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2014 ; 7
(3
): 193-9
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Lessons from the infuse trials: do we need a classification of bias in scientific
publications and editorials?
#MMPMID24878967
Hashmi S
; Noureldin M
; Khan SN
Curr Rev Musculoskelet Med
2014[Sep]; 7
(3
): 193-9
PMID24878967
show ga
The original 13 Food and Drug Administration industry-sponsored recombinant human
bone morphogenetic protein-2 (rhBMP-2) trials investigating its use in spinal
fusion all reported no associated adverse events. However, subsequent series of
studies began reporting complication rates that were much higher than those that
were initially published. Critical analysis of the original rhBMP-2
industry-associated data found systematic alignment favoring positive outcomes
with no proven clinical advantage over bone graft. The sources of potential bias
leading to inaccurate reporting of original rhBMP-2 efficacy and safety profile
include flawed study design, methodological technique, data reporting and
analysis, and significant financial conflict of interest. As such, to ensure the
integrity of the scientific literature, further measures should be taken by
researchers, surgeons, authors, journal editors and reviewers to assess for
potential sources of bias.