Therapeutic Goods Advertising Consultative Council meeting 17 October 2018

ff to Canberra to present, “An evaluation of the first 12 months of the TGA’s new advertising system” on behalf of Choice.

The research was performed by Monash University Research and “Whack-a-mole” students.

Monash Whack-a-mole project
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Surf Coast Spring Skepticamp VII – 14 September 2019

My presentation, “Shayna Jack, sports supplements and regulators” may be of interest.

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Australian Pharmacies sell contaminated CAMs; TGA regulation ratshit!

Recent Australian research has found nearly 50% of CAM products tested had contamination issues, with some showing the presence of animal ingredients, nuts, wheat, pharmaceuticals and toxins: See:

This is yet another example of the failure of the TGA’s trust-based regulatory system for listed products that has no pre-market evaluation and trusts sponsors to obey the rules. This research amplifies the TGA’s own limited findings on post-market surveillance, their recent consumer survey and the high level of upheld advertising complaints.

No wonder the industry is resisting publication of the names of companies and products failing TGA post-marketing surveillance!

It’s time the Australian National Audit Office (ANAO) repeated their 2011 audit to examine the effectiveness of the TGA’s administration of complementary medicines regulation.

Too many problems have continued for too long and consumer detriment is the result.

Postscript 06/09/2019:

From Pharmacy Daily 06/09/2019

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‘Reprehensible’ prescribing to vulnerable patients

MWI complaint submitted and publicised 23 June 2016; legal threats rebutted by Maurice Blackburne Lawyers pro bono, won 2016 Choice Shonky award, three years later we finally have an outcome.

“A medical practitioner has been found guilty of professional misconduct after prescribing compounded phentermine, diethylpropion and hCG to assist patients with weight loss.

Drugs prescribed by MWI

See also:

Good to see that legal wheels turned for Dr Goyer, albeit slowly! But what about the compounding pharmacist who was also involved?

https://acpharm.com.au/

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More complaints to TGA about illegal body building and weight loss supplements

The TGA recently had a $10 million fine awarded by the Federal Court against Peptide Clincs Pty Ltd for breaches of advertising regulations, including advertising prescription-only medicines to the public. However, the company involved had gone into liquidation some months earlier and will not pay. In its media release the TGA said,

Please report non-compliant advertisements to the TGA, such as those promoting unapproved therapeutic goods that claim to be image enhancing. The TGA will investigate and take action.

Indeed, similar complaints have been submitted some time ago, but still lack a published outcome. For example, Evolution Supplements King Kong stack

https://evolutionsupplements.com.au/evo-labs-kong-60-capsules/

More recently, complaints have been submitted about Muscle Peptides Australia and Peptides Direct Australia & NZ (some products promoted below).

So, there is plenty of examples to exercise the TGA’s new compliance and enforcement powers. Hopefully, before more companies go into liquidation!

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Multiple breaches of the Therapeutic Goods Advertising Code by companies advertising weight loss products

The Therapeutic Goods Advertising Code (No. 2) 2018, s.26(3)(a) says:

An advertisement for therapeutic goods containing any claim relating to weight management must not feature individuals in images or visual representations

This version of the Code took effect on 1 January 2019. The TGA noted that they would show discretion about its enforcement for the first 6-months of 2019.

In a complaint sent to the TGA on 29 July 2019 (AC-MBNGMHNQ/2019) I documented 103 advertisements, from 35 advertisers, concerning 19 products that breach this section of the Code (and many others). One example is appended.

https://www.superpharmacy.com.au/products/blooms-melt-weight-management-60-vege-capsules

Numerous previous complaints about weight loss products had been submitted to the TGA on 6 July 2018 (AC-GBKDH2XG/2018) and 16 August 2018 (AC-NJ15VLQ9/2018). To-date, no outcome has yet been published by the TGA.

Meanwhile, misleading claims for complementary medicine weight loss products continue, invariably using imagery of slim, svelte bodies, despite this also being a breach of the current Therapeutic Goods Advertising Code.

In 1989, 34% of Australians were categorised as overweight and obese, in 2018 that figure has increased to 67%. Obesity is a risk factor for heart disease, diabetes, cancer and other chronic diseases. It’s estimated to cost the economy $8.6 billion (2011-12).

Concerns about shonky complementary medicine weight loss products were initially published in 2008. By 2018, complementary medicine weight loss products accounted for 8.7% of the total market, or $430m million in sales.

The overweight and obese are a vulnerable and increasing population and such people are inevitably attracted to products promising a “quick fix”. It is particularly reprehensible that misleading and deceptive claims for these products continue to be made as they are likely to divert consumers from more evidence-based weight loss programs as well as waste their money.

In 2017 the National Strategic Framework for Chronic Conditions (NSFCC) recognised obesity as a chronic disease and specifically named ‘industry’ and ‘all levels of government’ as part of the solution.

It appears that both the complementary medicine industry and the TGA have abdicated their responsibility to assist the NSFCC and control the unethical promotion of weight loss products.

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MyDNA pharmacy assistant rewards program

I allege that this program breaches S.18 of the Therapeutic Goods Advertising Code (No.2) 2018

“An advertisement must not offer any personal incentive to a pharmacy assistant, or any retail salesperson who is not a health professional, to recommend or supply therapeutic goods”.

Screenshots of the advertisements taken 17/07/2019 follow:

https://www.mydna.life/rewards/

I submit that this is an egregious breach of an important consumer protection provision of the Code and my complaint to the TGA (AC-1M5393FG/2019) should be assessed as high priority.

I ask the TGA to order this program be rescinded and ensure a prominent notice is placed in all media where the program was promoted highlighting the S.18 breach of the Code.

Update 20/07/2019 AJP: myDNA has withdrawn its pharmacy assistant rewards program after Friends of Science in Medicine’s Ken Harvey made a complaint to the TGA

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More problems with Traditional Chinese Medicine (TCM)

All contain Fallopia multiflora also known by the Chinese name ‘he shou wu’ (何首乌)

Following a safety investigation by the TGA, Global Therapeutics, is recalling all batches and all pack sizes of its Fusion Hair Tonic and Oriental Botanicals Hairpro capsules, due to the risk of liver injury caused by an ingredient: Fallopia multiflora also known by the Chinese name ‘he shou wu’ (何首乌). It is marketed for hair thinning, ‘blood tonifying’ and a variety of other conditions.

See: https://www.tga.gov.au/alert/hair-tonic-and-hairpro-capsules and https://www.tga.gov.au/alert/fallopia-multiflora-he-shou-wu

It is now a TGA requirement that listed medicines containing Fallopia multiflora for oral use to have the following warning on the product label: ‘Warning: Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional’.

However, other products containing Fallopia multiflora continue to be promoted without these warnings (above). Do they escape warnings by being regarded as a food, not a medicine? See:

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University of Sydney pulls claims elderberries can fight flu

https://www.theage.com.au/national/university-of-sydney-pulls-claims-elderberries-can-fight-flu-20190515-p51nij.html

University of Sydney Media Release
Elderberries

The university initially stood by the claim, but on Monday, following repeated questions from The Age and The Sydney Morning Herald it acknowledged there was no evidence to support that assertion.

It now has withdrawn the press release and launched an investigation into how it was produced, and said it would change its practices to always highlight industry funding.

The study itself involved dosing human cells in a lab with concentrated elderberry juice. There were no tests on humans, or even on mice. In addition, the press release did not mention the study was funded by Pharmacare, a company that sells elderberry-based natural supplement Sambucol.

“This is an appalling misrepresentation of this Pharmacare-funded in-vitro study,” said associate professor Ken Harvey, president of Friends of Science in Medicine. “It was inappropriate and misleading to imply from this study that an extract was ‘proven to fight flu’.” See also:

https://www.3aw.com.au/flu-vaccines-yes-elderberries-no-university-forced-to-apologise-for-false-cure-claims/

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New WHO Guidelines on risk reduction of cognitive decline and dementia

https://www.who.int/mental_health/neurology/dementia/guidelines_risk_reduction/en/

Relevant to concerns about FSANZ Standard 2.6.5 which has allowed products such as Souvanaid® and Ceretain® to be self-assessed and promoted for the dietary management of Alzheimer’s dementia or related mild cognitive impairment.

https://www.souvenaid.com.au/ https://www.ceretain.com.au/

On supplements, WHO says: Vitamins B and E, polyunsaturated fatty acids and multi-complex supplementation should not be recommended to reduce the risk of cognitive decline and/or dementia. Quality of evidence: moderate. Strength of the recommendation: strong.

As reported by CBS News: Eating well, and possibly following a Mediterranean-style diet, may help prevent dementia, the guidelines say. But they take a firm stance against vitamin B or E pills, fish oil or multi-complex supplements that are promoted for brain health because there’s strong research showing they don’t work.

“There is currently no evidence to show that taking these supplements actually reduces the risk of cognitive decline and dementia, and in fact, we know that in high doses these can be harmful,” said the WHO’s Dr. Neerja Chowdhary. “People should be looking for these nutrients through food … not through supplements”. Maria Carrillo, chief science officer of the Alzheimer’s Association, agreed.

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