Can you trust Band-Aids?

Can you trust Band-Aids?

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

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

Specifically, they say it will heal twice as fast:

Band-Aid packaging, front and back.

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

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

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

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

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

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

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

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

Kia ora,

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

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

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

Sincerely,

Mark Hanna
Chair, Society for Science Based Healthcare

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

Dear Mr Hanna,

Re: Band-Aid® Brand Adhesive Bandages

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

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

Thank you for your enquiry.

Yours sincerely,

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

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

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

Sincerely,

Mark Hanna
Chair, Society for Science Based Healthcare

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

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

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

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

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

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

ASA Complaint 17/185

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

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

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

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

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

And if no one complains, nothing happens.

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

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Pharmacy ethics: Have your say

Pharmacy ethics: Have your say

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

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

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

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

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

    1. Do you think the term “patient” is the best word to use, most of the time, to express the relationship that exits between the pharmacist and the person they are directly or indirectly caring for or providing health care information to?
    2. Are there any specific clauses where you can think of different term that could be more appropriate?
  3. Considering the new clauses that relate to the sale of complementary and alternative medicines (CAM, clauses 1g, 4h and 4hh): Do you find it clear that the Council is not opposed to the sale of CAM when they have demonstrated benefits for patients, have minimal risks, and the patient is making an informed choice?
  4. Are there any other comments you would like the Council to consider?

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

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

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

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

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

State-Approved Health Fraud Scams

State-Approved Health Fraud Scams

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

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

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

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

Health Fraud Scams – US Food & Drug Administration

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

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

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


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

Support for a healthy heart.

Maintains joint health.

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

Wink wink, nudge nudge.

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

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

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

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

And so are the ASA’s requirements:

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

Therapeutic and Health Advertising Code – Advertising Standards Authority

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

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

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

Weleda New Zealand

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

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

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

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

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

Weleda New Zealand

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

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

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

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

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

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

Medsafe

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

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

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

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

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

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

Medsafe

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

So what is there to be done about it?


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

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

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

Weleda New Zealand

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

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

Weleda New Zealand

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

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

Medsafe

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

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

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

Advertising Standards Authority


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

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

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

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

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

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

$26m for Acupuncture

$26m for Acupuncture

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

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

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

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

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

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

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

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

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

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

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


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

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

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

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

Response to Mark Hanna (19 April 2016) | ACC

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

Misleading claims common among chiropractors

Misleading claims common among chiropractors

Most New Zealand chiropractors make misleading claims.

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

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

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

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

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

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

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

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

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

Statement on advertising | Chiropractic Board of Australia

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

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

A chiropractor shall not advertise any material which relates to the chiropractor’s qualifications, practices, treatment or the premises where they practice chiropractic if the material… uses testimonials whether from patients or any other person

Advertising Policy | New Zealand Chiropractic Board

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

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

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

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

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

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

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