. . . .The case for why Merck and Schering-Plough investors ought to be worried -- about the early termination of Arbiter 6-HALTS. Do go read it all, as it is chock-full of valuable perspective, and background, on the Merck-Schering-Plough Cholesterol Franchise Joint Venture -- but here are the snippets I found most-resonant:
. . . .This is not a repeat of last year: HALTS was only going to enroll 400 patients, half as many as ENHANCE, but it was stopped after only 180 patients had finished the study. . . .
This early look was highly unusual for an imaging study, but it had been spelled out in a paper in which Taylor set out their plan for conducting HALTS. . . .
In order for the study to be stopped at the 180-patient mark, the result had to be so convincing that looking at another 220 people's carotid arteries wouldn't change a thing. Either there would have to be no difference at all or "the effect would have to be large," says James Stein, an artery imaging expert at the University of Wisconsin-Madison. In other words, HALTS has gone from a study where a muted result seemed likely to one where a clear and definitive outcome seems assured.
Before, one might have expected that Niaspan, which raises good cholesterol (HDL) and cuts bad cholesterol (LDL), would do only somewhat better than Zetia, which just cuts the bad LDL. But now we know that's not going to happen. . . .
Do go read it, end to end -- it is well-thought out -- and quite well-sourced.
