Whether The American Constitution Society seeks "to revitalize and transform the legal debate, to counter the narrow conservative vision of American law that lacks appropriate regard for the ways in which the law affects people's lives" or is in fact the least necessary organization in legal education, the Columbia chapter has had a blog since October, and I've singularly failed to mention it. They use Blogger, but if they had an RSS feed I'd be linking to them.
Today, however, there's a column by "Liz" (full disclosure--I have no idea who this is) that's gotten me a bit confused, and so I'm going to "fisk" it. However, unlike your normal fisking, I'm going to start up front by saying I don't really know enough about genetics to make heads or tails of this. This isn't an argument. The questions asked below aren't rhetorical, they're real, and if any of my readers have some medical/scientific knowledge, please fill me in.
After some introductory text, the article starts as follows:
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.
In a slight gripe with the CLSCACS Blog, it would have been nice to link to the report. I'm pretty certain it's the report
here, though again, this isn't my forte.
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.
Now, here's where I would have expected to see something saying that a less restrictive means of determining who the drug would help, and who it wouldn't, actually exists. Here's what follows:
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.
One would have thought that "pretty much" and "identical" here was begging the question, since there would seem to be a difference due to the experiment. Even the
National Human Genome Research Institute source that the ACS quotes approvingly below doesn't say that genetics have
no role in disease:
What about health disparities? Are genetic differences between populations likely to have a role in health status, both in the US and around the world? In many instances, the causes of health disparities will have little to do with genetics, but rather derive from differences in culture, diet, socioeconomic status, access to health care, education, environmental exposures, social marginalization, discrimination, stress and other factors. Yet it would be incorrect to say that genetics never has a role in health disparities. This is most obvious in the unequal distribution of disease-associated alleles for certain recessive disorders, such as sickle cell disease or Tay-Sachs disease, but has also been noted recently for certain nonmendelian disorders, such as Crohn disease.
The question of whether genetics will explain a substantial proportion of health disparities for most common diseases is largely unanswered and will be clarified only by further research studies of many populations. Given that the frequency of many genetic variants is not equal in all parts of the world6, however, genetic variations conferring disease susceptibility are expected to be unequally distributed, at least in some cases.
But again, I don't know enough to evaluate that statement. Liz continues:
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?
I can't find anything that says a drug company is
stating there's a physical or genetic difference between African American and white heart failure patients. I couldn't find any of the application documents on the FDA website, although I
did find this:
a 2003 report stating that the FDA was now requiring reporting on race and ethnicity in drug trials. But relevant to any evaluation would be: is the drug company implying that the difference stated exists? Or are they claiming that only for this group do they know that a reasonable chance of successful treatment exists? The two would seem to be very different statements. (Again, there's a frustrating lack of linking to sources.)
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.
Again, no support for this is offered. Does anyone have some? (Again, the only source cited by the ACS, Dr. Frances Collins, seems to disagree. See the third paragraph in the document linked above and
here.)
Skipping ahead some, we come to this:
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.
Now, so far, so good. The report then quotes this statement from Francis Collins (The source being
here, and they forgot to state that he's the Director of the
National Human Genome Research Institute, which is why he's persuasive):
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."
Now, here's my question: can you actually make a case that, even
if this deserved strict scrutiny, it wouldn't pass? First, to even bring a case, you're going to have to have someone who's disadvantaged by the FDA denying access to BiDil to them. This would seem to have to be a non-African American with heart disease who can prove that he would be helped by the drug. After all, for strict scrutiny to be applied, there has to be some group who's being disadvantaged, and you're going to be hard pressed to show that someone's disadvantaged by a drug that's not going to work on him.
(Or I suppose you could say that the disadvantage of "disproving" the social-science theory of race through the FDA approval is more disadvantageous to African-Americans than lack of access to the drug, but this too seems like one heck of a tough sell.)
But then you're going to have to prove that drug approval solely for African-American's isn't the least restrictive means to accomplish what even Liz says is a compelling government interest. To do this, it would seem to me that you'd have to show either that (a) self-identified race (because the NEJM study did correlate with something, whether we say there's such a thing as race or not) is not a reasonable proxy for who this drug is going to work for; or (b) the development of a test for whatever genetic markers do determine the drug's usefulness will be cheap enough that it doesn't crowd out other research. I'd also think you'd want to show that the side-effects for non-effective use (i.e. if you give BiDil to non-African Americans) are non-negligible, and that the money spent developing a genetic test wouldn't be more usefully spent on other heart disease (or even disease-treating) programs with a wider applicability.
In other words, given the high priority that health gets for compelling government interests, and the fact that no less restrictive means seems available, why even bother trying to apply strict scrutiny to it, as any attempt to do so is likely to merely find that it passes muster?
Looking at some of the cited literature, it doesn't seem that there's much fear that scientists aren't trying to uncover the exact genetic nature of what race is a proxy for anyway. For instance, this study, cited in the NEJM work, spends the last two paragraphs arguing that just such research is needed.
Now, I suppose there could be some fear that, even were a test for genetic markers developed that allowed BiDil to be used on those who do not self-describe as African Americans, the manufacturers wouldn't want to sell to them. The only reason I can see for this, really, is that the cost of the test outweighed the value of the medicine, taken in aggregate. (i.e. If you tested every caucasian heart patient, you'd get a higher cost from testing and false positives/negatives than you saved by handing out the medicine.) But again, if that were the case the action would seem to pass strict scrutiny as well.
Otherwise, one is left with the curious situation of a drug manufacturer refusing to sell to non-African Americans though they possess a test which would make it profitable for them to do so. But this seems a curious concern.
So I'm assuming that there is a large amount of the science I'm simply not understanding. As it stands, I can't see why Liz is so concerned.
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