Journal Says Medtronic Docs Left Out Side Effects in Infuse Studies

A major medical journal is attacking clinical trials for <"http://www.yourlawyer.com/topics/overview/Medtronic_Infuse_Bone_Graft">Medtronic Inc.’s Infuse bone growth products that were conducted by researchers with financial ties to the device maker, claiming the studies omitted or downplayed serious side effect associated with the product. According to various media reports, an entire issue of The Spine Journal is devoted to repudiating the Medtronic Infuse studies, which are characterized as misleading and biased.

According to The Spine Journal, clinical trials for Infuse under-reported the occurrence of problems like male sterility, infection, bone loss and unwanted bone growth. According to a report in The Wall Street Journal, The Spine Journal asserts that in 13 Medtronic-funded studies conducted between 2000 and 2010, those problems occurred in 10% to 50% of patients who were administered Infuse or a sister product. However, the complications weren’t reported in the final published articles, even though they were peer-reviewed.

The Wall Street Journal’s own analysis of Medtronic documents and disclosures on the company’s website indicate that 15 of the surgeons responsible for questionable Medtronic Infuse research were paid at least $62 million by the company for unrelated work. According to Eugene Carragee, the Spine Journal’s editor, every large Infuse study involved at least one researcher who received at least $10 million in royalties from Medtronic.

“I was really shocked,” Carragee, a professor at Stanford University, told Forbes Magazine “I wouldn’t have thought I was very naïve about this stuff. I’ve been doing this for 25 years.”

According to The New York Times, it’s unusual for doctors to publicly chastise colleagues, as the editors and authors of The Spine Journal have done. And editors of other medical journals told the Times they could not remember a previous instance in which a publication had dedicated an entire issue to do so.

The revelations in the Spine Journal, which according to the Times expanded the number of studies pointing to serious side effects suffered by patients given Infuse, is bringing more heat on Medtronic. The product has already been the subject of several Senate Finance Committee probes, and the U.S. Justice Department is in the midst of an inquiry looking into off-label use of Infuse. As we reported last week, these latest revelations have already prompted Senators Max Baucus, (D- Mont.) and Charles E. Grassley (R-IA) both members of the Finance Committee, to write to Medtronic to demand that it turn over records detailing payments made to doctors who conducted research on Infuse.

For its part, Medtronic is defending Infuse. The Spine Journal Articles “do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold,” Omar Ishrak, chairman and chief executive officer of Medtronic, said in a statement released yesterday. “Based on that data, we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use” of Infuse, he continues.

In an interview with The Wall Street Journal, Richard Kuntz, Medtronic’s chief scientific officer, said Ishrak asked him to put together a team of internal and external researchers to review all the issues raised by The Spine Journal and report back to him within 90 days.

In interviews with The New York Times, other Medtronic officials tried to distance themselves from the content of the studies in question. They pointed out that while Medtronic routinely reviews studies of its products prior to publication, outside researchers, not Medtronic, had determined the significance of data and how it should be presented.

Infuse Bone Graft 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. 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.

According to The New York Times, Infuse is used in a quarter of the estimated 432,000 spinal fusions performed in the U.S. each year. Medtronic earned an estimated $900 million from Infuse in its most recent fiscal year.

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