the drug was approved despite that committee’s near unanimous objection.
“With almost fifty years in the field, I know how hard dementia can be for families and communities,” said Peter Whitehouse, MD, chair of the meeting. “Aducanumab has not been proven valuable to people or society and may in fact be harmful.”
The statement is published on the website of the Right Care Alliance, an advocacy group that works to hold industry accountable to patients over profits. With many of the Alzheimer’s experts serving as advisors, the RCA is also leading the development of a citizen petition that will be submitted to the FDA in following months using an established regulatory process.
“The American people need an FDA they can trust to make decisions based on the highest standards of evidence,” said Vikas Saini, MD, chair of the Right Care Alliance and a co-chair of the meeting. “This drug needs to be withdrawn from the market until there is adequate evidence to support its efficacy, which there currently is not.”
The Right Care Alliance is a grassroots coalition of clinicians, patients, and community members organizing to make health care institutions accountable to communities and put patients, not profits, at the heart of health care.