Tag Archives: CAM

Dirty tactics when SensaSlim first copped a spray

Posted in Big Placebo, Health, Scam by

June was a bad month for miracle diet spray SensaSlim. To date I’ve only published The Sensaslim Affair by Ken Harvey, SensaSlim Jockeying for credibility, Beware the lure of new treatments – a very pragmatic piece by Professor John Dixon and Louisa Hall’s piece – which I’ll get to.

We know that Dr. Ken Harvey is one of seven, perhaps nine, complainants and that Professor Lesley Campbell, from the St Vincent’s Hospital diabetes centre is another. As can be read in the above the complaint was simple in that SensaSlim was making ridiculous claims of efficacy. In the absence of any evidence – the much hyped “research” has still not been validated – the claims were most likely fabricated.

Almost certainly others are franchisees left out to dry with their investment. SensaSlim had promised marketing and advertising help which never eventuated. Dr. Harvey was being sued for $800,000. On June 14th the case came before Defamation List Judge, Justice Lucy McCallum, in the Supreme Court at Sydney. The following consent orders were made by Justice McCallum, and published on the Support Dr. Ken Harvey Facebook page in response to SensaSlim’s Australian manager Adam Adams’ rather biased, if not gloating account. The thread has since been deleted by Adams:

  • The plaintiff file an amended statement of claim on or before 1 July 2011;
  • The defendants file a defence on or before 15 July 2011;
  • The plaintiff file any reply on or before 29 July 2011;
  • The defendants’ notice of motion dated 24 May 2011 be dismissed;
  • The plaintiff pay the defendants’ costs thrown away by reason of the plaintiff’s amendment to its statement of claim;
  • The proceedings be stood over to the defamation list on 15 August 2011;
  • The parties have liberty to relist the proceedings in the defamation list on 11 July 2011.

Basically this meant Dr. Harvey had not had the charges thrown out. The plaintiff – SensaSlim – was to file an amended claim by July 1st. SensaSlim thus had to pay Dr. Harvey’s costs because of their amended statement of claim and there was another opportunity on July 11th for potentially seeing the case dismissed. On June 17th, Louisa Hall writing for Fairfax noted the appalling situation that had allowed this action to come about.

Primarily that if any court action is underway complaints lodged with Australia’s TGA against the plaintiff can not be pursued through the Complaints Resolution Panel – CRP. This allows ongoing selling of, and profitting from, the product through it’s “outlandish” claims. Libel cases may take over a year leading to significant income for what may turn out to be a scam. This is a major flaw in TGA legislation. They will only invoke Section 30 of the Australian Therapeutic Goods Act, 1989, which would make ongoing selling and advertising illegal, when the company itself is deemed to be acting fraudulently. This would also remove SensaSlim from the Australian Register of Therapeutic Goods. But as noted here before, presently the TGA care not if a product works: only if it considered to be of acceptable risk.

In the article by Louisa Hall SensaSlim’s legal adviser, Terry Harrison denied the entire defamation suit aimed to gag Dr. Harvey. Interestingly almost two weeks before, SensaSlim Newsletter number 42 was falling into the odd lap. Written by Adam T. Adams – Australian Manager, it contained reference to the CRP in stark dissonance to Terry Harrison’s assurances.

It gives alarming insight into the arrogant stand-over talk directed at Area Managers, who no doubt smelled a rat months before. They had threatened legal action in lieu of repayment of their investment. Adams names them all [I won’t] and claims his legal advice is that this action is fatally flawed. These poor investors were left with the sole option of trying to sell their entire Areas and then… go away. What’s interesting is that the legal team acting for the disgruntled Area Mangers had included a CRP determination from March 30th, 2011. “CHC” is the Complimentary Healthcare Council. [Bold Mine except in red]. Adams wrote in part;

But that’s not the issue I want to make. The issue I want to make is in the letter [the law firm] said has (sic) follows. One of the reasons they [Area managers] wanted “out” was:

“… determination published by the Therapeutic Goods Advertising code complaints resolution panel on the 30th March 2011, clearly found examples of inconsistencies of many representations, (our client are certain that the fact that this panel will now review SensaSlim’s responses to the complaint, which were only received by the panel on the 30th March 2011 and issue a new determination, which our clients are confident will not materially change nor effect the existing determination)”.

You will be aware that I told you that Peter O’Brien was able to have the Complaints Resolution Panel withdraw their published determination. This was mentioned in Newsletter 38, where I advised:

“On Wednesday we received a phone call from a Area Manager, “DP”, saying that the Complaints Resolution Panel had brought down a decision and published it on their website in regard to a complaint about the SensaSlim website. We mentioned this to you previously that our competitors were filing complaints with a view to hindering our progress.

David directed us to the CHC website and a report had been published. Except the report stated that the CHC had found against the company because we haven’t filed a defence. Except we did file a defence on the 25 of January and again when confronted with this crises Peter O’ Brien swung into action with his legal teams and within one hour the CHC had taken the report off their website and agreed that the report is now redundant and that they would withdraw any ruling against SensaSlim”. But back to this week…

So the lawyers for the above Area Managers said that they were ‘confident’ that a review by the Complaints Resolution Panel will not change anything. They, [names deleted]  were ‘confident’ that the company would still be found to be at fault by the Complaints Resolution Panel. Is that ‘confidence’ built on anything except negativity or pessimism? I don’t think it is.

But they were SO WRONG.  So very very WRONG.

So here’s the good news. Last week Peter O’Brien was at his desk until 11pm the night before the CRP were to reconsider the matter, and back at 5 a.m., drafting, redrafting and writing a 9 page submission. With the assistance of his legal team and SensaSlim in London’s lawyers a very comprehensive submission was written stating that the CRP had absolutely no justification at law in adjudicating on the matter since the company had filed an $800,000.00 defamation lawsuit against Dr. Ken Harvey.

You see, it is written in Law that if the subject matter of the complaint is currently the subject of court proceedings, then the CRP are unable to adjudicate. I have attached a copy of the submission just so you get some understanding of the work, the very hard word that is happening behind the scenes that you never see, to uphold the good name of SensaSlim.

So when I read that Area Managers think that the management of this company would be best served if we were replaced by them, and there were others at the helm I think it is absolutely laughable. Too silly for words, really! “TB” who suggests such an action and thinks he could run the company better, is the one who said that they were confident, the CRP would find against us.

Peter O’Brien didn’t accept such a fate but together with his lawyers (by the way Robbinson Legal are the lawyers who acted for Paul Hogan in his case against the ATO, so they’re not frightened of a stoush either) found a way to defend the company. This defamation action, which could be in the courts for a year or two or even longer, basically gives an iron clad protection that nobody can raise a complaint against SensaSlim to the CRP and hurt us.

There are nine complaints that were received in a three day period two weeks ago. These were not complaints by members of the public, but clever legal crafted arguments by people acting on behalf of our competitors and big pharmaceutical companies. These are the same people who have written to the CHC to delay and hinder our progress and having our advertisements approved..and they also wrote to the TGA.

But let me say this. We will not allow their dirty tactics defeat us. We had a very big win this week with the determination by the CRP that they cannot adjudicate on any matters pertaining to SensaSlim.

It was known widely that the CRP decision was published, and then apparently removed within an hour or so. The reason given by the CRP was that SensaSlim claimed to have not been notified. That they never received email notification of the decision and thus did not file a defence. Yet above Adams is telling his own investors they did file a defence, the CHC got it wrong and Peter O’Brien “swung into action”. Confusing. We’ve also got a Big Pharma conspiracy and the lie that “competitors” are behind the “clever legal action”. Finally, there’s no ambiguity about legal action stifling complaints.

But there was more fun to be had. Over much of the first three weeks of June I was corresponding with an editor from Australia.to, a sub domain of World News site http://www.international.to/, a service of RogersDIGITAL.com, which had been “reporting” frequently and favourably about SensaSlim. Rogers Digital specialise in providing advertising techniques including brand direct response and behavioural targetting. They “deliver a diverse audience for advertisers including… women and men of all ages, shoppers, travellers and business and IT professionals”. Their advertising opportunities aim to meet “all the needs of marketers”, via websites “which reach ‘buy-ready’ customers”.

The reason for the correspondence was in response to my concern over a “news” article by a Peter O’Brien about the Jockey weight loss affair. Including;

The jockey of super horse Black Caviar has admitted using the controversial slimming spray as his secret weapon allowing him to calm his nerves, forget about food cravings and focus on Black Caviar, but critics warn that this could lead to unexpected excess weight loss and potential disqualification.

“I am aware of the law suit, but the benefits outweigh the risks,” Nolen said. “This has been a lifeline to many jockeys.”

The Thank you for suing us ad was also published. Both articles were under the sites “your say” URL’s. The advertisement, first published June 5th in The Sunday Mail, lacked a Complimentary Healthcare Council number, suggesting SensaSlim wasn’t accredited. Both the CHC and ACCC say this accreditation aims to provide;

“…. reliable and quality advice and information to our members, government, key stakeholders, the media and consumers.”

Correspondence dried up about the same time I spelled out the problems with SensaSlim’s “white paper”, and the fact Dr. Capehorn who was being used to endorse the product refuted that he made any comment supporting the jockey weight loss stunt. I also spelled out that Capehorn had quit his role with SensaSlim and issued statements through his lawyers. More so there were problems with Australia.to publishing even more articles claiming SensaSlim was represented at the 18th European Congress on Obesity in Turkey. I’ll get to that directly.

Interestingly the Thank you for suing us ad piece and the Black Caviar jockey piece by Peter O’Brien have disappeared. Follow those links and you get a 404. The following day I raised concerns with the editor about an article headed, “Obesity scientists told of SensaSlim slimming spray that has the effect of ‘Fooling the Brain’ into Thinking You’re Not Hungry” and another headed “Four Twins, a Jockey and a sensational slimming spray talk Turkey”. I received no reply. Ironically, both these articles now deliver a 404 message also.

I also asked Adam Adams to explain this claim of SensaSlim representatives attending the conference on the Support Dr. Ken Harvey Facebook Page on June 17th. By this stage most knew there was almost certainly no “evidence”, and it had become clear SensaSlim were not even at the Obesity conference. One complainant had attended the conference. Asked about the SensaSlim claims this person replied that none of the “so-called staffs said to have presented the work” could be found in the Congress abstracts. Secondly, no SensaSlim scientific presentation was witnessed. Thirdly, whilst there were outside booths at the conference at which weight loss products and devices may be advertised without any evidence, SensaSlim had manned none of them.

What happens next – June 22nd onwards – is well known, but also very funny in respect of SensaSlim’s June 21st newsletter written by none other than the elusive Peter O’Brien himself. Given time differences it would seem that the ACCC were moving to freeze SensaSlim Australian accounts at much the same time O’Brien opened his newsletter with “Hello Everyone, The  cavalry is on the way.” I’ll cover these events next with a look at the ridiculous “settlement” for the Black Caviar jockey stunt. For now a review of the ACA programme that pulls together the vital flaws in this blatant scam.

Beware The Lure Of New Treatments

Posted in Big Placebo, Health, Scam by

Originally published, June 14th © MJA Insight by John Dixon.

Associate Professor John Dixon is an NHMRC Senior Research Fellow in obesity research at the Baker IDI Heart and Diabetes Institute, Melbourne, and head of the obesity research unit, Department of General Practice, Monash University, Melbourne.

The excitement of being able to participate or even lead in the development of new treatments in difficult areas such as obesity, cancer prevention and treatment, arthritis and back pain is enticing.
Unfortunately for medical practitioners, there are business entrepreneurs ready to trade on their genuine enthusiasm and – dare I say – naivety. A recent example involves weight loss. It’s not easy to lose weight and even harder to keep it off. Motivation, willpower, energy in and energy out – it sounds so simple but it isn’t.
We now know weight and fat stores are carefully regulated by powerful physiological mechanisms that actually defend against permanent weight loss – all understandable when we consider that our body computes weight loss as a signal of starvation, famine and death.
With the failure of the pharmaceutical companies to develop acceptably safe medications in this difficult area, we are left with an enormous vacuum and a huge untapped market of people who want to lose weight. The field is fertile for the “scam” professionals and complementary medicines are an easy target.
As medical practitioners we can become unwittingly entrapped in these scams. We too want to believe someone has finally developed an effective remedy.
A recent example involved a mouth spray, launched onto the Australian market with great fanfare. There were statements of massive randomised controlled trials (RCTs) with exceptional results – results that those of us in the know would think were “too good to be true”.
How could this large, multicentre RCT involving thousands of people globally have not come to our attention? A prominent European weight loss physician was engaged as a consultant by the manufacturers/promoters with the promise of the trial data being supplied.
In the meantime, this physician’s name was widely used to support the claims, giving the appearance of expert validation, which aided promotion. However, the data to support the claims was never supplied, leaving the physician high and dry with his reputation damaged.
By the time the penny finally dropped he was in an uncomfortable position as the promoters had changed from being soft and appreciative to being aggressive, confrontational and threatening. This particular matter is heading for a legal resolution.
An Australian medical practitioner, concerned about the extraordinary claims being made about this product, openly questioned the results and advised the Australian Therapeutic Goods Administration of his concerns. He was also met with aggressive, confrontational behaviour and legal action by the same promoters.
This intimidatory modus operandi is often used by the unscrupulous to suppress the squeaky wheel and delay the appropriate assessment by regulators. Meanwhile, the income rolls in and by the time the dust settles the original product has had its day and the next scam is already up and running.
This practice is not restricted to weight loss. Wherever there are regulatory grey zones, for example complementary and traditional medicines, and cosmetics, unwary consumers and medical practitioners are at risk of being exposed to unscrupulous operators.
Beware the company that delays provision of quality data, or becomes defensive or aggressive, or attempts to turn the table of blame back on practitioners who push for answers and evidence.
It takes a very strong practitioner to weather this storm but protecting the wellbeing of Australian health consumers from expensive and potentially dangerous scams makes it worthwhile.

A health product activist in court and a regulatory body in question

Posted in Big Placebo, Health, Scam by
As Ken Harvey’s defamation hearing has begun it’s quite proper to ask questions about the impotent regulations that led to this point.
Source of article, “Prominent Activist In Court Dispute” – © Pharmainfocus July 13th, 2011 (ABC links added)
By Niamh Mullen
A defamation action against prominent activist Ken Harvey relating to a TGA complaint he made about a complementary product is scheduled for a hearing the Supreme Court of NSW today [Monday 13th].
Dr Harvey, a lecturer at La Trobe University in Melbourne, hopes to have the case taken by SensaSlim Australia thrown out. In March he submitted a complaint about the promotion of the weight-loss spray SensaSlim to the Complaints Resolution Panel, the TGA, and the Australian Competition and Consumer Commission (ACCC).
In April, the defamation action was launched. The defamatory imputations concern details of the complaint he lodged with the TGA and a report of the complaint that was published on the pharmacy news website
Auspharmacist.net.au. A Therapeutic Goods Regulation, called 42ZCAJ, means the TGA has had to stop all investigation of the complaint until the court proceedings have been finalised.
Dr Harvey has said this regulation provides an incentive to a sponsor that is being complained about to initiate a legal action. “They can drag out a court complaint; it can be very expensive for a complainant and often the complainants roll over because they can’t afford to continue the litigation. It’s a very fraught area and it’s not surprising that there aren’t many complaints,” he said on the ABC Radio National show, The Health Report. [MP3 here]. Dr Harvey said it illustrated the failings of the current regulatory system for complementary products. He pointed out that four months after a first complaint was submitted, promotion of the product continued. He said the regulators appeared to be “paper tigers”. He also said the case showed that making complaints to the appropriate authorities was not without risk.
Ken Harvey’s observations with problems about current legislation were;
Some sponsors have actually sued people who have put in complaints with what we call slap writs, strategic litigation against public participation. This can be a litigation which asks for example a stay of a report into these problems or into complaints on the grounds that this information is alleged to be defamatory. In practice what happens is that that stops the complaint resolution panel from hearing complaints because there is an obscure therapeutic goods regulation which says that if after a complaint has been made to a panel a proceeding begins in a court about the subject matter of a complaint the panel cannot deal with the complaint until the proceeding is finally disposed of.
Now that provides a lovely incentive to a sponsor that is being complained about to initiate a legal action which then stops the complaint, lets them continue to market and away they go. And of course they can drag out a court complaint; it can be very expensive for a complainant and often the complainant’s role over because they can’t afford to continue the litigation. It’s a very fraught area and it’s not surprising that there aren’t many complaints.
More so, a survey by the National Prescribing Service showed that 50% of Aussies assume complimentary medicines are independently tested. That means by a third party serving only to provide impartial results. Results that would rightly influence TGA decisions on what makes it to market in a lucrative multi-billion dollar industry. 70% of Aussies use a complimentary medicine at some point. That’s a large number but it’s a static figure. What concerns me is that some people use certain Complimentary and Alternative Medicines – CAM’s – regularly. Some of these, ensconced in the false believe that “natural” medicines are incapable of causing serious harm – if any – consume excessive amounts.
Interestingly, as can be seen below, the TGA does require, and reinforce, that manufacturers clearly label what is in the packaging. To list components of CAM’s. This satisfies TGA requirements that only ingredients on a TGA approved list are present, and accounted for. Some manufacturers go to great lengths to add some pizzazz by ambitiously qualifying what each ingredient supposedly does. You may have read these: “Each tablet/capsule/spoonful/dose contains 30 mg of xxx for added vitality, 43mg of diddlie dee to promote rapid wound healing, 12 mg of trala trala to assist in quality sleep… strong tissues, healthy bones, optimal nutrient uptake, sustained energy, immune integrity”, and so on. They do not have to advise that no independent clinical tests exist.
That means manufacturers of CAM can legally fail to inform the 50% of consumers under the impression of safe and effective testing that they are mistaken. As I’ve mentioned before, in such situations consumers are placing trust in the equivalent of a slogan.
In this light one may reasonably ask what is required to bring a product to market. In other words, how does a company successfully register their product on the Australian register of therapeutic goods to the satisfaction of the TGA prior to selling under the above conditions? Ken Harvey told ABC’s Joel Werner;
They’ve got to show that they are producing them in terms of good manufacturing practice standards. Secondly they’ve got to choose their ingredients from what is a relatively limited list held by the Therapeutic Goods Administration of ingredients they regard as relatively safe. Some sponsors regard this as a bit of a game, so if the ingredients for example in their product don’t happen to be on the list of the TGA you can happily tick whatever you find on a drop down list that you think is similar and the product will get up. And indeed recent audits from the TGA have found that up to 90% of violations when they actually sit down and get a human being to look at what’s been put into the automated system, the advantages from the manufacturers’ or sponsors’ point of view it is very easy to get these products to market.
The sponsor is meant to tick a box to say they hold evidence that the products work. When one checks up and looks at the scientific evidence it’s often very lacking for the claims that are made. The TGA do a limited amount of post-marketing surveillance in which they randomly look at products that have been listed. Those are the ones that they’ve been finding up to 90% violations. The only other constraint is people who put in complaints about complementary medicines and that system has got problems also.
Back to Niamh Mullen;
Also speaking on The Health Report, [a week later – MP3 here] the TGA’s National Manager, Rohan Hammett, said he was not aware that any individual had ever been subject to court action as a result of simply complaining through the usual complaints resolution processes. He also said it was normal practice for administrative proceedings to be put on hold when a higher court was considering a matter.
“Many of the complaints that actually arise about therapeutic products arise between commercial competitors. So one company may complain about another company’s advertising to seek to gain commercial advantage from that and hence there are processes in place that lay out clearly the steps for making an effective complaint. But also, where there are matters for courts to decide, they allow those courts to make those decisions and I think that’s actually an appropriate way for our legal system to operate,” Dr Hammett said.
That particular episode of The Health Report opens with a comment on TGA figures showing 9 out of 10 CAM products breach regulations in some way, with 22% unable to provide the evidence of efficacy they claimed existed. TGA national manager, Rohan Hammett sounded quite the apologist in saying;
Well Joel the data that we released on Friday is the sort of data that we’re hoping to make more available in the future to people about the compliance activities that the TGA undertakes. And these data do raise significant concerns about the current rates of compliance amongst the complementary medicine sector. I have to say though Joel, just to perhaps provide some context to that, many of the breaches in the compliance are of a relatively minor nature, people may for instance be using the wrong size font on a package of their complementary medicines in breach of a guideline that says the font has to be a certain size.
Or they may in fact have a document missing from their application. That is technically a breach but actually doesn’t affect the quality of the product in any way.
Somehow I don’t think consumers are worried that boasts of Xmg of diddlie dee providing strong bones or an aid to concentration may be written (aptly I might add) in large Comic Sans and not properly sized Ariel font. No, I’m pretty sure the 22% evidence vacuum trumps not having to fumble for ones glasses to read bollocks.
To put that in perspective, a large warehouse type chemist I visited had a CAM aisle easily 25 metres long. With shelves on both sides that’s 5 metres of products that do not have evidence backing the claims adorning their labels. In major suburban pharmacies one in five of those splendidly displayed products cannot be trusted.
There are demonstrably many benefits to Ken Harvey taking the actions he has over this unusual failure to regulate in the interests of community safety. To get a feel for the apathy and impotence of the TGA compare these two comments from different Health Report episodes. On May 16th Ken Harvey stated;
….. Why hasn’t anything happened? Well clearly I think there are two reasons. Firstly the complementary medicine industry is very reluctant to have anything happen because they are making good money doing what they’re doing. And the second problem I think is the Therapeutic Goods Administration. It’s a risk-based organisation, it can only put its limited resources where it thinks the big problems are and it would regard ripping off consumers as less of a problem than for example some prescription medicines which have really nasty side effects which can kill you.
However, not concentrating at all on the problem of complementary medicines has let the problem blow out. I might say there’s one other problem that people have perceived and that is that the TGA is 100% funded now by industry fees and again some people have unkindly suggested that if you’ve got an organisation 100% funded by industry that it may be more reluctant to take measures that would impact on industry profitability and indeed on the TGA’s own finances.
The following week this was brought to the attention of Rohan Hammett. He responded with spin;
Well Joel with respect to Dr Harvey those claims are absolute nonsense. The TGA is an organisation established by the Australian government to fulfil a public health role. I get up every day as do the other 600 employees here to improve public health in this country by making sure that people have access to safe and effective therapeutic products in a timely manner.
The fact that the industry has to pay fees to recover the cost of that regulation is a common practice across Commonwealth regulatory agencies. That removes the burden of the costs of that regulation from the tax payer. Why should the tax payer have to fund the regulatory costs for a commercial sector that is then going to generate profits from that regulation?
So just to emphasise that the TGA’s key stakeholders are clearly the Australian people and that is who we work for and our role is very much to provide public health benefits for them.
So to be clear, the TGA is most certainly 100% funded by the industry that’s failing to adhere to regulations. What Hammett thinks is nonsense is that this situation influences the capacity of the TGA to act with impartial conviction. He perhaps should have stopped there. The rest of his commentary appears to be special pleading.
In fact, the burden of proof is of course on the TGA to show that it’s present funding source is not a conflict of interest. That in my mind has not been done.