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.
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.
When Today Tonight reported on jokey Wanderson D’Avila suing the makers of a seemingly gimmicky weight loss spray for riding under weight, viewers were reassured that lawyers for both sides claimed it “wasn’t a publicity stunt”.
“It couldn’t be better publicity for a spray that’s made the headlines for all the right reasons”, grinned reporter Damien Hansen. How fast things change with SensaSlim now making the headlines for all the wrong reasons.
On June 1st, A Current Affair reported on “the slimming spray swindle” with investors claiming that a mere fraction of promised marketing and advertising actually eventuated. This left them unable to sell the product and may well explain why genuine SensaSlim is available on eBay for as little as $26:00 plus $7:70 postage. This is well under the $69:95 plus Air freight costs that SensaSlim are seeking on their website and markedly less than retail.
“They took us absolutely hook, line and sinker”, said advertising consultant Jack Singleton. He is owed $20,000 by SensaSlim – money he considers lost. What also stood out was the theme now dogging SensaSlim from Europe to Australia. That the much touted evidence is nowhere to be seen. As such the claims of research, subject numbers and results are simply hearsay. Effectively a slogan. As ACA rolled on SensaSlim credibility was challenged further.
Three of SensaSlim’s five ingredients are the same as SlimMist – one of the weight loss scams of once jailed Aussie fraudster and conman, Peter Foster. Going after SensaSlim further ACA noted that their head office is in Switzerland as was SlimMist and their use of twins in promotion was also a feature of one of Foster’s illegal dalliances. None of this is to be construed as conclusive evidence of a scam. It may all quite likely be coincidence. However, the absence of SensaSlim Australia’s Managing Director, Peter O’Brien, didn’t help “the world’s number one weight loss product”.
Indeed, the presence of Peter O’Brien hasn’t done the SensaSlim reputation any good either. As you can read in the previous post republished with permission from Dr. Ken Harvey, he is being sued for defamation after submitting a complaint about SensaSlim’s grandiose yet unverifiable promotional claims. This complaint was submitted to the Complaints Resolution Panel (CRP), the Therapeutic Goods Administration (TGA) and the Australian Competition and Consumer Commission (ACCC). These bodies deal with complaints about the relevant Advertising Code, Goods Act and Competition and Consumer Goods Act respectively.
Dr. Harvey is one of seven complainants. ACA reporter Justin Armsden sought to speak with two complainants both of whom are being sued for defamation by SensaSlim. As such they are unable to comment. However Armsden did some “digging” and presented two affidavits submitted to the NSW Supreme Court by Managing Director Peter O’Brien – the plaintiff. Here’s where things get interesting.
The witness to both affidavits is listed as Richard Scott Cooper and they are apparently signed by him. A cursory glance at an overlay of both signatures shows they are not the same.
Furthermore his capacity as witness is listed as “solicitor”. Yet Cooper was barred from practicing in NSW in 1990. There is not another Richard Cooper, Solicitor, registered in Australia. Cooper did some consultancy work for SensaSlim leaving the country in February this year. The documents were filed in April and May this year. Richard Cooper confirms that one signature is “definitely” not his. It is unclear how valid the other is.
We’ll get back to ACA and meet the erstwhile (and rather angry) Medical Research Director of SensaSlim, Dr Matthew Capehorn in due time. First, let’s review the Today Tonight segment involving jockey Wanderson D’Avila which, thanks again to Peter O’Brien, has made the news just recently. On June 5th O’Brien published an advertisement in The Sunday Advertiser.
Headed “Thank you for suing us” it has been positively covered on news site Australia.to. The most recent article on June 5th was written by one… Peter O’Brien. I have no idea if there is any relation, but the article is published under the sites “Your Say” URL. Both the advertisement and the article may be a subliminal riposte to the ACA revelations. The ad’ is self explanatory, whilst the article broaches the claim that the jockey of Black Caviar uses SensaSlim as his “secret weapon”, now with the added benefit of calming nerves.
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 O’Brien article claims the advertisement is a risky strategy that has “lawyers scratching their heads”. I disagree. The chances of Wanderson D’Avila being able to prove a causal relationship between losing an extra 800 grams and the correlating use of an as yet unproven agent are highly remote. However. Peter O’Brien – either one – may need to be aware that the advertisement lacks a Complimentary Healthcare Council number. According to both the CHC and the ACCC such accreditation aims to provide,
“reliable and quality advice and information to our members, government, key stakeholders, the media and consumers.”
There’s absolutely no ambiguity there. SensaSlim appear not to be members and not accountable to CHC obligations.
In closing, we can for now, be confident of one further black mark against SensaSlim.
Today Tonight on Wanderson D’Avila
Dr. Ken Harvey is an adjunct senior lecturer in the School of Public Health, La Trobe University, well known for his ethical stance against unproven and grandiose claims that often accompany alternative medicines and bizarre therapies. In fact on December 6th last year “Pharma in Focus” revealed that “up to 90% of complementary medicines reviewed by the TGA do not comply with regulatory requirements”. He has also carved a niche for himself through educating skeptics and advocates of evidence based medicine as to what are arguably shortfalls of current regulatory guidelines.
On March 18, 2011 I submitted my first complaint about the promotion of SensaSlim to appropriate authorities; the Complaint Resolution Panel (CRP) who hear complaints about alleged breaches of the Therapeutic Goods Advertising Code 2007, the Therapeutic Goods Administration (TGA), who administer the Therapeutic Goods Act 1989 and the Australian Competition and Consumer Commission (ACCC) who administer the Competition and Consumer Act 2010.
This complaint, and at least six others sent to the CRP by other people, alleged that the promotion of SensaSlim on the Internet, TV and in shops breached numerous sections of the above regulations.
My initial complaint had been worked up with the help of several pharmacists. In addition, specific promotion was directed at pharmacists to encourage them to stock and sell this product. Thus, on March 31, 2011 AusPharm published a brief but accurate account of the complaint detailing concerns about the claims made.
Later that day both AusPharm and I received a letter from the SensaSlim Australia Pty. Ltd, titled, “Notice of Intention to Commence Proceedings”. This, and subsequent communications from SensaSlim Australia Pty Ltd, threatened legal action against AusPharm and myself; initially aimed at removing the material on AusPharm, but subsequently (after AusPharm complied) threatening both my university and me with legal action unless my complaint was withdrawn.
My university could not be joined in the threatened legal action because the conditions of my Adjunct appointment were clear,
“During the period of this appointment you will receive no remuneration from La Trobe University. Nothing in this offer creates or implies an employment relationship between you and the University”.
I declined to withdraw my complaint. Whereupon, on April 19, 2011 a “Statement of claim” was issued against me in the NSW Supreme Court alleging that my complaint was defamatory and claiming “general and punitive damages for libel in the sum of $800,000.00”, plus costs.
This action had the effect of stopping the CRP from hearing all complaints about SensaSlim due to Therapeutic Goods Regulations 1990 42ZCAJ (2),
“If, after a complaint has been made to the Panel, a proceeding begins in a court about the subject matter of the complaint, the Panel cannot deal with the complaint until the proceeding is finally disposed of”.
I have now learnt that the CRP did make a determination about the promotion of SensaSlim in response to an anonymous complaint submitted in late January, 2011. The CRP agreed that the SensaSlim promotion breached multiple provisions of the Therapeutic Goods Advertising Code. The determination was posted on http://www.tgacrp.com.au on March 30, 2011 for less than one hour before it was taken down in response to a representation from SensaSlim Australia Pty Ltd. However, this determination was downloaded during this time and can be found here.
I have also been made aware of SensaSlim Newsletter No. 42 from Adam T. Adams which states in relation to the above,
“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”.
“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 [Complementary HealthCare Council] 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.”
My own lawyers filed a notice of motion in the NSW Supreme Court seeking orders to have the SensaSlim claim struck out and the proceedings dismissed because they disclose no reasonable cause for the action. In addition, my lawyers asked for an order that the plaintiff pay the defendants’ costs. These matters are now before the Court.
Meanwhile, the issues raised have been ventilated by the ABC “Health Report“, the “Croaky Health blog“, the Australian Skeptics and, last night, Channel SEVEN’s “todaytonight” and Channel NINE’s, “A Current Affair“.
The Medical Research Director of SensaSlim, Dr Matthew Capehorn, has now resigned. He stated,
“Despite requests, I have never seen evidence of the original clinical trial, and it has never been published in a peer reviewed medical journal. Therefore, the White Paper holds no scientific relevance, until that original trial is published”. “It has not been published at the European Congress of Obesity in Istanbul as suggested recently” and “video interviews were put on the SensaSlim website, without my approval or opportunity to review the content”.
As of today, SensaSlim is still listed on the TGA’s Australian Register of Therapeutic Goods (no: 1760039) which allows it to continue to be legally sold, it’s still actively promoted on numerous Australian Internet sites and Dr Capehorn is still featured spruiking the product.
There are a number of lessons that need to be drawn from this case study.
First, one might have hoped that university trained health professionals (Dr Capehorn and numerous Australian pharmacists) would have been more discerning in their assessment of the evidence for this ‘dietary aid’; but perhaps the return on investment offered was more compelling?
Second, one might have expected that the TGA would have responded to previous calls to look more rigorously at complementary medicines before they are listed on the Australian Register of Therapeutic Goods (ARTG).
Failing that, on receipt of well documented complaints, surely the TGA could have rapidly removed this product from the ARTG which would have made continued sales illegal? Ironically, the TGA have yet to respond to queries and complaints about this product that were sent to them direct. Perhaps the Pan Pharmaceutical class action has made the TGA more cautious about taking such action?
Finally, we are left with the ACCC, whom I understand have been investigating this matter for some time but are not yet ready to inform us of their findings.
It seems a sad reflection on the regulators that we are dependent upon complainants, investigative journalists, blogs, skeptics and pharmacy web sites to get the message out.
Written by Dr. Ken Harvey June 5th, 2011 and initially published on Medreach. Republished here with permission.
You can help Dr. Ken Harvey navigate this challenge by emailing Australian Skeptics, who have begun a programme to assist Dr. Harvey meet the financial burden. Simply email supportken [at] skeptics [dot] com [dot] au with a phone number and your pledge.
There is also a Facebook page run by supporters of Ken Harvey where you can find out more on this topic and have a look at the unique management of SensaSlim members who ask probing questions on Facebook.