Not even a day after I suggested, in the comment-threads, below, that CEO Clark would have to update his IMPROVE-IT projections pretty soon, he obliged, and just did so.
New Merck has apparently adopted the legacy Schering-Plough practice of putting material updating disclosures in "Investor FAQs" documents, but not (always) including them in official Merck press-releases. I think this is a silly -- and risky -- practice to undertake. But I'll save more detailed remarks on that topic for another day.
I think the reality is that the study will not be complete until 2014 or later. I also noticed (courtesy of a friend of the blog), that Leerink Swann has put out a note indicating that CEO Clark has apparently said IMPROVE-IT will not be halted for "futility".
In plainer English, what that means is that even if there is no statistically-significant difference between the two arms in the study (at either the 50% event marker, or the later 75% event marker), Merck will let it continue. In short, Merck will spend money on a futile study. In fact, I think it likely that the study is already showing futility. Allowing it to continue to completion -- in 2014 or beyond -- delays the inevitable (or so Whitehouse Station seems to believe), right?
Recall that we saw a less-polished version of this same approach -- in ENHANCE. I think a null result in IMPROVE-IT is a better than 50-50 probability, given the outcomes of ENHANCE, SEAS and ARBITER 6-HALTS.
Mark my words: I predict Whitehouse Station will move IMPROVE-IT's official projected completion date back once again, in early 2011, when the study fails to reach the 50% marker by the end of 2010 -- and that projected date will be mid-2014, or later. In any event, here is the new projection:
. . . .Merck submitted an update to clinicaltrials.gov to include a date of June 2013 as the new forecasted date for the completion of the IMPROVE-IT study. The revision is based on updated estimates reviewed by the IMPROVE-IT Executive Committee and Merck. The estimate for this event-driven trial reflects the most recent information on the pace of enrollment and the accumulation of clinical endpoints to date, and takes into account the minimum two and one-half years of follow-up called for in the study design. . . .
What is clear -- even now -- is that it may be almost a year, after study completion, before the final results are published -- so 2014 may come and go without published results.
7 comments:
Why stop a trial for futility when the absence of data provides no deterrent to a fraudulent multi-billion dollar franchise built on a wing and a prayer? Hopefully the scientists running the study have better sense to stop the futile madness than the phoney rent-a-docs running medical affairs for Schmerck.
I would love to see the clinical trial agreement governing this study.
It was signed back in 2005 -- when the study began -- so it likely gives the Principal Investigator the right to stop the trial only for safety concerns, or failure to enroll enough patients in a timely fashion (an event that has already passed) -- not futility.
Any other stoppage probably requires the consent of the sponsor -- Merck.
Probably, the right to continue an otherwise generally safe, but futile, study lies well within the discretion of the funding sponsor -- New Merck (back in 2005, the Merck-Schering-Plough Cholesterol Joint Venture).
I see a pattern here, don't you?
Namaste
No matter how 'safe' something is continuing a futile study is still unethical.
There is always some degree of risk, i.e. there are side effects or inability to switch therapies if something better is available.
If there is no possibility of benefit the risk benefit ratio is unacceptable and the study is unethical.
Even more so when announcing the results might alter prescribing patterns and diminish sales.
Would you like to be the person who develops rhadomyolysis and kidney failure during the study after it was known you couldn't get any benefit.
Salmon
Don't look for academic honesty out of Merck any time soon....
I quite agree, Salmon. . . it could well be argued that letting the patients stay on a futile med is the same as doing harm -- where statins, and niacin, have shown outcomes benefits, in study after study after study.
In some measure, the PI is allowing the patients' disease to progress unabated, when an already proven alternative is available, and inexpensively so.
Namaste
At what point should the drug die a death from a thousand nicks? The nicks are accumulating.
I'm afraid academic honesty has become an oxymoron, just like business ethics or ethical pharmaceuticals.
Salmon
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