
In July 2005, the FDA approved a new type of therapy for treatment-resistant depression: vagus nerve stimulation (VNS). However, the approval process incited controversy because the scientific team that was assigned to review the device rejected its approval unanimously 3 separate times. The reviewers were unimpressed with the efficacy research underlying the device, since the only reported placebo-controlled trial showed no significant difference between active and sham VNS.


