Department of Neurologic Surgery, Mayo Clinic, Rochester, MN 55905, USA; Macalester College, St. Paul, MN 55105, USA.
University of Minnesota, Minneapolis, MN 55455, USA.
Int J Drug Policy. 2023 Mar;113:103964. doi: 10.1016/j.drugpo.2023.103964. Epub 2023 Feb 10.
The use of neuromodulation in the treatment of psychiatric conditions is controversial despite its lengthy history. This particularly applies to the use of invasive neuromodulation, such as deep brain stimulation (DBS), to treat substance use disorder (SUD) due to the considerable risks of the procedures. However, given the advances in DBS research and the shortcomings of current treatment modalities for addiction, off-label use and clinical trials are being implemented for the management of treatment-refractory patients.
Here we conduct an ethical and legal analysis of DBS for SUD, referencing the four foundational principles of medical ethics and key legal concepts.
There are major concerns related to the capacity of a SUD patient to provide informed consent, as well as the risks and benefits of DBS compared to traditional treatment methods. In addition to ethical concerns, we explore potential legal issues that may arise from DBS in the treatment of addiction. These include the potential mandate of these procedures in the context of the criminalization of substance use, and the issue of familial consent in the decision-making process. Given the paucity of relevant clinical guidelines or legal cases, general medico-legal principles serve as the reference in making decisions about the responsible use of DBS as a treatment for addiction.
Given the rapidly increasing evidence for DBS as a treatment for SUD, it is an urgent imperative to consider the relevant key ethical and legal issues. Incorporating IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) framework into future research in DBS is recommended to evaluate patient safety and ethical perspectives. With the broad criminalization of SUD across the globe, legal coercion of DBS is not impossible, especially if proven to be effective to treat SUD. It is advised for stakeholders to urgently consider incorporating DBS-related drug policies so that the potential benefits of DBS within the rights of people with SUD are not hindered by the lack of clinical guidance and legislations.
尽管神经调节在精神疾病治疗中的应用已有很长的历史,但仍存在争议。对于使用侵入性神经调节(如深部脑刺激(DBS))来治疗物质使用障碍(SUD),这种争议尤其明显,因为这些程序存在相当大的风险。然而,鉴于 DBS 研究的进展以及成瘾治疗的当前治疗方法的局限性,正在对该治疗方法进行标签外使用和临床试验,以治疗治疗抵抗的患者。
本文通过参考医学伦理学的四大基本原则和关键法律概念,对 DBS 治疗 SUD 进行了伦理和法律分析。
DBS 治疗 SUD 存在重大问题,主要涉及到 SUD 患者提供知情同意的能力,以及 DBS 与传统治疗方法相比的风险和收益。除了伦理问题,我们还探讨了 DBS 在治疗成瘾方面可能引发的潜在法律问题。这些问题包括在物质使用的刑事定罪的背景下这些程序的潜在授权,以及在决策过程中的家庭同意问题。鉴于缺乏相关的临床指南或法律案例,一般的医学法律原则可以作为决定负责任地使用 DBS 作为治疗成瘾的方法的参考。
鉴于 DBS 作为 SUD 治疗方法的证据迅速增加,迫切需要考虑相关的关键伦理和法律问题。建议将 IDEAL(Idea,Development,Exploration,Assessment,Long-term follow-up)框架纳入 DBS 的未来研究中,以评估患者的安全性和伦理观点。鉴于全球范围内 SUD 的广泛刑事定罪,DBS 的法律强制并非不可能,特别是如果证明 DBS 对治疗 SUD 有效。利益相关者应紧急考虑制定与 DBS 相关的药物政策,以确保 SUD 人群的 DBS 潜在益处不会因缺乏临床指导和立法而受到阻碍。