Pharmacy Council’s Code of Ethics Proposal: Submissions Roundup

Pharmacy Council’s Code of Ethics Proposal: Submissions Roundup

The Pharmacy Council has proposed a change to their code of ethics, here’s everything you need to know.

EDIT 22/10/2015: When this article was published it didn’t include details of the Pharmaceutical Society’s submission. Since then, I have spoken with their Chief Pharmacist Advisor, Bob Buckham, about their submission. For more details, see my article summarising it: Pharmacists Don’t Want to Sell Unproven Products

The Pharmacy Council is the statutory body responsible for setting standards of conduct and competence of pharmacists in New Zealand. They have a code of ethics, the Safe Effective Pharmacy Practice Code of Ethics 2011, which currently includes a section that requires pharmacists must:

6.9
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 2011 (Pharmacy Council)

In August, the Pharmacy Council proposed to change this section of the code of ethics. The first part of the proposed change is to remove the requirement for complementary therapies and other healthcare products to be supported by credible evidence of efficacy before they can be promoted or supplied in a pharmacy. The other part is to add a requirement that purchasers must be given enough information about these products to make an informed choice:

6.9a
Only supply or promote any medicine or herbal remedy where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.
6.9b
Only supply any complementary therapy or other healthcare product where there is no reason to doubt its quality or safety and when sufficient information about the product can be provided in order for the purchaser to make an informed choice with regard to the risks and benefits of all the available treatment options.

Proposed supplementary wording to clause 6.9 of the Code of Ethics 2011 (Pharmacy Council)

As part of this proposal, the Pharmacy Council called for submissions from stakeholders. In my last article on this topic, I discussed the submission from the Society for Science Based Healthcare, of which I am a co-founder. Although the extended deadline for submissions passed last Friday, various other groups have made their views on this proposal clear and made their own submissions.


The Society for Science Based Healthcare

The Society for Science Based Healthcare is a group of consumer advocates, scientists, and medical professionals. I am one of its co-founders. The submission from the Society for Science Based Healthcare proposed a modified version of the new wording:

6.9a
Only supply any medicine or herbal remedy where there is credible evidence of efficacy.
6.9b
Only promote any complementary therapy or other healthcare product where there is credible evidence of efficacy.
6.9c
Only supply or promote any medicine, herbal remedy, complementary therapy or other healthcare product where there is no reason to doubt its quality or safety, when there is not credible evidence to suggest that the product lacks efficacy.
6.9d
Provide sufficient information about any medicine, herbal remedy, complementary therapy or other healthcare product product in order for the purchaser to make an informed choice with regard to the risks and benefits of all the available treatment options.

Pharmacy Council Code of Ethics Proposal (Society for Science Based Healthcare)

After lodging a complaint last year with the Pharmacy Council regarding an incident in which a patient was misled by an Auckland pharmacy that recommended and sold them a homeopathic product, both the Pharmacy Council and the Health and Disability Commissioner refused to enforce the code by telling the pharmacy not to promote or sell the homeopathic product, despite the fact that it was not supported by any credible evidence of efficacy.

In principle, the society would oppose the change. However, having have found that the existing section of the code is disregarded rather than enforced, the society decided it was best to try to turn the code into something the Pharmacy Council might be willing to enforce that could still offer protection to patients.

It is currently widespread practice for New Zealand pharmacies to supply and promote healthcare products which are not supported by credible evidence of efficacy, such as homeopathic products.

Pharmacy Council Code of Ethics Proposal (Society for Science Based Healthcare)

This view that the current code of ethics is commonly disregarded has been shared among many of the other submissions that have been made public, and appears to be supported by a statement made by the Pharmacy Council chairman Dr Andrew Bary in a recent article on Stuff.co.nz:

But Pharmacy Council chairman Dr Andrew Bary said the rules as they stood were “unworkable” and many pharmacists, including himself, were already selling complementary medicines, even if they didn’t believe their claims.

Doctors and pharmacists clash over complimentary medicines (Stuff.co.nz)

The Society for Science Based Healthcare’s submission also argued that there are both potential risks and potential benefits to these products being sold in pharmacies. The proposed new wording is intended to provide the best risk/benefit profile for patients.

On the one hand, if these products are available in a pharmacy consumers will be more likely to visit a pharmacy to purchase them. This can put them in a position where a pharmacist is able to provide them with evidence-based advice, so they can make an informed decision on purchasing the best product for whatever problem they are experiencing. If the product were not available in a pharmacy, they may instead seek it from a source which would not provide them with this information, or which may misinform them.

On the other hand, when a product is available in pharmacies it is likely to lead consumers to believe that it is an effective, evidence-based product. This is often used as a selling point by products which are not supported by evidence. For example, the homeopathic product No-Jet-Lag advertises itself as being available at “Most chemists nationwide“. In this way, pharmacists stocking products without credible evidence of efficacy can also contribute to an increase in consumer demand for them. For all intents and purposes, supplying a product in a pharmacy is also a form of promotion.

Pharmacy Council Code of Ethics Proposal (Society for Science Based Healthcare)

When it was submitted this submission had a list of 36 supporters, 24 of whom are healthcare professionals or PhD scientists


The NZ Skeptics

The NZ Skeptics’ submission opposed the change. It also proposed that the Pharmacy Council maintain a list of products or product categories that are not supported by credible evidence of efficacy, to make it easier for pharmacists to determine which products could or could not be sold in pharmacies. The motivation for this recommendation is similar to one made in the Society for Science Based Healthcare’s complaint last year:

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. 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.

NaturoPharm Wartoff Complaint (Society for Science Based Healthcare)

To inform their submission, the NZ Skeptics conducted a “secret shopper” exercise with their members to discover what actually happens when consumers talked to pharmacy staff about homeopathy.

We found that around half of the pharmacies visited had staff that were willing to promote or supply homeopathic products without adequately explaining the current lack of evidence.

It seems that some pharmacies did not stock homeopathy, but a significant number of others did have homeopathic products on their shelves and in most of these pharmacies staff were willing to offer homeopathy as a viable treatment, with no information offered about a lack of efficacy.

With the code being an important patient protection mechanism, we’re disappointed to see it so readily disregarded.

Submission to the Pharmacy Council’s 2015 Code of Ethics Consultation (NZ Skeptics)

The NZ Skeptics have made these reports available on their website: Pharmacy Homeopathy Reports. As well as this, they conducted a non-exhaustive search for New Zealand pharmacies promoting homeopathic products online, and made the results of this available too: Pharmacies Promoting Homeopathy.

One argument that is used to support pharmacies selling products with no credible evidence of efficacy is that, if pharmacists were prevented from selling these products, then patients’ freedom of choice would be infringed. This argument has been made, for example, by Pharmacy Council chairman Dr Andrew Bary when he was interviewed on Radio New Zealand about this proposed change:

You know, I think we need to respect the wish of the consumer from time to time, so you know, individuals have their own cultural and traditional beliefs around certain alternative and complementary therapies… So I think that the key thing is that we are setting out that we think pharmacists should be informed about the efficacy of the evidence for each individual product when they are promoting and making recommendations to people. But at the same time, we need to put the person at the centre, the consumer, and respect their wishes and desires.

Pharmacy Council moves to change code of ethics over homeopathy (Radio New Zealand)

The argument has also been put forth by pharmacists that sell these products in their pharmacies:

“Many patients believe homeopathy has been of benefit and they should be given the freedom to choose it if they want, [Lincoln Mall Pharmacy owner pharmacist Caleb Townsend] says.”

Pharmacists support patient choice with homeopathy (Pharmacy Today)

It may be worth noting that Lincoln Mall Pharmacy is one of the ones on the NZ Skeptics’ list of pharmacies promoting homeopathy online, and the Pharmacy Today article notes they have “qualified homeopaths onsite”. An Advertising Standards Authority complaint laid by Society for Science Based Healthcare member Simon Clark was settled in June when the pharmacy opted to remove claims that homeopathic products can “treat a wide range of illnesses and concerns” from an online listing.


Ben Albert et al.

Dr Ben Albert is a paediatric endocrinologist who researched fish oil for his PhD, which made headlines earlier this year after his research was published in the Nature journal Scientific Reports. Along with five other doctors, he has written a submission to the Pharmacy Council opposing the change.

Despite coming from a group of individuals rather than a professional society, the submission boasts the impressive support of 180 medical doctors, predominantly senior consultants, representing all medical specialties. It also has the support of the NZ Society of Paediatric Surgeons and the NZ Resident Doctors Association, which represents over 90% of the resident medical officer workforce in New Zealand. Its authors are:

  1. Dr Benjamin B. Albert FRACP, Paediatric Endocrinologist and Clinical Research Fellow. Liggins Institute, University of Auckland.
  2. Professor Wayne S. Cutfield MD FRACP. Professor of Paediatric Endocrinology, and Director of A Better Start National Science Challenge, Liggins Institute, University of Auckland. Past president, Australasian Paediatric Endocrinology Group. Past president, Asia Pacific Paediatric Endocrine Society.
  3. Professor Paul L. Hofman FRACP. Professor of Paediatric Endocrinology, Director of the Maurice and Nessie Paykel Clinical Research Unit, Liggins Institute, University of Auckland. President Asia Pacific Endocrine Society. Past president Australasian Paediatric Endocrinology Group.
  4. Professor Alistair J. Gunn PhD FRACP. Professor of Physiology and Paediatrics, and Head of Department of Physiology, University of Auckland. Paediatric Endocrinologist.
  5. Associate Professor Timothy Kenealy PhD FRANZCGP, Professor of Integrated Care, University of Auckland. General Practitioner.
  6. Dr Olivia J. Albert FANZCA. Anaesthetist, Royal Hospital for Women, Sydney, Australia.

The specific recommendations made in their submission are:

  • Reject the proposed change, or reinsert the requirement for “credible evidence of efficacy” in to clause 6.9b. We suggest this wording.

    • where there is no credible evidence to suggest a specific complementary and/or alternative medicine/product is effective, or the proposed effect of the product is scientifically implausible pharmacists should not promote or recommend its use
  • Current ethical standards should be enforced
  • Treatments and products that do not have “credible evidence of efficacy” such as homeopathic remedies, ear candles and magnet based therapies should be listed by the PCNZ, with the intention that they are not sold in pharmacies.

Submission to the Pharmacy Council of New Zealand (Ben Albert et al.)

The last recommendation echoes that of the NZ Skeptics, aiming to simplify things for pharmacists by providing a list of products or product categories which clearly are not supported by credible evidence of efficacy.

The rationale for their opposition to the change is laid out clearly and concisely in the submission:

The suggested change is in opposition to the general principles of the code, and the expectations of the public and other members of the multidisciplinary science based healthcare team.

This change would make it permissible within the ethical code for pharmacists to promote and sell products that are unproven and even scientifically implausible. We believe that this is harmful and wrong.

the current code should be enforced, not amended.

Submission to the Pharmacy Council of New Zealand (Ben Albert et al.)

They raise another counterargument to the “freedom of choice” argument, noting that pharmacists should be wary of their conflict of interest between advising against patients purchasing products that aren’t supported by evidence and selling more products to generate more profit for the pharmacy:

pharmacists (like many health providers) have a conflict of interest when they sell and give advice about health products from which they make profit. There is evidence that financial pressures do impact the clinical decisions of pharmacists1. One of the reasons that a code of ethics is important is because it provides guidance where the interests of pharmacists and patients differ.

1 Chaar B, Brien Ja, Krass I. Professional ethics in pharmacy: the Australian experience. International Journal of Pharmacy Practice. 2005;13(3):195-204

Submission to the Pharmacy Council of New Zealand (Ben Albert et al.)

They also raise the issue that products sold in pharmacies are likely to be seen as effective by the public, which can lead to harm when they are sold in pharmacies:

Many patients will assume that the pharmacist endorses the health products sold in the pharmacy as scientifically supported. But many pharmacists sell products that are known to be ineffective, such as homeopathic remedies3 or potentially harmful, such as ear candles4. Selling such products conflicts with the principles of the current code5 as it reduces patient autonomy. The patient that wrongly assumes that a health product is scientifically supported is ill-prepared to make an informed decision.

3 Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002;54(6):577-82.
4 Seely DR, Quigley SM, Langman AW. Ear Candles-Efficacy and Safety. The Laryngoscope. 1996;106(10):1226-9.
5 Zealand PCoN. Code of ethics 2011: Pharmacy Council of New Zealand; 2011 [cited 1015 17 September]. Available from: http://www.pharmacycouncil.org.nz/cms_show_download.php?id=200.

Submission to the Pharmacy Council of New Zealand (Ben Albert et al.)

Although this submission has not been made public, it shares much in common with a letter to the editor from the same authors that was published today in the New Zealand Medical Journal.

I spoke with Dr Albert to ask what motivated him to take action on the Pharmacy Council’s proposal, here’s what he had to say:

For years it has bothered and surprised me that products that are entirely implausible such as magnets and homeopathic remedies, and harmful products such as ear candles are sold in pharmacies. When scientifically trained and trusted health professionals promote and sell such treatments they betray the trust of the public who will quite reasonably assume such products are endorsed by the pharmacist and supported by scientific evidence. The current PCNZ code of ethics indicates that it is unethical and unprofessional for pharmacists to sell these products. The right course of action is to stop selling them. To instead change the code to redefine ethical behaviour appears cynical and makes the sale of unsupported or harmful treatments no less wrong.

Dr Ben Albert


The New Zealand Medical Association

The New Zealand Medical Association is New Zealand’s largest medical organisation, representing over 5,500 medical professionals. The New Zealand Medical Association’s submission strongly opposes the change. They echo the views of other submissions that in the face of widespread behaviour at odds with the current code, the way forward should be change behaviour to match the code rather than to relax the code to permit existing behaviour:

The NZMA is strongly opposed to the above proposed change

We do not believe that pharmacists should be selling ‘treatments’ that are known to be ineffective or lack evidence of effectiveness. We contend that doing so is unethical. While this practice may be happening under the present Code, we believe that the PCNZ should be seeking ways to enforce the Code rather than amend it to accommodate this practice.

Submission to the Pharmacy Council of New Zealand (New Zealand Medical Association)

The NZMA acknowledged the trust placed in pharmacists by the public, and how this affects the way in which products sold in pharmacies are perceived:

It is our view that allowing pharmacists to sell ineffective therapies or products is contrary to the profession’s own aspirations, including of trustworthiness and professionalism. More broadly, it undermines the social contract between the public and the profession. The pharmacist is trusted by patients and other members of the health care team precisely because of their scientific training. The sale of products by pharmacists that knowingly do not work is inconsistent with the high trust health care professional the public expects and the profession requests.

Submission to the Pharmacy Council of New Zealand (New Zealand Medical Association)

The NZMA also deals with the “freedom of choice” argument in a similar way to the other submissions:

We understand that patient autonomy and freedom of choice are being advanced as the rationale for the proposed rewording to the Code. We believe these are spurious arguments on which to remove the requirement for “credible evidence of efficacy” for pharmacists to sell complementary therapies or other healthcare products. Freedom of choice should not transcend the health and well-being of the patient. Furthermore, such products are already available to people to purchase at other outlets, such as health food shops and supermarkets.

Submission to the Pharmacy Council of New Zealand (New Zealand Medical Association)

The NZMA raised some new concerns, regarding the potential impacts of the proposed change:

The proposal is of all the more concern given the current lack of regulation of complementary therapies in New Zealand.

We are also concerned at the impact of the proposal on equity. Patients that are least likely to consult a doctor could end up being even more likely to purchase costly ‘healthcare’ products from their pharmacy that do not work.

The proposal also undermines the wider health sector’s efforts to improve health literacy.

Submission to the Pharmacy Council of New Zealand (New Zealand Medical Association)

The NZMA’s final recommendation is for the requirement for credible evidence of efficacy to be kept and enforced, and until it is enforced for the newly proposed requirement for supplying sufficient information to make an informed choice to bridge the gap:

Ideally, we would like to see pharmacists end the sale of complementary therapies or other healthcare products for which there is no credible evidence of efficacy (ie, meet their obligations under the existing Code). Until such time, we would suggest the addition of a subclause to 6.9 which addresses the need to provide sufficient information for herbal remedy, complementary therapy or other healthcare product. Accordingly, we proposed the following wording:

6.9
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.
6.9a
When supplying a herbal remedy, complementary therapy or other healthcare product, sufficient information about the product must be provided in order for the purchaser to make an informed choice with regard to efficacy of the product and the risks and benefits of all available treatment options.

Submission to the Pharmacy Council of New Zealand (New Zealand Medical Association)


The Pharmacy Guild

The Pharmacy Guild represents pharmacy owners in New Zealand. The Pharmacy Guild’s submission supports the Pharmacy Council’s proposed change:

We support the Council’s intentions of the proposed changes to clause 6.9 of the Code of Ethics 2011 (the Code).

Consultation on the proposed wording to clause 6.9 of the Code of Ethics 2011 (Pharmacy Guild)

The primary motivation for this support seems to be a combination of the “freedom of choice” argument I described above, and the potential for benefit described in the Society for Science Based Healthcare’s submission:

We believe that if pharmacists were prevented from selling natural products then patients wanting these products would continue to source them from somewhere. We consider that it is far safer for consumers to approach pharmacists for advice and that they purchase supplies of complementary medicines from a pharmacy rather than over the internet for instance, where the quality and safety of a product cannot always be guaranteed.

Consultation on the proposed wording to clause 6.9 of the Code of Ethics 2011 (Pharmacy Guild)


As well as these submissions, I have been made aware of a few more, mainly submitted by individuals. Of those I am aware of, such as Edward Linney’s submission, they are predominantly opposed to the change for many of the reasons described in these submissions. I am aware of one instance of an ex-pharmacist who supports that change who is now a practising homeopath and, scarily, was previously employed by the Pharmacy Council as their Professional Standards Advisor even while they were practising as a homeopath. However I don’t know if they have made a submission.

I’m also aware that the Pharmaceutical Society has made a submission. Whereas the Pharmacy Council regulates pharmacists, the Pharmacy Guild and Pharmaceutical Society are membership organisations; the Guild represents pharmacy owners and the Society represents pharmacists in general. Although I have tried to get in touch with them, I haven’t seen the Pharmaceutical Society’s submission and can’t provide comment. I will update this article if that changes.

However, I am aware that the Pharmaceutical Society has close ties to the New Zealand Medical Association, even to the point where they have a joint agreement for members to abide by both organisations’ codes of ethics. So I expect that if they have made a submission it may be along similar lines to the NZMA’s submission.

If anyone knows of any more information that I’ve missed in this article, please leave a comment below.

Ethical Pharmacy Practice 6: An Opportunity for Change

Ethical Pharmacy Practice 6: An Opportunity for Change

I’ve written a lot about ethical pharmacy practice in New Zealand, advocating for New Zealand pharmacists to choose not to promote or sell healthcare products that aren’t supported by credible evidence of efficacy. I’ve also complained in the past about misleading advertising of ineffective healthcare products in pharmacies. I strongly believe that we should be able to feel confident going into a pharmacy that we will get evidence-based advice on purchasing effective healthcare products, and not be misled.

The Pharmacy Council is responsible under the Health Practitioners Competence Assurance Act for setting standards of ethical conduct for pharmacists in New Zealand. Section 6.9 of their current Safe Effective Pharmacy Practice Code of Ethics 2011 states that pharmacists must:

6.9
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.

The Pharmacy Council is currently proposing to change this section of their code of ethics to the following wording, prior to the entire code being reviewed in 2016:

6.9a
Only supply or promote any medicine or herbal remedy where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.
6.9b
Only supply any complementary therapy or other healthcare product where there is no reason to doubt its quality or safety and when sufficient information about the product can be provided in order for the purchaser to make an informed choice with regard to the risks and benefits of all the available treatment options.

I have referred to section 6.9 of that code of ethics many times, as I feel it is a great standard which should offer a significant degree of consumer protection. However, despite there being ample evidence that homeopathic products are ineffective, most New Zealand pharmacies continue to sell them. I have heard many stories of people encountering misinformation about homeopathy in New Zealand pharmacies that sell it. The section of the code of ethics that is meant to protect consumers against this simply has not been enforced.

Even when the Society for Science Based Healthcare lodged a formal complaint directly to the Pharmacy Council about an instance where someone was recommended and sold a homeopathic product in a pharmacy (but didn’t realise it was homeopathic until they got home), both the Pharmacy Council and the Health and Disability Commissioner (who had the complaint forwarded to them from the Pharmacy Council) refused to enforce it. Neither of them were willing to tell pharmacies that they could not sell any specific product.

So although I really do like the old wording, I think this change could be an opportunity to turn the code of ethics into something that really can help consumers. As part of the proposed change, the Pharmacy Council is calling for submissions on it, so I see this as an opportunity to make things better.

At the Society for Science Based Healthcare, we have prepared a proposal to submit before the deadline of 5pm on the 1st of October 2015. I’ve included this proposal below for you to read, and you can also find it on our site: Pharmacy Council Code of Ethics Proposal

If you agree with our submission and would like to support it, please leave a comment below or get in touch. You can contact the Society for Science Based Healthcare via email at sbh@sbh.nz. We will be sending this submission to the Pharmacy Council on Wednesday the 30th of September Thursday the 8th of October (the Pharmacy Council extended their deadline).

Of course, you can also send in your own submission on this proposal. Details on how to do this can be found in the Pharmacy Council’s proposal document.


Last year the Society for Science Based Healthcare submitted a formal complaint to the Pharmacy Council regarding an Auckland pharmacy that had misled a consumer by promoting a homeopathic product as effective, then selling it to them. Although the council did write to the pharmacy, to our knowledge it did not consider whether or not the Safe Effective Pharmacy Practice Code of Ethics 2011 section 6.9 had been breached as alleged in the complaint. The council forwarded the complaint to the office of the Health and Disability Commissioner, but both organisations were unwilling or unable to enforce it as this would involve telling a pharmacy which products they can or cannot sell. Neither the Pharmacy Council nor the Health and Disability Commissioner seems willing to enforce a code of ethics when this would involve telling pharmacists which products they can or can’t stock.

The Pharmacy Council’s proposal document notes that the Council “has a duty to protect the public”. A code of ethics which is not enforced may as well not exist. We feel the addition of a new section requiring that sufficient information can be provided to consumers in order for them to make an informed choice regarding whether or not to purchase a complementary therapy is in line with what consumers could reasonably expect. We hope that complaints about potential breaches of this standard would be considered by the Pharmacy Council or another body, so that it can offer some measure of consumer protection.

However, we think the wording could be improved by changing “when sufficient information about the product can be provided” to “when sufficient information about the product is provided”.

It is currently widespread practice for New Zealand pharmacies to supply and promote healthcare products which are not supported by credible evidence of efficacy, such as homeopathic products. This is despite several prominent healthcare organisations, including the Royal Australian College of General Practitioners (RACGP) and the New Zealand Medical Association (NZMA), speaking out against these products being prescribed or promoted by healthcare practitioners. Most recently, the Pharmaceutical Society of Australia (PSA) published a statement on the 10th of September that:

PSA does not support the sale of homeopathy products in pharmacy.

When it comes to pharmacies stocking healthcare products that are not supported by credible evidence of efficacy, or for which there is credible evidence that they are not effective such as in the case of homeopathic products, it is important to weigh up the potential risks and benefits.

On the one hand, if these products are available in a pharmacy consumers will be more likely to visit a pharmacy to purchase them.. This can put them in a position where a pharmacist is able to provide them with evidence-based advice, so they can make an informed decision on purchasing the best product for whatever problem they are experiencing. If the product were not available in a pharmacy, they may instead seek it from a source which would not provide them with this information, or which may misinform them.

However, there are certain circumstances in which any potential for this benefit can be lost completely:

  1. If consumers are sent away from pharmacies when they ask about these products. We are aware, for example, of numerous instances of people being recommended by pharmacy employees that they should instead go to a dedicated natural health product store for information on homeopathic products.
  2. If pharmacists create an environment in which consumers are likely to be misled, for example by employing a homeopath to give non evidence-based advice to their customers.
  3. If a pharmacy sells these products online, in which case they can be purchased without any opportunity for a pharmacist to provide enough information for consumers to make an informed decision.

On the other hand, when a product is available in pharmacies it is likely to lead consumers to believe that it is an effective, evidence-based product. This is often used as a selling point by products which are not supported by evidence. For example, the homeopathic product No-Jet-Lag advertises itself as being available at “Most chemists nationwide“. In this way, pharmacists stocking products without credible evidence of efficacy can also contribute to an increase in consumer demand for them. Supplying a product in a pharmacy is effectively also a form of promotion.

Although some benefit can be gained from pharmacists stocking products that are not backed by credible evidence of efficacy, in order for consumers to make an informed choice about purchasing these products it is important that they be made aware of this lack of evidence. It should be an ethical requirement that pharmacists will not promote any healthcare product where there is not credible evidence of efficacy.

The Pharmacy Council’s consultation document for this proposed change says that:

In instances where there is credible evidence to suggest a specific complementary and/or alternative medicine/product lacks efficacy, pharmacists should not promote or recommend its use

We agree with this, but feel it has not been clearly conveyed in the proposed new wording for section 6.9. We feel it would be useful for this to be included more clearly.

We also feel that the important distinction between healthcare products is not whether they are considered a complementary therapy, herbal remedy, or medicine, but whether or not they are supported by credible evidence of efficacy. However, we recognise that medicines and herbal remedies typically have greater risk than other healthcare products, so it may be more suitable to have more stringent requirements for when pharmacists may supply them.

With this in mind, we propose the following wording:

6.9a
Only supply any medicine or herbal remedy where there is credible evidence of efficacy.
6.9b
Only promote any complementary therapy or other healthcare product where there is credible evidence of efficacy.
6.9c
Only supply or promote any medicine, herbal remedy, complementary therapy or other healthcare product where there is no reason to doubt its quality or safety and when there is not credible evidence to suggest that the product lacks efficacy.
6.9d
Provide sufficient information about any medicine, herbal remedy, complementary therapy or other healthcare product product in order for the purchaser to make an informed choice with regard to the risks and benefits of all the available treatment options.

Finally, we feel that certain words could benefit from guidance on their definitions. In our 2014 complaint we raised with the Pharmacy Council that the meaning of “credible evidence” was not clear but were informed it was not their role to clarify this. However we feel it would be useful for an organisation such as the Pharmaceutical Society to publish guidance notes on this after the code has been updated.

We also feel that the meaning of “promote” should be clarified in the same way so it is clear where exactly the line is drawn. For example, we feel it is currently unclear which of the following activities might be considered promotion for the purpose of this code:

  • Advertising the availability of a healthcare product at a pharmacy
  • Featuring a product on a pharmacy’s website
  • Including an advertisement for the product on a pharmacy’s website on a page from which it can be purchased

If you agree with our submission and would like to support it, please leave a comment below or get in touch. You can contact the Society for Science Based Healthcare via email at sbh@sbh.nz. We will be sending this submission to the Pharmacy Council on Wednesday the 30th of September Thursday the 8th of October (the Pharmacy Council extended their deadline).

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.

100% Natural and Chemical Free

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

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

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

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

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

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

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

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

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

Both are synthetic chemicals.

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

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

Accordingly, the Complaints Board ruled to Uphold the complaint.

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

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

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

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

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

Elsewhere on her website, she recommends that if you:

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

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

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

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.

When Marketing Trumps Science

Recently I’ve run across a couple of New Zealand companies that sell therapeutic products – one a weight loss pill, the other a jet lag drink – that seem to put marketing first and let science take the back seat. This is by no means new behaviour, but I want to use them as examples to illustrate this widespread problem and suggest what can be done to combat it.

Before promoting a therapeutic product, you should first have good reason to believe that it works. This, I hope, is common sense, but it’s also enshrined in the Fair Trading Act and the Therapeutic Products Advertising Code as they prohibit unsubstantiated claims. This means you have to test the product, and do so rigorously. Rigorous clinical trials are expensive to undertake though, so they’re quite a prohibitive first step.

Instead of jumping straight into the deep end, a useful first step can be to undertake a smaller and less rigorous (and therefore less expensive) experiment. In order to answer the question of whether or not a product actually works you need to conduct a more rigorous trial. There’s a great cost involved in doing this, but if the results of a preliminary trial are optimistic then you have reason to expect a more rigorous trial might give similar results, so the expense might be worth it. You may even be able to get some funding to help with a more rigorous trial on the basis that the preliminary results were positive.


This is what Tuatara Natural Products has been doing with their weight loss pill “Satisfax”. They have completed a low quality preliminary trial on their product, which has been colloquially dubbed the “Fat Mates” trial. Although I don’t believe it has yet been published in a journal at the time I’m writing this article, it was registered retrospectively in the Australian New Zealand Clinical Trials Registry: Effect of the dietary supplement Satisfax (Registered Trademark) on weight loss in overweight volunteers. Some information on the data in the trial can be found on their website as part of an analysis by Dr Chris Frampton: Analysis of Satisfax® Clinical trial

As you can see on the trial registration page, this was an uncontrolled trial on overweight adults. The original plan was to recruit 100 volunteers with the hope that at least 60 will complete the trial. I have to say I’m a bit confused about how many people were in the trial, as apparently the recruitment was increased to 200 applicants after applications opened (a change that has not been reflected in the trial’s registration) yet apparently about 400 people applied. One article claims there were 200 participants, a later media release from Tuatara Natural Products seems to imply 100 were recruited, and the analysis of the trial says there were only 81 participants. Either way, 81 participants completed the full 8 weeks, and 52 of them took the recommended dose for the whole duration of the trial.

If there were 19 or 119 participants who didn’t complete the trial, the statistical analysis seems to ignore them with no justification given. This is unusual – a 19% drop out rate is significant and shouldn’t be swept under the rug. A lot of the time Tuatara also seems to ignore the 29 participants who didn’t drop out but also didn’t take the full dose for the whole duration.

The Science Media Centre posted the responses of 2 experts, Associate Professor Andrew Jull and Professor Thomas Lumley, to a press release from Tuatara Natural Products in February. It’s a good analysis of some of the weaknesses with the study, and I recommend you read it: Kiwi diet pill claims – experts respond

This trial was uncontrolled, and therefore also unblinded and unrandomised. As Professor Lumley explains, this is a problem if you want to draw strong conclusions from its results. It is of low methodological quality, but that’s okay. There is no problem with doing less rigorous trials first if they’re done in order to determine if more rigorous trials are necessary. Dr Glenn Vile, Chief Technical Officer of Tuatara Natural Products and the principal investigator for this study, wrote the following in a comment on a post on the “Fat Mates” trial by Dr John Pickering:

The Fat Mates trial was designed by clinical trial specialists to generate information about the Satisfax® capsules that would help Tuatara Natural Products plan a larger and longer double blind, cross over, placebo controlled trial.

We will use this information to proceed with the next clinical trial, but in the meantime we were so excited the weight loss achieved by most of our Fat Mates was much greater than the placebo effect seen in other weight loss clinical trials that we decided to launch the product so that anybody who is overweight can try Satisfax® for themselves.

Dr Glenn Vile

I think the first part of what I’ve quoted above describes exactly what Tuatara Natural Products should be doing. They’ve conducted their low quality trial, and intend to use its results to proceed with a larger, longer, and more rigorous clinical trial. This is the right way to proceed – they now have an indication that their product might be effective, so they should do the research to find out.

The problem is that that’s not all they’re doing. After performing only a small low-quality trial, they’ve released their product for sale online and have been making a lot of noise about it. In my opinion, they’ve been significantly overstepping the results of their clinical trial. For example, in his comment Dr Vile also said:

our initial trial has shown [Satisfax] to be extremely effective in some overweight people.

Dr Glenn Vile

In their media release on the 20th of February, they reported the average weight lost only by the 52 participants who took the full dose to completion (rounded up from 2.9 kg to “close to 3kg”) but not the average weight lost by all participants. They then reported in bold that the top 26 participants lost more weight, and the top two participants lost even more weight than that!

This cherry picking of the best results appears to have been part of Tuatara Natural Products’ marketing strategy for at least a few months now. In January, Stuff published an article on the trial highlighting the single person who lost the most while participating in it: Blenheim ‘fat mate’ loses 13.5kg in 8 weeks.

That article particularly highlights the person who lost the most weight out of all those in the trial, at 13.5 kg (confusingly, the maximum weight loss reported in the analysis of the trial’s results is 13.3 kg). However, she was one of only 2 participants who lost over 10 kg, and on average the 52 participants who took the recommended dose for the full eight weeks lost 2.9 kg. Losing 13.5 kg is very far from a representative example. I’m not surprised that they didn’t choose instead to focus on the participant who gained 1.2 kg despite taking the recommended dose for the whole duration, but that is actually much closer to the mean change in weight.

The article is, for all intents and purposes, one big testimonial in favour of Satisfax. It was an article, not an advertisement, which is important because in New Zealand it’s illegal to publish any medical advertisement that:

directly or by implication claims, indicates, or suggests that a medicine of the description, or a medical device of the kind, or the method of treatment, advertised… has beneficially affected the health of a particular person or class of persons, whether named or unnamed, and whether real or fictitious, referred to in the advertisement

Medicines Act 1981 Section 58(1)(c)(iii)

This effectively bans all health testimonials from advertisements. I think this is a good part of the law, as testimonials can be both very convincing and completely misleading; a quack’s dream. Banning them should force businesses to instead focus on the results of research on their products, but this hasn’t stopped Tuatara Natural Products from getting stories written about the most extreme testimonials they could find from people who have lost weight at the same time as they were taking Satisfax.

More recently, Tuatara Natural Products has put out a press release multiple times (at least on the 20th of February and again on the 4th of March) that I think rather oversteps the results of their small preliminary trial:

A NEW ZEALAND SOLUTION TO A GLOBAL PROBLEM A little pill is providing an exciting answer to one of the worlds greatest and fastest growing problems: Obesity.A NEW ZEALAND SOLUTION TO A GLOBAL PROBLEM

A little pill is providing an exciting answer to one of the world’s greatest and fastest growing problems: Obesity.

Press Release – Tuatara Natural Products

I simply don’t think they are at all justified in saying that their new product is “providing an exciting answer to… Obesity”. They are putting marketing ahead of science, and that’s not okay.


Another company that seems to put marketing before research is 1Above. They make a drink which they claim can help you recover faster from jet lag, and have recently been in the news for signing a sponsorship deal with the fantastically successful golfer Lydia Ko.

At the end of that article about their sponsorship deal the reporter, Richard Meadows, made some comments regarding the science behind jet lag relief products and asked some good questions of 1Above’s CEO, Stephen Smith (emphasis mine):

[1Above’s] product contains a mixture of vitamins B and C, electrolytes, and Pycnogenol, a pine bark extract.

The efficacy of flight drinks to combat the effects of jetlag is unproven.

Late last year pharmacists were warned after the Advertising Standards Authority upheld a complaint against an ad saying a homeopathic anti-jet lag pill really worked.

[1Above CEO Stephen] Smith said 1Above would not be doing clinical trials, which were highly expensive and not necessary.

“What we tend to use is testimonials from people who have used the product and swear by it.”

Smith said the key ingredient, Pycnogenol, had itself had been tested in dozens of trials, including its effects on reducing jetlag.

Kiwi startup 1Above signs golf No 1 Lydia Ko

Yes, you read that correctly. The CEO of 1Above literally said that they won’t be doing clinical trials because they are “not necessary” and that they use testimonials instead.

As I said before, using testimonials to promote a therapeutic product, like a drink to help you recover faster from jet lag, can be both very convincing and completely misleading. There’s a reason why testimonials implying health benefits are illegal in New Zealand, and I hope that 1Above’s marketing will not violate this regulation.

Not all testimonials are prohibited, of course. It’s entirely acceptably to provide a testimonial from someone who thinks their drink tastes great, or that they provide great service. Basically anything for which a single person’s experience can provide a useful insight. Therapeutic effects, almost without exception, do not fall into this category, which is a big part of why we need to do clinical trials in the first place. If they quote someone in saying that their product helped them recover faster from jet lag, they may be in danger of breaching the Medicines Act.

For example, I’d expect they probably shouldn’t use a testimonial that says this:

Testimonial on the 1Above website, collected 2015/03/05
Testimonial on the 1Above website, collected 2015/03/05

On their website, 1Above currently does refer to research on one of the ingredients in their product, “pycnogenol”. Professor Lumley recently wrote a post about this on his other blog, Biased and Inefficient, regarding these studies and how they are used by 1Above: Clinically Proven Ingredients

I recently contacted 1Above to ask about some discrepancies I found between the abstract of the study they cited for showing pycnogenol reduced the duration of jet lag and their description of it on their website:

I was interested to see the claim your company made that Pycnogenol® has been shown to support circulation and reduce the length and severity of jet lag.

I have found the study “Jet-lag: prevention with Pycnogenol. Preliminary report: evaluation in healthy individuals and in hypertensive patients” that is mentioned on your website as the source for this claim, but I am only able to access the abstract of this preliminary report. Unfortunately, as far as I can tell, the study protocol didn’t involve blinding of participants or researchers.

The participants in the study took 50 mg Pycnogenol 3 times per day, but I haven’t been able to find out how much is contained in your products. Is this information available anywhere on your website? I notice the study also says the participants took this regimen for 7 days, starting 2 days prior to departure. Is this comparable with how your product is intended to be used?

I also noticed some differences between the description of the study and its results between the abstract and your website, I would be grateful if you could explain to me the source of these differences.

The abstract states the control group took, on average, 39.3 hours to recover and the experimental group took, on average, 18.2 hours to recover. However your website reports these as 40 and 17 hours respectively.

Also, your website states that the study involved 133 passengers (it’s not clear from the description on your website if they all took Pycnogenol or if some of them were in the control group) who reported the time it took them to recover from jetlag. However, the study’s abstract states that in the first experiment, which is the only one that involved the reporting of the time taken to recover from jetlag, only involved 68 participants – 30 in the control group and 38 in the experimental group.

I would be grateful if you could explain these differences to me, and if you could send me any other relevant scientific information that supports this claim.

To their credit, since receiving my message they did update their website to fix the discrepancies in the reported number of participants and times taken to recover from jet lag, and their CEO replied to thank me for pointing these discrepancies out.

However, they didn’t respond to my other questions about the amount of pycnogenol in their products or the study involving the participants taking pycnogenol for 7 consecutive days, starting 2 days before their flight, which is inconsistent with how 1Above recommends their products be used.

This is just one more company basing their marketing on preliminary trials instead of using them as the basis for research that could actually answer the question of whether or not a product is useful. Worse than Tuatara Natural Products, they even go so far as to consider clinical trials “not necessary” and apparently intend to rely on testimonials instead. It would be much more appropriate for them to spend some of their $2.4 million annualised income on researching their product rather than paying for a sporting celebrity to endorse them.


I try to make my rants constructive, so I want to end this article with the question “What can we do about this?”. If you have any suggestions, I’d love to hear them in the comments section.

I think the most important thing that anyone can do to address this problem is to ask for evidence. If you see a claim made about a product that you think you might buy, then get in touch with the company selling it to let them know you’re considering buying it and to ask for evidence. If they don’t have a good enough answer, then let them know that’s why you won’t be buying their product. If they give you evidence to back up their claim, then great!

The UK organisation Sense about Science has created a website for just this purpose: www.askforevidence.org

Asking for evidence doesn’t have to be a big deal, involving a formal letter or anything like that. When you see a weight loss product advertised on a one day deal site, a copper bracelet that apparently offers pain relief advertised on a store counter, or a jet lag cure promoted on Twitter, make your first response be to politely ask for evidence.

This isn’t a problem that’s going away any time soon. As consumers, we deserve to be able to make informed decisions about the products we buy, and when companies put marketing before research it becomes harder to make these informed choices. But if we work together then we can encourage companies like Tuatara Natural Products and 1Above to improve their behaviour and attitudes toward marketing and research.

Let’s turn “what’s the evidence?” into a frequently asked question for all companies that sell therapeutic products.

Irradiation of Food and Compulsory Labelling

Queensland Fruit Fly | Photo by James Niland
Queensland Fruit Fly | Photo by James Niland

Biosecurity is a big issue for New Zealand. Being a group of islands fairly isolated from all other landmasses and having quite a unique native ecosystem (many native birds with no native mammalian predators and few native land mammals), we have a lot to lose from introduced species. There are also biological threats to industry that we have to try really hard to keep out of the country, such as Queensland fruit fly. There’s good reason why the Ministry for Primary Industries (MPI, formerly MAF) reacted so strongly when one of these flies was found in Whangarei in April 2014. If enough of these flies made it into New Zealand to self perpetuate, they could cause massive damage to New Zealand’s $5 billion horticulture industry.

In order to kill off any biosecurity risks, including disease-causing organisms and foodborne pests, various treatments (also known as “phytosanitary actions” when used on plant products) can be used when importing products into New Zealand. Different products that can be imported each have an Import Health Standard (IHS) that documents the process of importing them.

For fruit and vegetables being imported, they need to come with a phytosanitary certificate from their country of origin, to say that either they have been inspected by someone from MPI and they couldn’t find any pests, they come from a certified pest free area, or they have been treated to kill any pests. A sample of the products is also inspected by MPI when arriving in New Zealand, and if any pests are found then the products will have to be treated if they are to enter New Zealand.

The treatment used depends on a few things, such as what pest was found that they’re trying to kill. For example, assuming I’m interpreting the IHS correctly, if Thrips palmi is found in a shipment of capsicum from Australia it would be fumigated with methyl bromide at 32 g/m3 for 2 hours. Whereas if Conogethes punctiferalis were found, then the capsicum would be irradiated with a minimum dose of 250 Gy (Grays; 1 Gray is equivalent to 1 Joule of energy absorbed per kg of food).

EDIT 2015/02/01:

The previous paragraph is incorrect. Those treatments are the ones that should appear on the phytosanitary certificate, having been performed in the country of origin. The treatments done if a pest is found when they arrive in New Zealand are determined in the Approved Biosecurity Treatments Standard. So for fresh fruit and vegetables (page 37), if insects except for fruit flies (not slugs and spiders) are found then they have to be fumigated with methyl bromide at a particular rate and temperature for a particular duration (presumably depending on the pest and the produce). Looking at this standard, it seems human food doesn’t get irradiated if pests are found when it arrives in New Zealand. According to MPI’s list of treatment providers (direct PDF download), there is only one facility in New Zealand able to provide food irradiation, which is in Wellington.


Methyl bromide is an insecticide, and it’s also recognised as an ozone-depleting substance. Because of this, its use is tightly controlled. It’s only allowed to be used for a few specific purposes, one of which is quarantine, and New Zealand has to provide statistical data to the Ozone Secretariat on the annual amount of methyl bromide that we use. It’s nasty stuff – even skin contact with high enough concentration of the gas can cause severe blistering – but after being used to fumigate food it apparently dissipates fairly rapidly. There are some objects that MPI won’t fumigate with methyl bromide for various reasons, which are described in their info sheet I linked to above.

Irradiation is quite different. Using either Cobalt 60, x-rays, or an electron beam food is blasted with a specific amount of ionising radiation. Cobalt 60 is a radioactive source of this radiation, but as it emits gamma rays instead of neutrons it doesn’t make anything else around it radioactive. Both x-rays and electron beams are created by non-radioactive sources and can be switched on and off.

When food is irradiated, the process kills any organisms that are living in the food, including disease-causing organisms and pests. The food does not become radioactive, instead it will just be slightly warmed from the energy it absorbs. Also, the radiation will trigger some chemical changes, but these occur only in amounts comparable to heat treatments. In this way it’s quite similar to the process of pasteurisation used to make milk safe to drink.

In 2010, following an extensive literature search, the European Food Safety Authority (EFSA) published their Scientific Opinion on the Chemical Safety of Irradiation of Food. They found that the new evidence published since their previous decision in 2003 wasn’t enough to change their opinion that “there is not an immediate cause for concern” regarding the safety of irradiated food.

Irradiated Food symbol | FSANZ
Irradiated Food symbol | FSANZ

The strongest negative evidence they found seemed to be a case in which cats ate a diet consisting largely or entirely of highly irradiated (25.7 to 53.6 kGy, i.e. 100 to 200 times as much as in the capsicum example from earlier) cat food and subsequently suffered from leukoencephalomyelopathy (LEM). This evidence doesn’t necessarily have any relevance to humans though; in another report dogs ate the same pet food and didn’t exhibit LEM. Also, as the incident was only linked to one specific lot of one specific brand of pet food it’s unclear if irradiation was the culprit at all.

Even though irradiated food appears to be entirely safe to eat and not significantly different from food that hasn’t been irradiated, it is currently compulsory to label irradiated food in New Zealand under the Australia New Zealand Food Standards Code Standard 1.5.3.

MPI’s Food Smart website has an informative page on food irradiation. It’s quite clear on several important points (you can read their full answers on the page):

Does irradiation change food?

At the approved doses, changes to the nutritional value of the food caused by irradiation are insignificant and do not pose any public health and safety concerns.

Some treated foods may taste slightly different, just as pasteurized milk tastes slightly different from unpasteurized milk. There are no other significant changes to these foods.

Does irradiation make food radioactive?

No.

Is it safe to eat irradiated food?

Yes. Irradiation of food does not make the food unsafe to eat.

The World Health Organisation, the Food and Drug Administration in the US and the American Medical Association all agree that irradiated food products are safe to eat.

The FDA’s page on food irradition has an informative “Debunking Irradiation Myths” inset:

Irradiation does not make foods radioactive, compromise nutritional quality, or noticeably change the taste, texture, or appearance of food. In fact, any changes made by irradiation are so minimal that it is not easy to tell if a food has been irradiated.

FDA

It also states that:

FDA has evaluated the safety of irradiated food for more than thirty years and has found the process to be safe. The World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA) have also endorsed the safety of irradiated food.

FDA


Earlier this week, the Herald published an article by Sue Kedgley on irradiated food. In my opinion that article is a load of unscientific scaremongering. Here are a few excerpts that appear clearly intended to be more emotive than informative:

But irradiated food is anything but fresh. It’s been exposed to radiation doses that are between three and 15 million times the strength of x-rays. The Brisbane radiation facility uses Cobalt 60 to irradiate food, a radioactive material that is manufactured in Canadian nuclear reactors, and shipped to Australia in special unbreakable steel canisters.

I visited the Brisbane irradiation facility in 2004. Boxes of food travel by conveyor belt into an irradiation “chamber”. The irradiation process breaks down the molecular structure of food; destroys vitamins in food, and creates free radicals and other “radiolytic compounds” that have never been found in nature, and whose effect on human health is not known.

Also of concern is the fact that in 2008 the Australian Government was forced to ban irradiated cat food after more than 80 cats died or became seriously ill after eating irradiated cat food.

This begs the question – if cats can die, or become ill from eating irradiated cat food, what could be the cumulative effect on humans of eating significant quantities of irradiated food? There’s no benefit to New Zealand consumers, and only risks to our growers, from imported irradiated produce.

Her comment that irradiation “breaks down the molecular structure of food [and] destroys vitamins in food” is quite at odds with the evidence that the nutritional content of irradiated foods are not changed significantly. This statement is entirely blown out of proportion, it’s like describing a papercut as having “ripped my flesh apart”.

She also doesn’t mention any of the details regarding the cat food incident, such as that their diet consisted largely or wholly of food irradiated 100-200 times as much as human food generally is, that the same food seemed to have no negative effects when eaten by dogs, or that the incident was only linked to one specific lot of one brand of cat food. How it relates to humans consuming irradiated food, if it has any implications on that at all, is not clear but her reaction is just scaremongering.

Her article appears to have been prompted by a couple of changes to the regulations that are being considered:

FSANZ is currently assessing Application A1092 seeking permission to irradiate twelve specific fruits and vegetables. A call for submissions on our assessment is expected to be released in the second half of 2014.

Food Standards Australia New Zealand | Food irradiation

FSANZ plans to start work on recommendation 34 (that the requirement for mandatory labelling of irradiated food be reviewed) later this year.

Food Standards Australia New Zealand | Labelling review

Here’s a link to Application A1092. That page specifies the 12 fruits and vegetables involved as apple, apricot, cherry, nectarine, peach, plum, honeydew, rockmelon, strawberry, table grape, zucchini, and scallopini (squash).

Ms Kedgley describes these potential changes as:

the Government is about to approve the importation of irradiated apples, peaches, apricots and nine other fruit and vegetables from fruit fly-infested Queensland.

If they succeed, retailers will be able to sneak irradiated produce into the food chain, and it will be sold, unlabelled, as if it was “fresh”.

Surely consumers have a right to know whether the apples they are buying are fresh, or have been imported from Queensland and exposed to high doses of radiation to sterilise them and kill off potential fruit fly lava?

Red apple
Red apple | Photo by Abhijit Tembhekar

Looking at the IHS for fresh fruit and vegetables (direct PDF download), you can see that honeydew, rockmelon, strawberry, grape, zucchini, and scallopini are already included, they just aren’t yet allowed to be treated via irradiation. As far as I can tell the others – apple, apricot, cherry, nectarine, peach, and plum – can’t currently be imported from Australia.

Given that the entire function of irradiating food is to kill unwanted organisms such as Queensland fruit fly larva, I think it seems disingenuous of Ms Kedgley to repeatedly refer to it as though allowing these products in will bring Queensland fruit fly to New Zealand. The reason why we can’t currently import these products is because of that fly, but allowing them to be treated by irradiation would let us safely import them.

On the issue of labelling, this seems to be a very similar issue to compulsory labelling of genetically modified foods and foods containing genetically modified ingredients (this is currently mostly compulsory in New Zealand). In that case, as with food irradiation, opposition generally seems to be driven by idealogical issues with the technology used or misinformed beliefs that it’s somehow unsafe, even though it’s entirely safe. It’s effectively a lose/lose situation – if labelling isn’t mandatory then “What are they trying to hide?” but if it is mandatory then “They wouldn’t have to put it on the label if it wasn’t bad for you”.

If you want to oppose the addition of those 6 new fruits to the list of foods that can be imported from Australia on the basis of supporting New Zealand farmers then okay, that’s a different argument altogether that has nothing to do with irradiation. There doesn’t seem to be much reason to oppose this on grounds that irradiated food may be unsafe to eat though.

Foods are not allowed to be irradiated unless they have been through a pre-market safety assessment process conducted by FSANZ

http://www.foodsmart.govt.nz/elibrary/food_irradiation_.htm

Given that irradiated food doesn’t appear to be unsafe, is there really any reason to keep labelling of irradiated food compulsory? If anything, isn’t compulsory labelling most likely to make people think that means it’s bad or unsafe when it isn’t? If it’s all about allowing consumers to make informed decisions, that would be rather counterproductive.


I’m lucky enough to know someone who’s a food scientist. Claire Suen has an MSc in Food Science from the University of Auckland, and I contacted her to ask for her thoughts on the process of food irradiation. Here are some of the things she had to say in response to some of the common arguments opposing food irradiation:

[Irradiation] changes the nature of food: carcinogenic, loss of nutrients etc.

So does cooking, burning toast, deep frying, etc. Irradiation causes minute changes to the food and some loss of nutrients such as vitamins, but these have all been thoroughly researched and the results are readily available. In short, no significant changes to the food have been found.

Regarding the lost of nutrients, I usually point out to people that this is negligible considering the nature of the food.

FSANZ have published some comprehensive risk assessment reports in the past, and using the latest report on tomato as an example:

Nevertheless, even assuming an upper estimate of vitamin A and C loss of 15% following irradiation from all fresh tomatoes, capsicums and tropical fruits (with existing irradiation permissions), estimated mean dietary intakes of these vitamins would decrease by 2% or less and remain above Estimated Average Requirements following irradiation at doses up to 1 kGy, with dietary intake typically derived from a wide range of foods.

The impact of cooking and storage time on nutrients in food is far more severe than the effects of irradiation.

Here’s a link to that FSANZ report on Irradiation of Tomatoes & Capsicums (direct DOC download)

There are better alternatives

Irradiated food saves cost for the manufacturers/importers/supermarkets because it eliminates otherwise costly alternatives.

Methyl bromide for example, is not 100% effective against insect eggs and larva, particularly if they are buried inside the fruit or seed. Storage pest such as beetles and weevils are extremely difficult to control and often need a combination of methods such as heat treatment, and fumigation. For herbs and spices, irradiation can be used to control pathogens such as salmonella and E. coli. No other method is as effective. But because consumers in NZ are against it, we have to use methods such as steam sterilisation and heat treatment, which impacts on the flavour and quality of the product. Consumers sometimes do not understand the amount of work MPI and the importers have to do to make sure foreign organisms do not get in the country. All it will take is a slack importer, a missed check, or an incomplete fumigation. What of the products that have to be destroyed due to microorganism contamination, or spoilage? If they had been irradiated, this wastage wouldn’t happen.

We don’t need irradiation since we can just buy local products

Unfortunately NZ is a small country and we have limited produce. I’m not saying we can’t get by without EVER importing anything, but, it seems to me that these people don’t realise just what the consequences are. Sure, we don’t have to import apples, or nectarines, but what about the tropical fruits not grown locally? Or spices? Let’s not eat fresh mango again, or curries, since pepper used to be worth its weight in gold because it’s not grown in Europe. We can’t get away from importing and by not using irradiation, NZ business have to use more costly, and less effective alternatives, which means all these cost are passed ultimately onto the consumers. I understand people’s concern that this will hurt local producers, but that is a question of economy and has nothing to do with the safety of irradiated food.

Now coming to the question of labelling

Unfortunately, it’s a no-win situation. If we label then consumers will think something is wrong with it, if we don’t label it’s as if we are hiding something. There is simply no way to beat that logic. In my opinion, if we don’t label products which have been heat treated, or fumigated, then we shouldn’t need to label for irradiation. But because consumer backlash is so strong, I wouldn’t want to give haters a chance to play the “Ah ha you are hiding something” or “give me my freedom of choice” card.

I say let’s put irradiated fruits on the shelves and label it as such so I can chose to buy it because it will be cheaper and better!

I think that last point says it all really. As a food scientist, Claire is quite familiar with the topic of food irradiation, and she would choose to preferentially buy irradiated food because she understands the process to be safe, effective, and not detrimental to the food.

New Zealand Skeptics Conference: Fighting Pseudoscience

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

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

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

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

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

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

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

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

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

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

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

Copper & Magnetic Healing: How to Respond to Complaints

Last Saturday, I was in a store that had a display on their counter advertising copper and magnetic jewellery:

Copper & Magnetic Healing

As you may be aware, claims that copper jewellery are able to help with arthritis are relatively common, although the evidence is pretty negative. The claim about magnets attracting iron in your blood and thereby increasing circulation is pure pseudoscience though. Usually, if I do something about an ad like this, I lay a complaint directly with the Advertising Standards Authority. This time though, I thought I’d try directly contacting the store to see if they’d fix this situation without requiring any regulatory intervention.

You can read the full email I sent to the company at the bottom of this post, but essentially I described the regulations around claims in advertising needing to be substantiated, and gave some evidence that these claims probably weren’t substantiated. Here’s what I recommended as a course of action:

I understand that these claims were likely supplied to [your store] by the supplier of the copper and magnetic jewellery, and that no one at [your store] has had any intention of misleading your customers. I recommend that you immediately remove the “Copper & Magnetic Healing” display, and contact the manufacturer to ask them for evidence to substantiate these claims. Unless you are in possession of such evidence, you should avoid making therapeutic claims regarding these products.

I’ve had a wide variety of responses from my ASA complaints in the past, so I wasn’t sure how I should expect this business to respond. To make sure my email wouldn’t just be ignored, I asked them to get back to me within a week to let me know what they’d do, so I could know whether or not I should complain to the ASA.

In this case, I was very impressed to hear back from them the next day to tell me that the stores had been advised to remove the displays and they would contact their supplier to ask for evidence to substantiate the claims they’d provided. They also seemed to realise that the chance of the supplier being able to give the kind of evidence required was pretty slim.

A couple of days after that, I heard back from them again to confirm that, as expected, their supplier was unable to provide evidence that would substantiate the claims made about the jewellery. Because of this, they told me that from now on they would only advertise them as jewellery – not “healing jewellery” or anything like that.

I’m very happy to have seen such prompt and responsible action taking following a complaint. I hope this can serve as an example to other businesses.


If you see a therapeutic claim advertised somewhere, and you think it might not be backed up appropriately by scientific evidence, perhaps consider doing something about it. A good start could be to just ask for evidence. If you’d like them to remove a claim if it turns out not to be backed up by evidence, you can recommend that they do this (and your recommendation will be backed up by the Fair Trading Act).

If they refuse, which I would hope is unlikely, then you could lay a complaint with the ASA. The ASA requires that advertisers must be able to substantiate therapeutic claims that they make; it’s not up to you to prove them false, it’s up to advertisers to prove them correct.

If you do contact a business about a claim they’re making, I would suggest a few things:

  1. Be polite. This costs you nothing, and if you come across as rude or antagonistic it’s not going to lead to a productive exchange.
  2. Recommend a course of action. Ideally make it something that is easy for the business to do.
  3. Give an ultimatum. This should still be polite, but I would recommend asking the business to tell you what they’re going to do within a certain timeframe (such as one week) so you’ll know whether or not it’s necessary to bring their claim to the attention of the Advertising Standards Authority.

If you’re interested in doing something about a dodgy medical claim, the Society for Science Based Healthcare can help you to understand the regulation and put together a complaint.


This is the email I sent to the store on Sunday, with the name of the store removed:

To whom it may concern,

I was in [your store] earlier today, and I noticed a display for copper and magnetic bangles and rings on the counter (see photograph attached).

This display contained a number of therapeutic claims about the products. As I hope you are aware, the Advertising Standards Authority requires that all therapeutic claims made in advertisements must be truthful and have been substantiated (see their Therapeutic Products Advertising Code Principle 2). Similarly, the Fair Trading Act 1986 Section 12A states that unsubstantiated representations must not be made in trade.

To my knowledge, none of the therapeutic claims made on the display are substantiated.

A systematic review of the evidence regarding the use of static magnets for reducing pain, published in 2007, found that “The evidence does not support the use of static magnets for pain relief, and therefore magnets cannot be recommended as an effective treatment.”

Relatively little research has been done on the use of copper bracelets for pain relief, but a well-designed trial published in 2009 found that “Our results indicate that magnetic and copper bracelets are generally ineffective for managing pain, stiffness, and physical function in osteoarthritis. Reported therapeutic benefits are most likely attributable to non-specific placebo effects.”

The Advertising Standards Authority upheld a complaint in 2013 against claims made on the Woolrest Biomag website, partly due to the fact that their claims that the magnets in their products can increase circulation by “drawing trace elements, for instance, iron, towards the magnets” and by causing “blood vessels to dilate” did not appear to be supported by any evidence and were therefore likely to mislead consumers.

I understand that these claims were likely supplied to [your store] by the supplier of the copper and magnetic jewellery, and that no one at [your store] has had any intention of misleading your customers. I recommend that you immediately remove the “Copper & Magnetic Healing” display, and contact the manufacturer to ask them for evidence to substantiate these claims. Unless you are in possession of such evidence, you should avoid making therapeutic claims regarding these products.

Please reply to this email by the 23rd of November to inform me of what action you will be taking, so I will know whether or not it will be necessary for me to lay a complaint to the Advertising Standards Authority to settle this matter.

Sincerely,

Mark Hanna
Society for Science Based Healthcare