The Cleveland Clinic said it would not be given to patients Wednesday night, strongly reflecting concerns over the approval of the controversial new Alzheimer’s disease treatment aducanumab.
The clinic, one of the country’s largest and most respected medical centers, said in a statement that a committee of experts “examined all available scientific evidence for this drug.” This is also called aducanumab.
“Based on current data on its safety and efficacy, we have decided not to carry aducanumab at this time,” the statement said.
Clinic spokespersons allow individual doctors there to prescribe aducanumab to patients, but those patients must go elsewhere to receive medications given as monthly intravenous infusions. Said.
The stance of major medical centers is the latest fallout from the June 7 Food and Drug Administration approval and a decision that has spurred Congressional investigations.
Many Alzheimer’s disease experts and other scientists are uncertain whether the drug helps slow cognitive decline, and in the best-case scenario, aducanumab can cause cerebral swelling and cerebral edema. While showing that, the evidence states that it suggests only a slight slowdown.
The medicine is also expensive. Manufacturer Biogen sets the price at $ 56,000 a year.
recently Research Of the nearly 200 neurologists and primary care physicians, most disagreed with the FDA’s decision and said they had no plans to prescribe medication to their patients.
In response to growing criticism last week, FDA Deputy Commissioner Dr. Janet Woodcock called for an independent federal investigation into the FDA’s approval process: “These concerns could undermine public confidence in the FDA’s decision. To the extent, I believe. It is important for an independent agency to review the event in question. “
Two nearly identical clinical trials of aducanumab were discontinued early because an independent data monitoring committee concluded that the drug did not appear to help patients. Subsequent analysis by Biogen showed that participants who received high doses of the drug in one study had a very slight slower decline in cognitive function (0.39 on an 18-point scale), while participants in the other study did not. It turns out that I didn’t benefit.
Approximately 40% of study participants developed cerebral hemorrhage or cerebral edema, most of these cases were mild or manageable, but approximately 6% of participants from the study due to serious side effects from these conditions. I dropped out.
After evaluating the data at the end of last year, the FDA advisory board of external experts strongly It is advisable to oppose approval, And three of its members Protest and resign Last month when a government agency opposed the advisory board’s advice. American Geriatrics Society “It’s premature because there isn’t enough evidence,” he urged authorities not to approve the drug.
In response to widespread criticism last week that it approved aducanumab for people with Alzheimer’s disease The FDA has significantly narrowed the recommended use of the drugThe lack of data on the use of aducanumab in the late stages of Alzheimer’s disease states that it should only be used in people with mild memory or thinking problems.
Ohio Clinic says patients will not be given medication for Alzheimer’s disease
Source link Ohio Clinic says patients will not be given medication for Alzheimer’s disease