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Health committee With respect to Vioxx first, the information about Vioxx only came to light because the manufacturer was trying to expand the indications for which it was approved. They thought it would help to prevent colon cancer. The researchers had to twist themselves into knots to hide the
March 13th, 2008Committee meeting
Carol Kushner
Health committee Yes, we should be using comparators other than placebo, in addition to placebo. We should be using the best drug to treat a given condition against a new drug to see whether in fact the new drug that's coming out actually performs as well.
March 13th, 2008Committee meeting
Carol Kushner
Health committee I think you're quite right that there is a huge responsibility on Health Canada to become more effective as communicators of this information. Right now, the ways in which doctors are advised about problems with drugs don't appear to be that effective, necessarily. They are proba
March 13th, 2008Committee meeting
Carol Kushner
Health committee I think we ought to actually spend a little bit of time looking at the research in this area, because it suggests that patient or consumer reporting directly is a far richer resource than when the report is reduced, through coding, to a few words. I think there will be a real los
March 13th, 2008Committee meeting
Carol Kushner
Health committee Yes, I do. Now, at the moment we don't have a formal position on our board about mandatory reporting. Our board is somewhat divided. Some people, especially physicians, are saying, “I would spend all of my time making these reports. You have no idea how many people are experien
March 13th, 2008Committee meeting
Carol Kushner
Health committee Okay, I'll be very brief. The issue around industry-funded groups is that in general—and this is a generalization—they tend to emphasize faster access to new products and they under-emphasize safety concerns. Almost always they are talking about needing access. That seems partly
March 13th, 2008Committee meeting
Carol Kushner
Health committee The important thing here is transparency and access. Right now, an awful lot of data that comes forward to Health Canada the public never sees and the doctors never see. Negative trials are usually not published. One of the issues related to finding out that, for example, SSRIs d
March 13th, 2008Committee meeting
Carol Kushner
Health committee It's very worrying. We've already seen Canadians suffering significant harm from drugs that went through the old system—even the old, old system, before we speeded up approvals to the point where they are today, because approval times have come down significantly. One of the prob
March 13th, 2008Committee meeting
Carol Kushner
Health committee Yes.
March 13th, 2008Committee meeting
Carol Kushner
Health committee I would add that there are already provincially funded agencies. There's a provincial contribution already built into the proposal I was speaking of, in that the Manitoba Centre for Health Policy or ISIS or some other agencies have indicated a willingness and an expertise in this
March 13th, 2008Committee meeting
Carol Kushner
Health committee I would only add that I think fewer than a hundred girls in the 12- to 13-year-old age category were actually subjected to clinical trials. There have been some assumptions made in the clinical testing: first of all, that younger girls would be similar to older girls and young
March 13th, 2008Committee meeting
Carol Kushner
Health committee At PharmaWatch, we don't have a specific position on creating a separate agency, but we do have a specific position on creating an arm's-length from government research arm through this proposal we've been supporting to collect post-marketing information about specific products.
March 13th, 2008Committee meeting
Carol Kushner
Health committee I have one sentence left. My last sentence is that the proposed budget for this project, which I think is around $20 million a year, $21 million for the first year, is a tiny fraction of the $26 billion we now spend on drugs. Thank you.
March 13th, 2008Committee meeting
Carol Kushner
Health committee Thank you. I'm here to support a proposal that has been made to the federal, provincial, and territorial ministers of health. It comes out of a need to make clear how to improve post-market surveillance. There are recent news stories about Vioxx, hormone replacement therapy, and
March 13th, 2008Committee meeting
Carol Kushner