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Data Reviews Find Bone-Growth Product Has Limited Benefit, May Cause Harm

Safety problems with Infuse attracted government scrutiny in 2011 (June 18)

The controversial bone-growth product Infuse (recombinant human bone morphogenetic protein-2 [rhBMP-2], Medtronic) may not be as safe as standard bone grafts taken from patients, according to two independent reviews published in the June 18 issue of the Annals of Internal Medicine.

Researchers at Oregon Health & Science University in Portland and at Britain’s University of York reviewed randomized, controlled trials of rhBMP-2 versus iliac crest bone graft (ICBG) in spinal fusion surgery for degenerative disc disease and related conditions as well as observational studies in similar populations to determine the safety and efficacy of rhBMP-2. The primary outcomes were pain, fusion, and adverse events. Eighteen randomized controlled trials involving a total of 1,408 patients were analyzed.

The reviewers found that, at 24 months, pain scores were 3.5% lower (better) with rhBMP-2 than with ICBG, and radiographic fusion was 12% higher. However, at or shortly after surgery, pain was more common with rhBMP-2 (odds ratio, 1.78). Cancer was also more common after rhBMP-2 (relative risk, 1.98), although the small number of events prevented the investigators from reaching any definite conclusions.

“The use of rhBMP-2 in spinal fusion surgery increases the likelihood of successful fusion at up to 24 months, but this does not seem to translate into a clinically significant reduction in pain,” the authors remarked. “The small improvements in fusion and in the level of pain reduction, which manifest after 6 months, also seem to come at the expense of more frequent pain in the immediate postoperative period and, possibly, an increased number of cancer cases.”

The FDA approved Infuse (rhBMP-2) in 2002 to stimulate spinal bone growth in patients with degenerative disease affecting the lower spine. In 2011, the product was the subject of investigations by the U.S. Senate and the Department of Justice over omissions of safety problems from its clinical trial data and over off-label use.

Sources: Annals of Internal Medicine; June 18, 2013; and Reuters; June 17, 2013.

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