One 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:

Furthermore, the purpose of comparative effectiveness research is:

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 States4 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 Australia6 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, it had been argued that vertebroplasty was so successful that RCTs were unnecessary or even unethical!4 Not surprisingly, the two RCTs turned the practice of vertebroplasty on its head.

In view of the seminal importance of these studies and seeking to inform the broad readership of the Journal, I duly sought an editorial from the lead authors of the NEJM studies, Professor Rachelle Buchbinder from the Monash Department of Clinical Epidemiology at Cabrini Hospital in Melbourne and Professor David Kallmes from Mayo Clinic in Rochester in the US.

Then strange things began to happen. Just before the editorial was published, I received an email critical of its content. Then, subsequent to its appearance in the 2 November 2009 issue of the Journal, further emails arrived advising, among other things, that the editorial be retracted.

Medical science has always thrived on debate in an open forum, wherein discussion and interpretation of the evidence is to be encouraged. Yet, I was the recipient of closed communications pointing out the weaknesses of the RCTs, as well as suggesting that the reputations of the NEJM and the Medical Journal of Australia had been diminished by the original publication of the RCTs and our subsequent editorial. More sinister, perhaps, is the fact that Professor Buchbinder was subjected to a far more vitriolic campaign, necessitating the threat of legal action (Rachelle Buchbinder, personal communication).

In this issue of the Journal, we publish the views of Clark and colleagues, a group of Australian vertebroplasty experts,8 and the rejoinder by Buchbinder and colleagues.9 Clark et al point, among other things, to problems with patient selection and recruitment as a reason for the negative findings of the RCTs, while Buchbinder et al robustly defend the findings and their subsequent interpretation. It is up to the readers of the Journal to decide for themselves whether the two trials and the editorial that sought to interpret them represent the best available evidence on the effectiveness of vertebroplasty.

Where do we go from here? It is easy to be critical of study methods, findings and interpretations, but I strongly believe that, when considering important clinical issues, criticisms must not be ad hominen but be supported by new data. It may well be argued that vertebroplasty should no longer be performed except in the context of a study aimed at resolving unresolved questions.4 At the very least, vertebroplasty practitioners should now relate the outcomes of the NEJM trials in their discussions with patients before proceeding to gaining their informed consent.10