Floreani, Golden and the myth of homeopathic immunisation

For a mob that officially professes “no position” on vaccination the Chiroprctors’ Association of Australia disseminate ample false, misleading and quite dangerous antivaccination hanky panky.

Take CAA NSW branch vice president, Nimrod Weiner. The Weiner from Newtown Community Chiropractic whose Nimroddery was pegged as a “rant on vaccines” by The Australian. Although he feverishly ran for cover after outraging real doctors, not-a-real-doctor Weiner’s “rant” bibliography can be found here. A hodge podge of dusty conspiracy twaddle and outright lies, much from the Australian Vaccination Network it alone refutes Weiner’s claim:

I’m good at knowing how to read a research aritcle, and knowing whether it’s viable or not. I’m also good at collecting a lot of research. This vaccine topic I update every single week. So what we’re looking at is new as of yesterday morning.

He didn’t write that, but announced this to attendees of his seminar Vaccinations: An informed choice, in what can quite justifiably be called a lie. There’s more on the entire debacle along with a Radio National segment here. At times we’ve met other crackpots from the CAA. Jason Parkes and Rob Hutchings, both of whom approach their profession like a religious fundamentalist approaches taking up arms. Warren Sipser who believes vaccines cause harm yet chiropractic “repairs DNA”. Genevieve Keating is another pleasant sounding predator who specialises in convincing parents chiropractic builds super human kids. They lean toward the weird beliefs of founder Daniel David Palmer and his views on “God given energy flows”.

Sipser was the subject of an article in The Australian headed The Chiro Kids which brought home just how ludicrous (and scurrilous) the new brand of Mystical Chiropractors really are. Thanks to Dr. Rachael Dunlop we can read the CAA’s Media Release warning CAA members of that article. It’s disturbing stuff given these quacks are subsidised by our government (Medicare foots the bill for five sessions per year) and health insurers. Written by CAA national president Simon Floreanai, it is a straight out attempt at damage control, obfuscation and dodging questions.

Floreani himself has run antivaccination clinics and is a member of the Australian Vaccination Network. He describes Dorey’s little fraudulent scheme as a valuable resource for patients. Simon is married to Jennifer Floreani, famous for writing an article supposedly describing (Update – as noted below the bogus article has been removed but can be found here pp. 348-349) her newborn’s battle with pertussis, picked up from an older sibling. Given the outcome and treatment the article is almost certainly fraudulent, but if perchance the diagnosis is correct then at best it is reckless neglect and at worst simple child abuse.
She writes (bold hers):

This experience did indeed test our resolve and we were forced to draw on our support network of healthcare providers. We performed chiropractic checks on our baby daily and utilised a whooping cough homeopathic. I dosed myself with an array of vitamins to boost his immunity via breast milk and kept him hydrated with constant breastfeeding.

Whooping cough is often slow to develop and may respond well to conservative management, including chiropractic, osteopathy, homeopathy, herbs, acupuncture or acupressure. Within two days, the severity of our baby’s symptoms cleared and within a two week period, each of our boys had a complete resolution of their symptoms.

Fortunately for the Floreani’s this little tale is just that – a tale and a comical one too. Every type of “conservative management” is absolutely non efficacious. Babies with pertussis gag, choke and may have profound difficulty breathing making this nonsense of super fortified breast milk as a realistic option seem laughable. More so, there’s no evidence an increase of maternal vitamin intake when breastfeeding will do anything but produce expensive maternal urine. Even more farcical is the notion of “boosting immunity” with vitamins. Either way, if their baby did have pertussis there’d be no magic recovery after two days but admission to intensive care many days later as the insanity of their hokery pokery gradually sank in. Yet, that’s not really the point.

The dangerous, deluded and unconscionable message pushed on parents here is that using your breasts, vitamins and witch doctor spells, you can clear up a potentially fatal disease within two days. It’s outrageous and a bald faced lie that I cannot even begin to comprehend the motivation for. What’s infuriating is that chiropractors exploit the confirmation bias in parents and the Floreani’s are prime examples.

Parents who believe these nonsense manipulations cure everything report that yes treatment keeps children healthy. They also report inaccurately that lapses in treatment lead to poor health. Knowing this, chiropractors are famous for setting treatment frequencies, with some even insisting on treatment contracts. That the locus lies with parental bias has been shown splendidly in trials on colic.

As we know, chiropractors claim they can “successfully treat” colic or – in their lingo – Irritable Baby Syndrome. Trials show that if parents believed their baby received chiropractic care, whether they did or did not, they reported improvement. If they believed that no chiropractic care was applied – even when it was – they reported a worsening of colic. You can catch up with Simon Floreani admitting no proper trials exist here on Lateline back in July 2009.

He’s caught out claiming injuries from neck manipulation are one in 5.85 million cases when in fact they are gauged at 1.3-5 per 100,000 manipulations, by insurer Kaiser Permanente, who refuse to cover the practice. In short Floreani is claiming instance of vertebral injury is 60 – 300 times less than it is.

On August 21st this year, a video entitled “Homeopathy evidence and research” filmed by Simon Floreani and featuring homeopath and fraud Isaac Golden, appeared on YouTube. The video below looks initially at the rise of the Mystical Chiropractors and then picks through Golden’s claims of Cuban “homeopathic immunisation” and his own so-called PhD on “homeopathic immunisation”.

When used to defend against a complaint to the TGA about homeoprophylaxis, Golden’s PhD actually helped uphold the CRP decision of misleading claims by fellow crook, Fran Sheffield. This is because even Golden admits in his thesis text that his sample was flawed in size and there was no chance of contracting infection. In short he showed nothing.

Enjoy…

Homeopathy is baloney

A nice video montage of various clips relating to the pros (cough) and cons of homeopathy.

If homeopathically labelled it might read Facts 40C, Baloney 15C. This means that factual material has been vastly more diluted than complete baloney. Which means there’s more impact from fact in this video than hokery pokery. That in itself makes no sense – so we’re off to a good start.

The surprisingly honest episode of Today Tonight featuring Richard Saunders of Australian Skeptics is interspersed with other material. Paul Offit explains the uselessness of Oscillococcinum, James Randi pops in with a refreshing use of the words “health scam”. Simon Singh appears on the BBC and Aussie TV and we meet Mark Wild, a British filmmaker whose decision to use a homeoprophylactic for malaria almost killed him.

Don’t miss the hilarious Charlene Werner casually redefining Einstein’s equation whilst lecturing in homeopathy. And we thank “quantum healer” Joshua Bloom just for using the word “quantum”. Kudos to the guy from Futurama.

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

Paul Offit discusses Oscillococcinum

Oscillococcinum is a homeopathic scam sold as a cold and flu “remedy”. Supposedly made from burberry duck heart and liver because (according to homeopaths), these are “reservoirs” for influenza virus it is in fact, sugar.

It’s an ideal example of the problems Aussies face with homeopathy regulated under our TGA. As we know homeopathic “medicines” are “often so diluted they don’t contain any of the active ingredient”. Australia’s TGA regulations on homeopathic and anthroposophic “medicines” are quite plain in that this fact ultimately dictates that homeopathic products must comply with The Australian Code of Good Manufacturing Practice –  cGMP standards. Overseas sponsors must provide evidence that this standard is met. Whether or not this is actually occurring has no bearing on the rationale.

The rationale for this is that although most homoeopathic (and some anthroposophic) medicines are diluted to the point where it is no longer possible to detect any of the original mother substance, a major factor in ensuring the low risk nature of these medicines is making sure that the mother substances are properly identified, and the dilution and succussion processes are appropriately monitored.

Translation? Some homeopathic products claim to be made from nasty and potentially high risk “mother” substances. The final product from homeo-hokery pokery actually contains no active ingredient, and the TGA is all about preventing risk. So to be certain you’re selling nothing nasty – or rather, nothing at all – your hokery pokery will be subject to cGMP. Efficacy is neither here not there when it comes to alternative “medicines”.

This is rather strange because in 2003 The Expert Committee on Complementary Medicines in the Health System [ECCMHS] recommended that;

Homoeopathic medicines and related medicines making therapeutic claims be regulated to ensure they meet appropriate standards of safety, quality and efficacy.

Efficacy? Quality? Therapeutic claims? Regulation? This is simply not not what we see today, despite the fact 1600 complementary “medications” were recalled in 2003. Recently efficacy was raised again in the transparency review of the TGA. Plainly this is just not good enough.

Remember that a dilution of 1 in 100 is designated by “C” – a centesimal. Oscillococcinum is 200C. In Australia 200C is also known as “bugger all”. Yet, Aussies pay good money for this apparent remedy. This scam.

Paul Offit sums this up nicely in about 2 minutes, and I added some slides for sex appeal.

Paul Offit discusses Oscillococcinum

Transparency review of the TGA

On July 20th the Review to improve the transparency of the Therapeutic Goods Administration was published.

From an evidence point of view the only game in town is the burgeoning market in what the TGA must only deem to be relatively low risk compounds, sold to a trusting public as alternative or complementary “medicines”. Under present regulations products do not have to demonstrate efficacy. They are thus registered only on a risk basis. Evidence need not be supplied proving claims advertised on packaging. Only an assurance that evidence exists. All that brain developing, flu resisting, sexual performing, “wellbeing” heightening hokudus pokudus has the credibility of a greeting card slogan. So, how does this happen?

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.

Results of a Post-Listing compliance review over 2009-2010 was posted by the TGA on May 11th, 2011:

Between July 2009 and March 2010, the TGA completed 110 compliance reviews of Listed complementary medicines. Of these, 31 were random and 79 were targeted.

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

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

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

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

Clearly then, the system can be abused and often is, highlighting the paper tiger status of the TGA, and the overburdened, under-resourced Complaints Resolution Panel. One issue that has been widely publicised followed a complaint by Dr. Ken Harvey about the SensaSlim weight loss spray. It’s now widely known that con man Peter Foster is indeed behind this global scam, with his name appearing on court documents. When Harvey’s complaint became known Ken was hit with a SLAPP – Strategic Lawsuit Against Public Prosecution. In this case SensaSlim sued for defamation. Under current guidelines all complaint processes must be halted until other lawsuits are finalised. This can take well over 12 months during which time profits continue to roll in. There’s very little in the review below that leads one to conclude such conduct is going to be more effectively dealt with.

Whilst there are naturally occurring OTC products of known efficacy such as Omega 3 fish oil and St. John’s Wort, efforts must be made to seek sources such as Arthritis Australia or Beyond Blue to ascertain effectiveness. In both these cases not all arthritis nor all depression types respectively, respond to either product. A tragedy that has unfolded is the partnering of Arthritis Australia with daylight robbers, Ethical Nutrients. This rather unethical company will charge $70:00 and more for a small bottle of Omega 3 fish oil.

It sits in splendid spotlit glory in a refrigerator in the pharmacy, even though it need not be refrigerated until after opening. Stalk a few shelves and you’ll find another brand for around $20 – 25:00. It’s important to realise the most common form of arthritic aches and pains is osteoarthritis. OA has not been demonstrated to benefit from Omega 3 beyond anti-inflammatory properties, and thence provision of some pain relief in some very few instances. Much is made of the reduction of enzymatic activity responsible for cartilage damage. Less is made of the fact this is not clinically significant.

Rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis inflammation has been shown to respond. Omega 3, available from a number of foods and nuts has a beneficial effect on inflammation. But that hasn’t stopped Ethical Nutrients relentless advertising campaign adorned with the Arthritis Australia logo. If you’re thinking of using these products be sure you have ongoing inflammation or in the case of depression less than moderate. Be wary who you speak to in seeking advice, and please consult your doctor. Promoters of “alternative” income sources operate just as effectively by demoting sound medical treatment.

Also, keep in mind none of these magical concoctions have ever been considered for PBS listing or are cheaper for concession card holders.

Nonetheless, one may take some comfort from recommendation seven below. It directly addresses the absence of evidence loophole, also hinting at public education. Whilst many will hang doggedly onto entrenched habits, this recommendation and the paragraph on page 53 provide a valuable tool for skeptics and evidence based health advocates seeking to educate a largely science illiterate community.

  • Recommendation 7 [Page 5]:

The TGA implement mechanisms to educate and inform the public that listed medicines are not evaluated for effectiveness by the TGA prior to market.

  • Concerns over complimentary medicines and homeopathic products. [Page 53]

The assessment by the TGA of complementary medicines (such as vitamin and mineral supplements, herbal medicines and especially homeopathic products) was raised as an important issue, in both the consultations and the submissions. Contributors were concerned that the recognition of these products by the TGA, and the AUST L number on the label, provided the public with a perception that the claims made for these products had validity.

At both the consultative sessions and in submissions, it was asserted that many therapeutic claims, or claims regarding efficacy and safety made for complementary medicines, cannot be supported from the limited scientific evidence available, while information about possible adverse effects, especially their interaction with conventional medicines, is often lacking. However, complementary medicines are not permitted to state any interactions with conventional medicines in any material that could be considered advertising.

It was accepted that the majority of complementary medicines are low-risk products, but low-risk does not mean no-risk.

Submissions claimed that many complementary medicines are heavily promoted as ‘natural’ or ‘natural alternatives’, with the implication that they are harmless. It was said that this can result in consumers not advising their medical practitioner or pharmacist about their use, and that health practitioners often do not ask about them.

Some submissions sought not just greater transparency on what an AUST L number means with respect to the TGA’s risk-based assessment of safety, quality and efficacy. They asked for changes in labelling and legislation. Some suggested that all labels, promotion and ARTG Public Summary documents of AUST L products should contain the warning, ‘These products have not been evaluated for efficacy by Australian health authorities’.

Other submissions sought changes to the evidence-based requirements for listed medicines, to more clearly distinguish evidence-based complementary medicines from those that were not. Some submissions requested universal evaluation of all therapeutic goods for efficacy, arguing that there was no such thing as complementary medicines, only medicines with evidence of efficacy and those that lacked evidence. In particular, many submissions strongly put the view that the listing of homeopathic products by the TGA be ceased, as it is perceived to provide an unwarranted or inappropriate endorsement of the products that may be no better than a placebo.


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