Ethical Pharmacy Practice 5: Looking for Leadership

Pharmacy
Pharmacy by russellstreet on Flickr CC BY-SA 2.0

In New Zealand, the Pharmacy Council is legally responsible under section 118(i) of the Health Practitioners Competence Assurance Act 2003 for setting standards of ethical conduct for New Zealand pharmacists. As part of this, they’ve written a Safe Effective Pharmacy Practice Code of Ethics, which requires 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.

Safe Effective Pharmacy Practice Code of Ethics Section 6.9

Last November, a case was brought to our attention at the Society for Science Based Healthcare of a salesperson in an Auckland pharmacy recommending and selling a homeopathic product to someone who didn’t realise until they’d bought the product and taken it home that it was homeopathic and that there is no credible evidence of its efficacy. The society wrote a formal letter of complaint to the Pharmacy Council about this, alleging that it was a clear violation of this section of their code of ethics.

As part of this complaint, we made a series of recommendations:

As a result of this complaint, we want pharmacists to have the opportunity to do the right thing and fulfill their ethical obligations. In order to achieve this, we suggest that the Pharmacy Council consider the following courses of action:

  1. Advise [the pharmacy] of their ethical obligation not to purchase, supply, or promote any healthcare product where there is not credible evidence of efficacy.
  2. Recommend that [the pharmacy] review their stock, starting with [the homeopathic products we found in their store], to ensure that they meet this ethical obligation. If they are not currently aware of credible evidence of efficacy for these products, they should request it from the manufacturer and, if they are not supplied with credible evidence of efficacy within a certain specified timeframe (we recommend 10 working days) to remove the products from sale.
  3. Recommend that [the pharmacy] undertake training of their staff to ensure that no one is giving unfounded healthcare advice to customers.
  4. Relay these recommendations to other New Zealand pharmacies so that they are also given the chance to ensure that they meet this ethical obligation.
  5. To assist pharmacies in evaluating whether or not a healthcare product is supported by credible evidence of efficacy, the Pharmacy Council should develop and publish guidelines regarding what constitutes credible evidence of efficacy. This need not be a strict requirement so much as a useful guide that pharmacists can use to establish a consistent minimum standard of evidence.

The Society for Science Based Healthcare

The Pharmacy Council said that creating a guideline for standards of evidence was not their role, although they suggested that it may be appropriate for the Pharmacy Guild or the Pharmaceutical Society to create such a guideline and forwarded the letter of complaint on to these organisations. To my knowledge, neither of them has created any such guideline.

The Pharmacy Council also wrote to the pharmacy in question. When I visited it some months later I found the same homeopathic products were still for sale, although they had at least been moved behind the counter.

I don’t know if that particular pharmacy still actively promotes and tries to sell these products, but on Twitter the other night I was told of another case where a sales assistant at a New Zealand pharmacy tried to sell a homeopathic product while clearly lacking any useful knowledge about homeopathy:

In response to the Society for Science Based Healthcare’s complaint, the Pharmacy Council also offered to remind pharmacists of their obligations with respect to selling any alternative medicines in their next newsletter. Last week, 9 months after having received our complaint, they finally published this newsletter. Here’s what they said:

Complementary and Alternative Medicines — Best Practice Guidance for Pharmacists

As medicines experts, pharmacists have built their reputation on providing accurate, unbiased information on the use, safety and effectiveness of all medicines, including complementary and alternative medicines. Pharmacists must be familiar with the latest information on the medications they supply to their patients, and seek independent information to maintain an objective viewpoint so they can help individuals make informed choices (Competence Standard O1.2.4).

Homeopathy in particular has had much attention over recent times, specifically regarding its plausibility and efficacy. Nonetheless, many people, including some healthcare professionals, continue to use or practise homeopathic medicine and advocate its safety and efficacy.

It is not Council’s purpose to endorse any particular complementary or alternative medicine or practice; however, Council believes it is necessary for pharmacists to have a basic knowledge of complementary and alternative medicines to engage with and advise patients appropriately.

This approach also ensures pharmacists can meet their duty of care to patients and the profession. Pharmacists should be able to counsel patients about complementary and alternative medicines’ general use, the current evidence and any safety issues, including their use with other medications.

Pharmacy Council July 2015 Newsletter

Although I’m glad to finally see a statement from the Pharmacy Council about homeopathy, I am disappointed at the weakness of this statement. Especially in contrast with their clear and strong code of ethics that requires pharmacists only sell healthcare products with credible evidence of efficacy – something that is clearly not the case for homeopathy.

However, I’m aware that the Pharmacy Council’s role is restricted to the responsibilities set out in the Health Practitioners Competence Assurance Act. So perhaps it would be better to expect professional organisations representing pharmacists to speak out against this. We have recently seen this to be the case with organisations of other healthcare professionals, such as the New Zealand Medical Association whose chair recently agreed on national radio that homeopathy is “just rubbish”.

In New Zealand there are two professional organisations (that I’m aware of) that represent pharmacists: the Pharmacy Guild and the Pharmaceutical Society. They are not so limited in position by the law as the Pharmacy Council, so I would hope to see stronger positions supporting science based healthcare from them.

Over the weekend, the annual Pharmacy Awards were held, hosted by both the trade magazine Pharmacy Today and by the Pharmacy Guild. Surely, at an event like this we should expect to see a celebration of outstanding examples of pharmacies providing quality healthcare services, right? For the most part, I hope, that may have been the case, but I was rather disheartened to see one award that flies in the face of this goal.

The official description for the Best Complementary Healthcare Campaign award is (with my emphasis added):

To win this award you need to have come up with a complementary health promotion or ongoing programme that has contributed to improved retail result, in areas such as, vitamins, supplements, sports nutrition or homeopathy.

Pharmacy Awards | Best Complementary Healthcare Campaign

I was shocked and dismayed to see this. Pharmacists should win awards for providing an excellent healthcare service. Not for selling more fake medicine.

Of the previous winners listed, one is Auckland pharmacist Martin Harris. I’ve written about him briefly before in another article about homeopathy being sold in New Zealand pharmacies, quoting him from a Pharmacy Today article in which he defended the practice:

Auckland pharmacist Martin Harris says there is good evidence for homeopathy in the field of quantum physics.

“There’s no placebo-controlled, double-blind randomised controlled trials using one remedy and one result because homeopathy doesn’t work that way, it works on energy,” Mr Harris says.

Conventional medicines have been proven to have side effects and contraindications, but pharmacies still sell them, he says.

Mr Harris, who specialises in nutrition medicine, admits he is no expert when it comes to homeopathy, and his Massey pharmacy sells only a few homoepathy products.

But he would be very disappointed if he was not allowed to sell the products as an option, he says.

Pharmacists support patient choice with homeopathy – Pharmacy Today

Mr Harris last won the “Best Complementary Healthcare Campaign” award in 2012, but perhaps you could hope the pharmacist community has since stopped celebrating such massively misguided interpretations of the evidence (and ethics) surrounding homeopathy. Unfortunately, this does not seem to be the case, as Mr Harris took home the Supreme Award at this year’s Pharmacy Awards despite selling homeopathic products in his pharmacy and appearing to be proud of it.


The pharmacist community makes no secret of the fact that it wants to play a larger role in New Zealand’s healthcare system, calling for changes such as allowing pharmacists to dispense contraceptive pills without a prescription and and provide a substitute for a GP’s services in some circumstances. From my position as an external onlooker, it does seem like there is a certain degree of pharmacists wanting to extend their practice and doctors trying to defend their turf, although I also think both sides have good arguments to make. So long as any changes primarily act to serve the healthcare needs of the public, I’m happy.

However, running a successful pharmacy is a balancing act between running a profitable retail store and providing a reliable healthcare service. Pharmacies can do a great job at improving access to essential healthcare services such as vaccinations and smoking cessation, but on the other hand many of them also boost their profits by selling healthcare products that do nothing aside from emptying your wallet. A recent opinion piece in Pharmacy Today that acknowledged this balance recommended upselling Vitamin C when customers asked about cold/flu products. While this would surely increase the pharmacy’s profits, the best available evidence doesn’t show that Vitamin C supplementation can help with the common cold or influenza.

There is a clear need for leadership within the pharmacist community regarding putting customers’ healthcare needs before profits. We trust pharmacies to provide us with reliable healthcare products and advice, but so long as they keep fake medicine on their shelves I’m not convinced they deserve this trust. To quote the hover text of this relevant xkcd strip:

I just noticed CVS has started stocking homeopathic pills on the same shelves with–and labeled similarly to–their actual medicine. Telling someone who trusts you that you’re giving them medicine, when you know you’re not, because you want their money, isn’t just lying–it’s like an example you’d make up if you had to illustrate for a child why lying is wrong.

Randall Munroe – xkcd: Alternative Literature

I believe pharmacists generally do care about providing the best health outcomes for their customers. What I want to see is more pharmacists putting patients before profits, following in the footsteps of Australian pharmacist Grant McGill by choosing to remove homeopathic products from their shelves.

Ethical Pharmacy Practice 4: Paving the Way

This year has not been a good year for homeopathy. There have been many blows to the industry in the form of more research finding it ineffective, position statements from organisations of health practitioners discouraging its use, and successful complaints to regulatory authorities. And this trend shows no signs of abating.

In March, the Australian National Health and Medical Research Council (NHMRC) published their Statement on Homeopathy, following a rigorous review of the evidence encompassing over 50 systematic reviews. The conclusion was clear:

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

Statement on HomeopathyNational Health and Medical Research Council (Australia)

Most organisations of medical professionals have codes of ethics that make it clear prescribing or selling treatments which are not supported by evidence is unethical. Putting two and two together, these ethical standards and the clear findings of the NHMRC have prompted the Royal Australian College of General Practitioners (RACGP) to publish a position statement on homeopathy:

The RACGP supports the use of evidence-based medicine, in which current research information is used as the basis for clinical decision-making.

In light of strong evidence to confirm that homeopathy has no effect beyond that of placebo as a treatment for various clinical conditions, the position of the RACGP is:

  1. Medical practitioners should not practice homeopathy, refer patients to homeopathic practitioners, or recommend homeopathic products to their patients.
  2. Pharmacists should not sell, recommend, or support the use of homeopathic products.
  3. Homeopathic alternatives should not be used in place of conventional immunisation.
  4. Private health insurers should not supply rebates for or otherwise support homeopathic services or products

Position statement: homeopathyRoyal Australian College of General Practitioners

Following this, in an interview with Radio New Zealand the chair of the New Zealand Medical Association (NZMA), Dr Stephen Child, made the NZMA’s position clear:

Susie Ferguson: So Australian doctors being told not to be prescribing this, and they should come off the shelves as well so people couldn’t even buy them over the counter. Would you support that happening here?

Dr Stephen Child: Well yes, it’s an ineffective treatment. It’s basically giving a glass of water or a sugar pill to patients, and I think you would consider that unethical if I gave you a sugar pill and charged you eighty dollars for that.

Doctors Told to Stop Prescribing Homeopathic ProductsRadio NZ

Homeopathy has never been supported by evidence, but the recent findings from the NHMRC have strengthened the scientific consensus and allowed many organisations to take a stronger stance against it.

When there is also a clear ethical mandate not to promote or provide healthcare that is not supported by evidence, all it takes to put two and two together is a little courage.

Now, Kingsley Village Pharmacy in Australia is paving the way, stating that their “Homeopathic products [are] going in the bin”:

The owner of Kingsley Village Pharmacy, pharmacist Grant McGill, has explained why he made this decision:

I’ve never promoted or recommended these products but I’ve accepted them passively and I felt a bit hypocritical having them on the shelves.

I operate a bit differently to corporate chains and believe a pharmacy should be professional rather than a place selling a lot of cosmetics.

If someone comes in with sleep problems, I will look at what is known to help and address things like sleep hygiene issues, rather than recommending flower essences.

Pharmacist bins ‘crap’ homeopathic productsThe West Australian

When the Twitter account for the pharmacy was asked if they thought their customers would notice or care about the change, they said:

A tweet from Grant McGill echoed the same sentiment as the reason for this change:

Through the Society for Science Based Healthcare, I have called previously for New Zealand pharmacists to stop selling homeopathic products.

When I had an complaint upheld against an Auckland Pharmacy for a misleading display stand for the homeopathic product No-Jet-Lag, that pharmacy promised to remove the product from sale and I hoped that New Zealand pharmacists would follow their example.

But it isn’t feasible for me to complain about each and every homeopathic product sold in a New Zealand pharmacy (although that hasn’t stopped me complaining about some). New Zealand pharmacists need to follow Kingsley Village Pharmacy’s example and remove the products not because complaints have been upheld, but because there’s no evidence they work so it’s clearly the ethical thing to do.


The Pharmacy Council of New Zealand is the body legally responsible under the Health Practitioners Competence Assurance Act for setting standards of ethical conduct to be observed by pharmacists on this side of the Tasman. To this end, they have published a Safe Effective Pharmacy Practice Code of Ethics. Section 6.9 of this code is very clear when it comes to pharmacists’ ethical responsibilities surrounding evidence-based healthcare:

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

Safe Effective Pharmacy Practice Code of EthicsPharmacy Council of New Zealand

Despite this, as mentioned in the Radio New Zealand interview with Dr Stephen Child from the NZMA, “In New Zealand, many pharmacies stock a range of homeopathic treatments”. When New Zealand pharmacists have been challenged on this point, their defences have ranged from bizarre misunderstandings of the evidence (e.g. “Auckland pharmacist Martin Harris says there is good evidence for homeopathy in the field of quantum physics”) to arguments that patient choice overrides their ethical responsibility:

But homeopathy is part of a holistic approach to healthcare, according to Auckland pharmacist Caleb Townsend, whose Lincoln Mall Pharmacy has qualified homeopaths onsite.

There is not one system that suits all people, Mr Townsend says in an email.

“Homeopathy is seen at this pharmacy as complementary to conventional medicine, in much the same way as acupuncture, vitamins and herbs are.”

Many patients believe homeopathy has been of benefit and they should be given the freedom to choose it if they want, he says.

“We have not yet become a society where cultural beliefs are legislated out of existence.”

Pharmacists Support Patient Choice with HomeopathyPharmacy Today

Dr Child provided a response to this line of argument in his interview:

Well, again as I say they argue that it’s mainly free trade basically, or a free market, so if people are willing to pay the money, and they think it works, then what are they doing that’s wrong?

And my problem with that argument though is to say that if they are telling the patient that it works then they are misleading in their advertising and even the Consumer Guarantee Act that it’s not allowed to mislead the consumer.

Second of all there’s an imbalance of a relationship when you come in to see a health practitioner and you’re the patient.

And thirdly when you’re suffering and you’re unwell you’re possibly not in a position to make an informed, balanced decision as a consumer. So I’m not even sure the free market argument would suggest that it would be legitimate practice.

Dr Stephen Child, Doctors Told to Stop Prescribing Homeopathic ProductsRadio NZ

The Society for Science Based Healthcare has also been in touch with Green Cross Health, an umbrella organisation that owns brands such as Unichem and Life Pharmacy and represents over 300 New Zealand pharmacies, to ask if they have a commitment to uphold section 6.9 of the Pharmacy Council’s code of ethics. Despite following up multiple times, the closest thing to a direct answer Green Cross Health has given to this question is:

While we support best practice we are also supportive of consumer choice.

Green Cross Health

The remaining defence of this practice is that pharmacists do more than provide healthcare, they also have to run a business. Following his Radio NZ interview, Dr Child alluded to this in an article from Pharmacy Today following his Radio NZ interview:

“Medically, it’s unethical to provide a treatment that’s not proven,” Dr Child says.

However, he has stopped short of telling pharmacies not to sell homeopathic products.

“It’s not really appropriate, I believe, for the medical profession to tell pharmacies how to run their business and how to act.”

Pharmacies have a difficult balance between providing healthcare and running a business, Dr Child says.

“It must be very difficult because they are a business as well.”

Homeopathy discredited again on both sides of the TasmanPharmacy Today

There is a range of behaviours among New Zealand pharmacies when it comes to promotion of homeopathy. Some few pharmacists refuse to sell the products at all, whereas many stock them but might not actively promote or recommend them. On the extreme end of this ethical scale, there are pharmacies like Lincoln Mall Pharmacy in Auckland, which promotes “homeopathic consultations” from homeopaths within the pharmacy, and Simillimum Pharmacy in Wellington, which describes itself as a “homeopathic pharmacy”.

The fact that there are some pharmacists who operate without relying on profits from selling homeopathic products indicates that it is entirely possible. Those pharmacists who passively sell them likely don’t rely on the profits made from those products as the difference between financial success and failure, so I’d hope they wouldn’t use higher profits as a justification for breaching their ethical obligations.

If any pharmacy has got to the level where their business would fail financially were it not for homeopathic products and services that they sell, then their business practices would blatantly violate their ethical responsibilities. I should think the risk of financial failure in a case like this should certainly not be an acceptable excuse for such unethical conduct.

Kingsley Village Pharmacy in Australia has set a great example for all pharmacists, having the courage to take a stand on ethics and stop selling homeopathic products. New Zealand pharmacists who currently have them on their shelves should follow in these footsteps.

To borrow Grant McGill’s words, pharmacists need to stand up for patient outcomes.

Then and Now: The New Zealand Complementary Medicines Industry

Supplements

In 2007, the Ministry of Health undertook a review of the “complementary medicines industry” in New Zealand, and found that a significant majority of companies weren’t complying with consumer protection legislation.

The review was never made public, but when I saw it mentioned in a recent article in North & South magazine I asked the ministry for a copy. It has been released to me under the Official Information Act.

Since it was written in 2007, both the industry and the regulations have undergone changes, so the review’s findings won’t be accurate now. However, I think it’s worthwhile looking at it to get a general understanding of the relationship between this industry and its regulators.


North & South June 2015

The June edition of North & South has published an article that Peter Griffin and I co-wrote about the implications of a recent Press Council ruling. Excluding letters to the editor, this was the first time something I’ve written has appeared in mainstream print media. Filled with vain excitement, I purchased a magazine for the first time.

When I saw the cover of this issue, promoting a story by Donna Chisholm entitled “Truth (and Lies) About Supplements”, I realised that it was a much better reason for me to buy this magazine than just to see my own name in print. I wasn’t disappointed either, the story is a great summary of the issues surrounding supplementation, and it’s written from a New Zealand perspective. I’d recommend that everyone interested in this topic pick up a copy of North & South to read it.

This is something I’m interested in so I already follow the news on this topic. A lot of what was discussed in the article I’d already seen, but there was also some very interesting stuff in there that I’d never heard anything about before. One of those things was a review of New Zealand natural health websites that the Ministry of Health undertook in 2007, apparently finding that nearly 80% of them were not complying with the Medicines Act:

[Natural Products NZ executive director Alison] Quesnel’s confidence in the veracity of claims made in New Zealand may also be misplaced. A Health Ministry review of 263 industry websites in 2007 found nearly 80 per cent making illegal therapeutic claims. A later “compliance awareness programme” discovered that more than half the ads on websites for natural products made therapeutic claims, with a third of the websites making “high-level” claims.

Chisholm, Donna (2015). The Truth (and Lies) About Vitamins. North & South, June, p41

When trying to find this review online, the closest I could find was a Regulatory Impact Statement that the Ministry of Health published in 2010, about “The Development of a Natural Health Products Bill”. This document doesn’t contain the review, it only references some of its results.

After Donna Chisholm told me that she found the information from her article in this document but didn’t have a copy of the review, I contacted the Ministry of Health to ask if it was available anywhere online, and if it wasn’t if they could send me a copy. They interpreted my email as an Official Information Act request, and within a couple of weeks the report appeared in my inbox.

EDIT 2015/05/31 3:44 pm: As Thomas Lumley has pointed out in the comments, they were entirely correct to interpret it in this way. I just hadn’t thought of it as an OIA request at the time.

Usually I use the great website FYI to make OIA requests. It’s a great service which I’ve mentioned before, that allows OIA requests to be made in a way that makes both the request and the response public. It was relaunched this year with sponsorship from the New Zealand Herald. This time, however, I didn’t realise at first that my email would be interpreted in this way, so the request and response aren’t hosted on FYI.

However, I have uploaded the report and made it available here: Overview of the New Zealand Complementary Medicines Industry. I found it quite interesting reading, and a bit disappointing that it was never released publicly until now, when it’s 8 years old. Please keep that in mind when reading it.


The report gathered information on businesses operating in this industry to produce estimates about the industry as a whole. The report includes information like the proportion of companies of various sizes (e.g. < 10 employees). Once again, remember this report is 8 years old at the time I’m writing this, so the state of the industry has certainly changed since then.

The section which I found most interesting by far is, of course, Non-Compliance. Here’s the blurb for that section (the emphasis is mine):

Of the companies where it was possible to obtain specific details about their products, an assessment was made of the level of non-compliance with the current Medicines Act (1981) and the Dietary Supplements Regulations (1985). Non-compliance was defined only on the basis of the presence of therapeutic claims associated with the product and no attempt was made to determine any other aspect of non-compliance e.g. the presence of scheduled medicines. Dietary supplement-type products (intended for oral use) carrying therapeutic claims and other products (including foods, cosmetics and complementary medicines) carrying therapeutic claims (i.e. unlicensed medicines) all came under the umbrella of “non-compliant”.

Medsafe. (2007, August 29). Overview of the New Zealand Complementary Medicines Industry.

Any product that is promoted with therapeutic claims as defined in the Medicines Act (this definition was updated in July 2014) is considered a medicine for regulatory purposes. I’m not a lawyer, and I’ve never been involved in the approval process for a medicine, but my understanding is that means it needs to go through a process that requires rigorous evidence to support its safety and efficacy, then before it can be sold it must be approved by the Minister of Health.

This is why products that haven’t gone through this process but still have therapeutic claims made about them are “unlicensed medicines”. Because the claims make them medicines for regulatory purposes, but they have not been approved. They might do what they’re claimed to do or they might not, but what they have in common is skirting the regulations that require them to back up claims of safety and efficacy.

It also means that the same product could be treated as an unlicensed medicine in one context but be perfectly acceptable in another. For example, if I advertise bananas as a cure for cancer, then that’s an unlicensed medicine. If I advertise bananas as a tasty fruit, that’s perfectly acceptable.

The review reported the number of compliant vs. non-compliant products found, as well as companies with and without non-compliant products:

Number of Non-compliant Products
Non-Compliant 6253 (51%)
Compliant 6008 (49%)
Total no. products found 12,261
Number of Companies with Non-compliant Products
No. of companies (%)
Compliant 58 (22%)
Non-compliant 205 (78%)
Total no. companies 263

To get some rough idea of the completeness of this review, the Ministry of Health’s natural health products bill regulatory impact statement I mentioned earlier, which I believe was written in 2010 and is an interesting document to read, estimates that there are around 6,600 products and 450 companies in total. However, they also noted that the estimate of 6,600 products might be a significant underestimate and that the real number might have been as high as 20,000.

The regulatory impact statement describes this as “A systematic review of websites undertaken in March 2007”, and gives some examples of non-compliant claims:

Examples of low level claims included claims for providing relief from the symptoms of arthritis or psoriasis, relieving the symptoms of seasonal allergies such as hay-fever, relief of pre-menstrual tension, or temporary relief of the pain of gout, headaches or migraine. Higher level claims included claims for preventing, treating or curing serious diseases, such as cancer.

Ministry of Health. (2010). Regulatory Impact Statement. The Development of a Natural Health Products Bill.

The review broke down the level of non-compliance into low and high severity, and reported the average for different companies:

The severity of non-compliance was also assessed. The severity of non-compliance was based upon the type of therapeutic claims being made by the company for their products and was divided into either high (claims of efficacy about a product for serious diseases and conditions including cancer, depression, diabetes etc.) or low (therapeutic claims likely to be appropriate for a low risk medicine). An “average severity” of the therapeutic claims made be [sic] each company was grouped into low or high.

Medsafe. (2007, August 29). Overview of the New Zealand Complementary Medicines Industry.

Severity of Non-Compliance per Company
Average severity of non-compliance No. of companies (% of total)
Low 144 (74%)
High 50 (26%)
High for >80% of products in catalogue 26 (10%)

The type of product was also reported for non-compliant products:

The non-compliant products (i.e. those carrying therapeutic claims) were further subdivided into cosmetic, food, dietary supplements and complementary medicines to provide some information about the types of products that were non-compliant. Cosmetics included products which were intended to have a primarily cosmetic purpose eg. moisturisers with anti-aging claims and food included products consumed in a normal diet such as fruit drinks carrying therapeutic claims. Dietary supplements included vitamins and minerals and products generally meeting the definition of a dietary supplement according to the Dietary Supplements Regulations 19851 apart from the claims made. Complementary medicines included products that did not fall into any of the above categories, including creams and balms with no primary cosmetic purpose and herbs with a traditional history of use as a medicine.

1 Dietary supplement means any amino acids, edible substances, foodstuffs, herbs, minerals, synthetic nutrients, and vitamins sold singly or in mixtures in controlled dosage forms as cachets, capsules, liquids, lozenges, pastilles, powders, or tablets, which are intended to supplement the intake of those substances normally derived from food.

Medsafe. (2007, August 29). Overview of the New Zealand Complementary Medicines Industry.

Unsurprisingly, as this was a review of the “complementary medicines industry” and “complementary medicines” was the catch-all category, most non-compliant products were in that category. I’m not sure why the total number of non-compliant products is lower than the 6253 non-compliant products reported earlier in the review.

Areas of Non-Compliance
Number (% of total)
Cosmetics 250 (5%)
Foods 252 (5%)
Dietary supplements 1357 (27%)
Complementary medicines 3170 (63%)
Total number of non-compliant products identified 5029

This was all 8 years ago, so what’s happened since? I don’t have any comparable data on how the state of the industry compares to these results today, but the Regulatory Impact Statement document I’ve mentioned a few times offers some insight here. Here’s what was done following this review:

In a subsequent compliance awareness programme, the websites reviewed contained advertisements for over 12,000 products with just over half of these advertisements including therapeutic claims. Out of 355 websites reviewed as part of this programme, 107 were found to be making high-level claims.

Ministry of Health. (2010). Regulatory Impact Statement. The Development of a Natural Health Products Bill.

Miracle Cure!

That’s roughly 30% making high-level claims, which is higher (although possibly not significantly) than the 26% found in the review. Overall non-compliance is “just over half”, compared with 78% from the earlier review. So it’s not entirely clear what impact this “compliance awareness programme” had, but if I had to guess based on what information I have it seems it may have resulted in some low level claims being removed but had no effect on high-level claims.

I asked for this in my OIA request as well, but no written report was prepared so I was just sent the raw data. Unfortunately, this came in the format of a spreadsheet saved as a PDF. It’s text searchable, but given the format and inconsistencies with how results are reported within the file it’s not easy to tell what it says about the industry overall. Also, presumably as it was only ever intended to be an internal document, it contains some strange stuff. For example, it reports Deer Velvet NZ as having 3 out of 1 non-compliant complementary medicines and notes that Crombie and Price “Have homeopathic lollipoops for kids”, whatever that might mean.

You can look at the data yourself here: Compliance of complementary medicines manufacturers 2 October 2007

EDIT 2015/05/31 5:48 pm: Thanks again to Thomas Lumley, who pointed out on Twitter that the open source software Tabula is able to pull the data out of that PDF and turn it into a CSV. I’ve made a CSV version created with Tabula available as well. Here’s a link to it on Google Drive, note that Drive doesn’t display large CSVs very well but you can download it or, if you’re signed in with a Google Account, open it as a Google Spreadsheet: Compliance of complementary medicines manufacturers 2 October 2007

The Regulatory Impact Statement document also has a section on “Compliance and enforcement difficulties” which I found very interesting (emphasis mine):

It has long been recognised that the regulation of natural health products is inadequate and working on achieving new legislation has been underway for close to 20 years. Because new legislation has been anticipated, only limited amendments have been made to update existing legislation, and enforcement activities have largely been limited to dealing with the most serious breaches, such as promoting a product as a cure for cancer when that product is not an approved medicine, or supplying a product that purports to be a dietary supplement but contains undeclared ingredients that are prescription medicines.

Enforcement actions usually arise following investigation of a complaint or concerns about product arriving at the New Zealand border. Enforcement is complicated because the interface between the Medicines Act and Dietary Supplements Regulations is not clearly stated. As a consequence it is usually unclear whether non-compliance should be dealt with under food or medicines legislation. The outcome is generally destruction of product or removal from the market, rather than prosecution. The penalty for non-compliance is extremely low ($500) in comparison with similar legislation and does not act as an effective deterrent.

Enforcement of the Dietary Supplements Regulations has long been problematic due to the large number of breaches relating to the prohibition of therapeutic claims. Past attempts to raise awareness and enforcement of the legislation relating to natural health products met with resistance from both suppliers (who fear they will lose sales) and consumers (who fear they will lose access to products they consider are important to their health and well-being).

There is no provision in the Regulations for a register of dietary supplement products or suppliers. Hence it is difficult to trace suppliers and take appropriate action to protect the public from harm when safety issues arise.

Ministry of Health. (2010). Regulatory Impact Statement. The Development of a Natural Health Products Bill.

This was written 5 years ago. In that time, new legislation has continued to be anticipated: the Natural Health and Supplementary Products Bill was introduced in September 2011 and passed its second reading in March 2013, but hasn’t progressed since then. Throughout this period, enforcement of consumer protection legislation to prohibit misleading therapeutic claims has remained very low. Even in cases where I’ve submitted complaints, months have often passed before any action was taken by Medsafe.

This makes it sound like the sooner this bill passes, the better. But if the Natural Health and Supplementary Products Bill passes in its current state, it will allow “traditional evidence” to be used to support health claims. It defines this essentially as evidence of use:

traditional evidence means evidence of traditional use of a substance based on knowledge, beliefs, or practices passed down from generation to generation

Natural Health and Supplementary Products Bill 324-2

On the other hand, the bill also requires that summaries of the evidence used to support health claims be provided on a public website in section 13(2A):

Before completing the product notification, the product notifier must make available on an Internet site, in respect of each health benefit claim made for the product, a summary of the evidence that the product notifier relies on to support the claim.

Natural Health and Supplementary Products Bill 324-2

I think that part of the bill is fantastic, but I don’t think it will be directly useful to consumers. Surely only a very small minority of consumers will bother to go online to check what evidence is used to support health claims. In cases where claims are supported only by evidence of traditional use, I think a large number of consumers could be misled, and that seems to me like a pretty big loophole in a piece of legislation intended to protect consumers from misleading health claims about “natural health and supplementary products”.

I hope that the bill will pass soon, so that the “natural health” industry will not continue to be effectively unregulated as it has been for years, but I also hope that before this happens the bill will be fixed so that the only evidence permitted to support health claims is evidence that actually supports those health claims.

Ethical Pharmacy Practice 3: Running Out of Excuses

Ethical pharmacy practice is something I have written about before. If you’ve read those posts, please bear with me as I cover some familiar background.

In New Zealand, we are lucky enough to have an industry code of ethics for pharmacists, published by the Pharmacy Council of New Zealand, which holds pharmacists to high ethical standards. This code of ethics is the Safe Effective Pharmacy Practice Code of Ethics. One of the most important parts of this code of ethics is section 6.9, which states:

[PHARMACISTS] 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.

Pharmacy Council’s Safe Effective Pharmacy Practice Code of Ethics Section 6.9

The Pharmacy Council of New Zealand isn’t a voluntary member organisation like the Pharmacy Guild or the Pharmaceutical Society. Instead the council is established as part of the Health Practitioners Competence Assurance Act 2003. Their roles are set out in this act and include:

  • Registering pharmacists
  • Reviewing and maintaining the competence of pharmacists
  • Setting standards of clinical competence, cultural competence, and ethical conduct for pharmacists

Which means that the Safe Effective Pharmacy Practice Code of Ethics is not a voluntary code of ethics. It is published by the body whose legal duty it is to set the standards of ethical conduct for pharmacists. Yet all over New Zealand, many pharmacists ignore it.

Walk into any New Zealand pharmacy. Chances are that you will find a section where they advertise and sell a range of homeopathic products. To anyone familiar with the evidence for homeopathy, it will come as no surprise when I tell you that there is no credible evidence of efficacy for any homeopathic product. Therefore, it seems to me, New Zealand pharmacists have an ethical obligation not to promote or sell them.

Yesterday, the Australian National Health and Medical Research Council (NHMRC) issued their final statement on homeopathy, following an incredibly extensive and rigorous review of the literature. They looked at over 1,800 scientific papers, and found that 225 met their criteria for methodological rigour, sample size, and placebo control. Their main finding was:

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

NHMRC Statement: Statement on Homeopathy

As I said, this conclusion does not come as a surprise. This research is the latest in a long line of reviews of the evidence for homeopathy that drew essentially the same finding:

  • A 2002 systematic review of systematic reviews of homeopathy published in the British Journal of Clinical Pharmacology concluded that:

    the hypothesis that any given homeopathic remedy leads to clinical effects that are relevantly different from placebo or superior to other control interventions for any medical condition, is not supported by evidence from systematic reviews. Until more compelling results are available, homeopathy cannot be viewed as an evidence-based form of therapy.

    A systematic review of systematic reviews of homeopathy

  • A 2010 systematic review of systematic reviews of homeopathy published in the Medical Journal of Australia concluded:

    The findings of currently available Cochrane reviews of studies of homeopathy do not show that homeopathic medicines have effects beyond placebo.

    Homeopathy: what does the “best” evidence tell us?

  • A 2010 report from the UK House of Commons concluded:

    homeopathy is a placebo treatment.

    Evidence Check 2: Homeopathy

  • In 2013, the NHMRC published a report based on their research that found:

    There is a paucity of good-quality studies of sufficient size that examine the effectiveness of homeopathy as a treatment for any clinical condition in humans. The available evidence is not compelling and fails to demonstrate that homeopathy is an effective treatment for any of the reported clinical conditions in humans.

    Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence

I could go on, but I hope by now you get the idea.


New Zealand pharmacists need to respond to the NHMRC’s research. And if they mean to practice responsibly and ethically, that response should be to immediately stop all promotion and sale of homeopathic products. The ethical standard to which they should be held is clear, and it is not consistent with promoting or supplying homeopathic products.

Last year, I complained to the Advertising Standards Authority under the auspices of the Society for Science Based Healthcare about a homeopathic product for preventing jet lag (No-Jet-Lag) that was advertised in Parnell Pharmacy. The pharmacy responded by removing the advertisement, and agreeing to stop selling the product if it was found that the claims were not supported by credible evidence, and my complaint was upheld. Unsurprisingly, my complaint was upheld when the ASA decided claims such as “it really works” were not supported by credible evidence. However, despite Parnell Pharmacy’s example, many New Zealand pharmacies still sell this exact product.

The NHMRC’s report represents the same finding, but on a larger scale. New Zealand pharmacists who promote and sell homeopathic products should follow the responsible example of Parnell Pharmacy, and remove homeopathic products from their shelves.

ACC and Acupuncture 3

I’ve written a couple of times in the past about ACC and Acupuncture:

To summarise, in 2014 a couple of Official Information Act (OIA) requests to ACC uncovered information about how much they had spent on acupuncture treatments over the past decade, as well as a more detailed breakdown of how much was spent on acupuncture used for different categories of injury (the detailed breakdown also included data for 2013/2014).

Information released in parliament in 2004 also revealed how much money ACC spent on acupuncture in the decade from 1994-2004, as well as projections on how much they expected to spend on acupuncture from 2004-2009.

As you can see from the chart below, their projections turned out to be rather inaccurate, and ACC spending on acupuncture has been absolutely booming:

ACC Acupuncture 1994-2014

In August, I submitted my own OIA request asking for:

copies of or links to all literature reviews regarding the effectiveness of acupuncture for any condition undertaken by ACC

I was told that:

There are only two ACC literature reviews on the efficacy of acupuncture.

It was with this information that I wrote my previous two posts on this topic. Here are the important parts of those reviews’ conclusions:

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.

There is limited good quality evidence to conclusively determine acupuncture’s efficacy in treatment of mental health conditions such as Major Depressive Disorder, Dysthymia, Anxiety Disorder, Borderline Personality Disorder and Post Traumatic Stress Disorder.


When I went to write on this topic again last year during “Acupuncture Awareness Week”, I found two more ACC literature reviews on the efficacy of acupuncture (as well as other treatments) on the ACC website:

On the topic of acupuncture, these reviews concluded that:

The evidence is either weak or absent for:

acupuncture

current evidence does not support the use of acupuncture to treat people with [Traumatic Brain Injury].

Feeling rather frustrated that ACC’s response to my earlier request (which arrived less than 2 weeks before last year’s September election) was apparently false, I sent a more specific followup:

I would like to reiterate my request to be provided with copies of or links to all literature reviews regarding the effectiveness of acupuncture for any condition undertaken by ACC. For the sake of clarity, I would like to be explicit that this includes both reviews that looked at several treatment options including acupuncture, and reviews that were commissioned by ACC as well as those directly undertaken by ACC.

I hope anyone reading this would agree that this followup should absolutely not have been necessary, and all the information I was requesting here should have been provided in ACC’s response to my original request before they’d be breaking the law.

However, when ACC finally acknowledged my request over a week after having received it, they maintained that “the information provided to [me] on 3 September 2014 was complete” and that this was therefore a new, separate OIA request. Because of the break over summer, this gave them until the 20th of January to respond to my request.

At 4 o’clock in the afternoon on the 20th of January, I heard back from ACC with an answer that essentially felt like “find the information yourself, it’s online”. Instead of providing me with copies of or links to any reviews, they told me the name of one review commissioned by ACC and that it could be found online, and provided me with 2 links to pages on their website that listed all of their reviews.

Interestingly, although I don’t believe the 2011 review has been released except in response to an OIA request, it was not mentioned in ACC’s response and they told me that:

ACC does not hold any other information that has not been published.

Having taken some time to go through all the reviews found on the pages I was linked to in order to find all those which mention acupuncture, I came up with the following list. As well as a link to the review and its title and date where I could find one, I am quoting the relevant conclusions below.

Although they have told me so incorrectly in the past, I have ACC’s word that these are all the ACC literature reviews that evaluate acupuncture. As you can see, they are inconclusive or negative for all but a few specific conditions: Frozen shoulder, chronic neck pain, chronic shoulder pain.

In 2014 ACC spent $30,000 on acupuncture to treat burns, $59,000 on acupuncture for concussion and brain injury, and $591,000 on acupuncture for fracture and dislocation. They apparently spent $22,592,000 on acupuncture for soft tissue injuries, but I find it highly unlikely that all of this money was used to treat frozen shoulder, chronic neck pain, and chronic shoulder pain.

ACC’s expenditure on acupuncture shows no sign of slowing. It grew 17% from 2011/12 to 2012/13, then a further 17% from 2012/13 to 2013/14, leaving the expenditure for 2013/14 at over $24,000,000. It’s certainly not a large part of ACC’s total expenditure, but it’s no small sum of money.

ACC is publicly funded. Publicly funded healthcare should be based on rigorous evidence. ACC does not appear to have evidence that would allow them to conclude that acupuncture is an effective treatment for any more than these conditions. It is well past time for ACC to re-evaluate their expenditure on acupuncture. It should only be funded when used to treat conditions in a way that is supported by rigorous evidence, and that is certainly not the case currently.

I will end this post the same way as I have ended my previous posts on this topic, with my recommendations for how ACC should deal with this issue:


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 legislation 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.

ACC and Acupuncture 2

The ACC has responded to my Official Information Act request that I mentioned in my last post on ACC and acupuncture. Here’s what I asked for in my request:

Dear Accident Compensation Corporation,

In response to an Official Information Act request from Kevin McCready in June (https://fyi.org.nz/request/1749-continue…), Mrs Koleti Vae’au wrote that:

In 2011, ACC’s research team 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. In terms of other injuries, evidence of the benefits of acupuncture was either inconclusive or insufficient.

I have been unable to find this particular review by searching on the ACC website, although I have found other reports such as the “Effectiveness of acupuncture in selected mental health conditions” brief report from earlier this year.

Also, if ACC has any guidelines for carrying out these reviews, could you please provide me with a copy of or link to these guidelines.

Sincerely,

Mark Hanna

Here’s a (direct PDF download) link to the mental health review that I mentioned in my request: Effectiveness of acupuncture in selected mental health conditions – Brief report [2014]

The brief conclusion of this report is:

There is limited good quality evidence to conclusively determine acupuncture’s efficacy in treatment of mental health conditions such as Major Depressive Disorder, Dysthymia, Anxiety Disorder, Borderline Personality Disorder and Post Traumatic Stress Disorder.

As I mentioned in my last post on this topic, ACC released their review of the evidence for acupuncture in the management of musculoskeletal pain in response to another OIA request. That review can be read in full here: The efficacy of acupuncture in the management of musculoskeletal pain

Here’s what ACC said in response to my OIA request yesterday:

There are only two ACC literature reviews on the efficacy of acupuncture. These are:

The efficacy of acupuncture in the management of musculoskeletal pain.

I understand from your email of 25 August 2014 that you have accessed a copy of this report and therefore do not require another copy.

Effectiveness of acupuncture in selected mental health conditions — Brief report 2014.

As you have identified, this is available on the ACC website.

In regard to ACC guidelines on literature reviews, ACC follows standard practice when undertaking literature reviews, and there are no ACC specific guidelines on this practice.

After my previous post on this topic, I was contacted by Ross Mason who told me about a similar OIA request he had made some years ago. One interesting thing I read in their response to him, which was written by the same person as their response to me, was this (bolded emphasis mine):

2. Evidence of the efficacy of the use of CAM treatments/programmes;

Schedule 1 Part 1 sections 1 & 2 of the [Accident Compensation] Act detail ACC’s liability to pay for the cost of treatment. These provisions in part include the requirement that the treatment is necessary and appropriate and of the quality required for the purpose. ACC has always required that new treatments for which payment is requested are supported by evidence of effectiveness. However it must be noted that there are many treatments that treatment providers utilise that do now have a well established evidence base.

Examples of the research that ACC does in considering new treatments can be found on the “For Providers” section of the ACC website – http://www.acc.co.nz/about-acc/research-sponsorship-and-projects/research-and-development/evidence-based-healthcare-reports/index.htm

If requested to fund CAM, ACC would require that evidence be provided for the treatments [sic] efficacy. ACC evaluation process of the evidence is detailed on the ACC website in the “For Providers, Clinical Best Practice” section – http://www.acc.co.nz/for-providers/clinical-best-practice/index.htm.

The first link, to the “Evidence based healthcare reports” page, seems to provide a little more detail on what was described as “standard practice” in response to my request:

Evidence based reviews

These reports assess the effectiveness and safety of health interventions. They are developed according to a robust methodology similar to that used by the Centre for Evidence Based Medicine (external link) and the Scottish Intercollegiate Guidelines Network (external link). This includes systematic searches of the literature, critical appraisal of existing research evidence and peer review by clinical experts.


ACC has funded acupuncture treatments for over a decade, spending over $24 million on it last year alone.

In August 2011, ACC reviewed the evidence regarding the efficacy of acupuncture for musculoskeletal pain and found that (emphasis mine):

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.

In March 2014, ACC published a brief report on the effectiveness of acupuncture in selected mental health conditions didn’t find enough good quality evidence to provide any recommendation.

No other review of the evidence for acupuncture has been undertaken by ACC. Despite this, over the last year ACC spent significant amounts of public money on acupuncture treatments for other medical issues such as burns ($30,002), lacerations and puncture wounds ($309,458), and fractures and dislocations ($591,613).

In the past year, they spent $22,592,552 on acupuncture for soft tissue injuries. Unfortunately, their recent response to another OIA request shows that they haven’t been keeping track of which body parts were treated, so we’ve been unable to determine how much of this substantial amount of money was spent on treatments that ACC’s own findings say are not supported by evidence.

As far as I’ve been able to tell, ACC’s funding scheme for acupuncture simply isn’t consistent with the evidential requirements they claim to require, and is instead largely based on the pre-scientific notions (to quote the author of their 2011 review) detailed in their Acupuncture Treatment Profiles document. When these issues were raised with the previous ACC minister Nick Smith in 2009 he promised a review of their effectiveness would be undertaken, but in the 5 years since then no such review has taken place. This latest response of theirs has only made me feel even more strongly about my recommendations for change:

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 legislation 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.

The Price of Painkillers Part 2: Only Misleading in Australia

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

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.

ACC and Acupuncture

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.

EDIT 2014/08/30

In a discussion of this post on Facebook, Jonathan Grady raised a good point about what this might have involved. It’s still just speculation, but I thought it was worth mentioning here:

Well, I know of no evidence that acupuncture is useful in the treatment of hearing impairment per se. There’s no plausible mechanism at work. But it could well, in some instances, be used plausibly to treat tinnitus, as tinnitus has a high component of subjective influences such as mood and levels of physiological and psychological arousal (similar to perceptions of chronic pain and of “phantom limb” syndrome). Placebos have some good efficacy in the treatment of tinnitus and, as we all know, acupuncture is really not much more than a placebo treatment. But it certainly won’t help you hear any better…

Jonathan Grady, Practicing Audiologist and Consulting Expert Member of the Society for Science Based Healthcare


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 legislation 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

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.