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.