Schwitzer health news blog

Would back surgery be approved if it were a drug?

An Australian pain specialist writes an intriguing letter to the BMJ this week, entitled, "What if back surgery was a drug?" He wrote:

"I find it fascinating that surgical treatments and medical treatments are evaluated very differently in the literature and by ethics committees. Let’s say you told a human research ethics committee (HREC) that you expected only a short to medium term reduction in radicular pain (editor's note: that means pain that radiates from the back to the legs - or sciatica) with no real improvement in disability or axial back pain for a drug treatment. You go on to say that treatment had a 70% chance of entrenching the axial back pain as permanent, a 5% chance of worsening the pain, 1% risk of permanent neurological damage, with lesser chances of major vessel damage or paraplegia, I wonder how many HRECs would approve it ? If you then presented a literature search that relied mainly on a 30 year old study with major design flaws and a couple of meta-analyses of poor data you could reasonably expect to be sent packing. By way of comparison, in Australia last year lumiracoxib was banned by the Therapeutic Goods Administration for causing fulminant hepatitis at a rate of one in 15,000, with two deaths out of an estimated 60,000 patients who received it.

Without a standard battery of outcome measures which can be used in both surgical and non-surgical trials, and without sham surgical studies, which must measure pain related disability and psychological outcomes (since there is clear evidence that these influence overall disability in a major way) it is difficult to interpret the vast but mostly useless back pain literature."

That is why evidence-based and shared decision-making - which presents a balanced presentation of tradeoffs, of harms & benefits, and of uncertainties - is so important.

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