Spine Journal Dedicates Latest Issue to Infuse Controversy
BY LAUREN UZDIENSKI, JUNE 29, 2011
The backlash against Infuse is escalating this week with the announcement that the Spine Journal would dedicate its June issue to bias in published data on Infuse. In addition to highlighting the under-reporting of adverse events, the journal argues for improvements in transparency and disclosure requirements in the scientific literature.
The issue features a scathing editorial as well as multiple new studies on the risks of Infuse. Notable, one review demonstrated that authors with financial ties to Medtronic reported 10 to 50 times fewer complications with Infuse than were found in the original FDA summaries or other documents. The New York Times quotes the Spine Journal in reporting that the median amount of money paid to researchers affiliated with Medtronic ranged from $12 million to $16 million, with most of that going to a few individuals. Another review suggested that Infuse may contribute to root irritation, a condition of the central nervous system that can cause pain. A new clinical study suggested that using "patient pain" as a reason not to take iliac crest autograft may be overstating the "severity and frequency" of this risk. Finally, additional clinical data showed a substantial rate of osteolysis in Infuse patients that does not resolve (54% early incidence rate, 41% at one to two years).
In the issue's editorial, Dr. Eugene Carragee et al note that Infuse has come to be associated with inflammatory reactions, cancer, osteolysis, infection, implant dislodgement and sterility, despite the fact that the earliest Infuse reports claimed not a single adverse event among 780 protocol patients. The Spine Journal is making its own transparency process more rigorous, promising a number of editorial, procedural and disclosure-related changes to be announced in upcoming issues. The paper concludes, "It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual."
Medtronic released a statement last night in response to the Spine Journal, wherein new Chairman and CEO Omar Ishrak says that "integrity and patient safety" are his priorities. Further, he emphasized that whatever the conclusions of a given published paper, Medtronic's submissions to the FDA were complete and the labeling accurately reflects instructions for use and potential adverse effects.
