Lectures in Canberra; ANU & FSANZ

In Canberra from 25th-27th March 2019 staying at University House, a guest of the ANU.

Two lectures to ANU BHSc students:

One lecture to FSANZ Consumer and Public Health Dialogue:

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SBS Insight – Vitamins: Sorting science from scam

https://www.sbs.com.au/news/insight/tvepisode/vitamins-supplements

The vitamins and dietary supplements industry has doubled over the last 10 years – we’re now spending an estimated $4.9bn each year on complementary medicines. But while some medical professionals say they work, others say the scientific evidence isn’t there, and warn we could be wasting money and risking our  health.

Available on SBS OnDemand: https://www.sbs.com.au/ondemand/video/1448561731545

See also: A closer look at Australia’s most popular supplements

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Laboratory tests commonly used in complementary and alternative medicine


Malvern Natural Health Care
https://www.mnhc.com.au/about-us/


Does it? See: Laboratory tests commonly used in complementary and alternative medicine: A review of the evidence.

Ann Clin Biochem. 2019 Feb 27:4563218824622. doi: 10.1177/0004563218824622. [Epub ahead of print]

Abstract

It is increasingly easy for the general public to access a wide range of laboratory tests. Tests can be ordered online with little or no input from a health professional. The complementary and alternative medicine (CAM) community promote and sell a wide range of tests, many of which are of dubious clinical significance. Many have little or no clinical utility and have been widely discredited, whilst others are established tests that are used for unvalidated purposes. They range from the highly complex, employing state of the art technology, e.g. heavy metal analysis using inductively coupled plasma-mass spectrometry, to the rudimentary, e.g. live blood cell analysis. Results of ‘CAM tests’ are often accompanied by extensive clinical interpretations which may recommend, or be used to justify, unnecessary or harmful treatments. There are now a small number of laboratories across the globe that specialize in CAM testing. Some CAM laboratories operate completely outside of any accreditation programme whilst others are fully accredited to the standard of established clinical laboratories. In this review, we explore CAM testing in the United States, the United Kingdom and Australia with a focus on the common tests on offer, how they are reported, the evidence base for their clinical application and the regulations governing their use. We will also review proposed changed to in-vitro diagnostic device regulations and how these might impact on CAM testing.

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Clean energy disruption


Excellent meeting at packed Hawthorn Arts Centre Venue on 27 February 2019.

Great presentations now available at: http://www.lighterfootprints.org/2019/02/slides-from-wed-27-forum-on-energy.html

From the presentation of Simon Holmes a Court: Not event at a trot… Australia’s emissions reductions progress.
This says it all!
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Yet again a Victorian chiropractor manipulates a baby’s spine in ‘deeply disturbing’ video

Chiropractor
Andrew Arnold performing controversial spinal treatments on a newborn 

Victoria’s health minister Jenny Mikakos has condemned a Melbourne chiropractor filmed hanging a two-week-old baby upside down by his ankles. She slammed the treatment as “unacceptable” and called on the Australian Health Practitioner Regulation Agency (AHPRA) to act.

“The Chiropractic Board of Australia must condemn this practice as unprofessional and unacceptable and the AHPRA must act quickly to stop these rogue practitioners in their tracks,” she told 9News.

Friends of Science in Medicine (FSM) paediatric expert, Professor Don Cameron said, “The treatment demonstrated in the video is nothing more than ludicrous nonsense. It is inappropriate for any chiropractors to be treating infants as this is not without risk of significant harm; also, the ‘Activator’ device used by the chiropractor, has no sound scientific basis and is at best, an expensive placebo”.

If you watch the longer 3:19 video, the chiropractor is also tapping the sacrum and skull: Craniosacral therapy! This “therapy” lacks a biologically plausible mechanism, shows no diagnostic reliability, and provides no clinical effect; see: https://www.painscience.com/articles/craniosacral-therapy.php.

Yet plenty of people are offering it:

“Chiropractors continue to pursue expanding their practices into paediatrics, in particular, neonates. The federal government should legislate that no child under 8 years can be treated by chiropractors” said FSM Professor Alastair MacLennan.

FSM President, Professor Ken Harvey repeated his concerns that pseudoscientific, ineffective, dangerous and poorly regulated ‘treatments’ and ‘products’ are increasingly being inflicted on a public that is poorly served by regulators such as the Australian Health Practitioner Regulation Agency (AHPRA) and the Therapeutic Goods Administration (TGA) who are supposed to protect them.

“In 2016 there was similar publicity about chiropractor Ian Rossborough. He was prohibited from manipulating children while he underwent “education”. There is now no indication on his AHPRA record of any of this and presumably he is now free to continue to treat neonates and children. I imagine the same pattern will occur with
Andrew Arnold. It’s time the Australian Health Practitioner Regulation Agency (AHPRA) stopped slapping these practitioners with a limp lettuce leaf and acted decisively”, said Professor Harvey.

An interview of Professor Harvey by Nadia Mitsopoulos on ABC Radio Perth is available.

A FSM press release is also available.

A letter to the Victorian Health Minister has been sent by FSM

A letter to “The Age” has been published:

Dangerous practices

Manipulation of babies’ spines (The Age, 20/2) is unnecessary, unproven and potentially dangerous. Chiropractors who convince mothers that their babies have mythical subluxations and deformities following birth, which can be magically manipulated away (for multiple fees), are dangerous. Effective regulation of pseudo treatments for non-existent disorders by non-medical practitioners is almost non-existent. It is time that alternative therapists stopped targeting children and regulators such as the Australian Health Practitioner Regulation Agency acted.

Associate Professor Ken Harvey, public health and preventive medicine, Monash University

Additional media cover:

2016 coverage of this issue:

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60 Minutes: Health supplements could contain heavy metals, arsenic and even snow leopard

https://www.9news.com.au/2019/02/10/01/53/60-minutes-vitamin-supplements-protein-shake-valerian-green-tea-health
Above video without advertisements



Liver transplant surgeon Dr Paul Clark says Australians should know that their supplements may be doing more harm than good. Dr Clark breaks down the potential affects of popular supplements like Valerian, St. John’s Wort and green tea extract.

Monash University Public Health Physician Dr Ken Harvey calls out “crap” complementary medicines including ‘Vitamin Gummies’ marketed towards child fussy eaters – saying they’re loaded with sugar and do more harm than good.

See also: Kids’ vitamin gummies: unhealthy, poorly regulated and exploitative

Media:

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Forthcoming SBS Insight program on Vitamins and Supplements

With Jenny Brockie

I spent 3 hours with a very pro-supplement audience, being filmed by SBS last night (6/02/2019) . I was surprised by the number of ‘true believers’. I give talks on complementary medicines to U3A classes but I have never found people in those groups as closed-minded as several in the SBS audience. Like anti-vaxers, they seemed to have a religious certainty that was impervious to any concept of ‘scientific evidence’.

I complemented these people for wanting to take responsibility for their health, but gently suggested that the plural of anecdote is not evidence! I mentioned that there are many reasons why consumers (and health professioanls) can believe a treatment works, when it does not. These include the placebo response, the natural history of disease, confirmation bias and cognitive dissonance. That didn’t go down well!

The Head of the TGA, John Skerritt, as usual, attempted to defend the indefensible (appended)

Postscript 11/02/2019

Prof Skerritt answered my email below and I responded.

From: ken.harvey@medreach.com.au <ken.harvey@medreach.com.au>
Sent: Thursday, 7 February 2019 08:01
To: Adj Prof John Skerritt (John.Skerritt@health.gov.au) , etc.
Subject: Re: Last night’s SBS Insight program recording; areas of dispute with the TGA

Dear John, et al,

I should like to follow-up several issues about the regulation of complementary medicines and their advertising which we publicly disagreed about last night.

The TGA makes no judgement as to whether complaints classified as low priority breach the Therapeutic Goods Advertising Code.

Yet the TGA assesses and triages all complaints received and reports some were, “not in the TGA’s jurisdiction” and for others, “no breach of advertising legislation was found”. So how can you say that the TGA makes no judgement that, “those [complaints] classified as low priority and closed by sending a compliance notice with educational material” are not in breach of the Code?

I also note that a letter sent to advertisers in response to one of my own complaints (obtained by FOI) listed specific sections of the Code for the advertiser to review. If the TGA made no judgement that these sections of the Code were not breached, why list them?

In a paper discussed with the TGA about these matters, I noted that at the time of writing (17 January 2019), 628 complaint outcomes with a 2018 reference number had been published on the TGA website. Four were judged not in the TGA’s jurisdiction. Of the remaining 624, 10 (1.6%) were judged not to breach the Code while 614 (98.4%) did. Of the latter, 591 (96.3%) complaints were classified as low priority and closed by sending the advertiser a compliance notice with educational material. The remaining 23 (3.7%) complaints were classified as higher priority, all were said to be closed with, or without, formal action.

This statistic of around 98% of all complaints were found to breach the Code is similar to what the old CRP found.

Do you deny that, on the basis of complaints received both by the old CRP and by the new TGA complaint system, there is a major on-going problem with non-compliant advertising?

Only 30% of TGA post-marketing reviews of listed products are found to lack evidence to justify the claims made

The following tables are compiled from tables 25 & 26 of https://www.tga.gov.au/sites/default/files/annual-performance-statistics-report-july-2017-june-2018.pdf

It is likely that many medicines cancelled by the sponsor to avoid a compliance review also had significant regulatory breaches.

In short, TGA post-marketing reviews of listed products show a much higher rate of compliance breaches than you stated.

TGA GMP requirements assures product quality of complementary medicine.

First, the breaches of manufacturing quality found in the post-marketing reviews (above) show that the TGA’s occasional inspection of manufacturing facilities for GMP does not guarantee product quality.

Second, and more important, is the failure of the TGA to check for clinically active ingredients in often complex herbal products. I’ve attached a paper co-authored by a member of last night’s audience, Joanna Harnett, “An evaluation of garlic products available in Australian pharmacies”. The authors noted that the quality indicators evaluated in their study, including evidence for the formulation used, labelling, product, safety,  manufacturing information and key constituents, varied significantly between the garlic products available in Australian pharmacies.

Given these results, how can health professionals and consumers recommend or choose garlic products for the management of hypertension and/or dyslipidaemia?

An audience member with quadriplegia who used a cranberry product in the hope of preventing recurrent urinary tract infection, is also likely to be disappointed. The effectiveness of cranberry products appears to depend on the concentration of proanthocyanidins, which prevent uropathogenic P-fimbriated E. coli from adhering to bladder cell receptors. If the bacteria are not able to adhere to cells, they cannot grow and cause infection. As the attached Cochrane review notes, cranberry preparations need to be quantified using standardised methods to ensure they contain enough of the ’active’ ingredient, before being evaluated in clinical studies or recommended for use.

Health professionals and consumers want complementary medicines that address real medical needs and deliver proven health outcomes. The current TGA trust-based, light-touch regulatory system fails to deliver this outcome. Instead, it has produced a market-place flooded with over 11,000 dubious products, marketed by celebrity endorsement and promotional hype, not clinical evidence.

With respect to complementary medicines, the TGA has failed to deliver the object of the legislation under which it operates: assuring the quality, safety and efficacy of therapeutic goods.

Sincerely,
Ken

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New Head for Health Watchdog

Monash University Associate Professor Ken Harvey AM is the new President of Friends of Science in Medicine. He replaces Professor John Dwyer AO, the founding president.

Friends of Science in Medicine (FSM), founded in 2011, has grown to become a major critic of unscientific health practices and fraudulent health claims. It has advised governments and media, made numerous submissions to inquiries and provided extensive public advice concerning dubious health claims and practices. It successfully advocated the removal of private health insurance taxpayer-funded rebates from ‘natural’ therapies that lacked evidence of efficacy.

Professor Harvey said, “Valuing scientific rigor is especially important in an age where unsubstantiated health claims are rampant and scientific consensus is ‘imbalanced’ by the views of extremists”.

FSM campaigns against the unethical promotion of therapeutic goods and services to consumers.

“We critique unproven and exploitative services offered by medical practitioners, such as the infusion of intravenous vitamins and chelation therapy. We are equally concerned about Traditional Chinese Medical Practitioners claiming that acupuncture can treat infertility or Naturopaths advocating homeopathy” said Professor Harvey.

“We encourage tertiary institutions and students of medicine and health sciences to critically appraise therapeutic products and services as part of the courses offered. Complementary medicines provide a fertile field for students to assess the often-outrageous claims made and report regulatory breaches”.

Last year, the Therapeutic Goods Advertising Code Council and Complaint Resolution Panel (CRP) were abolished and the Therapeutic Goods Administration (TGA) took over the advertising complaint system. Health Minister Hunt said these measures, “will enable potential harms from inappropriate advertising to be comprehensively prevented”.

“Research by members of FSM, and consumer’s lack of trust in the TGA, show that the Minister’s assertion has not been realised”, said Professor Harvey.

He concluded, “The critique by Royal Commissioner Haynes on regulatory failure in Australia’s financial services industry is equally applicable to the TGA. A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom and consumer detriment. These are important Federal election issues”.

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TGA – Chemist Warehouse Resolution – Distribution of samples of therapeutic goods at public events

I recently became aware of a TGA regulatory decision about this matter dated 26 September 2018. The TGA had found that Chemist Warehouse proposed to include therapeutic goods in seat cushions badged with their company name at the 2018 AFL and NRL Grand Finals.

It said the TGA has worked with Chemist Warehouse to ensure that none of the seat cushions to be placed at the NRL Grand Finals will contain therapeutic goods other than some approved sunscreen samples. The AFL Grand Final samples will also only contain cosmetic and other products and some menthol lozenges.

In fact, a complaint had been submitted to the TGA after the 2017 AFL Grand Final when Chemist Warehouse distributed 110,000 cushions and sample packs to patrons. The packs contained a free sample of Swisse Ultiboost Magnesium tablets (60), and an exclusive offer (buy one, get one free) for the entire Voost range of complementary medicines including cranberry, glucosamine, fish oil, memory tablets and sleep tablets (illustrations below).

The complaint alledged that the Chemist Warehouse promotion breached the Object of the Therapeutic Goods Advertising Code and the spirit of s.4(8). In addition, the claims made on the product pack breach s.4(1)(b), 4(2)(a), 4(2)(c) 4(2)(f) and 4(2)(j) of the Code. Furthermore, the Chemist Warehouse Voost Exclusive Offer (buy one, get one free) breached s.4(8) of the Code.

Typically, no determination or outcome of this complaint was ever received from the TGA nor was any published. However, it’s nice to know that the TGA have subsequently “worked” with Chemist Warehouse to stop this happening again. It would have been nicer if the TGA had informed the complainant that action had been taken!

Chemist Warehouse CEO Mario Tascone distributing sample bags at the MCG on 28 September 2017
Contents of the sample bag
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TGA’s first comprehensive consumer survey: Results on complementary medicines

During June and July 2018 the Therapeutic Goods Administration (TGA) conducted a survey of Australian adults. It employed a dual sampling methodology: a quota driven population-based sample (Panel) and an Opt-in sample sourced through known TGA contacts, networks and consumer stakeholders. The sample included a mix of the Australian population and includes participation across age, gender, all states and territories and metropolitan and regional locations.

A total of 1,729 responses to the survey were recorded during the survey period; 1,045 (60%) responses were received via the population based (Panel) sample, with the remaining 684 (40%) responses received through the Opt-in sample.

There was a considerable gender and age difference between the two groups: females;
Panel, 50% compared to Opt-in, 66% and age over 55: Panel, 33% compared to
Opt-in, 50%. However, the groups did not differ in complementary use, around half of each sample reported they used these medicines.

Overall, the responses showed that there were considerable concerns held by survey participants relating to statements about complementary medicines.

TGA Consumer Survey 2018

Across the range of measures relating to complementary medicines, 18-34-year old’s consistently show the highest level of nett agreement with the above statements and those in the 55-plus group show the lowest levels of nett agreement.

The results for other medicines showed higher positive responses to the same questions reflecting the difference between the “light-touch” regulatory standards for complementary medicines compared to the higher standards applied for other medicines.

An ongoing focus on addressing and responding to consumer concerns about complementary medicines was recommended.

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