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Devices, Drugs, and Difference: Deep Brain Stimulation and the Advent of Personalized Medicine

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Handbook of Neuroethics

Abstract

In this chapter, the specific challenges of device regulation are addressed with the suggestion that this analysis might be optimized by analogy to personalized medicine, now ascendant in molecular therapeutics. The challenge of device versus pharmaceutical regulation is made through the example of deep brain stimulation (DBS). Unlike drugs, devices are few in number, expensive to develop and administer, and require discrete medical-surgical interdisciplinary expertise. They are personalized in their scope, are therapeutic and investigative tools, and uniquely face barriers related to intellectual property exchange and conflicts of interest. The recent controversy over FDA’s Humanitarian Device Exemption (HDE) of DBS in the obsessive-compulsive disorder is offered as evidence of regulatory insufficiency and the failure to distinguish research from therapy due to the therapeutic misconception. An alternative fiscally and methodologically viable research pathway is advanced for quality DBS research. The conclusion is on a hopeful note, with the speculation that the advent of personalized medicine in other investigative realms may provide innovative solutions to regulation which promote scientific discovery and meet patient-centered needs.

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Acknowledgement/Disclosures

Dr. Fins acknowledges the collegiality of the working group, “Deep Brain Stimulation in Psychiatry. Guidance for Responsible Research and Application,” of the Europäische Akademie. Universitätsklinikum Bonn. Bonn, Germany. He also gratefully notes the support of the Buster Foundation, the Jerold B. Katz Foundation, as well as a Clinical and Translational Science Center (UL1)-Cooperative Agreement (CTSC) 1UL1 RR024996 to Weill Cornell Medical College and its Ethics Core. He also thanks the editors of this volume for their invitation to collaborate and their helpful critiques.

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Authors and Affiliations

  1. Division of Medical Ethics, New York Presbyterian–Weill Cornell Medical Center, Weill Medical College of Cornell University, 435 East 70th Street, Suite 4-J, New York, NY, 10021, USA

    Joseph J. Fins

  2. Consortium for the Advanced Study of Brain Injury (CASBI), Weill Cornell Medical College & Rockefeller University, New York, NY, USA

    Joseph J. Fins

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  1. Joseph J. Fins
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Correspondence to Joseph J. Fins .

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Editors and Affiliations

  1. Institute for Ethics and History of Medicine, University of Tübingen, Tübingen, Germany

    Jens Clausen

  2. The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia

    Neil Levy

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Fins, J.J. (2015). Devices, Drugs, and Difference: Deep Brain Stimulation and the Advent of Personalized Medicine. In: Clausen, J., Levy, N. (eds) Handbook of Neuroethics. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-4707-4_33

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  • DOI: https://doi.org/10.1007/978-94-007-4707-4_33

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