![]() ![]() The York group echoed the efficacy findings but said that cancer data were inconclusive. More damagingly, the Oregon researchers wrote that rhBMP-2 was associated with an increased chance of cancer, with a 24-month risk ratio of 3.45, although the actual event rates were low. The Oregon group concluded that Infuse had similar rates of successful fusion as iliac crest bone autografting, the gold standard treatment for spinal fusion, in which bone harvested from the hip is used to fix the spine. Under Yoda’s umbrella, Oregon Health and Science University and the University of York reviewed the entire body of scientific evidence regarding the safety and effectiveness of Infuse. Medtronic engaged and funded the Yale University Open Data Access (Yoda) project, an effort to disseminate trial data and improve transparency, to see off this criticism. Two years ago, research was published claiming that complication rates with Infuse were greater than shown in the previously reported medical literature. rhBMP-2 has been linked with adverse events including retrograde ejaculation, radiculitis and cancer. Infuse is a formulation of a synthetic bone growth factor, recombinant human bone morphogenetic protein-2 (rhBMP-2), and is implanted during spinal surgery. Sales were already on a downward trend, and this could well now accelerate. Infuse was approved in the US in 2002 and accounts for 3% of Medtronic’s revenue, bringing in $528m worldwide in fiscal 2013. One study has shown that Infuse is no better than bone grafting and carries an increased risk of cancer, and also reported that the earlier Medtronic-funded Infuse trials were indeed biased. Now the results are in, and they have done no such thing. Consequently Medtronic gave the nod – and $2.5m – to two trials to prove both company and product beyond reproach. In 2011, researchers looking at Medtronic’s spine fusion product Infuse suggested that it was less safe and effective than company-funded research suggested, and furthermore that this research had been biased. The trouble with calling for an investigation to clear your name is, as Oscar Wilde could have told you, that it only works if you’re innocent. ![]()
0 Comments
Leave a Reply. |