BiDil

BiDil is a FDA approved drug that is a mixture of isosorbide dinitrate and hydralazine hydrochloride that is used in tandem with other medications to treat congestive heart failure, a “progressive weakening of the heart muscle to the point where it can no longer pump blood efficiently” (Kahn 2007). BiDil is a type of vasodilator that expands blood vessels to allow blood to flow more easily to the heart (Encyclopaedia Britannica). Originally BiDil was meant for all patients suffering from congestive heart failure; however, research that led to its approval by the FDA tested only on the self-identified African American population. This led to marketing that targeted this specific racial group leading to much controversy and backlash from the medical and patient community (Wheeler 2016).

BiDil was first submitted for FDA approval by Dr. Jay Cohn, a cardiac specialist and creator of the drug, but approval was denied because of the size of the study. This research occurred during the postgenomic age when the science community sought to understand if there were biological and genetic differences between race groups and debating whether some race groups were more predisposed to developing certain diseases than other race groups (Wheeler 2016). Some observations seen in racial groups seem to prove the argument for genetic differences between races. One such observation was that more African Americans had heart disease and high blood pressure than their white counterparts suggesting a possible genetic basis. This hypothesis changed the marketing of BiDil to target only self- identified African Americans simultaneously stepping towards “a new era of personalized medicine” (Kahn 2007). Dr. Cohn went back to his research lab and looked at the data to compare the drug results on his self-identified black patients with other race groups and found a huge decrease in mortality for blacks (Wheeler 2016). A pharmaceutical company, NitroMed, became interested in further testing this finding by conducting a trial, the African American Heart Failure Trial, and found that mortality had decreased for African Americans by 43% after using BiDil (Brody H and Hunt LM 2006). These results lead to FDA approval in 2005 but only for heart failure in African Americans.

Although this BiDil seemed to doctors, such as Dr. Cohn, an important addition to medicine, much controversy surrounded the fact that it targeted a historically oppressed minority group. Using race as a scientific construct has been debated even after the human genome project, a project that mapped the genes of human DNA, revealed that all humans are made up of the same genetic material regardless of race (Brody H and Hunt LM 2006). This suggested that race had no biological basis and BiDil was turning medicine into something subjective and socially constructed. Many doctors such as Dr. Cohn believe that identifying links between race and certain diseases can improve the quality of patient health because prevention would be fully utilized. However, these have been disproven biologically and in quantitative research. A study conducted by Dr. Richard Cooper looked at a patient pool of 85,000 from countries such as the U.S, Nigeria, Russia, Poland, Finland, and Germany. He examined patients from different countries and compared levels of hypertension, a contributor to heart disease, and found that the countries with highest levels of hypertension were ones with small black populations such as Russia, Poland, and Finland. Countries with least hypertension were Nigeria, a majority black population. The culprit of heart disease does not lie in race but factors of diet and socioeconomic disparity (Wheeler 2016).

Racial classifications in medicine have been credited to the “socio-economic structure of American health care and medical research” by scholars such as Jonathan Kahn. He believed that this construct contributed to racial disparities in health care but that race was “useful fiction” and the first step towards more diversity in medicine (Aarden 2012). Kahn did not disregard genetic diversity but stated that the medical research and the pharmaceutical market supported the “white norm” which created inequalities for minorities and sloppy interpretations of statistics. His solution was to diversify biomedical research and expand racial categories. Other scholars such as Anne Pollock were more concerned with genetic determination as the contributing factor to racial disparities, not so much socio-economic factors. She argued that the race has always been a category that divided a population but that it could be good and bad in its influence in medicine She did not believe that race should determine medical treatment yet she argued that race could encourage individuals to strive to overcome health adversity (Aarden 2012).

The issue of race in medicine is powerful and far-reaching. It challenges medical professionals and scholars to evaluate the accuracy of data and efficacy of results. The BiDil trial only tested self-identified African Americans and did not test other race groups to compare data. Race also influenced the pharmaceutical world by creating a niche market for individuals that identified as a certain race. In an assessment on race-based drugs, Brody et. al explain that “BiDil offers a good example of how sociocultural factors in disease causation may be overlooked as a result of an overly simplistic assumption of a racial and hence presumed genetic difference” (Brody H and Hunt LM 2006). The danger of misinterpretation of race in medicine is that it could influence government policy and affect the quality of patient health. There is no real evidence that black people are predisposed to congestive heart failure more so than their non-black counterparts yet the FDA, a federal agency, approved BiDil for treatment of African Americans. Moving forward, the science community and federal government must work to be cognizant of social issues and how these issues affect health care and future biomedical research.

References:

Aarden, Erik.

2012 Joint Book Review: Jonathan Kahn, Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age and Anne Pollock, Medicating Race: Heart Disease and Durable Preoccupations with Difference Kahn Jonathan Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age. Columbia University Press. Accessed January 15, 2017. http://journals.sagepub.com.proxy.library.vanderbilt.edu/doi/pdf/10.1177/0038038513500100

Brody H, Hunt LM.

2006. BiDil: Assessing a Race-Based Pharmaceutical. Annals of Family Medicine. Accessed January 16, 2017.

Encyclopaedia Britannica. Encyclopædia Britannica, 2013. s.v “Cardiovascular drug.” Accessed January 17, 2017. https://www.britannica.com/topic/cardiovascular-drug#ref295299.

Kahn, Jonathan.

2007 “Race in a Bottle” Scientific American 297, no. 2 (August 2007): 40–45. doi:10.1038/scientificamerican0807-40.

Wheeler, Soren.

2016. Race and Medicine. Radio Lab. Accessed January 16, 2017. http://www.radiolab.org/story/91657-race-and-medicine/.