On Dec. 6, the Brigham’s Connors Center for Women’s Health and Gender Biology held their annual research showcase, with this year’s theme being, “Intentional Inclusion of Representative Populations in Clinical Research.”
Keynote speaker, Karen Costenbader, MD, MPH, Department of Rheumatology, Inflammation, and Immunity, and director of the Brigham Lupus Program, has dedicated her career to addressing health disparities among individuals with lupus.
An illness that predominantly impacts women of color, lupus is a chronic autoimmune disease that occurs when immune cells—which typically help the body fight infection—instead attack healthy cells and tissues. While there is no cure for lupus today, clinical research remains imperative to understanding the disease and developing viable treatment options.
Costenbader recently spoke with the Brigham Bulletin about why lupus disproportionately affects women of color, why minorities are often underrepresented in clinical research and what we can do to address these health equity challenges.
What motivated you to study lupus?
KC: I first became interested in studying lupus when I was in medical school. The disease deeply fascinated me. An autoimmune attack on organs? Hearing about that intrigued me, and I wanted to understand the biological and genetic underpinnings of the disease.
I was also fascinated by the fact that it primarily affects young women. I wanted to know why it was impacting people my age.
In your presentation, you talked a lot about social determinants of health. Can you explain what those are and how they impact someone’s risk of developing lupus?
KC: In medical school, I learned that lupus was all about genetics. You inherit genes that give you a predisposition to developing this autoimmune disease. And while we’ve done enormous genome-wide association studies since then and are starting to get to the bottom of the genetic underpinnings of lupus, we didn’t appreciate the role that the environment plays in one’s susceptibility to this disease back then.
Today, we think that about 20 percent of your disease outcome is due to actual medical factors. The rest, however, have to do with social determinants of health, which are all the environmental factors that impact your health, like air pollution, smoking, obesity and stress.
These also include issues like access to care, preventive care delays and the quality of care one receives. Even things like your access to education, transportation, jobs and childcare are also associated with an influencing risk of developing lupus and poorer outcomes among those affected.
Many marginalized populations across the United States face increased exposure to adverse social determinants of health. And in this case, I think women, particularly women of color, are disproportionately susceptible to these factors
What barriers do lupus patients, specifically women and women of color, face to accessing treatment?
KC: There are significant barriers to accessing care for lupus among women and women of color. This is a bigger problem than just at the Brigham, and it’s a bigger problem than just lupus. Our country has very uneven access to medical care in general. So, many of the findings for people with lupus are probably also true for many other diseases. It’s really a larger problem that the United States must rectify.
In our work, we’ve studied people with lupus with Medicaid insurance. Medicaid is the federal state-administered program for people below the poverty line. We found vast, unexplained and horrible disparities in the quality and timeliness of care, and a lot of these are by race and socioeconomic status.
Racial minorities and those of lower socioeconomic statuses generally tend to receive lower-quality care, waiting longer to receive treatment from the time of diagnosis, and generally have less access to medical services altogether.
Why are minority populations often inadequately represented in clinical research trials, and how can we work to close these gaps?
KC: So that’s the hard part. Now that we recognize that these groups are very susceptible to developing lupus and that modifiable risk factors exist, we need to determine how to address them. One of the best ways to understand medical diseases is through clinical research studies and trials, and these require patient recruitment.
A lot of clinical lupus studies predominantly include white women. For example, the Nurses’ Health Study, a major research collaboration investing chronic illnesses in women, is 95 percent white. This study has provided a tremendous wealth of information about health and disease in women, but for diseases like lupus, we need to include the most affected populations, like women of color, in order to understand how to treat the disease among people most impacted by it.
There are many reasons why it’s been hard to involve representative populations in lupus clinical research. Even my own patients turn me down routinely when I ask if they would like to enroll in a research study. We had a two-day conference about issues in October 2019, and we talked about deep historical reasons, including distrust of academic medicine, that play a role in people’s unwillingness to participate in clinical research.
There are also major time concerns. People are busy; they don’t want to fight traffic or take time off from work to come in for extra visits, extra blood draws and questionnaires.
There’s also the idea that the people enrolled in these trials are the guinea pigs. In a randomized trial, not everyone gets the investigational treatment. Some people get the placebo, which is usually a drug known to work, but isn’t the one being evaluated. My patients will say, well, if you think I should get the medication, just give it to me, and if you think I shouldn’t, don’t give it to me. Usually, we don’t know which is best, as that’s the reason we are doing the trial, but patients may not be comfortable with the chance that they may not receive the experimental treatment.
Does the Brigham have any programs to help increase underrepresented groups’ recruitment in clinical research?
KC: It does, and there are a lot of projects underway. For example, our research group and the Mass General Brigham Biobank have merged to do outreach to every socio-demographic group. We’re trying our best to enroll diverse populations into those larger studies. But it’s also a time investment. We need to build trust and get out in the community. We have community outreach and engagement activities through the lupus center and the Brigham has an increasing number of programs and organized health equity initiatives as well.
What more can we do to increase representation in clinical research?
KC: I think we also need to focus on medical education and physician training, weaving cultural competency into medical school curriculums to improve physician-patient relationships.
We’ve learned from previous research that improving care often translates to improving research. Many past studies have shown that the most critical factor in determining whether someone will be amenable to participating in a research study is their bond with the person who introduced it.
If patients trust the provider who suggests the trial or study, they will be much more receptive to participation. So, I think that putting time and attention into building these relationships is imperative to improving both clinical research recruitment and health outcomes among lupus patients.