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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?

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).

Chair and Session organiser:

• Assoc Prof Ken Harvey, President Friends of Science in Medicine. Background to the case studies.

Presenters:

• 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.
• Paulina Stehlik, Research Fellow and Evidence Based Practice Professorial Unit Coordinator at the Centre for Research in Evidence-Based Practice at Bond University; President of the Gold Coast Skeptics. Case study: Declaring products not to be therapeutic goods: Ear candles, Magnets, Homeopathic products?
• Mal Vickers, Master of Public Health student at the School of Public Health and Preventive Medicine, Monash University. Case study: The TGA’s new advertising complaint system; is it better than the old one?

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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.

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