BiDil: A Case Study of Racial Medicine

Current Issues

Controversy and Stakeholders: Competing Knowledge Systems and Strategies
Several layers of controversy over the theoretical, ethical, scientific, and logistical underpinnings of BiDil’s development, approval, and marketing engulf its narrative. Three primary controversies manifest themselves: 

1. The scientific legitimacy of pharmacogenetics and racial medicines is a highly             disputed topic. 
2. The decision-making processes and power dynamics related to the development approval, and marketing of BiDil are of concern, especially relative to the advancement of the profit-maximizing agendas of pharmaceutical companies. 
3. The social impacts of racial medicine are contested and uncertain, especially those relating to the meanings of race and the health disparities between races. 

This section will detail the stakeholders of each side of each controversy, as well as their competing knowledge systems and strategies, particularly focusing on the poor statistical and research practice, the politicization of the approval process, and the negative social externalities of BiDil and racial medicines like it.

Scientific Legitimacy of Pharmacogenetics and Racial Medicines
Whether or not the field of pharmacogenetics is a legitimate science is a heavily debated concept. Pro-pharmacogenetic parties include most major pharmaceutical companies (NitroMed, Merck, etc.), the FDA, the Department of Energy (funds the Human Genome Project), the Department of Veterans Affairs (VA) (funded V-HeFT I and II), and individual scientists and doctors such as Jay Cohn and Peter Carson. Specifically, ardent fans of BiDil include the American Heart Association, the Association of Black Cardiologists (ABC), Howard University, the Congressional Black Caucus, the National Minority Health Month Foundation, the Health Brain Trust, and the National Association for the Advancement of Colored People (NAACP) (Jones, 2005). These individuals, associations, institutions, and departments believe the future of medicine lies in genetically specific drugs. Shastry (2005) states, “drug responses appear to be genetically determined, and the relationship between genotype and drug response may have a very valuable diagnostic value. Identification and characterization of a large number of genetic polymorphisms (biomarkers) in drug metabolizing enzymes and drug transporters in an ethnically diverse group of individuals may provide substantial knowledge about the mechanisms of inter-individual differences in drug response.” The Human Genome Project can be considered an artifact of this discourse, since the understanding of the genetic differentiation between races is the basis for pharmacogenetics and racial medicines like BiDil.

Opposition to these premises is equally strong. Social scientists (political scientists, anthropologists, sociologists, etc.), insurance companies (their risk of paying for expensive medications increases as they take on new African American insurees), a whole other fleet of doctors and scientists, as well as other individual scholars and critics of pharmacogenetics uphold that “all humans are only one percent different (or less) from one another in terms of genetic structure” (Jordan, 2008, pg. 57). Further, “in the effort to tabulate and analyze this one percent difference, preliminary results have shown that only 15 percent (0.0015 percent) of this relates to race” (Ibid.). The threshold value that denotes significant population subdivision (FST) is .250.[1] Thus, relative to the case of BiDil, “the description of African Americans or of any other “race” as a unitary racial group is false” (Ossorio & Duster, 2005, pg. 117–118) because “humans do not have biological races. Physical traits don't partition individuals or populations into groups that match our social categories” (Graves and Rose, 2006). Moreover, even if African Americans were a significant population subdivision, “it is still a gross overstatement to assert that all African Americans will respond positively to BiDil treatments” (Jordan, 2008, pg .58). According to Root (2003), "the populations, if biologically different at all, aredifferentiated only by average frequencies of a few polymorphic genes. In addition, the differences are not concordant; the differences between populations with respect to one gene vary independently of any differences in another, and, as a result, there is no cluster of genes possessed by all and only individuals customarily sorted at some site as members of the same racial group." Bamshad and Olsen (2003) and Barbujani et al. (1997) agree, stating "differences among continents represent roughly 1/10 of human molecular diversity, which does not suggest that the racial subdivision of our species reflects any major discontinuity in our genome." Thus, many deny the ability to distinguish meaningful differences between the genotypes of races.

Decision Making: The Politicization of BiDil's Approval

Also contributing to the resistance of pharmacogenetics and BiDil is the concern over the approval processes and the constitution of a racial drug via agenda setting rather than legitimate research. Lawyer and Professor Jonathan Kahn is a prominent critic of the political context which allowed inadequate research and data to legitimate BiDil. He boldly states, “BiDil is not indeed a race-specific drug” (Personal Interview, April 7, 2010). Kahn (and Sankar, 2005, Pg. 7) reasons:

“the study did not compare blacks to whites. It enrolled only blacks. It proved that black subjects given BiDil, along with their standard heart medication, did better than black subjects given a placebo along with their standard heart medication. A study of white heart patients; Californian heart patients; or even of patients with no particular racial, ethnic, or geographic labels might have returned the same finding… The great irony here is that NitroMed admits that BiDil might work in people who aren’t African American, and many of the A-HeFT investigators themselves have expressed the hope that the drug is prescribed to anyone who might benefit from it, regardless of race. NitroMed, it seems, is perfectly happy with this apparent contradiction—so long as the actual approval from the FDA is race-specific.”

Thus, for many stakeholders, the approval of BiDil is contributed not to significant advancements in pharmacogenetics that have afforded scientists and doctors a deeper understand of heart failure in African Americans, but rather to the agenda of the federal government to write health disparities off to inadequate science. Kahn states (Personal Interview, April 7, 2010), "The federal government is very pro-pharmacogenetics. By developing racialized drugs and marketing them as the cure for racial health disparities, the government and institutions who are responsible for the social inequalities and environmental factors that actually cause health disparities are erased of guilt." The government may shift the attention away from housing, education, employment, and health care inequalities and promote the fact that they are addressing health disparities via medicines, while also stimulating significant profit for the private pharmaceutical industry.  

The prospect of considerable private profit is considered an incentive for approving a falsely-marketed drug. NitroMed predicted BiDil’s revenue in the first year of sale would approximate $120 million, reach $350 million within a few years, and possibly exceed $1 billion annually later (Pihl-Carey, 2005). The skyrocketing stock value of NitroMed during BiDil’s development and approval is a legitimating artifact of this position. 

Negative Externalities of Racial Medicines

The final component of the controversy over BiDil pertains to the empirical, social consequences of racial medicine. Many are concerned about changes in the perceived social and biological meanings of race. As detailed by Omi and Winant (1994, pg. 63), “race was [first] conceived as a biological concept, a matter of species.” During Europe’s Enlightenment, Voltaire wrote, “if [the negro] understanding is not of a different nature than ours…it is at least greatly inferior. They are not capable of any great application of association of ideas” (in Omi and Winant, 1994, pg. 63). These authors as well as the narrator of Race: The Power of an Illusion, explain Jefferson’s rather similar perceptions being advanced in America: “in memory, they are equal to whites, in reason much inferior…[and] in imagination they are dull, tasteless, and anomalous” (1994, pg. 63). For more than a century, these scientific underpinnings justified the socio-economic and political inequalities bestowed upon races other than white. Only recently has society come to agree that race is not a biological difference but rather a social construction, and thus, only recently has society begun to take affirmative action to reverse the effects of biologically-induced racism by granting equal suffrage, health care, education, housing, social services, and employment to non-white races.

Considering all of the time and slow, grueling hard work it has taken to get society as far as it has come in its understanding of race as a social rather than biological construct, the deep concern amongst opponents of racial medicine is that its availability on the market will again reverse society’s understanding of the concept of race back toward a biological difference that warrants differential treatment.

More specifically, individuals have pointed to the fact that, while perhaps the possibility of significant difference of individual genotypes exists, self-identified racial categories and appearances should not serve as surrogate information for the deeper information necessary to make medical judgments about genetics. Lawyer and law Professor Jonathan Kahn states, “the categories of self-identified race which we use for our census serve their purpose in such a social context. But, there are many forms of danger in cutting and pasting those same social categories from a social context to a scientific, medical context in which case they are a proxy for other genetic factors” (Personal Interview, April 7, 2010).  The Economic and Social Research Council’s (ESRC) Genomics Policy and Research Forum agrees, proposing the abandonment of racial categories “in favor of those biological realities for which it is a proxy” (R. Taylor, 2006, pg. 3).

Amongst others, Sally Satel disagrees. She openly names herself a ‘racially profiling doctor’ and argues that, “as a ‘rough marker’ of underlying genetic differences, race is useful for diagnosis and prescription” (Tutton, 2004). While not disclosing her methodology of determining a patients race, she does admit her prescriptions vary based on her “clinical experience and on the findings of current research” (Ibid.). Crowe et al. (2005) agree, calling race a prognostic indicator. While race is an imperfect indicator for genetic information and lifestyle habits that may increase or decrease the risk of certain diseases, it is an indicator none the less and at least a starting reference point for diagnoses.

Regarding the ability of racial medicines to correct health disparities amongst races, anti-BiDil persons are sure such medications will do exactly the opposite and actually exacerbate the disparities. A whole host of structural incentives inform this prediction. First, since the US’s capitalist economic arrangement allows the marketization of drugs, a pharmaceutical company’s incentive is to produce drugs for profitable markets. In effect, the African American population proves to be a rather profitable market due to their prevalence in America. Conversely, the Hmong population, while equally entitled to health care, is not likely to have the option of medicine that is specialized for its race and ethnicity. African Americans may soon choose from an entire cocktail of drugs to treat their various diseases and illnesses, and Hmongs may still be vying for access to basic prenatal care because they pose such a small market. Thus, not only are the races of America are set against each other to compete for a supply market, but also, amidst those racial populations that do prove to be profitable markets, access will favor the wealthy elite of those populations, for they will be the population who have the time, resources (insurance!), and access to such specialized medicines as BiDil. Not surprisingly, this is the population that already has access to the best health care.

Furthermore, as race specific medicines become available, insurance rates for the featured races will increase, since the likelihood of the insurer having to pay for a particularly expensive treatment increases. As a result, even basic medical treatment become more expensive (a higher deductable) and less accessible. Sankar and Kahn (2005) affirm this projection, stating, “the new drugs developed for specific “racial” conditions will be prohibitively expensive for those minorities who may not have the resources (i.e., insurance, financial benefits) to purchase these exclusive, expensive treatments.” So, what anti-BiDil advocates foresee developing from racial medicine is not a bridging of the gap between the health care access and status of races, but an incredible exacerbation of these social inequalities. While BiDil supporters are convinced that natural science and the market are the avenues through which such disparities may be corrected, oppositional voices call for social mechanisms (policy, assisted rather than market allocation of public benefits, etc.) to correct social inequalities.

Finally, in a broader sense, the development of racialized medicine advances the pill popping discourse of Western medicine and subdues alternative medical systems like Native American, Traditional Chinese, and Naturopathic Medicines. While Western medicine is aggressive, invasive, non-holistic, and instant-fix focused, alternative apporaches such as herbal remedies, vitamin supplements, acupuncture and yoga, aromatherapy, chelation therapy, and lifestyle changes seek to make the mind, body, spirit, and environment one holistic entity requiring gentle, long term approaches to well-being (Jaffe, 2010). As Americans, we jump at the opportunity to prescribe expensive, private-profit generating drugs for illnesses that have social causes which go unaddressed. BiDil is a significant page in the narrative of Western medicine, and critics of Western medicine lament the advancement of pharmacogenetics for its negative implications for gentler, alternative medicine (Ibid.)  

Similar to other cases of private industry and government controlled science, the role of the citizen has been rather minimal since opportunities to directly influence decisions and outcomes are rare. Primarily, lay citizen activity around racial medicines, specifically Bidil, has consisted of citizens participating in the original V-HeFT and A-HeFT studies, and they have been largely African American citizens with heart complications (not a cross-section of the population). Save for those citizens that are affiliated with a nationally recognized lobbying organization, association, or institution (NAACP, ABC, etc.), citizens have not been involved in the deliberation of the availability of racial medicines or the advancement of pharmacogenetics. This is true for a few reasons. First, BiDil's poor marketing has left racialized medicine below the radar of most lay citizens. A large portion of the population may not even know racialized medicines exist, and amongst those that do, the perceived threat may be little to none considering the unpopularity of poster child BiDil. Second, recent health debate and activism has focused upon health care reform and making general health care more accessible; the political opportunity to spur debate about racialized medicines is not available now because it simply is not a priority. Perhaps a more salient frame for the issue would remedy its non-priority status, like intellectual property rights upon genetic information.

Under such circumstances, those wishing to obstruct the proliferation of racial medicines do have options for action. Typical of most health social movements (organic and all natural foods, anti-BPA, environmental toxin exposure, etc.) action often takes place on a grassroots level, grows slowly, and faces a lot of resistances from mainstream sources like the government and private industry. Court room victories and instant passing of legislature are rare events, but not unobtainable goals. While a petition may be circulated and sent to the FDA, NitroMed, or another actor, Kahn (Personal Interview, April 7,2010) actually recommends several other specific, consumer-based and grassroots mechanisms of opposition. He advises opponents to:

• abstain from participation in studies for racial medicines
• refrain from taking racial prescription drugs
• promote alternative medicine
  
• target systemic causal factors of health disparities. Housing, employment, education, and environmental exposure inequalities all contribute heavily to health disparities. You can fight these social inequalities via activist and  volunteer organizations that work to educate, lobby at legislature, and build  community safety, health, and opportunity.  

Figure 3: The Human Genome

The science of pharmacogenetics seeks to unlock genetic difference, but...

"Humans do not have biological races"
(Graves and Rose, 2006)


























"The great irony here is that NitroMed admits that BiDil might work in people who aren’t African American, and many of the A-HeFT investigators themselves have expressed the hope that the drug is prescribed to anyone who might benefit from it, regardless of race."
(Sankar and Kahn, 2005)

VIDEO: Racial Medicine: BiDil and African Americans

Professor Ann Morning, NYU Sociology, discusses BiDil's research, history, legitimacy, and implications.

 Figure 4: DNA

Historically, the notion of race was constructed upon the basis of biological differenct. Today, we have deconstructed that pairing, and we fear racialized medicine may resurrect it.

Figure 5: A Pill for Every Illness

Racialized medicines are not the answer to racial health disparities. Rather, we need to address societal inequalities in access to adequate housing, education, employment, preventative health care, and political resources.

Figure 6: Heart Acupuncure

Alternative medicines are available and viable options for Americans wanting to steer clear of expensive and aggressive drug treatments with negative side effects.