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Why the complementary medicine regulatory push was shelved


Doug Hendrie


17/02/2021 5:34:51 PM

Medical Board oversight will return to a broader risk-based approach rather than singling out areas of medicine.

Pharmacist inspecting complementary medicine.
The Medical Board of Australia received more than 13,000 submissions during the consultation process.

Integrative medicine GPs have praised the Medical Board of Australia’s (the Board) decision to back away from mooted tighter regulations on complementary and unconventional medicine, and emerging treatments.  
 
Rather than issuing separate guidelines, the Board will continue to rely on the existing code of conduct for Australian doctors – an approach the RACGP called for in its submission.
 
The Board has signalled it will shift to a risk-based approach in identifying risky therapies across all areas of medicine, rather than one focused on areas of practice. 
 
The 2019 plan was originally framed as a way to tighten regulation over the wider reaches of therapies. But, some integrative GPs say that the Board’s plan threw the net too wide, casting doubt over evidence-based complementary therapies, such as acupuncture for migraine, in the process.
 
Board Chair Dr Anne Tonkin told newsGP consultation had shown that the solution they had proposed did not match the risks they were trying to manage.
 
‘In effect, the solution we had proposed did not match the problem we were trying to solve and the labels we used – complementary and unconventional medicine and emerging treatments – were not helpful in defining the level of risk posed to patients,’ she said.
 
‘[There is] no simple equation linking areas of practice with risk to patients, and that high-risk practice is not confined to one area of medicine.
 
‘Lots of practitioners use complementary medicine and unconventional treatment who are not integrative medicine practitioners. At the time, we felt we could capture a number of high-risk treatments.
 
‘It turned out we couldn’t in the end. Nobody thought we’d managed to capture the definition of these areas – and that’s not from want of trying. It turned out to be really difficult to define.’
 
According to Dr Tonkin, practitioners felt the definition the Board was using had been capturing trialled and tested treatments.
 
‘A whole bunch of emerging treatments aren’t risky at all, as they’ve been trialled carefully and have lots of evidence – whereas older ones might be riskier,’ she said.
 
‘The situations I’m concerned about are when people are treated with drugs or hormones when they don’t have a need for them. There can’t be a benefit if nothing is wrong in the first place.
 
‘We realised that unsafe or high-risk practices exist across lots of areas of medicine. So the best thing was to rely on the Code of Conduct.’
 
In conjunction with the Australian Health Practitioner Regulation Agency (AHPRA), the Board is developing an alternative – what Dr Tonkin describes as a ‘much more sophisticated risk-based approach’.  
 
More than 13,000 submissions were received during the consultation process, with the Board seeking feedback about whether more safeguards were needed for patients seeing medical practitioners who provide ‘complementary and unconventional medicine and emerging treatments’.

Dr_Ken_Harvey-Article.jpgPublic health expert Associate Professor Ken Harvey is disappointed the Board has reverted to the status quo.
 
The Board has also flagged a need to ensure vulnerable patients are provided with the necessary information to give genuinely informed consent.
 
Dr Carolyn Ee, Chair of the RACGP Specific Interests Integrative Medicine network, told newsGP she agrees with the Board decision to shift its focus and rely on the existing code of conduct. 
 
‘I don’t think we can say let’s look only at these [areas] and not others,’ she said.
 
‘The college felt the current code of conduct provides a robust safeguard for our patients, and it’s clear that the Medical Board – after 13,000 submissions – has decided that’s the right approach. 
 
‘It’s clear we as GPs really need to focus on informed choice, and we are well placed to do this.’
 
GP and President of the Australasian Integrative Medicine Association Dr Penny Caldicott told newsGP the move is ‘great news’.
 
‘In a way, this has been a good process – we have developed a good relationship with the Board, and it also brought the [integrative medicine] community together to get clear on what we are doing and how we work with each other,’ she said.
 
‘Many, many of the 13,000 submissions came from the public and the Board was surprised by this. It’s a big win for the public. In all this debate over many years, the public voice hasn’t really been heard.’
 
Dr Caldicott believes the ‘vast majority’ of what integrative medicine practitioners do is very low risk.
 
‘We’re GPs first and foremost – we do everything GPs do, as well as offer other solutions, or at times taking a dive into the influences for disease processes,’ she said.
 
Despite many welcoming the decision, public health expert Associate Professor Ken Harvey has expressed disappointment, pointing out that the decision could leave patients potentially unprotected from rogue practitioners offering unproven or outright dangerous therapies. 
 
Instead, he told newsGP that the Board has reverted to the status quo.
 
‘The key issue really is that patients are being exploited by non-evidence based practice like stem cell therapy or chelation therapy that can sometimes be attractive to vulnerable people,’ he said.
 
‘Clearly it was all too hard for the Board. They are concerned but they’re not really offering any solution. Quite frankly, I’m disappointed.’
 
What is needed, according to Associate Professor Harvey, is for the Board and for integrative medicine doctors to collectively agree on a list of higher-risk therapies where evidence is not yet in.
 
‘Surely it would be relatively easy for the Board to say – these things lack evidence and until such time as evidence is available – don’t do it,’ he said.
 
Associate Professor Harvey’s organisation, Friends of Science in Medicine (FSM), called for the Board to list specific, potentially dangerous, therapies in their submission for the consultation.
 
‘Therapies that are not evidence-based really shouldn’t be offered other than in clinical trials,’ he said.
 
‘Yes, medicine changes and we don’t want to stifle innovation or emerging treatments that may eventually become standard. But the only way of sorting that out is with randomised clinical trials – not from gurus saying we will fix you with our stem cells.’ 
 
In response to his calls, Dr Tonkin said producing a list of unproven and potentially dangerous therapies is outside the Board’s scope.
 
‘Having a list is a really good idea – but it’s not something the Board would do,’ she said.
 
‘We don’t tell doctors how to practice – we give them the Code of Conduct. It’s much better if, when we are notified, we deal with each case individually and look at the risk framework for the practitioner, what they’re doing and if they have taken any steps to control risk.
 
‘We are all about the protection of the public and assessment of risk.’ 
 
Through FSM, Associate Professor Harvey has complained about a number of practitioners making unverified claims about stem cell therapies.
 
‘It’s a slow process – you have to pick them off one by one,’ he said. ‘They just keep popping up.’
 
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A.Prof Vicki Kotsirilos, AM   18/02/2021 4:54:55 PM

Thank you to the RACGP for supporting its members!
GPs are in an excellent position to integrate evidence based therapies and provide patients with personalised medical care, and well balanced information.


Dr Graham James Lovell   19/02/2021 10:40:55 AM

Can Dr Tonkin answer WHO would be interested in proactively protecting the public?
I find it unbelievable that as Doctors trying to benefit our patients we aren’t given a clear list of what therapies would be unacceptable by AHPRA.
How can Dr Tonkin recommend it as a good idea, and know what therapies they have been retrospectively handling complaints about, but not publish this as a list.
Would it not be appropriate to now publish that list for the treatments found inappropriate over the last 10 years?
Is this something that requires Government intervention to retrieve that information?