Medical Journal Blasts Medtronic Infuse Bone Graft Data over Alleged Bias

New York, NYA review article published on Tuesday in The Spine Journal is sounding the alarm over data on Medtronic’s Infuse Bone Graft. Co-authored by three US-based physicians, the article states that in 13 trials which included 780 patients, industry funded researchers failed to report a single adverse event involving Infuse.

The journal article reportedly goes on to state that the authors of nearly all the trials had financial ties with the manufacturer, with investigators earning as much as $26 million per study.

The lack of adverse events reported is in sharp contrast to data the FDA has, which include at least 38 reports of complications associated with recombinant human bone morphogenetic protein (rhBMP). In 2008, the FDA issued a public health warning regarding life-threatening complications associated with the product.

The article in The Spine Journal follows only days after a Senate Finance Committee initiated an inquiry into the fees doctors receive from Medtronic and whether or not those physicians reported or failed to report associated adverse events.

Launched in 2002, Medtronic’s Infuse has reportedly been used in roughly 500,000 patients who underwent spinal surgery.