BiDil for heart failure in black patients: Implications of the U.S. Food and Drug Administration approval
BiDil for heart failure in black patients: Implications of the U.S. Food and Drug Administration approval
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DOI：
10.7326/0003-4819-146-1-200701020-00009
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发表时间：
2007-01-02
影响因子：
39.2
通讯作者：
Fernandez, Alicia
中科院分区：
文献类型：
--
作者：
Bibbins-Domingo, Kirsten;Fernandez, Alicia
2005年，盐酸肼嗪和硝酸异山梨酯的组合被美国食品和药物管理局（FDA）批准用于治疗黑人患者的心力衰竭。与长期以来不考虑人口分类而批准一般临床适应症药物的做法不同，FDA将解决健康方面的种族差异的需要列为其决定的重要因素。作者认为，尽管这一决定可能是出于好意，但它是基于对试验结果的有缺陷的科学解释，这些试验结果声称不同种族的药物反应不同，并且忽略了关于健康和医疗保健中种族差异原因的大量文献。由于其对未来药物批准的潜在影响，FDA的决定是医学治疗和种族的科学和政策话语的挫折，特别是阻碍了旨在消除健康和医疗保健差距的努力。
In 2005, the combination of hydralazine hydrochloride and isosorbide dinitrate was approved by the U. S. Food and Drug Administration (FDA) for treating heart failure in black patients. In departing from its long history of approving drugs for general clinical indications without regard to demographic classification, the FDA cited the need to address racial disparities in health as an important contributor to their decision. The authors argue that this decision, although perhaps well-intentioned, was based on flawed scientific interpretation of trial results that claimed differential drug response by race and ignored the considerable literature on the cause of racial disparities in health and health care. Because of its potential impact on future drug approvals, the FDA's decision is a setback in the scientific and policy discourse on medical therapeutics and race and specifically hinders the efforts aimed at eliminating health and health care disparities.