During the course of this past year, Stanford orthopedist Eugene Carragee, MD, and his colleagues have done an extensive review of the data on a commonly used spinal fusion product and have found it causes vastly more complications than reported in early industry-sponsored studies. Their review (.pdf), published in today's The Spine Journal (which Carragee edits) found the complications, including male sterility, infection, bone and nerve problems and possible increased cancer risk, were at least 10 to 50 times greater than originally reported. The authors of the early studies, who reported virtually no adverse effects, received many millions of dollars from the product manufacturer, Medtronic, Inc., the review found.
"If there weren't millions of dollars riding on it, this would be a dry discussion on the appropriate use of statistics and methodology," Carragee, a professor of orthopedic surgery, told me. "The problem is in the last 10 years, between $3 billion and $5 billion has been spent on this product, and it's not clear what benefit has been achieved, compared with how many patients have been harmed by it. The industry estimate of harm is simply wrong."
The review of the data, widely reported in the media, already has triggered a Congressional investigation, with the Senate Finance Committee requesting that Medtronic turn over all documents related to complications from the product, including communications with doctors who conducted the early trials. The product, a bioengineered protein known as rhBMP-2, is marketed under the brand names Infuse and Amplify.
Exposing these issues represents a bold move by Carragee, who is taking on an extremely powerful industry. But Carragee, who has served with the U.S. military in Iraq and elsewhere, says he's just doing his job.
"This should be the bread and butter of what clinical publications do, which is critically evaluate the evidence and create a dialogue about the advantages and disadvantages of treatment," he said. "It only appears courageous because some others haven't done it."
Previously: Stanford study links spine product to male infertility
Photo by Norbert von der Groben