The consumer advocacy group Public Citizen is pressuring Food and Drug Administration officials to resign following last week's approval of the controversial treatment for Alzheimer’s disease, an intravenous therapy with shaky scientific backing.
"The FDA’s non–evidence-based decision to approve [the treatment] aducanumab ultimately represents the pinnacle of the agency’s egregious disregard for science,” Michael Carome, the director of Public Citizen’s Health Research Group wrote to Health and Human Services Secretary Xavier Becerra. “We therefore urge you to immediately request the resignations or seek the removal of the three individuals most responsible for the agency’s aducanumab approval decision."
The group has urged Becerra to request the resignations of acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research Director Patrizia Cavazzoni, and CDER’s Office of Neuroscience Director Billy Dunn.
“New leadership of the FDA and CDER is a prerequisite for restoring the agency’s credibility and reversing the slide in the agency’s standards for ensuring the safety and effectiveness of new drugs,” Carome said.
The monthly Alzheimer’s treatment called aducanumab, also known by its brand name Aduhelm, from biopharmaceutical company Biogen was approved by the FDA last week via the “accelerated approval” pathway, meaning the company will have to produce results from a postmarket study to prove efficacy. The intravenous treatment would be administered by a healthcare provider in a clinical setting.
It is a monoclonal antibody that clears a “sticky” plaque in the brain made up of the protein beta-amyloid, which accumulates in the brains of Alzheimer’s patients and is believed to cause memory and cognitive problems. However, trial results did not provide proof of a clear benefit against the progression of the disease.
Carome also said that the next FDA head should consider withdrawing the approval for Biogen’s treatment.
Biogen sparked outrage among patient advocacy groups soon after winning approval for aducanumab when it set the treatment’s list price at $56,000 for a year’s worth of treatments. Those groups argued that many of the 6.2 million Alzheimer's patients over 65 will not be able to afford the treatment.
The federal government healthcare program for seniors over 65, called Medicare, would cover at least part of the cost of the expensive treatment, but it is unclear how many enrollees will actually be prescribed by a doctor to get it. Government spending on aducanumab alone is estimated to exceed $57 billion in a single year if just 1 million people enrolled in Medicare, the government healthcare program for seniors, were prescribed the treatment, according to a report from the Kaiser Family Foundation. Aduhelm patients will also require related medical services such as regular neurological imaging, including CT scans, to make sure the treatment is doing its job. KFF estimated that a single year of treatment and other necessary expenses that come with it, such as co-pays for doctor visits to treat side effects, would cost patients about $11,500.
Washington Examiner Videos
Original Author: Cassidy Morrison