FAST FIVE: "A Dangerous Precedent" – 3rd FDA Advisor Quits After Controversial Alzheimer's Drug Approval
“A Dangerous Precedent” – 3rd FDA Advisor Quits After Controversial Alzheimer's Drug Approval While the mainstream media focused on the hope-filled headlines that, for the first time since 2003, the FDA approved Biogen's Aduhelm treatment for Alzheimer's Disease; few, if any, were fully aware of the levels of controversy behind the scenes.
It turns out that despite the fact that not one member of the FDA Advisory Committee voted to approve Aduhelm, the FDA recently approved this Alzheimer therapy anyway, relying on an alternative measure of activity.
As Statnews reports, since the FDA's decision, three members of that FDA Advisory Panel have quit.
As Nature.com reports, others worry that drug developers might abandon other targets.
If demonstrating that amyloid-lowering activity is enough to win regulatory approval, it might discourage developers from focusing on treatments with the big cognitive benefits that patients need, say some scientists.