As of about four hours ago, now, we crossed the 600 day threshhold — 599, and counting down. By the time the definitive study is published, it will be likely that over $23 billion will have been spent by patients, insurers and the governments of the world — all without knowing whether the combo-drug is anything other than a very expensive placebo, in the effort to manage the elevated cardio-vascular event risks, occasioned by high cholesterol readings.
If there is a poster-child for what was wrong with the prior paradigm of secretive — and “marketing” driven — study protocols, ENHANCE, and the drug called Vytorin — might well be it. The IMPROVE-IT study came along lately, primarily to actually try to answer the questions ENHANCE left woefully unanswered. So here we sit — almost two years away from an answer, and the drug has been sold — into the billions of dollars per year in the US — since 2006. Of course, there are older, cheaper drugs that have proven CV-event risk reduction effects. That is primarily why this all matters, so terribly much. Patients could be on them, instead.
From the last time I mentioned IMPROVE-IT, in any event, then:
. . . .I will take a moment to point out that ever since mid-2008, I alone have been reporting that there was no way legacy Schering-Plough could get definitive outcome results as early as Ex-CEO “Fast” Fred Hassan was telling Wall Street. And that was before the trial had to be “super-sized” (increasing the patient count to over 18,000), in order to see a statistically-significant outcome. [Here is the clinicaltrials.gov webpage for the IMPROVE-IT study, with a listing of the background history — including changes to the trial design, at least as to the n studied.]
So, back when everyone inside Schering-Plough, and most in the MSM, were predicting a 2011 read-out of IMPROVE-IT, I prepared the graphic at right, and started my 2014 countdown clock, at left. . . .
Do stay tuned — 599 and change, left to go.