State-Approved Health Fraud Scams

State-Approved Health Fraud Scams

A decades old loophole in New Zealand’s patient protection legislation is letting quacks get away with health fraud, right under the regulator’s nose.

In New Zealand, patients are protected from health fraud scams by the Medicines Act. This legislation, which is enforced by Medsafe, only allows products making strong health claims to be sold if they have been approved by the Minister of Health.

In order to get approved, a medicine needs to pass a rigorous submission process that includes providing robust evidence to substantiate all of the health claims that will be made about it. In this way, patients should be protected against health fraud scams.

Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses.

Health Fraud Scams – US Food & Drug Administration

Except, there are some products that have this approval but are not been backed up by evidence.

When the Medicines Act came into effect 35 years ago, in 1981, all products that would be covered by the legislation which were already on the market were given automatic approval. This included a bunch of homeopathic products manufactured by the company Weleda.

Weleda, unfortunately, is still in operation today and still sells many of the same products. They operate out of Havelock North, which strikes me as somewhat ironic given their business is based on selling water as medicine. They’re far from tiny, too. In the 2014 financial year alone they made $4.85m in revenue from retail sales.


Usually, when you see a homeopathic product for sale in New Zealand, its marketing materials will be full of weasel words like “supports”. These ads typically manage to imply a whole lot without really saying anything at all.

Support for a healthy heart.

Maintains joint health.

Supports your body’s natural response to winter ills and chills.

Wink wink, nudge nudge.

There are also many cases where this promotion oversteps the generous line set by the Advertising Standards Authority. Myself and others at the Society for Science Based Healthcare work to bring these to the ASA’s attention when we find them, as part of our efforts to reduce the amount of medical misinformation people are subjected to.

Usually this is a pretty straightforward process, especially for homeopathic products. After all, the evidence on homeopathy is abundantly clear:

there are no health conditions for which there is reliable evidence that homeopathy is effective.

Statement on Homeopathy – Australian Government National Health and Medical Research Council

And so are the ASA’s requirements:

Statements and claims shall be valid and shall be able to be substantiated. Substantiation should exist prior to a claim being made.

Therapeutic and Health Advertising Code – Advertising Standards Authority

However, a recent complaint that we’d expected to be as straightforward as previous ones turned out to be anything but. My colleague at the Society for Science Based Healthcare, Mark Honeychurch, submitted a complaint earlier this year about an advertisement for one of Weleda’s products: Weleda Cold and Flu Drops.

The ad for this product on Weleda’s website gave clear directions for its use, which included strong and unambiguous claims about what the product is meant to do:

Take at the onset of cold or flu to relieve symptoms — fever, muscle ache, headache, sore throat, sneezing and runny nose. Take with Weleda Echinacea/Thuja Comp. Active Strength Immune Support for additional effectiveness. Does not cause drowsiness.

Weleda New Zealand

The problem with this ad is, of course, that there’s no evidence that this product can relieve any of those symptoms. Nor is it at all plausible.

That formed the basis of Honeychurch’s complaint. So it was quite a surprise when the ASA ruled to not uphold it, and passed on this response from Weleda:

Weleda Cold & Flu Drops is a registered medicine with Medsafe (TT50-8039) and is permitted to carry therapeutic claims. In relation to the complaint, the recommendations for the product on the website are consistent with the registered packaging indications which are as follows:

  • Take at the onset of cold or flu to relieve symptoms – fever, muscle ache, headache, sore throat, sneezing and runny nose.

Given that the statement on the website is consistent with the registered indications, we consider that the claims do not contravene the Therapeutic Products Advertising Code. We trust that our response resolves this issue.

Weleda New Zealand

Communication with Medsafe quickly uncovered the fact that this approval was granted in 1981, when the Medicines Act came into effect. The issue we identified was that Weleda was using this approval as a substitute for the substantiation required by the ASA’s codes. Under usual circumstances this would make some sense, as Medsafe’s approval typically requires that sort of substantiation. But these are not usual circumstances, and we thought this was a misuse of the approval Weleda had been granted.

Honeychurch sent a list of written questions to Medsafe, to get to the bottom of this and to aid with his appeal to the ASA. Two of his questions were particularly important, in my opinion. The first sought to clarify whether or not Weleda had ever given Medsafe evidence that their product can do what it says on the label:

What substantiation, if any, was used to accept these indications [for Weleda’s Cold & Flu Drops], either when the product was “grandfathered” into Medsafe’s Current registration system, or at any other time?

The product was grandfathered into the current regulatory Scheme following the enactment of the Medicines Act 1981. Products that were eligible for grandfathering were those that were already marketed in New Zealand and had a demonstrated history of safe use. For grandfathered products, the date of approval was deemed to be the earliest date of market availability provided by the product owner.

The product was originally indicated as a homoeopathic medicine for all types of influenza and Colds. These indications Were accepted at the time.

Subsequent to the original approval under the Medicines Act the indications have been modified in 2007 and 2014. The modified indications have been accepted as they are all encompassed by the Original appoval.

Medsafe

The lack of a clear answer from Medsafe here is frustrating. As far as I can tell, their answer means Weleda demonstrated that their product had a history of safe use, and provided the earliest date of its market availability. But it also seems Weleda never gave Medsafe any evidence to support the claims made about the product’s efficacy.

The other important question Honeychurch asked regarded the scope of the problem. Although this was the only homeopathic product we’d found to have been approved by Medsafe, it seemed unlikely to be the only one that exists.

What other Weleda products, and homeopathic products from other manufacturers, are registered with Medsafe as medicines, and what indications are there for each of them?

You can search for Weleda’s approved medicines that have been transferred into the therapeutics database using the search function above [http://www.medsafe.govt.nz/regulatory/DbSearch.asp] and entering Weleda into the sponsor box. Please note that products in the database are those which have undergone regulatory activity since being grandfathered.

Weleda also notified over 1000 homoeopathic medicines to be grandfathered. The approved product details are only held in hard copy files. Many of the products are intended to be supplied to practitioners of homoeopathy or direct to patients through speciality retail stores.

Providing the requested information would require extensive research and collation and Cannot be Completed within the timeframe you have indicated as necessary for your to lodge an appeal to the Advertising Standards Authority.

Medsafe

As a lower estimate of the number of health fraud scams approved by Medsafe, “over 1000” is a pretty scary number.

So what is there to be done about it?


Honeychurch started by submitting an appeal to the ASA, hoping the answers he’d recieved from Medsafe would be enough to overturn the decision. After all, the decision should hinge on the assumption that Medsafe’s approval of Weleda’s products implies the substantiation required by the ASA’s codes, and that assumption appears to be false.

But the ASA instead ruled to maintain their original decision. This ruling was released today, and makes for interesting reading. For example, this part of Weleda’s response clarifies that they truly have never had to submit evidence of efficacy for their products, simply because they have been sold for a very long time (emphasis in the original):

Weleda accepts that Weleda Cold & Flu Drops was ‘grandfathered’ into the current medicines registration system following the enactment of the Medicines Act 1981 (which replaced the Food and Drug Act 1969 which in turn replaced the Food and Drugs Act 1947. Cold and Flu Drops received ‘default’ approval as a medicine on 31 December 1969, three months before the Food and Drug Act 1969 came into force on 1 April 1970. This ‘grandfathering’ process however was applied to all relevant products at the time, including what may be called ‘conventional’ medicines. There was no favouritism toward one type of medicine or another and there was no requirement to (re-)submit evidence of efficacy to be registered.

Weleda New Zealand

The rest of their response makes it seem pretty clear to me that they’re using this historical approval as a shield to stop the ASA from requiring they provide robust evidence of efficacy that simply does not exist:

In the absence of a statutory or regulatory requirement under either the Food and Drug 1969 [sic] or the Medicines Act 1981 for Weleda to freshly prove the efficacy of our Cold & Flu Drops, we do not accept that it is open to M. Honeychurch to demand we do so by way of this proceeding — particularly when they have provided no evidence to support the view that Cold and Flu Drops has no efficacy.

Weleda New Zealand

And if that all wasn’t clear enough, Medsafe also weighed in on the issue of whether or not substantiation had been supplied by Weleda (this time the emphasis is mine):

The ‘approval date’ published on the Medsafe website in relation to this product (and most Weleda products) indicates approval at 31 December 1969. This means that these products were determined to have been legally on the market prior to the commencement of the Food and Drug Act 1969 and could continue to be marketed under the current legislation, with the same indications. Proof of efficacy is not held by Medsafe.

Medsafe

In my opinion, the decision the ASA should have been making should have been “does this advertisement breach our codes?”. Indeed, this is the question they usually ask when dealing with a complaint, and the fact that advertisements that breach their codes might not be downright illegal isn’t usually enough to stop them from upholding a complaint. But for some reason they’ve decided this case is different:

In relation to the complaint before it, the Appeal Board considered the key issue was a matter outside its jurisdiction, namely the process agreed to with the regulator during a change to legislation some decades ago.

The appeal Board noted the position of the Complainant with regard to the ‘grandfathering’ of certain products but agreed this was a matter that should be raised directly with Medsafe.

Advertising Standards Authority


The “grandfathering” process that allowed these hundreds of ineffective health products to get a free pass seems to have been intended to keep low risk products on the market, regardless of whether or not they are effective. With the unfortunately named Natural Health Products Bill lined up to wrap some much needed patient protection legislation around the area of low risk health products of dubious efficacy, it might seem like a great time for these “grandfathered” products to be transferred into that framework.

Unfortunately, the proposed regulations associated with the Natural Health Products Bill explicitly exclude homeopathic products from their rules. In our dealings with Medsafe, time and time again I have come away with the clear impression that they only care about safety issues. So long as a health fraud scam is safe, Medsafe is content to do nothing about it.

Magic water? Sure, it’s just water. What’s the harm?

I can certainly see the justification for that. Safety issues are typically more pressing than low risk products that are only doing more indirect harm like causing people to delay effective treatment, putting strain on finances, and damaging public health literacy. Often it’s entirely appropriate for Medsafe to rely on our first line of defence – the Advertising Standards Authority – to deal with misleading health claims. But when that fails, something needs to be done.

There is an ocean of health fraud scams in New Zealand. It’s high time the regulator responsible for enforcing our patient protection legislation started giving a damn about it.

We’ve got in touch with Medsafe to request a meeting in the new year, to discuss what path there might be for addressing the issues I’ve touched on here. While I’m hoping for the best, I’m not holding my breath.

100% Natural and Chemical Free

This afternoon, the Advertising Standards Authority released their decision to uphold an interesting complaint regarding advertisements for a couple of cleaning products on a website. Here is the ASA’s description of how the products were described on the website:

The Wendyl’s website (http://wendyls.co.nz/) for “100% natural cleaning and beauty products” advertised their products as having “all their ingredients listed and contain no fillers, chemicals or synthetics.”

The webpage for Wendyl’s Oxygen Bleach 1KG (sodium Percarbonate) stated, in part:

This is powdered hydrogen peroxide which is a greener alternative to chlorine bleach because it breaks down to oxygen and water in the environment.

The webpage for Wendyl-San oxygen soaker 1KG stated, in part:

I’ve spent years testing this oxygen soaker and stain remover and I’m so glad to have something which is so free of chemicals and additives. Secret ingredient is sodium percarbonate, a powdered hydrogen peroxide bleach which breaks down in the environment to oxygen and water…

The complainant, food scientist Claire Suen, said that they breached the Advertising Code of Ethics and the Code for Environmental Claims. This excerpt is, I think, a good summary of their complaint:

The advertiser uses words such as “100% natural”, and “contains no fillers, chemicals, or synthetics”.

However, the product in question is sodium percarbonate, which is not a naturally occurring product. The main active ingredient, hydrogen peroxide, is also not a naturally occurring product and it is not stable in nature.

Both are synthetic chemicals.

After hearing from the advertiser as well, the Advertising Standards Complaints Board sided with the complainant. Here is a summary from the headnote of their decision:

The Complaints Board said it accepted the Advertiser’s view that “sodium percarbonate is a much safer and more environmnetally friendly alternative to chlorine bleach” but not that it was “chemical free” and “100% natural.” The Complaints Board said the advertisement was likely to mislead consumers into thinking the products were “100% natural” and “chemical free” when they actually contained naturally occurring chemicals, in breach of Principle 2 of the Code for Environmental Claims and had not been prepared with a due sense of social responsibility to consumers in breach of Principle 1 of the Code for Environmental Claims.

Accordingly, the Complaints Board ruled to Uphold the complaint.

The most interesting part of this complaint is, I think, who the advertiser is. As well as selling cleaning and beauty products online, Wendyl Nissen writes a weekly column for the New Zealand Herald called “Wendyl Wants To Know“. The Herald describes the column as:

Each week, Wendyl Nissen takes a packaged food item and decodes what the label tells you about its contents.

Have a look for yourself, but from the columns of hers that I’ve read it seems the main argument is typically along the lines of “natural is good, chemicals are bad”. So I find it very ironic that she’s now had a complaint upheld against her for misleadingly claiming that a product she sells is “100% natural” and “chemical free”.

For a counterexample to the attitude of “natural is good, chemicals are bad”, you need look no further than the “recipes” section of her website. There, she has some pet recipes which she makes available for free including one for De-Flea Powder for Cat Biscuits and another for Doggy De-Flea Treats. In both recipes, she claims the active ingredients are yeast and garlic:

The theory behind this powder is that fleas hate the taste of yeast and garlic so will hop off and look elsewhere.

Elsewhere on her website, she recommends that if you:

Put a garlic clove in your pet’s water you can help deter pests such as mites and fleas.

Although it certainly is natural, garlic is also toxic to cats and dogs, especially for cats. I couldn’t find any warnings about this on Wendyl Nissen’s website.

The lessons to be learned? Natural isn’t always good, and don’t take advertisers’ word for it when they claim something is “100% natural” or “chemical free”. As always, ask for evidence.

New Zealand Skeptics Conference: Fighting Pseudoscience

Over the weekend, I attended the New Zealand Skeptics Conference at Auckland University. It was a great weekend, with consistently good speakers. Not only did we have the hosts of the popular Skeptics Guide to the Universe podcast and George Hrab from the Geologic podcast over from America, we also had a lot of fantastic local speakers like Nicola Gaston and Michelle Dickinson (Nanogirl).

If you weren’t able to attend and want to know what you missed, the conference program is currently still available online. I think the website will be reused for next year’s conference in Christchurch though so that won’t last forever.

As well attending some really great talks, I was also able to meet a lot of people who I’d previously only spoken to online. Nicola, Michelle, Jonny, Will, and everyone else I met over the weekend, it was wonderful to meet you all! I was also rather honoured to be given the “Skeptic of the Year” award at the conference dinner, for my consumer advocacy work and for helping to found the Society for Science Based Healthcare.

If you have a close look at the conference program, you might notice that I was scheduled to hold a workshop on “Fighting Pseudoscience” on the Saturday afternoon. As I have done with my previous talk at Auckland Skeptics in the Pub, I’d like to put my slides from this up online. Here they are:

If you view them on Google Drive (click the “Google Slides” link in the lower right) you’ll also be able to see my notes for each slide.

I think the workshop went really well, there was a lot of good discussion with the audience and I hope I was able to motivate some of them enough to make complaints of their own. Unfortunately I was only able to get through a single example in the time I had instead of the four I had prepared, but that was due to the time spent in discussion with the audience so it wasn’t really a problem.

Siouxsie was kind enough to get a few copies of the Ponsonby News (which it’s always fun to hear her rant about on the Completely Unnecessary Skeptical Podcast) to pass around the audience, and a few people found advertisements in the health section that seemed likely to be misleading.

There were also a couple of copies of the Advertising Standards Authority’s Codes Booklet that I was able to pass around the audience (thanks to Lisa Taylor for letting me borrow her code booklet for this). A few people asked me afterwards how they could get one of these booklets. One option would be to email the ASA to ask for one or to tick the box asking if you’d like one when you submit a complaint online. Another option is to print the PDF yourself. The ASA’s codes are all available on their website too, so don’t feel like you have to print the PDF if you’re happy to use an online reference.

Finally, everyone who attended my talk got a copy of a “Complaining Cheat Sheet” that I’d put together for the Society for Science Based Healthcare (thanks to Nancy Lan for helping me a lot with the design). The idea behind this was that it can feel like quite a task to go through the ASA’s codes to find out which sections of which codes an ad might violate, especially if you’re not already familiar with them. This cheat sheet can serve as a quick reference to some of the most commonly violated sections of the ASA’s codes, as well as a guide to how to prepare and submit a complaint.

I’ve embedded the complaining cheat sheet below, and it’s available via the Society for Science Based Healthcare’s website: Complaining Cheat Sheet

Please download it, print it, share it widely, and most importantly use it. It was made to make it easier for anyone to complain about misleading advertising in New Zealand, so the next time you see an ad that you think is misleading, instead of just being annoyed try complaining. Together we can make New Zealand a safer environment for consumers.

Ethical Pharmacy Practice 2: Time for a Spring Clean

In July, I wrote an article on Ethical Pharmacy Practice and Homeopathic No-Jet-Lag. In it, I described the importance of the role pharmacies play in the healthcare system, and their ethical obligation not to mislead consumers or promote ineffective healthcare products. In particular, I described an advertisement I saw in an Auckland pharmacy for a homeopathic product called “No-Jet-Lag”, and the complaint I submitted to the Advertising Standards Authority about it via the Society for Science Based Healthcare. There’s also a write up of this decision and the 2 others released at the same time on the Society’s website: Pharmacy to Remove Homeopathic Product Following Complaint

On the 9th of October, the ASA released their decision to the public. They ruled to uphold my complaint, which means the advertisement has to be removed. More importantly, in response to my complaint the pharmacy made a promise to remove the product from sale if the complaint was upheld. Here’s what they said:

We believe that the manufacturer, Miers Laboratories ought to respond to the substantive complaint that it’s [sic] representations fail to comply with the Therapeutic Products Advertsing [sic] Code.

We believe that the product is sold in many pharmacies in New Zealand and it is somewhat arbitrary that our pharmacy is the subject of the complaint.

We are interested in the outcome of the complaint and can indicate that if the Authority upholds the complaint we will remove the product from sale. In the meantime, the product has been removed from the counter and placed on a less prominent position.

I agree with their first two points. While I think pharmacies shouldn’t promote or sell healthcare products without a sound understanding of the evidence behind them and the claims made about them, I also think it’s reasonable to expect the manufacturer (who also produced the advertising in this case) to substantiate the claims. Moving the display to a less prominent position in the meantime seems like a reasonable compromise as well, although of course I’d prefer it if the product were never stocked in the first place.

I also agree with them that their inclusion in this complaint is somewhat arbitrary. For that reason I am not going to specify in this article which pharmacy it was. If you really must know then you can read the full decision on the ASA’s website. As they said, many New Zealand pharmacies sell this product and I think this complaint applies to all of them.

I also think this pharmacy’s promise to remove the product from sale in the event that this complaint is upheld, as it now has been, is the appropriate response. I think that every single New Zealand pharmacy that stocks No-Jet-Lag should follow suit. There are a lot of them. The website for this product even claims on its New Zealand Retail Outlets page that “Most chemists nationwide” stock it.

As I mentioned in my original post on this topic, and in my complaint, New Zealand pharmacists are bound by the Pharmacy Council’s Safe Effective Pharmacy Practice Code of Ethics 2011. Perhaps the most important part of this industry code of ethics, at least in my mind, is section 6.9:

YOU MUST:

Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.

This is a very fine standard to adhere to, and I would hope that all businesses to which it could possibly apply would adhere to it as well, although realistically I know that’s not the case.


In response to the complaint, Miers Laboratories submitted a few studies to the ASA. They were pretty laughable though when you look at the sample size:

In all our research we base our work on previous studies, the first study for jet lag used 5 people, then it was 10 and at the time the accepted worldwide minimum was 12 for clinical trialOur [sic] bigger study used 19 people.

So basically “most of our studies didn’t even meet the very low minimum accepted size, and even the largest one was tiny”. Very impressive, Miers Laboratories.

The 19 person study they mention is also promoted on their website, and I pre-emptively discussed it in my complaint. It seems the Advertising Standards Complaints Board essentially agreed with my criticisms:

The majority of the Complaints Board said the statement “It really works” was an absolute therapeutic claim and, as such, required a high level of support. However, it noted the trial population in the pilot study was small, the methodology was not robust and the results had not been published or peer reviewed. The Complaints Board also noted the study was an in-house trial conducted by the Advertiser rather than independent research.

Given the weaknesses in the study, the majority of the Complaints Board said the Advertiser had not satisfactorily substantiated the claim the product “really works” and, as such, the Complaints Board said the advertisement had the potential to mislead consumers. Consequently, the Complaints Board said the advertisement did not observe a high standard of social responsibility required of advertisements of this type. Therefore, the majority of the Complaints Board ruled the advertisement was in breach of Principles 2 and 3 of the Therapeutic Products Advertising Code.

For context, Principle 2 of the Therapeutic Products Advertising Code states that:

Advertisements must be truthful, balanced and not misleading. Claims must be valid and have been substantiated.

And Principle 3 states that:

Advertisements must observe a high standard of social responsibility.

This is basically exactly the result I was hoping for, which is great. However, I was a little concerned by one part of the decision:

A minority of the Complaints Board disagreed [that the advertisement was in breach of Principles 2 and 3 of the Therapeutic Products Advertising Code]. It acknowledged the study sent by the Advertiser to support its claims. While it noted the issues with the study, the minority of the Complaints Board was of the view the product was not harmful and said the consequences of the product not working were not significant or serious for the consumer.

I’d expect anyone who has ever paid money for a pill to prevent jet lag would disagree with this, although it is obviously a lot more serious than something like a cancer treatment that doesn’t work. More importantly, although I do agree that it’s important to consider the severity of what happens if the product doesn’t work, I hope that the ASA will not give a free pass to misleading therapeutic advertising simply because it’s for a condition that they deem insignificant.


Now that this complaint has been upheld, the pharmacy in question has promised to remove No-Jet-Lag from sale. I hope this is the start of a spring clean for all New Zealand pharmacies that stock this product. They should follow this responsible example and take the opportunity to examine other products they have for sale – especially homeopathic products – to ensure that they are abiding by their ethical duty not to promote or supply healthcare products for which there is no credible evidence of efficacy.

You can help. Next time you see a homeopathic product in a pharmacy, ask them what the evidence for it is. If you see this particular product, ask them if they’re aware that the Advertising Standards Authority upheld a complaint against it on the basis that the evidence for it just isn’t good enough.


EDIT 2014/10/12

It’s great to see that several media outlets have picked up this story:

ASA Complaint: Osmosis Skincare’s Drinkable Sunscreen

In May this year, One News ran a story on a US skincare company releasing what it was calling “drinkable sunscreen”. Around the world, various sceptical websites also picked up the story, such as Doubtful News and Neurological Blog. The message was roughly that a “drinkable sunscreen” is a cool idea that isn’t entirely implausible, but that this company’s “Harmonized Water” product seemed to be entirely ineffective pseudoscience.

I tweeted about the story from One News, noting that the article seemed like little more than free advertising of what really seemed like quite a dangerous product. Thomas Lumley, a professor of Biostatistics at Auckland University who runs the great blog Stats Chat, picked up this story and wrote about it there: Revolutionary new advertising success

He also pointed out to me on Twitter that this company, Osmosis Skincare, has a New Zealand distributor, and that they have a website. Here’s that website’s Harmonized Water product listing page. If you look at it now, you’ll luckily see that although it does list a large number of “Harmonized Water” products that almost certainly don’t do what is claimed about them, it does not include any products that claim to be able to be used as “drinkable sunscreen”. The reason for this is that the Advertising Standards Authority has upheld a complaint I lodged against their online advertisements for these products.


As part of submitting this complaint, I took screenshots of the advertisements. I’ve embedded these below so you can see the claims as they were originally made:

Osmosis Skincare - UV Neutralizer Tan

Osmosis Skincare - UV Protection No Tan

My full complaint is available for you to read, as well as Osmosis Skincare’s response and the ASA’s decision, on the ASA’s website. I encourage you to read it in full, but I’ve put some of the highlights in this article.


The gist of my complaint was, as usual, that I don’t believe the advertiser has any evidence to support the claims they were making about the product. I also argued that the advertisements “abuse scientific terminology in a way that seems intended to exploit consumers’ lack of knowledge”.

In my complaints I generally also argue that making misleading or unsubstantiated therapeutic claims is socially irresponsible, and when the ASA upholds my complaints they tend to agree. In this case though, I felt the advertiser went a step further:

The New Zealand Cancer Society website writes, on the dangers of unprotected sun exposure:

New Zealand has the highest rate of melanoma in the world, and other skin cancers are also very common. You can help reduce your risk of skin cancer by using sunscreen the right way.

By misleading consumers into believing they are protected when in fact they very likely are not, this advertisement is likely to increase their risk of contacting [sic] melanoma due to unprotected exposure to UV radiation from the Sun. This misrepresentation is highly irresponsible.

Soon after submitting my complaint, I saw that the British Association of Dermatologists had published a response to these products. It’s worth reading in full, but here’s a highlight:

We want to make it immediately clear at this stage, the formulation is 100% water and, as far as our experts are concerned, it is complete nonsense to suggest that drinking water will give you a Sun Protection Factor (SPF) of 30.

They also contacted Osmosis Skincare to ask what the “scientific basis” for their claims was. The full message and its response are available at the link. Osmosis Skincare confirmed that the product is 100% water and didn’t provide them with any evidence to support their claims.


In Osmosis Skincare’s response to my ASA complaint, they said they’d made some changes like calling the products “UV Neutralizer” instead of “UV Protection”. How they thought this made it acceptable is entirely beyond me.

They also said the following:

This is a new type of technology being used in this way and Head office can reference the internal research they did showing the product to be effective, but their independent clinical trial isn’t until the 28th of June, whereby they will put 30 people outside for one hour in San Diego, CA at noon supervised by a plastic surgeon. So perhaps we have some extra time to submit these results? We are told our UK distributor will also be conducting their own study. We have been selling this in New Zealand for the past couple of years without any issue.

I can’t say I was surprised to read that the “independent clinical trial” they were planning on would have a tiny sample size of 30 and be without a control group, let alone adequate randomisation and blinding.

DermNet NZ has a page on sunscreen testing and classification that says sunscreens in New Zealand are now tested in vitro. That makes perfect sense to me, partly because in vivo testing for something like sunscreen seems like it would likely be unethical (which is mentioned on DermNet’s page) and partly because the difference between sunscreen and no sunscreen – blocking UV radiation when placed on the skin surface – would presumably be much easier to test and measure than more complex medical outcomes.

I would also imagine that the placebo effect will not have a strong influence here, but that’s only a guess and I have no evidence to support that. However, a study like this would still need a control group to be able to tell how much of a difference the product made, and in such a design it would still be more rigorous to randomise participants and blind both them and the researchers to eliminate potential sources of bias.

It will be interesting to see if this trial is published, and what its methodology and findings are. Especially since they’ve publicly reported beforehand that an independent trial was due to be done.


The Advertising Standards Complaints Board seemed to agree with my complaint on all its main points. To quote the summary of their decision (which they note is not the decision itself, but the whole decision is available on their website):

The Complaints Board acknowledged the changes made by the Advertiser, however, it said that the amended advertisement was still misleading, abused the trust and exploited the knowledge of the consumer by stating that the product offered sun protection using scientific terminology without adequate substantiation. It said this was exacerbated within New Zealand as sun exposure can have significant negative effects in comparison with other countries.

Accordingly the Complaints Board said the advertisement was in breach of the Therapeutic Products Advertising Code and did not observe a high standard of social responsibility effecting a breach of the Therapeutic Products Advertising Code.

In their full decision, the complaints board noted that although Osmosis Skincare alluded to evidence, they didn’t actually provide any. They also raised the valid point that their US-based clinical trial’s “application in a New Zealand context considering the strength of the sun was questionable”. They also said that:

the advertisement was likely to abuse the trust and exploit the knowledge of the consumer by stating the product offered sun protection “30 x more than normal” and used scientific terminology like “isolates the precise frequencies” without adequate substantiation.

I have to applaud the complaints board here for taking a stand against this sort of language, which abuses scientific jargon in a way that makes the advertisement sound more authoritative than it should. As they would have been able to uphold the complaint on the sole basis that the claims are unsubstantiated, I’m glad they also decided to take on this language as well.


To their credit, Osmosis Skincare has quickly removed the advertisements for these products entirely from their New Zealand website, even before the ASA’s decision was released. However, as you’ll have seen if you clicked on the link to Osmosis Skincare’s “Harmonized Water” product listing page at the top of this article, they still sell a number of these products that also seem to make unsubstantiated therapeutic claims.

All of my complaints about misleading healthcare claims, including this one, are now submitted under the Society for Science Based Healthcare. If you’re interested in these complaints, have a look at their website. You can also keep up to date with their complaints on Twitter @SBHNZ.

July 2014 Auckland Skeptics in the Pub

Every month there’s a meetup at Juice Bar in Parnell, Auckland, of the Auckland Skeptics in the Pub group. This month, I was asked to be the speaker. The topic of my talk was the regulation surrounding medical advertisements in New Zealand, and what can be done by members of the public to counteract some of the misinformation out there.

I’ve shared the slides for my talk, and you can see them embedded below. Please have a look at the speaker’s notes too, as I have some relevant quotes and links in there:

Ethical Pharmacy Practice and Homeopathic NO-JET-LAG

Pharmacies are an integral part of the healthcare industry. They provide a valuable decoupling between the doctor you see for an examination and potentially a prescription, and the institution that stands to profit from the medicine you pay for. Without this separation, there’s the potential for a conflict of interest where the physician examining you would profit more from giving you a prescription than they would from telling you that you’re fine and sending you on your way.

I’m not trying to imply that bias has been entirely removed from the healthcare industry, but having independent pharmacies fill prescriptions from doctors does help. You unfortunately don’t generally see this sort of separation of interests in the alternative healthcare industry, where practitioners who claim to know the secret true cause of your “dis-ease” or “lack of wellness” (blocked chi, misaligned chakras, vertebral subluxation complexes etc.) also just so happen to also offer the solution; for a price, of course.

This association between pharmacies and doctors leads pharmacies to be respected and trusted institutions. After all, we expect the person behind the counter – the pharmacist – to not only be able to dispense the correct amount of the correct drug we’ve been prescribed, but also to have a sufficient understanding of how it works so they can advise us on such things as precautions we should take. “Do I need to take this with food?”, “Will this make me drowsy?”, and so on. However, pharmacies also need to be profitable to work as a business, which is why you’ll also be able to find all sorts of non-prescription products for sale such as cosmetics and non-prescription medication. Because of their involvement with the healthcare industry and respected status, it’s important that these other products sold in pharmacies also be reliable, and they should not be stocked without good reason. Essentially, pharmacies should be held to a relatively high ethical standard.

In New Zealand, there is a crown entity known as the Pharmacy Council that is established by the Health Practitioners Competence Assurance Act 2003. The Pharmacy Council is responsible for duties such as registering pharmacists and setting standards of conduct, although in cases where pharmacists require disciplining that is carried out by another crown entity also established by the Health Practitioners Competence Assurance Act: the Health Practitioners Disciplinary Tribunal. In order to ensure that pharmacists are held to an appropriate ethical standard, the Pharmacy Council has developed a Safe Effective Pharmacy Code of Ethics, published in 2011, which is publicly available on their website.

In my opinion, this Code of Ethics is an admirable document, and I’m encouraged by the idea that New Zealand pharmacists might be held to such an appropriate ethical standard. For example, it defines its principles to be the following:

AS A PHARMACIST YOU MUST:

  1. Make the health and well-being of the patient your first priority.
  2. Promote patient self-determination, respect patients’ rights, autonomy and freedom of choice.
  3. Use your professional judgment in the interests of the patients and the public and promote family, whānau and community health.
  4. Show respect for others and exercise your duties with professionalism.
  5. Actively seek and apply contemporary pharmacy knowledge and skills to ensure a high standard of professional competence.
  6. Act in a manner that promotes public trust and confidence in pharmacists and enhances the reputation of the profession.
  7. Practise in a manner that does not compromise your professional independence, judgement or integrity, or that of other pharmacists.

The Code of Ethics goes on to expand on each of its principles in seven sections. I encourage you to read through the document, as it’s interesting to come to a better understanding of the ethical standards to which New Zealand pharmacists should be held. For example, part 2.4 regards the patient’s right to informed consent:

YOU MUST… Explain the options available to patients and the public, to help them make informed decisions. Make sure the information you give them is impartial, relevant, up-to-date and independent of personal commercial considerations.

The section of this Code of Ethics which I found most interesting, as well as most encouraging, is section 6.9 (emphasis mine):

YOU MUST… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.

Although it is written here in this code, most people who use a pharmacy in their day to day lives aren’t aware of it. Instead, it is more like an unspoken assumption: if it’s sold in a pharmacy, then surely it’s legitimate, reliable, and effective. And of course, this should be the case – if there is no credible evidence of efficacy then an ethical institution should neither promote nor supply it. The Pharmacy Council has also published Advertising Guidelines, and its General Principle 7 reiterates this point (emphasis mine):

Any medicine, complementary therapy, herbal remedy or other healthcare product associated with the maintenance of health must have credible evidence of efficacy and safety (Code of Ethics 2011: 6.9). Health claims for complementary therapies or herbal remedies must be able to be substantiated and must not breach the Medicines Act with regard to therapeutic purpose.

Unfortunately, it appears many New Zealand pharmacists do not abide by these rules. I was unfortunate enough recently to discover an instore display in an Auckland pharmacy for a product called “NO-JET-LAG”. While I was in the pharmacy, I took a photograph of this display with my phone:

NO-JET-LAG

As you can see, this display makes some strong and explicit claims regarding the effect of the product:

TRY NO-JET-LAG
It Really Works

Effective

Homeopathic Jet Lag Prevention

Hang on a minute… “Homeopathic”… That sounds familiar. I wonder what exactly is in these pills? Luckily, there’s a website listing their ingredients:

The five homeopathic remedies listed below are the active ingredients in No-Jet-Lag.

Arnica Montana 30C (Leopard’s Bane), Bellis Perennis 30C (Daisy), Chamomilla 30C (Wild Chamomile), Ipecacuanha 30C (Ipecac), Lycopodium 30C (Clubmoss)

If you’ve read my post on homeopathic dilutions, you may recall that “30C” means the ingredient has been diluted by 1/100 30 times. That is a mind bogglingly large dilution. If you were to end up with just one single molecule of the original ingredient at the end of that, you’d have to start with 1060 molecules of it.

That’s a hard number to visualise though, and it’s hard to think of things in numbers of molecules, so let’s compare it to something more familiar. The Earth is made up of roughly 1050 atoms, so the amount of ingredient we’d have to start with would be roughly 10,000,000,000 (yes, that’s ten billion) times bigger than the planet. Even the Sun only has around 1057 atoms in it: still 1,000 times fewer than the number we’d need. Needless to say, after the dilution is done there is absolutely no amount of any of these ingredients remaining in any “NO-JET-LAG” pills.

Knowing this, it seems rather implausible that they’d be effective for anything at all, let alone specifically preventing jet lag, but all the same it’s best to look at the evidence. The manufacturer’s website has a Scientific Test page. Now, given that I have spent some time writing up a complaint to the Advertising Standards Authority because I don’t think this evidence even comes close to being enough to substantiate the claims made about these products, I don’t particularly want to write out the same arguments all over again. So I am going to make this complaint public. While the first section specifically regards the instore display I saw in Parnell Pharmacy on the 2nd of July, the other sections are about the evidence regarding “NO-JET-LAG” and the ethical implications of my complaint, and these sections apply to all of the many New Zealand pharmacies that promote and supply this product.

This complaint should be read with the following in mind: Assuming I am correct regarding the evidence for this product, I think the appropriate response of pharmacies stocking it would be to immediately remove it from their stock, and to apologise to the customers they have failed to protect. The Code of Ethics for an industry is the absolute minimum acceptable level of ethical behaviour, and it appears for all the world that many New Zealand pharmacies haven’t even been doing that.

(Note that the original complaint was in plain text but I’ve edited it to add appropriate formatting here)


An instore advertisement for “NO-JET-LAG” in Parnell Pharmacy contains misleading therapeutic claims, in violation of the Therapeutic Products Advertising Code Principle 2. Because these claims are misleading, the advertisement also fails to observe the high standard of social responsibility required of it by the Therapeutic Products Advertising Code Principle 3.

The advertisement contained the following text (also see image attached):

TRY NO-JET-LAG
It Really Works

NO-JET-LAG
Homeopathic Jet Lag Prevention
Natural | Effective | No Side Effects or Drug Interactions

The Perfect Travel Companion

The product packaging, also visible from the front in the attached image, displayed this text:

The Perfect Travel Companion

NO-JET-LAG
Long Haul, for flights longer than 7 hours
Homeopathic Jet Lag Prevention

The strong and absolute therapeutic claims “Homeopathic Jet Lag Prevention”, “Effective”, and “It Really Works” require robust substantiation. Although it may not fall within the ASA’s jurisdiction, it is important to consider the advertisement within therapeutic context implied by its placement on the front desk of a pharmacy and by the prominently displayed name of the product “NO-JET-LAG”.


As far as I can tell, the only substantiation offered by the manufacturer is a small (n=19) pilot study that does not appear to have been published in a peer-reviewed scientific journal. This pilot study can be found on the manufacturer’s website: http://www.jetlag.co.nz/jet-lag6.html

Although it is not stated in the study, the POMS scale on which subjects rated their level of “fatigue-inertia” (the only measured end point reported to have statistically significant differences between control and experimental groups) is measured on a scale from 0-28. In this context, the mean difference between control and experimental groups of 3.84 is less impressive than in the context of a smaller scale that seems a sensible conclusion from reading the study, given that the y-axis of the bar chart only goes from 0-12. The non-significant measure of “vigor-activity” is similarly displayed on a chart with a y-axis from 0-22, whereas the actual scale is from 0-32.

Also, the POMS scale includes 6 measurements, yet there is no mention in the study of having corrected their statistical analysis for multiple measurements. Assuming that no adjustment for this was made, as none is mentioned in the study, this means that although one of the 6 measurements purportedly reached statistical significance it is fairly likely to have been a false positive. From random chance alone, the chance that 1 out of 6 measurements would reach this level of statistical significance is approximately 1/4 (26.5%). A relatively conservative method of correction, the Šidák correction, would alter the required p-value for statistical significance in this case to 0.0085. However, the measurement’s p-value of 0.026 doesn’t even come close to crossing below this threshold and would therefore not normally be considered statistically significant.

The study also brings the effectiveness of its participant blinding measures into question with the following statements:

When asked if they knew whether they had taken the remedy or the placebo, they said that at the time of arrival in Germany the whole party all felt very tired but most were already fairly sure which treatment they had taken.

On the outward journey, of the 19 taking part 13 (68%) correctly guessed whether they had taken the placebo or No-Jet-Lag. Of the others, three did not know and three incorrectly assigned themselves to the wrong group.

On the return journey, two were incorrect, three did not know and 14 (74%) correctly guessed.

Also, one of the study’s authors was the Director of Research at Miers Laboratories, the manufacturer of this product. It is not clear how much influence the manufacturer had over the study design or operation, or to what extent it may have been funded by them.

So, as far as I’ve been able to find, the only evidence that could be used to support the very strong claims made on this advertisement is a small unpublished non-independent pilot study with questionable blinding that does not appear to have reached the threshold for statistical significance. In short, the claims do not appear to have been adequately substantiated, and should therefore be considered to violate the Therapeutic Products Advertising Code Principle 2.


Although it falls outside of the ASA’s jurisdiction, I feel it would be appropriate to briefly discuss the Pharmacy Council’s Safe Effective Pharmacy Practice Code of Ethics 2011. Section 6.9 of this industry code of ethics states that:

YOU MUST… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.

I sincerely hope that the manufacturer of this product has high quality rigorous scientific evidence that substantiates the claims made about this product hidden away somewhere and that, despite the fact that the only evidence they publicise on their website is the tiny low quality pilot study I discussed above, they have shared this evidence with every single one of the many New Zealand pharmacies who stock their product. If not, and things really are as they seem, then this would be an appallingly widespread violation of perhaps the most important part of the Pharmacy Council’s Code of Ethics.