Two FDA Advisory Committee Members Quit Over Controversial Approval of New Alzheimer’s Drug

Amid concerns about the unorthodox approval of the new Alzheimer’s drug Aduhelm, which critics have called “reckless” since it has not been proven effective and may actually worsen some patients’ conditions, at least two members of a panel of FDA advisors have resigned in protest.

The FDA’s decision to grant accelerated approval of the first Alzheimer’s therapy drug Aduhelm this week has drawn a great deal of criticism, after the regulatory agency granted approval of the drug despite the panel’s near unanimous recommendation against doing so just a few months ago.

In the latest fallout from the decision, two members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee have announced their resignation in protest.

Aduhelm is the first novel therapy approved for the treatment of Alzheimer’s since 2003, after being granted approval through the FDA’s Accelerated Approval Program on Monday. The drug is designed to reduce the presence of amyloid beta plaques in the brain, which are believed to be linked to the progression of the disease. However, in a November 2020 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, eight of the 11 members voted that one of the major clinical trials supporting approval of the drug did not provide strong evidence of Aduhelm’s effectiveness. Only one member of the committee voted “Yes” and two others were uncertain.

The committee voted similarly on another study’s findings, which looked at the drug’s effectiveness, with seven members voting the evidence was not convincing, four voting they were uncertain, and none of the members voting they were convinced the study showed Aduhelm actually works.

A third vote on the overall evidence resulted in a 10-0 vote against whether there was primary evidence of Aduhelm’s effectiveness, with one member voting they were uncertain.

As a result of the FDA’s decision to grant approval of Biogen’s Aduhelm, despite the lack of clinical trial data, Washington University neurologist Dr. Joel Perlmutter and Mayo Clinic neurologist Dr. David Knopman, who are members of the advisory committee, resigned from the panel.

On June 9, The Washington Post reported Knopman indicated he did not “wish to be part of a sham process”. Perlmutter reportedly said he resigned solely due to the FDA’s Aduhelm decision.

In addition to near-immediate panel member resignations, the FDA faced public criticism from the prominent consumer watchdog group Public Citizen on Monday, stating the agency “inappropriately collaborated with Biogen” to rush out what Public Citizen says is an unproven treatment, and may be ineffective or dangerous.

The FDA used its Accelerated Approval Program to rush the drug through, claiming it meets an unmet medical need. However, if the drug shows no benefits in post-approval studies, it could face removal from the market.

The agency has defended its decision, saying it knows it will be controversial, but claiming the FDA’s decision-making process in approving Aduhelm was no different in how it approves any other drug.