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FDA data reveals racial discrepancies in cardiovascular drug trials

By
Nicole Girten, Emine Yücel and Zhihui Xing
FDA data shows that, of 12 clinical trials for heart drugs in the last four years, nine were made up of 80% White participants and less than 6% Black participants. Photo by orzalaga/Pixabay
FDA data shows that, of 12 clinical trials for heart drugs in the last four years, nine were made up of 80% White participants and less than 6% Black participants. Photo by orzalaga/Pixabay

Data from the U.S. Food and Drug Administration shows that Black Americans are recruited for drug trials at substantially lower rates than White Americans.

Seventy-five percent of cardiovascular drug trials reported from 2015-2019 had major racial discrepancies, according to recent data from the FDA. Nine out of the 12 trials report 80% or more White participants and less than 6% African American participants.

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Previous research has revealed that, historically, minorities, women and those older than 65 have been underrepresented in clinical trials.

Dr. Clyde W. Yancy, chief of cardiology at Northwestern University's Feinberg School of Medicine, said the problem of underrepresentation was so significant that in 2016 the "FDA introduced guidance to attempt to directly address it." But, "in the absence of a mandate, the guidance has not yielded a major change."

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Several studies this year, including research by the CDC, have shown many deaths related to COVID-19 were due in part to cardiovascular diseases. And Black Americans, who are affected by heart problems at higher rates than White Americans, are disproportionately dying of COVID-19 in cities across the United States.

According to the CDC's COVID-19 data tracker, while Black Americans make up 13% of the country's population, Black non-Hispanic patients make up 22% of total deaths caused by the novel coronavirus.

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An analysis by the American College of Cardiology supported the CDC's findings, concluding that heart complications are common in patients suffering from COVID-19. And since there are no specific therapies available to target myocardial injuries sustained from COVID-19, Black people are at a higher risk of heart complications.

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A question of trust

In the traditional drug trial model, clinical research coordinators and doctors, partnering with research organizations, handpick patients for drug trials. According to Yancy, with this model, mistrust and subconscious bias can cause significant racial discrepancies among the recruited participants.

"If the investigator or the investigation team doesn't trust a patient to execute the trial dutifully then they won't bring that patient into the trial," Yancy said.

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But trust goes both ways, he said. Patients can also opt-out from participating in a trial if they feel that an investigator isn't transparent and honest about exposure and risk.

Black patients said the generational mistrust the Black community has toward medical professionals, which is largely based on experiments like the Tuskegee study, continues today.

"History has shown that in the past, healthcare trials have not always been favorable to African Americans," said Elizabeth Corshu, a registered nurse and a heart patient.

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Corshu said she was shocked that this experiment wasn't taught in any of her nursing classes. "It was something that I learned on my own," she said.

Doctors refuse care

During her pregnancy, Corshu was experiencing signs of heart failure. As a Black medical professional with almost 10 years of experience, she recognized the symptoms and reached out to her doctor but her continuous efforts were dismissed.

A week after the 30-year-old gave birth to twin boys, her symptoms started escalating. She found herself in the hospital describing the exact tests she wanted her doctors to complete.

The doctors were surprised when Corshu, a young patient with no history of heart problems or high blood pressure, showed signs of peripartum cardiomyopathy, a rare type of heart disease related to pregnancy.

Although Corshu was able to use her medical knowledge to advocate for herself, she was angry for the women that came before her who couldn't.

A 2016 study showed 40% of first and second year medical students falsely believed that Black people had thicker skin than white people and thus a higher tolerance for pain. According to the Association of American Medical Colleges, Black people's pain is often disregarded and under-treated, which can have fatal consequences.

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After her diagnosis, Corshu was approached about participating in an experimental drug trial, but she refused. She said in order to build goodwill within the Black community, drug companies need to be transparent with their goals and have some involvement within the community instead of trying to turn a profit through a new drug.

Darlene Scott, 45, participated in a cardiomyopathy study with Pfizer over two years ago and is a participant in a lifelong study for sarcoidosis, an autoimmune disease that caused her to have an enlarged heart.

Scott, an associate professor at the Virginia Union University, said that, in general, the Black community has great mistrust toward medical professionals and she understands why.

"So many tests and trials have been done on us without our permission and they've had detrimental effects," she said.

According to Yancy, unless the FDA's guidance of diverse representation in clinical trials becomes a requirement, particularly National Institutes of Health directed studies, the racial discrepancies will not get much better.

Improving situation?

However, Yancy is hopeful. He said, typically, the representation in drug trials today is closer to 20% for non-White participants. He said the FDA data, which shows Black or African American participation at less than 6% in most cardiovascular clinical trials, is not representative of all past or on-going studies.

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In fact, according to a 2018 NIH report, which included data from 22 NIH funded institutions, about 24% of participants in cardiovascular clinical trials identified themselves as non-White -- 15% of these participants were Black.

In contemporary clinical research, large academic medical systems, like Northwestern Medicine, have private electronic databases that compile information on all patients that visit Northwestern affiliates. Instead of handpicking participants, clinical researchers and clinical trial coordinators allow computers to filter through the database to find patients who fit their criteria.

Yancy said that although electronic databases are better at combating bias compared to the traditional model, there's still inequity that stems from socioeconomic status, especially when considering who can afford to visit private hospital systems.

Amgen Inc., Novartis International AG and Portola Pharmaceuticals, companies with cardiovascular drug trials in the FDA database, declined multiple requests to comment on the racial inequalities of their respective studies.

Pfizer Inc., however, pointed out that at least one of its studies featured proportion of Black participants similar to population estimates in the United States.

"We prefer to focus our limited media resources on the company's multi-prong efforts to address COVID-19," the spokesperson said. "Beyond that, it seems very misguided to highlight as an example the participant diversity of our Vyndaqel ATTR-ACT trial, especially since 14% of patients in that trial were Black -- roughly the U.S. national average for African Americans based on U.S. Census population estimates."

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While Yancy said that racial disparities have decreased under the current model, there is still room for improvement.

"The future is a place where we have a universal learning health system, where engagement in clinical research is almost entirely passive," Yancy said. "Every patient who comes into the health system is a candidate," which would reduce subconscious bias and inequities created by socioeconomic status.

He also said that participation in clinical trials should be non-controversial and a "component of citizenship," but would require a cultural shift in order to break the enduring mistrust between Black people and the medical community.

"[The culture] needs to move away from cynicism, distrust, fear and uncertainty," Yancy said. "This is part of our responsibility as citizens."

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