In recent years, vaping has emerged as an alternative to traditional smoking, with e-cigarette devices forming a key part of plans to reduce smoking rates and associated health risks.
Linsey Haswell and Nathan Gale are part of a team that’s set out to measure the nature and extent of toxicant exposure and potential biological effects from e-cigarette use. The team compared clinical measurements from exclusive e-cigarette consumers with smokers assessing the impacts of vaping, and consider the harm reduction potential of e-cigarettes in a shifting consumer landscape.
For more information on the disclaimers and the study please visit BAT.com.
Read their original research in the journal of Internal and Emergency Medicine.
Image source: BAT
The following transcript is automatically generated.
00:00:06 Will Mountford
Hello I’m Will, welcome to researchpod.
00:00:09 Will Mountford
In recent years, vaping has emerged as an alternative to traditional smoking, with e-cigarrete devices forming a key part of plans to reduce smoking rates and associated health risks.
00:00:20 Will Mountford
Linsey Haswell and Nathan Gale are part of a team that’s set out to measure the nature and extent of toxicant exposure and potential biological effects from e-cigarrete.
00:00:29 Will Mountford
The team compared clinical measurements from exclusive e-cigarrete consumers with smokers, assessing the impacts of vaping and consider the harm reduction potential of E cigarettes in a shifting consumer landscape.
00:00:41 Will Mountford
For more information on the disclaimers and this study, please visit bat.com and read their original research in the Journal of Internal and Emergency Medicine.
00:00:54 Will Mountford
And joining me to talk about their work from 80 Linsey and Nathan. Good morning and hello.
00:00:59 Nathan Gale
00:00:59 Will Mountford
Could you tell us a bit about your work at BAT and how that relates to the research that we’re talking about today?
00:01:05 Nathan Gale
I’m Nathan Gale. I’m clinical studies manager for bat. I have a bachelor’s degree in molecular science and joined bat almost 20 years ago as an analytical chemist.
00:01:16 Nathan Gale
I’ve been working in human research for over a decade and the majority of that in clinical research, designing leading and interpreting a range of clinical studies primarily on our alternative nicotine and tobacco products.
00:01:28 Nathan Gale
And for this particular study that we’re discuss.
00:01:30 Nathan Gale
Today I was Batts lead from conception and throughout the clinical execution.
00:01:35 Will Mountford
Thank you very much for that. And Linsey, can you tell us a bit about yourself as well?
00:01:39 Linsey Haswell
Hi, I’m Linsey Haswell. I’m a clinical scientist here at BAT.
00:01:43 Linsey Haswell
I have a degree in genetics and I have worked in academia for five years and very similar to Nathan.
00:01:49 Linsey Haswell
I joined the AT over 18 years ago. I originally joined the AT in vitro capacity and I worked in the lab for 15 years and then for the last three years I have been working alongside Nathan in the Clinical department.
00:02:04 Linsey Haswell
The human based studies.
00:02:06 Linsey Haswell
And I supported Nathan throughout the practical.
00:02:09 Linsey Haswell
Part of this.
00:02:09 Linsey Haswell
Study I have also been heavily involved in the writing and preparation of the manuscript that we’re going.
00:02:16 Linsey Haswell
To talk about today.
00:02:22 Will Mountford
First, I think we should cover some of the background. Some of the scope of where this fits into public health works fits into personal health and how timely it is that we’re talking about today.
00:02:31 Nathan Gale
Of course, if we look backwards, so back in the 1950s, evidence started emerging around the health risks associated with smoke.
00:02:40 Nathan Gale
And B 80s R&D science function was established in the mid fifties 1956 with an aim to understand these risks and to support the development of less harmful alternatives to cigarette smoking.
00:02:53 Nathan Gale
We now know that it’s the burning of tobacco or combustion at high temperature that creates more than 7000 chemicals, many of which are harmful and have been associated with smoking related disease. Now today, surprisingly to many 1.3 billion people around the world smoke.
00:03:13 Nathan Gale
That’s up from 1.1 billion in 2019.
00:03:17 Nathan Gale
And this is despite the serious health risks that we’re all aware of, associated with smoking.
00:03:23 Will Mountford
That is surprising considering, well, everything. What role then does your research team have in responding to those numbers?
00:03:33 Linsey Haswell
Clearly the best way to avoid these health risks would be to not start smoking in the first place. Or quit.
00:03:39 Linsey Haswell
Unfortunately, not all smokers are able or willing to quit, so that’s why BAT has created a portfolio of alternative tobacco and nicotine products where people can still consume nicotine but without the burning of tobacco.
00:03:53 Linsey Haswell
At our global R&D headquarters in Southampton, we have conducted over 150 studies on these alternative products and the paper we want to discuss today. That’s our first clinical exposure study on our views electronic cigarettes also known as vapour products.
00:04:11 Will Mountford
That leads neatly on to the next question and kind of advancing where this fits into harm reduction.
00:04:17 Will Mountford
How is harm being reduced and how does that compare to other harm reduction initiatives from outside of tobacco research?
00:04:24 Nathan Gale
So harm reduction is a social policy, and it’s aimed at minimising harm caused from behaviour that can be hazardous.
00:04:31 Nathan Gale
But it can’t be completely avoided or prevented. So if I take some everyday examples of that, we can’t avoid people driving cars or other vehicles or riding motorbikes, but for harm reduction.
00:04:44 Nathan Gale
Seat belts and crash helmets were introduced and a further example is we’ll never be able to stop people unwillingly or willingly being exposed to the sun’s harmful rays.
00:04:54 Nathan Gale
The sunscreen was developed to minimise the effects of those things, so the idea of applying harm reduction to cigarette smoking really gained prominence in the 1970s.
00:05:06 Linsey Haswell
So today, several prestigious health authorities such as the US Institute of Medicine and the UK Royal College of Physicians have explored the idea that tobacco, as long as it is consumed not through combusted, means that tobacco and nicotine could still be consumed pleasurably by relatively less masking methods. This comes from.
00:05:27 Linsey Haswell
Concept back in the 70s suggested by a researcher called Michael Russell, where he commented that people smoke for nicotine but died from the tar and this is suggesting a potential pathway that eliminates much of the harm arising from smoking combustible tobacco.
00:05:45 Will Mountford
In terms of less risky means, a lot of what we’re talking about today.
00:05:48 Will Mountford
Is based off.
00:05:49 Will Mountford
Of E cigarettes, which I understand is separate from vaping and there are other nicotine replacement products.
00:05:55 Will Mountford
What makes something an e-cigarrete versus a vape device? And does that fit under any umbrella of nicotine replacement? What’s kind of the categorization that we’re?
00:06:04 Will Mountford
00:06:05 Linsey Haswell
So nicotine replacement products, which are typically patches and gums, but you also get inhalers as well. They first became available as smoking cessation aids right back in the 1970s.
00:06:17 Linsey Haswell
And while these in our teas do work for some people who want to quit smoking, unfortunately they don’t work for everybody. This is probably because they don’t really provide exactly the same.
00:06:27 Linsey Haswell
Sensorial or consuming experience that people are used to when they smoke. Ever.
00:06:33 Nathan Gale
Yeah. And it’s important to note that NRT are medically licenced smoking cessation treatments, whereas our alternative tobacco and nicotine products are actually consumer products backed by science, but they’re not medically licenced for cessation.
00:06:47 Nathan Gale
We were the first company to have a medical licence for an electronic cigarette product called the Evoque, but at the time the licence was granted.
00:06:55 Nathan Gale
The product wasn’t commercially viable as technology and consumer preference had changed.
00:07:00 Will Mountford
So the market demand has changed around that considerably there.
00:07:04 Nathan Gale
It has, yes, you know, consumers are generally more accepting of these consumer type products. And as Lindsey mentioned, these licenced nicotine replacement therapies.
00:07:13 Nathan Gale
Whilst they may work for some, don’t actually work for all smokers, so it’s important to offer a range of these you know, potentially less harmful products to smokers.
00:07:22 Linsey Haswell
So you’ve got a number of different alternative products on the market at the moment. We have modern oral pouches or nicotine pouches and these are disposable nicotine pouches that consumers place between their gum and their upper lip.
00:07:35 Linsey Haswell
And they typically use them for about 20 minutes at a time, and the nicotine and flavours are then released and absorbed.
00:07:42 Linsey Haswell
In their mouths.
00:07:43 Linsey Haswell
We also have tobacco heating products and these are where we have tobacco containing rods that are inserted into a heating device that generates A nicotine consuming aerosol that people inhale. But you know it’s heated. Definitely not.
00:07:57 Linsey Haswell
Tested and we also have, you know, vapour or electronic nicotine products and these are battery power devices where you have an E liquid that typically contains nicotine and flavouring that then is heated to create again an aerosol that contains nicotine and that people inhale that.
00:08:14 Will Mountford
With the changing products made available from bat.
00:08:18 Will Mountford
The going from just burnt tobacco to what is currently available in any future products that do come.
00:08:24 Will Mountford
Up any listeners might have questions regarding what kind of place you have as a tobacco company and as a provider in that harm reduction, and the research space around all of that. So is there any work that you think listeners should be aware of?
00:08:39 Will Mountford
To kind of ground how the work that we are talking about today does have its clinical value, does have its medical utility, does have its important place in literature and is not just going to be a corporate press release?
00:08:52 Linsey Haswell
So obviously the best way to avoid the risks associated with cigarette smoking is to not start or quit. However, not everyone is able or willing to quit, so that’s why here at BAT we’ve developed a portfolio of alternative tobacco and nicotine products and these products aim to satisfy and provide a great experience.
00:09:13 Linsey Haswell
For people without the risk associated with combustible cigarettes and currently today we have 23 million consumers of these alternative prop.
00:09:23 Nathan Gale
Absolutely. I mean, when you think about a continuum of risk for nicotine and tobacco products like we talked quite a lot about combustible cigarettes here and they’re like the most, they’re at the extreme end of the continuums of both exposure to toxicants and the risk associated with consuming tobacco and nicotine. And primarily the reason for that is the.
00:09:43 Nathan Gale
Generation of toxicants when you combust tobacco. So what? We are focused on is developing a range of different nicotine and tobacco.
00:09:54 Nathan Gale
Where smokers who are unwilling or unable to stop using nicotine can potentially switch to these products and use them instead of cigarettes, thereby reducing their exposure to toxicants and reducing their potential risk of developing smoking related diseases in the future. And we have a robust risk assessment.
00:10:13 Nathan Gale
Framework which we employ to evaluate these newer generation products.
00:10:18 Nathan Gale
And that runs right through from assessing the chemistry of those products, looking at the constituents and the aerosol through to preclinical testing and looking at in vitro models and responses to exposure to these new products.
00:10:32 Nathan Gale
All the way through to what we’re discussing today, which is clinical data where we’re looking at assessment of exposure and potential risk in actual humans.
00:10:40 Nathan Gale
So the gold standard would obviously be long term epidemiological data. When people switch to using these products, do we see less morbidity, less mortality as compared to when people continue smoking cigarettes?
00:10:54 Nathan Gale
But in the absence of that long term epidemiological data, there isn’t a single study that can be conducted to definitively answer that question.
00:11:02 Nathan Gale
About the potential health impact of these alternative nicotine and tobacco products.
00:11:07 Nathan Gale
So we have to take a weighted evidence approach to this and back in 2001, the US Institute of Medicine recognised the need for this framework to evaluate whether these new alternative products could reduce health risks while offering smoke as a satisfactory alternative to continued smoking.
00:11:24 Nathan Gale
And the US Institute of Medicines Report explored key questions to help determine that comparative risk. So do the products decrease exposure to harmful substances?
00:11:35 Nathan Gale
Is that decreased exposure associated with a decreased risk to health and are there surrogate indicators of harm other than diagnosed cases of disease?
00:11:46 Nathan Gale
That can be.
00:11:46 Nathan Gale
Measured to gauge the comparative health risk in the short term and what are the public health implications?
00:11:51 Nathan Gale
00:11:52 Nathan Gale
So drawing on this work by the US Institute of Medicine.
00:11:55 Nathan Gale
Bat developed a scientific risk assessment framework, which has been published and peer reviewed, and this guides our approach to researching the effects of our new alternative tobacco and nicotine products compared to.
00:12:08 Will Mountford
Nathan, you mentioned that there were the surrogate indicators and all of the decreased exposure. What kind of research and how much of that research has BAT done to find out what can be made better for that public health intervention reason? Linsey, can you tell us?
00:12:23 Will Mountford
More about that.
00:12:24 Linsey Haswell
So yeah, using the framework that Nathan mentioned, we undertake studies on our products that cover emissions exposure and risk. And to date, we’ve published more than 150 studies on our new alternative products.
00:12:38 Linsey Haswell
And this body of evidence shows that for our vapour and modern oral products or nicotine pouches, these products emit 99% less toxicants compared to cigarette smoke.
00:12:49 Linsey Haswell
And for our heated tobacco products, you know where they admit 90 to 95% less toxicants compared to combustible cigarettes. We’ve shown that they have little or no effect on the biology.
00:13:00 Linsey Haswell
Cell types that we’ve looked at so far.
00:13:03 Linsey Haswell
And for our clinical studies for modern oral or nicotine pouches and our tobacco heating products, we have shown significantly better biomarker results for biomarkers that are linked to smoking related diseases. And when we compare those to the use of combustible cigarettes.
00:13:23 Will Mountford
We talk about biomarkers, we talk about surrogate indicators.
00:13:27 Will Mountford
Again, I think it’s important to state some terms and make sure we’re starting off with some familiarity of what we’re looking at here and we’re going to get into some quite molecular, if not atomic, definitions.
00:13:37 Will Mountford
So when we say biomarker in this case, what exactly do we mean? Where could we find them and what do they indicate further down the line?
00:13:45 Linsey Haswell
So when we talk about a biomarker, this is an objective measure that you could look at in somebody’s breath, their blood.
00:13:52 Linsey Haswell
Or their urine.
00:13:54 Linsey Haswell
And it captures or tells you something about what is happening to those cells or that Organism at that moment in.
00:14:00 Linsey Haswell
Time. So for us in this study, we’ve looked at biomarkers and exposure and biomarkers of potential harm, A biomarker exposure, a great example of that is an alcohol breath test. So when you consume alcohol, you’re then able to detect that exposure to alcohol in your exhaled breath.
00:14:20 Linsey Haswell
A biomarker of potential harm that is an early indicator of the development of a disease, so or an everyday example of that might be increased sugar levels in your urine and that would be associated potentially with indicating the risk of development of diabetes.
00:14:35 Linsey Haswell
Fire markers can also be affected by a number of different things. They can also be affected by the environment that you live in, the diet and lifestyle that you have, and even the genetics.
00:14:46 Nathan Gale
Yeah. And in this study, as Lindsey mentioned, we looked at a range of biomarkers of exposure and they were selected from the World Health Organisations Study Group on tobacco Product regulation who created an initial list of priority toxicants that they recommend reduced in cigarette smoke.
00:15:04 Nathan Gale
So to give an example of one of the biomarkers of exposure that we assessed in this study.
00:15:08 Nathan Gale
Cigarette smoke contains benzene. We can assess the amount of exposure to benzene by measuring its metabolite, which is known as spma in a smoker’s urine, or in a participant’s urine. We also looked at a range of biomarkers, potential harm, and these are.
00:15:26 Nathan Gale
Early indicators of processes linked to smoking related diseases and an example of one of the indicators we looked at is called cyclam.
00:15:34 Nathan Gale
One which is a biomarker which we can measure in the blood and increased levels of that biomarker associated with a process called endothelial dysfunction, which is a step along the path to the development of cardiovascular diseases.
00:15:48 Nathan Gale
For a couple of the markers we looked at, they’ve kind of fall into both buckets. So Nnal is a biomarker of exposure to a tobacco specific carcinogen known as NK.
00:15:59 Nathan Gale
Itself is also a carcinogen and is associated with the development of lung cancer, so it’s also considered a biomarker potential harm for lung.
00:16:09 Nathan Gale
COHB or carboxyhemoglobin is an exposure marker for carbon monoxide, but again that marker is also associated with decreased oxygen carrying capacity in the blood, and again the development of cardiovascular disease.
00:16:23 Will Mountford
How many people have been examined in this particular study? Some of the sample size and the scope? How far reaching? How you know, broad and deep? Are we talking about an investigation here?
00:16:34 Linsey Haswell
So in this study, we wanted to quantifiably assess the differences between current electronic cigarette users and current smokers. Right.
00:16:43 Linsey Haswell
And here we had seven primary endpoints and they were for biomarkers of potential harm that are associated with the potential development.
00:16:51 Linsey Haswell
Of smoking related diseases.
00:16:53 Linsey Haswell
We also had eight fire markers of exposure here and as Nathan mentioned, they were best on The Who top Reg 9 toxicant list.
00:17:02 Linsey Haswell
And the types of people that we wanted to look at in that study, we wanted to look at healthy normal adult subjects.
00:17:08 Linsey Haswell
So these were people aged between 19 and 55, and then we had four different separate populations or groups of people in this.
00:17:16 Linsey Haswell
Study. We obviously had people that use electronic cigarettes and these were people who exclusively used electronic cigarettes and they self reported using the views products EPEN 3 and epod for at least six months prior to beginning the study.
00:17:33 Linsey Haswell
And we wanted to look at people that were spontaneously using exclusively used products. So these are products that they have chosen.
00:17:40 Linsey Haswell
And we’re using in their everyday.
00:17:42 Linsey Haswell
Lives. We also wanted to compare this to obviously current cigarette smokers. So again, these were people who were self reporting, use of combustible cigarettes for at least six months before the study started and they used typically more than 10 cigarettes per day.
00:17:58 Linsey Haswell
We also had some former smokers in there, so these were people again who’d self reported quitting smoking for at least six months prior to starting the study.
00:18:07 Linsey Haswell
And we also had never smokers in there, so never smokers are people who you would also consider non-smoking and has smoked less than 100 cigarettes in their lifetime and had smoked none in six months prior to starting of this study.
00:18:21 Will Mountford
He mentioned the current smokers. There is that people who are exclusively using burnt tobacco or is there some overlap between smoking cigarettes and also smoking any electronic device?
00:18:32 Linsey Haswell
Again, these were people who exclusively used combustible cigarettes and didn’t use any other nicotine or tobacco containing products.
00:18:41 Nathan Gale
Yeah. As Lindsey mentioned in our groups of exclusive views, users and exclusive former smokers, we wanted people who had been exclusively using views for at least six months.
00:18:54 Nathan Gale
And in the former smoker group, people that quit smoking for a minimum of six months. Now, when we brought these people to the clinic.
00:19:01 Nathan Gale
We looked at cotinine in their urine, which gives us an indication as to whether they’re actually a nicotine user or not.
00:19:08 Nathan Gale
And we also look to exhale carbon monoxide, which gives us a further indication as to whether they are actually smoking combustible products or not.
00:19:17 Nathan Gale
And it’s really important that this was verified, because if we had people who had told us they’d quit smoking or were exclusively using views that they are actually smoking cigarettes, this would have quite a large effect on the study data.
00:19:31 Nathan Gale
Now the urinary cotinine and exhaled carbon monoxide measures that I mentioned are quite useful, but they’re quite short term measures and they certainly wouldn’t cover the previous six months.
00:19:41 Nathan Gale
So what we used in this study was something called cyanoacrylate valine, or cbal for short, which is a blood adduct of a cigarette smoke toxicant.
00:19:51 Nathan Gale
So we can measure this.
00:19:52 Nathan Gale
In the blood.
00:19:53 Nathan Gale
And because it’s an adult which sticks to red blood cells, it takes around 120 days for all your red blood cells in your body to be cleared and replaced.
00:20:02 Nathan Gale
So that marker in the blood gives us a really good indication as to whether people have been smoking for a longer period of time and just adds to that.
00:20:11 Nathan Gale
Confidence that the people in the views group and the former smoker group genuinely not been smoking for at least six months.
00:20:20 Nathan Gale
So we recruited 213 participants for this study, which took place at a clinic in central London.
00:20:26 Nathan Gale
And when we got to the end of the study, we had 205 participants who completed the study and were compliant with that blood C bowel measure that I just mentioned. So we had a good split of female and male participants in the study.
00:20:41 Nathan Gale
Around 41% female and 59% male, and the average age of the subjects was around 31 years old in the e-cigarrete and user group, we had 93 participants complete. We had 40 smokers complete.
00:20:56 Nathan Gale
35 former smokers and 37 never smokers.
00:21:01 Will Mountford
Well, you’ve mentioned the population and the location in terms of the schedule and the regular role of the assessment and all of the samples that were collected.
00:21:11 Will Mountford
Was there any particular methodology, any procedures that were being followed, and from there we can lead into the results of what that all found?
00:21:19 Nathan Gale
Yes. So the design of the study and the procedures that participants went through, I can give you a brief overview of that.
00:21:25 Nathan Gale
So on day one, so the first day of the study, potential participants are invited to attend the clinic in central London to undergo what we call screening. This involves A variety of physical tests and assessment of their medical vital signs.
00:21:40 Nathan Gale
Looking at alcohol, drug and pregnancy testing and also confirming nicotine use and smoking status.
00:21:48 Nathan Gale
Using those measures I mentioned before, exhale carbon monoxide and cotinine and also applying questionnaires to look at people’s extent of tobacco and nicotine use as well.
00:21:57 Nathan Gale
And this screening is designed to achieve 2 purposes. Essentially, first of all, to make sure it is safe for that potential participant to actually take part in the study. So the findings from that screening.
00:22:08 Nathan Gale
Assessment are reviewed by a medically qualified person at the clinic and secondly to make sure that the subject is appropriate for the scientific means for the.
00:22:18 Nathan Gale
So after that screening had been performed on the same day, individuals who met those inclusion criteria were enrolled immediately and began to participate in the study, so they were kept in the clinic.
00:22:30 Nathan Gale
They supplied their own electronic cigarettes or combustible cigarettes, depending on which group of the study they’re in. They were asked to bring sufficient.
00:22:38 Nathan Gale
Numbers of those to cover their typical use for an entire 20.
00:22:41 Nathan Gale
4 hour period.
00:22:43 Nathan Gale
And they are allowed to use them as they typically would use those.
00:22:46 Nathan Gale
Products throughout their 24 hour period there in the clinic.
00:22:50 Nathan Gale
We collected all of the urine that was voided by each of the subjects and we performed blood sampling and these were the key bio samples for looking at biomarkers of exposure, potential harm and also the haemoglobin sebal adopt. We also performed some physiological assessments.
00:23:07 Nathan Gale
And had our participants complete a quality of life questionnaire as well.
00:23:10 Nathan Gale
So then at the end of day two, there were some final health and safety assessments to make sure nothing significant had changed with the participant during the.
00:23:18 Nathan Gale
Study and then the participant was discharged from the study and then a follow up phone call was performed with that participant around seven days later, just to make sure they hadn’t had any adverse experiences since then been discharged from the site.
00:23:31 Nathan Gale
Those blood and urine samples that we collected were then transported to our partner labs. So the majority of the biomarkers of exposure in the study were analysed by a lab called analytics biologische forschunglabor or ABF who are based in Plannig in Germany and the biomarkers potential.
00:23:49 Nathan Gale
Some were performed by ABF again others performed by Solarion based in Zurich in Switzerland and a couple of the markers were also assessed by a local medical laboratory called the Doctor’s Laboratory based in London.
00:24:01 Will Mountford
and with all of that in mind.
00:24:03 Will Mountford
How does smoking electronic cigarette use prior exposure never smoking?
00:24:09 Will Mountford
How do they all compare? Is there anything that is markedly different, better or worse remarkable? What’s the results?
00:24:17 Linsey Haswell
So the results of our study have shown.
00:24:19 Linsey Haswell
Views consumers have favourable changes in buyer market exposure and biomarkers of potential harm. When you compare those compared to those who smoke.
00:24:30 Linsey Haswell
Only for the priority to smoke toxicants that we looked at or the bar markers exposure in this study, all of the biomarkers exposure that was eight that we looked at in the study had lower levels.
00:24:41 Linsey Haswell
And those were significantly lower as measured by stats when you compared the views users to smokers for the bar markers of potential harm, we saw favourable changes between views users and the smokers across all of the seven that we measured in this study. We actually saw statistically significant.
00:25:01 Linsey Haswell
Changes in three out of those biomarkers of potential harm, and they were actually related to cardiovascular disease.
00:25:09 Linsey Haswell
So we saw favourable changes in 11 DTX which is a far marker of platelet activation. We also saw statistically significant changes in carboxyhemoglobin.
00:25:20 Linsey Haswell
And this is a biomarker that is related to the oxygen carrying capacity of red blood cells and again related to cardiovascular disease.
00:25:28 Linsey Haswell
And we also saw significant reductions in soluble icam, which is a endothelial dysfunction biomarker, again linked to cardiovascular disease. We also saw significant reduction.
00:25:40 Linsey Haswell
And Neil, which is the biomarker of exposure but also a biomarker of potential harm because it has been linked to the development of lung cancer.
00:25:51 Linsey Haswell
And as Mason mentioned before, we also did some physiological measures and some surveys as well on our participant, particularly, we had done a quality of life survey and we actually saw some favourable changes in the general health outcome there or item on that questionnaire, which also was very encouraging for us.
00:26:09 Linsey Haswell
Also worth noting as well because we looked at 7 markers here for our markers of potential harm. We also did some statistical adjustment for multiple comparisons which because we looked at 7:00, we also wanted to decrease the chance of a false positive here in this case as well. So you know we did some robust statistics in this study.
00:26:29 Linsey Haswell
You as well.
00:26:30 Will Mountford
Yes, you mentioned carboxyhemoglobin cyclam NHL. There’s all ones that we highlighted earlier. So out of the significance of those thresholds, how significant are we talking as again you mentioned the difference between absolute risk and measured risk.
00:26:46 Nathan Gale
So if we take NAL as an example as Lindsey mentioned.
00:26:51 Nathan Gale
There are significantly lower levels of nnal measured in the views users compared to the levels of nnal measured in the.
00:26:58 Nathan Gale
Brokers and actually those levels of nnal in the views users, the numbers were not that different to what we saw in the former smoker and never smoker group.
00:27:07 Nathan Gale
So that really indicates that these views users levels aren’t just slightly reduced compared to smoking. We’re really getting down towards the levels of people who have completely quit smoking for at least six months.
00:27:19 Nathan Gale
And even potentially towards those levels that you would see in people who have never.
00:27:24 Will Mountford
And with the trial design you mentioned some of the structure and the limits of it as a kind of comparison to any other investigations, there might be that looking maybe long term or cross-sectional.
00:27:37 Will Mountford
Is there anything that you think is going to be an advantage of how this study has been conducted or any questions that it raises for future investor?
00:27:46 Nathan Gale
Yeah. So I mean big advantage of this study compared to sort of longitudinal studies is this study involved a single clinic visit.
00:27:53 Nathan Gale
It really captures the lived experience of people who are using these products with as Linsey mentioned earlier, the participants self selecting use of these products and using them in the way they want to in their everyday lives.
00:28:06 Nathan Gale
That’s quite a stark contrast to a longitudinal switching study where you would bring in someone who is a smoker and then you would force them to switch to using your specific product and look at the change in that individual overtime.
00:28:20 Nathan Gale
So in this study, with the single clinic visit, what we were assessing is the difference between groups of participants.
00:28:27 Nathan Gale
So we’re not controlling for baseline when these people were perhaps smokers compared to a longitudinal study where you’re actually looking at differences within participants and changes from baseline. So a limitation or a challenge.
00:28:41 Nathan Gale
With this sort of single cross-sectional type study is it increases the potential for large variability because we’re not controlling for baseline.
00:28:49 Nathan Gale
So the findings we’ve actually achieved in this study, in my opinion, are all the more impressive given that risk of greater variability, big advantage of running a study of this type.
00:28:58 Nathan Gale
As I mentioned single clinic visit, the study can be run a lot quicker. Took us around 1 to 1 1/2 years to complete this study end to end whereas with the switching study depending on the.
00:29:09 Nathan Gale
Switch duration. You’re looking at around 2:00 to three years to complete this type of.
00:29:15 Nathan Gale
And these studies, that’s really important duration of these studies is really important for consumer products in this really fast evolving environment where new technologies are being developed on a very, very regular basis and consumer preferences are in a state of change as well.
00:29:36 Linsey Haswell
So in this study, we wanted to assess the differences between current exclusive electronic cigarette users and current smokers. And we looked at biomarkers of exposure and biomarkers of potential harm.
00:29:50 Linsey Haswell
And what are the results of these studies have shown is that consumers of B 80s views epod and epen 3 electronic cigarette products have shown better.
00:30:00 Linsey Haswell
Results for the biomarkers exposure, the eight that we looked.
00:30:03 Linsey Haswell
At here which are.
00:30:04 Linsey Haswell
Linked to this smoke toxicant generated by The Who, and we also looked at our markers of potential harm and we saw significant changes in three out of the seven that we looked at when we compared users or electronic cigarettes compared to small.
00:30:21 Nathan Gale
Yes, this is really positive set of results and we strongly believe that the results we’ve got here underscore the contribution that vapour products can make towards tobacco harm reduction.
00:30:32 Nathan Gale
And so the study adds to an already significant and constantly growing body of evidence around vaping potentially being a less risky alternative for smokers who would otherwise.
00:30:42 Nathan Gale
Continue to smoke.
00:30:44 Will Mountford
And if there’s anyone listening to this from a consumer background from a healthcare provider background, from a research background, is there anything that you think they should come away from this interview knowing at any next steps that you think would be useful for them to take?
00:30:58 Linsey Haswell
We really think that these results show that electronic cigarettes have a role in tobacco harm reduction and we think this study shows that our consumers should have high confidence in BT’s well stewarded products and that they’re backed by science. We do the research.
00:31:16 Linsey Haswell
00:31:17 Linsey Haswell
We also think it would be really good if regulators and policymakers also considered our results in achieving their objective of reducing smoking prevalence in countries.
00:31:29 Linsey Haswell
I also think these results are important for the wider scientific community as well, and other people in related industries such as you know, other important players in the tobacco industry.
00:31:40 Will Mountford
And if people want to know more, either to find out more about the detail of this study or find out more about any future research from BB80, where can they find that and where can they find you?
00:31:49 Linsey Haswell
So our paper has been published in the Journal of Internal and Emergency Medicine. It was published on the 30th of May, which is actually World Vape Day.
00:31:58 Linsey Haswell
And if you go into the journal website, we are actually in a special collection which is being compiled. There’s a number of different papers there. The title of that one is the health impact of electronic cigarettes and tobacco heating system.
00:32:12 Linsey Haswell
And our publication is Open Access, so anybody can click on it, it’s free to download and read.
00:32:19 Nathan Gale
Yeah, as an organisation we’re really keen on openness and transparency and we published the findings of our research on our science website, which is bat hyphen science.com and on our corporate website that.com.
00:32:31 Nathan Gale
We also have a feature from our Director of Research and Science, Doctor James Murphy, covering this study and his take on what it means for tobacco.
00:32:39 Nathan Gale
Our reduction, so I encourage people to visit the corporate website and see James’s thoughts.
00:32:45 Linsey Haswell
And if anybody has any questions that they’d like to ask us, you can certainly contact us through back signs, but our contact details are also in our publication.
00:32:54 Linsey Haswell
If you want to download and contact us about any questions or comments you might have, we always look forward to talking.
00:33:00 Linsey Haswell
To people about it.
00:33:01 Nathan Gale
Just want to thank you will for hosting this podcast. Myself and Linsey really enjoyed discussing this key study and we really hope it’s an interest.
00:33:08 Nathan Gale
To your listeners.
00:33:10 Will Mountford
Thanks so much for your time and speak with you again sometime soon.
00:33:13 Linsey Haswell
Thank you very much. Absolutely thank you.