Communication Strategies Must Be Tailored to a Medication's Targeted Population: Lessons from the Case of BiDil.

BACKGROUND: The American population's diversity continues to grow, and its racial and ethnic mixes are changing. The US healthcare system must confront this changing reality. The introduction of isosorbide dinitrate/hydralazine hydrochloride (BiDil) to the US marketplace was a move toward recognizing these changing consumer needs. BiDil was approved specifically as a secondary treatment for heart failure in African-American patients. It remains the first and only drug approved by the US Food and Drug Administration for a race-based indication. To ensure commercial success, a drug must be made "visible" to healthcare providers and to consumers. OBJECTIVES: To describe and analyze the case of BiDil and its potential implications for drugs developed for targeted populations to help them avoid a similar fate of market withdrawal because of commercial considerations. METHOD: This analysis is based on 12 comprehensive interviews with 5 clinical investigators, 1 minority healthcare provider, and 5 pharmaceutical representatives, as well as a review of the literature. Overall, 12 one-hour semistructured interviews were conducted. Of the 11 interviewees, 10 were interviewed once and 1 was interviewed once early in the process and then had a second interview by the end of the study. When the 12 scheduled interviews were completed, the recordings were transcribed and subjected to analysis through the use of a readily available computer software package, using concepts and themes collected from the literature and the interviewees' responses. RESULTS: The interviewees lacked consensus regarding the unique nature of BiDil. The clinical researchers considered it innovative in identifying that taking the 2 drugs together produced the greatest clinical effect in African-American patients with heart failure. For them, BiDil represented an innovation in the emerging field of personalized medicine. However, they were dismayed to see that these beliefs were challenged by the medical community and their physician colleagues. They reported that practicing, mainly primary care physicians considered the development of a branded medication that combined 2 older drugs to be superfluous, because the same effect could be achieved by administering each agent individually at the same time. Obtaining a patent for BiDil, therefore, was seen simply as a desire for commercial gain. During the approval hearings, representatives of the sponsored company attributed these concerns to "misinformed physicians" and "uninformed patients." CONCLUSION: The case of BiDil demonstrates that a marketing strategy for a population with unique health issues requires an understanding of underlying cultural, social, and economic underpinnings. Ignorance of these dynamics within the African-American community was blatantly reflected at the launch of the drug. Although BiDil remains a treatment option, there is no marketing effort to promote its use. The failure to capture the targeted market for the drug has important implications for the future of commercial considerations in the development of race-based medications.