Spinal Tap: Reviews Question Benefit Of Medtronic Spinal Product

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As the result of an unusual effort designed to bolster transparency in clinical trials, two independent analyses have found that a used as a bone graft substitute in fusion surgeries offers little over conventional procedures and may be linked to an increased risk of cancer as well as the possibility of sterility in men.

Beyond the findings, the significance of these analyses is that they were funded by Medtronic (MDT), which was widely criticized after reports disclosed that doctors with financial ties to the device maker were aware of serious problems with the Infuse spinal fusion product, but never disclosed potential health complications in articles in medical journals. Their articles greatly boosted usage, including off-label use (see this and this).

The conflicts not only prompted an investigation by the US Senate Finance Committee, but an entire issue of The Spine Journal was devoted to reviewing 13 studies previously published elsewhere and discovered that side effects were downplayed or omitted. As a result, Medtronic agreed to provide the Yale University Open Data Access Project with patient-level data for independent review.

The publication “heralds a historic moment in the emerging era of open science,” according to an editorial in The Annals of Internal Medicine, which published the two . “The YODA project seeks to address the problem of unpublished and selectively published clinical evidence. Nearly half of clinical trials are never published and many that are have long delays in publication.”

“…Amid the current dialogue about open science in medicine, few imagined that such a prominent company would voluntarily make available all of its internal patient…Read more

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