June 19, 2013 — The Annals of Internal Medicine has published two studies showing that Medtronic’s Infuse bone-growth protein is no better for spinal fusion surgeries than traditional bone grafts, and may increase the risk of cancer. The conclusions are based on data provided by Medtronic, in an attempt to clear up controversy surrounding the product.
Studies of the Medtronic Infuse bone-growth protein:
- Safety and Effectiveness of Recombinant Human Bone Morphogenic Protein-2 for Spinal Fusion (York, Cambridge, United Kingdom)
- Effectiveness and Harms of Recombinant Human Bone Morphogenic Protein-2 in Spine Fusion (Oregon)
When the Infuse was first sold in 2002, studies showed that it produced superior patient outcomes and had a low risk of side effects. By 2011, more than one million people had been treated with Infuse — often in “off-label” surgeries that were never approved by the U.S. Food and Drug Administration (FDA).
The controversy began in 2011, when The Spine Journal published a series of reports showing that the favorable studies were conducted by researchers whom Medtronic paid millions of dollars in consulting fees, royalties, and more.
Medtronic sought to dispel allegations of wrongdoing by providing $2.5 million to researchers from Yale who studied the data. One team from Oregon found that Infuse provided no clinical advantages over a bone graft, but might increase the risk of side effects like cancer. Another team from Britain found that Infuse was safe and effective, but no better than traditional bone grafts.
Medtronic defends Infuse by pointing out its primary advantage over traditional bone grafts. Traditionally, surgeons harvest bone from another area of the patient’s body (usually the hip) to use in a bone graft. Patients who are treated with the Infuse only need one surgery.