Archive for May, 2011

According to the TGA’s latest findings regarding compliance with labeling regulations of complementary medicines  listed on the Australian Register of Therapeutic Goods (ARTG), you can’t trust what you read on the labels. http://bit.ly/kfSJB2 .

Now just think for a minute about what these results actually mean. The regulatory agent of the Commonwealth Government conducted a total of 201 reviews of products listed on the ARTG to assess their compliance with the relevant requirements for them to be sold legally. Interestingly, the TGA uses both targeted and random methodology, presumably in an effort to get best use of limited resources that they are given. Unfortunately it means that the interpretation of these findings is hard to generalize, but for your sakes, dear readers, I will have a stab. You can agree or not as you see fit.

Let’s start with the targeted results. One would presume that these were chosen for review because a complaint had been made, or the product had for some other reason come to the attention of bureaucrats within the agency. So I guess you would expect that the results would be….unflattering. And so they were. Details are a little scarce on TGA’s website, but they do report that for the nine months from July 2009 – March 2010

Concerning the 79 targeted reviews completed, the reasons for targeting and the data reviewed differed widely:

* Label reviews were conducted on 52 medicines, of which 34 had compliance issues.
* Information included on the ARTG was reviewed for all 79 medicines, of which 54 had compliance issues.
* Manufacturing/quality/formulation reviews were conducted on 50 medicines, of which 30 had compliance issues.
* Evidence reviews were conducted on 15 medicines, of which 9 had claims that were not substantiated by the evidence submitted.

For the six month period July – Dec 2010, the following is reported

Of the 59 targeted reviews:

* Label reviews were conducted on 26 medicines, of which 20 had compliance issues.
* Information included on the ARTG was reviewed for all 59 medicines, of which 36 had compliance issues.
* Manufacturing/quality/formulation reviews were conducted on 22 medicines, of which 8 had compliance issues.
* Evidence reviews were conducted on 11 medicines, of which 9 had claims that were not substantiated by the evidence submitted.

So let’s recap those figures. Over an eighteen-month period, the targeted review process disclosed that for ‘label reviews’ ie the actual packaging of the products reviewed, which consumers rely on to make informed and literate decisions about their own, and their childrens’ health, 54/78 had ‘compliance issues’ ie would be reasonably expected to mislead consumers. That is 69% by my calculations.

The next category is ‘Information Included on the ARTG’. That is, the information provided by the product sponsor to the TGA to justify its inclusion on the register as a therapeutic good. Let me say that again. This is the information provided to justify why it is a therapeutic good. TO THE GOVERNMENT REGULATOR.
90 out of the 138 products reviewed (yes folks that is 65% of them) provided information to the TGA which was found to have ‘compliance issues’. In bureaucrat-speak that means they provided misleading or false information about the very ability of their product to provide a benefit.

If you are still reading at this point, I assume you are expecting more bad news. You’re in for a treat, as the next category assessed was ‘Manufacturing/quality/formulation Reviews’. This is the basic manufacturing quality control data. Simply put, can you be sure that you have gotten what you paid for, even if it is worthless therapeutically? Sadly, you can’t even be remotely confident, as 38/72 products reviewed (52% for those playing at home) had ‘compliance issues’. So with these products you can’t be confident that you’re even getting what you paid for HALF THE TIME. Seriously folks, even if you have a complementary supplement or herb or whatever that has evidence to support it, you won’t be getting it more often than you will if these figures are to be extrapolated.

And finally, the crowning turd in the waterpipe (as General Melchitt would say) are the figures regarding evidence of efficacy. It might be worth recounting at this point, the TGA’s own words regarding the listing of these products on the ARTG.

The indications / claims on Listed medicines are not subject to pre-market evaluation at the time of Listing. However, the Act requires that, at the time of Listing, sponsors certify that they hold the evidence to support indications and claims made in relation to Listable goods. The evidence held by sponsors must be sufficient to substantiate that the indications and claims are true, valid and not misleading.

Sorry if this is getting boring, but it is a fundamental requirement of listed goods that the sponsors must state that they can provide evidence (only if requested mind you) to support the claims they make. The implication is that the TGA is prepared to believe that most quacks are scholars and gentlemen/ladies who simply wouldn’t dream of making a quick and easy buck by sucking people in. Given that 18/26 of the reviewed products……..fully 69% of the reviewed products FAILED TO PROVIDE THIS EVIDENCE there is really no role left for satire or humour. You simply have to conclude that the entire TGA regulatory framework is regarded as a joke by the CAM industry. I mean, what conclusion can you come to based on these audit figures other than that the entire CAM enterprise is taking the piss out of the TGA and laughing up their sleeve at the thought of being called to account?? They cannot possibly be taking this stuff seriously.

OK, you might argue, that was the ones who were targeted by TGA for special attention. Let’s call them the rogue element, the outliers, the dangerous fringe with no regard for public safety. No true Scotsman, sorry CAM supplier would behave like that. Answering this point of view is presumably the reason for the random audits. Surely they would provide a truer, more reassuring snapshot of the real state of the industry. Let’s check the results again….

Of the 31 random reviews conducted, the following compliance issues were recorded:

* 20 medicines had labelling issues such as non-compliance with labelling requirements and/or breaches which may mislead consumers.
* 12 included incomplete and/or inappropriate information on the ARTG.
* 22 were found to have manufacturing and/or quality issues.
* 14 did not have adequate evidence to substantiate claims made about the medicines.

Of the 32 random reviews conducted, the majority of compliance issues found were considered to be minor or moderate in nature. The following compliance issues were recorded:

* 15 medicines had labelling issues such as non-compliance with labelling requirements and/or breaches which may mislead consumers.
* 7 medicines had incomplete and/or inappropriate information on the ARTG.
* 17 medicines were found to have manufacturing and/or quality issues.
* 13 did not have adequate evidence to substantiate claims made about the medicines.

To summarize, for the labeling category, 55% failed the audit; 30% supplied incorrect or incomplete information to ARTG; 62% failed the quality of manufacturing standard and 43% could not even supply evidence to support their claimed indications.

Again, it is impossible to escape the conclusion that sponsors of CAM products listed on the ARTG simply do not care about the regulations. By comparison, the process as outlined on the TGA website for Over-The Counter (OTC) or prescription medications include onerous requirements for establishing efficacy, safety and quality of manufacture, and strict enforcement of regulations regarding packaging and advertising.

If Australians are to have any faith at all in their regulatory framework, these figures must improve markedly. Imagine if food packaging listed the wrong ingredients 55% of the time ! Imagine the outcry if oil companies were wrong about the composition of their premium unleaded 62% of the time, or if they made claims about low emissions and better fuel economy that could not be backed up evidence 43% of the time. This is an industry that is taking even its most loyal supporters for a ride and treating them like mugs.

The TGA is to be congratulated for devoting its scarce resources to establishing this massive, systematic fraud being perpetrated on consumers, but the embarrassing fact remains that by even publishing these sort of figures, it is damning itself as the supposed watchdog of these industries. There deserves to be a huge public outcry over these findings, and they support calls for regulation of the so-called CAM industry to be taken away from the industry itself and given to a massively beefed-up TGA with enforcement powers similar to the ACCC, ASIC or ATO to back them up. To duck this issue is to admit that there is no political will to tackle a scandalous and cynical fraud that is being perpetrated on the public.