Hawkins-Taylor Chamika, Carlson Angeline M
Health Improvement Coordinator with Blue Cross Blue Shield of Minnesota, Minneapolis.
Clinical Assistant Professor, Department of Pharmaceutical Care & Health Systems, University of Minnesota College of Pharmacy, Minneapolis. This article is based on Dr Hawkins-Taylor's PhD dissertation at the University of Minnesota College of Pharmacy.
Am Health Drug Benefits. 2013 Sep;6(7):401-12.
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.
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.
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.
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."
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.
美国人口的多样性持续增长，其种族和民族构成正在发生变化。美国医疗保健系统必须面对这一不断变化的现实。硝酸异山梨酯/盐酸肼屈嗪（BiDil）在美国市场的推出是朝着认识到这些不断变化的消费者需求迈出的一步。BiDil被特别批准作为非裔美国人心力衰竭的二线治疗药物。它仍然是美国食品药品监督管理局批准的首个也是唯一一种基于种族适应症的药物。为确保商业成功，一种药物必须让医疗保健提供者和消费者“看得见”。
描述和分析BiDil的案例及其对为特定人群开发的药物的潜在影响，以帮助它们避免因商业考虑而遭遇类似的市场撤市命运。
本分析基于对5名临床研究人员、1名少数族裔医疗保健提供者和5名制药代表进行的12次全面访谈以及文献综述。总体而言，共进行了12次一小时的半结构化访谈。在11名受访者中，10人接受了一次访谈，1人在过程早期接受了一次访谈，在研究结束时又接受了一次访谈。当完成12次预定访谈后，对录音进行转录，并通过使用一个现成的计算机软件包进行分析，运用从文献和受访者回答中收集的概念和主题。
受访者对BiDil的独特性质缺乏共识。临床研究人员认为它具有创新性，因为它确定了将这两种药物联合使用对非裔美国人心力衰竭患者产生的临床效果最佳。对他们来说，BiDil代表了个性化医学这一新兴领域的一项创新。然而，他们沮丧地发现这些观点受到了医学界及其医生同行的质疑。他们报告说，执业医生，主要是初级保健医生认为开发一种将两种老药组合在一起的品牌药物是多余的，因为同时单独使用每种药物也能达到相同的效果。因此，为BiDil获取专利仅仅被视为对商业利益的追求。在批准听证会上，赞助公司的代表将这些担忧归因于“消息不灵通的医生”和“不知情的患者”。
BiDil的案例表明，针对具有独特健康问题人群的营销策略需要理解潜在的文化、社会和经济基础。在该药物推出时，对非裔美国人社区内这些动态的忽视被公然反映出来。尽管BiDil仍然是一种治疗选择，但没有营销努力来推广其使用。未能抓住该药物的目标市场对基于种族的药物开发中未来的商业考虑具有重要影响。
