Medtronic deals with questions of biased research

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In a strong course of action, The Spine Journal recently dedicated its entire June issue to a review of recombinant bone morphogenetic protein-2 (rhBMP-2)-a synthetic bone growth product-and has shined a bright light on allegedly biased research done by the Minneapolis-based maker of INFUSE Bone Graft. The medical journal claims Medtronic officials failed to acknowledge serious side effects of rhBMP-2.

“The history of rhBMP-2 research is a cautionary tale for all medical professionals, researchers and patients,” said Christopher Bono, MD, the June issue acting editor in chief in a statement. “The spine care field is currently at a precarious intersection of professionalism, morality and public safety.”

The Spine Journal reported that complaints to journal editors and media reports of questionable research and publishing practices prompted staff to conduct a comprehensive review of past rhBMP-2 research studies.

In the main editorial written by the journal’s panel of spine experts, the authors state that “it harms patients to have unaccountable special interests permeate medical research” and “harm has been done.”

In one review of 13 studies, the journal found that authors, many of whom had financial ties to the sponsor, reported 10 to 50 times fewer complications with rhBMP-2 than were found in the original summaries to the Food and Drug Administration or other documents.

A separate study also in the issue finds rhBMP-2 use could cause a higher incidence of male sterility than described by past industry-sponsored researchers.

Medtronic CEO Omar Ishrak responded to the Spine Journal issue in a statement released June 28.

“While the Spine Journal articles raise questions about researchers’ conclusions in their published peer-reviewed literature, the 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.”

Ishrak added that his company believes the safety profile reported to the U.S. Food and Drug Administration and on the product label support the safe use of rhBMP-2 for the identified indications. According to information from the company, the protein first received FDA approval in 2002 and the product has been approved for three indications.

News reports of the financial link between surgeons who conducted clinical trials of the product and Medtronic have mounted. In a June 29 article, the Wall Street Journal reported its own analysis of Medtronic documents uncovered that over the past decade, 15 of those surgeons have collectively received at least $62 million from the company for unrelated work.

These news reports and the Spine Journal issue come on the heels of an investigation launched just two weeks ago by Senate Finance committee chairman Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa) in which Medtronic was asked to provide a list of documents, including financial records and communications between the company and the doctors who received royalty payments.

The company has said it will comply with the Senate’s request.

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