Friday, February 23, 2018

Not Quite Digital Health But An Anti-Scientific Outrage Nevertheless!

This appeared last week:

Thank God, Australia is now licensed to ‘moisten intestines’ and ‘replenish the gates of vitality’

16/02/2018 Edwin Kruys

A while back I spoke with a politician who was very cross about the decision by the Therapeutic Goods Administration (TGA) to make codeine products no longer available without prescription. When I asked why, the answer was, “Codeine is great for jet lag, especially with a Scotch.”

Clearly there was some confusion here about the indication of (the painkiller) codeine, which can cause serious side effects, especially in combination with other drugs and alcohol.
An ‘indication’ is defined in the law as ‘the specific therapeutic use(s) of the goods.’ Confusion about indications of medications is common. For example, people often mistakenly believe that green snot is an indication for antibiotics or that back pain is an indication for diazepam (Valium).
And, just to be clear, codeine is not indicated for jet lag.

Dryness in the triple burner

Unfortunately the Australian Government has just muddled the water by passing two bills in the Senate that allow manufacturers of vitamins, supplements and herbal complementary medicines to use a range of odd claims, such as ‘expel damp-heat in the bladder’, ‘moisten intestines’ and ‘cool blood heat’.
I have no idea what this means. The TGA’s new list of permitted indications is not based on scientific evidence.
RACGP President Bastian Seidel expressed concern about many of the indications. He said: “(…) phrases such as ‘moistens dryness in the triple burner’, ‘replenishes gate of vitality’ and ‘softens hardness’ have no place in any genuine healthcare situation. These types of claims are extremely misleading and could lead to significant harm for patients.”
More here with lots of outraged comments:

Here is a link to the list:


There has been a huge amount of commentary on this in mainstream media.

This is typical.

'Softens hardness': TGA under fire for health claim list that critics say endorses pseudoscience

Esther Han
Published: February 9 2018 - 12:15AM
Hundreds of bizarre health claims such as "tonifies kidney essence" and "opens body orifices" will be approved by the Therapeutic Goods Administration and appear on complementary medicine labels under new laws being pushed by the federal government, horrifying doctors.
In July last year, the TGA began developing a list of "permitted indications" that would restrict vitamin and herbal medicine companies to make only government-approved health claims on their products once the Therapeutic Goods Amendment bill passes.
Health groups were expecting a list of about 100 clinical indications, each backed with scientific evidence. Instead, it has ballooned to more than 1000 claims, most of which they say are misleading, potentially harmful and based on pseudoscience.
"The TGA held industry consultations and just lost the plot; it gave them a licence to deceive," said Allan Asher, a regulatory expert and former deputy chair of the Australian Competition and Consumer Commission.
"Everybody thought things would get better, but it's made things worse because the indications will be government-approved and government-required, and under product liability laws, if something is required by a government, it can't be found to be a hazardous product."
If the bill passes, complementary medicine companies will only be able to draw from the list of permitted indications (that is, claimed purpose or health benefit) when registering, and later labelling, their products. The list will be a legislative instrument.
The latest draft list contains innocuous items such as "relieves itchy eyes" and reassuringly shows the TGA has struck off dubious claims such as "helps increase hand to eye coordination", noting "remove - not plausible".
But critics claim 86 per cent of the 1019 indications are not supported by scientific evidence, including "softens hardness", "replenishes gate of vitality" and "moistens dryness in the triple burner".
"There's this yawning loophole where if you can't say that it's scientific, you can say there's evidence it's traditionally been used," said Mr Asher, chair of the TGA Complaints Resolution Panel, which will be scrapped under the bill.
"I'm worried consumers will think these traditional claims have some form of government imprimatur and are thus likely to be effective, when there is no such guarantee."
Two years ago, the National Health and Medical Research Council reviewed 225 research papers on homeopathy and concluded there was no good quality evidence to support the claim that homeopathy works better than a placebo.
Complementary medicines include vitamins, mineral and nutritional supplements, homeopathic, aromatherapy products and herbal medicines. Seven out of 10 Australians take some form of vitamin or supplement.
Dr Bastian Seidel, president of the Royal Australian College of General Practitioners (RACGP), said some of the indications were a dangerous mixture of "fiction and hope" and, at worst, could interact with pharmaceuticals and be harmful.
Lots more here:


All I can say is that the TGA are to be condemned for all this. There are better ways to allo use of non-scientific treatments without appearing to endorse them! Well said Edwin!

David.

4 comments:

  1. Just yet another sign of the crisis our Governembt and Politics are in. We seem to be in a never ending cycle of second rate marketing dribble, power points and dragging each other into the realm of gutter press and reality TV standards.

    Would be nice if they stopped.

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  2. Who on earth authorised this? And what right do they have to lesson the reputation and brand of the TGA? This IMHO is a blatant misuse of the TGA and destroys trust and respect in the TGA as an institution. The Minister needs to get his act together.

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  3. "The TGA is required to recover its costs through fees and charges for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities."

    http://www.tga.gov.au/fees-and-payments

    Maybe the TGA is trying to increase its activities/coverage and hence get more money.

    I doubt that the Minister has much say in the mater.

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  4. So a Government department such as TGA is prone to revenue generating forces. That is not good and we can possibly see the results. How long till the GovHR become a revenue source? And the implications of that?

    ReplyDelete