Discourse and Dissent

by James Cavuoto, editor

Like any area of scientific discovery, the field of neuromodulation depends heavily on timely and open dissemination of research findings and trial results. Traditionally, scientific journals have filled this function and the peer-review process that determines which papers get published provides the essential feedback that helps build consensus among the key stakeholders in the field. This feedback enables investigators and clinicians to weed out studies with poor scientific rigor and promulgate groundbreaking studies that move the field forward.

But increasingly, investigators are turning to more timely forums to solicit and offer feedback on novel ideas and controversial topics. While annual meetings such as the North American Neuromodulation Society offer in-person opportunities for the exchange of ideas, for many professionals, social media outlets, with their 24/7 publication schedule and complete lack of refereeing fill the void of immediacy that they seek.

Such was the case recently when three prominent pain physicians, Ryan D’Souza from Mayo Clinic, Michael Schatman from NYU, and Nasir Hussain from Ohio State Wexner Medical Center, sought to engage their colleagues in what they felt was an essential dialog concerning their editorial this month in the Journal of Pain Research. The article, entitled “A Call for Reckoning and Reform in Interventional Pain Medicine and Neuromodulation Research,” took the pain neuromodulation industry to task for fostering the perception that the field is “driven more by industry than evidence, and by expedience rather than inquiry.”

Chief among their criticisms is the undue influence that industry players exert over pivotal trial study designs and the suppression of less favorable data. As an example, the authors cited a study of 60-day temporary peripheral nerve stimulation sponsored by SPR Therapeutics. “A closer examination of the published figures reveals that only the data from the responder subgroup were displayed, masking the broader variability of outcomes of the entire cohort,” the authors wrote. They also mentioned the impact of catchy branding such as “restorative neurostimulation” from device manufacturers and the failure to disclose conflicts of interest.

Not content to wait for the fallout from this bombshell report to hit the pages of the journal, the lead author, D’Souza, posted on LinkedIn a plea for clinicians, researchers, policymakers, and industry leaders to weigh in on the published piece. And several pain clinicians did just that, mostly praising the authors for their work.

This editor joined the fray, acknowledging the fact that multi-billion dollar neuromodulation firms such as Medtronic, Abbott, and Boston Scientific likely use their financial clout as leverage in clinical studies but pointing out that neuromodulation device trials are often at a disadvantage compared to pharmaceutical trials because of the requirement for a sham stimulation arm that could suppress a significant advantage that device therapies would have over drug interventions. Much of that argument was discussed in this space last year and we were pleased to have D’Souza’s endorsement of that piece. “Very well-written and 100% agree on all the points you make in the article. Well done!,” he posted in the thread.

Another commenter, Kip Ludwig from the University of Wisconsin, took issue with this editor’s point of view, pointing out that sham arms can uncover other “nuisance variables” besides placebo effect and highlighting the much greater statistical power of drug trials, with their five-digit n’s.

While the discourse on social media sites like LinkedIn can be less polished and not as erudite as in the pages of a scientific journal, the immediacy of the feedback and the interpersonal nature of the interaction make that medium a useful resource for investigators and industry observers alike.

We would like it if many others joined the dialog and offered their feedback on the important issues that the journal authors have requested.