As the health care industry works to address disparities in clinical trial participation, some Mayo Clinic doctors trying new approaches. In this episode, Drs. Sharonne Hayes and Michele Halyard detail the deliberate exclusion of women from these studies, and the dramatic effects on health outcomes for women, from decades of misdiagnosis of heart attacks and heart disease to delayed detection of breast cancer. Encouraging more researchers to diversify their patient pool is not enough; the most successful efforts around gender equity in research and treatment have relied upon community partnerships with groups like Coalition of Blacks Against Breast Cancer.
“The number one reason that women do not participate in clinical trials is they were never asked.” – Sharonne Hayes, M.D.
“So part of it, I think, is education of our community. So really talking about the importance of research and how it’s not creating an unhealthy situation for a patient, and really creating understanding on the part of the patients because we’ve educated in a way that reaches them.” – Michele Halyard, M.D.
Read the transcript:
Lee Hawkins: Welcome to the Mayo Clinic Rise for Equity Podcast. My name is Lee Hawkins. I’m your host today. And in this episode we’re discussing gender equity in medical research. Our guests today are Dr. Sharonne Hayes, who is a cardiologist and professor of cardiovascular medicine at Mayo Clinic and Dr. Michele Halyard, who is a medical doctor, a professor of radiation oncology and a vice dean at the Mayo Clinic Alix School of Medicine.
Lee Hawkins: Welcome to you both.
Sharonne Hayes: Nice to be here.
Lee Hawkins: Today, I want to focus on a very disturbing issue that you’re both committed to changing. And that’s the reality that historically and even in contemporary times, women have been overtly and deliberately, in some cases, excluded from medical research. It’s less so now, but the fact is that they’re still not included in adequate numbers, and that affects care. How pervasive of a problem is this and does it still exist writ large in the health care industry?
Sharonne Hayes: Well, I think women have been well-represented in medical research on things that we traditionally think of as women’s problems. It’s been described as bikini medicine, so breasts and ovaries and pregnancy. But for things like lung cancer or cardiovascular disease, heart attacks, less so because those have been often thought to be primarily male diseases.
Michele Halyard: And I think prior to the 1970s, people thought women shouldn’t participate in medical research. They thought first, they were busy caring for their children, and so we don’t want to burden them with participating in research. And they also felt that perhaps the biology was not as important, the biological differences between men and women. It really wasn’t until probably the nineties when the National Institutes of Health mandated that women and minorities be included in medical research, that the behavior began to really change substantively.
Sharonne Hayes: But there’s still gaps. And they’ve assessed this so we still have big gaps and I will just speak to cardiovascular disease because that’s my specialty. The first huge federally funded trial to better understand risk factors for cardiovascular disease was called MR FIT. That was the acronym. It enrolled over 80,000 men, not one woman. And it wasn’t until about 25 years later that they actually had the Women’s Health Initiative, which looked at women in very important ways related to hormone therapy (and other areas), but not in some of the same ways that might lead to better understanding heart attacks, for instance.
Lee Hawkins: And as a cardiologist, you told me that when you started, there were textbooks that basically said that having chest pain, if you’re a woman versus a man, wasn’t very important. So women with chest pain were assumed to not have bad things happen to them, but men did. And of course, we now know that women have a higher likelihood (of dying from a heart attack).
Sharonne Hayes: That actually came from the Framingham study. So that big study in Massachusetts, they interpreted their data and said, okay, if you take women who have chest pain and men who have chest pain, men go on to have heart attacks and high rates. Women don’t. So we don’t need to study them. That was back in the in the sixties and that set the stage. (They said) we don’t really need to include women, you know, on a scientific basis.
Lee Hawkins: Okay. But women have a higher likelihood of having a heart attack. Is that right?
Sharonne Hayes: Well, they do worse after heart attack. They actually present about ten years later. So they’re sex and gender differences. And I think if we don’t study them and include women, we will not understand them.
Lee Hawkins: As we start to see, there are subsets of women. So what are the barriers that exist for women of color?
Michele Halyard: So I think particularly with women of color and when you particularly look at Black women, there’s a history of distrust within the medical field. So, number one, there aren’t a lot of physicians and particularly not a lot of researchers of color. And so that natural trust in who’s creating the studies and who’s offering studies to you may not be there.
Also, there’s a history of abuses of research prior to all of the regulations that we have in place (now) that prevent taking advantage of people. There’s a history of abuse with the Tuskegee experiment where men were purposefully infected with syphilis and withheld treatment, and research was done on that. That really has carried through generations, at least in the Black population.
So that’s just one example of where mistrust or distrust of the medical system really can impact research participation. But also, often research studies are available in academic medical centers, and sometimes there’s an under-representation in terms of diversity of patient population within those centers. And so the opportunities to enroll patients in clinical trials are not there. And there were also some studies that would suggest that perhaps people of color aren’t offered clinical trials, or they don’t want to participate in a clinical trial, or they, no matter how educated, they’re not going to really understand about this trial. Simple things, such as having bilingual consent forms sometimes are lacking. So there are a myriad of problems within the health care system that impact participation in clinical trials.
Lee Hawkins: Okay, one thing that really stood out to me was the fact that there are upper age limits in some studies. So that makes it impossible for people who are 65 or older sometimes to participate.
Sharonne Hayes: So, you know, when we’ve talked about why women aren’t participating, there’s distrust, there’s some misunderstanding, some of it has to do with bias or our perceptions of women or assumptions about biology. Like if we study men, we can just take what we learn and apply it to women.
But for instance, women on average have their heart attacks about ten years later than men. And some of the early thrombolysis trials, they had an upper age limit of 65. So they weren’t excluding women by saying women can’t participate. They excluded women because most of the women were older when they came in with their heart attack.
So I think if we’re going to solve this problem of underrepresentation of women in clinical trials, we have to look at multiple areas. We have to educate and inform the women about how important it is for them to be a part of this, for their own good. A lot of women are more willing to participate in medical research for altruistic reasons. This might help my daughter, my mother, my sister. So appealing to whatever motivation might be important to them. But also looking at our study design. For example, in setting the number of visits they have to make – that might require many bus trips for somebody who lived in a neighborhood far from the health care center. So you give (participants) transportation or child care. I think if we’re going to get at this, it has to be a really holistic view.
Lee Hawkins: And research institutions. Are there things that they can do and are doing to start to address this issue?
Michele Halyard: So part of it, I think, is education of our community. So really talking about the importance of research and how it’s not creating an unhealthy situation for a patient, and really creating understanding on the part of the patients because we’ve educated in a way that reaches them. What are the safeguards that are in place assuring them that we’re not just doing research on you just to write papers, but we’re actually returning the information back to the community, which often is a gap.
People can participate in research studies, but if they never are privy to the results of the study and how it helps them, that’s really important (information for them to know). Also decentralizing research centers. So often, as Dr. Hayes said, people are expected to come to the academic health center or come to the place where the clinical trial is being conducted, which is far from where they live.
Really looking at innovative ways of partnering with community health organizations that serve people within their community, serve women within their communities, to break down some of those barriers and really enhancing the pipeline of women physicians, women scientists, underrepresented physicians and scientists. So they become a part of the solution of research and can really connect with communities.
Lee Hawkins: And you both worked together on some projects with an organization of African-American women called the The Links Incorporated. Tell me about this work.
Michele Halyard: So The Links Incorporated is a national African-American professional women’s organization that really is built around friendship, but also importantly, community service. So we looked at the research attitudes of women, Black women, about participation in research, because the dogma had always been that Black women, Black people in general don’t want to participate in research. In our study, we found that that wasn’t true.
We found that there was willingness to participate. Now, this was a highly selective subset. These women were middle to higher socioeconomic status. They were educated. So it’s not necessarily a generalizable population, but it did break down or help to break down some of those myths that, you know, just because you’re Black doesn’t mean that you want to participate.
And that’s the kind of research that needs to be done to break down some of the biases that have been held for a long time within medicine.
Sharonne Hayes: That that research came out of a mutual friend who was heading up something for the Links Incorporated and she said: I went to a Mayo event and one I was one of very few Black women there.
She’s a physician and she said, no one has ever asked me to participate in a clinical trial. I know how important they are. I know. And if I am a Black educated doctor and nobody’s asking me to do that, I think there’s more women like me. I think if we look at the science we learn that actually that’s true.
And then where that initial survey led to was implementing and testing on the community of women. What are the messages and education that they would need in order to better understand and be comfortable participating?
Lee Hawkins: What kind of incremental progress have you seen? I know you’ve both worked on this. You’re very committed to this issue. Have there been times that you’ve been able to say, oh, man, this is a major breakthrough?
Michele Halyard: Well, I think that there certainly have been many, many instances where within the medical profession and research, we’ve been able to impact the quality of life, the duration of life, the longevity of life. I’m a cancer doctor. I treat breast cancer. And I’ve seen so many improvements in understanding the biology of breast cancer and doing the research to show how targeted therapies can improve the survival in women who used to die routinely of certain types of breast cancer.
So through my lifetime, I have seen the survival of cancer patients just significantly increase, particularly as a result of research. And that’s both in majority and minority populations.
Sharonne Hayes: Cardiology is very cool because we have lots of tools in our toolbox and we’ve have made a lot of progress. I mean, the rates of heart attacks overall has gone strikingly down over the past 40 years. But for about two or three decades, women’s were higher than men. They were not going down. So men’s rates of heart attack were going like this and women’s like this. And finally, that wakeup call. We need to include women in cardiology trials. So now women’s rates are going down. Where they’re not going down is sort of middle-aged women. Those women who are kind of 40 to 59.
Their rates of heart attacks are actually going up a little bit. And if you think about it, we talked about reproductive age women often being excluded from clinical trials. You know, those crazy hormones. We have to deal with that and control for that.
I do think one of the things that’s coming out that will help is external factors. So say a journal commits to saying we’re not going to publish this study unless there is adequate representation of women and minorities, unless you justify why you designed the study that way. Now, I can tell you if I’m a researcher and I know that I could do all this work and I might not even be able to get it published in a good journal, I probably will work a little harder getting women in there. So I think there’s lots of ways carrots and sticks that can help us.
Lee Hawkins: But what’s great is that as things evolve and you make continued progress, you’re building in equity all the time, making sure and being cognizant of that. Is that true?
Michele Halyard: I think so. I think I think more than we did in the past. I think there’s still more room to go. You know, the inequities within the health care system still exist. People of color still die more often from the major killers, cardiovascular disease, cancer.
Lee Hawkins: I can tell you that. And I’ve seen it in my own family. And I think with most people of color, we all have a story.
Michele Halyard: Yeah. And so we have a lot of work to do. We have a lot of work to bring more people into the field who are going to really look at the issues that impact women and people of color and really take that up, as you know, their personal mission, their personal research agenda to help to break down some of these disparities in treatment, and also break down some of the systemic barriers that exist.
Lee Hawkins: How often are we seeing these conversations happening at medical conferences?
Michele Halyard: So I think over the last couple of years, particularly with the heightened emphasis on racism and the bringing it to the forefront in the American society, that we are seeing more discussion at medical conferences, particularly conferences like the RISE conference, where it’s really focused around justice, equity, diversity and inclusion. I think when I look at my own specialty in radiation oncology, we have more and more emphasis on health disparities, racism, inequities.
I really do think that there is a heightened sense but where we really need to translate it back into is the day to day practice. It’s one thing to go to a conference and hear about it. It’s another thing to take what you’ve learned and take it back into the practice and change what you do on a day to day basis.
Slowly, we’re getting there. We’ve made more progress over the last few years then we have had in the past and hopefully we’ll make more progress in the future.
Lee Hawkins: Do you see your colleagues who are not women or who are not people of color taking on the responsibility? Or are you the one being asked to sit on panels and to speak and do the public event?
Michele Halyard: You know, I think at Mayo, we’re very fortunate to have colleagues who are not people of color or who are not women who are doing these types of studies. I can think of a study that I participated in helping to design with an organization that I helped to form called the Coalition of Blacks Against Breast Cancer. It was a study looking at the experience of Black women with breast and ovarian cancer and their attitudes towards genetic testing.
And it was done by white researchers who realized that they did not have the cultural knowledge to necessarily effectively conduct that research in a way that it could be conducted better bringing in women of color. And so we brought in members of our organization to help give advice on the design of the study, the questions that were asked, how was the information presented back to the community?
And I think it produced a better product. It was it was quite comical at times because there were a little cultural nuances that we would tell the team about that they would say, oh, I never would think about that. Right? As white women they wouldn’t have thought about if you phrased something like this or you put these colors together, it has a significance in the Black community. Or if you ask something this way, it may be interpreted this way. And so I think it really was a nice partnership to accomplish research that is now spurring more research. But again, with a diverse research team.
Sharonne Hayes: A lot of the men researchers or white majority researchers do look to us as cultural brokers. I often will pick up the phone, gosh, the NIH says I need to recruit a lot of women to this. Sharonne, how might you help me? Can you help me do that? So the intent is good. I think the true partnership that Michelle described is what it should look like. Sometimes it is like, help me write a paragraph in my grant so I can make sure that it’s looks important. I think that’s the minority. But anyway that person now is aware of the issue. And I can work with that individual to help them understand why it’s not just to check the box for NIH, but why their research will be better because they make this effort by including women. And I’ve got a lot of colleagues who are who have drank the Kool-Aid or whatever, but they are making sure they’re publishing and saying the title of their manuscript is Sex and Gender Differences in Device Implantation or in Access to This and That.
So they’re looking at the research they’re already doing and starting to recognize there actually are sex differences in our outcomes. We should report those where I would say a decade ago, a lot of them would say that’s interesting but unimportant. And now they’re realizing it is important and are leading with it because often the reason it’s so important for the major researchers who often are majority researchers is they often have the funding and resources to do this kind of work.
So getting them with the program and excited about this new area of science that they may be able to contribute to. I mean, that’s the carrot, right? That’s like, wow, if you include more women, you actually will have a better study and might get three papers out of it or you’ll be able to help this many more people.
Lee Hawkins: Are there things that people listening to this podcast, especially if they’re in the medical field, can do that are actionable right now to affect this issue?
Sharonne Hayes: I would say talk to your female patients about why participation and medical research writ large, not just clinical trials, is important for you, for your family and for your community. Because physicians, particularly primary care physicians or personal physician, are trusted individuals for patients. And so even if you don’t do research, having a conversation and educating your women patients about what research is and why, if somebody asked them because of a condition that they had or maybe just is a normal control to participate, that they should that they should consider it. Because every physician can do that, even if they don’t do research.
Michele Halyard: And I would also say that if you’re in a position to enroll someone on a clinical trial and you’re sitting in front of a patient, and it flits across your mind to talk to them about a trial and you don’t to stop and do a gut check and say, why am I not asking that patient about this clinical trial? What biases may I have that stop me from offering this clinical trial to this patient?
Sharonne Hayes: The number one reason that women do not participate in clinical trials is they were never asked.
Lee Hawkins: So that’s the starting point, I guess, right?
Sharonne Hayes: That is the starting point.
Lee Hawkins: How easy is that? Okay. Well, thank you very much. You’re just both brilliant. And I look forward to seeing more of you both as time goes forward. Thank you so.
Sharonne Hayes: Thank you.
Michele Halyard: Thank you.
Lee Hawkins: And I’m Lee Hawkins. This has been Mayo Clinic’s Rise for Equity podcast. We’ll see you next time.
