Honest Universe
Category: Scepticism
What we owe our pets
I recently complained about a vet promoting quackery in the Bay of Plenty Times. In response to my complaint, the editor agreed to publish a response I wrote, regarding what we owe our pets. Now that it's been up for a little while, I'm also publishing it here on my blog.
The Bay of Plenty Times recently published an opinion piece by veterinarian Liza Schneider about avoiding and treating cat abscesses. Liza Schneider runs the Holistic Vets clinic in Tauranga, and is the president of a special interest group of New Zealand vets focused on "complementary veterinary medicine".
At the end of her article, she said "complementary therapies like homeopathy, herbal medicine, ozonated gel, hyperbaric oxygen therapy and others can help aid healing tremendously."
The claimed efficacy of homeopathy is in stark contrast with evidence-based practice. As the UK's Royal Council of Veterinary Surgeons said in a statement last year, "Homeopathy exists without a recognised body of evidence for its use. Furthermore, it is not based on sound scientific principles."
Like children, our pets rely on us to make healthcare choices for them. Just as pets cannot talk to us about their symptoms, they are unable to discuss treatment options, make an informed decision of their own, or consent to treatment. These important decisions are left to their carer, and their vet is the carer's guide to making this decision.
When we welcome a pet into our homes, we take on a responsibility to care for them. When their health becomes an issue, they have no choice but to rely on us to make the best decision in their stead. We must be their advocate.
If we choose poorly, their health may suffer. In my view treatments like homeopathy, which are not supported by robust evidence, will at best cost you money and do nothing, but at worst they may delay effective treatment.
Though we are fully capable of making informed decisions about our own healthcare that might involve trying treatments that are not backed by good evidence, I strongly believe that we have a duty to our pets not to experiment on them in this way.
This responsibility also applies to veterinarians. When a vet says things that are not soundly based on scientific evidence, such as "homeopathy… can help healing tremendously", I believe they are failing in that responsibility.
The New Zealand Veterinary Association has a policy on the use of "complementary and alternative treatments" that requires, among other things, that vets must say if a treatment they are advocating is not supported by evidence:
"Clients must be made aware of the likely effectiveness of a given treatment according to recognised peer-reviewed veterinary medical publications, notwithstanding the individual beliefs of the veterinarian. They must also be told the degree to which tests, treatments or remedies have been evaluated and the degree of certainty and predictability that exists about their efficacy and safety."
I sincerely hope that your vet fulfils this responsibility in their practice.
By Mark Hannain Health and Medicine, Homeopathy, Medicine, New Zealand, Scepticism 2018/03/21 496 WordsLeave a comment
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:
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:
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:
https://www.thewarehouse.co.nz/p/band-aid-tough-strip-regular-20s/R917865.html
https://shop.countdown.co.nz/Shop/ProductDetails?stockcode=225613
https://nzonlinechemist.co.nz/products/bandaid-plastic-strips-25s
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?
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.
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?
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.
By Mark Hannain ASA, Australia, Health and Medicine, Medicine, New Zealand, Regulation, Scepticism, Society for Science Based Healthcare 2017/11/28 1,221 Words2 Comments
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.
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.
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.
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.
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.
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.
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.
By Mark Hannain Alternative Medicine, ASA, Complaints, Health and Medicine, Homeopathy, Law, Medicine, New Zealand, Regulation, Scepticism, Society for Science Based Healthcare 2016/12/15 2,167 WordsLeave a comment
Steffan Browning Leaving Parliament
Steffan Browning will leave his role as an MP next year, which is a great opportunity for the Green Party to ditch their anti-science baggage.
I have a love-hate relationship with the Green Party. I love their social policies, but as someone who dedicates a lot of my time to fighting pseudoscience I have a hard time justifying support for a political party with anti-science tendencies.
In the lead up to the 2014 general election, when I was considering where I would place my party vote, I emailed the Greens' then health spokesperson Kevin Hague with some questions about Green Party health policy.
Hague's response satisfied me that, despite the party's reputation, references in their health policy to being evidence-based were more than just lip service. I voted for them.
Then, just a month later, Green MP Steffan Browning went and endorsed homeopathy as a treatment for ebola.
Luckily, the response from Green Party leadership was pretty good. Browning's "Natural Health" portfolio was taken away from him and folded into Hague's health portfolio, after which then co-leader Russell Norman was pretty clear:
It's not something we support and it's not Green Party Policy.
Green MP regrets call to treat Ebola with homeopathy – One News
The Green Party was awarded two awards by the NZ Skeptics at their 2014 conference. One, the Bent Spoon award, goes each year to "the New Zealand organisation which has shown the most egregious gullibility or lack of critical thinking in public coverage of, or commentary on, a science-related issue". In 2014, it went to Steffan Browning.
But they also chose Russell Norman for a Bravo award
for quickly responding to Steffan Browning's comments and stating that this was not something the Green Party would support as they take "an evidence based approach".
Bravo Awards – NZ Skeptics
After this wobble, it looked like the Greens had recovered and maybe taken another little step away from their anti-science past.
But since then both Russell Norman and Kevin Hague have left the Green Party. Though they are by no means the only great people in the Greens, I feel they had shown themselves to support evidence-based policy. I've been worried for some time now that it might signal a return to the Greens' anti-science past, especially as Steffan Browning still held their GE portfolio despite his anti-science views on that topic.
The Greens' reputation took another blow in my mind this year, as I discovered when researching DHB candidates for links to quackery that the Greens were backing Sue Kedgley in her stand for the Wellington City Council and the Capital & Coast DHB.
I felt strongly enough about this that I wrote to the Greens to express my disappointment.
When Steffan Browning put his foot in it soon after the election by supporting homeopathy for ebola, I worried I might have made the wrong choice. But the swift reaction from the party's leadership again convinced me I'd done the right thing.
Now I see that the Greens are supporting Sue Kedgley as one of their candidates for Wellington City Council. I'm really, really disappointed about this. And it makes me worry for the party's future.
I'm sure you're aware of Ms Kedgley's history of being on the wrong side of scientific evidence, especially when it comes to healthcare. I know I am. I have seen her be an anti-vaccine scaremongerer, try to get quackery like homeopathy integrated into the medical system, oppose safe and effective food biosecurity technology like irradiation, and misleadingly call smart meters a "threat to health". I could go on and on; there seems to be no shortage of opinions Ms Kedgley has espoused that are at odds with the scientific consensus.
With Kevin Hague now leaving the Greens to his new role at Forest & Bird, seeing this makes me very concerned about the current direction of the Green party. Steffan Browning still holds his GE portfolio despite his unscientific views in that area, and the party is throwing its weight behind a city council candidate like Sue Kedgley. It makes me think perhaps the Greens aren't the evidence-based party I hoped they could be.
Unfortunately, Kedgley has now been re-elected to both the Greater Wellington Regional Council and Capital & Coast DHB
With all this context, I hope you can all understand why I'm happy to hear the news today that Steffan Browning is not seeking re-election in 2017.
This could be a great opportunity for the Green Party to shed their anti-science baggage and commit themselves to becoming the evidence-based party that many people, including myself, want them to become.
A good start would be re-addressing their stance on GE technology to align it more closely with scientific evidence.
But also, I feel like the time has come for the Greens to cut ties with Sue Kedgley. She hasn't been on their list since 2011. Although Browning is stepping down as a Green MP voluntarily, this is a chance for the Greens to move past their anti-science past by cutting ties with Sue Kedgley.
Here's hoping that, in 2017, they will be an evidence-based option.
By Mark Hannain New Zealand, Politics, Scepticism, Science and Society 2016/12/15 2016/12/15 853 Words8 Comments
Bad Science Case Study: Dog Bones
The New Zealand Herald and Jimbo's have provided us with an idealised "bad science" case study.
Today, the Herald published an article about a "trial" published by pet food manufacturer Jimbo's: No bones about bones
The trial was intended to evaluate how eating bones affects the dental health of dogs. Thankfully the article makes it pretty clear why Jimbo's would be looking into this, although it reads more like a quote from a press release than the declaration of a conflict of interest that it really is:
Jimbo's sells over 300 tonnes of bones per year which help thousands of cats and dogs keep healthier teeth.
This trial seems rather special in that it's a rare composite of just about every aspect of poor methodology all put together at once. I think it makes for an excellent "bad science" case study, which could hopefully be a good resource for journalists who might find themselves in danger of reproducing the Herald's results.
And it's not just journalists that can benefit from understanding this. Being aware of the potential shortcomings of research can make everyone more savvy when it comes to parsing science news. None this is particularly hard to understand at a high level.
Pared way down, designing a study is about two things:
Finding a way to test a hypothesis by attempting to disprove it.
Taking measures to account for as many sources of bias as possible.
Jimbo's failed the first of those objectives spectacularly, but at least they were up front about it:
The Jimbo's Dental Trial was carried out because we wanted to prove what we already knew – that a species-appropriate diet including a bone a day can improve or maintain dental health in our furry friends.
Jimbo's Dental Trial – 2015
It's roughly possible to pair up different aspects of good methodology to the source of bias they're trying to account for. For example, having a large sample size is a way to diminish the effects of random variation within your sample population.
Here's a list of the methodological problems with this Jimbo's trial, and the corresponding sources of bias that they aren't accounting for:
Source of bias
Publication bias, where positive results are more likely to be published than negative results.
How you should account for it
Register your trial ahead of time, and ensure it gets published in a peer-reviewed scientific journal.
What Jimbo's did in their trial
As far as I can find, the trial wasn't pre-registered. Instead of being published in a peer-reviewed scientific journal, it was published as a PDF on the Jimbo's website.
Random variation within your sample population.
Have as large sample size as possible. Of course larger sample sizes makes research more expensive, but if your sample is too small you won't be able to reliably detect an effect.
The study used a sample of eight dogs. This was further reduced to seven after one dropped out for not following the diet.
Regression to the mean, changes unrelated to the experiment, Hawthorne effect etc.
Have an appropriate control group, for example a group of dogs not on the special diet.
The study did not include a control group.
Bias, unconscious or otherwise, from researchers making measurements.
Blind researchers making measurements so they don't know whether the participant they're evaluating was in the control group or the experimental group.
There was only an experimental group, so blinding was not possible.
2016/10/30 Edit: Thomas Lumley has made a good point about blinding over on StatsChat. That is, the researcher evaluating the photos could have been blinded to whether each one was a "before" photo or an "after" photo. The study doesn't mention if this was done, however.
Differences between the populations in the control and experimental groups.
Randomise which group each study participant ends up in.
There was only an experimental group, so randomisation was not possible.
The trial also lacked any sort of statistical analysis. Without a control group, there isn't really a good way to do this, but it seems like Jimbo's didn't even try to figure out how likely it was that their result was a false positive.
I always find it amusing to see research that fails so spectacularly to be well-designed, as this has, but there's a downside as well. This was picked up completely uncritically by the New Zealand Herald. In fact their story reads to me more like an advertisement or press release than the critical analysis I'd expect to see from a high quality media outlet.
Although in the end, the Herald did one thing right. They provided a link to the original research so all of its readers could see for themselves how spectacularly bad it is.
By Mark Hannain Bad Journalism, Bad Science, Health and Medicine, New Zealand, Scepticism 2016/10/31 2016/10/31 842 WordsLeave a comment
Colloidal Silver Blues
Don't be fooled, colloidal silver sprays and creams won't benefit your health.
In the continuing trend of the New Zealand media advertising ineffective health products as though it's news, stuff.co.nz has published an article pushing colloidal silver for treating infections and skin conditions.
EDIT 2016/06/16: Last night I emailed the editorial team at stuff.co.nz with my concerns about this article. This morning they have responded to my complaint by withdrawing the article and replacing it with a correction. I think this is a commendable response. Here is part of the message I received in response this morning:
Your concerns were justified. The article clearly fell a long way below our editorial standards. We have moved to retract the article and replace it with an apology. You can read that at this link.
Geoff Collett, National Life & Style editor
The article quotes a naturopath and sales representative from Skybright Natural Health, a company that sells colloidal silver products, saying that:
Ionic colloidal silver is anti-bacterial, anti-fungal and anti-viral. It supports the immune system when the body is under attack and micro-organisms cannot build up resistance to it.
It's also completely safe for every single person in the family to use, babies included.
Skybright1
What the article doesn't tell you is that there's no evidence colloidal silver can do any of that. And we've known this for quite some time. In 1999, the FDA issued a rule on colloidal silver stating that:
all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
Over-the-Counter Drug Products Containing Colloidal Silver Ingredients or Silver Salts | Final rule by the FDA
And despite that rule being 17 years old now, the state of the evidence remains unchanged. America's National Center for Complementary and Integrative Health (NCCAM) has a rather succinct "bottom line" on colloidal silver products, last assessed as up to date in September 2014:
How much do we know about colloidal silver?
There are no high quality studies on the health effects of taking colloidal silver, but we do have good evidence of its dangers.
What do we know about the effectiveness of colloidal silver?
Claims made about the health benefits of taking colloidal silver aren't backed up by studies.
What do we know about the safety of colloidal silver?
The U.S. Food and Drug Administration (FDA) has said that colloidal silver isn't safe or effective for treating any disease or condition.
Colloidal Silver | NCCAM
Colloidal silver has been on my radar for quite some time now. Here in New Zealand, it's been promoted for various conditions: predominantly infections and skin conditions, but also extending as far as cancer. The evidence for its efficacy is equally absent for all of these claims.
I'm aware of three New Zealand companies that have been challenged on their colloidal silver health claims via complaints to the Advertising Standards Authority: Colloidal Health Solutions, Salud New Zealand, and Liquid Pearl. None of these advertisers were able to provide evidence to support the health claims they were making. (For full disclosure, I gave advice to the complainants for two of those complaints.)
In 2013, I got in touch with another company promoting colloidal silver products in New Zealand, "Health House". I wanted to know what evidence they had to back up the claims they were making. In particular, I wanted to know if they had any evidence that came from the product being tested in vivo, i.e. in a living organism.
Much of the evidence used to back up health claims about colloidal silver products comes from in vitro testing, as opposed to being tested in people or animals. This is dangerous; many many potential new drugs may appear effective in in vitro tests but then turn out to be ineffective or worse, unsafe, when tested in animals or people. So if we rely on this low quality evidence to make health decisions, we run the risk of using ineffective and/or harmful products.
Unsurprisingly, the response I received from Health House was that that they don't have any credible evidence to back up their claims. As well as telling me this, they also decided to send me a list of (anonymised) customer testimonials.
In my opinion, this is a very deceitful tactic. Relying on incredibly low level evidence to back up health claims, and promoting them alongside testimonials which can be both misleading and very convincing, is not an ethical way to promote a healthcare product or empower patients to make informed decisions. That said, it is also a very common tactic among promoters of colloidal silver and other ineffective health products.
Using health testimonials in advertising is prohibited in the Medicines Act for this very reason, although that provision is hardly observed and barely enforced.
As well as saying colloidal silver can treat various conditions, promoters like Skybright also claim it is safe. In the quote for the stuff.co.nz article, Skybright even said it was safe for use on babies. As far as I'm aware, that's essentially true, but with one big caveat. The reason it's true is that it's only legal to sell colloidal silver in New Zealand if it's at too low a concentration to have any effect.
In 2003, then Minster of Health Annette King answered a question about colloidal silver from Rodney Hide (quoted in part):
Rodney Hide: is Medsafe permitting colloidal silver manufacturers and promoters in New Zealand to distribute material containing therapeutic claims; if so, why; if not, what has it done to stop such distribution?
Annette King: No. Distributing material containing therapeutic claims for colloidal silver products would breach the Medicines Act 1981… Colloidal silver products containing less than 10 parts per million of silver do not need consent to distribute under the Medicines Act providing no therapeutic claims are made. Therefore, once references to therapeutic claims have been removed and as long as the product contains less than 10 ppm of silver, there is nothing to prevent these products being advertised again.
5463 (2003). Rodney Hide to the Minister of Health | New Zealand Parliament
Even if colloidal silver was able to treat infections, at a concentration as low as 10 ppm it would be surprising if it had any effect. Luckily, those effects you'll be missing out on include your skin turning permanently blue.
I'm not joking. It's called argyria. Your skin turns blue and stays that way, and it can be caused by taking too much colloidal silver. It looks like this:
That's a photo of Paul Karason, probably the most famous sufferer of argyria caused by colloidal silver. More cases of harm caused by colloidal silver can be found documented on the website whatstheharm.net. One sufferer of argyria caused by colloidal silver, Rosemary Jacobs, has written about the dangers of colloidal silver and the ignorance of some naturopaths promoting it.
While legally sold colloidal silver products aren't likely to be harmful, there is a real potential for harm if you're going to make your own colloidal silver. DIY "make it yourself" colloidal silver kits aren't hard to find for sale online, including on sites like Trade Me. I honestly do worry that someone is going to read that it's safe for babies, and wind up using some colloidal silver someone made at home which is far more concentrated than 10 ppm.
On a lighter note, it just so happens that my favourite bit of New Zealand pseudoscience comes from an ad for Skybright's colloidal silver cream, so of course I just have to share it here. When you see as much quackery as I do, it helps to be able to laugh at it on occasion.
In the listing for Skybright colloidal silver cream on the NetPharmacy website (it's a real Auckland pharmacy, not just online), the promotional text explains:
when cells become infected with a bacteria they lose a positive electron and become negatively charged
Skybright Colloidal Silver Cream | NetPharmacy
1EDIT NOTE 2016/09/27: The naturopath who was cited in the Stuff article has contacted me to say that they had left Skybright before the Stuff article was published, and that the quote has been incorrectly attributed to them. As such, I have changed the attribution to Skybright.
By Mark Hannain Alternative Medicine, Bad Journalism, Colloidal Silver, Health and Medicine, Naturopathy, New Zealand, Scepticism, Society for Science Based Healthcare 2016/06/16 2016/09/27 1,374 Words10 Comments
$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:
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
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.
By Mark Hannain ACC and Acupuncture, Acupuncture, Alternative Medicine, Health and Medicine, Medicine, New Zealand, Scepticism, Society for Science Based Healthcare 2016/05/04 1,474 Words1 Comment
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:
Migraine pain
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:
withdraw the "Live Well Headache" television advertisement ("the advertisement") about the therapeutic good "Nurofen" which was the subject of the complaint;
withdraw any representation, in the context of headaches, that the advertised therapeutic good "Nurofen" goes "straight" to the source of the pain;
not use the representations in (b) above in any other advertisement; and
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:
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:
are effective only in treating a particualr condition or conditions or pain in a particular part or parts of the body; or
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
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)
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
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.
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.
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:
The Price of Painkillers
The Price of Painkillers Part 2: Only Misleading in Australia
By Mark Hannain Australia, Health and Medicine, Law, Medicine, Regulation, Scepticism 2015/12/14 2015/12/16 2,590 Words4 Comments
It's Detox Season
Summer is detox season, but beware misleading health advice.
Every summer, we are bombarded with advertisements, editorials, and advertorials chastising us for all the toxins we have poisoned ourself with by indulging in fruit mince pies and Christmas ham. But it's okay, we are told, for there is a solution to this toxic overload. And that solution is…
The detox
Sound advice and playing to our holiday guilt gets a foot in the door. Eat your greens, shed those Christmas kilos, make a New Year's resolution to avoid toxins. They may even appeal to the rationalist in us: your kidneys and liver are your detox organs, but they need support to do their job optimally.
Next comes the sale. They just so happen to know the perfect thing you can do to detox. Their dietary supplement, their green juice, their herbal tea. This is the secret to ridding your body of toxins, we are told.
But these products, so often forgotten by March, rarely stand up to closer inspection. No evidence (although perhaps some testimonials) are offered in support, specific toxins are rarely mentioned, and claims about what the products can do are often restricted to vague claims such as "support your body's natural detoxification process". Such ambiguity is necessary to avoid being held accountable for specific claims.
In practice, the current regulations allow for claims like "supports your body's natural detoxification process" to be made without supporting evidence. If a product is said to "support" something that happens already in a healthy person, and there's no evidence it has harmful side effects, the regulators will tend to steer clear of it.
This hasn't stopped action being taken against detox claims. In the past two years, there have been 12 complaints against detox ads laid with the Advertising Standards Authority. In every single case, the advertisement was found to be misleading.
So who can we trust? In the case of advertisements and advertorials it's clear that the company behind them has something to gain from us buying their products. Conflicts of interest are important, and in those contexts they are clear. But can we trust other sources of information to be accurate and free from this bias?
If conflicts of interest are hidden from us, we can be misled. A well-informed society depends heavily on the press, and it's in our best interest for mainstream media to report without having undeclared conflicts of interest. One of the Press Council's principles describes why conflicts of interest are an important consideration for the press:
To fulfil their proper watchdog role, publications must be independent and free of obligations to their news sources. They should avoid any situations that might compromise such independence.
The New Zealand Herald recently published a column giving health advice about detoxing from an expert, but didn't adequately declare the author's conflict of interest. In truth, the columnist makes a living from the sale of the exact products they were promoting in the article, but you wouldn't know unless you did some digging.
The column was published on Sunday November 29, just before the start of detox season. It was headlined "Detoxing: What you need to know" and clearly marked as the opinion of Sandra Clair:
Sandra is described briefly before and after the article:
Sandra is a medical herbalist, medical anthropologist, and columnist for the NZ Herald.
Sandra Clair is the founder of Artemis (artemis.co.nz) offering New Zealanders a premium range of traditional plant medicine products. She is one of New Zealand's most highly qualified health professionals in her field, as a Swiss trained medical herbalist and a medical anthropologist (M.A.). Sandra is currently completing a PhD in health science at the University of Canterbury in collaboration with the Chair for Natural Medicine of the University of Zürich, Switzerland.
She's clearly framed as an expert in the field she's writing about, rather than someone with a conflict of interest. So it certainly wouldn't surprise me if someone reading her article about everything they "need to know" about detoxing would take her advice seriously. But let's take a closer look at the advice she gives.
The article starts off giving some sound advice, appealing to the sceptic in us that knows "quick fix" health products are often too good to be true:
At this time of year, detox diets and miracle products spring up like brightly coloured daisies. Many of them promise quick weight loss and eternal youth at the drop of a hat, or a pill.
It is easy to get swayed by enticing marketing when trying to find an approach to rejuvenate or drop those annoying extra kilos.
However, most of these products and fad diets are neither successful nor sustainable, and their harsh, artificial composition can strip the body of essential nutrients resulting in a worse state of health.
So far, I'd been nodding along to her article. She's got her foot in the door, and it's not too long before she moves on to the sale. According to Ms Clair, the secret to detoxing is drinking two types of herbal tea, and making this a lifestyle change instead of something you do for just a brief duration:
In more serious health issues it is advisable to follow a targeted cleansing regime for a minimum of eight weeks, as this is the minimum time it takes for the liver to restore and cleanse deeper layers. By the end of that time most people find it easy to incorporate better choices into their daily lives for long-term health.
The easiest way to support your body's daily detoxification is to take a medicinal tea with bitter liver herbs before breakfast. Liquid plant medicine is perfect for detoxification since water has additional flushing benefits over and above the therapeutic ingredients of the tea.
Follow this with a kidney cleansing medicinal tea mid-morning to complete the flush by removing the released water-soluble toxins. Golden rod, horsetail, birch leaves, nettle and raspberry are traditionally used to improve kidney function and help clear the body of water-soluble metabolic wastes and toxins, excess sodium, uric acid and inflammatory by-products. I call this combination your daily 'internal shower'.
At first glance this just looks like advice from an expert in the field, not a marketing pitch for specific products. But not all is as it seems.
As mentioned in Ms Clair's bio, she is the founder of Artemis Natural Healthcare. And it just so happens that Artemis sells a "Liver Detox Tea" and a "Kidney Cleanse Tea". The wording in her article seems like it could easily have been tailored specifically to match the marketing for these teas, listing their ingredients and using terms such as "kidney cleansing medicinal tea" and "medicinal tea with bitter liver herbs".
Surprise surprise, if you search for either of those phrases from the article on Google in a New Zealand context, the first results are for Artemis' products:
I found about these products when the December catalogue for Health 2000, which is New Zealand's natural health retailer and has been in trouble in the past for misleading claims about toxins, was released on the Wednesday after the Herald article. It advertises Artemis' "Liver Detox Tea", which prompted me to check further and led to me finding out about their "Kidney Cleanse Tea" through their website.
I sent a message to the New Zealand Herald's online editors the day after I found this out, to express my concern about this conflict of interest and about the misleading content of the article. It's been over a week now, and disappointingly I've had no response from them. You can read my message at the bottom of this article.
The morning after I sent that message, the New Zealand Herald was distributed along with a copy of the Health 2000 December catalogue. The same catalogue advertising one of the products Ms Clair was surreptitiously promoting in her Herald column only days earlier.
As far as I'm aware the New Zealand Herald has yet to acknowledge the full extent of this conflict of interest, but I hope that hearing about this will make you think twice before trusting detox advice. Without taking the time to look behind the curtain, it can be hard to tell if someone stands to gain financially from the advice they're giving.
As always, if you think a health claim might not be all it claims to be, the best approach is to ask for evidence. If all you're given is anecdotes, it's probably not trustworthy. In the case of detox advice, asking for specifics on which toxins they're talking about can also be a good approach.
It seems appropriate for me to state here that I have no conflicts of interest to declare. All I'll gain if you take my advice to be sceptical of misleading detox claims is peace of mind.
Here is the letter I sent to the New Zealand Herald's online editors:
Earlier this week I read an opinion piece published on your website by Sandra Clair, entitled "Detoxing: What you need to know" (http://www.nzherald.co.nz/lifestyle/news/article.cfm?c_id=6&objectid=11552384)
I'm concerned that the article contains misleading content and that her substantial conflict of interest is not made adequately clear to readers.
As noted at the bottom of the article, the author is the founder of Artemis, a for-profit business that sells herbal healthcare products. One of the products this company sells, advertised in the latest Health 2000 catalogue which was released this week, is "Liver Detox Tea". You can see it advertised on page 22 of the catalogue online here: http://www.health2000.co.nz/december-2015_1268
In Ms Clair's article, she says:
This very closely echoes the marketing for her business' "Liver Detox Tea" product.
Artemis also sells a "Kidney Cleanse Tea" to "Flush those toxins away". According to the Artemis website it contains Birch leaves, Golden Rod, Horsetail, Nettle, and Raspberry leaf. In her article, Ms Clair also says:
This too very closely echoes the marketing for her business' "Kidney Cleanse Tea" product.
It seems fairly unlikely that the timing of her article and the increased marketing of "detox" tea products by her business are a coincidence. It is absolutely in the interest of your readers to be made aware of her conflict of interest involving these products, and it does not seem to me like this has been done adequately.
Furthermore, I'm concerned that much of the information presented in her column is likely to be misleading. It is absolutely true, as she says in the opening paragraphs, that "detoxification" is the role of your kidneys and liver. However, the article is written in such a way as to imply, without any supporting evidence as far as I am aware, that products like the "Liver Detox Tea" and "Kidney Cleanse Tea" sold by her company are able to provide health benefits such as "improved immune system" and "better circulatory and lymphatic function".
I'm also concerned that the article advises readers to "Reduce pharmaceutical drug intake". As the conflict of interest statement refers to Ms Clair as "one of New Zealand's most highly qualified health professionals in her field", I am concerned that this advice might be taken seriously by some readers and as reliable health advice, and result in some degree of harm.
I think we are all aware that summer is the time of year where businesses in the "natural health" industry most strongly market "detox" products. As the chair of the Society for Science Based Healthcare, I see a significant amount of misleading advertising for these products, particularly at this time of year.
Over the past two years, 12 advertisements about detox products have been complained about to the Advertising Standards Authority, and in every one of those cases the advertisement was found to be misleading. Many more of these advertisements will surely have been similarly misleading, but will not have attracted formal complaints.
I understand that opinion pieces such as this may not be bound by the same requirements for accuracy and balance as non-editorial content, but I hope that you nevertheless do care about and understand the importance of the accuracy of content presented as expert health advice.
I hope you will discuss these matters with Ms Clair, and ensure that her conflict of interest is stated much more clearly if you publish future articles from her.
Here's the follow-up message I sent the next morning:
Further to my message last night regarding your columnist Sandra Clair's conflict of interest, this morning I see that the New Zealand Herald was distributed with the December Health 2000 catalogue.
This is the catalogue that I raised as a concern due to the fact that it advertises Ms Clair's "Liver Detox Tea" product.
The fact that the New Zealand Herald is distributing marketing for one of the products lauded in a Herald article makes it all the more important that the nature of this conflict of interest is made clear to readers.
I hope you will treat this matter seriously.
By Mark Hannain Alternative Medicine, Bad Journalism, Detox, Health and Medicine, New Zealand, Scepticism 2015/12/11 2017/11/15 2,276 Words3 Comments
What Fake Astrophotography Can Teach Us
The New Zealand Herald has an article today about a cool and very popular image of the Moon positioned perfectly within a radio satellite, produced by astrophotographer Chris Pegman: Supermoon image goes into media orbit
Image by Chris Pegman
The article talks about how there has been debate online about whether or not this could be taken without resorting to Photoshop. It concludes that "the verdict was that it might be, but it would require an incredible amount of planning" but this isn't strictly correct.
The apparent rotation of the Moon changes as it travels through the sky. When it rises, it will appear to be "on its side" relative to when it is at its zenith, and when it sets it will have rotated further still.
This is most obvious with a crescent Moon. Depending on if it's waxing or waning, the Moon will rise with the crescent facing either down or up, then when it's at its zenith the crescent will be facing sideways, and as it sets it will have rotated around further. Of course, the lit side of the Moon always faces the Sun. It's the fact that the Earth rotates beneath us that makes it look like the Moon is rotating as it travels across the sky.
Here's an example of this which I took with my phone in July, showing a waning crescent Moon shortly before sunset:
Always look up pic.twitter.com/PIeT6umK0u
— Mark Hanna (@HonestUniverse) July 21, 2015
We can see from the lunar maria (the dark areas) that the Moon in Chris Pegman's picture is rotated how it would be if (when viewed from the southern hemisphere) it were near its peak, not near the horizon, so his picture couldn't be produced without artificial manipulation.
Mark Gee is a fantastic astrophotographer from Wellington. In October he captured a time lapse of a full moon rising, in which you can clearly see that angle of the Moon is not the same as in Chris Pegman's image when it rises: Supermoon rises over New Zealand timelapse.
There's a Twitter account called Fake Astropix, which tweets fake astronomical images with the reasons why they are recognised as fake (well, as much as can be given within a tweet).
I find these reasons can be very educational and thought provoking. For example, it's impossible to take a photo from Earth where the Sun and Moon don't appear to be roughly the same apparent size. Also, the full moon can't appear next to the Sun in the sky (remember the lit side faces the Sun). So "debunking" these fake astronomical images can be a good educational exercise that makes you think a bit more carefully about how things work in our solar system.
Do you have any fake astronomical images that you can share, along with the reason why you can tell it must have been faked?
Have you seen any astronomical images that you think might be fake but you're not sure? Share them here and let's investigate, and see if we can learn something.
By Mark Hannain Astrophotography, Scepticism, Science, Science Communication 2015/11/12 2015/11/12 509 WordsLeave a comment