Category: Australia

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.

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

Ethical Pharmacy Practice 4: Paving the Way

This year has not been a good year for homeopathy. There have been many blows to the industry in the form of more research finding it ineffective, position statements from organisations of health practitioners discouraging its use, and successful complaints to regulatory authorities. And this trend shows no signs of abating.

In March, the Australian National Health and Medical Research Council (NHMRC) published their Statement on Homeopathy, following a rigorous review of the evidence encompassing over 50 systematic reviews. The conclusion was clear:

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

Statement on Homeopathy – National Health and Medical Research Council (Australia)

Most organisations of medical professionals have codes of ethics that make it clear prescribing or selling treatments which are not supported by evidence is unethical. Putting two and two together, these ethical standards and the clear findings of the NHMRC have prompted the Royal Australian College of General Practitioners (RACGP) to publish a position statement on homeopathy:

The RACGP supports the use of evidence-based medicine, in which current research information is used as the basis for clinical decision-making.

In light of strong evidence to confirm that homeopathy has no effect beyond that of placebo as a treatment for various clinical conditions, the position of the RACGP is:

  1. Medical practitioners should not practice homeopathy, refer patients to homeopathic practitioners, or recommend homeopathic products to their patients.
  2. Pharmacists should not sell, recommend, or support the use of homeopathic products.
  3. Homeopathic alternatives should not be used in place of conventional immunisation.
  4. Private health insurers should not supply rebates for or otherwise support homeopathic services or products

Position statement: homeopathy – Royal Australian College of General Practitioners

Following this, in an interview with Radio New Zealand the chair of the New Zealand Medical Association (NZMA), Dr Stephen Child, made the NZMA’s position clear:

Susie Ferguson: So Australian doctors being told not to be prescribing this, and they should come off the shelves as well so people couldn’t even buy them over the counter. Would you support that happening here?

Dr Stephen Child: Well yes, it’s an ineffective treatment. It’s basically giving a glass of water or a sugar pill to patients, and I think you would consider that unethical if I gave you a sugar pill and charged you eighty dollars for that.

Doctors Told to Stop Prescribing Homeopathic Products – Radio NZ

Homeopathy has never been supported by evidence, but the recent findings from the NHMRC have strengthened the scientific consensus and allowed many organisations to take a stronger stance against it.

When there is also a clear ethical mandate not to promote or provide healthcare that is not supported by evidence, all it takes to put two and two together is a little courage.

Now, Kingsley Village Pharmacy in Australia is paving the way, stating that their “Homeopathic products [are] going in the bin”:

The owner of Kingsley Village Pharmacy, pharmacist Grant McGill, has explained why he made this decision:

I’ve never promoted or recommended these products but I’ve accepted them passively and I felt a bit hypocritical having them on the shelves.

I operate a bit differently to corporate chains and believe a pharmacy should be professional rather than a place selling a lot of cosmetics.

If someone comes in with sleep problems, I will look at what is known to help and address things like sleep hygiene issues, rather than recommending flower essences.

Pharmacist bins ‘crap’ homeopathic products – The West Australian

When the Twitter account for the pharmacy was asked if they thought their customers would notice or care about the change, they said:

A tweet from Grant McGill echoed the same sentiment as the reason for this change:

Through the Society for Science Based Healthcare, I have called previously for New Zealand pharmacists to stop selling homeopathic products.

When I had an complaint upheld against an Auckland Pharmacy for a misleading display stand for the homeopathic product No-Jet-Lag, that pharmacy promised to remove the product from sale and I hoped that New Zealand pharmacists would follow their example.

But it isn’t feasible for me to complain about each and every homeopathic product sold in a New Zealand pharmacy (although that hasn’t stopped me complaining about some). New Zealand pharmacists need to follow Kingsley Village Pharmacy’s example and remove the products not because complaints have been upheld, but because there’s no evidence they work so it’s clearly the ethical thing to do.

The Pharmacy Council of New Zealand is the body legally responsible under the Health Practitioners Competence Assurance Act for setting standards of ethical conduct to be observed by pharmacists on this side of the Tasman. To this end, they have published a Safe Effective Pharmacy Practice Code of Ethics. Section 6.9 of this code is very clear when it comes to pharmacists’ ethical responsibilities surrounding evidence-based healthcare:

YOU MUST:… 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 – Pharmacy Council of New Zealand

Despite this, as mentioned in the Radio New Zealand interview with Dr Stephen Child from the NZMA, “In New Zealand, many pharmacies stock a range of homeopathic treatments”. When New Zealand pharmacists have been challenged on this point, their defences have ranged from bizarre misunderstandings of the evidence (e.g. “Auckland pharmacist Martin Harris says there is good evidence for homeopathy in the field of quantum physics”) to arguments that patient choice overrides their ethical responsibility:

But homeopathy is part of a holistic approach to healthcare, according to Auckland pharmacist Caleb Townsend, whose Lincoln Mall Pharmacy has qualified homeopaths onsite.

There is not one system that suits all people, Mr Townsend says in an email.

“Homeopathy is seen at this pharmacy as complementary to conventional medicine, in much the same way as acupuncture, vitamins and herbs are.”

Many patients believe homeopathy has been of benefit and they should be given the freedom to choose it if they want, he says.

“We have not yet become a society where cultural beliefs are legislated out of existence.”

Pharmacists Support Patient Choice with Homeopathy – Pharmacy Today

Dr Child provided a response to this line of argument in his interview:

Well, again as I say they argue that it’s mainly free trade basically, or a free market, so if people are willing to pay the money, and they think it works, then what are they doing that’s wrong?

And my problem with that argument though is to say that if they are telling the patient that it works then they are misleading in their advertising and even the Consumer Guarantee Act that it’s not allowed to mislead the consumer.

Second of all there’s an imbalance of a relationship when you come in to see a health practitioner and you’re the patient.

And thirdly when you’re suffering and you’re unwell you’re possibly not in a position to make an informed, balanced decision as a consumer. So I’m not even sure the free market argument would suggest that it would be legitimate practice.

Dr Stephen Child, Doctors Told to Stop Prescribing Homeopathic Products – Radio NZ

The Society for Science Based Healthcare has also been in touch with Green Cross Health, an umbrella organisation that owns brands such as Unichem and Life Pharmacy and represents over 300 New Zealand pharmacies, to ask if they have a commitment to uphold section 6.9 of the Pharmacy Council’s code of ethics. Despite following up multiple times, the closest thing to a direct answer Green Cross Health has given to this question is:

While we support best practice we are also supportive of consumer choice.

Green Cross Health

The remaining defence of this practice is that pharmacists do more than provide healthcare, they also have to run a business. Following his Radio NZ interview, Dr Child alluded to this in an article from Pharmacy Today following his Radio NZ interview:

“Medically, it’s unethical to provide a treatment that’s not proven,” Dr Child says.

However, he has stopped short of telling pharmacies not to sell homeopathic products.

“It’s not really appropriate, I believe, for the medical profession to tell pharmacies how to run their business and how to act.”

Pharmacies have a difficult balance between providing healthcare and running a business, Dr Child says.

“It must be very difficult because they are a business as well.”

Homeopathy discredited again on both sides of the Tasman – Pharmacy Today

There is a range of behaviours among New Zealand pharmacies when it comes to promotion of homeopathy. Some few pharmacists refuse to sell the products at all, whereas many stock them but might not actively promote or recommend them. On the extreme end of this ethical scale, there are pharmacies like Lincoln Mall Pharmacy in Auckland, which promotes “homeopathic consultations” from homeopaths within the pharmacy, and Simillimum Pharmacy in Wellington, which describes itself as a “homeopathic pharmacy”.

The fact that there are some pharmacists who operate without relying on profits from selling homeopathic products indicates that it is entirely possible. Those pharmacists who passively sell them likely don’t rely on the profits made from those products as the difference between financial success and failure, so I’d hope they wouldn’t use higher profits as a justification for breaching their ethical obligations.

If any pharmacy has got to the level where their business would fail financially were it not for homeopathic products and services that they sell, then their business practices would blatantly violate their ethical responsibilities. I should think the risk of financial failure in a case like this should certainly not be an acceptable excuse for such unethical conduct.

Kingsley Village Pharmacy in Australia has set a great example for all pharmacists, having the courage to take a stand on ethics and stop selling homeopathic products. New Zealand pharmacists who currently have them on their shelves should follow in these footsteps.

To borrow Grant McGill’s words, pharmacists need to stand up for patient outcomes.

Ethical Pharmacy Practice 3: Running Out of Excuses

Ethical pharmacy practice is something I have written about before. If you’ve read those posts, please bear with me as I cover some familiar background.

In New Zealand, we are lucky enough to have an industry code of ethics for pharmacists, published by the Pharmacy Council of New Zealand, which holds pharmacists to high ethical standards. This code of ethics is the Safe Effective Pharmacy Practice Code of Ethics. One of the most important parts of this code of ethics is section 6.9, which states:

[PHARMACISTS] MUST:… 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.

Pharmacy Council’s Safe Effective Pharmacy Practice Code of Ethics Section 6.9

The Pharmacy Council of New Zealand isn’t a voluntary member organisation like the Pharmacy Guild or the Pharmaceutical Society. Instead the council is established as part of the Health Practitioners Competence Assurance Act 2003. Their roles are set out in this act and include:

  • Registering pharmacists
  • Reviewing and maintaining the competence of pharmacists
  • Setting standards of clinical competence, cultural competence, and ethical conduct for pharmacists

Which means that the Safe Effective Pharmacy Practice Code of Ethics is not a voluntary code of ethics. It is published by the body whose legal duty it is to set the standards of ethical conduct for pharmacists. Yet all over New Zealand, many pharmacists ignore it.

Walk into any New Zealand pharmacy. Chances are that you will find a section where they advertise and sell a range of homeopathic products. To anyone familiar with the evidence for homeopathy, it will come as no surprise when I tell you that there is no credible evidence of efficacy for any homeopathic product. Therefore, it seems to me, New Zealand pharmacists have an ethical obligation not to promote or sell them.

Yesterday, the Australian National Health and Medical Research Council (NHMRC) issued their final statement on homeopathy, following an incredibly extensive and rigorous review of the literature. They looked at over 1,800 scientific papers, and found that 225 met their criteria for methodological rigour, sample size, and placebo control. Their main finding was:

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

NHMRC Statement: Statement on Homeopathy

As I said, this conclusion does not come as a surprise. This research is the latest in a long line of reviews of the evidence for homeopathy that drew essentially the same finding:

  • A 2002 systematic review of systematic reviews of homeopathy published in the British Journal of Clinical Pharmacology concluded that:

    the hypothesis that any given homeopathic remedy leads to clinical effects that are relevantly different from placebo or superior to other control interventions for any medical condition, is not supported by evidence from systematic reviews. Until more compelling results are available, homeopathy cannot be viewed as an evidence-based form of therapy.

    A systematic review of systematic reviews of homeopathy

  • A 2010 systematic review of systematic reviews of homeopathy published in the Medical Journal of Australia concluded:

    The findings of currently available Cochrane reviews of studies of homeopathy do not show that homeopathic medicines have effects beyond placebo.

    Homeopathy: what does the “best” evidence tell us?

  • A 2010 report from the UK House of Commons concluded:

    homeopathy is a placebo treatment.

    Evidence Check 2: Homeopathy

  • In 2013, the NHMRC published a report based on their research that found:

    There is a paucity of good-quality studies of sufficient size that examine the effectiveness of homeopathy as a treatment for any clinical condition in humans. The available evidence is not compelling and fails to demonstrate that homeopathy is an effective treatment for any of the reported clinical conditions in humans.

    Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence

I could go on, but I hope by now you get the idea.

New Zealand pharmacists need to respond to the NHMRC’s research. And if they mean to practice responsibly and ethically, that response should be to immediately stop all promotion and sale of homeopathic products. The ethical standard to which they should be held is clear, and it is not consistent with promoting or supplying homeopathic products.

Last year, I complained to the Advertising Standards Authority under the auspices of the Society for Science Based Healthcare about a homeopathic product for preventing jet lag (No-Jet-Lag) that was advertised in Parnell Pharmacy. The pharmacy responded by removing the advertisement, and agreeing to stop selling the product if it was found that the claims were not supported by credible evidence, and my complaint was upheld. Unsurprisingly, my complaint was upheld when the ASA decided claims such as “it really works” were not supported by credible evidence. However, despite Parnell Pharmacy’s example, many New Zealand pharmacies still sell this exact product.

The NHMRC’s report represents the same finding, but on a larger scale. New Zealand pharmacists who promote and sell homeopathic products should follow the responsible example of Parnell Pharmacy, and remove homeopathic products from their shelves.

The Price of Painkillers Part 2: Only Misleading in Australia

Yesterday, I wrote about how various painkillers with the same active ingredients often cost different amounts. In particular I talked about Reckitt Benckiser’s “Nurofen” ibuprofen products, some of which are advertised as targeting specific types of pain even though it doesn’t seem plausible, given that they are essentially exactly the same, that they could target different types or sources of pain.

There are a few aspects of their advertising that I think gives this impression. For one, they have products that seem intended for specific types of pain that have names like “Nurofen Migraine Pain” and “Nurofen Back Pain”. For another example, if you look on their website you’ll see that the claim “Targeted relief from pain” is pretty prominently displayed alongside their logo in the upper left hand corner:

Nurofen

The packaging of their products repeats this claim, also pretty prominently:

ibuprofen lysine 342 mg (equiv. ibuprofen 200 mg)

In 2011 Professor Paul Rolan*, head of the medical school at the University of Adelaide, laid a complaint with the Therapeutic Goods Administration (TGA) regarding a TV advertisement for Nurofen as a treatment for headaches regarding this claim. The TGA is roughly Australia’s equivalent of New Zealand’s Medsafe, as they are responsible for the regulation of therapeutic goods.

For some reason (I’m assuming it’s a bug, and have emailed them about it), although the decision is still listed on the TGA’s Complaints Resolution Panel’s website, its full details aren’t currently available. However, they have been archived in full elsewhere. The thrust of the complaint was that:

The complainant accepted that the advertised product “is undoubtedly effective” as a treatment for headache, but argued that “it works by being absorbed in the blood stream and being distributed widely around the body, not only to where it is needed but to everywhere else as well”, and that “there is no ‘targeting’ to the head and hence the phrases ‘targeted pain relief’ on the packet and the claim made in the advertisement ‘goes straight to the source of the pain’ are factually incorrect and misleading”.

The relevant section of the Therapeutic Goods Advertising Code was section 4(2)(c), which states that:

An advertisement for therapeutic goods must not… mislead, or be likely to mislead, directly or by implication or through emphasis, comparisons, contrasts or omissions

Reckitt Benckiser’s response was basically that they weren’t being misleading because anyone seeing their advertisements would realise that when they say Nurofen “goes straight to the source of pain”…

an ordinary and reasonable person viewing the advertisement would interpret it as conveying “that Nurofen goes to and acts at the source of the pain associated with a headache, namely where the headache is located in the head” and not “that Nurofen will only go to and act at the source of the pain.”

I don’t find myself convinced by this rebuttal. It seems analogous (if you’ll pardon the violent example) to saying a bomb targets a single person, but that’s not misleading just because it also happens to destroy everyone nearby as well.

You can read the full findings of the panel yourself at the link above, but for a synopsis they essentially agreed with Professor Rolan in that:

26. The Panel did not accept that, in being dispersed throughout the body, the advertised product could reasonably be said to “target” or “go straight to the source of” headache pain or the site of a headache.

They also found Reckitt Benckiser’s rebuttal unconvincing:

28. The Panel noted that the advertiser had argued that consumers were generally well aware that Nurofen was suitable for many types of pain. On this basis, the advertiser argued that consumers would not interpret the advertisement as conveying a “targeted” action in the sense alleged by the complainant.

29. The Panel did not accept this argument. While the Panel accepted that consumers might generally be aware that Nurofen is suitable for many types of pain, this does not mean that a reasonable consumer would be aware that Nurofen is normally distributed throughout the body when taken. The Panel was satisfied that a reasonable consumer, noting the references to “targeted relief of pain” and “going… to the source of pain”, would conclude that the active components of the product travelled specifically to areas of the body affected by pain – in this instance, the part of the head affected by a headache. The reasonable consumer would also conclude that the active components of the product would not travel elsewhere throughout the body to any significant degree. The Panel noted that although the advertisement did not state exactly how Nurofen might physically concentrate in areas of the body affected by pain and target them, it did convey that Nurofen would do so. That Nurofen might also be understood to be beneficial for other types of pain did not alter this, because in such cases Nurofen would again be understood to concentrate at the site of pain.

As a result, Reckitt Benckiser was told to stop that particular advertisement and to not make the same representations in other advertisements. Of course, this only applies in Australia; to my knowledge Reckitt Benckiser hasn’t changed their advertising strategy here in New Zealand. As far as I know, it also hasn’t been challenged here.

I’m reminded of another case of what I consider to be misleading advertising from a pharmaceutical company that I’ve written about previously. When GlaxoSmithKline has advertised their “Panadol Extra” product, they have claimed it is “37% more powerful than standard paracetamol tablets”. The catch is that, when they say “more powerful”, they’re referring to potency, not efficacy, so instead of meaning the pills give 37% more powerful pain relief it means you can take 37% less Panadol Extra to get the same amount of pain relief. This might be difficult, however, considering that a single Panadol Extra pill contains exactly the same amount of paracetamol as a standard paracetamol tablet – 500 mg.

* Professor Rolan is also a member of Friends of Science in Medicine, a great Australian organisation dedicated to promoting science and fighting pseudoscience in the medical field. They do some great work across the ditch; I’m a member and I think they deserve your support as well.

ASA Complaints: Niagara Healthcare

In September, I found an A4 insert in the New Zealand Herald advertising for Niagara Healthcare. A big red heading: “Arthritic Relief?” caught my attention, and when I looked a little closer I found it accompanied by some big red flags. This advertisement for a “FREE TREATMENT” that seemed like it could relieve practically any type of pain, as well as several other ailments, looked a little too good to be true, and experience has taught me that when something looks too good to be true, it probably is.

My first response to this advertisement was to look for any research I could find corroborating its claims. This took me to the Niagara Healthcare website for New Zealand. They appear to be based in Australia, and have a separate but nearly identical website for their New Zealand branch. Their website’s key benefits page, which states that “Much research has been conducted on the physical benefits of Niagara’s Cycloid Vibration Therapy since 1954”, contained a convenient list of therapeutic claims for me to look at:

  • Increase local area blood flow
  • Assist in the reduction of musculoskeletal pain
  • Increase joint mobilisation
  • Reduce excess oedema (swelling) whether the cause is vascular or lymphatic
  • Assist in the treatment of wounds where an improvement in circulation is a factor
  • Assist in the treatment of pressure ulcers where and [sic] improvement in local circulation is a factor

The only study I was able to find (searching Google Scholar and PubMed) with the keywords “Cycloid Vibration Therapy” was a small uncontrolled preliminary study of 21 patients. That is nowhere near enough to substantiate a therapeutic claim. Luckily for me, there were also 4 other studies cited on the webpage.

I was able to find the full text of what I believed may be the first study mentioned. This study appeared to use a Niagara Healthcare product, Lymphease, but it was only a pilot study with a small sample size and no control group, not a clinical trial as claimed on the website, and therefore not rigorous enough to substantiate any therapeutic claims.

Interestingly, although this was not stated on Niagara Healthcare’s website, this study was funded by “Cyprossage Pty Ltd”, which holds the patent for the product used in the study. Both Cyprossage Pty Ltd and Niagara Healthcare are divisions of CT Healthcare Pty Ltd, and they share the same director, Anthony Thompson. Even if everything else in these advertisements checked out, this would violate the ASA’s Therapeutic Products Advertising Code Part B2 R4.3:

Publication of research results in an advertisement must identify the researcher and the financial sponsor of the research.

I was only able to find citations of the second and fourth studies, and only the abstract of the third study. As far as I was able to tell, the second and fourth studies were not clinical trials, and the third study did not adequately account for the placebo effect via its “no treatment” control group. These papers were also published in 1984, 1981, and 1961 respectively. Worryingly, the Australian version of this webpage describes those same studies as “recent”, despite the majority of them having been published years before I was born. If this was Niagara Healthcare putting their best foot forward, it wasn’t very impressive.

I was also able to find that the Advertising Standards Authority in the UK upheld a complaint against Niagara Healthcare in 2005, on the basis that the therapeutic claims they were making were not adequately substantiated. It looked like the evidence behind the advertisement didn’t live up to the claims, which was particularly worrying considering that the print advertisement claimed that the products had been “Medically proven for 60 years”, and had been approved by TAPS. The Therapeutic Advertising Pre-vetting System, TAPS, is a service provided by the Association of New Zealand Advertisers (ANZA) that is intended to help advertisers avoid publishing ads that violate the relevant codes and legislation.

The back of the print advertisement also contained a testimonial. I still don’t understand how a medical advertisement containing a testimonial could have been approved by TAPS, considering that the Medicines Act 1981 Section 58 subclause (1)(c)(iii) effectively prohibits all testimonials in medical advertisements:

no person shall publish, or cause or permit to be published, any medical advertisement that… directly or by implication claims, indicates, or suggests that… a medical device of the kind… advertised… has beneficially affected the health of a particular person or class of persons, whether named or unnamed, and whether real or fictitious, referred to in the advertisement

After finding how problematic these advertisements seemed to be, I laid a complaint with the Advertising Standards Authority. My complaint ended up being treated as two separate complaints: one for the print advertisement and a separate one for the website advertisement. On Friday, the ASA released their decision regarding both of these complaints. They were both upheld, meaning that the ASA has told Niagara Healthcare the advertisements must be removed. As I do with all my complaints, I have set up a monitoring service so I will be notified of any changes to the web advertisement. So far, the only change is that a note that the research they cite was funded by them has been added to their Key Benefits page.

I found the advertiser’s response to my complaints quite interesting and, I think, revealing. To start with, they claim that the printed material was published incorrectly, and contained obsolete material. This seems odd to me, considering that the ad had been approved by TAPS, which requires a fee, and stating that it contained obsolete material implies that the material was once correct, but this certainly does not seem to be the case.

In attempting to substantiate their therapeutic claims, it seems the advertiser provided a clinical evaluation performed by CT Healthcare, which it called “an Australian based manufacturer”. CT Healthcare is the parent company of both Niagara Healthcare and Cyprossage (the company that funded the small trial mentioned on the Niagara website). Here’s what the ASA had to say about that:

The Complaints Board also noted the substantiation provided by the Advertiser which was a “Report Review” on “Vibration Therapy.” It said while the Advertiser provided references on the subject and the claims were of a low level, the Complaints Board were of the view that it did not provide adequate substantiation particularly because the review was not conducted independently.

The advertiser also tried to substantiate their therapeutic claims by providing the ASA with certificates from the Australian Register of Therapeutic Goods (ARTG).

[The Advertising Standards Complaints Board] was of the view that the certificates provided were not categorical evaluations of the product, but rather they confirmed registration of the products.

As well as finding that the therapeutic claims made in their advertisements were not substantiated, the complaints board said that…

The Complaints Board agreed with the Complainant that the lack of the research listed under the heading “Medical Research”, its quality and the fact that some of it had been paid for by the Advertiser was not robust enough to support the statement “much research had been conducted on physical benefits of Niagara’s Cycloid Vibration Therapy since 1954” as the overall consumer takeout of that statement would be this meant 60 years of independent peer-reviewed medical studies which was not the case.

The most interesting part of this whole thing is, I think, the way in which the advertiser tried to defend their statement that their products have been “Medically proven for 60 years”. Here is how the advertiser tried to justify this statement:

However, to provide clarification regarding the statement on the advertisement Niagara devices have been proven for 60 years, this originates from the basis that CT Healthcare has been involved in medical research relating to the product since 1952.

The complaints board responded to this by stating that the words used in the advertisement simply did not mean what the advertisers claim they meant, and therefore exploited consumers’ lack of knowledge. I think the board’s response was entirely appropriate, and consider such behaviour from a medical advertiser, whom consumers should be able to take at their word, to be utterly reprehensible.

In the end, the complaints board said that both advertisements were in breach of Principles 2 and 3, and Part B2 Requirements 4(a) and 4(b) of the Therapeutic Products Advertising Code. They also said that the website advertisement was in violation of Part B2 Requirement 4(c). Here’s a quick rundown of what those codes are (some paraphrased by me):

Principle 2
Must not be misleading and claims must be substantiated
Principle 3
Must observe a high standard of social responsibility
Part B2
Refers to advertisements for medical devices targeting consumers
Requirement 4(a)
Must not be misleading
Requirement 4(b)
Must not abuse trust or exploit lack of knowledge
Requirement 4(c)
Must not exploit the superstitious or, without justifiable reason, play on fear or cause distress.

You can read the full decision of the complaints board, including my original complaint and the advertiser’s response, on the ASA’s website:

I’ve also uploaded a scanned copy of the print advertisement that you can look at: Niagara Healthcare Herald Insert

Even though the ASA’s Advertising Code of Ethics Basic Principle 1 and its Therapeutic Products Code Principle 1 both require that “All advertisements must comply with the laws of New Zealand”, the complaints board had this to say about the testimonial in the print advertisement:

The Complaints Board noted that compliance with the laws of New Zealand under Basic Principle 1 under the Code of Ethics and Principle 1 of the Therapeutic Products Advertising Code were also raised in the complaint. While acknowledging they are part of Advertising Code, the Complaints Board agreed that whether or not the advertisements complied with the laws of New Zealand was a matter for the Courts.

I’m of two minds about this. For one, I agree that it’s appropriate for the ASA not to overstep their authority, and that the courts are the appropriate place for it to be determined whether or not the law has been breached. However, this precedent effectively makes the first principles of the majority of their codes useless, by placing them outside of their own jurisdiction.

If the complaints board is not willing to consider whether or not an advertisement is in breach of New Zealand law, then the advertising codes should be modified to emulate the relevant laws. These include sections 57 and 58 of the Medicines Act 1981, particularly section 58 subclause (1)(c)(iii), which effectively prohibits the use of testimonials in medical advertisements.

This is a step that has been taken by at least one other New Zealand body that is involved in regulating advertising. The New Zealand Chiropractors Board’s Advertising Guideline section 3(f) prohibits the use of testimonials, in accordance with the Medicines Act.

In my opinion, perhaps the most important aspect of this complaint, taking into account that it was upheld, was that the print advertisement had been approved by TAPS. Even though the complaints board found that the advertisement was full of misleading claims that weren’t backed up by the required evidence, the advertiser was able to convince TAPS to approve this ad for publishing.

Another complaint (not one of mine) about an advertisement approved by TAPS was also recently upheld on the basis that it contained unsubstantiated therapeutic claims: Complaint 13/372 against BioMag.