Obsessing About DBS

Many of us who have observed the growth of the neurotechnology industry over the last 10 years have felt frustrated at times by the slow pace of government approval of promising new therapies. It becomes particularly so when technology originally developed by U.S. research institutions and startup firms reaches the market first in Europe, simply because many companies have decided that obtaining CE Mark is a much easier path then getting a PMA approved by the FDA.

So it came as somewhat of a shock to us earlier this month when nine medical professionals questioned the speed with which Medtronic received FDA approval of its DBS system for treatment of obsessive-compulsive disorder in an article in HealthAffairs. It became more of a shock to discover that several of the authors, including Helen Mayberg of Emory University and Bart Nuttin of University Hospitals in Leuven, Belgium, were pioneers in the use of DBS for treating psychiatric disorders. And to make matters worse, the authors were arguing for Congress to tighten the rules for humanitarian device exemptions.

Fortunately, not all DBS researchers agree. At the recent AAAS meeting in Washington, DC, Benjamin Greenberg of Brown University and Butler Hospital—a pioneer in DBS for OCD—argued that the HDE process was appropriate for the new therapy, noting that only about 15 patients nationally have received DBS in each of the last two years despite extensive outreach to clinicians for his current NIMH-funded DBS clinical trial. Greenberg said that the potential complications are very similar to those observed among the tens of thousands of patients who have undergone DBS for Parkinson’s Disease. He also noted that OCD patients selected for his study have an excellent understanding of the risks, burdens, and potential benefits of DBS.

The field of DBS for treating psychiatric disorders is extremely competitive both among manufacturers and researchers affiliated with them. It may well be that by obtaining FDA approval for OCD via the HDE channel, Medtronic—and its investigators—obtained a leg up on the competition by being able to reach out to clinical and patient communities a year or two before they might have otherwise. But that “early” approval helps clinicians and researchers fine-tune the therapy and helps shed light on the neural circuits involved with normal and abnormal CNS function. Forcing patients to wait longer for FDA approval of a therapy that they want carries risk too. Just ask the patients who were treated successfully with Northstar’s cortical stimulation system for depression but were forced to be explanted when that company when out of business. Or the individuals with spinal cord injury who saw their hope of getting the Andara regrowth stimulation system dashed when Cyberkinetics ran out of money waiting for its HDE approval.

James Cavuoto
Editor and Publisher