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The document was released by the TGA in response to an FOI for Infringement Notices and Enforceable Undertakings issued by the TGA against sponsors on the ARTG.

In other words, someone was trying to find out which companies who have products on the Australian Register of Therapeutic Goods and have been issued with infringement notices for unspecified breaches.

In April this year the TGA began a transparency review so consumers would be better informed about their practices. If this is the result then they’re doing it wrong.

I lold.

Download a copy of the form here.

As someone on Twitter said

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UPDATE: I was informed last night that the TGA has listed 13 dodgy devices on the ARTG in the past week. Seven are holographic devices, five are ‘energy patches’ and another is a TENS device. Amongst the “energy patches” are Lifewave, (yes those make-shit-up, nanotechnology homeopathic pieces of gauze) and holographic energy bracelets, (see Power Balance) called CieAura.

Regular readers would know by now that the process of getting a product listed on the ARTG is based on an honesty system where sponsors type in their product, select the ingredients from a pre-approved list, pay a fee (< $1000) and bing! Get an official looking L number for their product and a listing on the official government list of medical devices. I can’t say this often enough (and perhaps I should, given that I’m probably tipping sponsors off to ways around the TGA) but you don’t need to provide evidence up front. You just have to say you possess it.

I’ve blogged about this before.

That CieAura would make it onto the ARTG is just embarrassing given that they’re just a copy of PowerBalance who were chased out of Australia earlier this year by the ACCC (the TGA did play a role). And Lifewave? You only need to Google them to find links to scam websites and other dubious activities. Plus, they are homeopathic (so there’s nothing in them) and they are non-transdermal (so they don’t transfer anything into your system) so what exactly do they do then? Precisely.

Fortunately, there has been some good news this morning about this debacle. I’ve been informed that The Lifewave patches have been cancelled from the ARTG and the CieAura holographic bracelets are under investigation. I’ll keep you posted. In the meantime let’s continue to play whack-a-mole with the TGA, mischievous sponsors and the TGA. Cause until the legislation is changed, this process will continue unabated.
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An article from Australian Doctor described how a complaint against the makers of Nurofen – an ibuprofen based pain killer – were directed to stop claiming their product could “go to the site of pain”.

According to the article:

Reckitt Benckiser Australia Pty Ltd was ordered by the TGA’s complaints resolution panel to withdraw a television advertisement for Nurofen that claimed the product “targeted relief from pain” and “goes straight to the source of pain”.

However in a statement, Reckitt Benckiser said it did not agree with a number of the sanctions imposed by the TGA panel and therefore,

Nurofen advises that consumers will continue to see the familiar branding of the Nurofen target and messages of Nurofen working at the site of pain. This branding includes TGA approved claims on packs that Nurofen provides targeted relief from pain.

Sigh.

Of course Reckitt Benckiser are by no means the first company to essentially flip the bird and say “get stuffed we’ll do what we want” to the TGA. Indeed, today’s statement follows a damning audit of the TGA’s management of complementary and alternative therapies released recently, which essentially described the TGA as having no teeth to enforce rulings against companies who do the wrong thing. Mick Vagg has covered some of the details here.

The audit came after a review of a random sample of listed products – “listed” meaning supplements, vitamins, (some) homeopathic preparations and other products classified as “low risk” including 31 types of ear candles, which found over ninety percent of products breached TGA guidelines. This review was from 2009/2010 and the one 5 years prior to this found over seventy five percent of products breached guidelines.

Out of the 31 products which were selected for the 2009/10 review, only 3 were found to fully comply (I’ve blogged about this previously here). Of the rest, 22 were found to have manufacturing and/or quality issues, 20 had labelling issues such as non-compliance with labelling requirements and/or breaches which may mislead consumers, 12 included incomplete and/or inappropriate information, and 14 did not have adequate evidence to substantiate claims made about the medicines.

Let’s go over that again.

• 22 were found to have manufacturing and/or quality issues
• 20 medicines had labelling issues or breaches which may mislead consumers
• 14 did not have adequate evidence to substantiate claims made about the medicines

When it comes to consumer protection this is a pretty poor report for the TGA.

As a result of these failures, a significant number of products were removed from the Australian Register of Therapeutic Goods (ARTG).

It’s worth noting however that Nurofen is a registered drug, not a listed one (for the difference see my post here) so stricter rules apply when it comes to regulation of what’s in it and whether it works. With AUST L (listed) drugs, for example, companies or “sponsors” are not required to present evidence of safety and efficacy before they are rubber-stamped for sale by the government. However AUST R (registered) drugs – of which Nurofen is one – are.

Indeed AUST L drugs are considered low risk by the TGA, so have a soft-touch system of registration. To apply for an official number you go online, select from a list of pre-approved ingredients, describe what your product does, state you have evidence for your claims in your possession (but no need to produce it!) pay a fee and voila! Bob’s your uncle.

The fact that most consumers don’t know this was the basis for the recent call to label CAM in Australia with the disclaimer “This product has not been tested”. You can imagine how this went down with the industry.

However, advertising rules for L and R drugs are essentially the same – basically you can’t make claims which you can’t substantiate and if you do, the TGA can order you to remove them. Whether this be from a website – as has happened several times now with Homeopathy Plus! – or a television commercial, as is the case for Nurofen.

Once a complaint about a product is received (and the TGA relies on consumers to make complaints as they are not pro-actively seeking products which breach guidelines), the TGA will preside over it and if it’s upheld, direct the company to remove the offending material and/or publish a disclaimer. But, as has been known for some time and was also highlighted in the recent audit and on Lateline, approximately thirty percent of companies ignore these sanctions. And they can, because the TGA has never in its history enforced them. Ever.

From the audit:

Due to the very low financial penalties currently available (a maximum of $6,600 for individuals and $33,000 for corporations) for advertising offences in the Act and other investigative priorities for the TGA, it is not cost-effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence for consideration of prosecution by the Director of Prosecution.

It has never been cost-effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence.

In other words, the cost of prosecuting a company outweighs the fine, so it’s not worth it and it’s never been done. This of course makes the TGA the laughing stock of drug manufacturers. If you read between the lines of the Nurofen press release you can see it loud and clear:

Nurofen advises that consumers will continue to see the familiar branding of the Nurofen target and messages of Nurofen working at the site of pain…

Well of course they will. I mean $33,000 is a pittance for a large Pharma company anyway. It’s laughable to think this would be a deterrent to making some claims that might not be “quite right” but sound pretty good in marketing terms.

Homeopathy Plus! also declined to comply for similar reasons, saying they didn’t agree with the TGA’s findings that homeopathic immunisation is ineffective against polio, meningococcal, cholera, whooping cough and other serious diseases. They’ve since gone onto claim homeopathy can cure breast cancer, treat meningococcal disease and radiation poisoning. Jumped. The. Shark.

To go back to the TGA’s findings about Reckitt Benckiser, the complaints resolution panel found that;

reasonable consumers … would conclude that the active components of the product travelled specifically to areas of the body affected by pain — in this instance, the part of the head affected by a headache

Which I think is a fair call. But this is not how pain killers work. To say they are “targeted” is just nonsense.

Yet, this is not the first time Nurofen have been called out for shonky advertising. Indeed last year they were honoured with a 2010 Choice Shonky Award for a very similar thing;

From the Choice website;

Nurofen has … a range of caplets for migraine, back, tension headache and period pain. Yet a closer look at the ingredients shows they’re identical from product to product. So does the back pain version somehow magically go straight to your back – and only your back – as soon as you’ve swallowed it? Could you, say, choose to treat only your back pain while keeping your headache? The answers are no, no and definitely no.

As long as the TGA has no teeth to enforce dodgy claims and advertising breaches I expect we’ll see this type of behaviour continue. And even if they were to fine companies for breaches, 33,000 or 6,600 bucks is a pittance to most drug companies – whether CAM or science-based. There seems little deterrent to stop when there’s money to be made and no-one’s gonna stop you anyway.

In my opinion this is about consumer protection and if the TGA fails to do that, then I wonder what good they’re doing at all.

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In a spot check on about 400 products, 9 out of 10 were found to breach regulations. As a result a ”significant number” of products were removed from the Australian Register of Therapeutic Goods or ARTG, which currently lists 10,250 complementary medicines, including vitamins, minerals and herbal preparations. The breaches, largely relating to false claims of curative powers on labels, means the products can no longer be legally sold. Which products have been removed and precisely why, was not revealed by the TGA.

The complementary medicine business is worth over 4 billion dollars a year in Australia, but evidence that they work is not required by the TGA before they are assigned an official looking number and appear on the shelf of your local pharmacy next to aspirin and cough medicine.

Instead, the TGA operates a “self assessment” online registration system and undertakes post market reviews where approximately 25% of products are randomly selected for a review of their labels, product specifications and summary of evidence. Although the TGA website states “… evidence must be held by sponsors which demonstrates the indications and claims are true, valid and not misleading” the latest review indicates this is clearly not the case for the majority of products. A second issue is that even when products are removed from the listing, manufacturers can simply go back on line and re-register the product under a different name effectively getting it listed again in 24 hrs.

There are two types of drugs and clinical devices controlled by the TGA, those which have been evaluated for safety, quality and efficacy are designated a number preceded by “AUST R”. An example is antibiotics or hay fever medication bought over the counter at the chemist or even low risk products such as cough medicines. According to the TGA website, “The degree of assessment and regulation they undergo is rigorous and detailed, with sponsors being required to provide comprehensive safety, quality and efficacy data.”

On the flipside, “AUST L” are called listed products and include complementary and supplementary medicines such as homeopathy, ear candles and detox kits, many of which have not gone through clinical testing or indeed have any scientific evidence that they work (in the case of ear candles there is evidence that they cause harm). Listed medicines are considered by the TGA to be of lower risk than registered medicines, thus they are not assessed for efficacy by the TGA but only for quality and safety.

Clearly the problem here is the TGA’s reliance on “self assessment” as a means for determining a product’s efficacy. But it gets worse when you scrutinise precisely what they define as evidence for these products.

There are two streams of “evidence” accepted by the TGA, one being scientific and the other “traditional use”. Traditional use refers to documentary evidence that a substance has been used over three or more generations for a specific health related or medicinal purpose. Traditional therapies include Traditional Chinese Medicine (TCM), traditional Ayurvedic medicine, traditional western herbal medicine, traditional homoeopathic medicine*, aromatherapy and other indigenous medicines.

Further, there are also increasing levels of evidence within this, the greater your evidence the more claims you are entitled to make. For example, three independent written histories of use in the classical or traditional medical literature are acceptable and/or availability through any country’s government public dispensaries. So this includes chiropractic in Australia and homeopathy in the UK.

Recently the TGA announced a comprehensive review of the way it communicates regulatory processes and decisions to the public in an effort to improve transparency. The aim of the overhaul is multifaceted but one aspect is to ensure that the Australian public is better informed about the benefits and risks of therapeutic goods, including all medicines and devices. In particular the TGA aims to inform consumers that they do not test AUST L drugs, and as such cannot guarantee that they work as claimed.

So the TGA will continue to accept AUST L products for listing under the clearly flawed self-assessment programme and as a method for improving transparency, inform consumers that their system doesn’t really work. It’s also worth noting that as a consumer you are free to make a complaint about a TGA listed products, and if they agree the product has breached regulations, the complaints resolution panel will issue retraction orders to the company. However if the company chooses to ignore the sanctions, the TGA will not enforce them. Between 30 and 50% of companies called out for making false claims do ignore the sanctions and the TGA has never made a prosecution for refusing to comply. Another issue concerning transparency for the general public is they results of an investigation by the TGA do not appear on their website for up to 6 months. So a consumer searching the web has little chance of knowing that the product is making false claims.

This black hole where TGA complaints disappear was covered by ABCs Lateline programme earlier this year with respect to a Homeopathy website which claimed they could cure cancer and AIDS with water. When the story broke the owner of the website not only continued to ignore the sanctions but jumped the shark by publishing a response to the story replete with dozens of spurious links as to why their claims were correct.

One would hope that the review currently up for public comment will address and correct some of these issues. As it stands the burden is on the consumer to determine whether a product works or not, as an official looking AUST L number is no guarantee that the product does what it claims. And according to the recent review, 9 out of ten product don’t. Asking a pharmacist – which is where many of them end up – whether the product works can also be hit as miss and myself and Richard Saunders have experienced when enquiring of pharmacists about homoeopathy and being told it was “herbal”.

If you are in Australia you can submit comment to the review by February 11th. The panel are asking for submissions from health professional and the general public on topics such as about instances where it could have been useful for you to have had access to better information about your medicine, supplement or device and how you would like to have access to this information whether through your pharmacist or on the internet.

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Comment from the Sydney Morning Herald here
More from the Sydney Morning Herald here

* One wonders what defines “traditional homoeopathic medicine”. Perhaps it’s homeopathy prior to the “water has a memory” theory – a fairly recent invention – to get around that pesky Avogadro’s number which dictates that after a certain level of dilution there are no molecules of the active ingredient remaining. Homeopaths get around this problem by saying that the water maintains a memory of the original substance. But conveniently the water does not remember all the other things it has seen such as faeces, parasites, viruses and other nasties.

Fran Sheffield runs the woo-fest website that is Homeopathy Plus! The same website that was the subject of a recent Therapeutic Goods Administration (TGA) investigation which found her website contained misleading information. Including such gems as “homeopathic immunisation” is as effective as vaccination and that homeopathy can treat cancer, AIDS and other terminal diseases.

Regular readers might remember her being responsible for the e-newsletter alerting us to the “homeopathy cures breast cancer study” which myself and David Gorski subsequently took to pieces. Sadly, only a few weeks ago this study ended being tabled as evidence for an EDM submitted by UK MP David Tredinnick (the one who believes blood does not clot under a full moon therefore surgeons do not operate) in the House of Commons. Thanks to the quick action of Simon Singh and Evan Harris, the EDMs were modified pointing out the utter fail that this study is, including the fact that one of the authors publicly dissociated herself from the study in a comment left on my blog.

As a result of an investigation into the HP! site, the TGA recommended Fran Sheffield publish a retraction in a prominent position on her website. But as is her want, she has refused to do so and since the TGA have no powers to enforce the ruling, so her website remains unchanged.

Following the finding by the TGA, Steve Cannane’s Lateline did a story where he interviewed Fran Sheffield about her reasons for not putting up the retraction. It was clear to me from the story that she sincerely believed the nonsense spouted on her website, thus saw no reason why she should conform with a TGA ruling to the contrary.

But it seems that since the TGA ruling and Lateline story, Fran has made even more outrageous claims and jumped the shark.

She even wrote a response on her website to the Lateline story where she Gish galloped references in support of homeopathy as an effective treatment for cancer and AIDS.

In her most recent flyer (below) for a seminar running in early August she claims homeopathy works for fractures (ummmm, okay), fear of flying (??), workaholism (huh?) and nose bleeds (I have one from reading this BS).

To be fair, she does get some things right. She says homeopathy works for hangovers – well sure it does, a nice big glass of water can be great for dehydration resulting from excessive alcohol consumption. And homepathy is good for plants – I add homeopathy/water to my plants water about once a week, they love it!

But seriously, Fran Sheffield, if I fractured a bone in my body, I reckon the first place I would go is a hospital, for some good old fashioned plaster – not run my leg under the tap. This information is wrong and dangerous. About the only thing homeopathy is good for is dehydration. And the TGA sits back doing nothing. Disgraceful.

Speaking of homeopathy for burns, Arnica Montana made these claims for the victims of the the Bali bombings and the Victorian bushfires back in February 2009.

Dodgy devices to be regulated 25-May-2010 By Michael East

THE manufacturers of shonky devices used by alternative therapists to carry out what they claim are diagnostic tests will soon have to provide clinical evidence that they work under new Therapeutic Goods Administration regulations.
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The changes, which will be introduced in July, are in response to growing concerns about the number of in-vitro diagnostic devices employed by alternative therapists.
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Among the products advertised on the internet is the “Hemaview”, which, according to its manufacturer, uses one or two drops of blood projected onto a video screen to diagnose “nutritional deficiencies, organ dysfunction and certain biochemical imbalances”.

Director of the Alfred Hospital’s department of haematology Professor Hatem Salem said users of the device were “pulling the wool over people’s eyes”.
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“The notion that one can diagnose all sorts of ailments by examining a drop of blood on a video screen is both ridiculous and plain stupid.”
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Currently the TGA is only able to regulate diagnostic devices included on the Australian Register of Therapeutic Goods, including those that test for HIV and hepatitis C, as well as those used in the home.
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However, many of the in-vitro diagnostic devices used by alternative therapists have been exempt from scrutiny because they are not considered medical devices.
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From July the makers of all in-vitro diagnostic devices will then be required to show clinical evidence that their products work but will have four years to fulfil the new requirements. They will also have to make clear to the public the potential risks of the devices.

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I’m afraid I’m sceptical. Required to show clinical evidence? To whom? Unfortunately the TGA does not have a very good track record of policing things like this.

Remember the homeopath who made all sorts of outrageous claims about magic water as a substitute for vaccination? Fran Sheffield of Homeopathy Plus! simply didn’t agree with TGA findings that her claims were misleading, so chose to ignore a ruling to remove such material from her website. And in an example of laughing in the face of the law, the day after she was exposed on ABC1′s Lateline programme by Steve Cannane, she jumped the shark.

In a post entitled; “Lateline: Can homeopathy safely protect against epidemic and infectious diseases? Can homeopathy treat serious diseases such AIDS and cancer?” she went even further, claiming that water could safely treat AIDS and cancer.

So, whilst I applaud this legislation in principle, how does the TGA, or other relevant health authorities plan to police it?

I regularly attend the Mind Body Spirit/Wallet Festival in Sydney where there is a plethora of snake oil salesman using Hemaview and collecting money hand over fist from gullible clients. It’s a perfect set-up; let us diagnose you with some allergy or somesuch and then when I reach over here, I have a bucket of powder for the special price of way-too-much which will fix you right up!

In NSW in 2008, legislation was introduced to regulate unregistered health practitioners, that is, those who are not already represented by a regulatory body like doctors or dietitians. Section 17 of the Code of Conduct states that a health practitioner must display the code and a document that gives information about where clients can complain to the Health Care Complaints Commission (HCCC) if necessary.

I have dutifully trotted off to the MB$ four times now, will my code clutched tightly under my arm and as yet, I have not once seen the code displayed. It’s now become a bit of a joke between my friends and as such, we have nick-named our futile search “Code of Conduct Bingo”.

This “festival” had enough quackery and snake oil to start a factory. (As an aside, one also has to wonder how much of the takings are declared to the tax department at the end of the four day love in). Make no mistake, a large amount of cash is collected, when you count up the magic scalar energy infused Fusion Excel Pendants for $150-$200 (available from Alibaba.com for 6 bucks a pop) or the $45 for a 20 minute reading with a psychic (queues last week extended half way across the exhibition hall). Or the dangerous and useless ear candles, which you can buy wholesale for 20 cents a pop, or pay about 15 bucks for three at the MB$ (after you pay your 16 bucks to get in). Or how about a $60 Power Balance Bracelet (available from Alibaba.com for between 50 and 80 cents).

In the two years I have been attending, I have not been aware of any representatives from relevant health bodies lurking around – this doesn’t mean they are not there of course. It would hardly make sense to walk around declaring your identity if you wanted to catch people in the act.

But certainly, I’ve been mistaken for such as person, at a Hemaview stand in fact. A colleague and I were asking for published evidence for the statement “clinically tested” which was splashed all over their stand, when the pamphlet he was holding was rapidly snatched out of his hand and the previously helpful assistant demanded, “are you Doctors?? Why do you want to know?…ARE YOU FROM THE TGA?”

Thou doth protesteth too much methinks.

It becomes very difficult not to lose your temper with these people, particularly when you know they are blowing it out their arse.

The first time I was exposed to a Hemaview/Live Blood Analysis person at the MB$, I was carefully shuffled away by my friend as my voice began to break and my ears to steam. It took him a good 10 mins to calm me down from the tidal wave of bullshit that had passed over me. You see, as a scientist I knew the terminology spewing from the representatives gob was real, but the deceit of peppering sciencey sounding words into a spiel about woo, to make it sound legitimate was too much for my science educated brain. She was right when she observed, just before I was escorted to the nearest corner, that I had been “affected by what she said”.

It’s just it was not in the way she presumed.

Another time at another Hemaview stand, I was with a nurse colleague when we were surreptitiously moved on with a nod the boss man. I guess he had twigged we were onto their profitable little scam.

It is interesting nonetheless, to observe the way woo-purveyors react to being challenged on their claims. After a fair bit of experience, I’ve come up with a theory. The ones who get angry and ask you to leave, are probably knowingly deceiving the punters. You might call them frauds or con men. The ones who genuinely try to answer your questions, even if their explanations are completely implausible and off with the fairies, are probably genuine, even if they are deluded.

It’s a bit like the psychics who spot you in the crowd, knowing who you are, and point out there are a lot of fake psychics here today.

I’M DEFINITELY NOT A FAKE, but look over there – he is!!!

So, personally, I am not confident this new legislation with have much of an impact of the alternative medicine industry. And it also seems odd that they are given four years to comply. Why so long? One thing is for certain though, the addition of legislation designed to clean up the industry will lend it unwarranted legitimacy. Imagine how happy snake oil purveyors will be to declare that their quantum energy box has been approved by the government.

The TGA is failing the Australian public. It’s a disgrace.

This year’s vaccine contains three viral components,
• A/California/7/2009 (NYMC X-181) (A/California/7/2009 (H1N1) – like) 7.5 µg haemagglutinin per dose
• A/Wisconsin/15/2009 (NYMC X-183) (A/Perth/16/2009 (H3N2) – like) 7.5 µg haemagglutinin per dose,
• B/Brisbane/60/2008 (B/Brisbane/60/2008 – like) 7.5 µg haemagglutinin per dose, a combination not used in Australia before.

Ian Barr, the deputy-director of the World Health Organization’s influenza centre in Melbourne, was interviewed for the World Today on ABC radio on Monday April 26th, about the question of whether the current seasonal flu combination has been tested in clinical trials.

IAN BARR: In Australia we don’t require that the influenza vaccine, the seasonal vaccine is tested for combinations but they have done that overseas, so they have tested in fact giving a full seasonal vaccine with the swine flu, so four vaccines at once if you like and there were no untoward effects there.

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So I think there’s a high expectation that the combination of these three viruses will be no different from any other three viruses which we include every year without doing formal safety testing which takes quite a period of time and it is extremely expensive and time consuming.
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CHARLOTTE GLENNIE: So in your opinion the fact that it is a combination vaccine would have nothing to do with this situation that we’ve got at the moment as far as you know now?
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IAN BARR: I think that’s unlikely to be a factor. Certainly all viruses are slightly different but in terms of how they’re produced in the laboratory and tested in laboratory and then made in the commercial scale vaccine production areas, they’re all investigated individually for any particular differences in those viruses which might lead to some of these things we’re seeing currently, such as fever.

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So I think that it’s unlikely but I guess we have to wait and see on analysis of these particular batches.

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But subsequent tests by the TGA and other independent agencies have not identified a batch related problem. The Federal Government’s chief medical officer, Professor Jim Bishop, says there is no evidence to suggest that faulty batches of flu vaccine are to blame for adverse reactions in children, although further testing is yet to be completed.

Could old technology be to blame?

But rival vaccine manufacturers are questioning the manufacturing technique used by CSL Limited. Influenza Deeds of Agreement are in place with CSL Limited and Sanofi Pasteur for the supply of seasonal, pre-pandemic and pandemic influenza vaccines, but CSL is the primary supplier of AH1N1 vaccines to the Australian government.

CSL was once a division of  the Federal government. Known as the Commonwealth Serum Laboratories, it was established in Australia in 1916, then incorporated in 1991 and listed on the Australian Stock Exchange in 1994. But CSL continue to maintain a close relationship with the government much to the critique of their rivals.

Flinders University’s Professor Nikolai Petrovsky, the research director of rival vaccine manufacturer Vaxine, says CSL’s relationship with the Federal Government virtually guarantees it funding. So CSL has no interest in developing better vaccines with new technology such as genetically engineered proteins.

“They’re comfortable to really exploit the old technology which is highly profitable to sell each year to the Australian Government.”

CSL’s seasonal flu vaccine, Fluvax, is based on technology which involves growing the influenza virus in eggs – a technology which has been around for about 50 years. Professor Petrovsky says the CSL vaccine varies from batch to batch.

“That’s one of the consequences of using a 50-year-old technology, you get that variability,” he said.

He is calling for an independent inquiry into the Federal Government’s relationship with CSL.

A spike in vaccinations means a spike in reactions?

To date, there have been 57 reports of adverse reactions (including high fevers and convulsions) in WA, six in Victoria, four in NSW and Queensland, two in South Australia and one each in Tasmania and the ACT. One child died in QLD after receiving a flu injection. Initial findings from the coroner did not find the vaccine at fault but tests are ongoing.

Prof Bishop said some three million doses of the seasonal flu vaccine have gone out this year, with up to two-thirds sent to WA.

It could be a “partial explanation” as to why the western state has experienced a much higher rate of complications, normally expected in one out of every 1000 to 10,000 cases, Prof Bishop said.

WA provides the seasonal flu shot for free to children under five, whereas the rest of the country doesn’t.

The WA trials were started after the 2007 flu season, after 8 children across Australia under five years of age, died within 24 hours of developing mild and non-specific symptoms of respiratory infection. Although the cause of death has not been reported in many of these cases, these deaths appeared to be associated with influenza A.

In 2008, almost 65,000 children aged 5 and younger in Western Australia received free flu vaccinations made by CSL and Sanofi- Aventis SA as part of a trial that reduced hospitalizations by 88 percent, the state’s health department said in a statement last year.

Each year, CSL’s Fluvax vaccine contains fragments of three different types of influenza virus as recommended by the TGA and this depends on the strains of infectious flu in the environment. In addition, flu viruses mutate from season to season so vaccines become less effective and need to be modified to keep up with the current mutants.

The components have been tested individually but not in combination.

Although the current Fluvax® combination has not been tested in Australia, the individual components have.

Fluvax® Jnr (2005/2006 batches) showed very good safety and efficacy profile in clinical trial.
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Safety and efficacy of CSLs Fluvax® Jnr – seasonal flu vax (no thimerosal, no H1N1) This study was undertaken using the 2005-2006 flu vaccines, is designated the Paediatric study CSLCT-FLU-04-05 and was published in 2009.

The safety, tolerability and immunogenicity of Fluvax® vaccine was tested in 298 participants from a paediatric population (> 6 months to < 3 years and > 3 years to < 9 years).

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Group A
Equal to or greater than 6 months to less than 3 years old
Biological: Influenza Virus Vaccine
2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
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Group B
Equal to or greater than 3 years to less than 9 years old
Biological: Influenza Virus Vaccine
2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
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The total number of participants was 298 (Group A n=151; Group B n=147). There were no reports of serious adverse events related to Fluvax® vaccine during the vaccination period. Within 7 days after administration of Fluvax® vaccine, all adverse experiences reported with an incidence of 2% or greater. Unsolicited adverse events were collected for 30 days post-vaccination. Very common unsolicited events (< 1/10) reported were rhinitis, cough, teething and influenza-like illness.

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Panvax® Jnr was tested in a 2009 trial and showed ~30% adverse effects in children under the age of 8.

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Testing began on CSLs 2009 H1N1 Influenza Vaccine (CSL425) in July 2009, on 370 kids aged between 6 Months to 8 Years.
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CSL Limited makes two AH1H1 vaccines, Panvax® and Panvax® Jnr (thimerosal free). The clinical trial is registered and published here.
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Mild adverse effects were defined as adverse events easily tolerated by the participant, causing minimal discomfort and do not interfere with everyday activities (e.g., soreness at injection site)?.
Following the first vaccination:
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• 16.3% had a mild fever (>37.5 degrees C < 38.5 degrees C) in the 15µg group
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• 23% had mild fever in the 30 µg group
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Combined mild adverse reactions, for 15 µg and 30 µg were 31.9% and 33.7%, respectively.

For moderate adverse reactions, 15 µg and 30 µg were 18.9% and 27.2%, respectively. This was defined as significantly discomforting, interferes with daily activity.

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The clinical trial data was evaluated by the Therapeutic Goods Administration (TGA) and reviewed by the expert Advisory Committee on Prescription Medicines (ACPM). The evaluations found the vaccine, delivered in two doses not less than 28 days a part in children aged 6 months to 9 years, to be both safe and to offer good protection.

Panvax® was approved by the TGA on December 3, 2009 and the national immunisation program began on 30 September 2009.

The TGA has been closely monitoring any side effects from the use of the vaccine. To that date approximately 6 million doses of Panvax® had been distributed in Australia. As at 31 December 2009 a total of 1289 suspected side effects have been reported to the TGA following vaccination with Panvax® in Australia.

This is the current trial of the 2010 vaccine, containing A/California/7/2009 (NYMC X-181), (A/California/7/2009 (H1N1) – like)  A/Wisconsin/15/2009 (NYMC X-183), (A/Perth/16/2009 (H3N2) – like)  & B/Brisbane/60/2008 (B/Brisbane/60/2008 – like)
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Current Influenza Vaccine Study in 6 month to 17 year olds
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Australia is considering introducing the Influenza vaccine for all children under 5 years. At the same time, this study aims to improve our knowledge of the safety of Fluvax® in children aged from 6 months to 17 years old. Information from this study will help future decisions on how best to use Fluvax® in children.
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What does the study involve? Each participant will be in the study for about 6 or 7 months. They will receive 1 or 2 doses of Fluvax®, depending on their age and how many doses of ‘flu vaccine they have had in the past. You will be asked to record certain reactions that might occur for 30 days following each vaccination.

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This study has been approved by a human research ethics committee. In Perth the study is run by the research staff at the Vaccine Trials Group, Telethon Institute for Child Health Research in conjunction with Princess Margaret Hospital for Children and the University of Western Australia School of Paediatrics.

The latest information on the website says; “recruitment complete” which means they have enough people for the trial. I don’t know what stage they are at with respect to results. There is a brochure available here.

Parents call for calm.

Meanwhile, some parents are calling for calm and warning others not to shun vaccines completely.

Kellie Connolly writing for the Daily Telegraph on April 30th, recounts how her three year old contracted swine flu last year and was extremely ill for 2 months. He couldn’t keep food down for 13 days, lost a third of his body weight and he eventually developed pneumonia.

When she took him for his flu shot this year, around the time of the recent scare, he suffered an adverse reaction of high temperatures, vomiting and headaches.

Kellie says that of course she has concerns and she expects the authorities to thoroughly investigate them, but she was adamant;

“..As a mother of a child who’s had a terrible case of swine flu, and then witnessed an adverse reaction to a vaccine, I still say VACCINATE for everything else recommended by our health officials.”

Similarly,
Kylie Orr on the Essential Baby blog says;

“Why would I question a free service provided by the government, which has been exhaustively researched and documented? I am not a scientist, medical practitioner or spokesperson for a pharmaceutical company.”

Ultimately, I am a mum and if the experts tell me immunising my child is the best bet for keeping them safe from potentially deadly diseases, well that’s enough for me. If someone offers a counter argument, showing me figures and relevant links, backed up by science…..”

The vaccination programme for under fives remains suspended. You can report an adverse effect to vaccination, or other drugs at the TGA website.

(NB: I say magic because there is no known mechanism described in science to explain how these things apparently “work”, and I place work in inverted commas because these things have no effect above placebo, so technically they don’t work either).

A print advertisement and Australian website linking to the American version was found to breach the Advertising code sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(2)(i), 4(7), 5(2), 7(3) (see box below) following a complaint by an individual.

The website, classified as an advertisement by the regulatory body, promoted a range of LifeWave patches, namely the SP6 patch, Y-Age patch, Icewave patch, Energy Enhancer patch, and Silent Nights patch. For a description of the apparent functions of these patches (and an interesting exchange with a believer), you might be interested in reading my previous blog about Lifewave here.

This is an interesting case for consideration, since The Panel first had to decide who was responsible for the advertisements as the parent website (lifewave.com) is based in the US and the website which attracted the complaint is linked to it from Australia. They concluded that the website was in fact the responsibility of the Australian distributor, given that the url had been personalised (www.LifeWave.com/bodyinharmony).

Information on retailer websites is the responsibility of the website publisher

Publishers of websites should be aware that they are responsible for the material they publish, regardless of whether they have copied that material from product packaging or other websites. Some online retailers appear to be of the view that it is acceptable to duplicate information from such sources for the purposes of advertising products for sale, but take no responsibility for the publication of the information.
Reproduced from the Complaints Resolution Panel website.

The Panel found that the claims relating to the patches being effective in appetite control, craving control, weight loss, detoxification, antioxidant boost, anti-aging, skin repair, pain relief, relief of pain from injuries, relief of chronic pain, relief of migraines, relief of arthritis, enhancing energy, enhancing stamina, reducing fatigue, and promoting restful sleep, had not been verified, were misleading, and could not be substantiated by the advertiser, therefore constituted a breach of the code [Section 4(2)(a)].

In the report published on the website, the Panel stated that;

“…they were not satisfied that the material provided by the advertiser constituted even minimally persuasive evidence that the advertised products could have the therapeutic benefits claimed in the advertisements”.

In particular the Panel targeted testimonials published on the website. As part of the code, testimonials are required to be documented, not misleading and be regarded as plausible illustrations for the potential benefits of the product. The concluded that claims such as “wow 20 seconds my pain was gone” and “90 seconds lower back pain was gone”, were indeed not plausible and therefore breached the code (Section 4.7).

The Panel did not accept photos like these as sufficient evidence that Michael Phelps uses Lifewave patches. Funny that.

The website also made claims that the patches were used by the swimmer Michael Phelps and several AFL football players, but the advertiser was unable to provide evidence for this, apart from the following statement;

“(they had) been told by LifeWave staff in Australia who hold training sessions that Michael Phelps has used the patches and that a few of the AFL teams have begun using the patches” and “there are photos on the internet that show Michael Phelps with the patches on his body.”

Then panel deemed this insufficient evidence and therefore concluded that these claims breached the code.

In Australia it is prohibited to advertise products that claim to treat or cure serious diseases/ailments, such as cardiovascular disease. The Panel deemed that the Lifewave website breached this section of the code [5(2)], by including “research” information which referred to “heart rate variability enhancement through nanotechnology” and many other references to heart rate variability, “increase[ing] glutathione levels in the body”, and other references to health issues.

In a meeting held on April 16, 2009, The Panel ruled that the advertiser was to withdraw the advertisements from further publication; and withdraw any representations that the advertised products are safe, or that they have benefits in relation to appetite control, craving control, weight loss, detoxification, antioxidant boost, anti-aging, skin repair, pain relief, relief of pain from injuries, relief of chronic pain, relief of migraines, relief of arthritis, enhancing energy, enhancing stamina, reducing fatigue, or promoting restful sleep.

The Advertiser was given 14 days to comply with this ruling and was instructed to provide evidence to The Panel of this compliance.

Which apparently the advertiser decided did not entirely suit them, since you can still find the website, in it’s shiny misleading, code breaching glory.

Which leads me to question; who is responsible for enforcing these rulings? How is it that these people get a slap on the wrist, ignore the ruling and carry on their merry way, selling products for which there is no evidence of efficacy? There should be a process whereby I can easily and quickly alert the TGA to the non-compliance and there should be substantial penalties for non-compliance.

Until there is, then the TGA Complaints Resolution Panel is about a effective as an ashtray on a motor bike = useless.

For example, hair analysis (see here and here) proponents who claim to able to cure all manner of incurable illnesses by identifying food allergies with magic machines are particularly offensive to me. Advice such as, “Just cut out tomatoes and walnuts, drink gin but not wine and your terminal cancer will magically go away” are just about the lowest of lows in my opinion.

Today I heard about a new scam artist on the prowl in Sydney. His name is (name removed for legal reasons), a man with no medical or scientific training but who claims to have invented or discovered an organic formula to cure AIDS, cancer, diabetes and high blood pressure. A report by Harley Dennett detailing these claims appeared in the Sydney Star Observer on Thursday February 5 th.

The report states the man, who runs a skylight installation business on the Northern beaches “produced magnified pictures of blood cells to justify his cure claim” (which sounds suspiciously like live blood analysis to me..). According to the report, he would not let the Star Observer retain the photos for examination claiming;

“I’ve got the negatives but I’d rather keep those in a top secret facility”.

“The pharmaceuticals don’t want this getting out, so I’m trying to keep it low profile with like-minded people I can trust”.

The Star Observer reports the man has previously been investigated by the Therapeutic Goods Administration (TGA). On this occasion, the man has allegedly been soliciting for donations to fund a backyard trial for his top secret cure-all.

Professor Sean Emery from the National Centre in HIV Epidemiology and Clinical Research said anyone claiming a cure or asking for money should set off alarm bells. “Often people who peddle these things say there’s a conspiracy against them, that the drug companies don’t want you to know about their treatments”.

Soliciting donations for a dubious clinical trial is not illegal in Australia but the government’s SCAMwatch website advises victims to report cases to authorities via SCAMwatch or directly to the TGA.

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Summary:

Edzard Ernst, the professor of complementary medicine at the University of Exeter and co-author of the book Trick or Treatment, published a review article in 2004 in the Journal of Laryngology and Otology entitled: “Ear candles: a triumph of ignorance over science”. He concluded; “Ear candling is one of those CAM modalities that clearly does more harm than good…..it’s mechanism of action is first implausible and second, demonstrably wrong..in my view, therefore, it should be banned (1)”.

Many scientific studies have been conducted on ear candling, several examining the claim that they remove ear wax. In order to do this, they would need to draw a vacuum. A study by Seely et al., (2) using 2 different brands of ear candles, demonstrated this not to be the case.

The Seely study also contains a clinical arm, where 122 ear nose and throat specialists were surveyed. The authors reported 21 cases of serious injury caused by ear candling. In 6 of these cases, patients temporarily lost their hearing. Other problems reported among the group included, 13 cases of burns, 7 cases where the wax from the candle had blocked the ear canal and 1 case of a punctured ear drum (2).

Based on this evidence and studies conducted by their own laboratories, the Canadian authorities have banned ear candles from sale and import into Canada.

When you look at the evidence, ear candling is dangerous. What part of putting burning sticks in your ears sounds like a good idea to you?

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Introducing ear candles!

This week I present to you an alternative modality that encompasses just about every misconception made by CAM, defies the laws of science in every possible way, and above all is dangerous. Most of us would remember our mothers telling us not to put anything in our ears smaller than our elbows rght? I don’t remember her ever mentioning burning sticks, but then why would she, she knew I was not that gullible. Unfortunately, the same cannot be said for other people….

What is ear candling?

An ear candle, ear cone or Hopi ear candle is a narrow, hollow cone that has been soaked in beeswax or paraffin and allowed to harden. The process of ear candling involves the patient lying on his or her side while someone else inserts the point of the cone inside the ear. The top of the cone is then set on fire and left to burn for 5 – 15 minutes.

The health claim most often made for ear candling is that the flame creates suction, which draws ear wax out of the ear canal. Proponents say the evidence for this is in the candle itself – when you have finished candling, you cut open the candle to expose the brown waxy mush at the bottom which they claim is ear wax and “toxins”. Promoters also say that ear candling can cure a wide range of medical problems, including ear aches, headaches, sinus pain/infections, sinus pressure, tinnitus, vertigo. In addition, they are said to remove impurities from the ear passages by drawing excess yeast, fungus, and bacteria from the sinuses and lymph glands and even revitalize the chakras. Of course, I could go on, but I think you get the idea…

Yet, absolutely none of this is true.

Ear candling does more harm than good.

oooh, yukky ear wax and toxins...oh hang on, it's just candle wax. Science says so.

I’m almost embarrassed to tell you that good science from proper scientists and doctors has been wasted testing these things. The seminal study on the safety and efficacy of ear candles was published in the journal Laryngoscope in 1996. The authors were particularly interested in the claim that the candles create a vacuum so they used a pressure device to measure changes in pressure for the duration of the burn. In 20 trials with 2 different candle types, they detected no negative pressure at any point during the trial.

In a clinical trial also conducted as part of this study, 4 people (2 with ear wax and 2 without), the authors reported the candles did not remove ear wax as proposed and in fact, in some cases candle wax was actually deposited in patient’s ears (2).

The authors also conducted a survey of 122 ear nose and throat specialists and found 21 cases of serious injury caused by ear candling. In 6 of these cases, patients temporarily lost their hearing. Other problems reported among the group included, 13 cases of burns, 7 cases where the wax from the candle had blocked the ear canal and 1 case of a punctured ear drum (2).

Edzard Ernst, professor of complementary medicine at the University of Exeter and co-author of Trick or Treatment, published a review article in 2004 in the Journal of Laryngology and Otology entitled: “Ear candles: a triumph of ignorance over science”. He concluded; “Ear candling is one of those CAM modalities that clearly does more harm than good…..it’s mechanism of action is first implausible and second, demonstrably wrong..in my view, therefore, it should be banned” (1).

The website quackwatch also published a frequently cited article where they illustrate the dangers of ear candling with the following stories;

A Canadian woman who experienced stuffiness in the nose and ear pains while scuba diving went to a local health-food store and was referred to a “qualified” candler. During the “treatment,” she felt an intense burning in her ear. At the emergency room, attempts to remove wax that had dripped from the candle onto her eardrum failed. Surgery was required, and a hole in her eardrum was discovered, which presumably was caused by the procedure. She recovered fully and luckily her hearing was not affected. The practitioner apologized, compensated the woman, and stopped performing ear candling.

In addition, instances of house fires associated with ear candling have been reported in Alaska, one of which led to the user’s death. On January 27, 2005 a 59-year-old woman ignited her bedding when she dropped an ear candle that she was attempting to use the ear without assistance. The candle ignited the bedding then quickly spread to curtains and other combustibles in the room. The woman escaped the fire however, suffered an asthma attack in hospital and later died.

Ear candles are banned for sale or import in Canada, but sold in Australian Pharmacies.

Based on this evidence and studies conducted by their own laboratories, the Canadian authorities banned ear candles from sale and import into Canada. The Health Canada website has this to say about ear candling;

…the sale of this product for therapeutic purposes in Canada is illegal. As well, both Canada and the United States have issued directives that ban the importing of ear candles. Some promoters try to avoid the Regulations by advertising that ear candles are for entertainment purposes only. However, Health Canada maintains that these people are selling the product illegally, for medical purposes, as there is no other reasonable use for ear candles.”

Which makes it even more preposterous that in Australia they are listed with the TGA meaning they can be sold in pharmacies alongside science-based medicine.

This is a complete failure on behalf of the TGA with respect to protecting the public from harm. The Australian Register of Therapeutic Goods Devices lists 13 different types of ear candles including this nonsense, Alternet Detox Spa Series Ear Candles and these from Why Karma Natural Health Products described as “to apply a simple treatment of ear cleansing directly to the ear”. You know, one has to wonder what the role of this clearly constipated government body is in protecting the public from harm when they register this nonsense. You only need make a cursory glance at PubMed, to determine that these things are not only nonsense, but dangerous.

I personally have had experiences with staff in pharmacies regarding these devices, one who old me she wouldn’t recommend then to customers but they sell really well so what can you do, and another who looked at me blankly when I suggested that ear candles have no place in a pharmacy. Of course, I don’t expect a kid with an after school job to know that these things are a scam and worse still, can perforate your eardrums, but I do expect the pharmacist to know. And I do expect the government to not turn a blind eye.

Ear candling does not stem from ancient Indian tribes.

Here’s an example of one ear candle company who have hijacked the history of an ancient Indian tribe to add legitimacy to their product.

The Biosun company claims that their “Hopi Ear Candles are” based on “the formula that is traditional to the Hopi Indians of the USA- cotton, beeswax, honey, sage, chamomile and St John’s Wort. The Hopi who are renowned for their great medicinal knowledge collaborated with Biosun to pass their formula on to the rest of the world”.

Pfft. Well not according to Vanessa Charles, the public relations officer for the Hopi Tribal Council, who has stated there is no such treatment within traditional Hopi healing practices. Vanessa has said that ear candling “is not and has never been a practice conducted by the Hopi tribe or the Hopi people”. And even though The Hopi tribe has repeatedly asked Biosun, to stop using the Hopi name Biosun has not complied with this request and continues to claim that ear candles originated within the Hopi tribe.

If I have still not convinced you that ear candles are a load of rot, why not become an earconologist? Become a Certified Earconologist with a Correspondence Course from The Awareness Institute and perform a wonderful service to yourself and others. “The course consists of learning about the History of Ear Candling, Ear Anatomy, Candling Procedure, Cause and Effect, and much more”.

It just goes to show, people will believe just about any nonsense.

The take home message:

1) EAR CANDLES ARE DANGEROUS AND STUPID.

2) THEY DO MORE HARM THAN GOOD.

3) THEY WILL NOT REMOVE WAX FROM YOUR EARS.

4) IN SOME CASES THEY HAVE DEPOSITED WAX.

5) DON’T USE THEM.

1. The Journal of Laryngology and Otology. “Ear candles: a triumph of ignorance over science”. Ernst, E. (2004) 118: pp 1-2.

2. Seely DR, Quigley SM, Langman AW. Ear candles- efficacy and safety. Laryngoscope. 1996: Oct;106(10):1226-9.