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Yale Releases the Findings of the Medtronic-Commissioned Infuse Bone Graft Study; Parker Waichman LLP Comments
Date:6/18/2013

the Milwaukee-Wisconsin Journal Sentinal’s website.

And while Medtronic’s product did fuse spinal vertebrae more quickly than a traditional bone graft, the speed factor “appeared to lack clinical relevance,” according to the other team, led by researchers from the University of York in England, as the New York Times article reported.

Dr. Harlan M. Krumholz, a Yale professor who oversaw the review, noted that while the two teams’ findings slightly varied, they still pointed in the same direction. “The general, overall picture is that they failed to find a big benefit” for Infuse, Dr. Krumholz told the New York Times. “And they found there might be some harms.”

“The research released this week on Medtronic’s Infuse is revealing,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “There may be no real advantage to using Infuse, except for the speed factor. At the same time there is a possibility that Infuse may cause cancer or, if you’re a male, sterility.”

Medtronic approached Yale University researchers after a June 2011 study published in The Spine Journal disclosed that Medtronic-paid researchers had failed to report serious potential complications from use of Infuse bone graft products in spinal surgery.

In addition, as noted in an Oct. 25, 2012, Bloomberg Businessweek report, the U.S. Senate Finance Committee found problems with most of the initial Medtronic-supported Infuse research used to promote the product. The article noted that doctors and researchers who authored at least 11 medical journal reports about Infuse were paid about $210 million in royalties and consulting fees. Senate investigators also charged that Medtronic deliberately manipula
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