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讨论扩大试验性药物的获取途径时的“虚假希望”论点:批判性评估。

The 'false hope' argument in discussions on expanded access to investigational drugs: a critical assessment.

机构信息

Department of Medical Ethics, Philosophy and History of Medicine, Erasmus MC, University Medical Centre Rotterdam, Wytemaweg 80, 3015, Rotterdam, CN, The Netherlands.

出版信息

Med Health Care Philos. 2022 Dec;25(4):693-701. doi: 10.1007/s11019-022-10106-y. Epub 2022 Aug 11.

DOI:10.1007/s11019-022-10106-y
PMID:35951276
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9366814/
Abstract

When seriously ill patients reach the end of the standard treatment trajectory for their condition, they may qualify for the use of unapproved, investigational drugs regulated via expanded access programs. In medical-ethical discourse, it is often argued that expanded access to investigational drugs raises 'false hope' among patients and is therefore undesirable. We set out to investigate what is meant by the false hope argument in this discourse. In this paper, we identify and analyze five versions of the false hope argument which we call: (1) the limited chance at benefit argument, (2) the side effects outweighing benefits argument, (3) the opportunity costs argument, (4) the impossibility of making informed decisions argument, and (5) the difficulty of gaining access argument. We argue that the majority of these five versions do not provide normative ground for disqualifying patients' hopes as false. Only when hope is rooted in a mistaken belief, for example, about the likelihood of benefits or chances on medical risks, or when hope is directed at something that cannot possibly be obtained, should it be considered false. If patients are adequately informed about their odds of obtaining medical benefit, however small, and about the risks associated with an investigational treatment, it is unjustified to consider patients' hopes to be false, and hence, to deny them access to investigational drug based on that argument.

摘要

当重病患者达到其病情标准治疗轨迹的终点时,他们可能有资格使用通过扩大准入计划监管的未经批准的、研究性药物。在医学伦理话语中,人们常常认为扩大研究性药物的使用会给患者带来“虚假希望”,因此是不可取的。我们着手调查在这种话语中虚假希望论点的含义。在本文中,我们确定并分析了虚假希望论点的五个版本,我们称之为:(1)受益机会有限的论点,(2)副作用大于益处的论点,(3)机会成本的论点,(4)无法做出知情决策的论点,以及(5)获得准入的困难的论点。我们认为,这五个版本中的大多数并没有为否定患者的希望是虚假的提供规范依据。只有当希望是基于对医疗风险的获益可能性或机会的错误信念,或者当希望指向不可能获得的东西时,才应被认为是虚假的。如果患者充分了解他们获得医疗获益的可能性,无论多么小,以及与研究性治疗相关的风险,那么认为患者的希望是虚假的,并因此基于该论点拒绝他们获得研究性药物的理由是不合理的。

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本文引用的文献

1
The Role of Physicians in Expanded Access to Investigational Drugs: A Mixed-Methods Study of Physicians' Views and Experiences in The Netherlands.《扩大获得研究性药物的机会中医生的作用:荷兰医生的观点和经验的混合方法研究》
J Bioeth Inq. 2021 Jul;18(2):319-334. doi: 10.1007/s11673-021-10090-7. Epub 2021 Feb 15.
2
Immune Checkpoint Inhibitors for the Treatment of Cancer: Clinical Impact and Mechanisms of Response and Resistance.免疫检查点抑制剂在癌症治疗中的应用:临床影响及反应和耐药的机制。
Annu Rev Pathol. 2021 Jan 24;16:223-249. doi: 10.1146/annurev-pathol-042020-042741. Epub 2020 Nov 16.
3
Medicine's collision with false hope: The False Hope Harms (FHH) argument.医学与虚假希望的碰撞:虚假希望伤害(FHH)论点。
Bioethics. 2020 Sep;34(7):703-711. doi: 10.1111/bioe.12731. Epub 2020 Mar 5.
4
Patient's Perspectives on the Notion of a Good Death: A Systematic Review of the Literature.患者对“善终”观念的看法:文献系统综述。
J Pain Symptom Manage. 2020 Jan;59(1):152-164. doi: 10.1016/j.jpainsymman.2019.07.033. Epub 2019 Aug 9.
5
Is There a Problem With False Hope?虚假希望存在问题吗?
J Med Philos. 2019 Jul 29;44(4):423-441. doi: 10.1093/jmp/jhz010.
6
New drugs: where did we go wrong and what can we do better?新药:我们错在哪里,如何才能做得更好?
BMJ. 2019 Jul 10;366:l4340. doi: 10.1136/bmj.l4340.
7
Availability of Investigational Medicines Through the US Food and Drug Administration's Expanded Access and Compassionate Use Programs.通过美国食品和药物管理局扩大准入和同情用药计划获得研究药物。
JAMA Netw Open. 2018 Jun 1;1(2):e180283. doi: 10.1001/jamanetworkopen.2018.0283.
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Haematological immune-related adverse events induced by anti-PD-1 or anti-PD-L1 immunotherapy: a descriptive observational study.抗PD-1或抗PD-L1免疫疗法诱导的血液学免疫相关不良事件:一项描述性观察研究。
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