Right, but if the FDA's job is to verify the claims made by Biogen then it shouldn't be a surprise that it was approved. Have there been any studies that show that plaque-reducing drugs don't ameliorate Alzheimer's? or is there just no evidence to support it yet?
The FDA scientific advisory committee rejected Biogen's claims in a unanimous vote. (Note that Biogen actually claimed in its application that aduhelm ameliorates Alzheimer's). The history of the aduhelm approval process just has a stench about it; you can see earlier posts by this author on the topic (linked to in the original article) to see some of that come out.
> Have there been any studies that show that plaque-reducing drugs don't ameliorate Alzheimer's?
There are, I believe, about a dozen drugs that tried to reduce plaques that have all failed to ameliorate Alzheimer's. And several of them despite actually demonstrating reduction of plaques.
Approving a drug based on a theory that it might help is not a good approach. If you're asking for approval to sell a drug to the public you need more than a hope. Some degree of solid proof that there are better outcomes with it than without seems a bare minimum threshold and Biogen couldn't clear it.
