Leveling the Playing Field

The FDA’s decision to deny approval of Cyberonics’ VNS therapy for treatment-resistant depression [see article, this page] is as troubling as it is confounding. Like Cyberonics CEO Skip Cummins, we find the decision “totally outrageous, incomprehensible, and out-of-the-blue.” But we also wonder whether undue influence from the pharmaceutical industry, which makes $14 billion per year off of antidepressant sales, could have come into play, a sinister outlook that the hosts of CNBC’s Kudlow & Cramer show have raised in the past.

Whether or not there was any behind-the-scenes activity involved, it seems that the deck is stacked against device manufacturers like Cyberonics and in favor of drug manufacturers, in terms of the FDA’s policies, personnel, and practices. One of the issues raised in the FDA’s denial letter had to do with placebo effects after one year. While placebo trials are a simple matter for drug manufacturers, the prospect of producing placebo, or sham VNS stimulation in a patient for a period of one year would produce ethical problems for Cyberonics, since most institutional review boards would never approve the procedure. Also, given our lack of complete understanding of the nervous system, some researchers believe the placebo effect to be a form of neuromodulation. If it turns out that VNS is a greater beneficiary of placebo effect than pharmaceuticals (perhaps because the patient is more aware of its presence), why should that differential be erased?

More troubling, neurological device manufacturers face a Catch-22 dealing with the FDA. Because of the “invasiveness” of the procedures, devices such as VNS, DBS, and spinal cord stimulation systems are often relegated to the most hard-core cases, the patients who have proven unresponsive to drug treatment. Yet the FDA seems to apply the same or more stringent statistical standards for these patient populations, a standard the drug companies would never meet. In the case of treatment-resistant depression, it seems absurd to demand randomized samples to control for other treatment modalities, given that none of them worked in the first place.

We are not in a position to state that VNS is the ultimate solution to psychiatric disorders like depression or anxiety. But by slamming the door on neurological devices for treating depression, the FDA has severely handicapped the clinical community by removing a powerful and flexible alternative means of therapy. Once a first-generation stimulation device reaches the psychiatric disorder market, the possibility of creating new and improved treatments by modifying stimulation parameters or treatment regimens seems considerable. Unfortunately, until the FDA’s playing field is leveled, clinicians and their patients will be deprived of that possibility.

James Cavuoto
Editor and Publisher



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