A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors

Carragee, Eugene J.; Ghanayem, Alexander J.; Weiner, Bradley K.; Rothman, David J.; Bono, Christopher M.

doi:10.1016/j.spinee.2011.06.001

Cited by 98 publications

(70 citation statements)

References 27 publications

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“…Physician-industry relationships can create a risk of bias in research study designs, experimental technique, and result interpretation and may affect treatment decisions in patient care [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] . However, physicians are in the best position to provide valuable innovations in design and safety that are mutually beneficial for patients, physicians, and industry 1 .…”

mentioning

confidence: 99%

Inconsistencies Between Physician-Reported Disclosures at the AAOS Annual Meeting and Industry-Reported Financial Disclosures in the Open Payments Database

Hannon

Chalmers

Carpiniello

et al. 2016

The Journal of Bone and Joint Surgery

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mentioning

confidence: 99%

Inconsistencies Between Physician-Reported Disclosures at the AAOS Annual Meeting and Industry-Reported Financial Disclosures in the Open Payments Database

Hannon

Chalmers

Carpiniello

et al. 2016

The Journal of Bone and Joint Surgery

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“…Further study is needed as to whether there are editoriallevel conflicts in disc replacement studies. Recent actions taken by spine journal editors on other topics in spine surgery, including creating special embargoed issues with multiple redundant commentaries, demonstrate the ability of journal editors to advocate about specific issues [66,67].…”

Section: Financial Conflict Of Interestmentioning

confidence: 99%

Bias in cervical total disc replacement trials

Radcliff

Siburn

Murphy

et al. 2017

Curr Rev Musculoskelet Med

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Purpose of review Cervical disc replacement (CDR) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion in selected cases. Despite favorable literature, CDR is not universally accepted because of concerns regarding bias in the existing literature. The purpose of this review is to identify the possible biases in the disc replacement literature. Recent findings Recent studies that compare CDR and ACDF have demonstrated equivalent or superior outcomes, lower rates of secondary surgery, and equivalent safety at mediumand long-term follow-up. In our review, we identified four types of bias that may affect the CDR literature: publication bias, external validity, confounding bias, and financial conflicts of interest. Summary Bias, whether intentional or unintentional, can impact the interpretation and outcome of CDR studies. Recognition of this issue is critical when utilizing the existing literature to determine the efficacy of CDR and designing future studies.

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“…However, in 2011, Carragee et al [45,46] reviewed the complications associated with the use of BMP-2 in spine surgery. They identified a significant number of industry-sponsored trials (N = 13) "remarkable for the complete absence of reported rhBMP-2 related clinical events".…”

Section: Graftmentioning

confidence: 99%

Growth factors in orthopaedic surgery: demineralized bone matrix versus recombinant bone morphogenetic proteins

Hinsenkamp

Collard

2014

International Orthopaedics (SICOT)

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During recent decades the utilisation of growth factors, especially BMPs, has received an increasing interest in orthopaedic surgery. For clinical implantation the two main options are demineralised bone matrix (DBM) and recombinant bone morphogenetic proteins (rhBMP). Many clinical studies agree on an equivalent osteoinductive effect between DBM, BMPs and autologous bone graft; however, the different origins and processing of DBM and rhBMP may introduce some fluctuations. Their respective characteristics are reviewed and possible interactions with their effectiveness are analysed. The main difference concerns the concentration of BMPs, which varies to an order of magnitude of 106 between DBM and rhBMPs. This may explain the variability in efficiency of some products and the adverse effects. Currently, considering osteoinductive properties, safety and availability, the DBM seems to offer several advantages. However, if DBM and rhBMPs are useful in some indications, their effectiveness and safety can be improved and more evidence-based studies are needed to better define the indications.

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A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors

Cited by 98 publications

References 27 publications

Inconsistencies Between Physician-Reported Disclosures at the AAOS Annual Meeting and Industry-Reported Financial Disclosures in the Open Payments Database

Inconsistencies Between Physician-Reported Disclosures at the AAOS Annual Meeting and Industry-Reported Financial Disclosures in the Open Payments Database

Bias in cervical total disc replacement trials

Growth factors in orthopaedic surgery: demineralized bone matrix versus recombinant bone morphogenetic proteins

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