“Big Pharma” fails to convince TGA of product efficacy

In April last year, pharmaceutical company Key-Sun Laboratories were unable to substantiate claims they had made in an advertisement for a cold & flu product to the Therapeutic Goods Administration’s Complains Resolution Panel, Australia’s consumer protection watchdog for therapeutic goods.

The product, “Oscilococinum” is a manufactured by Boiron – who themselves were the target of a million-dollar class-action lawsuit for the same product, which they settled for $5 million dollars.

The findings by the TGACRP outlined in this document noted that Key-Sun, the advertiser, presented two studies to the TGA in an attempt to demonstrate the product was effective in relieving “fever, chills, body aches, and pains” as part of a cold or flu.

The findings include:

The Panel was satisfied that this evidence was not of a type, range, or quality that could support representations made in advertisements directed to consumers. The Panel also noted that the advertiser had not provided evidence that the studies provided reflected the full balance of evidence available in relation to the advertised product.

Big Pharmaceutical companies such as KeySun need reassess just why they are in the market place; this a blatant financial exploitation of the ignorant and misinformed, and their actions only reinforce the false tenants of homeopathics to those who could very well die as a result.

Unsurprisingly, many cynical advocates of homeopathy don’t consider similar products to fall under the category of “conventional” medicine, but considered an alternative to medicine.

I’m inclined to agree – Homeopathy is not medicine.

HomeopathyPlus to be reviewed by the TGA’s Secretary

A copy of the letter sent to the complainant

HomeopathyPlus is an online retail outlet for products and books about homeopathy; and advocates a number of dangerous concepts to the public under the guise of “informed choice’. Consumer protection groups have highlighted the blatant disregard for the health of Australians demonstrated by HomeopathyPlus’ advertisements in the past.

The latest news is an escalation because of Homeopath, Fran Sheffield’s refusal to adhere to legislation put in place to prevent Australians from being exposed to unbiased, or even fabricated information about the products they are considering to use on their own.

An investigation in to HomeopathyPlus’ unethical advertising practices was initiated after a complaint was registered with the TGA. The complaint was about an advertisement put up on HomeopathyPlus’ website by Fran Sheffield for a “homeopathic prevention for meningococcal disease”.

On the 16th of June 2011, that investigation, by the Therapeutic Goods Administrations’ Complaint Resolution Panel (TGACRP) determined that Fran Sheffield’s advertisement had breached ten sections of legislation.

Specifically, the Therapeutic Goods Advertising Code Sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(d), 4(2)(f), 4(2)(i), 4(4), 4(5), 5(2), 6 – See the TGACRP’s Determination

This includes the advertising of unrealistic expectations of a products’ effectiveness, abusing the trust of consumers, using language that could bring about fear or distress, and inadequate evidence being presented to support the claims made in the advertisement, despite being given time to both prepare and submit the evidence to support the claims made.

Fran Sheffield, the person responsible for the advertisement on HomeopathyPlus’ website, and the primary profiteer from the advertisement ignored the TGACRP requests to “Withdrawal of representations”, “Withdrawal of advertisement”, and to include a “Publication of a retraction” – None of these have been complied with.

Because of this, the complaint has now been referred to the TGACRP’s Secretary with the recommendation that the Fran Sheffield be ordered to comply with the requests made in the determination.

£51 Pounds for 1L of Water Diluted in Water

20110828-012339.jpg

Bullshit Price for Bullshit Remedy

The folks over at Helios are raking it in with their homeopathic water. That’s right, water diluted in water.

At £51 a liter, it equates to about $78 for us Aussies. It is revealing about the nature of homeopathic manufacturers, given the homeopathic community often rants about the profits made by “Big Pharma”, despite large chunks of that profit being used towards developing new and better medicines.

There is little evidence to show that Helios actually produces any of these remedies in accordance with homeopathic “tradition”. They may use some of the crazier methods like  emptying the vials and refilling them over and over, or having a platform shake a container with their initial ingredient then replacing that container with water, or – they may not even waste their time doing anything at all.

It’s possible Helios are simply selling blank pills and supplying spring water rather than tap water.

It certainly wouldn’t surprise me if they were.

Update: @MLOCallaghan from Nerditorial was kind enough to bring these Homeopathic Ear Wax Drops to my attention:

Expensive "medicine".

At  £44.39 for 10mL, that brings the cost of 1L of these ear drops to £4438. For us Aussies, that’s $6,869/L

Water at that price should be criminal.

Coles Supermarkets finally responds..

In response to my Open letter to Coles Supermarkets (which is also available at The Manly Daily), Coles Supermarkets have finally responded. I can’t say that I’m surprised at the response – it’s about what I expected; and it would seem that the original letter was not actually read – as there is not a single acknowledgement of the issues raised.

I’ll Fisk the letter, and send it back to Coles for further comment.

Dear Mr Mills

Thank you for your recent email regarding the evailability of homoeopathic products at Coles. Please accept our apologies for the unintended delay in responding to you.

After receiving your request, we contacted our Merchandise Team and wish to advise that at Coles our customers come always first and hence we decided to range the Brauer range of products to give customers the opportunity to purchase them from Coles.

Thanks for taking the time to respond.

Unfortunately, it must be said that the response is less than satisfying.

The sale of sugar pills as medicine is a case of customer wallets coming first; regardless of the “our customers come first” wrapping Coles Supermarkets may wish to give it.

Being so inspired to “give customers the opportunity to purchase […] from Coles”, does Coles intend to acquire and sell other equally ineffective products, such as the “Anti Hair Lice” Unicorn Badge? What about the “Magnetic” Menopause Relief pad? Is this the new direction Coles Supermarkets wishes to take its company – to be the purveyor of pseudo-science?

As apparently no one looked at the clinical evidence:
British Journal of Clinical Pharmacology 2002 December; 54(6): 577–582
doi: 10.1046/j.1365-2125.2002.01699.xfollow
Link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1874503/

What will it take to convince Coles Supermarkets that selling Homoeopathy is intellectually retarded?

If no one read or understood what was written in the original letter I am happy organise medical doctors to get in contact (person or phone) with someone in a position to begin the phasing-out of the sale of Homoeopathy by Coles Supermarkets.

The Brauer products have been around for a number of years and are ranged in most pharmacies and health food stores in Australia.

I absolutely agree. Brauer have been successful in selling sugar pills at a massively inflated price to both the public, and to Coles. Unfortunately, the sale of their product in Pharmacies is not indicative of efficacy.

For instance, until recently pharmacies were still selling PowerBalance Bands – A product with unsubstantiated, pseudo-scientific claims. Similar to your response, pharmacies provide the intellectually and ethically challenged concept of “choice”. It is a poor reason to stock a product that is not just unproven, but has been systematically disproved. Even today, some pharmacies still sell EKEN Power Bands – the same product as PowerBalance, but under a different brand name.

Brauer Natural Medicine operates a manufacturing facility that is licenced by the Therapeutic Goods Administration to produce listed therapeutic goods for sale in Australia. These products are made in strict accordance with the TGA’s code of Good Manufacturing Practice.

This has NOTHING to do with what I have contacted Coles about.

The fact that Brauer have a licence from the TGA to manufacture goods demonstrates nothing more than the TGA being satisfied that the manufacturing PROCESS adheres to the TGA’s regulations.

I am not making a claim about an unsafe manufacturing process. I am informing you, Coles, that what you have decided is that it is ethically permissible to sell products that do not have a sound theoretical basis, have not been proven to work, and have been systematically disproved.

If it sounds a though I am repeating, I am – I want to be very clear: What you are selling is pseudo-science.

Each individual product is formulated using ingredients that have a history of use for the listed indications, that in some cases goes back nearly 200 years.

Tradition or antiquity is not sufficient evidential basis for a product that claims to be a medicine. It is well worth noting that 200 years ago (when homoeopathy was invented) it was not known that germs existed, that blood-letting was a good way to make people get better because they believed they may have had an excess of “yellow bile, or “black bile”, and it was believed that people got sick because of “bad air”; in fact, advocates of Homeopathy believe that “disruptions in the body’s vital force” – from magical “bad air” – are the cause of all illnesses — Obviously, modern medicine has moved on from nonsensical beliefs such as these.

I’m confident that the Managing Director of Coles, Ian McLeod would rather take a proven sleep drug over a sugar pills to sleep better at night (perhaps you may wish to ask him to confirm); yet this is the useless “choice” being advocated by Coles through the sale of Homoeopathy – a product with NO robust clinical evidence for its use.

In accordance with the TGA’s requirements for listed products, Brauer holds the evidence to substantiate the indications listed for these products.

The “evidence” held by Brauer is nothing more than a Homoeopathic Pharmacopoeia – A book that demonstrates that Homoeopathy was used more than a couple of decades ago. Again, this is not evidence that the product works – rather, it is evidence that the product was used beyond a specified quantity of years. Repeating again: This is NOT evidence that the product works.

We care about our customers wellness and by ranging homeopathic products we are giving them a natural product choice, should they wish to purchase.

While sincerity for customer wellness is nice to hear, the rhetoric fails to be put in to practice. The complete opposite is demonstrated. What Coles Supermarkets is doing is confusing a situation for people who do not understand what homoeopathy is, which may very well lead them down a path of using it for other serious ailments – for which there are a HUGE number of homoeopaths quite willing to tell them they can take Homoeopathy as an Anti-Malarial, as a cure for cancer, as a way to treat autism, and as a treatment for serious infections.

Here’s the equivalent “choice” you provide –

You have cancer. Do you want:

1. The best possible medical treatment
2. To be slapped with a fish

While the correct answer is blatantly obvious, by providing “choice” where it is redundant Coles gives people the equivalent “choice” of treating cancer with a fish-slapping.

Once again, thank you for taking the time to contact us. We appreciate your feedback and look forward to your future custom at Coles.

Yours sincerely
[redacted]
CUSTOMER CARE CONTACT CENTRE

While I understand that Brauer would have been consulted for the response, it seems as though Brauer approached Coles to sell their product for them – If this was not the case, did Coles’ Merchandise Team seek out Brauer before or after deciding it was an good idea to falsely sell sugar pills as a medicine?

Kind Regards,

Bayani Mills