I now firmly suspect this will be a fruitful line of questioning on both the Merck, and Schering-Plough second quarter earnings conference calls -- on the morning of July 21, 2009. In any event, I'll live-blog it all:
Per Peter Loftus, once again -- do go read it all, over at The Wall Street Journal:
. . . .But some analysts and investors interpreted the trial's early halt to mean that Niaspan clearly outperformed Zetia in the trial. Natixis Bleichroeder analyst Jon LeCroy downgraded Merck shares Thursday to hold from buy, saying a Zetia "loss" in the trial would be the "third blow" against the drug, following two trials released in 2008 that raised questions about its efficacy and safety.Shares of Merck, Whitehouse Station, N.J., dropped $1.14, or 4%, to $26.90. Schering-Plough, Kenilworth, N.J., fell 63 cents, or 2.5%, to $24.66. . . .
LeCroy reduced his estimates of Zetia sales in coming years, dropping it to $1.9 billion from $2.1 billion in 2010, for example. He also reduced his sales estimates for Vytorin, which is a single-pill combination of Zetia and the cholesterol drug simvastatin. . . .
Morgan Stanley analyst David Lewis said in a note that he wouldn't be surprised if [Abbott's] Niaspan was superior to Zetia in the study, but it was difficult to quantify how much this would help sales of Niaspan, given the limited information released so far. . . .
Deutsche Bank AG analyst Barbara Ryan believes it's "very unlikely" that Niaspan showed superiority. She said it was likely that "investigative futility" or enrollment problems, or both, were the reasons for the termination. She suggested that if Niaspan had shown superiority, that outcome would have been communicated by now. . . .
[Later,] she added she expects sales of Zetia and Vytorin "to continue to bleed market share, from currently already very low levels. . . ."
Several of these analysts' thoughts echo mine, below, overnight.
8 comments:
Not that I'm a fan, but, it looks Fred was a 'mad' genius getting Merck to buy S/P for $40B. What a salesman!
Quite so, Anonymous No. 1.
I do think so, too. But when one is selling securities -- as CEO Hassan was -- he had a duty to tell the whole truth, right? Not just the favorable part of it -- that ended up helping him out of an increasingly tight jam. The SEC rules required as much. Will he be held accountable? I dunno.
To be fair, though (I suppose to the astonishing level of "inattention to details", over at Whitehouse Station), Zetia's problems, such as they are -- were always equally well-known (or, at least "knowable") to Merck, Schering-Plough's J/V partner on the global cholesterol franchise. . . .
So -- why, again -- are these various buckets of slop worth something like $45 billion, given the increases in stock prices?
And again, I dunno.
Namaste
For once Barb Ryan actually may have gotten something right. If one will look further, one would see that the commitee reviewed "blinded" data. Niaspan MOA is to increase HDL while Zetia's MOA is to decrease LDL. Allen Taylor, who (BTW is a member of MEDSTAR Research-NO friend of SP.) was trying to see if increases in HDL could lower CIMT more than decreases in LDL (i.e. Zetia) The theory holds that if one could increase HDL to an even ratio to LDL then LDL would not deposit in the arterial walls. This trial is a blinded bust because the theory behind it stunk to begin with. Ultrasound techniques to observe statin treated patients for deltas in CIMT isn't viable. If you review the METEOR Trial for Crestor, it took 40mg of Crestor in Statin Naive patients just to get an 0.0014 of a MM decrease in CIMT. We are talking one thousandths of millimeters deltas here people on baseline CIMT measurements of 1.2 to 3.5 MM.
This was an Abbott trial with the deck somewhat stacked (low HDL patients with normal LDLs - clearly a target for Niacin-based products), so one on the surface would imagine that it would be a slam dunk. But given that it is an IMT trial and was relatively brief, you'd imagine that the results could very well be inconclusive. I'm of the belief that if it were successful, Abbott would've come forward already or would've finished the trial. I believe that it is inconclusive - the POV of the scientific community is very much against the legitimacy of IMT, so Abbott is cutting and running early on this one.
Thanks -- as to the penultimate Anonymous commenter, I think yours essentially agrees with the "functional unblinding" theory, but gets there via another route. That is, if we are looking at teeny differences in potentially pretty thick arterial walls, all being measured by relatively blunt means, we are likely to see the data is all so tightly grouped around a mid-point, that no statistically-significant result would appear in 180 patients (the point at which the trial was halted), or 400 (or perhaps even 1,000) patients.
Thus the trial was halted, in your view -- a theory that has intuitive appeal to me.
As to the final Anonymous comment, both Dr. Allen Taylor, and Abbott itself have publicly stated -- on the record -- that Abbott had nothing to do with stopping the study, and that Abbott does not yet know the reason for the termination.
I doubt Dr. Taylor would ruin his stellar scientific reputation for integrity, by prevaricating on such an obviously verifiable matter.
Abbott doesn't know (yet) what happened here -- even if the deck was stacked in Niaspan's favor, as you posit.
So, I'd be betting with Marilyn Mann, here: this study showed "no good news" for Zetia -- and potentially very bad news for it, if Niaspan outperformed it, in about the same proportions that it had previously outperformed other "placebos".
Okay -- perhaps that last bit was unfair -- but is it really implausible?
We shall see. Do stop back.
Namaste
Just a question: why did it take so long for the news media to catch up on this story? As mentioned it was over on CafePharma, essentially, the day it was posted on ClinTrials. At this point that was about 2 weeks ago.
Were they asked to hold off on reporting or investigating?
Inquiring minds would like to know!
I think it was a pure miss -- a mistake. It's an information firehose, at full throttle -- and we all are all trying to take a cool, civilized sip out of it. So much sails by, so fast. . . .
Look, some (many?) accuse me of being obessed about these matters, and yet, I missed it, for over two weeks. Only through a good friend -- after Loftus wrote -- did I get a heads-up/learn about it (belatedly). Why? Because I hadn't checked that email box, in a while.
So -- I think this is as much a story about the digital age -- of "information overload", as it is a story about the study termination, proper. Finding the signal in all that noise is tough -- even when we are focused on looking for it.
Does that make sense?
[In fact, now that I think about it, I may put something out along those lines, later tonight.]
Thanks! -- Do stop back in.
Namaste
Ack! "obessed" should be "obsessed". Crud.
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