The random thoughts of a sceptical activist

The trouble with babies

When it comes to supplying the Advertising Standards Authority with evidence that backs up claims you’ve made in an advert, it’s a good idea to make sure it does actually back up the claims you’ve made. Common sense, really. Saves a lot of hassle. And an adverse adjudication. And adverse publicity.

It’s a fallacy of personal incredulity I know, but I’d have thought that Philips Electronics UK Ltd — part of giant Royal Philips Electronics of The Netherlands — would have been circumspect when it came to ensuring they have the appropriate evidence for claims they were making.

The advert

They advertised a new Philips Avent Feeding Bottle in, of all places, Boots’ Health & Beauty magazine. Boots are under particular scrutiny from all sides at the moment: they have admitted (to a House of Commons Select Sub-Committee, no less) they had no evidence for the efficacy of the homeopathic potions they sell and the Merseyside Skeptics (as part of the 10:23 campaign), myself and Skeptic Barista have questioned Boots about this. We’re all waiting for replies.

However, back to babies’ feeding bottles.

One complainant challenged whether the claim that the bottle was “clinically proven to reduce colic and help settle your baby” was misleading and could be substantiated.

Pretty straightforward. Philips made the claim; someone who saw the advert wondered if Philips could substantiate the claim.

It’s worth making sure we understand what ‘clinically’ means in this context. ‘Clinical’ is the adjective:

said of medical studies: based on, or relating to, direct observation and treatment of the patient, as distinct from theoretical or experimental work. Source.

A clinical trial has to be carried out on people.

So, did Philips have clinical evidence that proved their product reduced “colic and help settle your baby”?

Of course they did!

Philips Electronics UK Ltd (Philips) said they invested heavily in clinical research with world-renowned institutions, such as the Institute of Child Health (ICH) in London. They provided copies of two clinical trials conducted by ICH involving the Avent bottles, one supported the claim “clinically proven to reduce colic” and the other supported the claim “clinically proven to … help settle your baby”, and pointed out that they were the first company in the world to produce an anti-colic bottle backed by a randomised clinical trial.

Randomised clinical trial? Two boxes ticked at least!

Before looking at the evidence, what has a feeding bottle got to do with colic anyway?

The ASA understood that, when using a conventional feeding bottle, a baby created a vacuum in the bottle that might hinder sucking. We also understood that the Avent bottle had been designed to counter that effect by allowing air to enter the bottle as the baby sucked, thereby avoiding a vacuum.

The study Philips submitted:

…assessed the relationship between bottle type and colic in babies.

So colic is something to do with a vacuum in the bottle hindering sucking and letting air in prevents it. Nothing to do with subluxations, then?

Anyway. The ASA noted:

…that the first study, which was a published conference paper…

Ah! Not in a peer reviewed journal, then. Lose a point.

…babies were randomly assigned to a breastfed group, anti-vacuum (Avent) group or conventional bottle group

A three-armed study including a control group. More kudos.

The babies:

…were assessed at two and six weeks of age

Another ‘Ah!’. More of that later.

How were they assessed?

…through the use of diaries kept by mothers, which recorded different aspects of their babies’ behaviour.

OK. We can hardly expect to ask the babies themselves how they feel! There is no mention of blinding, though, so I would have to assume that the mothers using bottles were not blinded to the type of bottle allocated to the arm they were in.

The results?

We noted that the results of the study showed that at two weeks old babies on the anti-vacuum bottle spent significantly more time awake and content, and that there was a significant trend to less recorded colic than with the conventional bottle.

Good. The evidence is on their side.

We noted that the anti-vacuum group recorded a duration of colic that was closer to that of the breastfed babies, who recorded the least amount and duration of colic.

So their new bottle was as nearly good as breast feeding and significantly better than the competitor’s bottle.

However,…

Oops! Something’s wrong.

…we also noted that at six weeks of age there were no reported differences between the anti-vacuum and conventional bottles.

So, the trial only showed results at two weeks and that at six weeks, there was no difference between the two bottles.

But babies don’t stop being babies at six weeks.

We considered that the study supported a claim that the product was clinically proven to reduce colic in babies at two weeks of age, but noted that the ad made a general claim that we considered would be understood by consumers to refer to babies of all ages.

The ad was making a general claim that applied to babies of all ages, not just to those who were two weeks old or six weeks old.

The ASA therefore concluded:

We therefore concluded that the study did not support the claim made in the ad.

Philips had supplied a second paper, which was:

…a summary of an unpublished study that assessed whether feeding with anti-vacuum bottles influenced milk intake and growth and infant behaviour. We understood that the study compared the effects of two different anti-vacuum bottles, including Avent, but did not assess how those bottles compared with a conventional bottle. We also understood that the babies were randomised to the two bottles and assessed at two weeks of age through parental diaries that recorded their babies’ behaviour. We noted that at two weeks the study showed that, whilst fussing (or settling a baby) was the single commonest crying behaviour during the trial, babies using the Avent bottle had significantly less reported fussing than those using the other anti-vacuum bottle, and that that difference was greatest at night.

They really should have known that a summary of an unpublished study that had no control group and, again, was just on babies up to two weeks old would cut no ice with the ASA. Why did they even bother?

Lessons learned?

One of the key things about any trial that has to be considered before its findings are applied in practice is whether your target population is significantly different from the study group that the trial involved.

Now, using the findings of a trial done on, say,  men aged 25 to 50 years on 24 year olds may be justifiable; using it on those over 65, possibly not. Nor teenagers.

What is clear is that you cannot use the results of a study of two and six week old babies and attempt to claim it also applies to babies of, say, two or six months without a solid justification — if at all. Any such justification would need to be properly assessed on a case-by-case basis and there can be no generalisations.

Philips provided no such justification, so they lost.

We considered that the study supported a claim that the product was “clinically proven to … help settle your baby” at two weeks of age when compared to a competitor’s anti-vacuum bottle. We also considered, however, that consumers were likely to understand the claim to refer to all babies and to be a comparison with conventional bottles. We therefore concluded that the study did not support the claim made in the ad.

We concluded that the claim “Clinically proven to reduce colic and help settle your baby” had not been substantiated and was misleading.

On this point the ad breached CAP Code clauses 3.1 (Substantiation) and 7.1 (Truthfulness).

Although Philips won on a second point of complaint, the ASA concluded:

Action

The ad must not appear again in its current form.

Making claims and taking advice

Perhaps they thought they’d never be held to account for the claims they made.

Perhaps they thought they could deal with any complaint from the ASA?

Perhaps they thought the rules were there to be broken?

They really should have known better — there was no excuse. Even if they had no doubts about whether claims they were making were sound, they could have consulted the Copy Advice team who supply free advice on adhering to the Code of Advertising Practice:

What is Copy Advice

A fast, free and confidential service designed to help you create non-broadcast marketing communications or multi-media concepts that comply with the British Code of Advertising, Sales Promotion and Direct Marketing (CAP Code).

When to take Copy Advice?

We can advise on likely compliance of your ads with the rules at any stage before publication.  But advertisers and agencies are urged to make Copy Advice an early part of their creative process so we can help you avoid costly mistakes later and get campaigns right first time.

It’s not rocket science.

The small print

What is being claimed now for the Philips Avent bottle? Boots have it on their website (cached pdf):

Philips AVENT Durable BPA-Free Bottle are clinically proven to reduce colic* and to help settle your baby, especially at night**

*At 2 weeks of age babies fed with an AVENT Bottle showed less fussing compared to babies fed with another leading bottle. ** At 2 weeks of age babies fed with an AVENT Bottle showed less colic compared to babies fed with a conventional bottle.

The claims now match the evidence and they could have saved themselves a lot of trouble if they had done that from the start. (However, I do wonder who reads the small print.)

It certainly looks like Boots have taken swift action after the adverse ASA adjudication — unlike another organisation I could mention.

Philips Electronics UK Ltd (Philips) said they invested heavily in clinical research with world-renowned institutions, such as the Institute of Child Health (ICH) in London. They provided copies of two clinical trials conducted by ICH involving the Avent bottles, one supported the claim “clinically proven to reduce colic” and the other supported the claim “clinically proven to … help settle your baby”, and pointed out that they were the first company in the world to produce an anti-colic bottle backed by a randomised clinical trial.

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