State-Approved Health Fraud Scams

State-Approved Health Fraud Scams

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

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

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

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

Health Fraud Scams – US Food & Drug Administration

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

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

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


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

Support for a healthy heart.

Maintains joint health.

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

Wink wink, nudge nudge.

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

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

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

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

And so are the ASA’s requirements:

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

Therapeutic and Health Advertising Code – Advertising Standards Authority

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

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

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

Weleda New Zealand

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

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

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

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

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

Weleda New Zealand

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

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

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

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

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

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

Medsafe

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

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

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

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

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

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

Medsafe

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

So what is there to be done about it?


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

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

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

Weleda New Zealand

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

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

Weleda New Zealand

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

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

Medsafe

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

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

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

Advertising Standards Authority


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

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

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

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

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

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

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Steffan Browning Leaving Parliament

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.

Mark Hanna

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.

Bad Science Case Study: Dog Bones

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:

  1. Finding a way to test a hypothesis by attempting to disprove it.
  2. 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.

  • Source of bias
    Random variation within your sample population.

    How you should account for it
    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.

    What Jimbo’s did in their trial
    The study used a sample of eight dogs. This was further reduced to seven after one dropped out for not following the diet.

  • Source of bias
    Regression to the mean, changes unrelated to the experiment, Hawthorne effect etc.

    How you should account for it
    Have an appropriate control group, for example a group of dogs not on the special diet.

    What Jimbo’s did in their trial
    The study did not include a control group.

  • Source of bias
    Bias, unconscious or otherwise, from researchers making measurements.

    How you should account for it
    Blind researchers making measurements so they don’t know whether the participant they’re evaluating was in the control group or the experimental group.

    What Jimbo’s did in their trial
    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.

  • Source of bias
    Differences between the populations in the control and experimental groups.

    How you should account for it
    Randomise which group each study participant ends up in.

    What Jimbo’s did in their trial
    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.

A Sceptical Guide to DHB Voting

A Sceptical Guide to DHB Voting

I’ve looked into this year’s district health board candidates to help you keep quacks off your DHB this election.

Unless you live in Southland, this year you probably get to vote for several spots on your local district health board. With the move to DHBs making decisions about water fluoridation, there’s a danger that some of the candidates standing could be anti-fluoride or worse. And if they’re crafty, they likely won’t make that clear in their candidate profile that you get in the post with your voting papers.

Over the past week or so, I’ve looked through all the profiles for DHB candidates throughout the country, and followed up on anything that looked like a red flag for quackery. While many candidates looked great, I also found some that you probably don’t want to vote for such as a homeopath who’s been censured for false advertising, someone who promotes detox diets through her business and claims they can cure allergies and other diseases, and a chiropractor who claims to treat babies for colic. And that’s just the tip of the iceberg.

We’re also lucky that the anti-fluoride lobby group Fluoride Free New Zealand has published a survey with responses from many council and DHB candidates regarding their thoughts on fluoride. It’s very kind of them to have spared a thought for sceptics and published such a useful resource.

All the information I found has been compiled, with the help of Hayden Donnell, into a voting guide over on The Spinoff. If you still have your DHB candidates to vote for, have a read before you do:

Quack hunt: Our vital tool for stopping anti-science crackpots infiltrating your DHB

Strip searches in prisons – what is reasonable?

Strip searches in prisons – what is reasonable?

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

Here’s an excerpt:

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

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

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

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

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

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

Keep reading

Colloidal Silver Blues

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:

Argyria | Paul Karason

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.

$26m for Acupuncture

$26m for Acupuncture

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

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

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

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

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

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

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

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

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

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

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


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

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

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

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

Response to Mark Hanna (19 April 2016) | ACC

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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