The system is 95% incomplete, so there has to be a massive increase in reporting, and the quality reports have to be there.
I favour a model in which we train clinicians, who are responsible for the recognition and reporting of adverse reactions, to do the work, and not just increase public awareness of reporting. It's great to have consumer reporting; there's nothing wrong with that, and I encourage it. But to get the substance of the reports we need, we really need dedicated professionals to monitor and evaluate drug responses. That's the information that will be most helpful.
In Spain it is a criminal misdemeanour to not report an adverse drug reaction, but it hasn't changed reporting. Vioxx was removed from the market because of Merck's own trial that confirmed the cardiovascular risk. No surveillance system in the world--mandatory or voluntary--picked up that risk, despite the fact it was the most frequently prescribed drug in the history of the world.
I suggest that surveillance systems run by governments traditionally haven't accomplished the goal of helping us identify significant risk in many cases. They can help in many ways, but I think we have to look to science to help us understand better ways to informed solutions. If we can have safety solutions we'll get reporting, because clinicians want safety solutions.
When I started my work I went to the oncologists at the Children's Hospital in Vancouver and told them what I was proposing to do. The head of the medical oncology unit said, “You know, it's an interesting study looking at the genetic basis of adverse drug reactions. We don't have adverse drug reactions in oncology.” That's either a sign of ignorance or arrogance, but it's neither; it's nomenclature. She doesn't think about reactions that are expected, like hearing loss and heart toxicity, as being adverse. She thinks of them as being a consequence of using the drug.
Now that they see that we can actually predict in whom the most serious toxicities are likely to occur, that's where reporting, funding, and support comes from. That's the way to get reporting. Maybe it's to mandate it, but it's to get individuals who are responsible for capturing these reports and individual institutions.