What we owe our pets

What we owe our pets

I recently complained about a vet promoting quackery in the Bay of Plenty Times. In response to my complaint, the editor agreed to publish a response I wrote, regarding what we owe our pets. Now that it’s been up for a little while, I’m also publishing it here on my blog.


The Bay of Plenty Times recently published an opinion piece by veterinarian Liza Schneider about avoiding and treating cat abscesses. Liza Schneider runs the Holistic Vets clinic in Tauranga, and is the president of a special interest group of New Zealand vets focused on “complementary veterinary medicine”.

At the end of her article, she said “complementary therapies like homeopathy, herbal medicine, ozonated gel, hyperbaric oxygen therapy and others can help aid healing tremendously.”

The claimed efficacy of homeopathy is in stark contrast with evidence-based practice. As the UK’s Royal Council of Veterinary Surgeons said in a statement last year, “Homeopathy exists without a recognised body of evidence for its use. Furthermore, it is not based on sound scientific principles.”

Like children, our pets rely on us to make healthcare choices for them. Just as pets cannot talk to us about their symptoms, they are unable to discuss treatment options, make an informed decision of their own, or consent to treatment. These important decisions are left to their carer, and their vet is the carer’s guide to making this decision.

When we welcome a pet into our homes, we take on a responsibility to care for them. When their health becomes an issue, they have no choice but to rely on us to make the best decision in their stead. We must be their advocate.

If we choose poorly, their health may suffer. In my view treatments like homeopathy, which are not supported by robust evidence, will at best cost you money and do nothing, but at worst they may delay effective treatment.

Though we are fully capable of making informed decisions about our own healthcare that might involve trying treatments that are not backed by good evidence, I strongly believe that we have a duty to our pets not to experiment on them in this way.

This responsibility also applies to veterinarians. When a vet says things that are not soundly based on scientific evidence, such as “homeopathy… can help healing tremendously”, I believe they are failing in that responsibility.

The New Zealand Veterinary Association has a policy on the use of “complementary and alternative treatments” that requires, among other things, that vets must say if a treatment they are advocating is not supported by evidence:

“Clients must be made aware of the likely effectiveness of a given treatment according to recognised peer-reviewed veterinary medical publications, notwithstanding the individual beliefs of the veterinarian. They must also be told the degree to which tests, treatments or remedies have been evaluated and the degree of certainty and predictability that exists about their efficacy and safety.”

I sincerely hope that your vet fulfils this responsibility in their practice.

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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.

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.

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.

$26m for Acupuncture

$26m for Acupuncture

Last week, ACC’s spending on alternative therapies was in the media spotlight. There were pieces on both TV3’s Story and Stuff asking the question of whether or not this spending is justified.

This was prompted by some new information that’s been released by ACC under the Official Information Act, regarding their funding of acupuncture treatments.

ACC reports spending over $25 million per year on acupuncture, even though ACC’s reviews of the evidence for acupuncture have been largely inconclusive or negative. There were only three types of injury for which they have concluded acupuncture may be effective:

Frozen Shoulder
There is some evidence that exercise and acupuncture, compared with exercise alone, may lead to better outcomes.

The Diagnosis and Management of Soft Tissue Shoulder Injuries and Related Disorders (2004)

The evidence for the effectiveness of acupuncture is most convincing for the treatment of chronic neck and shoulder pain. In terms of other injuries, the evidence is either inconclusive or insufficient.

Pragmatic Evidence Based Review: The efficacy of acupuncture in the management of musculoskeletal pain (2011, emphasis mine)

Until recently, the only available breakdown of ACC’s spending on acupuncture treatments was categorised by “injury diagnosis”. Unfortunately, this breakdown is not very useful because it lumps 94% of acupuncture spending into a single treatment category:

Cost for acupuncture treatments by injury diagnosis
Injury Diagnosis 2014/15
Amputation / Enucleation $3,798
Burns $32,062
Concussion / Brain Injury $62,738
Deafness $1,280
Dental injuries $7,015
Foreign body in Orifice / Eye $4,517
Fracture / Dislocation $662,598
Gradual Onset $76,997
Hernia $1,734
Inhalation / Ingestion $907
Laceration / Puncture Wound $317,251
Mental Injury / Nervous Shock $170
Occupational Disease $681
Other $428,645
Soft Tissue Injury $24,788,178
Total $26,388,572

Earlier this year, I met with someone from ACC to discuss what data is available that might help me answer the question of whether or not ACC’s funding of acupuncture is supported by the conclusions of their evidence-based reviews. They suggested that I ask what the top read codes are that are used for acupuncture treatment in ACC claims.

In ACC’s terminology, a read code is a five character code that denotes a specific injury type. For example, “S572.” denotes a lumbar sprain, whereas “TE532” means a toxic reaction to a bee sting.


Following this meeting, I sent another Official Information Act request to ACC. I asked for the number of accepted claims and cost of treatment of acupuncture in 2014/15 categorised by read code, and for any significant confounding factors that would make the data difficult to interpret. That was something that had been discussed at my meeting with ACC earlier, so I knew the best I was going to be able to get was an estimate, and wanted to make sure I knew just what the information I’d be given would and would not mean.

To answer the question of confounding factors, ACC explained in their response that they had categorised claims by their primary read code, and that this information isn’t able to tell me exactly how acupuncture was used in individual claims:

The read code information provided in this response records the primary read code of every claim that has received a payment for acupuncture treatment. As you [are] aware, there can be more than one read code under a single claim.

The read code information alone does not indicate how acupuncture was used in individual claims, because it is not possible to determine whether acupuncture was used in relation to the primary read code or some other read code on the claim. This would only be possible by reviewing individual claims. This is also the case with the primary body site and primary diagnosis information provided. Please take this into account when considering the data provided.

Response to Mark Hanna (19 April 2016) | ACC

The response also had a pleasant surprise, in that ACC had supplied some extra data I hadn’t asked for, in case it would assist me. This contrasts somewhat with some of the frustration I’ve felt in the past with delayed and denied requests, but I’m very happy with how they responded this time.

The extra information they provided is a breakdown of acupuncture spending by primary injury site. Unlike the injury type breakdown I’d been provided in the past, this could be very helpful in determining how much of ACC’s funding of acupuncture treatments is aligned with the findings of their own reviews of the evidence.

Since their reviews only found positive conclusions for two injury sites – neck and shoulder – it seems like it should be a reasonable first estimate to look at the proportion of ACC’s spending on just these injury sites, allowing for the charitable assumption that these were all treating chronic neck or shoulder pain, or frozen shoulder. Allowing for some amount of error because of the caveats ACC mentioned, ideally this would come pretty close to 100%.

Acupuncture payments on claims by the primary injury site (2014/15 financial year)
Primary injury site of claim Claims Paid Count Cost ($) Ex GST
Abdomen/pelvis 1,846 $715,099
Ankle 4,557 $1,705,021
Back Except Head Vertebrae <4* $2,043
Chest 899 $331,676
Ear 17 $5,691
Elbow 724 $279,223
Eye 27 $8,968
Face 338 $128,708
Finger/thumb 868 $357,476
Foot 1,064 $364,063
Hand/wrist 2,111 $814,730
Head (except Face) 426 $142,220
Hip, Upper Leg, Thigh 2,511 $894,522
Internal Organ 13 $6,466
Knee 5,029 $1,854,745
Lower Back/spine 22,865 $9,628,926
Lower Leg 1,095 $369,616
Lung 4 $2,097
Multiple Locations 55 $22,540
Neck, Back Of Head, Vertebrae 8,262 $2,982,805
Nose 39 $15,075
Other Internal Organ 9 3,127
Shoulder (incl Clavicle/blade) 9,454 $3,640,599
Toes 226 $84,162
Unobtainable 705 $276,004
Upper And Lower Arm 2,293 $863,645
Upper Back/spine 2,531 $863,912

*Small numbers were reported as <4 or <$500 in order to protect privacy

Although shoulder and neck are in the top three primary injury sites for acupuncture, together they made up just 25% of the cost of acupuncture claims to ACC. This leaves just under $20 million for claims involving other primary injury sites.

I hadn’t expected to see such a strong trend toward a single injury site that was neither shoulder nor neck, but there were more claims with the lower back as the primary injury site than there were for neck and shoulder combined.

Looking at the data for individual read codes, I found that 33% of all ACC’s spending on claims involving acupuncture had a primary read code of “S572.”, which indicates a lumbar sprain.

Because of the caveats mentioned earlier, it’s likely that not all of the $8,652,237 spent on these 20,409 claims was for acupuncture used to treat a lumbar sprain. But it certainly indicates that ACC spends a large amount of money on ACC for lumbar sprain – large enough to be measured in the millions.


ACC has evaluated the evidence for acupuncture used to treat lower back pain. Its 2004 New Zealand Acute Low Back Pain Guide* categorised acupuncture as having “Evidence of no improvement in clinical outcomes”.

*ACC’s website notes that “due to the age of this guideline, some sections may have been superseded by more recent evidence”, although as far as I can tell they haven’t published an updated guideline.

Their more recent (2011) review on acupuncture for musculoskeletal pain concluded that:

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

Pragmatic Evidence Based Review: The efficacy of acupuncture in the management of musculoskeletal pain (2011)

This is hardly the sort of ringing endorsement that I’d expect to back up the spending of millions of dollars of public money each year on a treatment for lower back pain.

Until recently, the National Health Service (NHS) in the UK would pay for acupuncture to treat lower back pain. But the Guardian reported in March that acupuncture for lower back pain is no longer recommended for NHS patients. The latest draft guidelines for lower back pain, which will replace the previous guidelines from 2009, involved a thorough review of the evidence and recommended not offering acupuncture at all for treating lower back pain. Its summary for acupuncture notes that:

comparison with sham acupuncture showed no consistent clinically important effect, leading to the conclusion that the effects of acupuncture were probably the result of non-specific contextual effects.

Low back pain and sciatica: management of non-specific low back pain and sciatica (draft) | National Clinical Guideline Centre

“Non-specific contextual effects” is just a more descriptive way of saying “placebo effect”.

In the last year, the New Zealand government has been under intense criticism for spending $26 million over three years on a referendum for changing the flag. More recently, the importance of funding evidence-based treatment has been emphasised in the media when reporting on Pharmac’s decision not to fund the effective, yet extraordinarily expensive, melanoma drug pembrolizumab (branded as Keytruda), estimated to cost $30 million annually.

In this context, it seems increasingly bizarre that ACC continues to spend $25 million or more each year on a treatment that they themselves have found is not supported by evidence for at least three quarters of the injuries it’s used to treat.

Misleading claims common among chiropractors

Misleading claims common among chiropractors

Most New Zealand chiropractors make misleading claims.

Through my role as the chair of the Society for Science Based Healthcare, I see a lot of misleading health claims in advertisements. Many of them are pretty clearly bogus; I’ve seen claims that drinking “harmonized water” is as good as sunscreen and that bacteria make your cells each lose a positive electron.

But not all misleading claims are obvious. Many might sound plausible, especially if you don’t know much about the therapy or if they come from someone in a position of authority. This, I think, is where they can be the most dangerous. Luckily we have rules in place to prevent this, but the complaint-based systems we rely on require cooperation from advertisers. When the rules are widely ignored, we simply aren’t protected.

In 2015 my colleague at the Society for Science Based Healthcare Mark Honeychurch and I gathered data on how common misleading claims from chiropractors are in New Zealand. We systematically searched through the first 30 pages of results of an anonymous Google search for “Chiropractor New Zealand”. For all 137 websites we found for New Zealand chiropractic clinics, we recorded the presence or absence of claims that chiropractic manipulation can help with ADHD, allergies, asthma, bed wetting, colic, or ear infections. We also looked for health testimonials used as a marketing tool.

We picked that list of conditions based on the results of successful complaints to the Advertising Standards Authority, and on our failure to find credible evidence to support the claims when searching the scientific literature ourselves. We included health testimonials in our search because they can be both very convincing and highly misleading. We have legislation prohibiting them in medical advertisements, and for good reason.

Today, our results have been published in a letter to the editor at the New Zealand Medical Journal: Chronic misleading online advertising by chiropractors

Claim Quantity Proportion
ADHD 34 25%
Allergies 48 35%
Asthma 54 39%
Bed Wetting 43 31%
Colic 59 43%
Ear Infections 55 40%
Any condition 74 54%
Testimonials 48 35%
Any condition or testimonials 96 70%
Total 137 100%

Unfortunately, we weren’t surprised to find that such a high proportion of New Zealand chiropractors who advertise online make unsubstantiated claims about what they can treat. Similar research has found as high as 95% of English chiropractor websites make unsubstantiated claims.

This problem is also widespread in Australia, where the Chiropractic Board of Australia recently published a Statement on advertising addressing this problem along with several others:

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.

Statement on advertising | Chiropractic Board of Australia

We have a Chiropractic Board here in New Zealand as well, which was set up to regulate chiropractors under the Health Practitioners Competence Assurance Act. They have their own Advertising Policy:

All advertising must… be presented in a manner that is accurate, balanced, and not misleading

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… uses testimonials whether from patients or any other person

Advertising Policy | New Zealand Chiropractic Board

Even if we didn’t have these rules laid out in an explicit “this is for chiropractors” format, we also have the Fair Trading Act and the Advertising Standards Authority’s codes of practice both requiring that claims made in advertisements must be substantiated, and the Medicines Act prohibiting health testimonials in advertisements.

How the regulation is enforced currently is not working. Our findings make that abundantly clear. If we’re going to solve this problem, the Chiropractic Board needs to take a more active role.

The New Zealand Chiropractors’ Association’s response to our findings has been that they are “not really current now”, and “the issues had been addressed recently, and the numbers would be much different now”. However, when Mark Honeychurch re-checked all 137 sites this morning for the claims we were looking for he found that only 15 (11%) had changed in this respect. Eight of those sites had removed claims (four of them had disappeared entirely), whereas seven had claims we didn’t observe last year. The problem is not solved yet.

Here’s what I want to see the New Zealand Chiropractic Board do about this:

  1. Publish a public statement on advertising, like the Chiropractic Board of Australia did, making it abundantly clear that this behaviour is not acceptable.
  2. Take an active role in maintaining compliance, by seeking out and contacting chiropractors that are making unsubstantiated and misleading claims. We are willing to share the data we collected with the Chiropractic Board to assist this effort.
  3. Sanction any chiropractors who might continue to make misleading claims after being told to stop. It is not appropriate for a registered healthcare professional to mislead their patients – any who continue to do so simply should not be trusted to hold that position of authority.

Perhaps just as importantly, I want to see New Zealand chiropractors themselves clean up their act. Those chiropractors who already ensure that they don’t engage in this behaviour should lead the charge for change within the industry – from my vantage point it sure looks like it could use some leadership on this.