In a way I'm here because twenty years ago women sitting around this table and in the House thought that sex and gender mattered, and we needed to develop infrastructure and knowledge to help. Someone very wise, a mentor in my career, said, “Madeline, you've got to know that it takes a generation”, and I guess it does.
Why I think we need to see things like sex and gender in drug reviews in law is because it's hard to do, tough to do, and costs to do it. I'm working right now with the Canadian Cochrane Collaboration, which as you may know the CIHR has funded to help improve the analysis of evidence. One of the things we're finding is because the Food and Drug Administration in the United States requires sex as an issue in clinical trials, there are an awful lot of women in these trials, but no one's analyzing the data. It doesn't make any sense to me. You think you've done it, and you think you can go home and do something else, and you take another look and you realize.
So I think we're a long way away yet. We're building the case. We have some few researchers. The Department of Health supports a program called the centres of excellence for women's health, which I think was originally a multi-party initiative, which is helping build the data that I'm able to show you. So we can show not that this is a morally right thing to do, but it costs us not to do it. On the issue of including it in a regulation, I think we need training. I still think we need third-party analysis and audit processes to help advance that. These are skills that people are still learning, from a drug reviewer to a policy analyst. I think that those of us in the community need to help step up to the plate to help train and build capacity in the department.
My own feeling is that when we took women out of clinical trials because they might get pregnant, that was a somewhat paternalistic approach to a very complicated problem. It's true that we gave thalidomide to women when we didn't know anything about its effects on fetuses, and we've definitely learned the hard way. But I think women are much more sophisticated now about that. We have drugs on the market that do harm fetuses if women are pregnant, and they are taking them. Touch wood--except for a few examples, it's worked out well.
So I hope that's enough.