In a significant reflection of concern over the approval of the controversial new Alzheimer’s drug EduHelm, two major US health systems have decided they will not give it to patients.
The Cleveland Clinic, one of the nation’s largest and most respected medical centers, said in a statement that a panel of its experts “reviewed all available scientific evidence on this drug,” also known as aducanumab.
“Based on current data regarding its safety and efficacy, we have decided not to take aducanumab at this time,” the statement said.
A spokesperson for the clinic said individual physicians can prescribe Eduhelme to patients, but those patients will have to go elsewhere to receive the drug, which is administered as a monthly intravenous infusion.
Dr. Sam Gandy, director of the Mount Sinai Center for Cognitive Health, said Mount Sinai’s health system in New York City has also decided not to administer EduHelm.
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Dr. Gandy, who is also a professor of psychiatry and neuroscience, said the decision was prompted by the fact that it called for a federal investigation to look into the FDA’s decision and the agency’s relationship with Biogen, the drug’s maker. . “Unless an investigation by the Department of Health and Human Services’ inspector general, EduHelm will not be considered for infusion into patients on any of its premises,” he said, reaffirming the integrity of the FDA-Biogen relationship and keeps on. To confirm the FDA’s basis for approving the drug.
The rejection by major medical centers is the latest fallout from the Food and Drug Administration’s approval of the drug on June 7, a decision that has also prompted a congressional investigation.
Many Alzheimer’s experts and other scientists have stated that it is unclear whether the drug works to help slow cognitive decline and, in the best case scenario, the evidence suggested only slightly slowing it, while also showing that eduhelminthe brain. May cause swelling or bleeding of the brain.
Dr. Gandy, in his personal practice, says that he tells patients that “no improvement was made by Eduhelm and that patients’ cognition always declined at some rate.”
Medicines are also expensive. The manufacturer, Biogen, has set its price at $56,000 a year.
recently 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 mounting criticism, Acting FDA Commissioner Dr. Janet Woodcock called for an independent federal investigation into the agency’s approval process, writing that “the extent to which these concerns may undermine public confidence in the FDA’s decision.” I believe it is important that this issue be reviewed by an independent body.”
Two nearly identical clinical trials of Aduhelm were stopped early after an independent data monitoring committee concluded the drug was not helping patients. A later analysis by Biogen found that participants who received higher doses of the drug in one trial experienced a significantly slower rate of cognitive decline—0.39 on an 18-point scale—but participants in the other trial experienced none at all. There was no profit.
About 40 percent of trial participants developed brain hemorrhages or swelling of the brain, and while most of those cases were mild or manageable, about 6 percent of participants dropped out of the trials because of serious adverse effects from those conditions. Dr. Gandy said that in his private practice one patient had to be abandoned because the patient had 10 brain microhemorrhages.
After evaluating the data late last year, an FDA advisory committee of outside experts strongly said recommended against approval, and its three members resigned in protest Last month when the agency deferred the advice of the advisory committee. American Geriatric Society He had urged the agency not to approve the drug, saying it would be “premature in the absence of sufficient evidence”.
Last week, in response to widespread criticism that it approved EduHelm for anyone with Alzheimer’s, FDA sharply limits recommended use of drug, adding that it should only be used for people with mild memory or thinking problems because there were no data on the use of Eduhelme in the later stages of Alzheimer’s.