Further to my previous post, Marketing magazine has covered the story here:
Forest slams ASA decision on DoH smoking ad claims
There are so many angles to this dispute I don't know where to start, but it's interesting to note the ASA's extraordinary U-turn between June and July.
On June 10, when the ASA executive upheld (for the third time) our complaint against the Department of Health "mutation" ad, they wrote:
The ASA acknowledged that the DH had provided a range of peer-reviewed papers. We took expert advice. We noted that the papers supported higher mutation rates among smokers versus non-smokers and acknowledged the DH’s assertion that this was evidenced by the linear dose-response relationship between cigarettes smoked.
We noted that not all the papers presented discussed smoking [my emphasis] and the linear dose-response relationship used to calculate mutation accumulation. However, we were satisfied that the papers suggested that there may be a linear dose-response relationship between mutations and cigarette smoking. We considered the selection of mutation rates derived from the whole genome sequencing data and noted that they were estimated mutation rates per cigarettes smoked.
We noted that only one of the papers [my emphasis] provided formed the basis of the claim in the ad, that “every 15 cigarettes you smoke will cause a mutation”. That paper was based on a sample derived from the bone marrow metastasis of one patient [my emphasis] with small cell lung cancer.
The patient’s smoking history was not recorded [my emphasis], but we understood that the sample had histological features associated with tobacco smoking and therefore it was possible to identify mutations that arose specifically from smoking. The claim was not appraised in the detailed results section of the paper and appeared only in the discussion part, therefore it was not possible to establish how the figure of 15 cigarettes had been calculated [my emphasis].
We also noted that the claim was prefixed with several caveats [my emphasis], “On average, lung cancer develops after 50 pack-years of smoking ... If the majority of mutations derive from the mélange of mutagens present in tobacco smoke, the clone of cells that ultimately becomes cancerous would acquire, over its lifetime, an average of one mutation for every 15 cigarettes smoked.”
We considered that the paper, and the selection of estimated mutation rates from whole genome sequencing, indicated that there was an average of one mutation per 15 cigarettes smoked but that this figure was open to variance [my emphasis].
Because the ad made a definitive claim that a mutation would arise from every 15 cigarettes smoked, which was not supported by the evidence [my emphasis], we concluded that the ad was misleading.
The ad breached BCAP Code rules 3.1 (Misleading advertising) and 3.9 (Substantiation).
Action
The ad must not appear again in its current form. We told the Department of Health that in the absence of sufficient evidence [my emphasis] they should not make definitive claims for the number of cigarettes that would cause a mutation in future.
Somehow, five weeks later, the ASA Council took a very different position. Rejecting our complaint – and their own executive's recommendation – their assessment now read:
The ASA acknowledged that the DH had provided a range of peer-reviewed papers. We took expert advice. We noted that the papers supported higher mutation rates among smokers versus non-smokers.
We noted that not all the papers presented discussed smoking and the linear dose-response relationship used to calculate mutation accumulation. However, we were satisfied that the papers indicated that a broadly linear dose-response relationship between mutations and cigarette smoking existed. We considered the selection of estimated mutation rates per cigarette smoked derived from the whole genome sequencing data in the papers.
One of the papers provided supported the basis of the claim in the ad, that "every 15 cigarettes you smoke will cause a mutation". That paper was based on a sample derived from the bone marrow metastasis of one patient; we understood that the sample had histological features associated with tobacco smoking and therefore it was possible to identify mutations that arose specifically from smoking.
Additional data supplied by the DH [my emphasis] included a selection of estimated mutation rates from whole genome sequencing of 21 subjects. It showed that the majority of those cancerous cells sequenced had more than one mutation per 15 cigarettes smoked, and that only a small number had a mutation rate per cigarette smoked that was less than the number claimed. The data suggested that the average number of mutations per cigarette smoked was significantly higher than indicated by the 15 cigarette figure in the ad and we therefore considered that the DH had presented a conservative figure which ensured the claim was not exaggerated.
Because the ad made a conservative claim, which was supported by the evidence, we concluded that the ad was substantiated and unlikely to mislead.
We investigated the ad under BCAP Code rules 3.1 (Misleading advertising) and 3.9 (Substantiation) but did not find it in breach.
Action
No further action necessary.
The crucial words here are 'Additional data supplied by the DH'.
When did the DH supply this 'additional data'? Was it before or after the ASA executive submitted its (third) draft recommendation upholding our complaint? Or was it earlier?
The DH was given every opportunity to challenge our complaint. Officials even had a meeting with the ASA executive.
Yet the DH clearly failed to convince the ASA officials because as late as June 2014, when the executive drafted its third recommendation, the ASA was still upholding our complaint.
Something – I don't know what – happened between then and July 18 when the ASA Council met to consider the recommendation.
If new evidence was produced why wasn't Forest made aware of it so we could challenge it?
More to the point, why didn't the DH produce this evidence at the very beginning of this farcical process?
Perhaps, like me, you're beginning to think the evidence didn't exist when the ad was commissioned and broadcast and the DH has spent a large part of the last 18 months trying to find evidence to support the claim that 'Every 15 cigarettes you smoke will cause a mutation'.
Whatever the outcome of our complaint, the DH and their allies on the ASA Council has come out of this very, very badly.
The people I feel sorry for are the ASA staff whose recommendation that our complaint be upheld was rejected.
To have all that hard work undone by a bunch of part-time quangocrats must be incredibly frustrating. Humiliating, even.
Writing to Forest on July 19, the ASA executive wrote:
We realise this decision will disappoint you, but thank you nonetheless for taking the trouble to raise the matter with us.
Yes, the decision did disappoint us but, let's be honest, it was no more than we expected.
This is Britain 2014. No-one's allowed to challenge the Department of Health and win.
And that's a fact.
See also: Why the eleventh hour ASA U-turn? (Liberal Vision)
Simon Clark