Friday, November 14, 2014

Forbes' Matt Herper Offers His Very Cogent Take -- On Monday's IMPROVE-IT Outcome Scenarios

Well, we are just a little more than three days away from learning what that decade long study will teach us about the "lower is always better" hypothesis -- on LDL cholesterol levels -- vis a vis actual clinical outcomes. And every smart journalist I know in the field has a piece up, about what to expect. Even so, Matt's is among the best. [Ed Silverman deserves a highly honorable mention here too.]

Below is a bit of Matt's nuanced piece, along with the portion I too think captures the most probable event, come Monday -- do go read it all, but here is a bit:

. . . .In other words, the Vytorin story has made the FDA nervous not about heart drugs, but all drugs. And, for that reason, the IMPROVE-IT result could help shape the industry.

There are basically only three things that can happen on Monday. . . .

2. We Get Mud. This is what I and a lot of cardiologists I’ve spoken to over the past seven years about this trial expect. The idea is that the study would fail on its main goal because Zetia’s effect is weak and other factors make it hard to pick up, including patients dropping out of the study or switching to higher potency drugs like Crestor or Lipitor. But an analysis that only looks at patients who stayed in the study might show a benefit – or at least a trend to one. This will leave experts arguing over what the results mean, and will leave Vytorin and Zetia in their current state of limbo – do they work or not? – forever. . . .
We will offer our post-mortem thoughts, after the press releases, on Monday. I'm off to an early Friday start, now -- my best, to all of you!

No comments: