Drugs for Early-Stage Alzheimer’s?
Drugs for Early-Stage Alzheimer’s (good New York Times editorial):
“The Food and Drug Administration has proposed lowering the bar for approving drugs to treat people at the earliest stages of Alzheimer’s disease, before they have developed any serious impairment or overt dementia. The goal is commendable — to find ways to prevent or slow the progression of this terrible disease before it can rob people of their mental capacities. But the proposal raises troubling questions as to whether the agency would end up approving drugs that provide little or no clinical benefit yet cause harmful side effects in people who take the medications for extended periods…Independent analysts need to look hard at whether the F.D.A. should lower the bar for these drugs — or should demand a very high level of proof of safety and effectiveness before exposing still-healthy people to possible harm. Even if drugs are eventually approved under this new approach, it will be imperative to force manufacturers to conduct follow-up studies, as required by law, to see if patients benefit in the long run. This is a task they are often slow to perform once a drug is on the market.”
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