Watchdog Group Chastises Aducanumab Approval, Calls for More Resignations

FDA_Al Drago/CQ Roll Call

Al Drago/CQ Roll Call

Since the U.S. Food and Drug Administration (FDA) approved Biogen’s controversial Alzheimer’s drug aducanumab, three members of the advisory committee have resigned. One watchdog organization is calling for more top agency officials to resign, including acting Commissioner Janet Woodcock.

In an eight page letter to U.S. Department of Health and Human Services Secretary Xavier Becerra, Public Citizen said Woodcock and other FDA officials involved with the approval of aducanumab, marketed under the brand name Aduhelm, should resign.

Public Citizen also noted that Center for Drug Evaluation and Research Director Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Billy Dunn should also resign following the decision to approve the drug despite ongoing concerns about its efficacy in treating Alzheimer’s. In its letter, the FDA should have rejected aducanumab until additional clinical data could be produced to support an approval. 

In addition to a question over efficacy, Public Citizen also wrote that the $56,000 annual list price for Aduhelm threatens the financial stability of Medicare.

Michael Carome, director of Public Citizen’s Health Research Group, chastised the FDA’s decision to approve aducanumab for Alzheimer’s disease regardless of the severity of the condition. Carome said the approval showed a “stunning disregard for science” and damaged the FDA’s standards regarding the approval of new drugs. Furthermore, Carome said the approval of aducanumab “ranks as one of the most irresponsible and egregious decisions in the history of the agency.” He added that the approval is a blow to the FDA’s credibility as the gold-standard of regulatory agencies. 

“The primary beneficiaries of the agency’s action are Biogen and its shareholders, who undoubtedly are ecstatic about their soon-to-be-reaped windfall profits from sales of the company’s exorbitantly priced but ineffective drug.” Public Citizen said in its letter. 

After a rocky clinical development program, the FDA greenlit aducanumab, including a 2019 decision by Biogen and developmental partner Eisai to abandon the drug development following a futility analysis of trial data that suggested the drug would not hit study endpoints. The decision was reversed following an analysis of the trial data that showed the drug had hit its endpoints. Aducanumab moved forward through regulatory hurdles until it was approved by the FDA, despite a rejection of the drug by the agency’s FDA’s Peripheral and Central Nervous System Drugs Advisory Committee last year.

The letter questioned the communication between the FDA and Biogen after aducanumab was initially abandoned. That close working relationship “dangerously compromised the independence and objectivity of senior staff and clinical reviewers,” Public Citizen said. 

Additionally, the letter raised questions over the targeting of amyloid plaque to treat Alzheimer’s. Use of aducanumab is predicated on the still-unproven “amyloid hypothesis,” Public Citizen said. 

As BioSpace previously reported, when it approved aducanumab, the FDA said it determined there was “substantial evidence” Aduhelm helped patients. 

“As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease, the agency said. The approval marked the first drug authorized for Alzheimer’s disease in 20 years.

Following that decision, three members of the advisory committee resigned from their positions. David S. Knopman, a neurologist at the Mayo Clinic, and Joel S. Perlmutter, a neurologist at Washington University in St. Louis were the first to resign. One day later, Aaron Kesselheim, a professor of Medicine at Harvard Medical School followed. When Kesselheim resigned, he told Reuters the FDA should re-evaluate how it uses the advisory committees. 

“… because I didn’t think that the firm recommendations from the committee in this case … were appropriately integrated into the decision-making process,” he said.

Back to news