21st Century Psychiatry
The 2013 Annual Meeting of the American Psychiatric Association, held in San Francisco earlier this month [see Conference Report, p7], was significant for several reasons. First, the association had just released the fifth edition of Diagnostic and Statistical Manual of Mental Disorders and the new version was fodder for much discussion. While there is not universal agreement among professionals with everything in DSM V, the revision does offer more precise diagnoses in many cases and it also breaks out some disorders because of a greater understanding of basic causes.
Still lacking in the manual—and the field—however, is a precise elucidation of the neural circuits involved with psychiatric disorders. This is an area where neurotechnology has much to offer, if regulators, insurers, and clinicians will let it happen.
The meeting was also noteworthy because some new neurotechnology therapies were presented. The addition of Brainsway’s Deep TMS therapy for refractory depression and NeuroSigma’s trigeminal nerve stimulation system for ADHD are welcome additions to a growing repertoire of neurotech device interventions for psychiatric disorders.
But while we celebrate these positive developments, we must also be mindful of negative events that cast a shadow on the neurotechnology market for psychiatric disorders. It was discouraging to learn that the Centers for Medicare & Medicaid Services declined to reconsider its previous noncoverage decision for vagus nerve stimulation for treatment-resistant depression, despite a wealth of new data submitted by Cyberonics.
We’re also concerned that the FDA is threatening to require a PMA for transcranial electrical stimulation devices, which could force vendors such as Fisher-Wallace Laboratories to withdraw their products from the U.S. market until they complete a laborious and lengthy approval process normally only required for new Class III devices. Over the years, there has been an accumulation of positive data supporting the use of transcranial AC stimulation devices in the treatment of anxiety, insomnia, depression, and other psychiatric disorders.
If government regulators are so concerned about heightened safety and efficacy standards for neurotech interventions, perhaps they should apply a similar standard for pharmaceutical therapies for psychiatric disorders. It is well known that upwards of 30 to 40 percent of patients fail to respond to antidepressant medications.
When you factor in the costs to our healthcare system for ineffective drug regimens and when you consider that neurotech interventions are largely reserved for the hardest to treat patient populations, the comparative effectiveness of neuromodulation therapy looks very good.
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