The fallout from Medtronic‘s (NYSE:MDT) controversial Infuse bone putty spread to a pair of orthopedics publications when the publisher of Orthopedics This Week called for the resignation of Dr. Eugene Carragee as editor of The Spine Journal.
Last month a long-awaited Yale review found that Medtronic’s Infuse product, which uses recombinant human bone morphogenetic protein-2 or BMP-2, was equivalent to the gold standard of iliac crest bone grafts in some spinal fusion procedures. A flurry of editorials ensued, including from OTW and Carragee.
OTW and its founder and publisher, Robin Young, later called for the North American Spine Society to review Carragee’s role in the Infuse controversy.
"I’m not concerned about Carragee’s role as a critic, as someone who has reviewed old studies and found them to be wanting. In that role he’s done just fine," Young told MassDevice.com. "But he is editor-in-chief of The Spine Journal and he’s taken on the role of advocate and of being a partisan. … The core issue is bias. Bias in the original [Spine Journal] study and bias in the way the information was presented.
Young cited "a number of really troubling flaws including exclusion of data" in Carragee’s June 2011 review of a slew of original study publications on Infuse.
"For example, Carragee makes the point that in the 13 original studies, none mention adverse events, and he makes the point in this study, he said the word ‘zero.’ Zero means zero – nothing," he told us. "But then I went back and I found that 1 of the studies had a table that listed adverse events. I brought that up to Carragee.
"He didn’t do a thing, he ignored it," Young said.
In an exclusive interview with MassDevice.com, Carragee denied Young’s accusations and termed the call for his ouster "amazing."
"That’s a fabrication," Carragee said of Young’s version of events subsequent to The Spine Journal‘s June 2011 expose on Infuse. "That has not been disputed anywhere except by [Young]."
Asked if he’s used Infuse in his own spine surgery practice, Carragee said, "Sure."
"I’ve published results of using [Infuse] in 100s of patients," he told us. "Simply on the facts, [Young’s] incorrect that I have a reckless bias against the product or its availability, as I’m the only one who’s said it should be on the market. … My problem is not with the product. It’s with the representation of its efficacy and risks."
As for charges of bias, Carragee said it’s the job of the editors of peer-reviewed publications to be prejudiced in favor of patient safety.
"We’re obliged to have a partisan advocacy for patient safety. An editor who’s not doing that is not taking the job seriously," he said.
Carragee also said that Young has a conflict of interest of his own to contend with, namely Medtronic’s past sponsorship of OTW and Young’s side business as an orthopedics consultant. Young has avoided writing a letter to the editor at The Spine Journal detailing his concerns, as Carragee claims to have suggested, because he wants to avoid disclosing his financial ties to the orthopedics industry, Carragee contended.
Medtronic paid $2.5 million to Yale and provided all of the data in its possession on Infuse for the Yale studies, carried out by teams at England’s York University and the Oregon Health & Science University, after the controversial June 2011 issue of the Spine Journal claimed that the risk of adverse events with Infuse could be as high as 50%.
Carragee, writing in response to the Yale project results, highlighted the bias found in early publications on Infuse.
"In some cases, an extraordinary merry-go-round of comprehensively conflicted faces are found at each check and balance: In one instance, it seems the principal investigator with strong financial ties to Medtronic helped design a trial, and then the same person acted as the surgeon and, for consistency, monitored complications, then went on to author the paper, whose drafts were written in whole or in part with the company, and then submitted the manuscript for review to…well…himself as editor in chief or section editor of the journal!" Carragee wrote. "In some cases the editor in chief of the journal reviewing his own paper was also, in fact, both the developer and the royalty holder on one or more products being investigated. It would be hard to envision a situation less likely to produce an unbiased journal publication. And now the [Yale Open Data Access Project] group – echoing The Spine Journal’s critical review from 2 years ago – tells us that important concerns about BMP-2 complications were ‘underreported’ or just missing. As YODA project director Harlan Krumholz, MD, SM, delicately puts it, ‘Evidence suggests that some data are not missing at random.’ Annals editors are more blunt: ‘Early journal publications misrepresented the effectiveness and harms through selective reporting, duplicate publication, and underreporting.’ Ouch."