Category: Law

Official information kept secret too long

Official information kept secret too long

Official information is being kept secret for longer than it should be. For the past few months, I have been gathering and analysing data from 12 government agencies, looking at how they handle requests made under the Official Information Act.

My findings reflect what many have observed more anecdotally: responses to requests for information are often sent at the very last minute, and seem to often be delayed unnecessarily. Though it can be difficult to demonstrate that a response was not sent “as soon as reasonably practicable” — a requirement under the law — in any particular case, looking at a larger data set reveals some of the strategies used to delay the release of official information.

You can read my article here: Official information kept secret too long

NZ Police pursuits keep killing people

NZ Police pursuits keep killing people

Despite a repeated cycle of calls for change, people keep dying in police pursuits in New Zealand. Just today, a teenager and a child died as the result of a police pursuit in Palmerston North.

News stories like these keep appearing. In February this year I asked NZ Police to release a number of statistics regarding police pursuits so I could examine what, if anything, has changed. I began to write about it in March but didn’t end up publishing it, having intended to put it on a new “features” subdomain I’ve been working on where I’ll be able to do some more complicated stuff than WordPress will allow.

One of the statistics I included was the number of people who have died as a result of police pursuits since the most recent review began. I’ve gotten very sick of having to update that number. So out of that frustration, I’ve published my article. You can read it here: NZ Police pursuits keep killing people

New Zealand should not regulate naturopaths

New Zealand should not regulate naturopaths

Naturopaths can kill, but regulating them is not the answer.

Over the weekend, the Sunday Star Times published an article by Simon Maude on an unnamed naturopath whose inept attempts at cancer treatment led to the death of an Auckland woman last year: Naturopathy under microscope after cancer sufferers speak from under shadow of death

At the same time, an article syndicated to Stuff from the Sydney Morning Herald detailed a court case in which a naturopath in Australia nearly killed a baby through their dietary advice for the infant’s eczema: Australian naturopath admits ‘raw food’ diet advice endangered baby’s life

As a result, the question has been raised of whether or not naturopaths should be regulated in the same way as medical doctors, pharmacists, and chiropractors.

In the Sunday Star Times article, vice president of the New Zealand Society of Naturopaths Sharon Erdrich laments what she sees as the root of the problem:

New Zealand Society of Naturopaths vice-president Sharon Erdrich says the society wants tighter regulations.

“In Germany, naturopaths are very heavily regulated, there’s regulation in the United States and Australia has some controls.”

Even though there is “potential for harm, basically anyone in New Zealand can call themselves a naturopath,” Erdich says.

(As an aside, Ms Erdrich’s clinic offers such bogus health services as quantum reflex analysis and live blood analysis, and an article she published in 2016 says “The first, and most important thing you can do” if you have cancer is to book an appointment with a naturopath.)

This argument was continued in an editorial in The Press this morning: New Zealand should require naturopaths to be registered

Here is the root of the argument, as expressed in that editorial:

Naturopathy is also enabled by tertiary institutes offering courses which are recognised by the official New Zealand Qualifications Authority framework.

This means that, even though anyone can claim to be a naturopath in New Zealand (there is no law stopping them), practitioners can arm themselves with diplomas and degrees and present themselves as equal to other health professionals.

That being the case, safeguards should be put in place for the public.

The most useful of these would be to require naturopaths to be registered, and made subject to similar disciplinary processes demanded of other health professionals when they can’t make good on their promises.

NZQA approving courses on quackery, such as their Certificate in Acute Prescribing with Homeopathy, is a real problem. But these calls for naturopaths to be registered are missing the point, I think.

The problem is not that “anyone can claim to be a naturopath in New Zealand”; the problem is that naturopathy is quackery. We already have regulation to address quackery, the real problem is that the existing regulation is not adequately enforced. Both the Fair Trading Act 1986 and the Medicines Act 1981 prohibit the misleading claims which are the basis of the practice of naturopathy.

For example, the Fair Trading Act prohibits the use of any “unsubstantiated representations”, as well as “conduct that is misleading or deceptive or is likely to mislead or deceive”, in trade. The Medicines Act prohibits the use of health testimonials (which can be both very convincing and entirely misleading), and claims to treat serious illnesses such as cancer, in advertisements.

The Sunday Star Times article also notes that naturopaths, despite not being subject to specific regulation, are still subject to the Health and Disability Code of Rights:

Regulation is not being considered as the ministry has not received an application from naturopaths to become regulated under the Health Practitioners Competence Assurance Act 2003.

Health practitioners including naturopaths remain subject to the Health and Disability Code of Rights, “whether they are regulated or not”.

Consumers may complain to the Health and Disability Commissioner about care.

The Health Practitioners Competence Assurance Act 2003, which regulates professions such as medical doctors and pharmacists, also prohibits anyone from claiming or implying that they are registered as or qualified to be registered as any type of regulated health professional. This is the provision that could prevent anyone not registered from calling themselves a naturopath.

We have already seen, here in New Zealand, that regulating a health profession prone to making misleading claims does not stop that practice. In research conducted by myself and Mark Honeychurch in 2016, we found that the majority of New Zealand chiropractors who advertise online make misleading claims about what they can treat. Including them in the regulatory scheme has not stopped this behaviour at all, rather it has just allowed them to continue misleading patients from a position of authority, able to use the protected title of “Dr”.

The Health Practitioners Competence Assurance Act sets up authorities to regulate each health profession that is composed of members of that profession. The Medical Council, the Pharmacy Council, and the Chiropractic Board are all examples of this.

But a Naturopathy Board filled with naturopaths would not be able to effectively regulate naturopaths. Quacks can’t regulate quacks effectively. All regulating them would do is give them the appearance of legitimacy and authority.

The real problem with all of this regulation is that it is not enforced. The solution, therefore, should be simple: enforce it.

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.

Strip searches in prisons – what is reasonable?

Strip searches in prisons – what is reasonable?

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

Here’s an excerpt:

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

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

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

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

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

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

Keep reading

Misleading claims common among chiropractors

Misleading claims common among chiropractors

Most New Zealand chiropractors make misleading claims.

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

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

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

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

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

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

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

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

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

Statement on advertising | Chiropractic Board of Australia

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

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

…

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

Advertising Policy | New Zealand Chiropractic Board

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

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

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

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

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

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

Are You an Organ Donor?

Are You an Organ Donor?

Organ donation is important. When a person dies in a way that leaves them brain dead but their other organs still viable, such as an intracranial haemorrhage in an intensive care unit, their organs can be transplanted to save others’ lives in a way nothing else can. Only a few organs, kidneys for example, can be donated by live donors. But others, like lungs and hearts, can only be given posthumously.

This is something most of us will already know, but it’s something else entirely for it to have saved the life of someone you know. I want to start this article by telling you a story.

Poppy McKay is a family friend. She’s 24 years old, and she is probably alive today because of an organ donor who is sadly not.

She was diagnosed at birth with cystic fibrosis, an incurable genetic disease that primarily affects her lungs and digestive system. For her whole life, she’d been in and out of hospital, having to undergo daily treatment.

In early 2012, most of her treatment was stopped as it was no longer being effective. The only option left to her, she was told, was to be assessed for a lung transplant. She was put on the active list later that year. She spent her 21st birthday on the list, and by the end of the year could barely walk up the stairs at home. Her lungs were so weak she wasn’t even able to blow into the machine to measure their function.

But then the phone rang, and the transplant coordinator said she should go to the hospital immediately because they had a pair of lungs for her. After a long operation starting in the early hours in the morning, she came out of the operating theatre with a new pair of lungs.

Since the transplant, she progressed from breathing with help from a machine, to breathing on her own, to walking with a frame, and then without one. When I see her now, you could tell me she’d never been sick a day in her life and if I didn’t know better I might believe you.

Organ donations like this are very special. They can save the lives of multiple people, but only at the cost of another life. I think it says a lot about a person, and their family, when they allow this to be done.

Are you an organ donor? When I ask that question, do you think to check your driver licence? That’s the closest thing New Zealand has to recording a person’s status as an organ donor. When you apply for a driver licence, as part of the process you are asked this question:

Would you be willing to donate organs in the event of your death?

New Zealand Transport Agency | Organ and tissue donation

You can’t apply for a licence unless you tick either “Yes” or “No” in response to this. If you tick “Yes” then the word “DONOR” will be printed on your licence. Either way, you’ll very likely consider the question answered and not worry about it for most of the rest of your life, and you might feel justified in doing that. But you’d be wrong.

When I was applying for my licence a few years ago, I noticed this text on the NZTA website (the emphasis is mine):

Ticking the ‘Yes’ box on your driver licence form only means that you have indicated your wish to be identified as an organ and tissue donor. It does not automatically mean that your organs or tissues will be donated in the event of your death. In practice, your family will always be asked for their agreement to organ and tissue donation.

If your family knows what your wishes are in regard to donation, they will be more likely to follow them through in the event of your death. Having your wishes displayed on your driver licence is just one way of making them known to your family. You should also discuss your decision with them.

New Zealand Transport Agency | Organ and tissue donation

I emailed Organ Donation New Zealand about this in 2012, to ask if there was anything I could do that would guarantee that my wish to be an organ donor would be respected if I were ever in a situation where I was a potential organ donor. I was told that my family and friends would be asked about my wishes and if they would agree to consent. I emailed them again last week and they confirmed that this answer is still true today.

I’m lucky in that my family and I are on the same page about organ donation. Having spoken to them about it recently, I can be entirely confident that they would respect my wish to be an organ donor if they ever had to. I’m sure not everyone is in the same position, although until recently I could only speculate as to how common that would be.

Last week, Andy Tookey from the organ donation lobby group GiveLife released a press release in response to information released to him under the Official Information Act. Mr Tookey was kind enough to send me the documents released to him, and gave me permission to publish them here.

The document includes a copy of the most recent audit of potential donor deaths in New Zealand. One part of this document in particular was very interesting to me, and I’ve duplicated it here:

ICU deaths 1,123
Ventilated in ICU and died with severe brain damage 367 (33% of ICU deaths)
Of these 367
Discussed with Organ Donation New Zealand 35% (129)
Organ donation mentioned 43% (159)
Organ donation formally discussed 37% (135)
Of the 135 where organ donation was formally discussed
Families agreed to donate 39% (53)

It’s that last figure in particular which I find interesting. In all the cases where organ donation was formally discussed with the family of a potential organ donor in 2015, they only agreed to it 39% of the time. The reasons the families refused the remaining 61% of the time weren’t recorded, and I could imagine in some cases they might have known their loved one did not want to be an organ donor.

For comparison, I’ve seen several figures of the proportion of NZ driver licences with “DONOR” printed on them, which all centre at around 50%*. Given the discrepancy between this and the proportion of families that agreed, it seems likely at least some of the time the family would have acted against their loved one’s wishes and prevented them from being an organ donor.

To help make sense of all this I spoke to Associate Professor Colin Gavaghan, an expert in medical law and ethics at Otago University. I asked him about what the law says about how organ donation handles informed consent, what problems he sees with the current system, and what could change so someone could be assured that their wish to be an organ donor could be respected even if their family disagrees. Here’s what he told me:

The use of organs in NZ is covered by the Human Tissue Act 2008. The Act has a number of stated purposes, the first of which is to ensure that the collection of human tissue occurs only with proper recognition of, and respect for:

  • the autonomy and dignity of the donor;
  • the cultural and spiritual needs, values, and beliefs of the deceased’s immediate family;
  • the cultural, ethical, and spiritual implications of the collection or use of human tissue; and
  • the public good associated with collection or use of human tissue.

Straight away, the potential for conflict between some of those objectives becomes obvious. How are medical staff to balance the autonomous wishes of the deceased with the beliefs of their immediate family, if those are not aligned? How is the public good of organ donation to be balanced with the “cultural, ethical and spiritual” values of those who don’t agree with organ donation?

Luckily, the Act makes it clear that those objectives are not equally weighted. As the Ministry of Health point out “The Act makes informed consent the fundamental principle underpinning the lawful collection and use of human tissue from deceased people.” [http://www.health.govt.nz/our-work/regulation-health-and-disability-system/human-tissue-act/about-human-tissue-act]

What that means is that if you have documented your wishes before you die, those wishes should be the most important determinant of what happens after death. No other authority is needed.

That’s the theory, anyway. In reality, there are a few factors that make things a bit more complicated.

1. The Act doesn’t require doctors to take your organs. Your consent authorises the salvaging of your organs, but it doesn’t make it compulsory for anyone to do so. In some ways, this discretion seems sensible. We wouldn’t, I assume, want to force doctors to harvest organs that are likely to be unsuitable for transplant. There may also be cases where evidence arises that the deceased may have changed their mind after indicating their consent. More controversially, the MoH notes that ‘the immediate family may be distressed by a decision to proceed with donation.’ How much weight should be given to that is contentious, and I’ll come back to it in a minute.

2. By far the most common way for New Zealanders to record their wishes about organ donation is via their driving licenses. Both the Act and the MoH make it clear, however, that this won’t constitute “informed consent” for legal purposes.

I can see why this would be the case. Unlike the UK’s donor card, for instance, the NZ driving license doesn’t allow people to specify which organs they would be willing to donate. (I’ve never really understood what would motivate someone to agree to donate all of their organs, but not, say, their pancreas. But ultimately, it’s their choice.)

This is problematic for a couple of reasons. One is my suspicion that most people who fill out that part of the license actually do so believing they are giving legally valid consent. If so, that’s just bad in itself; if we value autonomy (as the Act claims to) then it seems generally wrong when people do things under false beliefs. But it might also be bad in that it discourages them from taking other steps that might actually be legally significant. Why bother if you think the info on your driving license is enough?

Even if people were to recognise that the driving license doesn’t amount to “informed consent”, it isn’t entirely obvious what they could do instead. Unlike the UK and Australia, NZ doesn’t have a register where people can record their wishes. The Act provides that one could be set up, but thus far, there has been no political will to establish one.

I’m not sure whether establishing a register would be worthwhile in terms of increasing the supply of donor organs. It’s possible that it would cost too much to set up and run, and divert too much money from more worthwhile initiatives. But there may be cheaper options available that could be almost as effective.

Although they were rendered largely redundant by the Register, I still have my UK Donor Card, a wallet-sized statement of willingness to donate my organs after I die. It contains simple tick boxes to indicate views regarding specific organs.

I can’t think of any reason why something similar couldn’t be distributed in NZ, and be so constructed as to contain enough information to constitute “informed consent”.

3. The Act makes it clear that, where valid consent is obtained from the deceased, no-one else should be able to override that. As the MoH says: “The framework does not allow others to legally veto an individual’s consent”.

In practice, however, we know that immediate family (and sometimes more distant family) are routinely asked to make the decision. Unfortunately, this doesn’t just happen in NZ, but in the UK as well. It happens even in situations where the relevant law has made it clear it isn’t required.

There can be good reasons to consult the family of the deceased. As the UK NHS explains, “In the event of your death, the person closest to you (usually your next of kin) will be asked to confirm that you hadn’t changed your mind before your death.” (http://www.nhs.uk/conditions/organ-donation/Pages/Donationprocess.aspx)

A lot can depend, though, on how the approach is made and the questions asked. There’s a difference between asking the family if the deceased changed their mind, and asking them for their own consent. In the UK, where it’s also worryingly common for families to override consent in this situations (500 recorded instances since 2010) various strategies are being tried out to reduce this phenomenon.

For instance, the relatives of the deceased can be provided with an information sheet, gently but clearly explaining that the deceased has consented to organ donation, and that this will be what happens unless they know of a good reason why it should not. This might not sound very different to what happens at the moment, but the hope is that it will make it clearer that it isn’t up to the family to decide what should happen, but rather, to inform the medical staff of any relevant information that they may not know.

What of the situation where the bereaved relatives are genuinely distraught at the prospect of the organs being taken? There’s no clear answer here, but my own view is that the wishes of the deceased, and the value of the potential donation, should still carry greater weight.

There are 3 reasons why I say this. First, we don’t give that sort of weight to family wishes in any other circumstances. If I refuse life-saving treatment, that refusal has to be honoured, regardless of how much my family might want me kept alive. Likewise, I can’t imagine any competent adult having their consent to treatment being invalidated on the basis that their family don’t wish them to have it.

We have, as a society, accepted the primacy of individual autonomy in just about every other medical situation. It isn’t clear why organ donation should be the exception.

Second, it isn’t clear to me that immediately bereaved people are generally in a state of mind to make properly reflective choices about such matters. Certainly, it doesn’t seem likely that they will make a better decision (in the sense of being a balanced one) than that made by the deceased themself when they set down their wishes in advance, presumably in the cold light of day.

Third – and this is important – if really we’re going to start down the road of overruling individual autonomy on the basis of the interests of other people, then let’s consider all of those interests – not only those of the immediate family, but those of the potential donor recipients. And their families. Of course, the medical staff who are seeking consent to take organs won’t have to face those people, and explain to them that – while a perfectly good organ was available – someone has just refused to let them have it.

To summarise, I’d favour 2 changes:

  1. A means should be made available for people to express their wishes about organ donation in a manner that will be regarded as legally valid consent. This could be via a register, or a donor card, or something else. This should replace the section of the driving license, which has substantial potential to be misleading with regard to its legal status.
  2. Where legally valid consent from the deceased is available, the practice of routinely seeking consent from what will frequently be traumatised, overwrought bereaved relatives should end. Instead, relatives should approached with a sensitive statement to the effect that the deceased has consented to their organs being taken, and that this is what will happen unless the relatives know of any specific reason why it should not. Of course, the possibility remains that certain families with very strong anti-donation views will lie about this, but it’s hard to imagine that being a common occurence.

Associate Professor Colin Gavaghan

I also asked Poppy, as someone who has personally been involved with organ donation, what her thoughts on this issue were:

I have an issue with people not being able to be in “control” of the last wish they could potentially have by, when unable to communicate with them, their families or loved ones can say no to organ donation.

A donor registry could be a good option. I haven’t done a lot of research around it but know it’s successful in some countries. If anything, it brings a hell of a lot more awareness, and even if we still had the same law as the driver’s license one, you would think seeing as a much more informed decision had been made to register themselves as donors, the families may not oppose it as often.

Having been in the position of needing a transplant, I obviously believe that everyone who can be a donor, should be a donor. Everyone who wants to be a donor, should be allowed to keep their wishes.

However, I have never been on the other side. Having to already deal with the fact a loved one is going to die, some people may find it too hard to then have their body “chopped” up and not be buried/cremated whole. I believe that if someone has expressed strongly enough their feelings of being a donor, their loved ones would want to honour it. More awareness needed?

My main advice for people who want to be organ donors and their families is to “have the conversation”. Make sure those who will be responsible to make the decision for you if you’re ever in that situation knows your wishes and how strongly you feel about it. Research success stories of organ donation/transplant and see how life changing it can be for up to 8 people per donor, not only life changing for them but for their families and friends.

Poppy McKay

The idea of a register is one that Andy Tookey from GiveLife has also been pushing for. In my opinion, it seems the current system is simply not robust enough. It fails to capture people without a driver licence, for example, and also isn’t enough to constitute informed consent. I don’t know if a register is the right way forward, but I do think it seems like a good suggestion and I hope it will at least be considered. There should be a way for people to be assured that their wishes regarding organ donation will be respected after they’ve died.

So, what should you take away from this article? If nothing else, remember this:

  • Your driver licence saying you’re an organ donor doesn’t mean you would be if you ever could be
  • In order for you to be an organ donor, it is important that your family understands your wishes, and that you’re on the same page. Talk to them about it.

I would also like to give my sincere thanks to Colin and Poppy for their contributions to this article. Thank you both!

* I’ve seen figures of 48.8%, 49%, and 52% over the past few days, but I haven’t found a primary source for any of them. I’ve asked NZTA for the information via the Official Information Act, but I expect it will take them a while to give it to me. Here’s a link to the OIA request on FYI.org.nz – Organ donor preference on driver licences

Nurofen: Does It Really Target Pain?

Nurofen: Does It Really Target Pain?

Nurofen provides targeted relief from pain. Or does it?

For a long time now, the pharmaceutical company Reckitt Benckiser has sold a range of their ibuprofen product Nurofen, which are marketed for four specific types of pain:

  • Back pain
  • Migraine pain
  • Period pain
  • Tension headache

Since at least 2008, Nurofen has marketed these specific pain relief products saying they “provide targeted relief“. From watching their TV ads, you could be forgiven for believing that Nurofen will “act at the site of the pain” or “target headaches at the source of pain“. Their logo, a bullseye target, is often shown alongside the tagline “Targeted relief from pain”. Their New Zealand website describes their range as being “made up of a number of different products to target specific conditions, from back pain to cold and flu symptoms”. This Nurofen TV ad from the UK even shows a Nurofen logo performing a sort of “seek and destroy” manoeuvre to find a bull in a maze the shape of someone’s head, in a metaphor for dealing with headache pain.

The Nurofen brand really has been built around the idea of “targeted relief”. The message is clear, or at least I thought so when I saw ads like these on TV. But is it true?

Well, it’s complicated. The main Nurofen products come in two formulations, containing either 200 mg ibuprofen or 342 mg ibuprofen lysine (which is equivalent to 200 mg ibuprofen). There is evidence that these products can provide pain relief, but the way in which they do so is not targeted. In fact, all of the specific pain products have identical formulations: 342 mg ibuprofen lysine. It doesn’t matter if you have back pain, period pain, migraine pain, or tension headache. You can take any of those Nurofen products for the same effect.

In 2010, Australian consumer affairs magazine Choice awarded Nurofen their “shonky” award for these products. They revealed not only that these specific pain products are identical and unnecessary, but also found:

The shonkiest aspect is that, in some stores we surveyed, the targeted painkillers are almost twice as expensive as their all pain equivalent products.

The 2010 Shonky Awards: Shonky for pain in the hip pocket | Choice

In 2011 the Therapeutic Goods Administration (TGA), which is roughly the Australian equivalent of New Zealand’s Medsafe, received a complaint about this advertising from Professor Paul Rolan. The complaint essentially said that, although the products were effective, the claims that they provide “targeted relief” were misleading. The legislation administered by the TGA prohibits advertisements for therapeutic goods from being misleading, so the complaint was investigated. If you want to read more about this complaint, I wrote about it last year: The Price of Painkillers Part 2: Only Misleading in Australia

The TGA found that Professor Rolan’s complaint was justified, and issued sanctions to Reckitt Benckiser saying they must withdraw the misleading advertisement and representations (the TGA didn’t have jurisdiction of the products’ packaging, except when images of it were used in advertisements). But that didn’t stop Reckitt Benckiser from claiming that Nurofen offers “targeted relief”. Instead, they issued a statement two months later saying they would not comply with the TGA’s sanctions:

Nurofen advises that consumers will continue to see the familiar branding on the Nurofen target and messages of Nurofen working at the site of pain. This branding includes TGA approved claims on packs that Nurofen provides targeted relief from pain

Nurofen maker says ads will carry on | Australian Doctor quoting Nurofen

Three days after that, the TGA made a decision to issue an order to Reckitt Benckiser “as the Advertiser had not fully complied with the Panel’s determination issued on the 30 August 2011”. The order itself came nearly a full year after the decision to issue it, and required that Reckitt Benckiser:

  1. withdraw the “Live Well Headache” television advertisement (“the advertisement”) about the therapeutic good “Nurofen” which was the subject of the complaint;
  2. withdraw any representation, in the context of headaches, that the advertised therapeutic good “Nurofen” goes “straight” to the source of the pain;
  3. not use the representations in (b) above in any other advertisement; and
  4. where the representation has been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representation has been published or is intended to be published by such parties, to advise those parties that the representations should be withdrawn.

…

Pursuant to subregulation 9(2) of the Regulations, the order is subject to the conditions that within 10 working days of being notified of this order, Reckitt Benckiser (Australia) Pty Ltd is required to provide evidence to the delegate of the Secretary [to the Department of Health and Ageing] of compliance by Reckitt Benckiser (Australia) Pty Ltd with the order set out in paragraphs (a) to (d) above including a written response indicating that they will continue to abide by this order.

Nurofen – Reckitt Benckiser (Australia) Pty Ltd – Complaint No. 2011/06/001 | Therapeutic Goods Administration

One month after the order, Reckitt Benckiser advised that they had complied and would continue to comply with the order. But this didn’t slow them down at all.

Associate Professor Ken Harvey wrote an article for The Conversation the month after this response, explaining why the order had essentially failed:

In response [to the order], regional director of Reckitt Benckiser, Lindsay Forrest, said he was, “delighted with the TGA Delegate’s ruling as it validates our decision to challenge the CRP [Complaints Resolution Panel] findings, specifically in relation to our ability to communicate our long standing messages of targeted pain relief in relation to pain, including headaches”. The media statement continued, “Reckitt Benckiser’s current media plan will not be impacted by the TGA Delegate’s decision as it currently complies with all the TGA Delegate’s findings”.

It is my view that TGA delegate’s ruling has unnecessarily and incorrectly limited the Regulation 9 order to the specific words, “goes straight to the source of the pain” thereby failing to taking [sic] into account the CRP’s equal concern about the words, “targeted relief from pain”. In addition, by focusing only on the television ads for headaches and not taking into account the wider ongoing Nurofen campaign that uses look-alike branding the TGA delegate has failed to protect consumers.

TGA failure gives Nurofen consumers a headache | Ken Harvey

Professor Harvey went further, and laid a complaint of his own with the TGA and the Australian Competition and Consumer Commission (ACCC) in August 2012. The ACCC is essentially Australia’s equivalent to New Zealand’s Commerce Commission.

In 2013, Australian consumer affairs show The Checkout aired a segment on Nurofen’s targeted relief products, clearly showing the inconsistency between their marketing and reality with quips such as “When I have a tension headache, I take Nurofen Back Pain for fast, targeted relief”.

By the time that episode aired, the status quo remained unchanged from 2011, when Reckitt Benckiser refused to comply with the TGA’s ruling. As far as I’m aware, nothing changed until March 2015.

EDIT 2015/12/16: Since publishing, I’ve found more information on what happened between 2012 and 2015. Professor Harvey’s 2012 complaint to the TGA, along with another anonymous complaint on the same grounds, was successful. In July 2013, the CRP issued a written determination saying Reckitt Benckiser had breached the Therapeutic Goods Advertising Code.

Just like in 2011, soon after this the TGA was forced to take further action as Reckitt Benckiser had refused to comply with the CRP’s determination. An investigation into this lack of compliance lasted from 16 July 2013 until 11 April 2014, at which point the TGA delegate to the Secretary of the Department of Health decided the TGA was correct and Reckitt Benckiser’s advertisement really was misleading.

Another order was issued to Reckitt Benckiser, saying they must:

  1. withdraw any representations, including implied representations, that imply that any two or more Nurofen products that contain equivalent ibuprofen quantities and include the same product specific indications on the Australian Register of Therapeutic Goods:

    1. are effective only in treating a particualr condition or conditions or pain in a particular part or parts of the body; or
    2. are not effective in treating other conditions or pain in other parts of the body, where they are indicated for those other conditions or pain in particular parts of the body
  2. not use the representations referred to in paragraph (a) above in any other advertisement unless the Advertiser satisfies the Secretary that the use of the representations would not result in a contravention of the Therapeutic Goods Act 1989 (the Act), the Regulations or the Therapeutic Goods Advertising Code 2007 (the Code)
  3. where the representations in paragraph (a) have been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representations have been published or are intended to be published by such parties, to advise those parties that the representations should be withdrawn.

Nurofen – Reckitt Benckiser (Australia) Pty Ltd – Complaints No. 2012-08-010 and 2012-10-024 | Therapeutic Goods Administration

As with their order in 2011, this order was issued with the condition that Reckitt Benckiser must notify the TGA within 10 working days that they’d comply with the order, and supply evidence of this compliance. There was also another condition, regarding how their Nurofen specific pain products must be advertised:

any representation that refers to two or more Nurofen products that contain equivalent quantities of ibuprofen and include the same product specific indications on the Australian Register of Therapeutic Goods must clearly indicate, in the body of the advertisement, that the two products can be used for the same purposes and are interchangeable (or words to that effect). An asterisk in the body of an advertisement with full detail explained elsewhere, for example in a footnote, will not be sufficient to satisfy this condition

Nurofen – Reckitt Benckiser (Australia) Pty Ltd – Complaints No. 2012-08-010 and 2012-10-024 | Therapeutic Goods Administration

On the 9th of May 2014, Reckitt Benckiser said they would comply with this order. But they didn’t. Which takes us to the legal action taken against them by the ACCC in March 2015…

That’s when the ACCC issued a press release saying they were taking Reckitt Benckiser to court:

The Australian Competition and Consumer Commission has instituted proceedings in the Federal Court of Australia against Reckitt Benckiser (Australia) Pty Ltd (Reckitt Benckiser), alleging that it made false or misleading claims that its Nurofen Specific Pain Products were each formulated to treat a specific kind of pain, when the products are identical.

ACCC targets alleged false and misleading Nurofen claims | Australian Competition & Consumer Commission

Today, the Federal Court of Australia has found in favour of the ACCC:

In proceedings commenced by the Australian Competition and Consumer Commission, the Federal Court has found that Reckitt Benckiser (Australia) Pty Ltd (Reckitt Benckiser) engaged in misleading conduct in contravention of the Australian Consumer Law by representing that its Nurofen Specific Pain products were each formulated to treat a specific type of pain, when the products are identical.

Court finds Nurofen made misleading Specific Pain claims | Australian Competition & Consumer Commission

Finally, four years after Professor Rolan’s original complaint and many more after Reckitt Benckiser first started marketing Nurofen as providing “targeted relief from pain”, they were found guilty in court of making misleading claims.

What does this mean for Australia?

The Federal Court’s ruling makes several orders of Reckitt Benckiser. It seems that we won’t see a repeat of Reckitt Benckiser’s 2012 behaviour, as the ACCC’s press release states that:

Reckitt Benckiser admitted that it had engaged in the contravening conduct and consented to the orders made by the Court.

Court finds Nurofen made misleading Specific Pain claims | Australian Competition & Consumer Commission

And what were those orders? They were much more extensive than those given by the TGA three years ago:

The Court ordered that Reckitt Benckiser remove the Nurofen Specific Pain products from retail shelves within 3 months. The court has also ordered that Reckitt Benckiser publish website and newspaper corrective notices, implement a consumer protection compliance program, and pay the ACCC’s [legal] costs.

The ACCC has agreed [on] an interim packaging arrangement with Reckitt Benckiser for use following the removal of these products. This will clearly disclose to consumers that the products are equally effective for other forms of pain.

Court finds Nurofen made misleading Specific Pain claims | Australian Competition & Consumer Commission

A later hearing will also determine what financial penalty will be imposed on Reckitt Benckiser.

What does this mean for New Zealand?

Immediately? Probably nothing. Particularly after seeing how keen Reckitt Benckiser was to avoid changing their marketing in 2011, I very much doubt they are going to change their New Zealand marketing because of an Australian court case.

However, as noted in articles from Pharmacy Today and Stuff today, the Commerce Commission is investigating Reckitt Benckiser in New Zealand for the same reasons. In a Stuff article from March, the Commerce Commission is quoted as saying they were “also looking into the matter and would be following the ACCC’s investigation closely”. So it may only be a matter of time before we see similar legal action against Reckitt Benckiser in New Zealand.

If we do see legal action though, I don’t expect it to be resolved quickly. Even in cases where it’s clear that marketing is misleading, it can take a long time for the Commerce Commission to make a difference. In the only direct experience I’ve had with them, they took two years to issue a warning about a very cut and dried case of misleading advertising from Baa Baa Beads, which had refused to remove misleading advertisements following upheld Advertising Standards Authority complaints.

In the meantime, the best way to protect yourself against misleading marketing is to educate yourself. Be sceptical. If you think a claim might not be true, don’t hesitate to ask for evidence.

What does it mean for consumers?

Not much. You should certainly be aware that Nurofen’s specific pain products are all identical. You can take Nurofen Migraine Pain for period pain, and it will be just as effective as Nurofen Period Pain. You shouldn’t, for example, take both the back pain and period pain products if you are experiencing both back pain and period pain.

You should also be aware that, despite the marketing, ibuprofen painkillers like Nurofen don’t target anything. If you were misled by this, it’s unlikely it caused you any harm, but you still have the right to make informed choices about your health. Harmless or otherwise, misleading marketing about healthcare products like Nurofen does violate this right.

But perhaps the most important message of all to take away has very little to do with Nurofen at all. Because ibuprofen, the active ingredient in Nurofen, is not patented. You can buy a generic ibuprofen painkiller that is equivalent to Nurofen for fraction of the price.

For example, you can buy 24 caplets of Nurofen Back Pain (active ingredient 342 mg ibuprofen lysine, equivalent to 200 mg ibuprofen) for $17.55 from Pharmacy Direct. Or, you could buy 24 “Home Brand” caplets of 200 mg ibuprofen for $2.99 from Countdown. Yes, the branded one does cost over five times as much as the unbranded one.

If you do want to buy Nurofen specifically, make sure you’re not paying more for the same product. When I compared prices for different Nurofen “specific pain” products on Pharmacy Direct last year, I found some were more expensive despite the pills themselves being identical.

As this article discusses specific brands of pharmaceutical products, I feel it is appropriate to state that I have no conflicts of interest to declare.

I have written about this issue previously here:

  1. The Price of Painkillers
  2. The Price of Painkillers Part 2: Only Misleading in Australia

Why Same-Sex Marriage Should Be Legal

The NZ Herald has published an article about the result of an unscientific internet poll on whether or not same-sex marriage should be legalised. Ignoring the obvious issues with lending credence to the results of a self-selecting internet poll, I’d like to focus on one quote from the article in particular:

Opponents of gay marriage say the jump shows people are waking up to the negative social effects of changing the Marriage Act.

In typical Herald style, no source is given for this assertion, but I’ll be nice and not dwell on that failure either.

What I’d like to talk about is that there are no “negative social effects” of allowing same-sex marriage. In fact, many states around the world have legalised same-sex marriage and the very fabric of their society disappointingly failed to unravel in the aftermath.

To the great surprise of homophobes everywhere the only effect of legalising same-sex marriage is same-sex couples getting married. Of course, this fact is conveniently ignored when the laws of their own country are being considered; they all seem to believe that their home is the one place that finally won’t be able to handle the unending horror of some other couples getting married while happening to not be of opposing sexes.

Of course, all of the arguments against allowing same-sex marriage fall flat pretty quickly.

The claim that marriage is somehow intended to be for procreation is bizarre considering that it’s obviously not immoral for infertile people to get married, and that having menopause before you have kids doesn’t mean you also have to have a divorce.

The claim that children need a mother and a father similarly falls flat when you observe not only that single parents are commonplace but that same-sex couples seem to do just fine as parents. For example, to quote a 2008 review by Charlotte J. Patterson published in the journal Child Development1:

To date, however, there is no evidence that the development of children with lesbian or gay parents is compromised in any significant respect relative to that among children of heterosexual parents in otherwise comparable circumstances.

Opponents of marriage equality often also argue that, if a child’s parents are gay, the child might also grow up to be gay. I’m tempted to look up the evidence to see whether or not this claim is true but to be honest I don’t think it matters. So what if legalising same-sex marriage makes being openly gay more common? It’s not as though it will eventually lead to everyone being gay, just like how opposite-sex marriage being legal hasn’t made everyone straight, so we hardly need to worry about humanity dying out because no one’s making babies any more.

The claim that legalising same-sex marriage has negative effects on society in general is pretty obviously untrue when you observe the countries that have legalised same-sex marriage. For example, take a look at Norway, Sweden, Iceland, Denmark, Spain, Canada, Netherlands, and Portugal. Despite having legalised same-sex marriage, these 8 countries (out of 11 which I believe have currently legalised same-sex marriage) are all in the top 20 of The Economist‘s 2005 Quality of Life Index2.

Sure, legalising same-sex marriage might piss off some homophobes, but’s that’s no more worth considering than the argument that apartheid shouldn’t have been abolished because it could piss off some racists.

Another common argument is that marriage has traditionally been defined as between a man and a woman so it can’t be changed because mumble mumble… This is quite simply trying to avoid thinking too much so you can maintain your unsupported biases. If an established idea is challenged you don’t get to ignore the challenge because the idea is already established. Instead you must re-evaluate the idea in light of the challenge in order to determine if it still appears to be worth supporting.

Ideas worth supporting must have more than just tradition to stand upon. Other traditional ideas about marriage, like a wife being her husband’s property and interracial marriage being prohibited and supposedly immoral, have previously been abandoned and now (rightly) seem abhorrent to modern society.

The typical fundamentalist rantings about homosexual behaviour being prohibited by their religious book are bizarre enough that I’d hope not to even have to bother responding to it, but I’m not quite naive enough to think that’s the case. In the words of Gregory House, “I don’t have time to talk you out of your religion”, so instead of bloating this post with anti-apologetics I’ll settle for thanking those bigots for making it so easy to point out that religion is not a reliable source of moral advice. For all I care a church can be as bigoted as it wants, but a secular government can’t.

One final argument, which I think is one that finally gets close to the real issue at hand, is that marriage is a religious institution, so it’s not a government’s business to mess with it. Honestly, I think this argument might have been enough one day, but not today. The reason it no longer holds water is that the premise on which it rests – that marriage is solely a religious institution – is no longer true. Marriage is a public service, provided by the government, and a secular government has no business telling its citizens they don’t have a right to a public service because they or their partner are the wrong sex. As I said earlier, for all I care a church can be as bigoted as it wants, but a secular government can’t.

If marriage were still solely a religious institution several aspects of modern society would be quite different. Surely people with no religion, such as myself, would not be allowed to get married. Also, a secular government would have no business giving special rights to married couples, as this would be discriminating based on religion. I also think that, were that the case, making civil unions available to all couples would be a valid approach for a government to provide equality. However, the fact that marriage is not solely a religious institution, but a social service, means this is not enough. “Separate but equal” is not equal.

It’s worth noting that, as a result of the select committee’s report, New Zealand’s Marriage Amendment Bill has been amended so that marriage celebrants will not have to conduct marriages of same-sex couples if it offends their religious sensibilities.

  1. http://onlinelibrary.wiley.com/doi/10.1111/j.1467-8624.1992.tb01679.x/abstract
  2. http://www.economist.com/media/pdf/QUALITY_OF_LIFE.pdf