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
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
Can’t shift those love handles? Diet not working? Sick of your cellulite? What about those new machines that freeze or fry your fat away? Anything to do with cellulite or fat removal is bound to be a good money spinner. When it doesn’t involve diet and exercise it’s assured of getting considerable media attention. Cellulite is a problem encountered by more than 90% of women of all ages, both fat and thin, and most of us are overweight. So should we be rushing out for our non-invasive ‘liposculpting’ or is this yet another weight loss scam targeting some of our most vulnerable consumers?
There are quite a few high-tech body sculpting devices, which either cool or heat the dermis, that claim to be successful at permanently removing cellulite and fat.
Can’t shift those love handles? Diet not working? Sick of your cellulite? What about those new machines that freeze or fry your fat away?
Anything to do with cellulite or fat removal is bound to be a good money spinner. When it doesn’t involve diet and exercise it’s assured of getting considerable media attention. Cellulite is a problem encountered by more than 90% of women of all ages, both fat and thin, and most of us are overweight. So should we be rushing out for our non-invasive ‘liposculpting’ or is this yet another weight loss scam targeting some of our most vulnerable consumers?
Many claim to be ‘Government Approved’ and to consumers this means that they are scientifically proven to work.
In reality, the Therapeutic Goods Administration (TGA) does not ‘approve’ therapeutic goods, they ‘accept’ them.
Class IIb devices and below do not get a mandatory application audit and, according the Therapeutic Goods Act, if an application for one of them is effective, it must be accepted and included on the Australian Register of Therapeutic Goods (ARTG).
In theory, it should be difficult and costly for manufacturers to get their hands on EC certificates for these Class IIa devices without acceptable clinical evidence, but this assumes that the EU notified bodies are doing the required audits.
Also, the TGA’s regulation of ‘low risk’ goods is an honesty based systems.
Consequently, their policy of reviewing only one in ten new listings has resulted in hundreds of ineffective goods listed.
Fortunately, there are complaints mechanisms through the TGA for consumers to challenge the claims stated by sponsors in their applications.
In 2010, following pressure from consumers, medical professionals and consumer protection groups, the TGA has been investigating complaints against a wide range of medical devices.
Despite being on the ARTG for up to ten years, a range of medical devices, including skin contouring systems, have now been cancelled.
Sadly, neither consumers nor health practitioners were notified and so they are still widely promoted to us as the only public notifications are buried somewhere in the electronic pages of the weekly Government Gazette.
So what are these ‘body sculpting’ devices and do they work?
The heating device includes both massage and infrared technology which raises skin temperature to around “50-70 Degrees Celsius”.
Sponsors of the cooling device, a treatment called cryolipolysis, claim that this “effective and painless” procedure “targets and breaks down fat cells” by reducing their temperature to around -7 Degrees Celsius, whereby “the dead cells are then removed naturally through the liver” taking “two to three weeks .. to leave the body through the urine”.
Despite the claims made for these devices, neither of them helps you lose weight.
Even so, both the media and websites continue to promote them as “non invasive procedures” claiming that they are a painless, easier solution to liposuction and everything you need to remove fat and to “reduce the appearance of cellulite”.
But research tells a different story.
The evidence for the ‘cryolipolysis’ is a pig experiment and some uncontrolled and observational data on humans; mostly not blinded, with poorly measured outcomes.
The FDA recently approved one device for “cold-assisted lipolysis”, based on these studies.
Lipolysis is merely the reaction that breaks down stored fat into glycerol and fatty acids, which then go back into circulation, to be stored in other fat cells.
This response does not result in any weight loss and may even produce potentially dangerous changes in circulating blood lipids inflammation due to the damaged or dead cells.
Both of these were shown to occur in the published experiments.
Treatments cost around $2000.
For ‘liposculpting’ heating devices, several studies have been published that concluded that the device is “mildly effective in reducing the cellulite grade and so, improving its orange-peel appearance.”
The FDA has approved them on that basis.
Hand held devices cost upwards of $300.
In the 12 January 2011 issue of the Government Gazette, the first notification relating to a body sculpting device appeared.
It also included a recent initiative from the TGA, that now includes more information regarding the reasons for the initial decisions, that the sponsor had three months to amend the claim in their Public Summary from “cosmetic skin contouring” to “collagen contraction”.
There are over 20 devices on the ARTG, with several cancelled or under investigation, and other devices which sponsors claim “are not classified as a medical treatment under the TGA”.
With many of us eager to try anything we see on TV, no matter how preposterous or optimistic the claims are, some pharmacies are also selling these devices. Remember fat is not “lost”; it goes somewhere else in the body.
So, would we like to see the appearance of our cellulite temporarily reduced or our fat mobilised? Maybe so, but to me is seems a very expensive, uncomfortable and potentially dangerous procedure with very poor results.Return to home