Communities Most Impacted by Racial Bias

Health equity is a challenge for the bio/pharmaceutical industry. It is no secret that there are biases within the pharmaceutical and healthcare industries based on race, age, ethnicity, gender, sexual orientation, and other factors, which can be seen in the types of treatments that are researched and developed, as well as through the people and communities that have historically had access to and been included in clinical trials.

Pharmaceutical Executive interviews Rose Blackburne, MD, MBA, vice president, global head, general medicine, PPD Clinical Research, Thermo Fisher Scientific, to further discuss health equity in clinical research.

Rivers: How would you describe the state of the industry as it relates to racial bias in medicine today?

Blackburne: The pharmaceutical/biotechnology/life sciences industry is very focused on racial bias as a driver of health inequity, including how it can undermine the inclusion of underrepresented populations in clinical trials as a function of improved health outcomes. While addressing racial bias is not a new interest for the industry, there has been a much renewed focus on this issue as a result of recent societal events, like the severe racial and ethnic disparities in COVID-19 outcomes seen early in the pandemic; the racial unrest stemming from the murder of George Floyd in 2020; as well as similar racially-motivated violence prior to the pandemic that brought a wider recognition that racism has a structural basis and is embedded in long-standing social policy. In addition, FDA released several guidances prior to and since 2020 that emphasize enhancing the diversity of clinical trial populations and expanding clinical trial inclusion eligibility, study design, enrollment, and recruitment efforts. Most recently, U.S. Congress passed legislation that will require sponsors to submit diversity action plans to the FDA for Phase III and other pivotal trials, the first time there has ever been a standard for diversity in clinical trials in law.

Within the medical and scientific community, there have been longstanding critiques of using racial classifications in the diagnosis and treatment of disease. Recently, there also have been calls for research studies and guidance in the medical community to further name and examine the role of racism versus race as a key driver of health inequities to avoid perpetuating disproven understandings of biological differences by race.

Similarly, there is an increased focus within the medical community to examine and revise the use of race in medical care and training, as well as to acknowledge the role of racism in shaping treatment decisions.1 This body of work with Kaiser Family Foundation (KFF) documents several ways race impacts medical care and teaching:

• Provider bias and discrimination can drive disparities, contributing to racial differences in diagnoses, treatment decisions, and pain management;
• Disease stereotyping and nomenclature where medical training approaches and materials misuse race as a surrogate for genetic ancestry and socioeconomic status, while some disease names use racial and geographic terms that can improperly link them to certain communities;
• Use of race in clinical algorithms, tools, and guidelines in which some clinical estimators or algorithms assign differential risks or treatments to patients based on race, which can lead to misdiagnosis and inappropriate treatment; and
• Race-based pharmacological prescribing guidelines where race plays a factor in the dosing and prescribing of certain drugs for patients.¹

Rivers: Which communities are most impacted by racial bias in medicine and why?

Blackburne: To better understand how and why different communities are impacted differently by racial bias, it’s important to first understand implicit bias. Implicit bias is the tendency to unconsciously associate groups (e.g., people of color) or category markers (race/ethnicity, age, gender, socioeconomic status, etc.) with a negative evaluation (implicit prejudice). In the healthcare and clinical trial setting, patients experience biases in their care with negative evaluations and perceptions based on race/ethnicity, cultural and language barriers and differences, socioeconomic status, health insurance status (e.g., private insurance versus limited or no access to health insurance coverage), disease chronicity and healthcare treatment, and/or use of social services due to immigration status or other factors.

The Institute of Medicine 2002 report, Unequal Treatment, as well as the Centers for Disease Control and Prevention (CDC), note that because of these types of biases, racial and ethnic minority populations experience significant health disparities that result in differences in health outcomes that reflect social inequalities.^2,3 Certain populations, such as “Asian Americans, Black or African Americans, Hispanics or Latinos, Native Hawaiians and other Pacific Islanders, American Indians, and Alaska Natives, face negative effects as a result of implicit bias in healthcare.”⁴

There has been significant research conducted over the previous decades that continues to confirm these findings. Implicit bias tests conducted in the United States show, for instance, that physicians are more likely to provide requested pain treatment for white patients compared with Black patients.⁵ Studies show that American healthcare professionals, even those who considered themselves anti-racist, demonstrate a significant implicit bias against patients of color and a preference for white patients.^6,7

With specific regard to geography, many rural American population groups experience significant health disparities. In the United States, rural areas refer to locations such as Appalachia, Southeastern states, Mississippi Delta, US-Mexico border counties, Native American tribal reservations, and Alaska Native villages. As reported by the CDC, “rural risk factors for health disparities include geographic isolation, lower socioeconomic status, higher rates of health risk behaviors, limited access to healthcare specialists and subspecialists, and limited job opportunities. Rural residents also are less likely to have employer-provided health insurance coverage, and, if they are poor, often are not covered by Medicaid.”^8,9

Rivers: Are there other social determinants that can/should be addressed that impact health equity? If so, how can/should those be addressed?

Blackburne: The CDC and other health authorities have identified five key areas of the social determinants of health,¹⁰ which are:

• Neighborhood conditions
• Educational attainment
• Economic stability
• Healthcare access
• Social contexts

These factors—apart from medical care and biological differences—support the growing body of evidence that suggests that racial disparities likely reflect discrimination (referred to as structural racism), which influences the way in which minorities experience poor healthcare and negatively biased treatment within the healthcare system and ultimately result in disparately poorer health outcomes across disease areas.

According to KFF, a “significant and long-standing body of research suggests that provider and institutional bias and discrimination are drivers of racial disparities in health, contributing to racial differences in diagnosis, prognosis, and treatment decisions.”¹¹ Prior work also suggests that healthcare disparities were historically more likely to be perceived by healthcare providers as individual patient factors rather than provider or health system influences.

Another example is KFF’s 2020 “Undefeated Survey on Race and Health” of adults, which found that Black and Hispanic adults are more likely than white adults to report they were personally treated unfairly because of their race or ethnicity while receiving healthcare in the past year.¹² Black adults also are more likely than white adults to report negative experiences with healthcare providers, including feeling a provider did not believe they were telling the truth, being refused a test or treatment they thought they needed, and being refused pain medication.

Rivers: Where do you hope to see the pharma industry in five to 10 years as it relates to health equity? How do you think we can get there?

Blackburne: Looking toward the future, the pharmaceutical/biotech industry can lead the healthcare industry in addressing health equity by linking disease outcomes to safe treatments, as well as the impact of access to high-quality equitable healthcare, addressing and acknowledging the root cause and role structural racism has on disparate health outcomes, embedding cultural competency and implicit bias training and awareness into healthcare and clinical trials as a care option. There is also a huge opportunity for continued innovations in personalized medicine, digital health, and decentralized clinical trials that bring research closer to patients, leveraging real-world data and bringing the voice of the patient more fully into the drug development process.

References

1. How the Use of Race in Clinical Care Can Contribute to Health Care Disparities. Kaiser Family Foundation, December 9, 2021, https://www.kff.org/racial-equity-and-health-policy/press-release/how-the-use-of-race-in-clinical-care-can-contribute-to-health-care-disparities/
2. Unequal Treatment: Understanding Racial and Ethnic Disparities in Health Care. Institute of Medicine, March 2002, https://nap.nationalacademies.org/resource/12875/disparities_admin.pdf
3. CDC’s Efforts to Address Racism as a Fundamental Driver of Health Disparities. Centers for Disease Control and Prevention, April 13, 2022, https://www.cdc.gov/minorityhealth/racism-disparities/cdc-efforts.html.
4. Racial Discrimination in Healthcare: How Structural Racism Affects Healthcare. St. Catherin University. June 2021, https://www.stkate.edu/academics/healthcare-degrees/racism-in-healthcare
5. Hoffman KM, Trawalter S, Axt JR, Oliver MN. Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites. Proc Natl Acad Sci (PNAS). 2016;113(16):4296-4301. doi:10.1073/pnas.1516047113
6. Green AR, Carney DR, Pallin DJ, et al. Implicit bias among physicians and its prediction of thrombolysis decisions for black and white patients. J Gen Intern Med. 2007;22(9):1231-1238. doi:10.1007/s11606-007-0258-5
7. Racism in Health Care Isn’t Always Obvious. Scientific American, July 9, 2020, https://www.scientificamerican.com/article/racism-in-health-care-isnt-always-obvious
8. About Rural Health. Centers for Disease Control and Prevention, May 9, 2023, https://www.cdc.gov/ruralhealth/about.html
9. Rural Health Disparities. Rural Health Information Hub, November 28, 2022, https://www.ruralhealthinfo.org/topics/rural-health-disparities.
10. Dalsania AK, Fastiggi MJ, Kahlam A, et al. The Relationship Between Social Determinants of Health and Racial Disparities in COVID-19 Mortality. J Racial Ethn Health Disparities. 2022;9(1):288-295. doi:10.1007/s40615-020-00952-y
11. Tong, M., Artiga, S. Use of Race in Clinical Diagnosis and Decision Making: Overview and Implications. Kaiser Family Foundation (KFF), December 9, 2021, https://www.kff.org/racial-equity-and-health-policy/issue-brief/use-of-race-in-clinical-diagnosis-and-decision-making-overview-and-implications/
12. Hamel, L., et al. KFF/The Undefeated Survey on Race and Health. Kaiser Family Foundation (KFF), October 13, 2020. https://www.kff.org/racial-equity-and-health-policy/report/kff-the-undefeated-survey-on-race-and-health/