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Article Excerpt
Introduction
Does the selective use of advanced medical technology to benefit one group over the other contradict the goals of justice? This question spurs the efforts of bioethicists, scholars of biopolicy, (1) and medical and biotechnical regulatory agencies in their efforts to analyze the effects of a changing technology within the context of a stable liberal democracy. Yet this concern seems to provoke only modest debate among political scientists and policy scholars (Churchill, 1997; Somit & Peterson, 1990, 1996, 1999). This is unfortunate, as the ever-evolving fields of medical technology continue to throw open questions of political and social justice. Specifically, do public policies sufficiently protect all members of the polity from technological exploitation? It is the contention of this article that that policy scholars should engage in an analysis of problematic cases (such as that of BiDil) in order to make clear the problems of social justice in policies designed to regulate the application of high-technology medical research.
In order to address these questions, the article proceeds in the following way. Subsequent to a brief analysis of the problem of deploying the concept of race in medicine and introducing the concept of pharmacogenomics, I present an abbreviated history of the BiDil controversy. The presentation of the main streams of critique surrounding BiDil sets the stage for the argument that current policy research does not adequately address the problem of race and social justice in medical policies. I argue for a revised framework that advocates the review of the justice implications of biomedical policies as part of initial policy studies in this area. The article concludes with some recommendations on how the examination of justice in biomedical policies may lead to more race-equitable outcomes in medicine. Specifically, I argue that future policies that address the deployment of pharmacogenomics should confine the technology to the role of a compensatory tool.
Subject Overview
The sensitive history of racial discrimination in medicine complicates discussions of public health and biomedical technology policies (Bhopal, 1997, 2004). The lingering effect of individual and institutional racism in the scholarly, medical, and larger communities both incites and stifles academic and political discourse. Specifically, discussions of race consciousness in medicine are provoked by our frightful image of medicine in a race-defined environment--the Tuskegee Syphilis Experiment--images of suffering in the name of 'medical science' (Bowman et al., 1999; Fairchild & Bayer, 1999; Feagin, 1978, 2001; LaVeist, 2002, 2005). Conversely, hindering efforts to discuss issues of race and medicine from a race-neutral perspective are reservations about essentialism, or the benign neglect of important differences (Bobbio, 2000, pp. 7-8).
Scholars of social science ought not to downplay the importance of discussing race in the context of medicine. In a state working to promote justice for all members, any systematic denial of basic social goods, to include health, requires serious attention from all sectors. Recent studies of the disparities in health access and health outcomes in minority populations, particularly the African American population, highlight the depth of inequalities within American medicine and medical care (Byrd & Clayton, 2000; LaVeist, 2002, 2005; Link & Phelan, 2005; Rosenbaum & Teitelbaum, 2005; Williams, 2005). (2) Multiple factors cause health disparities while some of the same causes combine to impede the development of solutions for the amelioration of health care disparities. These factors include the changing demographics of the American population, the shifting numbers of insured versus uninsured citizens, and the changing definitions of legally ineligible beneficiaries of state-supported medical care, lack of a single causal theory for health care disparities, and the changing nature and role of medical technology. The concatenation of each of these factors seems to widen the chasm between the medical haves and the medical have-nots in America today (LaVeist, 2005).
Partly because of the complexity of the health disparities problem, the policies designed to alleviate disparities are many and varied. Although there are many topics to be discussed under the umbrella 'health disparities,' I focus here on the role that specific changes in medical technology play in alleviating the problem of racial disparities in health care (Banquet et al., 2006; Burchard et al., 2003; Helmuth, 2000; Mullins et al., 2005; Newman et al., 2006; Olifi et al., 2005). Specifically, this discussion focuses on the role that pharmacogenetics and pharmaceutical interventions present for addressing health disparities. At its core, the promise of pharmacogenetics is the application of the minimal, individualized therapeutic dose, based on research into inherited metabolic traits, for the treatment or prevention of disease (Linder, Prough, & Valdes, 1997; Service, 2005). As suggested by Iohom, Fitzgerald, & Cunningham (2004),
Pharmacogenetics has been defined as the study of variability in drug response as a result of heredity factors. More recently, the term 'pharmacogenomics' has been introduced. The value of an understanding of pharmacogenetics for the clinician is to enable optimum therapeutic efficacy; to avoid toxicity of those drugs whose metabolism is catalyzed by polymorphic isoenzymes; and to contribute to the rational design of new drugs. (p. 441)
Using the well-known case of BiDil (3)--a pharmaceutical intervention for the treatment of advanced heart failure, targeted for use among African Americans--I ask whether the emerging field of pharmacogenetics offers an alternative path for resolving health disparities. In doing so, I probe the implications of pharmacogenetics as a unique problem for racial justice in medical care. I do not suggest here that pharmacogenetics is a "magic pill" to cure America of racial inequalities in medicine (Sankar et al., 2004). Rather, I assess the background of the issue as an example of a study of social justice within biomedical policy solutions that seek to improve the health of disadvantaged minorities.
An Abbreviated Account of the History and Politics of BiDil
The importance of research on the causes and treatments of heart failure among African Americans should not be understated. As noted by researchers within multiple heart failure studies-including the famed Jackson Heart Study-African Americans are more likely than their Anglo counterparts to suffer from, and quickly succumb to, the effects of heart failure. (Aronow, Alan, & Kronzon, 1999; 'The African American Cardiologist,' 2002, p. 45). Thus, research into the high morbidity and mortality rate for African Americans is of paramount social, economic, and political importance.
BiDil, released to the public in 2005, is a combination drug therapy that provides disproportionate benefits to African Americans suffering from heart failure. BiDil, while being marketed as a new drug, is a combination of existing heart failure drugs--isosorbide dinitrate and hydrazaline. Many heart failure patients take these existing drugs separately or combined in dosages that do not mimic the singular, patented formula of BiDil. It is different from the angiotensin converting enzyme inhibitor drugs (ACE inhibitors) such as enalapril, and while the exact mechanism of action of BiDil is unknown, research shows that isosorbide dinitrate is a vasodilator with effects on both arteries and veins (Loeb et al., 1993). The dilator properties of nitrates result from the release of nitric oxide (NO) that leads to the relaxation of vascular smooth muscle, and hydralazine is an arterial dilator (Elkayam & Bitar, 2005; Ziesche et al., 1993). Researchers suspect that BiDil acts by increasing the amount of NO in the blood in order to cause the smooth muscle cells of the arterioles to relax, allowing for increased blood flow (Balakrishnan, 2004, pp. 74-76). (4) The research on heart failure among African Americans suggests that as African Americans tend to have lower levels of NO, the increase in NO along with the vasodilation will result in a dramatic and disproportionate benefit (Carson et al., 1999; Yancy, 2000).
The History and Controversy of BiDil--The history of BiDil is a case study in the complex interactions of medical research, race, politics, and policy. In 1978, subsequent to his participation as specialist and analyst in a Department of Veterans Affairs study of heart failure treatments (Veterans Administration [Vasodilator] Heart Failure Trials [V-HeFT] I and II), (5) Dr. Jay Cohn (6) submitted a 'methods' patent for the standardization of two previously utilized therapies into one unique dosage (later BiDil). The original patent on BiDil was for the particular combination of the two therapies only. As Sankar and Kahn (2005) note,
Cohn could not get what is known as a 'combination of matter' patent because the combined form of these two generic drugs did not act differently than using each separately. A methods patent would give the holder a monopoly on marketing the combination for a particular purpose ... but it would not give the holder the power to prevent generic manufacturers from producing and selling the individual drug. (emphasis added; p. 456)
Dr. Cohn later sold this patent to a drug company, Medco, which conducted further studies on the standardization of this combination therapy. Subsequent to their study...
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