Re:Third member of U.S. FDA advisory panel resigns over Alzh...
by jcranmer on Friday June 11, 2021 @01:11PM
(#27475940)
> Better would be for the only role of the FDA in decisions like this to be determining if the manufacturer is making fraudulent claims.
Let us recall some of the key facts about the drug in question here. There were two trials. One of them showed such little benefit that it was halted midtrial on the basis that it would be unethical to continue giving people a drug that didn't work. The second showed marginal benefit.
Biogen argued that there is a rational explanation that explains the two trials that points to the drug working. The expert committee at the FDA had 10 people vote "that's bunk", 1 person vote "unsure", and nobody vote "I agree." That's a pretty strong endorsement for saying "Aduhelm treats Alzheimer's" is a fraudulent claim, and yet the FDA decided that the claim is merely disputed.
The only way you can look on the FDA's decision favorably is if you know nothing about how drug development works, which is unfortunately true of almost the entire public. (Here's two facts that are important to keep in mind: most drug candidates don't work, and placebo effects are very real and surprisingly powerful).
Let us recall some of the key facts about the drug in question here. There were two trials. One of them showed such little benefit that it was halted midtrial on the basis that it would be unethical to continue giving people a drug that didn't work. The second showed marginal benefit.
Biogen argued that there is a rational explanation that explains the two trials that points to the drug working. The expert committee at the FDA had 10 people vote "that's bunk", 1 person vote "unsure", and nobody vote "I agree." That's a pretty strong endorsement for saying "Aduhelm treats Alzheimer's" is a fraudulent claim, and yet the FDA decided that the claim is merely disputed.
The only way you can look on the FDA's decision favorably is if you know nothing about how drug development works, which is unfortunately true of almost the entire public. (Here's two facts that are important to keep in mind: most drug candidates don't work, and placebo effects are very real and surprisingly powerful).