Keeping the standards high

tug of war

Australian complementary medicines are regulated at internationally high standards, says CMA in response to recent criticisms from “fringe groups”

Complementary medicines in Australia are regulated to the highest standards in the world and more strictly than products from the USA and even the UK, says Carl Gibson, CEO of Complementary Medicines Australia.

Mr Gibson was responding to recent comments by well-known CAM critic Dr Ken Harvey, who said  the Therapeutic Goods Administration was doing a “terrible job on complementary medicines labelled (AUST L) which they use as a cash cow without providing commensurate regulation or consumer protection”.

Dr Harvey was reacting to the first AUST L(A) listing to be given to a herbal complementary medicine – Caruso’s Prostate EZE Max.

“Whether registered or listed on the Australian Register of Therapeutic Goods (ARTG), Australian complementary medicines are manufactured to pharmaceutical standards in approved licensed facilities,” Mr Gibson wrote in a letter sent to AJP.

“Medicines are manufactured following good manufacturing practice (GMP); products meet the strict guidelines set by the TGA”.

“The industry, the CMA and the TGA work together to promote the appropriate regulation and advancement for our world-class sector, one that supports a growing number of jobs nationally and internationally”.

“Over seven out of 10 Australians choose complementary medicines as part of their healthcare routine, and these are an important part of the service provided to consumers by pharmacies.

With changes to the classification of complementary medicines that require even more significant evidence to support claims, consumers can feel more confident than ever,” Mr Gibson said.

The recently introduced Aust-Listed (Assessed) pathway ensured that medicines that carry this on their label are “‘assessed’ for efficacy”, he said.  

“They have had their health claims assessed extensively by the medicines regulator. The TGA examines and evaluates the presented evidence in detail before approving this classification. Because of this due diligence, consumers can be assured that extensive data support the indications made on the label”.

However, despite its success, the complementary medicines industry in Australia has a “small group of vocal critics”, Mr Gibson said.

“The detractors repeatedly called for more evidence to support complementary medicines. Now that the TGA has responded by introducing the Aust-Listed (Assessed), the anti-complementary medicines fringe group is attacking the new registration pathway, and trying to undermine evidence based complementary medicines.

So on one hand they call for more evidence and on the other they dismiss the evidence,” he said.

“In a recent editorial in AJP, the critics criticised the Aust L (Assessed) pathway. It is clear that they did not have access to the detailed evidence collated and submitted to the TGA to support high-level.

By doubting the experts at the TGA, the anti-complementary lobby is undermining this important pathway to the detriment of Australia’s innovative companies investing in evidence-based research. This fringe group may be Friends of Science; but they are strangers to facts”.

“Our quality control is world-class. Our reputation relies on it,” he said.


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  1. Carl Gibson (CMA) said, “It is clear that [the critics who criticised the Aust L [Assessed) decision on Caruso’s Prostate EZE Max] did not have access to the detailed evidence collated and submitted to the TGA.”

    We asked Caruso’s for any additional evidence not in the public domain and received no answer. Journalists also asked the TGA for more information and were told,

    Assessed listed medicines applications must provide a literature search on the product or active ingredients and an application dossier containing supporting information that is evaluated by the TGA. A single study in isolation is not sufficient to approve an Assessed listed medicine.

    TGA Assessed listed medicines evidence guidelines require a minimum of one double blind randomised controlled trial on the efficacy of the finished product, and two examples of supporting evidence, such as relevant scientific monographs &/or evidence-based reference texts for the ingredients used.

    The published paper by Coulson et al does not support the TGA’s assessment of the Caruso’s Prostate EZE Max. Also, the published trial did not adhere to CONSERT recommendations on reporting randomized, controlled trials of herbal Interventions.

    In addition, the supporting evidence on the two main ingredients is inconclusive. Cochrane have reviewed Serenoa repens (saw palmetto) and concluded that, even at double and triple doses, it did not improve urinary flow measures or prostate size in men with lower urinary tract symptoms consistent with BPH. Cochrane have also reviewed Pygeum africanum and concluded that, while it may be a useful treatment option for men with lower urinary symptoms consistent with BPH, the studies reviewed were small in size, of short duration, used varied doses and preparations and rarely reported outcomes using standardized validated measures of efficacy.

    The TGA have said they do not normally disclose details of a company’s application and dossier to people outside that company. However, they do summarise this information for AUST R products as Australian Public Assessment Report for Prescription Medicines (AusPAR). We suggested the TGA should do the same for AUST L(A) assessments. Without this, it is hard to have confidence in the TGA’s assessment.

    Finally, the TGA has said that information that is not disclosed may be accessible under the Freedom of Information Act. A FOI application is currently being prepared.

  2. luis miguel trapaga

    The comments regarding the TGA and the article “Keeping The Standards High” from Ken Harvey are a little high handed given the remarkable Homeopathy Review that Harvey directed for the National Health and medicine Research council. This review is currently before the federal Ombudsman. The review failed to follow the protocols of the NHMRC, buried their original review, failed to respond to FOI requests for those results, failed to mitigate bias; actually failed to carry out a credible review.

    • Ken Harvey

      Oh dear! I did not “direct” the NHMRC review on Homeopathy, nor was I member of the Homeopathy Working Party that guided the literature review. I did represent the Consumers Health Forum (with Alison Marcus) on the Health Department’s 2015 Natural Therapies Review which concluded (as did the NHMRC) that there was insufficient evidence to support private health insurance coverage of 16 Natural therapies, including Homeopathy. There is currently a new review looking at more recent evidence that might support these therapies, to which I have no active involvement. None of this is relevant to the current debate about Aust L(A).

  3. Hubertus Jersmann

    Mr Gibson states that the complementary medicines were manufactured to high standards. I am not in the position to check that claim, but if it were true that does not confer efficacy or “no harm”.
    I cannot find any sufficient evidence that “Caruso’s Prostate EZE Max” is efficacious.
    Perhaps providing that evidence would be stronger than statements such as “7 out of 10 Australians use CAM”. Likewise, it is irrelevant how small or large groups of critics are or how “vocal” they are:
    the scientific evidence should speak. Science is not democratic or populistic, science uses data. If CAM have quality data behind them then that is all I need as a scientist to accept them.

  4. Ron Batagol

    I read with interest the comments of Carl Gibson, in response to the analysis by Ken Harvey and John Dwyer of the publicly available data to support the TGA’s AUST L(A) classification of Caruso’s Prostate Eze Max.

    Harvey and Dwyer identified discrepancies in the only paper published about this product. So, it’s perfectly reasonable for them to ask, “what additional evidence is available, to bring the product to an Aust L(A) (assessed listed) classification?” Far from “undermining or attacking” the Aust L (A) process, this is a logical expectation, given TGA’s stated criteria for this process.

    I have also notified the TGA about discrepancies between recommendations in specific PI’s & CMI’s, both with respect to pregnancy use and in other medication safety areas, which were at odds with the evidence-based expert opinions, and I have been gratified when these discrepancies have eventually been rectified by TGA.

    I support the call for the TGA to provide the same transparency of decision-making with respect to assessed listed medicines as they do for registered medicines (the AusPAR process).

    Finally, with more than 1200 leading scientists, clinicians, lawyers and consumer advocates as supporters, Friends of Science in Medicine is hardly a “fringe group”!

  5. Truk2

    This CMA response is a classic red herring.
    The criticism was that the products allowed through the AUST L(A) pathway have very weak support in terms of evidence. Such as a product that was either supported only by a single paper that had ‘discrepancies’, or was supported with evidence that is completely non-transparent.

    The CMA spends most of it’s response instead trying to pretend that the issue is about manufacturing quality. They talk about what a ‘leading’ sector they are, how many jobs they have, and how popular they are with consumers.
    This really only shows that the CMA is willing to promote itself by trying to circumvent criticism with fallacies.
    When they do talk about evidence, they vaguely assert that customers can be confidant of there being ‘extensive data’, but this vague handwaving doesn’t address the criticism at all. It is much like a used car salesman saying “Trust me”. It doesn’t inspire confidence.

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