Therapeutic Products Bill

The New Zealand Skeptics Society is a non-profit body that exists to promote critical thinking. We are frequently contacted by the media to provide informed comments on science and pseudoscience, and support evidence-based policymaking. We offer public education on rational thinking, helping people to understand the gap between proven ideas and nonsense. We think that one of the most important jobs MPs have is to protect the citizens of New Zealand from the harm caused by unproven products and services.

We are generally pleased with the direction of the Bill and its attempt to update the Medicines Act and regulate Natural Health Products. It will be a positive step to have a comprehensive set of rules that help to ensure that medicines, medical devices and Natural Health Products are safe for New Zealanders to consume.

However, we consider that some important changes will be required if the proposed legislation is to achieve its intended purpose, which is to provide an appropriate level of assurance that products imported and supplied within New Zealand are both safe and effective.

Our proposed changes are as follows:

Explanatory Note Part 4, Issuing Market authorisation for NHPs

The statement that market authorisations for NHPs differ from the provisions relating to medicines “to reflect the fact that the risks associated with NHPs are generally less than the risks associated with medicines” should be removed, as this is an unsubstantiated claim. There is no evidence given to support this statement, and it gives a misleading impression that NHPs are safer than scientifically tested and controlled medicines and devices, whereas in reality we know that many natural health products sold in New Zealand have been prepared with ingredients that are dangerous, including homeopathic nosodes (“containing” diseases such as HIV, tuberculosis and typhoid), black salve, colloidal silver, spider venom, digitalis and much more.

4.a Proportionate risk

We are concerned that only immediate risk may be considered when evaluating Natural Health products. We see many NHP practitioners make claims that their product is a panacea that is able to cure all ills. These kinds of claims carry a long-term risk of erosion of the public’s health literacy, and are likely to lead to people believing that NHPs are efficacious, and consequently trusting these practitioners when it comes to serious health issues like cancer. Sadly, even in a country as small as New Zealand, we have regular news stories about people who have died from treatable diseases because they have trusted their Natural Health practitioner.

See our comment on Section 122 for more details about this issue of false assumptions about the safety of NHPs.

9.3.c Market authorisation of NHPs

We do not understand why there would be a different rule for NHPs from medicines and medical devices – surely any therapeutic product should be able to prove its efficacy or performance. NHP practitioners talk about how their products can help treat medical conditions, so why shouldn’t they have to show efficacy? This issue is repeated throughout the legislation.

10.2 Controlled Activities

We think that surveys (e.g. “92% of respondents reported that their skin looked healthier after using our cream”) should also be subject to appropriate regulations, and be added to this list. This should ensure that people’s subjective opinions and the outcomes of poor questionnaire methodology or data sampling are not presented as facts, and therefore would protect against misleading both the public and regulators.

11.1 Who can carry on a Controlled Activity

NHP practitioners of different modalities have a wide range of both education and regulation, with many having little to none of either – and certificates often being able to be purchased over the internet. With this lack of standardised and robust control over their practice, it seems imprudent to give them the ability to carry on controlled activities in the same way as health professionals such as pharmacists, doctors and veterinarians.

We are also concerned that here, and in other parts of this legislation, “health practitioners” are allowed to carry on controlled activities. Although most health practitioners are evidence-based, and medically trained, the HPCA Act 2003 also includes chiropractors and osteopaths as “health practitioners”. Neither of those are evidence-based practices, and are widely considered by medical professionals to be pseudoscience.

12.3 Restrictions on advertising NHPs

We are very happy to see, in principle, that there will be a prohibition on giving false or misleading information about NHPs, although we are concerned that the details of the legislation in this Bill don’t actually support this.

13. Efficacy of NHPs

We are extremely concerned that, unlike efficacy for medicines and performance for medical devices, there is no requirement for NHPs to show that they are effective at treating anything.

We think that, at the very least, information about any proven effectiveness of Natural Health Products should be collected alongside safety and quality information – even if this list does not match the list of allowed claims. This will ensure that health professionals will know which of the allowed claims are backed by scientific evidence, and which are not.

However, we would ideally like to see NHPs treated like any other health product, where claims of their efficacy can only be made where there is robust evidence to substantiate the claims. To do anything less than this does a huge disservice to a public who are trusting this legislation to protect them.

Simply put, if efficacy does not have to be shown for NHPs, we believe people shouldn’t be allowed to make any therapeutic claims about them. If NHPs are omitted from a requirement to have their efficacy proven, they shouldn’t be able to subsequently make claims of efficacy. If, when they obtain market authorisation, they can show efficacy in being able to treat certain medical conditions, only then should those conditions be added to their allowable health claims list for advertising. Allowing NHPs to skip the requirement to give evidence of their efficacy, but then allowing them to make claims of efficacy in their advertising, is a case of letting them have their cake and eat it too – and it’s obvious this is not in the best interests of consumers.

We’re sure that NHP sellers will be able to advertise their products effectively without needing to make unsupported therapeutic claims about them. We already see practitioners using vague words and phrases like “supports”, “promotes” and “winter ills and chills” to avoid falling afoul of the current Medicines Act regulations. Ensuring that nobody can make unsupported claims about NHPs under the new legislation will just mean that Natural Health practitioners will continue to use this kind of advertising to make the same empty promises they are already making. There is no need to weaken the law for these products, especially when this weakening would come at the expense of the public’s health and safety.

We are concerned that some NHP practitioners could use an NHP product’s inclusion in this list in their marketing material and elsewhere to imply that the product is effective. We think that it should be made clear in the Bill that inclusion of an NHP in the scheme does not equate to the product having any health benefits, and we would like to see inclusion of a clause outlawing the use of this list in this manner.

18. Naturally Occurring Things

We think that this section needs to also cover naturally occurring things that haven’t been changed from their naturally occurring state, if the person selling them for a therapeutic purpose has not made any changes to them.

30.3 (a) Antioxidants

Although we understand that antioxidants are generally used as a preservative, we are concerned that therapeutic claims are often made about antioxidants, and so they’re often treated by advertising as more than just an “additive”. We’re not sure if they belong in the NHP ingredient list in (1), but they seem like a special case that might not fit (3) as well as the others do.

31. Homeopathic Products (Low Concentration NHPs)

We consider that Low Concentration NHPs (better known as homeopathic treatments), or any other NHP that is administered, packaged or prescribed in a manner akin to the way a medicine is packaged, administered or prescribed, should be required to have market authorisation, and should not be removed from the scheme due to having “sufficiently low risk”. This would allow for control of the risk of harm from contaminants, as well as mitigate failure to seek conventional treatment and minimise financial harm.

57.1.b.vi NHPs for Animals

We see no reason why administration of medicines (1,b,v) and use of medical devices (1.b.vii) on an animal are covered in this section, but not administration of NHPs to animals (1.b.vi). We think that for consistency, and to provide adequate protection for our furever friends, animals should be covered by 1.a.vi.

61.4 Traditional Use

We are extremely concerned in this part of the legislation by the inclusion of “traditional use” as a supposed method of substantiation of a health claim. Historical or traditional use of a health product, “natural” or otherwise, is most definitely not evidence of efficacy and should not be considered substantiation. Many ineffective or dangerous natural health products have been used by NHP practitioners in the past, and continue to be used today. Considering historical use as a form of substantiation is a type of logical fallacy, usually called the “appeal to antiquity”.

In an ideal world consumer protection should take precedence over the desires of NHP practitioners. We would expect that NHPs, like all other medical products, would need to have evidence of efficacy before anyone was able to make health claims about them. On the face of it, it seems outrageous that any New Zealand legislation would consider allowing people to make health claims about a product that were not backed by robust scientific evidence. Medical practitioners all over New Zealand are concerned about the increase in use of NHPs in our country, and this legislation is likely to worsen the problem.

However we understand that, sadly, we don’t live in an ideal world where laws are always there to protect consumers from harm. Therefore, if this idea of traditional use remains in this piece of legislation, we would like to see the word “substantiated” removed from this section. It seems disingenuous at best to claim that evidence of historical or traditional use substantiates any kind of health claim. Scientific evidence can substantiate a health claim, as the scientific method seeks to uncover the truth. But traditional use only tells us that people have believed in the past that the product may work, and bears little relation to the truth of whether it actually works.

We think that “traditional use” needs to be adequately defined in this legislation, and should only include NHP that have been used for many decades, and where there are no known direct harms from the history of its use.

61.5 Pharmacopoeias

Pharmacopoeias usually contain thousands of medical products and their uses. Some of these, such as many countries’ national pharmacopoeia, are evidence-based and medically accurate. But others, especially those that deal with NHPs (such as the Pharmacopoeia of the People’s Republic of China and others), are not evidence-based, and contain listings of thousands of natural treatments that are either ineffective or dangerous.

We notice that nowhere in the regulation does it mention which pharmacopoeias will be included, and we are understandably concerned about the possibility of the defunct Natural Health Product Bill’s pharmacopoeias being included in this legislation, as most of them (with the exception of the British, European and United States Pharmacopoeia) are not based in science. For reference, the pharmacopoeias that we consider to be an issue, and are concerned may be included in this legislation, are the:

  • American Herbal Pharmacopoeia
  • Ayurvedic Pharmacopoeia of India
  • British Herbal Pharmacopoeia
  • European Scientific Cooperative on Phytomedicines (ESCOP)
  • German Commission E Monographs
  • Indian Herbal Pharmacopoeia
  • Pharmacopoeia of the People’s Republic of China
  • United States Pharmacopeia and National Formulary
  • World Health Organisation Monographs on Selected Medicinal Plants

If any of these unscientific pharmacopoeias are to be used, we would expect at the very least that there are tight controls over which products from them are included, with products excluded if they are considered to be dangerous, removed if they are later found to be dangerous, and no new products added without a thorough vetting process for their safety.

62.4 Removal of Health Benefit Claims

We would like to see the inclusion of the ability for anyone in New Zealand to apply to the Regulator to have a health benefit claim removed from the allowed list for an NHP, if evidence shows that the product is ineffective, misleading or dangerous.

112. Personalised NHPs

Allowing an exception to these regulations for personalised NHPs, when the regulations are written to ensure our safety, appears to be a dangerous loophole. If the point of this legislation is to protect people from ineffective and potentially harmful health products, that’s what this Bill should do, without any exceptions. This new legislation is a good opportunity to be able to increase the protections available to consumers.

112.5 Who is an NHP Practitioner

Part 5.a of section 112 appears to allow anyone to be considered an NHP practitioner just by selling an NHP to a consumer. These non-regulated practitioners could avoid these regulations all together simply by mixing a custom NHP formula for a consumer. If this legislation is meant to protect people, it should do that effectively. We would like to see regulation around who can call themselves an NHP practitioner, through professional bodies, like there currently is for medical professionals.

124. Market Authorisation of NHPs

The current proposed Bill and explanatory note make it clear the intention is that applications for market authorisations for NHPs would be automated, and lodged through an online portal with applicants making a declaration that the criteria for an authorisation are met, and that the applicant’s declaration that the criteria for an authorisation are met is prima facie evidence of that fact. This will undoubtedly allow products that do not meet the criteria, including those that are unsafe, to go to market and leave the onus on individuals and consumer protection organisations to point out any issues and go through a time-consuming process before they can be removed.

Given the extensive history of NHP practitioners making unsubstantiated, often fanciful, claims about their products, we think that section 124 of this Bill should be modified to ensure that all market authorisations for NHPs are manually screened, and the veracity of the information provided in applications should be tested. We believe that trained medical scientists would be the correct people to perform this screening, rather than individuals from within any particular NHP discipline.

193.2 What is an Advertisement

We are happy to see that the definition of advertisement in this section includes websites, social media posts and other online media formats.

194. Advertising

Overall this section is positive, and offers a good level of protection for consumers (with the obvious issue that the list of permitted health claims for NHPs is not robust enough to ensure that the public is not misled about the efficacy of an NHP).

From experience, we know that NHP practitioners are often happy to verbally make unsupported claims about the efficacy of their products/services, even if they never make these claims in written material. It appears likely that this practice will continue under this new law. We would be keen to see the addition of a section of this legislation that covered any claims made verbally about an NHP in a similar way to how section 194 does for advertising.

We also think that this new legislation would be the ideal time to prohibit direct advertising of prescription medicines to consumers, as it currently is in most countries worldwide. It has been an embarrassment to New Zealand for many years now that we are one of very few countries that allows direct advertising of medicines to consumers, although so far any efforts to fix this issue have not been fruitful.

192-199. Fast Track

We believe that this legislation should provide a fast-track method for handling reports of:

  • unauthorised health benefit claims (section 192)
  • general misrepresentation (section 190)
  • misrepresentation as someone allowed to perform an activity (section 191)
  • providing misleading or incorrect information to the regulator (section 199)
  • advertising without market authorisation (section 193)

This fast-track process should require a temporary suspension of these activities within a short time (such as 7 days), pending an investigation, where clear evidence of a breach has been provided. If such conduct has occurred, it would likely be very difficult for the regulator to establish breaches, except where these are brought to their attention. We think that potentially unsafe products should be removed from the market without delay, and this would in turn disincentivise any person wishing to deliberately subvert these regulations for profit.

376. Infringement

We applaud the inclusion of infringement provisions in this Bill, and look forward to seeing their proactive use.

380.3 Consultation

We think that consultation with only “people likely to be affected” by these rules is not broad enough, and this should be explicitly extended to all New Zealanders. This will ensure that important rules such as the allowed health benefit claims for NHPs receive sufficient input from the public.

Conversion Practices Prohibition Legislation Bill Oral Submission

The submission below was given via a Zoom call to Members of the Justice Committee on Wednesday the 15th of September 2021, as a follow-up to the Society’s written submission. The submission was presented by committee members Bronwyn Rideout and Mark Honeychurch, and MPs asked questions after the submission was read out.

The Evidence

We often hear of conversion therapy as a thing that happens in the United States of America – controversial figures such as Joseph Nicolosi, and groups like NARTH and Exodus International. So it’s been horrifying to read stories in the news over the years, and especially recently, about New Zealanders who have endured this dubious therapy.

At the NZ Skeptics, we’re all about evidence. There is no good quality evidence that conversion therapy works, and Wikipedia rightly calls it a “pseudoscience”. Not only this, but there’s a lot of evidence that conversion therapy is harmful.

Professional bodies around the world have evaluated the evidence, and broadly agree that conversion therapy should never be used. In New Zealand, the relevant professional bodies consider the practice to be against their code of ethics.

We know there was a study conducted by Robert Spitzer that is often used as evidence for the efficacy of conversion therapy, but Spitzer retracted the study, and later said “I was quite wrong in the conclusions that I made from this study. The study does not provide evidence, really, that gays can change.”

J. Michael Bailey’s 2016 review of the scientific literature concluded that “There is no good evidence that sexual orientation can be changed with therapy, and we strongly doubt it can be.”

A 2017 literature review from Cornell University looked at 47 scientific papers on conversion therapy. Of the 13 papers that were able to come to a conclusion about the therapy, 1 claimed it was successful and 12 claimed it was ineffective or harmful. The review concluded that “there is no credible evidence that sexual orientation can be changed through therapeutic intervention… There is also powerful evidence that trying to change a person’s sexual orientation can be extremely harmful.”

The evidence is clear. Conversion therapy does not work, but it is harmful.

The Legislation

The international studies we’ve seen show that most people go through conversion therapy because of their religious belief, and this is often due to pressure from their church. This has also been the case for many of the hundreds of New Zealanders who have been through conversion therapy.

Not that numbers should matter, but we’re at the point now where half of New Zealanders are not religious. There really should be no exemption for religious groups to be able to continue facilitating or offering conversion therapy. We hope that this bill will ensure that any individual – or organisation – involved in providing conversion therapy will be held accountable.

We know that health practitioners are not above making bad decisions, such as offering unproven therapies. For example, some GPs in NZ currently offer their clients therapies such as homeopathy that we know through scientific testing don’t work. It’s not a stretch to imagine that some health practitioners would consider it acceptable to offer conversion therapy. We therefore think it is unwise to give health practitioners any kind of exemption in this bill.

Many countries, such as India, Taiwan, Brazil and Germany – and parts of Australia, Canada and the US – already have conversion therapy bans in place, and Israel and the UK are currently in the process of introducing a ban. Several other countries, such as Argentina, Fiji and Samoa, have a specific ban on health professionals offering conversion therapies. We’re a little behind the curve on this important issue, but it’s great that as a country we’re finally doing something about it.

Given the lack of evidence of efficacy of conversion therapy, and the clear harms it causes, it seems like a no-brainer that we should have a law banning the practice. We hope that this new piece of legislation not only becomes law here in New Zealand, but also that it doesn’t end up being watered down to the point that it becomes ineffective. We hope to see this legislation become something that properly protects those who are at risk from being given conversion therapy, no matter who is organising or providing it. These at-risk people absolutely do not deserve to be told that their sexual orientation, or their gender, is “wrong”, and that they can be “fixed” through the use of a pseudoscientific, damaging treatment.

Submission on the Conversion Practices Prohibition Legislation Bill

The NZ Skeptics’ Submission

on the Conversion Practices Prohibition Legislation Bill

About us

The NZ Skeptics are a New Zealand/Aotearoa charity dedicated to education and the promotion of evidence-based practices, both in government policy and elsewhere in New Zealand public life. Healthcare decisions are an important part of this ideal, and we strongly support any measures that seek to follow best evidence and help protect consumers from harm. 

Our View

In line with our sister organisations in Australia and the United Kingdom, it is the position of the NZ Skeptics that we support the banning of conversion therapies as outlined in Section 5 of the proposed Act.

‘Conversion’ or ‘reparative’ practices incorporate a wide range of activities that seek to change or suppress a person’s sexual orientation, gender identity, or gender expression. In both the past and present, such therapies have included so-called clinical treatments such aslike ice-pick lobotomies, electro-convulsive therapies, and aversion programmes that include pharmaceutical regimens that induce vomiting while church-based organisations utilise exorcisms, and intensive praying sessions (either in groups or one-on-one).

To date, no evidence has been produced in New Zealand or internationally to support the effectiveness of conversion therapies. Instead, the only consistent outcome of the practices listed above is harm and life-long trauma to those who have endured them. Reputable organisations worldwide such as the American Psychiatric Association, the American Psychological Association,  Royal Australian College of Physicians, the NHS, and the United Nations have acknowledged and published similar findings.

The absence of support from these and major regulatory and professional bodies and employers has consequently driven such practices underground. The treatments and their providers are unregulated; neither undergo rigorous and ongoing continuing education programmes or annual auditing, as required of any other professional charged with the care of the minds and bodies of New Zealand citizens.

Religious freedom is not violated when banning conversion therapy. Dr. Ahmed Shaheed, UN Special Rapporteur on Freedom of Religion or Belief stated to British Members of Parliament that the banning of conversion therapy in no way violates freedom of religion under international law because of the state’s obligation to protect the life and dignity of LGBT+ persons.

Our Recommendations

As part of our mission to promote evidence-based policy-making and healthcare, the NZ Skeptics continually seek the advice of experts and findings of contemporary research with which to inform our positions on a variety of topics. The evidence is clear that conversion therapy is worse than ineffective, indeed it appears to be outright dangerous; provision of such therapies should be seen by New Zealanders as akin to fraud.

However, the banning of conversion therapy is not simply a health issue, but one that encompasses personal, religious, political, and societal beliefs and practices about gender diversity and identity; Elements which cannot be appreciated with statistics alone. Ongoing persecution of LGBTQIATakatāpui+ communities internationally is an ongoing concern for our organisation, and we see the presence of conversion therapy in New Zealand as a terrible proof of the insidiousness and persistence of bigotry both within our country and outside our borders. To this end, NZ Skeptics finds it vital to consider the voices and recommendations of persons who are either experienced in matters of conversion therapy, or who have been the targets of such unethical treatments, and place our support behind them.

In general we support the wording of this Bill. Here are our thoughts on the parts of the Bill that we feel need changing to ensure it adequately protects people from harmful conversion practices:

Clause 5

We do not think that health practitioners should be exempt from this Bill. We consider that the caveats in 5 (2) are sufficient to protect health practitioners who are “offering legitimate support or therapy”, and we are concerned that health practitioners could conceivably claim to be offering conversion therapy within their “scope of practice”. As such, this appears to be a loophole that we would like to see closed. We recommend the removal of 5 (2) (a) from the Bill.

We do not believe there should be an exemption for religious people or groups in the Bill, and we hope that MPs will resist any pressure from religious groups for any kind of religious exemption to be added. Similarly, we do not think that it would be appropriate for an exemption for parents to be added to the Bill. We recommend that no further exemptions are added to the Bill.

Clauses 8 and 9

We believe that organisations (companies, charities, societies, churches) are often involved in offering, organising and promoting harmful conversion therapy, and would like to see the inclusion of the ability for charges to be brought against organisations as well as individuals. We recommend the inclusion of organisations as well as people as parties to an offence.

We believe that the inclusion of only imprisonment is inadequate to allow for effective sentencing. We would also like to see a fine added, to give judges more options for choosing an appropriate sentence for the offending, and for organisations we would like to see the inclusion of appropriate sentencing options, such as the removal of charitable status. We recommend the addition of more sentencing options, such as fines.

Clause 10

We think that clause 10 is important, and that consent should not be considered a defence in this piece of legislation. We recommend that clause 10 is kept in its current state.

Clause 12

We believe that the requirement of clause 12 for consent from the Attorney-General before prosecution can occur is an unnecessarily high bar. Our understanding is that Attorney-General consent is usually required for laws where there is a significant risk of misuse of the legislation. This does not appear to be likely to be the case for a conversion therapy law, which is designed to protect minority groups who are at risk. We recommend the removal of clause 12 from the Bill.

Other

We believe that monitoring and feedback are important, and that for new legislation to be effective, it should include a review process. For example, it would be good to see this law, when enacted, go through a review of the process and its effectiveness within its first five years, and to allow for amendments as necessary as a result of the review’s recommendations.

Thanks

Finally, we would like to gratefully acknowledge the efforts of Shaneel Lal and InsideOut in their campaign, and support the important work they have done in this area.

Thank you for the opportunity to make a submission on this important piece of new legislation.

Submission on Hate Speech Proposals

NZ Skeptics submission on the Ministry of Justice Proposals against incitement of hatred and discrimination

The NZ Skeptics

We are a New Zealand/Aoteaoroa charity dedicated to education and the promotion of evidence based practices, both in government policy and elsewhere in New Zealand public life. We believe that all government policy decisions should be informed by the best available evidence from relevant groups. We believe that legislation should be based on reality and evidence, rather than on unproven ideas.

The Proposals

Our concern is regarding Proposal five, with the addition of incitement to discriminate to the Human Rights Act.

We accept that inciting others to hate a group of people for their religious belief can be (and has been) a problem in this country, and that it makes sense to have some level of legislation to protect people from this behaviour. 

Our approach is generally to criticise ideas and behaviours rather than people, and our approach is to never intentionally incite hatred of a class of people, even those we disagree with. We tend to single out people who we think are out to scam people and knowingly and egregiously promote misinformation.

We think, however, that even using insults to incite others to hate a religious belief, or to discriminate against people who hold a religious belief, should not necessarily rise to the level of being a crime.

It is important for beliefs to be open to criticism – including through the use of ridicule and insults. Beliefs are different from innate properties of a person or group of people, such as their sexuality, gender, race or national origin. A belief is not an intrinsic attribute of a person, but rather the act of believing is a personal choice. Because of this, there should be latitude for robust criticism of religious beliefs, and of those who choose to follow those beliefs – even if that criticism could be construed as being insulting or abusive, and perceived as inciting others to discriminate or hate.

It is easy to think of examples of religious groups in this country who regularly speak out against the rights of those they consider “immoral”, such as gay and lesbian couples, or those who choose to have an abortion. We do not think that it should be illegal for people to be able to use insults as a way to criticise these groups for example, even if these insults are intended to incite others to discriminate against them. We think there are occasions where groups should be discriminated against, in order to lessen their ability to spread dangerous misinformation. Denying hateful religious groups a platform from which they can speak messages of hate could be argued to be discrimination, but we think that the ability to use activism in this way is legitimate and should remain legal. We would not want to find ourselves being threatened with a lawsuit if we asked our members to boycott a hateful religious group, and used insulting language in order to make our request.

Our worry, also, is that extreme religious groups with whom we disagree, such as those who criticise gay and lesbian couples, might be afforded a different level of shielding from prosecution simply because of their perceived traditional religious roots.

We think that it is important for any legislation around religion and hate speech to differentiate between religious believers and religious beliefs. We would like to see allowance made in legislation for speech that may be considered as inciting discrimination or hatred, when that speech is aimed not at people but at their beliefs. This is especially important when these beliefs are not only wrong but also dangerous or hurtful, such as religious shunning, gay conversion therapy or taking money from the poor. Our ability to criticise these erroneous, damaging beliefs should not be curtailed.

We think that any protections given to religious groups should also be afforded to agnostics, atheists and other non-believers. Especially when it comes to ethnic groups with high levels of belief, non-believing members of those ethnic groups can find themselves targeted by hate speech for their choice to not believe. We see no reason that these people should not be protected by hate speech laws in the same way that religious people will be under the new proposals.

Pharmacy Council Code of Ethics Review Consultation

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The NZ Skeptics are a voice of reason in New Zealand, and aim to promote the scientific method and evidence-based decision making throughout the public sphere. Healthcare decisions are an important part of this ideal, and we strongly support any measures that seek to follow best evidence and help protect consumers from harm. Thank you for giving us the opportunity to have a say in this consultation.

In a similar manner to the “Pharmacy Council Complementary and Alternative Medicines – Statement and Protocol for Pharmacists”, we will refer to these products as “CAM” and “CAM products” within our submission. However we are hesitant to use this acronym because of its inclusion of the word Medicine, where these products have not proven themselves to be medicines.

1. Can you think of any ethical values for the pharmacy profession that appear to be omitted from the revised code?

Yes.

We believe that the current 2011 Pharmacy Council Code of Ethics, which states (in clause 6.9) that 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” is, in principle at least, a good guideline for pharmacists.

Many pharmacies currently supply and promote CAM healthcare products for which there is a very obvious lack of credible evidence of efficacy – even with this code of ethics in place. We are concerned that the general trend in New Zealand has been for pharmacies to sell more CAM over time, presumably driven by a situation where many pharmacies struggle to make enough money to remain viable businesses when selling prescription and over-the-counter medicines alone. An example of this trend is that there is an annual Pharmacy Award for the Best Complementary Healthcare Campaign.

Pharmacists, and pharmacies, enjoy a high level of trust from the public due to their knowledge and expertise, and the importance of the task of dispensing prescription medicines and advising patients that has been entrusted to them. Unfortunately, in order to improve their viability as businesses, many pharmacies appear to have decided to trade on that trust and sell CAM products that purport to improve people’s health, but which do not have good quality evidence backing their use.

The vast majority of these CAM products are unlikely to ever be shown to be efficacious (due the lack of any plausible mechanism of action), and in the short term they are harmless at best – if we ignore their direct financial cost to patients. In the long term, however, these ineffective products are likely to damage patients’ health literacy, making them less knowledgeable about what constitutes good healthcare. They will also tend to make patients less likely to seek proper medical care for their health conditions, instead relying on these unproven products for their future health needs.

If pharmacies find that they need to supplement their income by selling products other than prescription and over-the-counter medicines, there are many products that they could sell that are not health related. We think that it would be much better for pharmacists to avoid the risk of ethically unsound practices, and we would expect the Pharmacy Council’s new Code of Ethics to be an aid in ensuring that pharmacies behave ethically in this regard and do not sell any products that have not been proven to work.

Unfortunately the new code of ethics appears to weaken the stance taken by the 2011 code, rather than strengthening it; only requiring that a pharmacist satisfies themselves that a product is appropriate for the patient (clause 1g).

In essence the proposed new code seems to be worded in a way that, in a perfect world, patients would be protected from the sale of ineffective health products. All pharmacists, and pharmacy staff, would have a good level of knowledge of the evidence base for all CAM products they sold, and they would be free of all biases.

However, in reality, there are a wide range of beliefs about CAM amongst pharmacists and pharmacy staff – and not all of these beliefs accord with the best evidence for these products.

The “secret shopper” exercise undertaken by members of the NZ Skeptics two years ago showed that pharmacies, and pharmacists, are more likely to promote an ineffective product (homeopathic products, in the case of our exercise) than to warn of its ineffectiveness. If the behaviour that we saw in 2015 is indicative of the general stance that pharmacies hold with regard to CAM, and we think that this is a fair conclusion, we believe that pharmacists are often not acting in the best interests of the patient when it comes to CAM. They may not be in possession of the best available evidence, and there is also a real risk that a pharmacy’s need to make money can cloud proper judgement when it comes to selling these products.

For these reasons, we consider that leaving individual pharmacists to be the judges of what constitutes a good level of evidence for a CAM product is not prudent. We believe that it is the Pharmacy Council’s responsibility to help pharmacies navigate the myriad of CAM products that are currently on the market, and ensure that they are not selling ineffective products to patients. We think that the Pharmacy Council should not be scared to provide a robust level of guidance for pharmacists when it comes to both unproven and ineffective CAM products.

We believe that this guidance can be effected in part by creating a list of classes of CAM products that have been shown to be ineffective (such as homeopathy), and which should not be sold in pharmacies. The Pharmacy Council should also target the most popular CAM products being sold in pharmacies, and create information resources for both pharmacists and patients explaining the current evidence, or lack of evidence, for these products. These resources could include booklets that are made available in pharmacies, and given out when these products are purchased, and web pages that are placed online, either on the Pharmacy Council’s website or a site specifically for providing information about CAM products.

2. Considering the explanation of the term “patient” and equivalent terms in the key terms (key terms):

a. Do you think the term “patient” is the best word to use, most of the time, to express the relationship that exits between the pharmacist and the person they are directly or indirectly caring for or providing health care information to?

Yes.

We think that the word “patient” is a positive step towards impressing on pharmacists the importance of the relationship they have with the public, and the trust that the public place in pharmacists to behave in a way that is in individual patients’ best interests.

b. Are there any specific clauses where you can think of different term that could be more appropriate?

No

3. Considering the new clauses that relate to the sale of complementary and alternative medicines (CAM, clauses 1g, 4h and 4hh): Do you find it clear that the Council is not opposed to the sale of CAM when they have demonstrated benefits for patients, have minimal risks, and the patient is making an informed choice?

No.

We think that the clauses do not make it clear that they are not opposed to the sale of CAM “when they have demonstrated benefits for patients, have minimal risks, and the patient is making an informed choice”. What the clauses appear to do, instead, is to allow the sale of CAM when an individual pharmacist believes that these products “have demonstrated benefits for patients, have minimal risks, and the patient is making an informed choice”.

This is a subtle, but important, difference. We think that the proposed code would allow for a pharmacist to sell homeopathic products, for example, simply by holding a sincere belief that these products “have demonstrated benefits for patients, have minimal risks, and the patient is making an informed choice”. This belief would not accord with reality, but merely holding it appears to be sufficient to circumvent this code.

To paraphrase the songwriter Tim Minchin, “what do you call Complementary and Alternative Medicines (CAM) that have demonstrated benefits for patients? Medicine”

4. Are there any other comments you would like the Council to consider?

Yes.

We would like to see the Pharmacy Council produce a set of clear rules for when a product can be deemed to be ineffective; a clear, transparent process outlined for dealing with complaints against pharmacies selling products that are not evidence based; and clear penalties for pharmacies that are found to be in breach of these guidelines. The new code does not appear to allow for this to happen, and instead we suspect that it is unlikely that the Pharmacy Council will end up using this new code to censure a pharmacy for selling ineffective health products.

We would be interested to find out, given the many apparent breaches of the current code of ethics where pharmacies are selling CAM without credible evidence of efficacy, how often pharmacies have been found by the Pharmacy Council to be in breach of the code, and what action was taken in each case.

We would also like to see the Pharmacy Council introduce a way to effectively measure whether pharmacies are following the code of ethics – some method of proactively auditing the compliance of pharmacies. These checks would have to be incognito, to ensure that an accurate measure is taken of how pharmacies are promoting CAM to patients.

Submission on the Health (Fluoridation of Drinking Water) Amendment Bill

Fluoridation

The NZ Skeptics believe that the available scientific evidence shows community water fluoridation to be both a safe and effective measure for reducing incidence of tooth decay. What we see in the behaviour and tactics of the anti-fluoridation movement in New Zealand echoes similar behaviour we see from other ideologically anti-science groups, such as the anti-vaccination movement. This includes “cherry picking” of only the evidence that supports their position while ignoring any data to the contrary, misrepresenting scientific studies, and flouting New Zealand regulations in order to misinform the public.

 

We believe that the anti fluoridation movement has come out against this bill not because they believe that local councils are better able to make healthcare decisions for the public, but because it is easier for them to influence and subvert these decisions when they are made at a local council level – as we have seen them do in the past.

The Proposal

The NZ Skeptics support the proposed change of moving the decision to fluoridate water supplies away from local councils, and transferring it to District Health Boards

As water fluoridation is a public health measure, we believe that DHBs will be better suited to make an informed decision than local councils are. DHBs have staff on hand who are proficient in reading and analysing scientific studies, and they also monitor the health of their district’s residents. These two skills will allow DHB staff to advise the Board members of each DHB as to whether fluoridation is an appropriate measure.

Other agencies

We would like to note that if a change is made to move the decision making process to central government rather than to DHBs, we would be supportive of this move.

 

Thank you for the opportunity to be able to give our opinion on the proposed change to this important health measure.

Consultation on amendment to the Medical Council’s statement on advertising

Medical CouncilThe Medical Council asked for submissions on a proposed amendment to their statement on advertising in relation to the use of testimonials, with the amendment prohibiting the use of testimonials by doctors in advertising. The consultation asked three questions, and here are the answers that the NZ Skeptics gave:

 

1. Do you agree with Council’s proposed prohibition of the use of testimonials in medical advertising? Why or why not?

We agree. Testimonials are by their nature anecdotal, and as such their use in medical advertising is problematic for a number of reasons. These can be summarised by stating that it is impossible to imply any meaningful evidence of efficacy from a testimonial.

Although testimonials do not demonstrate the efficacy of a treatment, or the ability of a doctor, they do tend to influence a patient’s choice. Many patients will not understand the distinction between evidence and testimonials, and could easily be led to assume that a testimonial is direct validation of a medical service. Evidence offered to aid a patient’s choice, in the form of well designed trials, systematic reviews and meta analyses, should be the kind of supporting evidence offered by a medical practitioner. Prohibiting testimonials would serve to eliminate a potential emotive factor from a patient’s choice, leaving them with the confidence that they have not been unduly influenced in this way.

The widespread use of testimonials by ‘alternative’ medicine practitioners (those that have no scientific evidence or plausibility) is of interest, since it would appear that testimonials might be the last bastion among these practitioners – those that have no other avenue with which to suggest that their services work, except to solicit previous customers who are persuaded by their own experience to write testimonials.  Of course testimonials can be, and often are, ‘cherry picked’ by alternative medicine practitioners, so that only the positive testimonials are shown.

If testimonials were allowed to be relied upon to persuade patients to seek treatment from a medical doctor, there could never be certainty that the true balance of testimonials was in favour of the medical service. Intellectual dishonesty, amounting to data manipulation, could never be ruled out.

Additionally, any tendency for wishful thinking and the “I’ll try anything” rationale, which is human nature (especially among seriously ill patients), is particularly susceptible to the use of testimonials.

 

2. Do you agree with Council’s proposed definition of ‘testimonial’? What other changes (if any) should Council incorporate in its definition of ‘testimonial’?

For the most part, we agree. However we would like to offer a few suggestions.

Firstly, Footnote 7 states “you are not responsible for any unsolicited testimonials or comments that are published on a website or in social media over which you do not have control of”. This seems like a possible loophole, and we wonder if wording about taking reasonable steps to prevent or remove such unsolicited testimonials should be included here. Clearly practitioners should not be held responsible for things said out of their control. However, a less scrupulous practitioner might use this exemption to circumvent the prohibition of testimonials by keeping themselves separated from the direct process of solicitation, perhaps via the use of a proxy.

Secondly, the proposed definition refers specifically to “a doctor’s care, skill, expertise or treatment”. However some websites, such as that of the Apollo Medical Centre (http://www.apollomedical.co.nz/testimonials.php), include testimonials that refer to the centre as a whole rather than to specific named doctors. The following testimonial from ‘Sarah’ is an example of this:

“When I came to Apollo Medical as an acute patient visiting from Wellington, I felt self assured and confident that I was getting very good care.  Everything ran very smoothly with my visits being followed up by the nurse and the results clarified by the doctor.  When it is not your regular medical centre you do feel quite vulnerable, but at Apollo I felt very well cared for, even though I was not a regular patient.  Everyone was very pleasant and kind, and I would not hesitate to go there again if needed.” [Emphasis added]

Sarah refers to her feelings about the quality of care that she received from the medical centre as a whole, including at least one nurse and doctor. It’s unclear whether this type of testimonial would fall under the definition given by the Medical Council, and we suggest rewording to extend the clause to cover testimonials where doctors are a part of the group being endorsed, to the extent that they have control over this advertising.

 

3. Are there any other changes that Council should incorporate to Clause 13?

Yes, we would like to see Council include a sentence such as “Doctors should not solicit patients to submit testimonials to third party websites” in Clause 13, or alternatively in Footnote 7.

Submission on The Regulation of Natural Health Products consultation

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Below is the NZ Skeptics’ submission on the recent Regulation of Natural Health Products consultation, run by the Ministry of Health. The consultation is related to the Natural Health and Supplementary Products bill, which is likely to become a new piece of New Zealand legislation in the near future. Our submission is a point by point response to the questions raised by the consultation document, which can be found, along with supporting documents, at:

http://www.health.govt.nz/publication/regulation-natural-health-products-consultation

 

The Regulation of Natural Health Products

 

Ingredients

 

1. Are there other criteria that the Committee should consider when adding a substance to the permitted substances list?

Yes. Possible interactions with both prescription pharmaceuticals and other natural health products should be considered when adding a substance to the permitted substances list.

A history of safety issues and patterns of historical misuse of a substance should also be considered. This history should be gathered from reliable sources located globally, not just in New Zealand.

 

2. Of the criteria proposed, are there any that you think should not be considered by the Committee when adding a substance to the permitted substances list?

No. All of the proposed criteria appear to be important for ensuring the safety of substances, and we hope that they all become part of the final criteria used to evaluate substances.

 

3. Should the criteria to be considered by the Committee be weighted or ranked in some way?

Yes. Concern for safety is paramount, so any safety assessment should hold increased weight.

 

4. Do you agree that full formulation details of proprietary ingredients should be disclosed?

Yes. We wholeheartedly agree that full formulation details should always be disclosed to both the Authority and consumers. The safety of consumers relies on all ingredients and amounts being known, and matters of consumer safety should always trump those of commercial interest. We also believe that for consumers to be able to make informed choices about their healthcare, they have a right to know the ingredients of any healthcare product they are taking.

 

5. Are there substances that could be added to or should be removed from the draft permitted substances list?

Yes. Although we did not have the resources to check through the entire list of draft permitted substances, we were very surprised at how long the list was. Ideally we would like to see all substances, outside of those with a proven therapeutic benefit, having to go through a submission process which involves the paying of a fee, rather than automatically being added at no cost. This ensures that due diligence is performed on all substances.

Health benefit claims

 

6. Are the following factors the right ones to consider when deciding if claims may be made about named conditions:

  • non-serious
  • self-limiting
  • suitable for self-management
  • suitable for self-diagnosis
  • likely to cause serious consequences without health practitioner consultation?

Yes. These are a good minimum set of conditions. No claims should be made for conditions that do not take into consideration all of these factors. These factors would benefit from being turned into a more formal, precise set of rules, to ensure they are consistently applied to all potential allowed conditions.

 

7. Should other factors be considered?

Yes. We believe that conditions should only be added to the allowed list if it has been found by the Authority that at least one natural health product has been shown to be effective in treating the condition. This would go some way towards showing a plausibility for other natural health products also having the potential to have a positive effect on the condition.

 

8. Should the factors be weighted or ranked in some way?

Yes. The factors that have a more direct effect on consumer health risks should be ranked higher, e.g. the seriousness of the condition.

 

9. Are there conditions you think should be added to or removed from the draft list of conditions about which health claims may be made?

Yes. There are several items on the list of conditions that are prefixed or suffixed with “unspecified”, such as “bacterial infection unspecified” and “allergy, unspecified”. We wonder if some of these definitions are too broad, and should either be removed or replaced with specific conditions.

We recommend that time is spent on ensuring this list is acceptable to a range of health professionals (accredited medical science health professionals, rather than alternative therapy professionals) and any relevant professional bodies (again we would prefer to see no alternative therapy professional bodies involved, given their conflict of interest).

We would also like to see an explicit provision for the regulations about health claims to include any claims made within the name of a natural health product. We are concerned that some products currently have names which make health claims, including naming specific medical conditions in the product name. Examples of products sold in New Zealand with this issue are:

Evidence

Relevance and representativeness of evidence

 

10. Are there other criteria that should be included, or should any of the listed criteria be excluded?

Yes. We think that it is not enough for evidence to “not conflict with a wider body of evidence”. It would be better to have the reverse of this criteria, that evidence should “agree with a wider body of evidence”. This strengthens the criteria to ensure that a single study would not be considered sufficient evidence, in cases where there has been a lack of research conducted on a product’s efficacy.

Traditional evidence

 

11. Are these appropriate sources of traditional evidence?

No. Ideally, there should be no mention of historical use when it comes to the marketing of natural health products and no claims should be able to be made about a product on the basis of this traditional evidence. Our understanding is that historical use does not have a good track record when it comes to proving either that a product is able to treat a medical condition, or that the product is safe. The vast majority of natural health products with evidence of historical use to treat a condition have either a) not been proven to actually treat the condition or b) been positively shown to not treat the condition.

At least some consumers are likely to be led to believe that evidence of historical use is evidence of efficacy. If this information is allowed to be used in any way for making health claims about a product, those consumers will be misled into thinking that the product is able to treat a health condition. This should be enough of a reason to ensure that historical use is not allowed to be used as evidence for a natural health product.

It is telling that the section on traditional evidence in the guidelines is so much shorter than the section on scientific evidence. The scientific method is a well tested way of testing whether claims are true or not, and as such it is necessarily strict about how scientific tests are conducted and what can be considered an acceptable level of evidence. Traditional evidence, on the other hand, is not encumbered by a requirement to prove that its claims are true – merely that its claims are old. Accepting traditional evidence, in any form, is enacting a great disservice to New Zealanders, who rely on the government to ensure they are protected from ineffective or dangerous treatments.

If historical use will be allowed as evidence, there are some issues that we have with the guidelines.

We do not believe that an individual should be taken on authority when making claims about whether there is evidence of traditional use for a treatment. Written documented evidence of historical use should be a bare minimum accepted, and this should be evaluated critically before being accepted. No matter what the position of an individual in a culture, their claims should be subjected to scrutiny – arguments from authority should not be accepted.

We are also worried about the pharmacopoeia that have been listed. We believe that these should not be taken on face value as evidence of traditional use, and that external validation of their claims must be required. Obviously, for any volume first published before the traditional use time period, this would be sufficient evidence that the treatments listed within the volume fit the criteria of traditional use. However, we are concerned that some of these pharmacopoeia may contain treatments that have only relatively recently been used.

In fact, any single source that claims historic use of a natural health product should not be taken at face value. Multiple independent forms of evidence should be required before it is accepted that a product has a long history of use.

 

12. Are there other sources of traditional evidence that should be accepted?

No. We are concerned that the existing sources of traditional evidence are already too broad, and that the average consumer will give traditional use claims more weight than they merit. Adding more sources would only exacerbate this problem.

 

13. Do you think 75 years is an appropriate minimum period of use for something to be considered to be traditionally used?

No. We consider that use should only be considered as traditional if it pre-dates the spread of the scientific method in medicine. A useful yardstick for this date is the publication of An Introduction to the Study of Experimental Medicine by Claude Bernard in 1865. At the very least, we believe that a fixed date should be chosen for deciding if something has been traditionally used, to simplify management of which treatment types are considered to qualify or not qualify. If a time period is used (e.g. 75 years), the Authority will need to track when treatments change from not qualifying as being traditionally used to qualifying. Given the large number of natural health products available, this could be burdensome task.

Scientific evidence

 

14. Are there other factors we should consider when determining if a type of study is acceptable?

Yes. The guidelines suggest linking the level of study considered acceptable as evidence with the risk of using a product. We do not consider this to be a sensible position to take. The level of evidence required should not be linked to the risk of taking the product, but only to the level of claims being made about the product. The more specific and definite the medical claims, the higher the level of evidence that should be supplied. Whether the product is low or high risk, however, should not influence the level of evidence deemed acceptable.

We consider that peer review is an absolute minimum for deciding that a type of study is acceptable. Allowance will have to be made for the varying quality of peer reviewed journals, especially given the proliferation of unscrupulous journals in recent years that have been known to compromise on peer review. A good overview of this issue can be read at http://science.sciencemag.org/content/342/6154/60.full

 

15. Are the types of studies that are acceptable clear?

No. It is not clear that all the types of studies listed have a requirement that they are peer reviewed. We believe that this requirement is important and should be explicitly mentioned.

 

16. Should other types of studies be considered acceptable?

No. Some of the existing list of types of studies considered acceptable are already at what appears to be a lower standard than would be acceptable to MedSafe or the Advertising Standards Authority as evidence of efficacy. Any further adding of acceptable types of studies would only risk weakening this consumer safeguard.

Summary of evidence

 

17. Are the evidence guidelines clear?

No. The Draft Guidelines for Natural Health Products Evidence Requirements document contains several worrying details.

There is a statement that “Scientific evidence does not take precedence over traditional evidence”, in the General requirements for evidence section of the guidelines. We are concerned that it is not clear from the document what reasoning has been used to discern that traditional and scientific evidence are equal in this way.

It is our understanding that science has made great strides in providing us all with affordable, effective healthcare, whereas most traditional treatments have not been adopted by modern medicine precisely because they have not been shown to be effective. To equate the two forms of evidence is to totally ignore the fact that the scientific method has proven itself time and time again, and has earned the right to be considered a more trustworthy way of proving a claim than has the simple idea that something has been used for a long time. Many treatments that have a long history of use are now known to be dangerous, such as bloodletting and purging.

Given that evidence of traditional use is, in effect, evidence that a treatment was developed when we were a lot more ignorant that we are now about medicine and healthcare, we strongly resist the idea that the two should be given equal footing.

This principle of not accepting scientific evidence over traditional evidence leads to the unfortunate statement later in the guidelines that “Traditional claims that have been scientifically proven not to be correct can still be made”. We believe that this is unacceptable, and that if there is good quality positive scientific evidence to show that a claim is false, that claim should not be allowed to be made at all – including in the context of historical use.

We believe that all evidence should be available in English. The guidelines state that “The evidence that you hold to support your claim must be in English, or you must be able to provide a verified English translation if requested by the Authority.“ We believe that it is important to allow consumers to be adequately informed, and as such an English version of any evidence held should always be made available in an easily accessible format.

We would like to see provision made for consumers to have access to the full text of any studies cited in support of a health benefit claim. It would be disappointing to have natural health companies making claims that cannot be readily verified because the studies cited are locked behind a paywall and out of reach of consumers due to the cost involved. Given how often we have seen natural health companies claim that a study supports their position, where a subsequent reading of the text has shown that the company has either accidentally or deliberately misconstrued the results of the study, we feel that making it easy for consumers to verify a given summary of a scientific text would be beneficial.

The list of health benefit claims given in the guideline are inclusive, which is laudable. The five claims given are:

  • maintenance or promotion of health or wellness
  • nutritional support
  • vitamin or mineral supplementation
  • affecting or maintaining the structure or function of the body
  • relief of symptoms.

Given these definitions, we hope that the new regulations will cover the types of claims that are currently exempted by TAPS Guideline 13, such as:

  • Helps smooth digestion
  • Aids the digestive process
  • Supports normal digestion
  • A natural approach for digestion

We believe that these claims are all likely to mislead consumers into thinking that a product is effective for a given health condition, and as such the new regulations should require evidence for these claims.

For products that come under the purview of the new regulations, we would like to see provision to ensure that companies don’t deliberately use vague claims to avoid having to supply supporting evidence. For example, non-specific claims about “the immune system” or “mental wellbeing” should not be allowed.

 

18. Are there other evidence-related topics that should be included in these guidelines?

No.

Manufacturing

The Code of Manufacturing Practice

 

19. Do you agree with the proposed Code of Manufacturing Practice?

No. We have problems with the general thrust of the Code, as it is summarised in the consultation document.

We see no reason for there to be any gap between the legislation and the Code of Manufacturing Practice coming into force. We hope and assume that most natural health product manufacturers are already following a code of manufacturing practice that is closely aligned with the proposed new Code, and so meeting the requirements of this Code should be a quick and simple task.

We also strongly disagree with the principle that the manufacturing regulation of natural health products should be proportionate to the risks of their use. We feel that manufacturing risks are independent of the risk of a product’s use, as these risks come from outside of the intended use of a product. For example, contamination of a product is an equally risk-laden issue whether the product itself is considered low risk or high risk .

Manufacturing exemptions

 

20. How frequently should audits be required? Should this differ for different levels of risk?

We agree that it is acceptable for audit frequency to depend on risk. We think that the risk level should be informed by such measurements as the history of a manufacturer’s prior infringements and the compliance history of the product with other manufacturers.

We do not agree that there should provision for any manufacturer to be exempt from auditing.

 

21. Do you think there should be exemptions from manufacturing licensing?

No. If anything, small volume manufacturers of natural health products have a greater potential to create products that carry risk. All consumers deserve the same protection, whether they are purchasing a product from a high volume manufacturer or a small scale manufacturer.

Fees

 

22. Are these the right things for the Authority to charge for? Are there other things for which the Authority should charge?

We are not concerned with the services that the Authority will charge for.

 

23. Are the charges structured appropriately?

We are not concerned with the structure of the charges.

 

24. Do you have any comment on the proposal that notification be for a July–June financial year, and/or the proposals to handle the transition period?

No.

 

25. Do you have any comment on the level of the charges?

Yes. Although we have no specific recommendations for fees, we believe that overall the annual amount collected in fees should be sufficient to fund a robust system of proactive regulation. These fees should allow for:

  • Frequent manufacturing audits
  • Random manufacturing spot checks
  • Independent product checks to ensure the accuracy of both the ingredient list and listed dosages
  • Frequent evidence checks for evidence supplied in product notifications
  • The use of qualified scientists in relevant fields to evaluate supplied scientific evidence

Ideally, we would prefer to see the product registration system as an approvals based system rather than a notification system. We think that an enforced check of all product registrations should be performed, and that the natural health products industry should bear the cost of this process via product registration fees.

We would like to see the Authority make provision for a robust, proactive, transparent complaints procedure. Ideally this procedure would involve the proper consideration of all complaints laid before it, rather than a cherry picking of only those complaints deemed to be the worst offences. We would also like to see this procedure made as transparent as possible, with the complainant kept informed at all stages of a complaint’s processing, and information on complaints and their outcomes made public on a website. The website should also allow for online complaint filing, and have clear instructions on how to make a complaint and what kinds of issues merit a complaint.

 

26. Do you have any comment on the assumptions around volumes each year? Would you expect higher volumes in the first year?

No.

 

27. How many products do you anticipate notifying initially, and in the next two to three years?

No, we have no expectation around this.

 

28. Do you agree that manufacturers are best placed to commission any quality control activities, such as audit, that might be required by the Code of Manufacturing Practice?

No. We consider that allowing product manufacturers to self audit is taking an unacceptable risk. Natural product manufacturers should not be trusted to be able to effectively police themselves, especially given the global track record for natural products failing to conform to their stated ingredients lists:

 

29. Are there additional issues relating to fees and charges that you would like us to consider?

No.

Very low-volume products

 

30. Do you see a case for reducing fees for very low-volume products?

No. Fees should be reduced in circumstances where it can be shown that associated costs are lowered. However, we do not see how a low-volume product would entail a lower cost to the Authority in managing the product registration, and so we do not believe that these products should qualify for reduced fees.

 

31. How would you define very low-volume products?

We believe that any natural health product, even one that is custom made for a consumer with a volume of only a single unit, should be regulated. Therefore, although we have no recommendation of an upper limit for what is considered low-volume, our lower limit would be 1.

 

32. Do you have any suggestions for the design of any provisions, including:

  • limits on the number of products that any notifier can have fee exemptions for
  • administrative efficiency
  • any other issues that might be associated with low-volume products?

 

No.

Labelling

 

33. Do you agree that labels should meet the proposed presentation requirements?

Yes. There should be a procedure in place to ensure all labels meet the requirements before a product can be sold, and a process for consumers to report products that fail to meet the labelling standards.

 

34. Are the proposed minimum labelling requirements the right ones?

Yes. The labelling requirements are well thought out, and will help to protect consumers through allowing them to be sufficiently informed about the product.

 

35. Should product labels include unique identifiers?

Yes. Unique identifiers should be on all labels, and there should be provision for this identifier to be searchable in an online product database of all registered natural health products.

Given the proliferation of internet enabled smartphones, we would like to see this process made as simple as possible by the inclusion of a QR code on labels as an added unique identifier. This code, when scanned by the consumer’s smartphone camera, would open the product registration webpage in a browser on the consumer’s phone. The technology to allow this to happen is already freely available, so the cost to add this feature would be minimal.

The unique identifier section of a label could look like this example:

NHP QR Code

 

36. Is there any other information that should be included, or should any of the listed information be excluded?

Yes. We believe that intended purpose of the product should only be allowed to be included on the label if there is scientific evidence to underpin the claim. We do not consider historical evidence alone to be sufficient to warrant the inclusion of a claim that the product is able to treat any medical condition.

If evidence of historical use is allowed to be included on product labels, we believe that it should be accompanied by a disclaimer which explains that the claim does not constitute evidence of efficacy. The disclaimer could take the form of:

Traditionally used for x. This is not evidence that this product is able to treat any medical condition, only that it was believed to do so in the past.

Notification

 

37. Is there information that you think should be included in, or excluded from the notification process?

Yes. We think that, along with the summary of evidence, a summary of risk should be included. Manufacturers should be expected to have researched any risks associated both with each active ingredient and with the formula of ingredients. Any adverse effects recorded in medical journals or databases from around the world should be summarised and included in the report, along with links to the source data.

 

38. What information that we are proposing be notified do you think should not be made publicly available and why?

None. We believe that full transparency is important to allow consumers to make an informed choice about their healthcare.

 

39. Should products that sell in less than a certain quantity per year be exempt from notification?

No. We believe that any exemption to notification is a risk. If exemptions to notification are to be allowed, this should be related to risk. We do not consider the quantity sold to be a reliable indicator of reduced risk to the consumer.

 

40. Should products for which the annual sales amount is less than a certain figure per year be exempt from notification?

No. Similarly to question 39, We do not consider the annual sales amount to be a reliable indicator of reduced risk to the consumer.

 

41. Should exemptions on other grounds be considered?

No. We think that the exemptions listed in the consultation document, for one-off products and homeopathic products, will both increase the risk to consumers. The only way to ensure that these products are safe is to subject them to the same regulations as other natural health products.

The three main risks with natural health products, as defined in an overview at the beginning of the consultation document, are that:

  1. The ingredients in the product could be unsafe.
  2. Consumers may delay seeking conventional medical treatment.
  3. Products could be manufactured in an unsafe way.

We consider all of these risks to apply to both homeopathy and one-off products, as much as they do to other natural health products.

For example, with homeopathy, the only way to ensure that an active ingredient has been diluted to the point that it is safe, and that there no contaminants due to unsafe manufacturing, is to test the product. An easy way to ensure the safety of homeopathic products is to not exempt it from the regulations. Failing that, there should be provision that exempted products carry a warning that they are not covered by the regulations. This warning could look like:

This health product has been exempted from regulation by the Natural Health Products framework. Any health claims made by this product have not been vetted in any way.

We are concerned that if homeopathic and other exempt products are not covered by the new regulations, consumers will assume that they are covered and will not notice the lack of regulatory labelling on these products. As such, the warning above would need to be made obvious on the packaging.

Homeopathy is well known as a natural health product that has caused consumers to delay medical treatment. A website called What’s the Harm has documented some of these cases from around the world at http://whatstheharm.net/homeopathy.html

 

42. To be fair to all product notifiers, how should requests for exemptions be verified to ensure they actually qualify?

We believe that exemptions are anathema to the idea of ensuring consumer safety. We hope that no ad hoc exemptions would be accepted, as they would allow a product to bypass this scheme – a scheme which is rightly designed to protect consumers.

Recognised authorities

 

43. Are there any additional purposes for which you think the Authority should also consider recognising other authorities?

Yes. We would be happy for other authorities to be recognised for several purposes, as long as those authorities can be shown to be both impartial and proficient. The purposes we think are suitable are:

  • Analysis of any health claims being made
  • Testing of product ingredients
  • Manufacturing spot checks

 

44. Are there any purposes for which you think the Authority should not consider recognising other authorities?

No.

 

45. What other authorities do you think the Authority should recognise and for what purpose?

As we have said previously in this submission, we believe that product registration should be an approvals rather than a notification system. We think that MedSafe would potentially be a proficient authority for tasks such as analysing the scientific evidence for product approvals.

Determining if your product is a permitted natural health product

 

46. Does the flow chart to determine if your product is a permitted natural health product make sense to you?

Yes. We wonder if an interactive version of this flow chart would be a useful addition to a Natural Health Product website that we presume will be created – maybe a list of questions with Yes/No buttons to answer them.

 

47. Are there other considerations that we should take into account?

No.

Other Issues

We hope to see the Natural Health Products website become a useful resource for finding information about all information useful to consumers, such as registered products (including full ingredients, the evidence summary, etc), deregistered products, permitted substances, allowed conditions, consumer complaints and manufacturer fines. To that end, we would like to see that an API is placed in front of this data to allow easy access, in accordance with the government’s commitment to Open Data. We also hope to see the website make use of modern technologies such as responsive design and Microdata, along with extensive hyperlinking, to make the site intuitive and easy to navigate on handheld devices as well as full sized computer screens.

We thank the Ministry of Health for giving us the opportunity to submit our thoughts on this new, important piece of legislation. We hope that our ideas are helpful in finalising the specifics of the bill and associated guidelines, and we would be keen to engage further with the Ministry on this topic in any way that we can help.

Edward Linney – Pharmacy Council Code of Ethics Consultation Response

Submission relating to proposals by the Pharmacy Council to alter Clause 6.9 of the code of Ethics

I am Edward Linney a consumer with an active interest in evidence based medicine.

I do not support the intent of clause 6.9b to avoid a requirement of credible evidence of efficacy for complementary therapy or other healthcare products.

Extract from consultation document

Proposed supplementary wording – two distinct parts – clause 6.9

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 thepurchaser to make an informed choice with regard to the risks and benefits of all the available treatment options.”

 

The addition of 6.9b explicitly avoids any requirement for there to be credible evidence of efficacy. It moves the roles of evaluation of scientific evidence from the scientists to the consumer. This is bizarre, we all understand that the patient purchasing the homeopathic remedy for example is a believer and is most unlikely to be able to make an informed decision in the complex task of selecting the best products to treat themselves with.

Pharmacies are businesses BUT they are run by scientifically qualified people and they trade on this image. They are the only place where the public can purchase prescribed pharmaceuticals. Pharmacists enjoy a very privileged position in that regard. In my view the public expects you to sell and promote products which are shown in appropriate testing to perform better than a placebo, in short evidence based products.

The National Health and Medical Research Council of Australia ( The Government if you will) published an unqualified opinion in March 2015 after wide public consultation and a meta analysis of many trials that homeopathy is no more effective than placebo in treating humans. It comes as no surprise to me that when the credibility of these products which are actively promoted and sold in all my local pharmacies is vanishing that the Council proposed to avoid the requirement for efficacy in the sale of these to the public by pharmacies.

I believe there is a connection between the growing awareness that homeopathic remedies are placebos and the intention to explicitly avoid efficacy in the code of ethics in relation to their sale in pharmacies. It is a business protection step taken now to ensure that members of the public cannot take pharmacies to task for breaches of their code of ethics.

I submit it is totally unethical for the Council to put in place a provision whereby a scientifically trained seller uses that credibility to then sell known placebos as if they have efficacy. It is a betrayal of the science that trained them and a cynical exploitation of their status as health professionals. I wonder if pharmacists will have a warning label on these products which states they have NO active ingredients and they are no more effective than placebos. Perhaps the Council, if it wishes to see pharmacists selling these products should insist on a step like this, that would be the truth and assist the informed choice you are advocating. It was not so long ago that the pharmacies used to say “the health professional you see most often”, sadly you cannot make this claim today given current practice in selling known placebos.

It is telling that the consultation document suggests not promoting or recommending products which lack efficacy but is unwilling to take the ethical step of including efficacy explicitly in the code. It is simply duplicitous and puts commercial gain ahead of evidence based operations in patient and public outcomes.

The Council should retain the requirement at all times when selling products that claim to assist medical situations that there MUST be credible evidence of efficacy. Not to do so is in breach of the duty of Council to promote good practice and protect the public by being complicit in the public opting for remedies which are placebos and thereby not using genuinely efficacious products that have been proven by proper trials. The patient outcomes are likely worsened if a placebo is used in place of the best treatment.

Pharmacies seek to be taken seriously and want to expand on their offering in the evidence based market by adding things like Wharferin testing for example. They cannot have it both ways they are either just a peddler of anything the public wants or are serious health professionals. Your decisions in this matter will answer that question.

Edward Linney

Pharmacy Council Code of Ethics Consultation

Submission to the Pharmacy Council’s 2015 Code of Ethics Consultation

The Pharmacy Council’s Code of Ethics 2011 appears to be a well written document which puts the wellbeing of the patient front and centre. This can be seen throughout the code, and is embodied in the very first clause:

1.1 Take appropriate steps to optimise medicines-related health outcomes for the patient as a fundamental principle of pharmacy practice.

The existing clause 6.9 of the code gives a good level of protection to patients, in that it states that pharmacies should not supply products where there is a lack of evidence of efficacy.

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.

In the Pharmacy Council’s Consultation Document, the proposed new wording of clause 6.9 of their Code of Ethics splits healthcare products sold in pharmacies into two broad categories:

  • medicine or herbal remedy
  • complementary therapy or other healthcare product

The reason for this split appears to be an effort to relax the code for the second class of products (complementary therapies and other healthcare products). Effectively, this would remove the code’s requirement for there to be “evidence of efficacy” before these products can be supplied by a pharmacist. Instead, the new code only requires that “sufficient information about the product can be provided”. As it stands, the existing code appears to be in place to protect patients – any weakening of the code is going to reduce this protection, and that can only be a bad thing.

The Pharmacy Council’s vision is “Safe Effective Pharmacy Practice”. We believe this proposed change in the Code of Ethics would compromise the “Effective” part of this vision, by making it more likely for individual pharmacies to sell products that do not meet any reasonable standards of credible evidence, and could therefore be reasonably considered to be ineffective.

In the “Background” section of the consultation document, the Pharmacy Council says:

Over a number of years there has been much debate and discussion regarding the  promotion, supply and sale of complementary and/or alternative medicines by pharmacists. This debate has primarily focussed on the efficacy of these therapies.

Given that most pharmacies appear to sell at least some complementary/alternative health products, we presume that this debate and discussion has been around whether pharmacies should stop selling these unproven remedies. The document goes on to say that “Over the past 12-months the level of sector and public interest has notably increased”.  We are glad to hear that the Pharmacy Council is aware of the concerns people have about the sale of alternative health products, but are concerned that their proposed solution, although it is technically a “fix” for the problem, is a step in the wrong direction.

The Pharmacy Council is faced with the issue of pharmacies’ actions conflicting with their Code of Ethics, and changing the code appears to us to be the wrong choice out of the two obvious options the Council has to choose from to help resolve this conflict. Instead of relaxing their Code of Ethics, we think that the Pharmacy Council should instead consider either putting in place an effective program that is able to ensure pharmacies are abiding by their existing Code of Ethics, or delegate this important function to another organisation that is better suited to the task. We think that a code of ethics that carries no incentive for compliance is not a code that is likely to be adhered to. The following paragraphs show that the existing code has not been followed by what appears to be a significant number of pharmacies, and that there is a need for active management of compliance to the code.

We have a concern that the Pharmacy Council’s expectation that “Pharmacists should be able to advise patients about the general use, current state of evidence, associated effectiveness and any safety issues relating to complementary and/or alternative medicines” is unrealistic given the current state of the pharmacy industry, and as such we tasked people around New Zealand with visiting their local pharmacy to ask about homeopathy. We chose homeopathy because there is a strong scientific consensus that homeopathy has no efficacy beyond the placebo effect, and there is no plausible mechanism of action:

“NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective” – Australia’s National Health and Medical Research Council

“Pharmacists should not sell, recommend, or support the use of homeopathic products” – Royal Australian College of General Practitioners

“PSA does not support the sale of homeopathy products in pharmacy” – Pharmaceutical Society of Australia

“The Royal Pharmaceutical Society believes that there is no evidence from randomised controlled trials for the efficacy of homeopathic products beyond a placebo effect, and no scientific basis for homeopathy“ – UK Royal Pharmaceutical Society

“By providing homeopathy on the NHS and allowing MHRA licensing of products which subsequently appear on pharmacy shelves, the Government runs the risk of endorsing homeopathy as an efficacious system of medicine” – House of Commons Evidence Check

“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” – New Zealand Medical Association Chair

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. Worrying statements that were reported to us fell into several broad categories. Firstly, there were recommendations from pharmacy staff:

“It brings the body back into homeostasis”

“I have had a number of people tell me it really helped”

“I asked if it was good – she said that it was very good. I asked if it was effective – she said that they were all effective and that the store sold a lot of those products. I asked if it was as good as prescription medication. She said that the sleeping aids would not knock you right out, but otherwise they were all superior to prescription medication. I asked why they were superior, she said because they can never do any harm and that many prescription remedies cause liver damage and / or addiction.”

“When asked if they were as effective, she said that it has to do with your belief system.”

“When asked how the homeopathic remedy that she could order in for me works she said that it would help my body to heal itself”

“The staff member told me that these products worked, and that science was starting to show this. She dismissed the idea that they only work as well as placebo, and insisted that they have a real effect.”

“I was told by a staff member from behind the prescription counter that homeopathy works, and that its extensive historical use was evidence of this. I was also told that the number of customers they have buying homeopathic products was testament to its efficacy.”

“different to normal medicine but with a mix of ingredients that would help”

“I asked about homeopathic sleep drops on the shelf below and was told they definitely work.”

“The pharmacist told me that the Weleda Cold & Flu remedy would absolutely help with a cold, and with flu symptoms as well. He said that I should take a large initial dose that would help me recover quicker.”

“he has no problem with recommending the Weleda products to customers”

“She said that Arnica was an absolute must-have, and then proceeded to take me to a section and offer me several bottles of different concoctions, all of which ad 9c or 10c after them, which I recognised as the symbol for incredible amounts of dilution”

“The pharmacist confirmed this was a homeopathic product and then started out by saying they had several mothers that swear by this product”

“was recommended a homeopathic sleep remedy”

“I was told that homeopathy would help with a cold, and that it works “holistically”. I was also recommended vitamin C, echinacea and aged garlic to treat the symptoms.”

“Three products were recommended for a cold. I was told it worked for the staff member’s son, better than any other medicine. I was told that echinacea would definitely treat my cold”

“I was told that homeopathic Weleda Echinacea would help lessen the length of a cold, and that homeopathy helps by boosting the immune system. The staff member also tried to sell me high dose vitamin C and a Go-Vir supplement.”

Next were staff members who weren’t sure what homeopathy was (In fairness, some of these pharmacies didn’t stock homeopathy):

“he was almost totally ignorant of the subject and thought it had active ingredients”

“the assistant had little knowledge or awareness about homeopathy thinking this was instead ‘natural’ or ‘herbal’ and directed me to these products instead”

“the younger ones simply had no idea what any of these things were”

“the staff member didn’t really seem to know what I was talking about”

“She said because they were natural, I asked her if she knew what was in them or how they worked. She said she would get her manager”

“the assistant had to ask the Pharmacist as she didn’t know what homeopathy was”

“She said she wasn’t sure, but she thought homeopathic was probably different to natural”

“I was told that there’s no chemicals, and instead it’s plant extracts.”

Several pharmacies were happy to recommend visiting somewhere that would give a more positive outlook on homeopathy and/or a greater range:

“they didn’t stock that product, but I could find it at Health 2000”

“suggested I come back tomorrow when the expert on homoeopathy would be in the shop”

“the assistant had little knowledge about homeopathy and referred me to a natural health food shop”

“if a customer wanted homeopathy products she would refer them to a local homeopathy dispenser”

“She recommended “Health 2000” for a greater selection”

“Suggested Simillimum [a local homeopathic dispensary] if I was after homeopathy”

“I was redirected to a local spiritual/natural health store for more range, and told that I would get good advice there.”

The full text of the reports we received accompanies this submission.

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. It was only on further probing that a subset of these staff members were then willing to share their thoughts that homeopathy isn’t generally understood to be effective.

In the main, the reports we received painted a picture that many pharmacies are selling ineffective health products, and that staff are either reluctant to speak their mind about their lack of efficacy or have a mistaken belief that it works. This is echoed by a recent statement attributed to the Pharmacy Council’s chairman:

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.

This statement concerns us as it suggests that even the head of the Pharmacy Council does not take the Council’s Code of Ethics seriously. With the code being an important patient protection mechanism, we’re disappointed to see it so readily disregarded.

Given the evidence we collected of pharmacies offering not just homeopathy, but also other unproven treatments, we wonder if it would be wise for the Pharmacy Council to consider running their own “secret shopper” visits to New Zealand pharmacies to ensure a consistent high standard of service.

As well as these pharmacy visits, a quick search of New Zealand pharmacies online showed a worrying number of pharmacies outright promoting homeopathy for sale. Examples of homeopathy being promoted by these pharmacies online are:

“A popular service we provide are concise acute homeopathic consultations”

“a range of homeopathic medicines to treat a wide range of illnesses and concerns”

“Homeopathic remedies offer gentle solutions to common complaints without the nasty side effects of many drugs”

“an all-natural allergen-free homoeopathic formula that provides soothing support for wind, colic, upset stomach, bloating and hiccups”

“[Homeopathic] tablets help the body cope with tobacco cravings and are a useful substitute for cigarettes”

“Weleda ARNICA 30C… Used to treat bruising and sprains”

“Treatments such as homeopathy… may be great avenues to consider if you’re suffering from chronic illness.”

More information about these websites accompanies this submission.

Pharmacies are in a privileged position in today’s healthcare industry, where the advice of pharmacy staff is trusted by patients. This position has been well earned, with a long history of highly trained professional pharmacists and other pharmacy staff giving valuable advice to patients. The Pharmacy Council’s Code of Ethics says as much in the introduction to Principle 6:

Patients, colleagues and the public place their trust in you as a pharmacy professional.

This trust will inevitably extend to the products on a pharmacy’s shelves – many people will believe that if a pharmacy is selling a product, there must be good evidence of efficacy. People will assume that because pharmacists are known to have the best interests of their patients at heart, they would not be willing to supply anything lacking in clinical evidence of efficacy.

The Pharmacy Council consultation document clearly states 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, and think that it would make a valuable addition to the code if “supply” is added. This paragraph regarding products where there is evidence of a lack of efficacy would make a good counterpoint to the existing clause, which talks of products with a lack of evidence of efficacy.

Additionally, as a part of this new clause, we would like to see provision for either the Pharmacy Council or another related body to maintain a list of classes of products where it is deemed that there is credible evidence of a lack of efficacy. This list would both help pharmacies to avoid unintentionally breaching the Council’s code of ethics, and would save individual pharmacists having to do their own time consuming research into these products. It is much more efficient, and would be a much more robust solution, if this research was performed once by a group of experts under the care of the Pharmacy Council, and that information was then shared with all pharmacies.

The document says that “It is not Council’s intention to endorse or prohibit the supply of any particular complementary and/or alternative medicine or product”. Whereas we understand that not endorsing a product is a wise stance, prohibiting the supply of products or classes of products that are ineffective, or even just recommending that pharmacies refrain from supplying them, would seem like a good way to ensure that pharmacies can easily abide by their Code of Ethics without having to try to figure out the Pharmacy Council’s intention. We support any measures the Pharmacy Council take that will make it easier for pharmacies to interpret the Council’s various codes, and it seems obvious that there is a need for clarity regarding clause 6.9 of the Code of Ethics.

Finally, the Council’s consultation document says that “Pharmacists must also respect patients’ rights to freedom of choice or autonomy in relation to their treatment options”. We hope that the Council understands that people’s freedom of choice would not be removed if pharmacies stopped selling unproven treatments. There are many other avenues in New Zealand where patients would continue to be able to purchase these products. As an example, pharmacies generally don’t sell therapeutic magnetic bracelets, as these are considered not to be efficacious, but they are still available for New Zealanders to buy at alternative health stores and online sites.

In conclusion, we do not support the Council’s wording of the proposed supplementary clause to section 6.9 of the Pharmacy Council Code of Ethics 2011. We are concerned with the Council’s motivation for making this change, and would prefer to see the current wording both kept and enforced. We would also like to see a different supplementary clause (6.9b) to the Council’s suggested clause added:

6.9a 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.

6.9b Do not purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is credible evidence to suggest it lacks efficacy. A current list of these categories of products can be found <on the Pharmacy Council website / at http://www.pharmacycouncil.org.nz/xxxxxxx / in Appendix X>.

This submission has been prepared by the NZ Skeptics, and is approved by its Committee:

  • Mark Honeychurch
  • Barry Lennox
  • Keith Garratt
  • Matt Beavan
  • Daniel Ryan
  • Michael Edmonds
  • Lisa Taylor
  • Robert Woolf
  • David Riddell
  • Brad MacClure
  • Vicki Hyde
  • Craig Shearer

Pharmacies Promoting Homeopathy

This report is part of the NZ Skeptics’ Submission to the Pharmacy Council‘s consultation of their Code of Ethics.

The pharmacies below are were found by a quick google search to be promoting the sale of homeopathy in New Zealand. This list is by no means exhaustive. The text shown under each pharmacy’s name was copied from the supplied URLs in early September 2015.

Lincoln Mall Pharmacy

http://www.ecostore.co.nz/retailers/lincoln-mall-pharmacy

We are a friendly team based in eco-friendly Waitakere City. We are a group of registered pharmacists, qualified homeopaths and knowledgeable pharmacy assistants. This pharmacy was originally started by a New Zealand pharmacist who trained in England and held a special interest in homeopathy. A popular service we provide are concise acute homeopathic consultations

http://yellow.co.nz/y/lincoln-mall-pharmacy-henderson

Lincoln Mall Pharmacy offers a range of homeopathic medicines to treat a wide range of illnesses and concerns.

Whether you have a small rash or are looking for a more holistic treatment to an underlying issue, we have a range of options.

Stay Well Pharmacy

http://staywellpharmacy.co.nz/products/

Homeopathy

Pregnant? On lots of medication? Have allergies? Homeopathic remedies offer gentle solutions to common complaints without the nasty side effects of many drugs. We stock the most popular ranges in New Zealand.

Pain Relief

Headache, Joint pain, Back pain, Stomach pain, Period pain, Arthritic pain, Pain from Sports injuries, the list goes on…

…Do you want pharmaceutical treatment or homeopathic? Is the pain local or referred, chronic or acute? Don’t just listen to the Marketers, listen to the medical experts.

Life Pharmacy Manukau

http://www.lifepharmacy.co.nz/p/?i=9858259

Colic Calm Homeopathic Gripewater 60ml is an all-natural allergen-free homoeopathic formula that provides soothing support for wind, colic, upset stomach, bloating and hiccups.

Maungatapu Pharmacy

http://www.maungatapupharmacy.co.nz/category/7741

The Quit Smoke Pack contains Quit Smoke Withdrawal that supports the body through the process of giving up smoking. Quit Smoke Craving tablets help the body cope with tobacco cravings and are a useful substitute for cigarettes. Quit Smoke is a non-drug nicotine free programme that is not habit forming.

Best results are obtained when using both products together. Quit Smoke can be especially useful for pregnant women who should avoid potentially toxic nicotine replacement therapies. Vitamin B complex, Zinc and Vitamin C supplements may be beneficial.

Prices Pharmacy

http://pricespharmacy.co.nz/homeopathic-1/

Weleda ARNICA 30C 30ML

  • Is a high dose supplement
  • Used to treat bruising and sprains
  • For athletes and those active in sports

Massey Amcal Pharmacy

http://www.nutrimedpharmacy.co.nz/

http://www.pharmacytoday.co.nz/in-print/2015/march-2015/april-2015/pharmacists-support-patient-choice-with-homeopathy.aspx

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

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

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

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

NetPharmacy

http://www.netpharmacy.co.nz/

“Treatments such as homeopathy, nutrition counselling and acupuncture are all associated with naturopathy, and may be great avenues to consider if you’re suffering from chronic illness.”

http://www.netpharmacy.co.nz/practitoner-ranges

http://www.netpharmacy.co.nz/herbs-and-vitamins/homeopathy

Pharmacy Homeopathy Reports

This report is part of the NZ Skeptics’ Submission to the Pharmacy Council‘s consultation of their Code of Ethics.

The following are reports gathered in response to a request the NZ Skeptics sent out to its Alert newsletter subscribers. All identifying information about the sender of each report has been removed from the document.

I visited the UFS pharmacy on Courtenay Place in Wellington this morning.

I couldn’t see any homeopathic products on the shelves, so I asked the Pharmacist if they had any. She said she thought they only stocked a couple of Welada ones, but if a customer wanted homeopathy products she would refer them to a local homeopathy dispenser.

I asked if she thought that homeopathy worked and she answered that she didn’t know enough about it to comment or recommend it’s  use.

I know that  Garry Logan Chemist will not sell homeopathy as he says it is nonsense and does not do as claimed.

On Web 16-Sep-2015 I went to two pharmacies in the Hillcrest suburb of Hamilton.

The  Hillcrest Pharmacy had no homeopathic remedies.

Master Ave Pharmacy was different story. I went there at 12:30 pm and spoke with Paula, who worked there as a herbalist. She recommended Naturo Pharm Travel Remedy. When I asked how it works she said “It brings the body back into homeostasis”. When I asked whether it actually worked she said she “Was on the fence about whether homeopathy really works. But I have had a number of people tell me it really helped.”

Where: Uni Pharmacy, Canterbury University, Ilam, Christchurch

When: 2:00pm 16/014

The pharmacy stocked 6 Naturo Pharm Homeopathic products.

When asked, the assistant had little knowledge or awareness about homeopathy thinking this was instead ‘natural’ or ‘herbal’ and directed me to these products instead – clinicians and blackmores.

She Suggested vitamin C or Berocca for a more ‘natural’ cold medicine

Today (16 Sep 2015) I went to Lamb’s Pharmacy & Natural Therapies (173 Karangahape Rd, Auckland).  I selected a tube of anti-fungal cream and asked if they had any homoeopathic remedies for the same conditions.  The pharmacy assistant showed me two ranges (brands) of homoeopathic remedies that they stocked.  She wasn’t aware of any antifungal creams but said she wasn’t an expert and suggested I come back tomorrow when the expert on homoeopathy would be in the shop.  She asked another person (who I assumed was the pharmacist) if they had a homoeopathic anti-fungal agent but he was non-committal.

I formed the conclusion that they stocked the homoeopathic items for those who knew which one they wanted but that they didn’t know much about them and weren’t pushing them.  The assumption was that they work, for they never said I would be better off sticking to the evidence-based anti-fungal cream.

Looking at one range of homoeopathic remedies (sorry, I didn’t note the name of the brand), I saw one that was labelled “Candida Albicans”.  I knew that to be fungal but when I looked at the box, it didn’t say what it was good for, and the assistant didn’t know.

Where: Marslands Family Pharmacy, Cnr Preston Rd and Marshlands Rd, Christchurch

When: 5:00pm 16/09/15

The pharmacy stocked 7 Naturo Pharm Homeopathic products.

When asked, the assistant had little knowledge about homeopathy and referred me to a natural health food shop.

I went to Albany Care Pharmacy at the Albany Megacentre (next door to The Warehouse) searching for Tru2U Cherry juice, a product suitable to help children sleep. http://tru2u.co.nz/

They did not have any and asked me what it was for, I explained that it was for my restless son and was recommended a homeopathic sleep remedy. I didn’t realise that I was purchasing a homeopathic product and realised after opening the bottle that the primary ingredient was alcohol. Given what I know about homeopathy I wasn’t particularly happy with the fact that the only actual ingredient would have been alcohol so I returned the product. They seemed completely baffled by my objection to giving alcohol as a “sleep remedy” to a child.

I went to the Feelgood Pharmacy in Dinsdale, Hamilton today (17th September).

I went in and looked through their “natural health” section, which had a lot of vitamin and mineral supplements, but not any homeopathic remedies. A staff member asked if I needed any help. I said that I was interested in homeopathic remedies. She pointed out the supplements, so I asked about actual homeopathy. She said that they had some rescue remedy (actually a Bach flower remedy) and I said that I would like to see that.

With the rescue remedy there was also the full Naturo Pharm range. I asked if it was good – she said that it was very good. I asked if it was effective – she said that they were all effective and that the store sold a lot of those products. I asked if it was as good as prescription medication. She said that the sleeping aids would not knock you right out, but otherwise they were all superior to prescription medication. I asked why they were superior, she said because they can never do any harm and that many prescription remedies cause liver damage and / or addiction.

I phoned a couple of pharmacies complaining of sinus pain.

At Unichem Hamilton East (14 Beale St) I asked if they had any Kali-bichromicum (as suggested by mothering.com). The staff member who answered said that they didn’t stock that product, but I could find it at Health 2000. I asked if there was anything else that she could suggest. She suggested Marshmellow, which she said was as effective as a prescription medication (the marshmallow was a triple strength preparation) and that it worked by suppressing the production of mucus. It was late in the conversation that I realised that this was a herbal remedy, not homoeopathic.

Pharmacy 547 ( 533 Grey St, Hamilton East) said that they do not stock any homeopathic remedies because there is no evidence that they work.

At the Hillcrest Healthcare Pharmacy (153 Cambridge Rd, Hamilton), Julie said that they don’t stock any homeopathic remedies for sinus pain, but could order them in. When asked if they were as effective, she said that it has to do with your belief system. She did suggest several conventional medications, and some other alternative medications (e.g Otrivin oil). When asked how the homeopathic remedy that she could order in for me works she said that it would help my body to heal itself.

Erin at Anglesea Clinic Pharmacy (Thackeray St) asked me some pertinent medical questions (other health problems, current medications, asked me to describe the pain) then suggested Go Healthy Decongest. A triple strength preparation, she said that the horseradish would help clear my nose, and the garlic and vitamin C would support my immune system. This is of course herbal, not homeopathic.

Christchurch South City Pharmacy

https://sleepdrops.co.nz/

The product was called Sleep drops

The assistant knew the only active ingredient in it was ethanol. She said she had not been trained in the product but other staff had. She said the people who bought it wanted a natural product.

I talked to a female staff member at Kenepuru pharmacy in early 2014 about the homeopathic products they sold (there were maybe 5 or 10 on display). The staff member told me that these products worked, and that science was starting to show this. She dismissed the idea that they only work as well as placebo, and insisted that they have a real effect.

I asked in Porirua Pharmacy in mid 2014 why they sold homeopathic products – they have quite a range of both homeopathic and herbal remedies on their shelves.

I was told by a staff member from behind the prescription counter that homeopathy works, and that its extensive historical use was evidence of this. I was also told that the number of customers they have buying homeopathic products was testament to its efficacy.

Amcal Pharmacy

Medical Supply Store

Address: 51/53 George St, Tuakau 2121

Phone:09-236 8014

Is willing to sell and promote homeopathy. I have had sever talks with the pharmacist about this and he was almost totally ignorant of the subject and thought it had active ingredients. I asked what was in a bottle and he said, whatever it says on the label. He was a very young guy. He also said that its what customers wanted.

All on 18th September 2015 ~5pm

Bunny Street

Used to have just Arnica but not any more

Believes it doesn’t work

Suggested Simillimum if I was after homeopathy, but wouldn’t recommend it.

 

Unichem top of Willis

Had about 20 homeopathic remedies, some mixed with medicines.

I was told that a Weleda remedy would help with a cold.

It was described as different to normal medicine but with a mix of ingredients that would help.

When pressed about whether it works, I was told that it helps if you believe in it.

 

Life Pharmacy Manners

First I was pointed to a honey pill for a cold, but the person checked and said it probably wasn’t homeopathic. She said she wasn’t sure, but she thought homeopathic was probably different to natural.

I asked about homeopathic sleep drops on the shelf below and was told they definitely work.

 

UniChem Cuba Mall

I asked if they had anything homeopathic for a cold. The staff member pointed out 2 separate shelves with homeopathy on them.

When asked for details, they grabbed a pharmacist.

The pharmacist told me that the Weleda Cold & Flu remedy would absolutely help with a cold, and with flu symptoms as well. He said that I should take a large initial dose that would help me recover quicker.

Address: Unichem 3 Pilgrim Pl, Sydenham, Christchurch 8011

Talked to one guy there and asked him three questions:

Do you sell Homeopathy?

He said they did and showed me where they stock 6 Weleda products, 3 x arnica producst and 3 others. Weleda was the only brand of Homeopathy they sold.

Does Unichem inform you about how to give advice on homeopathy products?

He told me Unichem does not give any advice on Homeopathy products.

What do you think about Homeopathy products?

He told me he was aware that there is no evidence for the efficacy of Homeopathy and that he tells people that if asked. He also said he has no problem with recommending the Weleda products to customers

So my general feeling was that he was ‘on the fence’ about homeopathy. probably due to never seriously looking into it. But also because he may have seen a lot of people happy to purchase it.

This shop had a really tiny selection of homeopathy and it was tucked right away in an obscure corner (maybe because whoever arranges the stock knows its all BS and does their best to curb sales 🙂 But they still sell it.

Where: Life Pharmacy, The Palms Shopping Centre, Shirley, Christchurch

When: 12:30pm  19/09/15

The pharmacy stocked 4 Naturo Pharm Homeopathic products on its shelves.

When asked, the assistant had to ask the Pharmacist as she didn’t know what homeopathy was.

When she returned she said “we don’t stock that here”

Unichem Pharmacy Tower Junction Christchurch

They had two types of homeopathic sleep drops on the shelf that I could see.

A staff member came over to serve me and I asked her why they were selling them. She said because they were natural, I asked her if she knew what was in them or how they worked. She said she would get her manager. The manager said they hadnt had training on them. I asked her why they stocked them and she replied that it was unichem policy and even if she didnt order them they would get sent to her, she didnt have a choice.

One of the products showed lots of ingredients in it, but (should have worn reading glasses) I am pretty sure they were homeopathic quantities.

I recently went into a pharmacy as I was about to have an operation and wanted advice on what vitamins promoted healing and if there were any supplements that I could take that would aid my recovery.

The lady serving me said that she’d recently had an operation and she’d taken some great things which helped.

She said that Arnica was an absolute must-have, and then proceeded to take me to a section and offer me several bottles of different concoctions, all of which ad 9c or 10c after them, which I recognised as the symbol for incredible amounts of dilution, at which point I left the pharmacy – completely gobsmacked and with my faith in pharmacology quite damaged!

As a store offering science based remedies to medical problems, I think that offering me distilled water as a effective remedy is irresponsible and undermines the credibility of medical science.

The Pharmacy was ProChem pharmacy at 1862 Great North Rd, Avondale 1026.

Life Pharmacy,  The Palms, ChCh

No homeopathic medicines in the shop, but there was a mind-boggling array of other “stuff” from plants, minerals, organic things, etc, etc.  The staff member said they don’t carry it.  However, there was one that was very, very, close the old “Rescue Remedy”  a Bach flower remedy.  She said that some people found it very good.

Sydenham Pharmacy, South ChCh.

No homeopathic medicines in the shop, and the staff member didn’t really seem to know what I was talking about. Was keen to flog me a Probiotic, for a mere $76 for a 60 day supply.

Date

25 September 2015

Pharmacy

Unichem Rototuna, Hamilton

Product

Sleep Support System Sleep Drops for Babies 30mls $39.99

Ingredients (taken from website)

Organic Coconut Glycerine, purified water, ethanol, Corydalis ambigua (Corydalis), Eschscholzia californica (Californian poppy), Humulus lupus (Hops), Lavandula officinalis (Lavender), Matricaria recutita (Chamomile), Passiflora incarnate (Passionflower), Piper methysticum (Kava), Scutellaria baicalensis (Baical Skullcap), Albizia lebbeck (Albizia), Viburnum opulus, (Cramp bark) Zizyphus jujuba (Zyziphus) with Homeopathic Calc phos, Chamomilla, Colocynthis, Kreosotum, Mag phos, combined with flower essences.

Directions

Drops are put under the tongue, or close to the tongue and lips, inside the mouth. To support regular sleep, administer 1-2 drops when your baby goes down. Babies can also have 1 drop to reestablish calm. If they wake during the night, your baby can be given another drop each 5 to 10 minutes of awake time until sleep is restored.

Caution

Infants sensitive or allergic to any of the ingredients should avoid this product.

There is 0.005grams of dried herb equivalent per 5 drops dose so herb/drug interactions should be impossible. If you are concerned about this possibility please follow the advice of your medical practitioner.

Consultant

The sales consultant handed me over to a pharmacist

The pharmacist confirmed this was a homeopathic product and then started out by saying they had several mothers that swear by this product.  She was quite dubious when making this statement and was checking for how I would respond to that and paused for a second.  As I didn’t jump on that particular bandwagon, she then went on to say that to be honest, there was no good science that could support this product.

I went in and asked about homeopathic remedies for a sore stomach/heartburn and asked about alternatives as they all didn’t recommend one. I’ve got no idea whether Homeopathic remedies are offered for it but it seemed like something that they would and wouldn’t cause concern if I didn’t consult a Doctor or left without making a purchase. Besides I’m familiar with the symptoms and conventional medicines (antacids).

Antidote Meridian: 267 George St, Dunedin, 9058 (Meridian Mall)

Very limited selection and didn’t recommend any of it. Asked if I’d used it before (I said no but a friend recommended it) but didn’t discuss whether it worked or offer conventional medicines. She recommended “Health 2000” for a greater selection, really confused why they’re the most supportive of Homeopathy and knew which products were Homeopathic of the stores and yet weren’t profiting from it themselves.

Stock Grade: B

Science Grade: D

 

Unichem Centre City: 133 Great King St, Dunedin, 9016 (Centre City Shopping Centre)

Had limited stock but more than the other stores, a large stand of “Artemis” teas greeted me at the front of the store, the store assistant recommended these but had no idea what any them were even for, let alone how they claimed to work. But she seemed happy to sell them to me anyway, literally just reading flavours on the box to see if I’d like any of them. Seems like just expensive tea to me. She then gave up on selling the teas and took me over these supplement bottles and recommended one, again no mention of how or whether they work. I’m not even sure if these were Homoeopathic, they looked like normal vitamin pills but had names like “St John’s Wort” so probably some form of “Natural” bullshit.

Stock Grade: D

Science Grade: D

 

Unichem Knox: 402 George St, North Dunedin, Dunedin 9016

Ironically the two Unichem branches contrasted the most, they didn’t stock Homoeopathic products at, had a “natural” section but completely ignored it, asked about the symptoms and went straight to endorsing the conventional antacids.

Stock Grade: B

Science Grade: A

 

Albany St Pharmacy: 27 Albany St, Dunedin, New Zealand

The first younger guy had no idea, at first I was concerned when he started turned the older lady and she whispered to him. But she whispered “No”. She still suggested ginger but they didn’t stock Homoeopathic or Natural Products and they again asked about symptoms and took me straight to conventional antacids.

Stock Grade: A

Science Grade: B

I went to the Unichem Pharmacy, 95 Ashby Avenue, Glendowie. They didn’t have many homeopathic products on sale apart from Naturopharm Arnica and a couple of other creams.

When I asked them about evidence that they worked they said that they are honest with customers and say that there is only anecdotal evidence that any of the natural products like supplements work. Then I asked whether they thought it was ethical to sell them and the pharmacist said that it was better that the products were on sale at a Pharmacy rather than a health food shop as the pharmacist can tell the patient when it is necessary to see a doctor rather than take the product wheras at a health food shop staff have no training.

Unichem High Street Lower Hutt

Around 10 homeopathic products on the shelves

I was told that homeopathy would help with a cold, and that it works “holistically”. I was also recommended vitamin C, echinacea and aged garlic to treat the symptoms.

 

Unichem Lower Hutt

Had about 100 homeopathic remedies under a banner of “Weleda Medicine”

I was told that there’s no chemicals, and instead it’s plant extracts.

Three products were recommended for a cold

I was told it worked for the staff member’s son, better than any other medicine.

I was told that homeopathic echinacea would definitely treat my cold

They said that homeopathy treats the underlying body.

 

Burns Pharmacy Petone

I was told that homeopathic Weleda Echinacea would help lessen the length of a cold, and that homeopathy helps by boosting the immune system.

The staff member also tried to sell me high dose vitamin C and a Go-Vir supplement.

I was redirected to a local spiritual/natural health store for more range, and told that I would get good advice there.

 

Unichem Petone

Only had arnica and Sleep Drops

The staff member was cagey, only saying that sleep drops would help in the “natural way”, and that they would take a while to have an effect.

 

Petone Countdown Pharmacy

Only had Sleep Drops but told me they don’t work beyond placebo!!!

I have been to several pharmacies in my region and had various responses with regards to the sale of homeopathic products.

Johns Photo Pharmacy and Herbal Dispensary on Cameron Rd in Tauranga promotes itself on these pages

http://www.naturaltherapypages.co.nz/therapist/2258

I have discussed the promotion of  products in their pharmacy that are supported by evidence based data- (ie homeopathic remedies)- on one occasion the pharmacist (who I suspect was an employee and a new graduate) said that her hands were tied and it was sold to meet the demand of customers.

On another occasion I have noted that the Bureta Pharmacy in Bureta Road doesn’t appear to sell or promote any homeopathic remedies- recently I discussed purchasing a product to assist with my daughters travel sickness and I was recommended active therapeutics/ antihistamines rather than the homeopathic remedy I was recommended at the TravelPharm in Auckland International Airport.

The Central Parade Pharmacy in Mount Maunganui also has a homeopathic/ natural remedies counter, and indeed my own GP has suggested I seek treatment from this pharmacy from a homeopath to deal with hormonal imbalance.