Three experts have resigned from a Food and Drug Administration (FDA) advisory committee after the agency approved Aduhelm, an Alzheimer's drug, despite nearly unanimous opposition from the panel. The drug, also known by its generic name aducanumab, was approved on Monday, sparking a mix of celebration and concern among patients, caregivers, and doctors.
Dr. Aaron Kesselheim, a professor at Harvard Medical School and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women's Hospital, was the latest to resign. He criticized the FDA for approving Aduhelm without sufficient evidence of its effectiveness, warning that this decision could set a concerning precedent for future drug approvals.
Kesselheim's resignation letter to acting FDA Commissioner Janet Woodcock described the approval as "probably the worst drug approval decision in recent U.S. history." He expressed concerns over the FDA's last-minute switch to an accelerated approval process for Aduhelm, which requires the drug's makers to conduct another study post-approval. Kesselheim also alleged that the advisory committee was given different criteria to consider than those cited by the FDA in its decision explanation.
The FDA defended its decision, stating that the benefits of Aduhelm for Alzheimer's patients outweighed the risks. However, the approval has led to the resignation of three committee members, including neurologists David Knopman and Joel Perlmutter, reducing the panel's external membership by a third.
Aduhelm, developed by Biogen and Eisai, is the first new Alzheimer's therapy approved since 2003. It targets amyloid plaque in the brain, a hallmark of Alzheimer's disease, but its effectiveness in improving patient outcomes remains uncertain. The drug's high cost, estimated at $56,000 annually, has also raised concerns about its accessibility and impact on healthcare affordability.
Despite the controversy, some patient advocates have welcomed the FDA's decision, viewing it as a positive step towards faster approval of treatments for debilitating diseases like ALS (amyotrophic lateral sclerosis). The ALS Association, for example, has called for similar expedited approval processes for promising ALS therapies.
