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Senators Asking Questions about Medtronic Infuse Studies

Jun 22, 2011 | Parker Waichman LLP

Medtronic is facing more scrutiny over its Infuse Bone Graft product.  Senator Max Baucus (D-Montana), the chairman of the Senate Finance Committee, and Senator Chuck Grassley (R-Iowa), the committee's ranking Republican, want to know about payments the device maker made to doctors who published Medtronic-funded Infuse studies.

According to a New York Times article, the Senators' questions come a week before a spine journal is set to publish a study which found that some Medtronic-funded research published between 2000 and 2009 may have hidden serious side effects associated with the bone growth product.

“Reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling,” Senator Baucus said in a statement. “We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits."

The Senators asked Medtronic to provide "all documents and communications pertaining to adverse postoperative events and/or medical complications relating to the use" of Infuse, including emails and letters between Medtronic and the surgeons who conducted Infuse clinical trials.  The letter also seeks "detailed account payments" made to the doctors, including when the payments were made, their amounts, and what they were for.  Medtronic has until July 11 to respond.

In their letter to Medtronic, the Senators' listed three specific side effects:  abnormal bone growth, swelling in the neck and throat, and a form of sterility.

A Medtronic spokesperson told the Times that the company will cooperate with the Senators' requests, but also noted the three side effects mentioned in the letter were all listed as side-effect warnings on the Infuse product label.

Infuse is made from recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  It is approved for treating degenerative Disc Disease and open fractures of the tibia, and for use in certain dental procedures.  In the past, it has also been used in cervical spin surgeries, though it is not approved for that use.

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