Time for a Change

There are the duties and responsibilities which all physicians have to uphold the canons of their profession. There are then the obligations of those on whom we rely for impartial interpretation and analysis of clinical and scientific evidence.

It has become increasingly clear that The Spine Journal Editor-in-Chief, Dr. Eugene Carragee, has abandoned even the pretense of impartiality.

Dr. Eugene Carragee needs to step aside. If he doesn’t, the publisher (Elsevier) and the board of trustees for the North American Spine Society (NASS) need to meet and review Dr. Carragee’s research and public comments regarding BMP-2, Infuse, Medtronic and all of the clinical researchers who’ve been attacked by him in both press release form and in the pages of The Spine Journal.

As for The Spine Journal, the peer review publication of the North American Spine Society which has been the standard for excellence in clinical and scientific spine research since 2001, it must act immediately. Dr. Carragee’s failure to maintain impartiality and good judgment have clearly damaged this outstanding journal.

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.

It is impossible not to cringe when reading the following hyperbolic public statements from the Editor-in-Chief of The Spine Journal

• “The YODA (Yale University Open Data Access Project) report published today in the Annals of Internal Medicine is the latest shock in a series of re-examinations of Medtronic’s ill-fated biologics product.”
• “Ten years after BMP-2’s introduction, we cannot identify a single well-proven area of benefit, but we know it can kill you in the cervical spine and probably can promote cancer, which can then kill you.”
• “The hyperbolic fever of BMP-2 promotion before its current fall from grace turned spinal conferences into Elmer Gantry-styled revival meetings.”
• “Many of us feel like 10-year-olds after the Black Sox series: “Say it ain’t so, Joe.”
• “BMP-2’s fifteen minutes of fame had ticked by. The cost: maybe 15 billion dollars, maybe cancer, maybe worse.”
• “In the end, less than one percent of the 250 participants voted for the old dream…people seemed kind of bored. Older guys thought of the Black Sox, groaned as they got up. Young guys glanced at the time (how confident the reps had seemed). But their attentions had moved away from the carnival hoopla of yesteryear. In the end, people yawned and some chuckled to themselves and… finally…left the room.”

Though Carragee is the Editor-in-Chief of The Spine Journal, he is also the lead attacker against BMP-2, Medtronic and in that role is an advocate for a particular point of view.

When Carragee appoints himself lead author of BMP-2 studies which subsequently appear in The Spine Journal during his tenure as Editor-in-Chief and when, in those same articles, he excludes data which contradicts his pet thesis, uses faulty analysis to arrive at conclusions consistent with his anti-BMP-2 campaign, and accuses researchers of financial bias where none, in fact, exists then everyone should be alarmed.

Dr. Carragee’s colleagues will ultimately determine whether his campaign against BMP-2, Medtronic and those researchers who participated in BMP studies has merit. But the pages of The Spine Journal and the press office of the North American Spine Society are no place for the kind of hyperbolic advocacy he engages in.

The Yale review of all of Medtronic’s patient level BMP-2 data stands in stark contrast to Dr. Carragee’s handling of the BMP-2 research and researchers in both the pages of The Spine Journal and in press releases issued by NASS.

According to Carragee, for example: “the risk of adverse events [from using BMP-2] is 10 to 50 times higher than reported in trial publications”.

10x to 50x higher. The YODA study authors (the York analysis, Simmonds et al.) checked that claim. Here is their conclusion: “Our review differs from the existing review (the authors then cited the Carragee comments of 10x-50x)” and that after reviewing all of the data, the difference between the adverse events reported in the trial publications and actual adverse events was minimal.

Quoting from page 883 of the York analysis, the results of their analysis for adverse events was inconclusive and “The only clear evidence of a difference was for pain at or shortly after surgery, which was more common in the rhBMP-2 recipients (odds ratio, 1.78).”

Not exactly 10x-50x. Not even 2x.

That’s a mis-measurement of a scale that, for the Editor-in-Chief of The Spine Journal, approaches scientific mal-practice.

An Editor-in-Chief of a premier peer review journal who lacks balance, judgment and ultimately authority has nothing.

Elsevier and NASS have an obvious decision to make but a difficult process to go through. Carragee won’t likely let these two venerable organizations off the hook. He should do the right thing but is probably too caught up in his own advocacy to see the situation he has created.

He has spoken eloquently in the past about eliminating bias from clinical research. Therefore some people will argue that Dr. Carragee should be allowed to finish out his multi-year contract as The Spine Journal’s editor.

Given Dr. Carragee’s now open partisanship and documented lapses with regard to his own BMP-2 research, we don’t agree.

If Elsevier or NASS will, as we recommend, review Dr. Carragee’s statements and invite those former BMP-2 researchers whom he has accused of being bought and paid for by Medtronic to present their side of the story, we are confident that the arguments on behalf of Carragee as Editor-in-Chief of The Spine Journal will collapse in their entirety.

After reviewing all of Dr. Carragee’s press releases as well as published research in the same journal for which he is editor, we believe there is only one conclusion: Dr. Eugene Carragee must resign his position as Editor-in-Chief of The Spine Journal.

Robin R. Young, Publisher
Orthopedics This Week
Wayne, Pa
June 25, 2013