I see that some of the Merck/Vioxx coverage has been along the lines of "Company Finally Heeds Warnings of Unsafe Drug." Boy, the tort attorneys have to love that sort of thing. It's true that Merck had some signs that Vioxx could have cardiovascular problems, but there are a lot of drugs, unfortunately, that show rumblings of this sort. Some of them turn out to be false alarms, and some of them turn out to be real. This one turned out to be real with fangs.
If we immediately pulled every drug that showed any indication of trouble, it's for sure that no patients would come to harm. But we wouldn't have very many drugs, either. It's possible that Merck could have moved more aggressively to see if Vioxx had these problems or not - but if companies immediately ran fully-powered studies to address every red light that comes on, we'd have even more enormous costs to make up than we do already. Nothing's free.
Our job, on the discovery and development side, is naturally to try to find things with the largest positive footprint and the smallest negative one. The size of the latter one never goes to zero; it can't. We try to figure out how big it is, but you can never be really sure until after the drug goes onto the market. It's sad, it's unnerving, but it's absolutely true. The mission of the FDA, in an ideal world, would be to ensure that only drugs that can cause no harm make it to market. In the world we find ourselves in, though, the mission is to balance the potential harm a new drug could cause with the good it could do. That's an awfully tough assignment.
And the job of the injury lawyers is to swoop down after the worst happens, cawing about "defective products" and "willful negligence", and bearing away the biggest chunks their beaks can carry. The sky over Merck is getting dark with them right now.
Speaking of carrying away things in beaks, remember the University of Rochester? A group there made some of the early COX-2 discoveries, and on the strength of a patent, wanted a piece of all the earnings of COX-2 inhibitor drugs. The suit failed, after years of wrangling, on the grounds that the patent did not provide any such compounds, nor did it (or could it) describe what such a drug would look like or be composed of. But if they'd won, do you think they'd be willing to pick up some of the liability? Soak up a little of the lawsuit pain? Or were they only in it for the sunny days while the money was flowing? What do you think?