Interviewed on ABC Melbourne by Lindy Burns, Leo Igwe, West and Southern African Director for the International Humanist and Ethical Union, discusses the struggle faced by skeptics and humanists on the African continent.
A regular contributor to The Skeptic magazine and The Humanist in Australia, Leo’s work is well known amongst humanists and skeptics. Facing superstitious beliefs, clever scams, exploitation and violent retribution for exercising free thought – including attacks on his family – Leo has a difficult role. Having recently spoken to Victorian Skeptics and Victorian Humanists Leo also spoke at Trades Hall in Melbourne.
One issue that stuck in my mind after hearing Leo speak is that whilst one child dies from malaria every 30 seconds in Africa frequently the cause is assumed to be witchcraft. In view of this, parents do not take the ill children to hospital but to evangelical churches where exorcisms and prayers are offered as a “cure” instead. These children die long painful deaths, although some do make it to hospital… eventually.
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 free‐text 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 cost‐effective 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 non‐compliant 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 non‐compliance 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
Today Meryl Dorey returned to the Supreme court NSW to resume her fight to overturn the NSW HCCC decision that the AVN should place warning notices that it provided anti-vaccination information on it’s website.
She was cross examined for 20 minutes and the court convened. She returns in another 2-3 months;
Dorey has claimed that the HCCC investigation was “illegal” as the AVN was outside HCCC jurisdiction being not a health care provider or health educator under the HCCC Act. Dorey also claims the investigation was flawed because it was not independent, but by a government organisation that “set out to support government policy which is pro-vaccination”.
Whilst still publically maintaining lack of jurisdiction to members today, referring her members to this denialist conspiracy rant, I understand that Dorey and the AVN are certainly within HCCC jurisdiction. The AVN conceded so in court on July 28th. Unseen developments aside this is likely to remain.
On July 26th, 2010 the HCCC published a public health warning following the AVN’s failure to post warnings that it was anti-vaccination. Prior to this the HCCC had investigated two complaints that the AVN provided false and misleading information. The HCCC concluded it’s investigation on July 12th and gave the AVN 14 days to publish the following on it’s website:
The Australian Vaccination Network’s purpose is to provide information against vaccination in order to balance what it believes is the substantial amount of pro-vaccination information available elsewhere;
The information provided should not be read as medical advice; and
The decision about whether or not to vaccinate should be made in consultation with a health care provider.
As you can see this is markedly more tame than the public health warning. There’s no mention of;
provides information that is solely anti-vaccination
contains information that is incorrect and misleading
quotes selectively from research to suggest that vaccination may be dangerous
Or;
… the AVN provides information that is inaccurate and misleading. The AVN’s failure to include a notice on its website of the nature recommended by the Commission may result in members of the public making improperly informed decisions about whether or not to vaccinate, and therefore poses a risk to public health and safety.
Meryl Dorey
So to spell out the obvious, most of what Meryl Dorey is railing against is by her own hand. All this effort to pretend she’s not anti-vaccination need never have been wasted. The hysteria over her being a risk to public health, quoting selectively from research, giving incorrect and misleading information leading to improperly informed decisions was all her own doing. I cannot stress that enough. The difference between what the HCCC requested and what Dorey created is huge.
Also her claim of not being under HCCC jurisdiction and not giving medical advice somewhat deconstructs itself by her refusal. By refusing to inform readers information shouldn’t be read as medical advice, we may infer that she believes it should. By refusing to support consultation with a health care provider she is in effect denying sound medical advice. Later ramblings about suppression of her right to free speech are as good as incomprehensible.
This initial decision was backed by Victoria’s Chief Health Officer Dr. John Carnie, speaking on ABC’s The World Today, July 13th, 2010:
On July 12th – HCCC announcement day – the AVN having metamorphosed into a watchdog popped out a cracker of media release from “media spokesperson”, Meryl Dorey: Vaccine Safety Watchdog to Fight Government Censorship;
Consumer advocacy and vaccine safety watchdog group, the Australian Vaccination Network (AVN), has announced that it will be investigating all options in order to respond to the outrageous attack on free speech inherent in the recent allegations made against it by a NSW state authority, the Healthcare Complaints Commission (HCCC). The HCCC, in a report just released, has deemed the AVN to be a ‘healthcare provider’ and, in this capacity, stated that it has published ‘misleading and dangerous’ information on the risks of vaccination [….]
You can’t make this stuff up. Even members were baffled by her position. “But Meryl, we are anti-vaccination… just comply”, was a position expressed. Nonetheless, this gave birth to the “attack on free speech” lie that gradually drew in our friend with intellectual wanderlust, Dr. Brian Martin. Consider this taste of (if I may be so bold) a deluded and paranoid attempt at rationale, to mislead members. Pay particular attention to claims that the OLGR found no evidence of fraud. You know, like this missing $12,000 or even this other missing $12,000;
As you all would be aware, the Health Care Complaints Commission (HCCC) illegally ‘investigated’ the AVN, and asked us to put a statement on our website to say, amongst other things, that we were anti-vaccine. We refused to do so and, as a result, they released a statement that we were providing deceptive and misleading information and were a danger to the public. The implications of this action are much further-reaching than the AVN as I will explain a bit further on.
This HCCC decision has been used by many other organisations and the media to defame and slander us – and why is that? Because we provide help and support to a sector of the Australian population that the government wishes didn’t exist – those who question authority, think for themselves and make health and wellness choices that go against the government’s and the medical community’s wishes. People like us should not exist as far as these bodies are concerned and they see the AVN as one of the ‘ringleaders’ if you will, of this sort of thinking. [….]
Right now, we are blocked at every turn because of this HCCC finding – and that was the whole idea behind this. Even the [OLGR] which openly admits that they found no evidence of fraud in the breaches they discovered in our operations – breaches of a purely administrational nature – have said that the HCCC findings will influence their final decision which is due out shortly.
And the HCCC had no jurisdiction to investigate us. Three lawyers, two barristers and a QC have all said this is the case. The HCCC acted outside their jurisdiction and outside the law.
It is certainly not the first time the HCCC has acted in an incorrect manner and this body, set up to protect the people of NSW from incompetent and dangerous doctors, seems to have a long history of being partial to the medical profession whilst coming down hammers and tongs against those in the natural health arena.
Speaking of the OLGR after this is over comes the appeal against the OLGR investigation and ministerial decision.
Dorey also dismisses the OLGR investigation and October 20th, 2010 revocation of their charitable fundraising status (authority to fundraise) by the Minister for Liquor, Gaming and Racing as “based on the HCCC decision”. [Letter here] More than anything, her conduct after this changed the view of Dorey as just an anti-vacccination crank and exposed the money making angle. Whilst not in the Sensaslim league, tactics are similar. Lie, feign outrage, produce confident media releases “clarifying” the egregious and erroneous mistakes of authorities, boast of confidence in being found not guilty and above all control the flow of information. Also simply inventing falsehoods and failing to deliver on legally obtained income such as magazine subscriptions.
Dorey also reported the OLGR audit findings as typical of any small, volunteer run organisation – size of donation tins, receipt giving and keeping of copies, etc – and had reported confidence that no fraud would be found. They also reported not having an auditor during the time they were found to be fundraising without a licence. During a rather delightful discovery it turned out the AVN had admitted having auditors over the time they told the OLGR that they did not. This was inadvertently admitted as part of a scam to raise money over a non existent advertisement.
So, what of this line Dorey feeds over and again to her members and the media? The OLGR are flawed because they relied on the HCCC. Because of the deceptive nature of AVN website presentation – which led to the HCCC request – the OLGR also concluded individuals may donate in good faith and “noted the HCCC decision”. That’s where it ends. The OLGR in no way “based” it’s decision on the HCCC, but arguably had the AVN complied initially the OLGR may have ruled somewhat differently. Perhaps a suspension of authority, I really don’t know.
Either way, Dorey can only blame herself and her arrogance for the HCCC public notice. As for the OLGR decision, in light of the evidence, this thief, liar and scam artist who has also lived on the takings from her loyal if clearly misguided members has really already won so much. The fact she believes she can legitimately trade as a charity again and has been wronged tells us far more about the psychology of Meryl Dorey than about the dynamics of her crimes.
During the course of the inquiry evidence of possible breaches of the Charitable Trusts Act 1993 was detected in relation to the following specific purpose appeals conducted by AVN:
1. Fighting Fund – to support a homeless family, allegedly seeking to avoid a court order to immunise a child with legal and living expenses. The appeal ran for a short time in 2008 and raised $11,810. None of the funds were spent on this purpose.
2. Advertising Appeal – initially this was an appeal for the specific purpose of raising funds for an advertisement in the Australian commencing in March 2009 and concluding July 2009. The specific purpose was changed during the course of the appeal to fund advertisements in Child magazine. This appeal raised $11,910. None of the funds were applied to the specific purposes. It is noted that AVN did spend some $15,000 during the period December 2009 to July 2010 on various forms of advertising.
3. Bounty Bag Program and Vaccination Testing – for a number of years AVN has solicited for donations generally in a manner where, despite it not being AVN’s intention, one specific purpose was created in that donations could only be spent on one or more of four purposes, including funding the provision of AVN material in the Bounty Bag program and testing of vaccines. No funds raised have been spent on these two purposes.
The amount raised for the Bounty Bag scam and promises of independent vaccine testing is reportedly around $308,000 over 3 years and 8 months [page 13].
On top of that are numerous other scams based on the same technique one of which called for members to consider donating their Maternity Immunisation Allowance. This kicked off almost two months to the day after her first media release on the topic mentioned in item 1 above. Dorey claimed others were doing so, because without AVN lobbying to “ensure legislation” for the MIA and Childcare Allowance, they wouldn’t have it anyway. This is entirely bogus. Presently Dorey is calling for help to read the policy documents on the Healthy Kids Check. Yet somehow just can’t quite report the facts to her members.
Losing In The Lucky Country 