If it's been shown to reduce plaque but not been shown to improve outcomes, is that positive evidence that it won't improve outcomes? Or is it more that noticing plaque reduction is fast while noticing outcome improvements would take a while? In other words, is this a case of "it's shown not to be efficacious, so wtf approval?" or is this more a case of "jury's out, so release it in the meantime"?
So the bar is really much higher than "did remove plaque" and the prior should be this wasn't going to improve clinical response. The fact that it didn't and was still approved is a complete abdication of what the FDA preaches. It's rare to see a uniform response from those that report on drug dev. but it has been unequivocal - the FDA needs to get its shit together.
I, personally, have little hope for that.
Also we are not really very interested in the effect on plaques, we are interested in things like cognitive behavior which are a lot easier to measure.
This statement is true, but the trial will have gone on long enough to note whether or not both plaque reduction and outcome improvements happen, because plaque reduction isn't considered sufficient evidence for outcome improvement, despite some attempts to force the FDA otherwise. (Although I guess the FDA has kind of caved in at this point, given that it's conditionally approving this on the basis of plaque reduction despite seeing no outcome improvement.)