In 2009, when researchers were preparing to publish findings from a pivotal trial of a novel spinal fusion product, they discovered that the number of cancer cases among patients treated with bone morphogenetic protein-2 (BMP-2) had crossed the threshold for statistical significance -- but they chose to omit this information from the manuscript.
Medtronic, the company that paid for the study, was also aware that cancer had gone from a non-significant adverse event affecting eight patients, to a small, but significant side effect seen in nine patients. But it, too, said nothing.
That silence constitutes an ethical breach, according to independent researchers, but it is only the latest controversy revealed during an ongoing investigation by the Journal Sentinel/MedPage Today into the relationship between a group of prominent spine surgeons who have been paid millions by Medtronic. MedPage Today
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