Over Promise and Therapeutic Delivery
Readers of this publication have been exposed to a number of new and promising forms of neuromodulation that exploit novel anatomical targets or unique stimulation paradigms. As we report on page 1 of this issue, several new neuromodulation approaches for treating pain have emerged recently, including subwave neuromodulation, chemogenetic neuromodulation, and HD-SCS. While previous generations of new SCS paradigms have demonstrated clinical, if not financial success, these newest approaches have yet to be proven.
Another form of neuromodulation that has attracted significant media attention in the last few years is optogenetic stimulation. A recent article in the journal Neuron by Penn researchers claimed that optogenetics could be an effective therapy in humans. The authors reported that based on feedback from 45 research labs, optogenetics in nonhuman primates had a 91 percent success rate.
But a rebuttal published in Oxford Open Neuroscience by Eliza Bliss-Moreau from UC Davis, Vincent Costa from OHSU, and Mark Baxter from the Icahn School of Medicine at Mount Sinai calls into question the data and conclusions in the Neuron article. The Oxford authors contend that the 91 percent success rate is greatly exaggerated, and that “we are a long way from being able to leverage optogenetics in ‘the service of patients with neurological or psychiatric conditions’ as the Neuron report claims.” They expressed similar concerns about chemogenetics.
The Oxford authors worry that the rush to use new technology for technology’s sake may deplete scientific resources when the failure rate of new techniques is high. “If scientists and funders think that a technology is more established and efficacious than it actually is, we run the risk of adopting it and abandoning technology that does work, and actually slowing, rather than speeding discovery,” said lead author Bliss-Moreau.
The neuromodulation industry would be wise to heed this caution. The industry has already been hurt by failed clinical trials of promising new therapies for treating stroke and depression—despite the fact that the science behind both was sound and would eventually be borne out. Pushing optogenetics and chemogenetics as viable therapies before there is a clear translational path could produce similar negative effects.
We feel much more optimistic about “subwave” stimulation of dorsal horn dendrites described by Marc Russo. This is in part because the early data looks promising but more so because the financial risks to vendors is so low. The therapeutic approach will work with all existing SCS systems and Russo has chosen to forego IP protection for his work.
We salute Russo and his team for their generosity and their commitment to advancing neuromodulation. But we’ll wait to see how the technology works in the field before we pop the champagne.
James Cavuoto
Editor and Publisher