A Yale University report concerning the bone graft product Infuse® is expected out next month.
Device maker, Medtronic, commissioned Yale University researchers to conduct independent studies of its Infuse® bone graft products, allegedly in response to a June 2011 report by industry journal, The Spine Journal, charging that the company failed to reveal that the bone graft product could cause potentially critical complications. U.S. Food and Drug Administration (FDA) warnings and a U.S. Senate investigation into Medtronic’s Infuse® practices have also plagued Medtronic.
“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.
The results of the Yale-commissioned review of Medtronic’s Infuse® products will be released in June, according to a recent HealthPointCapital report.
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.
“We look forward to the release of the Infuse study by Yale University,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “At the very least it should be quite revealing to see what an independent report on these potentially dangerous products has to say.”
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 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.
“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, 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.”