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Abstract
Building upon an earlier critique of the Food and Drug Adminstration (FDA) granting of a humanitarian device exemption for deep brain stimulation in treatment-resistant obsessive compulsive disorder, this article considers how we regulate and finance DBS. It suggests that these devices are mosaic in nature: both potentially therapeutic and probative and that their dual roles need to be appreciated to maximize their therapeutic and investigational potential.
Acknowledgments
Dr. Fins was an unfunded co-investigator of the deep brain stimulation study of the minimally conscious state funded in part by Intelect Medical, Inc. He gratefully acknowledges the support of a Clinical and Translational Science Center (UL1)-Cooperative Agreement (CTSC) 1UL1 RR024996 to Weill Cornell Medical College and its Ethics Core for support, as well as the support of the Buster Foundation.
Notes
I am indebted to my colleague, Helen Mayberg, for the comment on the scientific method and agnostism, as quoted in Carey (Citation2011).