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)
From: firstname.lastname@example.org <email@example.com>
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.