Beware the ELF in the cupboard

The recent report (2011-12) on the Auditor Generals performance audit into Therapeutic Goods Regulation of complementary “medicines”, is disturbing reading. It confirms that the CAM “industry” if you will may breach the Therapeutic Goods Act with little concern.

Under the authority contained in the Auditor-General Act 1997 the Australian National Audit Office (ANAO) undertook an independent performance audit in the Department of Health and Ageing (DoHA). The Therapeutic Goods Administration – part of the DoHA – has the role of regulating the Therapeutic Goods Act 1989. The Minister for Health and Ageing holds responsibility for the Act.

Back in June this year a Transparency Review of the TGA was published, which you can find in a separate post here. I also outlined the essential gateway that permits the wide scale manufacturing of bogus products, with bogus claims, sold for very real percentages of your hard earned money;

To register a product, sponsors use an electronic listing facility – ELF – by simply going online. Much like filling out a Facebook profile. Ingredients are selected from a drop down list. Near enough is good enough. These ingredients are already deemed riskish free by the TGA. Sponsors “self certify” under GMP requirements. Basically claiming that the goods are produced under Good Marketing Practice. Finally they tick a box indicating that they hold good evidence. Hand on heart no doubt. No checks are ever run. They pay the $600 fee and receive an AUST L number. These goods are then able to be listed on the Australian Register of Therapeutic Goods.

The Electronic Listing Facility software (now version 3) has the power to allow products for sale. It’s no surprise dear reader, to find that our friend the ELF features heavily in the independent audit. The Act was given extra zing in 2001 to allow easy market access of products deemed low risk because they, well, in the main don’t really do anything. It favours “sponsors” (producers) hiding true information from the public. Thus it is open to wide abuse and it seems this opening is a crowded one indeed.

The ELF also provides a free text field for sponsors to wax lyrical about the astonishing qualities and safety of products. Again, like a Facebook profile you may enter whatever you like. Or omit entering what you don’t like. Although introduced in 2003 it can have no impact on products already on the ARTG prior to it’s introduction. True to it’s sleepy nature the TGA have done nothing to check if existing (pre-2003) products comply with present standards. Which may well tell us more about what the TGA think of it’s own so-called standards than the egregious risk to public health it otherwise appears to be.

In respect of “pre-market assessment” on page 77 under 3.44, the ANAO noted four matters “whose consideration could improve their integrity”:

(1) indications and claims in older products have not been checked;

(2) arrangements for scanning freetext indications are not robust or comprehensive and require manual backup;

(3) the coded indications project—which could address both these issues by eliminating the free‐text field—has been proceeding very slowly; and

(4) some sponsors may, on occasions, be entering incorrect information into the ARTG intentionally.

If a product variation or grouping of products occurs ELF 3 will scan the records from pre-2003. Yet, this is widely known and sponsors avoid updating their records despite new research condemning effects or dismissing efficacy. Thus (for example), St. John’s Wort remains marketed as an effective depression treatment despite having no effect on endogenous depression and a poor effect on clinical depression. Fish oil sponsors continue to boast of success with osteoarthritis (OA) despite the anti-inflammatory effects only showing promise in rheumatoid arthritis. The promised “cartilage regeneration” occurs at a glacial pace compared to loss via OA, rendering it almost meaningless.

The list of “hangers on”, if you like, debunked in any manner of exercise is extensive. “Anti-oxidant” products incapable of meeting claims, detoxification kits that have negative effects actually resulting in jaundice and poor LFT’s, all homeopathic products, echinacea, dedicated preparations containing vitamins or minerals, crystal therapies, energy bands, sexual performance/libido enhancers, cognitive enhancement products, immune stimulants, herbal weight loss products and teas, etc, etc.

The TGA does no manual checking and the software cannot scan existing records for restricted or prohibited terms aiding this pseudoscientific white elephant. This is despite the fact the TGA is regularly adding new terms. So effectively;

  • Any product listed on the ARTG prior to 2003 escapes scrutiny for all restricted or prohibitive terms. Any such product escapes even the dubious self-certification standards by which new products are listed;
  • When the TGA adds a term or word to it’s list of restricted or prohibited words and terms, every single item listed prior to this is not checked for these same words or terms;
  • The TGA’s assessment system is incapable of scanning existing products and thus cannot correct for the impact of emerging research;
  • In the 8 years since implementation of the ELF the TGA has made no attempt to manually check pre 2003 listings;
  • Sponsors intentionally avoid updating information via the ELF, effectively misleading the public to continue to believe a product succeeds where it has been shown to fail;
  • Sponsors may enter incorrect information about a product intentionally and the product may still be approved for listing on the ARTG;
  • Nonetheless the TGA is working to address these shortfalls via a “coded indications” project, which the ANOA has identified at progressing too slowly.

Not surprisingly then when ANAO searched for “TGA Approved” and “safe” – the use of which is unlawful in advertising alternative products – thousands of examples were found. Of these thousands the ANAO provided “three egregious examples to the TGA” (p. 128). The TGA identified other breaches “such as ‘cancer‘”. As of June 20th, 2011 two of these three “egregious breaches” were not rectified.

Okay, so why? Well on page 130-131 we read that prosecution is the only option left to the TGA in these cases. Yet;

The TGA’s Advertising Unit is not aware of having successfully used the full range of sanctions, such as seeking a prosecution for breaches:

Due to the very low financial penalties currently available (a maximum of $6600 for individuals and $33 000 for corporations) for advertising offences in the Act and other investigative priorities for the TGA, it is not costeffective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence for consideration of prosecution by the Director of Prosecutions …

It has never been cost effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence.

The size of penalties attached to criminal offences may also mean that it is seen as not in the public interest to proceed. This view is consistent with legal advice provided to the Advertising Unit about specific breaches.

The TGA has also observed that “prosecution is currently the only available option where administrative requests fail to achieve compliance”. There have never been any cases that have been referred for prosecution action and accepted. As a consequence, the prospect of using prosecution action against noncompliant behaviour, and as a deterrent, seems limited.

Alrighty then. So it’s not cost effective or “in the public interest” to enforce regulations. Sponsors and manufacturers would know of this stunning record of no successful prosecution. They must be trembling in their Whitsunday banana lounges, dear reader. 80 of 82 complaints pertaining to the Advertising Code this year were upheld by the TGA. The two failed complaints were “between” competing companies. Yet there’s no way to follow through and prosecute for non compliance. That’s quite absurd in anybody’s reasoning.

In 2010 a DoHA review found 90% of products reviewed were found to be non-compliant with regulatory requirements. The infamous 31 products selected at random yielded 68 breaches;

  • 20 medicines had labelling issues such as noncompliance with labelling requirements and/or breaches which may mislead consumers.
  • 12 included incomplete and/or inappropriate information on the Australian Register of Therapeutic Goods (ARTG).
  • 22 were found to have manufacturing and/or quality issues.
  • 14 did not have adequate evidence to substantiate claims made about the medicines.

This comes on top of the 2003 recall of 1600 Pan Pharmaceutical products. In 2006 the TGA found 75% non-compliance with regulations. However, the TGA doesn’t use information gathered from post market reviews to sharpen up the prodding stick for frequent offenders or even the most frequently occurring characteristic of regulatory breaches. This is a major issue in presenting transparency and setting in train practices that would better inform the public.

Since 2005 it’s been government policy for the TGA to collect from sponsors a summary of evidence, for the purpose of informing the public. Sponsors are required to have this summary. The TGA inexplicably assumed this process of collection would be legislated for under the Australia New Zealand Therapeutic Products Agency. The ANZTPA process initially faltered and as the TGA is wont to do it consequently did… nothing.

But by golly, in May this year it “took steps” – yes “steps” dear reader – “to restart implementation of this policy”. Yes! To “restart” the policy. Which to me sounds like bureaucratic blubber indicating a pre-emptive attempt at damage control, if we scrutinise the dates of the auditing process.

So here we are still waiting to know what comes out of those magical places that use our little ELF. On top of the Transparency Review we may conclude there is little transparency for the public. If you’re not in the habit of reading research or taking an intellectual interest in alternative product dynamics (which indicates you’re almost certainly immune to hanky panky), you’d make a perfect customer. Ignorant, misled and unable to access proper information. All in all it’s pretty tragic.

Do be my guest and have a read.

Auditor Generals Report: Therapeutic Regulation of Complementary Medicines