Critical JAMA Article Causes Concern in SCS Market
by James Cavuoto, editor
December 2022 issue
A highly critical report published last month in JAMA Neurology casts doubt on the effectiveness of spinal cord stimulation for chronic pain. The report has raised concern among SCS vendors and pain doctors, some of whom challenge the findings and the methodology of the report and others who accept some of the criticism as fair game.
The article, titled “Long-term Outcomes in Use of Opioids, Nonpharmacologic Pain Interventions, and Total Costs of Spinal Cord Stimulators Compared With Conventional Medical Therapy for Chronic Pain,” was authored by two professors at UC San Francisco School of Medicine, Sanket Dhruva and Rita Redberg, and five professionals affiliated with UnitedHealth Group. Dhruva and Redberg specialize in cardiology.
The article analyzed data from 7,560 insured patients who had been treated with an SCS system. They concluded that patients receiving SCS therapy performed no better than those receiving conventional medical management. “In this large, real-world, comparative effectiveness research study comparing SCS and CMM for chronic pain, SCS placement was not associated with a reduction in opioid use or nonpharmacologic pain interventions at 2 years. SCS was associated with higher costs, and SCS-related complications were common,” the authors wrote. They also criticized other studies showing positive data on SCS effectiveness if there was industry sponsorship involved.
In an editorial in the same issue of JAMA Neurology, two other UCSF professors who specialize in pain medicine, Prasad Shirvalkar and Lawrence Poree, offered some counterpoints, though acknowledging the validity of some points raised in the article. They pointed out that the data lacks direct pain or function measures, relying on pharmacy usage and other factors as a surrogate for pain. “Variables such as opioid usage or follow-up visits pose a potential confound of circular logic, as these variables are also likely strong surrogates for healthcare utilization, and therefore cost,” Shirvalkar and Poree wrote.
The pair also pointed out that any examination of relative cost-effectiveness would take into account quality of life measures and should cover a time horizon longer than the two years used in the Dhruva study. Fiscal neutrality for SCS occurs somewhere between 2.5 and three years, they suggested.
Allen Burton, CMO of Abbott Neuromodulation, said in a LinkedIn post that there were “numerous important, significant flaws” in the article, and “many questions about the authorship—no neuromodulation or pain experts on the list, which calls their conclusions into serious doubt.”
Several other pain doctors weighed in on LinkedIn. Jonathan Hagedorn, an interventional pain physician at the Mayo Clinic, was somewhat sympathetic to the study. “I’m not interested in quick fixes or single, small industry-funded studies, both of which tend to be big on promises and low on real world reproducibility,” he said.
David Lee, a pain specialist from Fullerton, CA, commented, “We are taught to be skeptical about industry-sponsored studies. That is fair, but we should hold studies associated with healthcare insurers to the same scrutiny.”
John Ha, an interventional pain physician at the Rockford Pain Center, said “This is why I think it’s very important for implanters to collect their own clinical data. There are just way too many variables for one to have successful outcomes with neuromodulation.”