Category: Homeopathy

What we owe our pets

What we owe our pets

I recently complained about a vet promoting quackery in the Bay of Plenty Times. In response to my complaint, the editor agreed to publish a response I wrote, regarding what we owe our pets. Now that it’s been up for a little while, I’m also publishing it here on my blog.

The Bay of Plenty Times recently published an opinion piece by veterinarian Liza Schneider about avoiding and treating cat abscesses. Liza Schneider runs the Holistic Vets clinic in Tauranga, and is the president of a special interest group of New Zealand vets focused on “complementary veterinary medicine”.

At the end of her article, she said “complementary therapies like homeopathy, herbal medicine, ozonated gel, hyperbaric oxygen therapy and others can help aid healing tremendously.”

The claimed efficacy of homeopathy is in stark contrast with evidence-based practice. As the UK’s Royal Council of Veterinary Surgeons said in a statement last year, “Homeopathy exists without a recognised body of evidence for its use. Furthermore, it is not based on sound scientific principles.”

Like children, our pets rely on us to make healthcare choices for them. Just as pets cannot talk to us about their symptoms, they are unable to discuss treatment options, make an informed decision of their own, or consent to treatment. These important decisions are left to their carer, and their vet is the carer’s guide to making this decision.

When we welcome a pet into our homes, we take on a responsibility to care for them. When their health becomes an issue, they have no choice but to rely on us to make the best decision in their stead. We must be their advocate.

If we choose poorly, their health may suffer. In my view treatments like homeopathy, which are not supported by robust evidence, will at best cost you money and do nothing, but at worst they may delay effective treatment.

Though we are fully capable of making informed decisions about our own healthcare that might involve trying treatments that are not backed by good evidence, I strongly believe that we have a duty to our pets not to experiment on them in this way.

This responsibility also applies to veterinarians. When a vet says things that are not soundly based on scientific evidence, such as “homeopathy… can help healing tremendously”, I believe they are failing in that responsibility.

The New Zealand Veterinary Association has a policy on the use of “complementary and alternative treatments” that requires, among other things, that vets must say if a treatment they are advocating is not supported by evidence:

“Clients must be made aware of the likely effectiveness of a given treatment according to recognised peer-reviewed veterinary medical publications, notwithstanding the individual beliefs of the veterinarian. They must also be told the degree to which tests, treatments or remedies have been evaluated and the degree of certainty and predictability that exists about their efficacy and safety.”

I sincerely hope that your vet fulfils this responsibility in their practice.

New rules for pharmacists

New rules for pharmacists

The Pharmacy Council has (finally) published their new Code of Ethics 2018.

I’ve written several times on the ongoing saga of the Pharmacy Council’s Code of Ethics. In late 2014 we put together a complaint at the Society for Science Based Healthcare arguing that their Code of Ethics 2011 had been violated by an Auckland pharmacy, in which a salesperson had recommended and sold a homeopathic product to someone who didn’t realise they were buying quackery.

Following this complaint, the Pharmacy Council decided they would not enforce the rule in their Code of Ethics at the time that prohibited pharmacies from purchasing or supplying any health product that was not backed by “credible evidence of efficacy”.

This led to two protracted consultation processes, first about that specific part of the code and then about rewriting the code entirely. I worked on the Society for Science Based Healthcare’s submissions during each consultation period, and we met with the Pharmacy Council twice to discuss the topic.

The consultation processes also saw well-voiced support for strong patient protection rules coming from the New Zealand Medical Council and the Pharmaceutical Society (who represent professional pharmacists). Whereas the Pharmacy Guild (who represent pharmacy owners) was in favour of the more relaxed rules that had been suggested. For more detail on this, you can read my submissions roundup from 2015.

The Code of Ethics 2018 will come into force on the 12th of March 2018. It’s principle-driven, and accompanied by a number of guidelines that go into more detail on what’s expected of pharmacists in various areas. One of these guidelines is the Pharmacy Council Complementary and Alternative Medicines – Statement and Protocol for Pharmacists.

Unlike the Code of Ethics 2011, the new rules don’t prohibit pharmacists from selling quackery. While this is unfortunate, it’s seemed clear from the outset that the Pharmacy Council had no intention to keep this rule given they aren’t prepared to enforce it. Instead, there has been an increased focus on ensuring patients are given the opportunity to make an informed choice.

I’m feeling cautiously optimistic about the change. Though ideally pharmacists shouldn’t be lending their credibility to ineffective health products, if pharmacists must be allowed to sell quackery then I think the next best approach to regulation is to protect patients’ rights to make an informed decision.

On the face of it, I think the new rules seem good. But enforcement has been a concern in the past and parts of the previous code were widely disregarded. Come the 12th of March, I plan to have a look for pharmacists who aren’t complying with the new rules and lodge complaints to see how they are treated, and if the behaviour is corrected. Unfortunately, there are a few pharmacies in New Zealand that have a history of promoting quackery, including by selling ineffective health products online, which seems like a good place to start.

I’d recommend you read the rules for yourself if you’re interested, but here’s my summary of what I think are the most important new patient protection rules regarding informed consent:

[Principle 1H: A pharmacist] Before recommending, supplying or promoting a medicine, complementary and/or alternative medicine or other healthcare product or service, considers available evidence, and only supplies a product when satisfied that it is appropriate, and the person understands how to use it correctly and safely.

[Principle 4C: A pharmacist] Provides accurate, truthful, relevant, and independent information in an appropriate form that is not misleading to patients, the public and/or other healthcare professionals.

[Principle 4H: A pharmacist] Ensures that when providing any medicine, complementary and alternative medicine, or other healthcare product or service, that the health and wellbeing of the patient or consumer is the primary consideration, and that the benefit of use outweighs the risk.

[Principle 4I: A pharmacist] Does not engage in advertising, promotion or supply of goods or services that could include misleading or unsubstantiated claims, and/ or undermine public trust in the profession.

[Principle 6A: A pharmacist] Maintains contemporary knowledge of evidence-based practice.

Where it makes sense, all of these principles are effectively extended to non-pharmacist salespeople who work in pharmacies via Principle 5G:

[A pharmacist] Is responsible for actions of staff under their supervision.

Looking at the associated guideline on “complementary and alternative medicines”, the requirements in parts 14 and 15 seem like they will be particularly important for protecting patients from quackery in pharmacies:

14. When supplying products or information about treatments/products/services that have no current evidence of proven efficacy pharmacists are expected to:

a. ensure that patients are informed about the degree to which treatments or products have been evaluated, and

b. the degree of certainty and predictability that exists about their efficacy and safety

15. Pharmacists must advise patients when scientific support for treatment is lacking.

Part 18 of the guidelines also includes the following requirements:

e. provide sufficient information regarding the CM/NHP [Complementary Medicine/Natural Health Product] to allow patients to make informed choices

f. not misrepresent information or opinion. Patients must be made aware of the likely effectiveness of a given therapy according to recognised peer-reviewed medical publications, in spite of your personal beliefs

g. provide the patient with a timeframe for accessing conventional medicine if their condition is unresolved or there is no improvement

Time will tell if these rules really do enhance patient protection in the pharmacy industry, which has a long-standing problem with promoting quackery on the side.

From the 12th of March onwards, if you see behaviour that you think is non-compliant with the code feel free to let me know about it. I can be contacted via email at mark@honestuniverse.com.

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

Advertisers

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.

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.

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.

…

Homeopathy
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.

Ethical Pharmacy Practice 5: Looking for Leadership

Pharmacy
Pharmacy by russellstreet on Flickr CC BY-SA 2.0

In New Zealand, the Pharmacy Council is legally responsible under section 118(i) of the Health Practitioners Competence Assurance Act 2003 for setting standards of ethical conduct for New Zealand pharmacists. As part of this, they’ve written a Safe Effective Pharmacy Practice Code of Ethics, which requires that:

YOU MUST:

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

Safe Effective Pharmacy Practice Code of Ethics Section 6.9

Last November, a case was brought to our attention at the Society for Science Based Healthcare of a salesperson in an Auckland pharmacy recommending and selling a homeopathic product to someone who didn’t realise until they’d bought the product and taken it home that it was homeopathic and that there is no credible evidence of its efficacy. The society wrote a formal letter of complaint to the Pharmacy Council about this, alleging that it was a clear violation of this section of their code of ethics.

As part of this complaint, we made a series of recommendations:

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. Advise [the pharmacy] of their ethical obligation not to purchase, supply, or promote any healthcare product where there is not credible evidence of efficacy.
  2. Recommend that [the pharmacy] review their stock, starting with [the homeopathic products we found in their store], to ensure that they meet this ethical obligation. If they are not currently aware of credible evidence of efficacy for these products, they should request it from the manufacturer and, if they are not supplied with credible evidence of efficacy within a certain specified timeframe (we recommend 10 working days) to remove the products from sale.
  3. Recommend that [the pharmacy] undertake training of their staff to ensure that no one is giving unfounded healthcare advice to customers.
  4. Relay these recommendations to other New Zealand pharmacies so that they are also given the chance to ensure that they meet this ethical obligation.
  5. 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.

The Society for Science Based Healthcare

The Pharmacy Council said that creating a guideline for standards of evidence was not their role, although they suggested that it may be appropriate for the Pharmacy Guild or the Pharmaceutical Society to create such a guideline and forwarded the letter of complaint on to these organisations. To my knowledge, neither of them has created any such guideline.

The Pharmacy Council also wrote to the pharmacy in question. When I visited it some months later I found the same homeopathic products were still for sale, although they had at least been moved behind the counter.

I don’t know if that particular pharmacy still actively promotes and tries to sell these products, but on Twitter the other night I was told of another case where a sales assistant at a New Zealand pharmacy tried to sell a homeopathic product while clearly lacking any useful knowledge about homeopathy:

In response to the Society for Science Based Healthcare’s complaint, the Pharmacy Council also offered to remind pharmacists of their obligations with respect to selling any alternative medicines in their next newsletter. Last week, 9 months after having received our complaint, they finally published this newsletter. Here’s what they said:

Complementary and Alternative Medicines — Best Practice Guidance for Pharmacists

As medicines experts, pharmacists have built their reputation on providing accurate, unbiased information on the use, safety and effectiveness of all medicines, including complementary and alternative medicines. Pharmacists must be familiar with the latest information on the medications they supply to their patients, and seek independent information to maintain an objective viewpoint so they can help individuals make informed choices (Competence Standard O1.2.4).

Homeopathy in particular has had much attention over recent times, specifically regarding its plausibility and efficacy. Nonetheless, many people, including some healthcare professionals, continue to use or practise homeopathic medicine and advocate its safety and efficacy.

It is not Council’s purpose to endorse any particular complementary or alternative medicine or practice; however, Council believes it is necessary for pharmacists to have a basic knowledge of complementary and alternative medicines to engage with and advise patients appropriately.

This approach also ensures pharmacists can meet their duty of care to patients and the profession. Pharmacists should be able to counsel patients about complementary and alternative medicines’ general use, the current evidence and any safety issues, including their use with other medications.

Pharmacy Council July 2015 Newsletter

Although I’m glad to finally see a statement from the Pharmacy Council about homeopathy, I am disappointed at the weakness of this statement. Especially in contrast with their clear and strong code of ethics that requires pharmacists only sell healthcare products with credible evidence of efficacy – something that is clearly not the case for homeopathy.

However, I’m aware that the Pharmacy Council’s role is restricted to the responsibilities set out in the Health Practitioners Competence Assurance Act. So perhaps it would be better to expect professional organisations representing pharmacists to speak out against this. We have recently seen this to be the case with organisations of other healthcare professionals, such as the New Zealand Medical Association whose chair recently agreed on national radio that homeopathy is “just rubbish”.

In New Zealand there are two professional organisations (that I’m aware of) that represent pharmacists: the Pharmacy Guild and the Pharmaceutical Society. They are not so limited in position by the law as the Pharmacy Council, so I would hope to see stronger positions supporting science based healthcare from them.

Over the weekend, the annual Pharmacy Awards were held, hosted by both the trade magazine Pharmacy Today and by the Pharmacy Guild. Surely, at an event like this we should expect to see a celebration of outstanding examples of pharmacies providing quality healthcare services, right? For the most part, I hope, that may have been the case, but I was rather disheartened to see one award that flies in the face of this goal.

The official description for the Best Complementary Healthcare Campaign award is (with my emphasis added):

To win this award you need to have come up with a complementary health promotion or ongoing programme that has contributed to improved retail result, in areas such as, vitamins, supplements, sports nutrition or homeopathy.

Pharmacy Awards | Best Complementary Healthcare Campaign

I was shocked and dismayed to see this. Pharmacists should win awards for providing an excellent healthcare service. Not for selling more fake medicine.

Of the previous winners listed, one is Auckland pharmacist Martin Harris. I’ve written about him briefly before in another article about homeopathy being sold in New Zealand pharmacies, quoting him from a Pharmacy Today article in which he defended the practice:

Auckland pharmacist Martin Harris says there is good evidence for homeopathy in the field of quantum physics.

“There’s no placebo-controlled, double-blind randomised controlled trials using one remedy and one result because homeopathy doesn’t work that way, it works on energy,” Mr Harris says.

Conventional medicines have been proven to have side effects and contraindications, but pharmacies still sell them, he says.

Mr Harris, who specialises in nutrition medicine, admits he is no expert when it comes to homeopathy, and his Massey pharmacy sells only a few homoepathy products.

But he would be very disappointed if he was not allowed to sell the products as an option, he says.

Pharmacists support patient choice with homeopathy – Pharmacy Today

Mr Harris last won the “Best Complementary Healthcare Campaign” award in 2012, but perhaps you could hope the pharmacist community has since stopped celebrating such massively misguided interpretations of the evidence (and ethics) surrounding homeopathy. Unfortunately, this does not seem to be the case, as Mr Harris took home the Supreme Award at this year’s Pharmacy Awards despite selling homeopathic products in his pharmacy and appearing to be proud of it.

The pharmacist community makes no secret of the fact that it wants to play a larger role in New Zealand’s healthcare system, calling for changes such as allowing pharmacists to dispense contraceptive pills without a prescription and and provide a substitute for a GP’s services in some circumstances. From my position as an external onlooker, it does seem like there is a certain degree of pharmacists wanting to extend their practice and doctors trying to defend their turf, although I also think both sides have good arguments to make. So long as any changes primarily act to serve the healthcare needs of the public, I’m happy.

However, running a successful pharmacy is a balancing act between running a profitable retail store and providing a reliable healthcare service. Pharmacies can do a great job at improving access to essential healthcare services such as vaccinations and smoking cessation, but on the other hand many of them also boost their profits by selling healthcare products that do nothing aside from emptying your wallet. A recent opinion piece in Pharmacy Today that acknowledged this balance recommended upselling Vitamin C when customers asked about cold/flu products. While this would surely increase the pharmacy’s profits, the best available evidence doesn’t show that Vitamin C supplementation can help with the common cold or influenza.

There is a clear need for leadership within the pharmacist community regarding putting customers’ healthcare needs before profits. We trust pharmacies to provide us with reliable healthcare products and advice, but so long as they keep fake medicine on their shelves I’m not convinced they deserve this trust. To quote the hover text of this relevant xkcd strip:

I just noticed CVS has started stocking homeopathic pills on the same shelves with–and labeled similarly to–their actual medicine. 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.

Randall Munroe – xkcd: Alternative Literature

I believe pharmacists generally do care about providing the best health outcomes for their customers. What I want to see is more pharmacists putting patients before profits, following in the footsteps of Australian pharmacist Grant McGill by choosing to remove homeopathic products from their shelves.

Ethical Pharmacy Practice 4: Paving the Way

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

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

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

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

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

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

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

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

Position statement: homeopathy – Royal Australian College of General Practitioners

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

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

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

Doctors Told to Stop Prescribing Homeopathic Products – Radio NZ

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

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

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

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

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

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

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

Pharmacist bins ‘crap’ homeopathic products – The West Australian

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

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

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

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

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

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

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

Safe Effective Pharmacy Practice Code of Ethics – Pharmacy Council of New Zealand

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

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

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

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

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

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

Pharmacists Support Patient Choice with Homeopathy – Pharmacy Today

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

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

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

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

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

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

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

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

Green Cross Health

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

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

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

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

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

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

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

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

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

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

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

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

Press Council Complaint: Homeopathy in the Wairarapa Times-Age

In February this year, an article was published in the Wairarapa Times-Age (both in print and online) headlined Use of natural remedies is on the rise. The article discussed some specific cases of so-called “natural remedies” being used to treat serious diseases, such as intravenous vitamin C for leukaemia and homeopathy to treat various forms of cancer.

Except for a brief mention at the bottom of the article encouraging people with cancer to talk to their doctor before using any “alternative therapies”, there was no mention of the fact that none of the treatments discussed are supported by any reliable evidence. Instead, the article uncritically included various quotes such as this, from homeopath Claire Bleakley:

Featherston-based homeopath Claire Bleakley said she has treated cancer patients using similar natural remedies [to intravenous vitamin C] – significantly extending life expectancy.

She mentioned two of her patients in particular: A man with tumours who lived for seven years after being given two to live, and a woman with ovarian cancer who lived 15 years past her initial prognosis.

“There have been some exceptional results,” Mrs Bleakley said.

“We are indoctrinated to think chemotherapy is the only cure for cancer, but alternative [remedies] have been proven to be more life giving.”

Medical anecdotes such as these unfortunately tend to be very convincing despite the fact that they can also be completely misleading. The reasons why people might get better are varied and complex. Without running a controlled test, there’s no way to know whether or not a particular treatment contributed to an improvement in health. That’s exactly why we need to undertake rigorous clinical trials before we can say with confidence what the effects of any particular treatment are. It’s also why the Medicines Act prohibits the use of health testimonials like this in advertisements, although that restriction of course doesn’t extend to news articles in publications like the Times-Age.

I thought, and still do think, that the lack of balance in this article has the capacity to do serious harm. I wrote to the editor of the Wairarapa Times-Age to make my case, and to give some suggestions for how they might attempt to mitigate the damage this article could do, in a formal complaint:

To whom it may concern,

I am writing to you to make a formal complaint regarding the article “Use of natural remedies is on the rise” published in the Wairarapa Times-Age this morning:
http://www.nzherald.co.nz/wairarapa-times-age/news/article.cfm?c_id=1503414&objectid=11399310

This article uncritically promotes the use of so-called “natural remedies” such as vitamin C or homeopathy for the treatment of cancer. They are promoted by the inclusion of quotes such as “There have been some exceptional results”, regarding the treatment of cancer with homeopathic products.

None of the relevant controversy regarding these treatments is discussed in the article. Although there is a brief note at the end that “those living with cancer [are encouraged] to consult their doctor or specialist before embarking on any alternative therapies”, this does not sufficiently address the important and relevant fact that these treatments are entirely unsupported by scientific evidence, as well as the utter implausibility of treatments like homeopathy.

The failure to discuss the lack of scientific evidence supporting these treatments, as well as the complete lack of plausibility underlying homeopathy, violates the Press Council’s principle of “Fairness, Accuracy and Balance”. The description of this principle on the Press Council’s website states that:

“Publications should be bound at all times by accuracy, fairness and balance, and should not deliberately mislead or misinform readers by commission or omission. In articles of controversy or disagreement, a fair voice must be given to the opposition view.

Exceptions may apply for long-running issues where every side of an issue or argument cannot reasonably be repeated on every occasion and in reportage of proceedings where balance is to be judged on a number of stories, rather than a single report.”

This is not a long-running issue in which readers can readily be expected to be familiar with the lack of evidence supporting the treatments discussed in the article, so the exception should not apply. There is significant controversy surrounding the issues discussed in this article, but a fair voice has not been given to the opposition view.

Particularly as this article could lead to people living with serious diseases such as cancer to rely on ineffective treatments such as homeopathy, its lack of balance has the potential to cause real and serious harm. Therefore it is important that the Wairarapa Times-Age take appropriate action to prevent this harm by amending the article, publishing a prominent correction, or publishing a followup article linked to from today’s article, that discusses the lack of evidence and plausibility underlying the treatments discussed in today’s article.

If the Wairarapa Times-Age has trouble finding any experts to talk to about this topic, either the Society for Science Based Healthcare (http://sbh.org.nz/contact) or the Science Media Centre (http://www.sciencemediacentre.co.nz/contact-us/) will be able to help.

Sincerely,

Mark Hanna
Society for Science Based Healthcare

Despite sending a follow-up email a few days later, I still hadn’t heard back from the editor over the next 10 working days, which is the deadline set in the Press Council’s complaints process as the time to wait before escalating a complaint to them if you don’t hear back from the editor. After I forwarded my complaint to the Press Council, the editor contacted me to apologise that he’d overlooked my complaint messages, which was apparently due to his having to deal with another complaint about the same article from Peter Griffin, manager of the Science Media Centre (Peter is also the editor and manager of Sciblogs, where my blog is syndicated, and we’d discussed our complaints via email prior to submitting them).

When I forwarded my complaint to the Press Council, I fleshed it out a bit more. I won’t quote the whole thing here as a lot of it would just be repeating myself, although I’d be happy to share my full complaint if anyone would like to see it, but here is one part I added that I think is important and worth sharing:

As far as I’ve been able to tell, the Wairarapa Times-Age has not published a large number of articles regarding this, so it cannot be argued that the counterpoints have already been published in earlier articles.

When it comes to whether or not readers can be expected to be familiar with the important facts not mentioned in this article, I would like to bring the Press Council’s attention to a 2009 study (I am not aware of any more recent data collected on this) published in the New Zealand Medical Journal entitled “Beliefs about homeopathy among patients presenting at GP surgeries”. This study can be accessed for free on Page 94 of this PDF:
http://www.nzma.org.nz/__data/assets/pdf_file/0010/17794/Vol-122-No-1295-22-May-2009.pdf

This study found that only 8 out of 124 respondents disagreed to some extent that “There is good scientific evidence that homeopathy works”, and only 24 respondents reported that they believed homeopathic products were either “very dilute” or that there was “nothing there”. In contrast, 82 respondents agreed to some extent that “There is good scientific evidence that homeopathy works”, and 80 believed that homeopathic products are either “Very concentrated”, “Moderately concentrated”, or “Moderately dilute”.

Contrary to these common beliefs, most homeopathic products are diluted to the point that it is astronomically unlikely that there is even a single molecule of the original ingredient present in the product, and there effectiveness is thoroughly unsupported by scientific evidence. For example, a rigorous review undertaken by the Australian Government’s National Health and Medical Research Council (NHMRC) in 2013 investigated the evidence regarding homeopathy for 68 clinical conditions and concluded that “The available evidence is not compelling and fails to demonstrate that homeopathy is an effective treatment for any of the reported clinical conditions in humans”
(https://www.nhmrc.gov.au/_files_nhmrc/file/your_health/complementary_medicines/nhmrc_homeopathy_overview_report_october_2013_140407.pdf)

For this reason, and especially because the article discussed the use of ineffective therapies in the treatment of terminal illness, it is very important that stories such as this be balanced. As I stated in my original complaint to the editor, I believe the article in its current form has the capacity to do serious harm and that the Wairarapa Times-Age has a responsibility to mitigate this harm. An appropriate response would be amending the article, publishing a prominent correction, or publishing a followup article linked to from the article from the 10th of February that discusses the lack of evidence and plausibility underlying the treatments discussed in today’s article.

(The NHMRC link I provide there is from their 2013 conclusion. Within 2 weeks of submitting this complaint, however, they released their final statement on homeopathy, which states “there are no health conditions for which there is reliable evidence that homeopathy is effective”. This statement was not reported in the Wairarapa Times-Age)

Once the complaint was escalated to the Press Council, the editor of the Times-Age was given an opportunity to respond, then I had a final opportunity to write a short response to that. His primary argument was that the topic of “alternative medicine” was a long-running issue in a wider context, and that the exemption to the principle of balance should apply because other media have reported on the opposing side of the issue.

I strongly disagree with this argument. Although it’s true that media like the Wairarapa Times-Age do not exist in a vacuum, I don’t think this should mean that they don’t have a responsibility to provide balanced articles for their readers. The way I interpret the Press Council code, the exception can be useful when an article is part of a series of articles on the same issue, and when taken in the context of other articles in the series the overall view still maintains an appropriate balance. In the interest of balanced reporting, I believe exceptions to the principle of balance should be applied very sparingly.

Unfortunately, the Press Council disagreed with me. They have ruled not to uphold the complaint, and you can view their entire decision on their website here:
Case Number: 2426 MARK HANNA AGAINST WAIRARAPA TIMES-AGE

Here’s a link to their similar ruling regarding the complaint from the Science Media Centre:
Case Number: 2425 SCIENCE MEDIA CENTRE AGAINST WAIRARAPA TIMES-AGE

Here is a summary of their decision:

The Press Council agrees with the editor that the debate over alternative remedies is sufficiently well known not to require balancing comment in every story about them. The subject falls within the exception to the principle of balance for issues of enduring public discussion.

The complainant in this case raised the important question of whether the exception can be invoked for an article in a newspaper that may not itself have covered both sides of the debate. The Council considered this point closely and came to the view that the exception has not been applied as narowly as the complainant contends and should not be. A newspaper, even if it is the sole newspaper of its locality, does not exist in a vacuum. Its readers, meeting an uncritical story on the supposed popularity of homeopathy and natural remedies, are likely to be aware the efficacy of these treatments is strongly contested by medical science.

I think this is a very worrying precedent to set. Newspapers such as the Wairarapa Times-Age can now feel justified in publishing unbalanced articles on topics such as homeopathy without feeling bound to uphold the Press Council’s principle of balance. The public have a reasonable expectation, given that the Press Council exists to uphold standards in reporting and its first principle is that articles should be accurate, fair, and balanced. While it’s a good idea to take everything you read with a grain of salt, you should be able to feel justified in expecting media reports on controversial topics to provide a balanced view. I worry that people might read articles such as this with that assumption in mind, and falsely conclude that the views omitted from the article are not merited.

I’m also rather frustrated that the Press Council concluded that anyone reading articles such as this is “likely to be aware the efficacy of these treatments is strongly contested by medical science” even though I provided data from a survey that found only 6% of respondents disagreed that “there is good scientific evidence that homeopathy works”. I understand that the survey I cited was conducted 6 years ago, but as I said in my complaint I’m unaware of anything more recent.

Although I don’t think it is, I really hope that the Press Council’s conclusion that most people are aware that homeopathy is not supported by evidence is correct. Following last year’s story about Green MP Steffan Browning backing homeopathy for ebola and March’s story about the Australian National Health and Medical Research Council concluding that homeopathy does not improve people’s health, I think there is some basis to believe that more people are familiar with the lack of evidence surrounding homeopathy than 6 years ago, but I don’t expect there would be that large a difference.

One positive thing to take away from this, at least, is that the journalist who wrote the article said in a Facebook comment that she understood the article was unbalanced and that she should have done better. I hope she’ll take this as a learning experience and, when she or other Wairarapa Times-Age reporters write on matters of “natural health” in the future, that they get in touch with the Science Media Centre to provide that much-needed balance. If we can’t rely on the Press Council to hold journalists to a high standard of balanced reporting, then we’ll have to rely on journalists’ and editors’ own standards.

EDIT 2015/04/14 10:05 am: Peter Griffin, who also complained to the Press Council about this article, has published his thoughts on the ruling as well: When balance goes out the window

EDIT 2015/04/04 1:13 pm: The Wairarapa Times-Age has published a short article on this ruling: Times-Age supported by Press Council

EDIT 2015/04/14 2:21 pm: Grant Jacobs has also published a post with his thoughts on this ruling: Press Council rules on knowing readers minds?

EDIT 2015/04/15 2:51 pm: Andrew Bonallack, the editor of the Wairarapa Times-Age, has published his thoughts on the Press Council decision in an opinion piece for the Times-Age: Your right to choose sacrosanct

Ethical Pharmacy Practice 3: Running Out of Excuses

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

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

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

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

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

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

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

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

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

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

NHMRC Statement: Statement on Homeopathy

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

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

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

    A systematic review of systematic reviews of homeopathy

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

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

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

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

    homeopathy is a placebo treatment.

    Evidence Check 2: Homeopathy

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

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

    Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence

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

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

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

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

Ethical Pharmacy Practice 2: Time for a Spring Clean

In July, I wrote an article on Ethical Pharmacy Practice and Homeopathic No-Jet-Lag. In it, I described the importance of the role pharmacies play in the healthcare system, and their ethical obligation not to mislead consumers or promote ineffective healthcare products. In particular, I described an advertisement I saw in an Auckland pharmacy for a homeopathic product called “No-Jet-Lag”, and the complaint I submitted to the Advertising Standards Authority about it via the Society for Science Based Healthcare. There’s also a write up of this decision and the 2 others released at the same time on the Society’s website: Pharmacy to Remove Homeopathic Product Following Complaint

On the 9th of October, the ASA released their decision to the public. They ruled to uphold my complaint, which means the advertisement has to be removed. More importantly, in response to my complaint the pharmacy made a promise to remove the product from sale if the complaint was upheld. Here’s what they said:

We believe that the manufacturer, Miers Laboratories ought to respond to the substantive complaint that it’s [sic] representations fail to comply with the Therapeutic Products Advertsing [sic] Code.

We believe that the product is sold in many pharmacies in New Zealand and it is somewhat arbitrary that our pharmacy is the subject of the complaint.

We are interested in the outcome of the complaint and can indicate that if the Authority upholds the complaint we will remove the product from sale. In the meantime, the product has been removed from the counter and placed on a less prominent position.

I agree with their first two points. While I think pharmacies shouldn’t promote or sell healthcare products without a sound understanding of the evidence behind them and the claims made about them, I also think it’s reasonable to expect the manufacturer (who also produced the advertising in this case) to substantiate the claims. Moving the display to a less prominent position in the meantime seems like a reasonable compromise as well, although of course I’d prefer it if the product were never stocked in the first place.

I also agree with them that their inclusion in this complaint is somewhat arbitrary. For that reason I am not going to specify in this article which pharmacy it was. If you really must know then you can read the full decision on the ASA’s website. As they said, many New Zealand pharmacies sell this product and I think this complaint applies to all of them.

I also think this pharmacy’s promise to remove the product from sale in the event that this complaint is upheld, as it now has been, is the appropriate response. I think that every single New Zealand pharmacy that stocks No-Jet-Lag should follow suit. There are a lot of them. The website for this product even claims on its New Zealand Retail Outlets page that “Most chemists nationwide” stock it.

As I mentioned in my original post on this topic, and in my complaint, New Zealand pharmacists are bound by the Pharmacy Council’s Safe Effective Pharmacy Practice Code of Ethics 2011. Perhaps the most important part of this industry code of ethics, at least in my mind, is section 6.9:

YOU MUST:

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

This is a very fine standard to adhere to, and I would hope that all businesses to which it could possibly apply would adhere to it as well, although realistically I know that’s not the case.

In response to the complaint, Miers Laboratories submitted a few studies to the ASA. They were pretty laughable though when you look at the sample size:

In all our research we base our work on previous studies, the first study for jet lag used 5 people, then it was 10 and at the time the accepted worldwide minimum was 12 for clinical trialOur [sic] bigger study used 19 people.

So basically “most of our studies didn’t even meet the very low minimum accepted size, and even the largest one was tiny”. Very impressive, Miers Laboratories.

The 19 person study they mention is also promoted on their website, and I pre-emptively discussed it in my complaint. It seems the Advertising Standards Complaints Board essentially agreed with my criticisms:

The majority of the Complaints Board said the statement “It really works” was an absolute therapeutic claim and, as such, required a high level of support. However, it noted the trial population in the pilot study was small, the methodology was not robust and the results had not been published or peer reviewed. The Complaints Board also noted the study was an in-house trial conducted by the Advertiser rather than independent research.

Given the weaknesses in the study, the majority of the Complaints Board said the Advertiser had not satisfactorily substantiated the claim the product “really works” and, as such, the Complaints Board said the advertisement had the potential to mislead consumers. Consequently, the Complaints Board said the advertisement did not observe a high standard of social responsibility required of advertisements of this type. Therefore, the majority of the Complaints Board ruled the advertisement was in breach of Principles 2 and 3 of the Therapeutic Products Advertising Code.

For context, Principle 2 of the Therapeutic Products Advertising Code states that:

Advertisements must be truthful, balanced and not misleading. Claims must be valid and have been substantiated.

And Principle 3 states that:

Advertisements must observe a high standard of social responsibility.

This is basically exactly the result I was hoping for, which is great. However, I was a little concerned by one part of the decision:

A minority of the Complaints Board disagreed [that the advertisement was in breach of Principles 2 and 3 of the Therapeutic Products Advertising Code]. It acknowledged the study sent by the Advertiser to support its claims. While it noted the issues with the study, the minority of the Complaints Board was of the view the product was not harmful and said the consequences of the product not working were not significant or serious for the consumer.

I’d expect anyone who has ever paid money for a pill to prevent jet lag would disagree with this, although it is obviously a lot more serious than something like a cancer treatment that doesn’t work. More importantly, although I do agree that it’s important to consider the severity of what happens if the product doesn’t work, I hope that the ASA will not give a free pass to misleading therapeutic advertising simply because it’s for a condition that they deem insignificant.

Now that this complaint has been upheld, the pharmacy in question has promised to remove No-Jet-Lag from sale. I hope this is the start of a spring clean for all New Zealand pharmacies that stock this product. They should follow this responsible example and take the opportunity to examine other products they have for sale – especially homeopathic products – to ensure that they are abiding by their ethical duty not to promote or supply healthcare products for which there is no credible evidence of efficacy.

You can help. Next time you see a homeopathic product in a pharmacy, ask them what the evidence for it is. If you see this particular product, ask them if they’re aware that the Advertising Standards Authority upheld a complaint against it on the basis that the evidence for it just isn’t good enough.

EDIT 2014/10/12

It’s great to see that several media outlets have picked up this story: