Q&A: ‘Heavy, heartfelt history’ of drug trials for Black patients may fuel NASH disparities
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The Global Liver Institute has marked June 8 as International NASH Day, part of a public education campaign to raise awareness and urgency about fatty liver disease and its advanced form, nonalcoholic steatohepatitis.
According to the nonprofit organization, more than 115 million people worldwide are currently affected by NASH, and that number is expected to climb to 357 million people by 2030. This progressive form of nonalcoholic fatty liver disease is often underdiagnosed and underreported, with Black patients especially less likely to be diagnosed in early stages, despite facing worse outcomes, including mortality.
“We find a lot of racial and ethnic disparities across NASH. We see it less in Black people, but we do not understand why,” Nadege T. Gunn, MD, president and medical director at Impact Research Institute and adjunct assistant professor at Texas A&M University, said in an interview with Healio. “When we do see NASH and fatty liver in patients of color, although we are not recognizing it outright, immediately from the front end, it is more advanced or they are more likely to die or less likely to receive lifesaving treatments. We wonder why there is such a difference there.”
Gunn spoke with Healio about these disparities, the lack of Black representation in NASH clinical trials and possible steps for improvement.
Why are fewer Black patients diagnosed with NASH?
Gunn: The answer is unclear. We think, based on a lot of the research that has supported the prevalence and the demographics of NASH, that perhaps there may be a genetic reason why we do not see as many Black people with NASH. Or maybe they are underrecognized because we are not actively seeking them out or they are not seeking care, so we are not able to quantify accurately.
However, we do know that Black patients, as well as their white counterparts, have similar risk factors for fatty liver disease, including diabetes, obesity and hypertension. The question still exists as to why we are not seeing as many Black people up front with the disease. I have my speculations; however, they are not rooted in any real data.
Black patients who have these risk factors may also be subject to chronic kidney disease and may be on dialysis, which seems to be highly prevalent in African Americans. Since kidney disease takes the lead, the fatty liver disease and diagnostics around that become less critical.
Are physicians effectively performing early screenings in the Black community?
Gunn: When we talk about access to our Black patients, that is a heavy topic. We are talking about a group that has been traditionally or historically marginalized. There are potentially some inadequacies in our health care delivery to these individuals. I would not say that if a Black patient approached me as a physician with the required risk factors or clinical presentation that requires screening that they would not be afforded that. The problem is more or less the access to the health system. If they gain access, then ideally there should not be any issue.
What can be done to increase diverse representation in clinical trials?
Gunn: This conversation comes up a lot, especially among those who are from contract research organizations, sponsors and clinical trial sites. You want to diversify the clinical trial teams, making sure there are diverse physician investigators, research coordinators, research assistants and staff, so that there is a built trust within the clinical trial system. That in and of itself will attract Black individuals because they feel safe in those environments.
When it comes to bringing clinical trials to the patients, we talk about empowering the communities and leaders in communities of color to experience or buy into what clinical research has to offer, so they can convey that message to their communities and drive more interest.
We also know that there has been a heavy and heartfelt history around Black people in clinical trials. When we look at clinical research history among African Americans, such as Henrietta Lacks and the Tuskegee syphilis study, those feelings and sentiments are hard to undo. Black patients may harbor that history and have a little bit of skepticism around research.
I recently attended the Model Agreements & Guidelines International, or MAGI, Clinical Research Conference. One of the attendees mentioned that they were able to speak to the descendants of Henrietta Lacks and asked them, “If you knew that Black people were less likely to be in a clinical trial or have some skepticism around clinical research, what would that mean to you?”
They replied they would be sad that they are using the past to inform the future. If we do not stand up and be a part of research, then these medications that are approved are not going to have the same effects on us or they are not going to work in us as well. They would not ever want to see that the future Black community is continuing to be resentful toward clinical research, but rather that they are more empowered by what had happened and recognize that what had happened has led to a lot of change in regulations and research and they will be more encouraged to participate now.
When we look at the spectrum of clinical trials that are available, many of them are for the less advanced disease or for stage two or stage three fibrosis. Cirrhosis studies are few and far between. When we are afforded the opportunity to run a cirrhosis trial, we get excited, and they get filled superfast. When you think about Black people presenting later in the stage of NASH or NASH fibrosis, and few clinical trials available for advanced stage disease, you wonder if that already pushes the Black patients out just by virtue of clinical trial availability. There is a lot to unpack here and still many questions left to answer.
References:
- Building equity into the equation: Stopping NAFLD & NASH in Black Americans. https://globalliver.org/building-equity-into-the-equation-stopping-nafld-nash-in-black-americans/ Published March 11, 2022. Accessed June 5, 2023.
- International NASH Day. https://globalliver.org/event/international-nash-day/. Accessed June 2, 2023.
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