The Debate Over BiDil: Does Race-Based Marketing Have a Place in Modern Medicine?

Over the last few decades, advancements in genetic research and personalized medicine have led to targeted treatments for various health conditions. However, the use of race in determining medical treatments has stirred controversy and ethical debates.

The first medication approved for a specific race was BiDil — a combination pill marketed for Black people with heart failure. And while BiDil may have a proven benefit in this population, only a small percentage of eligible people are taking it.

With hospitalization and death from heart failure still on the rise in Black adults, where does BiDil fit into the picture? Below we explore BiDil and other race-based strategies in medicine, and how they may influence care.

What is BiDil?

BiDil is an oral medication that’s a combination of two generic drugs — isosorbide dinitrate and hydralazine. These drugs have been used separately for many years to treat high blood pressure and chest pain. But they had never been in the same pill together for heart failure until BiDil was approved.

Isosorbide dinitrate acts on both your arteries and veins by causing your body to release nitric oxide, which is key for relaxing your blood vessels. Hydralazine primarily works on your arteries but also helps keep nitric oxide around in your body longer.

BiDil and its generic are currently available as a tablet containing 20 mg of isosorbide dinitrate with 37.5 mg of hydralazine. You’ll typically take 1 to 2 tablets 3 times daily.

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History of BiDil’s approval

BiDil’s approval in 2005 sparked controversy about drugs approved for specific populations. But this wasn’t originally the intention.

BiDil was first submitted for approval in 1997, but it was rejected. The FDA didn't feel the evidence from clinical trials supported its use as a treatment for heart failure. Participants in these clinical trials were over 70% white.

However, researchers re-examined the data on advice from the FDA. They found that Black participants with advanced heart failure appeared to benefit from BiDil. These results led to the African-American Heart Failure trial.

A-HeFT (African-American Heart Failure Trial)

In the A-HeFT trial, participants who self-identified as Black or African American were divided into two groups. One group got the placebo (a dummy pill) and the other got a fixed-dose combination of isosorbide dinitrate and hydralazine (BiDil).

The results showed that BiDil, when taken with other heart failure medications, could lower death by over 40%. Hospitalizations for heart failure were also significantly less in the BiDil group. This was compared to a placebo group that did not receive the medication. In fact, researchers stopped the trial early after seeing a higher death rate in the placebo group.

This is why BiDil was ultimately approved, but only for self-identified Black adults with heart failure. However, there were many critics of the FDA’s decision to approve a medication for a specific racial group — especially since there’s no biological basis for race. There’s also incredible genetic diversity among people who identify as Black.

Even so, the FDA still says that the positive effects of BiDil in self-identified Black people are too great to be ignored. And, the medication doesn’t appear to help other people in the same way.

Other cases of race-based medicine

After BiDil’s approval, questions on race-based prescribing practices emerged. And many healthcare providers can’t agree on whether race plays a major role in deciding on appropriate treatment options.

Since a person’s race can be subjective, this doesn’t always lead to a similar genetic profile for any one race. What’s more, some argue that treatment plans based on race may affect health outcomes. Below are a few examples:

In each of these examples, lower scores or risk based on a person’s race could delay care. Often, the evidence backing these assessment tools couldn't explain how race affected scoring. This highlights why recognizing factors besides race is important in determining treatment options.

Does BiDil still have a place in therapy?

Despite initial evidence for using BiDil in Black adults with heart failure, studies show it’s not used very often.

Heart failure treatment guidelines still recommend BiDil for Black adults with advanced disease. But, it’s typically considered if you’re still experiencing symptoms after optimizing first-choice medications.

Prior to 2022, BiDil was only available as a brand-name medication. This may have created an additional barrier to accessing the medication. Today, you can save over 70% off the average retail price of generic BiDil with a free GoodRx discount.

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Written by:

Zuri C. Hawkins-Jarrett, PharmD, MPH, BCPS

Zuri Hawkins-Jarrett graduated with her doctorate in pharmacy from The University of Georgia College of Pharmacy. She completed her residency training with Piedmont Columbus Regional in ambulatory care.

Edited by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

Reviewed by:

Karla Robinson, MD

Karla Robinson, MD, is a medical editor for GoodRx. She is a licensed, board-certified family physician with almost 20 years of experience in health through varied clinical, administrative, and educational roles.

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