While fines have been doled out in recent months, some argue regulation of therapeutic goods is just not good enough, citing weight loss products, hangover cures and homeopathy
Therapeutic goods sold in pharmacy, and the evidence behind them, were the subject of intense debate at the annual Australian Skeptics convention, Skepticon hosted last weekend.
Complaints about the advertising of therapeutic goods numbered over 2200 in 2019-20, leading to the creation of over 3,000 cases. The TGA issued 155 infringement notices totalling nearly $1.6 million in total, with four cases escalating to court action.
However consumer advocates argue the TGA just isn’t doing enough, particularly in the areas of false and misleading advertising for products and indirect harm.
Public health physician Associate Professor Ken Harvey argued at a Skepticon 2020 panel session there has been no effective action taken on some products, such as weight loss or hangover products, since the TGA’s new complaint system commenced in July 2018.
Two FatBlaster Clinical products were recently cancelled, with Adjunct Professor John Skerritt, Deputy Secretary of Health Products Regulation at the Department of Health explaining this was due to “insufficient evidence, misleading presentation and inaccurate advertising claims”.
However A/Prof Harvey pointed out that the products continue to be promoted and sold in Australia despite being removed from the ARTG.
Adj Prof Skerritt said: “A range of pharmacies both online, Chemist Warehouse, My Chemist and a number of other pharmacy chains, have been given cease-and-desist notices to stop them advertising those products.
“You have to give a required frame time, so if they do not stop advertising those products by early November there can be further legal action against those companies.”
The rest of the FatBlaster range as well as other weight loss products continue to be sold, despite having similar advertising and ingredients to the products that were cancelled.
Although the TGA took action against homeopathic melatonin due to “misleading and deceptive claims”, other homeopathic products continue to be sold in the country.
Adj Prof Skerritt said “the framework that regulates medicines in Australia allows homeopathic products whether or not you believe such products are scientifically plausible.
“There are differing views among pharmacists as to whether they should sell complementary or homeopathic medicines. The PSA strongly encourages their members not to sell homeopathic medicines because of the lack of scientific plausibility, but a number of pharmacists choose to sell them.”
The pharmacist’s role
AJP spoke to a few owners about their stances towards homeopathy and complementary medicines in their pharmacies.
Sydney proprietor and pharmacist Veronica Nou said she “point blank refuses” to sell homeopathy in her pharmacies.
“There is absolutely not a jot of evidence to support it and plenty of evidence to support the thinking that it’s an incredible waste of money and just essentially expensive water,” she said. “I will not allow my professional credibility to be undermined by keeping this kind of product in the pharmacy.”
We won’t be a part of it because we won’t be a part of what we believe to be essentially a scam that’s ripping you off.
Another Sydney owner, Nick Logan, said his pharmacy doesn’t stock any homeopathy.
“Homeopathy has been disproven so many times that no one should ever stock it. We decided as a group not to validate stuff that has no evidence by stocking it. We have CMs but based on their evidence. Sometimes a dodgy product slips through my defence but not for long,” he said.
Mr Logan said his pharmacy doesn’t stock weight loss products such as FatBlaster.
“If someone asked me for FatBlaster I would encourage them to change their diet and start introducing exercise into their routine,” he said.
However he added that a nearby discount pharmacy “sells buckets of the stuff”.
Looking at the evidence
A/Prof Harvey says it is “reprehensible that misleading and deceptive claims” for products continue to be made, as they’re likely to divert consumers from more evidence-based treatments.
On being pressed as to why some products are still being sold while others have been cancelled, Adj Prof Skerritt says, “The law of the land is that we have to look at each of these products one at a time”.
“That’s because complementary medicines in Australia have this auto-listing scheme where the companies can list and then we’re required to do an evidence review if there’s concerns about the product.”
He said the system gives priority to cases where the risk of a product is considered ‘high’—for example, the marketing of ‘Miracle Mineral Solution’, black salve, cosmetic procedures or hyperbaric oxygen therapy.
Of the 3,047 cases in the last financial year, the majority (99%) were classified as low or medium risk, with just 18 high-risk cases and one labelled ‘critical’.
Meanwhile A/Prof Harvey argues that the solution is not to tackle the odd individual complaint. “The most secure response would be to reverse this situation” of automatic listing of medicines, he said.
Alternatively, such in earlier versions of the Therapeutic Goods Act, the Secretary had 28 days to make a decision about listing.
“[This] would give an alert TGA time to review new entries day by day and take action against unacceptable listings before the product could enter the market,” said A/Prof Harvey.