Editorial

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Welcome to the May 2012 homepage edition of i2P-Information to Pharmacists. Rollo Manning has been having some time out having staples removed from the site of his open heart surgery.He is now at home recuperating in Darwin, having arrived home last Friday, beating a cold and hasty retreat from Canberra.We all wish him a speedy recovery and hopefully, he will be fit enough to contribute by next month.
This month, Pharmedia discusses the toll that is taken when someone complains about you to an authority without good cause. Well, the good news is that you can now take action to protect yourself if such a complaint is made, and that may even include action for defamation. Read about a recent case involving two doctors, with Mark Coleman drawing on personal experience to illustrate.

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The Light and Dark side of some Pharmacies

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	Loretta Marron BSc articles by this author...
From a Skeptics Perspective: Loretta Marron, a science graduate with a business background, was Australian Skeptic of the Year for 2007 and in 2011. She edits the website www.healthinformation.com.au.

Living in outback Queensland, especially during the long periods of drought, the elderly grazier has struggled from day-to-day to keep his cattle property going.
He had only been 12 years old when his father died, but with the Second World War still raging, and with no men available, the local police officer had issued him with a drivers licence and told him to go home to help his mother run the property.
That had been the end of his schooling and to this day, he can still barely read and write.

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Now in his late 60’s, with DVT and poor circulation, despite the best efforts of his GP, he has leg ulcers that just seem to be getting worse.
He changes the dressings every day and while he never complains he really would like them to heal.

The bush telegraph continues to be one of the most effective communication systems in outback Australia, so when he heard about a colour therapy device that was effective for wound healing, he wanted to try it.
He was told it was a painless, ‘safe and effective’ treatment, and with promises that it would cure his ulcers, he quickly made an appointment to see the health practitioner.

The next week he drove the 5-hour round trip to the coastal city where the practitioner ran his clinic desperate to try this new treatment.
When he returned home, while he remained optimistic at first, as the weeks passed, he realised that he’d wasted his time and money.

Sponsored by the New South Wales based company Zepter International Pty Ltd, the first of a series of Bioptron Light therapy devices was approved by the Therapeutic Goods Administration (TGA) in October 2000 (Aust L 76193) and more recently in January 2007 (Aust L 134417).
Search the Australian pages on the web and you will get over 1000 links to this product, mostly with claims that it is TGA approved, and also as a treatment therapy for a wide variety of self-limiting and serious health conditions.

The claims made for this device, which appears to be little more than a torch with six different clip-on coloured polarised light filters, state that it is suitable for skin problems because it “improves microcirculation”, while “harmonizing metabolic processes”, “reinforcing the human defence system” and “stimulating regenerative and reparative processes of the entire organism”.

Other claims are that it is “a revolutionary breakthrough in medicine” and that “it relieves pain and decreases its intensity” while “boosting energy reserves”.

The advertising claims that yellow is applied to activate the kidney, orange restores the liver, stomach and spleen, purple supports the feet and yellow and green activates and balances the heart to “bring the bodies systems into balance, turning weakness to a new strength.”

Even though the device has now been cancelled, these claims are still being made on many Australian websites.

The TGA have known about the lack of efficacy for this device for some time.

In October 2007 a complaint against an advertisement for it was upheld by the Complaints Resolution Panel (CRP) when it was advertised as being able “to treat particularly serious conditions that can only be managed correctly by a doctor/nurse team” referring to conditions “such as back pain, knee pain, neck pain, arthritis, sciatica, ulcers (including gangrenous ulcers requiring amputation), scars, acne, burns, muscle pain, eczema, rosacea, and corns, as well as to wound healing.”

The complainant had been concerned that “in the case of a gangrenous ulcer, getting the correct treatment quickly is extremely important” and that “people suffering from gangrenous ulcers where amputation is required should not be encouraged to take their treatment into their own hands by a company profiting from selling light therapy machines” and that “to do so could mean they avoid life-saving surgery”.

On the 16 November 2007, the ‘Senior’ newspaper, with a circulation of over 1.2 million, who ran the advertisement for the Bioptron, was ordered to action a “withdrawal of advertisement; withdrawal of representations; publication of a retraction”.

In 3 February 2010, ten years after it was originally listed, the TGA cancelled this product from it register.

During that decade, thousands of these devices have been sold to patients and health practitioners across Australia who would have believed the product worked because of its Aust L number.
Over that time, countless patients, with leg ulcers and other serious conditions, have clearly wasted their time and money.

Practitioners are not in the jurisdiction of the TGA, so on the rare occasion that they cancel a product, they are only required to place a notice in the Government Gazette, where it appears in the depths of a large PDF file , and where it cannot be accessed by GOOGLE. This is the only information the TGA is required to provide the public, so no-one knows of this cancellation.

Consequently the Bioptron device continues to be marketed in Australia for “wound healing and drug free pain relief” and even some pharmacies are selling them .

Patient’s before profit? When it comes to both the TGA and some pharmacies - I don’t think so.

[i]  Complaints Resolution Panel, Complaints Register, Bioptron VIPL Light System http://www.tgacrp.com.au/index.cfm?pageID=13&special=complaint_single&complaintID=977

[ii] Government Gazette 3 February 2010 http://www.ag.gov.au/portal/govgazonline.nsf/8569D301E59D2033CA2576BE00834431/$file/GN%204.pdf

[iii] National Skin Institute, Bioptron Light Therapy http://www.nationalskininstitute.com.au/index.php?mode=Bioptron_Light_Therapy

[iv] RateMD.com, Bioptron Lamp http://www.ratemds.com/social/?q=node/18455

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