Complementary Medicines, Advertising Reform and the TGA

21 November, 2018

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)

Speakers:

Discussion:

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 »


The TGA Complaints (lack of) process

6 September, 2018

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 »


The Whack – a – Mole Project and the TGA.

8 November, 2017

by Ken Greatorex

 

Whack-a-Mole?

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”.

Read the rest of this entry »


Happenings Feb 2013

17 February, 2013

by

Mal Vickers

Pharmai love data

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

The New Zealand parents of a child that contracted tetanus change their mind about the benefits of vaccination.

“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.”

A family in the UK came to exactly the same conclusion – that vaccination isn’t so bad, the benefits of avoiding the disease far outweigh the small risks. They were struck Read the rest of this entry »


Happenings – June 2012

15 June, 2012

by Ken Greatorex


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 »


Happenings

18 May, 2012

by Ken Greatorex

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 »


TGA, Dr Ken Harvey and SensaSlim News

6 March, 2012

by Mal Vickers

 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!

As of the 29th of February, the TGA website announced:

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.

(Insert sound of clapping)

The promoter’s claims under scrutiny are that the product will:

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 »


Where Did the TGA Reforms Go?

29 December, 2011

by: Mal Vickers

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.

For quite some time there have been calls for change and the government appeared to be listening. With the SensaSlim scandal, the deaths of Gloria Sam and Penelope Dingle and the astonishing 90% level of non-compliance found with a random check of the ARTG by the Auditor General, changes seemed inevitable.

What happened? Where did the expected reforms go?

The first week of December saw some strange goings-on at the TGA Read the rest of this entry »


Flogging a Dodgy Cancer “Cure”? Say What You Like, the TGA Won’t Stop You

1 September, 2011

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 »


Ken Harvey Taken to Court

1 June, 2011

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 Report discusses the use of SLAPP (Strategic Lawsuit Against Public Participation) writs and the deficiency in current legislation which permits their use against TGA complaints.

For a more comprehensive report and information about making a pledge to assist with Dr Ken Harvey’s legal expenses, please see this story on the Australian Skeptics national web site.

The audio from The Health Report featuring the interview with Dr Ken Harvey can be heard here:

[or download the MP3 file]


Power Balance: the End of a Shonky Fad

5 May, 2011

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.

The recent ACCC threat to prosecute retailers who continued to sell them has had an immediate chill effect.

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 »


Herbal Remedies: new Rules in the EU

1 May, 2011

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. 

http://www.guardian.co.uk/uk/2011/may/01/new-eu-rules-on-herbal-remedies

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.

See our earlier article: https://vicskeptics.wordpress.com/2011/03/19/aca-miracle-fruit-or-fruity-marketing/


ACA: Miracle Fruit or Fruity Marketing?

19 March, 2011

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 »


TGA calls on Power Balance to withdraw claims and advertising

16 November, 2010

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 »


Some pointers on critically assessing the validity of claims

17 October, 2010

by Lucas Randall

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.

Read the rest of this entry »