August 6, 2009, should have been a crowning moment in the career of Rachelle Buchbinder, a rheumatologist and professor at Monash University’s department of epidemiology and preventive medicine.
Buchbinder had just published a study in the world’s most prestigious medical journal showing that vertebroplasty — injecting bone cement into a broken spinal bone — was no better at relieving pain than a pretend “placebo” procedure that only injected local anaesthetic.
To all intents and purposes, vertebroplasty didn’t work.
But vertebroplasty had already found its way into the medical firmament. The previous year US doctors had reaped US$40 million doing 73000 of them.
In hindsight the blowback was predictable, but it still blindsided Buchbinder. A slew of journal editorials and commentaries picked holes in her study, many written by doctors with financial ties to the procedure.
Says Buchbinder, “I was gobsmacked by the onslaught of criticism. It is an invasive procedure and not like having a Panadol. Why would you recommend a treatment that works only as well as placebo but has more chance of harm?”
Six years on vertebroplasty is still funded by Medicare in the US. But in Australia a review by the Medical Services Advisory Committee (MSAC) found the procedure was not effective and its Medicare coverage was rescinded in 2011.
Although the review amassed nearly 300 pages of data three committee members would not support its findings. Two of them performed vertebroplasties.
Why would doctors, charged with acting in patients’ best interests, be so reluctant to jettison a treatment science has shown to be ineffective and carries risks including clots on the lung, paralysis and even death?
It is a crucial time to answer the question.
In December 2015 a federal government-appointed taskforce submitted its initial report in a review of the evidence for all 5769 items on the Medicare Benefits Schedule (MBS). That’s the big book that tells you what tests and treatments, from a GP consultation through to CT scans and brain surgery, the government will pay for.
Nearly 150 of those items have been singled out as offering little or no benefit to patients, including X-ray in low back pain, coronary artery stents in stable angina and acupuncture for women in labour.
A recent Four Corners report claimed nearly a third of Australia’s 150 billion total health expenditure was wasted on worthless medicine. And Professor Bruce Robinson, chair of the MBS Review Taskforce, has said a quarter of items on the MBS, whose total cost to Medicare is $20 billion, remains unsupported by evidence.
Removing or limiting access to MBS items carries enormous savings potential. But Buchbinder’s experience suggests it won’t be easy getting doctors to stop doing time-honoured tests and treatments that don’t pass scientific muster.
And the stakes are highest for patients.
Dorothy* wore out plenty of maternity ward linoleum as a Melbourne midwife, and she used to enjoy long walks after work too. But when her knee started aching from osteoarthritis those distant rambles were reined in to a shuffle round the block.
The pain was excruciating at night, and she’d massage Dencorub into her ailing knee until the house smelt like a rubdown room. After months of painkillers an orthopaedic surgeon recommended an arthroscopy and trimming of the joint cartilage.
But there were studies going back six years showing the procedure didn’t help in osteoarthritis, and the UK National Institute for Health and Care Excellence (NICE) has since advised doctors not to do it.
Two weeks after surgery Dorothy’s pain was the same and within five weeks she was back on the operating table for a total knee replacement, which, after extensive rehab, did the trick. Dorothy is aggrieved she was not told the arthroscopy was unlikely to help.
“I probably would have liked to know about the trials and I probably would not have had it done” she said.
This is precisely the scenario that frustrates Buchbinder, a relentless campaigner against waste in medicine.
“There has been very little reduction in knee arthroscopies over the last decade. The guidelines only recently changed to advise against knee arthroscopy for osteoarthritis so the recommendations have taken a long time to reflect the evidence,” she said.
In a recent consultation paper the MBS taskforce echoed a widespread concern that a fee-for-service system rewards doctors for the number of procedures they do and not the outcomes they achieve.
But Buchbinder does not believe doctors are putting financial gain ahead of patient care. Nor does, Jenny Doust, a practising GP and Professor in the Faculty of Health Sciences and Medicine at Bond University.
“Doctors seriously believe that they are doing the best thing for their patient, but they’ve taken a very different level of evidence than what most people would consider evidence based medicine,” says Doust.
Sometimes that evidence is their own eyes.
In 2009 Dr William Clark, a dissenting member of the MSAC vertebroplasty committee, told the ABC’s 7.30 that patients talking of “slitting their throats, with unimaginable pain” were able to walk with just a dull ache after the procedure.
But Buchbinder’s study showed this could be a placebo effect where just expecting to get better can make you better. Placebos — sham treatments or pills — are particularly effective painkillers because believing pain will improve releases endorphins that block the brain’s pain signals.
Showing a treatment to be better than a placebo in a controlled trial is one route to getting approval for human use by the US Food and Drug Administration. But not all treatments need to be proven superior to a placebo. They just work.
Professor Guy Maddern, head of surgery at The Queen Elizabeth Hospital in Adelaide, cites liver transplantation.
“Despite all of the first six patients dying after transplantation, the subsequent results were so good that you were never going to turn back. There really wasn’t an option anyway. It was either medical management and death or a transplant and a real chance at life.”
When doctors’ observations still pass muster as proof it is understandable many won’t give up that standard even when science contradicts it.
But Maddern says the effectiveness of most treatments is not self-evident. He is part of the IDEAL international collaboration that develops rigorous evidence checks for innovative new surgery.
Meanwhile the MBS rewards Australian doctors for doing many tests and treatments with dubious evidence.
Adam Elshaug, associate professor of health care policy at the University of Sydney and a member of the MBS Review Taskforce, says the MBS is plagued by what he calls the “evidence paradox”.
“The great majority of items that made their way on to the MBS did so with very low levels of evidence, sometimes no clinical evidence at all, just opinion,” said Elshaug. “Today many of them wouldn’t be able to get back onto the schedule because they wouldn’t have the required levels of evidence.”
*Read the rest at health blog Croakey