For the most part, we see that a lot of the studies are in fact international. I go back also to some of our work with new and innovative therapies for rare disorders. Certainly for many of our patients, having no access to medicine is a much greater harm than not. And many patients do recognize that there are risks and benefits and trade-offs. I think what's important is to inform patients of that so they can make good, informed decisions.
Obviously the data have to be, as you say, internationally pooled. In many cases, you're only going to be able to pick up an adverse event, for instance, if you have access to the international database.
What I caution against, though, is what we consider to be some of these knee-jerk reactions. Every study can come out with a different set of outcomes. You have to have in place, the same as you have for an application for approval, a continuous-surveillance or post-market scientific framework. If in fact a physician were to receive a new alert every single time a new study came out and we had these rolling alerts coming out.... We're seeing that happening in some cases, in part because governments have tended to become very reactionary. So people are much more concerned about accusations of not being proactive or accusations of not being up to date with the information, and they end up with these rolling comments. I think that becomes as dangerous, in fact, as not providing the information.
What we need is a systematic framework: how much information, how do we collect it, when should it be made available, how is it analyzed, how is it communicated? Right now, all we're doing is working within very much an ad hoc kind of framework. I don't think we have a framework that really has been put together.