Following up on his work on the dangers of Medtronic’s Infuse spine fusion product and the conflicts of interest that appear to have facilitated its approval and adoption, the Milwaukee Journal Sentinel‘s John Fauber has the latest on high-profile sniping between two top orthopedic surgeons over the Spine Journal‘s recent Infuse issue devoted to the many complications and conflicts of Infuse.
The combatants in this case are frequent Fauber target and University of Wisconsin-Madison orthopedic surgeon Thomas Zdeblick, who has received $23 million from Medtronic since 2002, and Stanford orthopedic surgery professor and Spine Journal editor-in-chief Eugene Carragee, the Iraq veteran whose research helped spark the recent push against Infuse.
The showdown began with Zdeblick’s defiant response to the Spine Journal‘s Infuse research, a letter which included an apparent attempt to discredit Carragee’s review because the surgeon wasn’t performing the elective spine fusion surgeries while he was serving with the American military in Iraq. In response, Carragee says he took no extended leaves of absence during the period covered in his study. For the record, Carragee’s second tour of duty in Iraq was cut short in 2008 after he was injured in an attempted suicide attack.
The full text of Zdeblick’s initial letter and the response of Carragee and his co-authors has been published online, and the medical community has rallied around the decorated veteran.
In an email to the Journal Sentinel, Charles Rosen, president of the Association for Medical Ethics, was sharply critical of Zdeblick’s letter.
“Zdeblick’s assertions are so nonsensical that the whole letter strikes me more like the ravings of a guilty man who’s been cornered,” said Rosen, a clinical professor of orthopedic surgery at the University of California, Irvine.
Fauber’s review included a particularly tidy summary of the overall Medronic fracas, and I have included his wrapup below the fold in case anyone still needs to get up to speed on the issue.
The war of words is part of the surging criticism of Medtronic-funded research involving Infuse, which has annual sales of about $700 million.
In May, Carragee’s sterility paper was published.
Less than a month later, a U.S. Senate committee launched an investigation into reports that doctors with financial ties to Medtronic were aware of serious complications with Infuse yet failed to reveal those problems in medical journal articles.
Then last week, the Spine Journal devoted an entire issue to Infuse complications that were not reported and linked to the product in 13 papers written by those doctors – including some co-authored by Zdeblick – and published over the course of nearly a decade.
Among those complications: uncontrolled bone formation and the need for additional surgery; life-threatening inflammation; infections; implant movement; cancer risk; and effects on nerves leading to radiating leg pain, bladder retention and a complication that causes sterility in men.
The sterility paper, Senate investigation and Spine Journal review all were prompted in part by Journal Sentinel investigations about Infuse and the financially connected doctors, reports that were published over the past year and a half.