MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

By guest blogger Ken Harvey

Loretta Marron was the catalyst. The ‘critical thinking’ bug hit her as a child, reinforced by a BSc in Physics. If something didn’t sound logical, she couldn’t let it go. She had to check. She killed many a party by disputing misinformation – with evidence.

TV advertisements for magnetic underlays got her going, then homeopathic remedies, followed by ‘natural’ cures for cancer. To investigate outlandish claims and submit complaints, she needed to consult with experts. These included Professors John Dwyer (Medicine and Immunology) and Alastair MacLennan (Obstetrics and Gynaecology). They were always willing to help.

They also had concerns about universities teaching pseudoscience, such as ‘subluxation theory’ in chiropractic and ‘meridians’ in Traditional Chinese Medicine.

In late 2011, Professor Dwyer proposed that Loretta join forces with Professors Alastair MacLennan, Marcello Costa (neuroscientist), and Rob Morrison (science communicator) to form a new organisation promoting scientific evidence in health care. Friends of Science in Medicine (FSM) was born. John Dwyer was the inaugural President and Loretta Marron Chief Executive Officer (CEO).

The aim was to emphasise the importance of basing Australian health care on scientifically sound research and established scientific knowledge published in peer-reviewed journals of accepted standing. Valuing scientific rigour is especially important in an age where unsubstantiated health claims are rampant and scientific consensus is ‘imbalanced’ by the views of extremists.

FSM’s focus is helping consumers and health professionals to make more informed choices about medical interventions, medicines, and medical devices. We do this by submitting complaints about unethical practice, analysing policy, making submissions, encouraging regulators to act, and being a credible source of expertise for the media and others. We also encourage tertiary institutions and medicine and health sciences students to critically appraise therapeutic products and services as part of the courses offered.

Currently, FSM has more than 1,200 leading scientists, clinicians, lawyers, and consumer advocates as supporters. We also work closely with organisations such as Australian Skeptics and Choice (Australian Consumers Association).

I took over as President from John Dwyer in 2019. Loretta remains FSM CEO. The founding members continue their involvement as consultants. Ten years on, it’s worth reflecting on what has been achieved and the ongoing challenges.

An appendix lists some of the areas in which FSM has been involved and the outcomes achieved (often with the help of others).

Unethical promotion of therapeutic goods and services remain an ongoing concern. The advertising of therapeutic goods is subject to provisions in the Therapeutic Goods Advertising Code, first promulgated in 1999. Until July 2018, complaints about alleged Code violations were heard by the Therapeutic Goods Advertising Complaints Resolution Panel (CRP), thereafter by the Therapeutic Goods Administration (TGA).

FSM members submitted numerous complaints to the CRP and analysed the outcome. If a complaint was upheld, the CRP could only ‘recommend’ that it be removed. If it was not, the complaint was referred to the TGA for action. We found that certain companies consistently ignored the determinations of the CRP and, when referred to the TGA, took resulting action.

In July 2018, FSM engagement with numerous consultations and reviews eventually resulted in the TGA taking over the advertising complaint system. The TGA was given stronger investigative and compliance powers and a revised, legally enforceable advertising code. However, given the TGA’s previous track record, we continued to submit complaints, including many previously upheld by the CRP, but for which promotion continued.

An analysis of the first 12 months of the new system found that the TGA had classified most complaints as ‘low priority’. These were either ignored or closed by sending the advertiser a ‘Regulatory Obligation letter’ which stated that no further action would be taken. While the letter sometimes worked, often it did not. Stronger compliance powers were rarely used. The new complaint system was also less transparent than the one it replaced. For those low priority complaints with published outcomes, no details of the product, advertiser, or alleged Code violation were published, and no follow-up was recorded. Of 121 higher priority complaints, 79% failed to meet their key performance indicator, time to closure in 60–90 days. These included complaints about dangerous sports supplements and ineffective weight loss and hangover products.

In August 2020, an independent review of the first two years of the TGA’s compliant system was published. The study noted an unexpectedly high volume of complaints since the TGA took over the advertising complaints system, producing a large and growing backlog. A government-appointed consultant (ThinkPlace Pty Ltd) stated that providing more resources would not be in the public interest. Instead, they recommended a more cost-effective and efficient approach: amalgamating all complaints into an information database from which the TGA could consider compliance priorities.

As a result, complaints were closed by sending complainants a letter stating that their complaints will be used for ‘intelligence’ to set priorities. The TGA said risk assessment informed whether a complaint was converted into a case for investigation or stored in their information database to determine future compliance priorities. Therapeutic goods associated with COVID-19 were declared ‘priority 1’, while weight loss, hangover, and four other products groups were said to be ‘priority 2’.

A focus on COVID-19 stimulated the TGA to deal with some of these complaints more effectively. However, apart from token action on individual products, no systemic action was taken on weight loss, hangover products and many other objects of our complaints.

More recently, the TGA’s complaint database for 2018 -2020 has been removed and replaced by a new database containing only a few complaints pre-2021. In addition, the fields of many ‘products’ and ‘responsible person’, are missing. The TGA say that migration of data to the new system is continuing. Meanwhile, complainants now only receive an automated acknowledgment.

Transparency remains a problem as there is no clear indication of how many complaints the TGA receives, what they are about, how many are filed for ‘intelligence’’, how many are actioned, and what outcome eventuates.

Given this lamentable state of affairs, in association with Australian Skeptics, it is proposed to publish reports on all complaints submitted to the TGA in 2022 and their outcomes. Past experience shows that documenting problems, pointing out underlying issues and putting forward solutions can produce progress. But patience and persistence are required.

FSM has grappled with unethical advertising of pseudo-medical interventions. Controls differ for practitioners regulated by the Australian Health Practitioner Regulation Agency (AHPRA) and those regulated by State and Territory Health Complaints Commissioners. The former includes medical practitioners, pharmacists, nurses, chiropractors, osteopaths, and Traditional Chinese Medicine practitioners. The latter includes naturopaths, homeopaths, and practitioners of western herbal medicine.

FSM has held regular meetings with AHPRA senior managers. We have also met several of their national boards and attended stakeholder forums. Chiropractic was an initial focus. Many practitioners advertised that chiropractic care in pregnancy could shorten labour duration and prevent caesarean delivery – despite the absence of evidence. Pregnant women were warned that labour often resulted in the newborn babe’s spinal misalignment, which could lead to numerous problems unless put right by regular chiropractic adjustments. It was also claimed that chiropractic ‘adjustments’ could improve attention deficit hyperactivity disorder, infantile colic, and ear infection.

In 2015, FSM submitted hundreds of complaints to AHPRA, alleging that chiropractic websites were in breach of both s.133 of the Health Practitioner Regulation National Law Act 2009 and the Chiropractic Board of Australia’s Guidelines for advertising regulated health services. These provisions prohibit advertising which is false, misleading, or deceptive, creates an unreasonable expectation of beneficial treatment, or can encourage the indiscriminate or unnecessary use of health services.

Five years have passed since the Chiropractic Board first asked practitioners to ensure that their websites met legal advertising requirements. Over this time, the Board’s sole approach to this problem was educational. Although chiropractors consistently had the highest advertising complaints of all practitioners (38 per 1,000 chiropractors in 2013–14), no penalties nor disciplinary action had been applied for advertising offences.

FSM argued that repeated advertising offences required appropriate penalties. We also pointed out that some practitioners now invited patients to consult them about services they were no longer permitted to advertise. We said that limitations should be placed on chiropractic practice which lacked evidence.

AHPRA responded that, although it could act on misleading advertising, it had no power to restrict the scope of practice of chiropractors (or other registered practitioners). We said that, if lack of good evidence makes it illegal to publicly advertise a treatment, then it should be equally illegal to offer it to patients privately; after all, the real harm is caused by the treatment, not the advertising.

In 2019, following damning publicity and further representations, the Victorian Health Minister eventually instructed Safer Care Victoria (SCV) to undertake an independent review of the practice of chiropractic spinal manipulation on children under 12 years. The result was a recommendation that spinal manipulation should not be provided to children under 12 years of age, for general wellness or for the management of conditions such as hyperactivity disorders, infantile colic, or ear infections.

The Chiropractic Board has also stated that chiropractors are not trained to apply any direct treatment to an unborn child and should not deliver any treatment to the unborn child. Neither should they provide materials, information or advice that is anti-vaccination in nature. After numerous complaints from FSM members, the Chiropractic Board finally referred a prominent anti-vax chiropractor, Simon Floreani, to the Victorian Civil and Administrative Tribunal (VCAT). His registration was suspended for 6 months, and conditions placed on his re-registration.

FSM has not just been concerned about chiropractors. We have complained (with varied success) about medical practitioners promoting stem cell therapy for multiple sclerosis, Traditional Chinese Medical practitioners claiming that acupuncture can treat infertility and dubious laboratory tests used in complementary and alternative medicine.

In conclusion, the peddling of unproven and sometimes dangerous remedies has existed throughout human history.

There will always be companies (and individuals) who put the pursuit of profit before ethical behaviour. There will always be advocates for de-regulation and regulators captured by industry. To protect consumers there must be opposing forces. That is the role that FSM is proud to play, along with colleagues from the sceptical community and consumer movements.

Appendix

FSM activities and outcomes (often in association with others), 2011-2021.

  1. Removal of extravagant claims for acupuncture from the World Health Organization website and instigation of a WHO evidence review.
  2. Involvement in the 2015 Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies. This led to removal of cover for therapies that lacked evidence such as homeopathy, iridology, reflexology and naturopathy (currently being reviewed again to see if additional evidence exits).
  3. Removal of unproven/disproven courses or modules from Australian universities.
  4. Removal of continuing professional development (CPD) points required annually by relevant registered practitioners for a number of AltMed courses.
  5. Following complaints to the TGA, removal of some illegal medicines not on the Australian Register of Therapeutic Goods (ARTG).
  6. De-listing some complementary medicines and medical devices (such as ‘bio-resonance’ machines) lacking evidence.
  7. Getting the TGA to declare two products of self-declared ‘Foods for special medical purposes’ illegal therapeutic goods and have them removed from the market-place.
  8. Publishing academic articles, in peer-reviewed journals, documenting regulatory problems investigated and solutions suggested.
  9. Publishing articles in lay media on current problems including in The Conversation, MJA Insight and Pearls and Irritations (around 200 over the last 5 years).
  10. Responding to consultation requests from the TGA, Medical Boards, National Medicines Policy Review, and others.
  11. Achieving the suspension of anti-vax chiropractor Simon Floreani’s registration.
  12. Stimulating the Chiropractic Board to publish standards on pregnancy and paediatric care.
  13. Responsible for the setting up of AHPRA’s ‘Advertising Compliance’ section, including their pilot auditing system (yet to report).
  14. Responding to requests for information from journalists.
  15. Correction of misinformation from the Victorian government’s ‘Better Health’ Channel.
  16. Providing a complaints avenue for people who want to remain anonymous.

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