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Should DBS for Psychiatric Disorders be Considered a Form of Psychosurgery? Ethical and Legal Considerations

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Abstract

Deep brain stimulation (DBS), a surgical procedure involving the implantation of electrodes in the brain, has rekindled the medical community’s interest in psychosurgery. Whereas many researchers argue DBS is substantially different from psychosurgery, we argue psychiatric DBS—though a much more precise and refined treatment than its predecessors—is nevertheless a form of psychosurgery, which raises both old and new ethical and legal concerns that have not been given proper attention. Learning from the ethical and regulatory failures of older forms of psychosurgery can help shed light on how to address the regulatory gaps that exist currently in DBS research. To show why it is important to address the current regulatory gaps within psychiatric DBS, we draw on the motivations underlying the regulation of earlier forms of psychosurgery in the US. We begin by providing a brief history of psychosurgery and electrical brain stimulation in the US. Against this backdrop, we introduce psychiatric DBS, exploring current research and ongoing clinical trials. We then draw out the ethical and regulatory similarities between earlier forms of psychosurgery and psychiatric DBS. As we will show, the factors that motivated strict regulation of earlier psychosurgical procedures mirror concerns with psychiatric DBS today. We offer three recommendations for psychiatric DBS regulation, which echo earlier motivations for regulating psychosurgery, along with new considerations that reflect the novel technologies used in DBS.

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Notes

  1. www.clinicaltrials.gov, last visited Feb 15, 2017. Search covering deep brain stimulation and narrowed down to cases for psychiatric disorders in the USA.

  2. Search terms included: Deep brain stimulation AND (psychiatry OR Major depressive disorder OR obsessive compulsive disorder) only. Search was conducted on November 24, 2015 at http://www.ncbi.nlm.nih.gov/pubmed.

  3. According to a recent meta-analysis, 116 patients within 31 studies have received DBS for OCD (Alonso et al. 2015).

  4. In addition to the VC/VS, other target areas have been investigated including the nucleus accumbens (NAc), the subthalamic nucleus (STN), the anterior limb of the internal capsule (ALIC), and the inferior thalamic peduncle (ITP).

  5. A Humanitarian Use Device (HUD) is a "medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4000 individuals in the United States per year." A Humanitarian Device Exemption (HDE) is an application that is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of the Food, Drug, and Cosmetic Act. FDA approval of an HDE authorizes an applicant to market a HUD subject to certain profit and use restrictions. HUDs cannot be sold for profit, except in narrow circumstances.

  6. FDA, last visited May 19, 2017. https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/investigationaldeviceexemptionide/.

  7. Smith had been institutionalized since 1955 and was committed to a state hospital under Michigan’s criminal sexual psychopath law. In 1972, after having been notably free of violence or any other inappropriate aggression for many years, Smith was selected as a candidate for psychosurgery, to which both he and his parents consented.

  8. The Commission also formed a Minority Conference to ensure minorities were protected from abusive psychosurgical practices.

  9. Alabama, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Montana, Minnesota, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wyoming, Vermont.

  10. Arkansas (Ark. Code Ann. § 28-47-202 (2010)]; California, [Cal. Welfare & Institutions Code § 5325(g) (2016)]; Connecticut [Conn. Gen. Stat. § 17a-540 (2012)]; Missouri [Mo. Rev. Stat. § 630.005.1 (27) (2012)]; New Mexico [N.M. Stat. § 43-1-3 (2006)]; Oregon [Or. Rev. Stat. § 426.385 (2011)]. Four states had statutory definitions and regulations, but these statues have since been repealed: West Virginia; Mississippi; Maine; and Massachusetts. Interestingly, Oklahoma is the only state where a definition of 'psychosurgery' is provided through case law; see i.e., In re KKB, 609 P. 2d 747 (Okla. 1980).

  11. Sachdev and Chen (2009) argue that because the placement of a pacemaker is not considered ‘cardiac surgery,’ DBS should not be considered psychosurgery.

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  1. Devan Stahl and Laura Cabrera have contributed equally to this work.

Authors and Affiliations

  1. Michigan State Univeristy, College of Human Medicine, East Fee Hall, 965 Fee Rd, RmC213, East Lansing, MI, 48824, USA

    Devan Stahl

  2. Michigan State University, College of Human Medicine, East Fee Hall, 965 Fee Rd, RmC211, East Lansing, MI, 48824, USA

    Laura Cabrera

  3. Western Michigan University Homer Stryker M.D. School of Medicine, 1000 Oakland Drive, Kalamazoo, MI, 49008, USA

    Tyler Gibb

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Stahl, D., Cabrera, L. & Gibb, T. Should DBS for Psychiatric Disorders be Considered a Form of Psychosurgery? Ethical and Legal Considerations. Sci Eng Ethics 24, 1119–1142 (2018). https://doi.org/10.1007/s11948-017-9934-y

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