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 story appeared on SMH online today. It details plans to establish a register for quacks, apparently in an attempt to separate the wheat from the chaff. Sounds a little bit like the register set up in the UK recently and blogged about here.

I read this article with trepidation, firstly because I think putting quacks on a register lends legitimacy to their profession and this is undeserved in my opinion.

“The industry’s reputation was dealt a blow this month after the NSW Supreme Court convicted a homeopath of the manslaughter of his nine-month-old daughter, who died of septicemia caused by chronic eczema.”

Yes, the industry was dealt a blow, but this was not because of a shonky homeopath, this was because homeopathy does not work in the treatment of eczema. Or any other illness in fact. A meta-analysis published in the Lancet in 2005 compared 110 conventional and homeopathy trials and the effect of homeopathy was deemed no greater than placebo (Shang et al., Lancet 2005; 366: 726–32).

An editorial which appeared in the same issue of the Lancet stated; “despite 150 years of unfavourable findings…the more dilute the evidence for homeopathy becomes, the greater seems its popularity.” Why we keep wasting money and good science on testing it, to continually get the same answer is beyond me.

The article continues;
University of Queensland researcher Jon Wardle, who heads a steering committee to set-up a register said; “We are making sure that when the public sees a naturopath they have training, act ethically and if something goes wrong, there is a complaints procedure,” he said. Mr Wardle said the lack of formal accreditation meant people with as little as one week’s training could call themselves naturopaths and it is these people who dispense a large quantity homeopathic remedies.

This is where I get annoyed. Firstly, there is a complaints procedure in NSW. It was established with the new Code of Conduct for Unregistered Practitioners which was introduced in August 2008. Section 17 of the code states that practitioners must display the Code and information about the way in which clients may make a complaint to the HCCC if necessary.

Funny that, I went to Mind Body Wallet a few weeks back armed with my code and saw it displayed nowhere, neither at stalls doing invasive procedures such as live blood analysis, or massage or anywhere.

I have to say, I am not convinced that the relevant regulatory bodies/associations or members of them are particularly concerned about following the rules when it comes to legislation. In NSW at least, they seem to have dutifully ignored conforming to this recent legislation. I am suspicious that the establishment of a nationwide register is really just a sneaky way to add undeserved legitimacy to profession where there is scant evidence for efficacy.

But this is not the worst part about this article. The article was penned by 2 journalists, Rachel Browne and Melissa Singer, neither of whom seem to understand much about what constitutes conventional medicine or doctors. They refer to a British podiatrist and homeopath Tariq Khan, as Dr Khan. This is misleading and infers that Khan is a clinical doctor, naturopaths use the title ND, (and referred to by some as not a doctor). They tell us that Dr Khan recommends homeopathy be used in conjunction with conventional treatment. And of course a homeopath is going to endorse the use of homeopathy.

The man apparently had talks with the head of dermatology at St George Hospital, Dedee Murrell, to discuss using homeopathic remedies for an incurable disease, the rare genetic condition epidermolysis bullosa. Let me state that again. Homeopathy as treatment for an incurable disease. This following the beginning of the article where the journalists discuss the parents of Gloria Thomas being charged with manslaughter for shunning conventional medicine and treating their daughter’s eczema with homeopathy. She subsequently died.

This is very poor journalism. To begin an article with charges of manslaughter for a homeopathy-related death and then discuss using it for incurable diseases is just credulous on the part of Rachel and Melissa.

But then this; “The Royal Australian College of General Practitioners and the Australasian Integrative Medicine Association have given qualified support to the use of complementary medicine where there is research about its outcomes.”

Precisely Rachel and Melissa. There is research. To show it does nought. Take a look at the Lancet article. Visit PubMed for goodness sake. Do some research, please.

Thursday, April 23, 2009

Unregistered health provider ordered to stop misleading cancer patients

A Mackay woman who made misleading and deceptive claims about a mineral supplement has been ordered by the Brisbane Supreme Court to discontinue providing intravenous treatment to cancer patients. Minister for Fair Trading Peter Lawlor said unregistered health provider Jillian Margaret Newlands was caught administering a concoction made from a mixture of citric acid and sodium chlorite to cancer sufferers and claiming the product cured cancer.

“The Office of Fair Trading was alerted to Ms Newland’s activities following a Health Quality Complaints Commission investigation. The Office of Fair Trading sought an injunction under the Fair Trading Act 1989 to prevent her from misleading and deceiving consumers,” Mr Lawlor said.

“Ms Newlands has no formal qualifications as a nurse or naturopath,” Mr Lawlor said. “Ms Newlands went so far as to inject her ‘patients’ with a ‘miracle mineral supplement’ while dishonestly promoting its benefits with no scientific basis for her claims.

The court order obtained by the Office of Fair Trading banned Ms Newlands from administering any substance intravenously and supplying any goods, services or any other substance which has not been approved by the Therapeutic Goods Administration.”

“Ms Newlands was ordered to pay court costs of more than $12,000 and has also been restrained from making any claims she is able to treat, cure, or benefit any person suffering from cancer” he said. “She charged cancer sufferers up to $2000 for treatment services she administered in her home garage and went so far as to advise one cancer patient not to pursue chemotherapy treatment”.

“There was no evidence of any sterile handling techniques or any proper storage of medical utensils and equipment used by Ms Newlands at her home. “This sort of deceptive conduct is completely unacceptable.

If consumers have concerns in regards to their dealings with Jillian Newlands, they should visit their nearest healthcare professional immediately.

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This story begins with an investigation by A Current Affair earlier this year, with the help of our very own Loretta Marron, where she went undercover with a hidden camera. You can watch the video below.

Loretta Marron busts a cancer quack on A Current Affair

News articles of the story today cite evidence from a cancer patient who was told not to seek chemotherapy treatment. This cancer patient is our very own Loretta. In fact, it was her who contacted the QLD Health Complaints Commission and told them to get in touch with A Current Affair for the footage.

Readers of my Zone blog would also be aware that it is illegal in NSW to claim to cure incurable illnesses including cancer, in accordance with the Code of Conduct for Unregistered Practitioners. Perhaps QLD will one day get a similar code, but in the meantime I applaud the hard work and tenacity of Loretta Marron and congratulate her on her continued efforts to protect the vulnerable and sick from opportunistic quacks.