Race, Medicine, and Political Correctness

Henry I. Miller, Hoover Institution, October 9, 2013

Should “race” be a criterion for inclusion in a clinical trial—and, by extension, is it appropriate for drug labeling to mention it specifically? For instance, should a drug’s label say that only “white people” should take it? Those are complicated questions, but the simple answer is that you go where the data take you.

Clinical trials are not designed to show the effectiveness of a treatment (drug, medical device, or other intervention) in a completely random sample of people in the general population. Instead, researchers use a variety of strategies to select a subset of patients in whom the intervention will likely be easier to demonstrate. This concept is called “enrichment,” which is defined by the FDA as “the prospective use of any patient characteristic to select a study population in which detection of a drug effect (if one is in fact present) is more likely than it would be in an unselected population.”

As the FDA observes in an agency guidance document on enrichment strategies, “Some of these selection strategies are obvious (e.g., patients are enrolled only if they have the disease that the drug being studied is intended to treat), but there are many more ways in which patients are typically chosen to make detection of a treatment effect more likely.” An increasingly important approach is the use of biological indicators, or “biomarkers”—such as certain DNA sequences or the presence or absence of drug receptors—as an indicator of the likelihood that the intervention will be effective and, therefore, whether a given patient should be eligible for the clinical trial.

{snip}

Genetic markers are obviously useful for obtaining enrichment, but how about more subjective factors such as “race” or ethnicity?

Dr. Abigail Zuger, a professor of medicine at Columbia University in New York, has strong opinions about the subject: “It has been clear for decades that race has minimal relevance to the body’s inner workings. Research has repeatedly shown that the biologic variations among individuals of the same race are reliably great enough for race to retain little utility as a biologic predictor. You might as well sort people by height.”

Zuger’s disdain for sorting by height is misplaced: If you were testing a growth-promoting drug in children of short-stature, for example, you would select only subjects of less than average height for the trial. {snip}

Such uncompromising, sardonic statements appear to owe more to political correctness than to human biology—or to the actual practice of medicine. In fact, because they do sometimes reflect “the body’s inner workings”—that is, differences in physiology—diagnostic tests and therapeutic interventions targeted at certain ethnic or racial categories can be useful.

In order to screen for a number of genetic diseases that occur predominantly in Jews of Ashkenazi, or Eastern European, descent, for example, there is a group of genetic tests called the Ashkenazi Jewish Genetic Panel (AJGP). Similarly, sickle-cell anemia is found disproportionately frequently in blacks, and a hereditary enzyme deficiency that causes sensitivity to fava beans and certain drugs is found primarily in Africans and persons of “Mediterranean” descent; after exposure to quinine-like drugs, as many as 10 percent of black men develop a serious condition in which red blood cells lyse, resulting in severe anemia.

Thus, race or ethnic origin—although far less precise than molecular markers—can sometimes serve as a useful surrogate for more precisely defined genetic differences.

{snip}

But let us return to Dr. Zuger’s comments, made in the context of reviewing a book about a cardiac drug called BiDil, which was approved in the United States in 2005 specifically for black patients (although it can be prescribed off-label for anyone). Due to the lack of evidence of efficacy in early clinical trials, the drug, which is actually a combination of two proven cardiac medicines (the vasodilators hydralazine and isosorbide dinitrate), had been rejected by the FDA nine years previously for approval for patients of all races. But because analysis of the data in various subgroups revealed a suggestion of benefit to black patients, another trial was performed on 1,050 self-identified black patients with severe heart failure who had already been treated with—but had not responded to—the best available therapy.

The results were so striking—43 percent reduction in mortality and 39 percent decrease in hospital visits among patients who received BiDil—that the study was stopped early and the drug was approved. This is an enrichment success story. Since its approval, BiDil has not been a great commercial success but it remains on the market.

Commentators have expressed a wide spectrum of views about the appropriateness of a therapy designated for one racial group, some even calling it discriminatory. Francis Collins, then director of the U.S. National Human Genome Research Institute (and now head of the National Institutes of Health) said at the time BiDil was approved that “we should move without delay from blurry and potentially misleading surrogates for drug response, such as race, to the more specific causes.”

He was correct, of course. But you go to war against illness with the data you have, not the data you wish to have. Political correctness notwithstanding, drug testing, approvals, and labeling must go wherever the evidence leads.

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  • Puggg

    All this seems to be saying is that racial-medical science could benefit people of certain races, but we’re so scared of the results of thinking about race as anything other than just a mere triviality that the research has to be shut down.

  • Alfred the Great

    Surprise! There ARE differences among the races; more than just skin color. When I took care of my elderly parents, the first thing that the doctor asked me was to tell him everything that I knew about our family’s medical history. His reason for asking was, as he put it, “It is all about genetics.” There are diseases that blacks get that Whites do not and vice versa. Political correctness is SO sacred that the government is willing to let people die.

  • JohnEngelman

    Dr. Abigail Zuger, a professor of medicine at Columbia University in New York, has strong opinions about the subject: “It has been clear for decades that race has minimal relevance to the body’s inner workings.”

    – Henry I. Miller, Hoover Institution, October 9, 2013

    Anyone that delusional or dishonest should lose her medical license.

    • willbest

      Sadly, we don’t punish stupidity the same way we punish PC deviants.

      • JohnEngelman

        No one who is stupid could get a teaching position at Columbia Medical School.

        It angers me that flagrant lies about racial differences are accepted, while those who tell the truth are persecuted.

        • willbest

          I don’t know, if Elizabeth Warren can get a job at Harvard Law, I can’t believe that medical school would be immune to stupidity.

          • JohnEngelman

            Just because you disagree with Elizabeth Warren does not mean she is stupid.

          • Brian

            Warren has her flaws but she is not stupid. It does us no favors to understimate our foes. Besides, law truly is a social construct, unlike medicine which has to deal with biological reality sooner or later.

        • MBlanc46

          They’re untruths, all right, but I’d guess it’s self-delusion rather than conscious lying.

        • leftists are delusional

          “The trouble with our liberal friends is not that they are ignorant, but that they know so much that isn’t so.” – Ronald Reagan

          • JohnEngelman

            Most people allow their likes and dislikes to influence their judgement of what is true and false. This tendency is not restricted to liberals.

          • leftists are delusional

            Everyone deals with their own biases, the left however has the market cornered on delusion.

          • JohnEngelman

            Not really. The right denies scientific evidence in favor of the greenhouse effect, and believes that cutting taxes for the rich is consistent with balancing the budget.

          • leftists are delusional

            Except for the fact that anthropogenic global warming is a totally discredited myth (delusion) and government revenue rises when tax rates fall is a historically demonstrated reality you might have had a point.

            You are under the delusion that taxing an activity does not discourage said activity. But that is not reality.
            When you tax alcohol you reduce people’s desire and/or ability to consume, when you tax earnings you reduce peoples desire to earn more just to give it to the Treasury, especially true under Marxist progressive tax.

            But thank you for exhibiting the delusions of the left to confirm my point.

    • John Ulfsson

      ‘Dr. Abigail Zuger, a professor of medicine at Columbia University in New York, has strong opinions about the subject: “It has been clear for decades that race has minimal relevance to the body’s inner workings.”‘

      How do they just make blatantly false statements like this?

    • David Ashton

      It was “decades ago” that Stanley Garn said exactly the opposite in his book on human races.

    • Brian

      Doctor Zuger, sickle cell, cystic fibrosis, torsion dystonia, thalassemia, and Tay-Sachs are waiting on line three. Doctor Zuger, line three….

  • Spartacus

    “It has been clear for decades that race has minimal relevance to the
    body’s inner workings. Research has repeatedly shown that the biologic
    variations among individuals of the same race are reliably great enough
    for race to retain little utility as a biologic predictor. You might as
    well sort people by height.”

    ———————————————————————————————————————

    • David Ashton

      I’ve been meaning to ask you: what happened in between?

      • Spartacus

        White countries had ups and downs, black “countries” if you can call them that, were pretty much the same all along.

        • David Ashton

          Why these “ups and downs”?

          • Spartacus

            War, plague, degeneracy of racial stock, climate change… There are many reasons, some outside of man’s control .

          • David Ashton

            Now these comments are more up my street than threats of mass-murder. You may recall my post some time ago listing reasons for the fall of the western Roman empire.

          • Spartacus

            Not sure I have, or else I can’t remember . What article were they in?

          • David Ashton

            Weeks ago now – following an article by Engelman on the Roman State and Genetic Pacification. I kept my notes for it, but did not download it.

          • Spartacus

            Engelman’s article? Yeah, I think I remember reading that.

  • bigone4u

    In medicine, as in life, race is more than just a “social construct.” If only liberals would acknowledge that, it might be the start of that “honest conversation about race” they are always demanding.

    • JohnEngelman

      Liberals are never so hypocritical as they are about race. They call for a dialogue about race and claim to favor free expression, while suppressing opinions about blacks they do not like. They advocate school integration while refusing to send their children to predominantly black public schools. They force Protestant Fundamentalist children to learn the theory of evolution while denying the clearly Darwinian implications of books like The Bell Curve.

  • I agree with others who’ve said that we’ve replaced Christianity in the West, with secular progressive egalitarianism as the new moral belief system.
    So with that in mind, this story reminds me of other fundamentalists who’ll deny medical treatment to loved ones based on their faith based beliefs, to the point of letting those loved ones die, to prove their ‘theories’ as correct.

  • mgs166

    I say only give blacks access to medicine, treatment and medical facilities that they legitimately invented. This should wipe them off the face of the earth in about a century – give or take a day or two.

    • Tim_in_Indiana

      Maybe not wipe them off the earth, but reduce their numbers to that of pre-colonial Africa.

  • APaige

    I believe people with red hair have to have their anesthesia adjusted. Is that ‘hairism’ or an important medical decision to make based on genetics? I always tell my doctor the truth and I expect the same in return.

  • gemjunior

    She beez iggnint. Dahversitty is our stremf. White people be gittin’ sickle cell or is dat a black disease? Don’t all da darky India people be havin’ doze thalassemias? White wimminz be gittin osteoporosis when black wommin don’t git dat. Dere bones is like stone cement. Shheeeitt. It sounds like some stuff is diffrint fo’ sho. For real. Word.

  • Leelywhite

    I agree. When I studied medicine a good history included ethnicity and race. Blood and liver diseases such as thallasemia, g-6-p-d deficiency, sickle cell anaemia are all race and ethnicity related. in South Africa it is generally acknowledged that blacks have a low incidence of coronary artery disease compare with whites, but a much higher incidence of strokes. Why try to politicize empirical observation? Wishful thinking can never take the place of cold facts.

    • Bossman

      As I understand it, there is less plaque buildup in their arteries but their kidneys are less able to control blood volume especially under the influence of the mineral elements such as calcium, potassium, magnesium, sodium, etc.

  • SFLBIB

    I for one am tired of the overworked word, “discrimination” and all its derivatives.

    “When it comes to discrimination, we have to be willing to distinguish between different types of discrimination. Discriminating between different concepts is called intelligence. Refusing to lump all forms of discrimination together is called common sense. It is what keeps us from having blind bus drivers.” – Professor Mike Adams

  • Brian

    Ruh roh, Shaggy! Watch the blustering egals run for cover. Mt. Social Construct is rumbling and about to erupt.

  • Brian

    Is is true that torsion dystonia (and other sphingolipid diseases) are much more common among Ashkenazi Jews, and that there is a significantly higher IQ, generally, among the sufferers of these diseases?

  • disqus_Xz3UA6obwj

    So it discriminates. How does that alone make it wrong?

  • Bossman

    Yes, there are genetic differences but lifestyles, education, diet, personal hygiene and other variables should make a difference. Should it not? How much of black afflictions have to do with poverty and ignorance?