Medtronic Violates Patient Trust with Infuse Product Research

In 2011 a U.S. Senate committee began an investigation into reported financial ties Medtronic had to doctors that wrote influential journal articles. In 2011, the Spine Journal published an entire volume on misleading Infuse research. In the editorial (link here), “A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth” the authors noted that none of the articles with financial ties to Medtronic had accurate adverse event report numbers.

Now it appears we have a reason why those adverse events went unreported. The Senate Finance Committee report (link here) found Medtronic was heavily involved in writing and editing the content of 13 influential medical journal articles. The Committee said that Medtronic failed to disclose its role in influencing these articles. The Senate report found that the physicians who wrote these articles were compensated a total of $210 million for supposedly unrelated work, although in some instances the work appears closely aligned. For example, one doctor received $34 million from Medtronic for patents. According to the Wall Street Journal some of those royalties were for a device that Infuse is encased in when it is inserted into the spine.

The Committee findings raise serious questions about the integrity of the scientific findings that support using Infuse. Doctors cannot make an informed decision if the company manufacturing the product is also influencing supposed independent research.

Senate Finance Committee Chairman Max Baucus said it best in stating, “Medical-journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.”