As a physician who cares for people with Alzheimer’s disease, Thambisetty spoke about the harms of the drug. “These patients can experience headaches, falls, confusion, vision disturbances and it’s unclear if patients will be able to see obvious benefits on a day-to-day basis,” he said.
The data showed an increased risk of brain bleeds and swelling, i.e. amyloid-related imaging abnormalities (ARIA) occurred in 126 (14.0%) of subjects in the lecanemab group and only 69 (7.7%) of subjects in the placebo group.
This prompted the FDA to include a warning on the drug about the risk of swelling and bleeding in the brain.
Researching a compound properly takes time. An "accelerated approval process" is a bad idea.
There is no substitute for time.