Tag Archives: The Spine Journal

Medtronic hires Yale researchers to review Infuse data

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Medtronic, the manufacturer of spine fusion product Infuse, has hired Yale University researchers to review patient data and adverse event reports for the product.

spine

Photo by planetc1 via Flickr

The review follows months of reporting by John Fauber for the Milwaukee Journal Sentinel and Medpage Today that have raised questions about the independence of doctors involved in clinical trials for the product.

The Wall Street Journal’s John Carreyou and Tom McGinty also used their paper’s Medicare data stockpile to look at the conflicts of interest and royalty money that drive the popularity of spine fusion treatments whose effectiveness has been disputed.

Serious complications involving Infuse have gone unreported in medical journal articles that were written by doctors who have financial ties to Medtronic.

The June issue of The Spine Journal was devoted to unreported complications related to Infuse, revealing that “complication rates … were 10 to 50 times greater than the estimated complication rates revealed” papers co-authored by doctors with financial ties to the company.

In a statement about the review by Yale researchers, Eugene J. Carragee, M.D., editor in chief of The Spine Journal, says “this appears to be a big first step in the right direction” but points out three challenges that lay ahead for the reviewers.