Getting Under the Skin: Race-Based Guidelines and the Pursuit of Pharmacoequity

Beginning in 2017, the FDA’s Center for Drug Evaluation and Research has approved an average of 51 novel pharmacotherapies each year, an increase from 24 per year over a decade ago.¹ These therapies, used to treat conditions from cancer to cardiovascular disease, regularly make their way into clinical guidelines, as updated clinical trial and real-world data transform the standard of care we provide to patients.

Regrettably, despite the burgeoning innovation and availability of novel therapeutics, there remain rampant racial and ethnic health inequities in the USA. Moreover, the availability of these therapies is often disproportionally inaccessible to patients from Black, Hispanic, Native American, and Asian communities.² Eliminating treatment disparities and ensuring that all individuals, regardless of race, ethnicity, and socioeconomic status, have access to the highest-quality medications required to manage their health needs has been defined as pharmacoequity.³ In this Editorial, we discuss how pharmacoequity has eluded the US health care system for decades, and how to achieve this goal, we must place equity at the center of the entire therapeutic continuum (Fig. 1), including in the consideration of race in clinical guidelines.

Figure 1.

Advancing pharmacoequity across the therapeutic continuum. The figure represents the therapeutic continuum or the process through which a prescription drug makes its way to a patient. This process includes: 1) drug development, 2) drug trials and testing, 3) drug prescription, 4) drug receipt, and 5) drug adherence. At each step along this continuum, there is an opportunity to advance equity.

In a recent issue of JGIM, Anderson and colleagues examined a national cohort of patients with hypertension from 2008 to 2017 to determine whether treatment differed by race since the implementation of the Eighth National Committee (JNC8) hypertension guidelines.⁴ These guidelines were the first to explicitly provide a different first-line treatment recommendation for Black individuals with hypertension (calcium channel blockers, CCBs, or thiazide diuretics) compared to non-Black individuals for whom angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blocks (ARBs) remained first-line.⁵ The authors notably found that Black patients with hypertension were less likely (65.9%) to initiate recommended first-line hypertension treatment compared to non-Black patients (80.3%). This finding of disparities in hypertension treatment has been well-described; however, the focus on older Medicare beneficiaries in the era post-JNC8 guideline implementation provides an important addition to the literature.⁶

The analysis by Anderson et al. also provides an opportunity to ask the question, should there be different treatment guidelines for Black patients with hypertension? Broadly, the field of medicine is undergoing deep introspection over its use of race-based guidelines, including recent nephrology guidelines revamping the assessment of renal function,⁷ and discussions over the validity of race-based heart failure treatment⁸ as well as an atherosclerotic cardiovascular disease (ASCVD) risk calculator that differentially assess disease risk based on an individual’s race.⁹ Those who argue against such practices suggest that embedding race into clinical guidelines perpetuates long-held, false beliefs about physical and physiological differences between Black and White individuals.¹⁰ Proponents of race-based guidelines argue that these policies have been put in place to try and address long-standing racial disparities in our health system. Nevertheless, one must wonder whether adding “race” to a calculator or clinical guideline can ever fully explain the complex social and structural differences in access to care that underrepresented racial and ethnic groups experience in the USA. In fact, including “race” in clinical guidelines reifies the idea of disparities deriving from inherent physical differences and obfuscates structural racism as a driver of health inequalities, thus limiting our ability to understand how oppression “gets under the skin” by leading changes in physiology. Furthermore, as the findings by Anderson et al. suggest, even when race-based guidelines are in place, they may not actually reduce treatment disparities, and in some cases such disparities might worsen.

So how can we achieve health equity, including in hypertension management, while ensuring scientific and clinical integrity related to the social construct of race and racism as determinants of health? First, we must better understand the etiology of differential prevalence of hypertension, and other cardiometabolic conditions, in Black individuals and communities in the USA and how social, structural, ancestral, genetic, and historical determinants intersect to widen this disparity. Second, as we seek to effectively treat patients with hypertension, we must move beyond race-based guidelines and rather strive to improve effective and equitable treatment for communities that have not experienced equal access to care. We are likely a few years away from the Ninth Report of the Joint National Committee on hypertension management and it is our hope that race-based medication management of hypertension would not be included in these guidelines. Rather than seeking a “silver bullet” therapeutic alone, we can focus on implementing multilevel strategies to effectively treat all patients with hypertension.¹¹ Such strategies might include patient-directed educational tools, provider-direct equity dashboards to audit prescribing practices by race and ethnicity, and system-level policies to improve access, including broader investments in community-based interventions that are tailored for Black communities.¹² Finally, addressing the myriad challenges in ensuring affordable access to guideline-recommended pharmacotherapies, eliminating bias in medication prescribing (implicit or explicit), and reducing the ever-rising cost of prescription drugs will bring us closer toward achieving pharmacoequity, including in patients with hypertension.³

In the era of personalized medicine, ensuring that all patients have equitable access to treatment, from costly novel drugs to traditional generics, will be critical to advancing health equity in the USA. Whether or not race should be taken into account when developing treatment algorithms and clinical guidelines pathways is the question that this generation of scientists and clinicians must answer, particularly given the rapidly changing racial and ethnic demographic in the USA. We believe rather than taking a reductionist approach that focuses on which medications individuals who identify as Black versus non-Black should take, we can achieve pharmacoequity by boldly developing policies that acknowledge structural racism and eliminate the systemic barriers to care that have kept the historically excluded without equal access to life-saving therapies for too long.