Medtronic remains positive about the Yale study findings, and said that this is a step toward more transparency in its practices. One 2013 lawsuit with several plaintiffs said the company improperly marketed its product and influenced research to sell it. In addition to shareholder lawsuits, people injured by INFUSE also filed lawsuits. Medtronic paid $85 million in 2012 to settle a lawsuit filed by shareholders because the company did not reveal that as much as 85.2 percent of INFUSE sales came from “off-label” uses not approved by the FDA. In fiscal 2013, INFUSE brought in global sales of $528 million, well below the $800 million in fiscal 2011.Īfter the release of this latest study, Medtronic shares fell 1.5 percent, and analysts say the drop could continue, mainly because of cancer link. Sales in recent years are considerably lower. When INFUSE was released in 2002, its sales were nearly $1 billion. “Infuse remains a very important treatment option, and Medtronic is committed to ongoing research to continue to build the body of evidence,” Medtronic Executive Vice President Chris O’Connell told Minnesota Public Radio (MPR). Medtronic told Reuters that it funded “real-world usage” of INFUSE to look into the concerns about cancer risk and results should be released from its analysis in fall of 2013. The findings do corroborate the cancer link found by earlier studies, including those conducted by Carragee’s team. However, the results were not clear and had a broad range of risk from 14 percent lower to 454 percent higher. research teams found slight increases in cancer risk in patients who used INFUSE. INFUSE Cancer Riskīoth the Oregon and U.K. The Yale study also found evidence of a disturbing side effect previously noted in past studies – INFUSE may cause cancer. Rosen said, “It’s like cement around the nerves.” Charles Rosen, a spine surgeon at the University of California Irvine Medical Center not involved in the study, told MedPage Today that in three months he removed excess bone from five people who used INFUSE. Carragee’s Stanford group found that the complication rate was actually 10 to 50 times higher than previously reported.Īccording to Carragee, INFUSE can cause complications like reverse ejaculation and sterility in men, wound complications, difficulty swallowing and breathing that can be fatal when used in the neck and formation of excess bone.ĭr.
Eugene Carragee’s 2011 report published in the Spine Journal.
“We didn’t find that it was any better than doing the typical bone graft.” “There were many more harms reported in the actual data than were reported in many of the publications,” Chou said. The researchers also discovered a troubling finding: biased reporting of the benefits of INFUSE. Study co-author Robert Chou, of the Evidence-Based Practice Center at Oregon Health and Science University, told Minnesota Public Radio (MPR) that his team found no “reason to use this product at this point” for typical low-risk patients. In addition, INFUSE may carry complication risks that doctors will have to carefully weigh in each patient. The doctors never disclosed their ties to Medtronic. In 2012, Bloomberg reported the Senate Finance Committee found that Medtronic “ghost-wrote” portions of medical studies and paid physicians hundreds of millions to promote INFUSE. Eugene Carragee, spine surgeon and editor of the Spine Journal and chief of spinal surgery at Stanford Medical School, said the company promoted the benefits of INFUSE while obscuring its risks.Ĭarragee’s findings spurred a government investigation. Previous studies, including 2011 articles published by Dr. They published their findings in the June 17 issue of Annals of Internal Medicine. The independent groups found no advantage to using the synthetic bone graft despite previous claims that the product was superior to harvesting patient bone. The groups also had access to safety reports provided to U.S. The teams analyzed study data from 17 spinal studies involving more than 2,000 INFUSE recipients. The university worked with two other independent groups – Oregon Health & Sciences University in Portland and the University of York in the United Kingdom. The study was the first in Yale’s Open Data Access (YODA) project headed by professor Harlan Krumholz. After growing controversy surrounding the genetically engineered bone morphogenetic protein (BMP-2), Medtronic CEO Omar Ishrak authorized a $2.5 million grant to have independent researchers from Yale University study the product.
A new study from researchers at Yale University suggests that Medtronic’s INFUSE Bone Graft provides little benefit to traditional spinal fusion treatment and can increase complications.Īccording to Medtronic, more than 1 million people received INFUSE, which grows bone and has uses in spine surgery and facial reconstructive surgery.
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