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 week 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.
Now OTW and its founder and publisher, Robin Young, are calling for the North American Spine Society to review Carragee’s role in the Infuse controversy.
"It has become increasingly clear that The Spine Journal Editor in Chief, Dr. Eugene Carragee, has abandoned even the pretense of impartiality," Young wrote. "This is not about BMP-2 or Infuse or Medtronic. This is about scientific impartiality, avoidance of hyperbole in pursuit of clinical accuracy and navigating the often conflicting opinions of passionate clinicians. In short, it is about mature scientific leadership. Our peer review journal editors must be paragons of clinical and scientific judgment.”
Young told MassDevice.com that his call for Carragee to step down is "unprecedented" for his publication, driven by Young’s view that Carragee has taken on the role of an advocate against Infuse.
"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 us. "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.
"We’ve never done this before. I’m doing it now, publisher to publisher, and it has nothing to do with the stance he’s taken. It has nothing to do with Infuse or Medtronic. It has to do with impartiality, honesty, accuracy and integrity. And I’m calling on the guy and saying, ‘enough’. That’s why we’re doing it."
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. "Then I kept digging and I found another 1 of those original 13 studies, which actually had 3 arms to the study, and the 3rd arm argued against Carragee’s conclusion. I went back to Carragee’s study and I found he excluded the 3rd arm."
Young also takes exception to some of the language Carragee used in his response to the Yale review, including a reference to baseball’s 1919 "Black Sox" gambling scandal.
"It is appropriate for someone who is trying to be an advocate for a certain point of view, but it is not appropriate for these guys that we look to to give us an impartial interpretation and analysis. It is not their role. They are supposed to be the judge in the courtroom, not the prosecutor," Young told us.
Carragee did not immediately respond to an email seeking comment. A call to his Stanford, Calif., office went unanswered.
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."