Vertebroplasty, evidence and professional protest

Comparative effectiveness research may stimulate heated debate, but ultimately, those who question its findings need to provide high-quality data to support their arguments ne consequence of the continuing rise in the cost of health care has been the emergence of comparative effectiveness research. 1 This variant of evidence-based medicine is defined as:. .. the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose , treat and monitor a clinical condition, or to improve the delivery of care. 1 Furthermore, the purpose of comparative effectiveness research is:. .. to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels. 1 When confronted with health care consuming an ever-increasing percentage of the gross domestic product, politicians and policymakers have enthusiastically embraced comparative effectiveness research, 2 and Prime Minister Rudd is no exception. In a recent speech, Mr Rudd proclaimed that medical research needed to play a greater role in reducing burgeoning health budgets. " Patients need treatments, technologies and procedures for which there is evidence from research that these are safe and effective. " 3 He cited a recent article in the New England Journal of Medicine (NEJM), in which research by an Australian team " found a commonly available treatment for fractures of the bones of the spinal cord was in fact no better than doing nothing at all. " 3 He was referring to the treatment of osteoporotic vertebral fractures with vertebroplasty — that is, the percutaneous injection of medical cement into the fractured vertebral body. Such procedures are performed in some 100 000 patients per year in the United States 4 and about 700 patients per year in Australia. 5 Late last year, this area of practice received a seismic shock when the NEJM simultaneously published two randomised controlled trials (RCTs) — one conducted in Australia 6 and one in the US, the United Kingdom and Australia. 7 These trials were conducted independently of each other, and both showed that the outcomes of vertebroplasty in patients with osteoporotic vertebral fractures were no different than for a placebo procedure. It was doubtlessly anticipated that publication of these two RCTs would inflame debate, arousing passionate defence of vertebroplasty. 4 This is to be expected whenever evidence-based medicine clashes with the collective wisdom of clinical experience. For more than a decade, …