Something to think about.
This year a drug company is going to ask the FDA to approve a heart failure medicine for African Americans. Not Caucasian patients. Just black ones. With little or no guidance on what it is or means to be white or black. Why should this be of interest to the legal community? Well, the FDA shouldn’t be able to do this, and it’s debatable whether or not it’s really a good idea.
A little background. Last November, the New England Journal of Medicine published a study about BiDil, the aforementioned drug. BiDil treats heart disease and has been tested in the past, unsuccessfully, in a diverse community. When researchers went back and analyzed the data, they discovered that while the drug was ineffective overall, it was fabulously successful in treating folks that were identified as African American. In fact, when the researchers initiated a study whose only participants self-identified as being African American, they had to stop it prematurely, because the drug was so effective they felt it would be wrong to withhold it from the control group.
The FDA, which falls under the umbrella of the Department of Health and Human Services, is responsible for certifying all prescription drugs as being safe and effective before they are put on the market; there is no real question that everything they do constitutes state action. Thus, if they choose to label something on the basis of race, shouldn’t this action be strictly scrutinized? If so, the approval of BiDil solely for African Americans must advance a compelling government interest by the least restrictive means necessary. No doubt, the treatment of heart failure serves a compelling government interest. Even more so if we look at BiDil’s story through the lens of affirmative action. African Americans suffer from a variety of health problems at disproportionately high rates due to a variety of environmental factors. BiDil’s approval for African Americans may just be one step towards righting past health care wrongs. Still, despite the fact that this drug will help African Americans suffering from heart disease in the short term, allowing the FDA to slap a race-based label on the drug may not be least restrictive means of putting it on the market and is probably not a good thing for the African American community in the long term.
For years, scientists, researchers and other academics have been shouting that race is a social construct. In fact, the preliminary sequencing of the human genome told us that regardless of whether or not our physical characteristics (a.k.a., " phenotype" to geneticists) identify us as black, white or Asian, we are pretty much genetically identical to one another. And yet, here we have a drug company implying that African American heart failure patients are physically (read: genetically) different from white heart failure patients. How can they do this? Were the social construct theorists wrong?
No. The reality is that BiDil’s efficacy likely has little to do with race as commonly perceived. "African American" is just filling in as a proxy for the genetic markers that code proteins which ultimately lead to the ways in which the human body interacts with the drug. Anyone may have these genetic characteristics. Allowing BiDil’s marketers to make the quick leap from "genetic markers" to "race" may have long term implications for medical and social policy if not fully thought through by policy makers now, before the FDA has acted. It would be a huge injustice for the FDA to keep BiDil from patients who could benefit from it. Nevertheless, BiDil’s makers and the FDA should not be permitted to shortcut the drug approval process by referring to BiDil’s efficacy within one community. The drug company should be required to find out what exactly is making the drug so effective in the African American community. The FDA should compel BiDil’s makers to research what exactly "race" is serving as a proxy for and approve the drug for all individuals with such characteristics, whatever their ancestry.
The last thing we need is the FDA’s stamp of approval on dubious biological differences between races. This could open up a whole can of worms. For starters, how do we decide who qualifies as African American? Is it a phenotypic designation? More research is needed to identify how people self-select their racial identity. Again, it would be wrong to deny sick patients an effective drug. Therefore, the FDA should approve BiDil for African Americans only so long as it takes to develop a test to identify all the individuals who could be treated by BiDil, whatever their race. In the words of Francis Collins, "a true understanding of disease risk requires a thorough examination of root causes. ‘Race’ and ‘Ethnicity’ are poorly defined terms that serve as flawed surrogates for multiple environmental and genetic factors in disease causation, including ancestral geographic origin, socioeconomic status, education and access to health care. Research must move beyond these week and imperfect proxy relationships to define the most proximate factors that influence health."