Dr. Selloway, a lead investigator for studies on the drug, was not paid for this work but has received research and consulting fees from Biogen. He said doctors should only use the drug on patients whose status matches those in clinical trials.
"There's no evidence that it could be beneficial for any other stage of Alzheimer's," he said.
Mary Sano, director of the Alzheimer's Research Center at Mount Sinai in New York City, said the criteria she and other panelists outlined were "very important", saying that "it will be very restrictive and the ability to use this drug with." Sharing a wide range of people with others will, at least at this point, be severely restricted. "
For dementia clinicians, treating people with only mild symptoms would mean that "most of your staff is unlikely to be an option in your current practice," said Dr. Sano.
In its decision, the F.D.A. acknowledged that there was not the level of evidence of benefit that the agency normally requires. As a result, it's making it available to Aduhelm under a program called accelerated approval, which spearheads the drug's ability to lower amyloid levels in the brain. But reducing amyloid is not the same as slowing down symptoms of dementia. Many amyloid-lowering drugs failed to slow the decline in clinical trials, a story that makes some experts particularly suspicious of trusting Aduhelm based on the evidence presented so far.
Also, given the agency's focus on amyloid in its approval decision and the fact that all participants in the clinical trial were required to have high levels of amyloid, experts were surprised that the F.D.A. Label does not require patient screening for the protein. Doctors at the Alzheimer's Association Forum all said that high levels of amyloid, typically measured by PET scans or spinal puncture, should be a prerequisite for treatment.
Several of the panelists said that relatively few doctors and clinics, at least initially, would be able to adequately diagnose, screen, and treat patients.
"This is not a simple drug," said Dr. Paul Aisen, director of the Alzheimer's Therapeutic Research Institute at the University of Southern California and co-author of an article for the F.D.A. to approve the drug. "I think that selecting the right people to treat and monitor treatment requires knowledge and experience, and there are very few clinicians who have this experience."
