IMPROVE-IT: Now due in 2013 -- or Even Later?

I've reordered the side-bar, at left, and re-set the end-date on the count-down clock for the IMPROVE-IT study results. Why? Because I traded some private e-mail over the weekend with an expert in these matters, and because I just noticed what Matt Herper has independently written, in a similar vein, this morning:

. . . . Zetia and Vytorin, sold by Merck and Schering-Plough, contain an active ingredient that lowers cholesterol but hasn't been shown to save lives in large studies. An 18,000-patient trial testing the chemical is expected to wrap up in 2013, just a few years before the drugs lose patent protection and go generic. At that point, the companies will probably have booked at least $30 billion in annual sales. . . .

So -- instead of mid-2012 -- the countdown clock will use an end of 2013 date -- for now.

In the next few months, at approximately the mid-point of IMPROVE-IT (as Merck CEO Dick Clark mentioned on the Merck Q1 2009 earnings conference call), Schering-Plough and Merck will take an "blinded" look at the data, to decide whether a second increase in sample size is warranted. The partners upped the original study size (from 12,000) to 18,000, last Spring. The companies' official line is that this increase will improve the probability of a clear outcome -- up or down.

If the companies elect to increase the size again this summer, it will signal another delay -- beyond 2013 -- for IMPROVE-IT results, and perhaps, just perhaps -- that IMPROVE-IT is suddering the same potential for a "non-result" that afflicted ENHANCE. There would be scant other reason to increase sample size twice in such an already massive study -- except that the raw data, even while still-blinded, was showing no clear trend -- in any direction.

So -- instead of waitng "only" another 1,146 days to see the IMPROVE-ed results -- we'll now wait at least 1,695 days -- from today -- to find out whether Vytorin is actually saving lives. Cumulative sales of over $30 billion -- and we won't know whether it reduces cadiovascular risks/outcomes. Astonishing.