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his was an aside, at the end of my last, but it deserves its own post.
While speaking "Unscripted" with Jami Rubin, today at Goldman Sachs -- Merck CEO Dick Clark mentioned IMPROVE-IT. The specific statement he made, I don't think has been acknowledged before, officially by Merck: he said IF IMPROVE-IT reaches a half-way point during 2010, there will be a blinded look at the data. "IF" -- not "when" -- in 2010.
Fascinating.
I think it is at about 34:30 of this link. So -- it increasingly seems that (as Harlan Krumholz [Edit courtesy of Marilyn Mann, in comments!], Dr. Steve Nissen and others have astutely conjectured) the IMPROVE-IT study may never reach an endpoint of substance. Ouch. Much more background, on that notion, here:
[An Anonymous commenter wrote:] . . . .Mark these words: IMPROVE-IT will be at the very best a neutral study -- it will show no definitive difference at all between Vytorin and generic simvastatin. Given the number of events recorded to date (~2,300) in 15,000 patients enrolled and with enrollment having started in October of 2005, the PIs retained by Merck actually should have enough statistical power to detect a clinically meaningful difference in events. . . .[And, my reaction, at the time:] I think that has it just about perfectly right. For its part, New Merck is supposed to release a newly revised/projected end-date for IMPROVE-IT in the coming weeks, according to on-the-record remarks made by the study PIs, at AHA in Orlando, this week. Will the new date be in 2013? 2014? Or later? We'll see -- but my money is on the above analysis, regardless of what Merck "forecasts" (or guess-timates, more pointedly) here, as 2009 draws to a close. . . .
Indeed -- now, even CEO Clark is admitting as much.
4 comments:
I think Clark's comment just refers to the regular review of the data by the DSMB.
I agree with the commenter that a lack of benefit from ezetimibe in IMPROVE-IT would not be surprising, given the results of ENHANCE, SEAS, and ARBITER-6 HALTS. That *would* be a meaningful result, however.
Can you provide a link to the comment by Dr. Krumholz you are referring to?
In the editorials that accompanied the ARBITER 6 -- HALTS trial early termination, several leading authorities (including Dr. Krumholz, if I recall correctly) indicated that -- as an events-driven trial (and one with such a large "n": about 18,000 patients) -- it may well be that the study will never reach a sufficient number of events to make a "powered" outcome determination possible.
Will go look for it, but try the editorials in the Journal of Internal Medicine -- at about Thanksgiving 2009.
Namaste
Sorry Marilyn -- I was going too fast.
First, I just looked, and I cannot find such a comment attributed to Dr. Krumholz in the published reports. I did see one from Dr. Nissen -- so I duly revised my copy.
Thanks for the keen eyeballs -- your observations are always so valuable! -- Happy New Year, and New Decade!
Namaste
I do think CEO Clark is going to have to update the projected end-date for IMPROVE-IT on the 2009 Year-End earnings conference call (is that even scheduled yet?).
And I do think his comments at Goldman Sachs yesterday are intended to soften the blow -- when he admits that the study won't complete until after 2014 -- if at all.
Namaste
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