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创新的承诺与现实的证据。

Innovation Promises and Evidence Realities.

出版信息

Hastings Cent Rep. 2016 Sep;46(5):insidefrontcover. doi: 10.1002/hast.605.

DOI:10.1002/hast.605
PMID:27649835
Abstract

Over the past year media outlets and scientific and bioethics journals have reported about several medical and scientific innovations touted as having the potential to fundamentally change not only how diseases and disorders are diagnosed and treated but even how to alter the genomes of future generations. The purported "miracle" blood-testing technology of Theranos and the potential use of the genome editing technology CRISPR-Cas9 to modify human and nonhuman organisms reflect dramatic advances in scientific understanding about the biological mechanisms of humans and other living organisms. Yet evidence about whether these and other innovative biomedical technologies are safe and effective and lead to improved health outcomes for patients young and old is often in dispute. How to assess the safety and effectiveness of innovative biomedical technologies, who should be involved in that effort, and how to define risks and benefits of those technologies are questions at the intersection of values, interests, and politics.

摘要

在过去的一年中,媒体和科学与生物伦理学杂志报道了几项被吹捧为有可能从根本上改变疾病和障碍的诊断和治疗方式,甚至改变未来几代人基因组的医学和科学创新。Theranos 据称的“奇迹”血液检测技术,以及潜在的使用基因组编辑技术 CRISPR-Cas9 来修饰人类和非人类生物,反映了对人类和其他生物的生物机制的科学理解的巨大进步。然而,关于这些和其他创新的生物医学技术是否安全有效,是否能为年轻和年老的患者带来更好的健康结果的证据往往存在争议。如何评估创新的生物医学技术的安全性和有效性,谁应该参与这项工作,以及如何定义这些技术的风险和收益,这些都是处于价值观、利益和政治交叉点的问题。

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