Paul N W, Mitzkat A
Institut für Geschichte, Theorie und Ethik der Medizin, Universitätsmedizin Mainz, Am Pulverturm 13, 55131, Mainz, Deutschland,
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2013 Nov;56(11):1473-9. doi: 10.1007/s00103-013-1824-0.
Starting from an epistemological position of individualized medicine this article deals with the ethical analysis of this complex topic. The need for evidence-based decisions--as opposed to interest-driven decisions--is emphasised. Based on the argument of social justifiability it can be first stated as an intermediate result that genome-based research, which aims to promote individualisation of medicine, does not exclude research that uses other diagnostic markers, and the appropriate ethical standards can be applied. Second, the development of individualised preventive medicine in the field of multifactorial diseases should increasingly study the potential cost savings of genetic risk diagnosis compared to the costs for the actual treatment options. For proper, medically reasonable, ethically justifiable and socially desired implementation of all areas of individualised medicine, clear separation between research and care as well as the simultaneous implementation of ethical, legal, methodological and technical standards is desirable; however these must be continuously developed in order to respond to possible boundary changes that may arise. Finally, the challenge remains to make the efficacy, operationalisation, performance, and affordability of individualised medicine plausible in the context of social justifiability.
从个性化医疗的认识论立场出发，本文探讨了这一复杂主题的伦理分析。强调了基于证据的决策需求，而非利益驱动的决策。基于社会可辩护性的论点，首先可以得出一个中间结果：旨在促进医疗个性化的基于基因组的研究并不排除使用其他诊断标志物的研究，并且可以应用适当的伦理标准。其次，在多因素疾病领域，个性化预防医学的发展应越来越多地研究与实际治疗方案成本相比，基因风险诊断可能节省的成本。为了使个性化医疗的所有领域得到恰当、医学上合理、伦理上可辩护且社会期望的实施，研究与医疗之间应明确区分，同时实施伦理、法律、方法和技术标准；然而，这些标准必须不断发展，以应对可能出现的边界变化。最后，在社会可辩护性的背景下，使个性化医疗的有效性、可操作性、性能和可承受性合理，仍是一项挑战。
