While racial disparities are rampant in medicine, some evidence suggests that physicians and the public have little appetite for race-based drugs.
Bidil, a drug for heart failure, was approved by the U.S. Food and Drug Administration in 2005 after clinical trials showed that it significantly improved survival rates in a group of patients that described themselves as black. Some applauded Bidil’s approval for focusing on an underserved population, but others countered that race is a poor proxy for the genetic variation that likely underlies drug response. And because Bidil is a combination of two generic compounds that are individually available much more cheaply, some critics suggested that racially targeted prescribing was mainly a marketing tool.
The drug has since suffered poor sales. Nitromed, the company that developed Bidil, suspended marketing for it last year and announced yesterday that it is considering a buyout offer. A general reluctance to delve into race-specific medicine may partly explain its failure. According to Clyde Yancy, medical director of the Baylor Heart and Vascular Institute and president-elect of the American Heart Association, prescribing rates for both Bidil and its generic equivalents have been low. Yancy, who was involved in clinical trials of Bidil, talks with Technology Review about the best ways to approach racial disparities in medicine, and the need to move beyond race-based medicine.
Technology Review: Why is the issue of race so important in medicine?
Clyde Yancy: The demographics of our population are changing much faster than we thought. Within the practice lifetime of many health-care providers, we will be dealing with a much more diverse population than ever before. So it’s critical to understand the nuanced differences in disease presentation in different groups.
TR: How can we make sure that doctors are more sensitive to differences?
CY: Awareness. I don’t believe practitioners willfully overlook disease. But if they are not aware that diseases can present differently, change won’t come about.
TR: How much of a factor is genetic variability in explaining racial health disparities?
CY: Even with the most robust understanding of genetics, we may be able to explain only a small percentage of disparities in health care. More blacks have high blood pressure than whites. That’s a difference, not a disparity. But when we look at the percentage of blacks who have achieved blood-pressure goals, it’s very small. That may be a disparity; it may be due to lack of access to health care or lack of understanding of how malignant blood pressure can be in blacks. If we don’t address those issues, the difference has resulted in disparity.
TR: According to a 2007 report by the Pharmaceutical Research and Manufacturers Association of America, approximately 700 drugs in development are aimed at African Americans. How can we make sure that they are developed and marketed responsibly?
CY: First, we have to understand the impetus to develop a drug for any group and determine that it’s driven by a unique unmet need, not by marketing advantages. If there are 700 drugs under investigation, we’re talking about 700 different circumstances where someone has presumed they are targeting an unmet need. Frankly, I don’t think 700 such circumstances exist.
TR: In a recent review that you wrote on race and medicine, you said that translating differences in disease risk factors into race-based therapeutics has been awkward and ineffective. What do you mean?
CY: The general awkwardness surrounding racial issues in our society bleeds into medicine. There may be unique mechanisms at play in heart failure in some people described as African American. When a practitioner is presented with an African-American patient, they may be hesitant to offer the patient a drug based on their race. And some patients are put off when practitioners emphasize race.
We found in a study that even though there is a drug regimen that is uniquely beneficial to African Americans with heart failure, [prescribing rates are] no better than about 10 percent. And the rate of increase is significantly less than that for other effective therapeutic strategies. That tells me that without being able to articulate all the reasons, there is some hesitancy to proceeding forward with race-based medicine.
TR: Are you referring to Bidil?
CY: Yes, and any iteration of the parent compounds in Bidil have also been poorly prescribed. If the [generic parent compounds] had been prescribed, it would argue that science has been accepted and practitioners found a way to prescribe this to the target population.
TR: How should we move forward?
CY: We need to move away from race quickly. As we mature, we will be able to supplant the notion of race as predictor of response with something more palatable to the scientific community and to patients. Then we don’t have to bring the word heft of “race” into how best to care for patients.