Meanwhile, the physicians who have been criticized by Carragee and his team have denounced the The Spine Journal reports, blasting them as inaccurate. An official of Medtronic did not respond to a HealthLeaders Media request for comment, but the company's chairman and CEO, Omar Ishrak, issued a statement that "integrity and patient safety are my highest priorities," according to The New York Times.
Recently, there have been a back-and-forth series of letters – and attacks – that is nothing short of astounding. These aren't politicians. These are physicians. The media has described The Spine Journal's across-the-bow commentaries as unprecedented, but Carragee says he and his colleagues are just doing what they have to do. He has an easygoing demeanor and laughs a lot. He wants to right what he perceives as wrongs.
Carragee says The Spine Journal anticipates publishing more reports on clinical trials in an effort to improve "transparency in medical reviews published in journals that he says is long overdue.
A few years ago, Medtronic received approval to use Infuse for bone growth use in what Carragee called a "narrow indication" from the Food and Drug Administration. Since then, "there has been an explosion of use off-label," Carragee says. "There weren't complications listed in multiple papers from the industry. That was a red flag; that was not credible," he adds.
"By 2009, we started looking at it. We certainly weren't the only people thinking something pretty weird was going on," Carragee says.