The problem is, when you assess the benefit-risk at the time of drug approval, the process is not transparent. What usually happens is you have a group of experts who weigh the benefits against the harms and make a decision. There's no magic formula. They don't come up with a magic number that says the drug is approved or not. This is probably the most disturbing aspect—how decisions are taken.
I can tell you, having worked on this issue, that there is at present no mechanism or system that would provide additional information. However, I am involved in some initiatives designed to define the parameters in the decision-making process and come up with explicit criteria that could be communicated either to the practitioners or the public.
It's a difficult question to answer. It's extremely relevant, but I don't have any answer at present.