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Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug

Rejected submission by Anonymous Coward at 2021-06-12 03:43:55 from the FDA dept.
/dev/random

"The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients."

https://www.nytimes.com/2021/06/10/health/aduhelm-fda-resign-alzheimers.html [nytimes.com]

"The agency acknowledged the uncertainties about the medication but said its approval was justified by the seriousness of the disease and the dearth of options for treating it.
...

However, other experimental drugs have helped clear those plaques but not made any difference in patients’ ability to think, care for themselves or live independently.
...

Biogen, which developed the drug with the Japanese pharmaceutical firm Eisai Co., later said that a new analysis of one of the studies showed the drug worked at higher doses. The initial trial results were poor because the dose given to some patients was too low, the company said.

..

"Patients taking aducanumab saw their thinking skills decline 22% more slowly than patients taking a placebo. But that meant a difference of just 0.39 on an 18-point scale of cognitive and functional ability. It’s unclear how such metrics translate into practical benefits, such as greater independence or ability to recall important details."

https://www.latimes.com/science/story/2021-06-07/us-regulators-ok-alzheimers-drug-against-advice-of-experts [latimes.com]


Original Submission