US bone-growth studies under fire for alleged bias

WASHINGTON — A US medical journal on Tuesday published a scathing critique of industry-funded studies on spine research, alleging that they failed to report adverse events to the journals that publish them.The review study came days after the Senate Finance Committee launched an inquiry into whether doctors being paid by device giant Medtronic failed to report serious side effects from the bone-growth agent Infuse in clinical studies.The product was introduced in 2002 to help bones heal after spinal surgery and has been used in about 500,000 patients. Since its arrival on the market, it has also been linked to some cases of cancer, male sterility, throat swelling and leg pain.A Loyola University spokesman told AFP that some doctors in the spinal community believe that a "small number, fewer than five" fatalities may have resulted from its use, though no published data points to any deaths.The review article co-authored by three US-based doctors in The Spine Journal says that in 13 trials involving 780 patients, "industry-funded researchers did not report a single adverse advent involving Medtronic's Infuse Bone Graft."Meanwhile, the authors of "nearly all the trials had financial ties with the manufacturer, with investigators earning as much as $26 million per study," the journal reported.The product brings in about $900 million in annual revenues for Medtronic, according to US media.In 2008, the US Food and Drug Administration issued a public health notice about "life-threatening complications" associated with the product, also known as recombinant human Bone Morphogenetic Protein (rhBMP), when used in the upper or cervical spine."FDA has received at least 38 reports of complications during the last four years with the use of rhBMP in cervical spine fusion," the agency said at the time."These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing o

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