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Medical device giant, Medtronic, continues to pay millions to doctors who research on a controversial spinal product that has come into question, according to new federal data.

In 2014, Medtronic Sofamor Danek, paid $60.7 million in royalties to 79 doctors and their affiliates. Which includes payouts to the authors of disputed studies of the back pain treatment Infuse, a product responsible for hundreds of injury lawsuits.

Dr. Ken Burkus, a Georgia surgeon and lead author on six studies that omitted adverse events related to Infuse, got $374,000 in royalties last year. Dr. Regis Haid, an Atlanta neurosurgeon who led one of the studies, got $2.3 million. Payments for both were sent to third-party companies; neither returned calls for comment.

Although Medtronic’s propensity for paying royalties is not unique, the Minnesota device maker has become a flash point in a national debate about the role of money in medicine. Altogether, Medtronic paid $90 million in royalties in 2014, more than any other device company in the country.

Dr. Michael Carome of the consumer advocacy group Public Citizen says, “The goal of these types of fees is to influence prescribing behavior. Moreover the payments are, “in the financial interests of the company and the physicians, not the best interest of patients.”

Medtronic disagrees and argues that payments to physicians propel innovations that relieve pain and promote healing. “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,” Medtronic spokeswoman Cindy Resman replied via e-mail.

Royalties paid for patented and licensed innovations make up the largest portion of payments made to physicians at $800 million just last year, according to data included in the federal Open Payments Program. In fact, 7 of the 10 companies or divisions paying royalties in 2014 sell medical devices for skeletal problems.

Medtronic’s bone-growth system Infuse, one of the most controversial devices on the market, has helped thousands of patients suffering with serious back pain but it has also left thousands of others allegedly injured. Medtronic does acknowledge some associated risks.

The public debate over these types of payments is critical, as is federal payment disclosures because they act as a fail-safe in making the right decision for patients. “When you read a paper by a bunch of doctors that reads, “This device is good,” then you might start to use it if you know the research is independent, said Dr. Charles D. Rosen a California spine surgeon and co-founder of the Association for Medical Ethics. “If you find out all the doctors have received royalties and million-dollar consultancies, it doesn’t mean you’re going to rule out the device. But you will think twice because it might be a biased review.” And, that is a good thing.

 

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