Data available through the federal Open Payments database show that device maker Medtronic continues to pay millions of dollars to doctors whose research on the InFuse spinal fusion device has been called into question.
Medtronic’s spine division, Medtronic Sofamor Danek, paid $60.7 million in royalties to 79 doctors and their affiliates in 2014, according to data released last month. That includes money that went to the authors of disputed studies of InFuse, a product that is the subject of thousands of patient injury lawsuits, the Minneapolis Star Tribune reports. Dr. Ken Burkus, a Georgia surgeon and lead author on six studies that omitted adverse events related to InFuse, received $374,000 in royalties last year. Dr. Regis Haid, an Atlanta neurosurgeon who led one of the studies, got $2.3 million. Medtronic paid $90 million in royalties last year, the most of any device company.
Royalties paid for patented and licensed innovations make up the largest slice of payments to doctors, $800 million last year, according to data released under the Open Payments program. Such payments have put Medtronic at the center of the debate about the role of money in medicine, the Star Tribune reports. Dr. Michael Carome, who directs health research for the advocacy group Public Citizen, says, “The goal of these kinds of fees is to influence prescribing behavior,” and they are “not in the best interest of the patients.” But Medtronic officials argue that payments to physicians spur innovations that help patients. Medtronic spokeswoman Cindy Resman said in an e-mail, “When a new technology is used to improve care and outcomes for a large number of patients, it makes sense for a physician to benefit from their inventive contributions.”
The InFuse bone growth system is used in surgery to treat serious back pain; it incorporates synthetic human bone protein. InFuse received Food and Drug Administration approval for use in lower-back procedures, but it has been widely used “off-label” to fuse vertebrae in the upper (cervical) spine. The scrutiny of InFuse has focused on how Medtronic paid authors and then, according to e-mails released by the Senate Finance Committee in 2012, edited their journal articles to make InFuse seem safer and less painful than other techniques to fuse vertebrae through spine surgery. In 2011, in a special issue devoted to InFuse research, Spine Journal said the research failed to report serious complications, including male sterility, infections, increased cancer risk, bone dissolution, and worsened back and leg pain, according to Reuters.
A December 2014 retrospective report from the North American Spine Society says many patients undergoing spinal fusion do not need bone-growth protein. This includes healthy people who are only getting two lower vertebrae fused, most pediatric patients, and patients getting routine fusions of neck bones, according to the Star Tribune.
More than 6,000 patient-injury claims have been filed in court or are awaiting filing, securities filings say. The Star Tribune reports that Medtronic has paid an average $23,000 per case to settle 950 cases, and the device maker has set aside another $140 million for future legal costs.