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In a 2022 article for the Lancet, Farrokh Habibzadeh studied clinical trials in cardiology, mental health, and oncology, and found that in more than 70 percent of fifty-two studied trials, there were “significant disparities between the study sample and the typical population of patients, which hampers the external validity of the results obtained.” The review points out an additional study that found that a non-Hispanic white patient is three times more likely to be enrolled than that of a Hispanic patient and twice that of a Black patient.
That disparity has resulted in a significant shortage of information for minorities and women especially, and while things may be more equitable in the US, Dawn Stewart Harris understands just how much things need to change.
Harris, assistant general counsel at Bayer Pharmaceuticals and a practitioner in the pharma space for over twenty-five years, needs to look no further than her family’s front door to understand just how much further clinical trials have to go if they truly want to serve the betterment of all of society.
“You will see studies that call it a ‘unique’ cancer, but I’m not comfortable with that distinction. It’s not being studied or publicized. There’s a distinct difference there.”
Dawn Stewart Harris
Before she become a successful attorney, Stewart Harris thought she would be an oncologist herself. Her mother was diagnosed with breast cancer when Stewart Harris was in junior high, and as her mother went through medical mastectomy, her subsequent care was administered by a female oncologist, a revelation of sorts to Stewart Harris.
“We just didn’t have the resources of today or any of the information other than what you were getting from your doctor,” she remembers. “I was impressed with witnessing the care provided to my mother by a female oncologist and envisioned becoming an oncologist herself to care for women with breast cancer in the future. It didn’t turn out that way, but that was the first moment where I really felt like I knew what I should be doing.”
As it would turn out, breast cancer has been part of three generations of her family thus far. Stewart Harris’s mother is a survivor, and her daughter was diagnosed with breast cancer at just twenty-eight and successfully treated. With the medical advancements of today, Stewart Harris and her family were able to avail themselves with genetic testing. Her family carries an unusually high prediction toward triple-negative breast cancer, named because the cancer cells lack both estrogen and progesterone receptors and often as well as a protein called HER2.
Why haven’t you heard more about this cancer that has a higher incidence in premenopausal Black women? The cancer tends to occur in women younger than forty, and women who are Black.
“You will see studies that call it a ‘unique’ cancer, but I’m not comfortable with that distinction,” Stewart Harris says. “It’s not being studied or publicized. There’s a distinct difference there.”
The factors are many. There may not be a monetary incentive to study and treat a disease that tends to affect a smaller cohort of people. The pool of investigators nor the pool of study subjects are representative of the varied diaspora of people. Stewart Harris opines that those studying diseases like triple-negative breast cancer may find clinical diverse trial subjects too challenging to come by due to a lack of trust based on the historical performance of clinical trials on minorities, mirrored by a paucity of diversity amongst the trial investigators.
It’s not an indictment of physicians, clinical trials, or the healthcare industry. Stewart Harris understands the drivers of medical breakthroughs and what can seem like the painfully slow movement of treatment developments. But it is most assuredly a system that needs to evolve to better meet the health needs of minorities.
That’s why it’s so important for people like Stewart Harris to be positioned where she has the opportunity to contribute her unique perspective. She understands the challenges the Black community has faced when asked to trust the medical establishment that turned a blind eye to the infamous and horrible Tuskegee Study and the privacy and patient rights and concerns raised by the harvesting and studying of cells of Henrietta Lacks.
But whether it’s talking to her friends and colleagues about the vaccine or approaching her role as counsel in the healthcare industry with the patient in mind, Stewart Harris is doing her own part to help bring a voice to women and minorities that need it.
“As often the only Black woman in the room, I have to ask the questions that might not otherwise get asked.”
Dawn Stewart Harris
“I don’t think I’ll be the person to solve this complex issue,” Stewart Harris says. “But as often the only Black woman in the room, I have to ask the questions that might not otherwise get asked. I try to be the different perspective that you don’t always hear in a corporate office. And I’m glad I have the opportunity to help guide that journey in my own way.”
Stewart Harris herself has not been diagnosed with triple-negative breast cancer; nevertheless, having discovered that she carries the BARD1 gene mutation, she made the decision to get a proactive double mastectomy. Triple-negative breast cancer can be cured through treatment if detected within the first three stages. However, until clinical studies reflect the society they’re supposed to represent, advancements and treatment of triple-negative breast cancer may not take place, which is why Stewart Harris is doing all she can.
