Mike Huckman Now Joins The Arbiter 6 Fray

Apparently the “New Merck” press relations folks are doing Whitehouse Station no favors, here — in perhaps overly-zealous efforts to get stories on Arbiter 6 -HALTS spiked — they are just pouring gasoline on the media’s bonfires. There is much more in Mr. Huckman’s salty and entertaining piece, so do go read it all — but here’s at least a taste:

. . . .However, earlier this week a Merck PR guy asked me, “Why are you making this such a big deal? It’s a 200-patient study.” When I tweeted it, one of my journalism pals on Twitter replied that they’d (I’m shielding their identity and gender) been told even worse on several occasions by various corp comm pitbulls: “Don’t embarrass yourself,” they reportedly said in a desperate last-ditch attempt to get a story spiked. I think if anyone ever said that to me I’d blow a gasket. . . .

Mike Huckman is also now reporting that the full article on the trial’s end will appear in The New England Journal of Medicine, at 8 AM EST, Monday, November 16, 2009. We already know, via other published media reports, that it will be accompanied by at least one or two influential editorials — inside the peer-reviewed journal (still officially nameless) printing it.

Jacob Goldstein — Of The WSJ Health Blog — On Arbiter 6

This morning, the Wall Street Journal’s Health Blog is (mostly) downplaying the importance of a bad Arbiter 6 – HALTS outcome, thus:

. . . .Here’s the thing, though: It was a small study (about 200 patients) that didn’t measure the kind of real clinical outcomes — heart attacks, strokes, that sort of thing — that really matter for patients taking cholesterol drugs. Instead, the main goal was to measure thickening of the arteries, an outcome that is sometimes used as a proxy for heart-disease progression but isn’t definitive. . . .

So why is everybody so worked up?. . .

Now, not that I have any indication this is true, but what if – for example — Dr. Taylor’s Arbiter 6 – HALTS study was terminated early, not because of poor CIMT data for Zetia, but because of some safety event? What if, for example, the Zetia patients were experiencing a statistically-significant increase in some adverse event? More heart attacks, fibrillations or other cardiac events? That would be a very big, and bad, deal — Mr. Goldstein, even in a waifish-200 patient study.

That — I think — is why so many are traveling to Orlando Sunday night. They simply want to know. I respect Dr. Taylor immensely for handling this in the “old-fashioned” way — at a major conference, where many doctors, and their correspondingly-manifold viewpoints may be heard, and weighed — contemporaneously. That is, not pre-emptively press releasing, with only one definitive perspective (company-spin) on the results — in short, before others have had a chance to sift through them. No, everyone will get a bite at this apple, in real time. But Dr. Taylor’s approach has fueled Wall Street speculation, along the lines set forth above — because literally billions of dollars of drug sales hang in the balance.

New Merck Completes Phase III Study Enrollment — For Old Schering’s TRA Candidate

See the Yahoo! wire story, here. Note that, in the alpha-prefix-descriptor for the drug candidate, below — the “SCH” stands for legacy Schering-Plough. Candidates bearing the “MK” descriptors are legacy Merck. Just FYI [A slide from Old Schering's R&D Day 2008, at right -- click to enlarge]:

. . . .Merck announced today the completion of patient enrollment in the TRA 2˚P-TIMI 50 clinical trial, a Phase III, randomized, double-blind, placebo-controlled, multinational study of SCH 530348, the company’s investigational antiplatelet protease activated receptor-1 (PAR-1) inhibitor. The study, conducted by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, reached its target of more than 26,000 patients. . . .

Now we wait — perhaps as long as two years — for results.