As I Have Been Saying Since Early 2009: IMPROVE-IT Publishes In Late 2014


While I was off the grid, Merck filed its second quarter 2012 SEC Form 10-Q. Coming as no surprise to me — but as a concession from the captive science and marketing staff — is the admission in the SEC filing that the study called IMPROVE-IT (see countdown clock at left!) won’t be complete in 2012. Or 2013. [Both as earlier erroneously predicted by management.]

No, it is now likely that — even if the adjudicated data is rushed to publication — full IMPROVE-IT results, vetted and peer-reviewed, won’t be available until vary late in 2014. Or maybe even first quarter 2015. Ugh.

I hate being right about things like this:

. . . .In March 2012, the Data Safety Monitoring Board (the “DSMB”) of the IMPROVE-IT trial, a large cardiovascular outcomes study evaluating ezetimibe/simvastatin against simvastatin alone in patients presenting with acute coronary syndrome, completed the second pre-specified interim efficacy analysis of the study. The DSMB conducted the planned interim efficacy analysis after the trial had reached approximately 75% of the targeted 5,250 clinical endpoints called for in the study design. The DSMB recommended that the study continue without change in design and stated it planned to review the data again in approximately nine months. That review has been scheduled for March 2013, at which point nine months of additional data will have been adjudicated. Merck remains blinded to IMPROVE-IT safety and efficacy data. IMPROVE-IT is an 18,000 patient event-driven trial and, based on the current rate at which events are being reported, the Company now anticipates the targeted 5,250 clinical endpoints for study completion will be reached in 2014. . . .

What is immensely frustrating about all of this is that the captive marketing staff at legacy Schering-Plough (under Fred Hassan’s morally-vacant leadership), and then New Merck after it (under Mr. Clark, at least), continued to hold out hope for 2012 publication, as late as mid-2010. The Kool-Aid drinkers then shifted to early 2013 in late 2010, holding that view until late in 2011. As was increasingly plain to any disinterested set of eyes, since mid-2011, the rate of occurrence of events (it is an event-driven study, afterall) has long-pointed to a later finish. But sometimes no one wants to see what they don’t want to see.

New Merck under Mr. Frazier is — of late — far better about this “realistic case” truth-telling than old Schering-Plough, but there is still a fair amount of Kool-Aid drinking going on at Whitehouse Station.

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