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.


ACCC takes court action against Sensaslim for alleged misleading claims

© ACCC July 21st, 2011:

The Australian Competition and Consumer Commission has instituted proceedings against Sensaslim Australia Pty Ltd (Administrator Appointed) (Sensaslim), Mr Peter Clarence Foster, Mr Peter Leslie O’Brien, Mr Adam Troy Adams and Mr Michael Anthony Boyle.

The ACCC alleges that Sensaslim and several of its officers engaged in misleading and deceptive conduct and made false representations in relation to the identity of Sensaslim officers, the Sensaslim Spray and the business opportunities offered by Sensaslim.  The alleged conduct includes:

  • Failing to disclose the involvement of Peter Foster in the business of Sensaslim;
  • Falsely representing that the Sensaslim Spray was the subject of a large worldwide clinical trial when in fact no such trial was conducted;
  • Falsely representing that Dr Capehorn, an obesity specialist, gave unqualified support to the effectiveness of the Sensaslim Spray and the purported clinical trials;
  • Falsely representing that Michael Boyle was managing the business of Sensaslim;
  • Failing to disclose that Michael Boyle was intending to resign as Director immediately following the launch of Sensaslim;
  • Falsely representing that Sensaslim franchisees were already participating in, and profiting from, the Sensaslim franchise, that a Sensaslim franchise had a certain earning potential and that there was a “money back buy back guarantee”.

The ACCC is seeking court orders including declarations, injunctions, penalties, compensation orders, orders that Sensaslim officers be disqualified from managing corporations in the future and costs.  In the Federal Court NSW on 20 July 2011, Justice Yates made orders by consent granting leave for the ACCC to proceed against Sensaslim Australia Pty Ltd (Administrator Appointed) up to 27 July 2011.

Orders are extended to 27 July 2011 that Foster, O’Brien and Adams be restrained from taking further steps to make representations regarding the efficacy of the Sensaslim Spray where the basis for the representation is a clinical trial or scientific report, unless the clinical trial was conducted and is the subject of a scientific report which has been published in a peer reviewed scientific journal.

The matter has been adjourned for further hearing to 27 July 2011.

How Meryl Dorey stole $12,000 from AVN members and/or donors

Back in the days just before community members were forced to take a stand against the Australian Vaccination Network for their harassment and abuse of grieving parents, things were different. Having run almost unchecked as a largely law breaking enterprise their confidence and gall in scamming the public was at an all time high.

Yet the basis of Dorey’s urgent threats (directed at parents) of compulsory vaccination for toddlers never existed. Parent’s have never been forced to vaccinate children. The many alerts such as Action Alert – compulsory H1N1 (swine flu) vaccination just around the corner” were all scams to scare members into giving the AVN money. Dorey’s claimed funding destinations never existed. The most famous is the Bounty Bags rort. Assisted by sisters Jane and Nicola Beeby, the scam was to take donations to “fund” AVN material in Bounty Bags maternity packages. The problem was the Bounty Bags company despised the AVN and had nothing to do with them. AVN did the same with Copeland Publishing and their Child magazine – an example of which we’ll see below.

The AVN knew no bounds. They had logo polo shirts, T-Shirts boasting Love Them, Protect Them, Never Inject Them, media appearances, glossy magazines resembling competence, craftily tipping uncertain parents further into a maelstrom of doubt. “Tell them they have aborted foetal cells in them”, Dorey was want to advise her minions. Anti-freeze, immortal cells used in production lead to cancer, crushed up monkey kidney, heavy metals, mercury, mercury, mercury. Dorey zipped from community hall to community hall running the same unsubstantiated claims with photos easily dated from the 1970’s. Horrific injuries blamed on every type of vaccination. For unsuspecting Aussies they were dark days indeed. To this day, not one “vaccine injury” has been backed by evidence or accepted by ADRAC.

Until of course, selfless volunteers followed through with the laws they had flaunted for so long. Eventually The NSW Health Care Complaints Commission found that the Australian Vaccination Network website:

  • 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.

And because of this, in their public warning about the AVN, “the Commission recommended to the AVN that it should include a statement in a prominent position on its website to the following effect”:

  • The AVN’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 by the AVN should not be read as medical advice.
  • The decision about whether or not to vaccinate should be made in consultation with a health care provider.

The AVN never complied, refuting the HCCC observation of being anti-vaccination, claiming that they are for “informed choice”. Bizarre given that academic Brian Martin writes in defence of their “dissenting” anti-vaccination stance. He echoes Meryl Dorey’s complaint that they are an essential whistle blower suffering suppression of free speech.

Below we’ll get a touch of the charity fraud. But reading the group emails of how they mocked legitimate charities associated with medical care was chilling. “I tell them I’m a charity”, boasted Dorey. Ultimately this scam fell apart. The Office of Liquor Gaming and Racing stepped in conducting an “audit that revealed breaches of charitable fundraising legislation”. From the Lismore Northern Star;

These included fundraising without authority, unauthorised expenditure and failure to keep proper records of expenditure. The AVN offices were searched by the OLGR recently and staff were interviewed.

Dorey lied at the time to the public and the OLGR – as I reveal below. Despite these serious offences she claimed that the OLGR found their donation box was the wrong size and;

…the OLGR had found several errors with the network’s bookkeeping system and some minor problems with the way in which fundraising income was accounted for… errors which any small, volunteer-run organisation can and does make…

So let’s examine one very clear example. Documented no less in their own archives – in their own words. Signed off in the applicable financial statement, no less. Orchestrated by Meryl Dorey and the Beeby sisters and the AVN committee I’d like to bring to your attention the admission and publication by The Australian Vaccination Network that they successfully raised at least $11,910 which was to fund an advertisement.

I believe the manner and timing in which the money was raised, the prompt closing of the donation window and subsequent failure to reference the fate of the $11,910 is significant. The source for this is archived editions of Living Wisdom, running from March 2nd, 2009 to June 25th, 2009. These archives may be found here.

I might stress at the outset that material in AVN archives of Living Wisdom is in dissonance to Meryl Dorey’s assertion to the OLGR that the AVN did not have access to auditors between July 2nd 2007 and June 2nd 2009, when it was without authorisation to fund raise. The February 2009 edition, under the heading The AVN needs your help, includes;

The AVN has now reached a crisis point and it’s up to you to decide whether or not we are able to continue to provide these services.
Our auditors have told us that they they have serious concerns about our financial status and our ability to continue as a viable entity…. Our debts are just over $50,000 – more than half of that co-signed for by Meryl Dorey personally…..

On October 16th, 2010 Mel McMillan wrote an article in The Lismore Northern Star entitled AVN seeking legal advice. It includes;

It is understood that between July 2, 2007 and June 2, last year (2009), the AVN was without authorisation to fundraise.
Ms Dorey admits this was true but claimed the OLGR was aware of the AVN’s fundraising status. ‘During this time we were unable to find an auditor,’ Ms Dorey said.
‘It took the AVN 12 months to find an auditor and then another year before the audit was conducted because the AVN was put at the bottom of the new auditor’s work pile’, Ms Dorey claims.

I believe this disparity suggesting a delay until mid 2010 in finding auditors, is quite pertinent. Either Ms. Dorey misled members, readers and donors or misled the OLGR. Which brings the next matter – the successful collection of $12,000 into stark consideration. The appeal began in the very next Living Wisdom publication on March 2nd 2009, 11 days after the published claim that AVN auditors had “serious concerns about [the AVN] as a viable entity”.

Regarding the advertisement, the March 2nd, 2009 edition sought donations from members totalling $53,000 by Monday March 9th, 2009. It suggested readership numbers meant a donation of $20 would suffice. The AVN had been in touch with Generation Rescue in the USA (they claimed citing no correspondence) and were “given permission” to run their USA focused advertisement in Australia. Donors could email judy@avn.org.au for internet banking or donate directly into:
Australian Vaccination Network Gift Fund Westpac BSB 032591 Account – 196282

Further ambiguity as to financial record management appears in the same issue under Your support is amazing! It is claimed that the call for $50,000 11 days earlier had allowed the AVN to “continue… for now”. It includes;

The AVN committee is in the process of working with our accountants in order to develop systems which will make our operations more sustainable. In the meantime, if there are any business mentors out there who would like to help us with advice, that would be very much appreciated.

A suspicious typing error led to Generation Rescue being referred to as Operation Rescue, and was corrected later the same day. Yet they’d just been in frequent contact with Generation Rescue, negotiating a deal…. hadn’t they? Four days later on March 6th, 2009 under Update on Fundraising for Autism Ad, the AVN’s Living Wisdom claims a total raised of $5,000.

By March 31st, 2009 the AVN Living Wisdom claims under What’s been happening? – Item 1 – that $7,000 of $53,000 has been raised. At this point the authors claim to have been seeking to; “Fund a full page ad in The Australian newspaper”. However, rather than a one off ad, they now seek;

“a full page ad in every edition of Copeland Publishing’s CHILD magazine…. This will cost $26,000 in total”.

Copeland Publishing do not accept or agree with AVN material. An advertisement claiming vaccines cause autism is factually absurd, deeply offensive, runs against the ethics and standing of Copeland and CHILD magazine, and would have lost them support and paying customers. The closest the AVN have come was a discussion online to have members flood GP offices and “sneak” anti-vaccination material into existing copies of CHILD magazine.

This attack was phase two in a 2010 revenge attack on Copeland for refusing to publish AVN propaganda, earlier reported in an “Action Alert” by Dorey herself, calling for letters to bombard Copeland Publishing. Later praised here. And still later praised as a “fantastic job”.

The next mention of the fund raising drive is in Living Wisdom, June 14th, 2009 [incorrectly headed “July 2009”] under Two weeks left – please don’t let this effort go to waste! They write (again with no citation of Generation Rescue);

We need to raise $23,000 in total and if we get 2/3 of the money, the American organisation, Generation Rescue, will give us the other 1/3. So far, we have raised $7,000 and we need to raise another $8,000 before Generation Rescue will give us the rest. I feel that we have given it a really good go, but it’s time to say there needs to be a time limit.

We cannot get the media to cover this issue from our side at all. They still insist that there is no evidence that children are becomming autistic as a result of vaccination. We know this is not the case. The US vaccine court knows this is not the case. But the average Australian mum and dad still has no idea. It is vital that we get this information out there. It will blow the roof off of the claims by our government, our medical community and others who want to continue the cover-up of this issue.

Please, if you have not already donated towards this cause (please click here [Ed: no longer functioning] to read more about this effort and to see a copy of the ad), do so today. If you can, forward this letter (using the link below) to your friends, family, workmates or anyone else who has an interest in child health.

Today, is Monday, June 15th. We will give it until Monday, June 29th to raise the rest of these funds. Your help and support are very much appreciated.

Oh, one other VERY IMPORTANT thing. When you make your donation via our website, please use this link [archive] so we will know to direct your donation towards this fundraising appeal? It is for a $20 donation. If you want to donate more, just change the quantity (in other words, if you want to donate $100, just change the quantity to 5 and that will be 5 X $20 or $100 in total).

A fund raising closure date of June 29th is now set.
The bank deposit account details change to;
Westpac Account Account name – Australian Vaccination Network, Incorporated BSB – 032 591 Account Number – 188223

At this point the total sought is $15,000 – $7,000 raised plus $8,000 needed. On June 25th – 11 days later – an additional $4,000 is reported, bringing the total raised to $11,000. They write in Living Wisdom;

We are entering the home stretch folks. On June 14th in our last e- newsletter, I put out an appeal for the final $8,000 needed to get our ad regarding the connection between autism and vaccination into all of the Copland Publishing magazines (Sydney’s Child, Melbourne’s Child, etc.). We have raised about 1/2 of that $8,000 but, like the saying goes (sort of!), you can’t be a little bit pregnant or a little bit dead. $4,000 won’t get the ad in these publications – we need another $4,000 and we only have 3 days to get it.

Based on the last receipt of $4,000 in 11 days, or indeed the initial $5,000 in four days, if the fund raising was extended for a short time past the final 3 days, the $15,000 sought may have been achieved. The outcome of this fundraising attempt or the promised advertisement is not noted again. According to the OLGR it reached $11,910.

No mention is made of monies raised over the final three days in which donations would have continued coming in – perhaps the $4,000 sought. Nor indeed was there any mention of whether the AVN itself could contribute with the help of accountants the AVN claimed were making “our operations more sustainable”.

Donations appear to have been made, or at least called for, into two separate Westpac accounts. The AVN Gift Fund and The AVN Incorporated. No mention of trust account deposits is presented to members. Monies raised in this manner are legally bound to be placed in trust accounts and members notified.

The $11,000 is not mentioned again in subsequent Living Wisdom editions. The only reference to money (two weeks later) are calls to buy tickets to seminars, sign up for membership or subscribe to Living Wisdom. The at least $11,000 is by their own admission, in AVN hands. Money raised immediately after a separate appeal for $50,000 to keep the organisation afloat. After financial auditing found “serious concerns about [the AVN] as a viable entity”. The latter being acknowledged again on March 2nd, 2009.

Of course I informed the OLGR of how this “minor problem with how fundraising was accounted for”, by Dorey and most likely the Beeby’s. Both Meryl Dorey’s and Jane Beeby’s signature’s are on the annual financial statement covering this period. Again, in their own words they damn themselves. The question must be asked: Was there ever a real appeal to fund an advertisement? Or was it a ploy targetting readers touched by autism? The average Australian mum and dad still has no idea. It was a government and media cover up.

The evidence is overwhelming. The money appears as good as stolen. Dorey denies accountability to the OLGR, claiming their motivation to act is derived from the HCCC whose motivation was derived from “forces” intent on suppressing their civil rights. To point out these scams is according to Dorey and the likes of Dr. Brian Martin, suppressing their right to free speech.

I’m afraid I beg to differ.

On October 18th, 2010 the NSW Office of Liquor Gaming and Racing wrote to Mr. Ken McLeod in response to his many complaints about AVN breaches of the charitable fund raising act 1991. It included, along with 17 confirmed breaches of the Act:

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: [….]

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.

Two days later the Minister for Liquor, Gaming and Racing revoked the fundraising authority held by the AVN.

The Australian Vaccination Network: Meryl Dorey’s continued pertussis misinformation

Last time we left The Australian Vaccination Network, or rather President Meryl Dorey, we’d had a close look at her use of unrelated data sets and the tendency to use two figures twenty years apart, to argue pertussis vaccination is not efficacious.

Four days later, an AVN member repeated the very same claim on the very same forum. Also, back on the day I posted Meryl had written an extraordinary attack on official health figures based upon the newspaper article, More testing finds more coughing. Dorey’s completely unreferenced and innuendo filled post is entitled 100 times increase in Whooping Cough – is it REALLY just more testing? 

The article quoted is quite sensible and accurate. Dorey’s feverish and misleading extrapolation can only be examined if one reads her entire diatribe then copies and pastes the news article link at the bottom into a browser. What sets her off is focusing on the first paragraph, whilst ignoring the second. The article opens with the observation that better testing has more to do with the outbreak in NSW than with drops in immunisation. Then continues in the second paragraph with [bold mine] “there was no doubt whooping cough increased in areas with low vaccination rates”, according to Professor Booy who is a professor of child health at Westmead Children’s Hospital.

Dorey uses the same leap in notifications from 1991 to today, ignoring the peaks and troughs of infection, smirking that the outbreak, “isn’t real – it’s just more testing”. Then a simple falsehood. “So the fact that we have gone from 300 cases in 1991 to more than 35,000 cases today is just a figment of our imagination…”. From 332 cases in 1991 we had 34,794 last year and as of “today” have 18,299. Source here. Then it’s classic Reductio Ad Persecutorum, the classic logical fallacy named after Meryl Dorey herself.

And the vilification of families who have chosen not to vaccinate by the media, the medical community and the government that has occurred over the last 2 years because of this non-existent epidemic…

There’s been no vilification. Facts are facts. The Reductio Ad Persecutorum we see is entirely down to denial of vaccine efficacy and germ theory. Dorey ignores here the effect on herd immunity in areas with low vaccination rates, and has now redefined the epidemic as “non-existent”. Astonishing. The Hon Nicola Roxon, Federal Minister for Health and Ageing released Protecting Bubs: Whooping Cough Epidemic on February 21st this year, including;

As the current whooping cough epidemic continues, Health and Ageing Minister Nicola Roxon has reminded parents to protect their children with vaccinations, which can begin six weeks after birth.

“All parents should take advantage of the free vaccines provided by the Australian Government to protect young children from whooping cough,” Ms Roxon said. “Babies can be protected with vaccinations at six to eight weeks after birth, then at four months, and then when they reach six months old.

“Vaccines worth about $86 million will be provided in 2010-2011––free of charge for infants, children and adolescents.

[…..]

“Babies are not fully protected until their third dose of the vaccine, so it is important for those around new babies to be free of infection.

Remember, Dorey’s continued demonstrably false argument is that high vaccination rates and increasing pertussis cases prove the pertussis vaccine is not efficacious. This, she argues, is supported by a corresponding rise in diagnoses and notifications. In her article she is clearly selecting the reality of more widespread testing and using it out of context. Her context is that reported effective wider testing is a ploy by the government to dodge the higher notifications of pertussis (and thus vaccine inefficacy). In reality, more widespread testing explains the rise in notifications over the past four years.

Nonetheless she states without any supporting references;

But be that as it may, the fact is that the government has declared an epidemic by their own figures and now, faced with the inconvenient fact (which we have been stating for years) that vaccination rates are at an all-time high, they are now trying to say that there was no epidemic in the first place -it’s only smoke and mirrors. Don’t count on our statistics -they’re only rubbery figures, after all.

Oh, and we haven’t actually seen an increase in pertussis deaths either because Professor Booy says that they were much higher ten years ago. In fact, there were NO deaths at all from pertussis for well over a decade prior to the deaths that occurred in 2009 – one of which was in a child too young to be vaccinated and the other 2 in older, partially-vaccinated infants. So again, don’t trust the government’s statistics because they seem to be either inaccurate or simply made up on the spot!

“Inconvenient fact… smoke and mirrors… rubbery figures… no deaths ‘for well over a decade prior to … 2009’… statistics made up on the spot”. Statistics Dorey uses to make her entire “failed vaccine” argument, I might add. That’s quite a tantrum to throw over one small news article that refers only to vaccination rates in NSW, whilst Dorey is using national figures. Professor Peter McIntyre in a Rapid Roundup article for the Australian science media centre written in September 2010, addresses both death rates and the most important factor in recent diagnostic increases: Local GP access to PCR testing;

“The problem with whooping cough is that it is hard to get a laboratory diagnosis that is definite and doctors may not order the relevant tests so it does tend to be under-recognised. Having said that, the availability of the PCR test (since about 2000 in hospitals but especially over the past two years at the GP level) has greatly increased the number of cases and hospitalisations being recognised.

There have been big national epidemics in 1996/7, in 2000/1 and most recently in 2008/9. In South Australia, where this death occurred, the epidemic was later than in many other parts of Australia and is still current.

Bearing this in mind, it is important to note that despite a very large increase in reported cases in the 2008/9 epidemic compared with 1996/7, there were a total of nine infant deaths in 1996/7 but there have been, with the most recent death in SA, a total of four deaths recognised in 2008-2010.

Meryl Dorey also makes some alarming and demonstrably false claims about the documented mutation in two strains of pertussis. Firstly she claims it’s the “elephant in the room” that the medical community almost never refers to. This nonsense is followed by arguing that the cause is overuse of pertussis vaccination, “much like overuse of antibiotics” led to decreased antibiotic effectiveness. Vaccination levels required for herd immunity and “overuse” of antibiotics are quite different issues however.

Dorey argues incorrectly that nobody seems to know if the vaccine is ineffective or less effective. So, she then makes up her own mind claiming without evidence that the mutated strain is more virulent and dangerous, thus leading to more deaths here and around the world. Then we get this stunner;

So not only is the pertussis shot not preventing vaccinated people from getting pertussis – it could also be responsible for the increased death rate.

So what is happening? There are several strains of circulating bordetella pertussis bacteria. In early 2010 researchers from the University of NSW school of biotechnology and biomolecular sciences discovered mutations in the two most common strains – MT27 and MT70. The whole cell pertussis vaccine contained hundreds of antigens providing widespread protection. It also correlated to more cases of irritability and fever. The acellular vaccine introduced in 2000 is highly tolerable with several variations. Each variation contains between three to five purified pertussis antigens.

This certainly makes it easier for any potential mutation to defeat vaccine induced immunity. Yet in the absence of conclusive data we can only be sure that some strains will have greater effect. Co-author of the study Associate Professor Ruiting Lan says the acellular vaccine might have contributed to the mutation. What we can say is that the pertussis vaccine may not be fully effective.

Professor Lyn Gilbert is a clinical microbiologist at the University of Sydney. She was involved in the study and notes that whilst bordetella pertussis may mutate to bypass herd immunity, bacteria can and do evolve spontaneously. Dr Nick Wood, from the National Centre for Immunisation Research and Surveillance has also noted that antibiotic use may have played a role in this bordetella pertussis mutation. Do note this is not the overuse of antibiotics leading to antibiotic resistance and super strains Meryl Dorey was alluding to. The World Today covered this back on February 11th, 2010 including both Professor Lyn Gilbert and Associate Professor Lan;

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A comprehensive US article in The Journal of The American Medical Association, Research Aims to Boost Pertussis Control quotes Fritz Mooi, PhD, senior scientist at the National Institute for Public Health and the Environment, Bilthoven, the Netherlands. He suggests lowered efficacy and faster waning of immunity associated with the acellular vaccine isn’t a sufficient explanation, for the present outbreaks. He and his colleagues, “posit that this is occurring in response to selection pressure from the vaccine”. What’s quite bizarre is that Meryl Dorey posted this article on her Facebook page. It includes;

James Cherry, MD, a pediatrician at Ronald Reagan UCLA Medical Center, in Los Angeles, and one of the world’s leading experts on whooping cough, maintains that the increase in cases reflects greater awareness and improved recognition of the disease among clinicians as well as availability of better laboratory tests and greater access to them.

The one thing I don’t want to do here is to use Ms. Dorey’s misplaced confidence in blaming a pertussis mutation on “overuse” of vaccination, to convey a conclusive argument that B. pertussis strains MT27 and MT70 have not adapted to the acellular vaccine via mutation. This may well turn out to be the case, but it does not justify attacks on vaccination regimes or the vaccine. There have been mutations before through adaption of B. pertussis to the vaccine.

This was the case for The Netherlands outbreak in 1996. Ironically, Dorey has been referring to this outbreak for years as proof of general pertussis vaccine inefficacy. She has been most cautious to not admit or refer to the mutation in The Netherlands as this ran contrary to her claim that pertussis vaccination – both whole cell and acellular – was ineffective. Frankly it now beggars belief she has jumped on the band wagon only to use the situation in Australia to spread fear, rail at health departments, misinform and mislead further.

As I pointed out above, whilst Professor Booy is referring to sufficient levels of vaccination in NSW, Dorey has inexplicably launched an attack on Australia’s national figures. Less than a month before, a Herald Sun article reported AMA Victorian president Dr Harry Hemley as saying “immunisation in the community is tending to wane”.

Ultimately this is another hysterical and difficult to follow anti-vaccination rant from Meryl Dorey. She definitely wants to eat her cake and keep it also. In attempting this she meanders throughout the entire bakery emerging into the spotlight covered in flour and jam, with no more evidence than the odd crumb picked up accidentally along the way.

This Today Show clip on the pertussis epidemic offers good advice and disturbing figures.

SensaSlim: “The cavalry is on the way”

We last left SensaSlim on July 6th, after a look at some nasty tactics and the use of Rogers Digital marketing Australian news site, to publish “news” stories about their miraculous product.

Next up came the June 21st SensaSlim newsletter, scribed by the elusive Peter O’Brien. It opened with:

Hello Everyone,

The  cavalry is on the way.

I have just been informed that SensaSlim International have arranged for two of the coordinators of the clinical trials that were conduct by the Institut De Recherche Intercontinental to travel to Australia to assist us in defending the integrity of the worldwide trials.

The Institute are treating criticism of their trails very seriously. Dr Strebel who is currently in Moscow on a project and has made contact with SensaSlim lawyers to ensure they are given every assistance through the preparation of affidavits that can be presented to the Supreme Court of New South Wales with regard to the defamation proceedings brought against Dr Ken Harvey.

They are also going to assist us with the preparation of any material that needs to be submitted to the ACCC to dispose of the allegations that the trials are not conclusive. We will also be proposing to have the trials coordinators speak with Today Tonight whilst they are in Australia and other health writers to combat this attack against us.

I have now seen affidavits that have been filed in the courts in England by SensaSlim International against Dr Matthew Capehorn. There can be no doubt in anybody’s mind upon reading the material that Dr Capehorn was given the data he required to prepare the white paper and that he was prepared to continue to stand by the white paper conditional upon being paid additional money. As I have always said the dispute with Dr Capehorn has nothing to do with the evidence of the efficacy of SensaSlim but it is all about money.

Area Managers have asked me to confirm that SensaSlim was approved to be sold as a dietary aid by the Therapeutic Good Administration based upon the ingredients and not the clinical trials. The clinical trial data was of no interest to the TGA and nor did they ask for it. All they wanted to be satisfied with was the ingredients in the product and the formulation and if based upon the science the product would be able to achieve weight loss.

Those keeping up with the saga will recognise the arrogance in the wording of this newsletter on several points. Today Tonight have started to distance themselves from SensaSlim. It was beyond ambitious to suggest research authors from the Institut De Recherche Intercontinental (IRI) would – just like the cavalry – come a-recscuin’ by submitting materials, “to the ACCC to dispose of the allegations that the trials are not conclusive.” At much the same time the ACCC had discovered the IRI was a bogus entity and that photos depicting executives – or the cavalry, if you will – were also bogus, being photos of lung specialists from St Paul Lung Clinic in Minnesota, USA. SensaSlim legal eagle Terry Harrison said at the time, the Australian arm had cobbled the deal with Dennis Thornton of Lloyds Business Brokers, on behalf of SensaSlim Suisse Ltd. According to the director of Lloyds Business, Thornton was found dead last year. Australian Skeptics have an article here, reviewing the ACCC and Ken Harvey’s position.

The ACCC had won a federal court order to freeze SensaSlim’s Australian assets, most likely on the basis of fabricated trial evidence presented on Australian TV. Certainly for engaging in ‘‘misleading and deceptive conduct’’ under the Trade Practices Act 1971. The assets are frozen until a hearing on August 31st. This is the basis of Dr. Ken Harvey’s complaint against the company. A report, not written by Harvey, about this complaint was published on auspharmacist.net.au provoking SensaSlim to sue for defamation. Making the caper even more overtly scam-worthy was the fact the same pictures of the USA doctors were published on the site of the Mountebank Clinic. The “clinic” address is an industrial estate in Bargo, NSW.

“Mountebank” means:

“a person who sells quack medicines, as from a platform in public places attracting and influencing an audience by tricks, storytelling, sleight of hand, etc… a person who deceives others especially in order to trick them out of their money… any charlatan or quack”

Charming. The clinics’ director was passed off as an “Dr. Joseph Balsamo”, with an image of singer Alberto Balsamo and the qualifications of Flindsers University academic, Adjunct Associate Professor Mary Harris. The Mountebank gig is apparently part of Reef Health who open their website blurb with the strange line, “Reef Health Pty Limited is a 100% Australian company dedicated to natural products which are not only good for you, but actually help.” Reef Health is owned by Andrew Tarter/Tatar and his girlfriend Roxanne Naylor.

That doesn’t stop Roxanne auctioning herself off for a date on this crass dating site – What’s Your Price? She’s getting good mileage from that profile picture. Tatar – or Tarter – is a struck off Sydney solicitor arrested in Vanuatu in 2007 under suspicion of helping smuggle a convicted conman from Fiji. That conman was none other than Peter Foster. Naylor and Tatar are respectively CEO and General Manager of Kava Kwik – Vanuatu Instant Kava.

There’s a wonderful little exchange about sunny Vanuatu here on the Scam.com forum from October/November 2008. A Peter Foster claims to have been conned by a Sam Grant who pushes cancer cures and sells worthless “distributorships”. Grant sells, ahem, “neutraceuticals“. A Brian Smith also suggests Grant is a conman. Grant refutes Fosters account, denying he sells distributorships and pointing out Foster is in jail. Then an “ausman123” rips into “real scammers” Andrew Tarter/Tatar and Roxanne Naylor for scamming Sam Grant:

They own reefhealth.com which WAS reselling a product of sam grants (sic) in Australia. He did this in good faith and shipped all stock without payment.Andrew & Roxanne did not pay for ANY stock even though Sam shipped the orders. When Sam asked for his money Roxanne and Andrew went and registered domain names in Australia and the UK which are the brand name of Sam Grants product and redirected them to Reefhealth.com and posted a FALSE claim about the product.

Roxanne then sent an email to Sam saying that she would be interested in selling the domain back to him. Extortion?
So lets look at the facts:
1. Roxanne and Andrew have history of scams and running scams.
2. Roxanne and Andrew did not pay for stock and pocketed the money rather than paying the bill.
3. Roxanne and Andrew then bought brand domains names and redirected them to their website which they changed and put a FALSE statment about the product to trick customers.
4. Roxanne and Andrew then began posting FALSE information on Sam Grant calling him a scammer.
5. Peter Foster is an international SCAMMER who is associated with Roxanne and Andrew. Interestingly enough he is in Jail at the moment so for him to post on an internet forum while is jail is truly amazing.

Scammers scamming scammers? Or is it just a scam? Either way after this cosy chat and the information pulled together by The Age – and also independently by a member of Support Dr. Ken Harvey – it’s entirely possible Naylor and Tatar/Tarter were “fronting” for Foster. Reef Health accused The Age of “hacking” their Mountebank Clinic website and it disappeared on the same day. The Age has admitted using an incredibly complex and particularly darstardly piece of software known in hacking circles only as… “Google”.

The next day, June 23rd saw reports of a $4.2 million class action by over 70 franchisees conned into paying up to $60,000 to buy SensaSlim stock. They also fell for the line of supposed clinical trials and substantial evidence. Slater & Gordon are working with the ACCC in a bid for compensation, which may indeed prove difficult given SensaSlim’s Australian accounts hold approximately $230,000.

With regard to Dr. Ken Harvey’s defamation case, I mentioned last time that Justice Lucy McCallum had issued consent orders on June 14th. One of which was that, “The plaintiff file an amended statement of claim on or before 1st July 2011”. Sadly for SensaSlim this did not come to pass. Following the ACCC action their lawyers, Kennedy’s Australia withdrew from the case. By June 30th John Kukulovski of Jirsch Sutherland was appointed administrator and by July 5th it was reported he was recommending liquidation. Dr. Harvey has been awarded costs although until happily reimbursed cause for celebration must wait. His lawyers will apply to have the defamation case struck off on July 11th.

The paragraph above in which Peter O’Brien notes the TGA were not interested in product efficacy is accurate and gives insight into the problems with Australia’s regulatory system. Here’s the TGA’s public summary of SensaSlim. In effect the paper tiger position of the TGA is the genesis of this entire sorry saga – and an avalanche of other scams, shams and inefficacious “remedies”. The TGA claimed in June that it cancelled SensaSlim’s advertising approvals and welcomed the ACCC investigation. Pharmainfocus.com.au reported;

“TGA has already taken regulatory action through cancelling SensaSlim’s advertising approvals. We have tested their product and although we have found it does not contain any unsafe ingredients, TGA is continuing to assess other aspects of the product,” a spokesperson said.

Which is as usual, utterly useless. The TGA should invoke Section 30 of the Australian Therapeutic Goods Act, 1989 and deregister SensaSlim from the Australian Register of Therapeutic Goods – certificate here. Presently the anorexic slogan Nothing tastes as good as slim feels still heads up SensaSlim’s shiny new sales and advertising website, including the absurd “lose weight while you sleep” argument. As reported in today’s Weekend Health in The Australian;

But on a newly established website the company confirms it’s proceeding against Harvey. Although the TGA assured Weekend Health in June that it had cancelled SensaSlim’s advertising approvals, the firm continues to promote its product on the new site, claiming the spray is approved by the TGA and the Health Department.

[…..]

A TGA spokesperson wasn’t able to clarify the situation as Weekend Health went to press. Harvey suggests the case highlights “fundamental flaws” in Australia’s system of regulation and promotion of complementary products. Specifically, the TGA’s lack of teeth and a distinction between “listed” and “registered” products that is unclear to the public.

Listed products are assessed by the TGA only for safety and quality, while registered products are also tested for effectiveness.

Being snobbed off is nothing new for the TGA. The article also mentions some nasty tactics recently used to bully co-complainant Dr. Lesley Campbell over her position in Harvey’s defamation case. Another problem of course is the role of pharmacists in selling the product – just one of many unproven remedies they stock. SensaSlim are also hyping up The Australian spray weightloss challenge, and use the site to boast the Australian Register of Therapeutic Goods certificate.

The final balderdash to note is the “settlement” of the stunt case in which SensaSlim claimed the jockey of Black Caviar had lost too much weight. On examination it’s absurd. I opined to other’s on June 26th, when Yahoo 7 published the story that jockey’s are weighed pre and post race. Underweight jockey’s carry weights in their saddles. So Wanderson D’Avila was the correct weight and apparently magically lost 0.8kg within about 30-40 minutes before the next weigh in. Even The Age picked up this AAP story, in which D’Avila was apparently paid $12,500.

Fortunately Jonathan Holmes of ABC’s Media Watch gives this story – and much of the Sensaslim con it’s due, below. The final insult is that now – on their new website – SensaSlim is offered free to jockeys over the 2011 racing season. Again, they use the made up claims attributed to Dr. Capehorn. He denies ever making them and lists this, along with use of his endorsement and identity before he actually sighted evidence, as a key reason for quitting his role as Research Director. He is suing SensaSlim for breach of contract and they are suing him for breach of contract. Nonetheless the hilarity includes;

Dr Matthew Capehorn, SensaSlim Research Director and Clinical Director of the National Obesity Forum in the UK said, “The erratic dietary habits and pre-race preparations of many the nation’s jockeys is an ongoing tragedy waiting to happen.”

Dr Capehorn noted recent press reports in Australia that highlighted not only eating disorders in the sport but lethal lifestyle choices associated with the need to lose weight quickly. He said the same pattern could be seen in the racing industry around the world.

Jockeys are traumatised and tortured every day by food deprivation,” Dr Capehorn said. “The constant thoughts of food and being hungry have led to mental breakdowns, domestic violence and even suicide.

One can only anticipate the demise of this scam with something close to urgent glee. Nasty people, nasty tactics, nasty claims. Australia still lacks appropriate legislation to effectively and quickly deal with this type of nonsense. Though on the positive side, their assets are frozen, they went into liquidation on July 1st and Ken Harvey’s lawyers will apply to have the defamation case struck off on July 11th.

Sadly, I’m sure SensaSlim will go on to rort consumers in Europe for some time to come.