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Doctors tied to manufacturer report better outcomes, may influence spinal surgery

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After using a FOIA request to obtain documents the Food and Drug Administration had labeled “confidential,” Milwaukee Journal Sentinel reporter John Fauber has found that conflicts of interest may have played a role in the outcomes of clinical trials for Medtronic’s much-debated spinal fusion product BMP-2.

In a review of the study’s summary data for the newspaper, researchers at Dartmouth-Hitchcock Medical Center found 91 of the 364 patients in the trial – 25% – were implanted by surgeons who had a financial connection with Medtronic. Those doctors reported an 80% overall success rate, compared with 63% for doctors with no ties to the company.

Fauber also notes Medtronic’s response, which was to simply point to comments the company had made for a previous Fauber story.

At the time, [Medtronic spokeswoman Marybeth Thorsgaard] said the company fully disclosed the success rates of the doctors with financial ties to the company to the FDA. She noted that those doctors also had better results with the patients in the trial who did not get BMP-2.

In a companion story Fauber writes that, much like in the clinical trials, the journal articles published to push BMP-2 (and its off-label use) were riddled with conflicts of interest. One of his sources even called one article “egregious” for “blowing off” complications.

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Bloomberg’s Peter Waldman and David Armstrong write about the “national boom in costly fusion surgeries” and how “surgeons have prospered from performing fusions, which studies have found to be no better for common back pain than physical therapy is – and a lot more dangerous.” The pair also look at Medtronic’s payments and other ties to doctors who perform the surgery, as well as some of the risks of the surgery.

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

WSJ details conflicts that drive spine fusion surgery

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The Wall Street Journal‘s John Carreyou and Tom McGinty have taken advantage of their paper’s Medicare data stockpile to look at the conflicts of interest and piles of royalty money that drive the popularity of spine fusion treatments whose effectiveness has been disputed. Their work centers on Medtronic, which the Milwaukee Journal Sentinel‘s John Fauber also has written about.

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Photo by planetc1 via Flickr

For surgeons, the financial incentives to perform spine fusions can be strong. Though hospitals often lose money on the procedure when it’s performed on Medicare patients due to the high cost of the implants, the surgeons themselves can get paid as much as $12,000 per surgery.

Complex fusions … are reimbursed by Medicare at a sharply higher rate than decompressions, to account for the elaborate spinal devices used and the longer length of surgery. Complex fusions increased 15-fold among Medicare beneficiaries with spinal stenosis from 2002 to 2007, according to the JAMA study.

A big part of many surgeons’ income lies in their consulting and royalty arrangements with device makers, although disclosure of these arrangements remains piecemeal for now. Medtronic began releasing information about its payments to surgeons on its website in June, after coming under intense scrutiny from Sen. Charles Grassley (R., Iowa).

They’re required to keep some details under wraps, but the WSJ duo still manages to unleash anecdotes, including one about a surgeon who received “between $400,000 and $1.3 million in royalty, consulting and other payments from three spine-device makers.”

For reporters looking to understand the medical issues surrounding these procedures and why these conflicts can be detrimental to patients, see Janet Moore’s work in the Star Tribune.

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.