Analysis Questions Tests of Bone Growth Product Used in Spine Surgery
The product in question -- Medtronic's Infuse -- is a bioengineered bone growth material used in about 25% of the approximately 432,000 spinal fusions performed in the U.S. annually.
Although the product is approved for only one specific type of spinal fusion, physicians legally can use it for various other fusion procedures.
The Spine Journal devoted an entire issue to its review of the Infuse studies. Leading medical journal editors -- including the editors of the Journal of the American Medical Association and the New England Journal of Medicine -- say this may be the first time an entire issue of a medical journal challenged an approved product, the Times reports (Meier/Wilson, New York Times, 6/28).
Spine Journal Review Identifies Unreported Complications
According to an analysis led by Spine Journal editors, 13 studies of Infuse failed to report serious complications associated with the drug. Specifically, the analysis found that complication rates were 10 to 50 times greater than reported in the original studies (Fauber, Milwaukee Journal Sentinel/MedPage Today, 6/28). Â
However, the Times notes that Medtronic reported possible complications to FDA, which then required the company in some cases to include them on Infuse's label (New York Times, 6/28).
In addition, the Spine Journal reported that Medtronic paid researchers involved in the 13 studies a median of $12 million to $16 million per study. However, the authors' conflicts of interest were unclear or not reported.
According to the analysis, the failure to report complications could be placed on medical journal editors and reviewers, researchers' financial tiesÂ andÂ insufficient FDA oversight (Milwaukee Journal Sentinel/MedPage Today, 6/28).
Medtronic CEO Omar Ishrak said, "Integrity and patient safety are my highest priorities," adding that the company remains "committed to ongoing study of the safety and efficacy of [Infuse], especially in applications not covered by FDA labeling."
However, he said that "the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold."
Ishrak added that Medtronic "will continue to investigate questions surrounding researchers' potential conflicts of interest, refine our policies as warranted, and strive to lead the industry in ethical and transparent business practices" (Medtronic release, 6/28).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.