Independent Reviews: Infuse No Better Than Traditional Bone GraftJun 18, 2013
Medtronic’s Infuse product was found to provide limited benefits, working about as well as traditional bone grafts; it could cause harm, however, given the small increased risk of cancer it carries. These results are based on two independent reviews that were published this week.
In 2002, the U.S. Food and Drug Administration (FDA) approved Infuse for procedures fusing damaged vertebrae in the lower spine; Infuse was not approved for use on the upper, or cervical, spine, where it is broadly used, according to Bloomberg Businessweek. On July 1, 2008, the FDA released a notification warning that Infuse was associated with serious complications when used in cervical spinal fusions; these include excessive swelling in the neck, compressed airway, difficulty breathing, problems swallowing, and nerve damage.
Late last year, the U.S. Senate Finance Committee found problems with most of the initial Medtronic-supported Infuse research used to promote the product. Doctors and researchers authored 11 medical journal reports concerning Infuse and were paid about $210 million in royalties and consulting fees, according to Bloomberg Businessweek. Senate investigators also charged that Medtronic deliberately manipulated studies to minimize information on adverse reactions to Infuse, as well as to promote off-label use.
“Medtronic’s actions violate the trust patients have in their medical care,” Senator Max Baucus, a Montana Democrat and Committee chairman, said in a statement at the time, according to Bloomberg Businessweek. “Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.”
“This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” Dr. Krumholz told MedPage Today when advised of the Senate report. “It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit. It’s no wonder the public has lost confidence in the drug and device industries,” Krumholz added at the time.
Medtronic commissioned Yale University researchers to conduct independent studies of its Infuse products, allegedly in response to a June 2011 report by industry journal The Spine Journal. According to the report, Medtronic failed to reveal that Infuse could potentially cause critical complications.
The two, long-awaited independent reviews of Medtronic’s trial data were led by Dr. Harlan Krumholz, professor of medicine at Yale University, as part of the Yale University Open Data Access project. Two research teams—from Oregon Health & Science University in Portland and at Britain's University of York—conducted the reviews, according to Reuters.
The new analyses were published this week in the Annals of Internal Medicine and suggest that Infuse was associated with a small, increased risk of cancer; they also found that the initial Infuse trials underreported side effects and touted favorable results, according to Reuters. Doctors, in an editorial for the journal, said Infuse should be used for specific patients and its costs and risks should be thoroughly discussed.
The Oregon researchers discovered that, when used in spinal fusion procedures, Infuse worked no better than traditional fusion surgery in which bone is harvested from the patient’s body—specifically, the patient’s hip, which is called an iliac crest bone graft, according to The Star Tribune. “The review also found ‘substantial evidence of reporting bias’ in the previous studies on the product,” officials at Oregon Health and Science University said in a statement. “The review found that Medtronic-sponsored publications analyzed or reported results in biased ways to indicate that it was more effective,” they added, according to The Star Tribune. Researchers from the University of York discovered that, after two years, Infuse did not offer any clinically important pain reduction, Reuters stated.
The research findings suggest that Infuse should be used as an alternative for patients requiring multiple incisions for bone harvesting, according to an editorial by Dr Daniel Resnick of the University of Wisconsin and Dr Kevin Bozic of the University of California, San Francisco, Reuters reported.
“The take-home message from this debacle … is that the public needs better safeguards against conflicted and tainted medical research,” said Dr. Eugene Carragee, editor-in-chief of the Journal, according to The Star Tribune. “At present, Medtronic-sponsored surgeons may have to finally retire the line that ‘this product is completely safe, don’t worry about it,’ but I would not count on it.”