In the summer of 2020, the country surged with support for the Black Lives Matter (BLM) movement, in protest of the systemic racism that unfortunately still occurs in our country. Through peaceful protests, widespread donations and petitions, and increased media coverage, the world’s eyes were opened to the various social and political disparities that affect many minority groups. In this blog, I will look through my Philosophy of Biology and Health (PBH) lenses to discuss the health disparities faced by many people of color (POC) in terms of disease prevalence and under representation in the clinical trials used to develop drugs and vaccines.
Health disparities between different demographic groups is commonly defined as the “attainment of full health potential” for individuals, and is measured through differences in incidence rates, mortality rates, severity of the disease, and future side effects (NCBI). While health disparities can occur due to a variety of demographic factors such as gender, sexuality, age, and socioeconomic status, one of the predominant determinants of this disparity is race.
Like so many other healthcare related challenges, this discrepancy has become much more evident in light of the COVID-19 pandemic. Currently, as of February 18, 2021, the CDC reported that the risk of COVID-19 infection, hospitalization and death was substantially higher for many racial and ethnic minority groups. The table below summarizes the current CDC findings.
These health disparities did not begin with the current pandemic, they have long represented a challenge to our healthcare system across many disease areas. As an example, a 2018 study showed that asthma, a lung-condition that causes inflammation of the lungs, is 42% more likely to impact African Americans than white individuals. While white individuals had a 7.7% chance of receiving the disease, African Americans had a rate of 10%, and Native American groups were even higher at a rate of 12% (Lung.org). Regarding overall respiratory disease prevalence in the United States, African Americans and Hispanics made up 12% and 16% of the population, respectively (Journal of Women’s Health). Type 2 Diabetes is another disease that illustrates this disparity. Those of Hispanic heritage, both white and black, were reported to be 1.56 and 2.64 times more likely to contract adult-onset Type 2 Diabetes, respectively, in comparison to their non-hispanic counterparts (NHIS). Perhaps cancer represents the most significant health disparity based on race. African Americans are the most likely racial group to contract Breast, Lung, Colon, and Prostate cancer (RCCA). In addition to contracting the disease, African Americans have been found to have higher mortality rates across these different forms of cancer, on average, in comparison to other racial or ethnic demographics (Cancer.gov).
That these trends have been in place for so long is very disturbing to me. I think a lot needs to be done to understand the causes of these disparities and also to effectively address them. As a start, pharmaceutical companies should make sure that the clinical trials that are conducted to test the safety and efficacy of new treatments – drugs or vaccines – are representative of the population suffering from that underlying disease. In the United States, new drugs and vaccines must go through a series of clinical trial phases in order to be approved. These trials allow scientists, researchers, and doctors to test the safety and efficacy of the new medicines. Each study is conducted with clinical trial participants, usually patients previously diagnosed with the disease and sourced from various hospitals and medical programs. Upon completion, companies and scientists submit their research to the FDA for safety approval. The end goal is a medication that can be used across all patients of the disease, safely and effectively.
I have spent hours going through data on the FDA and related websites. I had assumed, before I began researching some of the data, that a critical requirement for the design of clinical trials would be the fair representation of the underlying patient population by race and ethnicity. However, over the past decades, many drugs and vaccines have been developed and approved based on clinical trials that do not correctly represent the racial and ethnic diversity of the underlying patient population. This is especially problematic for diseases that disproportionately impact POC and underrepresented racial minorities. For example, despite respiratory illnesses being predominant in African American and Hispanic populations, as of 2015, only 1.9% of clinical trials included a representative number of minority subjects (The Editors). In other respiratory disease studies, African Americans made up only 5% of the clinical trial subjects and Hispanics only made up 1%.
Another challenge is perhaps that the effectiveness of approved drugs and vaccines is not reported based on the race and ethnicity of the patients treated. Also, the adverse event data that are reported to the FDA to document the undesired effects of the medications do not require companies to report this information by race and ethnicity.
As I think about this issue from the PBH lenses, I believe there is much that can be improved to make our drug and vaccine development process more representative of the racial diversity of the affected patient population, and as a result make the new drugs and vaccines more effective and safer for all people. A few starting thoughts on potential improvements that I will continue to explore in the future include:
- FDA updating guidelines and requiring companies to design clinical trials that represent the racial diversity of the affected patient population
- Eliminating barriers (social, economic, trust, awareness, etc.) to the low representation of POC in clinical trials
- FDA requiring companies to report the effectiveness and adverse events of their drugs and vaccines by race and ethnicity