The TGA Complaints (lack of) process

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.

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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.

The Whack – a – Mole Project and the TGA.

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”.

Happenings Feb 2013

by

Mal Vickers

Pharma

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

Happenings – 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.

Happenings

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.

TGA, Dr Ken Harvey and SensaSlim News

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 29^th 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

Where Did the TGA Reforms Go?

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