Medtronic Makes Deal with Yale to Review Controversial Infuse Studies

Reeling from claims that research for its <"">Infuse Bone Growth product omitted important data regarding side effects, Medtronic Inc. has announced that it has commissioned Yale University to review its clinical trials for the product. The device maker also said it will make the data from the controversial Infuse studies available to the public.

The integrity of several Medtronic-funded Infuse clinical trials were called into question last month by a review in The Spine Journal. In an unprecedented step, an entire issue of the publication was devoted to Infuse, a spine product made from recombinant human Bone Morphogenetic Protein or rhBMP-2. The Spine Journal charged that the Infuse clinical trials downplayed its association with serious side effects, including male sterility, infection, bone loss and unwanted bone growth. At the same time, the journal’s editors criticized Medtronic for failing to disclose that it had paid many of the researchers involved in the trials millions of dollars in consulting fees.

According to a report from Bloomberg News, in response to the controversy, Medtronic has announced it will post its Infuse clinical trial results on the National Library of Medicine’s website.

“Had this information been publicly available, I don’t think the conclusions that were reached would have been reached,” Rick Kuntz, Medtronic’s chief scientific officer, told Bloomberg.

Bloomberg is also reporting that Medtronic will pay Yale University $2.5 million to review the trials. Yale has been charged with forming a steering committee, hiring two research organizations to conduct the reviews, and designing a database that will be available to outsiders.

Kuntz characterized the arrangement with Yale as an “historic agreement,” which would set a standard for the industry.

“For too long we’ve been in a situation where questions are raised about the safety of a product but companies don’t share the information,” he told Bloomberg.

Eugene Carragee, chief of spinal surgery at Stanford School of Medicine, as well as Editor-in-Chief of The Spine Journal, called Medtronic’s actions a “good first step,” but voiced doubts that the Yale review would ease concerns about Infuse.

“They simply are not going to have enough data on the main usage of it to give a really precise estimate of how safe or dangerous it is,” Carragee, who led The Spine Journal’s review of Infuse, told Bloomberg.

Infuse was approved by the U.S. Food & Drug Administration (FDA) in 2002. In July 2008, the FDA warned that the use of Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

The U.S. Senate Finance Committee has been investigating Infuse for several years, and recently – thanks to The Spine Journal review – demanded Medtronic turn over records detailing payments made to Infuse researchers. Meanwhile, the U.S. Justice Department is investigating off-label use of Infuse.

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