Devices & Diagnostics

Medtronic’s Infuse woes cause verbal boxing match between researchers

Medtronic (NYSE:MDT) may have to manage potential legal headaches regarding its controversial Infuse bone growth […]

Medtronic (NYSE:MDT) may have to manage potential legal headaches regarding its controversial Infuse bone growth product, but for two Infuse researchers in the world of academia with starkly contrasting views, the battle has become intensely personal.

MinnPost is reporting that one orthopedic surgeon who authored some of the Infuse studies that have been publicly criticized by colleagues in the field for understating the product’s risks, has taken aim at his chief critic.

Thomas Zdeblick, who has financial ties to the Minnesota medical device maker and is the head of the University of Wisconsin’s orthopedics and rehabilitation department, has sent a letter to the editor of the Spine Journal, who also happens to be a major critic of Zdeblick’s  Infuse research — Dr. Eugene Carragee, chief of spinal surgery at Stanford University.

In the letter entitled “Science, please,” Zdeblick begins by saying that “Carragee took an 18-month hiatus from performing elective civilian spinal surgery and began using BMP-2 (Infuse)  on his return. Although we all like to think of ourselves as  infallible, an 18-month hiatus can certainly alter surgical  technique, style, equipment. …”

That “hiatus” was because Carragee was serving as an Army reserve surgeon in Iraq.

The letter goes on to list specific complaints related to the methodology of the study that Carragee and other authors undertook, which prompted them to conclude that Infuse increases the risk of  male sterility. He also hinted that Carragee may not be a good surgeon.

Carragee and other study authors and Spine Journal editors were quick to respond to the letter. They wrote: “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. …”

Meanwhile, Zdeblick’s criticism of Carragee is not winning him any friends, according to a report in the Milwaukee Journal Sentinel and MedPage Today. The article notes:

“I was disappointed in Tom,” said Dan Spengler, MD, a Vanderbilt University orthopedic surgeon who co-founded the medical journal that Zdeblick now edits. “I thought he was a classier guy than that. I can’t even relate to someone who would say something like that.”

Zdeblick, who has received more than $23 million in royalties and other payments from Medtronic since 2002, serves as editor-in-chief of the  Journal of Spinal Disorders & Techniques. None of the royalties are for InFuse.

Both Zdeblick’s initial letter and Carragee’s response are available here.

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