CORRECTION: The original version of this report misstated Sen. Chuck Grassley's role on the Senate Finance Committee.
The chairman and a top Republican on the Senate Finance Committee are asking medical device company Medtronic about medical complications associated with its bone-growth protein in light of an upcoming medical journal study that found doctors who received consulting fees from the company did not report the problems.
According to The Wall Street Journal, Chairman Max Baucus, D-Mont, and Sen. Chuck Grassley, R-Iowa, sent a letter to Medtronic on Tuesday requesting communications and documents relating to Infuse Bone Graft, which is used in spinal surgery. The new study finds that complications with the protein showed up in clinical trials "but went unreported in a dozen research papers about those trials that Medtronic sponsored between 2000 and 2009," the newspaper said.
Infuse Bone Graft was approved by the Food and Drug Administration in 2002 for spinal surgeries that involved fusing together vertebrae in the lower spine but became widely used in other types of spinal surgeries without official agency approval.
Baucus and Grassley's letter expressed concerns that doctors conducting trials knew that Infuse could cause medical complications but failed to report it.
In an e-mailed statement to the newspaper, Medtronic said it provides data about adverse effects that happens during clinical trials to the FDA “irrespective of any financial relationship between the company and the clinical investigator.” The company confirmed receiving the senators’ letter and said it would respond to their request.
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