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.
8 comments:
But, I thought the original statement for halting the study excluded 'toxicity issues?'
http://cardiobrief.org/2009/07/08/arbiter-6-halts-trial-comparing-ezetimibe-and-niacin-terminated-early-by-steering-committee/
ARBITER 6-HALTS, a trial comparing ezetimibe to extended-release niacin in 400 patients already taking statins, has been terminated early by an independent steering committee. According to a statement entered on June 16, 2009 on the trial’s page on the clinicaltrials.gov website, the early halt of the trial was “based on results of a prespecified, blinded interim analysis. It was not stopped due to safety concerns.”
I stand corrected...not; toxicity but 'safety.'
Fair enough. We'll know on Monday, won't we?
You are right -- this is not likely to be a safety signal. (I suppose, except insofar as if it turns out that people at risk of heart attacks have been taking Zetia -- to no clinical benefit.)
Stay tuned for Monday.
Namaste
With the independent monitoring board cutting the study off, without a safety issue, it really leans towards a strong benefit in one arm of the study.
I can't see how it will be good news for Zetia.
Agreed. But it sure is a fun parlor game -- this speculating -- no?
Namaste
except for the impact that it may have on the remaining staff at the new Merck. I wonder how much sales drift and loss of income is calculated into the upcoming layoffs.
Well, I think the two CEOs already knew -- certainly, on the Q3 2009 Earnings calls, particularly. Bob Bertolini, the then Schering CFO made it clear that the companies weren't getting the "top-line" recovery in sales they had been hoping for -- and that additional reductions would have to come at the expense lines for the then-joint venture (now solely a Merck production).
I suppose the only thing CEO Clark hasn't really already planned for -- on Vytorin/Zetia -- is a "cliff" falloff. . .
Even so, it would not be inconceivable that FDA could ultimately pull Zetia/Vytorin off the market -- if something truly heinous had appeared in the truncated Arbiter 6 trial data.
But that occurence is an outlier.
Monday will be interesting, for all.
Namaste, and do stop back!
Okay -- while not technically a safety signal, per se, the 5% cardiac events on Zetia, as compared to 1% cardiac events on Niaspan -- out of Arbiter 6 NEJM data, tonight, seems to look a lot like the very worst scenario I mentioned on Friday.
Confidential to Mr. Goldstein -- this is a kinda' big deal, now.
Especially so, since Bots and Kastelein are saying IMPROVE-IT may never be completed. That was to be Vytorin/Zetia's last best hope for an outcomes-based redemption.
Namaste
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