Monash SPHPM Therapeutic Goods and Services Research Group 2020 pre- & post-COVID-19

Our action-orientated research helps consumers and health professionals make more informed choices about medicines and medical devices. We do this by analysing policy, making submissions to government, submitting complaints about unethical practice, encouraging regulators to act, being a credible source of expertise to the media, and advocacy with organisations such as Friends of Science in Medicine, Skeptics, Choice and Consumers Health Forum.

We used to meet face-to face…

Therapeutics goods and services research group team pre-COVID-!9.
Back row: Ken Harvey (Team Leader), Hannah Charles (MD SIP), Malcolm Vickers (MPH research)
Front row: Anjali Kumar (BBiomedSci honours), Shuyi Wu (BBiomedSci honours)

But not anymore….

Therapeutics goods and services research group team zooming post-COVID-!9.

Regardless, the team pushes on:

  • Mal Vickers is researching complementary medicines and advertising: The impact of Australian policy pre- and post-July 2018, as part of his MPH studies. He has two papers about his work accepted for publication.
  • Hannah Charles researched the literature for CoQ10 to see if it supported commonly advertised claims for this supplement. She has also followed up complaints about CoQ10 advertisements submitted to the TGA worked up by other students. This was all done in her 6-week MD SIP research attachment which has just finished.
  • Anjali Kumar is researching common indications and advertised claims for probiotics to establish if these are backed by scientific evidence and meet regulatory requirements. She is undertaking a BBiomedSci honours degree.
  • Shuyi Wu is researching the history of Chinese Traditional Medicine (TCM) and the role of the Chinese government in encouraging its use. She is then evaluating claims made for listed TCM products promoted for COVID-19 and menopause; in particular, the evidence base for the herbal ingredients used. She is also undertaking a BBiomedSci honours degree.

See also:

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COVID-19 Scams: Hydrogen Technologies Pty Ltd


On 14 April 2020 a press release from Hydrogen Technologies Pty Ltd said: ‘Molecular hydrogen and oxygen technology is not only helping open the airways of
Coronavirus victims by reducing the inflammation it causes in the lungs, but it also assists
the immune system and dramatically reduces the oxidative stress in the body that if not
addressed, can lead to multiple organ disfunction and failure. Both hydrogen and oxygen are a bodies key requirement to staying alive and well’. It also said:

IMPORTANT NOTE: This machine is not to be referred to as a Medical Device

Excerpt from video at

The web site also contains a page with videos titled the ‘Top 10’ with claims that molecular hydrogen can assist with heart disease, cancer, chronic obstructive pulmonary disease, accidents, stroke, Alzheimer’s, diabetes, influenza and pneumonia, kidney disease, suicide and mental illness.

I am unaware of any scientific evidence to support these claims. In addition, this list of diseases are restricted or prohibited representations that are not allowed to be advertised. Furthermore, this medical device is not included on the Australian Register of Therapeutic Goods (ARTG).

This promotion breaches numerous sections of the Therapeutic Goods Act 1989 (Compilation 72, 2019) and the Therapeutic Goods Advertising Code (No 2) 2018.

A complaint (AC-8IBKJXKR/2020) has been submitted to the TGA. In my opinion, an urgent retraction order and significant infringement penalties are warranted.

See also:

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COVID-19 Scams: Pete Evans BioCharger device

A $15,000 BioCharger device was recently spruiked by celebrity chef Pete Evans who claimed it could treat a range of ailments, including COVID-19. “It’s programmed with about 1,000 different recipes, there’s one in there for the Wuhan coronavirus,” Evans said.

Peak medical groups have criticised Evans saying that claims this device could be used to treat coronavirus are baseless, ill-informed and dangerous.

How does the BioCharger work?

Science-Based Medicine says, ‘BioCharger’s claims are too silly to take seriously. It’s based on fantasy, not science and at $15,000 it’s pretty expensive for a placebo’.

The TGA said it, ‘encourages anyone with concerns in relation to COVID-19 related claims being made about a therapeutic good to provide information via the online advertising complaint form‘. A Friends of Science in Medicine member has now submitted a formal complaint (AC-1S6DPV6J/2020) to the TGA.

It has also been suggested that celebrity chef Pete Evans should be reported to the Australian Competition & Consumer Commission (ACCC) as his claims for the BioCharger device are in breach of Australian Consumer Law (Competition and Consumer Act 2010 (Cth) Schedule 2 s. 18, 29, 224, 232 and the Competition and Consumer Act 2010 (Cth) s 137H). Prosecution of a similar matter by the ACCC in the Federal Court resulted in heavy fines on Fran Sheffield and Homeopathy Plus.

I have now referred this matter to the ACCC. It will be interesting to see which regulator will act, when and to what effect.

Update 24 April 2020

Following receipt of a number of complaints about the promotion of a ‘BioCharger’ device the TGA has fined Pete Evans’ company $25,200 for alleged COVID-19 advertising breaches.

Concern was expressed that the fine was less than the cost of two machines that Evans was flogging, was hardly a deterrent and the penalties available to the TGA are too low.

See also:

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COVID-19 scams: BergaMet Pro +

On 9 April, 2020 the web site for BergaMet Pro + claimed, ‘Ingredients in BergaMet Pro + provide a resistance to infectious pathogens such as SARS and COVID-19’ (appended).

Screen shot from 9 April 2020

This implied claim to prevent or cure COVID-19 resulted in a complaint to the TGA (AC-NTI67OV3/2020).

The ingredients of BergaMet Pro + (ARTG no: 253193) are:

  • alpha lipoic acid 50 mg (a naturally occurring fatty acid found in many foods),
  • ascorbic acid 25 mg (Vitamin C),
  • chromium picolinate 200 microgram (a form of the mineral chromium)
  • citrus aurantium (Bitter orange) 650 mg and
  • Olea europaea (European olive) 100 mg

The product is sponsored by DOJS Holdings Pty Ltd trading as Nathealthsolutions (ABN: 45 106 823 572).

The complaint pointed out that there is no evidence that the ingredients in this product can ‘provide a resistance to infectious pathogens such as to SARS and COVID-19’, that the latter are not permitted indications for complementary medicines and this advertisement breaches many sections of the Therapeutic Goods Advertising Code (No 2) 2018.

Nine ACA have publicised this matter:

Nine ACA 8/04/2020

ACA noted: ‘The TGA says it’s now investigating that case and it will take action if the law was breached’.

On 24 March 2020 a TGA media release said, ‘The TGA is monitoring non-compliance, particularly in relation to the advertising of products that claim to prevent or cure COVID-19 and will take action in relation to any advertisements that do not meet the requirements, including those that seek to mislead consumers.

Well, in my opinion, the law has definitely been breached by the implied claim to prevent or cure COVID-19. It will be interesting to see what action the TGA takes, especially as there have been four previously upheld complaints about BergaMet products. These included a request from a previous Complaint Resolution Panel determination (CRP-2016-12-001) for a retraction of misleading and deceptive claims (appended).


I have asked the TGA to order a similar retraction and apply infringement penalties to DOJS Holdings Pty Ltd.

The TGA have yet to publish an outcome for the latest BergaMet complaint (AC-NTI67OV3/2020).

Following the Nine ACA story the offending claim was removed. The last time I complained about a web site that was rapidly taken down when the media got involved the TGA said, ‘No action taken as no breach of therapeutic goods advertising legislation identified’.

This despite my complaint containing dated screen shots of the breaches because, by the time the TGA got around to looking, the offending material had been taken down! See: 30 January 2020, Nutrient Avenue, Herbs of Gold Burn with Svetol 60t, AC-ECJ0MAHF/2020.

So the TGA outcome for complaint (AC-NTI67OV3/2020) is awaited with interest.

See also:

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Professional misconduct: IV clinic pharmacist found guilty

In December 2015, two Monash summer vacation scholarship students helped me work up a complaint to the Pharmacy Board of Australia. The complaint alleged professional misconduct by IV clinic pharmacist, Shadi Kazeme.

Actress Ruby Rose and IV pharmacist Shadi Kazemeharmacist Sharmane Kazeme
Actress Ruby Rose and clinic pharmacist Shadi Kazeme

The Hydration Clinic was based at a medical clinic in South Yarra, Victoria with the support of Dr O’Gorman, director and general practitioner.  It subsequently expanded to Holdsworth House Medical Practice in Sydney in a clinic run by Dr Quan and partners. Shadi Kazeme was the pharmacist and clinic director.

The clinics promoted a range of IV infusions with claims which we alleged breached Section 133 of the National Law and also the Code of Conduct Pharmacy Board of Australia. Treatments (and claims) included:

  • Rejuvenate.ME ($249), “contains a high dose of Glutathione as well as a number of other vitamins”, a “very popular anti‐ageing remedy that produces fast results”. “The detoxifying  properties in this infusion helps to cleanse the body’s vital organs”.
  • Energise.ME ($289), “based on the famous Myer’s Cocktail”, “contains a carefully balanced blend of vitamins, detox agents and energy supplements with a hit of the anti‐aging Glutathione that floods the body putting your electrolytes back into equilibrium”.

Some publicity ensured:


Over four years later, on March 19, 2020 the Civil and Administrative Tribunal New South Wales found Shadi Kazeme guilty of unsatisfactory professional conduct and professional misconduct.

The Tribunal found that the practitioner posed a substantial risk to the health of members of the public and accordingly ordered that the practitioner is prohibited from providing health services offering intravenous infusions, intramuscular injections and other forms of injectables of vitamins, minerals, antioxidants and other similar products, for the period until she obtains a reinstatement order under Division 8 of Part of the Health Practitioner Regulation National Law (NSW) or its equivalent, or is re-registered as a health practitioner.

The practitioner was ordered to pay the Health Care Complaints Commission’s costs of these proceedings pursuant to clause 13(1) of Schedule 5D of the Health Practitioner Registration National Law (NSW) as agreed or as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW).

See also: ‘Banned from practice until November 2021‘.


The judgement was silent on the claims made for the infusions offered, but numerous other clinics currently offer similar IV drip treatment and make similar claims that lack scientific evidence. More complaints have been submitted.

These cases raise the question as to why regulators can’t take faster action to protect the public from the fraudulent claims made by IV drip clinics.

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Independent review: Consumer consultation

On 18 March 2020, the Review of the TGA Advertising Framework held a consultation with the consumer members of the TGACC. This was led by Rosemary Sinclair AM and involved Protiviti consultants, TGA staff and consumer rerpresentatives from Choice, Consumers Health Forum, Country Women’s Association of Australia and the National Rural Health Alliance.

Rosemary Sinclair AM


The purpose of the discussion was to gain consumer stakeholder feedback for the Independent Review of TGA Advertising Framework as included in the Therapeutic Goods Act 1989 (Cth). In particular, the effectiveness of  the advertising reforms from the MMDR Review, and other initiatives announced by the Minister in February 2018. For background see: ‘Independent review: Therapeutic goods advertising‘.

Agenda items

1 a) Code Amendments

Do you consider that the changes to the Code have: increased clarity and objectivity to support compliance and enforcement powers of the TGA; and improved consistency between the requirements for medicines and medical devices?

1 b) TGA as the Single Body for Complaints Handling

What are your views on the impact and effectiveness of the TGA as the single body responsible for implementing a complaints management process about the advertising of therapeutic goods to the public?

1 c) Broadened Sanctions and Penalties

What are your views on the impact and effectiveness of the broadened sanctions and penalties to deter inappropriate and misleading advertising of therapeutic goods?

2 a) Industry and Consumer Education Program

What are your views on the impact associated with the industry and consumer education program, including the educational material currently available through the advertising hub?

2 b) Performance Measures for Complaints Handling

Do you consider that the public performance measures for advertising complaints management are fit for purpose?

2 c) Stakeholder Engagement and the TGACC

What are your views on the impact of stakeholder engagement activities on therapeutic goods advertising with a particular focus on the effectiveness of the TGACC?

My notes (brief responses to the questoins above) are available here. See also:

The closing date for written feedback on the Review is Wednesday 22 April 2020. If consumers wish additional points to be made before that date please send them to me, either as comments to this post or by email to

Independent Review Consultants
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Outcome of two student complaints

The ‘outcome’ of two student complaints shows the limitations of the TGA’s advertising framework.

Outcome of student complaints: Case 1

On 11 December 2018, I submitted a compliant about Evolution Supplements, The King Kong Stack, TGA reference number AC-C7NJIKYV/2018. This complaint was worked up by one of my 2018 Summer School students (Lucy Romanoff). On 30 March 2019 , I complained that this and similar products were still being advertised and again on 8 August 2019.

Another complaint to TGA, 8 August 2019

The breaches included advertising Selective Androgen Receptor Modulators (SARMs) which are not approved for sale or promotion by the TGA. The use of SARMS has been linked to liver failure and increased risk of heart attack and stroke. Importing, supplying or possessing SARMs without a valid prescription, license or authority is illegal.

On 13 March 2020, the TGA commenced court proceedings against Evolution Supplements Australia and its sole director (Mr Cumhur Keskin) for alleged advertising breaches. Ironically, there is no mention of this in the TGA complaint outcomes database. This is a common problem; the TGA does not keep their complaint outcome database up-to-date.

It has taken 16 months from the first complaint to get to this point. Meanwhile, Evolution Supplements Australia continues to sell these products; presumably Mr Keskin is laughing all the way to the bank. His next response may be to declare bankruptcy (as did Peptide Clinics Australia) and escape all penalties.

Outcome of student complaints: Case 2

On 27 January 2020 I submitted a complaint about Contract Manufacturing & Packaging Services Pty Ltd & Zifam Pinnacle’s Skin Whitening product Facia Premium, TGA reference number AC-1J8YT9YX/2020.

TGA complaint, 27 Januaru 2019

The complaint had been worked up by one of my 2020 WIL STEM students, Aung Ko Oo. It has now been publicised by the ABC, ‘Beauty supplement claiming to be made in Australia to ‘whiten skin’ criticised as ‘unethical‘. However, despite the serious nature of this complaint, and the fact that this promoting this product overseas diminishes Australia’s reputation in the region, the TGA have not yet provided an outcome for this complaint. And why is the 2013 ACCM recommended warning about glutathione not in place?

Finally, this is a nice example of the role of the cosmetic / supplement industry. Their aim is to create dissatisfaction to sell products; brown people need to be whiter and white people need to be browner (despite the risk to the latter of malignant melanoma from too much sun and tanning clinics)! See also, Jeremy Taylor’s ‘Black and White Calypso‘ (Live).

There must be a better way for the TGA to of deal with these companies!

On Wednesday, 18 March 2020, I’ll be in Sydney attending a workshop (representing Choice) of the, ‘Independent Review of Reforms to the Therapeutic Goods Advertising Framework’ with TGA consultants, Ms Sinclair and Protiviti Pty Ltd. The numerous complaints worked up by my students (and the inadequete response of the TGA as documented by our research) will be important discussion points.

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Quackwatch joins the Center for Inquiry

For many years, and its related websites have been an indispensable and trusted resource in the fight to expose the fraud of health-related pseudoscience and fake medicine. Their mission will continue as part of the Center for Inquiry.

Quackwatch and its related sites house an exhaustive array of information, advice, and news for consumers, activists, media, regulatory agencies, and health professionals. Most of the sites are topic specific and focus on such subjects as Naturopathy, Chiropractic, Traditional Chinese Medicine (including acupuncture), Homeopathy, phony cancer treatments and questionable medical devices.

To ensure that the information remains available, Quackwatch has become part of the Center for Inquiry (CFI), which will maintain its sites and receive Dr. Barrett’s research library later this year.

The Center for Inquiry (CFI) is a nonprofit educational, advocacy, and research organization headquartered in Amherst, New York, with executive offices in Washington, D.C. It is also home to the Richard Dawkins Foundation for Reason & Science, the Committee for Skeptical Inquiry, and the Council for Secular Humanism. The Center for Inquiry strives to foster a secular society based on reason, science, freedom of inquiry, and humanist values. Visit CFI on the web at

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Monash students present at Skepticamp 2020

Two Monash BHSc students doing a work placement with me presented their work at the Airey’s Inlet Summer Skepticamp on February 29, 2020.

From left to right: me, Arghavan Shafiei and Aung Ko Oo

Their presentation documented a number of complaints they had worked up which were then submitted to the TGA. They discussed claims made for Microgenics Ginkgo 7,000 and other products containing Ginkgo Biloba, the Facia Premium Skin Whitening product containg glutathione exported to Sri Lanka and Blackmores Proseren (containg Saw
palmetto) promoted for Benign prostatic hypertrophy (BPH).

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Independent review: Therapeutic goods advertising

In February 2018, the Hon Greg Hunt MP, Minister for Health, committed to an independent review of the impact of the new advertising measures within two years from the commencement of the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018.

On 23 December 2019, a contract commenced with ThinkPlace Australia to review the TGA’s advertising complaints handling. In addition, an independent review of advertising reforms (the Review) has now commenced and is being led by Ms Rosemary Sinclair AM in association with Protiviti.

The independent review will assess the impact of the:

I represent Choice (Australian Consumers Association) on the TGACC. I (and others) have presented the following concerns about the above to the TGACC at meetings on 17 October 2019 and 20 Feb 2020:

  • Classification of complaints, especially the high proportion of complaints classified as ‘low priority’. The TGA declares that these complaints have not breached the Act and Code and closes them by sending a ‘regulatory obligation letter’ which states no further action will be taken. This is despite detailed representations in complaints of specific breaches of the Act and Code.
  • Numerous unresolved complaints, some dating back to July 2018 with an ever increasing backlog. For example, weight loss, hangover, homeopathic and other ‘traditional’ products, exploitative medical devices, and products at the food-medicine interface, especially dangerous sports supplements.
  • Common and ongoing Code breaches unaddressed, for example:
    • Failure of industry to keep up to date with new studies that invalidate older ones such as, Omega-3 for ‘heart health’, Glucosamine for osteoarthritis, Ginkgo biloba for mental enhancement.
    • Failure to recognize new restricted representations in permitted indications such as Benign Prostatic Hypertrophy (BPH) and Saw Palmetto.
  • KPIs that relate to process (time to close by sending a ‘regulatory obligation letter’), not outcome (time to compliance achieved).
  • Ineffective sanctions and penalties. For example:
    • The TGA recently had a $10 million fine awarded by the Federal Court against Peptide Clinics Pty Ltd for breaches of advertising regulations, including advertising prescription-only medicines to the public. However, the company involved went into liquidation some months earlier and did not pay. Similar complaints have yet to be addressed.
    •  InSkin Cosmedics Group Pty Ltd paid penalties of $37,800 in regard to the alleged supply and advertising of the Dermapen 4, a medical device that was not included on the Australian Register of Therapeutic Goods (ARTG). To date, this device (which still lacks an ARTG number) continues to be advertised by numerous clinics.
  • Additional loss of consumer protection that will result from the removal of therapeutic goods advertising pre-approvals from July 1, 2020 (out of scope of the Review).
  • Problems with TGACC meetings:
    • Voluminous agenda papers arrive late, leaving little time for detailed consideration.
    • Mainly talked at by TGA staff, very limited discussion of problems.
    • Not a forum that makes use of member’s experience and expertise.

See also:

Too many shonky therapeutic goods: Consumer protection required
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