| Abstract No.: | A-C1121 |
| Country: | Canada |
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| Title: | CURRENT AND EMERGING ETHICAL AND SOCIAL ISSUES OF DEEP BRAIN STIMULATION |
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| Authors/Affiliations: | 1 Ghislaine Mathieu; 1 Eric Racine*;
1 Institut de recherches cliniques de Montréal, QC, Canada
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| Content: | Background: Deep brain stimulation (DBS) is now standard procedure for patients with medically refractory movement motor disorders, such as Parkinson’s disease (PD) and essential tremor (ET). Since its approval by the United States Food and Drug Administration (FDA), over 40 000 patients have been implanted worldwide even though the mechanisms through wich DBS works are still investigated. DBS has several advantages over ablative lesioning procedures, and its relative safety and efficacy hold promises for use in numerous other motor and non-motor diseases. The extension of DBS applications could lead to major ethical and social challenges in terms of resource allocation and informed consent.
Methods: To provide a comprehensive overview of current and emerging issues, we performed an extensive literature review of clinical trials and ethics discussion using PubMed, the United States Patents and Trademarks Office (USPTO) database, the FDA regulations, and approval decisions, market reports studies, and business reports of key DBS manufacturers.
Results and conclusion: First, our review revealed a number of important ethical and social challenges for the current uses of DBS. These include informed consent for last-resort procedures, establishing sound patient screening criteria, defining risks and side effects, and promoting sound public understanding. These issues have been identified but research, especially conceptual and empirical research, is limited to identify specific challenges DBS patients and providers are facing. Given the emerging applications of DBS to a significant number of additional neurological and psychiatric conditions (e.g., severe depression, chronic pain, Tourette’s syndrome, OCD), we identified a number of emerging issues. These include, for example, commercialization issues due to the restricted number of manufacturers of deep brain stimulation systems, legal issues related to patenting surgical procedures specific to DBS implantation, resource allocation to cover for the extending targets of DBS, as well as personhood and enhancement. On the one hand, current manufacturers could face important challenges in the production of devices if uses extend to psychiatric diseases (beyond current clinical trials). Healthcare systems, on the other hand, may face significant resource allocation concerns if DBS extends to common treatment-resistant severe depression. Although still futuristic, the lifestyle use of deep brain stimulators to enhance mood and behavior would challenge the current role and ethical framework of neurosurgery teams. |
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