BiDil: The Ethical Dilemma of a Race-Based Pharmaceutical

Heart failure, a condition under the umbrella term of heart disease, is one of the leading causes of death in the United States. Heart failure occurs when the heart cannot pump enough blood and oxygen to support the other organs in the body, but it does not mean that the heart has stopped beating. According to the Centers for Disease Control and Prevention (CDC), roughly 5.7 million adults in the United States have heart failure and about half the people who develop the condition will die within 5 years of diagnosis. With a national expenditure of $30.7 billion for health care services, medications, and missed days of work, heart failure is a medical condition that affects everyone.

Although heart failure has implications that affects everyone living in the United States, some racial groups have a disproportionate load of the burden. According to the American Heart Association, the annual incidence of heart failure among white Americans is approximately 6 per 1,000 person-years, while the annual incidence of heart failure among African Americans is 9.1 per 1,000 person-years.[1] To further illuminate the issue, nearly 44% of African American men and 48% of African American women have some form of cardiovascular disease, including heart failure. 

BiDil was introduced as a “solution” for this stark racial disparity in heart failure. BiDil is a prescription medication used to treat heart failure by relaxing and widening the blood vessels, so blood can flow more easily to the heart. It is an oral medication usually taken three times a day or as directed by one’s clinical provider. The problem is that BiDil is the first drug approved by the Food and Drug Administration (FDA) marketed for a single racial-ethnic group, African Americans. The scientific evidence that led to the approval of BiDil only tested the drug among Black populations, meaning that the drug’s efficacy among other racial groups is unknown.[2]

When visiting the website for BiDil, I found an entire section that explains why heart failure is “different” for African Americans. When referring to Black Americans’ higher risk for heart failure partially due to high blood pressure and diabetes, the website claimed that these conditions affected the ways in which people’s hearts worked and blood flowed. BiDil’s treatment and consideration of race as a biological construct with genetic differences is extremely controversial and presents a huge bioethical dilemma. Research has shown that there is more variation within racial groups than between them, and the physical characteristics that we typically associate with race (i.e. skin color, facial features, hair texture) are phenotypical variations.[3] 

The conclusions from this research means that there are no drastic genetic differences within the human species despite the existence of racial groups. The fact that BiDil was only tested on Black populations or that it is selectively marketed to Black populations fails to consider the sociocultural factors underlying heart failure and that race itself is a social construction.

Some of the sociocultural factors underlying heart failure for African Americans is discrimination from general society and from healthcare providers, socioeconomic factors, and receiving lower quality medical care. If a Black person is of a lower socioeconomic status it could result in delays in seeking treatment, lower levels of disease awareness and health literacy, and poor adherence to treatment.[4] Furthermore, research has shown that even when African American patients have the same types of insurance and ability to pay as their White counterparts, they receive suboptimal healthcare. African Americans are still subjected to lower quality treatment, which is at least partly related to a medical system that is still dealing discrimination built on a history of racial notions from slavery and Jim Crow.[4]

BiDil’s presence in the market as a race-based pharmaceutical for heart failure harkens back to a time where White supremacists tried to use the religion and other social practices to justify slavery on the premise that Black people were and Other, and thus not human. It was not right back then, and it is still unethical today. It is essential that the social determinants of health and historic injustices are recognized when trying to address matters of health disparities.  

References

1. Go AS, Mozaffarian D, Roger VL, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics–2013 update: a report from the American Heart Association. Circulation 2013; 127:e6—e245.
2. Brody, H., & Hunt, L. M. (2006). BiDil: Assessing a Race-Based Pharmaceutical. The Annals of Family Medicine,4(6), 556-560. doi:10.1370/afm.582
3. Witherspoon, D. J., Wooding, S., Rogers, A. R., Marchani, E. E., Watkins, W. S., Batzer, M. A., & Jorde, L. B. (2007). Genetic Similarities Within and Between Human Populations. Genetics, 176(1), 351-359. doi:10.1534/genetics.106.067355
4. Sharma, A., Colvin-Adams, M., & Yancy, C. W. (2014). Heart failure in African Americans: Disparities can be overcome. Cleveland Clinic Journal of Medicine, 81(5), 301-311. doi:10.3949/ccjm.81a.13045