Chiropractors struggle to drop testimonials

Chiropractors struggle to drop testimonials

The latest newsletter from the regulator of chiropractors offers an insight into the industry’s culture problems.

In their June newsletter, the chair of the Chiropractic Board has admonished chiropractors for a discussion on how to circumvent consumer protection regulations:

At a recent chiropractic function, a presentation was given on advertising, chiropractors’ responsibilities and the Advertising Standards Authority (ASA). The information was well presented and informative however ensuing discussion revealed that the message is clearly not being heard by all. I urge you to please refer to my email of 30 August 2017 that clearly outlines your responsibilities, and reiterates very important points set out in the Board’s Advertising and Social Media Policy, and references to all other responsibilities. I was particularly disappointed in discussion among practitioners on how to best circumvent the prohibition on posting testimonials on Facebook – some very creative ideas were invented.

The Chiropractic Board published their current Advertising Policy in November 2015. It notes, correctly, that the use of health testimonials in advertising is prohibited in New Zealand by Section 58(1)(c)(iii) of the Medicines Act 1981:

A chiropractor shall not advertise any material which relates to the chiropractor’s qualifications, practices, treatment or the premises where they practice chiropractic if the material:

f) uses testimonials whether from patients or any other person (see section on Medicines Act);

This section [58 of the Medicines Act] provides further at Section 58(1)(c) that it is an offence to imply, claim, indicate or suggest that a medicine, treatment or device is a panacea or infallible for any condition or is recommended by an appropriately qualified person or had beneficially affected the health of a particular person or class of persons, whether real or fictitious.

This wording clearly prevents a health practitioner publishing testimonials.

Unfortunately, this law is widely ignored in New Zealand, particularly by promoters of dodgy health products. In my experience even when breaches are brought to the attention of the agency responsible for enforcing it – Medsafe, in this instance – nothing is likely to happen.

In 2015, my colleague at the Society for Science Based Healthcare Mark Honeychurch and I looked at how often New Zealand chiropractors were publishing health testimonials and various misleading health claims in online advertising. This was prior to the publication of the Chiropractic Board’s current advertising policy, but over 20 years after the law prohibiting the use of health testimonials in advertisements was passed. We found that just over a third of the 137 websites we looked at used health testimonials.

Thankfully, this does seem to have decreased following the introduction of the Advertising Policy, but the recent newsletter seems to imply that chiropractors are not happy about being unable to use testimonials to promote their services.

When looking at how often chiropractors use misleading claims and health testimonials in 2015, we hadn’t looked at advertising on social media. While writing this post, I have searched for “NZ chiropractic” on Facebook and clicked on the top three pages that showed up in the results – Bays Chiropractic NZ, Chiropractic Touch, and Revolution Chiropractic NZ – to have a quick look (I didn’t look through any comments or watch any videos) and see if any of them had been publishing testimonials there.

I didn’t see testimonials on the Bays Chiropractic NZ page, but I couldn’t help but notice that they shared an image in February featuring many misleading claims about chiropractic manipulation, including that it can reduce allergies, asthma, and ADHD. As the Chiropractic Board of Australia has clarified in their own Statement on Advertising in 2016, these claims are not supported by evidence:

Claims suggesting that manual therapy for spinal problems can assist with general wellness and/or benefit a variety of paediatric syndromes and organic conditions are not supported by satisfactory evidence. This includes claims relating to developmental and behavioural disorders, ADHD, autistic spectrum disorders, asthma, infantile colic, bedwetting, ear infections and digestive problems.

In August 2017, Chiropractic Touch posted a testimonial claiming that chiropractic manipulations had cured someone’s asthma. They used one of the “creative ideas” commonly used by chiropractors to try to circumvent the prohibition on publishing health testimonials: telling the testimonial in the context of it inspiring a chiropractor to pursue their career rather than framing it as a patient’s experience.

I didn’t see any testimonials on Revolution Chiropractic NZ’s page, but they do seem to publish a lot of posts about adrenal fatigue. Adrenal fatigue is a fake diagnosis that I’ve seen most often used by naturopaths to sell unnecessary supplements. Revolution Chiropractic NZ also shared some of the same misleading claims as Bays Chiropractic NZ, including particularly concerning misleading claims about being able to treat children and infants for conditions such as colic and ear infections.

Whatever improvements there may have been over the past few years, it seems the chiropractic industry in New Zealand is still struggling with its culture of ignoring or sidestepping patient protection regulations.

Advertisements

New rules for pharmacists

New rules for pharmacists

The Pharmacy Council has (finally) published their new Code of Ethics 2018.

I’ve written several times on the ongoing saga of the Pharmacy Council’s Code of Ethics. In late 2014 we put together a complaint at the Society for Science Based Healthcare arguing that their Code of Ethics 2011 had been violated by an Auckland pharmacy, in which a salesperson had recommended and sold a homeopathic product to someone who didn’t realise they were buying quackery.

Following this complaint, the Pharmacy Council decided they would not enforce the rule in their Code of Ethics at the time that prohibited pharmacies from purchasing or supplying any health product that was not backed by “credible evidence of efficacy”.

This led to two protracted consultation processes, first about that specific part of the code and then about rewriting the code entirely. I worked on the Society for Science Based Healthcare’s submissions during each consultation period, and we met with the Pharmacy Council twice to discuss the topic.

The consultation processes also saw well-voiced support for strong patient protection rules coming from the New Zealand Medical Council and the Pharmaceutical Society (who represent professional pharmacists). Whereas the Pharmacy Guild (who represent pharmacy owners) was in favour of the more relaxed rules that had been suggested. For more detail on this, you can read my submissions roundup from 2015.

The Code of Ethics 2018 will come into force on the 12th of March 2018. It’s principle-driven, and accompanied by a number of guidelines that go into more detail on what’s expected of pharmacists in various areas. One of these guidelines is the Pharmacy Council Complementary and Alternative Medicines – Statement and Protocol for Pharmacists.

Unlike the Code of Ethics 2011, the new rules don’t prohibit pharmacists from selling quackery. While this is unfortunate, it’s seemed clear from the outset that the Pharmacy Council had no intention to keep this rule given they aren’t prepared to enforce it. Instead, there has been an increased focus on ensuring patients are given the opportunity to make an informed choice.

I’m feeling cautiously optimistic about the change. Though ideally pharmacists shouldn’t be lending their credibility to ineffective health products, if pharmacists must be allowed to sell quackery then I think the next best approach to regulation is to protect patients’ rights to make an informed decision.

On the face of it, I think the new rules seem good. But enforcement has been a concern in the past and parts of the previous code were widely disregarded. Come the 12th of March, I plan to have a look for pharmacists who aren’t complying with the new rules and lodge complaints to see how they are treated, and if the behaviour is corrected. Unfortunately, there are a few pharmacies in New Zealand that have a history of promoting quackery, including by selling ineffective health products online, which seems like a good place to start.

I’d recommend you read the rules for yourself if you’re interested, but here’s my summary of what I think are the most important new patient protection rules regarding informed consent:

[Principle 1H: A pharmacist] Before recommending, supplying or promoting a medicine, complementary and/or alternative medicine or other healthcare product or service, considers available evidence, and only supplies a product when satisfied that it is appropriate, and the person understands how to use it correctly and safely.

[Principle 4C: A pharmacist] Provides accurate, truthful, relevant, and independent information in an appropriate form that is not misleading to patients, the public and/or other healthcare professionals.

[Principle 4H: A pharmacist] Ensures that when providing any medicine, complementary and alternative medicine, or other healthcare product or service, that the health and wellbeing of the patient or consumer is the primary consideration, and that the benefit of use outweighs the risk.

[Principle 4I: A pharmacist] Does not engage in advertising, promotion or supply of goods or services that could include misleading or unsubstantiated claims, and/ or undermine public trust in the profession.

[Principle 6A: A pharmacist] Maintains contemporary knowledge of evidence-based practice.

Where it makes sense, all of these principles are effectively extended to non-pharmacist salespeople who work in pharmacies via Principle 5G:

[A pharmacist] Is responsible for actions of staff under their supervision.

Looking at the associated guideline on “complementary and alternative medicines”, the requirements in parts 14 and 15 seem like they will be particularly important for protecting patients from quackery in pharmacies:

14. When supplying products or information about treatments/products/services that have no current evidence of proven efficacy pharmacists are expected to:

a. ensure that patients are informed about the degree to which treatments or products have been evaluated, and

b. the degree of certainty and predictability that exists about their efficacy and safety

15. Pharmacists must advise patients when scientific support for treatment is lacking.

Part 18 of the guidelines also includes the following requirements:

e. provide sufficient information regarding the CM/NHP [Complementary Medicine/Natural Health Product] to allow patients to make informed choices

f. not misrepresent information or opinion. Patients must be made aware of the likely effectiveness of a given therapy according to recognised peer-reviewed medical publications, in spite of your personal beliefs

g. provide the patient with a timeframe for accessing conventional medicine if their condition is unresolved or there is no improvement

Time will tell if these rules really do enhance patient protection in the pharmacy industry, which has a long-standing problem with promoting quackery on the side.

From the 12th of March onwards, if you see behaviour that you think is non-compliant with the code feel free to let me know about it. I can be contacted via email at mark@honestuniverse.com.

Can you trust Band-Aids?

Can you trust Band-Aids?

Band-Aid is a household name, but can you trust the way they’re promoted?

For years Johnson & Johnson, the manufacturers of Band-Aid adhesive bandages, have been making a simple claim about them. If you put a Band-Aid on a cut, it will heal faster than it would have if left uncovered.

Specifically, they say it will heal twice as fast:

Band-Aid packaging, front and back.

Johnson & Johnson is a large, well-known medical company. As well as Band-Aids, they make many other health and health adjacent products such as shampoo for babies, cold medicines, and mouthwash. For better or for worse, this means many of us are willing to accept their claims at face value.

In an ideal world, that would be fine. They don’t have a reputation for being misleading, like the reputation Reckitt Benckiser has earned for its misleading claims about Nurofen. They’re also not selling products that are clearly dodgy, like homeopathy or a quantum magnetic health analyser.

If all of us took the time to look into every health claim we encountered, we’d have no time left to eat or sleep. So, in cases like this, we often feel satisfied that if such a big company were making a dodgy claim someone would have caught it and called them out.

Well, that’s exactly what happened in this case. In early 2017, Dr Ken Harvey contacted Johnson & Johnson to ask them to provide the evidence for the “heals cuts twice as fast” claim they were making. In response, Johnson & Johnson did not send him the evidence. Instead, they opted to remove the claims.

“I gently asked them where was the evidence, it’s a fairly strong claim,” Dr Harvey told Fairfax. “And they hummed and hawed and eventually decided, I got a lovely letter from them, saying there was evidence – but they are removing the claims.”

Band-Aid promotions to be ripped off the shelf after complaints about healing claims | The Age

I was alerted to this by a member of the Australian patient advocacy group Friends of Science in Medicine*, which has similar aims to the New Zealand Society for Science Based Healthcare that I chair.

At the Society for Science Based Healthcare, we decided we wanted to make sure that the same change would be reflected over here. So, in April 2017, I wrote to Johnson & Johnson:

Kia ora,

I saw the other day that Johnson & Johnson will be removing promotional material in Australia saying Band-Aids are “clinically proven to heal wounds faster”. http://www.theage.com.au/national/health/bandaid-promotions-to-be-ripped-off-the-shelf-after-complaints-about-healing-claims-20170413-gvk985.html

Similar promotional material for Band-Aids exists in New Zealand. Does Johnson & Johnson also plan to remove these? For example, these online ads for various Band-Aid products all say they can make cuts heal twice as fast as if they were uncovered, and it looks like the same claim is made on the packaging too:

If Johnson & Johnson does not plan to remove these ads, will they be willing to publish the evidence alluded to in the statement provided to Australian media?

Sincerely,

Mark Hanna
Chair, Society for Science Based Healthcare

A couple of weeks later – after their Director of Regulatory Affairs for Australia, New Zealand, and Japan had returned from leave – I received this response:

Dear Mr Hanna,

Re: Band-Aid® Brand Adhesive Bandages

I refer to your correspondence in relation to our Band-Aid® Brand Adhesive Bandages.

I can confirm that the product sold in New Zealand is the same as the product sold in Australia. Any changes that we make to our promotional and packaging material for Australia will, therefore, be reflected in the New Zealand market.

Thank you for your enquiry.

Yours sincerely,

Andrew Harris B.Sc(Hons) PhD
Director, Regulatory Affairs

Great, the claim on the packaging would be removed! A win for consumers, all done and dusted I guess. Except… all those examples I sent to them were text on a supplier’s website. Would their suppliers all be told of the change they should make to the way Band-Aids could be promoted? I asked:

Thanks Andrew, it’s good to have confirmation on this. I assume, then, that Johnson & Johnson will be contacting all of its New Zealand retailers to ensure they update their marketing materials for these products?

Sincerely,

Mark Hanna
Chair, Society for Science Based Healthcare

This time, I never heard back. Obviously I can’t say for sure, but in my opinion it’s likely that Johnson & Johnson never responded to that question because they had nothing else to tell me that wouldn’t make them look bad.

I don’t think they ever had any plans to contact their suppliers about removing this claim from promotional material that Johnson & Johnson didn’t have direct control over. I also don’t think they’ve contacted their suppliers about this in the months since they agreed to change their packaging.

In fact, if you check those example links I sent to them in April, you might find the “Heals cuts twice as fast” claim is still there. At the time of writing, that claim was still present at all three links.

But it’s not just their suppliers that are the problem. In early June, a couple of months after Johnson & Johnson agreed to stop claiming that Band-Aids can heal cuts twice as fast, Society for Science Based Healthcare member Daniel Ryan noticed that the claim was still made on over a dozen pages on the Band-Aid New Zealand website. He laid a complaint about this with the Advertising Standards Authority.

Unsurprisingly, his complaint was settled in July when Johnson & Johnson voluntarily removed the claims:

The Chair [of the Advertising Standards Complaints Board] acknoweldged the Advertiser’s response to the complaint confirming it had made changes to the website voluntarily and without admission, removing packaging images containing statements which were of concern.

ASA Complaint 17/185

Though Johnson & Johnson are clearly happy to be seen doing the right thing – removing claims that they are unwilling or unable to substantiate – it seems to me that they have also been very willing to ignore many places where these claims continue to be made, and to delay their removal through inaction.

It reminds me of Reckitt Benckiser’s behaviour in the case of the misleading claims they made about Nurofen specific pain products. Even though they were eventually forced to remove the claims (accompanied by a paltry fine, in their case), they still made a healthy profit in the meantime.

Perhaps more importantly, during the intervening time in which the claims remained, they were only further cemented as part of public knoweldge. So even though they’re no longer used, they’ll probably still come to mind when people are deciding whether or not to buy them:

“Band-Aids heal cuts twice as fast? Yeah, I’m sure I heard that somewhere.”

This is often what supposedly reputable health companies rely on. Even if they’re forced to remove misleading claims, people will still remember the old claims.

And if no one complains, nothing happens.

* I’m also a member of Friends of Science in Medicine (though not particularly active, since I focus my efforts on New Zealand issues), and Dr Ken Harvey is on their executive.

New Zealand should not regulate naturopaths

New Zealand should not regulate naturopaths

Naturopaths can kill, but regulating them is not the answer.

Over the weekend, the Sunday Star Times published an article by Simon Maude on an unnamed naturopath whose inept attempts at cancer treatment led to the death of an Auckland woman last year: Naturopathy under microscope after cancer sufferers speak from under shadow of death

At the same time, an article syndicated to Stuff from the Sydney Morning Herald detailed a court case in which a naturopath in Australia nearly killed a baby through their dietary advice for the infant’s eczema: Australian naturopath admits ‘raw food’ diet advice endangered baby’s life

As a result, the question has been raised of whether or not naturopaths should be regulated in the same way as medical doctors, pharmacists, and chiropractors.

In the Sunday Star Times article, vice president of the New Zealand Society of Naturopaths Sharon Erdrich laments what she sees as the root of the problem:

New Zealand Society of Naturopaths vice-president Sharon Erdrich says the society wants tighter regulations.

“In Germany, naturopaths are very heavily regulated, there’s regulation in the United States and Australia has some controls.”

Even though there is “potential for harm, basically anyone in New Zealand can call themselves a naturopath,” Erdich says.

(As an aside, Ms Erdrich’s clinic offers such bogus health services as quantum reflex analysis and live blood analysis, and an article she published in 2016 says “The first, and most important thing you can do” if you have cancer is to book an appointment with a naturopath.)

This argument was continued in an editorial in The Press this morning: New Zealand should require naturopaths to be registered

Here is the root of the argument, as expressed in that editorial:

Naturopathy is also enabled by tertiary institutes offering courses which are recognised by the official New Zealand Qualifications Authority framework.

This means that, even though anyone can claim to be a naturopath in New Zealand (there is no law stopping them), practitioners can arm themselves with diplomas and degrees and present themselves as equal to other health professionals.

That being the case, safeguards should be put in place for the public.

The most useful of these would be to require naturopaths to be registered, and made subject to similar disciplinary processes demanded of other health professionals when they can’t make good on their promises.

NZQA approving courses on quackery, such as their Certificate in Acute Prescribing with Homeopathy, is a real problem. But these calls for naturopaths to be registered are missing the point, I think.

The problem is not that “anyone can claim to be a naturopath in New Zealand”; the problem is that naturopathy is quackery. We already have regulation to address quackery, the real problem is that the existing regulation is not adequately enforced. Both the Fair Trading Act 1986 and the Medicines Act 1981 prohibit the misleading claims which are the basis of the practice of naturopathy.

For example, the Fair Trading Act prohibits the use of any “unsubstantiated representations”, as well as “conduct that is misleading or deceptive or is likely to mislead or deceive”, in trade. The Medicines Act prohibits the use of health testimonials (which can be both very convincing and entirely misleading), and claims to treat serious illnesses such as cancer, in advertisements.

The Sunday Star Times article also notes that naturopaths, despite not being subject to specific regulation, are still subject to the Health and Disability Code of Rights:

Regulation is not being considered as the ministry has not received an application from naturopaths to become regulated under the Health Practitioners Competence Assurance Act 2003.

Health practitioners including naturopaths remain subject to the Health and Disability Code of Rights, “whether they are regulated or not”.

Consumers may complain to the Health and Disability Commissioner about care.

The Health Practitioners Competence Assurance Act 2003, which regulates professions such as medical doctors and pharmacists, also prohibits anyone from claiming or implying that they are registered as or qualified to be registered as any type of regulated health professional. This is the provision that could prevent anyone not registered from calling themselves a naturopath.

We have already seen, here in New Zealand, that regulating a health profession prone to making misleading claims does not stop that practice. In research conducted by myself and Mark Honeychurch in 2016, we found that the majority of New Zealand chiropractors who advertise online make misleading claims about what they can treat. Including them in the regulatory scheme has not stopped this behaviour at all, rather it has just allowed them to continue misleading patients from a position of authority, able to use the protected title of “Dr”.

The Health Practitioners Competence Assurance Act sets up authorities to regulate each health profession that is composed of members of that profession. The Medical Council, the Pharmacy Council, and the Chiropractic Board are all examples of this.

But a Naturopathy Board filled with naturopaths would not be able to effectively regulate naturopaths. Quacks can’t regulate quacks effectively. All regulating them would do is give them the appearance of legitimacy and authority.

The real problem with all of this regulation is that it is not enforced. The solution, therefore, should be simple: enforce it.

Pharmacy ethics: Have your say

Pharmacy ethics: Have your say

The Pharmacy Council has opened consultations on a proposed new code of ethics. Following an initial consultation in 2015 where they’d proposed changing one part of the existing code, the council has since decided the whole code could do with a review.

The Pharmacy Council is the regulatory body for pharmacists in New Zealand, set up by the Health Practitioners Competence Assurance Act 2003. As well as overseeing the registration of pharmacists, they are also responsible under Section 118(i) of the Act for setting standards of ethical conduct to be observed by pharmacists.

I met with the Pharmacy Council just prior to the new consultation being opened, as part of my volunteer work with the Society for Science Based Healthcare. They told us that the revised code is intended to be more principle-driven, with associated guidelines that will be able to be updated more easily so as to keep pace with the evolution of the healthcare industry and with new legislation.

As well as these principles, the proposal also includes a draft of the Pharmacy Council Complementary and Alternative Medicines Statement and Protocol for Pharmacists as one of its appendices, and the council is also seeking feedback on this part of their proposal. Here are the consultation questions they’ve put forward, though they note that these are only intended as a guide and submissions can comment on any part of the proposal:

  1. Can you think of any ethical values for the pharmacy profession that appear to be omitted from the revised code?
  2. Considering the explanation of the term “patient” and equivalent terms in the key terms (key terms):

    1. 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?
    2. Are there any specific clauses where you can think of different term that could be more appropriate?
  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?
  4. Are there any other comments you would like the Council to consider?

In the Society for Science Based Healthcare’s 2015 submission, we stressed the importance of a code of ethics that would effectively protect patients. The context of the original proposed change was a complaint we laid in 2014 regarding an Auckland pharmacy promoting and selling a homeopathic product, in which the Pharmacy Council determined it could not enforce its existing code of ethics:

The council forwarded the complaint to the office of the Health and Disability Commissioner, but both organisations were unwilling or unable to enforce it as this would involve telling a pharmacy which products they can or cannot sell. Neither the Pharmacy Council nor the Health and Disability Commissioner seems willing to enforce a code of ethics when this would involve telling pharmacists which products they can or can’t stock.

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

Our submission will view the draft revised code in this light, looking at it in terms of how effectively we could expect it to prevent patients from being misled in pharmacies.

If this is important to you too, I hope you’ll consider making a submission. As the consultation document notes, submissions can be sent via email to enquiries@pharmacycouncil.org.nz, and (at the time this article was published) submissions will close at 5pm on Friday 18 August 2017.

A Failure to Regulate

A Failure to Regulate

New Zealand has several layers of regulation to protect us against misleading health claims. Sometimes they all fail. My struggle against quackery over the last few years has given me some familiarity with the ways we’re protected against it, and with their shortcomings.

Misleading people about their healthcare options is something that is clearly unethical. To quote the alt text of Randall Munroe’s xkcd comic strip Alternative Literature:

Telling someone who trusts you that you’re giving them medicine, when you know you’re not, because you want their money, isn’t just lying–it’s like an example you’d make up if you had to illustrate for a child why lying is wrong.

Alternative Literature | xkcd

Whether or not someone making misleading health claims knows they’re not true, this is something that can pretty clearly cause harm. At the lower end, a useless health product promoted for something that will get better on its own will cause financial harm. At the higher end, misleading people about their healthcare options could lead them to delay or avoid life-saving medical treatment. In all cases, it involves a violation of the person’s right to make an informed decision about their healthcare.

Our protection

Advertisers

The first line of defence we have against misleading healthcare claims is the conscience of the person making the claims. If no one ever made claims that are misleading in the first place, we wouldn’t need any regulation to deal with it.

In some cases, the advertiser themselves may have been misled, such as a store having been misled by a supplier. Sometimes, as I have written here before, once they are aware they have been misled their conscience may lead them to fix the problem.

Industry bodies

The second line of defence is industry self-regulation. This can take a few forms, such as the codes of conduct of professional societies. Perhaps the most prominent piece of general industry self-regulation in New Zealand is the Advertising Standards Authority (ASA).

The ASA has codes for various types of advertising, including a Therapeutic and Health Advertising Code which requires that therapeutic claims can’t be made in advertising unless you have good evidence to back them up.

The ASA won’t go out looking for non-compliant ads; instead they rely on people submitting complaints to them. The ASA considers each and every complaint lodged with them, and will always act if they agree it’s justified under their codes. If they find that an ad which has been complained about does not comply with their codes, and the advertiser refuses to fix it, the ASA will uphold the complaint.

When the ASA upholds a complaint, they ask the advertiser to remove their ad. However, they don’t have any legal power to enforce this, and there aren’t any penalties for violating the ASA’s codes.

Some industry groups have made a commitment to comply with the ASA’s rulings. For example, the Newspaper Publishers’ Association of New Zealand (Inc) is a member of the ASA. If an advertiser refuses to comply with an ASA ruling, any organisation that is member of the ASA should refuse to publish the ad.

However, many misleading claims are published directly by the advertiser, for example when they appear online on the advertiser’s own website. These advertisers have typically made no such committment to abide by the ASA’s rulings, and the ASA relies on their voluntary compliance.

The law

The third line of defence is legislation. We have laws against various ways in which consumers can be misled, and these are enforced by various government agencies.

The Fair Trading Act 1986 is one of these laws. It has a requirement for substantiation similar to the one in the ASA’s codes:

A person must not, in trade, make an unsubstantiated representation.

Fair Trading Act 1986 Section 12A(1)

This law is enforced by the Commerce Commission. There are some important differences that set the Commerce Commission apart from the ASA:

  • The Commerce Commission has power to enforce the law. Whereas the ASA can only ask an advertiser to withdraw an ad, the Commerce Commission can take them to court.
  • The Commerce Commission will not act on every justified complaint it receives. Instead it will assess them and decide whether or not to take action. Sometimes the decision is made to take no action even if there is a breach of the Fair Trading Act.

Also at this level of regulation is the Medicines Act 1981, which is enforced by Medsafe. The Medicines Act restricts certain health claims, only allowing them to be made for products that have been approved by the Minister of Health to be sold as a medicine for that purpose.

New medicines can be approved through a process in which they must provide evidence of their safety and efficacy. There are also some products that were already around in 1981 when the Act came into effect were “grandfathered” into the scheme and granted automatic approval, regardless of the evidence for them.

Like the Commerce Commission, Medsafe will not act on every justified complaint they receive, even if the Medicines Act has been breached. They prioritise complaints, and in my experience will typically not act unless there is a clear safety issue.

This means that some parts of the Medicines Act, such as Section 58(1)(c)(iii) which prohibits the use of any sort of health testimonial in medical advertisements, can go entirely unenforced.

Consumer advocates

With almost every level of regulation, nothing will happen unless someone complains. The system relies heavily on individual consumer advocates and consumer advocacy organisations. Groups like the Society for Science Based Healthcare (which, to be clear, I’m the chair of), Consumer NZ, and the NZ Skeptics can do what the regulators can’t.

Though we don’t have any powers of enforcement, we can bring issues to the attention of regulators, work to educate and inform consumers, and raise awareness of issues that regulators have failed to resolve.

Such as the ongoing case of the Homeopathy Centre’s misleading advertising…

When it all goes wrong

In March 2015, I was sent a message about an advertorial written by a business called the Homeopathy Centre, which was published in the Christchurch Mail newspaper.

This business was making a lot of misleading claims about homeopathy, both in the advertorial and on their website. They were using pseudoscientific language to convince people that homeopathy is effective:

The carefully selected homeopathic medicine is energetic in nature and can stimulate the vital force, which is not material, but a vibrant energetic structure interconnected with the body and mind.

Homeopathy Centre

The ads also claimed homeopathy could help with a large number of health problems such as insomnia, anxiety, and a “Weak immune system”. The most prominent claim for homeopathy was:

No matter what state of health you are in, you can improve it!

Homeopathy Centre

Advertising Standards Authority

Through my volunteer work at the Society for Science Based Healthcare, I make a lot of complaints about misleading health advertisements.

Almost always, I go to the Advertising Standards Authority first. Misleading health claims are often made by people advertising their own products and services, so dealing with them directly is unlikely to be helpful. On the other side, neither the Commerce Commission nor Medsafe are likely to take action on small things such as misleading claims on the website of a small business. The ASA is a good middle ground, as they will take action on these small things and often end up fixing the problem. But sometimes, even when they uphold a complaint, nothing changes.

I lodged a complaint with the ASA regarding these ads soon after being made aware of them in March 2015. In May, the ASA decided my complaint was justified, and it was upheld.

…therefore the advertisements were misleading, had unduly glamorised benefits of homeopathy and had portrayed unrealistic outcomes.

Consequently, the Complaints Board said the advertisement had not been prepared with the requisite standard of social responsibility.

Complaint 15/137 Homeopathy Centre | Advertising Standards Authority

The advertiser’s response to my complaint was to say they did not plan on continuing the newspaper advertorial, and that they were in the process of making changes to their website “over the next few months”.

Normally, that decision to uphold my complaint would have been the end of it. Most advertisers are responsible enough to comply with the ASA’s rulings in this way. As far as I am aware, the Christchurch Mail did, but that wasn’t the case with the Homeopathy Centre’s website.

Whenever I complain about online content, I set up a change monitoring system that sends me an email if a web page changes. As a result, I am able to see in detail every change made to the pages on the Homeopathy Centre website since I complained two years ago. When I complained, I set up change monitoring for 40 pages on their website, including those directly relevant to my complaint.

Since my complaint in March 2015, only five of these pages have had any changes. Most of these changes are irrelevant, such as a change of address and an increase in their prices. Whatever the changes they’d planned on making to their website, they don’t appear to have happened yet – two years down the line.

I’ve been following up with the ASA to try to get the Homeopathy Centre to comply with this decision since June 2015.

Advertising standards authority, again

In March 2016, when it was clear the promised changes were not forthcoming, the ASA suggested I submit another complaint that they could consider anew and, if upheld, seek compliance on. So that’s what I did.

In July 2016, the ASA upheld my second complaint regarding the Homeopathy Centre website. This time, the advertiser’s complete response to the complaint was a simple attempt to opt out of regulation:

No thank you, I don’t wish to respond

Homeopathy Centre Christchurch

It was abundantly clear by this point that the advertiser had no interest in voluntary compliance. When you make a complaint to the ASA, they ask that you sign a waiver saying that, if they accept your complaint, you won’t take the issue to another authority. So I tried to work with the ASA to help them gain compliance.

New Zealand Council of Homeopaths

I pointed out that Elisabeth Fink, the director of the Homeopathy Centre since 2009, is a member of an organisation called the NZ Council of Homeopaths. According to the Homeopathy Centre website, she has been a member of this organisation since 1987.

This is important because the NZ Council of Homeopaths is another part of that second line of defence I mentioned earlier. They have Rules of Practice that requires, among other things:

Any advertising will not contravene the Commerce Act 1986, the Fair Trading Act 1986, section 58 of the Medicines Act 1981, and must be in compliance with current Code for Therapeutic Advertising of the Advertising Standards Authority.

Rules of Practice | NZ Council of Homeopaths

As the ASA had already ruled that the Homeopathy Centre’s advertising is not in compliance with their current code for therapeutic advertising, this seemed remarkably clear cut. Elisabeth Fink was breaking the rules of practice of a professional organisation she’d been a member of for nearly three decades.

The ASA agreed in November 2016 to get in touch with the NZ Council of Homeopaths to gain compliance via this route. Later that month, I was told the executive members of the council would meet within a week to discuss the issue, and that they were planning to address it with the advertiser.

Then, in February 2017, I had an update:

The NZ Council of Homeopaths has been in touch with the advertiser. Unfortunately they have not been able to make any progress. You have the option of referring the advertiser to Medsafe.

Advertising Standards Authority

Commerce Commission

With this email the ASA released me from the waiver I’d agreed to, which said I wouldn’t take my complaint up with another authority. My experience with Medsafe in the past has been that, unless there is a pressing safety issue, they are unlikely to take any action.

For example, I have a complaint regarding misleading health claims made about “Harmonized Water” with Medsafe that has been “active”, but without any meaningful action, since September 2014.

So I decided to try the Commerce Commission first instead. I’ve had some success with them in the past, where they issued a formal warning against an advertiser of “amber teething necklaces” (which, by the way, don’t help teething in any way and can be unsafe) who had refused to comply with upheld complaints from the ASA.

I lodged the complaint with the Commerce Commission in the wake of their action against Reckitt Benckiser for misleading marketing of Nurofen specific pain products. It was encouraging to have seen Dr Mark Berry, the Commerce Commission Chairman, recently say:

The Commission will continue to take cases where traders do not promote their products truthfully. Products need to be as described on the box, and these were not. We take a particularly dim view when goods for human consumption are misdescribed; especially where pharmaceutical or healthcare products are not promoted truthfully. With these types of products consumers have little opportunity to verify the claims being made and tend to rely heavily on what they are told by the trader. To be able to choose the product best suited for them, consumers must have accurate and reliable information

Dr Mark Berry | Commerce Commission Chairman

This morning, two months after lodging my complaint with them, I have heard back from the Commerce Commission. It was not good news:

Dear Mark

Thank you for the information you provided the Commerce Commission regarding Homeopathy Centre.

We have now completed our assessment of the concerns you have raised and are writing to advise you that we will not be taking any action against Homeopathy Centre at this time.

Commerce Commission

Though this is so far a repeat of what happened with Baa Baa Beads – the Commerce Commission initially decided not to act then later changed their mind – a repeat of that behaviour hardly feels like something to rely on.

What’s next?

Medsafe will be receiving a complaint about Homeopathy Centre shortly, but I don’t honestly anticipate that they will do anything about it. In the meantime, this company will continue to mislead the public about their healthcare options, as they have knowingly done for at least two years now.

The lesson I would like everyone to take away from this story is that a rule is only useful if it is enforced. You can have the best rules in the world, but if they’re not enforced they don’t matter at all. If consumer protection rules aren’t enforced, consumers are not protected.

In this particular case, the ASA cannot enforce its rules, the NZ Council for Homeopaths chooses not to enforce its rules, and the Commerce Commission chooses not to take action. More often, no one complains about misleading claims, so nothing happens.

As a result of all this and more, quackery thrives in our country.

State-Approved Health Fraud Scams

State-Approved Health Fraud Scams

A decades old loophole in New Zealand’s patient protection legislation is letting quacks get away with health fraud, right under the regulator’s nose.

In New Zealand, patients are protected from health fraud scams by the Medicines Act. This legislation, which is enforced by Medsafe, only allows products making strong health claims to be sold if they have been approved by the Minister of Health.

In order to get approved, a medicine needs to pass a rigorous submission process that includes providing robust evidence to substantiate all of the health claims that will be made about it. In this way, patients should be protected against health fraud scams.

Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses.

Health Fraud Scams – US Food & Drug Administration

Except, there are some products that have this approval but are not been backed up by evidence.

When the Medicines Act came into effect 35 years ago, in 1981, all products that would be covered by the legislation which were already on the market were given automatic approval. This included a bunch of homeopathic products manufactured by the company Weleda.

Weleda, unfortunately, is still in operation today and still sells many of the same products. They operate out of Havelock North, which strikes me as somewhat ironic given their business is based on selling water as medicine. They’re far from tiny, too. In the 2014 financial year alone they made $4.85m in revenue from retail sales.


Usually, when you see a homeopathic product for sale in New Zealand, its marketing materials will be full of weasel words like “supports”. These ads typically manage to imply a whole lot without really saying anything at all.

Support for a healthy heart.

Maintains joint health.

Supports your body’s natural response to winter ills and chills.

Wink wink, nudge nudge.

There are also many cases where this promotion oversteps the generous line set by the Advertising Standards Authority. Myself and others at the Society for Science Based Healthcare work to bring these to the ASA’s attention when we find them, as part of our efforts to reduce the amount of medical misinformation people are subjected to.

Usually this is a pretty straightforward process, especially for homeopathic products. After all, the evidence on homeopathy is abundantly clear:

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

Statement on Homeopathy – Australian Government National Health and Medical Research Council

And so are the ASA’s requirements:

Statements and claims shall be valid and shall be able to be substantiated. Substantiation should exist prior to a claim being made.

Therapeutic and Health Advertising Code – Advertising Standards Authority

However, a recent complaint that we’d expected to be as straightforward as previous ones turned out to be anything but. My colleague at the Society for Science Based Healthcare, Mark Honeychurch, submitted a complaint earlier this year about an advertisement for one of Weleda’s products: Weleda Cold and Flu Drops.

The ad for this product on Weleda’s website gave clear directions for its use, which included strong and unambiguous claims about what the product is meant to do:

Take at the onset of cold or flu to relieve symptoms — fever, muscle ache, headache, sore throat, sneezing and runny nose. Take with Weleda Echinacea/Thuja Comp. Active Strength Immune Support for additional effectiveness. Does not cause drowsiness.

Weleda New Zealand

The problem with this ad is, of course, that there’s no evidence that this product can relieve any of those symptoms. Nor is it at all plausible.

That formed the basis of Honeychurch’s complaint. So it was quite a surprise when the ASA ruled to not uphold it, and passed on this response from Weleda:

Weleda Cold & Flu Drops is a registered medicine with Medsafe (TT50-8039) and is permitted to carry therapeutic claims. In relation to the complaint, the recommendations for the product on the website are consistent with the registered packaging indications which are as follows:

  • Take at the onset of cold or flu to relieve symptoms – fever, muscle ache, headache, sore throat, sneezing and runny nose.

Given that the statement on the website is consistent with the registered indications, we consider that the claims do not contravene the Therapeutic Products Advertising Code. We trust that our response resolves this issue.

Weleda New Zealand

Communication with Medsafe quickly uncovered the fact that this approval was granted in 1981, when the Medicines Act came into effect. The issue we identified was that Weleda was using this approval as a substitute for the substantiation required by the ASA’s codes. Under usual circumstances this would make some sense, as Medsafe’s approval typically requires that sort of substantiation. But these are not usual circumstances, and we thought this was a misuse of the approval Weleda had been granted.

Honeychurch sent a list of written questions to Medsafe, to get to the bottom of this and to aid with his appeal to the ASA. Two of his questions were particularly important, in my opinion. The first sought to clarify whether or not Weleda had ever given Medsafe evidence that their product can do what it says on the label:

What substantiation, if any, was used to accept these indications [for Weleda’s Cold & Flu Drops], either when the product was “grandfathered” into Medsafe’s Current registration system, or at any other time?

The product was grandfathered into the current regulatory Scheme following the enactment of the Medicines Act 1981. Products that were eligible for grandfathering were those that were already marketed in New Zealand and had a demonstrated history of safe use. For grandfathered products, the date of approval was deemed to be the earliest date of market availability provided by the product owner.

The product was originally indicated as a homoeopathic medicine for all types of influenza and Colds. These indications Were accepted at the time.

Subsequent to the original approval under the Medicines Act the indications have been modified in 2007 and 2014. The modified indications have been accepted as they are all encompassed by the Original appoval.

Medsafe

The lack of a clear answer from Medsafe here is frustrating. As far as I can tell, their answer means Weleda demonstrated that their product had a history of safe use, and provided the earliest date of its market availability. But it also seems Weleda never gave Medsafe any evidence to support the claims made about the product’s efficacy.

The other important question Honeychurch asked regarded the scope of the problem. Although this was the only homeopathic product we’d found to have been approved by Medsafe, it seemed unlikely to be the only one that exists.

What other Weleda products, and homeopathic products from other manufacturers, are registered with Medsafe as medicines, and what indications are there for each of them?

You can search for Weleda’s approved medicines that have been transferred into the therapeutics database using the search function above [http://www.medsafe.govt.nz/regulatory/DbSearch.asp] and entering Weleda into the sponsor box. Please note that products in the database are those which have undergone regulatory activity since being grandfathered.

Weleda also notified over 1000 homoeopathic medicines to be grandfathered. The approved product details are only held in hard copy files. Many of the products are intended to be supplied to practitioners of homoeopathy or direct to patients through speciality retail stores.

Providing the requested information would require extensive research and collation and Cannot be Completed within the timeframe you have indicated as necessary for your to lodge an appeal to the Advertising Standards Authority.

Medsafe

As a lower estimate of the number of health fraud scams approved by Medsafe, “over 1000” is a pretty scary number.

So what is there to be done about it?


Honeychurch started by submitting an appeal to the ASA, hoping the answers he’d recieved from Medsafe would be enough to overturn the decision. After all, the decision should hinge on the assumption that Medsafe’s approval of Weleda’s products implies the substantiation required by the ASA’s codes, and that assumption appears to be false.

But the ASA instead ruled to maintain their original decision. This ruling was released today, and makes for interesting reading. For example, this part of Weleda’s response clarifies that they truly have never had to submit evidence of efficacy for their products, simply because they have been sold for a very long time (emphasis in the original):

Weleda accepts that Weleda Cold & Flu Drops was ‘grandfathered’ into the current medicines registration system following the enactment of the Medicines Act 1981 (which replaced the Food and Drug Act 1969 which in turn replaced the Food and Drugs Act 1947. Cold and Flu Drops received ‘default’ approval as a medicine on 31 December 1969, three months before the Food and Drug Act 1969 came into force on 1 April 1970. This ‘grandfathering’ process however was applied to all relevant products at the time, including what may be called ‘conventional’ medicines. There was no favouritism toward one type of medicine or another and there was no requirement to (re-)submit evidence of efficacy to be registered.

Weleda New Zealand

The rest of their response makes it seem pretty clear to me that they’re using this historical approval as a shield to stop the ASA from requiring they provide robust evidence of efficacy that simply does not exist:

In the absence of a statutory or regulatory requirement under either the Food and Drug 1969 [sic] or the Medicines Act 1981 for Weleda to freshly prove the efficacy of our Cold & Flu Drops, we do not accept that it is open to M. Honeychurch to demand we do so by way of this proceeding — particularly when they have provided no evidence to support the view that Cold and Flu Drops has no efficacy.

Weleda New Zealand

And if that all wasn’t clear enough, Medsafe also weighed in on the issue of whether or not substantiation had been supplied by Weleda (this time the emphasis is mine):

The ‘approval date’ published on the Medsafe website in relation to this product (and most Weleda products) indicates approval at 31 December 1969. This means that these products were determined to have been legally on the market prior to the commencement of the Food and Drug Act 1969 and could continue to be marketed under the current legislation, with the same indications. Proof of efficacy is not held by Medsafe.

Medsafe

In my opinion, the decision the ASA should have been making should have been “does this advertisement breach our codes?”. Indeed, this is the question they usually ask when dealing with a complaint, and the fact that advertisements that breach their codes might not be downright illegal isn’t usually enough to stop them from upholding a complaint. But for some reason they’ve decided this case is different:

In relation to the complaint before it, the Appeal Board considered the key issue was a matter outside its jurisdiction, namely the process agreed to with the regulator during a change to legislation some decades ago.

The appeal Board noted the position of the Complainant with regard to the ‘grandfathering’ of certain products but agreed this was a matter that should be raised directly with Medsafe.

Advertising Standards Authority


The “grandfathering” process that allowed these hundreds of ineffective health products to get a free pass seems to have been intended to keep low risk products on the market, regardless of whether or not they are effective. With the unfortunately named Natural Health Products Bill lined up to wrap some much needed patient protection legislation around the area of low risk health products of dubious efficacy, it might seem like a great time for these “grandfathered” products to be transferred into that framework.

Unfortunately, the proposed regulations associated with the Natural Health Products Bill explicitly exclude homeopathic products from their rules. In our dealings with Medsafe, time and time again I have come away with the clear impression that they only care about safety issues. So long as a health fraud scam is safe, Medsafe is content to do nothing about it.

Magic water? Sure, it’s just water. What’s the harm?

I can certainly see the justification for that. Safety issues are typically more pressing than low risk products that are only doing more indirect harm like causing people to delay effective treatment, putting strain on finances, and damaging public health literacy. Often it’s entirely appropriate for Medsafe to rely on our first line of defence – the Advertising Standards Authority – to deal with misleading health claims. But when that fails, something needs to be done.

There is an ocean of health fraud scams in New Zealand. It’s high time the regulator responsible for enforcing our patient protection legislation started giving a damn about it.

We’ve got in touch with Medsafe to request a meeting in the new year, to discuss what path there might be for addressing the issues I’ve touched on here. While I’m hoping for the best, I’m not holding my breath.