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The FDA Has Approved A New Alzheimer's Drug — Here's Why That's Controversial
"But two large studies offered conflicting evidence about whether the treatment slows declines in memory and thinking. A panel of expert advisers to the FDA recommended in November that the agency not approve the drug.
As a condition of approval, the FDA is requiring Biogen, the drug's maker, to conduct another clinical study to confirm that the reduction of amyloid plaques results in clinical improvement for patients. If the subsequent study doesn't show a clinical improvement, the agency could move to withdraw the approval." https://www.npr.org/2021/06/07/1003964235/fda-approves-controversial-alzheimers-drug-aducanumab
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"The prescribing information includes another warning about hypersensitivity reactions, including angioedema and urticaria. The most common side effects associated with Aduhelm involved ARIA, headache, fall, diarrhea and confusion/delirium/altered mental status/disorientation."
Good post.
Patients receiving the treatment had significant dose-and time-dependent reduction of amyloid beta plaque, while patients in the control arm of the studies had no reduction of amyloid beta plaque.
Notice the article says nothing about improving the mental state of the patients, or reducing the memory loss. Amyloid beta is not the cause the problem Amyloid beta is the result of the real cause, and is produced by the body to solve the real problem.
My dad was involved in an early study of the same drug. Not approved. The dosage has now been changed. There are side effects. Yesterday, it was 50/50 that this would be approved. In one day it has gone from questionable to a “Wonder Drug.” My personal opinion is not high on helping many people. I hope I am wrong. Rotten disease. My dad will probably die from AZ in the next 2 months. Diagnosed over 15 years ago.