Do you want evidence with that?

The extraordinary standoff between the Therapeutic Goods Administration (TGA) and the website Homeopathy Plus! has escalated. Well, a bit.

As a bit of background you should know that to be sold in Australia, all health products must be on the Australian Register of Theraputic Goods. For a product to make treatment claims other than an anodyne “may assist with …”, the TGA must see evidence that those claims are supported. Typically this involves boxes and boxes of the original data from animal experiments and clinical trials, which are pored over by independent experts to evaluate the claims. Seriously, the boxes of data from the preclinical work alone can fill an entire wall to chest height.

Making treatment claims without evidence is considered rather naughty, after all the consequences of a product making a claim that it will reduce blood sugar levels in diabetics, when it doesn’t are somewhat more serious that a product claiming to leave dishes sparking clean when it doesn’t.

Back in 2009 a complaint was made to the TGA about advertisements for, amongst other things, “homoeopathic vaccines”, including “vaccines” for meningococcal disease. The meningococcal vaccine was a 10-60 dilution, and therefor has a negligible probability of having any molecule of the starting material in it.

Given that the homoeopaths freely admit this lack of material, and claim that an undefined “energy” is somehow producing this effect, and the seriousness of meningococcal infection, you would expect the TGA would require a bucket load of evidence, along the lines of the masses required for conventional medicines, to allow these vaccines to be licensed to be advertised and sold. A couple of papers in homoeopathic publications so obscure I can’t even find their abstracts will not cut it.

Unsurprisingly, if somewhat slowly, the TGA had determined in August 2011 that Homeopathy Plus! was making claims for homeopathic, homeoprophylaxis and homeoprophylactic products that were misleading and unsupported by evidence (see here for some examples), and told them to alter their advertising and website.

Homeopathy Plus! promptly ignored them.

The next step could have been legal action to force Homeopathy Plus! to make the changes or fine them. Instead the TGA have done the equivalent of looking stern and wagging their finger harder and issued another order for them to alter the advertising and web site and issue a retraction (see the full text in legalese here).

As of this evening (March 29) Homeopathy Plus! has not altered its website. Anyone willing to take a bet on the chances of Homeopathy Plus! complying this time?

Join the conversation

24 Comments sorted by

  1. Ilijas Milišić

    logged in via Facebook

    Very pertinent article, reminding us of how impotent the TGA is to protect the Australian consumers.

    During the Fukushima disaster Homeopathy Plus! sent out a newsletter to all its subscribers with brand new homoepathic products designed to counteract radiation poisoning. More water for consumers, and more money for Homeopathy Plus! preying and exploiting fears.

    There has also been a Facebook page set up to provide a discussion forum for the outrageous conduct of Homeopathy Plus! over the last few years.

    https://www.facebook.com/StopHomeopathyPlus

    Please go and take a look, all participation is welcomed.

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  2. Nelly Kibly

    Teacher

    Don't know if you saw the 193 comments on THE CONVERSATION for article "No need for alternative medicine crackdown" 15th March. I am shocked that places like Homeopathy Plus are not having their pants sued off. Why is the TGA so impotent?

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  3. Mat Hardy

    Lecturer in Middle East Studies at Deakin University

    Maybe a belief in homeopathic treatements is a kind of modern Darwinian selection pressure that we should just let run its course?

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    1. Peter Ormonde

      Peter Ormonde is a Friend of The Conversation.

      Farmer

      In reply to Mat Hardy

      I think that's pretty spot on actually Mat.

      I'm all in favour of governments protecting consumers from predators and deceptive conduct... but how does one actually protect people from themselves? Should one bother?

      There is an alternative to banning this sort of silliness outright. Quite simply, every unfounded claim - every homeopathetic panacea- should carry a simple statement of fact... that the manufacturer is unable to provide any evidence whatsoever to support the claims being made, that the therapeutic action of the product cannot be demonstrated in clinical trials, and that the manufacturers cannot explain how it works.

      Then we slap a 150% tax on it and spend the dough on researching sensible stuff.

      This keeps the grinding mills of evolution whirring away while turning out a useful outcome. Not least that, given the enthusiasm of Prince of Whales (sic), we might also see a wider social benefit.

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    2. Laurie Willberg

      Journalist

      In reply to Peter Ormonde

      At the same time all pharmaceutical drugs should carry a black box warning that no long-term studies have been conducted into adverse effects or interactions with other drugs and that they are not guaranteed to produce the same results in each patient. GPs should be required to explain the risks/adverse effects of each drug prescribed with statistical evidence provided to patients indicating what their odds are of experiencing both positive and negative effects, with the very clear understanding…

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    3. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Laurie Willberg

      "There have been no double-blind random-controlled studies ever performed on conventional vaccines"

      Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data. BMJ. 2012 Mar 27;344:e1401. doi: 10.1136/bmj.e1401.
      http://www.ncbi.nlm.nih.gov/pubmed/22454089
      Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: A randomized, placebo-controlled, double-blind, Phase I clinical…

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    4. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Laurie Willberg

      "There have been 2 very notable homeoprophylaxis efforts recently in Brazil for Dengue fever, and in Cuba for Leptospirosis which have produced results that were far more significant than conventional vaccination. "

      No sorry, the report of the Cuban Leptospirosis "homoeopathic vaccine" was fatally flawed. see
      http://apgaylard.wordpress.com/2010/08/08/much-ado-about-nothing/
      and
      http://scienceblogs.com/insolence/2010/11/homeopathy_in_cuba.php
      for layperson friendly descriptions
      and here for a general discussion of "homoeopathic vaccines"
      http://www.sciencebasedmedicine.org/index.php/homeopathic-vaccines/

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    5. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Laurie Willberg

      "At the same time all pharmaceutical drugs should carry a black box warning that no long-term studies have been conducted into adverse effects or interactions with other drugs"

      You mean like this
      http://www.drugbank.ca/system/fda_labels/DB00641.pdf?1265922794
      Where it does explain long term effects and drug disease interactions?

      These information packs are mandated by the FDA, TGA etc. No drug is released without extensive testing of drug interactions (some weird ones will slip though, but it's still better than CAM modalities, which are largely untested).

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    6. Darren Jones

      Biotechnology Manager

      In reply to Laurie Willberg

      Oh boy.

      First, let's deal with your purported status as a 'journalist', just to clear up where your conflicts of interest might lie here. I presume that you are the same Laurie Willberg found here at Homeopathy World Community:
      http://homeopathyworldcommunity.ning.com/group/veterinarians/forum/topic/listForContributor?user=30z9dfa03zcev

      Perhaps you can tell us why you signed on here as a 'journalist' rather than stating your affiliations and involvement with homeopathy front and centre? I…

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    7. Peter Ormonde

      Peter Ormonde is a Friend of The Conversation.

      Farmer

      In reply to Laurie Willberg

      Laurie...

      Stop making stuff up. Wishing doesn't make it true. While the placebo effect has been well documented, belief is not particularly effective as a substitute for facts.

      Here's an anecdote:

      For my sins a few years back I found myself enduring a stint on the Science Faculty board of the joint I was at. My first meeting was considering a proposal from the Administration to establish a faculty of Traditional Chinese Medicine.

      Muggins here straight from working in an area not…

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    8. Rachael Dunlop

      Post-doctoral fellow at University of Technology, Sydney

      In reply to Darren Jones

      Curious, as Laurie has also been commenting on this thread https://theconversation.edu.au/evidence-based-medicine-v-alternative-therapies-moving-beyond-virulence-5978#comments (sorry, I can't post the direct permalink as I can't seem to find it under new formatting - search for "conflicts") where the subject of declaration of conflicts of interest by one commentor was raised. Although Laurie wasn't asked directly, I wonder why he chose not to declare his?

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    9. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Laurie Willberg

      "The mechanism of action of over 80% of conventional drugs is "unknown".

      Incorrect, we know the mechanism of action of the vast majority of drugs, if you look at the top 50 PBS drugs for example, the mechanisms of all these are known. There are protein kinase inhibitors, calcium channel blockers, steroid receptor activators, Renin-angiotensin system inhibitors and HMGCoA reductase inhibitors to name a few mechanisms.

      (Top 35 PBS drugs, see how many mechanisms you can find)
      Ranibizumab Rosuvastatin Bevacizumab Adalimumab Clopidogrel Quetiapine
      Golimumab Amlodipine Ustekinumab Desvenlafaxine Insulin Duloxetine Sitagliptin Ezetimibe Fentanyl Docetaxel Paracetamol Oxycodone Tiotropium
      Buprenorphine Budesonide Etanercept Imatinib Zoledronic Sitagliptin Fluticasone Risedronate Perindopril Nicotine Calcipotriol Alendronate Bisoprolol Enoxaparin

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    10. Sue Ieraci

      Public hospital clinician

      In reply to Darren Jones

      Ah - now I get it. Mr Willberg must be a homeopathic journalist.

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  4. Mark Summerfield

    logged in via Twitter

    It is possible that the TGA does not have the funds to commence legal proceedings (which I assume would be before the Federal Court) in every such case that arises. Government authorities are not exempt from paying court fees, or market rates for counsel to appear on their behalf.

    If this speculation is right, the TGA would not be the only authority charged with enforcing regulations in the public interest, but inadequately-funded to actually use whatever teeth it may be given.

    It would be interesting to hear from someone in the know.

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    1. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Mark Summerfield

      The TGA is damned if they do, and damned if they don't. They come in hard like they did with Pan pharmaceuticals, people are up in arms about their authoritarianism, they come in soft like with Homeopathy Plus! and people complain they are too lenient.

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    2. Rachael Dunlop

      Post-doctoral fellow at University of Technology, Sydney

      In reply to Mark Summerfield

      Hi Mark,

      "Under the Therapeutic Goods Act, there is no provision for the TGA to impose civil penalties for breaches of the advertising code. The TGA can only remove products from the register and refer repeated breaches of the advertising code to the Commonwealth Director of Public Prosecutions for criminal prosecution, where the maximum penalty is a $6600 fine for individuals and $33,000 for corporations."

      See http://bit.ly/H2xqHX

      The fines are less than the costs associated with prosecution hence, the TGA has never exercised this power. There would need to be a change of legislation for this to be altered, which I guess was the point of the recently completed transparency review of which the government ignored most of the more useful recommendations.

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    3. Mark Summerfield

      logged in via Twitter

      In reply to Rachael Dunlop

      Thanks for the information.

      Is there a role for the ACCC, pehaps?

      Although they do not seem very interested in commencing civil proceedings other than in high-profile cases (e.g. Apple iPad '4G'). This is not necessarily a criticism of the ACCC - with limited resources it make sense to focus on cases which will act as a prominent example, and warning, to others. However, it does little to protect those consumers who are more likely to be fooled by dubious claims of medical efficacy than overstated claims of technical capability.

      Either way, it comes down to the fact that action is not economically justified, even if desirable from a policy perspective.

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    4. Rachael Dunlop

      Post-doctoral fellow at University of Technology, Sydney

      In reply to Mark Summerfield

      A complaint about HP! has been made to the ACCC, see http://m.smh.com.au/national/health/warning-on-homoeopathy-vaccines-20120325-1vsix.html

      "In a new complaint to the TGA and the Australian Competition and Consumer Commission, Dr Harvey said Homeopathy Plus! was advertising a "safe and sensible" way of preventing and treating whooping cough without the risk of "dangerous side-effects". The website also includes allegations that currently used vaccines are contributing to a range of illnesses.

      Fran Sheffield, director of Homeopathy Plus!, said although she had no scientific evidence to support the efficacy of her whooping cough products, homoeopaths had seen them working for more than 200 years."

      So I guess we just wait and see.

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    5. Peter Ormonde

      Peter Ormonde is a Friend of The Conversation.

      Farmer

      In reply to Rachael Dunlop

      Rachael,

      The British Society of Homeopaths which represents professional homeopaths, says:

      "The Society acknowledges that the evidence to support the use of homeopathic prophylactics that is, using homeopathic remedies as a preventative treatment, is largely anecdotal and therefore the use of this method is currently speculative.”

      Apparently the jury is in, at least for Dr Harvey and Ms Sheffield. I wonder if actually contracting whooping cough could be considered a "dangerous side-effect".

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    6. Peter Ormonde

      Peter Ormonde is a Friend of The Conversation.

      Farmer

      In reply to Ian Musgrave

      Pan was a slightly different kettle of fish though Ian... the TGA moved after 100 people reported adverse reactions to Pan's Travacalm and 19 had been hospitalised.
      Pan actually pleaded guilty in court to inflicting grievous bodily harm and manufacturing counterfeit pharmaceuticals. They were fined $3 million.
      But the court case Pan initiated turned on fine points of administrative law, arguing that the TGA exceeded its legal powers by pulling the manufacturing licence and ordering a recall of…

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  5. Ken Harvey

    Adjunct Associate Professor of Public Health at La Trobe University

    If you want even more documentation of the sad state of the TGA look at what they posted last week:

    http://www.tga.gov.au/industry/advertising-reg9-2011-05-004-homeopathy-plus.htm

    Complaint submitted to Complaint Resolution Panel (CRP) 05/05/2011

    CRP determination "requesting" compliance sent to Homeopathy Plus 02/08/2011

    CRP informed Delegate of Secretary (TGA) of non-compliance on 06/09/2011

    TGA "ordered" compliance on 19/12/2011

    As of today, still no retraction on the Homeopathy Plus web site!

    The CRP and the TGA are "paper tigers" because they lack easily applied civil penalties such as fines and enforceable undertakings (which have been recommended in numerous government reports over the last decade).

    The ACCC have such powers but they also have many other priorities and responsibilities. The key question is why the government has failed to give the CRP &/or the TGA the sanctions required?

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