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Discussion Guide and Transcript
Season Two - Episode Two
Research Ethics Reimagined Season Two - Episode Two “Progress, Gaps, and the Future of Women's Health with Doretha Walker, MPA, PhD and Brenda Jamerson, PharmD”
- In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore the evolution and future of women's health research since the NIH Revitalization Act of 1993. Our guests are Doretha Walker, MPA, PhD, a social impact and advocacy specialist, and Brenda Jamerson, PharmD, an adjunct assistant professor at Duke University School of Medicine with expertise in pharmacogenetics and drug development. Listen on Spotify | Listen on Apple| Listen on Amazon Discussion Questions
- 1.) Advancements in Women's Health Research
- Jamerson mentions women's participation in clinical trials has increased from less than 20% to nearly 50% since 1993. How has this increased representation contributed to advancements in women's healthcare, and what areas have benefited most?
- Walker discusses how conversations about women's health issues like menopause have become more open and normalized. How might reducing stigma around women's health topics contribute to better health outcomes?
2.) Diversity and Inclusion in Clinical Trials
- The speakers discuss how women metabolize drugs differently than men due to biological factors. How might this understanding change approaches to dosing and treatment across different medical conditions?
- Walker emphasizes the importance of involving communities in research design from the beginning. What strategies could researchers use to meaningfully engage diverse communities in the research process?
3.) Future Directions in Women's Health Research
- Our guests identify several ongoing gaps in women's health research, including mental health and cardiovascular disease. What approaches might help address these persistent gaps?
- Jamerson suggests that decentralized clinical trials could make research more accessible. How might technology and alternative research methodologies help overcome barriers to participation in clinical research?
Key Terms and Acronyms
- NIH Revitalization Act of 1993: Federal legislation requiring the inclusion of women and minorities in all NIH-funded clinical research.
- Sex as a Biological Variable: A 2016 NIH policy requiring researchers to account for sex-based differences in their study designs and analyses.
- Decentralized Clinical Trials: Research studies conducted outside traditional research centers, often using digital tools to collect data from participants in their homes or communities.
- Health Disparities: Preventable differences in health outcomes experienced by socially disadvantaged populations, such as the higher maternal mortality rates among Black women mentioned in the discussion.
Additional Resources
- NIH Office of Research on Women's Health - Federal office dedicated to promoting women's health research at NIH and throughout the scientific community.
- Society for Women's Health Research - Organization that promotes research on biological sex differences in disease.
- Diversity in Clinical Trials - FDA information on initiatives to increase diversity in clinical trials.
- PRIM&R's Research Ethics Timeline - A resource for exploring the milestones of research ethics, including developments in women's health research.
Transcript
Transcript, Season Two - Episode Two: “Progress, Gaps, and the Future of Women's Health with Doretha Walker, MPA, PhD and Brenda Jamerson, PharmD"
Welcome to Research Ethics Reimagined, a podcast created by Public Responsibility in Medicine and Research, or PRIM&R. Here, we talk with scientists, researchers, bioethicists, and some of the leading minds exploring the new frontiers of science. Join us to examine research ethics in the twenty first century and learn why it matters to you.
Hanna Holman: Welcome back to Research Ethics Reimagined. I'm your host, Hannah Holman.
Claire Carter: And I'm Claire Carter. Today, we're thrilled to be joined by two extraordinary guests whose work sits at the forefront of equity, advocacy, and ethical research.
Hanna Holman: First, have Dr. Doretha Walker, a social impact and advocacy specialist with expertise in public management, leadership, and the lived experiences of underrepresented groups in policymaking. Dr. Walker's work bridges the intersection of diversity, equity, and inclusion with scientific rigor, and she's widely recognized for her scholarly publications, conference presentations, and thought leadership on topics like implicit bias, cultural competency, and fostering equity in research communities.
Claire Carter: We're also joined by Dr. Brenda Jamerson, currently an adjunct assistant professor in the Department of Psychiatry and Behavioral Sciences at Duke University School of Medicine, and previously Associate Professor of Clinical Research at Campbell University College of Pharmacy. Doctor. Jamerson completed her postdoctoral fellowship in drug development at University of North Carolina, and has published her work in the fields of pharmacogenetics and drug development. Her current research interests and expertise are in the areas of promoting health and research literacy research ethics and most recently, the use of artificial intelligence to assist patients with accessing health research, and clinical trials.
Hanna Holman: In this episode, we'll explore the evolution of women's health research since the NIH Revitalization Act of 1993. We'll discuss how women's health understanding has evolved, key advancements, and the impact of the lack of diversity in clinical trials. Our guests will also highlight critical gaps in women's health research and how we can address them. Dr. Walker, Dr. Jamerson, welcome to the podcast. Thank you so much for being with us today. Let's get into our first question. It wasn't until 1993 that President Bill Clinton signed the NIH Revitalization Act requiring the inclusion of women and minorities in all NIH funded clinical research. Since then, how have you seen the understanding of women's health evolve?What key advancements or shifts stand out for you?
Doretha Walker: I'll start. I think for me—and I'm probably older than all of you— the advancements in breast cancer detection and the treatment stand out. I remember getting my first mammogram compared to getting them now and how it's just— I'm not gonna say comfortable— but it's a lot more comfortable. Then also now being able to see the scans and actually having the conversation around it. Because before when I would go in, you'd get it and you'd be like, 'Yeah, we'll just call you if there's a problem.' But now being able to have the conversation with people who actually understand what's happening and comfort level because one of my friends died from breast cancer.
So my very first mammogram after her death was highly charged. I was going in there and even though I didn't think I had it, but just the fact that she had died from it...having someone actually recognize and actually having the conversation. That didn't happen to me before. So now there's more of a conversation. You actually get to see the scans, the 3D mammograms. Now they're like, 'Okay, we're going to warm this up so it's not so cold,' the whole process. So for me, that's what stands out first and foremost.
Brenda Jamerson: I'm glad you brought that up about breast cancer, and breast cancer research has just exploded since 1993. I mean, some of the big issues we've seen in breast cancer research have been in pharmacogenetics and genetics, where I'm sure everyone on the call has heard of the BRCA gene. You’ve heard of the fact that now we have immunotherapies for breast cancer. So, individuals who were previously receiving what would have been a death sentence for breast cancer, now, through genetic research, we actually have not just palliative care but curative care for individuals. I would just highlight, you know, it's my background as a drug development pharmacist and someone who's interested in this whole genetic field, that we’ve seen the number of women in clinical trials go from less than 20 percent to now nearly 50 percent.
So that's kind of a big evolution and a lot of the breakthroughs that have been highlighted are all because of that
Doretha Walker: And also for me, the menopause and hormone therapy conversation, I remember when I had my period, I just got a book. I was like, read about it. And now that I'm in menopause, just having the conversation, because again, not really understanding what was happening and all of a sudden my body's doing things that I didn't even understand and just being able to have the conversation. And now there's, I mean, Halle Berry's even championed menopause and she's got this whole initiative. So I'm really happy that we're having the conversation, not just in private spheres, but also on television. You're seeing more people talking about what's happening after you reach a certain age on TV. So it's not just that taboo subject that you just get the book or you're like in the back room with your friends trying to figure out what happens.
Brenda Jamerson: "Yeah, I certainly hope that this area, as you mentioned, becomes one where people are more comfortable with the conversation. That's really important. I think as more research is done, even in postmenopausal women, we’ll understand better. What previously happened is that people didn’t fully grasp the benefits of hormonal therapy in menopause until we actually started studying it. This research allows the everyday person to say, ‘Okay, I now understand the information about the risks and how this can help with my symptoms, whether it’s hot flashes or something else.’ It gives individuals the information they need to make their own decisions about how it might affect their sexual life or daily symptoms.
So, it's important for research to extend beyond just the reproductive years and into the menopausal years.
Doretha Walker: Now, we’re having conversations with our friends, and we’re saying, “Okay, this is working for my friend over here.” So when I go to my doctor, I can inquire and ask, “Would this work for me?” Now I’m empowered because there’s more information available. I’m not just relying on websites that may not have credible information. There are avenues where I can go to become more informed and empowered.
And then, what language do I use when asking the question? What do I do if my doctor pushes back? That’s another thing we’re talking about—we need to advocate for ourselves, but what happens when your doctor says, “No, we’re going to do this,” and you’re left wondering, “But why?”
It’s about being empowered and not feeling like you have to accept whatever is offered. In the past, it felt like, “Okay, this is all there is. Just take it and go with it.” But now, you can say, “Well, I’ve heard this, I’ve read these studies, I’ve done my homework,” and challenge the decision. It’s not about challenging your doctor, but rather having a dialogue and saying, “This is my body. I need to be involved in the discussion about how we move forward.” I think that’s really important, and we’ve made great strides in providing the tools to make that happen.
Brenda Jamerson: I've also seen, since this has happened, that research has exploded in areas like postpartum depression, which was once considered a taboo topic that no one talked about. Being able to conduct research in the area of reproductive health is crucial. Recently, we've seen some drugs approved for this area. I think we need to continue supporting our NIH research scientists. This is likely where the revitalization act originated, as you mentioned, Hannah—continuing to push the envelope.We haven't arrived yet. I think that's what we're both saying. We need to keep having these research conversations to ensure people know where the research needs to go."
Doretha Walker: And take away the shame. There's no shame in saying, 'I'm feeling a little different.' Remember a long time ago, there was this book, It's Okay Not to Be Okay. I think we need to embrace that saying: It's Okay Not to Be Okay. There are resources out there. It's okay not to be okay.
You shouldn't be not okay forever, but it's okay not to be okay. And then go and get the resources. But again, we have to provide those resources—those credible resources, those viable resources, those really good resources—across the spectrum. Because, as we know, there are certain people who don’t have access to good healthcare, let alone mental healthcare. We just need to keep moving forward, and we need to be good stewards of the information and make sure that we're using our platforms, whatever they are, to make sure that people in our circles have that information. Because once you put it in your circles, it's going to bleed out.We just need to make sure that all of us have good information and access to good information. And then, when you ask the question, make sure the person's actually listening to you. Because that's the other thing: you're asking questions, and nobody's listening to you because that's not how it's normally done. I believe in honoring the lived experiences of others. We just have to make sure that when we're asking the questions, we're listening to the answers, and then we're helping come up with better solutions.
And then the last one is about fertility and reproductive health. I'm glad that there's research actually being done on that to make sure that those who want to have children are given the best options so that they can have children. Those who choose to have children need to have the best options and the best care. And we know that Black women die three times more when they're giving birth than white women. We need to delve into that. I know there's a lot of research being done on that, but I think we need to come up with better solutions so that every person who decides to have a child and goes through maternity has a safe birth and that their children are provided with optimum care so that no child dies and no woman dies giving childbirth.
Brenda Jamerson: Yeah, that’s so true, Dorothea. I mean, in terms of when you talk about health disparities among women, we know maternal health and having safe childbirth is one of the big areas where we still see a lot of disparities. So, you know, that’s a public health effort. It’s kind of a boots-on-the-ground effort to get the word out on how people can be more safely helped. From the research, we know what some of those are and what people can do, like folic acid, for example, and the nutritional elements during pregnancy. The research over the past 20 years has actually given us those answers. And I think through public health efforts, we can get the word out to individuals and provide access to care so they can see providers who can give them that information.
Doretha Walker: Absolutely. Again, it’s all about the information and how the information is getting out. Because we know the digital divide is wide, and it’s just going to get wider. So, we just have to figure out how to get the information out to people. And then, once you get the information out, how do you get them into spaces—safe spaces—where they’re talking about their issues, whether they’re trying to get pregnant or they are. And again, it’s all about that safe space because we all have stories where people go into a medical establishment and get turned away or get talked down to, and then they leave, and something horrific happens. So, again, we have to get the information out there, but we also have to create those safe spaces for people to go.
Claire Carter: Absolutely. Let's move into our next question. So how does the lack of diversity in clinical trials impact the advancement of women's health? Doretha Walker: I'm going to let Brenda start with that one. Brenda Jamerson: We'll start on the plus side. The plus side is, when I think of diversity, I think of men and women. I think of all the categories, including individuals who are African American, Caucasian, Hispanic, women, etc. So, on the plus side, we have seen that improvement in women, as I mentioned, now up to about 50 percent. But where the lack of diversity still exists for women is in the underdiagnosis of cardiovascular disease. And still, they’re not in cardiovascular clinical trials. So, that lack of diversity related to women being in cardiovascular trials exists because the presumption or assumption that more men get heart attacks or myocardial infarctions than women is actually a myth. More women are dying from cardiovascular disease than from cancer. So, we need to pay attention to the way women present differently when they have cardiovascular disease compared to men. You know, they might not have the left arm radiating pain; they might just have anxiety issues. So, that lack of diversity is affecting the way we can understand and treat women with cardiovascular disease. The second area that’s been in the news more recently is underrepresented minorities in clinical trials. We need to have everyone getting access to studies across the board because, particularly for cancer treatments, the access to immunotherapies is huge and could make a huge difference in the way people can eventually, perhaps, live longer. So, research in these areas is not just investigative studies; it could actually provide a health benefit for individuals who have access to research and studies.
Doretha Walker: And again, we’re creating those safe spaces for people to enter into because I think the safer the space is, the more welcoming it feels. You feel like, 'I can do this. They’re not going to look down on me. They’re not going to talk down to me. They’re not going to do all those X, Y, Z things that we hear are happening to historically excluded populations.' So, again, on the side of historically excluded populations, it’s good. But also, I think on the side of the researcher, it’s also good because you get firsthand experience of being with those populations. And I think that’s what’s going to dispel the myths and the stereotypes and all the other things that happen. Hanna Holman: Yeah, absolutely. Doretha Walker: Would you dose a woman differently than a man?"
Brenda Jamerson: Well, I think, yeah, sex is a biological variable, with women actually metabolizing drugs differently than men. That’s a major thing we have to pay attention to when we do clinical studies to make sure we get the dosing right in men versus women. We need to understand whether or not drugs have differences in women, basically because of hormones, you know, hormonal effects, because they’re going to affect drug disposition. Of course, body weight, the amount of fat one has on their body, and then the way the liver acts. For those reasons, your dosing could be different. An item we were just chatting about a second ago, what the NIH has done lately, is making sure that researchers categorize people by sex so that we can say for sure we know what happened with each sex group, what happened with each weight group differently. And without that diversity, without knowing that, you could kind of only find that out after the drug’s been approved, and now you’ve dosed millions of people and you have to sort of reel everything back because you found out something you didn’t know ahead of time.
Hanna Holman: Absolutely. More diverse research is better research. You for your answer on that question. Just going forward a little bit, women's health has historically been under researched in many areas. We do have the 1993 Revitalization Act and we have the 2,001 NIH policy guidelines on inclusion of women and minorities in clinical research. But what do you still see as the most critical gaps in women's health research today? And do you have any tactics you would recommend to address those gaps now? Brenda Jamerson: I'd say one of the biggest gaps that we see—I just mentioned cardiovascular disease is a big gap—and you mentioned those two policies that came out, Hannah. Another one that's now sort of in the mainstream understanding of how we can better utilize it to make sure women get well-researched is the 2016 Sex as a Biological Variable Act, rulemaking, which actually said researchers have to pay attention to this and categorize everything as I've mentioned. I think one area that's still not very well-researched is in mental health. So, you know, there are a lot of differences in the prevalence of depression that happens in women versus men. As I just mentioned, postpartum, a second ago, that happens in women versus men. So understanding why that's the case and why we’re seeing differences in men versus women is an issue. Doretha Walker: So, when people become pregnant, they're very rarely involved in any kind of clinical trials. On the one hand, you could sort of understand that because you don’t know what the impact is going to be on the fetus. But then, also, that leaves out women who have other health issues while pregnant and are not getting the care they need. So, we need to stop treating pregnant people as just hosts of babies and instead treat them holistically. There's a movement to include more pregnant people in clinical trials. And again, I know you have to be very careful in doing that because you don’t want to intentionally harm anybody. But there has to be a way to do it so that a person doesn’t necessarily always have to stop their care and well-being just because that person happens to be pregnant. The tactic for that has to be slowly introducing pregnant people into clinical research, one step at a time. And perhaps this is the third phase, after you’ve done your research on all different other people who are not pregnant, and then slowly integrating pregnant people into the research.But I think it’s unfortunate because I’ve had friends who were pregnant and said, 'Okay, I’ve got to get off this medication that’s for my X, Y, or Z because now that I’m pregnant, we don’t know what the impact is going to be on my baby.' And I understand that, but people don’t stop being people just because they become pregnant.
Brenda Jamerson: I think one of the ethical issues in terms of that is we want to give people their choice. We're not saying, 'Hey, we'll make a choice for you on whether or not you can be in the clinical trial.' In terms of pregnant women being in a study, we know there's a pathway to understand the safety of how that can affect a fetus. Does it cross the placental barrier? All those kinds of things. Once we've cleared certain hurdles—like, does it cross the placental barrier? Will it show up in breast milk? Do we have enough data now to know how this is going to affect someone who could be pregnant?—then we can help that population get the information they need to make choices about whether they want to be in studies.But I also want to address the question of how we can change the picture of how people can be involved in studies, particularly those who may not have been included previously. You mentioned, Dorotha, something I thought was really key: on the research investigator side, maybe they are the gatekeepers who keep people out of research. If their attitudes change, then things might change as well. We know that many people who want to be in studies are never asked to participate. Or maybe providers feel like they can say no without even asking the person. What I'm a proponent of now is using artificial intelligence to get information into plain language. This would ensure that not only the gatekeepers have the information, but also that people can have it themselves in a way they can understand. They can then go to their research investigator, doctor, or whomever is doing the research, and say, 'I heard about this. This is something that interests me, and I’d like to enroll.' So I think changing the power dynamic is crucial. What I've heard about quite a bit is that the power now resides in the hands of the patients. This shift could change who gets into studies.
Doretha Walker: And I think that's why it's important to have platforms that provide credible information—not all this fear-mongering stuff—and that we were able to point them to those credible websites. Because if you—you can come up with all kinds of things. I remember one time I had a headache or something, and I went in there and I was like, "Oh no, now I need a lobotomy," or whatever, because there was all this stuff. My symptoms could be 2,500 different things. And I'm not that kind of doctor. So we just need to make sure that we provide avenues of credible information, like you said, in plain language, in spaces where people go, like community centers or even supermarkets. So when you're standing, when you're at checkout, surely we can come up with something that we can put—maybe supermarkets aren’t the best place—but put it where people just happen to read it, like at a bus stop or whatever. We need to be more intentional about where we place the information, in spaces where a lot of people are going to walk by it and actually see it. Even if they have questions about whether the study is for them or not, they can have the conversation. Maybe it’s for one of their friends. We just need to make sure that we can point people to avenues that have credible information. And also, if it's provided by people who look like them or share a language, that's important too. It goes back to the whole discussion about the investigator and the power dynamics—whether it's intentional or not, there’s that hierarchy of who’s “better” in a white coat. Am I going to go to you? Am I going to trust you? But if you have someone who looks like them, speaks the language, and maybe even is similar in age, that’s going to make a big difference.
Brenda Jamerson: Yeah, I love the idea. I was at a little meeting yesterday, and they were bringing up the use of doulas for maternal care. I just love that idea of people being out in the community who are, like you said, part of the community. If you're Latina, you can have someone who can help culturally and, using your language, speak with you about the best thing to do while you're going through your pregnancy. So all those things, I think we need to bring every single armament to the fight so that we can make sure people get the word, whether it's social media—because that's where people are. Having trusted sources on social media in the future is going to be important as well.
Doretha Walker: And also, about changing how you do your research. I just did a presentation last week on different ways of doing research. One of them was like, you give your participants a camera and let them chart what’s happening to them every day. Or you shadow someone; you go with them when they visit their provider so you can see how it's difficult to fill out forms or whatever is happening. There are different ways to do the research so that it's not so scary or foreign. It's like, okay, I’m honoring your story, but how do I tell your story? Let me follow you and let you guide me on the best way to do it. Granted, in clinical research, yes, you definitely have to follow certain guidelines. But how you approach the person and get to the information, there’s a variety of ways that you can do it. You just have to make sure you document it. We're talking about informed consent. There are so many different levels to that. So there are many different ways to approach people to ensure that you get a diverse group of participants. You just might have to change the way you’re delivering it.
Brenda Jamerson: You know what, I'm glad you brought that up because it reminded me of something I think is going to be a game changer in this area: decentralized clinical trials. There’s so much that people can do now. You can even have telehealth visits on your smartphone, so you don’t have to go see that provider anymore to be in a study, or even send in a kit so you can mail in your samples. I think these methods make it more convenient for people because many of those we want to involve in research can’t get off work during the 9-to-5 hours when offices are open. So having different strategies, like decentralized studies, where you can participate from home, do home visits, use your smartwatch, and use your smartphone to show people what you’re doing, is 100% a great idea. We need to do more of that.
Claire Carter: You guys are making such wonderful points. And that brings us into our next question. So how can research and heathcare be more inclusive of factors like gender, race, socioeconomic status, and LGBTQ plus health? And do you think this effort will be more difficult in light of recent federal changes? Doretha Walker: I think it’s going to be more difficult in light of federal changes. I mean, we’re already seeing it now with cuts to funding for studies, but I still think we have to keep moving forward and trying to find alternative ways to fund. And I know that sounds like pie in the sky, but we can’t stop. We can’t stop. I think it goes back to what we were saying before—more inclusive enrollment. How do you do that? Where are you advertising for your study? If it’s only on campus, that’s all you’re going to get. Do you do it in a grocery store? Maybe not, but it depends on what it is. I also think researchers need to be more diverse. If they’re always the same people and they look the same and aren’t representative of the community you want to research, you’ll have a hard time getting diverse participants. When the COVID vaccine came out, I was talking to my brother, because he hadn’t taken it, but his job required him to. We had the conversation about which one to choose, and we went with Moderna because they actively sought out African Americans and people of color to be part of their research study. That was publicized. I’m not saying the others didn’t, but we heard about Moderna. So again, putting it out there: when drugs, devices, or whatever are approved, who were the people involved in the research? If you hear there were a lot of Latinos or indigenous people involved, it gives you reassurance. It makes you feel safer about doing it.But again, it goes back to creating those safe spaces. When I say I want to be in a clinical trial and show up, I shouldn’t be talked down to or pushed aside. We have to create those safe spaces. Brenda Jamerson: Yeah, and also, I think related to making sure it's more inclusive in light of recent federal changes, as was asked. I think research at the academic institution, I think that's been in the news. That's going to be a lot tighter because those funding budgets are not quite the same. But I'm going to go back to my original thought here, which is that if you get the research ideas out to the people, in many ways, a lot of people in underrepresented communities were not necessarily going to the Yales and the Harvards for research anyway. They need to do it in the community. And I think using maybe this opportunity to make a pivot, to involve more community centers in research, right? They've been left out. There is a whole federally qualified health center network that is in poor and underserved communities, low SES communities, around the United States. Involve them more in research because they are right there in the neighborhood. So I think we need to start thinking more creatively. Yes, maybe the whole academic research paradigm is not going to ever be the same, but we can still continue on to involve people that need to be in studies by going to where they are, not asking them to come to where the research is.
Doretha Walker: And also involving them on the front end—going into communities, letting them help you design the research—because then you get that buy-in because they were part of it. And again, I don't mean having someone do some nuclear biology when that's not their field, but what I mean is just saying, "Okay, this is what we want to study. How do you suggest we go about doing it? What questions do we need to ask?" Or going in there and finding out, like, what is your main health problem? And let's come up with research so that we can tackle that. Because when you get the community buy-in, then you're going to get more people who are going to be in the research because they're going to say, "Oh yeah, I know Dr. So-and-so. We worked together on the research project." And that's advertisement, too. Cause, you know, word-of-mouth… I mean, you just think about it. If you want to go to a restaurant, you look at the reviews. So, again, same with research. We can look at the word-of-mouth: Who participated in this research? What, you know, what percentage of whomever? Who was involved in it? So, on a lot of IRB applications, I see academic ones. It's like, "Was the community involved in this research? And if yes, how? And if not, why not?" So, again, you're involving the community because if they're buying in, they're going to tell their friends in the community. And that's when you're going to get the recruitment that you need. But you have to be upfront. It can't be this whole cloak-and-dagger thing. They just need to be involved in all aspects of the research process—from the design to the implementation. And again, to the follow-up. Like I say, return the results from where it was harvested. Again, once you finish the research, go back and say, "This is what happened." Don't just write about it in some medical journal that the people who were involved in the research never get to see.
Brenda Jamerson: That last point about getting the research information back to people actually has a circular effect, right? If you've been in a study and never seen the research results, and a lot of people have that experience, what does that do the next time you're asked to be in a study? The issue has been that information resides in some peer-reviewed journal somewhere, and it doesn't necessarily make its way to the people involved. So, using our tools—like our AI, for example—sometimes we can actually help put that information into plain language, so people can better understand it. And then, involving them on the front end is important. For instance, I think women might have different questions. They might want to know, if they’re involved in a study, how it could affect them during different phases of their menstrual cycle. You know, maybe that should be a question asked in the research. These are the kinds of questions that, because the research has primarily been driven by male investigators, might not even occur to them. So involving people from the start, ensuring the research is inclusive from front to back, is critical. We just need to keep pushing that narrative because it’s so easy to forget.
Doretha Walker: Yeah, because it's hard work. It's hard involving the community. You're getting the pushback, and then they're asking you questions that you never even thought about because that's not where your mind was. And I think about, too, when you're studying—and I always say you research with people, not on them—like when you're in indigenous communities and you're violating some kind of cultural norm, and you don't know it because you don't have that guide with you to say, "Okay, no, we don’t do things that way. You have to ask the elder first," and the elder has, you know, whatever the protocol has to be. You just have to make sure that you're following it. And if you don't, you're not going to get that diverse group of people. So again, it's like changing that mindset of creating optimal research. And "optimal" means we have to have different kinds of people so that we can create the best research, which is going to put out the best product that's going to benefit everybody.
Hanna Holman: I love what you said about these federal changes being an opportunity too. It's definitely a loss, but it's also an opportunity to move more into the community. And if we're doing research on a more local level, it's just going to become more diverse because of the people that live in, small communities, rural communities. I love that. Doretha Walker: It creates more value to the people who you're trying to better their lives anyway. Hanna Holman: Absolutely. And when research is done on a federal level, people can't always see the way that it impacts them individually. Yeah. No, I love that. That was great. We do have, again, a lot of federal changes going on in a recent executive order, which is 14168, defending women from gender ideology extremism and restoring biological truth to the federal government. This executive order includes changes to sex based definitions. And I wanted to ask both of you, how do you think these changes will impact gender specific care, if at all? Doretha Walker: I think this erases a segment of people. And when you start erasing one segment of people, it becomes so easy to erase other segments of people. So, I think that this is going to be problematic. And then I also wonder about insurance coverage. There are drugs that are used to support transitioning from male to female, female to male, or that are also used in cisgender people who need that medication. So now I'm wondering if insurance companies are going to say, "Nope, you can't use that because it's in support of this," even though that's not what it's going to be used for. So I think it's going to have far-reaching implications other than just harming a segment of people. It's gonna harm other people as well.
Brenda Jamerson: Well, yeah, it seemed to me it was sort of saying almost similar kinds of things to the— as I mentioned, the sex as a biological variant, which came out of NIH research in 2016. Know sex is women born with an XX chromosome. And based on that, you have different hormonal and physiological ways that you differ from people born with an XY chromosome. So, this particular executive order is sort of now talking about gender, which is different than biological sex. And talking about gender, it would, as Dorita said, affect the one percent or so of people who would be affected by being XY, but then also now have been involved in gender-based research as transgenders. They would be affected. The ninety-nine percent-plus people that have been the research on the women’s NIH women’s sex as a biological variant would not be affected by this particular executive order. Doretha Walker: That’s where I see the impact being, is we would lose. They will be affected because there are drugs that are used in support of transitioning, and cisgender people use those drugs for something different. And if the whole gender-affirming care—if any drug falls under that, insurance is gonna look at it a lot harder, whether or not it’s being used in support of somebody transitioning or not. It could be used for something else. My fear is that the insurance is going to say, “Oh, no, it’s on one of these drugs on this list, so you can’t have it.” So I think we all are going to be affected—or those of us who need drugs. I think this is going to affect everybody. I think it’s going to impact all of us.
Brenda Jamerson: Well, of course, say never. The drugs like estrogen, testosterone, progesterone, Lupron—all those drugs have been on the market and available, you know, before they were used for gender-affirming care. So, like I said, never say never, that those drugs being available to people that need them outside of that—they've already been available for people outside of that. But I take your point that you never know in our crazy climate that we're in right now where things go. But my point is just that those drugs have been available prior, and putting on my pharmacy hat, I don’t see, for the use case or the uses that they’ve been prescribed for previously, that they would be banned.
Doretha Walker: I hope you're right. I hope you're right, but I just don't, I don't think so. But I hope you're right. I'm gonna be optimistic, and since she's the pharmacist, I'm gonna say, I hope you're right. But based on what I'm seeing already, I don't think so. Claire Carter: Well, thank you so much. Do you want to end with one final question on an up note? What gives you hope about the future of women's health? Doretha Walker: That we're having conversations. We're not like in the back room talking about menopause or talking about infertility. We're actually having conversations. And now, you can go and you can question your doctor, and you can get second opinions. So, you can shop around; you can actually find what's best for your situation. And it's not a one-size-fits-all.
Brenda Jamerson: Yeah, I have a lot of hope for when I’ve seen what we’ve done so far or seen in the research community and clinical community—these great breakthroughs that have happened in cancer research with immunotherapies curing cancer and cardiovascular disease, where women are now being included in a way they hadn't before. And when I see mental health now being on the radar screen for people to evaluate, we didn’t talk about the fact that women have a lot more autoimmune diseases, like lupus and different inflammatory conditions. And the fact that you now see a lot of research being put into that, with money being put into those research areas now. So, I have hope that that’s going to continue the trajectory, because women make up more than 50% of the population—a little bit over 50% of the population. And so, as our needs are driving the research agenda, we’re front and foremost in terms of how that carries over to even men who need some of these treatments as well.What happens with us will happen to and help change the way of the entire world. We'll have better cures and better treatment. Claire Carter: Oh, wonderful. Well, this was such a great conversation. I think this is a great place to wrap up. Dr. Walker and Dr. Jamerson. Thank you both so much for joining us today. The insight you've shared, along with the dedication and the expertise that you bring to this work is truly impactful. I know our listeners will leave with a greater understanding of the importance of advancing research and innovation in women's health. Doretha Walker: Thank you. And thank you for bringing us together. Brenda Jamerson: Thank you. Thank you. Doretha Walker: Claire. Thank you. Brenda Jamerson: Thank you Hanna Holman: Thank you guys so much. Brenda Jamerson: It's been great. We appreciate you. PRIM&R: Thank you for listening to Research Ethics Reimagined, a podcast created by Primer and produced by Syntax in Motion. Please subscribe and share with your friends and colleagues. To learn how to become a member of Primer, please visit us at www.primer.org. Be sure to join us next month as we continue our conversation with scientists, researchers, bioethicists, some of the leading minds exploring new frontiers of science.
Brenda Jamerson: I've also seen, since this has happened, that research has exploded in areas like postpartum depression, which was once considered a taboo topic that no one talked about. Being able to conduct research in the area of reproductive health is crucial. Recently, we've seen some drugs approved for this area. I think we need to continue supporting our NIH research scientists. This is likely where the revitalization act originated, as you mentioned, Hannah—continuing to push the envelope.We haven't arrived yet. I think that's what we're both saying. We need to keep having these research conversations to ensure people know where the research needs to go."
Doretha Walker: And take away the shame. There's no shame in saying, 'I'm feeling a little different.' Remember a long time ago, there was this book, It's Okay Not to Be Okay. I think we need to embrace that saying: It's Okay Not to Be Okay. There are resources out there. It's okay not to be okay.
You shouldn't be not okay forever, but it's okay not to be okay. And then go and get the resources. But again, we have to provide those resources—those credible resources, those viable resources, those really good resources—across the spectrum. Because, as we know, there are certain people who don’t have access to good healthcare, let alone mental healthcare. We just need to keep moving forward, and we need to be good stewards of the information and make sure that we're using our platforms, whatever they are, to make sure that people in our circles have that information. Because once you put it in your circles, it's going to bleed out.We just need to make sure that all of us have good information and access to good information. And then, when you ask the question, make sure the person's actually listening to you. Because that's the other thing: you're asking questions, and nobody's listening to you because that's not how it's normally done. I believe in honoring the lived experiences of others. We just have to make sure that when we're asking the questions, we're listening to the answers, and then we're helping come up with better solutions.
And then the last one is about fertility and reproductive health. I'm glad that there's research actually being done on that to make sure that those who want to have children are given the best options so that they can have children. Those who choose to have children need to have the best options and the best care. And we know that Black women die three times more when they're giving birth than white women. We need to delve into that. I know there's a lot of research being done on that, but I think we need to come up with better solutions so that every person who decides to have a child and goes through maternity has a safe birth and that their children are provided with optimum care so that no child dies and no woman dies giving childbirth.
Brenda Jamerson: Yeah, that’s so true, Dorothea. I mean, in terms of when you talk about health disparities among women, we know maternal health and having safe childbirth is one of the big areas where we still see a lot of disparities. So, you know, that’s a public health effort. It’s kind of a boots-on-the-ground effort to get the word out on how people can be more safely helped. From the research, we know what some of those are and what people can do, like folic acid, for example, and the nutritional elements during pregnancy. The research over the past 20 years has actually given us those answers. And I think through public health efforts, we can get the word out to individuals and provide access to care so they can see providers who can give them that information.
Doretha Walker: Absolutely. Again, it’s all about the information and how the information is getting out. Because we know the digital divide is wide, and it’s just going to get wider. So, we just have to figure out how to get the information out to people. And then, once you get the information out, how do you get them into spaces—safe spaces—where they’re talking about their issues, whether they’re trying to get pregnant or they are. And again, it’s all about that safe space because we all have stories where people go into a medical establishment and get turned away or get talked down to, and then they leave, and something horrific happens. So, again, we have to get the information out there, but we also have to create those safe spaces for people to go.
Claire Carter: Absolutely. Let's move into our next question. So how does the lack of diversity in clinical trials impact the advancement of women's health? Doretha Walker: I'm going to let Brenda start with that one. Brenda Jamerson: We'll start on the plus side. The plus side is, when I think of diversity, I think of men and women. I think of all the categories, including individuals who are African American, Caucasian, Hispanic, women, etc. So, on the plus side, we have seen that improvement in women, as I mentioned, now up to about 50 percent. But where the lack of diversity still exists for women is in the underdiagnosis of cardiovascular disease. And still, they’re not in cardiovascular clinical trials. So, that lack of diversity related to women being in cardiovascular trials exists because the presumption or assumption that more men get heart attacks or myocardial infarctions than women is actually a myth. More women are dying from cardiovascular disease than from cancer. So, we need to pay attention to the way women present differently when they have cardiovascular disease compared to men. You know, they might not have the left arm radiating pain; they might just have anxiety issues. So, that lack of diversity is affecting the way we can understand and treat women with cardiovascular disease. The second area that’s been in the news more recently is underrepresented minorities in clinical trials. We need to have everyone getting access to studies across the board because, particularly for cancer treatments, the access to immunotherapies is huge and could make a huge difference in the way people can eventually, perhaps, live longer. So, research in these areas is not just investigative studies; it could actually provide a health benefit for individuals who have access to research and studies.
Doretha Walker: And again, we’re creating those safe spaces for people to enter into because I think the safer the space is, the more welcoming it feels. You feel like, 'I can do this. They’re not going to look down on me. They’re not going to talk down to me. They’re not going to do all those X, Y, Z things that we hear are happening to historically excluded populations.' So, again, on the side of historically excluded populations, it’s good. But also, I think on the side of the researcher, it’s also good because you get firsthand experience of being with those populations. And I think that’s what’s going to dispel the myths and the stereotypes and all the other things that happen. Hanna Holman: Yeah, absolutely. Doretha Walker: Would you dose a woman differently than a man?"
Brenda Jamerson: Well, I think, yeah, sex is a biological variable, with women actually metabolizing drugs differently than men. That’s a major thing we have to pay attention to when we do clinical studies to make sure we get the dosing right in men versus women. We need to understand whether or not drugs have differences in women, basically because of hormones, you know, hormonal effects, because they’re going to affect drug disposition. Of course, body weight, the amount of fat one has on their body, and then the way the liver acts. For those reasons, your dosing could be different. An item we were just chatting about a second ago, what the NIH has done lately, is making sure that researchers categorize people by sex so that we can say for sure we know what happened with each sex group, what happened with each weight group differently. And without that diversity, without knowing that, you could kind of only find that out after the drug’s been approved, and now you’ve dosed millions of people and you have to sort of reel everything back because you found out something you didn’t know ahead of time.
Hanna Holman: Absolutely. More diverse research is better research. You for your answer on that question. Just going forward a little bit, women's health has historically been under researched in many areas. We do have the 1993 Revitalization Act and we have the 2,001 NIH policy guidelines on inclusion of women and minorities in clinical research. But what do you still see as the most critical gaps in women's health research today? And do you have any tactics you would recommend to address those gaps now? Brenda Jamerson: I'd say one of the biggest gaps that we see—I just mentioned cardiovascular disease is a big gap—and you mentioned those two policies that came out, Hannah. Another one that's now sort of in the mainstream understanding of how we can better utilize it to make sure women get well-researched is the 2016 Sex as a Biological Variable Act, rulemaking, which actually said researchers have to pay attention to this and categorize everything as I've mentioned. I think one area that's still not very well-researched is in mental health. So, you know, there are a lot of differences in the prevalence of depression that happens in women versus men. As I just mentioned, postpartum, a second ago, that happens in women versus men. So understanding why that's the case and why we’re seeing differences in men versus women is an issue. Doretha Walker: So, when people become pregnant, they're very rarely involved in any kind of clinical trials. On the one hand, you could sort of understand that because you don’t know what the impact is going to be on the fetus. But then, also, that leaves out women who have other health issues while pregnant and are not getting the care they need. So, we need to stop treating pregnant people as just hosts of babies and instead treat them holistically. There's a movement to include more pregnant people in clinical trials. And again, I know you have to be very careful in doing that because you don’t want to intentionally harm anybody. But there has to be a way to do it so that a person doesn’t necessarily always have to stop their care and well-being just because that person happens to be pregnant. The tactic for that has to be slowly introducing pregnant people into clinical research, one step at a time. And perhaps this is the third phase, after you’ve done your research on all different other people who are not pregnant, and then slowly integrating pregnant people into the research.But I think it’s unfortunate because I’ve had friends who were pregnant and said, 'Okay, I’ve got to get off this medication that’s for my X, Y, or Z because now that I’m pregnant, we don’t know what the impact is going to be on my baby.' And I understand that, but people don’t stop being people just because they become pregnant.
Brenda Jamerson: I think one of the ethical issues in terms of that is we want to give people their choice. We're not saying, 'Hey, we'll make a choice for you on whether or not you can be in the clinical trial.' In terms of pregnant women being in a study, we know there's a pathway to understand the safety of how that can affect a fetus. Does it cross the placental barrier? All those kinds of things. Once we've cleared certain hurdles—like, does it cross the placental barrier? Will it show up in breast milk? Do we have enough data now to know how this is going to affect someone who could be pregnant?—then we can help that population get the information they need to make choices about whether they want to be in studies.But I also want to address the question of how we can change the picture of how people can be involved in studies, particularly those who may not have been included previously. You mentioned, Dorotha, something I thought was really key: on the research investigator side, maybe they are the gatekeepers who keep people out of research. If their attitudes change, then things might change as well. We know that many people who want to be in studies are never asked to participate. Or maybe providers feel like they can say no without even asking the person. What I'm a proponent of now is using artificial intelligence to get information into plain language. This would ensure that not only the gatekeepers have the information, but also that people can have it themselves in a way they can understand. They can then go to their research investigator, doctor, or whomever is doing the research, and say, 'I heard about this. This is something that interests me, and I’d like to enroll.' So I think changing the power dynamic is crucial. What I've heard about quite a bit is that the power now resides in the hands of the patients. This shift could change who gets into studies.
Doretha Walker: And I think that's why it's important to have platforms that provide credible information—not all this fear-mongering stuff—and that we were able to point them to those credible websites. Because if you—you can come up with all kinds of things. I remember one time I had a headache or something, and I went in there and I was like, "Oh no, now I need a lobotomy," or whatever, because there was all this stuff. My symptoms could be 2,500 different things. And I'm not that kind of doctor. So we just need to make sure that we provide avenues of credible information, like you said, in plain language, in spaces where people go, like community centers or even supermarkets. So when you're standing, when you're at checkout, surely we can come up with something that we can put—maybe supermarkets aren’t the best place—but put it where people just happen to read it, like at a bus stop or whatever. We need to be more intentional about where we place the information, in spaces where a lot of people are going to walk by it and actually see it. Even if they have questions about whether the study is for them or not, they can have the conversation. Maybe it’s for one of their friends. We just need to make sure that we can point people to avenues that have credible information. And also, if it's provided by people who look like them or share a language, that's important too. It goes back to the whole discussion about the investigator and the power dynamics—whether it's intentional or not, there’s that hierarchy of who’s “better” in a white coat. Am I going to go to you? Am I going to trust you? But if you have someone who looks like them, speaks the language, and maybe even is similar in age, that’s going to make a big difference.
Brenda Jamerson: Yeah, I love the idea. I was at a little meeting yesterday, and they were bringing up the use of doulas for maternal care. I just love that idea of people being out in the community who are, like you said, part of the community. If you're Latina, you can have someone who can help culturally and, using your language, speak with you about the best thing to do while you're going through your pregnancy. So all those things, I think we need to bring every single armament to the fight so that we can make sure people get the word, whether it's social media—because that's where people are. Having trusted sources on social media in the future is going to be important as well.
Doretha Walker: And also, about changing how you do your research. I just did a presentation last week on different ways of doing research. One of them was like, you give your participants a camera and let them chart what’s happening to them every day. Or you shadow someone; you go with them when they visit their provider so you can see how it's difficult to fill out forms or whatever is happening. There are different ways to do the research so that it's not so scary or foreign. It's like, okay, I’m honoring your story, but how do I tell your story? Let me follow you and let you guide me on the best way to do it. Granted, in clinical research, yes, you definitely have to follow certain guidelines. But how you approach the person and get to the information, there’s a variety of ways that you can do it. You just have to make sure you document it. We're talking about informed consent. There are so many different levels to that. So there are many different ways to approach people to ensure that you get a diverse group of participants. You just might have to change the way you’re delivering it.
Brenda Jamerson: You know what, I'm glad you brought that up because it reminded me of something I think is going to be a game changer in this area: decentralized clinical trials. There’s so much that people can do now. You can even have telehealth visits on your smartphone, so you don’t have to go see that provider anymore to be in a study, or even send in a kit so you can mail in your samples. I think these methods make it more convenient for people because many of those we want to involve in research can’t get off work during the 9-to-5 hours when offices are open. So having different strategies, like decentralized studies, where you can participate from home, do home visits, use your smartwatch, and use your smartphone to show people what you’re doing, is 100% a great idea. We need to do more of that.
Claire Carter: You guys are making such wonderful points. And that brings us into our next question. So how can research and heathcare be more inclusive of factors like gender, race, socioeconomic status, and LGBTQ plus health? And do you think this effort will be more difficult in light of recent federal changes? Doretha Walker: I think it’s going to be more difficult in light of federal changes. I mean, we’re already seeing it now with cuts to funding for studies, but I still think we have to keep moving forward and trying to find alternative ways to fund. And I know that sounds like pie in the sky, but we can’t stop. We can’t stop. I think it goes back to what we were saying before—more inclusive enrollment. How do you do that? Where are you advertising for your study? If it’s only on campus, that’s all you’re going to get. Do you do it in a grocery store? Maybe not, but it depends on what it is. I also think researchers need to be more diverse. If they’re always the same people and they look the same and aren’t representative of the community you want to research, you’ll have a hard time getting diverse participants. When the COVID vaccine came out, I was talking to my brother, because he hadn’t taken it, but his job required him to. We had the conversation about which one to choose, and we went with Moderna because they actively sought out African Americans and people of color to be part of their research study. That was publicized. I’m not saying the others didn’t, but we heard about Moderna. So again, putting it out there: when drugs, devices, or whatever are approved, who were the people involved in the research? If you hear there were a lot of Latinos or indigenous people involved, it gives you reassurance. It makes you feel safer about doing it.But again, it goes back to creating those safe spaces. When I say I want to be in a clinical trial and show up, I shouldn’t be talked down to or pushed aside. We have to create those safe spaces. Brenda Jamerson: Yeah, and also, I think related to making sure it's more inclusive in light of recent federal changes, as was asked. I think research at the academic institution, I think that's been in the news. That's going to be a lot tighter because those funding budgets are not quite the same. But I'm going to go back to my original thought here, which is that if you get the research ideas out to the people, in many ways, a lot of people in underrepresented communities were not necessarily going to the Yales and the Harvards for research anyway. They need to do it in the community. And I think using maybe this opportunity to make a pivot, to involve more community centers in research, right? They've been left out. There is a whole federally qualified health center network that is in poor and underserved communities, low SES communities, around the United States. Involve them more in research because they are right there in the neighborhood. So I think we need to start thinking more creatively. Yes, maybe the whole academic research paradigm is not going to ever be the same, but we can still continue on to involve people that need to be in studies by going to where they are, not asking them to come to where the research is.
Doretha Walker: And also involving them on the front end—going into communities, letting them help you design the research—because then you get that buy-in because they were part of it. And again, I don't mean having someone do some nuclear biology when that's not their field, but what I mean is just saying, "Okay, this is what we want to study. How do you suggest we go about doing it? What questions do we need to ask?" Or going in there and finding out, like, what is your main health problem? And let's come up with research so that we can tackle that. Because when you get the community buy-in, then you're going to get more people who are going to be in the research because they're going to say, "Oh yeah, I know Dr. So-and-so. We worked together on the research project." And that's advertisement, too. Cause, you know, word-of-mouth… I mean, you just think about it. If you want to go to a restaurant, you look at the reviews. So, again, same with research. We can look at the word-of-mouth: Who participated in this research? What, you know, what percentage of whomever? Who was involved in it? So, on a lot of IRB applications, I see academic ones. It's like, "Was the community involved in this research? And if yes, how? And if not, why not?" So, again, you're involving the community because if they're buying in, they're going to tell their friends in the community. And that's when you're going to get the recruitment that you need. But you have to be upfront. It can't be this whole cloak-and-dagger thing. They just need to be involved in all aspects of the research process—from the design to the implementation. And again, to the follow-up. Like I say, return the results from where it was harvested. Again, once you finish the research, go back and say, "This is what happened." Don't just write about it in some medical journal that the people who were involved in the research never get to see.
Brenda Jamerson: That last point about getting the research information back to people actually has a circular effect, right? If you've been in a study and never seen the research results, and a lot of people have that experience, what does that do the next time you're asked to be in a study? The issue has been that information resides in some peer-reviewed journal somewhere, and it doesn't necessarily make its way to the people involved. So, using our tools—like our AI, for example—sometimes we can actually help put that information into plain language, so people can better understand it. And then, involving them on the front end is important. For instance, I think women might have different questions. They might want to know, if they’re involved in a study, how it could affect them during different phases of their menstrual cycle. You know, maybe that should be a question asked in the research. These are the kinds of questions that, because the research has primarily been driven by male investigators, might not even occur to them. So involving people from the start, ensuring the research is inclusive from front to back, is critical. We just need to keep pushing that narrative because it’s so easy to forget.
Doretha Walker: Yeah, because it's hard work. It's hard involving the community. You're getting the pushback, and then they're asking you questions that you never even thought about because that's not where your mind was. And I think about, too, when you're studying—and I always say you research with people, not on them—like when you're in indigenous communities and you're violating some kind of cultural norm, and you don't know it because you don't have that guide with you to say, "Okay, no, we don’t do things that way. You have to ask the elder first," and the elder has, you know, whatever the protocol has to be. You just have to make sure that you're following it. And if you don't, you're not going to get that diverse group of people. So again, it's like changing that mindset of creating optimal research. And "optimal" means we have to have different kinds of people so that we can create the best research, which is going to put out the best product that's going to benefit everybody.
Hanna Holman: I love what you said about these federal changes being an opportunity too. It's definitely a loss, but it's also an opportunity to move more into the community. And if we're doing research on a more local level, it's just going to become more diverse because of the people that live in, small communities, rural communities. I love that. Doretha Walker: It creates more value to the people who you're trying to better their lives anyway. Hanna Holman: Absolutely. And when research is done on a federal level, people can't always see the way that it impacts them individually. Yeah. No, I love that. That was great. We do have, again, a lot of federal changes going on in a recent executive order, which is 14168, defending women from gender ideology extremism and restoring biological truth to the federal government. This executive order includes changes to sex based definitions. And I wanted to ask both of you, how do you think these changes will impact gender specific care, if at all? Doretha Walker: I think this erases a segment of people. And when you start erasing one segment of people, it becomes so easy to erase other segments of people. So, I think that this is going to be problematic. And then I also wonder about insurance coverage. There are drugs that are used to support transitioning from male to female, female to male, or that are also used in cisgender people who need that medication. So now I'm wondering if insurance companies are going to say, "Nope, you can't use that because it's in support of this," even though that's not what it's going to be used for. So I think it's going to have far-reaching implications other than just harming a segment of people. It's gonna harm other people as well.
Brenda Jamerson: Well, yeah, it seemed to me it was sort of saying almost similar kinds of things to the— as I mentioned, the sex as a biological variant, which came out of NIH research in 2016. Know sex is women born with an XX chromosome. And based on that, you have different hormonal and physiological ways that you differ from people born with an XY chromosome. So, this particular executive order is sort of now talking about gender, which is different than biological sex. And talking about gender, it would, as Dorita said, affect the one percent or so of people who would be affected by being XY, but then also now have been involved in gender-based research as transgenders. They would be affected. The ninety-nine percent-plus people that have been the research on the women’s NIH women’s sex as a biological variant would not be affected by this particular executive order. Doretha Walker: That’s where I see the impact being, is we would lose. They will be affected because there are drugs that are used in support of transitioning, and cisgender people use those drugs for something different. And if the whole gender-affirming care—if any drug falls under that, insurance is gonna look at it a lot harder, whether or not it’s being used in support of somebody transitioning or not. It could be used for something else. My fear is that the insurance is going to say, “Oh, no, it’s on one of these drugs on this list, so you can’t have it.” So I think we all are going to be affected—or those of us who need drugs. I think this is going to affect everybody. I think it’s going to impact all of us.
Brenda Jamerson: Well, of course, say never. The drugs like estrogen, testosterone, progesterone, Lupron—all those drugs have been on the market and available, you know, before they were used for gender-affirming care. So, like I said, never say never, that those drugs being available to people that need them outside of that—they've already been available for people outside of that. But I take your point that you never know in our crazy climate that we're in right now where things go. But my point is just that those drugs have been available prior, and putting on my pharmacy hat, I don’t see, for the use case or the uses that they’ve been prescribed for previously, that they would be banned.
Doretha Walker: I hope you're right. I hope you're right, but I just don't, I don't think so. But I hope you're right. I'm gonna be optimistic, and since she's the pharmacist, I'm gonna say, I hope you're right. But based on what I'm seeing already, I don't think so. Claire Carter: Well, thank you so much. Do you want to end with one final question on an up note? What gives you hope about the future of women's health? Doretha Walker: That we're having conversations. We're not like in the back room talking about menopause or talking about infertility. We're actually having conversations. And now, you can go and you can question your doctor, and you can get second opinions. So, you can shop around; you can actually find what's best for your situation. And it's not a one-size-fits-all.
Brenda Jamerson: Yeah, I have a lot of hope for when I’ve seen what we’ve done so far or seen in the research community and clinical community—these great breakthroughs that have happened in cancer research with immunotherapies curing cancer and cardiovascular disease, where women are now being included in a way they hadn't before. And when I see mental health now being on the radar screen for people to evaluate, we didn’t talk about the fact that women have a lot more autoimmune diseases, like lupus and different inflammatory conditions. And the fact that you now see a lot of research being put into that, with money being put into those research areas now. So, I have hope that that’s going to continue the trajectory, because women make up more than 50% of the population—a little bit over 50% of the population. And so, as our needs are driving the research agenda, we’re front and foremost in terms of how that carries over to even men who need some of these treatments as well.What happens with us will happen to and help change the way of the entire world. We'll have better cures and better treatment. Claire Carter: Oh, wonderful. Well, this was such a great conversation. I think this is a great place to wrap up. Dr. Walker and Dr. Jamerson. Thank you both so much for joining us today. The insight you've shared, along with the dedication and the expertise that you bring to this work is truly impactful. I know our listeners will leave with a greater understanding of the importance of advancing research and innovation in women's health. Doretha Walker: Thank you. And thank you for bringing us together. Brenda Jamerson: Thank you. Thank you. Doretha Walker: Claire. Thank you. Brenda Jamerson: Thank you Hanna Holman: Thank you guys so much. Brenda Jamerson: It's been great. We appreciate you. PRIM&R: Thank you for listening to Research Ethics Reimagined, a podcast created by Primer and produced by Syntax in Motion. Please subscribe and share with your friends and colleagues. To learn how to become a member of Primer, please visit us at www.primer.org. Be sure to join us next month as we continue our conversation with scientists, researchers, bioethicists, some of the leading minds exploring new frontiers of science.
Research Ethics Reimagined guests are esteemed members of our community who generously share their insights. Their views are their own and do not necessarily reflect those of PRIM&R or its staff.