The conflict-of-interest spotlight is once again shining on the orthopaedics industry. But this time the controversy surrounds spine doctors who are citing “biased and corrupted” research published by colleagues. The Spine Journal’s entire June issue is dedicated to reviewing clinical studies and research involving recombinant bone morphogenetic protein-2 (rhBMP-2), the synthetic bone growth protein that is the active ingredient in Medtronic’s Infuse bone graft.

The journal’s review of industry-sponsored rhBMP-2 studies and literature, dated between 1995 and 2010, found that the authors, many of whom had financial associations with the device maker, reported 10 to 50 times fewer complications than what had been found in FDA summaries. It also stated that the median financial ties with the industry sponsor ranged from $12 million to $16 million per study.

The studies found rhBMP-2 side effects that included inflammatory reactions, cancer, osteolysis, infection, implant dislodgment, and male sterility. Although such serious side effects were documented to FDA and in trial hearings, there was a “glaring absence” of these adverse effects in the published versions of the trials, according to the journal.

“Years ago, spine surgeons read the amazing reports on rhBMP-2 in trusted medical journals and eagerly began to use the product on thousands of patients for both FDA-approved and off-label uses,” said Eugene Carragee, MD, editor-in-chief of The Spine Journal, in a statement. “When adverse effects and even catastrophic complications began to be reported by independent researchers, whispers and then, ultimately, shouts of research and publishing improprieties started swirling.” As a result, the editors of the journal felt it was their duty to independently look at the issue. Within the 13 studies, they found four major problems:

• Conflicts of interest were not reported or were unclear.
• Study design was biased against spinal fusion alternatives.
• There were invalid claims related to the risks and complications of using a patient’s bone to aid in fusion.
• Common and serious complications weren’t reported in the larger trials.

Senators Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) also made inquiries to Medtronic and requested documents regarding the Infuse product. The fact that the spine doctors have publicly called out colleagues, citing “years of living dangerously with the promotion of bone growth factors” in scientific publications has attracted mainstream media attention and could be what prompted Medtronic’s CEO Omar Ishrak to release a company statement addressing the issue. “Integrity and safety are my highest priorities,” said Ishrak. “While the Spine Journal articles raised questions about researchers’ conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to FDA in the approval process...” The company also issued a document that outlines the safety profile of Infuse and how it has managed conflicts of interest in general.

Disclosure and transparency are two words that should be in the vocabulary of every manufacturer and doctor. We live in a much different world today, and it’s in your best interest to be informed about disclosure and knowing how to manage any financial arrangements.