Honest Universe

Superstition, pseudoscience, and scepticism

The Price of Painkillers Part 2: Only Misleading in Australia

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Yesterday, I wrote about how various painkillers with the same active ingredients often cost different amounts. In particular I talked about Reckitt Benckiser’s “Nurofen” ibuprofen products, some of which are advertised as targeting specific types of pain even though it doesn’t seem plausible, given that they are essentially exactly the same, that they could target different types or sources of pain.

There are a few aspects of their advertising that I think gives this impression. For one, they have products that seem intended for specific types of pain that have names like “Nurofen Migraine Pain” and “Nurofen Back Pain”. For another example, if you look on their website you’ll see that the claim “Targeted relief from pain” is pretty prominently displayed alongside their logo in the upper left hand corner:

Nurofen

The packaging of their products repeats this claim, also pretty prominently:

ibuprofen lysine 342 mg (equiv. ibuprofen 200 mg)

In 2011 Professor Paul Rolan*, head of the medical school at the University of Adelaide, laid a complaint with the Therapeutic Goods Administration (TGA) regarding a TV advertisement for Nurofen as a treatment for headaches regarding this claim. The TGA is roughly Australia’s equivalent of New Zealand’s Medsafe, as they are responsible for the regulation of therapeutic goods.

For some reason (I’m assuming it’s a bug, and have emailed them about it), although the decision is still listed on the TGA’s Complaints Resolution Panel’s website, its full details aren’t currently available. However, they have been archived in full elsewhere. The thrust of the complaint was that:

The complainant accepted that the advertised product “is undoubtedly effective” as a treatment for headache, but argued that “it works by being absorbed in the blood stream and being distributed widely around the body, not only to where it is needed but to everywhere else as well”, and that “there is no ‘targeting’ to the head and hence the phrases ‘targeted pain relief’ on the packet and the claim made in the advertisement ‘goes straight to the source of the pain’ are factually incorrect and misleading”.

The relevant section of the Therapeutic Goods Advertising Code was section 4(2)(c), which states that:

An advertisement for therapeutic goods must not… mislead, or be likely to mislead, directly or by implication or through emphasis, comparisons, contrasts or omissions

Reckitt Benckiser’s response was basically that they weren’t being misleading because anyone seeing their advertisements would realise that when they say Nurofen “goes straight to the source of pain”…

an ordinary and reasonable person viewing the advertisement would interpret it as conveying “that Nurofen goes to and acts at the source of the pain associated with a headache, namely where the headache is located in the head” and not “that Nurofen will only go to and act at the source of the pain.”

I don’t find myself convinced by this rebuttal. It seems analogous (if you’ll pardon the violent example) to saying a bomb targets a single person, but that’s not misleading just because it also happens to destroy everyone nearby as well.

You can read the full findings of the panel yourself at the link above, but for a synopsis they essentially agreed with Professor Rolan in that:

26. The Panel did not accept that, in being dispersed throughout the body, the advertised product could reasonably be said to “target” or “go straight to the source of” headache pain or the site of a headache.

They also found Reckitt Benckiser’s rebuttal unconvincing:

28. The Panel noted that the advertiser had argued that consumers were generally well aware that Nurofen was suitable for many types of pain. On this basis, the advertiser argued that consumers would not interpret the advertisement as conveying a “targeted” action in the sense alleged by the complainant.

29. The Panel did not accept this argument. While the Panel accepted that consumers might generally be aware that Nurofen is suitable for many types of pain, this does not mean that a reasonable consumer would be aware that Nurofen is normally distributed throughout the body when taken. The Panel was satisfied that a reasonable consumer, noting the references to “targeted relief of pain” and “going… to the source of pain”, would conclude that the active components of the product travelled specifically to areas of the body affected by pain – in this instance, the part of the head affected by a headache. The reasonable consumer would also conclude that the active components of the product would not travel elsewhere throughout the body to any significant degree. The Panel noted that although the advertisement did not state exactly how Nurofen might physically concentrate in areas of the body affected by pain and target them, it did convey that Nurofen would do so. That Nurofen might also be understood to be beneficial for other types of pain did not alter this, because in such cases Nurofen would again be understood to concentrate at the site of pain.

As a result, Reckitt Benckiser was told to stop that particular advertisement and to not make the same representations in other advertisements. Of course, this only applies in Australia; to my knowledge Reckitt Benckiser hasn’t changed their advertising strategy here in New Zealand. As far as I know, it also hasn’t been challenged here.

I’m reminded of another case of what I consider to be misleading advertising from a pharmaceutical company that I’ve written about previously. When GlaxoSmithKline has advertised their “Panadol Extra” product, they have claimed it is “37% more powerful than standard paracetamol tablets”. The catch is that, when they say “more powerful”, they’re referring to potency, not efficacy, so instead of meaning the pills give 37% more powerful pain relief it means you can take 37% less Panadol Extra to get the same amount of pain relief. This might be difficult, however, considering that a single Panadol Extra pill contains exactly the same amount of paracetamol as a standard paracetamol tablet – 500 mg.


* Professor Rolan is also a member of Friends of Science in Medicine, a great Australian organisation dedicated to promoting science and fighting pseudoscience in the medical field. They do some great work across the ditch; I’m a member and I think they deserve your support as well.

The Price of Painkillers

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DISCLAIMER: Since I mention some specific branded pharmaceutical products in this article, I want to make it very clear that I don’t intend to promote any particular product and have no conflict of interests to declare.


Last Saturday, the New Zealand Herald’s Consumer Affairs reporter Morgan Tait published a very good article about a topic I’ve come across before. Many painkiller products cost different amounts despite having exactly the same active ingredients, and for some reason this isn’t common knowledge. Here’s a link to her article: Expensive and cheap pain-relief pills use same ingredients

I first discovered this from watching a Consumer Advocacy TV show from Australia called The Checkout. It’s quite light-hearted in its approach to issues, which I admit I find a bit painful at times, but that’s just a matter of taste and the information in the show is pretty consistently good. Although its content is sometimes only relevant to an Australian audience, a lot of it is also relevant to New Zealanders and I’d highly recommend you watch it if you get the chance.

Their episode that deals with painkillers is season 1 episode 5. The main point, which is also made in Ms Tait’s recent article, is that many painkillers you can find in pharmacies and supermakets cost different amounts but have exactly the same active ingredients. The prime example given in both the article and the episode is Nurofen.

Nurofen is an ibuprofen-based painkiller made by the pharmaceutical company Reckitt Benckiser. They sell a product range of “specific pain relief” products:

  • Nurofen Migraine Pain
  • Nurofen Tension Headache
  • Nurofen Back Pain
  • Nurofen Period Pain

(Before I go into any criticism of these products, I do want to note that the efficacy of these products is not something I mean to call into question. I only intend to examine issues associated with their advertising and sale.)

If you look at the Nurofen website, you’ll also see that they have a lot of marketing claiming that their products can target specific types or sources of pain. For example, here’s the Nurofen logo as it appears in the upper left corner of their New Zealand website:

Nurofen

As you can see, their slogan “Targeted relief from pain” is pretty prominently displayed. Other sections of the site, such as their “Nurofen Treatment Advisor” (which recommends Nurofen products based on what sort of pain you say you have) also imply that certain products are more applicable to certain types of pain than others. However, all of the products I listed above have exactly the same active ingredient: 342 mg ibuprofen lysine.

I hope I don’t need to explain that, as all products are taken in the same way (a “caplet”) and contain the same active ingredient, your body isn’t able to distinguish between them so they’re all going to act in exactly the same way. If you take a Nurofen “Nurofen Period Pain” caplet for your migraine pain, it will be just as effective as a “Nurofen Migraine Pain” caplet.

The obvious explanation for this is that having specific products makes it easier for consumers to understand that this product can help with their specific type of pain. It probably helps Reckitt Benckiser sell more products too, just quietly. However, I can definitely see how this could be confusing to consumers – I know I was surprised for this very reason when I found out the products were effectively identical – and if the products are available for different prices people might end up paying more than they need to for exactly the same product.

The price issue, of course, is not an issue if all the products cost the same. However, this isn’t always the case. After I first became aware of this in March this year, I had a look and found that Pharmacy Direct stocked these products for different prices:

Of course it’s not particularly surprising that the 12 caplet packs are relatively more expensive than the 24 caplet packs, but the price differences between packs of the same size seems quite odd. I also find it very strange that it’d be cheaper to by two 12 caplet packs of Nurofen Migraine Pain than a single 24 caplet pack of the same product.

I emailed Pharmacy Direct on the 27th of March to ask about the price discrepancies. Their response was basically that yes, the products do all have exactly the same ingredient, and they thought the suppliers did that for marketing reasons. They told me that the difference in price was due to them selling more of some packs than others, so they can justify buying more of them from their supplier and getting a bulk discount that allows them to sell the products to consumers for a lower price. They also offered me the option to pay the lowest price for any of the products if I mentioned our conversation in the “notes” section when buying them online.

If you’re looking for a cheaper ibuprofen-based painkiller as an alternative to Nurofen, you can buy a 24 pack of Countdown’s “Homebrand” version (just one example, I’m sure there are others) for $2.99. That’s $0.12 per pill, compared with $0.73 per pill as the cheapest Nurofen branded option from Pharmacy Direct. Now if you check the packet you’ll see that Nurofen pills contain 342 mg of ibuprofen lysine, whereas this particular unbranded option contains 200 mg of ibuprofen per pill.

I’m by no means an expert on the differences between ibuprofen and ibuprofen lysine, but I’m under the impression that 342 mg ibuprofen lysine will have a faster onset than 200 mg ibuprofen but provide the same amount of pain relief. If anyone knows more please say so in the comments. If you look at a pack of Nurofen, you’ll see that they’re considered equivalent:

ibuprofen lysine 342 mg (equiv. ibuprofen 200 mg)

ibuprofen lysine 342 mg (equiv. ibuprofen 200 mg)

Other types of painkiller can suffer from similar problems. For example, a 20 pack of Panadol (500 mg paracetamol) from Countdown costs $4.19, but a 20 pack of their own equivalent “Home Brand” paracetamol (which also contains 500 mg paracetamol per pill) costs $2.19.

While these cheaper alternatives do often contain the same amount of the same active ingredient (or equivalent), they’d unlikely to be exactly the same. For example, they may use different “fillers” to make up the rest of the pill. If you’re concerned about the differences or want to know more, your GP or pharmacist should be able to give you some advice.

It can be worth looking for an unbranded version if you’re looking to save. So-called “generics” are typically made available after the patent on a drug ends, and other companies are able to start producing and selling it. They tend to be much less expensive, and are sometimes subsidised if you have a prescription, but are often also less well-known.

Written by Mark Hanna

2014/08/28 at 1:45 pm

ACC and Acupuncture

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Over the past year or so, various Official Information Act (OIA) requests have been made via the website fyi.org.nz, which allows for these requests and their responses to be made public. I have written previously about the results of some of these requests regarding ACC and Alternative Medicine. I’ve also shared some more information on Twitter, which Thomas Lumley has documented on the StatsChat blog: Sticking it to ACC

Following my previous post on this matter I also wrote to the ACC Minister, Judith Collins, in May to outline my concerns. Here’s what I said in my email:

Dear Ms Collins,

My name is Mark Hanna. I’m a consumer advocate from Auckland with a particular interest in alternative medicine. Over the past year and a half I’ve been actively trying to reduce the amount of misinformation regarding alternative medicine so often seen in advertisements, mainly by lodging complaints with the Advertising Standards Authority.

Last year, prompted by an earlier Official Information Act request, two friends of mine submitted OIA requests of their own to the Accident Compensation Corporation inquiring as to how much funding it had provided to “alternative therapies”:

The latter request has attracted some media attention: Big bill for alternative health

In looking further into this issue, I found that in 2004 Dr Paul Hutchison submitted a number of very interesting questions to the Minister of the ACC regarding their funding of acupuncture, such as how much had been paid, how much they expected to pay in the future, and whether the treatments covered were supported by scientific evidence.

I’m also aware, largely due to its mention in the recent article, and also due to this article from 2009, that in 2009 then-ACC Minister Nick Smith said the ACC would review the effectiveness of these treatments. Unfortunately, it seems no such review has been conducted.

Piecing together the information released by the ACC regarding their funding of acupuncture, I believe it paints a rather disturbing picture. I have attached a chart constructed from the data released by the ACC in response to your 2004 questions, and their updated expenditure data released earlier this month.

Now, of course, this wouldn’t be a problem if the ACC’s funding of acupuncture were due to a strong evidence base in favour of its effectiveness and safety. Unfortunately, this does not seem to be the case.

The earlier OIA request I mentioned asked the ACC how they measure the effectiveness of treatments that they fund. Their answer included the statement that:

With respect to processes and requirements for measuring effectiveness, Treatment Profiles have been developed for 150 common injury types. Treatment Profiles are guides to the treatment and rehabilitation services ACC expects a practitioner to provide to a client for a particular injury. They describe current ‘good practice’ and what outcomes should be achieved.

However, viewing the ACC’s Acupuncture Treatment Profiles document, I find instead that it is based on statements such as these:

  • “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”

That is only a small selection of the many statements in that document that are clearly – even blatantly – no more than pseudoscience at best. They certainly do not give the impression of science-based decision making.

In light of all this, I believe it is high time the ACC conducted a rigorous review of the evidence regarding acupuncture so as to cease funding treatment options that do not appear to be effective or science-based.

As current ACC Minister, I hope you will be able to help facilitate what seems to me like a long overdue review of the effectiveness of acupuncture and related practices as they are funded by the ACC.

Sincerely,
Mark Hanna

Here’s the chart I attached to that email:

ACC Acupuncture Spending 1994-2013

I heard back from Ms Collins on the 18th of June, you can view her response here:

Response from Judith Collins 18 June 2014

In her response, she described review ACC undertook of some of the evidence regarding acupuncture in 2011:

In 2011, ACC’s research team also conducted a literature review of the efficacy of acupuncture in the management of musculoskeletal pain. It found the most convincing evidence for the effectiveness of acupuncture related to the treatment of chronic neck pain and the improvement of pain and mobility in chronic shoulder pain. Evidence on the effectiveness of acupuncture is not dissimilar to other physical therapies such as physiotherapy, chiropractic and osteopathy.

Since that response, another OIA request was submitted to ACC by Mark Honeychurch, co-founder of the Society for Science Based Healthcare, asking for a breakdown of acupuncture spending by condition. To make the request easier, the categories requested were the same as those used by ACC’s Injury Statistics Tool. You can view the results from that request directly as a PDF or as a Google Spreadsheet.

The vast majority of the spending (around 94% for each of the last 2 years) was for soft tissue injuries. However, without a more detailed breakdown we don’t yet know how many of this was supported by ACC’s findings regarding the evidence for acupuncture.

Although the amount of money is piddling in comparison, I have to admit I find it rather concerning to see that, over the past decade, ACC has spend $9,000 on acupuncture for deafness.


I currently have an outstanding OIA request with ACC, asking for their 2011 review as well as any others they’ve conducted regarding acupuncture, and any guidelines they have for conducting these reviews.

Although my request asked for “copies of or links to all literature reviews regarding the effectiveness of acupuncture for any condition undertaken by ACC”, in their initial response to my request they only identified that I had asked for “A copy of The efficacy of acupuncture in the management of musculoskeletal pain conducted by ACC’s research team”.

I’m still waiting to hear back regarding if this means it’s the only such review, or if there are others as well. However, I have found other reports on the ACC website, like this one on the Effectiveness of acupuncture in selected mental health conditions, so I suspect there should be more reviews than just the 2011 one.

Yesterday, in response to a separate request from Kevin McCready, ACC has released this 2011 review. Although the names and qualifications of the author or authors were also requested, ACC denied this part of McCready’s request and removed that information from the report:

ACC declines to provide the names and qualifications of the staff members who compiled the literature review as there is a need to protect people’s privacy. We have also been unable to identify why the release of this information would be in the public interest.

You can find the full report, minus the name of the reviewer, here: The efficacy of acupuncture in the management of musculoskeletal pain

Here are the “Key findings” of this review:

General

  • There is insufficient evidence to make a recommendation for the use of acupuncture in the management of acute neck, back or shoulder pain
  • There is emerging evidence that acupuncture may enhance/facilitate other conventional therapies (including physiotherapy & exercise-based therapies)
  • There is a paucity of research for the optimal dosage of acupuncture treatment for treating shoulder, knee, neck and lower back pain
  • Studies comparing effective conservative treatments (including simple analgesics, physical therapy, exercise, heat & cold therapy) for (sub) acute and chronic non-specific low back pain (LBP) have been largely inconclusive

Lower back

  • The evidence for the use of acupuncture in (sub)acute LBP is inconclusive
  • There is limited evidence to support the use of acupuncture for pain relief in chronic LBP in the short term (up to 3 months)
  • The evidence is inconclusive for the use of acupuncture for long term (beyond 3 months) pain relief in chronic LBP
  • There is no evidence to recommend the use of acupuncture for lumbar disc herniation related radiculopathy (LDHR)

Neck

  • There is good evidence that acupuncture is effective for short term pain relief in the treatment of chronic neck pain
  • There is moderate evidence that real acupuncture is more effective than sham acupuncture for the treatment of chronic neck pain
  • There is limited evidence that acupuncture has a long term effect on chronic neck pain

Shoulder

  • There is good evidence from one pragmatic trial that acupuncture improves pain and mobility in chronic shoulder pain
  • There is limited evidence for the efficacy of acupuncture for frozen shoulder
  • There is contradictory evidence for the efficacy of acupuncture for subacromial impingement syndrome

Knee

  • There is no evidence to recommend the use of acupuncture for injury-related knee pain

Ankle

  • There is no evidence to recommend the use of acupuncture for ankle pain

Regarding the evidence found for neck and shoulder pain, it seems important to note a couple of caveats:

The “good” evidence for shoulder pain was from a single trial: Molsberger et al. 2010. This trial had a decent sample size of 424, and compared Chinese acupuncture to sham acupuncture.

The abstract doesn’t specify any details of the sham treatment, but the full paper describes it as involving the same number of needles and number and frequency of treatments, but the needles were placed at non-acupuncture points and inserted less than 5 mm (compared with 1-2 cm in the acupuncture group). I was glad to see one of the inclusion criteria was that participants be naïve to acupuncture, so they could be effectively blinded to this.

The full paper makes it clear that “Treatment assignment… was known to the acupuncturist” so this study wasn’t double-blinded.

The report also notes that its conclusions contrast with an earlier Cochrane review on Acupuncture for shoulder pain, which found that:

There is little evidence to support or refute the use of acupuncture for shoulder pain

The Cochrane review was carried out in 2005, though, prior to some of the studies examined in the ACC review such as Molsberger et al 2010.

It's surprisingly hard to find a stock photo of acupuncture involving gloves

It’s surprisingly hard to find a stock photo of acupuncture involving gloves

While the overall evidence for neck pain was described as “good”, when compared with sham acupuncture (which is the most appropriate control if you want to account for the elaborate placebo effect of acupuncture) the evidence was not so strong. It’s not clear what the sham protocol was, or if it allowed for the blinding of both participants and practitioners.

It seems Judith Collins’ description of the review’s conclusions was taken practically verbatim from its “Summary Message”, although she also seems to have opted to remove the sentence regarding the evidence for injuries other than those involving chronic neck and shoulder pain, which I’ve highlighted below:

The evidence for the effectiveness of acupuncture is most convincing for the treatment of chronic neck and shoulder pain. In terms of other injuries, the evidence is either inconclusive or insufficient. The state of the evidence of the effectiveness of acupuncture is not dissimilar to other physical therapies such as physiotherapy, chiropractic and osteopathy.

For a more direct comparison, here’s her wording again:

In 2011, ACC’s research team also conducted a literature review of the efficacy of acupuncture in the management of musculoskeletal pain. It found the most convincing evidence for the effectiveness of acupuncture related to the treatment of chronic neck pain and the improvement of pain and mobility in chronic shoulder pain. Evidence on the effectiveness of acupuncture is not dissimilar to other physical therapies such as physiotherapy, chiropractic and osteopathy.


Despite the findings of this report, ACC still seems to be spending a lot of money on treatments that their own review concludes are not supported by evidence. It’s hard to quantify exactly how much of their expenditure on acupuncture – over $24,000,000 over the 2013/14 financial year – went toward these treatments, but Daniel Ryan (also from the Society for Science Based Healthcare) has submitted another OIA request asking for a further breakdown of spending by body part.

In their response to Kevin McCready’s request, however, they have said that:

ACC funds acupuncture for conditions where prescribed by the client’s medical professional. This includes conditions other than musculoskeletal pain, and for non-chronic pain.

I’m trying to give them the benefit of the doubt, but from this it sounds like their review of the evidence may play no part in the decision of whether or not to fund acupuncture treatment for any particular condition.

Instead, it appears ACC will fund any acupuncture treatment so long as the patient was:

referred for acupuncture by a health professional who is covered by the Health Practitioners Competence Assurance (HPCA) Act.

Perhaps this explains ACC’s worrying funding of such treatments as acupuncture for deafness, but I certainly don’t think it excuses it.


Although the report makes an “Important Note” at the top that “The content [of this document] does not necessarily represent the official view of ACC or represent ACC policy”, I did find one particular section in the background section quite interesting. First off, TCM acupuncture is described as:

Drawing of the human body showing acupuncture meridians

TCM acupuncture involves inserting needles into traditional meridian points with the intention on [sic] influencing energy flow within that meridian

As far as I’m aware, that’s a fairly accurate description of how modern acupuncturists tend to claim their treatments work. For example, the New Zealand Register of Acupuncturists’ explanation of How Acupuncture Works claims that:

Any disruption or blockage of the flow of Qi along the meridians will in time affect the associated organ, resulting, for example, in decreased function or pain. Acupuncture aims to correct this flow of Qi, and thereby restore the balance within the body

This explanation also seems to be reflected in ACC’s Acupuncture Treatment Profiles document. However, the reviewer then went on to say that:

many physicians currently practicing acupuncture reject such pre-scientific notions described above

I think that description of acupuncturists’ claims to be able to manipulate qi flow with their needles as “pre-scientific notions” is absolutely spot on. The existence of qi and meridians is not supported by any evidence, and when this practice was developed it was based more on philosophy than evidence. In that way, it’s similar to extinct medical philosophies such as the “Western” medical philosophy of humorism.

One aspect of acupuncture that I find illustrates quite well the fact that its development was not supported by evidence is that horses are said to have a gall bladder meridian. This gall bladder meridian has even been the subject of published papers in journals such as the “Journal of Acupuncture and Meridian Studies”. What’s so odd about that, though? Horses don’t have a gall bladder.

Statements such as many of those found in ACC’s Acupuncture Treatment Profiles, which was “developed by the New Zealand Register of Acupuncturists Inc. in consultation with the New Zealand Acupuncture Standards Authority in a joint initiative with ACC”, are pretty self-evidently pseudoscientific. For example:

“Qi is the vital force of life which… Is the material substrate of the Universe”

If I want to know about the “vital force of life” or the “material substrate of the Universe”, I’ll ask a biologist and a physicist, respectively. So I asked a biologist and a physicist what they thought of these claims regarding “Qi”. Here’s what they had to say:

From my perspective as a biologist, that quote about Qi bears a lot more relation to the old and discredited concept of ‘vitalism’ than it does to modern biology. There is no evidence Qi exists, let alone that the lines along which Qi is supposed to flow through the body exist (and indeed, different ‘schools’ of acupuncture seem to deal in different ‘meridians’ – they can’t all be right!)

Alison Campbell, Senior biological sciences lecturer at the University of Waikato

I think it is self-evident that modern physics does not hold that qi is the “material substrate of the universe”; I would just say that qi is not something you find in physics textbooks; going beyond that might be beating a dead horse.

Richard Easther, Professor and Head of Department of Physics at the University of Auckland

(Alison and Richard often have interesting things to say. If you’d like to follow them, Alison blogs at Bioblog, and Richard at Excursionset.com. You can also follow him on Twitter @REasther.)


Now you have some insight into what I consider to be the problems with ACC’s funding of acupuncture. I’ve had people suggest to me, though, that some people do seem to benefit from acupuncture, so perhaps I shouldn’t be so interested in removing it from ACC.

Before I respond to that, I want to make one thing clear. I am not and will not argue for preventing people who want acupuncture from having acupuncture. Patient autonomy is an immensely important aspect of healthcare, and people have the right to make their own healthcare choices.

My primary motivation, as with all my involvement in dealing with dodgy healthcare claims, is echoed in the mission statement of the Society for Science Based Healthcare:

We believe that a strong basis in rigorous science is a necessary prerequisite for providing safe and effective healthcare. Decisions regarding public funding of healthcare in New Zealand should therefore be science based. We support public health measures that have a clear basis in science and evidence, and oppose those that do not.

We will work to counter misinformation about health issues propagated by individuals and organisations in New Zealand.

Consumers have the right to make an informed decision about their healthcare, and should not have to worry about being misled by unsubstantiated claims.

People have the right to make their healthcare choices, but they should not be misinformed by claims like “this needle will unblock qi flow through your meridians”.

Also, and this is more relevant to the case at hand, a treatment that is not supported by rigorous evidence is at best an experimental treatment. Generally the only ethically appropriate situation for an experimental treatment to be used is in a well-designed clinical trial, although in certain cases an argument can also be made for compassionate use exceptions.

However, this is not what is being funded. ACC is funding acupuncture for indications for which there is either insufficient evidence, no evidence, or negative evidence, and it is funding it in a clinical setting.

Furthermore, the ACC registered acupuncturists that benefit from this framework are generally proponents of the “pre-scientific notions” of qi flow and meridians. Whether they intend to or not, I think ACC is effectively promoting this via their association with these practitioners, and through official documents such as the Acupuncture Treatment Profiles. I also think this promotion is likely to do harm to the public understanding of science, particularly medical science.

ACC funding implies governmental approval, and many more obviously ineffective services such as “energy therapies” make similar justifications to acupuncturists. If consumers are led to believe that practitioners who base their practice on “pre-scientific notions” like qi flow are reliable and trustworthy, it seems reasonable to me to expect that they will think the same of practitioners who base their practice on other concepts such as aura healing.

So, what do I think should be done? I think ACC needs to review its funding scheme for acupuncture. I think their approach to this should start with reviewing their Acupuncture Treatment Profiles document, ensuring that the only treatments contained within it are those supported by rigorous evidence, and purging pseudoscientific claims from it. If they find they need to undertake further reviews of the evidence for the use of acupuncture for particular indications, then they should do that before approving funding for it.

I think ACC should then only agree to pay for acupuncture treatments that are aligned with their Treatment Profiles document, which they should commit to reviewing at regular intervals to keep it in line with the latest evidence (I’m not sure what time interval would be most appropriate, and I understand that there is a cost involved in that work).

I’m not sure, but it’s possible some changes to legislature may be required before this becomes a reality, but if that’s the case those changes should happen. A government body should not be bound by law to fund healthcare that is not supported by evidence.

There’s one last thing I’d also like to see, although I really feel like this is a long shot. I think ACC should take an active role in discouraging healthcare practice based on the “pre-scientific notions” described in their 2011 review. I think they should do this by distancing themselves from those acupuncturists who promote it and who base their practice on it, by refusing to grant them status as registered ACC practitioners if they are found to rely on it.

But I won’t hold my breath.

Osmosis Skincare’s Drinkable Sunscreen Trial

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If you haven’t already read my post about Osmosis Skincare’s Drinkable Sunscreen, you might want to do that before you read this one. A brief overview is that Osmosis Skincare claims drinking their “harmonized water” prevents sunburn. I complained to the Advertising Standards Authority that this claim wasn’t backed up by evidence and the complaint was upheld, now those products have been removed from their New Zealand website as a result.

In their response to this complaint (which you can read via the ASA’s website), Osmosis Skincare said that (emphasis mine):

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.

Osmosis Skincare NZ – Response to ASA complaint 14/287

When reading this, I noticed that the study design seemed to be lacking a control group (which prohibits randomisation and blinding) and that the sample size seemed very small. These are all properties of low-quality science, but with only this brief summary to go by I couldn’t draw in any firm conclusions. In any case, as they were making therapeutic claims without any evidence to back them up, the complaint was upheld.


A few days ago, the head office of Osmosis Skincare issued a press release regarding this “independent clinical trial”, which has now been completed. I have to say I wasn’t particularly surprised to read that the trial was actually not independent. The press release introduces it by saying:

Osmosis Pür Medical Skincare executed the [Harmonized Water UV Neutralizer] line’s first clinical trial on June 28, 2014.

Osmosis Skincare – First Drinkable Sunscreen Releases Clinical Trial Results

The press release also claimed that the trial was randomised (emphasis mine):

The randomized clinical trial was designed to evaluate a new technology…

Osmosis Skincare – First Drinkable Sunscreen Releases Clinical Trial Results

When a clinical trial is randomised, that means that participants are allocated into different groups in a way that is determined randomly. These different groups typically consist of an experimental group, which receives the treatment being tested, and a control group, which receives either a placebo or sham version of the treatment or the standard of care against which the experimental treatment is being compared. Randomly allocating participants into these groups helps avoid any systematic differences between the groups that could be a source of bias in the results.

Of course, this necessitates multiple groups for participants to be included in. With a sample size of 30, this means each group would only contain around 15 people. However, the press release isn’t done with its surprises yet:

24 patients ranging from 18 to 60 with various ethnic backgrounds and skin types were exposed to one hour of sun to one side of the body between noon and 1pm after ingesting 3ml Osmosis Harmonized Water UV Neutralizer

Osmosis Skincare – First Drinkable Sunscreen Releases Clinical Trial Results

The press release doesn’t mention 6 other participants in a control group, so it’s not clear yet if there was another (smaller) group that just isn’t mentioned here or if, for some reason, they went with 24 participants instead of the 30 they’d planned on using earlier.

The “Summary of Results” says that:

All 24 patients were evaluated before, and immediately after the exposure as well as the following morning. There was no evidence of sunburn on 16 patients, 5 had minor or partial sunburns and 3 had notable sunburns in the study.

This proves UV Neutralizer effectively limited the sun damage for a majority of the users that consumed it.

Hang on a minute, “proves”? I’m not sure how on Earth they’d expect to be able to honestly evaluate the effectiveness of their product without first establishing some baseline to use as a comparison. It reads as though they’ve assumed that, if their product didn’t work, then all participants would have received notable sunburns. If they want to gather evidence regarding the effectiveness of their product in an intellectually honest way, they’d need to either compare it to a placebo or to the standard treatment, so they can actually see if it cause different results than nothing or if it’s as good as the real deal.

Instead, though, we get quotes like this:

The definitive results from this trial prove that the scalar wave technology in Harmonized Water works.

Dr. Ben Johnson, Founder and CEO of Osmosis Pür Medical Skin Care – First Drinkable Sunscreen Releases Clinical Trial Results

The press release then provides links to the clinical trial and photos of participants.

If you click on those links, you’ll probably notice a couple of things right away. First, instead of being published in a peer-reviewed scientific journal, the link to the clinical trial takes you to a folder on “box.com”, a cloud storage website. Second, the PDF containing photos of participants only contains 16 participants, not the 24 we’re told participated in the trial. I’ve no idea why that is the case, or how they determined which 8 participants to exclude.

The paper, entitled “Evaluation of a Novel Form of Sun Protection”, seems laid out pretty much as one would expect from a real clinical trial, published in a peer-reviewed scientific journal. Its first author is Paul Ver Hoeve, the doctor that supervised the experiment, and the second author is Ben Johnson, the founder and CEO of Osmosis Skincare (although that conflict of interest isn’t stated in the paper itself). I’m really wondering why this was ever described as “independent”. Hopefully this was just a piece of honest confusion on the part of whoever was liaising with the ASA on behalf of Osmosis Skincare NZ.

Unsurprisingly, although the authors included 8 distinct references (out of 11 in total) for the claim that topical sunscreens can cause inflammation, this claim went unreferenced:

Upon ingestion of 2-3 ml of the [harmonized] water, the scalar waves reportedly work their way through the molecules of water in the body until they reach the water in the dermis. This process has been shown to take an hour on an empty stomach, 90 minutes if any food is present in the stomach.

Paul Ver Hoeve, Ben Johnson – Evaluation of a Novel Form of Sun Protection

The “Subjects and Methods” section starts with a very concerning sentence. As far as I can tell, this is the entire basis for describing the study as “randomized”:

In this study, 24 patients were randomly selected as test subjects with no consideration for their natural skin tone.

Paul Ver Hoeve, Ben Johnson – Evaluation of a Novel Form of Sun Protection

As I mentioned earlier, when a clinical trial is described as “randomised” that means participants are randomly allocated to different treatment groups. It absolutely does not mean “patients were randomly selected as test subjects”. I’m not sure what that even means. It sounds like it’s referring to their recruitment method, but no more detail is given so I can’t really tell what this is supposed to say about the study design.

In my opinion, using this as justification for describing this experiment as a “randomized clinical trial” is very misleading.

The report goes on to state that:

The decision was made to not do a double-blind test for this application because of the ethical implications of knowingly causing a sunburn in many people.

Paul Ver Hoeve, Ben Johnson – Evaluation of a Novel Form of Sun Protection

Despite this apparent ethical concern, I can see no indication of the trial being approved by an Institutional Review Board (IRB). I believe IRB approval is required of all human subject research in the USA that is publicly funded, but privately funded research like this doesn’t have the same requirement. I’m not sure how it would affect a trial’s chances of being published in a peer-reviewed journal, perhaps someone who knows more could weigh in via the comments.

Performing “a double-blind test” in this case would require giving some participants water then leaving them to burn in the sun for an hour, and they’re right to say that’s pretty obviously unethical. I think the fact that they realise this but it’s also what they did in their trial should have been a pretty big red flag that they could use some ethical oversight.

They also don’t mention what seems to me is obviously a more ethical and rigorous way to conduct the trial. Even if they didn’t manage blind the researchers, it would have been better for everyone if the experimental group were compared to a control group that had applied topical sunscreen instead. This would allow them to have a “randomized clinical trial” that is actually randomised, as well as giving them a baseline to compare their results to so they might have a chance to draw some useful conclusions.

The actual results of the experiment were that:

There was no evidence of a sunburn on 16 patients, 5 had minor or partial sunburns and 3 had significant sunburns in the study.

Paul Ver Hoeve, Ben Johnson – Evaluation of a Novel Form of Sun Protection

Now I don’t know about you, but 1/3 of participants getting sunburned doesn’t exactly sound like a rousing success to me. They went on to try to justify these failures by saying:

All of the patients who burned said they would not normally lay [sic] out in the sun for one hour. Many of them said they burn with the use of other sunscreens as well.

Paul Ver Hoeve, Ben Johnson – Evaluation of a Novel Form of Sun Protection

The report gives no indication that the other 16 participants were asked the same questions, so there’s no way of telling if this could have contributed to the results, let alone accounted for them. As far as I know, this hasn’t prompted Osmosis Skincare to put a warning label on their products that it’s not effective for people that don’t usually expose themselves to the sun very much. It also doesn’t stop the authors from putting the results down to these answers entirely:

While the results were not 100%, the authors believe this was due solely to the excessive amount of sun they received to their relatively virgin skin and their overall health.

Paul Ver Hoeve, Ben Johnson – Evaluation of a Novel Form of Sun Protection


Society for Science Based Healthcare

This trial had a tiny sample size, and was uncontrolled (therefore also non-randomised and unblinded), as well as being industry-funded and co-authored by the founder of the company that makes and sells the product. And on top of all that it didn’t even seem to have had particularly positive results.

If there’s any conclusion that can be drawn from this study, it’s that Osmosis Skincare is willing to do bad science and use its mediocre results to promote their products. Considering they were already making the same therapeutic claims before this experiment, I can’t say I find that surprising.

If Osmosis Skincare NZ stands by this research, and considers it rigorous enough to justify the sort of claims they were previously making about these products without substantiation, then they should appeal the ASA’s decision to uphold a complaint against them. I’d certainly like to see them try.

If you see this product being promoted or sold in New Zealand, please contact the Society for Science Based Healthcare with the details.

ASA Complaint: Osmosis Skincare’s Drinkable Sunscreen

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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

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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:

Written by Mark Hanna

2014/07/15 at 12:47 am

Ethical Pharmacy Practice and Homeopathic NO-JET-LAG

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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.

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