Tag Archives: TGA

Paul Offit discusses Oscillococcinum

Posted in Big Placebo, Health, Scam by

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

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

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

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

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

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

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

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

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

Paul Offit discusses Oscillococcinum

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.

SensaSlim Saga Update

Posted in Alternative "medicine" scams, Big Placebo, Health, Scam by

Last we left SensaSlim, it’s ever ambitious team of supporters was getting a dressing down on behalf of The Australian Competition and Consumer Commission securely ensconced within the Federal Court in NSW.

On July 20th, Justice Yates had, according to the ACCC website;

… 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.

SMH also ran a piece outlining the bans sought by the ACCC against these rather dishonest chaps headed up by one Peter Clarence Foster, one of the least credible exports from our nation girt by sea;

THE consumer watchdog is seeking a 20-year ban on the corporate life of serial conman Peter Foster, over his alleged misleading and deceptive conduct with the weight loss business, Sensaslim Australia.

Lengthy bans are also sought against fellow Sensaslim Spray proponents Peter Leslie O’Brien (15 years) and seven years for Adam Troy Adams. The ACCC has not sought to disqualify a former Sensaslim director, Michael Anthony Boyle from managing corporations, but is seeking a three year ban on him being involved  in businesses which have franchising characteristics. [….]

The ACCC alleged that Sensaslim made false or misleading representations about the profitability of the business to investors who bought franchises. Sensaslim had claimed that franchisees had the potential to earn $4000 a week after they invested $59,950, and there was a ”money back buy-back guarantee”.

The ACCC said there was not the potential to generate the earnings, there were no franchisees generating the projected earnings, and there was no guarantee of a refund. The ACCC also alleges false and misleading conduct by the use of testimonials of the clinical effectiveness of the spray ”when in fact no such [clinical] trial was conducted”, and the failure to disclose Mr Fosters’ involvement in the business.

The next piece of interest was published August 9th, in The Age’s Small Business section. Authorities move to dump conman’s weight-loss spray from market. At this point SensaSlim were eight days overdue in publishing the legally required warning about the action being taken against the company, on the front page of their website.

A HERBAL diet spray linked to notorious conman Peter Foster looks set to be taken off the market, six months after health authorities first received a complaint about it.

Last week, the Therapeutic Goods Administration’s complaints resolution panel called for SensaSlim to be removed from the register of therapeutic goods, which means the spray cannot be advertised or sold.

Executive officer of the panel, Judith Brimer, asked the TGA to cancel its listing after SensaSlim Australia failed to withdraw advertising that lacked approval. A spokeswoman for the TGA said it was considering the request. The panel’s call comes six months after Melbourne academic Ken Harvey first complained about the product, prompting SensaSlim Australia to launch a defamation case against him. [….]

On July 27, the ACCC won orders in the Federal Court for the company to change the front page of its website to inform visitors of the legal action against it. While the notice was required to be posted within five business days, it did not appear on the site yesterday.

Meanwhile, Dr Harvey continues to defend the defamation case launched against him by the company, which is seeking $800,000 damages. Dr Harvey said he hoped the case, which has cost him about $30,000 to date, would be dismissed this month. Supporters are raising money to cover his costs. More than 100 franchisees are believed to have paid $60,000 each to sell SensaSlim, which has sold for about $1200 a litre or $60 for a 50 millilitre bottle.

Their RTG listing is here for your perusal dear reader, the TGA Summary here. Yet, as we know there’s no joke about seasoned con men. The ACCC may get these critters off Australia’s back, reap some monies and give them some bad press overseas but in reality they’ll just keep singing in the hope of scamming the larger European market. A scroll back through some articles here gives a hint at how much energy they put into feigning disgust at having their good names tarnished and pointing to the (still) available ARTG certificate, on the Australian Weight Loss Challenge site. The “challenge” has grown from about four to thirteen participants in just over a month.

Last night a little birdie on Twitter asked if this was real. SensaSlim director files million dollar law suit against Dr. Ken Harvey. Well, yes it is true. But my, what a tantrum Peter O’Brien seems to have had;

In a writ filed in the Supreme Court of Queensland, Mr O’ Brien claimed that Dr Harvey had no grounds for calling for SensaSlim to be withdrawn from sale given that there are no safety issues over it.

“The TGA authorised SensaSlim for sale on the basis of its unique formulation and active ingredients,” Mr O’Brien said. “It is issued with a TGA Listing number approving it for sale  as a weight loss aid.”

The Sensaslim Solution formulation combines five of the most thoroughly researched weight loss ingredients over the past 30 years.   It uses all natural active components extracted from rare fruits and minerals, which together, act to stimulate the body’s natural fat burning processes, reduce cravings of sugar and carbohydrates, maintain energy metabolism, inhibit fat synthesis, increase fat oxidation, encourage lean muscle mass and decrease body weight.

Sensaslim also contains a natural analgesic which acts to desensitise taste receptors on the tongue.

“For any  product to be withdrawn from the market it has to be because of a safety issue, and Dr Harvey knew that,” Mr O’Brien said.

“He was attempting to create headlines and be mischievous and we are calling him to account.” he said. “He is a man pursuing a personal vendetta and is followed by a small group of people who pride themselves on being sceptics and cynics’. “It is one thing for him to disagree with our advertising, but it is completely outrageous to call for a product to be withdrawn from sale simply because he is against all things natural,”

Mr O’Brien said Dr Harvey was a “chronic complainer on the complementary healthcare industry who becomes louder and more vengeful and spiteful as he realises he becomes less relevant.”

“What Dr Harvey can’t tolerate is the growth in the natural nutrition and healthcare industries, at the cost of big pharmaceuticals,” Mr O’Brien said. […..]

Wait on, wait on. What sort of news agency is going to spruik a product and run a personal attack under a seemingly routine type headline? No comment from Dr. Harvey either, which is tacky given he consults and lectures on the various conflicts of interest that do plague pharmaceutical companies. It is entirely correct and proper for Dr. Harvey to call sham products to account as well as highlight the contributing flaws in Australian regulation. This does not equate to a conflict of interest born of bias toward pharmaceuticals.

Dr. Harvey is a man of impressive integrity who has worked in Australia and overseas to ensure consumers are able to access the drugs they need. He’s worked with local S.E. Asian NGO’s helping to lobby their own governments to introduce policies that enable the sort of access we take for granted as well as tackling the horrific reality of counterfeit medication.

This also had a familiar ring to it. Much like the earlier articles about the wonder spray, the expansive jockey story and the Thank you for suing us article written by a certain Peter O’Brien that had me corresponding with an editor from international.to. Or the claims of presenting these stunning clinical trial results to scientists at the 18th European Conference on Obesity in Turkey. I’d been reliably informed they were nowhere to be seen in Turkey. As I wrote back on July 6th.

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.

However the editor initially responded citing he’d never heard the claims I was making. Despite links provided about the missing evidence, complaints and accusations from Dr. Capehorn. Then when the proverbial hit the fan I received on June 16th;

Thanks for taking the time to provide more details…

Our role is to be objective and your point of view is valuable..  we will not take sides….

What was once a public interest story has certainly grown into something more now that there are court cases, TV segments and reports from customers ( good and bad )..

We will get back to you..  and I would need your permission to enable me to pass on your email to a reporter to pursue ?

All the best

But I never did hear back and don’t really see why I should have. That’s their call. As I pointed out in the prior article, international.to is owned by RogersDIGITAL a marketing company based in Australia. They have had a website overhaul since I last described the pseudo-psychological marketing lingo’ on their site. Presently they have a rather prominent: We publish news, press releases and advertising on websites owned and operated by our media group.

Which might well explain the far more honest footnote to Peter O’Brien’s latest rant on international.to

Editor Note.. This press release was created and submitted by Mr O’Brien. It is not news. It is not our editorial content . IT IS A PRESS RELEASE. It is for information purposes only. http://www.International.to publishes verified press releases upon application to http://www.NewsMediaReleases.com. As with any press release it is marked as such and is not intended as a report or coverage of an event or occurrence.

A press release, news release, media release, press statement or video release is a written or recorded communication directed at members of the news media for the purpose of announcing something ostensibly newsworthy. [….]

So, we can really only wait and see how much of this is a serious endeavour and how much is to maintain the ongoing song pitched to gullible buyers and presumably very angry franchisees.

In short is it just another last ditch push to make money from the sinking ship SensaSlim by coating the hull in fake credibility?

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.