BiDil: Assessing a Race-Based Pharmaceutical

To the cogent article by Brody and Hunt, I would reinforce the following points:

First, it is critical that all who participate in the planning, conduct, and translation of research understand that the scientific questions we can answer are limited both by what we ask and how we seek the answer. If we ask the question and seek the answer in a limited fashion (as in the evaluation of BiDil by A-HeFT), then the answer itself will be limited in scope with the potential of missing important underlying contributors to disease and treatment responsiveness.

Second, there is a critical difference between the stratification of outcomes on race to evaluate potential confounding or interaction (which can occur whether observed differences are socially or biologically based) as a preliminary step in understanding the distribution of factors affecting health outcomes versus the restriction of trial enrollment to a particular group (however defined) for which a firm basis for inter-group differences is not established and then allowing FDA drug approval for that group based on the findings. The first manner of inquiry could be an appropriate means of hypothesis-generation, if observed inter-group differences are followed by appropriate inquiry into underlying contributors to the differences. The second manner of inquiry not only limits our ability to exhume underlying contributors to the disease and treatment responsiveness, but also may violate research regulations requiring the equitable selection of subjects.

Third, many sociocultural and environmental factors that disproportionately adversely affect the health of minorities in the United States are unlikely to be disease-specific. Failing to perform research considering these potential contributors prohibits us from developing effective and sustainable strategies to address the breadth of health conditions for which documented disparities exist, including hypertension and heart disease;1 diabetes;2 obesity;3 HIV/AIDS;4 and lung, colorectal, breast, and prostate cancer5 to name a few.

Finally, I would expand the rationale for the authors’ call upon clinicians to increase their understanding of the political, economic, social, and ethical issues at the core of the race-based medicine debate to include enhancement of our medical decision-making, in terms of consideration of the multitude of factors that influence disease processes and treatment responsiveness, and our participation in and endorsement of ethical and socially-responsible research. As the federal government and other research fundors increasingly emphasize translational research, so grows the importance of the participation of clinical providers in the design, conduct, and application of research.

References:

1. Holmes JS, Arispe IE, Moy E. Heart disease and prevention: race and age differences in heart disease prevention, treatment, and mortality. Med Care 2005;43(3 Suppl):I33-41.

2. Brancati FL, Kao WH, Folsom AR, Watson RL, Szklo M. Incident type 2 diabetes mellitus in African American and white adults: the Atherosclerosis Risk in Communities Study. JAMA. 2000; 283: 2253-9.

3. Dubbert PM, Carithers T, Sumner AE, Barbour KA, Clark BL, Hall JE, et al. Obesity, physical inactivity, and risk for cardiovascular disease. Am J Med Sci 2002; 324:116-26.

4. Smith DK, Gwinn M, Selik RM, Miller KS, Dean-Gaitor H, Ma’at PI, et al. HIV/AIDS among African Americans: progress or progression. AIDS 2000;14:1237-48.

5. Mullins CS, Cooke JL Jr, Wang J, Shaya FT, Hsu DV, Brooks S. Disparities in prevalence rates for lung, colorectal, breast, and prostate cancers in Medicaid. J Natl Med Assoc 2004;96: 809-16.

Competing interests:   None declared

(1) The article states that the benefits of the A-HeFT trial "should be readily achieved." Is there evidence that prescribing the generics used to make BiDil works as effectively as BiDil would? Are there any factors, other than the number of required dosages per day, that support a preference for BiDil?

(2) Does prescribing the generics rather than BiDil pose any separate risks to patient health?

(3) How do doctors determine whether to prescribe BiDil rather than the alternatives, if not by phenotype?

(4) Is there any way to test for the nitric oxide deficiency before prescribing BiDil? Could there be one in the near future?

Thank you for your article and guidance on this important issue.

Competing interests:   None declared

The Dangers of Racially-Tailored Medicine

Sharona Hoffman

In their informative article, the authors correctly assert that race is not a biologically valid concept and analyze the economic and political motivations for the development of BiDil. They also identify factors other than race that explain differences in disease vulnerabilities and treatment responses, including genetic variations, health habits, stress level, and environment. In light of this information, I would like to examine some of the dangers of pursuing racially-tailored medicine.

First, a focus on race in research and treatment can generate medical mistakes. The combination of BiDil and ACE inhibitors was tested only on African-Americans, and therefore, it is unknown whether non-African- Americans can benefit from it. Non-Blacks, consequently, might be deprived of a treatment that could be optimal for them. Furthermore, it is often very difficult to determine one’s race because millions of Americans are of mixed origins. In the 2000 census, almost seven million people checked off two or more categories in response to the race question, and experts state that approximately 75% of African-Americans have mixed ancestry. If physicians were to base treatment decision largely on race, it is unclear how they might treat patients of diverse ancestry.

Second, race-based medicine can lead to stigmatization and discrimination. A focus on medical differences among races and the suggestion that certain groups are more diseased than others or can’t be treated with standard therapy because of their skin color, could reinforce biases and prejudices. This, in turn, could lead to race-based discrimination in the workplace and elsewhere. Employers, for example, hope to hire the healthiest employees, who will not have absenteeism and productivity problems and will not raise health insurance expenditures by submitting costly claims. An emphasis on the racial associations of diseases or expensive treatments could generate further employment discrimination against African-Americans and others.

Third, racially-tailored medicine can exacerbate the distrust some African-Americans feel towards the medical profession in light of the Tuskegee syphilis study and other research abuses. Medications that are developed particularly for African-Americans might be deemed suspicious by many patients.

Finally, if race serves as a proxy for genetic variations and other factors, race-based medicine could violate anti-discrimination laws and research regulations requiring equitable selection of subjects. Researchers and clinicians must focus on the real contributors to disease in order to avoid compromising patient welfare and fueling the fires of ignorance and prejudice.

Competing interests:   None declared