My comment is that mandatory surveillance is great in concept but very poor in execution. It's very difficult. How are you going to regulate it? How will you know if somebody didn't report? How are you going to enforce it?
The difficulty for physicians, nurses, and pharmacists is that we have things like suicidal ideation occurring with antidepressant use, but those are background events that occur as a consequence of the underlying depression as well, so how do you separate out what really is an adverse effect of the drug--a negative health outcome--from an underlying disease? Those issues become very difficult to sort out. We spend an awful lot of time trying to regulate and manage clinicians to report things whose basis we don't really understand.
I prefer a solution-directed approach, which says that this is a particular reaction we're worried about. In the case of EVRA, I think we're probably going to find out it has to do with the delivery system--that we may have an increase in the release of hormones that's inordinately high from this particular patch. I don't know the answer to that, but a solution-directed approach would try to uncover the specific problems related to EVRA. I think we would do better if we concentrated on finding specific health issues and specific drug issues that we were concerned about and worked towards specific solutions. They're going to be different, depending upon the issue.
I don't favour mandatory surveillance, because I don't think it's going to work. It would be great if it did; I just don't think it's going to work. You need quality reports as well as numbers. Getting numbers isn't sufficient. You have to have quality in the reports; otherwise, it's useless.
Look at how many reports manufacturers provide already. They're mandated. There are hundreds of thousands in the United States; they're virtually useless because the lack of clinical information that's included about the patient is a predominant problem.