5 ms·

The way I understand it the claim that Biogen was making was that Aduhelm could reduce the amount of plaque in the brain. The thing that hasn’t been proven yet

The way I understand it the claim that Biogen was making was that Aduhelm could reduce the amount of plaque in the brain. The thing that hasn’t been proven yet is the relationship between this plaque and Alzheimers.

jcranmer 5y ago
The only reason people care about reducing the amount of plaque in the brain is the belief that that ameliorates Alzheimer's. This was of course the primary intended endpoint of Biogen's trials, but (like other plaque-reducing drugs) the fact that it hasn't ameliorated Alzheimer's has caused many to abandon that belief.
- jklein11 5y ago
  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?
  - jcranmer 5y ago
    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.
  - nieve 5y ago
    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.

jcranmer 5y ago

The only reason people care about reducing the amount of plaque in the brain is the belief that that ameliorates Alzheimer's. This was of course the primary intended endpoint of Biogen's trials, but (like other plaque-reducing drugs) the fact that it hasn't ameliorated Alzheimer's has caused many to abandon that belief.

jklein11 5y ago
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?
- jcranmer 5y ago
  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.
- nieve 5y ago
  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.