Kahn Jonathan
Hamline University School of Law.
Am J Bioeth. 2006 Sep-Oct;6(5):W1-5. doi: 10.1080/15265160600755789.
This article endeavors to place into context recent developments surrounding the United States Food and Drug Administration recent approval of BiDil (isosorbide dinitrate/hydralazine hydrochloride) (NitroMed, Inc., Lexington, MA) as the first ever race-specific drug--in this case to treat heart failure in African Americans. It focuses in particular on both commercial incentives and statistical manipulation of medical data as framing the drive to bring BiDil to market as a race-specific drug. In current discourse about pharmacogenomics, targeting a racial audience is perceived as necessary because at this point the technology and resources do not exist to scan efficiently every individual's genetic profile. The article argues that medical researchers may say they are using race as a surrogate to target biology in drug development, but corporations are using biology as a surrogate to target race in drug marketing. Pharmacogenomics may hold great promise, but on our way to that Promised Land, it is imperative to review such short cuts with a critical eye.
本文旨在梳理近期围绕美国食品药品监督管理局（FDA）批准BiDil（硝酸异山梨酯/盐酸肼屈嗪）（NitroMed公司，马萨诸塞州列克星敦）这一事件的相关进展。BiDil是有史以来第一种针对特定种族的药物，用于治疗非裔美国人的心力衰竭。本文特别关注了商业动机以及对医学数据的统计操纵，正是这些因素推动了BiDil作为一种针对特定种族的药物上市。在当前关于药物基因组学的讨论中，针对特定种族群体被认为是必要的，因为目前还没有技术和资源能够有效地对每个人的基因图谱进行扫描。文章认为，医学研究人员可能会说他们在药物研发中把种族作为一种替代指标来针对生物学特性，但企业却在药物营销中把生物学特性作为一种替代指标来针对种族。药物基因组学或许前景广阔，但在通往那片乐土的道路上，我们必须以批判性的眼光审视这些捷径。
