A Failure to Regulate

A Failure to Regulate

New Zealand has several layers of regulation to protect us against misleading health claims. Sometimes they all fail. My struggle against quackery over the last few years has given me some familiarity with the ways we’re protected against it, and with their shortcomings.

Misleading people about their healthcare options is something that is clearly unethical. To quote the alt text of Randall Munroe’s xkcd comic strip Alternative Literature:

Telling someone who trusts you that you’re giving them medicine, when you know you’re not, because you want their money, isn’t just lying–it’s like an example you’d make up if you had to illustrate for a child why lying is wrong.

Alternative Literature | xkcd

Whether or not someone making misleading health claims knows they’re not true, this is something that can pretty clearly cause harm. At the lower end, a useless health product promoted for something that will get better on its own will cause financial harm. At the higher end, misleading people about their healthcare options could lead them to delay or avoid life-saving medical treatment. In all cases, it involves a violation of the person’s right to make an informed decision about their healthcare.

Our protection


The first line of defence we have against misleading healthcare claims is the conscience of the person making the claims. If no one ever made claims that are misleading in the first place, we wouldn’t need any regulation to deal with it.

In some cases, the advertiser themselves may have been misled, such as a store having been misled by a supplier. Sometimes, as I have written here before, once they are aware they have been misled their conscience may lead them to fix the problem.

Industry bodies

The second line of defence is industry self-regulation. This can take a few forms, such as the codes of conduct of professional societies. Perhaps the most prominent piece of general industry self-regulation in New Zealand is the Advertising Standards Authority (ASA).

The ASA has codes for various types of advertising, including a Therapeutic and Health Advertising Code which requires that therapeutic claims can’t be made in advertising unless you have good evidence to back them up.

The ASA won’t go out looking for non-compliant ads; instead they rely on people submitting complaints to them. The ASA considers each and every complaint lodged with them, and will always act if they agree it’s justified under their codes. If they find that an ad which has been complained about does not comply with their codes, and the advertiser refuses to fix it, the ASA will uphold the complaint.

When the ASA upholds a complaint, they ask the advertiser to remove their ad. However, they don’t have any legal power to enforce this, and there aren’t any penalties for violating the ASA’s codes.

Some industry groups have made a commitment to comply with the ASA’s rulings. For example, the Newspaper Publishers’ Association of New Zealand (Inc) is a member of the ASA. If an advertiser refuses to comply with an ASA ruling, any organisation that is member of the ASA should refuse to publish the ad.

However, many misleading claims are published directly by the advertiser, for example when they appear online on the advertiser’s own website. These advertisers have typically made no such committment to abide by the ASA’s rulings, and the ASA relies on their voluntary compliance.

The law

The third line of defence is legislation. We have laws against various ways in which consumers can be misled, and these are enforced by various government agencies.

The Fair Trading Act 1986 is one of these laws. It has a requirement for substantiation similar to the one in the ASA’s codes:

A person must not, in trade, make an unsubstantiated representation.

Fair Trading Act 1986 Section 12A(1)

This law is enforced by the Commerce Commission. There are some important differences that set the Commerce Commission apart from the ASA:

  • The Commerce Commission has power to enforce the law. Whereas the ASA can only ask an advertiser to withdraw an ad, the Commerce Commission can take them to court.
  • The Commerce Commission will not act on every justified complaint it receives. Instead it will assess them and decide whether or not to take action. Sometimes the decision is made to take no action even if there is a breach of the Fair Trading Act.

Also at this level of regulation is the Medicines Act 1981, which is enforced by Medsafe. The Medicines Act restricts certain health claims, only allowing them to be made for products that have been approved by the Minister of Health to be sold as a medicine for that purpose.

New medicines can be approved through a process in which they must provide evidence of their safety and efficacy. There are also some products that were already around in 1981 when the Act came into effect were “grandfathered” into the scheme and granted automatic approval, regardless of the evidence for them.

Like the Commerce Commission, Medsafe will not act on every justified complaint they receive, even if the Medicines Act has been breached. They prioritise complaints, and in my experience will typically not act unless there is a clear safety issue.

This means that some parts of the Medicines Act, such as Section 58(1)(c)(iii) which prohibits the use of any sort of health testimonial in medical advertisements, can go entirely unenforced.

Consumer advocates

With almost every level of regulation, nothing will happen unless someone complains. The system relies heavily on individual consumer advocates and consumer advocacy organisations. Groups like the Society for Science Based Healthcare (which, to be clear, I’m the chair of), Consumer NZ, and the NZ Skeptics can do what the regulators can’t.

Though we don’t have any powers of enforcement, we can bring issues to the attention of regulators, work to educate and inform consumers, and raise awareness of issues that regulators have failed to resolve.

Such as the ongoing case of the Homeopathy Centre’s misleading advertising…

When it all goes wrong

In March 2015, I was sent a message about an advertorial written by a business called the Homeopathy Centre, which was published in the Christchurch Mail newspaper.

This business was making a lot of misleading claims about homeopathy, both in the advertorial and on their website. They were using pseudoscientific language to convince people that homeopathy is effective:

The carefully selected homeopathic medicine is energetic in nature and can stimulate the vital force, which is not material, but a vibrant energetic structure interconnected with the body and mind.

Homeopathy Centre

The ads also claimed homeopathy could help with a large number of health problems such as insomnia, anxiety, and a “Weak immune system”. The most prominent claim for homeopathy was:

No matter what state of health you are in, you can improve it!

Homeopathy Centre

Advertising Standards Authority

Through my volunteer work at the Society for Science Based Healthcare, I make a lot of complaints about misleading health advertisements.

Almost always, I go to the Advertising Standards Authority first. Misleading health claims are often made by people advertising their own products and services, so dealing with them directly is unlikely to be helpful. On the other side, neither the Commerce Commission nor Medsafe are likely to take action on small things such as misleading claims on the website of a small business. The ASA is a good middle ground, as they will take action on these small things and often end up fixing the problem. But sometimes, even when they uphold a complaint, nothing changes.

I lodged a complaint with the ASA regarding these ads soon after being made aware of them in March 2015. In May, the ASA decided my complaint was justified, and it was upheld.

…therefore the advertisements were misleading, had unduly glamorised benefits of homeopathy and had portrayed unrealistic outcomes.

Consequently, the Complaints Board said the advertisement had not been prepared with the requisite standard of social responsibility.

Complaint 15/137 Homeopathy Centre | Advertising Standards Authority

The advertiser’s response to my complaint was to say they did not plan on continuing the newspaper advertorial, and that they were in the process of making changes to their website “over the next few months”.

Normally, that decision to uphold my complaint would have been the end of it. Most advertisers are responsible enough to comply with the ASA’s rulings in this way. As far as I am aware, the Christchurch Mail did, but that wasn’t the case with the Homeopathy Centre’s website.

Whenever I complain about online content, I set up a change monitoring system that sends me an email if a web page changes. As a result, I am able to see in detail every change made to the pages on the Homeopathy Centre website since I complained two years ago. When I complained, I set up change monitoring for 40 pages on their website, including those directly relevant to my complaint.

Since my complaint in March 2015, only five of these pages have had any changes. Most of these changes are irrelevant, such as a change of address and an increase in their prices. Whatever the changes they’d planned on making to their website, they don’t appear to have happened yet – two years down the line.

I’ve been following up with the ASA to try to get the Homeopathy Centre to comply with this decision since June 2015.

Advertising standards authority, again

In March 2016, when it was clear the promised changes were not forthcoming, the ASA suggested I submit another complaint that they could consider anew and, if upheld, seek compliance on. So that’s what I did.

In July 2016, the ASA upheld my second complaint regarding the Homeopathy Centre website. This time, the advertiser’s complete response to the complaint was a simple attempt to opt out of regulation:

No thank you, I don’t wish to respond

Homeopathy Centre Christchurch

It was abundantly clear by this point that the advertiser had no interest in voluntary compliance. When you make a complaint to the ASA, they ask that you sign a waiver saying that, if they accept your complaint, you won’t take the issue to another authority. So I tried to work with the ASA to help them gain compliance.

New Zealand Council of Homeopaths

I pointed out that Elisabeth Fink, the director of the Homeopathy Centre since 2009, is a member of an organisation called the NZ Council of Homeopaths. According to the Homeopathy Centre website, she has been a member of this organisation since 1987.

This is important because the NZ Council of Homeopaths is another part of that second line of defence I mentioned earlier. They have Rules of Practice that requires, among other things:

Any advertising will not contravene the Commerce Act 1986, the Fair Trading Act 1986, section 58 of the Medicines Act 1981, and must be in compliance with current Code for Therapeutic Advertising of the Advertising Standards Authority.

Rules of Practice | NZ Council of Homeopaths

As the ASA had already ruled that the Homeopathy Centre’s advertising is not in compliance with their current code for therapeutic advertising, this seemed remarkably clear cut. Elisabeth Fink was breaking the rules of practice of a professional organisation she’d been a member of for nearly three decades.

The ASA agreed in November 2016 to get in touch with the NZ Council of Homeopaths to gain compliance via this route. Later that month, I was told the executive members of the council would meet within a week to discuss the issue, and that they were planning to address it with the advertiser.

Then, in February 2017, I had an update:

The NZ Council of Homeopaths has been in touch with the advertiser. Unfortunately they have not been able to make any progress. You have the option of referring the advertiser to Medsafe.

Advertising Standards Authority

Commerce Commission

With this email the ASA released me from the waiver I’d agreed to, which said I wouldn’t take my complaint up with another authority. My experience with Medsafe in the past has been that, unless there is a pressing safety issue, they are unlikely to take any action.

For example, I have a complaint regarding misleading health claims made about “Harmonized Water” with Medsafe that has been “active”, but without any meaningful action, since September 2014.

So I decided to try the Commerce Commission first instead. I’ve had some success with them in the past, where they issued a formal warning against an advertiser of “amber teething necklaces” (which, by the way, don’t help teething in any way and can be unsafe) who had refused to comply with upheld complaints from the ASA.

I lodged the complaint with the Commerce Commission in the wake of their action against Reckitt Benckiser for misleading marketing of Nurofen specific pain products. It was encouraging to have seen Dr Mark Berry, the Commerce Commission Chairman, recently say:

The Commission will continue to take cases where traders do not promote their products truthfully. Products need to be as described on the box, and these were not. We take a particularly dim view when goods for human consumption are misdescribed; especially where pharmaceutical or healthcare products are not promoted truthfully. With these types of products consumers have little opportunity to verify the claims being made and tend to rely heavily on what they are told by the trader. To be able to choose the product best suited for them, consumers must have accurate and reliable information

Dr Mark Berry | Commerce Commission Chairman

This morning, two months after lodging my complaint with them, I have heard back from the Commerce Commission. It was not good news:

Dear Mark

Thank you for the information you provided the Commerce Commission regarding Homeopathy Centre.

We have now completed our assessment of the concerns you have raised and are writing to advise you that we will not be taking any action against Homeopathy Centre at this time.

Commerce Commission

Though this is so far a repeat of what happened with Baa Baa Beads – the Commerce Commission initially decided not to act then later changed their mind – a repeat of that behaviour hardly feels like something to rely on.

What’s next?

Medsafe will be receiving a complaint about Homeopathy Centre shortly, but I don’t honestly anticipate that they will do anything about it. In the meantime, this company will continue to mislead the public about their healthcare options, as they have knowingly done for at least two years now.

The lesson I would like everyone to take away from this story is that a rule is only useful if it is enforced. You can have the best rules in the world, but if they’re not enforced they don’t matter at all. If consumer protection rules aren’t enforced, consumers are not protected.

In this particular case, the ASA cannot enforce its rules, the NZ Council for Homeopaths chooses not to enforce its rules, and the Commerce Commission chooses not to take action. More often, no one complains about misleading claims, so nothing happens.

As a result of all this and more, quackery thrives in our country.

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.


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.

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.


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.

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.


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.

Misleading claims common among chiropractors

Misleading claims common among chiropractors

Most New Zealand chiropractors make misleading claims.

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

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

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

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

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

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

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

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

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

Statement on advertising | Chiropractic Board of Australia

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

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

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

Advertising Policy | New Zealand Chiropractic Board

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

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

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

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

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

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

Pharmacists Don’t Want to Sell Unproven Products

Pharmacists Don’t Want to Sell Unproven Products

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

NaturoPharm Wartoff Complaint (Society for Science Based Healthcare)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Pharmacy Council’s Code of Ethics Proposal: Submissions Roundup

Pharmacy Council’s Code of Ethics Proposal: Submissions Roundup

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

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

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

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

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

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

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

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

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

The Society for Science Based Healthcare

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The NZ Skeptics

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

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

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

NaturoPharm Wartoff Complaint (Society for Science Based Healthcare)

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

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

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

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

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

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

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

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

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

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

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

Pharmacists support patient choice with homeopathy (Pharmacy Today)

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

Ben Albert et al.

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

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

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

The specific recommendations made in their submission are:

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

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

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

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

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

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

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

the current code should be enforced, not amended.

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

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

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

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

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

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

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

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

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

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

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

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

Dr Ben Albert

The New Zealand Medical Association

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

The NZMA is strongly opposed to the above proposed change

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Pharmacy Guild

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

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

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

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

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

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

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

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

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

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