Foxes and henhouses

As this edition of the magazine goes to press, the Federal Parliament is considering recommendations from the Senate Community Affairs Legislation Committee relating to two pieces of legislation – the Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017. The report was released to Parliament and the public only a couple of days before the printing deadline so I haven't had time to examine it in fine detail, but a quick perusal suggests that the makers and sellers of snake oil, sorry, "complementary medicines" will have even more freedom to deceive the public than they do now. The particular areas that interest me are changes to the advertising rules for therapeutic goods and the type of claims that can be made about them.

Readers with longish memories might remember the Pan Pharmaceuticals saga from 2003. Pan manufactured and packaged the majority of supplements and alternative medicines sold in Australia. (They were what is known as a "toll manufacturer" in that they produced goods for sale under the names of other companies, not their own.) A TGA investigation showed that the idea of quality control at Pan had nothing to do with either quality or control. (I had a client at the time who sold food and drug packaging machinery. They commented that the industry view of Pan was "Like the Keystone Kops".) The reaction of the alternative medicine industry was not to rejoice at the exposure of almost unbelievably bad manufacturing practices and the possibility of improvement but to loudly scream "witch hunt".

Following the Pan debacle there were several proposals to tighten up regulation of alternative medicines. These were not received well by the industry.

One of the current proposals is to reduce the requirement for preapproval of advertising content (this applies to all therapeutic goods, including real medicines), allowing self-regulation of what is said in advertisements with action only being taken afterwards if incorrect or misleading information has been publicised. There is a cliché about horses and stable doors that applies here. It is difficult to unsay things that have been said and damage done to consumers as a result of false claims can't be undone.

In 2003 there was a rule that all print advertisements for alternative medicines and treatments had to carry an approval number issued by the Complementary Healthcare Council of Australia (the industry body, renamed in 2014 to Complementary Medicines Australia). It was very rare to actually see an advertisement including such a number, and it is probably reasonable to assume that removal of any need for preapproval won't increase the honesty in advertising.

One of the 2003 suggestions was that it was deceptive to include the words "drug free" on the label of potions with pharmacological effects. Industry reaction was"

"Passage of TGR Amendment No.401 through the Senate would be a denial of our democratic right for responsible and commonsense information on complementary medicines."

Other changes to advertising rules were suggested and this was going to cause much distress.

"The advertising review has removed a lot of previously prohibited claims and introduced a system which allows a wider range of claims so long as they are balanced, truthful and not misleading. However, many claims that have been accepted for ten or more years are no longer acceptable and there is a real danger that many multi-component products will be lost as industry has 4 years to comply with the new requirements."

So here you see the industry admitting that for at least ten years its members had been making claims that were unbalanced, untruthful and misleading and instead of promising to clean up the act they wanted more than four more years to start telling the truth.

Another of the current proposals is to further weaken the requirement for evidence of efficacy by allowing even broader claims for traditional use. In 2003, the industry had this to say"

"The main objective of the CHC position is to get out of the pharmaceutical paradigm that is crippling the industry and denying consumers' access to products that are freely available in other comparable countries."

There are two possible interpretations of the expression "pharmaceutical paradigm". One is that it is the paradigm which says that products should be thoroughly tested and be shown to work before they are sold to the public. The other is that science should be relevant to research and the pursuit of knowledge. It says much that following these principles might result in "crippling the industry".

One manufacture of dietary supplements has already relabelled its "Hunger Control" pills to say "Traditionally used by tribal people of India to help reduce hunger levels". It seems that by selling traditional treatments for hunger like rice and vindaloo my local Indian restaurant is in the wellness business.

In 1849 French journalist Ambrose Karr coined the cliché Plus ça change, plus c'est la même chose (the more things change, the more they stay the same). Or, as the legendary baseball player Babe Ruth is alleged to have said, "It's deja vu all over again".

The full report can be found at https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/TGA2017MeasuresNo1/Report

This article was published as the Naked Skeptic column in the March/April 2018 edition of Australasian Science