Category: Health and Medicine

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 I’ve embedded these below so you can see the claims as they were originally made: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.

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.

ACC and Alternative Medicine

The Accident Compensation Corporation (ACC) is part of the healthcare system in New Zealand. To quote themselves on their purpose, they provide “comprehensive, no-fault personal injury cover for all New Zealand residents and visitors to New Zealand”. To put it simply, if you hurt yourself in an accident in New Zealand, ACC will likely pay for all treatment you require to recover from that injury.

They are not strictly part of the government, but they are a Crown organisation set up via the Accident Compensation Act 2001, and they are controlled directly by the government through an ACC minister. At the time of writing, the current ACC minister is Judith Collins. The ACC is funded publicly through various avenues, including levies on people’s earnings.

Recently, the current chair of the New Zealand Skeptics, Gold, submitted an Official Information Act (OIA) request (using the great service FYI, which makes these requests public) to the ACC asking:

Please can you tell me, for each of the last 10 years, how much the
ACC has paid out for each of the following services:

Acupuncture
Chiropactic
Osteopathy
Naturopathy

On the 20th of May 2014, the ACC responded to Gold’s OIA request with this information:

The following table shows the total amount (in dollars, excl GST) ACC has paid under Regulations for Osteopathic, Acupuncture and Chiropractic services for the last 10 years.

Financial Year $ cost
Osteopathy Acupuncture Chiropractic Total
2003/04 6,210,642 4,424,458 8,056,875 18,691,975
2004/05 6,767,849 5,452,119 8,007,011 20,226,979
2005/06 7,237,766 5,954,239 7,947,342 21,139,347
2006/07 8,038,676 7,616,042 8,734,453 24,389,171
2007/08 10,082,351 12,392,494 12,007,580 34,482,415
2008/09 10,945,880 15,761,415 13,173,902 39,881,197
2009/10 10,470,269 15,605,042 11,804,095 37,879,406
2010/11 9,802,401 16,225,902 10,832,912 36,861,215
2011/12 10,029,446 16,958,808 11,654,292 38,642,546
2012/13 10,964,806 19,961,329 12,312,832 43,238,967

…

Naturopath is not an ACC funded service; therefore your request for this information is declined under section 18(e) of the Act, as the document alleged to contain the information requested does not exist or cannot be found.

Here’s that information on a chart, excluding the totals. As you can see, spending on acupuncture in particular has increased dramatically over the last decade:

ACC spending on alternative therapies per financial year from 2003/04 to 2012/13
ACC spending on alternative therapies per financial year from 2003/04 to 2012/13

This OIA request was a follow-up to an earlier request from Mark Honeychurch regarding essentially the same information. The response to Gold’s request included a new column for 2012/13, as well as the “Total” column although that isn’t strictly new information. Also, the information from Gold’s request seems to have been a catalyst for an article published on the 24th of May 2014 on stuff.co.nz: Big Bill for Alternative Health.

This article did a little more digging, asking questions of doctors, acupuncturists, and the ACC. I highly recommend you read it. The most interesting part to me was this:

In 2009, then-ACC Minister Nick Smith questioned the ballooning ACC bill for complementary treatments and said their effectiveness would be reviewed.

Since then, the cost has risen another $5m but ACC said no review ever took place.

ACC Minister Judith Collins did not answer questions about the review.

It is not mentioned in this article, but I have known for some time that the ACC has a document published on their website entitled Acupuncture Treatment Profiles. The document describes itself as:

a valuable guide in the application of protocols that are included within a Traditional Chinese Medical (TCM) diagnosis, providing important information that assists an acupuncturist’s treatment strategy.

This appears to be an official ACC document, to be used by ACC-registered acupuncturists to determine appropriate methods of diagnosis and treatment that are approved for ACC funding. However, having a look through it one can’t help but notice egregiously wrong and pseudoscientific statements such as the following:

  • Acupuncture… Relieves pain by treating stagnation of Qi and Blood in the affected areas and channels
  • Qi is the vital force of life which… Is the material substrate of the Universe
  • Brain… Is considered to be the same in substance as marrow
  • the Kidney produces marrow

I shudder at the thought that the ACC levies I pay are partly used to fund this. It seems to me that it’s high time the ACC carried out a review of the evidence behind these therapies that it funds, so problems like this can be rooted out and dealt with. Publicly funded healthcare should be based on science, after all.

What Does “37% More Powerful” Really Mean?

Yesterday, the Advertising Standards Authority released a decision regarding a TV advertisement for Panadol Extra. The advertisement claims that the product is “37% more powerful than standard paracetamol tablets”. Although this is not the claim that was challenged in the complaint, the advertiser, GlaxoSmithKline (GSK), provided a citation in attempt to substantiate their claim.

However, it seems to me that the citation they provided substantiates a different claim. The study they provided, Laska et al. 1984, substantiates the claim that their product is 37% more potent than standard paracetamol tablets, not 37% more effective. As far as I’ve found, in pharmacology, potency refers to the dosage required to achieve a particular effect. In claiming that their product is “37% more powerful” they didn’t mean that it is able to provide 37% more pain relief, but that you don’t have to take as much of it to get the amount of same pain relief.

In order to convince the Advertising Standards Complaints Board that saying “more powerful” when they meant “more potent” was not misleading, GSK pointed to a 2009 ASA decision in their response to the complaint:

Importantly, the claim ‘37% more powerful than regular paracetamol tablets‘ and the associated graph in question relate to the potency of Panadol Extra compared with regular paracetamol tablets and NOT its efficacy. That is, the reference to potency refers to the ratio of doses required to achieve the same analgesic effect rather than any improved efficacy result.

In October 2009, a complaint was considered by the ASA in relation to the claim that Panadol Extra is ‘37% more powerful than regular paracetamol tablets’. The ASA Panel was of the view that this was an accurate description of potency and that it did not communicate efficacy improvements. The Panel was also satisfied that the claim 37% more powerful had been substantiated by the Laska 1984 study (Attachment 2). Accordingly, the Panel determined that the advertised claim was not, directly or by implication, deceiving or misleading consumers (Attachment 3).

Given the historical consideration of this claim by the ASA it is GSK’s view that the claim accurately communicates the potency of Panadol Extra and not the efficacy of this product compared to regular paracetamol tablets.

The complaints board seems to have accepted this argument, as they state in their decision that:

Firstly, the Advertiser addressed the claim “37% more powerful than standard paracetamol tablets” and the Complaints Board noted the percentage was in relation to the potency not the efficacy. It also noted the Advertiser provided robust substantiation to support the factual claim.

Partly as a result of this, the complaints board ruled to Not Uphold the complaint.

However, things aren’t quite that simple. First, the Commercial Approvals Bureau also responded to the complaint, stating that:

The claim of 37% improved efficacy over standard paracetamol is verifiable fact, and the client has sufficient data to substantiate this claim.

(Emphasis mine)

Apparently the Commercial Approvals Bureau was misled by the advertisement, interpreting its claim that the product is more powerful as regarding efficacy, not potency. To tell the truth, when I read the claim I made the same assumption. I was very surprised when GSK defended the claim by essentially saying they meant something else so it was okay, and honestly felt as though I had been misled.

It seems the complaints board have likely been misled as well. When GSK referred to the 2009 decision (09/626), they missed a very important point. That advertisement appeared in a publication specifically for medical professionals, and the complaints board had considered the likely interpretation of “more powerful” in that context. From their decision, they stated:

The Panel was of the view that within this informed environment, there would be a greater awareness and familiarity with analgesics, the difference between analgesic effect and potency, and a level of comfort with references to scientific studies and the capacity and the ability to access these studies, if further clarification was required of the reference to them.

Having made these observations, the Panel was of the view that medical practitioners reading the advertisement would understand the word “STRONGER” in the advertisement to mean potency.

In their response to this recent complaint, it seems GSK may have misled the complaints board when they told them that previous precedent has determined that “more powerful” means “more potent”, as they omitted the important and relevant fact that it was only decided to be the case for advertisements aimed specifically at healthcare professionals, not advertisements aimed at the general public such as this one.

It’s also relevant that, in some of the advertisements complaint 09/626 was about, GSK was making these claims:

Because Panadol Extra is 37% more powerful than regular paracetamol it provides extra pain relief and helps you break through the pain barrier

Panadol Extra…combines paracetamol with caffeine for 37% extra pain relief

That complaint was Upheld (in part) because the ASCB ruled that these claims had not been substantiated and were therefore misleading. Given that GSK has been willing to make this claim explicitly in the past, despite the fact that it seems to have been misleading, it would not surprise me at all if they intend for uninformed consumers to take away the same message from their more recent advertisement.

I also can’t help but wonder if the complaints board actually went through the details of complaint 09/626 when considering complaint 13/585, or if they just took GSK’s word for its contents. Their decision seems to imply the latter, unfortunately.

What do you think about the claim “37% more powerful”? Would you have assumed it meant “37% more pain relief”, or that it means you can take 37% less of the active ingredient in Panadol Extra than regular paracetamol to achieve the same result? Would you have been misled by this advertisement like the Commercial Approvals Bureau seems to have been?

Update 2014/03/27

I hadn’t realised that when I first wrote this article, but it turns out both Panadol and Panadol Extra each contain 500 mg of paracetamol per tablet. So although the main selling point of Panadol Extra seems to be that, because it also contains caffeine, you can take 37% less paracetamol to get the same analgesic effect, the pills themselves don’t actually contain any less paracetamol.

Doesn’t that make the claim that it’s more potent entirely irrelevant? They’re not claiming that it can product more pain relief at the same dose, they’re claiming that it can produce the same pain relief at a smaller dose. But then they’re not offering a smaller dose.

Maybe they expect you to cut off 37% from each Panadol Extra capsule before taking it. It seems more likely, in my opinion, that they’re just hoping people will misinterpret their claims in their favour, and expect Panadol Extra will provide 37% extra pain relief. You know, like they used to advertise before the ASA found those claims to be misleading.

How to Read Medical Advertisements

Lately, I have been familiarising myself with how medical advertisements are regulated here in New Zealand. In doing this, I have come to realise that regulatory bodies do not always interpret advertisements in the same way as I would expect the public to interpret them.

This sort of discrepancy can be, and frequently is, exploited by advertisers of medicine, both legitimate and less so. While it may be in the advertisers’ interest to have these differences in interpretation as it allows them to mislead the public about the effectiveness of their product, for the exact same reason it is not in the best interest of consumers.

In this article I describe how advertisers and regulators appear to interpret medical advertisements, and the implications of their interpretations. I hope that understanding this might enable others to understand what these ads are really saying. It is my sincere hope that, after reading this, you will never look at another medical advertisement in the same way again.

The first step I took in this project was familiarising myself with the codes of the Advertising Standards Authority (ASA), particularly those relating to therapeutic products and services. Their codes for weight management and ethics were also relevant. Based on these, I’ve submitted 11 complaints to the ASA since my first complaint last year, and I have more drafts that haven’t been submitted yet for various reasons.

As well as looking through the ASA’s codes, I’ve searched through previous decisions made by the Advertising Standards Complaints Board (ASCB) so I might better understand the codes’ application. The ASA website lets you search decisions from 2006 onwards, but older decisions can still be found by searching on Google within 203.152.114.11*.

If the ASCB decides to uphold a complaint, they request that the advertiser voluntarily withdraw the advertisement. As far as I am aware, it is at least very uncommon for an advertiser to refuse this request (the ASA website states that “This request is invariably followed.”) but the ASA does not have any actual legal authority with which they can enforce their decisions and they are unable to investigate breaches of the law as they only have jurisdiction over their codes.

When it comes to statutory regulation, Medsafe (part of the Ministry of Health) administers the Medicines Act 1981 and Medicines Regulations 1984, and the Commerce Commission enforces the Fair Trading Act 1986. For the most part, however, the advertising industry regulates itself via the ASA.

In reading past ASCB decisions about therapeutic advertising, I noticed that the ASCB frequently recommends the use of “TAPS”, the Therapeutic Products Pre-vetting System. Information on TAPS is available on the Association of New Zealand Advertisers (ANZA) website: TAPS.

Unfortunately, and somewhat counterintuitively, TAPS seems in practice to serve the opposite purpose of the ASA. The ASA and their codes mainly focus on protecting the consumer, particularly from misleading claims. In contrast, TAPS seems to focus on allowing advertisers to make whatever claims they want without running afoul of the ASA or the law. To see an example of this, see TAPS guideline 13, Examples of Health Claims in contrast to Therapeutic Claims Digestive System.

In this guideline, TAPS details the difference between a “therapeutic claim” and a “health claim”. “Health claims” are defined within this guideline as…

claims which support the normal physiological function.

“Therapeutic claim” essentially has 2 sets of definitions. One can be found within the ASA’s Therapeutic Products Advertising Code and the other in the Medicines Act 1981. The ASA defines “Therapeutic Use”, where a therapeutic claim is a claim for therapeutic use. Medicines Act defines “Therapeutic Purpose”, where a therapeutic claim is a claim for a therapeutic purpose. Both of these sets of definitions are fairly broad.

The ASA’s Therapeutic Products Advertising Code defines therapeutic use as…

Therapeutic use

  1. means use in or in connection with:
    1. preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in humans;
    2. influencing, inhibiting or modifying a physiological process in humans;
    3. testing the susceptibility of humans to a disease or ailment
    4. influencing, controlling or preventing conception in humans;
    5. testing for pregnancy in humans; or
    6. the replacement or modification of parts of the anatomy in humans; and
  2. includes any other use which the law provides shall be treated as a therapeutic use for the purposes of the code; but
  3. does not include any use which the laws provides shall not be treated as a therapeutic use for the purposes of this code.

The Medicines Act defines a therapeutic purpose as…

Meaning of therapeutic purpose
In this Act, unless the context otherwise requires, the term therapeutic purpose means—

  1. treating or preventing disease; or
  2. diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition; or
  3. effecting contraception; or
  4. inducing anaesthesia; or
  5. altering the shape, structure, size, or weight of the human body; or
  6. otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating or reducing or postponing, or increasing or accelerating, the operation of that function, or in any other way; or
  7. cleaning, soaking, or lubricating contact lenses.

TAPS guideline 1 – Therapeutic Claim/Purpose – has this to say about whether or not products are to be considered medicines:

Whilst natural, herbal, marine and dietary supplement products are not classified as medicines they would come under the Medicines Act for two reasons that might not be obvious. This means that certain herbal or dietary supplement products would be deemed to be a medicine for two reasons. This is because of a) a therapeutic claim as per the Medicines Act or b) the ingredients in the product which could be classified as a medicine under the Classification of Medicines

I’m not a lawyer, and in reading through the Medicines Act I haven’t been able to determine which section in particular causes this outcome. If anyone is able to shed any more light on this I’d be very grateful.

What I get from this, though, is that any advertisement that includes a therapeutic claim as defined in section 4 of the Medicines Act (quoted above) should be treated as a medical advertisement.

The guideline goes on to describe how advertisers can effectively circumvent this (emphasis mine):

a company may still advertise a product without getting consent [from the Minister of Health] and without a “therapeutic claim”. Essentially there is leeway for certain health or nutritional claims or statements relating to the normal physiological or biochemical function. This is covered generally by such statements as “assists or supports the normal physiological function”. Even terms like “enhancement” “fortify” and “improvement” would need to be used with care and would generally be a problem, as they imply an improvement or acceleration to the normal function. Often it is a simply a question of wording. For example, a statement such as “provides nutritional support for a healthy immune system” escapes therapeutic specificity whereas, “prevents, treats or cures flus or viruses” attracts liability and would be prohibited under the Medicines Act.

Here are some examples of “health claims” from TAPS guideline 13, which it claims “would not breach the Medicines Act”:

Aids healthy digestion

Helps restore normal bowel flora

Aids normal bowel function

According to TAPS, at least, none of the above claims would qualify for a therapeutic claim. This means that they would be considered to not require substantiation. For this reason, it is of the utmost importance for consumers to be able to distinguish between a therapeutic claim and a health claim. Therapeutic claims in advertising are required both by law and by industry regulations to be substantiated, whereas it seems health claims may be freely made without any supporting evidence whatsoever.

TAPS approval for an advertisement is something that the ASCB considers when an advertisement has been complained about, but it is not enough to prevent a complaint from being upheld. Here are some examples of previous ASCB decisions in which a complaint was upheld due to a breach of the Therapeutic Products Advertising Code despite the advertisement having attained TAPS approval:

Given the recommendations in the TAPS guidelines, it should be reasonable to assume that any advertisement with TAPS approval which makes health claims instead of therapeutic claims does so because it would be unable to substantiate those claims if a complaint were submitted to the ASA. It’s also likely that any claims containing a modifier such as “may” or “could” will be similarly unsubstantiated.

Advertisements with TAPS approval may cite a TAPS approval number, but as far as I’ve been able to find this gives no more information than that the advertisement has been approved, as there is no publicly accessible database of TAPS approvals and their details that I have been able to find.

Many complaints have not been upheld by the ASCB because the advertiser successfully managing to convince them that no therapeutic claims were made, even though the advertisement contains content likely to be interpreted by the public as a therapeutic claim. For example, take this complaint: 07/113 – BioMag Television Advertisement, which was not upheld by the ASCB.

For those of you unfamiliar with this product, it’s a magnetic underlay for your bed that is apparently intended to relieve pain. Here are some statements from a Woolrest Biomag NZ representative in response to complaint 07/113:

I have never said “underlays increase circulation“, on television. In fact I haven’t mentioned the word circulation this year, and in previous years under TAPs [sic] guidance I have only ever spoken of “supporting circulation“.

The word arthritis has never been used in our TV ads, in fact we do not refer to any specific pain conditions and never have.

[The complainant] also alleges we say the BioMag relieves pain. This is wrong. We are always careful to say it “could” relieve pain, as indeed tens of thousands of our clients can attest.

This sort of behaviour is representative of advertisers of products like this when responding to ASA complaints. Typically, their defense relies on convincing the ASCB that their advertisement contains no therapeutic claims, as opposed to providing substantiation for the claims they’ve made. For another example, see complaint 12/393, which I’ve already mentioned in the list above as having been upheld despite TAPS approval. The advertiser’s response to this complaint rested on the argument that no therapeutic claims were contained within the advertisement. In this case, the ASCB disagreed and, as the claims had not been substantiated, the complaint was upheld.

There are 2 main ways in which advertisers avoid the use of therapeutic claims.

First, by making “health claims”, which sound like therapeutic claims but tend to be technically meaningless (what the TAPS guidelines have called “escaping therapeutic specificity”). For example, a claim that a product “supports normal immune function” sounds as though it means it supports or improves immune function, but the advertiser could defend the claim by saying that by specifying that it supports normal immune function it does not imply that any physiological process is affected and therefore does not constitute a therapeutic claim.

Second, by using language in such a way as to not make an “absolute” claim. Often this involves qualifiers such as “may” and “could”, but it can also include words that normally would seem to imply therapeutic claims to the public, such as “supports”. For example, the complaints board decided not to uphold complaint 12/402 based partly on this:

Turning to the other claim that “the base of apple cider vinegar … assists your body in breaking up the mucous associated with winter ills and chills” the Complaints Board said the word “assists” was not an absolute claim.

Because of this, when reading, watching, or listening to a medical advertisement it is important to do a few things to make sure you are not misinterpreting it:

  • Identify “health claims”, as opposed to “therapeutic claims”, and realise that they most likely have not been substantiated.
  • Interpret every positive claim in the most conservative way possible. For example, if a product “may reduce pain”, it probably means “may not reduce pain, and hasn’t been proven to reduce pain”.
  • Interpret everything literally. Exaggeration and “puffery” are typically not allowed in medical advertisements, so you shouldn’t need to worry about misinterpreting something in this way. For example, if a product “helps resist winter ills and chills”, this does not mean “helps resist colds and the flu”. This also means that “supporting normal function” does not mean “supporting function”, as “normal function” refers to function when not interfered with.

Expect advertisers to always put their best foot forwards. If they are allowed to say their product “relieves cold and flu symptoms” then that is what they will say. If they say something like “helps you overcome winter ills and chills naturally” instead, it’s likely because they are not allowed to make the former, more definite claim.

Here are 2 examples of advertisements that are misleading yet manage to escape regulation.

1. Eken power bands: Golf Centre | Your Chemist

ASA complaint 12/393, already mentioned twice above, was upheld because an advertisement for this product implied unsubstantiated therapeutic claims:

Designed to assist with Strength, Balance, Flexibility, Endurance

Now that they cannot make such claims, the advertisements listed above instead simply list the same attributes without any description. It is still implied that the product is intended to improve the attributes, but not in such a way as a complaint would be likely to be upheld.

2. Detox foot patches: GrabOne

ASA complaint 12/502 was settled after someone complained that “the advertisement contained false and misleading claims that were not supported with evidence”. In response to this, the advertisers changed the advertisements so that the same false, misleading, and unsupported claims are still implied but are not made in such a way as to make a complaint likely to be upheld.

Note that this advertisement has a TAPS approval number. Instead of acting in the public’s interest by not allowing the advertiser to make false claims, they have helped them to make the same claims in such a way as the public will interpret them as claims and the regulators will not, effectively allowing them to escape regulation.

Finally, remember that not every advertisement is in line with the ASA’s codes and the relevant legislation. If you think an advertisement makes a therapeutic claim that is not valid and/or has not been substantiated, I encourage you to research it further and, if it appears your concerns are warranted, submit a complaint to the ASCB. Unsubstantiated therapeutic claims are in breach of the ASA’s Therapeutic Products Advertising Code principle 2.

*I have set up a search engine for this within my installation of Google Chrome, so I can search previous ASA decisions by entering “ASA ” into Chrome’s Omnibar on my computer. To do this yourself, click “Manage Search Engines…” inside Chrome’s Settings, scroll down and enter the following details to create a new search engine:

  1. ASA Complaints
  2. asa
  3. https://www.google.com/search?q=site%3A203.152.114.11+%s

Now, for example, if you want to search for “homeopathy” within previous ASA decisions you would just need to type “asa homeopathy” into Chrome’s omnibar and it will find all decisions containing the term “homeopathy”, including those from before 2006 like this decision from 2003.