Matt Herper is usually pretty solid -- well grounded -- in his perspective pieces on pharma science news. This one, however, clearly stands out.
For my money, Mr. Herper gets it "perfectly on pitch", here. After all, it is not just that it would be manifestly unfair to saddle a month on the job CEO with the setback of a drug candidate (which was, of course, wildly hyped by his former boss's merger-partner's CEO). Wait, did 'ya get all that? -- I mean "Fast" Fred Hassan (and Carrie S. Cox), here.
More than that, it is also true that at Merck (with its much tighter research procedural ship, than legacy Hassan's) -- it would be shocking if data from any clincial trial was "leaking out, early" to Merck's executive team, nefariously.
At legacy Schering-Plough, on the other hand (and at legacy-Pharmacia, with the same two top executives), there are still about seven pending federal lawsuits averring evidence of just that: illicit "smoke signals" about disappointing interim data (think ENHANCE here).
And so, under the most-modern clinical trial agreements (like those signed by Whitehouse Station's CSO), blinding/no-leak procedures are air-tight -- save for safety signals -- which are reported to an independent, non-company-affiliated panel. That's exactly what happened with Vorapaxar -- the DSMB shot off a flare, on safety-concerns. There were -- I am willing to (speculatively) wager -- less that 24 elapsed hours between the DSMB's call, and Merck's downbeat webcast, on the following morning.
So -- don't blame Ken Frazier for this -- unless and until someone comes forward with proof that Fred Hassan told both Dick Clark and Ken Frazier that the illicit Schering-Plough "African drumbeat" networks (long known to exist, but never conclusively proven to reach K-1) were already reporting excessive brain-bleeds in the TRA trials, prior to, or by November 3, 2009. [That was Schering-Plough's last day as an NYSE traded company; note that only a few days later, one of the main TRA clincial trials completed enrollment -- on November 13, 2009.]
In any event, do go read Matt's piece -- it is perfect -- and great read for a snowy weekend morning (with your coffee, of course): 
. . . .I think this is a natural response to the vorapaxar setback, which robs Merck of what could have been one of its biggest stock catalysts. But this isn’t Frazier’s fault. He has not hyped vorapaxar, and he better have been caught off guard by the bad news, because otherwise there would be a serious problem with the vorapaxar clinical trials. . . .
Precisely. And well-put, Matt.
No comments:
Post a Comment