Two wrongs don't make a right. So while Schering's behavior appears to mimic that of Steve Nissen and Atherogenics when it came to fiddling with imaging data or at least sitting on it, this is no way to win, earn, retain, build the trust of doctors and consumers in your products.
It won't be enough for Schering and Merck to launch a $5 million PR campaign on the product. This sullies the reputation of all other companies and calls into question the integrity of the conduct of clinical trials in general. Just as the blockbuster era is over, so too is the closed door approach to clinical trials at an end. The need for collaboration, transparency, sharing of data -- particularly about what doesn't work and for who -- is paramount. Further, we need to move beyond the "bet-the-farm" mentality where the fate and fortune of a drug hinges on the outcome of one large trial. ENHANCE was a study of the impact of a specific drug for a selective population. It raised more questions than it answered, as much of scientific research does. There are better ways to get at such information, which is what the Critical Path is all about.
I don't think Schering did anything wrong...it is likely given the advances in imaging technology and shifts in opinion about the reliability of intravascular scans (pro and con) an independent data monitoring board would have come to the same conclusion. But when faced with the complexities it should have handed it over to an independent panel. No one was thinking about the larger repercussions of not doing so. Or maybe they were and made the wrong choice. Now heads will roll and rightly so.
It won't be enough for Schering and Merck to launch a $5 million PR campaign on the product. This sullies the reputation of all other companies and calls into question the integrity of the conduct of clinical trials in general. Just as the blockbuster era is over, so too is the closed door approach to clinical trials at an end. The need for collaboration, transparency, sharing of data -- particularly about what doesn't work and for who -- is paramount. Further, we need to move beyond the "bet-the-farm" mentality where the fate and fortune of a drug hinges on the outcome of one large trial. ENHANCE was a study of the impact of a specific drug for a selective population. It raised more questions than it answered, as much of scientific research does. There are better ways to get at such information, which is what the Critical Path is all about.
I don't think Schering did anything wrong...it is likely given the advances in imaging technology and shifts in opinion about the reliability of intravascular scans (pro and con) an independent data monitoring board would have come to the same conclusion. But when faced with the complexities it should have handed it over to an independent panel. No one was thinking about the larger repercussions of not doing so. Or maybe they were and made the wrong choice. Now heads will roll and rightly so.
