A new ‘TGA assessed’ symbol and AUST L(A) listing on complementary medicines are meant to alert consumers that the TGA had assessed their health claims and found them supported by scientific evidence.
On May 26, 2021, Caruso’s Prostate EZE Max became the first herbal complementary medicine to receive a Aust L(A) listing. The product contains herbal extracts of Prunus africana (Pygeum), Serenoa repens (Saw palmetto extract), Epilobium parviflorum (willowherb), Cucurbita pepo (pumpkin seed oil) and lycopene (found in tomatoes and some other red fruits and vegetables).
The TGA-assessed indication is, “For the relief of nocturia (night-time urinary frequency) associated with medically diagnosed benign prostatic hypertrophy (BPH)”.
This decision calls into question the evidence assessment undertaken by the TGA.
Figure 1 (A and B) in Coulson et al showed changes in daytime and night-time frequency of urination in the herbal and placebo group, measured by a daily record in a patient diary, with the frequency averaged at 1 month, 2 months and 3 months.
There are several discrepancies between the urinary frequencies reported in the text of the article and the tables in Figure 1. In addition, the graphs do not include zero in the y-axis; therefore, small trends and differences are exaggerated. Furthermore, they fail to show the ± 95% confidence intervals of the mean urinary frequency at each time point. These problems raise questions about the quality of the research and the conclusions reached. Based on my own calculations, I have re-graphed the data below showing the ± 95% confidence intervals.
The TGA Evidence guidelines for listed complimentary medicines (page 41) say:
“Confidence intervals of 95% are commonly employed to show the range within which the true outcome value could be expected to occur with 95% certainty. When 95% confidence intervals are generated for primary study outcome measures, the 95% confidence intervals of the intervention and exposed groups must not overlap”
The TGA uses complementary medicines as a source of income, 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 two thousand new listings each year.
An application for listing costs the sponsor $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 per annum. Industry adds these costs to the price consumers pay.
Over the past 5 years, on average, the TGA assesses around 160 listed products a year, 75% of products evaluated have consistently been found non-compliant, mainly because companies were unable to produce evidence to substantiate claims for efficacy. About which the TGA takes only token action. The TGA has also given up on complaints.
Which raises the question, why is the TGA so lax in regulating complementary medicines?
At Skepticon 2020 I asked, is it due to:
- Industry lobbying government (and the TGA) to maintain a profitable and export orientated industry despite breaking the law to do so?
- A regulatory culture that favors industry assistance over consumer protection.
- Lack of expertise (insufficient medical, pharmacy and public health staff)?
- Limited financial resources (if so, why not increase industry charges)?
- And who is responsible?
I got no answers.
See also:
- TGA under fire after giving herbal prostate remedy its $16,000 tick of approval | Australian Doctor Group (ausdoc.com.au)
- TGA does ‘terrible job’ on CMs, say critics | AJP
- Complementary Medicines Australia responses to recent criticisms from “fringe groups”
The above response by CMA’s Carl Gibson says it all: “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.”
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