Circumventing the Market to Relieve Paralysis
You’ve been in a terrible accident. Everyone says that you are lucky to have survived, and you are. But a severe spinal cord injury means you can’t use your hands for the simplest tasks. Your family brushes your teeth and dresses you each day. You’ve lost bowel and bladder control. Sex will never be the same. But there is an alternative: a neuroprosthesis (a prosthetic nervous system) could restore function to your body, part by part.
This remarkable technology exists, but you can’t have it.
“It’s all economics,” explains Julie Jacono, director of Case Western Reserve University’s Institute for Functional Restoration (IFR), a nonprofit corporate surrogate that is pushing forward the final stage of testing for a platform of six neuroprostheses. The various implantable devices can each restore function to different parts of the body—allowing paralyzed patients to do things like stand again or move their hands. It’s incredibly promising. But because so few people suffer from spinal cord injuries, it isn’t profitable for a company to take the technology to market.
Most of us assume that once discoveries are uncovered in the lab, they’ll eventually make their way to patients. “It’s a field of dreams story, that if you build it they will come,” says P. Hunter Peckham, bioengineering professor and executive director of the Institute. “But I think we all know that that’s not the way any of these things work.”
According to the National Spinal Cord Injury Statistical Center, there are about 270,000 people in the U.S. with spinal cord injuries. Compared to the number of people suffering from more common conditions like diabetes or heart disease, says Jacono, “we are a decimal point in potential market size.”
They may not be hugely profitable, but the devices allow people to move again. Using an implantable pulse generator and series of electrodes, the devices create a parallel nervous system. Electrical stimulation runs through the wires to muscles and organs, thus returning function to the hands, bowels and bladder, restoring trunk control, cough reflex, relieving pressure sores, or even helping people stand again. The team is rolling out a plan to integrate multiple devices and wire them across a network.
Thus far, they’ve yet to run across a patient for whom the devices don’t restore some function. Peckham describes what he’s seen with the upper extremity device: turn it on, and they regain hand function. Turn it off again, they’re paralyzed.
“In the world of spinal cord injury there’s exactly the kind of technology that people have had access to for decades—wheel chairs, assistive technology. Then there’s the hope of a cure, through stem cells or some kind of natural, neurological regeneration. There’s no timetable to that,” says Jacono. “What we can deliver is a true reversal of spinal cord injury, for select functions, and we can do that in the near term.”
The devices offer dramatic results, but one company already failed in selling an earlier version of the upper extremity neuroprosthesis. Around 250 people received the device before the company collapsed. “It was backed by venture money and the growth of the company was not adequate to sustain the business. The product was enormously successful,” says Peckham, who was also lead researcher on the team that developed the device. “It was the financial model of that vehicle that was wrong. It wasn’t the technology.”
Seeing that company’s demise, and knowing that without some support the technology would never reach those who would benefit from it, Peckham and Jacono founded IFR to serve as a nonprofit proxy for the work that would normally be done under the auspices of a corporate body. “We have to find a way that’s going to make these breakthroughs available to people when there isn’t a standard commercial model,” says Peckham.
That last stage of medical translational research— taking drugs and treatments through the FDA’s final hurdle, a large pivotal study—isn’t cheap. This final step is normally bankrolled by a company hoping to legitimize a lucrative discovery. But there’s little incentive for companies to make an investment in proving efficacy without the promise of larger profits down the line. This reality has left the nonprofit IFR, operating with university and foundation support, in the unusual position of funding the translational research itself.
Peckham believes he’s under a moral obligation to see the research through to the end. “We have to find a way that’s going to make these breakthroughs available to people when there isn’t a standard commercial model,” he says.