The drug [is] an intravenous infusion, marketed as Aduhelm, that the company has since priced at $56,000 a year.
[...]
While some Alzheimer's experts did support the drug's approval given the dearth of treatment choices for patients, many say it was a mistake to approve a medication with such unclear evidence of benefit and that trials showed can cause brain swelling or brain bleeding.
[...]
Even some former employees at Biogen involved in earlier phases of the work on Aduhelm did not agree with the F.D.A.'s approval of the drug.
[...]
[The FDA] said it was greenlighting Aduhelm under a program called "accelerated approval," which allows the authorization of drugs without persuasive proof of benefit if they are for serious diseases with few treatment options and if the drug affects part of the disease's biology (known as a biomarker) in a way that is "reasonably likely to predict clinical benefit."
The reason the agency gave — that the drug reduces a key protein that clumps into plaques in the brains of people with Alzheimer's — is one that the agency official leading the aducanumab review had said in an earlier public meeting would not be used. Many Alzheimer's experts say there is not nearly enough evidence that reducing the protein, amyloid, slows memory and thinking problems.
[...]
While aducanumab was in trials, Dr. Dunn and Samantha Budd Haeberlein, who oversaw the drug's clinical development for Biogen, worked together on several other projects, interactions that some scientists, former F.D.A. officials and former Biogen employees said they thought blurred the expected boundary between a regulator and an official of a company in that regulator's purview.
The Alzheimer's drug story is so shocking it's almost funny...
Cons
It's priced at $56,000 a year.
It's unproven.
It can cause brain swelling or brain bleeding.
Even some former employees at Biogen involved in earlier phases did not agree with the F.D.A.'s approval of the drug.
Pro
I wonder if bribes were involved. This is shady as fuck...