Human Nature vs. Humanitarian Behavior

When the FDA initiated the Humanitarian Device Exemption for manufacturers of medical devices intended for a relatively small market of potential users, it was with compassion in mind for individuals suffering from a disease or disorder that is not juicy enough to attract traditional medical firms in our profit-driven economy. And so it should have been no surprise when the Boston Globe reported earlier this month that Cyberkinetics Inc. applied for an HDE for its Andara OFS neural regeneration stimulator.

But as it turns out, Cyberkinetics’ HDE application has drawn the attention of one critic, Miguel Nicolelis of Duke University. The newspaper quoted him as saying, “I have nothing good to say about this company. I see no solid science behind their latest attempt to make some quick revenue or save their stock price from collapsing altogether.”

Nicolelis is a brilliant neuroscientist and one of the pioneers of brain-machine interfaces. But his comments about the Andara device are troubling. If Nicolelis has evidence or data that contradicts the positive preliminary results, he should present them at an appropriate scientific meeting or publication. Also, his expertise as a neuroscientist does not make him the best source on Cyberkinetics’ business viability, a point evidently lost on the Globe reporter. (Of course, the same caution could also be raised about this editor and for that reason we recommend readers keep a healthy dose of salt grains available when reading our reports and forecasts.)

But most troubling is the notion that the Andara HDE application is somehow a disservice to the spinal cord injury community. Individuals with paraplegia and tetraplegia have suffered enough with their conditions and the apathy the clinical community, healthcare firms, and investors have shown toward restoring lost functions. Let us not forget that Christopher Reeve often chided researchers for taking too long to deliver new therapies to people with paralysis. It is a tragedy that he passed away without realizing his dream of walking again (though he did benefit from an FES diaphragm pacing system and John McDonald’s restorative therapy). Regardless of Nicolelis’ views of Cyberkinetics founder John Donoghue and his work on BMIs, he should not let that stand in the way of getting a promising regeneration therapy to users who need it now.

As we’ve said before, the media has paid more attention to the cortical control aspect of neural prostheses than the restoration of function itself and this no doubt helped stir up some of the animosity that exists among some BMI researchers today. In our view, any researcher or commercial firm—no matter how slick or media savvy—who can help paralyzed people sooner rather than later deserves our appreciation.

James Cavuoto
Editor and Publisher