I/416wT9hcK9L.jpg' alt='Human Bone Manual Elsevier' title='Human Bone Manual Elsevier' />Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein 2 for Spinal Fusion. A Meta analysis of Individual Participant Data Annals of Internal Medicine. Anthony H. Woodward, MD. Portland, Oregon. July 2. 4, 2. 01. Comment. TO THE EDITOR The meta analysis and the systematic review about rh. BMP 2 1 2 both published in the June. They were greeted with exuberant commentary in the Annals and elsewhere. They were reported in national and regional newspapers. But what new information do they offer Simmonds et al independently reanalyzed the individual participant data IPD provided by Medtronic, or said they did. For adverse events, Simmonds et al state page 8. One trial was checked, but it seems for the rest, Medtronic classifications were accepted. For their meta analysis of 1. Medtronic trials, however, Simmonds et al did use the supplied IPD rather than data reported in the previously published reports of these trials. They also used the Medtronic definitions of fusion despite concerns about their possibly excessive stringency page 8. Yu et al had patient level data from Medtronic via the YODA Project but not personal communication the actual patient charts. The data still came from Medtronic. Browse through 14,324,115 journal and book articles on ScienceDirect. ScienceDirect is the worlds leading source for scientific, technical, and medical research. Explore journals, books and articles. Even after this laborious reanalysis, Fu et al found that for its only approved spinal use anterior lumbar interbody fusion rh. BMP 2 provided slightly better fusion rates and greater overall success than using iliac crest bone graft, although the differences did not reach statistical significance. Simmonds et al found clear evidence that rh. BMP 2 improves rates of fusion although the eventual improvement in back pain and quality of life was below previously described, clinically meaningfully thresholds. Hardly an outright condemnation of rh. BMP 2. Both groups found increased adverse effects from rh. PMP 2. But Simmonds et al reported that the results of their analysis of the RCTs were generally inconclusive page 8. From their literature review, Simmonds et al concluded that rh. BMP 2 recipients were more likely to have heterotopic bone, leg pain and radiculitis, osteolysis, and retrograde ejaculation. The only report of significant increase in heterotopic bone was a 2 page report 3 in a Supplement of minimally invasive transforaminal fusion which doesnt sound like the approved use. The increased incidence risk of radiculitis does not reach statistical significance according to Figure 6 in the report by Simmonds et al. A higher rate of retrograde ejaculation in fusion procedures using rh. Noltes-The-Human-Brain-An-Introduction-to-its-Functional-Anatomy-With-STUDENT-CONSULT-Online-Access-6e-Human-Brain-An-Introduction-to-Its-Functional-Anatomy-Nolt-0.jpg' alt='Human Bone Manual Elsevier' title='Human Bone Manual Elsevier' />BMP 2 and an open anterior approach had already been reported 4. Fu et al also found many adverse effects but their meta analysis for anterior lumbar interbody fusion showed no significant difference s between groups for any specific adverse event, including lumbar radiculitis or retrograde ejaculation. The risk of cancer was evaluated in both reviews. Fu et al found that the use of rh. BMP 2 was associated with an increased risk for cancer through 2. Simmonds et al also found cancer was more common among rh. BMP 2 recipients. The inflammatory and repair processes are no longer simple events to describe in the light of the ever increasing knowledge in this field. This review is only a brief. Human anatomy. The navicular bone in humans is one of the tarsal bones, found in the foot. Its name derives from the human bones resemblance to a small boat, caused. Human Bone Manual Elsevier' title='Human Bone Manual Elsevier' />Only one study of the approved use of rh. BMP 2 was found with a report of cancer and the RR was not significant. IL9/9780123985309.jpg' alt='Human Bone Manual Elsevier' title='Human Bone Manual Elsevier' />The highest risk of cancer was reported in the trial of AMPLIFY this preparation of rh. BMP 2 on a different carrier from INFUSE for posterior lumbar fusion did not gain FDA approval. Again, the association of cancer with rh. BMP 2 had been reported previously 6. As far as clinical information then, nothing new but greater detail, accuracy and reliability. But what caught media attention was the omission in the previously published studies of reports of adverse events and of cancer in the recipients of rh. BMP 2. It is all too true that several papers claimed there were no adverse events from the use of rh. BMP 2, whereas the FDA reviews found many adverse events. Particularly disturbing is the absence of reports of cancer in the published studies of AMPLIFY when the FDA Panels identified an increased incidence of cancer in recipients of rh. BMP 2. Again, these discrepancies had already been publicized. Fu et al confirm the marked underreporting of the adverse events which occurred in patients treated with either rh. BMP 2 or iliac crest bone graft. But when all the information including that from the FDA and from Medtronic is analyzed, the incidence of adverse events is not much greater in the recipients of rh. BMP 2. The two reviews are accompanied by four editorials, including one cosigned by no less than 1. Annals, one from the Chief Medical Officer, Medtronic which can only be described as postmodern, and one from the director of the YODA Project who calls the publication of these reviews a historic moment. The North American Spine Society at www. The longer is attributed to Eugene Carragee, MD, Editor in Chief of The Spine Journal. Dr Carragee considers the report of the YODA Project to be the latest and saddest shock to Medtronics rh. BMP 2 product, confirming the findings of The Spine Journals editorial review of 2. Dr Carragee. Dr Carragee rightly castigates the Medtronic associated authors misrepresentation of the efficacy of rh. BMP 2 and underreporting of the complications of its use. He writes, As YODA project director Dr. Harlan Krumholz delicately puts it, Evidence suggests that some data are not missing at random. But that sentence is in a paragraph referring to clinical trials in general Dr. Krumholz gives 2 references, neither refer to BMP. Dr Carragee adds, The Annals editors are more blunt Early journal publications misrepresented the effectiveness and harms through selective reporting, duplicate publication, and underreporting. Ouch. In the online copy of Annals I do not see that statement. Iron Man 1 Pc Game Crack Download on this page. But neither review addresses the usual reason to use rh. Reinstall Windows Journal on this page. BMP 2 for lumbar fusion, which is to avoid the pain and possible complications of harvesting iliac crest bone graft. The reviewers lists of adverse events do not seem to include specific adverse events from iliac crest harvesting. This omission is surprising if the rates of clinical success and fusion after iliac crest bone graft or rh. BMP 2 are similar, then its advantage rh. BMP 2 for its only approved use in anterior lumbar fusion if the adverse events from iliac crest bone graft harvesting are counted. Excluding that unexplained increase in cancers, of course. He who pays the piper calls the tune Medtronic paid apparently directly and indirectly the surgeons who praised rn. BMP 2, YODA Project paid indirectly the reviewers who disparaged it. The irony is that its all Medtronics money. The pity is that Medtronic took the money from our healthcare insurance premiums and our contributions to Medicare. Anthony H. Woodward, MD. SW Lancaster Rd, Portland, OR 9. Potential Conflicts of Interest None. References 1 Simmonds MC, Brown JV, Heirs MK, Higgins JP, Mannion RJ, Rodgers MA, et al. Safety and effectiveness of recombinant human bone morphogenetic protein 2 for spinal fusion. A meta analysis of individual participant data. Ann Intern Med. 2. Fu R, Selph S, Mc. Donagh M, Peterson K, Tiwari A, Chou R, et al. Effectiveness and harms of recombinant human bone morphogenetic protein 2 in spine fusion. A systematic review and meta analysis. Ann Intern Med. 2. Gray RJ, Rampersaud YR.