The Rise and Fall of BiDil, a heart failure drug : A Story of Science, Race, and Power
BiDil was never just a pill. It symbolized the power dynamics in Western science, the illusion of objectivity, and the persistent failure of regulatory institutions to confront their history. Marketed as the first race-specific drug, BiDil’s approval for heart failure and eventual disappearance tell a cautionary tale about who gets to define medical truth, whose bodies serve as testing grounds, and why Western science continues to fail the very people it claims to help.
The Making of a “Race Drug”: Who Holds the Power?
BiDil was developed in the late 20th century as a heart failure medication. Initially, it was not designed for any particular racial group. In the 1980s, a white male scientist, Dr. Jay Cohn, conducted trials on a general patient population but failed to show statistically significant benefits. BiDil was headed for obscurity until a controversial decision was made: instead of refining the drug, its creators reframed the results. They claimed that it worked exceptionally well for Black patients—even though the original trials were not designed to study racial differences.
The decision to repackage BiDil as a “Black drug” was not based on genetic research but on post hoc data dredging. The development team, primarily composed of White scientists, leaned on the well-worn trope that African descendants have inherently different biology—an idea with deep roots in scientific racism. This was not a move to advance medical equity. It was a strategic decision to gain FDA approval and patent exclusivity. By making BiDil a “race drug,” the developers extended its patent life, ensuring greater profits.
Patients as Afterthoughts: Expert-Centric Science at Its Worst
BiDil’s approval process exposed the stark divide between expert-driven and patient-centric development. Unlike true patient-centered innovations, where communities play a critical role in defining their medical needs, BiDil’s journey was dictated by commercial and regulatory priorities. As a doctor in pharmaceutical science of African descent, I can also perceive a hint of unconscious Whitesavorism. It’s the ingrained belief in Western science that ‘saving’ historically and scientifically marginalized groups is an act of benevolence rather than another manifestation of power and control.
Some advocates, such as the Association of Black Cardiologists, the International Society on Hypertension in Blacks, the National Association for the Advancement of Colored People, and the Congressional Black Caucus, welcome the labeled innovation. They consider it the first improvable step toward addressing overlooked deeper health inequities. In Bidil, they saw the unlatched iron door to self-empowerment in Western science which otherwise traditionally designs for European descendants, the perceived humanity’s norm, and marginalizes the global majority. Others, like many monocultural experts of European descent, meaning the normalized humans, perceived BiDil approval as a failure that echoed debunked harmful racial science. Many of them feared the “Black” drug went against scientific standardization, meaning the reality normalization that supports Western science’s reproducibility, reliability, and trustworthiness.
Scientifically, no large-scale genetic studies validated the claim that BiDil worked better for African descendants. Little input was sought from those most affected by heart disease in these communities. Had patient voices been central to the discussion, they might have asked more pressing questions: Why was a drug being racialized when socio-economic and structural factors—like medical bias, environmental stressors, and access to healthcare—play a far greater role in health disparities? Why wasn’t there a broader push for equitable healthcare solutions instead of using race as a biological shorthand? Those questions resonated across the African diaspora, reaching France, where I was born and worked as a young regulatory scientist in the pharmaceutical industry.
Like my global community, I felt conflicted: I wanted to trust the FDA that the drug had a scientific ground for approval, while, like the racialized Black physicians, I couldn’t find science in it but a White pawn to self-empowerment. After lengthy personal expert deliberation, I dared to ask myself, as a patient, “If I had a heart failure, would I use this medicine.”
The reply was a clear no. I would have waited for more data. I wanted to see a head-to-head comparison with the most effective treatment. Meanwhile, I would have taken the medicine only if other drugs were ineffective. It was my patient’s interest. The FDA would likely have answered the same if it had actively listened to patients of African descent then, and hopefully, it’d answer now if faced with the same situation today. Thankfully, BiDiL wasn’t approved in Europe, so it’s a conundrum I would likely never have to face as a regulatory expert and a patient.
The FDA’s Role: A Legacy of Eugenics and Ignorance
When the FDA approved BiDil in 2005, it reinforced its long-standing entanglement with racial science. The FDA, created under Theodore Roosevelt—a known eugenicist—was built on a foundation that prized the purity of food and drugs but turned a blind eye to its complicity in racialized medicine. Throughout its history, it has approved drugs tested primarily on white males while mainly ignoring how they impact the global majority.
In its pursuit of “objectivity,” Western science has outsourced its humanity to the humanities since the 19th century, allowing it to sidestep its historical and ethical obligations. This divorce contributed to many dehumanizing, unscientific experiments, like the NHI syphilis study in Tuskegee, which deceived African American patients that they received treatment to study the natural course of the disease.
By framing race as a genetic category rather than a socio-political construct, the FDA displayed the very limitations of Western critical thinking when it comes to the global majority. Science is never neutral—it carries the biases of those who create it, and BiDil was a textbook example of how these biases manifest in drug approval processes.
The Fatal Flaw: Why BiDil Should Never Have Been Initially Approved Under those Conditions.
The fundamental flaw of BiDil was its scientific premise. The 2004 trial that led to its approval only included self-indentified Black patients, meaning there was no direct evidence that the drug would not work just as well for people of other racial backgrounds. The FDA approved BiDil despite this glaring flaw, prioritizing marketability over scientific rigor. As The Lancet pointed out, race-based medicine simplifies complex socio-economic and environmental factors into misleading genetic determinism, ultimately harming the very people it purports to help.
The Market Speaks: Why BiDil Failed
Despite the FDA’s approval and the initial excitement, BiDil failed commercially. African descendants, rightly skeptical of race-based medicine, did not embrace the drug. Medical professionals also hesitated—many recognized that its premise was flawed, and prescribing a “race drug” opened the door to ethical and legal concerns. BiDil’s marketing activities were scaled down following lower sales than expected, but its legacy lingers.
The FDA’s Progress in Addressing Health Equity
Since the BiDil controversy, the FDA has made significant strides in addressing health equity. It has become one of the leading regulatory agencies in the West to acknowledge and actively work against racial bias in medicine. The agency has implemented more stringent guidelines on diversity in clinical trials, ensuring that drugs are tested across diverse populations to account for structural and social determinants of health rather than relying on racial categories as proxies for genetic differences. Additionally, the FDA has promoted research into pharmacogenomics—an approach that moves away from race-based medicine and toward individualized treatment based on genetic and environmental factors.
Political Threats to Progress: The Danger of Regression
Despite this progress, the current political climate in the U.S. threatens to unravel these advancements. The potential nomination of figures to oversee the FDA and the NHI, like Robert F. Kennedy Jr., who has publicly espoused racial science beliefs—including the false claim that African descendants have stronger immune systems and should receive different treatments—poses a direct risk to the FDA’s commitment to health equity.
Political forces that seek to revive race-based medicine under the guise of “biological differences” threaten to reinforce outdated and harmful scientific narratives. If left unchecked, this could lead to a rollback of hard-won advances in equitable healthcare policies and a return to the same flawed thinking that gave rise to BiDil.
Lessons for the Future: How Do We Avoid Another BiDil?
BiDil’s story serves as a stark warning. If we want to avoid repeating this failure, we must:
- Challenge the Illusion of Western Science’s Objectivity – Centuries ago, a minority of ultra-privileged Europeans engaged in one the most narcissistic endeavors humanity had ever seen. They colonized the world to shape following their grandiose image. While transforming Earth in Europe 2.0, they forced Christianity and Western science upon the global majority. They dismissed other beliefs and knowledge as magical thinking. Meanwhile, they overlooked that most Western science is based on the irrational belief that knowledge produced on a normalized minority automatically applies to the marginalized majority. In this acknowledged context, when Western science claims objectivity and universality, it only continues the historical delusion that shaped the colonial culture in which it evolves. Then, science acts like the totalitarian cult that was the European colonization of humanity’s reality for the global majority.
Medical science must acknowledge its biases and confront its history of racial categorization with self-awareness. Addressing blind spots cannot happen in echo chambers. So, including scientists with diverse experiences can help to address the reality blindness toward humanity that Western science mistakes with objectivity. - Prioritize Patient-Centered Research –The global majority must be involved in defining their own medical needs rather than having solutions imposed upon them. Even if the FDA’s flawed scientific assessment saw BiDIL as effective, African American patients’ critical thinking saw a loaded history in the labeled innovative drug. So, in 2019, a couple of years before patent expiry, the firm that commercialized BiDil hired famous basketball player Shaquille O’Neil to promote the drug and appeal to patients through cultural affinity. Still, the latter weren’t convinced. BiDil became a commercial failure and the first 21st-century cautionary tale for the pharmaceutical industry.
- Shift Away from Race-Based Medicine – Instead of using race as a proxy for genetic differences, medicine should focus on individualized care based on genetics, environment, and lived experience. Upgrading scientists’ education and ensuring transparency of professional credentials on the topic is paramount for continuous progress and building trust with patients.
- Hold Regulatory Agencies Accountable – The FDA and other institutions must continue to reckon with their legacy of eugenics and racial science rather than perpetuating outdated frameworks. They need to address their unconscious Whitesavorism that often narrates those organizations as primarily serving the communities that Western science marginalized when the latter includes the global majority in its narrow, biased standards. I and most humankind might be a minority in the West, but we are the majority in the world: accountability saves first a discipline that claims to be objective and universal.
Black History Month is the yearly opportunity to educate experts and the public by addressing old narratives and magical thinking while showcasing the FDA’s latest progress to correct its mistakes. BiDiL has a particular place in FDA’s drug approval history as the first and hopefully the last 21st-century drug approved on the basis of an outdated and debunked concept from the 19th century.
The controversial medicine is still on the market. So, explaining every year the scientific ground of the approval in today’s scientific and social advancement to racialized Black patients can be one way to show the FDA’s commitment to protecting all patients and building trust with communities that are marginalized and dehumanized. - Protect Gains in Health Equity from Political Regression – Regulatory agencies must be insulated from political influences that promote pseudoscience, ensuring that health policies remain grounded in rigorous, patient-centered, and decolonized medical research. It’s a part of their renewed commitment to public health through patient empowerment and collaborative science.
BiDil was not a breakthrough. It was a blunder. A missed opportunity to truly serve the communities it claimed to help. And unless Western science confronts its limitations and history, BiDil will not be the last of its kind..
Do you want to deepen your scientific understanding of the BiDil clinical and statistical study design? Here are some insightful references:
Reappearance 