by Dr Ken Harvey, with an introduction by Ken Greatorex
To set the scene for those not familiar with the glacial machinations of Australia’s Therapeutic Goods Administration: Until recently in Australia we had a complaint process whereby if you wanted to complain about the advertising of a particular listed medicine, you submitted. to the Complaints Resolution Panel. It was woefully under resourced, but it did its job, carried out inquiries then reported established breaches in conduct to the TGA. The TGA acted – sometimes.
Then things changed. Against the urging of such groups as The Australian Skeptics, Friends of Science in Medicine, Choice and other consumer advocates, the TGA became the body which dealt directly with such complaints.
As one who attended and absorbed the excellent review from Professor Harvey and three of his students, the result of this change has been:
totally predictable
disappointing
(left to right: Mal Vickers, Kithmini Cooray, Mary Malek, Ken Harvey)
The audience did not agree that the ongoing advertising of ‘Bright Brains’, illustrated by Kithmini, had achieved compliance with the Therapeutic Goods Advertising Code 2015. In short, they disagreed with the TGA outcome statement about this complaint. Read the rest of this entry »
Here are reposts from two recent pieces by Dr Ken Harvey: Both examine Australia’s Therapeutic Goods Authority (TGA).
The first is a letter written to Melbourne’s Age newspaper.
The second, published on Dr Harvey’s own website is about Detox Foot Pads and more than adequately demonstrates the contention, made in the first piece, that the TGA is not really interested in consumer protection.
– – – – – –
Letter to The Age 5/9/18 Spotlight on regulators
Your editorial (4/9) says the government should have a more rigorous process to protect consumers from ineffective treatments and products. There are government regulators that are meant to do this job but they are weak and ineffective.Read the rest of this entry »
Whack-a-Mole was a popular 1970s arcade game which consisted of repeatedly hitting cartoon moles on the head with a cartoon hammer. Moles nevertheless kept cropping up with undiminished energy more or less at random; so the term Whack-a-mole came to signify “a repetitious and futile task.”
Problems with Regulation of Therapeutic Goods
The situation regarding the regulation of therapeutic goods in Australia is unsatisfactory. The complaints process is frustrating, exhausting and often ineffectual. Complaints to the Therapeutics Goods Administration (TGA) must be made against one product or service at a time. Because such complaints are almost invariably made by volunteers, and there is no financial incentive to complain, only a relatively tiny number of questionable products ever get put under the microscope.
An astonishing 87 % of such complaints have historically been upheld. Yet the offending companies rarely receive more than “a slap on the wrists”.
I love data and so does ‘Sense About Science’, the UK based pro-science trust. Sense About Science has launched the All Trials Campaign. The campaign aims to have pharmaceutical companies release the data from all the clinical trials they conduct.
Without the release of all data, pharmaceutical companies are free to indulge in selective publishing. That is, they may only publish the clinical trials that show the most favourable results for the products they would like us to consume.
The campaign coincides with the release of Dr Ben Goldacre’s new book ‘Bad Pharma’.
Countering Antivax Anecdotes with Provax Anecdotes
“Mrs Williams said they made what they thought was an informed decision not to vaccinate any of their children because of concerns over adverse reactions, but had since changed their minds.”
Mrs Williams is quoted as saying:
“It was hideous. He was spasming every three minutes. He was biting his tongue and bleeding. His arms were spasming and he was arching his back and his whole face and jaw was completely locked.”
Nuns Fight Back! In last month’s Happenings, we reported on an attempt by The Vatican to rein in America’s fifty thousand nuns. Here’s the latest. Meanwhile, Australia’s last openly progressive Catholic bishop, Canberra’s Pat Power resigned, citing the Vatican’s inability to listen, clergy sex abuse and the shortage of priests as the biggest issues facing the church.
In Australia, a supreme court judge has forced Jehova’s Witness parents to allow their four-year-old daughter to receive a blood transfusion, without which she had a life expectancy of a few weeks. Read the rest of this entry »
This is a collection of odds, ends and newsy bits that have taken our attention in the last month.
The Global Atheist Convention in Melbourne was as big an event as predicted. There was even an appearance by both militant Christians and Muslims. HERE.For Dick Gross’s review, see HERE
Eugenie Scott
The GAC was big enough to have its own fringe, in fact. Our own April Skeptics Café was billed as just such an event, featuring the delightful Eugenie Scott. It may not have represented an enormous crowd for Ms Scott – she is much in demand internationally as a speaker – but it set a record for La Notte’s Club Room. Read the rest of this entry »
OK – I admit I’ve been somewhat critical of the TGA in the past. However, in the spirit of fairness, when they do something right, I think I should say – hurrah!
The TGA will be making a final decision on the weight loss product, the SUPPREXXA Hunger Buster kit, after consideration of material provided by the sponsor, Chika Health Pty Ltd, in support of the claims made about the kit.
Assist Weight Loss, Decrease Hunger, Fight Fatigue, Stimulate Fat Burn and Improve Energy
The promoters also say it should be used:
…in conjunction with a healthy, energy controlled diet and exercise program.
To me, this looks like bait and switch advertising. Potential customers are seduced by the weight loss message, however, it may be that the only way weight is lost is by putting in the hard work with the diet and exercise program. Could potential customers simply not buy the kit (thereby saving $50) and Read the rest of this entry »
I think everyone is aware of the problem – magnetic underlays, ear candles, homeopathy and bogus weight loss products, to name but a few examples of modern day snake oil; products that make therapeutic claims but are unsupported by evidence that they work. The government agency responsible for protecting consumers from the greed and self-interest of quack medical products, the Therapeutic Goods Agency (TGA) appears powerless to stop it.
by Dr Mick Vagg, Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist at Barwon Health
This article has been reprinted from The Conversation website where it appeared on 1/9/2001.
If a manufacturer claimed its product was “clinically proven” and could relieve your symptoms of bloating and fatigue, would you believe it? What about if you were chronically or terminally ill and had tried almost everything else?
The latest audit of complementary therapies found as many as nine out of ten companies made misleading claims about their weight loss products, vitamins, lotions, pills and gadgets.
The release on Tuesday of the Australian National Audit Office’s (ANAO) report on the Therapeutic Goods Administration’s (TGA)
performance as regulator of complementary medicine products makes for alarming reading. Read the rest of this entry »
Dr Ken Harvey is well known to Vic Skeptics and readers of this site as a tireless campaigner against the sale of unproven medicinal products. His actions leading to adverse findings against the Power Balance Wrist Band have been well documented here. Now SensaSlim Australia Pty. Ltd have labelled Dr Harvey’s complaint to the Therapeutic Goods Administration about the promotion of their slimming product as “defamatory”. Their legal action, which seeks punitive damages has also successfully stalled the complaint process.
This podcast from ABC’s The Health Reportdiscusses the use of SLAPP(Strategic Lawsuit Against Public Participation) writs and the deficiency in current legislation which permits their use against TGA complaints.
What can we learn from the short history of the Power Balance wrist bands in Australia? It was a pseudo science fad that the Australian Skeptics played a part in ending.
Sports shops, health shops and retailers of all kinds have now removed Power Balance wrist bands from shelves and counters all over Australia.
How did it happen? Who’s behind it? Can we do the same to (insert your favourite pseudo science product here)?
What follows is a potted history of the end of the Power Balance fad. (If you disagree or have more to add please make a comment below.)
How did it all start?
2007 (USA)
Two young entrepreneurial brothers, in Orange County California, Troy Rodarmel and Josh Rodarmel started the company in early 2007.
The business model is quite straight forward: design colourful, stylish wrist bands that can be manufactured very cheaply in China and sell them locally at a much higher price. Market the bands by making health and technology claims and Read the rest of this entry »
Under new stringent guidelines adopted from this weekend, herbal medicines will now have to be registered. Products must meet safety, quality and manufacturing standards, and come with information outlining possible side-effects.
For many people, the surprise is that such regulatory oversight has not already been automatic.
This is the kind of approach that Skeptics have been asking Australia’s Therapeutic Goods Administration to adopt. At present, manufacturers can choose whether to apply for registration of each remedy as a Listed Product. The TGA’s rule-of-thumb is that listed products must be safe and efficacious; however, the TGA rarely tests Listed Products.
Another new miracle skin product suddenly appears on our retail shelves. Another uncritical product promotion gets a run on the ACA. There’s nothing new there, but this time ACA may have gone too far, by claiming that the product is TGA approved.
Sorry about all the acronyms in the opening splash. Just in case you’re not keeping up:
ACA = Channel Nine’s A Current Affair (It’s on between the news and Two and a Half Men.)
TGA = Therapeutic Goods Administration (Our thin line of government defense against medical quackery.)
I think we need to come up with a snappy name or acronym for that period of time between the introduction of a new miracle health product to our retail shelves, and the eventual release of data from clinical trials showing a distinct lack of the miraculous. Read the rest of this entry »
The promoters of Power Balance wrist bands are in trouble again. This time the Australian Therapeutic Goods Administration (TGA) has ruled against them.
In part the decision says:
In reaching this conclusion, the Panel noted that the claims made in the advertisements were extraordinary to such a degree that no reasonable retailer could publish them on the basis of assurances from the product sponsor, without requesting evidence that such claims could lawfully be made about the product.
The TGA are asking for the: Withdrawal of representations, Withdrawal of advertisement and the Publication of a retraction.
To re-cap; Power Balance wrist bands are coloured silicone rings with two small plastic holograms glued on. The popular silicone bands sell for about $60 (Aus). A pendant version of the Power Balance sells for about $90 (Aus). The promoters of Power Balance claim Read the rest of this entry »
Wide-scale access to the Internet has resulted in unprecedented access to information for the average citizen of any developed nation, and the more recent proliferation of mobile data devices and networks have exponentially increased our ability to reference the collective body of knowledge on a whim.
This access comes at a price however, as tech-savvy marketers have outstripped science and education practitioners’ resources, funding and drive to make information easily accessible, effectively saturating the search-engine and news-reporting info-spheres with commerce-driven interpretations of research, opinion, tradition and in many cases, out-right pseudo-science or fraudulent claims.
Whilst most developed economies provide some levels of consumer protection, in Australia including bodies such as the Therapeutic Goods Administration, the Australian Competition and Consumer Commission (ACCC), Australian Securities and Investments Commission (ASIC) various industry ombudsmen and voluntary ‘societies’ with industry codes-of-practice, most consumers have very limited understanding of the significant differences in evidentiary support pharmaceuticals require, for example, as compared with “complimentary” or “alternative” medicines.
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