Medicare funding could jeopardise the research needed to establish the benefits and risks of this procedure
Recent publications and regulatory decisions about the therapeutic use of vertebroplasty, or injection of bone cement into diseased vertebrae such as osteoporotic fractures, call for a closer look at the evidence. New drug treatments are not considered to have proven efficacy until, at the very least, they have been evaluated in randomised controlled trials. Even then, their safety is not guaranteed, particularly for uncommon adverse effects, or those for which there is a long delay between exposure and clinical manifestation. Adverse effects that have a high prevalence may also be difficult to detect, as exemplified by the much-delayed recognition of the association between myocardial infarction and strokes and rofecoxib.1 In Australia, drugs must also be shown to be cost-effective compared with existing subsidised treatments before they are accepted into the Pharmaceutical Benefits Scheme.
The full article is accessible to AMA members and paid subscribers. Login to read more or purchase a subscription now.
Please note: institutional and Research4Life access to the MJA is now provided through Wiley Online Library.
- 1 Monash Department of Clinical Epidemiology at Cabrini Hospital and Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC.
- 2 Centre for Rheumatic Diseases, Department of Medicine (Royal Melbourne Hospital/Western Hospital), University of Melbourne, Melbourne, VIC.
- 1. Caldwell BS, Aldington S, Weatherall M, et al. Risk of cardiovascular events and celecoxib: a systematic review and meta-analysis. J R Soc Med 2006; 99: 132-140.
- 2. Medical Services Advisory Committee. Minutes of meeting no. 31 — 24 August 2005 — Brisbane. http://www.msac.gov.au/internet/msac/publishing.nsf/Content/2005-aug-1 (accessed Aug 2006).
- 3. Hollingworth W, Jarvik JG. Evidence on the effectiveness and cost-effectiveness of vertebroplasty: a review of policy makers’ responses. Acad Radiol 2006; 13: 550-555.
- 4. Jarvik J, Deyo R. Cementing the evidence: time for a randomized trial of vertebroplasty. AJNR Am J Neuroradiol 2000; 21: 1373-1374.
- 5. Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med 2002; 136: 471-476.
- 6. Álvarez L, Alcaraz M, Pérez-Higueras A, et al. Percutaneous vertebroplasty: functional improvement in patients with osteoporotic compression fractures. Spine 2006; 31: 1113-1118.
- 7. Diamond TH, Bryant C, Browne L, Clark WA. Clinical outcomes after acute osteoporotic vertebral fractures: a 2-year non-randomised trial comparing percutaneous vertebroplasty with conservative therapy. Med J Aust 2006; 184: 113-117. <MJA full text>
- 8. National Health and Medical Research Council. NHMRC additional levels of evidence and grades for recommendations for developers of guidelines. 2005. http://www.nhmrc.gov.au/publications/_files/levels_grades05.pdf (accessed Aug 2006).
- 9. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273: 408-412.
- 10. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. JAMA 2001; 285: 320-323.
- 11. Ha KY, Lee JS, Kim KW, Chon JS. Percutaneous vertebroplasty for vertebral compression fractures with and without intravertebral clefts. J Bone Joint Surg Br 2006; 88-B: 629-633.
- 12. Trout AT, Kallmes DF, Kaufmann TJ. New fractures after vertebroplasty: adjacent fractures occur significantly sooner. AJNR Am J Neuroradiol 2006; 27: 217-223.
- 13. Bono C. Point of view: the honest truth about vertebroplasty. Spine 2006; 31: 1119.
- 14. Guduguntla M, Subramaniam R. Vertebroplasty: a new treatment for vertebral compression fractures. Aust Family Physician 2006; 35: 304-307.