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.

Dr Ken Harvey, a lecturer at Latrobe University School of Public Health, who authored the complaint (read the full complaint as a pdf here), objected to claims on the website that “homeopathic immunisation is effective against poliomyelitis, chicken pox, meningococcal disease, hepatitis (all types), Japanese encephalitis, Hib, influenza, measles, pneumococcal disease, smallpox, typhoid, cholera, typhus, whooping cough, rubella, mumps, diptheria, malaria, tetanus, yellow fever, dysentery and many other epidemic diseases”.

The websites, classified as advertisements for the purposes of the complaint, also claimed that “recent research conducted at Swinburne University by Australian homeopath, Dr Isaac Golden confirmed that homeoprophylaxis provides the same degree, or better protection, than vaccines with none of their side effects or complications.”

About influenza, the websites state that the homeopathic preparation, “Anas Barbariae relieves the intensity and shortens the duration of flu symptoms better than anti-virals…..without the side effects” and “symptoms are sometimes removed in a few hours”.

In reference to the claims about the positive results of Isaac Golden, Dr Harvey noted these claims are directly contradicted by the thesis from where they are sourced. Golden’s thesis contains the statement; “the effectiveness of the homeopathic immunisation programme could not be established with statistical certainty given the small sample size..”. In spite of this, and in lieu of providing further evidence,  the complainant stated (in part) that the thesis had “indeed reached a positive conclusion with a high degree of confidence”.

The findings from The Complaints Resolution Panel stated that although the complainant cited references for homeoprophylaxis, they “did not provide complete copies of the papers cited.” Further, the material on the websites was deemed “misleading”, “unverified” and “abused the trust or exploited the lack of knowledge of consumers” (my emphasis).

The Panel found that none of the material supplied by the advertiser supported claims made on the websites, and therefore the information was misleading and “likely to arouse unwarranted expectations” from consumers. The Panel ruled for Homeopathy Plus! and www.d-n-h.org to remove the misleading material and issue a retraction on their websites which is to remain for 90 days. The advertiser has 14 days to comply with the ruling.

Claims about efficacy of homeopathic immunisation are in direct contravention to statements from the National Council for Homeopathy London which “strongly supports the conventional vaccination programme..”. In Australia, The Executive Director of the Australian Natural Therapies Association said “no properly qualified natural therapist would recommend homeopathic immunisation as an alternative to conventional immunisation”.

This comes at a time when NSW Health authorities have issued a warning about meningococcal disease following the death of a woman in Sydney, and a spike in cases in NSW, with eight reported in December 2009, in Sydney.

For more information about homeopathy, see the 10:23 campaign. To participate in a mass homeopathy suicide attempt in Australia, see the events page on Facebook.

(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.

Unfortunately, it has become all too common commonplace that SCAMs (Supplementary, Complementary and Alternative Medicine) make unsubstantiated claims about their products and services.

It has also become commonplace that they get away with making such claims, seemingly without consequence.

As was the case when I was told at the Mind Body Wallet festival that my friend’s cancer could be cured with an AUD12,000 course of fruit juice diets, detox and herbs/supplements. Claims such as these are illegal in New South Wales under section 5 of the Code of Conduct for Unregistered Practitioners which states that;

“Health practitioners not to make claims to cure certain serious illnesses. (1) A health practitioner must not hold him or herself out as qualified, able or willing to cure cancer and other serious illnesses”.

So it was a surprise to see this happen today.

This is the work of a sceptical colleague, Michael, who issued a lengthy complaint to the Complaints Resolution Panel of the Therapeutic Goods Administration some time ago. Recently he received a 9 page facsimile advising that his complaints about Arnica Montana, a purveyor of homeopathy, regarding breaches of section 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(2)h, 4(2)(i), 4(7) and 5(2) of the advertising code were deemed valid.

Arnica Montana  Enterprises Pty Ltd were instructed to comply with the following sanctions: Withdrawal of Advertisement, Withdrawal of Representation and Publication of Retraction. This involved publishing a  retraction on the website which appears below.

Regular listeners to the Skeptic Zone and readers of the Zoners blog may recall I called these people out back in February for issuing a statement on their website about the use of homeopathy for severe burns and recommending its use for the victims of the Victorian Bush fires, known as “Black Saturday”, the worst natural disaster in Australia’s history. The website stated; “In the light of recent events in Bali and the bush fires in the Eastern States of Australia information about the use of Homeopathy by the ordinary person is knowledge that should be shared.”

The advertiser was given an opportunity to respond to the criticisms, and rejected the allegation that there was “anything deceptive or misleading” in the advertisement/website. The advertiser claimed that the website was “intended to be an information website to educate the public about the use of homeopathic remedies” but not to the exclusion of any other system of medicine.

But The Panel found that the advertisement breached sections of the code which prohibit advertisements for products that “abuse the trust or exploit the knowledge of consumers” and was “likely to arouse unwarranted and unrealistic expectations of product effectiveness”.

This was based on the finding that “the advertisement included claims of benefits in relation to burns, scalds, pain, traumatic shock, severe burns….no persuasive evidence was provided that the advertised products could have benefits in relation to the wide range of conditions referred to”.

Evidence? Why do you need evidence? The advertiser stated “controlled trials cannot be used for homeopathy but [that] there is a mass of unpublished evidence” and stated that they “would be grateful to know which section of the Code requires published scientific evidence as a precondition to advertising”. Besides they have testimonials all over their website…but wait, they were called into question too.

The Panel stated that the advertiser did not provide evidence that any of the testimonials in the advertisement were genuine.

According to the code; Section 4(7) requires that testimonials “must be documented, genuine, not misleading and illustrate typical cases only”.  The panel found that the advertiser did not provide any evidence that the testimonials were genuine, and cited this as an example;

“the calendula cream I make is specific to cancer skin keratoses and I have successfully treated many of these and established melanonas by using the sage cream at night and the calendula during the day”.

Interesting that it unlawful to publish testimonials that are not genuine or “atypical”. This could apply to many a woo website.

But then this;

The Panel noted that the advertisement breached section 4(5) of the code;

“..by implying that other therapeutic goods (namely vaccines and sunscreens) could be harmful….”

If you search the website for vaccination, you will get hits for the Australian Vaccination Network (AVN), Meryl Dorey and other misinformation that we have come to expect from the anti-vaxers. (Who would have thought, a homeopath condemning vaccination). I wonder where does the AVN website sit with respect to this? Would their website be deemed an advertisement? After all, they do sell literature and DVDS, but I suspect these products do not come under the auspices of “therapeutic goods”.

An advertisement is defined by The Code “…to include any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods”.

This is why the entire arnica montana website was deemed an advertisement; the Panel noted that it was clear that the website offered a range of products for sale, and was satisfied that the website as a whole constituted an advertisement for therapeutic goods.

Interestingly, the complaint summary cites the subject matter of the complaint as “website advertisement” and the sanctions as “withdrawal of advertisement”, thus implying the entire website is to be withdrawn. If you go to the website, you will see the published retraction, but the remainder of the website still functions as normal.

And if you think there’s no harm in homeopathy, then see this story.

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.