The Spine Journal Has Backbone! Devotes Issue to Corruption in Spine-Disorder Research with Medtronic Pay to Play Scheme

Emanating from the Dr Timothy Kuklo Medtronic Infuse research scandal, The Spine Journal devoted its entire June issue to the ongoing crisis in spine research due to greed, Big Pharma’s tentacles of bribe money and the utter lack of medical ethics. Its Editor in Chief, Eugene J. Carragee, MD should be praised for this unusual issue that attempts to unmask the research corruption that is sweeping the field of spinal research. However, this scandal was first revealed when the London-based The Journal of Bone and Joint Surgery withdrew Dr Kuklo’s August 2008 article, “Recombinant human morphogenetic protein-2 for type grade III open segmental tibial fractures from combat injuries in Iraq.” The American journal with the same name had rejected the article and it was eventually published in London. Obviously the problem of medical research integrity has metastasised.

It’s play to pay. Big Pharma gives orthopedic surgeons money; they then proceed to publish findings that exaggerate the efficacy of their products (criminally lie to mislead the medical profession to order products that are useless or ineffective); unsuspecting physicians who read their published papers treat patients believing in the integrity of peer-review articles; patients suffer; patients die; bigger homes get built, presidential suites are reserved; the lack of ethics sullies and disgraces an entire specialty of orthopedic medicine as one big boondoggle. Medtronic is basically a criminal enterprise that should be driven into bankruptcy with those responsible arrested and prosecuted.

Here is a title of an editorial that appeared in the June issue of The Spine Journal:

A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors
Eugene J. Carragee, MDa,*, Alexander J. Ghanayem, MDb, Bradley K. Weiner, MDc, David J. Rothman, PhDd, Christopher M. Bono, MD

It included this summary of research misconduct with refreshing passion and acerbic literary references.

 ‘‘There were no unanticipated adverse events related to the use of INFUSE Bone Graft.’’ (n524)Burkus et al. [1] (industry sponsored study, 2002).
 ‘‘[T]here were no complications attributable to the rhBMP-2/biphasic calcium phosphate [in posterolateral fusion].’’ (n520) Boden et al. [2] (industry-sponsored study, 2002).
 ‘‘There were no unanticipated device-related adverse events [using rhBMP-2 with an anterior cervical fusion].’’
(n518) Baskin et al. [3] (industry-sponsored study, 2003).
 ‘‘I have reported the clinical and radiographic results of three different interbody constructs in a single-level, stand-alone ALIF derived from several prospective multicenter studies. There were no adverse events due to rhBMP-2.’’ (n5326) Burkus [4] (industry-sponsored studies, 2004).
 ‘‘No unanticipated device-related adverse events occurred [with PLIF using rhBMP-2].This study seems to confirm the safety results.[of] using rhBMP-2.’’ (n534) Haid et al. [5] (industry-sponsored study 2004).
 ‘‘Analysis of our results demonstrated the safety and efficacy of this combination of cervical spine fusion therapy
[rhBMP-2]. a 100% fusion rate and no significant morbidity.’’ (n524) Boakye et al. [6] (industry-sponsored study).
 ‘‘No adverse event that was specifically attributed to the use of rhBMP-2 matrix [Amplify] in the study group was
identified.’’ (n5239) Dimar et al. (industry-sponsored study, 2009) [7].
 ‘‘Yes, isn’t it pretty to think so.’’ Ernest Hemingway, The Sun Also Rises.

This is a title of another article that conducted a summary review of the falsified industry-sponsored research on the efficacy of products used in the treatment of spinal fusion problems in patients.

Review Article
A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned
Eugene J. Carragee, MDa,*, Eric L. Hurwitz, DC, PhDb, Bradley K. Weiner, MDc

Abstract BACKGROUND CONTEXT: Increasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industry sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight.

PURPOSE: To compare the conclusions regarding the safety and related efficacy published in the original rhBMP-2 industry-sponsored trials with subsequently available Food and Drug Administration (FDA) data summaries, follow-up publications, and administrative and organizational databases.

STUDY DESIGN: Systematic review.

METHODS: Results and conclusions from original industry-sponsored rhBMP-2 publications regarding safety and related efficacy were compared with available FDA data summaries, follow-up publications, and administrative and organizational database analyses.

RESULTS: There were 13 original industry-sponsored rhBMP-2 publications regarding safety and efficacy, including reports and analyses of 780 patients receiving rhBMP-2 within prospective controlled study protocols. No rhBMP-2–associated adverse events (0%) were reported in any of these studies (99% confidence interval of adverse event rate!0.5%). The study designs of the industry sponsored rhBMP-2 trials for use in posterolateral fusions and posterior lateral interbody fusion were found to have potential methodological bias against the control group. The reported morbidity of iliac crest donor site pain was also found to have serious potential design bias. Comparative review of FDA documents and subsequent publications revealed originally unpublished adverse events and internal inconsistencies. From this review, we suggest an estimate of adverse events associated with rhBMP-2 use in spine fusion ranging from 10% to 50% depending on approach. Anterior cervical fusion with rhBMP-2 has an estimated 40% greater risk of adverse events with rhBMP-2 in the early postoperative period, including life-threatening events. After anterior interbody lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were higher after using rhBMP-2 than controls. Posterior lumbar interbody fusion use was associated with radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes. In posterolateral fusions, the risk of adverse effects associated with rhBMP-2 use was equivalent to or greater than that of iliac crest bone graft harvesting, and 15% to 20% of subjects with a greater apparent risk of new malignancy.

CONCLUSIONS: Level I and Level II evidence from original FDA summaries, original published data, and subsequent studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion. This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications.

For an index of other articles I have written on this Medtronic-Kuklo-et al troika of capitalistic greed, just type Kuklo in Search at top right of blog.

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