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EARLIER this year comment was invited on a proposal to regulate the advertising of therapeutic goods, causing a great deal of angst among complementary medicine practitioners.
The Therapeutic Goods Administration (TGA) invited comment on advertising reform proposals via a regulation impact statement (RIS) — “Regulating the advertising of therapeutic goods to the general public” .
Following a number of public campaigns against two of the proposals, and objections from naturopaths, herbalists, homeopaths and Blackmores, the closing date for comment has been extended to 5pm this Friday, 19 July.
After considering public submissions on this latest document, the TGA will prepare a final RIS for the government to consider the proposed regulatory reforms.
Concerns and recommendations about the need for advertising regulatory reform date back to the 2002 “Report of a review of advertising therapeutic products in Australia and New Zealand” and have continued ever since. The current RIS merely provides the latest battleground in which reform proposals have been fiercely contested by self-interested stakeholders, especially the complementary medicine sector.
So which of the eight advertising reform proposals put up by the TGA has aroused the ire of naturopaths, herbalists and homeopaths? It’s Proposal 6: Advertising directed to health professionals, option 2 and Proposal 5: Advertising of higher risk medical devices, option 2.
Currently, “health professionals” are defined as practitioners registered under the National Registration Accreditation Scheme (NRAS) administered by Australian Health Practitioners Regulation Agency (AHPRA). Complementary practitioners such as herbalists, homeopaths and naturopaths are defined as members of an Australian branch of one of the bodies listed in the TGA regulations.
The proposal relating to advertising directed to health professionals makes reference only to AHPRA-registered practitioners, thereby excluding herbalists, homeopaths, naturopaths and other complementary medicine practitioners who don’t have AHPRA registration. This would mean that advertising to non-registered practitioners would be regulated in the same way as advertising to the general public.
Advertising directed to the general public (whether published by or on behalf of the sponsor or a health care professional) must comply with a range of requirements prohibiting false, misleading and socially irresponsible advertising of therapeutic goods. The requirements also prohibit reference to serious conditions which require the diagnosis and/or management of a health care professional (among other matters).
In contrast, advertising directed to “health professionals” is exempt from TGA advertising requirements on the grounds that health professionals have the requisite knowledge to separate promotional wheat from chaff (an assertion that has been disputed).
Promotions to health professionals are subject to industry codes of conduct (of which there are many, regrettably with varied standards).
The TGA’s rationale for proposal 6 is that they are not assured that non-registered health practitioners are able to exercise specialist judgement when either treating patients with advertised therapeutic goods, or advising them about the use of advertised therapeutic goods.
This appears to be the main point of contention by the naturopaths, herbalists, homeopaths and Blackmores, who are vigorously opposing this option. They argue that complementary health care practitioners are educated and approved by government in the higher education as well as the vocational education and training sectors.
The reality is that naturopaths, herbalists and homeopaths have not achieved national registration for a number of reasons, including the plethora of organisations that represent them and their many and varied educational and professional standards.
Although there are well trained complementary health care practitioners whose practice is evidence-based, there are many others who use shonky diagnostic and therapeutic techniques such as bio-impedance analysis and live blood analysis, and who are unaware of their limitations.
TGA’s proposal 5 would prohibit the advertising of higher risk medical devices to the public, including class IV in-vitro diagnostic devices (those with a high public health risk). Naturopaths say this will reduce access to their tools of the trade, but it would produce an evidence-based debate about the public health risks of many of the devices they use.
TGA’s proposal 6 is also appropriate. False, misleading and socially irresponsible advertising of therapeutic goods should be prohibited, as should giving advice about serious conditions that require the diagnosis and/or management by an AHPRA-registered health care professional. This proposal may also provide the stimulus required for the complementary health care professions to get their act together to achieve registration status.
All proposals in the TGA RIS document deserve thoughtful input from medical practitioners and other stakeholders. It would be pity if their views were drowned out by a concerted campaign from naturopaths, herbalists, homeopaths and Blackmores.
Dr Ken Harvey is adjunct associate professor at the School of Public Health, La Trobe University. He has represented consumer organisations on many of the consultations mentioned above. He can be contacted via medreach.com.au
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Interesting coincidence, in this very same issue of MJA INSIGHT:
“However, a recent study in the UK showed that GPs regularly prescribe knowing that the drug in question will not improve things — antibiotics for viral infections, for example. Less frequently they may prescribe sugar pills.
Is this ethical? Should the patient be told or passively deceived? Opinion is divided, which for me raises the interesting question as to whether patients visit a doctor to be told everything or to be helped through an illness without necessarily being fully informed?”
Like Leviathan, I strongly support a team approach to health and well-being, involving doctors, nurses, midwives, physios, dietitians, speech therapists, psychologists, occupational therapists – these are all science-based therapies that work together. These progessions are truly complementary. What knowledge or skills do naturopaths have that are not already covered within these professions? Endeavour College is a major training institution for ”alternative” therapies – the website states that ”The study of Naturopathy includes herbal medicine, diet and nutrition, flower essence therapy, nutritional supplementation, naturopathic diagnostic techniques including iris analysis along with a general understanding of various forms of therapy.” Flower essences and iris analysis are not science. Why do we need a profession that mixes some science of nutrition with other highly dubious aspects, when we have dietiticians?
To Peter (17/7) it was recently estimated that of an approximate 50,000 vitamins, minerals and other supplements available in the US, then in the absence of specific deficienty states, only three have been shown to have any scientific benefit. You have spent 40 years feeling good from taking placebos, and enriching the manufacturers. Wake up and look at the science – despite your lack of specific knowledge I am sure you can do that – unless you like shelling out so much money on entertainment. Personally, I buy CDs.
Dieter L: Complementary is a much better term than Alternative. As part of a collaborative health care approach, detailed lifestyle modification (nutrition, exercise, etc) advice provided by a naturopath (or physio, or dietician, etc) can be an invaluable help to most time-poor medical practitioners. For safety’s sake a qualified doctor should be the initial triage step for somebody with worrying symptomatology and that fully-independent practice by those not qualified to diagnose serious illness is inappropriate. My cynicism derives from reading the signs advertising independent naturopaths who also practice iridology and homeopathy, which are absolutely indefensible, scientifically disproven woo-woo. Osteopathy and chiropractic run a third and fourth place regarding false claims.
I agree with Ken Harvey also in the example you give. It’s up to naturopaths to pointedly divorce themselves from the woo-woo and condemn those who fail to practice evidence based scientific health care. I would also freely condemn doctors who include such iridology/homeopathy entertainment (a few do) as shaming their qualifications and not fit to call themselves doctors. A scientific prism needs to be held up to every person who advertises themselves as a health practitioner. Those who practice scientifically are in (in whatever capacity, with appropriate safety boundaries) and qualify for health fund rebates. Those who do not are either to be regarded as entertainers or liars, and dealt with appropriately, and it goes without saying excluded from all taxpayer funding and from using the term “health”. The key to it all is merciless scientific rigour. There are a lot of sacred cows ripe for the sacrifice in all our fields.
”Millions of people all over the world practicing, using or believing in all kind of Natural Holistic type of Complementary Medicine, it has been with us forever, and it is not going to go away.” Millions of people all over the world also believe in astrology, and have done so for centuries, and it also is not going away but that doesn;t make it valid. It is difficult to understand what valid knowledge and skills are known to naturopaths that do not exist within medicine or nutrition science. If people were prepared to pay out of pocket for a hour with their GP and/or practice nurse, they could get a thorough medical assessment as well as lifestyle and advice and counselling, and get a referral to a dietician.
Hi Leviathan, I love treating “worried people well” 🙂 … anyhow, I have no problems with the medical system, many of my friends are Doctors, and I do know how hard and long they studied. But I also know about the time restrictions, treating priorities and even frustrations of not having enough time.
Personally, I believe naturopathics would be a valued addition to the health system, and yes, it would need some specific rules and regulation, and coming back to a specific part of the original article, I agree with with Ken Harvey; “the complementary health care professions to get their act together to achieve registration status”.
If you are totally against that option, I guess there is nothing to discuss. However if you could see that there is a possibility of “complementary” medicine being a valued addition to the medical system, than please support us, by adding specifc constructive criticism, one at a time.
By the way, the emphasis is on “complementary”. Naturopathic consultations are usually 1 hour, and in that consultation, we can take time to “complement” the medical system.
Dieter L: ” there are absolutely countless papers written on Vitamins, Minerals, Amino Acids regarding their therapeutic effect, and I am sure you would be aware of vitamins used in any medical practice”. Gosh, I didn’t realise vitamins were important in health – thanks!. The question is whether (as you seem to assert) health is improved by specific supplements over and above a normal balanced diet and exercise regime. Newsflash: using specific vitamins and minerals to counteract deficiencies is orthodox medicine. The roles of specific herbal preparatiions over and above their known constituent vitamins and trace element content is what is wide open to question and where the claimed evidence base fails. The bland contention that natropathic “doctors” promote wellness and actual doctors treat disease is laughable and shows ignorance of medical training. Megadose supplements are continually being evaluated over a variety of health areas and when proven efficacious are fed into normal medical practice. The use of herbs without a proper evidence base (and there are plenty of examples of that) constitutes entertainment, not science. Perhaps those of you with medical degrees who felt the need to supplement your qualifications with “naturopathy” missed the relevant undergraduate physiology and biochemistry teaching sessions, or perhaps you just enjoy treating the worried-well?
The issue should be very simple, there are Millions of people all over the world practicing, using or believing in all kind of Natural Holistic type of Complementary Medicine, it has been with us forever, and it is not going to go away.
We also know, that the medical system is totally overburdened. It is only logical, and in the benefit of the whole of society, that specific Complementary Practitioners, should be fully recognised.
It is also totally evident that by example, General Practitioners have no time to educate a patient in prevention and lifestyle modifications. The near epidemic proportion of overweight people, and the associated “possible” health risk, would be much better cared for by Naturopaths, and this is only one minor group, the by far larger group of patients are sent home by a general practitioner, because diagnosis and possible tests have produced no treatable disease.
As weird as it may sound, but by telling the patient that there is nothing wrong with them, GP’s indadvertedly are sending those patients to Naturopaths or other Complementary practitioners.
It is also evident, that one can’t class a whole group of people under one name, such as Complementary Medicine, this simply leads to confusion. To monitor proper education and clinical training, as well as registration, practitioners need to be known under their treatment modality, such as Naturopathy.
It is to the detriment of everyone, if qualified practitioners such as Naturopaths get confused with “fraudulent’ people who try to make money out of the misery of sick people.
By recognised training and registration all this could be remedied.
The issue is not so much ”different paradigms of health” but different understanding – or acceptance – of evidence. I agree that there should be no ”western” vs ”complementary” – there should be stuff that is shown to work (medicine) and abandonment of stuff that has not been shown to work, or is not scientifically plausible, except in controlled trials. This should apply to any therapeutic substance – whether herbally derived or ”manufactured”, whether a ”supplement” or a ”drug”. Incidentally, science-based medicine is not owned by the ”west” – people around the world will use, study and practice science-based medicine if they have access. I would also like to see all prescription of remedies separated from dispensing/retailing, removing the therapist’s vested interest in selling a remedy or supplement. Could “Sydney Naturopath and Herbalist” direct us to the body of evidence used in his/her practice? Perhaps each product leaflet from a supplement or homeopathic ”remedy” should include an analysis of its contents and the evidence of its efficacy.
Modern medicine and complementary medicine are based on different paradigms of health. Because of this, it is futile to try to pit one against the other, it is also petty to pass judgement on one another when our cultures of ‘health’ are so different. Why can’t we work together for the betterment of our clients? Isn’t that what it’s all about? Take away the theme of western versus complementary medicine, and we reach the most important issue: the health and wellbeing of the public. It seems to me that the industry of naturopathy, with the establishment of higher education, more rigorous evidence based study and research and registration organizations like ARONAH, is already forging ahead in the right direction to better regulate practitioners for the betterment of the public.
“Sue”, do we know which bacteria will resist which antibiotic? Which ovulation induction therapy will lead to ovarian cancer? Which proton pump inhibitor will cause osteoporosis? No, not much “evidence” out there to support adverse drug events. Every drug product information leaflet I pick up inevitably lists, warnings of liver cancer, aneurysms, blood clots, endless lists. Why aren’t these “rare” events researched so we can rule them out. Facts are, pharmaceutucal drugs do cause liver cancer, bacterial resistance, blood clots & the like. Hopefully MRSA doesn’t rear it’s ugly head in the hospital you work at.
“Lidija” – evidence-based medicine doesn’t just refer to therapies that are supported with randomised controlled trials – it also means that the therapy is based on the clinical sciences. With modern technology and centuries of reasearch, we know a lot about how human physiology works (though we clearly don’t know everything). We can directly image the cell membrane with electron microscopy. We know the concentration of potassium both inside and outside cells. We know how the kidney filter system works, and which antibiotics kills which bacteria best. We know what influences insulin secretion and what triggers ovulation. On that background, we can know with confidence that the homeopathic principle of ”like treats like” is not valid, and we also can directly observe and measure that extremely dilute solutions have no physiological effect on the body. That is evidence-medicine. I can understand a person with MS – or any other chronic disease, seeking whatever answers they can – but the fact is, MS (like many other chronic diseases) has a relapsing-remitting and unpredictable course. And, for your information, I work in a public hospital, I do not see pharmaceutical reps, but I attend workshops every year on the evidence base in my specialty. Oh, and I buy my own pens. You might want to ask your naturopath whether they see any product representatives, or directly sell any supplements themselves.
Fourteen years ago i was diagnosed with MS, the supposed evidence based medicine offered no hope only a barrage of medications with numerous side effects. I think the exact words were” you just have to live with it, make arrangement to do so”. As a last resort I consulted a naturopath with result that you can only dream about. I regained the use of my hand and legs, and are no longer suffering from fatigue, enabling me to returned to work full time as well as spending the last six years studying nutritional medicine and naturopathy at Endeavour College or Natural Health (evidence based) in order to understand how nutrition and herbal medicine can restore health to a supposedly lose cause. I can’t understand why orthodox medicine is so threaten, we would all do better to work together, rather than against each other. The only thing that matter is health is restored to those who are deny it. Have a good hard look at yourselfs and work out what is more important. I thank god that I choose to move from orthodox medicine to complementary medicine, even against my family’s wishes. I hope that I can share some of my knowledge with others, in order to show them that the have a right to feel well and are not something to be toy with.
We all just love to throw around this en vogue term “evidence-based medicine”, don’t we? What’s your source of evidence-based literature Sue? The young pharmaceutical rep that offers you lollies & free pens? Who’ll show you studies funded by his boss to support claims that their new drug is safe & effective. Where are the longitudinal studies on these drugs that you prescribe so willingly? What are the long term risks to your patients? You mightn’t even care. The only danger complementary medicine poses is to your inflated ego. Clever people are cottoning-on & are refusing to be drug addicted for the rest of their lives. Natural medicine is becoming increasingly popular whether you like it or not. I just find it sad that we can’t integrate the two because of old, dated values. Get with the times & have yourself a cup of chamomile tea, I promise you, it won’t kill you.
I am neither a qualified naturopath, nor am I a Medical Doctor. I have nevertheless been taking vitamins and similar supplements for approximately forty years achieving significant health benefits by doing so.
I am also a lawyer. It is my view that Proposal 6 will do significantly more harm to patients, far outweighing any potential benefit relating to advertising.
Under Proposal 6, advertising material regarding vitamins, minerals and herbs will be made available to GPs, Psychologists, Pharmacists, Optometrists, Chiropractors, Physiotherapists, Nurses and Midwives, Dentists, Dentists Hygienists, Dental Prosthetists, Dental Therapists and denied to the very people for whom it is largely intended – Naturopaths.
Does the TGA seriously believe that Chiropractors, Optometrists, Physiotherapists, Nurses, Midwifes or Dental Hygienists are in a better position to assist their patients with their knowledge of vitamins, minerals and herbs than Naturopaths who are specifically trained in the therapeutic uses of vitamins, minerals and herbs?
There is something rotten in the State of Denmark if they do – and something rotten in the State of Denmark if they don’t.
Homeopathy is the intentional use of placebo. A person who has trained in the clinical sciences must have a lot of congitive dissonance in using homeopathic ”remedies” – which can be so dilute that not a single molecule of the original substance is detectable, even if the ”mother tincture” were to have any therapeutic benefit. The principle of ”like treats like” is equally dubious – with examples like onion, which causes tears and a runny nose, being used to treat colds. Jean, when you procure ”remedies”, how can you verify their quality? How can you, or your patients, have any confidence about the contents of the bottle if there is no detectable ”remedy” in it? If someone swapped the labels, how would you know?
As a Dr and a Homeopath homeopathy is my most useful tool.
I would feel greatly handicapped if was unable to procure and prescribe remedies where appropriate to do so
”Dr Paul” – I am not trained in naturopathy, but all medical graduates are trained in ”nutrition” – from the salivary glands to the anal glands, from Vit B12 deficiency to haemochromatosis, from gastric acid secretion to carbohydrate metabolism. Certainly we are not trained in dietetics – we refer to qualified professionals in this area, just as we are not all trained speech therapists or physios. Ms Hunt ND talks of ”rigorous evidenced based training” and then mentions that she practises ”live blood analysis”, and fears that the loss of this might be detrimental to her patients. There is no scientific evidence for ”live blood analysis” as a diagnostic tool – indeed, it is often used as a way of promoting an unnecessary supplement. (see http://oig.hhs.gov/oei/reports/oei-05-00-00250.pdf). If a supplement is to treat a clinically-significant deficiency, which can’t be addressed by dietary change, it is medicine. If that medicine is from herbal origin, but purified and standardised, it’s still medicine. If dietary advice is necessary, we can refer to dieticians – whose entire training is in this area.
It always saddens me to hear biased, unqualified and generalised critique or straight out attack on naturopathy. It just shows, that Naturopathy has to be much more promoted to over come the ignorance attached to it.
Any generalised “term” to describe a Naturopath, Acupuncturist, Remedial Massage Therapist, Chiropractor, etc; unfortunately just leads to confusion. Terms like Alternative don’t really mean anything, and those terms have not been selected by qualified naturopaths.
Regarding, “prove in proper controlled trials that even 10% of your potions are therapeutic”; please be aware that there are absolutely countless papers written on Vitamins, Minerals, Amino Acids regarding their therapeutic effect, and I am sure you would be aware of vitamins used in any medical practice. Folic Acid, B12. Regarding Herbal treatments, if you are constipated and you don’t believe herbs are a useful treatment, take some Senna.
There are too many treatments to list here, here is just one more; Benign prostatic hyperplasia, medical treatment is virtually non-existing, most Doctors recommend to their patients to buy a supplement to relieve the uncomfortable symptoms of urinary frequency and urgency, which is extremely uncomfortable and painful. And yes, those supplements help.
I find constructive discussion so much more helpful.
I am a registered medical practitioner and a Degree qualified naturopath. I prescribe both medications, nutritionals and Herbal medicines using Peer reviewed journal or text book sources, not advertising materials. The lack of evidence claims by skeptics for herbal medicines is pure rubbish, there is an extensive evidence base should one care to become educated in such things. Clearly Sue I, and M Busby nor Ken Harvey for that matter, have no understanding of functional medicine or the primacy of nutritional imbalances to most chronic diseases that western medicine is so blatantly unable to halt the progress of.
Studying naturopathy is like studying the bible. You can study it with good intentions, you can know it inside out and back to front, but at the end of the day, it’s still mostly rubbish.
I am a fully quallified Naturopath, graduating with a Bach Hlth Sci degree (Nat) 4 yrs. The rigorous evidenced based training I undertook mainly at Southern Cross Uni underpins my ability to offer effective, safe and beneficial treatments to my clients in the future.
I also undertake extensive post graduate training some of which was Live Blood Analysis training. It offers my clients an accurate screening method. If proposal 5 Advertising of higher risk medical devices is not maintained at option 1 –status quo I fear this would compromise my ability to offer my best treatment possible to my patients.
Naturopaths are highly trained particularly in Western Herbal Medicine; Nutrition; Biochemistry, Integrated Pharmacology, clinical examinations etc. Naturopath’s are also required to undergo post graduate training to continue practicing. As such it could jeopardize public health if other allied health professionals could prescribe herbal tinctures and supplements if we could not. Whilst other allied health professionals are experts in their field, they lack the extensive training in Nutrition and Western Herbal medicine necessary.
The likely regulatory impacts of the proposals are catastrophic. This could compromise my patient’s welfare and put public health at severe risk.
I ask that you support our industry and help Naturopath’s continue to take some strain off the already congested medical system. Integration is key. I ask that you support no change to the status quo.
Please vote no on the above poll.
Genevieve Hunt N.D.
The elephant in the room here is in the term “Therapeutic Goods”. Nothing that has no evidence base should be promoted as being “therapeutic”. Any claim of health benefit needs to show a proper evidence base, as should all claims by “health practitioners” of every stripe. The term “alternative medicine” is completely misleading. If it works, and that is proven, it is called “Medicine”, otherwise the better term is “entertainment” and the practitioners of quackery should be called “entertainers” and excluded from all “health practitioner” terminology. Similarly, health insurers should be prohibited from taxpayer subsidy if they provide benefits for unproven therapies. Sue Ieraci hits the nail on the head. Come on naturopaths and herbalists. prove in proper controlled trials that even 10% of your potions are therapeutic, or stop whining.
.. it is not about medical advice, it is about advising people how to live a health life. Doctors are knowledgeable
about diseases and their treatments, Naturopaths are knowledgeable about health, prevention and drug less therapies, this distinction is often overlooked.
In my over 30 years of a practicing Naturopath, I have seen thousands of patients coming to me because they wanted answers of how to improve their health, which they didn’t get form their medical practitioner. I could use my knowledge to support those patients. Most of our advice and natural therapy is science and evidence based, other advise is given out of experience.
In every section of medicine, natural medicine included, is a need for improvement. However, just because of some fraudulent or unqualified people, one shouldn’t come to the conclusion that the whole field of Natural Therapy is a “danger” to society, quiet to the contrary, it would be a shame if the general public would not be allowed to select well qualified Naturopaths for their health improvement. It should be also acknowledge , that Naturopaths are as committed as medical practitioners to the care of their patients.
I do agree with Dr Ken Harvey about Naturopaths to achieve registration status, however I am sure he knows that powerful bodies have lobbied against that, and I think mainly out of ignorance. Most problems we have been accused of, have nothing to do with qualified Naturopaths, we are as much appalled about fraudulent praxices and unrealistic claims as any medical Doctor.
I find the comments by the posters about prescribing to be puzzling. Registered medical practitioners are required to prescribe safely and effectively – using therapeutic susbstances with an established pharmacological profile. Why would a GP want to prepare, prescribe or dispense non-standardised herbal remedies, and why would this regulation make them want to do so? On the contrary – it’s not about GPs prescribing herbs – it’s about people promoting herbs not making false claims for their efficacy or safety. Most disturbing from a consumer point of view is the dispensing of homeopathic remedies – for which it is impossible to establish that the highly diluted ”remedy” noted on the label is actually contained in the ”remedy”. Don’t worry, naturopaths. GPs won’t be hawking herbs.
It takes 4 years of study to earn a Bachelor of Health Science as Naturopath. How can a GP who has not studied the 4 year degree have the knowledge or understanding to prescribe herbal medicine safely or effectively? As a Naturopath I would not prescribe a GP’s medicine as I am not qualified and the same rules should be enforced for a GP when prescribing natural medicine. Without the qualification the patients health is at risk. There is a Naturopathic principle: First, to do no harm, by using methods and medicines that minimize the risk of harmful side effects. How can this be achieved without the relevant qualification?
If you want to give medical advice, and you are not a doctor ….there is a problem. Anybody can have a medical opinion and it may well be correct and based on valid information. But there is a lot more to doctoring which is hard enough for people who have the qualification, let alone somebody without that training. An air hostess knows a lot about aeroplanes and flying….but I would still rather have a pilot in charge, thank you.
So, medical doctors with no training in herbal medicines would be able to make therapeutic claims regarding herbal products, but herbalists and naturopaths with training in herbal medicines would not be able to make therapeutic claims regarding herbal products. Now that makes sense…[not!] Sounds more like a patch protection regulatory system to me.