Boston-based Mass General Brigham said Sept. 29 it will not administer Biogen's much-debated Alzheimer's drug Aduhelm to patients, The Boston Globe reported.
The FDA approved the drug in June, the first approval the agency has granted to an Alzheimer's treatment since 2003. Aduhelm is the first treatment approved by the FDA to slow cognitive decline from Alzheimer's, as the Alzheimer's drugs the FDA has previously cleared are aimed at alleviating symptoms rather than slowing the disease's progression.
However, medical and pharmaceutical experts have been vocally critical of the FDA's decision, saying there is not sufficient evidence to demonstrate the drug's efficacy and alleging an inappropriately close relationship between the FDA and the pharmaceutical industry.
Mass General Brigham joins other major health systems — including Cleveland Clinic, New York City-based Mount Sinai, Renton, Wash.-based Providence and the Department of Veterans Affairs — in refusing to offer the drug.
"We understand that this may be difficult news for some of our patients," Mass General Brigham said in a statement. "However, we fully support continued evaluation of this medication, and should new data become available, we will re-evaluate this decision."
The system made the announcement after its panel of medication experts reviewed the treatment, which costs $56,000 annually for a 163-pound patient. The panel decided Mass General Brigham shouldn't offer the drug on Sept. 20 following a "thorough review of clinical, economic and operational considerations," the system said.
Mass General Brigham is the largest healthcare provider in Massachusetts, where Biogen's headquarters is located.
"Patients and their families deserve to have choice and access to FDA-approved treatments, including the only Alzheimer’s disease treatment that addresses a defining pathology of the disease," Biogen said in a statement. "It is disappointing that Massachusetts General Hospital has chosen to deny patients that choice."
Mass General's Brigham's announcement is another example showing experts don't believe Aduhelm works the way Biogen purports, Sam Gandy, MD, PhD, who runs a center for cognitive health at Mount Sinai, told The Boston Globe.
"This emperor has no clothes," he said. He added that no patients or caregivers have asked him about Aduhelm the past four to six weeks, possibly because they have read about the debate surrounding the drug.
The HHS Office of Inspector General said Aug. 4 it will review the FDA's approval process for the drug.