August 23rd, 2014

Big Pharma anti-vaping ad complaint

Update: MHRA (predictably) rejected this complaint. So, medicine regulator defends regulated medicine maker in attack on non-medical but superior alternative to smoking. To do otherwise would have been to draw attention to the folly of regulating recreational nicotine products as medicines. See End of update . MHRA (predictably) rejected this complaint. So, medicine regulator defends regulated medicine maker in attack on non-medical but superior alternative to smoking. To do otherwise would have been to draw attention to the folly of regulating recreational nicotine products as medicines. See letter (PDF)

It’s perhaps a good sign that Big Pharma feels compelled to apply its boneheaded, plodding, utterly uncreative advertising skills to persuading smokers to use its inferior products rather than take up vaping. For a characteristically entertaining account of the righteous petulance of Big Pharma see Redhead Full of Steam . Even so, I found this advertisement annoying, especially as e-cig vendors can’t fight back and likely to be counterproductive for health (if enough people followed its advice). So I decided to see how they can be held to account. As it turns out MHRA is the regulator and it applies a code called the Blue Guide, Advertising and promotion of medicines in the UK . So here is the complaint:

_____________________ Complaint starts here _____________________

MHRA Advertising Standards Unit

Area 3-M MHRA,

151 Buckingham Palace Road,

LONDON SW1W 9SZ

4 August 2014

Dear sir or madam

1. The Complaint: Nicorette QuickMist ‘Don’t Vape. Quit for Good.’ advertisement

1.0 I would like to complain about the following advertisement for Nicorette Quickmist, a Johnson and Johnson product, with the headline “Don’t Vape. Quit for Good.”. This was photographed by me on a Northern Line tube train on 16 July 2014 and forms part of a campaign that I saw many times.

2. Grounds for complaint

2.0. Breach of the Code

By regulation 280 of the Regulations, an advertisement must: (1) comply with the particulars listed in the summary of product characteristics (SPC); (2) encourage the rational use of the product by presenting it objectively and without exaggerating its qualities; and (3) not be misleading.

2.1. Fails to comply with product’s Summary of Product Characteristics

The advertiser has no basis for positioning its product as an alternative to vaping or providing messages to consumers that are negative about vaping, especially when vaping may be beneficial to them – and more beneficial than the advertiser’s product (see 2.2 below). The medicine in question is to treat smoking dependence and is only indicated for smoking cessation, reduction and nicotine maintenance. The advertiser should stick to conveying accurately the product’s capabilities in this regard, not disparaging alternative strategies for which it has no supporting evidence on which to base its headline.

2.2. Fails to present the product objectively or without exaggeration

The advertiser has no evidence that its product is superior to vaping as a way of ameliorating the health risks of smoking. To the extent that there is evidence it points in the opposite direction, for example, a recent study of use of different approaches to unsupported smoking cessation, drew the following conclusion:

Conclusion: Among smokers who have attempted to stop without professional support, those who use e-cigarettes are more likely to report continued abstinence than those who used a licensed NRT product bought over-the-counter or no aid to cessation. This difference persists after adjusting for a range of smoker characteristics such as nicotine dependence. et al. Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study. Addiction Published Online First: 20 May 2014. Brown J, Beard E, Kotz D,Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study.Published Online First: 20 May 2014. doi:10.1111/add.12623

People attempting to quit smoking without professional help are approximately 60% more likely to report succeeding if they use e-cigarettes than if they use willpower alone or over-the-counter nicotine replacement therapies such as patches or gum

However, by asserting ‘Don’t Vape’ the advertiser is implicitly claiming superiority of its product over vaping as a strategy for addressing health risks of smoking, but has not established this and has no basis for claiming it or offering this advice. In making the assertion in the advertisement, the advertiser may be suggesting a course of action to the public that, on the basis of the evidence cited above, is less effective for the user and therefore causes greater harm. While it may be acceptable to convey the attributes of NRT to consumers it is misleading and potentially dangerous to take the further step of criticising an alternative, without a justification. The burden of proof does not rest with vapour product manufacturers, but with the advertiser advising use of its product rather than vaping. No such evidence exists.

2.3 The advert misleadingly implies users of QuickMist will have a reasonable chance of success in quitting

vast majority of users of this product will not ‘Quit for Good’ and nowhere does the advertisement convey the very poor probability of success. Simply adding the disclaimer that it ‘requires willpower’ does not do justice to the difficulty of quitting and to the ineffectiveness of these products – and the reason why vaping is proving attractive. The Theof this product will not ‘Quit for Good’ and nowhere does the advertisement convey the very poor probability of success. Simply adding the disclaimer that it ‘requires willpower’ does not do justice to the difficulty of quitting and to the ineffectiveness of these products – and the reason why vaping is proving attractive. The Cochrane review for NRT illustrates just how poor the success rates are, merely increasing unaided success rates of 3-5% by just 2-3% – therefore still leaving failures rates of 92-95%. As the Cochrane Review sates:

Studies of people attempting to quit on their own suggest that success rates after six to 12 months are 3-5% ( Hughes 2004a ). Use of NRT might be expected to increase the rate by 2-3%, giving a number needed to treat (NNT) of 33-50.

Though often expressed as providing a 50-70% increase in the chance of quitting, the experience for the vast majority of users will be failure and the number of people actually benefitting from following the advice in the advertisement may be as few as 1 in 50 based on the ‘Number Needed to Treat’ figures provided. If the advert conveyed the true likelihood of successfully quitting for good, then it’s advice ‘Don’t Vape’ would not be credible. Consumers are mislead by the appearance of a clear cut choice, but this is provided without the probabilistic context that would make the comparison of these options fair and realistic.

2.4 The advert misleadingly implies a conceptual difference between vaping and NRT which has no basis in reality

The advert implies that vaping is not for quitting but that NRT is for quitting and not long term nicotine maintenance. In fact both vaping and NRT can be used for exactly the same purposes. The QuickMist SPC shows it is indicated for quitting, cutting down, long term maintenance and ‘harm reduction’ and it is likely that given the low success for complete quitting using NRT, most of its users would not quit completely they continued with the product – exactly as they would with vaping.

Therapeutic indications Nicorette QuickMist relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. Nicorette QuickMist is indicated in pregnant and lactating women making a quit attempt. Nicorette QuckMist SPC 4.1

Vaping can be used in the following ways: to quit smoking and nicotine completely, either by ceasing to vape once craving have subsided or by continuing to vape using non-nicotine e-liquids; as a source of replacement nicotine to assist to cutting down for a continuing smoker; and as an alternative to smoking as a way of self-administering recreational nicotine while avoid the harms of smoking. By making the comparison “Don’t Vape. Quit for Good“, the advertiser has drawn a misleading distinction between vaping and NRT that has no basis in reality.

3. About this complaint

3.0 This complaint concerns an implicit attack by a advertiser of a licensed medical product directed towards products that are unlicensed as medicines but are lawful, and now widely used. The argument made above is that the strap line “Don’t Vape. Quit for Good” is inappropriate, misleading, potentially harmful and has no evidential basis as advice to consumers.

3.1 This complaint should not be considered by any of the the self-regulatory bodies as there are potential conflicts given the object of the negative part of the advertising is a non-medicinal product category.

3.2 I am not representing any commercial interest and have no competing interests. My focus is on tobacco harm reduction as a strategy for public health, and I believe this advertising is counter-productive for health in that respect.

3.3 I have no issue with NRT advertising as long as it does not detract from vaping and conveys meaningful information about its efficacy to consumers.

I hope this complaint is in form that will facilitate your investigation, but please do contact me if you would like further substantiating argument. I look forward to hearing from you.

Yours sincerely

Clive Bates

_____________________ Complaint ends here _____________________