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Lessons from the infuse trials: do we need a classification of bias in scientific publications and editorials?

  • Spine: BMP (K Singh, Section Editor)
  • Published:
Current Reviews in Musculoskeletal Medicine Aims and scope Submit manuscript

Abstract

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.

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Conflict of Interest

Sohaib Hashmi, Mohamed Noureldin, and Safdar N. Khan declare that they have no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

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Authors and Affiliations

  1. Division of Spine Surgery, Department of Orthopaedic Surgery, Wexner Medical Center at The Ohio State University, 456 W 10th Ave, Columbus, OH, 43210, USA

    Sohaib Hashmi, Mohamed Noureldin & Safdar N. Khan

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  1. Sohaib Hashmi
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  2. Mohamed Noureldin
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  3. Safdar N. Khan
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Correspondence to Safdar N. Khan.

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Hashmi, S., Noureldin, M. & Khan, S.N. Lessons from the infuse trials: do we need a classification of bias in scientific publications and editorials?. Curr Rev Musculoskelet Med 7, 193–199 (2014). https://doi.org/10.1007/s12178-014-9223-1

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  • DOI: https://doi.org/10.1007/s12178-014-9223-1

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