Race-based medicine has been one of the more contentious issues in pharmaceutical research and development over the past few years. Some argue that drugs specifically labeled to treat particular racial groups offer an invaluable way to fight racial disparities in health by targeting at-risk populations. Others claim that race-based medicine inappropriately treats race as a biological cause of racial disparities when broader social and environmental factors may offer better explanations.
Much of this debate involves the FDA’s 2005 approval of BiDil, which became the first drug to be labeled for a specific racial group – African Americans with heart failure. The heat generated from this debate has largely faded due to BiDIl’s market failure. But, it seems like a new drug may reignite a few flames.
Tradjenta was developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly to treat Type 2 diabetes. But results from a Phase III clinical trial recently showed that Tradjenta was particularly beneficial for controlling African Americans’ blood sugar levels. The press release notes:
African American adults are disproportionately affected by diagnosed diabetes. In the U.S., the risk of diabetes is 77 percent greater for non-Hispanic black adults, when compared to non-Hispanic white adults, with an estimated 18.7 percent (4.9 million) of all non-Hispanic black adults living with the disease.
John Smith, senior VP at Boehringer Ingelheim, praised these results in the same press release by noting that Tradjenta may “provide black or African American adult patients with another option to improve control of their blood sugar.”
Is another BiDil on the horizon? It’s important to acknowledge that Tradjenta had already received FDA approval to treat type 2 diabetes in the general population prior to the announcement of these race-specific results. This is different from BiDil, where investigators sought a race-specific indication from the FDA because they could not otherwise win regulatory approval as a race-neutral drug. Despite these differences, treating racial disparities in diabetes as a naturally observed group difference that can be at least partially resolved with a pill shares some similarities with the BiDil saga. In both cases, there is a tendency to naturalize racial disparities as a function of group difference rather than having a deeper engagement with the social determinants of health.
This leads to an important question: if Tradjenta already received approval for use in the general population, why would it not be effective in African Americans? Put differently, why go through the time and expense of conducting a clinical trial to demonstrate efficacy in a particular racial group when the drug has already been approved for everyone regardless of race?
It’s unclear how these recent clinical trial results might be used. Perhaps this is another example of using a clinical trial as a marketing device in the hopes of capturing a larger share of the market. What is clear, however, is that this probably isn’t the last word that we’ll hear about Tradjenta.