I have discussed Vytorin several times before. The combination of Zetia (ezetimibe), the cholesterol absorption inhibitor discovered at Schering-Plough, with Merck's (NYSE:MRK) simvastatin looked as if it should be a very effective cholesterol-lowering medication, but the real-world data have been consistently puzzling. There's a big trial going on that people are hoping will clarify things, but so far it has had the opposite effect. It's no exaggeration to say that the entire absorption inhibitor/statin combination idea is in doubt, and we may well learn a lot about human lipidology as we figure out what's happened. It will have been an expensive lesson.
So, in the midst of all this, what does Merck do but trot out another ezetimibe/statin combination? Liptruzet has atorvastatin (generic Lipitor) in it instead of simavastatin (generic Zocor), and what that is supposed to accomplish is a mystery to me. It's a mystery to Josh Bloom over at the American Council for Science and Health, too, and he's out with an op-ed saying that Merck should be ashamed of itself.
I can't see how he's wrong. What I'm seeing is an attempt by Merck to position itself should the ongoing Vytorin trial actually exonerate the combination idea. Vytorin, you see, doesn't have all that much patent lifetime left; its problems since 2008 have eaten the most profitable years right out of its cycle. So if Vytorin actually does work out, after all the exciting plot twists, Merck will be there to tell people that they shouldn't take it. No, they should take exciting new Liptruzet instead. It's newer.
If anyone can think of a reason why this doesn't make Merck look like a shady marketeer, I'd like to hear it. And (as Bloom points out) it doesn't make the FDA look all that great either, since I'm sure that Liptruzet will count toward the end-of-the-year press release about all the innovative new drugs the agency has approved. Not this time.