How an Unproven Alzheimer's Drug Got Approved

[dalton99a]

https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html

How an Unproven Alzheimer’s Drug Got Approved
Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.
By Pam Belluck, Sheila Kaplan and Rebecca Robbins
Published July 19, 2021 Updated July 20, 2021, 8:51 a.m. ET

Two months before the Food and Drug Administration’s deadline to decide whether to approve Biogen’s controversial Alzheimer’s drug aducanumab, a council of senior agency officials resoundingly agreed that there wasn’t enough evidence it worked.

The session, whose details have not been reported before, represented at least the third time that proponents of approving aducanumab in the F.D.A. had received a clear message that the evidence did not convincingly show the drug could slow cognitive decline.

On June 7, the F.D.A. greenlighted the drug anyway — a decision that has been met with scathing rebuke from many Alzheimer’s experts and other scientists and calls for investigations into how the agency approved a treatment that has little evidence it helps patients.

How and why the F.D.A. went ahead and approved the drug — an intravenous infusion, marketed as Aduhelm, that the company has since priced at $56,000 a year — has become the subject of intense scrutiny. Two congressional committees are investigating the approval and the price. Much is still unknown, but an examination by The Times has found that the process leading to approval took several unusual turns, including a decision for the F.D.A. to work far more closely with Biogen than is typical in a regulatory review.

[marble falls]

1. There's just too many alzheimer patients not to have something to sell them, ...

[MontanaMama]

2. My dad died of Alzheimer's in 2011.

I would have done anything to prolong his quality of life for as long as I could. $56,000 per year for a drug that doesn’t help? Isn’t Alzheimer’s tragic enough? This seems predatory to me.