Inclusive Vaccine Trials Are Vital, But Let’s Not Boost Biological Views of Race

The novel coronavirus and its devastating effects have starkly exposed U.S. racial and ethnic health disparities. Yet, despite ample evidence that health disparities are symptoms of social and economic inequalities resulting from a racist social system, narratives insisting on participation of marginalized people in clinical trials dangerously imply fundamental biological differences. Professional organizations, such as the American Medical Association, have taken the official stance that race and ethnicity are social constructs rather than discrete biological categories. Nonetheless, many COVID-19 researchers have attempted to increase the conventionally low levels of participation of people of color in clinical trials by implying inherent biological differences among racial and ethnic groups.

Specifically, when articulating the importance of clinical trial participation, many COVID-19 researchers and the media have reported that vaccines or therapies risk being ineffective or unsafe for people of color if such groups are not involved in the trials. For example, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a key figure in the U.S. response to COVID-19, stated, “If you don’t have [minorities] represented in the clinical trial, then you will not have definitively proven that the vaccine is safe and effective in them.”

The goal of this rhetoric is to encourage nonwhite participants to sign up for COVID-19 trials and to bolster trust not only in research but also in the vaccines and therapies that become available to the public. Black and Latinx individuals are often underrepresented in clinical research, and most researchers acknowledge that some members of these groups are mistrustful of research because of the medical establishment’s historical abuses of people of color. Indeed, the vast majority of individuals who have signed up as potential vaccine research participants have been non-Hispanic whites, but research teams for the trials have nonetheless employed concerted outreach efforts to enroll Black and Latinx participants at higher rates than is typical for most research, but notably still at levels below the prevalence of COVID-19 in these populations.

Campaigns to increase diverse trial participation by mobilizing threats of missing out on safe and effective COVID-19 vaccines are undoubtedly well-meaning. A video posted on the website of the U.S. Food and Drug Administration (FDA) highlights a Black clinical trial participant who explains to viewers that people like her need to enroll in research to “make sure the medical products that come to the market work just as well for us as they do in other communities.” However, the messaging that people of color must participate in research — using the language of a mandate, rather than an entreaty — to ensure they benefit from science reproduces dangerous medical assumptions about the “Otherness” of Black and Brown bodies. For example, many physicians incorrectly believe that Black people have thicker skin than whites, making them less susceptible to pain. As a result, Black people have been much less likely to receive medical treatment and relief for all causes of pain compared to whites.

Assumptions of difference are encouraged by a tendency for physicians and the general public to conflate genetic ancestry with race. For example, a higher prevalence of genetic diseases like sickle cell anemia in the Black population has led many to falsely conclude only Black people have the disease. Despite the fact that the scientific community widely acknowledges that there is more genetic diversity within racial/ethnic groups than between them, popular conceptions of a disease as “racial” tend to reify race as a biological category, with all members of minority groups assumed to be the same biologically because of some shared physical characteristics. These misconceptions set the stage for statements about how medical testing on people of color is necessary for the development of safe and effective vaccines and therapies for these groups. At the same time, it ignores the critical fact that FDA approval cannot guarantee that any product — vaccine, drug or device — will be safe and effective for anyone. Blaming people of color for the failure of therapies to safely treat their illnesses if those groups are not involved in clinical trials is a perverse interpretation of the system’s failure to regulate adequately the for-profit industry developing medical products.

Racial health disparities in treatment outcomes result from a research enterprise aimed at meeting FDA standards for market approval, not generating knowledge for clinical practice. Commercial clinical trials typically provide data that support a pharmaceutical company’s claim to the FDA that their product has benefits that outweigh its harms. Such benefits are nearly always evaluated in comparison to a placebo, an inert substance that can help assess whether an investigational drug or vaccine is better than nothing. Once drugs get to the market and are used in clinical practice, their treatment benefits are considerably more modest and the risks to patients from side effects are much greater.

Industry clinical trials regularly enroll participants who are not representative of the patient populations that will eventually be treated with FDA-approved drugs or vaccines. Instead of “typical” patients who physicians might see, trial participants tend to be younger and healthier, meaning they are less likely to be complex patients with multiple illnesses in need of treatment. For example, diabetes patients often struggle with other medical problems, including hypertension, cardiovascular disease and obesity, but clinical trials might exclude such patients when testing the safety and efficacy of a new diabetes medication. Because they have different medical issues, trial participants under 65 with fewer comorbidities cannot always provide data relevant to typical patient populations. The result is that FDA-approved drugs routinely underperform their clinical trial results, and this pattern contributes to health disparities by often having more significant effects on people of color.

For those focused on racial justice, the reason to attend to the messaging around clinical trial inclusion is simple: When patients do not seem to benefit from new medical treatments, it is wrong to assume that inherent differences stemming from their race and/or ethnicity are the cause. There might be physiological differences between those patients and the clinical trial participants upon whom those treatments were tested, but the differences should generally be ascribed to other factors, such as co-morbidities, weight, age and access to health care — factors that apply to many white patients as well. In many cases, patients of color may benefit less from FDA-approved treatments because they are sicker or have more advanced disease or health complications than their white counterparts — a trend facilitated, again, by racism and economic inequalities, not inherent biological differences.

The continued underrepresentation of people of color in most medical research nevertheless has important health equity implications. Clinical trial participation has the potential to provide benefits to those who enroll, albeit with concomitant risks, and it is essential from a social justice perspective for all members of society to have access to those benefits. In the context of life-threatening illness with no available cures or treatments already on the market, clinical trials provide the possibility for therapeutic benefit that might not be otherwise available. Many of the COVID-19 vaccine trials would fit into this category. The possibility for health benefit explains the brisk recruitment of participants for these trials relative to most other therapeutic areas. However, the societal benefits associated with clinical research often depend on who is funding the research and the scientific goals of the trials.

When discussing the stakes of minority participation in clinical trials, it is imperative to remember that medical research cannot be monolithically characterized as a social good. Instead of pushing for racial and ethnic diversity in all clinical trials, it is more important first to acknowledge that commercial science rarely meets the needs of most patients. Not all medical research is designed to answer the important questions that clinicians need to treat their patients. Not all medical research is aimed at developing novel therapies that are safer and more effective than what is already available. Not all medical research is worthy of the time, energy and risk that it asks of participants. Pharmaceutical companies are not transparent organizations, and their scientific agendas and communication with clinicians and the public are often guided by a desire to protect their intellectual property and make profits when and where they can.

Even — or especially — in the era of COVID-19, an examination of how commercial interests play into the design of clinical trials can help ensure that increased minority involvement will be more likely to meet the treatment needs and provide the most affordable therapies possible for those groups. This underscores the need for COVID-19 clinical trials to reflect the risk factors for how and why Black, Latinx and Indigenous people have higher rates of infection, severe illness and death. Recruitment of people of color should ensure that the clinical trial participants bear the same risk factors as the communities for which they stand in. Therefore, racial diversity in trials must include in-group diversity when it comes to age, income level, and other sociodemographic factors, with particular focus on enrolling elderly adults and medically complex patients, subpopulations upon which the virus has its most virulent effects. Otherwise, the result could be the exploitation of higher COVID-19 risks in people of color to enable bad science, overly hyped medications and vaccines, and exorbitant profits for the pharmaceutical firms that succeed in bringing their products to market.

With the number of U.S. COVID-19 infections and deaths soaring and the recent FDA approval of two vaccines, questions about how to ensure fair distribution of the vaccines and how to encourage community members to get vaccinated have begun to overshadow previous concerns about vaccine safety and efficacy. Vaccination will be an essential way to curb the pandemic and save lives. However, there should be no doubt that approved vaccines will prove less efficacious than the numbers currently being touted by Pfizer, Moderna and AstraZeneca. The vaccines will also inevitably lead to thousands, if not tens of thousands, of adverse reactions. While these trends in diminished safety and efficacy of approved vaccines relative to their clinical trial data should not stop campaigns to vaccinate those most vulnerable to COVID-19, it is also important to critically examine the clinical trial results and voice concern about legitimate safety issues.

The narrative that people of color should feel obligated to participate in medical research to ensure that any therapies or vaccines that come to market will “work” for them is ultimately one that supports the current racist social order. Insufficient representation in medical research is not the root cause of racial and ethnic health disparities, so it cannot be the ultimate solution. Medical research is particularly ill-suited to correcting those disparities when its reward structure is designed to generate profits for some and unequal access to therapies for others. COVID-19 has upended practically everything, but medical research cannot be made into an anti-racist institution merely by involving more racial and ethnic minorities in clinical trials. At the very least, the pandemic should not be used to entrench racism more by biologizing differences that have clear social and economic causes.