Concerning the approval of the controversial new Alzheimer’s drug Aduhelm, two major American health systems have decided not to give it to patients.
The Cleveland Clinic, one of the largest and most respected medical centers in the country, said in a statement a panel of experts had “reviewed all available scientific evidence about this drug,” which is also called aducanumab.
“Based on the current data on safety and effectiveness, we have decided not to wear aducanumab at the moment,” the statement said.
A spokeswoman for the clinic said individual doctors there could prescribe Aduhelm to patients, but those patients would have to go elsewhere to get the drug, which is given as an intravenous infusion every month.
The Mount Sinai health system in New York City has also decided not to give 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 due to the fact that a state investigation was requested to investigate the FDA’s decision and the agency’s relationship with Biogen, the manufacturer of the drug. He said, “Aduhelm will not be considered for infusing patients at any of its sites until” an investigation by the Inspector General of the Department of Health and Human Services “confirms the integrity of the FDA-Biogen relationship and continues.” to reaffirm the FDA’s approval basis for the drug.
The rejection by the major medical centers is the latest fallout from the approval of the drug by the Food and Drug Administration on June 7, a decision that has also fueled Congressional investigations.
Many Alzheimer’s experts and other scientists have said that it is unclear that the drug helps slow cognitive decline and that at best the evidence suggests only a slight slowdown while showing that Aduhelm causes brain swelling or hemorrhage could.
Dr. Gandy said in his private practice that he told patients that “Aduhelm did not improve anyone and the patient’s cognition continued to decline.”
Recognition…Biogen, via Associated Press
The drug is also expensive. Biogen, the maker, has set its price at $ 56,000 per year.
In a recent survey of nearly 200 neurologists and primary care physicians, most said they disagreed with the FDA’s decision and did not plan to prescribe the drug to their patients.
Last week, Dr. Janet Woodcock, acting FDA commissioner, in response to growing criticism of an independent state investigation into the agency’s regulatory process, wrote, “To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe” it is critically important that the disputed events are reviewed by an independent body. “
Two almost identical clinical trials with Aduhelm were stopped prematurely because an independent data monitoring committee concluded that the drug did not appear to be helping patients. A later analysis by Biogen found that participants who received the high dose of the drug in one study experienced a very slight slowdown in cognitive decline – 0.39 on an 18-point scale – that participants in the other study however, had not benefited from it at all.
About 40 percent of study participants developed cerebral hemorrhage or swelling, and while most of these cases were mild or manageable, about 6 percent of participants dropped out because of serious side effects from these conditions. Dr. Gandy said that one patient in his private practice had to drop out of the practice because the patient suffered 10 microbleeds in the brain.
After reviewing the data late last year, an FDA advisory committee strongly recommended outside experts against approval, and three of its members resigned in protest last month when the agency defied the advice of the advisory committee. The American Geriatrics Society had also urged the agency not to approve the drug because it was “premature in the absence of sufficient evidence.”
In response to widespread criticism that Aduhelm was approved for anyone with Alzheimer’s, the FDA last week severely restricted the drug’s recommended use, saying that it should only be used for people with mild memory or thinking problems as it doesn’t have any Data on the use of Aduhelm gave later stages of Alzheimer’s disease.