An independent, dual review, found that Medtronic’s InFuse® product provided limited benefits. The bone graft product was also found to cause potential harm, including a small increased risk of cancer and works no better than traditional bone grafts, according to the review.
The U.S. Food and Drug Administration (FDA) approved InFuse® in 2002 for use in fusing damaged vertebrae in the lower spine; InFuse® was not approved for use on the upper, or cervical, spine, where it is now widely used, according to Bloomberg Businessweek. In fact, the FDA released a July 1, 2008 notification warning that the InFuse® bone graft had been associated with serious complications, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing, and nerve damage, when used in cervical spinal fusions.
As we’ve long been following, Medtronic commissioned Yale University researchers to conduct independent studies of its InFuse® bone graft products, allegedly in response to a June 2011 report The Spine Journal, which charged that Medtronic failed to reveal that InFuse® could cause potentially critical complications.
The U.S. Senate Finance Committee also found problems with most of the initial Medtronic-supported InFuse® research used to promote the product. Doctors and researchers who authored at least 11 medical journal reports about InFuse® were paid about $210 million in royalties and consulting fees, according to Bloomberg Businessweek. Senate investigators also charged that Medtronic deliberately manipulated studies to mitigate any adverse reactions to InFuse® side effects, as well as to promote off-label use.
“This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” Dr. Harlan Krumholz, professor of medicine at Yale University, 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.
“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.”
Dr. Harlan Krumholz let the Yale University Open Data Access project which involved researchers at both the Oregon Health & Science University in Portland and at Britain’s University of York, according to Reuters.
The new analyses was just published in the Annals of Internal Medicine, and suggests that InFuse® was associated with a small, increased cancer risk and that InFuse® trials underreported side effects while touting favorable results, according to Reuters. Doctors writing in an editorial in the journal said that InFuse® should be used for specific patients; costs and risks should be thoroughly discussed.
In addition, 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, according to Reuters. “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. University of York researchers 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 those patients whose surgery would mandate multiple incisions for bone harvesting, according to an editorial written 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.”