Overview: Medtronic Infuse, a product that is used to stimulate bone growth in the spine, has become the subject of controversy in multiple ways. Healthcare professionals are concerned about the detrimental, potentially-deadly side effects and complications that can occur with Infuse, especially when it is used off-label. To make matters worse, evidence suggests that the research used to promote Infuse is flawed, as a recent Senate investigation reveals that Medtronic marketing employees helped write and edit a number of medical studies.
- Medtronic Infuse an artificial bone graft used in the spine; it has been associated with serious complications, especially when used off-label (i.e. used in cervical spine, used in children under 18)
- In June 2011, the Spine Journal dedicated an entire issue to the side effects of Infuse; the report criticized Medtronic-funded research for failing to list side effects such as excessive bone growth, male sterility and cancer
- Last year, a Senate report showed that Medtronic employees ghostwrote medical studies to portray Infuse in a positive light
Product: Medtronic Infuse Bone Graft
Manufacturer: Medtronic, Inc.
Side Effects & Complications
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Medtronic-Funded Research is Flawed, According to Senate Report
According to a report by the United States Senate Finance Committee, Medtronic helped write and edit 11 medical studies promoting Infuse. The report also found that a number of doctors listed as authors in the study received over $200 million in royalties and consulting fees. These financial ties were never mentioned in any of their papers. Furthermore, the Senate report said that none of the Medtronic-funded studies mentioned serious side effects. Although ghostwriting is not illegal, it is considered a serious breach of integrity in the scientific community. Research is used to make important decisions about a patient’s health, and biased opinions can have dire consequences. The studies that Medtronic employees helped write, for instance, portray Infuse as an innovative device with few risks. But other researchers have found otherwise. In fact, a group of spine experts took issue with this and published their findings in the June 2011 edition of The Spine Journal. The researchers pointed out that the Medtronic studies portrayed the device as a new, innovative product that would benefit patients but failed to mention side effects like male sterility, excessive bone growth and cancer. The authors questioned the integrity of the data and industry-funded research altogether.
Doctor Advocates for Non-Biased Research
Naturally, Infuse has been enshrouded in scandal following reports that Medtronic paid doctors to omit side effects from their studies. The company has asked Yale University to conduct an independent review of the product to once again assess its side effects and whether or not it is safe. Dr. Harlan Krumholz, a highly-respected professor of medicine at Yale, is leading the review. “I think that for many people at Medtronic, these episodes are a great source of embarrassment,” he said to Star Tribune. Dr. Krumholz emphasized the importance of neutrality in conducting research, stating that “Time and time again, I have seen instances where the process is not fully independent and, at the end, the science is being commingled with other interests”. Given the evidence that has turned up thus far, many believe that that is certainly the case for Medtronic Infuse.