Amidst allegations of omission of known safety issues during clinical trials and promotion of off-label use, Infuse Bone Graft, a product from Medtronic, is under investigation by the U.S. Senate and the Department of Justice. Infuse is a bone graft that contains a bone growth protein, designed to stimulate bone formation. The June issue of Spine Journal focused solely on growth products and the potential dangers of their use. Spine Journal reported that surgeons being paid by Medtronic did not report their findings of serious side effects from the use of Infuse including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. Data reported in the journal stated that complications occurred in 10% to 50% of patients included in 13 clinical trials run by Medtronic between 2000 and 2010.
Since the publication of the June issue of Spine Journal, even more findings have come to light. The editor-in-chief of Spine Journal and the author of the article focused on the previously unreported risks of Infuse and reports that a new study shows a better quantified link between Infuse and pancreatic, breast, and prostate cancer. The author, Dr. Eugene Carragee, recently presented findings that people had a 2.5 times great risk of developing cancer one year after Infuse was used and a five times greater risk after three years. Dr. Carragee is quoted as saying, “Almost certainly this is cancer promoting and not a carcinogenic.”
Off-label use of Infuse is also a concern. The current U.S. Department of Justice investigation includes an inquiry into whether or not Medtronic promoted the off-label use of Infuse. Infuse is currently only approved for use in some spinal fusion surgeries and dental procedures.
Medtronic has already started to feel the financial hit of the Spine Journal article. Infuse sales dropped 17% after the article’s publication. Even with this drop in sale, it is estimated that Infuse brought Medtronic sales of $750 million to $800 million in fiscal 2011.