As I was travelling on the London Underground the other day, I saw an advert that caught my eye.

Please note: if you are a journalist from the Daily Mirror and would like to use this photo in a story, it would be appreciated if you would ask permission first rather than just stealing it like you did with the last photo I posted of a dodgy advert.

That was a surprising claim, I thought. Just wipe a magic potion across your brow, and you get fast, effective relief from a headache.

So I had a look to see what the medical literature had to say about it. Here is what a PubMed search for 4head or its active ingredient levomenthol turned up:

A Google Scholar search similarly failed to find a shred of evidence that the product has any effect whatever on headaches. So I have reported the advert to the ASA. It will be interesting to see if the manufacturer has any evidence to back up their claim. I suppose they might, but they are keeping it pretty well hidden if they do.

But it occurred to me that something is very wrong with the way advertising regulation works. If the advert is indeed making claims which turn out to be completely unsubstantiated, the manufacturer can do that with no adverse consequences whatever. False advertising is effectively legalised lying.

When I last reported a misleading advert to the ASA, the ASA did eventually rule that the advert was misleading  and asked the advertiser to stop using the advert. It took almost a year from when I reported the advert to when the ruling was made, giving the advertiser completely free rein to continue telling lies for almost a whole year.

In a just society, there might be some penalty for misleading the public like that. But there isn’t. The only sanction is being asked to take the advert down. As long as you comply (and with very rare exceptions, even if you don’t), there are no fines or penalties of any sort.

So where is the incentive for advertisers to be truthful? Most dishonest adverts probably don’t get reported, or even if they do get reported the ASA might be prepared to be generous to the advertiser and not find against them anyway. Advertisers know that they can be dishonest with no adverse consequences.

I would like to suggest a new way of regulation for adverts. Every company that advertises would need to nominate an advertising compliance officer, probably a member of the board of directors. That person would need to sign off every advert that the company uses. If an advert is found to be dishonest, that would be a criminal offence, and the advertising compliance officer would be personally liable, facing a criminal record and a substantial fine. The company would be fined as well.

We criminalise other forms of taking money by fraud. Why does fraudulent advertising have to be different?

I blogged last year about my doubts about the following advert:

 

Those seemed like rather bold claims, which as far as I could tell were not supported by the available evidence. It turns out the Advertising Standards Authority agrees with me. I reported the advert last year, and last week the ASA finally ruled on my complaint, which they upheld.

It’s worth reading the ASA’s ruling in full. They were very thorough. They came to similar conclusions that I did: that although there was some hint of activity against a cold, there was no evidence of activity against flu, and even the evidence for a cold was not strong enough to make “clinically proven” a reasonable claim.

While the ASA get good marks for being thorough, they get less good marks for being prompt. It took them 11 months to make this ruling, which allowed Boots to continue misleading customers all that time. I suppose being thorough does take time, but even so, I’m disappointed that it took them quite as long as it did.

Boots are now no longer advertising Boots Cold and Flu Defence Nasal Spray on their website. They are, however, advertising a spookily similar looking product called Boots Cold Defence Nasal Spray. Although they have now dropped claims about flu, they are still claiming the product is “clinically proven” to both treat and prevent colds.

It is not clear to me whether this is the same product that’s just been rebranded or whether it is something different. I note that it says the active ingredient is carrageenan, which was the same active ingredient in the previous product. If it is the same product, then it’s good to see that they have dropped the flu claim, as that was totally unsupported. However, the cold claim is just as dubious as before, unless they have done new studies in the last year.

I have been in touch with the ASA about the Cold Defence product, and they have told me that since it’s a different product (or at least has a different name) it wouldn’t be covered by the previous ruling. If I felt that the claim was unjustified it would need a new complaint.

Is it just me who thinks Boots is being a bit cynical here? Unless the new product is something different that actually has a robust evidence base, they must know that the claim that it is clinically proven to treat and prevent colds does not stack up. But they are making it anyway. No doubt safe in the knowledge that by the time the ASA gets round to ruling on it, this year’s cold season will be well and truly over, and they will have had time to mislead plenty of customers in the meantime.

If the new advert is also found to be misleading, there will be no punishment for anyone at Boots. The worst that will happen to them is that they will be told to change the advert.

Why are big corporations allowed to mislead consumers with impunity?

My eye was caught the other day by this advert:

Quite a bold claim, I thought. “Defends against cold and flu” would indeed be impressive, if it were true. Though I also noticed the somewhat meaningless verb “defend”. What does that mean exactly? Does it stop you getting a cold or flu in the first place? Or does it just help you recover faster if you get a cold or flu?

I had a look at the relevant page on the Boots website to see if I could find out more. It told me

“Boots Pharmaceuticals Cold & Flu Defence Nasal Spray is an easy to use nasal spray with antiviral properties containing clinically proven Carragelose to defend against colds and flu, as well as help shorten the duration and severity of both colds and flu.”

It then went on to say

“Use three times a day to help prevent a cold or flu, or several times a day at the first signs helping reduce the severity and duration of both colds and flu.”

OK, so Boots obviously want us to think that it can do both: prevent colds and flu and help treat them.

So what is the evidence? Neither the advert nor the web page had any links to any of the evidence backing up the claim that these properties were “clinically proven”. So I tweeted to Boots to ask them.

To their credit, Boots did reply to me (oddly by direct message, in case you’re wondering why I’m not linking to their tweets) with 4 papers in peer reviewed journals.

So how does the evidence stack up?

Well, the first thing to note is that although there were 4 papers, there were only 3 clinical trials: one of the papers is a combined analysis of 2 of the others. The next thing to note is that all 3 trials were of patients in the early stages of a common cold. So right away we can see that we have no evidence whatsoever that the product can help prevent a cold or flu, and no evidence whatsoever that it can treat flu.

The “clinically proven” claim is starting to look at little shaky.

But can it at least treat a common cold? That would be pretty impressive if it could. The common cold has proved remarkably resilient to anything medical science can throw at it. A treatment that actually worked against the common cold would indeed be good news.

The first of the trials was published in 2010. It was an exploratory study in 35 patients who were in the first 48 hours of a cold, but otherwise healthy. It was randomised and double-blind, and as far as I can tell from the paper, seems to have been reasonably carefully conducted. The study showed a significant benefit of the nasal spray on the primary outcome measure, namely the average of a total symptom score on days 2 to 4 after the start of dosing.

Well, I say significant. It met the conventional level of statistical significance, but only just, at P = 0.046 (that means that there’s about a 1 in 20 chance you could have seen results like this if the product were in fact completely ineffective: not a particularly high bar). The size of the effect also wasn’t very impressive: the symptom score was 4.6 out of a possible 24 in the active treatment group and 6.3 in the placebo group. Not only that, but it seems symptom scores were higher in the placebo group at baseline as well, and no attempt was made to adjust for that.

So not wholly convincing, really. On the other hand, the study did show quite an impressive effect on the secondary outcome of viral load, with a 6-fold increase from baseline to day 3 or 4 in the placebo group, but a 92% decrease in the active group. This was statistically significant at P = 0.009.

So we have some preliminary evidence of efficacy, but with such a small study and such unconvincing results on the primary outcome of symptoms, I think we’re going to have to do a lot better.

The next study was published in 2012, and included children (ages 1 to 18 years) in the early stages of a common cold. It was also randomised and double blind. The study randomised 213 patients, but only reported efficacy data for 153 of them, so that’s not a good start. It also completely failed to show any difference between the active and placebo treatments on the primary outcome measure, the symptom score from days 2 to 7. Again, there was a significant effect on viral load, but given the lack of an effect on the symptom score, it’s probably fair to say the product doesn’t work very well, if at all, in children.

The final study was published in 2013. It was again randomised and double blind, and like the first study included otherwise healthy adults in the first 48 h of a common cold. The primary endpoint was different this time, and was the duration of disease. This was a larger study than the first one, and included 211 patients.

The results were far from impressive. One of the big problems with this study was that they restricted their efficacy analysis to the subset of 118 patients with laboratory confirmed viral infection. Losing half your patients from the analysis like this is a huge problem. If you have a cold and are tempted to buy this product, you won’t know whether you have laboratory confirmed viral infection, so the results of this study may not apply to you.

But even then, the results were distinctly underwhelming. The active and placebo treatments were only significantly different in the virus-positive per-protocol population, a set of just 103 patients: less than half the total number recruited. And even then, the results were only just statistically significant, at P = 0.037. The duration of disease was reduced from 13.7 days in the placebo group to 11.6 days in the active group.

So, do I think that Boots Cold and Flu Defence is “clinically proven”? Absolutely not. There is no evidence whatsoever that it prevents a cold. There is no evidence whatsoever that it either prevents or treats flu.

There is some evidence that it may help treat a cold. It’s really hard to know whether it does or not from the studies that have been done so far. Larger studies will be needed to confirm or refute the claims. If it does help to treat a cold, it probably doesn’t help very much.

The moral of this story is that if you see the words “clinically proven” in an advert, please be aware that that phrase is completely meaningless.