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

Objective

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 ken.harvey@medreach.com.au

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, Quackwatch.org 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 centerforinquiry.org.

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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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Fraudulent IV drip therapy

Misleading and deceptive claims for IV drip therapy
https://www.ivlounge.com.au/ivvitamintherapy.html
Screen shot 12/02/2020

The problem:

NSW businesses are making claims for IV drip therapy that lack scientific evidence and exploit consumers. Claims include, ‘combats hangovers’, ‘removes toxins’, ‘removes fat’, ‘anti-ageing’, ‘prevents colds’, ‘boosts immunity’, ‘relieves fatigue’, ‘provides mental clarity’ and ‘improves memory function’.

Some clinics are advertising IV drip therapy for serious conditions such as, ‘treatment for acute asthma attacks’, ‘chronic sinusitis’, ‘seasonal allergies’, ‘depression’ and ‘cardiovascular disease’. These claims are serious breaches of the Therapeutic Goods Advertising Code and the Therapeutic Goods Act.

Some businesses offer a mobile service where they will come to you and administer IV drip therapy at weddings, bucks and hen’s parties, or even poolside after a big night.

They claim to use registered, qualified nurses and medical staff. They charge from $149 to $299 and offer inducements: ‘buy 10 and save $350’.

My concerns:

In my opinion, the companies concerned, and the medical and nursing staff they employ are in breach of s.133 of the National Law. This is because the claims made are false, misleading and deceptive; most cannot be substantiated, they create an unreasonable expectation of beneficial treatment and they encourage the unnecessary use of health services.

In addition, the medical, nursing and compouding pharmacy staff involved in IV drip therapy are likely to be in breach of their respective Codes of Conduct because, by providing this service, they are not acting their patients’ best interests.

Action taken:

A complaint has been submitted to the NSW Health Care Complaints Commission and the TGA asking them to investigate these clinics and the registered health professionals that compound and administer the promoted treatments. If it is agreed that all involved break the law, then I ask that those involved be prosecuted to the full extent the law.

Misleading and decepitive claims of IV drip and IM therapy
https://www.ivhealth.com.au/intravenous-infusions-iv-health/ (12/02/2020)

See also:

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Complementary medicines: Exporting ‘White Australia Policy’

Found in Sri Lankan Pharmacy

Prof Weerasuriya ( University of Colombo) has complained that ‘Australian made’ skin whitening products are being sold in Sri Lankan supermarkets (and presumably other Asian counties).

Skin-whitening products are a multi-billion-dollar industry that push a racist idea that beauty equates with white skin and that lightening dark skin is achievable and preferable. This concept fuels intolerance of dark-skinned people, causes serious social harm and wastes consumer’s money.

The ‘Facia Premium Skin Lightening Formula’ is being illegally exported by an Australian company (Zifam Pinnacle) and as a skin whitening product. That is not a permitted or specific indication on the TGA’s ARTG product public summary (295927). This promotion brings Australia’s reputation into disrepute. It’s also an indictment of uncritical Australian export awards (below).

A complaint has been submitted to the TGA and to the Hon Karen Andrews MP, Minister for Industry, Science and Technology.

Regrettably, the Minister, and her Department of Industry, Science and Technology, has a track record of prioritising industry profitability over consumer and social justice concerns, see: Made in Australia?

Prof Weerasuriya from Sri Lanka comments:

  1. There are many skin whitening products on the market, including from giant multinationals such as Unillevers. They occupy significant shelf space in supermarkets.
  2. There is no scientific evidence that any of them work  as promoted.
  3. As Medicines Regulator I can see the clear discrepancy. The manufacturer obtains an Australian licence number for the product (which does NOT have skin whitening as an approved indication). The manufacturer then adds “skin whitening” claim as on the outer packaging when exporting – that is a violation of the Australian licence number regulations.
  4. The National Medicines Regulatory Authority in Sri Lanka is also lax – information is available on the Internet and the discrepancy can be pointed out but the product is registered and allowed into the country.
  5. The importer then sells the product with all the “Australian Prestige” misleading the consumer.
  6. Action needs to be taken on multiple points in the supply chain – publicity in the Australian media would help in cutting off the product at its source.
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Complimentary Medicines Australia ‘Fake News’

Extract from Pharmacy News 28/01/2020

In fact, these three products were all listed as ‘FAIL‘ on the TGA web site: https://www.tga.gov.au/ws-labs-index
Testing category: Programmed; Product type: Comp medicines; Release date: May 2019

Burn with Svetol
ARTG ID: 198697
Sponsor: Herbs of Gold Pty Ltd
Reason for testing: Survey of a Medicine/Device Group
Result: FAIL: Prohibited Substance Detected
Outcome: The Sponsor has CANCELLED the entry from the ARTG.
Product type: Complementary Medicines

Nature’s Way Metabolift Fat Burner
ARTG ID: 179535
Sponsor: Pharmacare Laboratories Pty Ltd
Reason for testing: Survey of a Medicine/Device Group
Result: FAIL: Prohibited Substance Detected
Outcome: The Sponsor has CANCELLED the entry from the ARTG.
Product type: Complementary Medicines

Fat Away
ARTG ID: 198892
Sponsor: Caruso’s Natural Health Pty Ltd
Reason for testing: Survey of a Medicine/Device Group
Result: FAIL: Prohibited Substance Detected
Outcome: The Sponsor has CANCELLED the entry from the ARTG.
Product type: Complementary Medicines

Extract from Pharmacy Daily 29/01/2020

Update 31/01/2020

One of these products, Herbs of Gold, ‘Burn with Svetol 60,t (ARTG no: 198697)’ is still being advertised and sold. This is a serious breach of the Therapeutic Goods Act 42DL(12). See advertisment below (screen shot taken today) :

https://www.nutrientavenue.com.au/products/herbs-of-gold-burn-with-svetol-60t
https://www.nutrientavenue.com.au/products/herbs-of-gold-burn-with-svetol-60t

A complaint has been submitted to the TGA (AC-ECJ0MAHF/2020).

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Vitamins are not a substitute for a healthy diet

Tweet from TGA 20/02/2020

In response to Victorian Government, Better Health Channel, article, ‘Vitamin and mineral supplements‘.

See also the excellent film ‘Vitamania‘.

Next, the TGA needs to expand the Heading of Section 25 of the Therapeutic Goods Advertising Code (No.2) 2018 to: ‘Vitamins, Minerals and other supplements’ and the text to: ‘Vitamins, Minerals, Fish oil and other supplements are no substitute for a healthy diet. Speak to your health professional before starting any new treatment, including supplements.’

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Work Integrated Learning (WIL): Monash BME 2032

Work Integrated Learning (Monash BME 2032) enables students to apply discipline related knowledge to authentic, real-world situations in non-clinical, industry-focused work environments. It also provides opportunities to establish closer links between future graduates and industry partners.



Aung Oo (BMS 2), Yuet Fonia Wong (BMS 2), me, Arghavan Shafiei (BMS 2), Jack Gerrard (Med 4)

This summer, three work integrated learning (BME 2032) students were joined by a Med 4 student who also wanted experience in a research unit.

The students participated in action-orientated research about therapeutic goods and services. The aim was to help consumers and health professionals cut through promotional hype, make more informed choices about medicines and medical devices and improve the regulation of therapeutic goods.

They looked at the evidence for complementary medicines, worked up complaints about unethical practice for sumission to the regulators, analysed policy and assisted with submissions to government.

A visit to Swisse Wellness Pty Ltd was arranged.

Also, a meeting with Nigel Pollard, Chairman, Natural Health Science Foundation Inc.

And a visit to Therapeutic Guidlines Limited.

See also:

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