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In a stark reflection of concern over the approval of the controversial new Alzheimer’s drug, Aduhelm, two major U.S. health systems have decided not to administer 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 had “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 offer aducanumab at this time,” the statement said.
A spokeswoman for the clinic said that individual doctors can prescribe Aduhelm to patients, but those patients would have to go elsewhere to receive the drug, which is given as a monthly intravenous infusion.
The Mount Sinai Health System in New York has also decided not to administer Aduhelm, said Dr Sam Gandy, director of the Mount Sinai Center for Cognitive Health.
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Dr Gandy, who is also a professor of psychiatry and neurology, said the decision was prompted by a federal inquiry requested to review the FDA’s decision and the agency’s relationship with Biogen, the manufacturer of the drug. He said: “Aduhelm will not be considered for an infusion in patients on any of its campuses until and unless” an investigation by the Inspector General of the Department of Health and Human Services “, affirms the integrity of the FDA-Biogen relationship and continues to reaffirm “the basis of the FDA for drug approval.
The rejection by major medical centers is the latest consequence of the drug’s approval by the Food and Drug Administration on June 7, a move that has also boosted congressional inquiries.
Many Alzheimer’s experts and other scientists have said that it is not clear that the drug works to slow cognitive decline, and that at best the evidence suggests only a slight slowdown while showing that Aduhelm could cause brain swelling or brain bleeding.
Dr Gandy said in his private practice that he told patients that “no one has been improved by Aduhelm and that patient cognition has always continued to decline at a certain rate.”
The drug is also expensive. Biogen, the manufacturer, has set its price at $ 56,000 per year.
In a recent survey of nearly 200 neurologists and primary care physicians, most said they did not agree with the FDA’s decision and did not intend to prescribe the drug to their patients. patients.
Last week, in response to growing criticism, Dr. Janet Woodcock, the acting commissioner of the FDA, called for an independent federal inquiry into the agency’s approval process, writing that “as far as these concerns could undermine public confidence in the FDA’s decision, I believe it is essential that the events in question be reviewed by an independent body.
Two almost identical clinical trials of Aduhelm were prematurely stopped because an independent data monitoring committee concluded that the drug did not appear to be helping patients. Subsequent analysis from Biogen found that participants receiving the high dose 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 did not. had not benefited at all.
About 40% of trial participants developed a cerebral hemorrhage or swelling in the brain, and although most of these cases were mild or manageable, about 6% of participants dropped out of the trials because of the serious side effects of these conditions. Dr Gandy said a patient in his private practice had to drop out because he was suffering from 10 brain microhemorrhages.
After evaluating the data late last year, an FDA external expert advisory panel strongly recommended against approval, and three of its members resigned in protest last month when the agency rejected the advisory committee’s opinion. The American Geriatrics Society had 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 had approved Aduhelm for anyone with Alzheimer’s disease, the FDA sharply reduced the recommended use of the drug, saying it should only be used for people having mild memory or thinking problems because there was no data on the use of Aduhelm in later stages of Alzheimer’s disease.
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