Alternative Labelling: “Untested”, “Unproven”, or Just Plain “Bullshit”?

It seems today’s dawn could herald in the TGA making a move to be pro-active in ensuring consumers are informed about the products they are purchasing.

Under “active consideration” is a new disclaimer that will be required to be used on at least, “alternative” remedies.

Contrary to popular belief, the TGA does not assess the efficacy of products that are “AUST L” labeled, in fact, “Sponsors” – That is, Distributors or Manufacturers are only required to declare they “hold evidence”.

They do not need to show it to anyone.

Further, there is a legal loop-hole that allows many products to be sold without being listed on the Therapeutic Goods Register. “Sponsors”, in this case, includes advertises and private practitioners, such as Homeopaths and “Traditional Chinese Medicine” practitioners may produce and sell products simply by declaring “Traditional Use” – again, no evidence required.

Marketing has played a huge part in encouraging Australians to buy unproven products; claims like “It’s Natural” spring to mind. It has been a tag-line that’s been exploited because of its “feel good” ring to it. Natural does NOT always mean good, and it certainly does not mean it works.

There is of course then, then use of “Weasel words”, subtle wording that make it appear that they make a claim, when legally, they do not. This is a popular way many “Alt-Med” advertisers get away with pushing nonsense to the public.

An article in today’s The Age (Push to label most alternative medicines as ‘untested’) states:

The TGA development follows the release this week of a report by the Australian National Audit Office which revealed surveys showing the agency had failed for several years to counter effectively widespread use of deceptive and misleading advertising of complementary and alternative medicines.

In 2003, a survey found that about 52% of Australian Households use some form or alternative medicines, products or services regularly; There are over 10,000 “Alternative” and “Complementary” products on the register, and almost none of them scrutinized for efficacy.

It’s not surprising then, that an Industry that was worth $800m in 2003 and is now estimated to be worth over $2 Billion Annually is strongly opposed to the new labels. An enforced “Untested” label is a great way of encouraging people making claims about their products to back it up with evidence.

Each year there is a massive amount of money being literally pissed away as more and more “Alternative” remedies find their way on to shelves (like Coles Supermarkets) by what seems to be an endless sea of bullshit claims.

This proposal is a welcomed potential win for Reason.

Skeptics in (or from) Australia: Contact your MP

Something has got to give.

I’m asking that we each take 15-30 minutes to put together a quick e-mail about Homoeopathy and send it to our local MPs – You can look up your local MP via the ABC’s “Find Your Local MP” webpage.

I recommend outlining the absurdity of the therapy, as some MPs may not be aware of Homoeopathy or may have been misinformed about what it is, what it contains, or the principles underpinning it.

It would be great time to include the fact that the Australian National Health and Medical Research Council (NHMRC) has drawn up a draft statement about Homoeopathy stating:

“it is unethical for health practitioners to treat patients using homeopathy, for the reason that homeopathy – as a medicine or procedure – has been shown not to be efficacious.”

I recommend outlining these key points:

  1. The proposed mechanism is scientifically implausible and unsubstantiated.
  2. The claimed efficacy is not substantiated by any robust study of homoeopathy.
  3. Systematic Reviews of Systematic Reviews of the evidence for Homoeopathy consistently find it is a product with no effect beyond placebo.

You may wish to bring up issues surrounding homoeopathy such as the harm that can be caused by turning a blind eye to non-efficacious treatments for conditions with potentially serious consequences. For instance, ailments like insomnia and snoring can lead to anxiety and depression disorders, high blood pressure, diabetes, heart disease and stroke. Both of these can be treated with science-based medicine, yet it is common to find Homoeopathic Remedies for them – and now, even in supermarkets where staff are ill-equipped to inform customers as to what Homoeopathy is.

It may be worth pointing out that:

  • “positive” studies for Homoeopathy almost always comes from within the profession and are generally surveys of how people “feel” rather than actual trials of a treatment;
  • it is common for homoeopaths to cite literature in defence of Homoeopathy, however when scrutinized, they are investigations of poor quality or do not support homoeopathic principles at all;
  • these “positive” studies are treated counter to how science-based medicines are scrutinized; instead of being peer-reviewed by professionals who seek to uncover flaws in testing methodology to encourage best-practice, they are generally published in niche pseudo-journals (or books) with little to no professional credibility.

You may also wish to point out the success of the recent world-wide 1023 campaign launched by the Merseyside Skeptics Society to bring attention to Homoeopathy, and the 2010 conclusion by the Science and Technology Committee (From the UK House of Commons) that the evidence provided by homoeopaths did not support their own claims.

If you are open to it, offer your MP the opportunity to contact you for more information. Do not feel you *have* to answer questions you do not know the answer to; if you feel overwhelmed ask your MP to write an e-mail with their concerns so that you may address them appropriately. If needed, get in contact with someone who you think CAN give them the information they are looking for.

You SHOULD include what kind of OUTCOME you would like to see from your MP, this may be by asking your MP to:

  • Raise the issue at a Party Meeting,
  • Raise the issue with the relevant Minister, Shadow Minister or Portfolio Holder,
  • Discuss the issue with their colleagues, or
  • Request a change in party policy.

You may want to urge your MP to Move a Motion in parliament along the lines of:

National Health Care should be a service that provides only science-based treatments; taxpayers should not be required to pay for, or subsidise the costs of unproven or dis-proven therapies.

Who could reasonably argue against that?

You may decide to be specific, perhaps about the Therapeutic Goods Administration, which despite its comprehensive review will continue to accept products for AUST L listing under a flawed self-assessment programme even though – according to the TGA’s own data – 9 out of 10 products  don’t do what they say they can. [this is a lengthy subject]

And lastly, I recommend inviting your local MP to a local Skeptics in the Pub/Cafe/Meet-up/Event where they can engage in discussions regarding critical thinking, education, reason, and science. This can help in strengthening a relationship to work closer in skeptical activism or outreach campaigns in the future.

 

If you have some time after that, check out:
FISHBARREL – The Quick way to report Quacks!

FishBarrel Australia

Earlier this week Xibis, owned by Simon Perry of the “Adventures in non-sense” blog released a Browser Plug-in for Chrome that makes reporting pseudo-scientific “therapeutic” products to the UK’s Advertising Standards Authority exceptionally easy.

“All development was done with the support and collaboration of my web software development company Xibis. The team have helped enormously with the technical development and have provided the server infrastructure. Xibis are specialists in building these sorts of web based productivity systems.” writes Simon.

The release was quickly picked up by The Lay Scientist and published by The Guardian: FishBarrel: New browser plugin lets you bust quacks in seconds.

For everyday consumers and the general public, the Therapeutic Goods Administration (TGA) does not require you to list out the particular legislation that an advertisement or website breaches (unless you are involved in the industry) — But, they say it helps.

Simon writes about FishBarrel: “FishBarrel also tracks all text complained about in a central database. When you turn on FishBarrel, any text complained about by other users is automatically highlighted.”

This will of course prevent you from submitting duplicate complaints to the TGA or ACCC – Awesome!

Effective, AND efficient! I love productivity!

Tonight, I mentioned some names over Twitter to see if we here in Australia could get the same thing going, knowing full well this would ultimately render Report a Rort virtually obsolete.

To my surprise, Simon responded within minutes offering to “hook it in” to FishBarrel to complain to the relevant regulatory bodies — making FishBarrel an Internationally Effective tool in combating Pseudo-science medical claims!

At this stage, only Xibis knows when this will happen – but I’m very excited about it!

Update: Simon has noted he is also incorporating American Regulators, the FTC and FDA and may pursue adding compatibility with New Zealand’s regulatory bodies too!

Therapeutic Merry-Go-Round

Last week the Therapeutic Goods Administration (TGA) knocked back my submission to them about the EKEN PowerBand. (See: http://reportarort.wordpress.com/2011/04/10/submitted-eken-powerband/)

“Thank you for your continued interest in this matter.

We did refer the matter to the TGA (as I advised you previously). The power bands have been assessed by the TGA not to be therapeutic goods. Unless products such as these make claims for therapeutic use, they are not considered by the Complaints Resolution Panel to be within its jurisdiction. For this reason, this complaint will be referred to the ACCC. I will ask the ACCC to keep you informed.”

Having had waited a week with no response so far, I looked in to why PowerBalance was a different story.

It was, and wasn’t.

The TGA said the same thing to Robert Smallwood, who claimed to have submitted a complaint to them about PowerBalance: “Not a therapeutic device”.

Robert wrote to the TGA as part of their Transparency Review: http://www.tga.gov.au/pdf/consult/tga-transparency-review-submission-1012-robert-smallwood.pdf

Robert makes a point that is well-known, especially to those selling bogus products: The TGA fails to enforce its findings against everyone, including “complimentary” and “alternative” practitioners.

I suspect it may be the lack of information on EKEN’s website; PowerBalance were quite specific in their website, but EKEN hides behind the ignorance of its’ customers – preferring to allow them to guess what they do and how they work, rather than to explicitly explain the mechanism.

Subsequently, Dr. Ken Harvey was able to compel the TGA to investigate the claims by PowerBalance, and as a result the complaint was found generally found to be justified.

It was those same justified complaints by Ken Harvey that formed the basis for my own complaint to the TGA about EKEN’s PowerBand. Same claims of Flexibility, Endurance, Balance, and Strength – all bullshit.

So, it’s intriguing to know why the TGA followed through against PowerBalance, but is seemingly trying to keep away from prosecuting EKEN for their therapeutic claims.

So, since I’m waiting for a response from the ACCC, I might take a look at Phiten Australia till then.

 

By the way — PlaceboBand. Cheaper, and does what it says.
You can go here to buy one for only $2.00 + P&H

 

SkepticBros PlaceboBand

SkepticBros PlaceboBand

What’s the problem, TGA?

Earlier this week I submitted a complaint about the EKEN PowerBand, a product that is reported to give its users increased Endurance, Balance, Strength, and Flexibility.

To my surprise, I got a reply from the TGACRP that essentially meant that they had no control over them – because the product was not on the Australian Register of Therapeutic Goods.

Oddly enough, they were able to take action against PowerBalance late last year.
So, I responded with some clarification of what was in my complaint (as it appeared the referenced legislation was not investigated sufficiently).

Thank you for your response.

I refer to your E-Mail response to my complaint about the EKEN PowerBand, and the finding that because the product is not on the ARTG it does not fall under the jurisdiction of the CRP.

I refer back to the legislation specified within the complaint, Section 42DL(1)(g) of the Act that prohibits the publications of advertisements for therapeutic goods that are not included in the register.

Therapeutic Goods Act 1989 – Sect 42DL
(1) A person must not publish or broadcast an advertisement about therapeutic goods:
(g) that are not entered in the Register; or

Therefore, according to the Therapeutic Goods Act, does indeed fall within the jurisdiction of the TGACRP.

If you feel I am incorrect in my interpretation of the 42DL(1)(g), please advise on what grounds the TGACRP acknowledged the legitimacy of the complaint about PowerBalance (a similar product in design, claimed mechanism, and claimed benefit) for my reference.

For clear precedence of this legislation in practice, I refer to the recent findings of the TGACRP:
http://www.tgacrp.com.au/index.cfm?pageID=13&special=complaint_single&complaintID=1650

32. Section 42DL(1)(g) of the Act prohibits the publication of advertisements for therapeutic goods that are not included in the Register. The advertiser acknowledged that the wrist band product is not included in the Register and the Panel was of the view that the product was promoted for therapeutic use. The advertisements therefore breached section 42DL(1)(g) of the Act and the Panel found this aspect of the complaint justified.

Please advise me on the outcome of any further inquiry you may make.

Sincerely,

Bayani Mills

So, hopefully this time we’ll make some headway on having this product removed.

I eagerly await.

PulsePharmacy Follow-up

While admittedly quite late, I finally got around to writing up and sending off my response to the reply from PulsePharmacy’s Senior Buyer regarding Eken PowerBands, and packaged it up along with other nonsense products they are selling through a recent news article featuring CHOICE

My initial E-Mail sent to PulsePharmacy, and their reply can be found here.

Thanks for your response regarding Pulse Pharmacy’s continued support for Eken PowerBands.

Eken PowerBands are not TGA R (Registered), rather they are TGA L (Listed) and as such Eken does not need to meet any kind of Standard to be listed by the TGA that would lend ANY kind of credence to their product — Unfortunately, they must only *claim* they have evidence. There is NO requirement to present the evidence to scrutiny by the TGA.

Interesting though that you said they meet the TGA requirements; perhaps they have supplied you with the scientific evidence they will provide to the TGA when they are investigated?

There is no good supporting evidence for the claimed mechanism of Eken’s PowerBands, and the continued sale of them, as is endorsed by Pulse Pharmacy, poses serious questions regarding Pulse Pharmacy’s ethical commitment to it’s consumers; even more so when some of the “tests” used in videos to support their claims require deliberate fraud to occur.

Refer: http://revision3.com/scamschool/placebobands

Surely, you understand that as you operate under the prestige of the title “Pharmacy”, consumers — and more to the point, the sick, look to Pharmacies for evidence based treatments for whatever their ailement may be.

To say this is a once-off lapse in product research would be disingenuous, as in the same store there were magnetic bracelets being sold as “Wellness Bracelets” — again, no evidence to support the implication that the bracelet would encourage this vague “Wellness”. But, for consumers, perhaps those that are ignorant, gullible, or desperate; they will buy those products in the sincere belief that their lives may be improved.

Perhaps you’ve seen the recent article:

Pharmacies selling ‘quack’ health products, CHOICE investigation reveals
Read more: http://www.news.com.au/breaking-news/pharmacies-selling-quack-health-products-choice-investigation-reveals/story-e6frfku0-1226018381502#ixzz1GQRnn4Hb

I strongly encourage Pulse Pharmacy to discontinue the sale of, and distance itself from the advocacy of Eken’s PowerBands and fraudulent claims. Pharmacies should get back to being places that only sell evidenced-based medicine; not a gift shop selling people “what they want to buy”.

I would suggest that a serious look your entire range of products would be prudent; perhaps it would provide shelf-space for actual health products and may prevent legal action under the newly released Australian Consumer Laws. (ACL).

Regards,
Bayani Mills

Pulse Pharmacy Replies re: Eken PowerBands

In reply to a recent E-Mail, Pulse Pharmacy (Australia) got back to me the other day with the following:

Hi Bayani

We are very aware of the bad press surrounding the Powerbalance bands and have certainly been monitoring the situation closely. We have a close relationship with Eken powerbands and are aware they have also been monitored closely by the ACCC but have been assured that their product is not breaching any standards. They have also met all TGA requirements.

We appreciate your feedback and we will continue to monitor this category closely.

Pulse Pharmacy, in addition to selling EKEN PowerBands within their stores, sells these Bands via their website. (http://www.pulsepharmacy.com.au/Product/Eken-Powerband-Blue–and–White-Extra-Small.aspx)

The 4 nFIT holograms result in a higher potency product which the wearer can instantly recognise.
•    Strength
•    Balance
•    Flexibility
•    Endurance
Wearers have reported increased core strength, balance, flexibility and endurance. See Testimonials for some great reports!

EKEN’s website (http://www.ekenpowerbands.com.au/specials/) quotes similar “hologram technology” to the recently reprimanded PowerBalance, stating:

nFIT (nano Frequency Infusion Technology) is our proprietary system for programming the EKEN holograms. This method ensures that each hologram receives a highly concentrated dose of the frequencies required to produce the highest quality power band on the market.

Personally, I’m really disappointed in the reply from Pulse Pharmacy; it’s a laissez-faire response to a situation where Pulse Pharmacy should be active in ensuring their products supply their consumers with effective treatments; and as a Senior Buyer – this is where I think their focus should be.

Pulse Pharmacy is seemingly more like a retail outlet with a licence to prescribe evidence-based medicines. I’m not even sure if their spin on “bad press” regarding PowerBalance is out of arrogance or ignorance.

Pulse Pharmacy stated that because they’ve been “assured” Ekan are not breaking ACCC standards, this makes it ethically OK to do so. Pulse Pharmacy noted that Eken met all the TGA requirements, which doesn’t say much at all. Listed Products aren’t required to provide evidence; just state that they have some in their possession.

PowerBalance made the same claim too, until the TGA withdrew representation after investigating due to complaints. (http://www.tgacrp.com.au/index.cfm?pageID=13&special=complaint_single&complaintID=1650)

I guess I’ll have to write up a response. In the mean time, I encourage you to do the same thing too!

Update: In response to a recent comment, I will include this link to another page that describes the EKEN Powerband Scam.

An Open Letter to Pulse Pharmacy

To Pulse Pharmacy,

While in one of your stores, specifically the Brookvale store at Warringah Mall, I noticed a display featuring the EKAN Power Band on your Service Desk.

Perhaps it has slipped by you, but recently the ACCC ordered PowerBalance, a Brand name offering the same “technology” as EKAN, to cease selling their product in Australia after Power Balance admitted that it has engaged in misleading and deceptive conduct in breach of s. 52 of the Trade Practices Act 1974. – http://www.accc.gov.au/content/index.phtml/itemId/964065

ACCC Chairman Graeme Samuel went on to warn consumers of  “***SIMILAR*** products on the market that make unsubstantiated claims, when they may be no more beneficial than a rubber band,” You can hear the comments made by the ACCC Chairman at http://bit.ly/hitQLR

EKAN states clearly on their website regarding their hologram “technology”:
“Each (EKAN) Power band is made of high-grade silicone and embedded with 4 nFIT holograms.”

Holograms? Yes, holograms. EKAN claim they give their Holograms a:
“highly concentrated dose of frequencies” —

Not withstanding the fact EKAN have misused the term “frequencies”, EKAN provide no scientific evidence to support its claims – At all. The public expects, and deserves it’s pharmacies to provide only science-based medicine. Placebo is not an alternative to actual efficacious, medical treatment; and Pulse Pharmacy shouldn’t be in the business of knowingly misleading it’s customers.

To also sell it straight from your website is disgusting and immoral.
http://www.pulsepharmacy.com.au/Product/Eken-Powerband-Black–and–White-Extra-Small.aspx

I hope you will reconsider your decision to sell this sham product, having now been informed of this, to do nothing would be making Pulse Pharmacy complicit in the scamming of your customers.

Regards,

Bayani Mills