Regulating to “normalise” low nicotine cigarette smoking would prevent 2.6m tobacco-related deaths in the United States by 2060 – and would accelerate already declined cigarette smoking prevalence to just 1.8%. This is according to Professor David L Ashley, inaugural director of the Centre for Tobacco Products at the US Food and Drug Administration (FDA), reports Chris Bateman for MedicalBrief.
He was delivering the keynote address to the global E-cigarette Summit – Science, regulation and public health, held in Washington DC on 17 May 2022.
Ashley said policy regulation normalising the smoking of low-nicotine cigarettes, along with education encouraging daily proper use of electronic nicotine delivery devices (ENDS), were the best current science-based harm reduction approaches.
The low-nicotine death reduction data he cites is premised on 16 million US citizens who would otherwise have initiated smoking not starting at all because of low nicotine policy regulation.
The summit
The E-Cigarette Summit describes itself as a neutral meeting point for scientists, regulators, industry, public health and practitioners “to explore the latest research on e-cigarettes and facilitate respectful debate on what remain highly controversial issues”.
Owned by Smooth Event Management in the United Kingdom, the summits are held in Britain or America, funded through delegate ticket sales: there is no sponsorship or funding from commercial or government organisations, and no commercial links or involvement with the tobacco, pharmaceutical or e-cigarette industries.
The 2022 conference and Ashley’s keynote address were introduced by Professor Thomas Glynn of the Stanford Research Centre, as being “in the name of ending the reign of the combustible cigarette – and the death and disease caused by them”.
In the keynote address, entitled “Thinking Outside the Box”, Ashley said his conclusion from studies to date is that it is possible to improve and maximise the effectiveness of e-cigarettes in smoking cessation – by changing the circumstances in which smokers are first introduced to them.
He emphasised that his address was “not about how to sell more e-cigarettes or to make manufacturers or retailers happy. It’s about improving the likelihood that when smokers encounter e-cigarettes, they will continue to use them to a point where they’ll stop smoking.”
E-cigarettes – A population health tool
E-cigarettes were a tool that could have a major impact on overall population health, Ashley said.
However, to date they had not met their potential, with too many adolescents starting to use e-cigarettes and too many smokers either becoming dual users or rejecting e-cigarettes and relapsing to smoking.
The goal was to exploit the potential benefits of e-cigarettes for reducing morbidity and mortality of tobacco smoking while minimising the unintended consequences.
Ashley emphasised that he no longer worked or spoke for the FDA, having left in 2017 and having spent 27 years at the Centres for Disease Control and Prevention (CDC). Today he is a research professor in the School of Public Health at Georgia State University.
He said traditional cigarette smoking among adults had declined steadily since the 1960s, though not as fast as the graphs suggested because of population increases and a slower decline in combustible tobacco’s harmful effects. While some suggested the introduction of e-cigarettes in 2010 accelerated this drop: “I must confess, I don’t see this.”
Adolescent cigarette smoking had decreased rapidly since the early1990s. However, smoking among both young people and adults appeared to be “bottoming out”, which was of “grave concern”, with close monitoring needed.
Smoking prevalence among 12th graders in the US has dropped from a 25% peak to 3% in 2020. Eighth and 10th graders tracked this but started and ended lower.
The FDA was “clearly and appropriately” concerned about young people’s use of tobacco.
Decreases in smoking prevalence differed, with a 2020 sounding showing college graduates at a 5.6% prevalence compared to 21% among young adults with less than a high school diploma. Lower income groups and LGBT communities were more likely to be smokers than high income and heterosexual cohorts.
In randomised controlled trials, e-cigarettes were shown to be 83% more effective than nicotine replacement therapy (NRT). But this was conditional upon a host of factors which included the free supply of products and behavioural coaching on how to get the most nicotine out of e-cigarettes.
In a ‘real world’ year-long study in Georgia in the US, 53.47% of dual users remained dual users, 37% rejected e-cigarettes and continued smoking and about 2.5% sequenced to exclusive use of e-cigarettes. Less than 7% quit altogether. The 20% of dual users who quit altogether represented half of that found in a previous study.
A recent population assessment of tobacco and health – the PATH study conducted by the CDC – showed similar results.
The ‘real world’ conclusion was that over 80% of dual-use smokers continued to smoke after trying e-cigarettes, either remaining e-cigarettes smokers or reverting to combustible tobacco. Less than 10% stayed with e-cigarettes.
“This is not what we want,” Ashley said.
Cessation breakthrough
The most useful revelation so far was that the frequent (at least daily) use of e-cigarettes (only) encouraged smoking cessation, with 17% of people quitting after 20 to 24 days and 32.6% quitting after 25 to 30 days. When smokers did not get what they wanted from e-cigarettes (mostly insufficient nicotine through improper use), they simply stopped using them.
There were unfortunately a lot of poor quality ENDS products on the market that failed to deliver enough nicotine to satisfy cravings. Studies revealed that the blood plasma levels of nicotine in e-cigarette-naïve smokers were negligible.
This supported the smokers’ claim that they did not deliver enough nicotine. Only six to 10 puff bouts on a decent quality e-cigarette started to deliver greater amounts of nicotine. This required coaching, “otherwise they may never make that transition”.
Behavioural support and motivation were also needed to get away from combustible cigarettes, Ashley stressed.
He encouraged tobacco shop owners to take a hands-on approach and teach their customers how to use vaping devices. There was also a glaring need for a study into the long-term outcomes of first-time e-cigarette users.
“Unless e-cigarettes are effective for smoking cessation, they will not work as a replacement technology,” he pointed out.
Smokers of combustible cigarettes need reduced incentives to smoke, and the addictiveness of cigarettes need slashing while providing effective alternatives. “State and local authorities have ways to bring this about, and they should do so,” Ashley emphasised.
This is the first of Chris Bateman’s coverage for MedicalBrief of the Summit. The second article can be accessed here:
E-cigarette Summit: Vaping improves odds of quitting tobacco smoking
See also from the MedicalBrief archives
The world’s deadly harm reduction policies unpacked – Clive Bates
The E-Cigarette Summit 2020 – Less harmful than smoking but not harmless
Vaping – Time for doctors to get on board
Tobacco harm reduction – ‘We’ll take to the streets” – Letlape