Category Archives: General

Oh, Oh, Oh, O’Brien of SensaSlim gives us more hanky panky

Posted in Big Placebo, General, Health, Scam by

Peter O’Brien, SensaSlim director and rumoured buddy of Peter Foster seems unable to break the back of his attention seeking behaviour.

Peter O'Brien

Firstly however, the good news is that the initial defamation case brought by SensaSlim for $800,000 against Ken Harvey was dismissed on Monday. Harvey was awarded costs but with a mere $280,000 in the SensaSlim kitty, he is unlikely to see any returns. There is quite a queue for payments from SensaSlim who misled investors on return potential. It turned out to be zero.

Five days ago we had a SensaSlim saga update which included reference to the press release-masquerading-as-news-until-you-read-the-disclaimer, of O’Brien’s intent to sue Ken Harvey for $1 million dollars. Like all the other articles O’Brien authored on international.to it is now a mere 404 page – and I’ll get onto that. There’s a section in the above post along with most of the disclaimer. It was a kind of desperate sales pitch, personal attack on Harvey and attempt to defend SensaSlim as a genuine product because TGA regulations are geared to prevent harm, not provide efficacy.

He’s right on the last point and the very fact this nonsense continues is a black mark against the “self certification” process of the TGA. This was raised during the recent transparency review of the TGA which you can read and catch up on here. With luck O’Brien has done Aussies a favour by exploiting this appalling hole in our supposed regulatory body for therapeutic goods. Frozen assets, links to crime figures, non existent research from non existent institutes, false claims about a dud product, duped investors, defamed obesity experts, fraud, [all earning ACCC charges of misleading and deceptive conduct under Trade Practices Act 1974], defamation cases dismissed, contempt of court (I’ll get to that also) and the product still remains listed with the TGA.

O’Brien need only insist that the ingredients have been proven and used in weight loss products (and he is), point to the TGA listing (and he is) and feign unfair criticism thus defamation on Dr. Harvey’s part (and he is) to keep making money from a useless product that was a scam from day one. The Australian reported on Tuesday that he is seeking $1.75 million in damages and costs. Check The Australian Skeptics for information on donations to help Ken Harvey or head on over directly to the designated PayPal account.

A TGA representative confirmed the SensaSlim listing as it has “no unsafe products”, and in a typical bureaucratic promise of a glacially paced plan, proffered;

However, the TGA is considering a number of matters regarding the listing of Sensaslim Solution on the Australian Register of Therapeutic goods.

Nonsense. Until the suit against Dr. Harvey (which is another S.L.A.P.P.) is finalised the Complaints Resolution Panel can do nothing. O’Brien continues to profit with the TGA’s blessing. On this point there is a brand new Get Up campaign launched by the founder of The Celestial Teapot skeptic group. Calling on state and federal governments to provide consumer protection from quacks and health scams. It’s a compelling argument and thankfully includes calling to account that Victorian government bastion of all things scam-worthy and useless The Better Health Channel – which tax payers fund. Other states have similar insults.

Back to O’Brien. Yesterday it emerged that the ACCC was launching contempt of court proceedings against Peter O’Brien. It was postulated he has sent more of those ridiculous and at times thuggish “newsletters” he and Adam Troy Adams favoured to franchisees, this time warning that cooperating with the ACCC might be financially costly. Yes you read that correctly. Cooperating with the ACCC to get back money SensaSlim scammed from them might be costly. However we now know the ACCC has been granted an injunction stopping this latest rather ambitious attempt to still scam his already hurting victims. O’Briens cavalry seem to have gotten lost.

Some welcome clarification emerged also. I’ve written a couple of times about some correspondence with an editor from international.to, which is owned by RogersDIGITAL marketing. I’d complained about the content of articles written by Peter O’Brien and glowing comments published beneath. They were eventually deleted, and correspondence ceased which as I said was fine by me. It was their call to resume any exchange. I’d argued elsewhere on the deletions, “…I doubt due to my objections, but rather their own integrity given the balance of developments”.

So a refreshing development came to pass. The “Greg” singing off emails is Greg Rogers from RogersDIGITAL, who was responsible for the impossible to miss disclaimer under O’Brien’s last piece. Not only was O’Brien none to happy with this piece of honesty, but had long been advising Rogers to delete email correspondence. Fairfax write;

Simon White, SC, for the commission, said Greg Rogers, of the online news and classified websites business Rogers Digital, had contacted the commission, concerned at emails from Mr O’Brien telling him he should delete every email after reading it, and warning of the confidential nature of business relations.

”If at any time in the future [he was questioned] you can honestly say every email was erased,” one email said.

Another said he should ”never admit you are paid for a story”.

If Mr Rogers agreed that he would delete all correspondence with himself, SensaSlim and another director, Adam Adams, we can ”move forward and do a lot of business”, Mr O’Brien wrote.

He said if Mr Rogers was interviewed by the ACCC voluntarily then ”you are doing so in violation of confidentiality, both real and implied”. ”I ask you immediately erase all communication.” [….]

“Greg, I have been reading very hostile comments on sites supporting Ken Harvey,” Mr O’Brien wrote. He queried a disclaimer on the story headlined ”Sensaslim director files million dollar law suit against Dr Ken Harvey” [sic] on a Rogers Digital website.

Oh my. All in all things aren’t presently looking up for Peter O’Brien. Although according to one report he has been listed as a creditor by SensaSlim administrators.

One awaits further developments.

Lest We Forget (Julian Burnside)

Posted in General, Health, Human Rights by

So here we are: Australia in 2011.  For convenience we have forgotten our origins, our good fortune, our blindness and our selfishness.  In place of memory we have constructed a national myth of a generous, welcoming country, a land of new arrivals where everyone gets a fair go; a myth in which vanity fills the emptiness where the truth was forgotten.

It is one of the most resonant phrases in our national mythology.  “Lest we forget”.  We say it, or think it, on 11th November each year and on Anzac day.

But forgetting lies at the heart of this country.  We have constructed a myth about ourselves which cannot survive unless we forget a number of painful truths.  We draw a veil of comforting amnesia over anything which contradicts our self-image.

Since John Howard saw the votes to be had by appropriating some of Pauline Hanson’s more repellent policy ideas, boat people have been tagged “illegals”.  Howard won the 2001 election on it; Abbott persists in it.  Gillard and Bowen go along with it like sheep because they have still not absorbed their own rhetoric.

We forget that boat people who come here to ask for protection are not illegal in any sense – they are exercising the right which every person has in international law to seek asylum in any country they can reach.

We forget that the first white settlers in this country were true illegals: sent here by English courts for a range of criminal offences, and the soldiers sent to guard them, and the administrators who, following London’s instructions, stole the country from its original inhabitants who, if possession is nine points of the law, had the backing of 30,000 years of law to justify calling the white invaders “illegals”.

And we forget, too, the line in the second verse of our national anthem: words that might fairly be understood as reflecting the simple truth recognised by the white settlers: for those who came across the sea there are truly boundless plains to share.  For refugees locked away on Christmas Island this must throw light on the frontier which delusion shares with hypocrisy.

And how many of us pause to remember how different it was for 85,000 Vietnamese boat people 30 years ago? They were resettled here swiftly and without fuss, thanks to the simple human decency which Malcolm Fraser and Ian Macphee showed, and which Abbott and Gillard so conspicuously lack.  We forget how hideously we scarred Vietnam; how we showered them with Agent Orange and trashed their villages and disfigured their people.  Just as we forget the effects of our collaboration in Iraq.  But if we knew back then why people flee the land of their birth, we seem to have forgotten it now.

When today’s refugees wash up on our shores, Abbott and Gillard, Bowen and Morrison all speak with concern about the boat people who die in their attempt to get to safety, but their concern is utterly false.  Instead of attacking the refugees directly, which is their real purpose, they attack the people smugglers instead.  Because, aren’t people smugglers the worst people imaginable?   They forget that Oskar Schindler was a people smuggler, and so was Dietrich Bonhoeffer.  And so was Gustav Schroeder, captain of the ill-fated MS St Louis which left Hamburg in May 1939 with a cargo of 900 Jews looking for help.  He tried every trick in the book to land them somewhere safe, but was pushed away.  He ended up putting them ashore again in Europe, and more than half of them perished in concentration camps.  Abbott and Gillard forget that Captain Schroeder was a people smuggler.

They forget too that, without the help of people smugglers, refugees are left to face persecution or death at the hands of whatever tyranny threatens them.  Let Gillard or Abbott say publicly that, in the same circumstances, they would not use a people smuggler if they had to.

Read more.

© Julian Burnside

Transparency review of the TGA

Posted in Big Placebo, General, Health, Scam by

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.