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 and the office of the Parliamentary Secretary for Health and Aging. Over the previous two years, the responsible minister had called for submissions, working groups, reports, re-drafting of codes of conduct, new knitting circles…. well perhaps not the last one. Invitations were sent out for a public announcement by the Federal Health Secretary Catherine King. The planned announcement was to occur in Melbourne on Monday 12th of December 2011. The party hats where ready and the sausage rolls were in the pie warmer.

However, it appears someone slipped on their keyboard at the TGA. The government briefing notes for the announcement were accidentally emailed to the wrong people on Wednesday the 7th of December.

Dr Ken Harvey tells the story:

I was intrigued to get an email [from the TGA] yesterday titled,” New EVENT Brief Request – TGA Reforms Announcement and then shortly afterwards a phone call from the TGA followed by an email request to delete it!

Ken also said he complied with the TGAs request by deleting the email; although it appears that not all of the accidental recipients complied with the request; news of the forthcoming TGA announcements leaked to The Australian newspaper.

The leaked briefing notes appeared to be the genuine article. They contained the amount of time it would take to get from Melbourne airport to the centre of Melbourne, where to find a car park, the dress code, etc. Not only that, but they included the actual notes of the speech that would be made. These notes revealed, despite widespread community concerns and consultations, that nothing much would change.

After the TGAs email slipup, the public announcement was cancelled. Instead, on Thursday the 8th of December at 4pm, the Parliamentary Secretary for Health and Aging hastily announced the TGA reforms (Can we call them reforms if nothing much changes?)

Its easy to be distracted by this circus and to forget the big picture; getting TGA reform right will save lives, improve health and save Australian consumers large sums of money. The TGA regulates the sale of all therapeutic products – everything from the life saving to the useless. Without necessary reforms to regulations, the blatant rip-offs, the scams and the pseudo-scientific marketing will continue.

The changes that might make the system better aren’t complicated. Here are a small number of suggestions, expressed as concisely as possible.

1. All therapeutic products should be treated equally and follow one set of regulations. Currently, the confusing Aust L and Aust R system is in place.

2. The TGA should require labelling which is clear and understandable to the majority of consumers as tested by market research. If necessary, label ineffective products Not Medicine.

3. Safety, efficacy and responsible marketing practices should be established before any product goes on sale. Currently, there are no such presale checks for responsible marketing and efficacy.

4. The evidence supporting a product’s efficacy should be available to all – consumers and health professionals alike. Its the responsible thing to do, allowing consumers to know what they are buying and doctors to advise patients appropriately.

5. Breaches of the Therapeutic Goods regulations should be enforced with fines and penalties in exactly the same way traffic offences are enforced. Currently, there is no enforcement and breaches are common.

6. Pharmacists already have a code that in theory makes them accountable to consumers. Pharmacists should be free to decide which products they stock in their pharmacies without interference from their corporate masters.

7. All deals between industry players that accompany the marketing of therapeutic products to consumers should be open to public scrutiny.

Do you agree? Please leave your comments below.

The TGA’s recently announced changes are a small step in the right direction; however, they fall a long way short of whats required.

What is apparently impeding change is a lack of government will and the greed and self-interest of the therapeutics industry… and I make no distinction between Big Pharma and Big Quacka.

Late breaking news is that the head of the TGA, Dr Rohan Hammett, has announced his resignation. It’s unclear if the announcement has anything to do with the slow pace of reform at the TGA. Dr Hammett, as head of the TGA, addressed the Australian Skeptics National convention last month.

4 Responses to Where Did the TGA Reforms Go?

  1. gyuri69 says:

    THE TGA IS LIKE THE PRIESTHOOD. Ostensibly they are there to save our souls, but most effort seems to spent on building palaces filled with gold and growing their bellies filled with feasts. Even more cynically: The government DOES NOT WANT the TGA to halt shonky health products …because all those health consumers would descend on the real medical system causing an even greeater cost blowout for their lousy socialist health system.

    • malvickers says:

      Hi Gyuri69, thanks for taking an interest. I’m just wondering about the wording “lousy socialist health system”. Whilst it’s possible to argue that the health system in socialist countries is poor you’d need to work hard to convince me that the health system in strongly capitalist countries was much better – yes I’m thinking of the USA.

      Getting back to Australia and TGA reform, it appears that both Liberal and Labour governments have done an equally poor job at improving therapeutic goods regulations. I’m advocating “consumer protection” and an “evidenced based approach”, I don’t really care which flavour of government wants to adopt that approach.

      • GEORGE QUITTNER says:

        The only way a “consumer” gets decent medical care is if the government does its job….which is to get out of the way of doctors and patients providing and obtaining the best service possible. The government’s role is to protect people from fraud, to foster healthy competition and to support the charities which help the helpless and hopeless. Our health system is getting sicker fast. Soon the last real GP (?me) will retire and Aussies will have lost a valuable asset and health advocate. This is absolutely as a result of Medicare …and politicians of all persuasions, as you rightly say.

  2. barry rogers says:

    For an entertaining discussion between homeopathy manufacturer brauer natural medicine and an irate customer, Maria Capelli, see https://www.facebook.com/BrauerAus?fref=ts The customer is making a complaint about poisonous material a product and at last look Brauer are trying to tell the customer that homeopathy gives a microdose of the symptom. Very entertaining.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s

%d bloggers like this: