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 ab

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  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 la

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

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

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

Health committee  I meant that you'll be following science. The science is there, and it's already been done. Warfarin genetic testing is being done now. Carbamazepine, a very well-used and well-accepted anti-seizure medication also used in some mental disorders, has a genetic test available to pr

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

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 inc

Health committee  I'll start, and then I'll let you comment, Madeline. Very quickly, I've spent a lot of time working with Health Canada, many years, and also the provincial governments. I have been profoundly shocked, perhaps, on the lack of progress in many issues. We seem to have the same mee

Health committee  Sure. I'll start this time. On the issue of other jurisdictions, in the United States the National Institutes of Health has a program called the pediatric pharmacology research units, or PPRUs. These were a result of modernization of the food and drug regulations, the FDAMA, the

Health committee  Sure. Good questions. There are two points. One is the incomplete nature of reporting, and the other is the quality of the reports, which is what we're talking about. So the first is incomplete reporting. Why don't people report? There are lots of reasons that people have cited

Health committee  We can train physicians and nurses and pharmacists to do their reporting. In the United States, where MedWatch came in with great fervour that it would increase reporting in 1996, in 1997 there was a 50% increase in adverse drug reaction reporting as a result of the online regist

Health committee  My comment is that mandatory surveillance is great in concept but very poor in execution. It's very difficult. How are you going to regulate it? How will you know if somebody didn't report? How are you going to enforce it? The difficulty for physicians, nurses, and pharmacists i

Health committee  It's a worthwhile goal; it's a worthwhile thing to pursue. The difficulty is resourcing this, because physicians, pharmacists, and nurses report the information they think you need to know. The four hours to put together one cysplatin case comes from experience and looking at man