Let's Talk About How Women Must Be Included in COVID-19 Research

The COVID-19 pandemic is both exacerbating and laying bare the ways in which marginalized communities continue to be further marginalized when it comes to healthcare access. Specifically, women, people of color, and transgender and gender non-conforming folks are often underrepresented or completely excluded from clinical trial and vaccine development. Jamille Fields Allsbrook, Director of Women’s Health and Rights at the Center for American Progress, sits down with us to discuss the ways in which disparities in representation lead to disparities in the development of clinical trials and vaccines. 

Already, communities of color were facing inconsistent access to comprehensive healthcare services, but the COVID-19 pandemic has also carried a disproportionate impact. The COVID-19 pandemic has also confirmed the deep-rooted issues of systemic racism, unsafe housing, and murders by police in communities of color. Many of these disparities become increasingly apparent when it comes to vaccine development and clinical trials in general.

Women, people of color, and pregnant people have been historically excluded from clinical trial development and data collection. There has yet to be adequate data collection around how transgender and gender non-binary people are being included in COVID-19 vaccine research.

This means we have a system in which cis-gender, white men are the model for clinical and vaccine trials, and these trials produce products that do not consider the unique needs of women, pregnant people, and people of color. Ultimately, lack of consideration for intersectionality in people’s lives creates an exacerbation of an existing public health crisis among people already most impacted.

Disparities are also commonly present in the U.S. healthcare system itself; for example, studies have shown that Black women’s pain is more frequently ignored by medical professionals. When well-intentioned hospitals limit the amount of people that can enter due to COVID concerns, Black women may not have a needed support system or helpful advocate during appointments. Pregnant people must also get consent from partners to participate in clinical trials if the benefit of the trial is solely for the fetus. This is a concern for bodily autonomy and reproductive rights.

Links from this episode

Center for American Progress on Twitter
Center for American Progress on Facebook
CAP’s report - Toward Equitable Treatments for Women’s Health During Coronavirus and Beyond
People of color are disproportionately affected by covid-19. Yet they are underrepresented in vaccine trials
COVID-19 Vaccines And Therapies Must Work For Black Mothers

Transcript

Jennie: Welcome to RePROs Fight Back, a podcast where we explore all things reproductive health, rights and justice. I'm your host, Jennie Wetter, and I'll be helping you stay informed around issues like birth control, abortion, sex education and LGBTQ issues and much, much more-- giving you the tools you need to take action and fight back. Okay, let's dive in.

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Jennie: Welcome to this week's episode of RePROs Fight Back. I'm your host, Jennie Wetter, and my preferred pronouns are she/her. So this week's intro is going to be a little heavy, but that's because that's where my mind and my heart are right now. As many of you know, I grew up in Wisconsin and I actually grew up about an hour and a half from Kenosha where the shooting of Jacob Blake happened. And I am always equal parts furious and heartbroken when there are police shootings of unarmed Black people, but something about this one being from where I'm from, it just hit a little bit differently. My heart’s just a little extra bit heavier and I'm a little extra angry that it happened in Wisconsin. And that's not to say that I didn't think that something like this couldn’t happen in Wisconsin. I mean, I grew up there. I'm from there. I know that's not true. It just feels different this time because it is so close to home. So, I've been struggling with that since that happened. And then on top of that to then have the shooting of protesters who were out protesting the shooting of Jacob Blake was also just rage-inducing and devastating, and just really makes it clear that things have got to change. We can't just keep going on as we are. There needs to be real systemic change in this country. We need to address the racism that is built into everything, into the systems, into the police. We have to change it. We can't go on like this. So that is really where my heart has been at. I’ve been sad and angry and all the things. And so, I did what I usually do. I'm lucky enough that I'm in a position then I'm able to donate when this happens. Not a lot, but I am lucky enough to be able to do some. So, I made sure to donate to the Milwaukee Freedom Bail Fund, which was providing bail support to the protesters in Kenosha now. So, I made sure to donate to somebody who was fundraising to take supplies to protestors in Kenosha, plus some other groups that I tend to donate to. So, I tried to do my part. It doesn't feel like enough, like I should be doing more, but that is what I did for now, but I'm sure I will be doing more going forward. And again, with the heavy heart for everything that's happening and the rage that it is still happening, let's move on to this week's episode.

Jennie: So, this week I had a really wonderful conversation with Jamille Fields Allsbrook at the Center for American Progress. We talked about a new report they put out that is looking at treatments for women's health and beyond. So, we know there are a lot of disparities in our healthcare system. And often when measuring a lot of this stuff, women, particularly women of color, aren't necessarily included in data or in clinical trials. So, testing for new vaccines, we're talking about the coronavirus vaccine. Often a lot of that testing is done on white men. And so we don't know how it's going to impact across race, across gender, how it's going to affect pregnant people. So, Jamille and I talk about this report and what it means that there are these disparities, not just in the healthcare system, but in the ways we are measuring data and in the ways we are developing treatments. So, with that, I'm going to take you to my interview with Jamille. Hi Jamille. Thank you so much for being here today!

Jamille: Hi Jennie. Thank you for having me, always a good to talk to you.

Jennie:So before we get started, do you want to do a quick introduce yourself and include your preferred pronouns?

Jamille: Sure. I am Jamille Fields Allsbrook. I am the Director of Women's Health and Rights at the Center for American Progress, where I lead our team on strategic planning related to things related to women's health and reproductive health and rights and maternal health. And my preferred pronouns are she, her and hers.

Jennie:I'm really excited to talk about this report that y'all did on COVID and the vaccine that's being developed… or hopefully will be developed soon. But I thought maybe we should start back a little bit and talk about what everything looks like right now. So if you want to talk a little bit on where we are with COVID right now, and I know another topic in that area that you're really good at also would be addressing racial disparities within COVID.

Jamille: So I think it's no surprise to all of your listeners that we are where we've been in terms of COVID. We still have significantly high rates, not every area has adequate testing and also a lot of the health providers and particularly those providers like safety net providers were already stretched before the pandemic and remain stretched, not seeming to let up anytime soon. Particularly related to the health disparities early on, I think many were predicting and unfortunately approved to be true that communities of color, particularly Black, Latino, and other communities would be among the hardest hit. And that is because of a number of factors. One, these communities tend to be essential workers. So, our grocery store workers, nurses, all those people who definitely we can't live without. So, they've still had to go to work. Many of us are working from home and that exposes them higher to those health disparities and more risk of COVID. Also the same communities had increasingly high rates of chronic illnesses and that's due to systemic racism that has long as it's done in our healthcare system and barriers to care and housing and environment and all of these things that we don't have time to talk about that have contributed to higher rates of asthma and cancer and HIV, and a number of other illnesses that would have made people more susceptible to not only get sick from COVID, but also be more likely to get seriously ill and some cases even die. And so again, we talk about all the time where we all would cope. It is that we have a pandemic, but we also have it being more severely impacting communities of color. So

Jennie: It's striking to me we're in this situation where you have this pandemic that is impacting everybody, but you were seeing these communities that were already so stressed by disparities in health care before this started being so much more impacted right now. And plus, all of the other things that are happening in those communities. It's a really tough time for communities of color right now.

Jamille: Yeah, for sure. I mean, one thing you mentioned sort of other things happening, police killings of unarmed Black men and shooting Black men and women that adds anxiety, obviously. So, there's been a number of studies that have talked about how people, all of us have been impacted and having increased levels of anxiety and mental anguish as a result of the pandemic and being stuck in our houses and not going to work and not seeing our friends. And for those who also have to worry about, “Oh, will the police bust in my house and kill me?” or “is my son, or daughter safe if they go on a nature walk or run?” That adds increased anxiety. The pandemic has just exposed and confirmed many of the things we already knew about the healthcare system, housing and systemic racism and all the things. And it's been a big confluence that has converged. And unfortunately, again, impacted communities of color the most. A lot of the Black listeners will be familiar with the phrase… if their mom was like mine she’d say “when America catches a cold Black people catch pneumonia,” and it's just been so proof of that.

Jennie: Absolutely. And I think this actually sets us up to go right into the next part of the conversation, which is talking about developing a vaccine around COVID and you all did a really great report. So, we're really working on finding a vaccine and some of those disparities that we're seeing within the healthcare system also show themselves within vaccine development. Do you maybe want to talk a little bit about that?

Jamille: For sure. So the report we put out was about inequitable treatments, and I should just say that it's an issue that we've thought about and the researcher for quite a bit, even before the pandemic hit, because unfortunately women and people of color and transgender and gender non binary folks are underrepresented, or just excluded completely from clinical trial development. And a way we know about many of your listeners will probably know about how healthcare system and systemic oppression that has impacted women and people of color. But I think a lot of people don't realize that it carries over into clinical research and trials. And so historically women, and that was the focus of the report, women were excluded completely from clinical trial development and the reason being that it would impact women's reproductive health and impact their fertility. And so, there was just a blanket exclusion over time. Women have been included and the policies have changed that women should be included, but there's still a lot of barriers that have prevented that from happening. And the same can be said about people of color. And so, people of color, there's a law that is supposed to require women and quote unquote “ethnic minorities” to be included and adequately represented in clinical trials. But that frequently doesn't happen. And still we're dealing with a system where cisgender white men are the model and the frame for clinical trials. And as a result, you get therapies being developed or vaccines that are being developed that don't consider some of the unique needs of different women and pregnant people and others. And so, there's been some stark examples in history related to women. Generally, we've seen Ambien was on the market for 20 years before they changed the dose because they realized the dose was too strong for women. And there was over like 700 car accidents that have involved people on Ambien. And so that was the lack of representation in the trials. Same as many probably know the HPV vaccine works wonders, helps prevent cancers, but research has come out showing that some of the vaccine does not address some of the strands that Black women get-- some of the HPV strands. So these are just a couple examples of where you see both people of color and women being excluded or not adequately represented, and then you can have adverse consequences.

Jamille: So I know it goes beyond policy for why women and in particular women of color, may be under represented. And I know there's strong history for why women of color might in particular may not be involved. It is a genuine and deserved mistrust of the healthcare system and mistrust of this idea that some professionals are running experiments on you and that has been born out of things like the Tuskegee experiment. And everyone remembers the example of Henrietta Lacks and all these examples, and even the founding of gynecology being on experiments on Black women's bodies. And so that has resulted in a mistrust from the community and to not want to participate in these trials, which I totally get and totally appreciate is absolutely understandable.

Jennie: Yeah, definitely understandable.

Jamille: But the adverse is that when we need these therapies and we need these treatments, we're not getting therapies and treatments that suit us at times. And so it can have dire health consequences, and it's not just because we don't show up and so we're not in the trials. I think also the research community has to contend with the fact of how they do recruitment and not going into these communities and not partnering with providers who these communities rely upon to make sure and explain the benefits and why it might be useful for those communities to participate in the trials. And I should also just say the point when we talking about clinical trials and clinical research, some of their trials are like the gold standard, but there's also just having data. And that has also been underrepresented and not inclusive. And a lot of that is due to systemic sexism and racism and the system that has just not found it valuable to count these communities. I mean, if you're not doing outreach to these communities and not putting the effort into make sure they're being involved, you're obviously going to have under-representation. I think another area that the report touched down on is barriers that pregnant people face in being included in these trials, then having data on how these drug therapies or whatever will affect pregnant or lactating people. Historically pregnant people have also been excluded from clinical research because of concern around the pregnant person or concern around the fetus. And over time scientists and medical experts have come to general consensus though, of course not everyone will agree that it actually ends up, it can be more harmful to not consider the needs of these communities. And that doesn't always mean that this community should be in a trial because if it's not safe, ethical, they should not be considered-- but still these communities should always be, and we should consider multiple stages of research and first needing to collect data as it relates to COVID early on. I think a lot of folks were like wondering and had a feeling and thought that based off of history of how pregnant people have fared under other respiratory illnesses like SARS or other public health crises, like Ebola and Zika, that pregnant people might be among the most harmed, but there wasn't systematic data collection on this community.

Jamille: And there still isn't a board. Generally the CDC put out some initial data a few weeks back that show that pregnant people are in fact more likely to get more seriously ill because of COVID compared to other non-pregnant people of reproductive age, more likely to put on ventilation, more likely to be hospitalized, more likely to be in ICU, but we still don't have enough data. So even before we could get to a clinical trial, we should be collecting people's data. And then the second part of that is that if it is safe and ethical to include this community, including pregnant people in those trials. And one reporter said, digging a few weeks back, that she found that I think it was one of the drug developers now is considering the needs of pregnant people. And so, what does that mean? If we put a vaccine out to the public, are we going to mark it and say it's safe for pregnant people, even if we don't know that? So it is more harmful to not consider this community and then to just go and say, well, market something as safe and effective for all when it may not be.

Jennie: Yeah. And I think that takes us back to the health impacts of this exclusion, right? When you don't know how it will impact the health of the people that aren't included in these trials or datasets, you get things like a lot of public health education around how symptoms present in men, not how it presents in women. And so people don't know how it presents differently.

Jamille: Yeah. One thing I should add on, some of us have intersecting lives. And so if you're not including women of color adequately, and you're not including pregnant people adequately for those pregnant people of color, you can have a real convergence of a perfect storm… in particular, Black and indigenous women were already three times more likely to die from pregnancy related complications before COVID. This same CDC initial data I was talking about…about pregnant people show that among Black pregnant people were more likely to catch COVID. And so without adequate treatment and without adequately considering these communities in a response, you can stand to exacerbate an existing public health crisis among these communities. So it can be even more problematic for pregnant people of color, Black and indigenous people, particularly yeah.

Jennie: Impacts on communities of color and among women with COVID are really striking. And I think also really important to something you were talking about is not collecting the data or the desegregated data. So not knowing how it's affecting these different groups.

Jamille: For sure, because how can we address a problem when we haven't even properly assessed it? And how can we even say, well, this community shouldn't be included. We haven't even done the initial research and data to know it, it wasn't until recent times. So before you even start doing the clinical research on humans, and then you also have this added issue of not only including pregnant people and women in clinical research, that's applicable to everyone. We also have underinvestment in research, in the conditions and illnesses that pregnant people and women generally are more likely to experience. So, we still don't know enough about fibroids or endometriosis, or even having more options around contraceptives. So, why is that? Why is there an underinvestment in these conditions that impact certain communities? Specifically with COVID and how it is impacting people?

Jennie: So we've talked about women and COVID. I think one of the groups we've talked about that you also haven't touched on yet is transgender and gender non binary people and how they're being represented.

Jamille: Unfortunately, the short answer is we don't know… there isn't adequate data around how these communities are being impacted. One thing we call for in the report is better collecting of data, not just on sex, but collect the data on gender, including people's gender identity, which frequently is not done. And when it is done, you might only have, let's say one great health center or provider collects that data. If you don't have some uniformity around it, then it's hard to make comparisons and hard to make broader generalizations about how these communities are impacted. And even when we, for instance, back to pregnant people, even when we do have some information about pregnant people frequently, it is pregnant women. And so it's hard to say, is it all pregnant people or just pregnant women? And so the short answer is we just don't know. And I think everybody probably reads the headlines and know that data about COVID is sketchy at best as a general matter. So we have completely disaggregated data by sex, gender identity, location, geography, age, race, and ethnicity, all those things, we just don't have. And so it makes it hard to paint a picture of how is this community being impacted? One thing we do know is that gender non binary people experienced a significant number of barriers to care. Even before the pandemic discrimination, we've seen the Trump administration roll back protections under Section 1557 for LGBTQ folks. We’ve seen some courts recently block that. Yay! But even though we don't know the data around how these communities have been impacted, it's not a far stretch to know that the barriers to care these communities have experienced have only been worsened.

Jennie: I think that's absolutely true communities that were already marginalized are just continuing to be further marginalized. And this pandemic is just exacerbating and laying it bare, which hopefully will be helpful to addressing that people are seeing it. But I don't know, that's my hope.

Jamille: I'm hopeful. I've been saying that everywhere I go is one thing that I'm hoping is a bright light at the end of this tunnel is that we don't have to keep proving how broken our healthcare system is. Let's skip past that point of the conversation. Let's just skip straight to the solutions. And we know they can't be just small little things. We need a complete overhaul, but that's not what we're here to talk about, but we do.

Jennie: So one of the things you talked about is the impact of COVID-19 on pregnant people and how it's impacting them. But we've talked a little bit less about the health system and the maternal health system and how that's being impacted by the pandemic.

Jamille: Good question. So, as I mentioned, there was already a crisis and that crisis underlined the maternal health crisis has been systemic racism for sure. And that has impacted and showed up in a number of ways which have been exacerbated because of COVID. So for example, there's been a number of studies that have shown that Black women's pain is more frequently ignored. And, uh, COVID concern overlying on top of that is that when you have hospitals limiting visitors, they’re limiting your support system. So whether or not you have a spouse in the room for delivery or a doula, it can mean that a Black pregnant woman is left there, basically exposed without someone there to advocate for them. So that has been a concern around COVID. We mentioned about how the healthcare system has stretched hospitals and providers who disproportionately serve communities of color. And so what that can mean is that we have pregnant people in hospitals that by not be adequately equipped to serve them and might not have enough beds or providers or others to serve them as well. And the last piece I'll say about pregnant people goes back to the clinical trials. I think a lot of people don't realize, and I'll say, quite frankly, I didn't realize it before digging into this work more is that there is a rule requiring that a pregnant person get the consent of their partner in order to participate in research if the benefit of the trial would solely be for the fetus. For those repro folks… the pregnant person, having to go ask their mate, can they participate in a trial, even if they've consented, even if they think that it's good for them. That can be an exacerbation… more pregnant people phase out of participating in trials, even for those who might want to.

Jennie: So there are a legion of problems. Let's talk a little bit about what needs to be done. What can we do? Jamille: First? We need better data. That's the first step, which sounds simple. And people always can discount that, but it's just important. We need better data because we need that to assess the problem in order to treat it. And we just don't have it. And so we need better this aggregated data. We need also a vaccine where it is safe and effective for pregnant people to use. We need…and I should say, Senator Elizabeth Warren and Congresswoman Lauren Underwood, both have introduced a bill to help set that effect both around data collection and ensure an adequate representation among pregnant people in clinical trials, it's called the Maternal Health Pandemic Response Act. So that could be a good step in the right direction, but even beyond just COVID, we also need to just completely revamp the system, both in terms of the data collection, but change our standards around what therapies get approved. So one way that we propose in the report to help address this problem is that the FDA should be not be approving therapies for everyone if we don't have data to show that the therapy is effective for everyone. So if we don't know is effective for pregnant people, or we don't know as effective for Black people or Asian people or Latino people, then they shouldn't get approved. That should be very clear but it's not, I think the clinical research community has to contend with recruitment efforts and reaching out and including a diverse, well-represented group of people in clinical trials, both for COVID and beyond. And then lastly, we also need to change some of those arcane regulatory standards that I think the general consensus now is that women and pregnant people should be included as a default, unless there's reasons to prove otherwise, but policy should match that. So, we shouldn't have policies requiring a pregnant person to go get consent of their spouse in order to participate. And also we need better education and make sure that people are fully informed about therapies and treatments so that there is agency to make a decision, which is obviously the crux of reproductive justice, to be able to make an informed decision before you input something into your body, about what are the benefits? And frequently sometimes we don't have that knowledge for ourselves.

Jennie: So important to have informed consent. Again, with that complicated history you touched on earlier, it's so important to make sure that people are informed about what they are consenting to put in their bodies.

Jamille: Definitely. One thing we touch on in the report is that communities of color are more likely to be involved in clinical trials that have some sort of reduced kind of informed consent. And they haven't been given enough information about it. There's this a building of trust, obviously that has to happen and policies have to change to do that, practices have to change to do that. A mindset has to change because I mean, I get it. But the research community has to change some things in order to make people trust and believe.

Jennie: [There’s also] the huge anti-vaxxer movement right now that may be challenging people to not get it. There's so much other stuff.

Jamille: Exactly. And we have to make sure we have insurance policies in place that make sure everyone able to get coverage for get the vaccine, are in good treatment and know people. If you're on an ACA plan, you should be able to get the vaccine without any cost. But what about those people who've signed up for the junk plans and what's going to happen with the treatment is that's not necessarily covered. So, this is so many things that we have to make sure the response considers all of us and all of us equitably. Jennie: So we always like to end with what can listeners do? What actions can listeners take?

Jamille: I would as a very concrete step…contact Congress members to support the Maternal Health Pandemic Response Act as a broader, just general matter beyond COVID. I would also encourage people to just show, to pay attention to the issue. And again, urge lawmakers to pay attention and recognize that it's a very wonky issue that many people might not realize, but it is the impact. It could be either life or death for us. And lastly, to just for those who do feel safer compelled to consider participating in some of the clinical trials.

Jennie: Jamille, thank you so much for being here. As always, it was a pleasure talking to you.

Jamille: It is a pleasure talking to you too, Jennie.

Jennie: Thanks for listening everyone. And we'll see you on our next episode of RePROS Fight Back. For more information, including show notes from this episode and previous episodes, please visit our website at reprosfightback.com. You can also find us on Facebook and Twitter at RePROS Fight Back, or on Instagram at reprosfb. If you like our show, please help others find it by sharing it with your friends and subscribing, rating and reviewing us on iTunes. Thanks for listening.

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