Spinal fusion surgeries have increased dramatically in the past decade, but questions persist about the costly technique that is often used to treat older patients with lower-back pain.
Physicians are sounding alarms over unnecessary spinal surgeries and are challenging the clinical trial process for one of the most popular spinal fusion procedures. Questions are being raised about possible conflicts and the millions of dollars spent on allegedly biased studies. It's time to address these longstanding issues.'
Are there too many spinal fusion surgeries? In discussions about spine fusion techniques for an article in this month's HealthLeaders magazine, Kamal Thapar, MD, medical director of neurosurgery and tertiary care services at Sacred Heart Hospital in Eau Clare, WI, was emphatic. "You can see the spine fusion rates and there is really no doubt fusion operations are being overdone," he said.
An April 2010 study in the Journal of the American Medical Association found a 15-fold increase in the number of spinal fusion surgeries performed for Medicare patients between 2002 and 2007. And older patients having aching backs are increasingly getting more costly and complex spinal fusion surgeries, resulting in higher rates of life-threatening complications and increasing costs to the healthcare system, according to the Oregon Health and Science University in Portland, OR.
We must determine 'where the money goes, and how it should be spent, with improved, cost-effective patient care the goal.
Are there too many conflicting interests in clinical trials for a popular spine fusion technique? The Spine Journal, the journal of the North American Spine Society, thinks so. Last month, The Spine Journal contradicted industry-sponsored clinical research on rhBMP-2, a controversial synthetic bone growth product often used in spinal fusion surgeries.
The journal scrutinized what it termed misleading and biased reports on the product, Infuse, a bioengineered material used mostly in spinal fusions, made by Medtronic, the nation's largest manufacturer of medical devices. The Journal noted that clinical studies of Infuse were conducted by surgeons who received millions of dollars from Metronic.
Medtronic estimates that Infuse is used in about one quarter of the more than 400,000 spinal fusions performed in the U.S. annually. The controversy over the clinical trials is being confronted head-on, and that is good for healthcare.
Responding to The Spine Journal reports, Medtronic earlier this month announced that it would pay Yale University $2.5 million to independently review the safety and effectiveness of its Infuse Bone Graft, which is supposed to stimulate bone growth. While critics have said the product has several side effects, including male sterility, company-sponsored researchers have blamed problems on surgeons, not on the products.
Medtronic's plan to pay Yale to evaluate its own product raises its own questions about conflict of interest.
"The financial arrangement, de facto, certainly creates a potential conflict of interest," Eugene J. Carragee, MD, editor-in-chief of The Spine Journal, and professor and vice-chairman of the Department of Orthopaedic Surgery at Stanford University School of Medicine, told HealthLeaders Media. "But the Yale group can put in certain safeguards to manage the risk of overt bias. I have no reservations about the integrity of the Yale group."
Although the Medtronic and Yale arrangement raises questions, there is widespread hope within academia and among physicians that Medtronic's decision to open for public review heretofore secretive results of clinical trials may have lasting, and positive consequences.
The review also will focus on data submitted from industry-sponsored studies submitted to the Food and Drug Administration but which was never published.
"It's a big plus – it breaks the glass ceiling, where device and drug manufacturers have said for many years that it was legally, logistically or financially impossible to even consider having a third party look at their data summaries," says Carragee. "This breaks the 'never, ever, can't do it mantra," he says. "Clearly, if Medtronic can do it with their No. 1 spine product, it can be at least on the table for discussions with companies who produce data that doesn't seem right."
Medtronic plans to give to Yale researchers all available patient data on rhBMP-2 from clinical trials it sponsored, both published as well as unpublished, and FDA adverse event reports for a comprehensive review, the Minneapolis-based company has stated. The company plans to make its clinical trial data available on ClinicalTrials.gov. It also plans to retroactively register all premarket approval and post-market studies that were completed before a requirement for registering such trials was set in 2007.
"Integrity and patient safety are Medtronic's highest priorities," Omar Ishrak, chairman and CEO of Medtronic said in a statement.
Carragee is hopeful about the broad ramifications of the Medtronic plan, but he also has concerns about the study of the spinal fusion product.
"There have been many years of repeated and categorical denials [of] associated complications by paid consultants or other surgeons with financial ties to the company," Carragee says. "Yale can get all the FDA reports in existence but because of the history of denying associated problems, they will have only the tip of the iceberg."
Harlan Krumholz, MD, a professor of cardiology and investigative medicine at Yale Medical School, will lead the independent review.
Krumholz's strategy "is to ask the right question and pick the right measurement – and it can get the right answer," Yale Medical School's Web site notes. Forbes Magazine also has called Krumholz "The Most Powerful Doctor You Never Heard Of." In the spinal surgery field, Krumholz's name will certainly become more known. Whether he pushes beyond the "tip of the iceberg" as Carragee fears, is not yet known.
Joe Cantlupe is a senior editor with HealthLeaders Media Online.
