Sharing the Task

The founding of the National Task Force on Consumer Access to Emerging Neurotechnologies is a promising development for the neurotechnology industry, as we report in our article on page 1 of this issue. Though the group’s formation was no doubt inspired by a series of negative events surrounding Cyberonics’ struggle to gain market approval and reimbursement for its vagus nerve stimulation system to treat refractory depression, we are heartened nonetheless by the goals and the efforts of the new organization.

In a short time, the task force has assembled an impressive membership drawing from the academic, clinical, payer, and mental health advocacy communities. They have also identified the key scientific, regulatory, financial, and political issues that stand in the way of delivering neurotechnology therapies to users who could benefit from them.

The task force wisely points out the dirty little secret of the neuropharmaceutical industry—that one third of individuals with depression are not successfully treated with currently available medications. This fact needs to be repeated over and over again to all who will listen, if for no other reason than to put into perspective the absurd standards by which neurotech devices are assessed.

It still astounds us that regulatory and reimbursement agencies would balk at a success rate of 40 to 50 percent for a therapy such as VNS or TMS for treatment-resistant depression when pharmaceutical therapies—in aggregate—exhibit at best a 67 percent success rate with the entire depression population. This is not only intellectually insulting, but a threat to the practice of psychiatry and the safety of a very sizeable patient population. If the government is so concerned with statistical evidence, they should pull from the market any individual antidepressant that fails to achieve the long-term success rate with TRD that VNS has achieved. Of course that would certainly make for some very angry pharmaceutical company executives. The notion that some regulators seem to have—if you can’t help everybody we won’t let you help anybody—is a perversion of government responsibility, in our view.

Clearly the task force members have their work cut out for them, beginning with the task of recruiting new sponsors. The head of the organization, Monica Oss of Open Minds, assures us this is a priority as it spins off to an independent 501(c)3 organization later this year.

The issues that Cyberonics has faced in the depression market with VNS will apply to Medtronic, St. Jude Medical, Neuronetics, Northstar, and other manufacturers of neurotechnology devices targeted at psychiatric disorders. We call on these firms to get on board with this task force, even if that means augmenting the membership beyond the initial group that Cyberonics funded.

James Cavuoto
Editor and Publisher