Health committee  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.

Health committee  Right. We take all of the data we've collected and begin to go after specific reactions that we think are genetically mediated. We found three in the first six months, and we stopped looking at our data. We are still collecting and accumulating data, but we have a limited budget and limited resources.

Health committee  I think the issue of how to ethically involve children and women in clinical trials when we know or might suspect that there is a problem depends on the question you're asking. It depends on what you want to study. If what you're trying to study is an effective anti-infective for a serious infection that occurs during pregnancy, then the ethical boundary you're crossing to treat women in a clinical trial to determine its effectiveness while exposing them to a potentially risky therapy can be weighed against the potential benefits of that therapy.

Health committee  Okay, first of all, I think it's true that women are guinea pigs, but so are men and so are children in this environment, in that we're using drugs while having a limited understanding of their safety and effectiveness. Then we use them in the real world, so to speak, and develop a larger understanding of their collective value or concern.

Health committee  Vaccines, just like drugs, have major adverse effects associated with their use, and death, of course, is the ultimate adverse event. What I would suggest is that if we want to have an effective post-market surveillance system, that means that when we actually provide the vaccine we collect data on the outcomes of interest and we collect it from both people who have reactions and people who don't have reactions.

Health committee  Children, like women, are somewhat disenfranchised from the system for the same good reason initially: to avoid testing drugs on children, women, and unborn children is probably a good ethical boundary to adhere to at some point. Unfortunately, that means these populations are largely untested when drugs enter the marketplace.

Health committee  That's right, but we're the first to sort of couple these things together, and the results are preliminary. As you know, the best work that's done by scientists is that which is peer reviewed. We should get this published, and then we should move this into the commercial market.

Health committee  Good morning, Madam Chair and committee members. I'm a clinician at the Children's Hospital in Vancouver, and I would like to speak to you today about post-market surveillance from the standpoint of somebody who works daily with patients in the Canadian health care system, and about what I think can be done about this system to make it even better.