Two major U.S. health systems say they will not administer the controversial new Alzheimer’s drug Aduhelm.
The decisions by the Cleveland Clinic and Mount Sinai’s Health System in New York City are the latest fallout from the U.S. Food and Drug Administration’s widely criticized approval of the Biogen drug on June 7, The New York Times reported.
Many experts say there’s no clear evidence the drug helps slow mental decline in Alzheimer’s patients, and the approval has triggered congressional investigations.
After an expert panel review of “all available scientific evidence on this medication,” the Cleveland Clinic has decided not to carry the drug at this time, the clinic said in a statement, the Times reported.
Individual doctors can prescribe Aduhelm, but those patients would have to go elsewhere to receive the drug that’s administered as a monthly intravenous infusion, the clinic added.
Mount Sinai’s decision not to administer Aduhelm was influenced by calls for a federal investigation into the FDA decision and the agency’s relationship with Biogen, Dr. Sam Gandy, director of the Mount Sinai Center for Cognitive Health in New York City, told the Times.
Many Alzheimer’s experts have said that it is unclear that the drug actually slows cognitive decline while there is also evidence that Aduhelm could cause brain swelling or bleeding, the Times reported. The drug is also expensive, with a price tag pegged at $56,000 a year.
In a recent survey of nearly 200 neurologists and primary care doctors, most said they disagreed with the FDA decision and did not plan to prescribe the drug to their patients, the Times reported.
Last week, in response to growing criticism, acting FDA Commissioner Dr. Janet Woodcock called for an independent federal investigation into the agency’s approval process.
“To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe it is critical that the events at issue be reviewed by an independent body,” she said at the time.
Visit the National Institute on Aging for more on Alzheimer’s disease.
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