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.

Strip searches in prisons – what is reasonable?

Strip searches in prisons – what is reasonable?

I’ve written two articles as a guest blogger for the NZ Council of Civil Liberties, on how the Department of Corrections conducts strip searches in prisons. The first of these articles has just been published, the second will be up in a few days. You can read the full article over on their website: Strip searches in prisons – what is reasonable?

Here’s an excerpt:

In New Zealand prisons, corrections officers conduct strip searches of prisoners in order to find contraband items such as drugs and weapons. Recently, the Department of Corrections has released information regarding how they have been conducting strip searches in response to two requests made under the Official Information Act. I believe their response to these two requests is cause for concern.

Strip searches are clearly invasive, and it’s clear that there is the potential for them to be abused, so it’s important that there are appropriate restrictions placed on them in the law and that the Department of Corrections is held accountable for administering them appropriately.

In March, an OIA request regarding strip searches in New Zealand prisons was sent to the Department of Corrections by Ti Lamusse, a member of the activist group No Pride in Prisons.

I happened to see this request, which was made publicly via the website FYI.org.nz, and the response to it raised more questions in my mind. Mx Lamusse’s request asked several questions, two of which were:

  • How many strip searches are conducted?
  • How many strip searches find anything?

Corrections released month by month data for the number of strip searches conducted and the number of contraband items found through strip searches, from June 2011 until June 2015…

Keep reading

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.

Are You an Organ Donor?

Are You an Organ Donor?

Organ donation is important. When a person dies in a way that leaves them brain dead but their other organs still viable, such as an intracranial haemorrhage in an intensive care unit, their organs can be transplanted to save others’ lives in a way nothing else can. Only a few organs, kidneys for example, can be donated by live donors. But others, like lungs and hearts, can only be given posthumously.

This is something most of us will already know, but it’s something else entirely for it to have saved the life of someone you know. I want to start this article by telling you a story.

Poppy McKay is a family friend. She’s 24 years old, and she is probably alive today because of an organ donor who is sadly not.

She was diagnosed at birth with cystic fibrosis, an incurable genetic disease that primarily affects her lungs and digestive system. For her whole life, she’d been in and out of hospital, having to undergo daily treatment.

In early 2012, most of her treatment was stopped as it was no longer being effective. The only option left to her, she was told, was to be assessed for a lung transplant. She was put on the active list later that year. She spent her 21st birthday on the list, and by the end of the year could barely walk up the stairs at home. Her lungs were so weak she wasn’t even able to blow into the machine to measure their function.

But then the phone rang, and the transplant coordinator said she should go to the hospital immediately because they had a pair of lungs for her. After a long operation starting in the early hours in the morning, she came out of the operating theatre with a new pair of lungs.

Since the transplant, she progressed from breathing with help from a machine, to breathing on her own, to walking with a frame, and then without one. When I see her now, you could tell me she’d never been sick a day in her life and if I didn’t know better I might believe you.

Organ donations like this are very special. They can save the lives of multiple people, but only at the cost of another life. I think it says a lot about a person, and their family, when they allow this to be done.


Are you an organ donor? When I ask that question, do you think to check your driver licence? That’s the closest thing New Zealand has to recording a person’s status as an organ donor. When you apply for a driver licence, as part of the process you are asked this question:

Would you be willing to donate organs in the event of your death?

New Zealand Transport Agency | Organ and tissue donation

You can’t apply for a licence unless you tick either “Yes” or “No” in response to this. If you tick “Yes” then the word “DONOR” will be printed on your licence. Either way, you’ll very likely consider the question answered and not worry about it for most of the rest of your life, and you might feel justified in doing that. But you’d be wrong.

When I was applying for my licence a few years ago, I noticed this text on the NZTA website (the emphasis is mine):

Ticking the ‘Yes’ box on your driver licence form only means that you have indicated your wish to be identified as an organ and tissue donor. It does not automatically mean that your organs or tissues will be donated in the event of your death. In practice, your family will always be asked for their agreement to organ and tissue donation.

If your family knows what your wishes are in regard to donation, they will be more likely to follow them through in the event of your death. Having your wishes displayed on your driver licence is just one way of making them known to your family. You should also discuss your decision with them.

New Zealand Transport Agency | Organ and tissue donation

I emailed Organ Donation New Zealand about this in 2012, to ask if there was anything I could do that would guarantee that my wish to be an organ donor would be respected if I were ever in a situation where I was a potential organ donor. I was told that my family and friends would be asked about my wishes and if they would agree to consent. I emailed them again last week and they confirmed that this answer is still true today.

I’m lucky in that my family and I are on the same page about organ donation. Having spoken to them about it recently, I can be entirely confident that they would respect my wish to be an organ donor if they ever had to. I’m sure not everyone is in the same position, although until recently I could only speculate as to how common that would be.

Last week, Andy Tookey from the organ donation lobby group GiveLife released a press release in response to information released to him under the Official Information Act. Mr Tookey was kind enough to send me the documents released to him, and gave me permission to publish them here.

The document includes a copy of the most recent audit of potential donor deaths in New Zealand. One part of this document in particular was very interesting to me, and I’ve duplicated it here:

ICU deaths 1,123
Ventilated in ICU and died with severe brain damage 367 (33% of ICU deaths)
Of these 367
Discussed with Organ Donation New Zealand 35% (129)
Organ donation mentioned 43% (159)
Organ donation formally discussed 37% (135)
Of the 135 where organ donation was formally discussed
Families agreed to donate 39% (53)

It’s that last figure in particular which I find interesting. In all the cases where organ donation was formally discussed with the family of a potential organ donor in 2015, they only agreed to it 39% of the time. The reasons the families refused the remaining 61% of the time weren’t recorded, and I could imagine in some cases they might have known their loved one did not want to be an organ donor.

For comparison, I’ve seen several figures of the proportion of NZ driver licences with “DONOR” printed on them, which all centre at around 50%*. Given the discrepancy between this and the proportion of families that agreed, it seems likely at least some of the time the family would have acted against their loved one’s wishes and prevented them from being an organ donor.


To help make sense of all this I spoke to Associate Professor Colin Gavaghan, an expert in medical law and ethics at Otago University. I asked him about what the law says about how organ donation handles informed consent, what problems he sees with the current system, and what could change so someone could be assured that their wish to be an organ donor could be respected even if their family disagrees. Here’s what he told me:

The use of organs in NZ is covered by the Human Tissue Act 2008. The Act has a number of stated purposes, the first of which is to ensure that the collection of human tissue occurs only with proper recognition of, and respect for:

  • the autonomy and dignity of the donor;
  • the cultural and spiritual needs, values, and beliefs of the deceased’s immediate family;
  • the cultural, ethical, and spiritual implications of the collection or use of human tissue; and
  • the public good associated with collection or use of human tissue.

Straight away, the potential for conflict between some of those objectives becomes obvious. How are medical staff to balance the autonomous wishes of the deceased with the beliefs of their immediate family, if those are not aligned? How is the public good of organ donation to be balanced with the “cultural, ethical and spiritual” values of those who don’t agree with organ donation?

Luckily, the Act makes it clear that those objectives are not equally weighted. As the Ministry of Health point out “The Act makes informed consent the fundamental principle underpinning the lawful collection and use of human tissue from deceased people.” [http://www.health.govt.nz/our-work/regulation-health-and-disability-system/human-tissue-act/about-human-tissue-act]

What that means is that if you have documented your wishes before you die, those wishes should be the most important determinant of what happens after death. No other authority is needed.

That’s the theory, anyway. In reality, there are a few factors that make things a bit more complicated.

1. The Act doesn’t require doctors to take your organs. Your consent authorises the salvaging of your organs, but it doesn’t make it compulsory for anyone to do so. In some ways, this discretion seems sensible. We wouldn’t, I assume, want to force doctors to harvest organs that are likely to be unsuitable for transplant. There may also be cases where evidence arises that the deceased may have changed their mind after indicating their consent. More controversially, the MoH notes that ‘the immediate family may be distressed by a decision to proceed with donation.’ How much weight should be given to that is contentious, and I’ll come back to it in a minute.

2. By far the most common way for New Zealanders to record their wishes about organ donation is via their driving licenses. Both the Act and the MoH make it clear, however, that this won’t constitute “informed consent” for legal purposes.

I can see why this would be the case. Unlike the UK’s donor card, for instance, the NZ driving license doesn’t allow people to specify which organs they would be willing to donate. (I’ve never really understood what would motivate someone to agree to donate all of their organs, but not, say, their pancreas. But ultimately, it’s their choice.)

This is problematic for a couple of reasons. One is my suspicion that most people who fill out that part of the license actually do so believing they are giving legally valid consent. If so, that’s just bad in itself; if we value autonomy (as the Act claims to) then it seems generally wrong when people do things under false beliefs. But it might also be bad in that it discourages them from taking other steps that might actually be legally significant. Why bother if you think the info on your driving license is enough?

Even if people were to recognise that the driving license doesn’t amount to “informed consent”, it isn’t entirely obvious what they could do instead. Unlike the UK and Australia, NZ doesn’t have a register where people can record their wishes. The Act provides that one could be set up, but thus far, there has been no political will to establish one.

I’m not sure whether establishing a register would be worthwhile in terms of increasing the supply of donor organs. It’s possible that it would cost too much to set up and run, and divert too much money from more worthwhile initiatives. But there may be cheaper options available that could be almost as effective.

Although they were rendered largely redundant by the Register, I still have my UK Donor Card, a wallet-sized statement of willingness to donate my organs after I die. It contains simple tick boxes to indicate views regarding specific organs.

I can’t think of any reason why something similar couldn’t be distributed in NZ, and be so constructed as to contain enough information to constitute “informed consent”.

3. The Act makes it clear that, where valid consent is obtained from the deceased, no-one else should be able to override that. As the MoH says: “The framework does not allow others to legally veto an individual’s consent”.

In practice, however, we know that immediate family (and sometimes more distant family) are routinely asked to make the decision. Unfortunately, this doesn’t just happen in NZ, but in the UK as well. It happens even in situations where the relevant law has made it clear it isn’t required.

There can be good reasons to consult the family of the deceased. As the UK NHS explains, “In the event of your death, the person closest to you (usually your next of kin) will be asked to confirm that you hadn’t changed your mind before your death.” (http://www.nhs.uk/conditions/organ-donation/Pages/Donationprocess.aspx)

A lot can depend, though, on how the approach is made and the questions asked. There’s a difference between asking the family if the deceased changed their mind, and asking them for their own consent. In the UK, where it’s also worryingly common for families to override consent in this situations (500 recorded instances since 2010) various strategies are being tried out to reduce this phenomenon.

For instance, the relatives of the deceased can be provided with an information sheet, gently but clearly explaining that the deceased has consented to organ donation, and that this will be what happens unless they know of a good reason why it should not. This might not sound very different to what happens at the moment, but the hope is that it will make it clearer that it isn’t up to the family to decide what should happen, but rather, to inform the medical staff of any relevant information that they may not know.

What of the situation where the bereaved relatives are genuinely distraught at the prospect of the organs being taken? There’s no clear answer here, but my own view is that the wishes of the deceased, and the value of the potential donation, should still carry greater weight.

There are 3 reasons why I say this. First, we don’t give that sort of weight to family wishes in any other circumstances. If I refuse life-saving treatment, that refusal has to be honoured, regardless of how much my family might want me kept alive. Likewise, I can’t imagine any competent adult having their consent to treatment being invalidated on the basis that their family don’t wish them to have it.

We have, as a society, accepted the primacy of individual autonomy in just about every other medical situation. It isn’t clear why organ donation should be the exception.

Second, it isn’t clear to me that immediately bereaved people are generally in a state of mind to make properly reflective choices about such matters. Certainly, it doesn’t seem likely that they will make a better decision (in the sense of being a balanced one) than that made by the deceased themself when they set down their wishes in advance, presumably in the cold light of day.

Third – and this is important – if really we’re going to start down the road of overruling individual autonomy on the basis of the interests of other people, then let’s consider all of those interests – not only those of the immediate family, but those of the potential donor recipients. And their families. Of course, the medical staff who are seeking consent to take organs won’t have to face those people, and explain to them that – while a perfectly good organ was available – someone has just refused to let them have it.

To summarise, I’d favour 2 changes:

  1. A means should be made available for people to express their wishes about organ donation in a manner that will be regarded as legally valid consent. This could be via a register, or a donor card, or something else. This should replace the section of the driving license, which has substantial potential to be misleading with regard to its legal status.
  2. Where legally valid consent from the deceased is available, the practice of routinely seeking consent from what will frequently be traumatised, overwrought bereaved relatives should end. Instead, relatives should approached with a sensitive statement to the effect that the deceased has consented to their organs being taken, and that this is what will happen unless the relatives know of any specific reason why it should not. Of course, the possibility remains that certain families with very strong anti-donation views will lie about this, but it’s hard to imagine that being a common occurence.

Associate Professor Colin Gavaghan

I also asked Poppy, as someone who has personally been involved with organ donation, what her thoughts on this issue were:

I have an issue with people not being able to be in “control” of the last wish they could potentially have by, when unable to communicate with them, their families or loved ones can say no to organ donation.

A donor registry could be a good option. I haven’t done a lot of research around it but know it’s successful in some countries. If anything, it brings a hell of a lot more awareness, and even if we still had the same law as the driver’s license one, you would think seeing as a much more informed decision had been made to register themselves as donors, the families may not oppose it as often.

Having been in the position of needing a transplant, I obviously believe that everyone who can be a donor, should be a donor. Everyone who wants to be a donor, should be allowed to keep their wishes.

However, I have never been on the other side. Having to already deal with the fact a loved one is going to die, some people may find it too hard to then have their body “chopped” up and not be buried/cremated whole. I believe that if someone has expressed strongly enough their feelings of being a donor, their loved ones would want to honour it. More awareness needed?

My main advice for people who want to be organ donors and their families is to “have the conversation”. Make sure those who will be responsible to make the decision for you if you’re ever in that situation knows your wishes and how strongly you feel about it. Research success stories of organ donation/transplant and see how life changing it can be for up to 8 people per donor, not only life changing for them but for their families and friends.

Poppy McKay

The idea of a register is one that Andy Tookey from GiveLife has also been pushing for. In my opinion, it seems the current system is simply not robust enough. It fails to capture people without a driver licence, for example, and also isn’t enough to constitute informed consent. I don’t know if a register is the right way forward, but I do think it seems like a good suggestion and I hope it will at least be considered. There should be a way for people to be assured that their wishes regarding organ donation will be respected after they’ve died.


So, what should you take away from this article? If nothing else, remember this:

  • Your driver licence saying you’re an organ donor doesn’t mean you would be if you ever could be
  • In order for you to be an organ donor, it is important that your family understands your wishes, and that you’re on the same page. Talk to them about it.

I would also like to give my sincere thanks to Colin and Poppy for their contributions to this article. Thank you both!


* I’ve seen figures of 48.8%, 49%, and 52% over the past few days, but I haven’t found a primary source for any of them. I’ve asked NZTA for the information via the Official Information Act, but I expect it will take them a while to give it to me. Here’s a link to the OIA request on FYI.org.nz – Organ donor preference on driver licences

Nurofen: Does It Really Target Pain?

Nurofen: Does It Really Target Pain?

Nurofen provides targeted relief from pain. Or does it?

For a long time now, the pharmaceutical company Reckitt Benckiser has sold a range of their ibuprofen product Nurofen, which are marketed for four specific types of pain:

  • Back pain
  • Migraine pain
  • Period pain
  • Tension headache

Since at least 2008, Nurofen has marketed these specific pain relief products saying they “provide targeted relief“. From watching their TV ads, you could be forgiven for believing that Nurofen will “act at the site of the pain” or “target headaches at the source of pain“. Their logo, a bullseye target, is often shown alongside the tagline “Targeted relief from pain”. Their New Zealand website describes their range as being “made up of a number of different products to target specific conditions, from back pain to cold and flu symptoms”. This Nurofen TV ad from the UK even shows a Nurofen logo performing a sort of “seek and destroy” manoeuvre to find a bull in a maze the shape of someone’s head, in a metaphor for dealing with headache pain.

The Nurofen brand really has been built around the idea of “targeted relief”. The message is clear, or at least I thought so when I saw ads like these on TV. But is it true?

Well, it’s complicated. The main Nurofen products come in two formulations, containing either 200 mg ibuprofen or 342 mg ibuprofen lysine (which is equivalent to 200 mg ibuprofen). There is evidence that these products can provide pain relief, but the way in which they do so is not targeted. In fact, all of the specific pain products have identical formulations: 342 mg ibuprofen lysine. It doesn’t matter if you have back pain, period pain, migraine pain, or tension headache. You can take any of those Nurofen products for the same effect.

In 2010, Australian consumer affairs magazine Choice awarded Nurofen their “shonky” award for these products. They revealed not only that these specific pain products are identical and unnecessary, but also found:

The shonkiest aspect is that, in some stores we surveyed, the targeted painkillers are almost twice as expensive as their all pain equivalent products.

The 2010 Shonky Awards: Shonky for pain in the hip pocket | Choice

In 2011 the Therapeutic Goods Administration (TGA), which is roughly the Australian equivalent of New Zealand’s Medsafe, received a complaint about this advertising from Professor Paul Rolan. The complaint essentially said that, although the products were effective, the claims that they provide “targeted relief” were misleading. The legislation administered by the TGA prohibits advertisements for therapeutic goods from being misleading, so the complaint was investigated. If you want to read more about this complaint, I wrote about it last year: The Price of Painkillers Part 2: Only Misleading in Australia

The TGA found that Professor Rolan’s complaint was justified, and issued sanctions to Reckitt Benckiser saying they must withdraw the misleading advertisement and representations (the TGA didn’t have jurisdiction of the products’ packaging, except when images of it were used in advertisements). But that didn’t stop Reckitt Benckiser from claiming that Nurofen offers “targeted relief”. Instead, they issued a statement two months later saying they would not comply with the TGA’s sanctions:

Nurofen advises that consumers will continue to see the familiar branding on the Nurofen target and messages of Nurofen working at the site of pain. This branding includes TGA approved claims on packs that Nurofen provides targeted relief from pain

Nurofen maker says ads will carry on | Australian Doctor quoting Nurofen

Three days after that, the TGA made a decision to issue an order to Reckitt Benckiser “as the Advertiser had not fully complied with the Panel’s determination issued on the 30 August 2011”. The order itself came nearly a full year after the decision to issue it, and required that Reckitt Benckiser:

  1. withdraw the “Live Well Headache” television advertisement (“the advertisement”) about the therapeutic good “Nurofen” which was the subject of the complaint;
  2. withdraw any representation, in the context of headaches, that the advertised therapeutic good “Nurofen” goes “straight” to the source of the pain;
  3. not use the representations in (b) above in any other advertisement; and
  4. where the representation has been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representation has been published or is intended to be published by such parties, to advise those parties that the representations should be withdrawn.

Pursuant to subregulation 9(2) of the Regulations, the order is subject to the conditions that within 10 working days of being notified of this order, Reckitt Benckiser (Australia) Pty Ltd is required to provide evidence to the delegate of the Secretary [to the Department of Health and Ageing] of compliance by Reckitt Benckiser (Australia) Pty Ltd with the order set out in paragraphs (a) to (d) above including a written response indicating that they will continue to abide by this order.

Nurofen – Reckitt Benckiser (Australia) Pty Ltd – Complaint No. 2011/06/001 | Therapeutic Goods Administration

One month after the order, Reckitt Benckiser advised that they had complied and would continue to comply with the order. But this didn’t slow them down at all.

Associate Professor Ken Harvey wrote an article for The Conversation the month after this response, explaining why the order had essentially failed:

In response [to the order], regional director of Reckitt Benckiser, Lindsay Forrest, said he was, “delighted with the TGA Delegate’s ruling as it validates our decision to challenge the CRP [Complaints Resolution Panel] findings, specifically in relation to our ability to communicate our long standing messages of targeted pain relief in relation to pain, including headaches”. The media statement continued, “Reckitt Benckiser’s current media plan will not be impacted by the TGA Delegate’s decision as it currently complies with all the TGA Delegate’s findings”.

It is my view that TGA delegate’s ruling has unnecessarily and incorrectly limited the Regulation 9 order to the specific words, “goes straight to the source of the pain” thereby failing to taking [sic] into account the CRP’s equal concern about the words, “targeted relief from pain”. In addition, by focusing only on the television ads for headaches and not taking into account the wider ongoing Nurofen campaign that uses look-alike branding the TGA delegate has failed to protect consumers.

TGA failure gives Nurofen consumers a headache | Ken Harvey

Professor Harvey went further, and laid a complaint of his own with the TGA and the Australian Competition and Consumer Commission (ACCC) in August 2012. The ACCC is essentially Australia’s equivalent to New Zealand’s Commerce Commission.

In 2013, Australian consumer affairs show The Checkout aired a segment on Nurofen’s targeted relief products, clearly showing the inconsistency between their marketing and reality with quips such as “When I have a tension headache, I take Nurofen Back Pain for fast, targeted relief”.

By the time that episode aired, the status quo remained unchanged from 2011, when Reckitt Benckiser refused to comply with the TGA’s ruling. As far as I’m aware, nothing changed until March 2015.

EDIT 2015/12/16: Since publishing, I’ve found more information on what happened between 2012 and 2015. Professor Harvey’s 2012 complaint to the TGA, along with another anonymous complaint on the same grounds, was successful. In July 2013, the CRP issued a written determination saying Reckitt Benckiser had breached the Therapeutic Goods Advertising Code.

Just like in 2011, soon after this the TGA was forced to take further action as Reckitt Benckiser had refused to comply with the CRP’s determination. An investigation into this lack of compliance lasted from 16 July 2013 until 11 April 2014, at which point the TGA delegate to the Secretary of the Department of Health decided the TGA was correct and Reckitt Benckiser’s advertisement really was misleading.

Another order was issued to Reckitt Benckiser, saying they must:

  1. withdraw any representations, including implied representations, that imply that any two or more Nurofen products that contain equivalent ibuprofen quantities and include the same product specific indications on the Australian Register of Therapeutic Goods:

    1. are effective only in treating a particualr condition or conditions or pain in a particular part or parts of the body; or
    2. are not effective in treating other conditions or pain in other parts of the body, where they are indicated for those other conditions or pain in particular parts of the body
  2. not use the representations referred to in paragraph (a) above in any other advertisement unless the Advertiser satisfies the Secretary that the use of the representations would not result in a contravention of the Therapeutic Goods Act 1989 (the Act), the Regulations or the Therapeutic Goods Advertising Code 2007 (the Code)
  3. where the representations in paragraph (a) have been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representations have been published or are intended to be published by such parties, to advise those parties that the representations should be withdrawn.

Nurofen – Reckitt Benckiser (Australia) Pty Ltd – Complaints No. 2012-08-010 and 2012-10-024 | Therapeutic Goods Administration

As with their order in 2011, this order was issued with the condition that Reckitt Benckiser must notify the TGA within 10 working days that they’d comply with the order, and supply evidence of this compliance. There was also another condition, regarding how their Nurofen specific pain products must be advertised:

any representation that refers to two or more Nurofen products that contain equivalent quantities of ibuprofen and include the same product specific indications on the Australian Register of Therapeutic Goods must clearly indicate, in the body of the advertisement, that the two products can be used for the same purposes and are interchangeable (or words to that effect). An asterisk in the body of an advertisement with full detail explained elsewhere, for example in a footnote, will not be sufficient to satisfy this condition

Nurofen – Reckitt Benckiser (Australia) Pty Ltd – Complaints No. 2012-08-010 and 2012-10-024 | Therapeutic Goods Administration

On the 9th of May 2014, Reckitt Benckiser said they would comply with this order. But they didn’t. Which takes us to the legal action taken against them by the ACCC in March 2015…

That’s when the ACCC issued a press release saying they were taking Reckitt Benckiser to court:

The Australian Competition and Consumer Commission has instituted proceedings in the Federal Court of Australia against Reckitt Benckiser (Australia) Pty Ltd (Reckitt Benckiser), alleging that it made false or misleading claims that its Nurofen Specific Pain Products were each formulated to treat a specific kind of pain, when the products are identical.

ACCC targets alleged false and misleading Nurofen claims | Australian Competition & Consumer Commission

Today, the Federal Court of Australia has found in favour of the ACCC:

In proceedings commenced by the Australian Competition and Consumer Commission, the Federal Court has found that Reckitt Benckiser (Australia) Pty Ltd (Reckitt Benckiser) engaged in misleading conduct in contravention of the Australian Consumer Law by representing that its Nurofen Specific Pain products were each formulated to treat a specific type of pain, when the products are identical.

Court finds Nurofen made misleading Specific Pain claims | Australian Competition & Consumer Commission

Finally, four years after Professor Rolan’s original complaint and many more after Reckitt Benckiser first started marketing Nurofen as providing “targeted relief from pain”, they were found guilty in court of making misleading claims.

What does this mean for Australia?

The Federal Court’s ruling makes several orders of Reckitt Benckiser. It seems that we won’t see a repeat of Reckitt Benckiser’s 2012 behaviour, as the ACCC’s press release states that:

Reckitt Benckiser admitted that it had engaged in the contravening conduct and consented to the orders made by the Court.

Court finds Nurofen made misleading Specific Pain claims | Australian Competition & Consumer Commission

And what were those orders? They were much more extensive than those given by the TGA three years ago:

The Court ordered that Reckitt Benckiser remove the Nurofen Specific Pain products from retail shelves within 3 months. The court has also ordered that Reckitt Benckiser publish website and newspaper corrective notices, implement a consumer protection compliance program, and pay the ACCC’s [legal] costs.

The ACCC has agreed [on] an interim packaging arrangement with Reckitt Benckiser for use following the removal of these products. This will clearly disclose to consumers that the products are equally effective for other forms of pain.

Court finds Nurofen made misleading Specific Pain claims | Australian Competition & Consumer Commission

A later hearing will also determine what financial penalty will be imposed on Reckitt Benckiser.

What does this mean for New Zealand?

Immediately? Probably nothing. Particularly after seeing how keen Reckitt Benckiser was to avoid changing their marketing in 2011, I very much doubt they are going to change their New Zealand marketing because of an Australian court case.

However, as noted in articles from Pharmacy Today and Stuff today, the Commerce Commission is investigating Reckitt Benckiser in New Zealand for the same reasons. In a Stuff article from March, the Commerce Commission is quoted as saying they were “also looking into the matter and would be following the ACCC’s investigation closely”. So it may only be a matter of time before we see similar legal action against Reckitt Benckiser in New Zealand.

If we do see legal action though, I don’t expect it to be resolved quickly. Even in cases where it’s clear that marketing is misleading, it can take a long time for the Commerce Commission to make a difference. In the only direct experience I’ve had with them, they took two years to issue a warning about a very cut and dried case of misleading advertising from Baa Baa Beads, which had refused to remove misleading advertisements following upheld Advertising Standards Authority complaints.

In the meantime, the best way to protect yourself against misleading marketing is to educate yourself. Be sceptical. If you think a claim might not be true, don’t hesitate to ask for evidence.

What does it mean for consumers?

Not much. You should certainly be aware that Nurofen’s specific pain products are all identical. You can take Nurofen Migraine Pain for period pain, and it will be just as effective as Nurofen Period Pain. You shouldn’t, for example, take both the back pain and period pain products if you are experiencing both back pain and period pain.

You should also be aware that, despite the marketing, ibuprofen painkillers like Nurofen don’t target anything. If you were misled by this, it’s unlikely it caused you any harm, but you still have the right to make informed choices about your health. Harmless or otherwise, misleading marketing about healthcare products like Nurofen does violate this right.

But perhaps the most important message of all to take away has very little to do with Nurofen at all. Because ibuprofen, the active ingredient in Nurofen, is not patented. You can buy a generic ibuprofen painkiller that is equivalent to Nurofen for fraction of the price.

For example, you can buy 24 caplets of Nurofen Back Pain (active ingredient 342 mg ibuprofen lysine, equivalent to 200 mg ibuprofen) for $17.55 from Pharmacy Direct. Or, you could buy 24 “Home Brand” caplets of 200 mg ibuprofen for $2.99 from Countdown. Yes, the branded one does cost over five times as much as the unbranded one.

If you do want to buy Nurofen specifically, make sure you’re not paying more for the same product. When I compared prices for different Nurofen “specific pain” products on Pharmacy Direct last year, I found some were more expensive despite the pills themselves being identical.


As this article discusses specific brands of pharmaceutical products, I feel it is appropriate to state that I have no conflicts of interest to declare.

I have written about this issue previously here:

  1. The Price of Painkillers
  2. The Price of Painkillers Part 2: Only Misleading in Australia

Why Same-Sex Marriage Should Be Legal

The NZ Herald has published an article about the result of an unscientific internet poll on whether or not same-sex marriage should be legalised. Ignoring the obvious issues with lending credence to the results of a self-selecting internet poll, I’d like to focus on one quote from the article in particular:

Opponents of gay marriage say the jump shows people are waking up to the negative social effects of changing the Marriage Act.

In typical Herald style, no source is given for this assertion, but I’ll be nice and not dwell on that failure either.

What I’d like to talk about is that there are no “negative social effects” of allowing same-sex marriage. In fact, many states around the world have legalised same-sex marriage and the very fabric of their society disappointingly failed to unravel in the aftermath.

To the great surprise of homophobes everywhere the only effect of legalising same-sex marriage is same-sex couples getting married. Of course, this fact is conveniently ignored when the laws of their own country are being considered; they all seem to believe that their home is the one place that finally won’t be able to handle the unending horror of some other couples getting married while happening to not be of opposing sexes.


Of course, all of the arguments against allowing same-sex marriage fall flat pretty quickly.

The claim that marriage is somehow intended to be for procreation is bizarre considering that it’s obviously not immoral for infertile people to get married, and that having menopause before you have kids doesn’t mean you also have to have a divorce.

The claim that children need a mother and a father similarly falls flat when you observe not only that single parents are commonplace but that same-sex couples seem to do just fine as parents. For example, to quote a 2008 review by Charlotte J. Patterson published in the journal Child Development1:

To date, however, there is no evidence that the development of children with lesbian or gay parents is compromised in any significant respect relative to that among children of heterosexual parents in otherwise comparable circumstances.

Opponents of marriage equality often also argue that, if a child’s parents are gay, the child might also grow up to be gay. I’m tempted to look up the evidence to see whether or not this claim is true but to be honest I don’t think it matters. So what if legalising same-sex marriage makes being openly gay more common? It’s not as though it will eventually lead to everyone being gay, just like how opposite-sex marriage being legal hasn’t made everyone straight, so we hardly need to worry about humanity dying out because no one’s making babies any more.

The claim that legalising same-sex marriage has negative effects on society in general is pretty obviously untrue when you observe the countries that have legalised same-sex marriage. For example, take a look at Norway, Sweden, Iceland, Denmark, Spain, Canada, Netherlands, and Portugal. Despite having legalised same-sex marriage, these 8 countries (out of 11 which I believe have currently legalised same-sex marriage) are all in the top 20 of The Economist‘s 2005 Quality of Life Index2.

Sure, legalising same-sex marriage might piss off some homophobes, but’s that’s no more worth considering than the argument that apartheid shouldn’t have been abolished because it could piss off some racists.

Another common argument is that marriage has traditionally been defined as between a man and a woman so it can’t be changed because mumble mumble… This is quite simply trying to avoid thinking too much so you can maintain your unsupported biases. If an established idea is challenged you don’t get to ignore the challenge because the idea is already established. Instead you must re-evaluate the idea in light of the challenge in order to determine if it still appears to be worth supporting.

Ideas worth supporting must have more than just tradition to stand upon. Other traditional ideas about marriage, like a wife being her husband’s property and interracial marriage being prohibited and supposedly immoral, have previously been abandoned and now (rightly) seem abhorrent to modern society.

The typical fundamentalist rantings about homosexual behaviour being prohibited by their religious book are bizarre enough that I’d hope not to even have to bother responding to it, but I’m not quite naive enough to think that’s the case. In the words of Gregory House, “I don’t have time to talk you out of your religion”, so instead of bloating this post with anti-apologetics I’ll settle for thanking those bigots for making it so easy to point out that religion is not a reliable source of moral advice. For all I care a church can be as bigoted as it wants, but a secular government can’t.

One final argument, which I think is one that finally gets close to the real issue at hand, is that marriage is a religious institution, so it’s not a government’s business to mess with it. Honestly, I think this argument might have been enough one day, but not today. The reason it no longer holds water is that the premise on which it rests – that marriage is solely a religious institution – is no longer true. Marriage is a public service, provided by the government, and a secular government has no business telling its citizens they don’t have a right to a public service because they or their partner are the wrong sex. As I said earlier, for all I care a church can be as bigoted as it wants, but a secular government can’t.

If marriage were still solely a religious institution several aspects of modern society would be quite different. Surely people with no religion, such as myself, would not be allowed to get married. Also, a secular government would have no business giving special rights to married couples, as this would be discriminating based on religion. I also think that, were that the case, making civil unions available to all couples would be a valid approach for a government to provide equality. However, the fact that marriage is not solely a religious institution, but a social service, means this is not enough. “Separate but equal” is not equal.

It’s worth noting that, as a result of the select committee’s report, New Zealand’s Marriage Amendment Bill has been amended so that marriage celebrants will not have to conduct marriages of same-sex couples if it offends their religious sensibilities.


  1. http://onlinelibrary.wiley.com/doi/10.1111/j.1467-8624.1992.tb01679.x/abstract
  2. http://www.economist.com/media/pdf/QUALITY_OF_LIFE.pdf

How to Read Medical Advertisements

Lately, I have been familiarising myself with how medical advertisements are regulated here in New Zealand. In doing this, I have come to realise that regulatory bodies do not always interpret advertisements in the same way as I would expect the public to interpret them.

This sort of discrepancy can be, and frequently is, exploited by advertisers of medicine, both legitimate and less so. While it may be in the advertisers’ interest to have these differences in interpretation as it allows them to mislead the public about the effectiveness of their product, for the exact same reason it is not in the best interest of consumers.

In this article I describe how advertisers and regulators appear to interpret medical advertisements, and the implications of their interpretations. I hope that understanding this might enable others to understand what these ads are really saying. It is my sincere hope that, after reading this, you will never look at another medical advertisement in the same way again.


The first step I took in this project was familiarising myself with the codes of the Advertising Standards Authority (ASA), particularly those relating to therapeutic products and services. Their codes for weight management and ethics were also relevant. Based on these, I’ve submitted 11 complaints to the ASA since my first complaint last year, and I have more drafts that haven’t been submitted yet for various reasons.

As well as looking through the ASA’s codes, I’ve searched through previous decisions made by the Advertising Standards Complaints Board (ASCB) so I might better understand the codes’ application. The ASA website lets you search decisions from 2006 onwards, but older decisions can still be found by searching on Google within 203.152.114.11*.

If the ASCB decides to uphold a complaint, they request that the advertiser voluntarily withdraw the advertisement. As far as I am aware, it is at least very uncommon for an advertiser to refuse this request (the ASA website states that “This request is invariably followed.”) but the ASA does not have any actual legal authority with which they can enforce their decisions and they are unable to investigate breaches of the law as they only have jurisdiction over their codes.

When it comes to statutory regulation, Medsafe (part of the Ministry of Health) administers the Medicines Act 1981 and Medicines Regulations 1984, and the Commerce Commission enforces the Fair Trading Act 1986. For the most part, however, the advertising industry regulates itself via the ASA.


In reading past ASCB decisions about therapeutic advertising, I noticed that the ASCB frequently recommends the use of “TAPS”, the Therapeutic Products Pre-vetting System. Information on TAPS is available on the Association of New Zealand Advertisers (ANZA) website: TAPS.

Unfortunately, and somewhat counterintuitively, TAPS seems in practice to serve the opposite purpose of the ASA. The ASA and their codes mainly focus on protecting the consumer, particularly from misleading claims. In contrast, TAPS seems to focus on allowing advertisers to make whatever claims they want without running afoul of the ASA or the law. To see an example of this, see TAPS guideline 13, Examples of Health Claims in contrast to Therapeutic Claims Digestive System.

In this guideline, TAPS details the difference between a “therapeutic claim” and a “health claim”. “Health claims” are defined within this guideline as…

claims which support the normal physiological function.

“Therapeutic claim” essentially has 2 sets of definitions. One can be found within the ASA’s Therapeutic Products Advertising Code and the other in the Medicines Act 1981. The ASA defines “Therapeutic Use”, where a therapeutic claim is a claim for therapeutic use. Medicines Act defines “Therapeutic Purpose”, where a therapeutic claim is a claim for a therapeutic purpose. Both of these sets of definitions are fairly broad.

The ASA’s Therapeutic Products Advertising Code defines therapeutic use as…

Therapeutic use

  1. means use in or in connection with:
    1. preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in humans;
    2. influencing, inhibiting or modifying a physiological process in humans;
    3. testing the susceptibility of humans to a disease or ailment
    4. influencing, controlling or preventing conception in humans;
    5. testing for pregnancy in humans; or
    6. the replacement or modification of parts of the anatomy in humans; and
  2. includes any other use which the law provides shall be treated as a therapeutic use for the purposes of the code; but
  3. does not include any use which the laws provides shall not be treated as a therapeutic use for the purposes of this code.

The Medicines Act defines a therapeutic purpose as…

Meaning of therapeutic purpose
In this Act, unless the context otherwise requires, the term therapeutic purpose means—

  1. treating or preventing disease; or
  2. diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition; or
  3. effecting contraception; or
  4. inducing anaesthesia; or
  5. altering the shape, structure, size, or weight of the human body; or
  6. otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating or reducing or postponing, or increasing or accelerating, the operation of that function, or in any other way; or
  7. cleaning, soaking, or lubricating contact lenses.

TAPS guideline 1 – Therapeutic Claim/Purpose – has this to say about whether or not products are to be considered medicines:

Whilst natural, herbal, marine and dietary supplement products are not classified as medicines they would come under the Medicines Act for two reasons that might not be obvious. This means that certain herbal or dietary supplement products would be deemed to be a medicine for two reasons. This is because of a) a therapeutic claim as per the Medicines Act or b) the ingredients in the product which could be classified as a medicine under the Classification of Medicines

I’m not a lawyer, and in reading through the Medicines Act I haven’t been able to determine which section in particular causes this outcome. If anyone is able to shed any more light on this I’d be very grateful.

What I get from this, though, is that any advertisement that includes a therapeutic claim as defined in section 4 of the Medicines Act (quoted above) should be treated as a medical advertisement.

The guideline goes on to describe how advertisers can effectively circumvent this (emphasis mine):

a company may still advertise a product without getting consent [from the Minister of Health] and without a “therapeutic claim”. Essentially there is leeway for certain health or nutritional claims or statements relating to the normal physiological or biochemical function. This is covered generally by such statements as “assists or supports the normal physiological function”. Even terms like “enhancement” “fortify” and “improvement” would need to be used with care and would generally be a problem, as they imply an improvement or acceleration to the normal function. Often it is a simply a question of wording. For example, a statement such as “provides nutritional support for a healthy immune system” escapes therapeutic specificity whereas, “prevents, treats or cures flus or viruses” attracts liability and would be prohibited under the Medicines Act.

Here are some examples of “health claims” from TAPS guideline 13, which it claims “would not breach the Medicines Act”:

Aids healthy digestion

Helps restore normal bowel flora

Aids normal bowel function

According to TAPS, at least, none of the above claims would qualify for a therapeutic claim. This means that they would be considered to not require substantiation. For this reason, it is of the utmost importance for consumers to be able to distinguish between a therapeutic claim and a health claim. Therapeutic claims in advertising are required both by law and by industry regulations to be substantiated, whereas it seems health claims may be freely made without any supporting evidence whatsoever.


TAPS approval for an advertisement is something that the ASCB considers when an advertisement has been complained about, but it is not enough to prevent a complaint from being upheld. Here are some examples of previous ASCB decisions in which a complaint was upheld due to a breach of the Therapeutic Products Advertising Code despite the advertisement having attained TAPS approval:

Given the recommendations in the TAPS guidelines, it should be reasonable to assume that any advertisement with TAPS approval which makes health claims instead of therapeutic claims does so because it would be unable to substantiate those claims if a complaint were submitted to the ASA. It’s also likely that any claims containing a modifier such as “may” or “could” will be similarly unsubstantiated.

Advertisements with TAPS approval may cite a TAPS approval number, but as far as I’ve been able to find this gives no more information than that the advertisement has been approved, as there is no publicly accessible database of TAPS approvals and their details that I have been able to find.


Many complaints have not been upheld by the ASCB because the advertiser successfully managing to convince them that no therapeutic claims were made, even though the advertisement contains content likely to be interpreted by the public as a therapeutic claim. For example, take this complaint: 07/113 – BioMag Television Advertisement, which was not upheld by the ASCB.

For those of you unfamiliar with this product, it’s a magnetic underlay for your bed that is apparently intended to relieve pain. Here are some statements from a Woolrest Biomag NZ representative in response to complaint 07/113:

I have never said “underlays increase circulation“, on television. In fact I haven’t mentioned the word circulation this year, and in previous years under TAPs [sic] guidance I have only ever spoken of “supporting circulation“.

The word arthritis has never been used in our TV ads, in fact we do not refer to any specific pain conditions and never have.

[The complainant] also alleges we say the BioMag relieves pain. This is wrong. We are always careful to say it “could” relieve pain, as indeed tens of thousands of our clients can attest.

This sort of behaviour is representative of advertisers of products like this when responding to ASA complaints. Typically, their defense relies on convincing the ASCB that their advertisement contains no therapeutic claims, as opposed to providing substantiation for the claims they’ve made. For another example, see complaint 12/393, which I’ve already mentioned in the list above as having been upheld despite TAPS approval. The advertiser’s response to this complaint rested on the argument that no therapeutic claims were contained within the advertisement. In this case, the ASCB disagreed and, as the claims had not been substantiated, the complaint was upheld.


There are 2 main ways in which advertisers avoid the use of therapeutic claims.

First, by making “health claims”, which sound like therapeutic claims but tend to be technically meaningless (what the TAPS guidelines have called “escaping therapeutic specificity”). For example, a claim that a product “supports normal immune function” sounds as though it means it supports or improves immune function, but the advertiser could defend the claim by saying that by specifying that it supports normal immune function it does not imply that any physiological process is affected and therefore does not constitute a therapeutic claim.

Second, by using language in such a way as to not make an “absolute” claim. Often this involves qualifiers such as “may” and “could”, but it can also include words that normally would seem to imply therapeutic claims to the public, such as “supports”. For example, the complaints board decided not to uphold complaint 12/402 based partly on this:

Turning to the other claim that “the base of apple cider vinegar … assists your body in breaking up the mucous associated with winter ills and chills” the Complaints Board said the word “assists” was not an absolute claim.


Because of this, when reading, watching, or listening to a medical advertisement it is important to do a few things to make sure you are not misinterpreting it:

  • Identify “health claims”, as opposed to “therapeutic claims”, and realise that they most likely have not been substantiated.
  • Interpret every positive claim in the most conservative way possible. For example, if a product “may reduce pain”, it probably means “may not reduce pain, and hasn’t been proven to reduce pain”.
  • Interpret everything literally. Exaggeration and “puffery” are typically not allowed in medical advertisements, so you shouldn’t need to worry about misinterpreting something in this way. For example, if a product “helps resist winter ills and chills”, this does not mean “helps resist colds and the flu”. This also means that “supporting normal function” does not mean “supporting function”, as “normal function” refers to function when not interfered with.

Expect advertisers to always put their best foot forwards. If they are allowed to say their product “relieves cold and flu symptoms” then that is what they will say. If they say something like “helps you overcome winter ills and chills naturally” instead, it’s likely because they are not allowed to make the former, more definite claim.


Here are 2 examples of advertisements that are misleading yet manage to escape regulation.

1. Eken power bands: Golf Centre | Your Chemist

ASA complaint 12/393, already mentioned twice above, was upheld because an advertisement for this product implied unsubstantiated therapeutic claims:

Designed to assist with Strength, Balance, Flexibility, Endurance

Now that they cannot make such claims, the advertisements listed above instead simply list the same attributes without any description. It is still implied that the product is intended to improve the attributes, but not in such a way as a complaint would be likely to be upheld.

2. Detox foot patches: GrabOne

ASA complaint 12/502 was settled after someone complained that “the advertisement contained false and misleading claims that were not supported with evidence”. In response to this, the advertisers changed the advertisements so that the same false, misleading, and unsupported claims are still implied but are not made in such a way as to make a complaint likely to be upheld.

Note that this advertisement has a TAPS approval number. Instead of acting in the public’s interest by not allowing the advertiser to make false claims, they have helped them to make the same claims in such a way as the public will interpret them as claims and the regulators will not, effectively allowing them to escape regulation.


Finally, remember that not every advertisement is in line with the ASA’s codes and the relevant legislation. If you think an advertisement makes a therapeutic claim that is not valid and/or has not been substantiated, I encourage you to research it further and, if it appears your concerns are warranted, submit a complaint to the ASCB. Unsubstantiated therapeutic claims are in breach of the ASA’s Therapeutic Products Advertising Code principle 2.


*I have set up a search engine for this within my installation of Google Chrome, so I can search previous ASA decisions by entering “ASA ” into Chrome’s Omnibar on my computer. To do this yourself, click “Manage Search Engines…” inside Chrome’s Settings, scroll down and enter the following details to create a new search engine:

  1. ASA Complaints
  2. asa
  3. https://www.google.com/search?q=site%3A203.152.114.11+%s

Now, for example, if you want to search for “homeopathy” within previous ASA decisions you would just need to type “asa homeopathy” into Chrome’s omnibar and it will find all decisions containing the term “homeopathy”, including those from before 2006 like this decision from 2003.