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Controversy over Medtronic’s bone-graft product takes nasty, personal turn

It’s getting personal.

One of the orthopedic surgeons who authored some of the studies that have been harshly criticized for downplaying or omitting the negative side effects of Infuse, the Medtronic-marketed bone-graft product used in spinal-fusion surgeries, has come out swinging at his main critic.

Dr. Thomas Zdeblick
Dr. Thomas Zdeblick

And, as the Milwaukee Journal-Sentinel reported on Wednesday, some of his orthopedic colleagues say he’s gone too far.

It certainly appears that he didn’t get all his facts straight.

The surgeon taking the swings is Dr. Thomas Zdeblick, who heads the University of Wisconsin’s orthopedics and rehabilitation department. He’s also the editor of the Journal of Spine Disorders & Techniques, and has strong financial ties to Medtronic.

The target of Zdeblick’s ire is Dr. Eugene Carragee, chief of spinal surgery at Stanford University and the editor of The Spine Journal. Last week, Carragee’s journal took the highly unusual step of devoting its entire issue to a scathing series of reports about Infuse. The reports focus on how 13 Medtronic-funded studies, including ones co-authored by Zdeblick, misled the medical community — and the public — about Infuse’s adverse side effects, which include infection, leg pain, sterility (in men), and an increased risk of cancer.

Dr. Eugene Carragee
Dr. Eugene Carragee

The Spine Journal’s articles also point out that many of the authors of those industry-funded studies, including Zdeblick, have earned millions of dollars from Medtronic in royalties or other fees.

The charges
But the swipe that Zdeblick takes at Carragee involves not that issue of The Spine Journal (it hasn’t been out long enough), but an earlier one. In May, Carragee and his colleagues at Stanford published a study in his journal that found that men who undergo spinal-fusion surgery with the Infuse product are about four times more likely to develop retrograde ejaculation, which can increase sterility, than men who undergo alternative fusion procedures.

In a letter to The Spine Journal, Zdeblick attacks Carragee’s methodology, including the doses of Infuse that Carragee used and the way he assessed retrograde ejaculation. Zdeblick also implies, not so subtly, that Carragee is simply not a good surgeon, and that’s why his surgeries resulted in more negative results than those done by Zdeblick.

“Maybe the specific techniques that Carragee uses should be compared with those of us that have not seen any difference. That would certainly educate patients and surgeons,” he writes.

Zdeblick also claims that Carragee took an 18-month hiatus from performing elective spinal fusion procedures to serve as an Army Reserve surgeon in Iraq.

“Although we all like to think of ourselves as infallible, an 18-month hiatus can certainly alter surgical technique, style, equipment, and so on,” he writes.


The response
In a response letter, Carragee and his Stanford colleagues answer these “unwarranted personal and professional attacks” one by one. They used the same dose as in the original Infuse studies, they note, and their method of assessing retrograde ejaculation was thorough and complete for all patients.

Furthermore, Carragee never took any type of extended military leave during the time of the study. He did go to Iraq for four months in 2005, but that was after the surgeries in the study were completed. He also went to Iraq at the end of 2007, but had to return in January 2008 — after being injured by a suicide bomb attack.

“Dr. Zdeblick has been a surgeon of considerable skill and energy,” Carragee and his colleagues write. “We are sorry to have received and to be obliged to respond to such ill-conceived, abusive and patently unfounded criticism. We made absolutely no personal attacks in our article and we stand by our conclusion that there is substantial evidence indicating anterior lumbar interbody fusion with [Infuse] carries an increased risk of a devastating complication that should have been disclosed to physicians.”

The Stanford researchers also take exception with Zdeblick’s claims that although he receives royalties for a device (the LT Cage) that “can be used with or without Infuse,” he has “absolutely no financial interest” in Infuse itself.

As Carragee and his colleagues point out, the LT Cage is the only device of its kind that has been approved by the U.S. Food and Drug Administration for use with Infuse. That means that each time Infuse is used, the LT Cage must be used as well.

‘Nonsensical’ assertions
Zdeblick’s attack on Carragee has not gotten good reviews by others in his field.

“I was disappointed in Tom,” Dr. Dan Spengler, a Vanderbilt University orthopedic surgeon who cofounded the medical journal that Zdeblick now edits, told Milwaukee Journal-Sentinel reporter John Fauber. “I thought he was a classier guy than that. I can’t even relate to someone who would say something like that.”

Dr. Charles Rosen, a clinical professor of orthopedic surgery at the University of California-Irvine and president of the Association for Medical Ethics, had even harsher criticism.

“Zdeblick’s assertions are so nonsensical that the whole letter strikes me more like the ravings of a guilty man who’s been cornered,” Rosen told Fauber. “His statements sound more to me like those of a lawyer who is trying to throw against the wall enough ridiculous arguments hoping something will stick and raise a doubt in the jury’s mind about his client who was caught red-handed.”

The two letters will be published online in The Spine Journal on July 12, but both are already available for reading in full on the website of the North American Spine Society, the organization that publishes that journal.

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