Spinal fusions are under more scrutiny than ever by patients, payers and spine surgeons themselves. A 2012 study based on data from the Healthcare Cost and Utilization Project Nationwide Sample published in Spine found spinal fusions jumped 137 percent from 1998 to 2008, with costs soaring from $4.3 billion to $33.9 billion in just 10 years.
While several reasons are cited for the increase — including a larger aging population, advanced technology allowing surgeons to perform cases on a broader patient population and wider spread access to fellowship-trained spine surgeons — stakeholders on all sides seek to decrease the fusion rate to only the most appropriate cases.
Just a year before the study hit, a series of articles published in The Spine Journal were critical of using recombinant bone morphogenic protein — rhBMP-2 — to achieve a fusion. The expensive material sold as Medtronic's Infuse was widespread during the decade leading up to these critical studies and has since experienced decline. According to Medtronic's recent fiscal year financial report BMP revenue plummeted from $119 million during 2013 Q2 to $96 million in 2014 Q2. The more recent Q3 data shows relatively flat BMP and spine sales.
"In every technology, in every field there is a pendulum that swings back and forth," says Daniel Resnick, MD, Congress of Neurological Surgeons President and Professor and Vice Chair of Neurological Surgery at the University of Wisconsin School of Medicine and Public Health in Madison. "There was tremendous enthusiasm for BMP and it was viewed by some as a wonder implant. We are on the backswing right now where people are figuring out when it's clinically- and cost-effective and necessary to use."
Controversy surrounding complications associated with rhBMP-2 use have deterred some from even on-label, FDA-approved use for some while others continue to experience success with the material. Few other synthetic options for spinal fusion exist today, but researchers and innovators are pushing to develop new fusion options and alternatives.
"There are other biologics out there such as platelet concentrates and stem cell concentrates, but not a lot of data supporting their use or non-use," says Dr. Resnick. "The jury is still out on the use of those products. There are some research projects looking at the genetics of disc degeneration and bone healing that may provide us with a means to restore a more natural disc function over time but those are still in the basic science stages."
In 2013, the Yale Open Data Access Project published findings on comparison between using rhBMP-2 for spinal fusion to harvesting iliac crest bone. The study authors concluded more research was needed to determine the relationship between BMP and cancer.
"As information becomes available that has less bias, produced by physicians who don't have consulting arrangements and research that isn't from industry-sponsorship, we will see what happens," says R. Alden Milam, MD, of OrthoCarolina based in Charlotte, N.C. "As a surgeon currently, it's difficult to trust what is in the literature for any of these biologics."
A North American Spine Society survey showed 58 percent of physicians were mildly concerned about the cancer risk posed by BMP and 40 percent were mildly concerned about retrograde ejaculation risks.
"The controversy around BMP has been dying down since YODA and is now swinging back to a reasonable area where it's used in high demand situations compassionately or the on-label indications, which I think is totally appropriate," says Dr. Resnick.
However, 41 percent of survey respondents decreased their frequency and dose of BMP due to concerns raised by The Spine Journal studies. Thirty percent have not changed their usage in the years since the studies were released.
"BMP will continue to be an important weapon in the spine surgeon's arsenal," says Kern Singh, MD, Co-Founder of the Minimally Invasive Spine Institute at Rush in Chicago. "Oftentimes, the media sensationalism of a medical device leads to its overuse and disuse. In this case, BMP was likely over utilized; however its efficacy cannot be questioned. The utilization of BMP needs to be accompanied by a detailed and educated conversation with the patient regarding the risks and benefits. With that being said, patients will continue to help surgeons make the best decisions."
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