Okay.
It might be helpful for you to know that I am a nurse by training. I work at a community health centre for women in Manitoba, where for 25 years we've been dealing with the issues of drug and device safety, including tracking women with diethylstilbestrol or DES exposure for screening, raising questions about the relative value and potential harm of hormone replacement therapy, the impact of reproductive technologies on the lives and bodies of women, and other issues around drug regulation.
Currently we are working on a team developing sex- and gender-based analysis tools for systematic review, hoping to improve our knowledge base for decision-making, and we are involved in the development of the proposed drug effectiveness research network, which I believe you are aware of.
The CWHN is a national network working to improve the lives of women and girls in Canada by undertaking research synthesis and collecting and distributing information. We are in fact a knowledge broker.
I am lucky enough to have participated in the consultations Health Canada has had on their proposed progressive licensing regime and the life cycle approach. This is laudable and demonstrates that Health Canada is finally moving to update its regulatory infrastructure.
The department I think also should be congratulated on its increased efforts to engage the public and community groups in its processes and deliberations. The establishment of the Office of Consumer and Public Involvement is an excellent example.
I also particularly wanted to take this time to thank the government for its rigorous defence in the CanWest Global charter challenge to the existing direct-to-consumer advertising regulations. Although we, like other groups, feel strongly that there's more to be done in this area, we are delighted and grateful for your active work in this area. Preventing direct-to-consumer advertising is directly related to keeping manageable and fundable medicare.
Given the rich testimony before you, though, I don't want to repeat what's already been said but want more to say that we absolutely support the recommendations and observations made to you by PharmaWatch, the Canadian Medical Association, the Canadian Health Coalition, Women in Health Protection, and Drug Safety Canada. My remarks are to enhance those areas.
Firstly, post-marketing surveillance is increasingly important to women, and of particular interest because the implementation of our commitments to sex and gender analysis in health research and the evaluation of health products is still not yet routine.
For example, in the United States eight of ten prescription medicines that were withdrawn from the market between 1997 and the year 2000 caused more adverse effects in women than in men, and they found that only 22 participants in the clinical trials were in fact women. This lack of subgroup analysis by sex leads to potential for error and for harm at the regulatory area and at the practice area. That's improving. Post-marketing processes are critical building blocks for women and for men. I would also suggest that you always include the term vaccines in your deliberations.
However, this must be a transparent process, not one managed by the industry. Like the move to the public reporting of clinical trials and clinical trial results, post-market surveillance, including adverse reaction reporting, must be publicly managed and publicly accessible. We also need to be including the existing products that are on the market, not just new products. This is really important because of the level of evidence for the evaluation of these products.
As you identified in your report “Opening the Medicine Cabinet”—one of my favourite documents of all time—increasing the capacity of Health Canada, and I would add of other infrastructures, is going to be absolutely essential. People cannot do this on the side of their desks. This includes supporting the proposed drug research and effectiveness network and expanding the work of CADTH, the Canadian Agency for Drugs and Technologies in Health. As well, as you have heard, there is an important and critical role for patients in adverse drug reporting and post-marketing surveillance, and infrastructure for outreach to them is needed.
However, improving post-marketing surveillance is only one component. I am, however, extremely fearful and worried that strengthening post-market surveillance will be used as an excuse, if not a smokescreen, for lowering the standard of evidence for the requirements of new health products.
There are already many problems for women, children, and the elderly. I would suggest that the current standards for the approval of a drug need to be nuanced and made more robust. We need products to be tested on the populations that are actually going to be using them. I know it sounds like a radical thought, but there you go. We need a framework, one that recognizes that standards for safety and effectiveness need to be different, depending on the goal of the product. Products that large numbers of Canadians use for prevention, such as hormone replacement therapy for women, or statins, need a different order of evidence from those used in life-threatening conditions. Drugs used by the elderly and Canadians who use multiple drugs need to be tested on those populations before they come on the market. If Canadians are going to be research subjects, I believe we have an ethical duty to tell them so.
As we evaluate drugs, we think it is important to include at the outset information about head-to-head trials and real-world effectiveness. We don't want to be doing this at the end. Developing a process for researchers, consumers, and citizen engagement in the approval of clinical trials, and in the anticipated pre-application consultations that will be put in place before a formal notice of compliance, would be a way to go.
We recognize that there are huge pressures on you as parliamentarians for drugs to be approved faster. Everybody lives that reality. However, I think there is now some evidence that the time requirements placed on Canadian and American reviewers is creating harm. A recent study has shown that safety problems in new drugs are very much tied to the timelines for their approval. I have the details of this study, but I won't take time to explain them now.
My next point is one that probably is predictable. It is improving the management of health products, incorporating sex and gender analyses into the regulations and legislation that you will be working on. Sex and gender are not just intellectual concepts at this point. We now know that sex and gender matter in ways involving the basic science, the basic genetic level. They manifest in many, many different ways. The pharmacokinetics and the pharmacodynamics of drugs are important. Examples include the effect of the menstrual cycle on the metabolism and use of drugs, and the way in which genetic expression and sex are linked. For example, for some reason, boys are particularly vulnerable to risks for cancer, asthma, birth defects, and learning and behaviour disorders. Women seem to have an increased risk of immune disorders and a higher risk of gene immune suppression disorders than men. We're at the very early stages of understanding this.
We also know there are big differences in the way in which women and men experience health services and health utilization. I won't reprint the front page articles from The Globe and Mail on the experiences of women and men when seeking hip replacement surgery.
We are learning more, but we have a long way to go. I think it is critical, and I would beg you to actively consider enshrining into legislation and regulation a policy that requires a sex and gender analysis in all aspects of the drug review and management process. The United States has moved to do so. Here in Canada we've made some good steps. We've had a guideline for almost a decade. But guidelines are only guidelines and the real money is in the regulation and the legislation.
I'm hoping we can talk a little bit more about that.
How am I doing for time?