Senators Demand Info on Medtronic Infuse Studies, Payments to Researchers

Two U.S. Senators have demanded that Medtronic Inc. turn over records detailing payments made to doctors who conducted research on its <"">Infuse bone growth product. Senators Max Baucus (D-Montana) and Charles Grassley (R-Iowa) made the demand in response to reports that Medtronic-paid researchers may have hidden serious Infuse side effects in their published articles.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.

According to The New York Times, the Senators’ query to Medtronic was prompted by a study set to be published in a spine journal that asserts some of the 13 Medtronic-sponsored Infuse studies published between 2000 and 2009 had failed to properly disclose complications. The authors of those papers had been paid millions of dollars in fees by Medtronic.

In their letter to Medtronic, Senator Baucus, the chairman of the Senate Finance Committee, and Senator Grassley, the committee’s ranking Republican, listed three specific side effects: abnormal bone growth, swelling in the neck and throat, and a form of sterility. Among other things, the letter points to an article published last year by the Milwaukee Journal Sentinel which reported that a Medtronic-funded study published in 2004 found that 75% of BMP-2 patients experienced the abnormal bone growth problem, yet the study authors concluded that ‘although not desirable,’ the bone growth “did not appear to have an ill effect on the patients.” By contrast, a separate 2008 study conducted by physicians without financial ties to Medtronic reported that “neurological impairment occurred” in five patients who had the same ectopic bone formation, the Senators wrote.

They also cited a New York Times report on a recent study that “found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft.” As we reported previously, an earlier Medtronic-paid study had failed to mention the side effect, as the researchers attributed it to surgical technique. The researchers who conducted the earlier study had received millions from Medtronic.

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.

As we’ve reportedly previously, the Infuse product has had a controversial history. In July 2008, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar products had caused serious and potentially life-threatening problems when they were used off-label in cervical spine (neck) surgeries. In 2009, a surgeon at the U.S. Army’s Walter Reed Hospital was accused of falsifying data for Medtronic-paid Infuse study involving wounded soldiers. That same year, questions were raised concerning another Infuse study at Walter Reed, and whether soldiers involved in it had given informed consent before spine surgery.

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