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Medtronic Infuse Disclosures Put Medical Journals in Spotlight

Jul 5, 2011 | Parker Waichman LLP

Some medical journals are facing fire again over their conflicts-of-interest policies in the wake of the latest Medtronic Infuse scandal.  The latest Medtronic Infuse controversy indicates that many prestigious medical journals aren't doing enough to spot obvious financial bias.

Last week, The Spine Journal published an entire issue dedicated to Medtronic’s Infuse product, a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery.  One of the articles included in the issue asserted  that in 13 Medtronic-funded studies  conducted between 2000 and 2010, side effects – including male sterility, infection, bone loss and unwanted bone growth - occurred 10 to 50 times more than what was stated in the final, peer-reviewed published articles.  According to that study, every large Infuse study involved at least one researcher who received at least $10 million in royalties from Medtronic.

Over the past several years, medical journals have made a lot of noise about beefing up their financial disclosure policies.  But according to a report from ProPublica, the information provided by these disclosures is often less than complete.  For instance, the New England Journal of Medicine, Journal of the American Medical Association, and the Annals of Internal Medicine use the same disclosure form developed in 2009 that that requires authors to disclose what types of payments they've received, but they don’t need to reveal how much they’ve been paid, ProPublica said. And while they must name the companies paying them, authors do not have to identify the drugs or devices that relate to the payments.

By contrast, The Spine Journal requires dollar amounts to be reported within ranges and makes the information available to readers.

Eugene Carragee, a professor of orthopedic surgery at Stanford University and editor of the Spine Journal told ProPublica readers "absolutely" need to be informed of the dollar amounts that doctors are receiving from industry.

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