Women's Issues in Cardiology: EP Lab Digest Speaks with Sherry A. Marts, PhD

Describe your role in the Society for Women's Health Research. How did you get involved with this organization? In addition, for those who may not be aware, describe the goals of the organization. I am the Vice President for Scientific Affairs. My primary role is to coordinate our outreach and interaction with the scientific community. My staff and I plan and host conferences we have a small program of research support for several interdisciplinary research networks that we sponsor, and generally what I do is interact directly with researchers and folks who are interested in either women s health research or sex differences research. I have a background in laboratory research. I initially got involved in research ethics, but then moved more into learning about how society and science interact. I was looking for a position where I could be an advocate for scientific research both in terms of public support for the research, and also to provide a voice to the researchers as well. The Society has three main strategic areas. We were founded in order to increase the inclusion of women in clinical trials, which back in the early 1990s was not something routinely done. We really wanted to get that changed to have women included as subjects in clinical research studies. We also took on this question of the difference between males and females and the need for more research and understanding on that in particular, understanding how that impacts diagnosis and treatment and prevention of disease. The third area is as a research efficacy group; we work very closely with members of Congress and those in the federal agencies to ensure that biomedical research has sufficient funding and that issues related to women and sex differences are adequately funded. Those are the three areas that we are most active in, in terms of our mission. We are also unique in that we see our audience as the scientists who conduct biomedical and sex differences research, the legislators and the policymakers, who have such an impact on research, and also the general public, who are curious to understand how this research can improve their health. There has been a lot of recent news items that have dealt with women's heart issues, including the news about both vitamin E and aspirin in women. Can you talk more about these findings? Why are these findings significant? Our initial reaction was: It took 15 years?. If you look back into our history, when we were arguing back in the early 1990s for the inclusion of women we cited the Physician s Health Study, which was all male participants and was the first study to look at whether or not aspirin could prevent a first heart attack. There were no women in this study, so the results of this study had no applicability as to whether or not this was useful to women; nonetheless, many women were recommended by their physicians to take aspirin because the reasoning was that it couldn t hurt. Now in this new study, we find out that ironically it doesn't seem to have a significant effect in terms of preventing first heart attacks. It does, however, seem to have a positive impact on ischemic stroke, but of course it does put one at higher risk of hemorrhagic stroke, although I don t think in this particular study that risk was significant. There was also some concern about intestinal stomach bleeding, as there always is with NSAIDS. Therefore, as I said, our initial reaction was: We ve been waiting 15 years for this?. We ve been waiting a long time to start seeing results coming out. This is an example of what I would call a catch-up study, where we have the data and the information in men, and the original study was done under the assumption that you could just extrapolate the data from men to women we now know that this is not is not the case. We are now doing these studies in women as a way of catching up to what we already know in men. The other issue is that now that women are being included in studies on a more routine basis, we need to ensure that investigators break the data down by gender to see if there are differences. This is true both for drugs and devices. We are really asking three separate questions as to what we as women would like to see in terms of intervention studies, drug studies and device studies. The first questions are does this work in men? and does this work in women?. If the answer to both of those is yes, then we need to ask does this work differently in men and women?. Therefore, there are really three different comparisons we are asking them to make whether it is comparing drugs to placebo or comparing devices and of those who do respond, they need to ask is there any difference in the response between men and women in both the therapeutic response and also the side effects or adverse effects of the intervention?. This a challenge for researchers, and we completely recognize that. It is a challenge to design and perform the study in a way that allows one to do the kind of statistical analysis that are necessary to really accurately answer those questions. It may be that the initial study will answer the question does this work and then if there is an indication in the data that there might be a difference, then that might be a motivation to go on and do a separate study actually comparing the action of the drug in men and women. There are many ways to design this and make it affordable so that the cost doesn t double or you don t have to put twice as many people in your study. However, we really do think that all three questions are important for anything that's going to be put on the market. Has there been an increase or decrease in number of women participating in clinical trials? What we are seeing, compared to 10 years ago, there has definitely been an increase according to the data available, it looks like we are seeing women included in studies in the appropriate proportions. You do have to think about it in terms that we don t expect every study to have 50 percent men and 50 percent women. There are some conditions that affect women more than men or that affect more men than women, and you d like to see the study population reflect that. It also depends on the kinds of questions you are asking and what is appropriate. The guidelines that are in place right now both at the FDA and the National Institutes of Health require the inclusion of women in appropriate numbers unless there is a scientific reason not to include them. Cost is not a scientific reason a scientific reason might be something like this is a drug for treating prostate cancer, and women don t have prostates. That is a fairly obvious example, and there are others that are a little more subtle than that, but this is the sort of thing that we would like to see. Anything that excludes women, we would like it to at least be on that kind of basis. Similarly for men, one of the things that we talk about a lot here is that there are ways in which the name of our organization has almost become a misnomer. We jokingly say it s not just women s health anymore we are really interested in this as a way of advancing the health of both women and men. We really do think that by looking at these comparisons, we are going to be able to start to understand what these differences mean and how they could lead to better health care for both sexes. What are some of the barriers adversely affecting women's participation in research? It is kind of intriguing because and this is based on some research we did a few years ago we have a campaign to try and educate women about clinical research and encourage them to participate. What the studies have shown is that for women, a large part of the problem is what I jokingly refer to as the hassle factors. Possible barriers include the issue of clinic hours, whether or not there is child care available during clinic visits, whether or not the clinic itself or the study site is located in a safe neighborhood where the women feel safe walking to and from their car, whether or not there is transportation for women who don t have cars. All of these kinds of issues are things that study investigators do not think about they don t think about how are the patients or subjects going to get to the clinic, they just think about how many visits and what will be done while they are there. However, in actuality, it turns out that this can be an important question to ask when designing a study. I remember when I was working on an institutional review board, getting a study that was going to require a certain number of study visits. On some of the study visits, they would only perform one procedure, and on another study visit they were going to draw blood for something else. One visit might have been for an x-ray, and another visit would be for a blood draw, for example. We looked at this and said, do you think you could do the x-ray and the blood draw on the same day?. Why are these separated so that there are so many study visits? Of course the investigator just hadn t really thought it through from the perspective of the potential subject. Therefore, those are the kinds of things that people have found are at issue. I think there is a subtler one that is starting to dissipate, but it s sort of a truism in the not-for-profit world: that people do not volunteer if they re not asked to volunteer similar to the notion that people won t donate if they re not asked to donate. Therefore, when we were designing our public education campaign, I made sure this was very important, because since every medical study you have read about has been done in men, you need to be asked to participate in research, otherwise you don t feel invited to the table. For an organization like ours to explicitly say to women you are absolutely needed to help us advance medical research, this has made a really big difference. How can we make sure women's health needs are met? What can be done to improve the quality of research for women? I think improving the quality of research specifically around the inclusion of women really has been a matter of educating investigators about what are the best ways to ensure that you have sufficient women in your studies and what kind of value added to the information you obtain is there for your having included women in your study. I think that is becoming more evident in the medical literature now and in the things that investigators read. I think the other side of that obviously is encouraging women to participate and be a part of the medical and clinical research enterprise. It is really crucial. Please describe the Women's Health Office Act. In the 1990s, a number of the agencies in the Department of Health and Human Services established offices of women's health. Currently, only two women's health offices in the federal government have statutory authorization: the Office of Research on Women's Health at the National Institutes of Health and the Office for Women's Services within the Substance Abuse and Mental Health Services Administration. All of the other women's health offices at HHS are there because the department has decided it is important for them to be there. Our concern is that we not lose that bit of progress that we've made. Therefore, the Women's Health Office Act will establish permanent authorization for these offices. The thing that is really interesting is that there are people who want to create an Office of Men's Health. In fact, because of this focus on sex differences, the offices of women's health have kind of covered this base as well. Now where a men's health office might help would be for something like prostate cancer or some of the other conditions that predominantly affect men. I think the fear that having offices of women's health is a way of excluding men is a little misplaced in fact, we are really about advancing health for everyone. Is there anything else you'd like to add? I think the other key issue that we have been trying to work on is the issue of educating those in the clinic, such as health practitioners and health care providers, about the importance of paying attention to what we are learning about sex differences and how that should impact care. We are still early on in much of the research. I think cardiovascular disease is probably an exception as well as possibly lung cancer, in which there hasn t been a major impact on clinical care yet, but I think the possibility is there and it s something that the practitioners need to start paying attention to.