Part 2 of Paul Smith's 'investigation'
Posted: Thu Apr 21, 2011 8:34 am
In part 2 of our series, PAUL SMITH asks if regulation can bring the alternative medicine industry into line, or if it could risk legitimising it.
FRANCINE Scrayen is crying. "Don't you understand why I'm so wary of you?" she asks down the telephone line. "Can't you tell that I've been to hell and back?"
It's hard to answer either question with a no. Mrs Scrayen has become a symbol of all that is wrong with the regulation of alternative medicine.
She is the Perth homeopath who treated Penelope Dingle -- the homeopath who diagnosedhaemorrhoids when Mrs Dingle said she had blood in her faeces, who later, when it turned out to be bowel cancer, influenced Mrs Dingle's decision to ditch chemotherapy, radiation and surgery in favour of homeopathy.
Mrs Dingle died in August 2005, having spent the final two years of her life in agonising, unnecessary pain, losing a fight against a disease she could have won. So no, it isn't hard to understand why Mrs Scrayen is wary about talking to reporters.
Yet the trauma of the experience has not caused her to retreat from view completely. Despite being exposed and condemned for her medical ignorance, Mrs Scrayen is still free under Australian law to put up her therapeutic shingle.
If you Google her name, you still come across a listing with a Kingsway address advertising her services as a homeopath.
"Look, I don't even understand the internet. I've not asked [for] my name to be there," she says. "I can't talk to you, do you understand?" She puts down the phone.
The death of Penelope Dingle sits as an extreme example of what can go wrong with alternative medicine. Mrs Dingle surrounded herself with practitioners who believed in the non-medical paradigm -- including one GP who prescribed her intravenous vitamin C injections, intramuscular mistletoe and Venus flytrap extract in the belief they could slow the growth of a tumour.
But her death also highlights wider concerns about the growth of complementary and alternative medicine in this country. Concerns that the alternative therapy industry -- described by some as a burgeoning $3 billion black market of healthcare, with practitioners estimated to number in excess of 20,000 -- is in urgent need of greater scrutiny.
Alternative medicine has infiltrated the mainstream. From university courses and health insurance offerings to the shelves of pharmacies around the country, as therapies that were once on the fringes become much more commonly used, the question becomes how the health system should respond.
Dr Jon Wardle, a naturopath and NHMRC scholar at the University of Queensland, is blunt: "It's a risk that a substantial part of the health system is left unregulated simply because it's seen as an alternative modality. This is a public health issue waiting to explode."
Both state and territory governments are aware of concerns about the unregulated nature of alternative therapies. A formal consultation is underway about how to regulate the unregulated. Various options are being put forward, ranging from leaving things as they are to introducing statutory laws to protect the public.
Meanwhile, alternative therapists are clamouring for recognition within more formal arrangements under the Australian Health Practitioner Regulations Agency -- alongside doctors, dentists, nurses and other health professions.
This process is already underway. Next year, traditional Chinese medicine will join AHPRA. Naturopaths and herbalists are expecting to put in a submission to join later this year.
For supporters, full registration will guarantee the basics: that practitioners can recognise blood in a patient's faeces as a red flag event, understand the limitations of their therapies, and know enough about what they are prescribing to ensure the risks of adverse reactions are reduced.
As Dr Wardle says, "They will also be able to be held accountable when they do the wrong thing. Regulating naturopaths and herbalists will mean that there will be a proper complaints system [which can lead to de-registration]."
But others worry that bringing alternative therapists under AHPRA will contribute to the creeping legitimisation of practices that have limited proof of efficacy, and are rooted in often scientifically bizarre theories.
The coroner in Mrs Dingle's case, Alastair Hope, holds that view. "I have serious reservations about any efforts to register or otherwise legitimise homeopathy or other similar alternative forms of medicine," he wrote at the end of his judgement. "Any apparent legitimisation of these regimes could provide mixed messages for vulnerable and often desperate cancer sufferers."
Australia's regulatory mechanisms are based almost solely on public risk. To become a regulated profession under AHPRA, its practitioners do not have to show evidence that what they provide works -- but simply that regulation under AHPRA will reduce the likelihood of patient harm.
Within the 10 professions already regulated under AHPRA, it is the profession's own associations that defines the scope and standards of good practice. Ultimately what can and cannot be done, provided patient harm is minimised, is determined by peers, not by any outside agency.
Dr Wardle argues there should be no alarm. He does not expect that AHPRA regulation would result in a quick evidence-based revolution for naturopaths and herbalists. But if regulation means practitioners are required to complete university degrees, abide by codes of conduct and pay lip-service to the restrictions imposed by respect for evidence, he suggests this will foster a culture willing to reject the more extreme viewpoints.
Yes, Dr Wardle says, regulation should ideally be based on the principle that a profession offers treatments proven to work.
"[But we do have] clauses that say things like practitioners must practise within 'accepted professional standards' and the codes of conduct of the boards are recommended to have a clause such as 'practitioners must practise in accordance with the current and accepted evidence base of the health profession, including clinical outcomes'," he says.
"[If naturopaths and herbalists are regulated under AHPRA], it will penalise shotgun- or protocol-based medicine, which is usually the kind we hear about with the same five or six products walking out the door for every patient. Practitioners will provide clinical justification for their treatments."
For the medical profession, this might be a major step in the right direction. But for many wanting to stop patient exploitation by the bad end of the CAM industry, it remains far from a complete solution.
Reaching beyond
To critics, especially those within the medical profession, modern chiropractics offers a prime example of a discipline reaching beyond its evidence base and its expertise.
Its 19th-century founder, Daniel David Palmer, believed 95% of all disease was the result of displaced vertebra.
Even though his bizarre theories are no longer accepted by most chiropractors, a significant number offer to treat anything from ADHD, allergies and asthma, to high blood pressure, bacterial infections, infertility and learning difficulties. Their scope of practice is not about lower back pain.
It also seems some chiropractors have taken on the role of educating the public about the dangers of vaccination -- in some cases by recycling the lies and half truths of the anti-vaccination lobby.
In public, at least, there has been little objection to this anti-vaccination stance from the chiropractic profession -- a profession whose code of conduct requires members to practise in an "evidence-informed context".
The Chiropractic Board of Australia has been largely silent. It appears that its only official statement on chiropractors and vaccinations was a vague warning last year about complaints it had received about "claims of effectiveness and advice about vaccinations".
Yet chiropractic is at the centre of another controversy in Melbourne, where RMIT University -- the self-proclaimed leader in chiropractic tertiary education -- is training hundreds of students a year in masters and bachelors degrees as part of "the world's first government-supported chiropractic program".
Whether universities should be teaching therapeutic theories that are alien to the concepts on which medical science is based is controversial. There has been outcry in the UK against institutions generating money by running courses in various complementary and alternative medicine disciplines. The University of Westminster, for example, was forced to scrap its BSc in Homeopathy two years ago after its vice-chancellor was attacked by the editor of the Catholic Herald, Damian Thompson, for "peddling mumbo jumbo".
But the precise role of Australian universities and colleges in the teaching of alternative therapies is a topic rarely debated here.
Last month, Loretta Marron, a former Australian Skeptic of the Year and one-woman crusader for science, wrote to the Federal Health Minister Nicola Roxon, urging her to shut down RMIT's paediatric clinic in Bundoora, which was set up, according to the university's website, "to provide assessment and care of children and infants".
Ms Marron argues that teaching students chiropractic techniques to use on infants, children and pregnant women is potentially dangerous. She is far from alone. Her 20-page submission included letters in support from some of medicine's biggest names -- including Professor Jennifer Couper, head of paediatrics at the University of Adelaide; HPV vaccine inventor Professor Ian Frazer, now director of the Diamantina Institute at the University Queensland; Professor Chris Del Mar, the GP and leading light in the Cochrane Collaboration from Bond University; and Professor Edzard Ernst, the world's first professor of complementary medicine. All raised concerns about chiropractic moving beyond its evidence base.
Professor Alastair MacLennan, head of obstetrics and gynaecology at the University of Adelaide and author of another letter in Marron's submission, said the "use of non-evidence-based alternative therapies in children is a form of child abuse, albeit well intentioned". He added: "The lay public, and in particular children, require protection from unnecessary physical manipulation."
"Parents of sick children are a particularly vulnerable group, easily exploited by chiropractors," Professor Joseph Forgas at the University of NSW declared in his contribution. "It is high time that the claimed chiropractic treatments of pregnancy, babies and young children should be regulated and join the long list of bogus therapies that we no longer tolerate."
Creeping pseudo-science
At the end of last year, journalists from the Skeptic -- the house magazine of the Australian Skeptics -- had a go at documenting what they described as the "creeping of pseudo-scientific subjects" into university course content.
Their article began with a basic review of the information sent out by the universities and colleges -- from the Canberra Institute of Technology's advanced diploma in naturopathy and the Sunshine Coast TAFE's diplomas in reflexology and Ayurvedic lifestyle consultation, to degrees in traditional Chinese medicine at Sydney's University of Technology, and Macquarie University's Masters of Chiropractic.
In all, the magazine found 11 of the country's 30-plus universities were running degree or diploma courses of "potentially questionable scientific value".
The Skeptic's journalists then set themselves the more difficult task of determining whether these courses were teaching about the therapies and the evidence for their safety and efficacy, without straying into promoting methodologies as "being valid and proven when the truth is quite opposite".
The magazine's journalists wrote to every institution and received answers from less than half.
Of those who did reply, most offered a cursory response. Professor Gary Martin, acting vice-chancellor at Murdoch University, said chiropractic was an "emerging profession … represented increasingly in universities". He said his university's environment facilitates "quality assurance, professionalism and scientific enquiry".
Vice-chancellor of UTS Professor Ross Milbourne simply said UTS' academic board reviews the academic and educational merits of all course offerings "in accordance with high levels of academic standards and academic review".
According to the Skeptic journalists, Professor Nicholas Klomp, dean of the faculty of science at Charles Sturt University, was the most willing to address the issues raised.
He said its course ensured students had formal health and scientific training, as well as an understanding of the need for evidence-based practice and the limitations of specific complementary therapies.
He said he believed universities had a role in improving the alternative therapy industry by improving the "scientific training of potential practitioners, so that they are likely to offer a service to the public that is less likely to make unfounded and or incorrect claims of efficacy or, worse, impede referral of genuinely sick clients to the more formal healthcare system".
The magazine decided there was an easier way to test whether colleges were peddling unproven methodologies -- by looking to see if they ran their own clinics using the techniques.
With RMIT the answer was yes. Murdoch University too. A clear sign, according to the journalists, that, as far as the universities were concerned, "these are proven modalities".
RMIT last month dismissed claims that its paediatric clinic was teaching potentially harmful theories. In the face of criticism from the medical community, the university remained adamant that it promoted evidence-based chiropractic education and practice, recognising there was an "overall lack of high-level clinical evidence" in the discipline.
So, given this, what conditions are treated at RMIT's Bundoora paediatric clinic?
"We do not aim to treat conditions," the university's PR man said. "We look at the biomechanical situation for an individual and make the appropriate gentle adjustments. This can improve the situations in other parts of the patient's health but RMIT is not claiming a direct cause.
"So, in that sense, we do not have a shopping list of conditions that we treat, apart from lower back pain and neck pain and headache."
However, Loretta Marron, who has yet to hear back from the Federal Health Minister, asks: "If there is no direct cause between 'gentle manipulation' and the improvement of patient's health, you wonder what is the point of these clinics offering treatments beyond lower back pain.
"For babies and small children, for non-musculoskeletal health conditions such as ADHD, asthma, otitis [media], bedwetting and other health conditions, chiropractic offers no value above placebo … but comes with significantly more risks than just doing nothing."
THE PRIVATE HEALTH INSURERS
TWO months ago, Australian Doctor took on one of its biggest challenges yet. To find out why the private health insurance industry, subsidised to the tune of about $3 billion a year by the taxpayer, spends money funding treatments ranging from iridology and homeopathy to reflexology and reiki massage. Not exactly the Watergate of health journalism but, in terms of the effort involved in getting answers, it felt like it.
Each of the big funds — NIB, MBF, Medibank Private and HCF — offer policyholders the option of cover for at least some alternative therapies. So we sent to each company a list of straightforward questions we hoped would function as night flares — to cast some light on the sums being ploughed in, the numbers of policyholders taking them up, and why the funds all seemed willing to pay for homeopathy, despite its evidence base being as flimsy as an Echinacea flower in a hailstorm.
Sadly, the responses were in most cases less than illuminating. MBF, for example, made almost daily promises to respond, but rarely kept those promises.
At one stage it ignored all Australian Doctor’s questions and wrote its own, a one-line question followed by six paragraphs of text talking about the need to respect members’ rights to make their own choices.
MBF is an interesting case, not only because it covers the widest range of alternative therapies of all the main insurers, but because its chief medical officer is Dr Christine Bennett, the former chair of the National Health and Hospitals Reform Commission tasked by the Federal Government in 2007 to draw up a blueprint for sorting out the ills of Australia’s health system.
When asked to respond to the original questions, the company still failed to make it clear whether it told its policyholders about the black hole of evidence for the efficacy of homeopathy and iridology.
And when we asked whether Dr Bennett “supports [the company’s] funding of Chinese herbalism, Feldenkrais, homeopathy, iridology, naturopathy and Western herbalism and could she explain the clinical justification for these therapies?” the response was crafted with a lawyer’s precision for avoiding the issue.
“MBF, of which Dr Christine Bennett is our chief medical officer, continues to support members’ decisions to consider natural and complementary therapies, in conjunction with advice from medical practitioners.”
NIB — which covers herbal remedies and naturopathy — ignored three of the seven questions we put to it. At first, it didn’t give any justification for why it funds these therapies. But after a follow-up email, it said it did so because of “the benefits it provides [customers]”.
Another email from Australian Doctor —“Is NIB saying that homeopathy has health benefits?” — seemed to dry the well of co-operation. “I have stated the reasons why customers seek treatment in my previous emails,” the PR man replied.
Medibank Private, it has to be said, gave a full response. It stressed that it did not pay for treatments or remedies, just a $20 benefit for the consultations. “We understand the clinical benefits are contested, however allowing our members to claim benefits for consultations is not intended to be an endorsement of the practice, but is simply a response to demand from our members. Medibank respects our members’ ability to make personal choices in regards to their individual well-being.”
HCF took a different tack, letting us know that it “preferred not to respond to each of our questions”. It also preferred not to explain why. In its response, it said homeopathy represented only 0.05% of its health benefit expenditure. It also claimed its “primary reference” was the work of Professor Edzard Ernst, director of complementary medicine at the University of Exeter and Plymouth, and his book called The Desktop Guide to Complementary and Alternative Medicine.
For anyone trying to justify homeopathy as a treatment worth paying for, using Professor Ernst as your “primary reference” is a brave choice, principally because, as the world’s only professor of complementary medicine, he thinks homeopathy is garbage.
“Homeopathy is among the worst examples of faith-based medicine,” he wrote in the American Journal of Medicine in 2009. “These axioms [of homeopathy] are not only out of line with scientific facts but also directly opposed to them. If homeopathy is correct, much of physics, chemistry, and pharmacology must be incorrect.”
So we sent HCF the link to the paper. HCF is yet to respond.
THE PRODUCTS …
AUSTRALIA’s top medicines watchdog, the Therapeutic Goods Administration, recently carried out a random spot check on about 400 complementary medicines — the vitamins, minerals and herbal supplements that make up a large part of the alternative health industry’s booming sales.
It found 90% breached the various regulations imposed on manufacturers, including making unsubstantiated curative claims. In a rare moment of action, the TGA pulled about a dozen of the products off the market, although it has yet to make public the identity of the products themselves.
To Dr Ken Harvey, a public health academic at La Trobe University who has become the country’s evidence-based Don Quixote, tilting against the windmills of bogus health products, Australia’s drug regulator was to be applauded for baring its teeth. But he is also conscious that the problem facing the agency is just the sheer scale of what it is now meant to police.
The latest estimates suggest that there are now more than 10,000 complementary and alternative products and medicines on the Australian Register of Therapeutic Goods (ARTG).
The TGA doesn’t evaluate all so-called lower risk medicines — the over-the-counter products, the herbs, vitamins, minerals — for efficacy. To ensure they can sell these products legally, the sponsors of these products must declare they have the evidence proving the therapeutic claims. The sponsor submits summary evidence to the TGA with the expectation that one in four products will be subject to post-marketing evaluation. It can take as little as 10 days and a $650 application fee to get a product listed by the TGA as a therapeutic good.
In 2007, the registration process for new mainstream medicine (which has to show safety and efficacy) cost in excess of $190,000.
The result is that ARTG has been home to a long line of dodgy weight-loss products, detox kits, homeopathic “medications” and, according to the Australian newspaper, a list of herbs and potions promising to “nourish the fei”, transform “turbid dampness” and sort out the “middle jiao”, along with various magnetic contraptions and devices that apparently relieve tinnitus, shingles, restless legs, sprains, muscle fatigue, high blood pressure and bed sores.
Dr Harvey’s question is why the TGA and the Federal Government have not even got as far as sticker warnings — something as basic as ‘This medicine has not been evaluated by Australian health authorities for efficacy’.
“I used to think it was a conspiracy between the makers of these products and the government,” Dr Harvey says. “Now, I’m not so sure. It feels like incompetence.”
For the companies that actively make false and misleading claims about the therapeutic value of their alternative products, the stick is usually wielded by the Complaints Resolution Panel. It’s the TGA’s key body in dealing with the shonks and charlatans, and is meant to “ensure public health and safety” while allowing what the TGA describes as “a dynamic and fair environment for the manufacturing of products”.
The CRP — as it’s often referred to — has also served as an acronym for both the products it is meant to investigate and an adjective of its own effectiveness.
In 2009, about one-third of those found to have breached the TGA advertising code simply ignored the panel’s recommendations, which usually come in the form of demands to retract unlawful claims and publish corrections.
--
Kind regards,
Fran Sheffield
Homeopathy Plus! (Tutorials - Remedies - Immunisation)
http://www.homeopathyplus.com.au
Do No Harm Initiative (Free Information on Homeopathic Immunisation)
http://www.d-n-h.org
Homeopathy for Autism (Guidelines for Treatment - Search for Practitioners)
http://www.homeopathy4autism.com
FRANCINE Scrayen is crying. "Don't you understand why I'm so wary of you?" she asks down the telephone line. "Can't you tell that I've been to hell and back?"
It's hard to answer either question with a no. Mrs Scrayen has become a symbol of all that is wrong with the regulation of alternative medicine.
She is the Perth homeopath who treated Penelope Dingle -- the homeopath who diagnosedhaemorrhoids when Mrs Dingle said she had blood in her faeces, who later, when it turned out to be bowel cancer, influenced Mrs Dingle's decision to ditch chemotherapy, radiation and surgery in favour of homeopathy.
Mrs Dingle died in August 2005, having spent the final two years of her life in agonising, unnecessary pain, losing a fight against a disease she could have won. So no, it isn't hard to understand why Mrs Scrayen is wary about talking to reporters.
Yet the trauma of the experience has not caused her to retreat from view completely. Despite being exposed and condemned for her medical ignorance, Mrs Scrayen is still free under Australian law to put up her therapeutic shingle.
If you Google her name, you still come across a listing with a Kingsway address advertising her services as a homeopath.
"Look, I don't even understand the internet. I've not asked [for] my name to be there," she says. "I can't talk to you, do you understand?" She puts down the phone.
The death of Penelope Dingle sits as an extreme example of what can go wrong with alternative medicine. Mrs Dingle surrounded herself with practitioners who believed in the non-medical paradigm -- including one GP who prescribed her intravenous vitamin C injections, intramuscular mistletoe and Venus flytrap extract in the belief they could slow the growth of a tumour.
But her death also highlights wider concerns about the growth of complementary and alternative medicine in this country. Concerns that the alternative therapy industry -- described by some as a burgeoning $3 billion black market of healthcare, with practitioners estimated to number in excess of 20,000 -- is in urgent need of greater scrutiny.
Alternative medicine has infiltrated the mainstream. From university courses and health insurance offerings to the shelves of pharmacies around the country, as therapies that were once on the fringes become much more commonly used, the question becomes how the health system should respond.
Dr Jon Wardle, a naturopath and NHMRC scholar at the University of Queensland, is blunt: "It's a risk that a substantial part of the health system is left unregulated simply because it's seen as an alternative modality. This is a public health issue waiting to explode."
Both state and territory governments are aware of concerns about the unregulated nature of alternative therapies. A formal consultation is underway about how to regulate the unregulated. Various options are being put forward, ranging from leaving things as they are to introducing statutory laws to protect the public.
Meanwhile, alternative therapists are clamouring for recognition within more formal arrangements under the Australian Health Practitioner Regulations Agency -- alongside doctors, dentists, nurses and other health professions.
This process is already underway. Next year, traditional Chinese medicine will join AHPRA. Naturopaths and herbalists are expecting to put in a submission to join later this year.
For supporters, full registration will guarantee the basics: that practitioners can recognise blood in a patient's faeces as a red flag event, understand the limitations of their therapies, and know enough about what they are prescribing to ensure the risks of adverse reactions are reduced.
As Dr Wardle says, "They will also be able to be held accountable when they do the wrong thing. Regulating naturopaths and herbalists will mean that there will be a proper complaints system [which can lead to de-registration]."
But others worry that bringing alternative therapists under AHPRA will contribute to the creeping legitimisation of practices that have limited proof of efficacy, and are rooted in often scientifically bizarre theories.
The coroner in Mrs Dingle's case, Alastair Hope, holds that view. "I have serious reservations about any efforts to register or otherwise legitimise homeopathy or other similar alternative forms of medicine," he wrote at the end of his judgement. "Any apparent legitimisation of these regimes could provide mixed messages for vulnerable and often desperate cancer sufferers."
Australia's regulatory mechanisms are based almost solely on public risk. To become a regulated profession under AHPRA, its practitioners do not have to show evidence that what they provide works -- but simply that regulation under AHPRA will reduce the likelihood of patient harm.
Within the 10 professions already regulated under AHPRA, it is the profession's own associations that defines the scope and standards of good practice. Ultimately what can and cannot be done, provided patient harm is minimised, is determined by peers, not by any outside agency.
Dr Wardle argues there should be no alarm. He does not expect that AHPRA regulation would result in a quick evidence-based revolution for naturopaths and herbalists. But if regulation means practitioners are required to complete university degrees, abide by codes of conduct and pay lip-service to the restrictions imposed by respect for evidence, he suggests this will foster a culture willing to reject the more extreme viewpoints.
Yes, Dr Wardle says, regulation should ideally be based on the principle that a profession offers treatments proven to work.
"[But we do have] clauses that say things like practitioners must practise within 'accepted professional standards' and the codes of conduct of the boards are recommended to have a clause such as 'practitioners must practise in accordance with the current and accepted evidence base of the health profession, including clinical outcomes'," he says.
"[If naturopaths and herbalists are regulated under AHPRA], it will penalise shotgun- or protocol-based medicine, which is usually the kind we hear about with the same five or six products walking out the door for every patient. Practitioners will provide clinical justification for their treatments."
For the medical profession, this might be a major step in the right direction. But for many wanting to stop patient exploitation by the bad end of the CAM industry, it remains far from a complete solution.
Reaching beyond
To critics, especially those within the medical profession, modern chiropractics offers a prime example of a discipline reaching beyond its evidence base and its expertise.
Its 19th-century founder, Daniel David Palmer, believed 95% of all disease was the result of displaced vertebra.
Even though his bizarre theories are no longer accepted by most chiropractors, a significant number offer to treat anything from ADHD, allergies and asthma, to high blood pressure, bacterial infections, infertility and learning difficulties. Their scope of practice is not about lower back pain.
It also seems some chiropractors have taken on the role of educating the public about the dangers of vaccination -- in some cases by recycling the lies and half truths of the anti-vaccination lobby.
In public, at least, there has been little objection to this anti-vaccination stance from the chiropractic profession -- a profession whose code of conduct requires members to practise in an "evidence-informed context".
The Chiropractic Board of Australia has been largely silent. It appears that its only official statement on chiropractors and vaccinations was a vague warning last year about complaints it had received about "claims of effectiveness and advice about vaccinations".
Yet chiropractic is at the centre of another controversy in Melbourne, where RMIT University -- the self-proclaimed leader in chiropractic tertiary education -- is training hundreds of students a year in masters and bachelors degrees as part of "the world's first government-supported chiropractic program".
Whether universities should be teaching therapeutic theories that are alien to the concepts on which medical science is based is controversial. There has been outcry in the UK against institutions generating money by running courses in various complementary and alternative medicine disciplines. The University of Westminster, for example, was forced to scrap its BSc in Homeopathy two years ago after its vice-chancellor was attacked by the editor of the Catholic Herald, Damian Thompson, for "peddling mumbo jumbo".
But the precise role of Australian universities and colleges in the teaching of alternative therapies is a topic rarely debated here.
Last month, Loretta Marron, a former Australian Skeptic of the Year and one-woman crusader for science, wrote to the Federal Health Minister Nicola Roxon, urging her to shut down RMIT's paediatric clinic in Bundoora, which was set up, according to the university's website, "to provide assessment and care of children and infants".
Ms Marron argues that teaching students chiropractic techniques to use on infants, children and pregnant women is potentially dangerous. She is far from alone. Her 20-page submission included letters in support from some of medicine's biggest names -- including Professor Jennifer Couper, head of paediatrics at the University of Adelaide; HPV vaccine inventor Professor Ian Frazer, now director of the Diamantina Institute at the University Queensland; Professor Chris Del Mar, the GP and leading light in the Cochrane Collaboration from Bond University; and Professor Edzard Ernst, the world's first professor of complementary medicine. All raised concerns about chiropractic moving beyond its evidence base.
Professor Alastair MacLennan, head of obstetrics and gynaecology at the University of Adelaide and author of another letter in Marron's submission, said the "use of non-evidence-based alternative therapies in children is a form of child abuse, albeit well intentioned". He added: "The lay public, and in particular children, require protection from unnecessary physical manipulation."
"Parents of sick children are a particularly vulnerable group, easily exploited by chiropractors," Professor Joseph Forgas at the University of NSW declared in his contribution. "It is high time that the claimed chiropractic treatments of pregnancy, babies and young children should be regulated and join the long list of bogus therapies that we no longer tolerate."
Creeping pseudo-science
At the end of last year, journalists from the Skeptic -- the house magazine of the Australian Skeptics -- had a go at documenting what they described as the "creeping of pseudo-scientific subjects" into university course content.
Their article began with a basic review of the information sent out by the universities and colleges -- from the Canberra Institute of Technology's advanced diploma in naturopathy and the Sunshine Coast TAFE's diplomas in reflexology and Ayurvedic lifestyle consultation, to degrees in traditional Chinese medicine at Sydney's University of Technology, and Macquarie University's Masters of Chiropractic.
In all, the magazine found 11 of the country's 30-plus universities were running degree or diploma courses of "potentially questionable scientific value".
The Skeptic's journalists then set themselves the more difficult task of determining whether these courses were teaching about the therapies and the evidence for their safety and efficacy, without straying into promoting methodologies as "being valid and proven when the truth is quite opposite".
The magazine's journalists wrote to every institution and received answers from less than half.
Of those who did reply, most offered a cursory response. Professor Gary Martin, acting vice-chancellor at Murdoch University, said chiropractic was an "emerging profession … represented increasingly in universities". He said his university's environment facilitates "quality assurance, professionalism and scientific enquiry".
Vice-chancellor of UTS Professor Ross Milbourne simply said UTS' academic board reviews the academic and educational merits of all course offerings "in accordance with high levels of academic standards and academic review".
According to the Skeptic journalists, Professor Nicholas Klomp, dean of the faculty of science at Charles Sturt University, was the most willing to address the issues raised.
He said its course ensured students had formal health and scientific training, as well as an understanding of the need for evidence-based practice and the limitations of specific complementary therapies.
He said he believed universities had a role in improving the alternative therapy industry by improving the "scientific training of potential practitioners, so that they are likely to offer a service to the public that is less likely to make unfounded and or incorrect claims of efficacy or, worse, impede referral of genuinely sick clients to the more formal healthcare system".
The magazine decided there was an easier way to test whether colleges were peddling unproven methodologies -- by looking to see if they ran their own clinics using the techniques.
With RMIT the answer was yes. Murdoch University too. A clear sign, according to the journalists, that, as far as the universities were concerned, "these are proven modalities".
RMIT last month dismissed claims that its paediatric clinic was teaching potentially harmful theories. In the face of criticism from the medical community, the university remained adamant that it promoted evidence-based chiropractic education and practice, recognising there was an "overall lack of high-level clinical evidence" in the discipline.
So, given this, what conditions are treated at RMIT's Bundoora paediatric clinic?
"We do not aim to treat conditions," the university's PR man said. "We look at the biomechanical situation for an individual and make the appropriate gentle adjustments. This can improve the situations in other parts of the patient's health but RMIT is not claiming a direct cause.
"So, in that sense, we do not have a shopping list of conditions that we treat, apart from lower back pain and neck pain and headache."
However, Loretta Marron, who has yet to hear back from the Federal Health Minister, asks: "If there is no direct cause between 'gentle manipulation' and the improvement of patient's health, you wonder what is the point of these clinics offering treatments beyond lower back pain.
"For babies and small children, for non-musculoskeletal health conditions such as ADHD, asthma, otitis [media], bedwetting and other health conditions, chiropractic offers no value above placebo … but comes with significantly more risks than just doing nothing."
THE PRIVATE HEALTH INSURERS
TWO months ago, Australian Doctor took on one of its biggest challenges yet. To find out why the private health insurance industry, subsidised to the tune of about $3 billion a year by the taxpayer, spends money funding treatments ranging from iridology and homeopathy to reflexology and reiki massage. Not exactly the Watergate of health journalism but, in terms of the effort involved in getting answers, it felt like it.
Each of the big funds — NIB, MBF, Medibank Private and HCF — offer policyholders the option of cover for at least some alternative therapies. So we sent to each company a list of straightforward questions we hoped would function as night flares — to cast some light on the sums being ploughed in, the numbers of policyholders taking them up, and why the funds all seemed willing to pay for homeopathy, despite its evidence base being as flimsy as an Echinacea flower in a hailstorm.
Sadly, the responses were in most cases less than illuminating. MBF, for example, made almost daily promises to respond, but rarely kept those promises.
At one stage it ignored all Australian Doctor’s questions and wrote its own, a one-line question followed by six paragraphs of text talking about the need to respect members’ rights to make their own choices.
MBF is an interesting case, not only because it covers the widest range of alternative therapies of all the main insurers, but because its chief medical officer is Dr Christine Bennett, the former chair of the National Health and Hospitals Reform Commission tasked by the Federal Government in 2007 to draw up a blueprint for sorting out the ills of Australia’s health system.
When asked to respond to the original questions, the company still failed to make it clear whether it told its policyholders about the black hole of evidence for the efficacy of homeopathy and iridology.
And when we asked whether Dr Bennett “supports [the company’s] funding of Chinese herbalism, Feldenkrais, homeopathy, iridology, naturopathy and Western herbalism and could she explain the clinical justification for these therapies?” the response was crafted with a lawyer’s precision for avoiding the issue.
“MBF, of which Dr Christine Bennett is our chief medical officer, continues to support members’ decisions to consider natural and complementary therapies, in conjunction with advice from medical practitioners.”
NIB — which covers herbal remedies and naturopathy — ignored three of the seven questions we put to it. At first, it didn’t give any justification for why it funds these therapies. But after a follow-up email, it said it did so because of “the benefits it provides [customers]”.
Another email from Australian Doctor —“Is NIB saying that homeopathy has health benefits?” — seemed to dry the well of co-operation. “I have stated the reasons why customers seek treatment in my previous emails,” the PR man replied.
Medibank Private, it has to be said, gave a full response. It stressed that it did not pay for treatments or remedies, just a $20 benefit for the consultations. “We understand the clinical benefits are contested, however allowing our members to claim benefits for consultations is not intended to be an endorsement of the practice, but is simply a response to demand from our members. Medibank respects our members’ ability to make personal choices in regards to their individual well-being.”
HCF took a different tack, letting us know that it “preferred not to respond to each of our questions”. It also preferred not to explain why. In its response, it said homeopathy represented only 0.05% of its health benefit expenditure. It also claimed its “primary reference” was the work of Professor Edzard Ernst, director of complementary medicine at the University of Exeter and Plymouth, and his book called The Desktop Guide to Complementary and Alternative Medicine.
For anyone trying to justify homeopathy as a treatment worth paying for, using Professor Ernst as your “primary reference” is a brave choice, principally because, as the world’s only professor of complementary medicine, he thinks homeopathy is garbage.
“Homeopathy is among the worst examples of faith-based medicine,” he wrote in the American Journal of Medicine in 2009. “These axioms [of homeopathy] are not only out of line with scientific facts but also directly opposed to them. If homeopathy is correct, much of physics, chemistry, and pharmacology must be incorrect.”
So we sent HCF the link to the paper. HCF is yet to respond.
THE PRODUCTS …
AUSTRALIA’s top medicines watchdog, the Therapeutic Goods Administration, recently carried out a random spot check on about 400 complementary medicines — the vitamins, minerals and herbal supplements that make up a large part of the alternative health industry’s booming sales.
It found 90% breached the various regulations imposed on manufacturers, including making unsubstantiated curative claims. In a rare moment of action, the TGA pulled about a dozen of the products off the market, although it has yet to make public the identity of the products themselves.
To Dr Ken Harvey, a public health academic at La Trobe University who has become the country’s evidence-based Don Quixote, tilting against the windmills of bogus health products, Australia’s drug regulator was to be applauded for baring its teeth. But he is also conscious that the problem facing the agency is just the sheer scale of what it is now meant to police.
The latest estimates suggest that there are now more than 10,000 complementary and alternative products and medicines on the Australian Register of Therapeutic Goods (ARTG).
The TGA doesn’t evaluate all so-called lower risk medicines — the over-the-counter products, the herbs, vitamins, minerals — for efficacy. To ensure they can sell these products legally, the sponsors of these products must declare they have the evidence proving the therapeutic claims. The sponsor submits summary evidence to the TGA with the expectation that one in four products will be subject to post-marketing evaluation. It can take as little as 10 days and a $650 application fee to get a product listed by the TGA as a therapeutic good.
In 2007, the registration process for new mainstream medicine (which has to show safety and efficacy) cost in excess of $190,000.
The result is that ARTG has been home to a long line of dodgy weight-loss products, detox kits, homeopathic “medications” and, according to the Australian newspaper, a list of herbs and potions promising to “nourish the fei”, transform “turbid dampness” and sort out the “middle jiao”, along with various magnetic contraptions and devices that apparently relieve tinnitus, shingles, restless legs, sprains, muscle fatigue, high blood pressure and bed sores.
Dr Harvey’s question is why the TGA and the Federal Government have not even got as far as sticker warnings — something as basic as ‘This medicine has not been evaluated by Australian health authorities for efficacy’.
“I used to think it was a conspiracy between the makers of these products and the government,” Dr Harvey says. “Now, I’m not so sure. It feels like incompetence.”
For the companies that actively make false and misleading claims about the therapeutic value of their alternative products, the stick is usually wielded by the Complaints Resolution Panel. It’s the TGA’s key body in dealing with the shonks and charlatans, and is meant to “ensure public health and safety” while allowing what the TGA describes as “a dynamic and fair environment for the manufacturing of products”.
The CRP — as it’s often referred to — has also served as an acronym for both the products it is meant to investigate and an adjective of its own effectiveness.
In 2009, about one-third of those found to have breached the TGA advertising code simply ignored the panel’s recommendations, which usually come in the form of demands to retract unlawful claims and publish corrections.
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Kind regards,
Fran Sheffield
Homeopathy Plus! (Tutorials - Remedies - Immunisation)
http://www.homeopathyplus.com.au
Do No Harm Initiative (Free Information on Homeopathic Immunisation)
http://www.d-n-h.org
Homeopathy for Autism (Guidelines for Treatment - Search for Practitioners)
http://www.homeopathy4autism.com