Wednesday, March 28, 2012

Merck: No Early Positive Outcome -- In Massive Vytorin® IMPROVE-IT Study

Not remotely shocking, but Merck's independent panel of safety monitors won't even look at the massive (18,000 patient) definitive Vytorin® study again for about nine months. This also demonstrates that there was no overwhelmingly positive signal, either -- such that Merck could have decided to declare victory, and stop IMPROVE-IT early.

No, IMPROVE-IT will now run to the end-date -- and we will all have to wait and wonder about whether the drug combo is improving any real world cardiovascular outcomes, until perhaps 2014. From Reuters:

. . . .Wall Street has been eagerly anticipating the interim report for the 18,000-patient Improve-It study to see whether Vytorin is helping improve heart outcomes, and thereby increase sales for the franchise.

However, Merck did not release any data on Wednesday, saying it has not seen the results of the interim analysis. It said only that the safety monitors overseeing the trial recommended it continue without change and that they plan to review the data again in about nine months. . . .

And so -- it may be mid-2014 before the final results are published -- as I've always suggested. That's about eight years of multi-billion dollar revenues for a drug combo that may well provide no outcomes benefit. As the Supremes ponder a revamp of the current system, it sure looks like the current [non-]system is broken, and wildly inefficient, here.

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