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.’
Aung Oo (BMS 2), Yuet Fonia Wong (BMS 2), me, Arghavan Shafiei (BMS 2), Jack Gerrard (Med 4)
Monash BME 2032 (Biomedical industry based learning) 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.
This summer, three BME 2032 students were joined by a Med 4 student who also wanted experience in a research unit.
The students are participating in action-orientated research about therapeutic goods and services. The aim is 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 are looking at evidence-based complementary medicines (AUST R and AUST L(A), working up complaints about unethical practice that will be submitted to the regulators, analysing policy and assisting with submissions to government.
Abdullah spent the summer of 2019 following up complaints sent to the Therapeutic Good Administration (TGA) which had been classified as ‘low risk’ and ‘closed’ by the regulator by sending a Regulatory Obligations letter to the advertiser. Complaints about Pain Erazor and the Pain®Gone pen were two pain-zapping products he reviewed. As expected, the TGA educational letter (which states that no further action will be taken) had no effect on ongoing promotion.
So, can a few zaps a day keep the pain away? With the exception of a possible placebo response, the answer is NO. Also, the Prime Minister might say, ‘How good is the TGA!’. We say, ‘There is considerable room for improvement!’
From left to right: Chiara Piazzese (BMS 2), (me), Chelsea Landwehr (Med 2) and Zoe Nikakis (BMS 2)
Respectively, they worked up complaints (which I supervised checked and submitted) about:
Fresh Start Everyday Detox (Sync Corporation): a product that claims to prevent hangovers by removing alcohol from the body. It also purports to remove parasites, bacteria, viruses, fungi, yeasts and radiation (AC-VY4MQ62F/2019).
MasterCell Clinic (Dr Soraya Felix): who claims to use stem cells to treat conditions such as multiple sclerosis, Parkinson’s disease, rheumatoid arthritis osteoarthritis and dementia (AC-1A5AMYFK/2019).
Mundicare® Cold Defence Nasal Spray which contains a seaweed extract, “clinically proven” to shorten the duration of a cold by up to 2 days (AC-3JAMPO3O/2019).
Together, they also worked up a complaint (that I supervised, checked and submitted) about breastexcellence.com.au (Dr George Mayson) who was promoting POLYTECH breast implants suspended by the TGA (AC-AVQKCMG9/2019).
For more information, or any concerns about this work, contact me.
The Australian Skeptics National Convention returned to the University of Melbourne’s Carrillo Gantner Theatre on 7th and 8th December 2019. One feature was a regulatory panel discussion: Could Australian regulators better protect consumers from misleading and dangerous advertising of products making therapeutic claims?
Ken Harvey (Chair) introducing case studies for discussion by the panel
Background: From July 2018 the Therapeutic
Goods Administration (TGA) took over the advertising complaint system from the
Complaint Resolution Panel (CRP). The TGA were given increased compliance and enforcement powers
that the CRP lacked.
The TGA also declared certain
products that had received numerous complaints not to be therapeutic goods,
thus hand-balling regulatory responsibility to the Australian
Competition & Consumer Commission (ACCC). The latter complained they were already overloaded, and a
specialist regulator was more appropriate.
Meanwhile, controversial promotion of products at the food-medicine interface, such as self-declared sports supplements and medical foods, highlighted problems with Food Safety Australia New Zealand (FSANZ), State and Territory Food authorities, and their interrelationship with the TGA. There was also concern about the TGA’s new complaint system.
Panel members:
Nicholas Heys, Deputy General Manager, Enforcement Coordination, Australian Competition & Consumer Commission (ACCC).
John Skerritt, Deputy Secretary for Health Products Regulation, Australian Department of Health.
Julie Woods, Discipline Leader (Nutrition), Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University (unfortunately unable to make it due to illness).
Basia Diug, Head of Undergraduate Courses and the Head (Quality and Innovation) of the Medical Education Research and Quality unit at the School of Public Health and Preventive Medicine, Monash University. Case study: Problems at the food-medicine interface.
I recently submitted a complaint to the TGA about the promotion by JT Medical of ARTG suspended POLYTECH Breast implants (AC-G8RWXAES/2019). I was concerned that these implants were being promoted to the public with no mention of the risks of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
The TGA’s decision to suspend certain breast implants was in response to the increasing incidence of BIA-ALCL and new evidence correlating BIA-ALCL to textured implant devices.
Despite this evidence, following application from six surgeons, the TGA has allowed 36 patients access to suspended breast implants via Special Access Scheme (SAS) B. Such applications must be reviewed and approved by TGA before a suspended product may be supplied to a patient. In granting approval, the TGA must consider the risks and benefits of the device proposed, and why a device currently included in the ARTG cannot be used for the treatment of the individual patient.
Given the reasons for the ARTG suspension, including that the claimed benefits of the highly textured surface of the device was not supported by the manufacturer’s evidence, it is hard to understand why SAS B approval was given, especially when the applications were for cosmetic breast augmentation, not breast reconstruction. In my opinion, these decisions undermine the credibility of the TGA.
The TGA has published, “Information for consumers: What you need to know about unapproved breast implants”. I am concerned that this document hands responsibility for what should be a regulatory decision to an ill-informed consumer in a power imbalance with her surgeon (who may have undisclosed conflicts of interest with the device sponsor).
There is a discrepancy between disclosure of remuneration by prescription medicine companies to Australian doctors compared with medical device companies. The former, stimulated by the ACCC who authorise Medicines Australia Code of Conduct, transparently publish such remuneration; the latter do not! In the USA transparency of payments to doctors by all therapeutic goods companies is mandated by law, in Australia it is not.
I have written to Health Minister Hunt requesting he initiates a Ministerial review of the decision by the TGA to give SAS B approval to use suspended breast implants for 36 patients following applications from six surgeons.
I have also requested he makes disclosure of remuneration to medical practitioners uniform for all manufacturers of therapeutic goods by including this provision as a condition of product listing / registration / inclusion on the ARTG.
In Australia, food and medicines are regulated under separate legislated frameworks commensurate with their intended use and the potential risks they pose to public health and safety. Whether a product for oral consumption is a food or a medicine in law can depend on its specific combination of ingredients, claims and overall presentation.
Sports supplements often carry explicit or implied claims relating to sport, fitness or recreational performance that mean they are likely to be consumed for therapeutic use, yet some of them may be considered to be food under law. Yet it is appropriate that those sports supplements that are taken to be for therapeutic use are subject to the same national system of controls that are established for other therapeutic goods.
The TGA is seeking comments from interested parties on a proposed approach to resolve some of the uncertainty around the regulatory status of sports supplements, to ensure they are regulated appropriately to safeguard public health and safety.
The deadline for receipt of submissions is close of business, Tuesday 3 December 2019.
Consumers would benefit from an easily identifiable visual representation of the proportion of imported ingredients.
Consumers would be informed of the proportion of ingredients that are imported.
Consumers are already familiar with the combination of AMAG logo and ingredient proportion bar chart from food labelling, so replicating that style on complementary medicines would require little adjustment from consumers.
Cons:
Manufactures may not want to provide information on the label that ingredients are imported.
More information on the label may be a cost to manufacturers.
Cost to manufacturers to track proportion of imported ingredients and adjust labelling as required.
Manufacturers may see the bar charts a detriment to their marketing efforts.
Conclusion:
Benefits to consumers should be prioritised over minor problems to manufacturers.
On 1 July 2018, the TGA became the sole advertising complaints handling body as a result of recommendations from the Medicine and Medical Devices Regulation Review (MMDR). The inaugural 2018-19 report on the TGA’s work as the sole advertising complaints handling body is now available: https://www.tga.gov.au/publication/therapeutic-goods-advertising-compliance-2018-19-annual-report. See also:
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