4 ms·
My point (a view shared by the article and many others) is that the FDA decided Aduhelm is safe but did a terrible job of deciding that it is effective. Safety
by axg11 5y ago
My point (a view shared by the article and many others) is that the FDA decided Aduhelm is safe but did a terrible job of deciding that it is effective. Safety is also not absolute. All medicines have adverse effects, safety is then relative to the benefits of the medicine.
- refurb 5y agoAccelerated approvals are just that - accelerated and don't require the same standard of proof of efficacy. Just like Avastin for Breast Cancer - it got accelerated approval, turned out it didn't work, so approval was recinded. The goal is to give patients access to potentially effective medications. They do this because people bitch when the FDA says "no".