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November 27, 2014

Senate panel says Medtronic edited clinical studies to tout spine product

A new report from a U.S. Senate committee alleges Fridley-based Medtronic Inc. was “heavily involved in drafting, editing and shaping the content of medical journal articles” to downplay the risks of its controversial Infuse bone graft product used in spinal surgery, the Wall Street Journal reports.

Investigators reviewed more than 5,000 internal documents subpoenaed from the medical device maker relating to 13 studies of Infuse. The report claims Medtronic paid physician authors of company-sponsored studies about $210 million in royalties and consulting fees over 15 years, Reuters reports. Those sponsored studies failed to mention complications from the product, including male sterility, an increased risk of cancer, infections, bone dissolution and worsened back and leg pain.

“Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events,” the company said in a news release.

The Star Tribune reports the Senate inquiry stems from allegations in June 2011 that “physician authors who had financial ties to Medtronic failed to report dangerous side effects associated with Infuse. These dangerous side effects were subsequently reported by medical researchers that did not have financial relationships with the company.”

Steven Miles, professor for bioethics at the University of Minnesota, tells WCCO-AM such practices are endemic in an industry with very little oversight. “At some point, what we are going to have to do is as a country is require that all raw data from every study to be public data so that re-analysis of every claim that is made can be fairly evaluated,” Miles said.

Click here, for the full report on “Medtronic’s Influence on Infuse Clinical Studies” by the U.S. Senate Finance Committee. Below are the panel’s findings:

* Medtronic was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic. The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles. Medical journals should ensure industry role contributions be fully disclosed.

* Medtronic paid a total of approximately $210 million to physician authors of Medtronic-sponsored studies from November 1996 through December 2010 for consulting, royalty, and other miscellaneous arrangements.

* An e-mail exchange shows that a Medtronic employee recommended against publishing a complete list of adverse events possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.

* Medtronic officials inserted language into studies that promoted InFuse as a better technique than taking a bone graft from the pelvic bone (autograft technique) by emphasizing the pain of the autograft technique.

* Documents indicate that Medtronic prepared Dr. Hal Mathew’s remarks to the U.S. Food and Drug Administration (FDA) advisory panel meeting prior to InFuse being approved. At the time, Dr. Mathews was a private physician but was hired as a vice president at Medtronic in 2007.

* Medtronic documents show the company unsuccessfully at- tempted to adopt weaker safety rules for a clinical trial studying InFuse in the cervical spine that would have allowed the company to continue the trial in the event that patients experienced severe swelling in the neck.