. . . .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.
3 comments:
"Quite well sourced" BS BS. Herper's article has zero credibility. All three docs quoted are Crestor paid docs funded by AZ who have an axe to grind with MERCK/SP due to lack of study funding or research grants. Money is that this study was terminated due to no differences in the mid point outcomes. Allen Taylor would be all over the presses if Niaspan proved to be superior or NI to Zetia...Bunch of BS from FORBES.
Well -- I hate to burst your bubble, but I doubt that you'll be able to establish much of that -- the "paid by" AZ/Crestor stuff.
Actually, Dr. James Stein (quoted by Herper, in the article), of the University of Wisconsin, Madison, has specifically sworn off such corporate payments. I blogged it under that link, earlier in the year. BTW, he was a Schering-Plough/Merck guy, before -- on the ENHANCE study. Do try to keep up, here.
I likewise doubt that Dr. Allen Taylor would ruin his stellar scientific reputation for integrity, by "pre-releasing", on such an obviously high profile matter, after his rather caustic, but appropriate comments about doing so -- quoted in the last bit of the blue text, above. . . .
As to the rest, we shall see. Do stop back.
Namaste
Sorry -- that was the blue text, below (from my previous post):
[From Dr. Taylor's writings on SEAS:]
". . . .The manner of release of the SEAS trial and the unblinding of two other ongoing trials raises important questions about the scientific process in an era of mass media communications. Premature release of data via a highly orchestrated media event does not serve the scientific community well. Premature unblinding of ongoing trials for commercial purposes is highly undesirable and compromises the integrity of these studies. Finally, approval of a first-in-class drug on the basis of biochemical surrogates is fraught with hazard. The ultimate price may be widespread utilization of agents that lack a favorable balance between safety and efficacy. . . ."
Namaste
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