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Medicalised Vapes Provoke Response

Health leaders, clinicians, and tobacco experts have welcomed the MHRA’s updated guidance for e-cigarette firms seeking a medicinal licence

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The updated guidance for e-cigarette firms seeking a medicinal licence for their products published by the Medicines and Healthcare Products Regulatory Agency (MHRA) has been welcomed by health leaders, clinicians and tobacco experts.

Prof Jacob George, Professor of Cardiovascular Medicine and Therapeutics, University of Dundee, stated: “This is very welcome news for millions of people who are trying to quit tobacco cigarettes. Clinical trial evidence suggests that it is more effective than nicotine patches for smoking cessation and it has positive effects on blood vessels when tobacco smokers switch to e-cigarettes.”

Dr Sharon Cox said: “In what feels like a real shift in support, licensed e-cigarettes may be offered on NHS prescription. Sounds great! The challenge is will they reach people who we know do not attend the stop smoking service?”

Cox added that there is a pressing need to invest in regional stop smoking services as they have been experiencing continual cuts to their budgets.

Rt Hon Sir Norman Lamb, former health minister and Chair of the Science and Technology Select Committee commented: “As an MP I chaired a select committee inquiry into e-cigarettes which concluded that there would be significant benefit to having medicinally licensed e-cigarettes which could be prescribed. Our committee was particularly concerned about the need for more effective help to quit for those with mental health problems, who have much higher than average smoking rates. I look forward to seeing the first licenced e-cigarette on sale, I am convinced this will be a game changer.”

Professor Alan Boobis, Chair of the Committee on Toxicity added: “I believe that in any discussion on public health it is important to include an objective assessment of potential harm. In the debate on the use of e-cigarettes, the Committee on Toxicity has assessed the relative risk from vaping.[2] I think it’s fair to say that using an e-cigarette that meets current consumer standards will be a lot less harmful than smoking cigarettes.

“Smokers trying to quit can try vaping, without waiting for a medicinally licensed product to go on sale before doing so. However, licensed vaping products will have to meet a defined standard set by the medicines regulator, the MHRA, and in return they will be available to clinicians to prescribe to their patients, which will be an important step forward.”

Professor John Britton, Emeritus Professor of Epidemiology, University of Nottingham said that having a medically licensed evape available for prescription “would be a major development”, but added a word of caution: “E-cigarette manufacturers have had the option to apply to the MHRA for a medicine license for years, but the costs of compliance with medicines regulations have been prohibitive and none has yet come to market.”

Professor Britton explained that this is why we desperately need a bespoke regulatory system for all nicotine products, one that allows market access and endorsement by health professionals in inverse proportion to health hazard. Otherwise, he says, “tobacco will remain the default choice of the more than six million smokers in the UK.”

Professor Peter Hajek, Director of the Tobacco Dependence Research Unit at Queen Mary University of London (QMUL), was also muted in his response: “I have an ambivalent take on this. On the one hand, the initiative provides a positive message that e-cigarettes are much less risky than smoking and help smokers quit. On the other hand, I am not sure that medicinal licensing of e-cigarettes is a good idea as it is likely that only tobacco industry will be able to face the costs that medicinal licensing entails, and they may only want products that will not endanger their core business.

“Smokers are more likely to benefit from e-cigarettes if they can select flavours, strengths and products that they like, rather than being limited to whatever becomes licensed. It also does not seem necessary for the NHS to pay for something that smokers are happy to buy themselves.

“Overall, it would seem easier to just recommend existing products which are well regulated by consumer protection regulations. There is sufficient evidence available now that these products are effective and dramatically reduce the risks of smoking.”

Deborah Arnott, Chief Executive of Action on Smoking and Health (ASH) was more positive: “The MHRA guidance opens the door to a day when smokers can be prescribed e-cigarettes to improve their chances of successfully quitting. Just as the MHRA led the world in licensing vaccines for COVID-19, today it is leading the world by backing medicinal licensing of e-cigarettes.

“Consumer e-cigarettes bought over the counter are proven to be the most successful quitting aid, but nearly a third of smokers have never tried them, and a similar proportion believe, wrongly, that e-cigarettes are as, or more harmful, than smoking. These are the smokers who are more likely to try vaping if they had the reassurance provided by a medicines licence and products which are available on prescription.”

Dr Paul Aveyard, GP and Professor of Behavioural Medicine at Oxford, commented: “The evidence is there that e-cigarettes are helping more smokers quit successfully than traditional nicotine replacement therapies such as patches or gum. However, until there is a licensed e-cigarette on the market doctors can’t recommend them as a smoking cessation tool or prescribe them to their patients. Having a prescribable e-cigarette will enable doctors to encourage their patients to use them and increase smokers’ chances of successfully quitting.”

Professor Nick Hopkinson consultant physician at the Royal Brompton and medical director at Asthma UK and the British Lung Foundation, added: “Most of the people that I see in clinic have lung disease which is caused and worsened by smoking. Despite this many still smoke, trapped by an addiction which for almost all of them began in childhood. There is already good evidence that commercially available e-cigarettes enable people to switch away from smoking to a much safer alternative. However, the development of medicinally licensed e-cigarettes would be a really important step forward, providing patients and healthcare professionals with an additional tool to break dependence on smoking, backed up by the reassurance that comes from a rigorous authorisation process.”

Professor Robert West, Professor of Health Psychology at University College London, praised the UK’s “balanced approach”, pointing out “there is strong evidence that this approach has been successful, increasing the numbers of smokers quitting with negligible take-up of e-cigarettes by non-smokers.”

He believes the MHRA’s move could expand access to e-cigarettes. But, like Peter Hajek, he adds that, “the regulatory hurdles to be overcome for a product to be licensed are still huge and I am not confident that any e-cigarette manufacturer that is independent of the tobacco industry will have the resources to overcome these hurdles.

This could very easily lead to a situation where tobacco company e-cigarettes with limited effectiveness can be prescribed while much better ones cannot. In my view, no healthcare provider should prescribe an e-cigarette produced by a tobacco company,” concluded West.

Professor Linda Bauld spent the day being interviewed on radio and television to confirm her opinion that it is “excellent news.”

Smokers have concerns about safety and misperceptions about the relative risks of e-cigarettes compared with tobacco. For some, cost is also perceived as a barrier. The option of having approved devices that could be prescribed would reassure smokers about relative risks and also assist in reaching those least able to afford e-cigarettes.

“Smoking remains the leading preventable cause of inequalities in health so anything we can do to help less affluent smokers in particular to quit is a step in the right direction.”

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Dave Cross

Journalist at POTV
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Dave is a freelance writer; with articles on music, motorbikes, football, pop-science, vaping and tobacco harm reduction in Sounds, Melody Maker, UBG, AWoL, Bike, When Saturday Comes, Vape News Magazine, and syndicated across the Johnston Press group. He was published in an anthology of “Greatest Football Writing”, but still believes this was a mistake. Dave contributes sketches to comedy shows and used to co-host a radio sketch show. He’s worked with numerous vape companies to develop content for their websites.

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