Tuesday, September 13, 2011

Interim Analysis Of IMPROVE-IT Delayed -- Yet Again. Yawn.

Regular readers will recall that for at least the last two and a half years (and most recently here), I have been suggesting that Merck has been too optimistic about when it would report any real definitive results from IMPROVE-IT -- see counter at left, as well. I've long held that we won't know the results until mid-2014.

Increasingly, Merck now agrees with my time line. Yawn.

You may also recall that at one point in early May of 2008, Ex-CEO Fred Hassan (he, of legacy Schering-Plough) had suggested that the results of IMPROVE-IT would be out by late 2011; in other words, almost three years eariler than his own staff had predicted, given the size of the trial. More hucksterism, by the captain of a sinking ship.

Laughable, if it didn't affect the lives of millions of people struggling with high cholesterol. More precisely, it will have been some eight years after FDA approval of Vytorin (and 12 years after approval of Zetia) -- and after over $14 billion in cumulative sales, before we know whether this combo pill is simply an extremely expensive placebo.

Here is a bit of the Reuters report, from today's Morgan Stanley conference, at which New Merck CFO Peter Kellogg spoke:

. . . .Whitehouse Station, New Jersey-based Merck said the executive committee overseeing a trial known as IMPROVE-IT has scheduled the study's second interim analysis for the first quarter of 2012, rather than late 2011, as previously anticipated.

Peter Kellogg, Merck's CFO, said at the Morgan Stanley global healthcare conference that the delay is purely one of scheduling and will not affect overall timing of the trial, expected to be complete in 2013.

"That [a delay in being able to publish results] has not been part of the discussion so far," he said. . . .

Finally, recall that this trial will resolve whether there is any benefit to taking the very-pricey branded combo pill. And so, of course, a jaundiced eye might suggest that "later is better," if one suspects it will not be a clear win for Merck. ENHANCE redux, anyone?


Anonymous said...

Seems like you're yawning an awful lot lately. Perhaps you need more rest.

Condor said...

Just wish that Merck would surprise me -- with some GOOD news.

All of these recent disappointments were long foretold, right here. . . I guess I just grow weary of being right all the time(!). . .

That's all.