School of Health and Social Care, University of Essex, Colchester, UK
School of Health and Social Care, University of Essex, Colchester, UK.
BMJ Evid Based Med. 2022 Jun;27(3):137-140. doi: 10.1136/bmjebm-2020-111635. Epub 2021 Apr 13.
The National Institute for Health and Care Excellence (NICE) has been presented as politically independent, asserting it is free from industry influence and conflicts of interest so that its decisions may be led by evidence and science. We consider the ways in which soft political factors operate in guideline development processes at NICE such that guidelines are not truly led by science. We suggest that while NICE procedures explicitly incorporate scientific principles and mechanisms, including independent committees and quality assurance, these fail to operate as scientific practices because, for example, decisions may only be challenged through the courts, which regard NICE as a scientific authority. We then examine what the NICE rapid guideline procedure for COVID-19 reveals about the practical reality of claims about the scientific integrity of NICE guidelines. Changes to guideline development processes during the COVID-19 emergency demonstrated how easy it is to undermine the scientific integrity of NICE's decision-making. The cancellation of the guideline programme and the publication of a rapid guideline process specifically to address the COVID-19 pandemic removed scientific checks and balances, including independent committees, stakeholder consultation and quality assurance, demonstrating that the relationship between NICE and the UK government is more complex than a scientific principle truism. We suggest that NICE is not (and indeed cannot be) truly independent of government in practice, nor can it be truly led by science, in part because of its relationship to the state, which it is simultaneously constituted by and constitutive of.
英国国家卫生与临床优化研究所(NICE)一直声称其在政治上是独立的,不受行业影响和利益冲突,因此其决策可以由证据和科学来引领。我们考虑了软性政治因素在 NICE 指南制定过程中运作的方式,以至于指南并非真正由科学引领。我们认为,虽然 NICE 程序明确纳入了科学原则和机制,包括独立委员会和质量保证,但这些机制未能作为科学实践运作,因为例如,只能通过法院对决策提出质疑,而法院将 NICE 视为科学权威。然后,我们研究了 NICE 针对 COVID-19 的快速指南程序揭示了关于 NICE 指南科学完整性的说法的实际现实。在 COVID-19 紧急情况下对指南制定过程的更改表明,破坏 NICE 决策的科学完整性是多么容易。指南计划的取消以及专门针对 COVID-19 大流行发布的快速指南程序取消了科学制衡措施,包括独立委员会、利益相关者咨询和质量保证,这表明 NICE 与英国政府之间的关系比科学原则的陈词滥调更为复杂。我们认为,NICE 在实践中并非(也不可能)真正独立于政府,也不能真正由科学引领,部分原因是它与国家的关系,它既是由国家构成的,也是构成国家的。