TGA does ‘terrible job’ on CMs, say critics

A new product has been given the first ever Aust L(A) listing for a herbal complementary medicine – but the move has attracted criticism

Dr Ken Harvey, president of Friends of Science in Medicine, and Honorary Adjunct Associate Professor at Bond University, and Professor John Dwyer AO, Past President of Friends of Science in Medicine, and Emeritus Professor of Medicine at UNSW Sydney, have written a piece in MJA InSight in which they ask “Where’s the evidence?” for the AUST L(A) listing of Caruso’s Prostate EZE Max.

The listing is the first AUST L(A) listing to be given to a herbal complementary medicine.

As outlined by the writers, the AUST L(A) pathway allowed sponsors of CMs to “list their products using intermediate level health claims if supported by a pre-market assessment of scientific evidence by the TGA”.

This was intended to facilitate access to more evidence-based products.

To date, there are now only two products with the listing – the other being Care Pharmaceuticals Hydralyte Orange Flavoured Effervescent Electrolyte Tablets, which the authors note is “unremarkable”.

They query the evidence behind Prostate EZE Max, which contains herbal extracts of Prunus africana (Pygeum), Serenoa repens (Saw palmetto extract), Epilobium parviflorum (willowherb), Cucurbita pepo (pumpkin seed oil) and lycopene.

It is indicated for the relief of night-time urinary frequency associated with medically diagnosed benign prostatic hypertrophy.

But Dr Harvey and Prof Dwyer write that they could only find one published article about the herbal medicine, a 2013 article covering a study funded by Caruso’s (Natural Health Pty Ltd).

This was a 2013 paper which they say has several problems, including “several discrepancies between the urinary frequencies reported in the text of the article and the tables”.

After asking whether there were more studies, they had no response from Caruso’s, they said.

“This raises a serious question – why did the TGA gave an AUST L(A) listing to this product?”

“Has Caruso’s provided more definitive (albeit unpublished) clinical trial results to the TGA? If so, the TGA should critically assess these studies and place a summary in the public domain, as they do with newly evaluated registered products (AusPARs).”

The pair suggest that given the small number of products with the AUST L(A) listing, “the industry considers a better return on investment comes from spending money on celebrity endorsement and promotional hype rather than undertaking research and paying the higher fees required for AUST L(A) listing or AUST R registration”.

“Complementary medicines labelled AUST L have no pre-market evaluation by the TGA. Sponsors self-certify regulatory compliance, including that they hold evidence for the claims made. TGA post-marketing surveillance assesses around 160 listed products a year (out of more than 10 000).

“Over the past five years, on average, about 75% of products evaluated have consistently been found non-compliant, mainly because companies were unable to produce evidence to substantiate claims for efficacy.

“Given this, it is not surprising that the confidence of GPs and consumers in the TGA’s regulation of complementary medicines is low. The TGA’s assessment of Caruso’s Prostate EZE Max as AUST L(A) is likely to reduce this confidence even further.”

Ken Harvey told the AJP that he felt that the TGA does well when it comes to regulating prescription medicines and vaccines.

“But they do a terrible job on complementary medicines labelled (AUST L) which they use as a cash cow without providing commensurate regulation or consumer protection.

“There are over 10,000 listed medicines (mainly complementary medicines) on the Australian Register of Therapeutic Goods (ARTG) with around 2000 new listings each year.

 “An application for listing costs $860, the annual charge to keep it on ARTG is $1,160, hence the TGA’s annual income from listed products is $1,720,000 + $11,600,000, i.e., $13,320,000.”

He said that despite the figure of 75% of products evaluating being non-compliant – “mainly because companies were unable to produce evidence to substantiate claims for efficacy” – the TGA takes only token action. He said the regulator has also “given up on complaints”.

“Which raises the question, why is the TGA so lax in regulating complementary medicines?”

Read the MJA InSight piece here.

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  1. Ron Batagol

    An important consideration here is that it has been well established that the symptoms of BPH and prostate cancer are similar, so it is critical that self-medication with ANY complementary or, indeed, any other medicine, must be supported by published references which stand up to the established methods of literature scrutiny, so as to validate the claims made by the manufacturer. The caveat is that, in any case, if symptoms persist, appropriate and timely medical assessment is essential!

  2. Sarah Culverhouse

    It would be great if AJP provided a balanced view on the topic of complementary medicines rather than the predictably alarmist and ill-founded view of Prof Harvey, i known knocker of comp meds. To gain AUST LA status a significant portfolio of evidence is required to be presented to the TGA, which i’m sure this author knows. It’s a shame this promising initiative by the regulator to encourage more rigorous evidence to support therapeutic claims has inspired this negative story as opposed to giving credit where credit is due.

    • I agree with Sarah that we should be encouraging ways to identify CM products with specific clinical trial evidence to support them. This is because the evidence is product specific given the inherent variability of the products.

      Crucially the AUST L(A) pathway also needs to provide the assurance that the marketed product is equivalent to the one used in any assessed research. This assurance is missing in the AUST L(A) assessment as the intervention used in the clinical trial is not well enough described to provide the market confidence that the product on the shelf is equivalent, and no explanation on this vital point has been provided. This is deeply regrettable and an opportunity lost.

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