Alzheimer's drug disappointment turns into breakthrough after data reanalysed

The BBC reports that approval for the use of a new Alzheimer's drug, aducanumab, is to be sought, after work on it was abandoned in March owing to disappointing trials:
"The announcement is somewhat surprising because the company had discontinued work on the drug in March 2019, after disappointing trial results.
But the company says a new analysis of a larger dataset of the same studies shows that higher doses of aducanumab can provide a significant benefit to patients with early Alzheimer's, slowing their clinical decline so they preserve more of their memory and every day living skills - things that the disease usually robs."
https://www.bbc.co.uk/news/health-50137041

I hope they are right, but I'm surprised that they are making these claims on the basis of what's apparently a post hoc analysis of the data six months after the initial analysis proved "disappointing." Isn't that the kind of thing people aren't meant to do in science these days?

It's different when you can make money from it I guess.

This seems likely to be a huge story, because it would be the first time a significant Alzheimer's drug had got as far as submission for regulatory approval.

Here's a blog post at sciencemag.org by Derek Lowe, discussing the evidence from the clinical trials in detail - including the fact that patients on aducanumab in one of the two trials actually did worse than those on the placebo according to the primary pre-specified criterion, even at the higher dose. (The company is claiming the trials had appeared unsuccessful because they had missed the beneficial effect of the higher dose.)
https://blogs.sciencemag.org/pipeline/ar...aducanumab

Lowe emphasises the tremendous public pressure the regulators will be under to approve an Alzheimer's therapy, and the likelihood that the manufacturer of the first drug to be approved will make huge profits from it - even if it turns out that it doesn't really help much.

It’s odd that they stopped the trial due to potential futility - I’m used to hearing about trials stopped because preliminary analysis showed harm. I guess that the trials may have been very expensive. But you would think that would be offset by how hugely profitable these antibody based therapies are when successful. For example, my daughter’s treatment is $280,000 a year, which is kinda insane.

I like how the articles made it sound like the reversal of the decision to seek regulatory approval was an act of kindness. Let’s get real - it’s about the money. Even if the FDA, in its current state, approves the drug for this use, insurance companies are the ones you have to convince since almost no private individuals will be able to pay for this. And they’re going to be just as skeptical as the rest of us about post-hoc sub-group analyses.

Linda