The other information, the other difficulty, is what is “useful information”? What is going to be useful to the practitioner in his day-to-day practice, and what is going to be useful to the patient in the decisions they have to make as to what level of risk they're willing to take? I remember when you were opening your presentation you made a distinction between adverse effects and side effects, but one can be the other. If I have a child who is at great risk of dying of cancer, and they have a drug they can give him, but the chances are, I believe you said, 60% that he'll have some heart disease because of that drug, if it's going to give him a reasonable chance of living, I'm going to consider it a side effect. If I know in advance that I'm taking this decision, that there is a risk, it becomes a little bit of a line as to what information you have as a practitioner or as a patient in the decision that you make. If I have severe enough pain, I might want Vioxx, and I'll accept the risk of the cardiac event that could ensue.
On April 1st, 2008. See this statement in context.