The Amgen study, while successful, was not all that compelling. Yes, the relative risk for the composite cardiovascular endpoints used in the study went down, but not by as much as observers were hoping for (15% reduction versus 20 or 25%). And when you get down to overall mortality, there was no change at all, which has to be a disappointment. Amgen has been arguing that this was a relatively short study, and that the first measurements were also taken at a relatively early point in the treatment, and that the overall trend is for better numbers as the treatment goes on (which may well continue). But while these points may be valid, it’s a little rich for Amgen to be making them, because they designed this trial themselves, presumably to generate the most compelling results in the shortest amount of time. The fact that they’re having to make such arguments at all is a sign that the trial definitely did not come out the way that they’d hoped – you can be sure that the plan was not to have to say “Well, gosh, it’s really not bad if you look closely”.