BiDil: The First Race-Based Heart Failure Drug and the Controversy It Sparked

The U.S. has a long and fraught history with racial categorization. Hence, it wasn't a shocker that the U.S. Food and Drug Administration (FDA) made headlines by approving BiDil, a heart failure drug, specifically for African American patients in June 23, 2005.

It was the first drug in U.S. history to carry a race-based label. For many, this decision symbolized long-overdue attention to racial health disparities. For others, it raised unsettling questions: Was medicine beginning to confuse social identity with biology? Was this really a breakthrough or a marketing strategy wrapped in scientific language?

At the time, African Americans were and still are disproportionately affected by heart failure. Higher hospitalization rates, limited access to advanced therapies, and poorer outcomes painted a grim picture. So when clinical trial results showed that BiDil reduced deaths and hospital visits in African American patients, it felt like a victory.

Families struggling with heart failure finally had hope. Community advocates welcomed the recognition of a health crisis that had long been overlooked. Some clinicians saw BiDil as a tool to begin closing the gap in treatment. On the surface, the approval looked like progress.

But beneath the hope, unease was growing.

Critics quickly pointed out that race is not biology. A label like “African American” cannot capture the vast genetic diversity within the population. Two patients may share the same racial identity but respond very differently to a drug — not because of race, but because of genes, environment, diet, or access to care.

By approving BiDil only for one racial group, regulators risked sending the wrong message: that biology neatly follows racial categories. For patients, this could feel like being boxed in — their identity reduced to a medical shorthand.

One cardiologist at the time described it bluntly: “Race is a social reality, not a molecular one.” That sentiment captured the heart of the controversy. ¹

Hydralazine and isosorbide dinitrate work together to ease the heart’s workload through complementary mechanisms:

• Hydralazine: This medication relaxes the arterial smooth muscles, which lowers afterload — the pressure the heart must overcome to pump blood. By reducing resistance in the arteries, the heart can pump more efficiently.

• Isosorbide Dinitrate: Acting primarily on veins, this drug reduces preload — the amount of blood returning to the heart. By decreasing the volume the heart has to manage, it eases cardiac strain. ²

Together, these actions help the heart pump more effectively, improve blood circulation, and alleviate symptoms of heart failure.

The pivotal study behind BiDil, known as A-HeFT (African-American Heart Failure Trial), included only self-identified Black patients. While the results were encouraging, the design created a blind spot. It did not provide information on how patients of other racial or ethnic backgrounds might respond to the therapy.

Other factors may have influenced outcomes too, including income, stress, access to quality healthcare, and other social determinants of health. By focusing only on race, the trial risked ignoring the full picture of why patients were getting sick and how best to treat them.

Additionally, the trial did not include genetic profiling, which could have identified markers associated with better responses to BiDil. The follow-up period was relatively short, averaging about 12 months, limiting insight into long-term efficacy and safety. These design choices restricted the generalizability of the findings and left unanswered questions about the broader applicability of the treatment.

Finally, the race-based labeling of BiDil raised ethical concerns, as it risked reinforcing stereotypes and conflating social identity with biological response.

Labeling BiDil as a “black drug” carried real consequences.

• Stigma: Some worried it reinforced stereotypes about inherent biological differences between races.

• Access: Patients outside the labeled group who might benefit could be denied treatment.

• Precedent: The approval opened the door for other race-based drugs, where social identity could overshadow real biology.

Many ethicists argued that this approach was a step backward. Medicine, they said, should treat people as individuals, not as categories.

BiDil remains FDA-approved but its marketing has declined over the years, in part due to modest sales. The race-specific patent for BiDil expired in 2020, and generic alternatives combining hydralazine and isosorbide dinitrate are now available.

References:

1. Brody, Howard, and Linda M. Hunt. “BiDil: Assessing a Race-Based Pharmaceutical.” Annals of Family Medicine 4, no. 6 (2006): 556–60. https://pmc.ncbi.nlm.nih.gov/articles/PMC1687161/

2. Pitt, Bertram, Susan Bakris, Inder Anand, John R. Cohn, Michael E. March, John S. Poole, and Michael R. Zile. "Hydralazine-Isosorbide Dinitrate in Heart Failure: Clinical Evidence and Mechanisms." Journal of Cardiac Failure 23, no. 2 (2017): 79–85. https://pubmed.ncbi.nlm.nih.gov/29086392/

3. Kahn, Jonathan. Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age. New York: Columbia University Press, 2013.

_MSM