400 Patient Niaspan-Zetia Trial Halted -- Last Month, Per NIH Website

Or, is this a "CIMT artifact/effect" in play, Yet Again?

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UPDATED @ 8:22 PM EDT

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[Note: A deeply-belated Hat Tip, to Marilyn Mann, for alerting me (via back-channel) to all of this. . . Thanks!]

Two anonymous comments have led to this update:

As to the first commenter -- I just looked, and could not find ARBITER 6 - HALTS (the relevant study), by name, or concept, either on Abbott's CafePharma board, or on the ones there for Schering-Plough and Merck.

Was the ARBITER 6 - HALTS outcome mentioned a long, long while ago?

I am sorry I missed it. Do stop back. [I've found it, now, thanks to a commenter.]

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As to the second set of anonymous comments -- True enough, some of my post was, in my haste to get this out, ambiguous. [I have done a little supplementing, below -- to add the ClinicalTrials.gov identifier link.] However, some of the second comment is (also) fundamentally mis-informed.

Abbott only indirectly paid for part of the study, according to Dr. Taylor. This may well-mean that some of it was funded by NIH or other governmental units -- especially likely, since it was initiated when Dr. Taylor was Chief of Cardiology at Walter Reed -- yep, that's the US Army's hospital.

And, as per the previously-filed FDA Form 1572 on ARBITER 6 - HALTS, Dr. Talyor is primarily responsible, as PI, or "Principal Investigator" for this particular study.

Neither Abbott, nor Schering-Plough/Merck had any control over ARBITER 6 - HALTS (side note: that last acronym is particularly ironic, tonight, no?). Dr. Taylor had that control, along with his independent advisory committee. Dr. Taylor has declined to name the members of the study advisory committee (presumably, the doctors who voted, with him, to terminate the study early).

As to why it might come up -- on the Schering-Plough, or Merck earnings conference calls -- the early termination may well be related to either (a) CIMT measuring problems (alleged by MSP to be one of the difficulties that led to the ENHANCE "no result" study endpoint), or (b) "functional unblinding" -- the notion that Dr. Taylor could tell, simply from the blinded data, that no statistically-significant difference would emerge, as a matter of pure mathematical certainty, from the entire study population (much more on this, under my link, in the main post, about "functional unblinding"). As you can see, it is alleged that ENHANCE results were knowable -- and, according to various would-be federal class action plaintiffs, known -- for more than a year, before Schering-Plough's official, formal disclosure, due to this very same effect.

Perhaps Dr. Taylor's data will either support, or discount, either (or both) of these competing notions. In any event, data on Zetia will be of much interest, as I for one am predicting a continued swoon in that franchise's sales for the second quarter of 2009 -- and perhaps below $400 million, for the Schering-Plough half of that overall franchise, for the quarter.

We'll see. What is clear is that Abbott did not control this study outcome. So it is likewise clear that Abbott likely does not know the details. Yet. Or, so Peter Loftus, at The Wall Street Journal, now reports.

Thanks for your thoughts -- do stop back.

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CNN/Money is now carrying a Dow-Jones story about the smallish study -- run by Dr. Allen Taylor -- a very-well respected expert in the field (three videos, of Dr. Taylor discussing earlier Zetia trials appear toward the bottom of this earlier post). The study was to look at a possible combination therapy -- adding Schering-Plough/Merck's Zetia, to Abbott's Niaspan. The study was halted, but not for safety concerns. Very mysterious. Or, not so much.

This is a guess, but translated, that likely means the combo wasn't looking likely to show any benefit. Think "functional unblinding", once again. Even so, it is arguably good news, as neither company will likely go forward with a perhaps $500 million-plus effort to create a market for the combo. Old Ben's adage would seem apt, here -- "A penny saved, is a penny earned" -- and, in this market, that is particularly true, with Zetia's continuing swoon, in the US. Per the CNN/Money story:

. . . .An independent steering committee stopped the trial based on results of a " pre-specified, blinded interim analysis," but not due to safety concerns, according to a notice posted on a U.S. National Institutes of Health online registry of clinical trials in mid-June.

It wasn't immediately clear whether the early termination was a negative sign for one or both of the drugs. . . .

The trial of 400 people at risk for heart attacks began in November 2006 and was expected to be completed later this year. In the trial, patients already taking so-called statin cholesterol drugs were given either Niaspan or Zetia. Niaspan is commonly used to raise good cholesterol levels, while Zetia is used primarily to lower bad cholesterol, though each has additional uses. Each drug works by a different mechanism, and can be used in combination with a statin.

Researchers tracked the drugs' effects on artery thickening after 14 months, using an ultrasound technique known as carotid intima-media thickness, or CIMT. The primary goal was to assess whether one drug provided a greater benefit. . . .

Fascinating -- I'd expect questions on this, from analysts, on the Q2 earnings conference call on July 21, 2009. For those keeping score at home, here is the CinicalTrials.gov page on this study. It was first listed as "terminated" on June 16, 2009. I am sure we will learn more about it, in the coming days and weeks.