Journal Questions Integrity of Medtronic Infuse StudiesJun 29, 2011 | Parker Waichman LLP
A major medical journal is slamming studies for Medtronic Inc.'s Infuse Bone Graft product, asserting that information regarding side effects was omitted from final published articles. The Spine Journal questions whether researchers’ financial relationships with Medtronic influenced what it characterizes as misleading and biased Infuse studies.
Infuse contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation. Infuse has a troubled history, and has already been the subject of investigations by the U.S. Senate Finance Committee and the U.S. Justice Department.
The Spine Journal took the unusual step of devoting an entire issue to the Infuse controversy.
"The history of rhBMP-2 research is a cautionary tale for all medical professionals, researchers and patients," Christopher M. Bono, MD of Brigham & Women's Hospital in Boston, MA and acting editor in chief of this issue of The Spine Journal, said in a statement. "As this matter demonstrates, the spine care field is currently at a precarious intersection of professionalism, morality and public safety. As physicians and journal editors, we felt an obligation to present a thorough examination of this controversial issue."
One of The Spine Journal articles asserts that in 13 Medtronic-funded studies conducted between 2000 and 2010, side effects – including male sterility, infection, bone loss and unwanted bone growth - occurred 10 to 50 times more than what was stated in the final, peer-reviewed published articles. According to that study, every large Infuse study involved at least one researcher who received at least $10 million in royalties from Medtronic.
According to The New York Times, Medtronic earned an estimated $900 million from Infuse in its most recent fiscal year, and the product is used in an estimated 432,000 spinal fusions performed in the U.S. each year. In 2009, the U.S. Food & Drug Administration (FDA) warned that Infuse and similar products had caused serious and potentially life-threatening problems when they were used off-label in cervical spine (neck) surgeries.
Last week, advance word of The Spine Journal's revelations prompted Senator Max Baucus (D-Montana), the chairman of the Senate Finance Committee, and Senator Chuck Grassley (R-Iowa), the committee's ranking Republican, to send Medtronic a letter demanding records of payments made to doctors who authored Infuse studies.