McGowan Michelle L, Settersten Richard A, Juengst Eric T, Fishman Jennifer R
Department of Bioethics, Case Western Reserve University School of Medicine, Cleveland, OH.
College of Public Health and Human Sciences, Oregon State University, Corvallis, OR.
Urol Oncol. 2014 Feb;32(2):187-92. doi: 10.1016/j.urolonc.2013.10.009.
The use of molecular tools to individualize health care, predict appropriate therapies, and prevent adverse health outcomes has gained significant traction in the field of oncology under the banner of "personalized medicine" (PM). Enthusiasm for PM in oncology has been fueled by success stories of targeted treatments for a variety of cancers based on their molecular profiles. Though these are clear indications of optimism for PM, little is known about the ethical and social implications of personalized approaches in clinical oncology.
The objective of this study is to assess how a range of stakeholders engaged in promoting, monitoring, and providing PM understand the challenges of integrating genomic testing and targeted therapies into clinical oncology.
The study involved the analysis of in-depth interviews with 117 stakeholders whose experiences and perspectives on PM span a wide variety of institutional and professional settings.
Despite their considerable enthusiasm for this shift, promoters, monitors, and providers of PM identified 4 domains that provoke heightened ethical and social concerns: (1) informed consent for cancer genomic testing, (2) privacy, confidentiality, and disclosure of genomic test results, (3) access to genomic testing and targeted therapies in oncology, and (4) the costs of scaling up pharmacogenomic testing and targeted cancer therapies.
These specific concerns are not unique to oncology, or even genomics. However, those most invested in the success of PM view oncologists' responses to these challenges as precedent setting because oncology is farther along the path of clinical integration of genomic technologies than other fields of medicine. This study illustrates that the rapid emergence of PM approaches in clinical oncology provides a crucial lens for identifying and managing potential frictions and pitfalls that emerge as health care paradigms shift in these directions.
在“个性化医疗”（PM）的旗帜下，使用分子工具实现医疗保健个性化、预测合适的治疗方法以及预防不良健康结果，在肿瘤学领域已获得显著关注。针对多种癌症基于其分子特征的靶向治疗成功案例，激发了肿瘤学领域对个性化医疗的热情。尽管这些明显表明了对个性化医疗的乐观态度，但对于临床肿瘤学中个性化方法的伦理和社会影响却知之甚少。
本研究的目的是评估一系列参与推广、监测和提供个性化医疗的利益相关者如何理解将基因检测和靶向治疗整合到临床肿瘤学中的挑战。
该研究涉及对117名利益相关者进行深入访谈的分析，他们对个性化医疗的经验和观点涵盖了广泛的机构和专业背景。
尽管对这一转变充满热情，但个性化医疗的推广者、监测者和提供者确定了4个引发更高伦理和社会关注的领域：（1）癌症基因检测的知情同意，（2）基因检测结果的隐私、保密和披露，（3）肿瘤学中基因检测和靶向治疗的可及性，以及（4）扩大药物基因组检测和靶向癌症治疗的成本。
这些具体问题并非肿瘤学甚至基因组学所独有。然而，那些最致力于个性化医疗成功的人认为肿瘤学家对这些挑战的应对具有先例意义，因为在基因组技术临床整合的道路上，肿瘤学比其他医学领域走得更远。本研究表明，临床肿瘤学中个性化医疗方法的迅速出现为识别和管理随着医疗保健范式朝这些方向转变而出现的潜在摩擦和陷阱提供了一个关键视角。
