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.

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

Pharmacists Don’t Want to Sell Unproven Products

Pharmacists Don’t Want to Sell Unproven Products

The Pharmaceutical Society doesn’t think pharmacists should be able to sell healthcare products with no evidence of efficacy.

Last week I wrote about the Pharmacy Council’s proposal to change their Code of Ethics, and summarised the submissions that I was aware of. One important organisation that was missing from that roundup is the Pharmaceutical Society.

The Pharmaceutical Society is a professional association representing New Zealand pharmacists. Given their important position in the pharmacy industry, I think their submission might arguably be the most important. Earlier this week I spoke with Bob Buckham, Chief Pharmacist Advisor at the Pharmaceutical Society, about their submission on the Pharmacy Council’s proposal.

The Pharmaceutical Society does not support the proposed change. Coming from the perspective of pharmacists, their submission also raised two important points around this issue:

  • Pharmacists need clarity: what behaviour is consistent with the Code of Ethics, and what is not?
  • The Code of Ethics is important and cannot be ignored. The Pharmacy Council must be willing to provide guidance and to enforce the code.

The reason why the Pharmaceutical Society does not support this change is similar to the reasons given by other organisations, in that it would implement a double standard:

The Society does not support the proposed supplementary wording in obligation 6.9 as the split wording in the two parts separates the therapy terms “medicine or herbal remedy” in 6.9a from “complementary therapy or other healthcare product” in 6.9b. The result is that the subsequent obligation attached to those therapies does not apply to the other.

To clarify further, “credible evidence of efficacy” is only required when supplying or promoting a “medicine or herbal remedy” (Obligation 6.9a) and “no reason to doubt… quality or safety and when sufficient information about the product can be provided” only applies to “any complementary therapy or other healthcare product.

The Society considers that the obligations of “credible evidence of efficacy” and no reason “to doubt… quality or safety” should apply to the supply or promotion of all therapies and products – ie. any medicine, herbal remedy AND any complementary therapy or other healthcare product.

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

Like other submissions, the Pharmaceutical Society does support the addition of a new clause about providing sufficient information for patients to make informed choices. However, they also made a similar suggestion to one in the Society for Science Based Healthcare’s submission in that the wording of this clause should be strengthened:

The Society also considers that “sufficient information about the product” must be provided in order for purchasers to make an informed choice with respect to efficacy of that product and the risks and benefits of that against other treatment options.

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

Aside from their comments on the new proposed wording, the Pharmaceutical Society raised concerns about the application of this section of the Code of Ethics. Part of their submission focussed on pharmacists’ responsibility to comply with the Code of Ethics:

Pharmacists must comply with the Code of Ethics
The Council have stated that it is not the purpose of the Code, or the Council, to endorse or prohibit the supply of any particularly complementary and/or alternative medicine, product, or practice. However, as the responsible authority for pharmacy under the Health Practitioners Competence Assurance Act 2003, standards of ethical conduct set by the Council must be observed by pharmacists. Indeed, in the Code of Ethics the Council requires that pharmacists must comply with “all the implied requirements of ethical practice” within the Code.

The Medicines Regulations 1984 (in Schedule 2 related to applications for a licence to operate a pharmacy) also refers to how pharmacists being employed or engaged in duties in a pharmacy are

not requested or required to act in a way that is inconsistent with the applicable professional or ethical standards of the pharmacy practice

Therefore, the obligations within the Code of Ethics must be interpreted clearly so that pharmacists have a clear understanding of what is considered ethical practice, but also so that the Council can investigate and act upon breaches of the Code.

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

This call for clarity has been a common theme among submissions. Both the NZ Skeptics’ submission and Dr Ben Albert’s submission called for guidelines on product categories that should not be sold in pharmacies due to a lack of evidence. Also, when the Society for Science Based Healthcare complained to the Pharmacy Council last year, one of the recommendations made was to for the Pharmacy Council provide guidance on this issue:

As a result of this complaint, we want pharmacists to have the opportunity to do the right thing and fulfill their ethical obligations. In order to achieve this, we suggest that the Pharmacy Council consider the following courses of action:

  1. To assist pharmacies in evaluating whether or not a healthcare product is supported by credible evidence of efficacy, the Pharmacy Council should develop and publish guidelines regarding what constitutes credible evidence of efficacy. This need not be a strict requirement so much as a useful guide that pharmacists can use to establish a consistent minimum standard of evidence.

NaturoPharm Wartoff Complaint (Society for Science Based Healthcare)

If it’s unclear where the line is drawn with regard to “credible evidence of efficacy”, it makes it more difficult for pharmacists to practice ethically. The Pharmaceutical Society’s submission raises questions about where this line might be drawn regarding alternative healthcare products, and talks about how the Code will be applied in practice:

Definition and interpretation of obligations
The wording of the proposed obligations 6.9a and 6.9b make reference to “credible evidence of efficacy” and “quality and safety”. Therefore, if presented with a complaint against a pharmacist claimed to be in breach of the obligations within the Code of Ethics, the Council is expected to determine what is “credible evidence of efficacy” and/or “quality or safety”.

The Society recognises that the application of a principles-based Code of Ethics to individual scenarios or circumstances is open to interpretation and challenge. Such scenarios are often not “black and white”, but “shades of grey” where a group of peers may have differing opinions to the acceptability or otherwise of a particular practice. It is expected that such “shades of grey” will always exist in pharmacy practice, as indeed it does in medicine and other areas of professional practice. However where a particular practice is determined to be unethical or unacceptably, this must be made clear. This is a difficulty faced when considering the evidence and use of complementary treatments against regulated medicines.

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

The submission goes on to compare “natural” or herbal healthcare products with homeopathic products, in terms of plausibility:

Complementary/alternative medicine: natural/herbal remedies
The Society recognises the history of pharmaceuticals, and indeed of the pharmacy profession, where the first “medicines” were derived from natural products. Many of these have been purified, refined and further manipulated in the development of modern day pharmaceutics. Much of modern pharmaceutical research continues to analyse the therapeutic potential of compounds found naturally occurring substances derived from flora and fauna. We recognise how the levels of evidence of the therapeutic benefits (or otherwise) of natural products can vary markedly, but understand the science behind their potential mechanisms of action has the same pharmacological basis and pharmaceuticals.

Homeopathy
We note the Council’s own ‘Complementary and alternative medicines – best practice guidance for pharmacists’ document makes reference to the Natural Health and Supplementary Products Bill which states:

currently there is no accepted scientific evidence for the effectiveness of homeopathy and therefore that health benefit claims should not be made for homeopathic products

This aligns with further documents and statements issued internationally, including the Australian National Health and Medical Research Council (NHMRC)(1), the Cochrane Library and others have noted homeopathic products show no effects beyond placebo. A large number of government committees, professional pharmacy and medical organisations internationally have issued statements reinforcing this lack of effectiveness of homeopathy in treating health conditions. The Pharmaceutical Society of New Zealand does not at this time have a position statement on complementary medicines or homeopathy.

Homeopathy is not herbalism, and homeopathic science is not consistent with currently accepted medical and pharmacological science. Some pharmacists, and indeed other health professions, have argued for the role of homeopathy as a valid form of treatment to meed patient demand, while acknowledging any “benefit” is achieved through a placebo effect, while not necessarily agreeing with the purported science behind homeopathic practice.

The question for the Council must then be whether it is considered ethical practice for pharmacists to charge a fee for products for which there is no accepted scientific evidence for effectiveness; OR for which they acknowledge a lack of evidence yet sell for the purposes of providing a placebo effect.

(1) National Health and Medical Research Council of Australia (NHMRC). NHMRC Information Paper: Evidence on the effectiveness of homeopathy for treating health conditions [Internet]. Canberra: National Health and Medical Research Council; 2015. Available from: https://www.nhmrc.gov.au/guidelines-publications/cam02

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

The Pharmaceutical Society also noted something that was raised in a few other submissions; when pharmacies sell ineffective products they lend them the credibility of their profession, which can inadvertently lead to patients being misled about their efficacy.

While we again note that the Council have expressed that it’s not their purpose or the purpose of the Code of Ethics to “endorse any particular complementary or alternative medicine or practice”, in setting the requirements for pharmacists to conform with obligation 6.9 (or 6.9a and 6.9b), the Council must determine whether the practice of homeopathy is consistent with the Code. Particularly when having homeopathic products available alongside pharmaceutical medicines, or indeed herbal/complementary medicines with their varied levels of evidence, potentially implies clinical benefit by association and provision through a respected and regulated health professional.

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

I’ve not yet been made aware of any other submissions that have been made to the Pharmacy Council, but I imagine a number of individuals at least will have made submissions that have not been publicised. As it stands though, the Pharmacy Council’s proposal seems to have strong opposition from all sides, with the only significant support I have seen so far coming from the Pharmacy Guild, who represent only those pharmacists who own their own pharmacies.

It seems no group other than pharmacy owners wants to keep the status quo of pharmacies selling ineffective products without consequences.

Pharmacy Council’s Code of Ethics Proposal: Submissions Roundup

Pharmacy Council’s Code of Ethics Proposal: Submissions Roundup

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

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

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

6.9
Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.

Safe Effective Pharmacy Practice Code of Ethics 2011 (Pharmacy Council)

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

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

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

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


The Society for Science Based Healthcare

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


The NZ Skeptics

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

As a result of this complaint, we want pharmacists to have the opportunity to do the right thing and fulfill their ethical obligations. In order to achieve this, we suggest that the Pharmacy Council consider the following courses of action:

  1. To assist pharmacies in evaluating whether or not a healthcare product is supported by credible evidence of efficacy, the Pharmacy Council should develop and publish guidelines regarding what constitutes credible evidence of efficacy. This need not be a strict requirement so much as a useful guide that pharmacists can use to establish a consistent minimum standard of evidence.

NaturoPharm Wartoff Complaint (Society for Science Based Healthcare)

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

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

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

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

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

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

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

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

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

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

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

Pharmacists support patient choice with homeopathy (Pharmacy Today)

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


Ben Albert et al.

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

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

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

The specific recommendations made in their submission are:

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

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

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

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

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

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

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

the current code should be enforced, not amended.

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

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

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

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

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

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

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

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

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

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

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

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

Dr Ben Albert


The New Zealand Medical Association

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

The NZMA is strongly opposed to the above proposed change

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


The Pharmacy Guild

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

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

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

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

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

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


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

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

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

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