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Medtronic Infuse Concerns Prompt Questions from Senators

Dec 19, 2011 | Parker Waichman LLP

Medtronic Inc. is taking more heat over its controversial Infuse bone graft product.  Now, three U.S. Senators are asking questions about Infuse, and want to know if research for the bone growth protein downplayed serious side effects, including cancer, associated with it.

Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery.  However, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion.  The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complication.

In their letter, Senators Charles Grassley, R-Iowa, Herb Kohl, D-Wis., and Richard Blumenthal, D-Conn.  inquire about Medtronic's tracking of safety information for devices once they have been released to the market.  But the Senators also ask specifically about side effects linked to Infuse.

"A researcher at Stanford University School of Medicine found a higher risk of cancer associated with Infuse, and there have been allegations that researchers who received funds from Medtronic, sometimes millions of dollars, did not report negative findings from clinical trials," the letter states.

The researcher mentioned in the letter is Dr. Eugene Carragee, who published a highly critical analysis of Infuse clinical trials in The Spine Journal this summer.  According to the article, Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Then just last month, during a presentation at the  North American Spine Society, Carragee  said a new analysis he performed of another Medtronic clinical trial raised serious concerns about a cancer risk posed by rhBMP-2.  That analysis involved a Medtronic trial for its Amplify product, which contains a higher dose of rhBMP-2.   Earlier this year, the FDA declined to approve Amplify because of its association with cancer. 

In an interview with The New York Times, Carragee said the cancer findings could have serious implications for people receiving Infuse.  Doctors often administered Infuse off-label at levels significantly above the recommended dosages, ones that approach or exceed the amount of rhBMP-2 found in a dose of Amplify, he said.


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