Wednesday, January 05, 2005

The Race Based Marketing of Prescription Drugs

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."


At 12:38 AM, Blogger Mike Russo said...

Hrm. This is actually really interesting. I'm quite sympathetic to the point that as we allow ourselves to uncritically use race-based descriptors, we reify the idea of race as having an existence independent of cultural construction. And I find the literature exploring the swampy ground upon which claims of genetic differences between the races rest quite persuasive (variation among is larger than variation between, and all that). And yet...

It seems to me that if the drug really does have significant benefits for persons of African descent, this in fact might be the most expedient way of marketing it. I definitely think that the drug company researchers should do further work to determine what the exact mechanism at issue is, but this is more because I think that understanding what's going on is likely to be a good thing, rather than hoping that some alternative descriptor is going to be forthcoming. After all, while the drug's efficacy is certainly due to a specific complex of genes which some individuals have and others do not, often these genes do correlate quite strongly with race, despite the big-picture that humankind shares an overwhelming amount of genetic material in common.

Complicating matters is the fact that sometimes, culturally constructed identities will eventually lead to genetic differentiation. To be Amish is a priori to be just the same as anybody else, of course, but due to centuries of a limited breeding pool, the population is genetically distinct (higher incidences of polydactyly, most notably). Persons of African descent tend to have an innate resistance to malaria, and concommitantly have the capacity to suffer from sickle-cell anemia (the adaptations are apparently linked); being from Africa doesn't mean anything, in terms of human dignity, but there are insects which carry malaria there. And then there are the Ashkenazi Jews; perhaps as a result of being confined in ghettoes for centuries, rather horrific selection pressures have left them less susceptible to polio, but the incidence of Tay-Sachs disease is much higher among them than in control populations.

All of which is to say that though the idea of race as innate genetic difference has only a very nebulous basis in objective fact, it's sometimes been a self-fulfilling prophecy in certain limited areas. To say that something is a social construct isn't to say that it has no real-world effect, after all.

Given all of the above, then, it seems to me that if the cultural construct "African-American" does a good job of tracking those who will be benefitted by the drug, using that label makes sense. There are alternatives, I suppose, but they all strike me as clumsy to one degree or another: one could use an alternative formulation, like "persons who have one or more ancestors who originally came from Africa", but that's just the same water in a different bottle. One could advertise the drug as possessing particular virtue for those who have a family history of 5-alpha-reductase deficiency, or whatever it winds up being, but that's not going to do very much good in terms of informing people about a potentially life-saving treatment.

I'm left thinking that this isn't so much a legal problem as it is a linguistic one (which certainly isn't to say it's not an interesting problem -- just the opposite). Again, I agree that it's imperative that we figure out what the exact mechanisms at work are, rather than relying on fuzzy cultural descriptors which lack much scientific rigor, but the technical descriptors we're likely to wind up with at the end of the inquiry aren't likely to come with very many easily accessible handles.

Overall, this is probably a species of the age-old equity vs. equality, race neutrality vs. race blindness debate, with a few added wrinkles. It's probably relevant that I come down closer to the paleoliberal position and don't think use of racial criteria is unconstitutional as such. Still, I don't think the above argument is completely a product of that bias.

[Apologies if any of this comes off as didactic; I haven't quit kicked the habit of lapsing into lecture mode when talking science]

At 1:13 PM, Blogger Publius said...

Liz, I disagree that this action should get strict scrutiny. An "African-Americans only" endorsement by the FDA is not irrational, is similar to the relaxed scrutiny in gender discrimination in cases where the discrimination is relating to real, biological differences.

Besides that, I think it's ridiculous to deny people life-saving drugs on the basis of a very indeterminate and vague slipperly slope argument. You say it will "open up a whole can of worms" but the only worms I see you listing are administrative problems. Surely the saving of lives justifies the (i think quite small) overhead.

At 2:27 PM, Blogger Liz said...

Publius- I actually think you are right, and that we need to reevaluate the way we look at race jurisprudence to figure out how to get this drug on the market. You cant really compare this to relaxed scrutiny for gender relations though--

The biological differences that lead to different treatment for women under the law are physiologically related to gender- in this case the physiological differences are not actually related to race as legally perceived.

The FDA regularly approves drugs for everyone but then puts a disclaimer on the label saying that the drug may be more or less effective in a particular community. Why not do that here?


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