The new drug application claiming treatment of a single, self-identified racial group raised a storm of controversy.
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Hydralazine/isosorbide dinitrate, sold under the brand name Bidil, is a fixed-dose combination medication used to treat self-identified black people with congestive heart failure. It is a combination of hydralazine hydrochloride (an arteriolar vasodilator) and isosorbide dinitrate (a nitrate vasodilator). It is the first race-based prescription drug in the United States.: 7
The Food and Drug Administration approved this race-specific medicine to treat heart failure in self-identified African-American patients. This drug was developed without regard to race or genetics, but it became convenient for commercial reasons to market the drug to black patients. The FDA allowed the drug company to test the efficiency in a clinical trial that only included African American participants which speculated that race causes an unknown genetic factor that affects heart disease. The creation and use of this medicine leads to a dangerous message; black people's bodies are so different from others that a drug tested in them is not guaranteed to work in other patients. In the end, the drug companies' marketing failed because black patients were wary of using a drug just for black people.
From 1980 to 1985 Dr. Jay Cohn of the University of Minnesota led a clinical trial in collaboration with the US Veterans Administration called the Vasodilator-Heart Failure Trial (V-HeFT I) that tested whether the combination of isosorbide dinitrate and hydralazine increased survival in patients with heart failure; the results were promising and the study was followed by V-HeFT II, which tested the combination against enalapril. In the meantime, Cohn applied for a patent on the combination treatment, which issued in 1989 as US Patent 4868179. Cohn licensed the patent to a company called Medco, and Medco spent the early 1990s preparing a New Drug Application (NDA) to get the FDA to approve BiDil on the basis of the V-HeFT trials. However, the trials were not designed to support an NDA, and in 1997 the FDA rejected the application because it did not have enough statistical power to show whether the combination really worked. The data was re-analyzed and found that the drug combination appeared to work better in self-identified African-Americans in the V-HeFT trial, and published a paper on that work, and filed a new patent on the use of BiDil in black patients. It had already been known that African-Americans with congestive heart failure (CHF) respond less effectively to conventional CHF treatments (particularly ACE inhibitors) than caucasians.
The new patent and the old patent were licensed to a company called NitroMed, which ran a clinical called the African-American Heart Failure Trial (A-HeFT), the results of which were published in 2004 in the New England Journal of Medicine. The clinical trial was stopped early because the drug worked so well; it reduced mortality by 43%, reduced hospitalizations by 39%, and improved quality of life markers in African-American patients with CHF.
On the basis of A-HeFT, the FDA approved BiDil in June 2005. In 2006, the Heart Failure Society of America included the use of the fixed dose combination of isosorbide dinitrate/hydralazine as the standard of care in the treatment of heart failure in blacks.: e44
Society and culture
The new drug application claiming treatment of a single, self-identified racial group raised a storm of controversy. Some hailed the development of BiDil as a breakthrough for Black Americans (such groups included the congressional Black Caucus, the Association of Black Cardiologists, the National Medical Association, and the National Association for the Advancement of Colored People) and a step to addressing the unique health care needs and health disparities of the African American community.
Others who criticized the preliminary studies argued that the original study did not have a significant number of Black-American subjects to make the BiDil's race specific claims, and that the results of only one clinical trial where Black-Americans were tested does not provide a full and comprehensive study. Furthermore, critics argued that self-identified racial identifications from patients as an indicator for race during the trials were not a sufficient categorization method because these self-identifications were socially constructed and have no biological connection to genomic data.
They argued that the trials represented a new form of scientific racism where race, a socially constructed category, would continue to be present in research as a placeholder for genomic identification.
Additionally, some disagreed with the design of the A-HeFT trial because the trial failed to include any non-African American test subjects. The trial was designed to include only Black American test subjects, therefore failing to show that BiDil has a greater effectiveness in Black Americans than in those of other races.
According to Jay Cohn, the pill's developer, the reason for including only Black American test subjects was the lack of funding for doing a trial in the full population. Meanwhile the patent for the drug was running out and the FDA refused to approve it due to lack of clinical trials, so a loophole was needed to make the sale possible for the company.
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