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| What is Wrong with Race-Based Medicine?
Introduction
Race enters into medicine in at least three different ways. First, it enters into many studies of how health risks vary within the population. In particular, race is used in the field of epidemiology to describe how the risk of disease is greater for some in the U.S. than others. Epidemiologists tell us, for example, that the rate of heart failure in the U.S. is more than twice as great for blacks as whites.
Second, doctors use race to decide how to treat their patients. Some cardiologists, for example, base their choice of drug for a patient with heart failure on the patient’s race and give one drug to a white and different drug to a black patient.
Third, pharmaceutical companies use race to win FDA approval for a prescription drug or promote the drug to doctors or their patients. So, for example, the FDA recently licensed a heart drug for use with black patients but not white.
I will try to convince you that there is something wrong with each of these uses of race in medicine. My talk has three parts. The first discusses the use of race to describe or explain differences in health risk, the second the use of race in the diagnosis or treatment of patients, and the third the use of race in the licensing or marketing of drugs and medical devices.
Section I: Race and Risk
Some people in the U.S. have type 2 diabetes and others do not. In an effort to understand why, epidemiologists divide the population into different ethnic or racial groups and compare the rate of diabetes in one group with that of another. According to their findings, the rate of diabetes is 1.4 times greater among blacks than whites, and blacks in America are at much greater risk of the disease than whites are. The statistics show that risk varies with race but not the race is a cause of the variation; the difference is risk could be the result of a difference in income or education or some other socioeconomics variable that is known to vary with race.
In order to better understand the relationship between race and risk, epidemiologists consider whether blacks and whites with similar income and education differ in their rate of a disease; they consider, in other words, whether racial differences in the rate of diabetes remain when the other risk factors are the same. What they find is that he differences in rates narrow but do not go away. In other words, a large number of blacks and whites alike in many social and economic respects are not alike in their risk of diabetes.
What would explain the residual difference? Two different explanations have been proposed, one biological and the other social. One implies that a biological difference between the race is responsible for the residual variation in risk, while the other that racial discrimination is responsible.
According to the biological explanation, blacks and whites in the U.S. differ in a gene that controls the body’s production or response to insulin, much as blacks and whites differ in a gene that controls skin color; what explains the residual racial difference in the risk of diabetes, on this view, is a genetic difference between the two racial groups.
According to the social explanation, many people who are seen as black are exposed to racial discrimination no matter what their income or education, and discrimination increases their susceptibility to a variety of diseases, including diabetes; what explains the residual racial difference in risk, on this view, is the difference in how blacks and whites are treated rather than any biological difference between them.
The biological explanation is often taken to show that the racial categories into which people in the U.S. are sorted are biological rather than social, but the explanation does not show that at all. A statistical difference between blacks and whites in a gene for insulin production no more shows that race is biological than a statistical difference between U.S. and Swedish citizens in a gene for eye color shows that citizenship is a biological category. A genetic difference between two groups is not evidence that the groups are biological. In the U.S., racial labels pick out social groups, but different social groups can differ in gene frequencies and, as a result, in the incidence of a biological trait.
Epidemiologists should continue to use race in their studies of disease, even though racial labels are easily misunderstood, and they should oppose efforts to prohibit government from collecting and publishing racial statistics, as for example, a recent ballot initiative in the state of California attempted to do. Statistics that describe differences between blacks and whites in the risk of death or disease are important even though race is a social rather than biological category.
Nevertheless, I do have some reservations about how racial labels are assigned in many epidemiological studies. In order to count the number of blacks and whites in the U.S. with diabetes, each member of the population has to be placed in a racial category. The epidemiologist or anyone else doing the counting has to decide to which category each person belongs. Increasingly, the decision is based on a self-report, and a person is assigned the race she reports herself to be in a population survey. But some people assign themselves a race different from the race others do.
Self-reported race is not be the bets form of racial identification when self-reported race and other-reported race are different and a variation in risk is due to racial discrimination. In such a case, other reported race is a better identifier, and the question a person should be asked is not what race she takes herself to be by what race others are most likely to take her to be.
According to many recent studies of how younger or first-generation Americans are reporting their race, many report themselves to be a race different from one thy are taken to be by a teacher, loan officer, doctor, policeman or prospective employer, and, as a result, other-reported race is often better than self-reported race for describing racial differences in the risk of many disease. Epidemiologists should continue to stratify the U.S. population by race, but they need to reconsider the methods they use to assign each member to a racial category, and they should not assume that a self-report is always the best measure of a person’s race or that one way of assigning race is best no matter what disease they study.
Section II: Race and Medical Treatment
Race is often used today in clinical medicine as a proxy for a medical trait. One variable X is used as a proxy for another Y when X is used in the place of Y to make a decision about a person’s treatment. So, for example, college admissions officers use an applicant’s score on an SAT test as a proxy for his academic promise when they use his score to decide whether to admit him. Policemen use race as a proxy for a motorist’s possession of an illegal. Substance when they use his race to decide whether to stop him.
Doctors use race as a proxy for a patient’s response to a drug when they use his race to decide whether to use the drug to treat him, and they use race as a proxy when they prescribe one drug for their black and a different drug for their white patients. Some cardiologists prescribe a blood-vessel drug (an ACE inhibitor) to treat their white patients with heart failure, but a heart-rate drug (a beta-blocker) to treat their black ones, since, according to a number of studies, blacks do not metabolize the blood vessel drug as effectively as whites do.
When race is used as a proxy in law enforcement, the police engage in racial profiling, but when doctors use race as a proxy in medicine they do as well. Most doctors, however, maintain that their use of race is different from a policeman’s, for while some studies show that race correlates with drug response, they say, none show that race correlates with crime.
Nevertheless, the studies doctors cite as evidence that race correlates with drug response rest on a number of false assumptions. How a person metabolizes a drug depends on his ancestry and not his race. When doctors use race as a proxy for a drug response, they assume that race is a good proxy for ancestry. But doctors usually rely on self-reports to assign a race to patients, and self-reported race is not a very good proxy for ancestry, since, in the U.S., many patients who check the “Black” or “White” box on a medical form are of mixed ancestry. As a result, the differences in drug response among patients identified as black can be as great as the differences between patients identified as black and patients identified as white, and targeting blacks for one drug and whites for another can adversely affect black patients for whom the “white” drug would be a more effective treatment.
Thus, treating all the blacks the same, offering them all the same treatment, can deny some blacks the bets available medicine, even though the doctor intends to offer every black patient the best one.
As a result of racial profiling in law enforcement, black and white motorists in the U.S. differ in their chance of being stopped by the police. The police treat motorists as if driving while black were itself a crime. Something similar is happening in medicine. As a result of racial profiling, black and white patients as if being black were itself a medical condition. But a race is neither a medical condition nor a crime. Racial profiling in both law enforcement and medicine rests on the use of race as a proxy for a trait that has little to do with race, and, as a result, racial profiling serves both motorists and patients badly.
Section III: Race and Medical Marketing
In the last section, I argued that when doctors use race as a proxy, they are not serving the interests of their black or white patients very well. But if doctors should not use race as a proxy when selecting a drug for their patients, neither should the FDA use race in deciding whether to license the drug nor a pharmaceutical company in deciding to whom to promote it.
One drug company, NitroMed, is promoting the drug BiDil as the drug of choice in the treatment of heart failure in blacks. If you are black, the company says in its promotional
Materials, we can best treat your heart disease. The story behind the claim is interesting. NitroMed received a patent on the drug a few years ago and the Sought FDA approval for use of the drug with patients.
The FDA requires a clinical trail to show that a drug is both safe and effective before giving approval. NitroMed conducted a clinical trail with BiDil, but when the experts at the FDA reviewed the study, they concluded that the drug did not significantly improve the heart condition of those who had enrolled in the trail.
The company was disappointed. But when statisticians at NitroMed looked again at the number, they discovered the BiDil did seem to improve the condition of the blacks in the study even if not the whites. The company conducted another clinical trial, but his time with all black and no white patients. Many blacks in the second trail showed improvement, and the company requested FDA approval for the use of the drug with black patients only; the FDA approved the use of BiDil for blacks but not for whites and, for the first time, licensed a drug to treat members of a single race.
The story was widely covered in newspapers and television. The headlines read “With Heart Disease, Color Does Matter” or “Good News, Black Drugs for Black People.” The Association of Black Cardiologists in American welcomed the news. The cardiologists hoped that, by prescribing BiDil, they would be able to increase the survival rate and quality of life for their black patients.
However, their hope is not well-supported by any of the evidence submitted to the FDA, for even if BiDil did increase the overall survival rate of blacks in each of NitroMed’s two trials, the variation in the effectiveness of the drug was considerable, and, the drug was effective for some but not other blacks in the trails. As a result, to prescribe the drug to all black patients could decrease the quality of life or survival rate from many blacks who would respond better to a different drug.
Moreover, the FDA, in licensing the drug for use with one race only, assumes that there is a reliable way to assign race to patients who suffer from heart disease, but there are different ways and none is very reliable. A patient can be white for a doctor who assigns race based on self-reports and black for a doctor who assigns race based on skin color. Moreover, if many of her patients are of mixed ancestry, two patients she labels ‘black’ can differ more genetically and, as a result, differ more in drug response than her black and white patients do.
Once the FDA approves a drug for use in treating one condition or with one group, doctors are allowed to prescribe it for any condition or group. These are called ‘off-label’ uses’, and an estimated 23% of all prescriptions are written for off-label uses in the U.S.. Thus, the FDA’s licensing for BiDil for blacks only is advisory, but the advice the agency is giving doctors, to treat race as a proxy for a response to drug, is bad advice, for race, as I explained before, is not a very good proxy for a genetic trait like the rate with which a drug is metabolized.
There is no good reason to believe that putting racial labels on drugs will increase the survival rate of blacks with heart disease, but there is good reason to believe that putting the labels on drugs will encourage the mistaken but common view that race is a biological rather than a social category. The headline “Good News, Black drugs for Black People” is good news for NitroMed but not good news for black people.
Conclusion
Race-based medicine is wrong for many of the same reasons that race-based policing is. The people we pick out as different races might be different but not in a way that should determine how they are treated either by a doctor or policeman. What is wrong with race-based medicine is that race is no better a category for a doctor to use to decide how a patient should be treated than for a policeman to use to decide whether a motorist should be stopped.
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| OMG. OUCH!
Imagine that you are in an operating room, about to undergo surgery for appendicitis. The surgeon explains that before the procedure begins, you will be given two drugs intravenously, an anesthetic and a muscle relaxant. Somone injects a syringe full of liquid into your arm, and soon you feel your arms and legs getting heavy. Within minutes, you find yourself unable to move at all - not even to breathe. (Fortunately, you have been hooked up to a respirator.) Although you expected to become sleepy, you are wide awake and can see, hear, and feel everything that is going on. To your dismay, you notice that the surgeon has picked up a scalpel. Apparently, someone has made a mistake and forgotten to give you the anesthetic. As the blade approaches your skin, you try desperately to yell, to move your arms, to do anything that would let the staff know you are awake, but you can't. All your skeletal muscles are paralyzed, and you can't even blink an eye! | | |
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