The road to Aduhelm: What one ex-FDA adviser called 'probably the worst drug approval decision in recent US history' for an Alzheimer's treatment
(CNN)Dr. Aaron Kesselheim had been on an advisory committee for the US Food and Drug Administration for a half-dozen years, but he had never been to a meeting like this one.
The approval has already renewed investment activity in Alzheimer's disease research and development, and we are optimistic that other innovative treatments will soon join Aduhelm.
Given the unmet needs for patients with Alzheimer's disease -- a serious, progressive and ultimately fatal disease -- the agency chose to use the accelerated approval pathway to allow earlier access to patients while we continue to acquire data on the drug's benefit.
We strongly advocated approval on the basis of the available science, knowing full well that this is no cure. It is a really marginal advantage, but that marginal difference can make a real difference for people who have a great need.
The idea at the FDA increasingly seems to be if a drug is potentially effective and not clearly harmful, the market should decide whether patients should use it.
