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.
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