Why do doctors order tests and treatments that don’t work and will the Medicare Benefits Schedule Review help? These questions are addressed by former emergency physician (and now author and bioethicist) Dr Paul Biegler in the following piece which discusses some of the reasons why consumers continue to receive services for which there is little or no evidence. Of particular note given the aim of the Government’s MBS Review, the article also outlines the limitations of relying on changes to the MBS to drive behavioural change among medical practitioners and suggests some alternative and complementary strategies.
Dr Paul Biegler writes:
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 study¹ 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.
Surprised by criticism
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by the Medical Services Advisory Committee (MSAC) found the procedure was not effective and its Medicare coverage was rescinded in 2011.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.
The MBS Review
In December 2015 a Federal Government appointed taskforce will submit 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 AU$150 billion total health expenditure is 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 $AU20 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 pain killers an orthopaedic surgeon recommended an arthroscopy and trimming of the joint cartilage.
But there were studies going back 6 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 says.
Changing medical practice
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 says.
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.
The role of the placebo
In 2009 Dr William Clark, a dissenting member of the MSAC vertebroplasty committee, told ABC 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 pain killers 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.
The limitations of personal observation
“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,” says 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.”
The need to “do something”
A recent report from the Grattan Institute found ineffective treatment was driven by a long standing ethos in medicine of “adding new treatments and doing more” not “removing old treatments and doing less”.
The report also says doctors are motivated by a desire to help patients by simply “doing something”, a desire Buchbinder struggles with regularly.
“I tell patients, ‘I’m really sorry I know you’re in terrible pain but this treatment doesn’t work,’” she says. “It’s really hard to say ‘I can’t help you’”.
Doust says the situation is compounded by doctors worrying more about missing a rare diagnosis than causing harm by over investigation, perhaps fearful of litigation.
And then there is the Herculean struggle to keep pace with scientific literature. The Grattan report said it would take a GP twenty hours a day to read all the journal articles on primary care.
To simplify things, the “Choosing Wisely” campaign is developing “Do not do” lists of procedures that should be avoided in routine practice.
Providing an alternative
Buchbinder wants to see knee arthroscopy for osteoarthritis on such a list but a recent editorial in the British Medical Journal found no evidence the lists reduce low value medical practices. Buchbinder tells an anecdote that hints at why.
It was routine to change patient’s IV drips every couple of days to stop infection until research showed it didn’t work. But colleagues couldn’t stop medical staff doing it.
Says Buchbinder, “They finally realised they had to give them something to do instead. So they gave them a checklist. Is the site red or is the IV blocked? Otherwise don’t replace it. Then people can actually deal with it. You have to give something in its place.”
But if you ask doctors to stop doing vertebroplasties or arthroscopies that are actually helping pain via a placebo effect, what are they to replace them with? It’s a pressing question because, like vertebroplasty, arthroscopy carries risks including infection and blood clots.
Doust notes that proven psychotherapies such as Cognitive Behaviour Therapy (CBT) help people at risk of chronic back pain and do so, like placebos, by altering expectations.
Says Doust, “A large part of the pain that patients feel and the concerns they have about their illness are wrapped up with how they feel about the illness. You need to manage those things”.
CBT is no panacea but it might be one alternative to the X-rays, CT scans and MRIs for uncomplicated back pain that cost Medicare AU$220 million annually and are prominent on “do not do” lists.
Removal from the MBS may not be the answer
But removing an item from the MBS sends a powerful message that it shouldn’t happen, which some doctors seem to favour.
Doust recently spoke to a group of physicians about shouldering responsibility for inappropriate care and embracing Choosing Wisely. A doctor told her, “Well, we don’t think we can take responsibility. We need someone to come along and say ‘No, you can’t do this’”.
Elshaug says removing items altogether is hard to justify because very few items are outright useless and many may be beneficial to some even if harmful to others. “The challenge is to encourage treatments in the green zone and discourage those in the red zone, and make progress in grey zone” he says.
Professor Brian Owler, President of the Australian Medical Association, sees this as a key challenge for the MBS review. Owler cites childhood tonsillectomy which used to be common but is now controversial because studies show it only marginally reduces recurrent throat infection.
“Actually tonsillectomy can be one of the most effective things you can do for a child if they’ve got obstructive sleep apnoea… it depends on the clinical indication”, says Owler.
Budget cuts or improved quality?
The AMA has criticised the MBS review as a thinly veiled instrument to cut the health care budget.
“The primary objective of the review is to save money for the government…I think the challenge is to make sure we come up with a more modern schedule that does reflect more modern clinical practice,” says Owler,
“But that will involve putting new items on. We don’t want to see a situation where we’re readily removing items but taking a long time to put new ones on to replace them.”
In its submission to the review the AMA called for clinical stewardship rather than a top down mechanism of restricting access to procedures.
Says Owler, “The way that we do things now is influenced by training, by continuing medical education. The MBS is just one tool in a whole range of ways that we shape clinical practice”.
Dorothy is forthright about the place of knee arthroscopy for osteoarthritis on the MBS. “Go for it and get it removed. If there is evidence that it doesn’t work it’s not doing anything positive for anybody. Why do it?”
And Buchbinder is resolute in her determination to see change.
“We use to think that we just stopped at the research. We published it and great we’ve done our job. I think that’s long gone now. Someone has to stand up because… I did medicine to help people not to harm people”.
Dr Paul Biegler is an Adjunct Research Fellow at the Centre for Human Bioethics at Monash University. His research interests include neuroethics, medical ethics, philosophical psychology, philosophy of emotion and the role of emotion in decision-making. Paul practised clinical medicine for 20 years, the last decade as a specialist in emergency medicine.
Buchbinder, R., Osborne, R. H., Ebeling, P. R., Wark, J. D., Mitchell, P., Wriedt, C., . . . Murphy, B. (2009). A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med, 361(6), 557-568. doi: 10.1056/NEJMoa0900429
Wulff, K. C., Miller, F. G., & Pearson, S. D. (2011). Can coverage be rescinded when negative trial results threaten a popular procedure? The ongoing saga of vertebroplasty. Health Aff (Millwood), 30(12), 2269-2276. doi: 10.1377/hlthaff.2011.0159
Revisions in vertebroplasty and vertebral augmentation – Medicare coverage criteria Written by Leslie Jones, CPC, CPC-H, RCC, CIRCC, AHIMA Approved ICD-10 Trainer | July 06, 2015
Vertebral Compression Fracture and Review of Interim Funded Service: Vertebroplasty for the Treatment of Vertebral Compression Fracture
MBS calls time on vertebroplasty rebates 18 October, 2011 David Brill
Medicare Benefits Schedule Review Taskforce
Elshaug, A. G., Watt, A. M., Mundy, L., & Willis, C. D. (2012). Over 150 potentially low-value health care practices: an Australian study. [Research Support, Non-U.S. Gov’t]. Med J Aust, 197(10), 556-560.
Parnell. Little benefit in one third of treatment. The Australian. Sep 16 2015
Moseley, J. B., O’Malley, K., Petersen, N. J., Menke, T. J., Brody, B. A., Kuykendall, D. H., . . . Wray, N. P. (2002). A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med, 347(2), 81-88. doi: 10.1056/NEJMoa013259
UK National Institute for Health and Care Excellence (NICE) recommendations
Dr William Clark, a dissenting member of the MSAC vertebroplasty committee on the ABC’s 7.30 Report
Benedetti, F., Mayberg, H. S., Wager, T. D., Stohler, C. S., & Zubieta, J. K. (2005). Neurobiological mechanisms of the placebo effect. Journal of Neuroscience, 25(45), 10390–10402.
Food and Drug Administration. (2001). Guidance for industry: E 10 Choice of control group and related issues in clinical trials. Rockville.
McCulloch, P., Cook, J. A., Altman, D. G., Heneghan, C., & Diener, M. K. (2013). IDEAL framework for surgical innovation 1: the idea and development stages. [Research Support, Non-U.S. Gov’t]. BMJ, 346, f3012. doi: 10.1136/bmj.f3012
Duckett, S., Breadon, P, Romanes, D. Fennessy, P., Nolan, J. 2015, Questionable care: Stopping ineffective treatments, Grattan Institute
Doust, J., & Del Mar, C. (2004). Why do doctors use treatments that do not work? [Editorial]. BMJ, 328(7438), 474-475. doi: 10.1136/bmj.328.7438.474
Malhotra, A., Maughan, D., Ansell, J., Lehman, R., Henderson, A., Gray, M., . . . Bailey, S. (2015). Choosing Wisely in the UK: the Academy of Medical Royal Colleges’ initiative to reduce the harms of too much medicine. BMJ, 350, h2308. doi: 10.1136/bmj.h2308
Painful truth about managing back pain July 24, 2014 Chris Maher, Ian Harris, Rachelle Buchbinder. SMH opinion piece
Burton MJ, Glasziou PP, Chong LY, Venekamp RP. Tonsillectomy or adenotonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis. Cochrane Database of Systematic Reviews 2014, Issue 11. Art. No.: CD001802. DOI: 10.1002/14651858.CD001802.pub3.
AMA media release government undermines MBS review with attack on medicare adn the integrity of doctors Sep 27 2015
AMA submission to Medicare Benefits Schedule Review Taskforce consultation paper Oct 26 2015
Great article. Most informative paper I have read for ages. Thanks heaps.
may be informative – but irrelevant
This silliness of medicine trying to ape the law in ‘evidence’ based decisions.
Actually evidence in law means – every fact is evidence – but is it admissible in
the case before the court.
There is a clear need for doctors experienced in a field to have a role to play in helping define what is or is not ethically, and on cost-benefit grounds funding. But having them trash good science that critiques procedures they have a vested financial interest in, takes this to another level. This is really pretty bad.
What if their professional standing as members of their college/speciality was at risk, if they are found to have acted in self-interest? I think that there has to be a balancing consequence to their role, as adjudicators of the public health funds directed to their field.