Medtronic Inc. is funding two independent reviews of studies of its Infuse bone graft in the wake of criticism of the clinical trials it conducted to support the device.
The world's largest medical device company said Wednesday it will provide a $2.5 million grant that will allow Yale University to conduct two independent reviews of the safety and effectiveness of Infuse, which has been on the market since 2002. Medtronic said it will provide Yale with all of the data from the clinical trials it sponsored, and all the side effect reports provided to the Food and Drug Administration.
The Minneapolis company will not participate in the reviews, which are expected to take about six months. They will be available within a year and a half. Medtronic said it will also make all of the Infuse clinical trial data available on ClinicalTrials.gov, and it will help Yale make the data available to researchers through an online registry.
Eugene Carragee, editor in chief of The Spine Journal, which has published articles critical of the company's studies, said that Infuse can be useful for some patients. But he added that "we do not have an accurate assessment of safety in 85 to 90 percent of the people receiving the product."
However, the Medtronic-Yale collaboration is good news, he said.
In late May, The Spine Journal published a study that linked Infuse to a condition that can cause infertility in men. A month later, the journal published an article that suggested some researchers who were involved in previous studies of Infuse did not disclose many serious side effects that were observed in patients. The Spine Journal is the official publication of the North American Spine Society.
The Wall Street Journal reported that 15 surgeons who were involved in the research were paid at least $62 million by Medtronic for other work. The Senate Finance Committee is looking into Infuse.
One industry analyst said Medtronic gets about $800 million in annual revenue from Infuse, which is used in spinal, oral, and dental graft procedures. Infuse contains a genetically engineered protein that can stimulate bone growth. It is used as an alternative to procedures like autologous grafting, where bone is taken from elsewhere in the patient's body. Those procedures can cause lasting pain.
In June, Medtronic Chairman and CEO Omar Ishrak said the second Spine Journal article raised questions about the conclusions the researchers reached in their published reports. However he said he backed the data Medtronic submitted to regulators to gain marketing approval for Infuse.