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Senators Expand Inquiry Into Medtronic Spinal Product, Royalty Payments

Financial ties in the drug and device industry have been the subject of our reporting—and growing congressional scrutiny—for some time now, but a letter from lawmakers to device-maker Medtronic suggests that investigators are now taking a closer look at how those financial interests played out in medical literature.

In a letter sent Tuesday by Sen. Charles Grassley, R-Iowa, and Sen. Max Baucus, D-Mont., lawmakers expressed concern that doctors with financial ties to Medtronic downplayed serious complications with Infuse—Medtronic’s blockbuster spinal bone-growth product—in medical journals. (Other companies produce similar products, but Medtronic leads the market, the Minneapolis Star Tribune has noted.)

Since Infuse was first approved by the Food and Drug Administration in 2002 for use in spinal fusion surgeries in the lower back, the bone-growth protein has been linked to male infertility, unwanted bone growth, and other complications.

The Milwaukee Journal Sentinel, which has reported extensively on Minneapolis-based Medtronic, noted the following about the disclosures—or lack thereof—regarding some of these complications:

Last month, the Journal Sentinel reported that since 2002, Medtronic and a group of doctors with financial ties to the company were aware that Infuse was linked to sterility in men.

But that crucial information was not revealed in medical journal articles written by those doctors, including surgeons who would receive millions of dollars in various royalties from Medtronic.

A Journal Sentinel analysis found that last year alone, Medtronic paid more than $6 million in royalties to a handful of doctors who, over the last nine years, co-authored several Infuse papers without cautioning that it was linked to male sterility. None of the royalty payments was for Infuse.

The letter from the lawmakers [PDF] requested documents of communications between Medtronic and clinical investigators, medical journals, physician consultants and the FDA that pertain to complications with Infuse.

Medtronic has received prior inquiries from Grassley that probed its financial ties with clinical investigators. As we noted, Grassley released a redacted disclosure form that showed some clinical investigators had financial interests tied to the outcome of the study or the product being tested.

The company told us at the time that conflicts of interest are “mostly perceived,” and that it adopted a new policy last year restricting the role of royalty-earning physicians in clinical trials. Under the new policy, physicians receiving royalties on a Medtronic product or receiving payments for consulting services may still write about their product. They’re also still allowed to serve as clinical investigators for Medtronic products for which they don’t receive royalties.

The company told the Journal Sentinel that it will respond to the lawmakers’ latest request. A Medtronic spokeswoman noted that some of the complications cited in the lawmakers’ letter were included in the FDA labeling for Infuse.

In 2009, a British medical journal retracted an article by a former Army surgeon—and Medtronic consultant—accused of falsifying research and overstating the benefits of Infuse in a medical journal.

The Justice Department has been investigating the matter as part of a larger probe into whether the company illegally marketed Infuse for uses that were not approved by the FDA, such as on the neck or anything other than a narrow range of lower back vertabrae. According to the Journal Sentinel, about 85 percent of Infuse use is off-label. 

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