Evidence of meeting #19 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was women.
A recording is available from Parliament.
Liberal
Susan Kadis Liberal Thornhill, ON
Thank you, Madam Chair.
Welcome to our guests.
I found the statistic particularly disturbing that eight out of ten people in the United States had experienced adverse drug reactions. I want to clarify. Was it eight out of ten people in the United States, or that eight of ten were women who experienced adverse drug reactions?
Executive Director, Canadian Women's Health Network
Eight out of the ten prescription medications that were withdrawn from the market between 1997 and 2000 caused adverse events in women...than in men. When they went deeper into that, it turned out that part of the reason was that only 22% of the participants in the trial were women.
Liberal
Susan Kadis Liberal Thornhill, ON
Along those lines, is there a difference between how women's drugs are treated as opposed to men's drugs? You seemed to imply in your presentation that there was a difference, but I wanted to confirm that.
Consider, just as an example, the HPV vaccine. Are we sufficiently cautious about the long-term implications? What resources are being put into studying the long-term effects?
Executive Director, Canadian Women's Health Network
As you may know, vaccine and drug approval processes in Canada right now are private except for very extraordinary circumstances, so I can't really comment on what happened internally in the department. However, as you may know, my agency has been involved in thinking about the issues of vaccines and long-term safety.
I must say that the data do not suggest that this vaccine is any more biologically, physiologically unsafe. The questions we were raising around the HPV vaccine really were about added value and cost-effectiveness, given the low amounts of cervical cancer that are in the country and given the fact that the women who do die from cervical cancer die from lack of care, not from their disease.
Liberal
Susan Kadis Liberal Thornhill, ON
You mentioned that drugs ideally should be tested on those who will be utilizing them. I think we would all agree on that. In the case of HPV in particular, as we understand it from our best information, young children were not tested but were recommended to be given the vaccine.
Would that be an example?
Executive Director, Canadian Women's Health Network
Yes, that would be an example from my perspective. Also, young boys were not included in those trials either.
Liberal
Susan Kadis Liberal Thornhill, ON
From a woman's perspective, what could be done to improve post-market surveillance, in your opinion?
Executive Director, Canadian Women's Health Network
I did spend a bit of time on the garbage-in, garbage-out issue. I actually feel strongly that what we need to be doing is looking at sex and gender at the beginning of the process--that is, what's going on in the clinical trials, what's the notice, what's the review, what's the notice of compliance? And because we're not, I think we need to make sure, as we engage citizens in post-market reviews and contributions through adverse events reporting, that we do some special outreach to women.
That being said, the fact is that if we look at who makes up health care providers, if we look at who makes up unpaid health care providers in families, it's women. Inevitably, then, whether we like it or not, we're going to be doing a lot of this reporting anyway.
An educational campaign and a skills campaign for the Canadian public to engage in so that they understand the differences and the symptoms--that's part of the process. It's tied into the quality of health information that patients get when they're given these drugs. They're often not told that they have a drug that's maybe had 5,000 people in it, or told any of those specific things that would make the consumer sit up, take note, and say, “Well, gee, that doesn't sound like me; I'd better be very careful.”
Doctors don't have the time, and there are very few materials I would trust right now, to provide what I would call the “decision support” tools that are needed. Hence, part of post-market surveillance is really about a health information system in a very different way.
Liberal
Susan Kadis Liberal Thornhill, ON
I may be wrong, but it seems to me that a lot of the issues with post-market surveillance, from your perspective, could be addressed, probably from both perspectives, at the earlier stage. In other words, the post-market surveillance part of that process is actually going to be solving problems and difficulties that could have been dealt with at an earlier stage.
Executive Director, Canadian Women's Health Network
Yes, we need to do it at the front end, but also we need to understand that things will creep up. Rare reactions will creep up.
The other reality is that because we don't require head-to-head--that is, comparisons between drugs and interventions--before we approve a drug, the other thing post-market surveillance does is tell us whether or not the product really works. I know it sounds silly even to say that, but we need to realize that taking something that doesn't work, for whatever reason you were given it, is not just an adverse event; it's an incredible waste of money, time, and resources.
Liberal
Susan Kadis Liberal Thornhill, ON
To our other guest, what do you believe should be done as far as post-market surveillance from the perspective of children?
Senior Clinician Scientist, Child and Family Research Institute, B.C. Children's Hospital, University of British Columbia
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 largely untested when drugs enter the marketplace.
I don't believe we can determine drug effectiveness and safety without post-market surveillance. It can't happen earlier. Clinical trials give us an idea of where drugs can be used safely and effectively, but actual use in large, diverse populations gives us our true understanding of where they're most valuable.
For children, it's equally important that we understand the scientific determinants of drug response. The difficulty in all of the discussions we're having this morning is heterogenity of response. For every one person who doesn't respond to a therapy there are three who do, and vice versa. For every five who respond well there's one who has a serious and permanently disabling adverse reaction. It may be fewer than one; I'm not using actual numbers here. I'm just suggesting there is wide variability. At the clinical level, we're constantly faced with what's going to work, what can we try, and what would be best to use.
Bloc
Christiane Gagnon Bloc Québec, QC
Thank you.
Good morning, Ms. Boscoe and Mr. Carleton. We are happy that you are here today. You have raised an important issue about the number of women and children participating in clinical trials.
I would like to talk about a vaccine that has caused a number of deaths. I am referring to Gardasil, which is used for the human papilloma virus. To date, it has caused 11 deaths in Europe and in the United States.
I would like to hear your views on this situation. How do you think Canada can be more proactive in providing the public with information? You are undoubtedly aware of what happened, are you not? Did the parents receive any information? Very few girls between the ages of nine and 15 participated in the clinical trials. Apparently, there were 1,200 girls, compared to 20,000 women from the female population in general. What would you like to see? We hear that there have been deaths and serious consequences. It is more than an adverse effect when people die, it is the limit of what is acceptable. How can a government be more proactive with respect to tragic situations like death?
Executive Director, Canadian Women's Health Network
That's an excellent question, and I think it's one of the reasons why I suggested that we keep vaccines in the drug and health product field. Right now they run in a separate.... They come from a separate history in medicine, and because we are now using them so much more regularly.... The last time it was hypertension, and the report before that was one on nicotine, a vaccine for smokers. So we're going to see a lot more of these kinds of products come on the market, and I think we are going to need to develop different frameworks.
I would say that in the past, as with any other pediatric drug, it's not been unusual as common practice for drugs, devices, and vaccines to be studied on one population and then used on another. The ethics involved here were particularly, to be honest, because of the unique nature of what they were doing. They were testing for HPV in vaginas, and to do that on young girls is problematic. So I am very sympathetic to the struggles ethically.
This vaccine does look like it could be a fabulous thing. Our position at Women's Health Network is that we would have preferred to have seen more research, better modelling. We don't, for example, really know the prevalence of the HPV vaccines that have caused harm in our backyard. In the backyard I'm in, it doesn't look like 16 and 18 are the big majority that they are in other countries. That's very important if we're going to start telling people that they're protected from something when they're not.
We're also very concerned that we know only that this vaccine lasts for about six years. It's been in clinical trials for only six years. If we look to our experience with chickenpox and mumps, we know the vaccines wear off. This is extremely worrying for those of us in the sexual and reproductive health game, because we may give this vaccine to a nine year old, but they become sexually active around age 16, 18, 19, as we see with our chlamydia rates, which are a really good example of what's going on there, despite what we say about protected sex.
So if we have a vaccine that's wearing off precisely when people are becoming sexually active, and we know from our experiences with chickenpox and other vaccines that wear off that, in fact, you can become sicker, what does that mean from an infectious virus perspective? I don't have the answer for that. I don't have the answer for that for the mothers and women who want to talk to me, and we need to know that.
Bloc
Christiane Gagnon Bloc Québec, QC
Perhaps Mr. Carleton would like to respond as well? I know that it was under investigation in Europe. Will they prove there is a causal link? In a case like this, when Canada goes ahead with a massive vaccination—we are talking about Health Canada—should we not have a much more proactive attitude instead of waiting to see what will happen? For example, shouldn't they suspend the vaccination or impose a moratorium on it? Can you give us your opinion on that?
Senior Clinician Scientist, Child and Family Research Institute, B.C. Children's Hospital, University of British Columbia
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 we collect data on the outcomes of interest and we collect it from both people who have reactions and people who don't have reactions.
In our case, I specifically went to pediatric hospitals and said “How many cases of cisplatin ototoxicity do you have?” They said they didn't know, they'd never looked at the hearing loss with cisplatin in a comprehensive way. So we began to uncover these cases. They're there, they're not hidden. And I would suggest that the same thing could be done with this HPV vaccine.
When women and girls are given this vaccine, their outcomes can be studied and the data can be collected systematically. We could have a sample of several thousand very soon. In my case, we collect biomaterial--saliva, or blood, or buccal swab--and we can look at whether the genes play a role in an adverse outcome in people who have the adverse effect versus those who don't. That's one way that we could deal with that issue.
Death occurs regardless of whether people get vaccinated or receive drugs. The question of causality is critical, and how to determine causality is extremely difficult. It's much easier to do when you can look at data from two sets of people who receive the vaccine--not just from people who had adverse reactions, but also people who didn't. That's what I would suggest would be a good approach in Canada.
Conservative
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Thank you.
Let me just carry on with this discussion.
It seems to me that what we're really dealing with is still the notion that women can be treated as guinea pigs. I'm wondering what has changed from the days of thalidomide, DES, the Dalkon Shield, and the Meme breast implant, to the point where we're at today with respect to, say, Gardasil and Evra, the oral contraceptive.
Is there any better protection for women, or are we still following strictly this risk-management model where we haven't studied the causality, we haven't made all the links, we don't know the cost-effectiveness, yet we put it out there and take the risk and we expect women to take the risk?
Madeline, and then Bruce.
Executive Director, Canadian Women's Health Network
I don't think it's changed that much, hence my suggestions this morning around both enshrining a requirement for sex and gender analysis but also trying to now move to some kind of richer framework for the evaluation of drugs prior to their approval, because I think we can make some prediction. If we say we know this drug is going to be used in 70- and 80-year-old ladies, that's who should be in the trial. If we think it's going to be used in nine-year-olds, that's who should be in the trial. It does change the way we do business, for sure, but I really agree with Bruce. We need to take the approach of a public health and population health management process.
I have to say as I think about this that the burdens on industry on managing all of this also seem somewhat unfair. We need to think of a system that runs from a public health process, that we're producing data and developing research and processes that actually are a seamless continuum, that look like a program, not a bunch of band-aids stuck together.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
On that—and, Bruce, I'd like you to comment as well—it seems to me that things haven't changed to any great extent in terms of government being able to ward off big pressures from drug companies to push something on the market without the tests being done and without the precautionary principle being followed.
I'd like to go back to Gardasil, because the first that I know this issue came up in terms of the public and Parliament was when Merck Frosst appeared before the finance committee in Montreal, before the 2006 federal budget, pushing this vaccine. We hadn't heard about it before. We hadn't heard that this was an answer to a serious problem. And suddenly in the budget, without any further studies or talk, there appeared $300 million for a vaccine that may not have been fully tested or may not be fully cost-effective. So I'm wondering what we do to prevent this kind of situation from repeatedly happening, where drugs get on the market, treatments get on the market, and in effect often women are the guinea pigs, or maybe children.
Senior Clinician Scientist, Child and Family Research Institute, B.C. Children's Hospital, University of British Columbia
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 a larger understanding of their collective value or concern.
Cost-effectiveness is a very difficult issue to deal with. I sit on CEDAC, the CADTH expert advisory committee that looks at cost-effectiveness. I can tell you personally that I find it an extremely difficult task, because we're looking at data from short-term clinical trials. In most cases we're talking about eight to twelve weeks of data by the time a drug enters the market. There can be more than one trial of that duration—sometimes longer, but often not. But uncontrolled experiments--in other words, the data on the use of drugs without a control group, just the post-market experience of users—are not very helpful in ultimately determining the drugs' cost-effectiveness.
So what we really need is much better data, longer-term data. I suggest that as a country of roughly 30 million people, we are not going to be able to change the international circumstances sufficiently and still receive, in many cases, the benefits of pharmaceutical products in ways that maybe the United States could muster with its buying power and its population.
What I would suggest is that we take an approach that recognizes our national health system, our collective ability to care for each other, which is phenomenally helpful in embedding networks and looking at post-market surveillance, and then when these drugs come on the market—and we presume their cost-effectiveness—we provide them under a framework that evaluates their true cost-effectiveness. It is better that we know ten years from now that a drug is cost-ineffective, and we stop paying for it, than to spend the next ten years wondering whether it is and talking about this ten years later, which is the current state of affairs.
I have spent more than fifteen years working with the provincial drug plan in British Columbia, a very frustrating fifteen years, in many cases, because there isn't a lot of interest in that kind of approach to drug coverage.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Let me ask another question to both Madeline and Bruce on this very issue, before my time is up.
Although the work of this committee is important, we also know that at the same time the government is pursuing its own post-market surveillance system and has put out a paper on strengthening and modernizing Canada's safety system, and has had some consultations and is preparing legislation.
So I would like to know from you, Madeline, first, whether or not you have participated in this and whether or not a gender analysis has been done of this whole approach. Second, what do you think of this whole shift toward a risk management model and a progressive licensing model which involves, according to the DM, implementing life-cycle approaches to regulating health products, thus shifting the focus from pre-market review to one that continually assesses a product's risks and benefits?
Madeline, and then Bruce.
Executive Director, Canadian Women's Health Network
I actually think this is a step forward in our thinking.
That being said, my remarks today were focused on two areas that I felt really needed enlightening. One was, of course, around sex and gender; but the other was about what that original bar was and what the risk management framework is. I think one can have a risk management framework and a company can say they are not going to do this because it is going to cost them $10 million.
As the Krever inquiry showed us, which is one of the reasons I think we are all here, to be honest—bless Mr. Krever—is that we did try at Health Canada to put a number on lives, and it didn't work out so well.
So I think a risk management framework saying that those dollars aren't on the plate, that the cost of that isn't on the plate, is okay. But that's where the commitment to a precautionary principle enshrined in the legislation will be an important piece, because it's the framework in which you can manage risk in a way that makes sense.
