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

The Australian Vaccination Network in court

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:

Download audio. Transcript here.

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.

In fact the OLGR found 17 breaches of the fundraising act including offences that carry fines and deliberate misleading of the public. Sadly penalties for charity fraud are quite lenient, which renders the creatures responsible as cowardly as they are reprehensible.

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.

From an OLGR letter to Ken McLeod, October 18, 2010:

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.

Sound familiar?

Hand me down clothes for the “mercury causes autism” mannequin

Back in early August Swinburne University of Technology published an astonishing media release.

Australian research finds autism risk

Date posted: 9 Aug 2011

A family history of pink disease is a significant risk factor for developing autism spectrum disorder (ASD), new research from Swinburne University of Technology has found.

The results of the study, conducted by Associate Professor David Austin and Ms Kerrie Shandley from the Swinburne Autism Bio-Research Initiative (SABRI), have been published in the Journal of Toxicology and Environmental Health. Pink disease was a form of mercury poisoning prevalent in the first half of the 20th century. [….] When mercury was identified as the culprit and removed as an ingredient in teething powders in the 1950s, the disease was essentially wiped out. […]

“Staggeringly, we found that one in 25 grandchildren of pink disease survivors aged 6-12 had been diagnosed with an autism spectrum disorder. This compares to the current Australian prevalence rate for that age group of one in 160. […] In the meantime, Austin suggests those with a suspected family history of pink disease to minimise their exposure to mercury. This is particularly important for young children and women who are pregnant or breastfeeding.

“This can be done by observing the recommendations of Food Standards Australia regarding seafood consumption, opting for non-amalgam dental fillings and requesting preservative-free vaccines from your doctor,” he said.

“Staggeringly”! I hope you got that. By what mechanism I wondered? That was absolutely crucial. Huge toxic loads of mercury caused Pink disease (acrodynia). Thimerosal is ethylmercury rapidly removed from the body, monitored to the nth degree to ensure safe exposure. Teething powders contained 65,000 micrograms per dose of mercurous chloride which decomposed into elemental mercury and poisonous mercuric chloride on exposure to sunlight.

Thousands of children died – between 10 and 33% of cases. Yet not all exposed children suffered acrodynia – it was a minority of 0.2%. Are they thus suggesting a pre-existing inherited genetic susceptibility or susceptibility brought on by acrodynia, which was known to cause infertility? How did parents of children in the Swinburne study fare, in view of other studies linking high maternal exposure to mercury to autism in offspring? How robust was the data collation?

Kerrie Shandley and David W. Austin return to The Journal of Toxicology and Environmental Health to publish Ancestry of Pink Disease (Infantile Acrodynia) Identified as a Risk Factor for Autism Spectrum Disorders. Yes, that Journal of Toxicology…. The one that provides succour to Dr. Mark Geier of chemical castration and misdiagnosis fame in his “ASD Centers” across eight USA states. In 2007 the journal published A Case Series of Children with Apparent Mercury Toxic Encephalopathies Manifesting with Clinical Symptoms of Regressive Autistic Disorders by the infamous father and son team of, to say the least, dubious reputation. Geier senior is presently watching as his medical licence is suspended in consecutive US states.

We can learn quite a bit of these author’s intentions, hence the quality of research, simply by checking their track record. In 2008 Shandley and Austin published An Investigation of Porphyrinuria in Australian Children. They leap straight into citing from known offenders perpetuating the mercury-autism link – Geier and Geier, Nataf et al., Bernard et al., Mutter et al., – in the abstract claiming;

These (atypical urinary porphyrin profiles in children with an autism spectrum disorder) serve as an indirect measure of environmental toxicity generally, and mercury (Hg) toxicity specifically, with the latter being a variable proposed as a causal mechanism of ASD…. To examine whether this phenomenon occurred in a sample of Australian children with ASD, an analysis of urinary porphyrin profiles was conducted. [….] Three independent studies from three continents have now demonstrated that porphyrinuria is concomitant with ASD, and that Hg may be a likely xenobiotic to produce porphyrin profiles of this nature.

The discussion is far more circumspect about this correlation [italics mine], despite the authoritative recommendation [in my bold];

 Furthermore, this study provides further evidence suggestive of an environmental toxicant variable, consistent with Hg, contributing to the maintenance, and possibly development, of ASD.

Given the consistency of the emerging research, health authorities worldwide need to move without delay to further elucidate the specific nature of the toxic insult.

The bibliography is rather short but as well as the above includes Edward Yazbak, Mark Blaxill – editor from Age of Autism – and Sally Bernard et al.’s Autism: a novel form of poisoning from Medical Hypotheses 2001. It’s a Who’s Who of vaccines cause autism mythology whose work is featured by Generation Rescue, The Australian Vaccination Network, Age of Autism and their ilk. Shandley and Austin write erroneously, citing Yazbak, that autism [the disease – not the diagnosis frequency] is “increasing at epidemic rates” then cite Blaxill et al, arguing it;

…. cannot be accounted for by changing diagnostic criteria or improved diagnostic systems

In fact changing criteria has been proposed for years by many paediatricians including Gillian Baird and quantified recently by Brugha et al, who used current diagnostic criteria to uncover a population of autistic adults only 2% smaller than the child population. However, whilst porphyrinuria may indicate environmental exposure to heavy metals including lead and mercury other studies have shown correlation to autism and not Aspergers. Yet this heavy metal/autism mechanism, and what it exactly means is even less certain.

Porphyrins are oxidised byproducts that have “escaped” the heme biosynthetic pathway. We expect to see elevated levels in the urine of elderly, nutritionally deficient, regularly medicated and physiologically distressed individuals. The body can generally physiologically manage toxic build up. Hepatic and renal pathways of elimination serve as detoxification routes for the body. Porphyrinuria heralds a drop in efficacy of biosynthesis or environmental toxic exposure.

If the autistic sample is not recently exposed to environmental toxicity – or as the authors may argue, mercury – then we have to accept compromised biosynthesis. Whether this is due to autism, which does accompany a range of physiological challenges, or whether compromised biosynthesis indicated by porphyrinuria is contributing to autism, is unknown. It’s worth noting that enzymatic and physiological abnormality at the molecular level has been hypothesised as contributing to hypo’ and hypersensitivity in autism. The pathophysiology of autism sufferers is extensive and well documented. The angle Shandley and Austin take is the dramatic call to discover the nature of the “toxic insult” potentially causing ASD. Reading between the lines, and all academic company considered, that “toxic insult” is mercury in vaccines.

This is brought home strongly by Austin’s lone foray the same year in The International Journal of Risk and Safety in Medicine. An epidemiological analysis of the ‘autism as mercury poisoning’ hypothesis, is a scruffy 11 point synopsis concluding that mercury does indeed cause autism. In point 9, he addresses “Mercury levels are higher in autistic than non-autistic children”. He argues that the “causal” hypothesis would suggest that mercury levels would be higher in autistic children. Of course, that’s just what we find chopping into this straw man. Nataf et al., Geier and Geier, Bradstreet and Geier et al., make up three references. The fourth is DeSoto and Hitlan who court ample controversy not least for citing Geier and Geier excessively.

He notes that either mercury causes autism or autism causes mercury. The second notion being “patently nonsensical” and unsupported by literature. Which is unusual because with the cause of autism unknown and the many times exposure to mercury has been ruled out the same could be said of the first notion. We do know that biologically, neurologically and physiologically autistic individuals face many hurdles, and as I suggest above biosynthetic dynamics can’t be ruled out or in.

I was treated once again to a fallacy I’ve had shoved at me in other areas in public health in which robust data indicate no causation between variables. A type of “better to be safe than sorry”, usually proffered by those bent on ideology. Austin here hijacks the “Precautionary Principle (‘First, do no harm’)” as point 10;

The science behind the autism as mercury poisoning hypothesis meets all epidemiological criteria across too many independent studies to be dismissed as coincidence. So, the hypothesis that mercury likely causes autism is confirmed epidemiologically.

He also rewrites history on Pink Disease in point 9, by suggesting that “despite limited evidence” mercury containing compounds were recalled. This is nonsense. Fierce resistance to accepting mercury poisoning was the norm with medical focus being on a physiological cause. It’s argued the mercury hypothesis gained stronger ground only when opponents “became old and disappeared from the scene”. Gaining credibility via attrition of opposition is not application of the precautionary principle. Austin here is exposed as deceptive, misleading readers for his own purposes.

He concludes his plunge from the windowsill of academic integrity with;

The existing literature provides grounds for suspicion that mercury plays a causal role in the development of autism. [….] …it would be negligent to continue to expose pregnant and nursing mothers and infant children to any amount of avoidable mercury. Health authorities worldwide should move without hesitation to ban and remove all mercury in all medical products at the earliest possible date.

Again with the dramatic calls. Where is this mercury really coming from? Ethylmercury or methylmercury in the diet, pre-term maternal diet, breast feeding or toxic exposure? We can infer with a good deal of accuracy he alludes to thimerosal in vaccines. It’s a shocking paper without even an acknowledgement of the impact of changing diagnostic criteria. The bibliography continues to fail with Boyd Haley, who pops up twice, Mark Blaxill again along with another showing from Sally Bernard. Indeed the “epidemiological analysis” of “existing literature” is a predetermined collation of biased and discredited publications.

Still, we can now return to the most recent paper with a clear understanding of these authors’ predetermined agenda.

To begin with they wheel out all the veteran offending authors, including their previous work to make the case there’s a relationship between mercury and autism. Well, third time lucky just doesn’t apply here. In the tradition of discerning character from the company one keeps, I think we can indeed confirm intention from citations. From the abstract they propose susceptibility and genetic predisposition to explain the small subset of Pink disease sufferers and of autism diagnoses today;

Pink disease (infantile acrodynia) was especially prevalent in the first half of the 20th century. Primarily attributed to exposure to mercury (Hg) commonly found in teething powders, the condition was developed by approximately 1 in 500 exposed children. The differential risk factor was identified as an idiosyncratic sensitivity to Hg. Autism spectrum disorders (ASD) have also been postulated to be produced by Hg. Analogous to the pink disease experience, Hg exposure is widespread yet only a fraction of exposed children develop an ASD, suggesting sensitivity to Hg may also be present in children with an ASD. The objective of this study was to test the hypothesis that individuals with a known hypersensitivity to Hg (pink disease survivors) may be more likely to have descendants with an ASD.

Fair enough. Yet as we’ll see both the genetic component and the exposure to mercury in subsequent generations is unconvincing. Besides, where might this mercury today be coming from?

Mercury contained in vaccines (as a preservative under the tradename Merthiolate, but more commonly known as thiomersal/thimerosal), dental amalgams (silver fillings), seafood, and the atmosphere is argued to be the primary set of sources of Hg exposure for infants both in utero and in their early years.

Well that’s pretty clear. Small children awaiting first or second teeth won’t be worrying about dental filings. Big Atmosphere is here to stay and dietary sources are by choice. In short the only tantrum one need throw is over vaccines. They continue firming the dual hypothesis of susceptibility and exposure to mercury;

… the Hg-autism hypothesis is, in reality, a two-part hypothesis that states that Hg exposure combined with a genetic/physiological sensitivity to Hg or a predisposition to impaired Hg excretion capacity leads to a chronic elevation of Hg in the brain and body.

The purpose of the present study was to test the Hg-autism hypothesis. If the hypothesis is indeed correct, and a sensitivity to Hg is heritable (genetic), the prevalence of ASD among the descendants of a cohort confirmed as having a hypersensitivity to Hg (pink disease survivors) should be higher than a comparable general population prevalence.

Results were reported in the media release and in Fairfax: Mercury poison linked to autism. We can also check back to the abstract for a more telling summary;

Five hundred and twenty-two participants who had previously been diagnosed with pink disease completed a survey on the health outcomes of their descendants. The prevalence rates of ASD and a variety of other clinical conditions diagnosed in childhood (attention deficit hyperactivity disorder, epilepsy, Fragile X syndrome, and Down syndrome) were compared to well-established general population prevalence rates. The results showed the prevalence rate of ASD among the grandchildren of pink disease survivors (1 in 25) to be significantly higher than the comparable general population prevalence rate (1 in 160). The results support the hypothesis that Hg sensitivity may be a heritable/genetic risk factor for ASD.

The most telling flaw is the efforts gone to in constructing the apparent genetic susceptibility to mercury leading to autism in grandchildren of acrodynia sufferers.

As identified earlier, numerous studies demonstrated a relationship between ASD and Hg. Our results suggest that this variable may have a heritable component and therefore, of course, a genetic basis. What our results do not do, however, is enable an understanding of the degree to which the susceptibility is inheritable and the mechanism by which this may occur.

Firstly if there’s a genetic component, why did the grandparents – and indeed the entire cohort of acrodynia children – not show prominent autism diagnoses. Secondly, how did the parents of the children escape autism? They lived in an era of mercury in house paint, mercury compounds in worming treatments, mercurochrome was a standard in First Aid kits – then suddenly vanished, industrial waste spilled into local rivers where kids regularly swam as standards of control were far more lax and mercury was used in the manufacturing of more products.

In short the parents with the same, “…heritable component and therefore, of course, a genetic basis”, were exposed to much more environmental mercury. Yet they emerge unscathed. Surely we should be seeing a reduction in ASD. Each subsequent generation is exposed to less mercury and the genetic component is halved. Unless there’s some incredible generational leap. Yet the authors themselves answer my initial question on mechanism – it’s unknown – and can offer no insight into the degree of genetic susceptibility.

So we must examine data collation. A survey completed by 522 infantile acrondyia sufferers. Self reporting data is perhaps the least reliable source of data in the absence of correction or follow up. In this case to correct for response bias it was crucial to chase up each and every one of the 522 respondents grandchildren to confirm that yes, they meet Australia’s criteria for autistic diagnosis. After all the authors are using the 1 in 160 frequency figure gained this way to claim “a six times higher” prevalence. The problem of perceived but undiagnosed autistic disorders may be impacting on results.

But they didn’t do this. The Age reports;

The authors said although they did not validate the autism diagnoses provided by the survivors in the surveys their study added to mounting evidence of a link between genetics, mercury sensitivity and autism spectrum disorders.

“The authors said”, eh? Right. It’s not as if they’re biased or anything – just look at their body of work. This emerging train wreck gets worse in that they likely promoted response bias. The study was advertised on the Pink Disease Support Group site. Yet the author’s write;

In order to minimize response bias, the true purpose of the study was not included on recruitment materials sent out to potential participants; instead, recruitment materials indicated that the purpose of the study was to investigate the general health outcomes of the descendants of pink disease survivors.

All up 23% of surveys were returned. What of the other 77%? Perhaps they had no descendants with health problems and thus were not motivated. Members of this support group with ill descendants are far more likely to respond, if not initially being prompted to join for the very reason the authors favour. Surely this “mounting evidence” would reach the ears of many Pink disease survivors. It’s even more likely those with autistic descendants would know of the hysteria over mercury in vaccines and thus reply, skewing results.

It is in fact arguable that some members of PDSG with autistic descendants – or who perceive they have autistic descendants, or have been told – gravitated toward membership because of the wide coverage of mercury being linked to autism. This point is just as likely as the supposed “six times higher” frequency rate. In truth we just don’t know. This is bad science that merely postulates a hand-me-down trick to breathe more life into the “mercury causes autism” corpse.

So in conclusion, we have two highly biased authors with a well documented track record of being unable to source reputable and bipartisan material on the issue of mercury and autism. They have a demonstrated propensity to argue against thimerosal in vaccines and immerse themselves in research and writing that we can only describe as being fringe or by known crackpots. David Austin in particular has previously written deceptive rubbish and aligned himself with known culprits in perpetuating known myths.

Shandley and Austin have a demonstrable predetermined agenda. Together they’ve come up with an appalling hypothesis because of this yet continue to cite these same biased sources. Their methodology is fatally flawed. Their conclusions are bordering on the absurd as they fail to justify the degree or mechanism of their observation which is based on unreliable data. To battle through this mess they cite over and again the same disreputable sources, which does not strengthen their argument. No dissenting citations are presented and challenged. They have published in a journal of dubious integrity and made public claims that remain scientifically unsubstantiated.

What.A.Mess. There’s nothing to see here – move along, move along.

When is it OK to steal children?

How Meryl Dorey exploited a family to steal $12,000 from donors

An excellent question and I’m glad you asked.

It has been posed before of course. By the same person who opined, and in circumstances similar to that which elicited, “Court orders rape of a child” after a mother was ordered in the Family court to vaccinate her daughter. Although continuing on with, “Think this is an exaggeration? This is assault without consent and with full penetration too…”, Meryl Dorey AVN president did attempt to explain herself. Or rather, offer a kind of acknowledgement of her members who were not up with the gravity of assault by vaccination and thus took offence.

I don’t won’t to hype this up as it was pretty gross. Yet it undermines the straight faced denials of being antivaccination. Indeed, of being “for informed choice”. It brings in an emotional element impervious to the very rational compromise that defines advocacy in a democracy. It moves it to the extremes of activism. The type of placard waving, spittle flying abuse of the status quo that doesn’t help anyone. And if actions speak louder than words, the August 2008 debacle that Dorey initially wrote about under When is it OK to steal children?, long ago destroyed any semblance of bipartisan credibility.

This is when the AVN usurped the actions of a family hiding an HBV positive mother, husband, newborn and 3 year old from DoCS, police and NSW health to avoid the standard HBV vaccine regimen to protect the newborn. DoCS had taken out a Supreme Court order to ensure vaccination of the neonate – but not the 3 year old. The parents kept it up long enough to ensure the six day window of opportunity for protection had expired. Then the AVN abandoned the parents to the law and the father to a possible jail sentence – only prevented by DoCS in view of family cohesion. Dorey went on to milk her members for money via a Fighting Fund which she began within 48 hours after the birth, rising to a Donation Challenge with $500 being the magic figure. With a long history of misappropriating funds, this would be easy.

Almost $12,000 was raised. The parents received none of this money. Members were coaxed along as if they were receiving funds and later congratulated for “your help” in securing a victory for the family. They were housed with a sympathiser or living in a motel and met their own costs. Dorey’s trick was to plead about more families sure to face this on a regular basis.

In fact she boasted of inside information (from the father she exploited no less) that it occurred regularly. The AVN was financially in need and had to stay open. The NSW Attorney General might pursue the family (wrong). The AVN were to lobby parliamentarians on behalf of members, over this very type of threat (still waiting).

According to NSW Office of Liquor Gaming and Racing in a letter to Mr. Ken McLeod on October 18th, 2010, we can read on page two;

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:

 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.

A similar case in QLD in which a 9 week premature baby was “vaccine injured” by the HBV vaccine (inexplicably leading to all three children being removed by DoCS) was set to cost the AVN $30,000. Apparently – as Meryl Dorey relays it – this family wished to refuse vaccination and so DoCS had deemed this worthy of removing all children. This resulted in “a challenge being set” by an anonymous donor and the infamous $500 Donation Challenge was born. All this just fades away as new scams arise. No accounts follow, no reports of progress, no follow up on expenditure.

This case began when a hepatitis B positive woman of Chinese heritage, married to a member of The Australian Vaccination Network gave birth to a boy in Sydney on August 19, 2008. NSW Health HBV policy directive January 27, 2005 states in part;

VACCINATION OF NEONATES
•    All pregnant women are to be offered screening for hepatitis B, surface antigen (HBsAg) and should be provided with verbal and written information about hepatitis B and the hepatitis B immunisation program. The health interpreter service is to be used whenever necessary.
•    Neonates born to HBsAg positive mothers are to be offered, hepatitis B immunoglobulin (HBIG) within 12 hours of birth and a total of four doses of hepatitis B vaccine to be administered at birth, two, four and six months of age.
•    All other neonates are to be offered a total of four doses of hepatitis B vaccine at birth, two, four and six months of age. The birth dose is to be administered using a monovalent thiomersal free vaccine, and offered within 7 days of birth. The subsequent 3 doses may be given in a combination vaccine as part of the routine Australian Standard Vaccination Schedule (ASVS).

First up, let me stress staff don’t bully, harass or intimidate parents. Dorey has made much of this fallacy, yet back in 2009 when investigating the veracity of another attempt to raise money to “steal babies” I was reassured by the head policy analyst of NSW Health and many senior hospital staff (who remembered this very case) that was a rather shocking, offensive and false accusation. The policy exists for staff – not as a directive for patient outcome. To this we can add that HBV is a notifiable disease, and the circumstances would have likely been submitted as a matter of course.

NSW Health state in Hepatitis B Control Guidelines;

Public health priority: High for newly acquired cases, routine for unspecified cases. PHU response time; Investigate confirm newly acquired cases and all other confirmed cases within 3 working days. Enter confirmed newly acquired unspecified cases on NDD (Notifiable Diseases Database) with 5 working days. Case management; Investigate likely source of newly acquired cases. Contact management. Ensure that contacts of newly acquired cases are offered post-exposure prophylaxis.

HBV is a public health risk. It must be reported and entered on a database. Case management includes tracking down the source of infection. Clearly this neonates welfare was paramount and perhaps an issue for health professionals before his birth. The HBV policy directive also stipulates that the Hospital Coordinator ensures parents and health care providers are made aware of the vaccination programme. Which means benefits and risks. HBV can be asymptomatic in pregnant mothers with high viral load, hence strong likelihood of transferring the virus. We may assume hospital staff were aware of this mothers status in this regard. Later news reports suggest this is the case.

Citing baseless concerns about aluminium (aluminum) in the vaccines causing more damage than hepatitis B the parents refused. Here’s where the danger of AVN misinformation kicks in. Aluminium is the most common metal in nature. Over our lifetime we accumulate between 50 – 100mg. During the first six months of life babies do receive about 4mg from vaccines in the form of an aluminium salt. There are various aluminium salts and HBV vaccine usually contains aluminium phosphate. Aluminium acts as an adjuvant – to promote immune response, concomitantly allow less antigen per dose and decrease toxicity of antigens. It’s worth noting that babies receive 10mg from breast feeding, 40mg from formula and 120mg from soy based formula over the same six month period.

All but 1% is eliminated. Elimination rates have been gauged at 50% in 24 hours, 85% in two weeks and 96% in about three years. Exposure via vaccines is significantly less than through food. Other medications and particularly antacids also present more aluminium. Over around 70 years numerous studies have found it to be safe. One of it’s tricks as an adjuvant is to keep antigens near the injection site to be more readily accessed by immune cells. This may cause irritation. There may be redness and at worst a nodule may form due to the aluminium. In view of hepatic damage, cancer, cirrhosis and towering lifestyle challenges from hepatitis, the risk/benefit is clear. [Source]

Naming the parents “Stephen and Cassandra” Dorey wrote on August 21st;

A NSW couple are tonight in hiding after hospital doctors and the Department of Community Services took out a court order insisting that their baby, who is now only 48 hours old, be vaccinated against Hep B.

Steven and Cassandra are the proud parents of baby Jonathan, born in Sydney on Tuesday this week. Cassandra had tested positive for Hep B several years ago and so, before leaving hospital with their newborn, she was advised to give the baby a Hep B vaccination. Having done her research, she believed that her child was at greater risk from the vaccine than from Hep B. She refused the shot as did her husband. After all, vaccination is not compulsory in Australia.

Because of this refusal, Cassandra and Steven were informed by hospital staff that they were not allowed to leave the hospital until the child was vaccinated. Refusal to do so would result in their arrest and a loss of custody. Due to these threats, they agreed to make an appointment at their GP on Thursday afternoon to have the shot administered. DOCs was called in to witness the vaccination and they were sent home with a warning that they had better show up for the shot. […]

The parents are now in hiding…

On August 23rd, the SMH reported;

A SYDNEY couple was on the run with their two-day-old baby last night after the Department of Community Services took out a Supreme Court order to have the boy vaccinated against hepatitis B. […..]

Professor Isaacs said the baby had a 5 to 40 per cent chance of contracting hepatitis B from its mother and “about 30 per cent of people with hepatitis B will develop cancer or cirrhosis and die young … I don’t understand why these people are willing to sacrifice their child for a warped idea when the benefits far outweigh the risks.”

LIVING WISDOM August 22nd 2008

It’s nice that the ABC refer to the AVN as an “anti-vacccination group” – twice – which Meryl denies constantly. Disturbingly as time went by Dorey’s ignorance about hepatitis B infection, viral load, symptoms, seroconversion, vaccine ingredients – in fact all the nuances she should know of became plain. Making much of the non compulsory nature of vaccination, Dorey also writes the next day under that image of antivaccination conspiracy horror we all know and love, Family forced into hiding because of vaccination;

Whilst it is true that the mother tested positive to Hep B several years ago, to say that she suffers from Hepatitis B is wrong. She has no symptoms of disease as most people who are exposed to this and develop antibodies to it don’t have any symptoms nor will there be any long-term problems as a result of their antibody status. The lack of knowledge about this status is shocking!

Yes the lack of knowledge is astounding. But on Dorey’s part. The above statement is shifting focus onto whether or not the mother is “suffering” as if this can qualify the scale of risk to the newborn. In fact it’s arguable, but not certain, that testing had revealed that this mother was presenting with high HBV DNA levels and/or was HBeAg-positive (indicating virus replication) whilst also being entirely asymptomatic.

Either way DoCS argued the the likelihood of neonate infection was high. Evidence supports action against hep B baby’s parents;

The Department of Community Services (DOCS) says it has compelling medical evidence to support the action being taken against a Sydney couple refusing to vaccinate their baby boy.

A court order forcing the parents to immunise their son against hepatitis B has been extended in the Supreme Court today.

DOCS spokeswoman Annette Gallard says it is highly likely the child will contract the illness from his mother if he is not vaccinated soon.

In all updates and gushing thank you blurbs, Dorey asks for donations. It was an ideal saga to groom members on an emotional level which is made clear by the many lies perpetrated. Like a rogue internet scam the real aim here is to make money. From Legal Update September 5th;

We are desperate to help these families as I’m sure many of you are too….. We are stretched beyond belief at this point in time and really need your assistance more than ever so please – if you have an extra few dollars there that you think you can spare, visit our web site and donate.

It contained an email that is almost too good to be true;

Dear Meryl

After the newsletter today I would like to donate more to the fighting fund. Can you let people know that if a further 10 people donate $500 each (or more) for this critical issue I will donate a further $500. Annonymously.

It could be any family in this position – if we act now it won’t be all unvaccinated families.
Thanks again for your untiring work and generosity of spirit

Kind regards
Name withheld upon request

September 2008, Update on Stephen and Cassandara;

…until we get legislation enacted in NSW specifically protecting the rights of parents to freely choose whether or not they want to vaccinate their children, this sort of discrimination will continue to occur and helpless, uninformed families will continue to buckle to the pressure to vaccinate their vulnerable children.

What will it take?

At this point, the AVN has been literally run ragged over this last 4 weeks. We have completely expended our very meagre resources and are in a very tenuous position indeed. Whilst we have raised funds to help Stephen and the other family in Ipswich (whose case is proceeding thanks to your help!) that we discussed in the last E-Newsletter, we ourselves have been left ragged and completely unfunded as a result.

Still later on September 25th, 2008 is Thank you doesn’t even come close. Something we’ve all heard before is the promise of missing magazines. But in bold is a clear breach of the Charitable fundraising act 1991;

Unfortunately, the AVN itself is not in such a good position. We have spent a lot of time and resources helping these families and it has taken a toll on both the AVN’s finances and on the production of our next issue of Living Wisdom magazine which many of you will have realised by now is running behind schedule […]

…many other families who either now or in the future may face a similar situation. We also know that many of you have been thinking – and rightly so – that if this sort of discrimination could happen to these families, it could happen to any one of us as well.

With this in mind, it is vital that the AVN stay open for business and in a strong enough position to help any other families faced with something like this.  Currently the AVN is facing the serious prospect of having to close because of financial constraints. We therefore ask that if you have donated funds to our legal Fighting Fund in recent times, you consider allowing us to use a portion of that donation for our day to day running expenses and to pay some outstanding debts.

If you have made such a donation to the Fighting Fund and would rather it remains there to be used only to pay the legal expenses of families fighting this discrimination, please let us know either by telephoning or email. If you did make a donation but we haven’t heard from you by 7th October 2008 about this matter, we will assume that you have no objection to the AVN utilising your contribution for the administrative and operational purposes of the AVN and the Living Wisdom magazine.

Of course, no follow up of just how much money was nicked because the AVN “assume you have no objection” was ever published. Not until the OLGR informed Ken McLeod that it was 100%. The above also claims “… thanks to your help one of these cases has been settled with a positive outcome”. Well, that’s a complete falsehood. No money went anywhere. The couple remained in hiding for about four weeks. Eventually they fronted the Supreme Court and with the help of DoCS (who did not press any charges), were able to return home without the father needing to serve the prison sentence the judge dearly wanted to give him.

As for the impending forced vaccination of so many others that Dorey needed money to prevent, they simply vanish. There’s no AVN record of the couples three year old being vaccinated nor any “victory” preventing this. Perhaps she was, perhaps not. The family disappears from AVN circles, hopefully settling into sound advice.

Within four weeks Dorey shifts her attack on the HBV vaccine from forced vaccination of babies to making up stories of health workers who had no choice. They were being forced into vaccination and contacting her as a result. They had “life threatening” reactions.

These workers were eventually diagnosed with Lupus Panniculitis, Dorey tells us. Plainly she is inventing claims of evil hospitals and staff hiding the truth from these poor people. Who, of course, can only be helped by Dorey, Google and the ever-rolling donation machine. This time members are offered “Pain Free Funding”, as Dorey asks for their maternity immunisation allowance and to be nominated at Ritchies supermarkets.

It’s a sickening scam given the AVN is not responsible for any legislative structure and couldn’t lobby the entrance to a hotel;

A couple of our members have recently donated part of their Maternity Immunisation Allowance to us. They said that without the AVN’s lobbying Parliament to get legislation put through to ensure their rights to government entitlements, they wouldn’t have this money or the Childcare Allowance anyway so they felt that we deserved part of it for our support of them. We thought this was a great idea! If you are in a position to give us a portion of your Maternity Allowance, we would be very grateful – just one more idea that hopefully won’t put too big a hole in anyone’s pocket.

If you’re familiar with the AVN you can see what went on here with the HBV family. The archives are here in which you’ll find no further mention of how donations were managed or who won these dubious prize offers.

A year later, Meryl Dorey would try awakening the scam again. This time seemingly inventing the entire charade.