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Tracy Cox color illustration of a “snake oil” salesman who opens his jacket to reveal an assortment of quack medical cures, pills, tonics, tools, etc. (Bay Area News Group/MCT via Getty Images)
Tracy Cox color illustration of a “snake oil” salesman who opens his jacket to reveal an assortment of quack medical cures, pills, tonics, tools, etc. (Bay Area News Group/MCT via Getty Images)

ScienceMay 19, 2017

Why Winston Peters is wrong about the anti-quackery bill

Tracy Cox color illustration of a “snake oil” salesman who opens his jacket to reveal an assortment of quack medical cures, pills, tonics, tools, etc. (Bay Area News Group/MCT via Getty Images)
Tracy Cox color illustration of a “snake oil” salesman who opens his jacket to reveal an assortment of quack medical cures, pills, tonics, tools, etc. (Bay Area News Group/MCT via Getty Images)

We need a new law to plug the big gap in our regulation of health products, argues Mark Hanna

Winston Peters has decided that we don’t need an incoming anti-quackery bill. He’s wrong.

In a press release earlier this week, Peters called for the poorly named Natural Health Products Bill to be scrapped:

“This Bill is regulatory overkill and the more New Zealand First looks into it, the more we realise the Natural Health Products Bill is a solution looking for a problem.”

“We believe the regulation of Natural Health Products and Supplementary Products is adequately provided for under other legislation.”

At first glance, this isn’t unreasonable. After all, we already have the Medicines Act and the Fair Trading Act to protect us from misleading claims about health products, right? Well, that’s true, but the best rules in the world don’t mean a thing if they’re not well enforced.

And, well, ours aren’t.

The Medicines Act prohibits the sale of any medicine that hasn’t been approved. Promoting a product in a way that implies it’s intended to diagnose, prevent, or treat health issues in humans is enough to make it treated as a medicine by the regulation, so it can’t be sold that way without approval.

But there’s an uncomfortable middle ground, where misleading health claims are made but they’re not serious enough for Medsafe, the regulatory body responsible for enforcing the Medicines Act, to decide to get involved.

The first line of defence in cases like this is the Advertising Standards Authority. The ASA is great considering what it is, but there are several problems with relying on them:

  • They rely entirely on receiving complaints from the public.
  • They give a free pass to a certain class of health claims that I think can be very misleading.
  • If they uphold a complaint, there’s nothing they can do to enforce it.

If you see an ad that says a product “supports healthy immune function”, for example, that doesn’t actually mean it does anything for your immune function. From the regulatory perspective, it just means it probably won’t mess with a healthy immune function – if that’s what you already have. Though they aren’t required to provide any evidence for that.

This class of health claims, which often use weasel words like “supports”, are commonly given a free pass even in cases where they seem clearly misleading. They’re the “wink, wink, nudge, nudge” of the health industry – trying to convey a different impression to regulators and the public.

But what about the Fair Trading Act? It essentially says you can’t make any claim about a product you’re selling without a good reason to believe it’s true: “A person must not, in trade, make an unsubstantiated representation.”

Maybe Peters is right. That should handle all of these cases of misleading advertising even when the Medicines Act and the ASA fall short.

The problem is, it doesn’t. Because there is far, far too much misleading advertising for the regulator – the Commerce Commission in this case – to take action against anything but a tiny section. They’re more likely to pay attention to issues that could affect New Zealand’s reputation as an exporter, such as false claims that a product has been made in New Zealand, than they are to address misleading health claims.

Medsafe has essentially the same problem. They greatly prioritise safety issues over issues of misleading marketing. This makes sense, but they don’t seem to have the resources to take action on the lower priority misleading marketing issues.

The result is a huge number of misleading health claims.

At the Society for Science Based Healthcare, a volunteer consumer advocate organisation that I chair, we do our best to fight this. We’ve made over 240 successful complaints about misleading health claims to the ASA since 2012. Just last week, the ASA released decisions on nine more successful complaints. But our efforts have hardly scratched the surface.

When we’ve tried alerting the Commerce Commission or Medsafe instead of the ASA, the results have almost without exception been disappointing.

A complaint that I laid with Medsafe about a company selling “harmonized water” to treat allergies, asthma, and more has been languishing without progress since September 2014.

The Commerce Commission recently took two months just to tell me they won’t do anything about a Christchurch homeopath who’s refused to comply with multiple complaints that have been upheld by the ASA.

It’s clear to anyone who engages with this system that there is a large gap in our regulation of health products. The Ministry of Health came to a similar conclusion in 2007, when they undertook an overview of the New Zealand complementary medicines industry. The overview found that 78% of companies selling these products were not compliant with existing regulation.

Yes, that was a decade ago, but there has been barely any change since then. I’ve been involved in anti-quackery activism for half of that time, and it seems to me that it’s just as prevalent now as it was five years ago.

Winston, if you have any more recent data please let me know. My email address is easy to find.

The vast majority of products at the centre of this problem fall into the confusingly named category of “natural health products”. This is the area that the Natural Health Products bill and its associated guidelines are intended to address.

They’re not perfect, by any means. For example, homeopathic products are explicitly excluded from the scheme, even though they’re both completely useless and often promoted with health claims. But overall it is certainly a step in the right direction.

Products will have to be registered to be sold, and there are requirements around things like ingredients and evidence. My favourite part of the bill is that each of these notified products will have to put a summary of the evidence for any health claims made about it in a publicly accessible database. Here’s what the proposed guidelines say:

“Product notifications will need to include a reference to a website with a summary of the evidence supporting the health claims for a product so that consumers can easily see the basis for the claims.”

This is a rare case where I, as an anti-quackery activist, agree with “natural health” industry bodies. They want the improved reputation that comes from regulation; I want better protection against quackery for New Zealanders. With this bill, we could find a happy middle ground where those products which are supported by evidence can be sold, and we have useful protective measures against being misled about products which aren’t supported by evidence.


The Spinoff’s science content is made possible thanks to the support of The MacDiarmid Institute for Advanced Materials and Nanotechnology, a national institute devoted to scientific research.

Keep going!
Drugs Tablets Pain Medication Pills Headache

ScienceMay 6, 2017

Cold discomfort pharma: what does the science say on whether the drugs work?

Drugs Tablets Pain Medication Pills Headache

Over-the-counter cold-and-flu remedies are mostly useless, says Consumer NZ. The industry strongly disagrees. Siouxsie Wiles takes a look at the studies.

Over the last few days a fight has broken out between Consumer NZ and the New Zealand Self Medication Industry over expensive cold and flu products. Consumer NZ says the products are no more effective than taking paracetamol, which can be bought for a fraction of the price. The MSI strongly disagrees and says consumers can continue to use over-the-counter cold medicines with confidence. Whom should we believe?

An artists impression of Siouxsie with the lurgy. Photo: Westend61/Getty

Last year I had one of the worst colds I’ve had in a long time. Some pesky rhinovirus had turned my nose into a virus-producing factory, and I felt so bunged up with mucus I could hardly breathe. Cue a trip to the pharmacy to buy one of the many cold and flu products which claim to provide fast and effective relief from blocked and runny noses. As well as paracetamol, they contain phenylephrine hydrochloride, included to act as a nasal decongestant.

Two hours later, and with none of the promised relief in sight, I jumped on to the internet to find out if it was safe to up the dose a little. As a research scientist, it wasn’t Google I searched, but PubMed, a search engine maintained by the US National Library of Medicine. This fantastic free resource allows anyone to access the abstracts of millions of studies published in scientific and medical journals. I found abstracts with catchy titles like “Oral phenylephrine HCl for nasal congestion in seasonal allergic rhinitis: a randomized, open-label, placebo-controlled study” and “A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber”. In other words, studies that looked at how effective phenylephrine is as a nasal decongestant. And they weren’t just asking people if they felt less congested. They were measuring stuff like “peak nasal inspiratory flow” and “nasal airway resistance”. Excellent, I thought. Hopefully they would have some information on different doses too.

Turns out the studies are clear: phenylephrine doesn’t do diddly-squat for nasal decongestion. Nada. Zilch. Even at doses four times higher than in the products we can buy in our pharmacies. Bugger. So how can it be included in those products? Turns out phenylephrine was approved by the US Food and Drug Administration (FDA) as a nasal decongestant back in the 1970s, apparently on the basis of inhouse studies by the pharmaceutical companies involved. It became more widely used in cold and flu products when pseudoephedrine, which really does work as a nasal decongestant, was restricted because it can be used to make the illegal drug methamphetamine (also known as P).

Presumably, when the companies had to replace pseudoephedrine in their products, it was easy to swap it out for something that sounded similar. It’s a pity phenylephrine doesn’t actually have the same effect on blocked noses. But it’s approved by the FDA, which seems to be all that the New Zealand Self Medication Industry needs to justify charging heaps more for what is effectively paracetamol. That’s certainly what it sounded like when Susie Ferguson challenged their executive director Scott Milne on Morning Report.

What’s depressing is that all of this was brought up a decade ago, when the change first happened and pseudoephedrine was restricted. How much money have people wasted since then? What’s even more depressing is that phenylephrine isn’t just some benign pseudo-pseudoephedrine. It’s a drug with its own potential side effects, which include slowing people’s heart rate. It could even be harmful for some people, especially if they are taking other medications.

The studies are definitely on Consumer NZ’s side, so you’d be best following their advice the next time you have a cold: take some paracetamol and put your feet up for a few days. The paracetamol won’t do anything for your stuffy nose, but it will relieve some of your other symptoms, and staying at home and resting will stop you spreading your cold around.


References

Day JH, Briscoe MP, Ratz JD, Danzig M, Yao R (2009). Efficacy of loratadine-montelukast on nasal congestion in patients with seasonal allergic rhinitis in an environmental exposure unit. Ann Allergy Asthma Immunol. 102(4):328-38. doi: 10.1016/S1081-1206(10)60339-0. [Link: https://www.ncbi.nlm.nih.gov/pubmed/19441605]

Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L (2007). Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Ann Pharmacother. 41(3):381-90. [Link: https://www.ncbi.nlm.nih.gov/pubmed/17264159]

Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Yao R, Staudinger H, Danzig M (2009). A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber. Ann Allergy Asthma Immunol. 102(2):116-20. doi: 10.1016/S1081-1206(10)60240-2. [Link: https://www.ncbi.nlm.nih.gov/pubmed/19230461]

Meltzer EO, Ratner PH, McGraw T (2015). Oral phenylephrine HCl for nasal congestion in seasonal allergic rhinitis: a randomized, open-label, placebo-controlled study. J Allergy Clin Immunol Pract. 3(5):702-8. doi: 10.1016/j.jaip.2015.05.007. [Link: https://www.ncbi.nlm.nih.gov/pubmed/26143019]

Meltzer EO, Ratner PH, McGraw T (2016). Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients. Ann Allergy Asthma Immunol. 116(1):66-71. doi: 10.1016/j.anai.2015.10.022. [Link: https://www.ncbi.nlm.nih.gov/pubmed/26560899]


The Spinoff’s science content is made possible thanks to the support of The MacDiarmid Institute for Advanced Materials and Nanotechnology, a national institute devoted to scientific research.