Centre for Science Studies, Department of Sociology, Lancaster University, Lancaster, UK.
Pharmacogenomics. 2014 Feb;15(3):297-304. doi: 10.2217/pgs.13.198.
This article investigates the number of drugs on the market with pharmacogenomics (PGx) biomarker data in their labels using two public sources - the US FDA and the PharmGKB.
The article analyzes the FDA Table of Pharmacogenomic Biomarkers in Drug Labels to show the number of drugs with PGx biomarker information in their labels. Scrutinizing the language of labels, it also engages with whether this information is intended to direct clinicians to take particular actions or not, and whether biomarker information is included on grounds of drug efficacy or to improve safety. The FDA table is compared to the PharmGKB Drug Labels with PGx info database to highlight how they differ in the number of drugs that they include.
Analysis of the FDA and the PharmGKB data show that approximately 12% of drugs licensed in the period 1998-2012 had PGx biomarker information included in their labels at the time of their approval. Of that number, labels direct clinicians to utilize PGx testing prior to prescribing treatments in only 14 cases. This clearly falls short of expectations many had in the 1990s about the transformative impact of PGx. In most cases, the inclusion of this information currently has limited or no direct clinical utility.
本文通过美国 FDA 和 PharmGKB 这两个公共资源，调查了标签中具有药物基因组学（PGx）生物标志物数据的药物数量。
本文分析了 FDA 药物标签中的药物基因组学生物标志物表，以展示标签中具有 PGx 生物标志物信息的药物数量。通过仔细研究标签中的语言，本文还探讨了这些信息是否旨在指导临床医生采取特定行动，以及生物标志物信息是基于药物疗效还是提高安全性而被纳入。本文将 FDA 表与 PharmGKB 药物标签与 PGx 信息数据库进行了比较，以突出它们在纳入药物数量方面的差异。
对 FDA 和 PharmGKB 数据的分析表明，在 1998 年至 2012 年期间获得许可的药物中，约有 12%的药物在获得批准时其标签中包含 PGx 生物标志物信息。在这一数字中，只有 14 种情况下标签指示临床医生在开处方治疗前进行 PGx 检测。这显然与 90 年代许多人对 PGx 具有变革性影响的期望相去甚远。在大多数情况下，目前纳入这些信息的直接临床应用有限或没有。
