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.
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.