Cleveland Clinic Says It Won’t Give Patients Aduhelm

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In a striking reflection of the concern over approval of the controversial new Alzheimer’s drug Aduhelm, the Cleveland Clinic said Wednesday evening that it will not be administering it to patients.

The clinic, one of the nation’s largest and most respected medical centers, said in a statement that a panel of experts “reviewed all available scientific evidence regarding this drug,” also called aducanumab.

“Based on the available data regarding its safety and efficacy, we have decided not to carry aducanumab at this time,” the statement said.

The clinic spokesperson said that doctors there can prescribe Aduhelm to patients, but these patients must go elsewhere to receive the drug, which is administered as a monthly intravenous infusion.

The major medical center’s stance is the latest result of the Food and Drug Administration approving the drug on June 7, a decision that also spurred congressional investigations.

Many Alzheimer’s experts and other scientists said it’s unclear whether the drug helps slow cognitive decline, and in the best-case scenario, evidence suggests only a slight slowdown, but also that Aduhelm can cause brain swelling or brain hemorrhage.

Credit…Biogen via Associated Press

Medicine is also expensive. Biogen, the manufacturer, set its price at $56,000 per year.

soon survey Most of the nearly 200 neurologists and primary care doctors said they disagreed with the FDA’s decision and did not plan to prescribe the drug to their patients.

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, saying, “I believe these concerns may undermine the public’s confidence in the FDA’s decision. It is critical that these events be reviewed by an independent body.”

Two nearly identical clinical trials of Aduhelm were stopped early because an independent data monitoring committee concluded that the drug was not helping patients. A later analysis by Biogen found that participants who took high doses of the drug in one trial experienced a very slight slowdown in cognitive decline—0.39 on an 18-point scale—but participants in the other trial experienced no benefit.

About 40 percent of trial participants developed cerebral hemorrhage or brain swelling, and while most of these cases were mild or manageable, about 6 percent of participants dropped out of trials due to serious adverse effects from these conditions.

After reviewing the data late last year, an FDA advisory committee of outside experts strongly recommended against approvaland three of its members resigned in protest when he failed to follow the advice of the agency’s advisory committee last month. American Geriatrics Association He also urged the agency not to approve the drug, saying it “would be premature given the lack of sufficient evidence”.

Last week, in response to widespread criticism that it approved Aduhelm for Alzheimer’s patients, FDA sharply narrows recommended use of drugAs there is no data on the use of Aduhelm in the later stages of Alzheimer’s, it should only be used in people with mild memory or thinking problems.

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