Women have been traditionally left out of medical research.
For decades, efforts to find cures for life-threatening conditions like cardiovascular disease and cancer excluded more than half of the U.S. population: women. Up until 1993, they were largely left out of medical research due to gender bias, and because of that, there’s still a major gap in healthcare and it shows. To this day, clinical trials primarily enroll male (mostly white) patients, with a persistent underrepresentation of women and people of color. And the numbers are telling: While women make up 50.8 percent of the country, only 41.2 percent of the clinical trial participants were female on average, according to a study published in the journal Contemporary Clinical Trials, which analyzed more than 1,000 trials from 2016 to 2019.
There have been some improvements — for instance, it’s now required by law to include women in clinical trials, but the medical community has a lot of catching up to do in terms of gender equality in research. There are still some major knowledge gaps in diseases that disproportionately affect women, such as cognitive disorders and rheumatoid arthritis. As a result, doctors now have no way of knowing how some vital treatments or therapies work for women specifically and how to improve them. Answers are hard to come by as well because women’s health is often underfunded. For instance, just 12 percent of federal funding for Alzheimer’s is geared toward research focusing on women, according to the nonprofit Women’s Health Access Matters.
That’s why the vaginal healthcare company Evvy created Equal Research Day in 2022, which falls on June 10 and promotes more inclusive research in an effort to close the gender gap.
The issue is personal for the company’s co-founders, Laine Bruzek and Priyanka Jain. “The gender health gap is why we quit our jobs,” Jain tells Katie Couric Media. “We were both women who had frustrating experiences in the healthcare system, and we did a little bit of research, and realized that it wasn’t just us going through this.”
The duo shed some light on the ongoing inequalities in clinical trials, what can be done, and how minorities are being especially impacted.
Katie Couric Media: Why is there a disparity in clinical research for women?
Priyanka Jain: Before 1977, women weren’t explicitly excluded, they just happened to be underrepresented. In 1977 women of childbearing age started being “actively excluded,” meaning that nobody of childbearing age who was a woman was allowed in any type of clinical research. And the reason for that was because of a drug called Thalidomide, which [was widely prescribed to women to help with morning sickness in the 1950s and later discovered to] cause birth defects. Even though it wasn’t being used widely, the response to that was to ban all women of childbearing age from clinical research. So from 1977 to 1993, no women of childbearing age were allowed in clinical research, and then in 1993 that was reversed.
That’s a huge gap. Can we catch up to address some of the lack of research geared toward women?
Laine Bruzek: The question is, are we willing to invest in it? And the numbers right now show we’re not investing in it. Despite these statistics, despite the facts, only 1 percent of the global healthcare budget goes to women’s health. Fem tech only gets 3 percent of healthcare investment dollars, and most of that goes to fertility and pregnancy. But we are more than our ability to reproduce. There are things like Alzheimer’s, heart disease, and cancer — things that are top killers of women.
Priyanka Jain: I think there’s a whole other piece around stigmas and taboos. A big reason that these problems continue to be so pervasive is that people don’t know. And I think a lot of the reason that people don’t know is because we don’t talk about it. That’s what I love about Equal Research Day: Evvy is deeply focused on the biomarker component of this problem, but we alone are not going to fix this. And that’s the focus of Equal Research Day. How do we convince the investors and policymakers? How do we get celebrities to talk about this so that we can destigmatize it? How do we bring together all those people so that we start to make strides at a faster pace than we are? Because it has been 30 years and we’re better, but we’re really still pretty far from finding solutions.
How has this lack of clinical research impacted Black and minority women in particular?
Priyanka Jain: When you look at the intersection of race and gender, somehow things get even more abysmal. Before 1993, Black people weren’t required to be in research, which is insane. The U.S. has the highest maternal mortality rate of any developed country, and this is especially true for Black women in the U.S. I’m also just shocked at how far we are from where we should be.
What are some ways to improve clinical research so that it better represents minorities and the LGBTQ community?
Laine Bruzek: We’ve really only made significant progress on the representation of cis white women in clinical trials. And the groups that remain underrepresented are non-white women, older adults, pregnant people, the LGBTQIA+ community, and people with disabilities. When it comes to the clinical research side, gender identity is often not collected in clinical trials, so not that much is known about the clinical trial participation rates of trans and non-binary people, so that’s something that would be amazing to see in the future.
Priyanka Jain: If you’re getting a grant from the NIH for your research, you have to report on the differences by sex. This includes whether the drug was more efficacious on men than women or more efficacious on women than men. You can’t just analyze the results overall. They have to be broken down by sex. And the question is, how can we also do that for other underrepresented groups so we’re not just grouping them into everyone else? And then to answer your question about educating providers, I don’t have a solution, but I will say it’s a massive problem and it’s not the doctor’s fault. How are they supposed to function in the way that our healthcare system sets them up? It’s like, “Oh here’s a patient that you have 10 minutes to talk to.” And in those 10 minutes, you’re supposed to listen to them and give them the right diagnosis and educate them about their treatment plan.
What do you hope to accomplish this year with Equal Health Research Day?
Laine Bruzek: It’s about raising awareness. And this year is our second annual Equal Research Day, so I really do feel like we’re still in the period of raising awareness. Most people don’t know that women weren’t required in clinical research until 1993.. For me, success would be when we tell people facts like that, they’ll say that they’ve heard or read about it somewhere. And hopefully, that would be because of Evvy’s outreach and because of the outreach of all of our amazing partner companies, and celebrities that are getting involved. I really think that to drive this change, we need everyone to be working together. We need doctors, patients, policymakers, funders, founders, and the whole ecosystem working together.
We absolutely stand on the shoulders of giants, especially people like Bernadine Healy, Janine Austin Clayton, and people who run the office of Women’s Health research at the NIH. There are so many amazing women and men who fought to get women included in clinical research and continue to do that to this day.
This story has been edited and condensed for length and clarity.
