Pharmacare Laboratories is facing a new complaint about its Kids Smart homeopathic medicines amid concerns parents who use the products may delay seeking medical treatment.
The complaint – lodged by a group of oranisations including CHOICE to the Australian Competition and Consumer Commission (ACCC) – alleges promotion of the Kids Smart products implies they are effective in ways that have not been established.
Complainants also claim that the promotion of homeopathic “Kids Smart Calm” for “restlessness, anxiety, irritability and agitation” is inappropriate and dangerous as these symptoms can signify potentially serious childhood infectious diseases such as bacterial meningitis that require medical attention.
Promoting homeopathic “Kids Cold and Flu” and “Kid Pain & Fever” remedies as “effective” against “fever, sore throat and body aches and pain” is also likely to deny children genuinely effective medication such as paracetamol, which can relieve these symptoms. The same holds for the homeopathic “Hayfever” remedy.
Over the past three years, Pharmacare Laboratories have had a least 16 complaints upheld by the Therapeutic Good Administration’s Complaints Resolution Panel (CRP), including a number of recommendations to the delegate of the secretary for non-compliance with CRP requests. Indeed, this company appears to treat the regulatory system with contempt.
In addition to CHOICE, the complaint is endorsed by the Consumers Health Forum, Friends of Science in Medicine, the Doctors Reform Society, the Australian Skeptics and Healthy Skepticism.
The complaint notes that in determination 2011/10/027, the CRP requested Pharmacare Laboratories to publish a retraction and withdraw representations made about claims for its Kids Smart range of homeopathic medicines because it breached a number of provisions of the Therapeutic Goods Advertising Code.
Other upheld complaints about the Kids Smart product range include 2011/10/011, 2011/10/011, 2011/09/043 and 2011/09/044. Pharmacare Laboratories has declined to comply with any of these determinations. And it continues to make the same claims on its website promoting these products.
Pharmacare Laboratories’ behaviour shows the impotence of the CRP (which has no power to enforce their determinations) and also the TGA (which has never taken a company to court for non-compliance with its Regulation 9 advertising orders).
It also highlights the importance of the TGA addressing recommendation 2c of the recent advertising consultation, “Develop a more effective approach to sanctions and penalties (including use of the infringement notice provisions)“, which currently appears to have no timeline.

The case illustrates long-standing and fundamental flaws in the regulation of homeopathic medicines in Australia. Homeopathic preparations more dilute than a one thousandfold dilution of a mother tincture are currently exempt from the Australian Register of Therapeutic Goods (ARTG).
This means that the TGA has no power to de-list or otherwise remove the above products from the market despite their gross advertising violations.
In April 2003, the Australian Expert Committee on Complementary Medicines in the Health System recommended that, “Homeopathic medicines and related medicines making therapeutic claims be regulated to ensure they meet appropriate standards of safety, quality and efficacy.”
In 2008, the TGA conducted a consultation on the “Regulation of homeopathic and anthroposophic medicines in Australia”. It was proposed that, “all homoeopathic and anthroposophic medicines must be included in the ARTG, regardless of the final concentration of the ingredients (subject to separate exemptions which will apply to homeopathic and anthroposophic preparations supplied directly to a practitioner for extemporaneous dispensing or compounding)”.
But the issue appears to have dropped off the TGA’s agenda. Despite the concern expressed by many submissions to the TGA transparency and advertising reviews, there’s no mention of homeopathic or anthroposophic medicines in the 2011 TGA Reform document.
The listing of these medicines needs to be pursued because the TGA’s failure to act on these matters has resulted in increasing proliferation of homeopathic products being promoted to the public with claims of efficacy that aren’t substantiated by scientific research.
And the claims go far beyond the allowable statement that “This homoeopathic medicine has been traditionally used for (indication)”. Bauer’s homeopathic product line provides many more examples.
This problem isn’t limited to Australia – see “Homeopathic Insect Repellent: Is there anything the Canadian Natural Health Products Directorate won’t approve?”
Submissions by many consumers and health professionals to recent TGA consultations noted that the continued inaction on such matters meant the community has lost trust in the TGA. The TGA was asked to address these important regulatory matters without further delay.
Given the ongoing impotence of the CRP and TGA, the ACCC has now been asked to take action against Pharmacare Laboratories on the grounds that the ongoing promotion of their Kids Smart range of homeopathic medicines involves misleading and deceptive conduct and is in breach of Australian Consumer Law (Competition and Consumer Act, 2010).
And CHOICE has today awarded a “Shonky” to Pharmacare Laboratories for their “Kids Smart range of homeopathic medicines”.
Dan Smith
Network Engineer
I can't think of a lower form of existence than making profits from giving pretend medicine to sick children. Utterly shameful.
Sue Ieraci
Public hospital clinician
Quite apart from any efficacy claims about homeopathy remedies, how would one even verify their authenticity?
If a homeopathic "remedy" is diluted so that no molecules of the alleged "mother tincture" are present, how is the consumer to confirm what the alleged "remedy" actually is?
How do homeopathic manufacturers carry out quality assurance? What do they measure?
IF all the labels fell off the bottles, how would anyone know that the "remedies" were originally meant to be? How do the manufacturers verify the dilutions?
Luke Weston
Physicist / electronic engineer
Perhaps The Conversation should have the capacity engineered into its website code for readers to "like" magnificent, important, valuable pieces such as this one by Dr. Harvey, much like we already do for other reader's comments.
Sean Manning
Physicist
I comletely agree. The rating of the comments is of secondary importance to the rating of the article quality.
Tim Scanlon
Debunker
The great thing about homoeopathic treatments is that they are free from the tap in your kitchen. Have a cold, drink some water, have a fever, drink some water, have a major debilitating life threatening disease, drink some water. Serving our kids water can't be bad, right?
Guy Curtis
Senior Lecturer at School of Psychology and Exercise Science, Murdoch University
People believe that ineffective therapies seem to work for well-documented psychological reasons, of which the placebo effect is just one: http://www.quackwatch.com/01QuackeryRelatedTopics/altbelief.html
There is now so much scientific information on homeopathy that there is no reason to think it works. Anyone with a half-decent education and a sound grasp of science, logic, and reality can't "research" homeopathy and conclude anything other than it's nonsense. Homeopathy is simply a fraud. What astounds me is that our regulations and regulators are so weak that people selling it and "practicing" it aren't simply shut down and/or charged with fraud.
Mike Jubow
forestry nurseryman
Guy, you have put your finger right on the button. It is fraud. Nothing else, just fraud. If we seriously want to get rid of these companies, all that is needed is for someone with deep pockets to file a complaint with the police. The simple way to prosecute the fraud case would be to get them to produce evidence of independent double blind trials showing that it works. Placebo effect is not proof that these so-called medicines work. Double blind trials were done some years ago in England and France by the Skeptics Society and as I remember, the placebo effect was considered the only active ingredient. We need to get rid of these pseudo-scientific leeches.
Guy Curtis
Senior Lecturer at School of Psychology and Exercise Science, Murdoch University
It shouldn't take deep pockets of an individual to prosecute fraud because it is a criminal matter, it should simply be the relevant level of policing (state or federal) doing their job.
Mike Jubow
forestry nurseryman
It seems to me, a person who, even having studied at university, likes to be the real hands-on-get-it-done type, that all the following guff about "medical subcultures", "social thinking and cultural identities" is just a load of waffle. If we want to see our children being given real medicine, make it law that it has to be approved as effective by independent, double blind testing or it is off the market. The rest of the charlatans and snake oil merchants, charge them with fraud, confiscate their ill-gotten gains for use in medical research and conveniently lose the bloody key when you lock the con men up. You might have guessed, I have a low tolerance level for fools, poseurs and con-merchants, but please keep it a secret.
Michael Bailes
logged in via Facebook
Sometimes I think belief is the only thing that matters
While there is a weird logic to Heinerman's remedies few seem to have noticed Australia has invented its own version "Australian Bush Flower Remedies" These seem to have been inspired by a spiritual walk in the bush. On facebook today I saw one being recommended to prevent skin cancer -"Mulla Mulla" which seems to be a grass with no pharmaceutical, historical or ethnobotanical healing tradition
http://ausflowers.com.au/
Until herbalists are properly academically trained (in Univesities) and some minimum educational standards are applied, this situation can only get worse
BTW
I noticed my (conventional) chemist had a large counter display of Bach's "Rescue Remedy" on his counter yesterday
Mike McRae
logged in via Twitter
While it's easy to point at journal articles, double blinded experiments and countless trials and say 'it's bunk!', it has to be understood that this is not a scientific issue, but a cultural one.
This isn't about scientific evidence existing, but medical subcultures determining what serves as adequate evidence in support of their respective views. Scientific communities and authorities can point, scream and accuse purveyors of alternative medicine as frauds all they want - the issues have been…
Read moreSue Ieraci
Public hospital clinician
Mike McRae - your cultural model doesn't excuse a huge multinational company form marketing littel bottles of water as "remedies" for children.
I don't see any "unsupported assertions on what needs to be done". I see general agreement that the scam should stop.
Martin Bouckaert
logged in via Facebook
"... but medical subcultures determining what serves as adequate evidence in support of their respective views."
In Salem Massachusetts 1692, nineteen men and women, all having been convicted of witchcraft, were carted to Gallows Hill, a barren slope near Salem Village, for hanging. Another man of over eighty years was pressed to death under heavy stones for refusing to submit to a trial on witchcraft charges. Hundreds of others faced accusations of witchcraft; dozens languished in jail for months…
Read moreMike McRae
logged in via Twitter
Excusing implies moral judgment. You're welcome to do that, but I'm more concerned with the pragmatics of finding ways to reduce the negative impacts of poor medical decisions. That requires understanding why alternative medicine persists and what cultural forces are at work.
You don't see unsupported assertions in any of the comments? I see it asserted as fraud and a scam. These terms imply that the sellers of these products recognise it's ineffective but sell it anyway. Quite an assertion based…
Read moreMike McRae
logged in via Twitter
"Now, I'm not comparing people who peddle homeopathic crap to the neurotic puritans of 1692."
Yet oddly you just did.
Nonetheless, if you seriously think science is an unbiased culture, I'm not sure what I can say. The difference is that science holds values in place that permit rigorous criticisms of ideas. I happen to think science is an immensely useful, pragmatic system. I write science education resources for a living. So I don't need to be sold on its uses.
However, my point is not…
Read moreMartin Bouckaert
logged in via Facebook
"Yet oddly you just did."
No, I didn't. Pay attention, because I'm only going to explain this once more.
I can compare the physical motion of a rock to the physical motion of a jet plane, but that doesn't mean I'm comparing a rock to a jet plane.
In this case, I'm giving you an example of why evidence needs to be determined without a bias. In other words, you cannot state your evidence that homeopathy works proves that it works just because you have a biased preference for homeopathy. Homeopathy…
Read moreMike Jubow
forestry nurseryman
Thank you Mike McRae, That was well put. We need more upstanding defense of the scientific method like yours, from more scientists in every field, enlightening the general public through the media and schools. Maybe then we, as a species, might get a bit ahead of the game.
Mike Jubow
forestry nurseryman
My above post was mistakenly addressed to Mike McRae. IT was really meant to be addressed to Mike Bouckert. I do not agree with Mike McReas' stance one iota.
Sue Ieraci
Public hospital clinician
Mike - a civil society requires a set of (largely agreed) moral values.
So, for example, you might be interested in looking at the reasons why vistims of domestic violence stay in abusive relationships, but, at the same time, our society makes interpersonoal violence illegal.
You might want to know why the structures of some churches and their priesthood have allowed the practice of sexual abuse of children to take place, but our society also calls for that behaviour to be illegal.
We can…
Read moreMike McRae
logged in via Twitter
Snark aside, for the most part we seem to agree, Martin. The sticking point seems to be that you're reading my 'is' for an 'ought'. I'm justifying nothing. I'm not supporting or refuting people's right to a different epistemology. That's another conversation.
What I am stating is the medical pluralism exists (which is self evident), and that a significant reason it exists has to do with a rejection of science as a value system in favour of other value systems. That is not synonymous with fraud…
Read moreMike McRae
logged in via Twitter
While I don't disagree with your examples, Sue, medical pluralism isn't quite the same thing as washing clothes. Cultural identity and scientific values aren't built up around laundry beliefs. Clearly the very fact that its easier for unsupported washing machine claims to be dealt with by consumer affairs than medical claims demonstrates this is a vastly more complex issue. The toothlessness of the TGA isn't arbitrary - there is a significant counter-culture reacting to the sense of science being an oppressive, authoritarian threat.
My attitude to domestic abuse, theft, or any other 'immoral' act is little different. I'm less concerned with retribution, and more interested in a utilitarian, evidence based approach to changing a culture to reduce its negative impact on individuals.
Sue Ieraci
Public hospital clinician
"Medical pluralism"? I might understand that term if the competing models were equally valid, but they are far from it. You do understand, don't you, that homeopathic "remedies" don't contain any of the alleged therapeutic substance? The are either water or water-alcohol mix, in a glass bottle, bashed on a hard surface, and sometimes dropped onto sugar or lactose "pillules".
OK - I'll enter the discuss about why so many people in our society spend money on so-called "CAM". Interestingly, the spending…
Read moreMike McRae
logged in via Twitter
Yes, I do understand (not wishing to plug my book, but I devoted a fair bit of a chapter on homeopathy and why it is a 'bad idea'). I've delivered talks in pseudoscience, and developed educational resources explaining how alternative medicine is not scientifically valid by definition. I'm very familiar with homeopathy and its incompatibilities with science. And I'm a science writer and educator by trade, writing and editing for a major science education resource. I'm a big fan of it myself…
Read moreLeon Stewart
Educator
Why do you assume that you occupy the moral high ground?
I believe this connects precisely with what Mike is trying to say in using the phrase 'medical pluralism'.
Too often within these conversations people co-opt science as if it's some kind of sacred belief system, and use the kind of language associated with the Salem witch hunt to describe 'the heathens' who subscribe to anything that cannot be seen by the scientific eye.
Open dialogue, open minds, require opening. Describing homeopathic…
Read moreLeon Stewart
Educator
Your tone is condescending and typical of so many 'scientists' in this discussion. Mike McRae is trying to bring a balance to this conversation but like anyone who opposes or even sends the slightest impression that they might not stand for the status quo, he is written to as if he is a naughty schoolboy.
"Pay attention ... I"m only going to explain this once"
Scientific / academic / open minded discussion? Hardly. But it surely pretends to be.
Challenging the dominant paradigm is a noble…
Read moreKen Harvey
Adjunct Associate Professor of Public Health at La Trobe University
See also: "Understanding the role of scientific evidence in consumer evaluation of natural health products for osteoarthritis an application of the means end chain approach"
http://www.biomedcentral.com/content/pdf/1472-6882-12-198.pdf
Sue Ieraci
Public hospital clinician
"Most people won't get what they want from a GP, unless all they want is a script for another round of "remedy" (officially acceptable as medicine)."
Leon Stewart - you are practising exactly the closed mind and narrow vision of which you are accusing others.
The real advantage of medicine is that it is a system of therapies, including pharmacology, but not limited to that. A large part of what GPs do involves reassurance and counselling, but the method of payment doesn;t encourage them to…
Read moreMike McRae
logged in via Twitter
Thanks Ken. Interesting paper, and one that aligns with a lot of the research on the issue with regards to other alternative fields. Also indicates it's not as simple as a belief in science versus an opposition to it, but is a complex spectrum.
Cheers.
Craig Morton
Biomedical Research Scientist
Please go to their website - it allows comments on each of these products.
I suspect anything sensible will be blocked by moderation, but it's worth a try!
Mike Jubow
forestry nurseryman
Craig, I had a look but couldn't find the comment page. I may have started at the wrong place. Could you please give me the web address? Thanks mate.
Craig Morton
Biomedical Research Scientist
It's a the bottom of each image on their webpage. For example:
http://www.kidssmart.com.au/kids-smart-products/kids-smart-natural-medicine-pain-fever/#comments
Sue Ieraci
Public hospital clinician
No new comments posted there - I suspect there has been some immoderate moderation.
Stephen Lehocz
Interested public.
I read your article and I wondered why did I take alternative medicine, because what you say had a logic to it. And believe it or not I do respect your advice. And I thought back to when I started to take them and I remembered that I took them because drugs and traditional medicines failed me.
Read moreSo the point you make about delaying life saving treatments lacks credibility. Mainly because the people who I’ve met who take alternative medicines take them because they did not achieve the desired outcomes…
Sue Ieraci
Public hospital clinician
Stephen - you misunderstand the significance of placebo-controlled trials. Yes - placebo effect works with all therapies. That's why an effective therapy has to be shown to be BETTER than placebo (or the existing therapy).
You may have personally met people who take other remedies because medicine hasn't helped them. The fact that you have not met those - like the tragic Penny DIngle - who forgo medicine for the scam remedies does not mean they dont exist. This is where the harm lies, quite apart from the ethical issues of deception and withholding effective treatment.
Stephen Lehocz
Interested public.
No I don’t Sue, your missing my point. The placebo effect is active in medicines of any description - including drugs. So to claim that alternative medicine works only from the placebo effect is very misleading.
Read moreYou mentioned Champix (in a previous post) has a success rate of 20%. Assuming a placebo responce of say 15%, (I know there is no exact figure for it) the success of Champix is only 5% more than the placebo. That is a tiny success rate. That would mean that Champix relies for most of it…
Sue Ieraci
Public hospital clinician
Stephen Lehocz says "The dangers from drugs still dwarves any risks from alternative medicines, to such a degree, that it is a craziness to harp on about a medicine that has no side effects."
Apples and oranges, Stephen.
Effective pharmaceuticals absolutely swamp "alternative medicines" in efficacy. (The "altern tives" are called "altern tive" because the DON't work better than placebo. If they did, they would be called "medicines".) Effective medicines inevitably will have some degree of side-effects because they have pharmacological effects. That;s why they work.
When anyone sells a product that is claimed to contain therapeutic ingredients, but is found not to, that is both false advertising and fraud. Pure and simple. If any pharmaceutical was sold as containing an antibiotic, or beta blocker, or whatever, but didn't contain a single molecule of that substance, that would be false advertising and fraud too. Why is it accepted of the "alternatives"?
Stephen Lehocz
Interested public.
Sue, thank you for repeating my viewpoint which I still stand by.
Read moreBut finally you bring up a very important point. Does it work?
Just because - you - can’t find any effective ingredients or any method by which something should work, does NOT mean it does not work. I would contend it’s a lack of ability to see other peoples viewpoints, except your own or you just believe what the “experts" tell you, without looking around and seeing what reality actually shows. Now that is very bad science. The…
Stephen Lehocz
Interested public.
Here is another article on the type of false advertising and fraud you mentioned:
https://theconversation.edu.au/insight-into-how-pharma-manipulates-research-evidence-a-case-study-4071
Sue Ieraci
Public hospital clinician
"Just because - you - can’t find any effective ingredients or any method by which something should work, does NOT mean it does not work."
No, Stephen. It's because these "remedies" contain no therapeutic ingredients AND they have not been found to work.
Sue Ieraci
Public hospital clinician
Stephen - whatever "pharma" does or doesn't do still doesn't make water with no therapeutic ingredients any more effective.
You "definitely dispute" my statement "Effective pharmaceuticals absolutely swamp "alternative medicines" in efficacy,..."?
Go ahead - what is your contrary evidence?
Stephen Lehocz
Interested public.
Sue, Big Pharma does have a great deal to do with this article as it talks talks about misleading claims and false advertising, so my comments about GSK hews very closely with the topic of this article. GSK’s crimes in the USA would indicate many deaths, and blunted lives by falsely advertising their drugs.
What you say is still your - opinion - with, from what my experience indicates, is dubious science.
As I said, from my personal experience and from what I have observed from improvements in myself and others, the alternative remedies have a great deal of workability. That is what I have observed. So do you expect me to throw all I have found to be true by personal observation of predictable (and repeatable) cause and effect away, just because you say it’s all false?
I have my own personal improvements in myself and others, which shows me that there is something very wrong with the premise of Ken’s article.
Evidence you asked for:
http://www.ncbi.nlm.nih.gov/pubmed/20674839