Development and application of an ethical framework for pediatric metabolic and bariatric surgery evaluation.

BACKGROUND: As severe obesity continues to rise among youth, metabolic and bariatric surgery (MBS) will increasingly be used as a treatment of choice for durable weight loss and improvement of obesity-related complications. MBS for youth with intellectual and developmental disabilities (IDD) and for preadolescents has raised ethical questions. OBJECTIVES: The purpose of this article is to present the creation and application of an ethical framework that supports why MBS should be considered in pediatrics based on the principle of justice without automatic exclusions. This framework also provides a guide for how to conduct a robust, ethically grounded evaluation of pediatric patients presenting for MBS in general, and among subpopulations including youth with IDD and preadolescents. SETTING: Academic medical center, United States. METHODS: An ethical framework was developed and applied through a collaboration between an MBS center at a children's hospital and the institution's ethics consult service. RESULTS: Application of the ethical framework to address 4 core ethical questions is illustrated using 2 hypothetical cases: 1 that highlights an adolescent with IDD and 1 that highlights a preadolescent. CONCLUSIONS: We have demonstrated the application of a novel, overarching framework to conduct the ethical evaluation of youth presenting for MBS. This framework resulted from a collaboration between MBS and ethics consult teams and has the potential to be used as a prototype for other youth-focused MBS programs. Next steps include prospective data collection to test the framework and determine its validity in the target population.

Ethical Challenges Confronted When Providing Nusinersen Treatment for Spinal Muscular Atrophy.

The US Food and Drug Administration's December 2016 approval of nusinersen for the treatment of patients with all subtypes of spinal muscular atrophy ushered in a new era for patients with spinal muscular atrophy, their families, and all those involved in their care. The extreme cost of the medication and the complicated logistical requirements for administering nusinersen via lumbar puncture have created practical challenges that raise important ethical considerations. We discuss 6 challenges faced at the institutional level in the United States: cost, limited evidence, informed consent, treatment allocation, fair distribution of responsibilities, and transparency with stakeholders. These challenges must be understood to ensure that patients with spinal muscular atrophy benefit from treatment, are protected from harm, and are treated fairly.