Leave No Patient Behind

When new neurotech therapies go right, everyone is happy. Patients get access to a therapy that addresses their disorder. Vendors get revenues from device sales, upgrades, and service. Clinicians get a new base of patients and gain expertise in their field. And payers get assurance that their subscribers are being cared for in a cost-effective manner.

When new neurotech therapies go wrong, it’s mostly the investors and entrepreneurs who are unhappy. Participants in a failed clinical trial are not out of pocket, clinicians generally get paid by the trial sponsor, and insurers aren’t on the hook for experimental therapies.

But what happens when the therapy works, but the company behind the new neurotech device fails for financial or other reasons unrelated to effectiveness of the therapy? Such is the dilemma many individuals suffering from migraine are now facing with the demise of two neurotech device firms in that space. As we report on page 1 of this issue, the recent failures of eNeura Inc. and Autonomic Technologies Inc. has left many users of their devices in the lurch. One eNeura customer complained on Reddit that their device stopped working even though there was time remaining on their subscription. A European implanter of ATI’s device reported in Lancet that patients have had devastating attacks because simple spare parts were unavailable.

These are not the only examples of effective neurotech products that were still in use when the manufacturers went out of business. When Nuvectra closed its doors last year, many chronic pain patients who had that company’s SCS system implanted were left wondering who would support them down the road. When Northstar Neuroscience closed in 2009 as a result of a failed stroke trial, several participants in a Northstar depression trial had to be explanted despite the fact they were getting good results from the cortical stimulation therapy. In the early days of this publication, we reported on the financial failure of the neuroprosthetics firm NeuroControl, which threatened the well being of hundreds of their quadriplegic customers who were happy with their implanted hand-grasp stimulator. Fortunately, Case Western Reserve University and the Cleveland FES Center stepped up to the plate and supported those users for many years. But they didn’t have to. Brown, MGH, and other non-profit institutions played a similar role with the BrainGate2 program after the demise of Cyberkinetics.

We envision several possible solutions to this problem. Bankruptcy courts should put implanted patients high on the priority list of creditors. Firms or institutions that volunteer to support existing patients should get IP priority on any technology that was used. And the government should underwrite funds needed for ongoing care of orphaned patients. We owe it to patients to live up to the adage, “Do no harm.”

James Cavuoto
Editor and Publisher


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