What’s Wrong with Race-Based Medicine?: Genes, Drugs, and Health Disparities

Posted in Articles, Health/Medicine/Genetics, Media Archive, Politics/Public Policy, United States on 2013-09-30 21:31Z by Steven

What’s Wrong with Race-Based Medicine?: Genes, Drugs, and Health Disparities

Minnesota Journal of Law, Science & Technology
Volume 12, Issue 1 (Winter 2011)
pages 1-21

Dorothy E. Roberts, George A. Weiss University Professor of Law and Sociology; Raymond Pace and Sadie Tanner Mossell Alexander Professor of Civil Rights
University of Pennsylvania

In June 2005, the Food and Drug Administration (FDA) announced a historic decision: it approved the first pharmaceutical indicated for a specific race. BiDil, a combination drug that relaxes the blood vessels, was authorized to treat heart failure in self-identified black patients. BiDil had been tested in the African-American Heart Failure Trial (A-HeFT) launched in 2001. A-HeFT enrolled 1,050 subjects suffering from advanced heart failure, all self-identified African Americans. A-HeFT showed that BiDil worked; in fact, it worked so spectacularly that the trial was stopped ahead of schedule. BiDil in-creased survival by an astonishing 43 percent. Hospitalizations were reduced by 39 percent. It was a momentous accomplishment for Jay Cohn, the University of Minnesota cardiologist who invented BiDil and had pioneered vasodilators as an important treatment for heart failure.

Given evidence of BiDil’s efficacy, but little evidence that race mattered to its efficacy, the FDA should have made one of two decisions: reject the request for race-specific approval or approve BiDil for all heart failure patients, regardless of race. Instead, the FDA put race at the center of its decision, sparking controversy and paving the way for a new generation of racial medicines.

No one is complaining that BiDil is available to people who will benefit from it. The problem is that BiDil was made available on the basis of race. Its racial label elicited three types of criticism: scientific, commercial, and political. I will discuss the first two controversies en route to what I consider the main problem with race-based medicine, its political implications. By claiming that race, a political grouping, is important to the marketing of drugs and that race-based drugs can reduce health disparities, which are caused primarily by social inequality, those who promote racialized medicine have made it a political issue. Yet, having made these political claims, these very advocates answer criticism by saying that we must put aside social justice concerns in order to improve minority health. This article explains why marketing pharmaceuticals on the basis of race is more likely to worsen racial inequities than cure them…

Read the entire article here.

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Funding Race as Biology: The Relevance of “Race” in Medical Research

Posted in Articles, Health/Medicine/Genetics, Media Archive, Politics/Public Policy, United States on 2013-01-08 22:04Z by Steven

Funding Race as Biology: The Relevance of “Race” in Medical Research

Minnesota Journal of Law, Science & Technology
Volume 12, Issue 2 (Spring 2011)
pages 571-618

Taunya Lovell Banks, Jacob A. France Professor of Equality Jurisprudence and Francis & Harriet Iglehart Research Professor of Law
University of Maryland School of Law

Note from Steven F. Riley: See the articles, “Fracture Risk Assessment without Race/Ethnicity Information,” and “Taking race out of the equation in measuring women’s risk of osteoporosis and fractures” about the positive results of taking “race” out of medicine.

I. INTRODUCTION: ‘DEM BONES, ‘DEM BONES, ‘DEM “BLACK” BONES

In 1940 the State of North Carolina classified my friend as “colored” despite her “white skin, blue eyes, [and] curling blond hair.” She—like her parents, grandparents, and many other black Americans—is often mistaken for white. Sixty years later when she went for a bone densitometry test—a must for postmenopausal women—the technician asked her to fill out a form that asked her race. Surprised, she asked why. The technician explained that “since the bones of black people are different than the bones of white people, the doctor needed this information to interpret the scan correctly.”

The radiologist who analyzed my friend’s bone scan acknowledged that there is a debate within the radiology community about the scientific validity of interpreting an X-ray through the lens of race. But, he claimed, it is impossible to interpret the bone scan without factoring in race because the machines that analyze the bone scan can only produce an analysis if the race of the person being analyzed is included. The doctor could not explain how the x-ray machine defined “race,” replying that the definitions “were created by the companies that built the machines.”

My friend asked if there was any way she could get more helpful advice about the condition of her bones. The radiologist thought for a moment, then suggested that perhaps my friend should have her bone densitometry test performed twice, once as “white,” then as “black.” The condition of her bones, he told her, would lie somewhere between the two results. However, my friend concluded that “one-half of a fantasy definition of ‘white’ plus one-half of a fantasy definition of ‘black’ will only yield one whole fantasy: it will not provide a sound medical diagnosis.”  Thus she marked “black” or “African American” because that had always been her legal and social identity. So what did the results really tell her doctor?

For years my friend taught and wrote about the social construction of race and knew that her doctor’s explanation about the use of race as a biological term by the radiology community was flawed. She found it reminiscent of the World War II era when the Nazis kept “separate blood banks for ‘Jewish blood’ and ‘Aryan blood,’ [and] American blood banks were separating ‘white blood’ and ‘black blood’.” The United States has a long and continuing history of “unconscionable medical research” involving black Americans.

In 1950 the United Nations Educational, Scientific and Cultural Organization (UNESCO), mindful of race-science’s dark and not so distant history, drafted a statement on the use of race in modern science. This statement, developed by an esteemed group of anthropologists, psychologists, and sociologists, concludes: “[f]or all practical social purposes ‘race’ is not so much a biological phenomenon as a [damaging] social myth.” Today most scientists agree that race and ethnicity (ethno-race) classifications are the result of social and political conditions, as opposed to biological differences. There is, however, disagreement about the scientific validity of these categories.

Even though an increasing number of scientists believe that too often ethno-race is used as a surrogate for various socioeconomic and environmental factors, for most of the late twentieth century social science and medical researchers continued to use ethno-race in a biological context.

Nevertheless, there are times when ethno-racial designations have value in medical research. As one scholar writes, “using race as a social category” to study the impact of racism on health and access to medical care is critical to eliminating health inequities based on race. But, she cautions that using race as a biological category can reflect and reinforce racial stratification as well as racist notions of inherent human difference. Several commentators call this phenomenon the reification of race, where the social concept of race is transformed “into a specific, definite, concrete, and now presumably genetic category which can feed back into preexisting lay understandings of racial difference.”…

…This article proceeds from the assumption that there are few clear instances, other than perhaps access to health care or measuring equality in medical treatment, where the use of ethno-race in medical research is appropriate. Even in those limited situations the justification for using ethno-race, how the ethno-racial categories are defined, and the method for assigning ethno-race warrant close scrutiny and oversight, especially when these studies are funded with federal money. In the next section, this article explains the scientific basis for that assertion. First, it explores the debates within the medical community about the connection between race and biology in biomedicine. Then it examines literature on race-related stress to determine whether this might be an instance where ethno-racial labels help explain health outcomes, and argues that guidelines or regulation are needed.

The third section of this article examines two sets of guidelines on the use of ethno-race in biomedical research: guidelines adopted by high impact medical journals, and federal guidelines on the use of ethno-race in federally funded biomedical research. Finding these measures inadequate, this article argues that the only way to quickly change research behavior in this area is through greater regulation and oversight of federal medical research grants. More stringent government regulation and oversight of federally funded biomedical research grants that use ethno-race may trigger changes in the medical culture faster than litigation.

In the fourth section this article proposes a regulatory scheme that offers a standard to measure the appropriateness of ethno-race in applications for federally funded biomedical research that will cause both researchers and grant reviewers to give more thought to how and why ethno-race is used in research protocols. This article concedes that this proposal is only a first step, and acknowledges that meaningful progress also requires strong and effective measures designed to change how biology is taught in undergraduate, graduate, and professional schools. But without a change in the medical culture, another generation of researchers and health care providers will be trained to think about ethno-racial differences inappropriately.

Before effective remedies for the problem described can be discussed, it is important to clarify both the meaning and use of the term “race” in scientific discussions. The next section of this paper looks at debates within the scientific community about the meaning of ethno-racial labels…

Read the entire article here.

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