And Now, Brian Orelli, at “The Motley Fool” Counters Herper’s. . . .

Brian Orelli thinks the Arbiter 6-HALTS early termination news is overblown:

. . . .I’m no fan of Merck (NYSE: MRK), but the sell-off of its shares yesterday seems a little overblown considering the lack of information. . . .

See anything in there that suggests that Niaspan prevailed over Zetia? Me neither, but, judging by Merck’s share decrease, it looks like that’s what investors and some analysts are worried about. . . .

Ahem:

I think what we see here is not so much that it might not be a “loss” for Zetia, as it is highly-unlikely to be a “clear win” for Zetia.

Given the above chart (click it to enlarge), Zetia, and its sister-drug, Vytorin, really needed some sort of a “home run” — just to have any shot of “staunching the bleeding” in U.S. market share, and sales, in the coming quarters. I think Forbes‘ Matt Herper is right — there is very little chance that Zetia posted a clear win, here. Thus, investors should be expecting more of the same (despite CEO Hassan’s contrary assurances), from Merck and Schering-Plough on July 21, 2009. Did I mention that I’ll live blog it? I will.

Matt Herper, at Forbes, Makes the Case. . . .

. . . .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.

Dr. Allen Taylor Offers Some Insights — On Arbiter 6-HALTS Early Termination

After the debacle of arguably delayed-disclosure that was ENHANCE, and the debacle or prematurely trumpeted disclosure that was SEAS — Dr. Allen Taylor has chosen to keep his study disclosures on a more sensible, and scientifically-sound, course. His approach to handling study results (including early terminations), looks positively “old-school” — in the best of ways. Here is what he told CardioBrief (do go read it all), just yesterday:

. . . .Taylor provided some clarification [regarding the Peter Loftus] DowJones story which stated that Taylor “said more information might be provided at a later date,” Taylor told CardioBrief: “Data will be publicly disseminated in a scientific forum at the earliest possible time.”

Asked about Abbott’s role in the trial, Taylor wrote: “Abbott played/plays no role other than funding support through an independent third party foundation.”

Finally, Taylor emphasized that the steering committee is strongly in favor of limiting speculation about the trial: “We made a committee decision to solely utilize the NIH website for our public disclosure — the intent is to limit speculation/manage expectations in favor of future, more substantive communications. . . .”

[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. . . .”

So — as a responsible scientist, Dr. Taylor has elected to prevent any of these companies from making “a highly-orchestrated media event” of Arbiter-6 HALTS. [Although, to be fair, I guess the journalists have done-so, anyway -- in some respects.]

Now we will all have to wait, and see, what the peer-reviewed journal articles have to say about why Arbiter 6-HALTS was terminated, early. Well-done, Dr. Taylor — as sanity, in scientific disclosure — makes an (at least partial) comeback.