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 SSRIs--the selective serotonin re-uptake inhibitors--which don't seem to work better than a placebo. There are news reports that lowering cholesterol may not be all that it's cracked up to be for large numbers of patients taking certain medications. Apparently it's not helpful to the elderly, and it has never been demonstrated to be helpful to women. Yet large numbers of people in these groups are taking these products and exposing themselves to serious risk.
Canadians desperately need unbiased information about how well drug products work in the real world—information from outside the clinical testing environment. We need to know if they live up to their early promise. We're getting indications that some of these products are not living up to their early promise, that they're not safe when taken as directed. We need clarity about the risk-to-benefit profile of each product as it's approved. We just don't know at this point, and what we don't know can hurt us.
This proposal that I'm urging you to support—PharmaWatch supports it and has been involved in its development—is to create a five-year program of post-market surveillance that could, if approved by these federal, provincial and territorial ministers, fill some important knowledge gaps.
It's being supported by a broad-based coalition of researchers, medical providers, consumer groups, and other health providers. It would be a pan-Canadian project. It would build on existing structures, so there would be no need to invest heavily in new infrastructure. You could use bodies like ICES, the Institute for Clinical and Evaluative Sciences, in Ontario, which already has built-in expertise in this arena. Of course, we need approval from the ministers of health in all the provinces and the federal government.
I see Carolyn Bennett smiling, because she knows how easy that is to achieve, right?
All I'm suggesting is that endorsement of this proposal from this group would be helpful in opening that door.
There are specific advantages to be had from this proposal.
First, there would be a broad-based committee made up of consumers, professional pharmacists, regulatory agencies, research centres, industry, and government, all working together to set the strategic direction and to identify the first drugs that would be part of the investigation.
Another advantage is that it could produce much more timely results. We waited four years to find out about Vioxx, 15 to 20 years to find out about HRT. We're waiting too long to find out what we don't know and what we need to know.
The results could also help provincial drug plans figure out which products they should include in their formularies. We need to know that we're getting our money's worth when we put out those government dollars.
The program would also provide a concrete demonstration of the usefulness of the national pharmaceuticals strategy. It has been around for four or five years, and I don't know that it's produced much.