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Editorial alleges bias in spine research

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Alexander J. Ghanayem

An editorial published in The Spine Journal has challenged the integrity of published industry-sponsored research involving a spinal bone-growth product.

The editorial, co-authored by Alexander J. Ghanayem, MD, calls into question the results of 13 trials involving 780 patients — all of which were reported to be free of adverse events — using Medtronic’s Infuse Bone Graft, a product approved for certain spinal fusion surgeries and designed to eliminate the need for hip bone harvesting.

The authors of the editorial noted that these trials were performed almost universally by authors with financial ties to Medtronic — with investigators earning as much as $26 million per study.

The FDA issued a public health notice in 2008 regarding recombinant human bone morphogenetic protein (rhBMP) and its use in upper and cervical spine fusion. The product, FDA officials claimed, had been implicated in 38 complication reports — including neck inflammation, as well as airway and neurological structure compression — during a span of 4 years.

“We all must do a better job”

The editorial comes on the heels of Senate Finance Committee chair Sen. Max Baucus (D-Mont.) and senior member Sen. Charles E. Grassley (R-Iowa) issuing a letter to Medtronic requesting documentation on the Infuse product due to concerns about reports of researchers in the relevant trials failing to report evidence about adverse events — and adding “substantial financial ties to the device manufacturer” were a cause for concern.

“Clearly, the entire concept of peer-reviewed literature, systematic topic reviews, and evidence-based clinical decision-making rests on the assumption that the published literature being reviewed has sufficient integrity to make the exercise worthwhile,” the authors of the editorial wrote.

“We find ourselves at a precarious intersection of professionalism, morality, and public safety,” the authors added. “We all must do a better job going forward.”

Medtronic’s response

“The Spine Journal articles do not question the integrity of the safety results reported by Medtronic to the FDA for product approval of INFUSE Bone Graft,” a Medtronic spokesperson told OrthoSuperSite.com. “Integrity and patient safety are Medtronic’s highest priorities, and we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use of INFUSE Bone Graft for the indicated indications.”

In an initial company response, Medtronic noted “the three adverse events highlighted in the letter are already listed as warnings on our FDA-approved product labeling.”

“We believe the questions raised about the peer-review process in the Spine Journal deserve further review and analysis, and we are committed to working with researchers and academia to evaluate any actions we should take that are within a manufacturer’s control,” the spokesperson told OrthoSuperSite.com.

References:

• Carragee EJ, Ghanayem AJ, Weiner BK, et al. A challenge to integrity in spine publications: Years of living dangerously with the promotion of bone growth factors. Spine J. 2011. doi:10.1016/j.spinee.2011.06.001
• www.medtronic.com

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