2 ms·
I’m finding it really hard to understand how this met approval to ‘give patients an option’ when the government just recently passed laws to expand access for u
by epmaybe 5y ago
I’m finding it really hard to understand how this met approval to ‘give patients an option’ when the government just recently passed laws to expand access for unapproved drugs. We even have expanded access programs that have been possible for years, with rapid turnaround when requested.
Maybe it’s easy to understand and it’s about money? Or is this a policy shift in the FDA to just approve ‘safe’ medications and not necessarily hold marketing approval for futility.
- epmaybe 5y agoFor those eventually reading the above comment at some point - I honestly forgot that the accelerated approval process exists, and that’s how this got approved. That basically means they get to say their drug was shown to affect surrogate markers (in this case, brain amyloid levels) and thus could be effective at treating symptoms, even though the trial was ended for futility. Feels like gaming the system in a way, and you can still market this very effectively without saying it can treat Alzheimer’s..”our drug was shown to reduce X, a key marker in Y”. I hate direct to consumer drug marketing.