Editorial

From the desk of the editor

Welcome to the May 2013 edition of i2P - Information to pharmacists.
Economic turbulence seems to now be arriving in Australia with forecasts of high inflation rates, which also means high interest rates following on.
This type of economic forecast also means that banks will be more fractious with their borrowers. They are already offside with pharmacy due to the high level of bankruptcies over the past two years.
There is a pent up demand for a general wage increase for pharmacists impacting at a point in this month where pharmacy gross profit generally, is in decline.

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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 is the Chief Executive Officer of the Friends of Science in Medicine and that organisation won Australian Skeptic of the Year for 2012. Loretta edits the websites www.healthinformation.com.au & www.scienceinmedicine.org.au

Safety concerns have been raised about the increasing use of breast imaging devices for breast cancer screening that are not part of the mammography screening program.
These include ‘mammographic computed tomography laser’, thermal, tactile and ‘electrical impedance’ imaging systems.
Costing upwards of $150 per appointment, practitioners state that they offer “the local community a safe option for mammography”.
Claiming that their devices are Therapeutic Goods Administration (TGA) approved, are these therapists providing an “objective, pain free, reproducible, sensitive, radiation-free, effective, reliable and accurate service” or are they putting lives at risk?

At a recent Senates Estimates hearing, Senator Judith Adams raised concern that clinics promoting questionable imaging technologies as pain-free alternatives to mammograms are targeting younger people and are “all really and truly getting beyond a joke”. She commented that consumers are being “misled into thinking the scans [are] able to detect cancers”.

Dr Rohan Hammett, Principal Medical Advisor, Therapeutic Goods Administration (TGA), responded during the hearing that two of the devices had been removed from the Australian Register of Therapeutic Goods (ARTG) and they were “actively making inquiries for those remaining four”.

However, Dr Hammett added that once removed, “they will not be used in the community”.

But with no mandatory recall on cancelled devices, practitioners will undoubtedly claim that the original ARTG Listing maintains ‘currency’ and will continue to use them.

These devices are classified as ‘low risk’ goods (Class IIa) by the TGA and have no pre-market scrutiny of the actual product specification, label, instructions, packaging, advertising or the evidence provided by the sponsor.

With the current random review system, less than 10% of new entries are investigated, and sponsors know that they have a 90% probability of acceptance to the ARTG which effectively guarantees them an entry.

The SureTouch™ system is based upon tactile imaging technology. Its listing on the ARTG states that it “should not be used for clinical decision-making” and that it is only “intended to document lesions as identified during a clinical breast exam”.

While claiming it is “suitable for any age, for any breast type or size”, therapists target younger women by stating that they offer an “accurate and comfortable screening solution” for the under 40’s.

However, claims made for the device are that it “has been proven to be over 94% accurate in recognising malignant tumours in all breast tissue” and that it is capable of “detecting lesions as small as 5mm”.

The Meditherm™ device was recently removed from the ARTG. The Meditherm sponsor was also required to print a retraction on their website that “thermography Australia regrets that they may have caused concern by previously having scientific reference links on the website. This information is not allowed to be provided in Australia and for this reason has been removed”.

Despite the cancellation, this device is still being used and promoted as being listed with the TGA with the overseas sponsor claiming it is an “extremely valuable test to help with the early detection of breast disease”.

While there is some evidence to support the use of commercially-offered imaging technologies in certain settings around breast screening, such as an adjunct to a physical examination when conducted by a doctor, the evidence does not suggest the devices can, for example, diagnose small tumours or screen for breast cancer.

According to Brisbane breast surgeon Ian Bennett “thermography was a primitive form of imaging not much better for detecting breast cancer than self-examination” because the cancer has to be fairly large for thermography to pick it up.

Despite the best efforts of the Department of Health and Ageing (DoHA) to warn consumers, the number of practitioners promoting thermal imaging to diagnose Breast Cancer, continues to grow. Use GOOGLE and search the ‘Australian Pages’ and you get over 1000 hits.

Many of the therapists using these alternative imaging devices have either no qualifications or have completed questionable ‘natural medicine’ correspondence courses.

Some even claim that “Mammograms cause breast cancer” and are more “hurtful than helpful”. Queensland's Chief Health Officer, Jeannette Young disputes this claim, saying the “radiation exposure from mammograms is ‘minuscule’”.

Other websites advertising thermal breast screening are also promoting the use of unproven alternative cancer cures such as Laetrile and Cansema.

The National Advisory Committee which provides policy direction for the BreastScreen program recently issued a statement that they “do not recommend the use of thermography for the early detection of breast cancer.”

Mammograms are free for women after their 40^th birthday and are much more effective in picking up breast cancers at an early stage than any alternative imaging technique.

Speaking as a Cancer survivor, who was diagnosed with Early Breast Cancer, the BreastScreen program was of enormous benefit to me and may have saved my life, and surely this is what’s really important.

I would strongly discourage other women from relying on alternative breast imaging devices. This is not about choosing one procedure over another; it is about using the only program that is backed by solid evidence.

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