I just received this article from Australian Doctor via my mate the Jelly Bean Lady.

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.

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.

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”.

“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.”

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.

However, many of the in-vitro diagnostic devices used by alternative therapists have been exempt from scrutiny because they are not considered medical devices.

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.

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.

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