Health committee  I personally don't share it. If I were reporting an adverse reaction, I hope I would be doing it out of altruism. The fact that I wouldn't immediately get a response back wouldn't bother me. I think there are two issues. To use the example of Vioxx, which everybody now accepts increases the risk of heart attacks, I've had a lot of patients on Vioxx.

Health committee  I see those centres being linked to the variety of stakeholders we've talked about--the federal government, the provinces, physicians, and patients--identifying areas of research priority. They would do that highly policy-relevant research and feed that information directly back to Health Canada, the provinces, and the policy-makers so they can use that in their policy-making.

Health committee  I guess my short answer would be that I would have preferred wording, not being a lawyer, saying that the post-marketing surveillance would “augment” the information from the initial randomized trials, rather than, as I think you said, “replace”, or whatever.

Health committee  “Shift the focus”, yes.

Health committee  Those strike me as reasonable. Also, I would not forget the provinces and physicians as important targets of post-marketing surveillance. In other words, Health Canada has a very blunt instrument, which is taking the drug off the market or not. As a physician, I would benefit a great deal from this kind of post-marketing surveillance because it would help me decide which kinds of patients...and it'll help me to better understand the risks and benefits in the real world.

Health committee  I'm saying that the information from the post-marketing surveillance will be as useful, if not more useful, to the provinces, the practising doctors, and the patients who have much more subtle things to do in their life than saying the drug can or cannot be licensed.

Health committee  As a physician, if I prescribe a drug thinner like Warfarin, which has a clear risk of major bleeding, and I tell my patient that's the risk and we agree that he or she wants to take the risk and then the patient has a bleed, to my knowledge I don't have an obligation to report it.

Health committee  Yes. I don't know the details of this study, but I think it's a perfect example of how one needs to balance the benefits and harms of medications in a rational way. To address your question about whether there are any other downsides to some of the post-marketing surveillance, the fact of the matter is that analyzing these databases that Steven and I have talked about is relatively cheap, because they exist.

Health committee  In terms of physicians reporting adverse events, I think you'd want to encourage physicians to do that for all drugs that they think there's an issue with. My point was around the use of some of these administrative databases, as Steven described, which would allow us to kind of data mine to look for adverse events for every single drug that's approved.

Health committee  I'm not sure I'm going to be able to answer the question particularly satisfactorily. The number of over-the-counter drugs that are available is relatively small, and I think there is some potential harm. With some of the drugs for arthritis, for example, for acute pain, I think some patients are self-medicating.

Health committee  First of all, around the progressive licensing, I interpreted it the same way that Steven did. So Health Canada might make a drug for cancer available to patients where, before, we might have required studies that showed a benefit in decreasing the risk of death with the cancer, and now it would be approved on the basis of showing a shrinkage of the tumour on an x-ray, for example.

Health committee  We were thinking about the network not as taking over the legislative mandate of Health Canada but as an independent and fairly nimble.... I appeared before this committee a while ago as a former chair of the Canadian Expert Drug Advisory Committee, and frankly, one of the reasons I didn't sit for another term was my frustration with getting anything moving that required all 13 provinces and territories and the federal government to agree upon something.

Health committee  Sure. I address that a bit in my remarks. I think, again, like anything in life, one is balancing two risks and harms. My view would be that right now the kinds of studies that industry has to come in with to have their drugs licensed are sort of a minimal standard in most times.

Health committee  I agree with you 100%. When my patients come in and say they want to take some homeopathic medication that has no side effects, I tell them that if there's a drug that doesn't have any side effects, I don't think it's going to be effective. I think you're absolutely right. The management of people with HIV has been transformed from people who are dead within six months to people who now live a long time--actually, they have a chronic disease.

Health committee  Good luck.