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How does prohibition of safer alternatives square with the Hippocratic oath? What are the ethics of accepting smokers' lives and wellbeing as collateral damage, in pursuit of the war on the nicotine industries? Why is giving alternatives to people who misuse substances viewed differently to permitting people who smoke access to less harmful alternatives? Supported by evidence from work successfully debunking bad science, including exposing research claims correlating viral TikTok videos about nicotine pouches to sales. Shouldn't we allow people to make informed judgements about their behaviour and their health?


Transcription:

00:03 - 03:12


[Garrett McGovern]


So what we're gonna talk about today is how prohibition of safer alternatives squares with the Hippocratic Oath, which doctors take. What are the ethics of accepting smokers' lives and wellbeing as collateral damage in pursuit of the war on the nicotine industries? Why is giving alternatives to people who misuse substances viewed differently to permitting people who smoke access to less harmful alternatives? supported by evidence from work successfully debunking bad science, including exposing research claims correlating with viral TikTok videos about nicotine pouches to sales. Shouldn't we allow people to make informed decisions about their behavior and their habits? So we've got two great speakers today who I'm gonna introduce to the stage. I'm going to give you a little bit about their biography and their background. They don't need very little introduction from me. First of all, and our first speaker is our very esteemed colleague, Jean-Francois Etter. He's a Swiss public health expert and researcher known for his work in tobacco control and smoking cessation. Jean-Francois holds a master's degrees in political science and public health, and a doctorate in political science. An honorary professor of the University of Geneva, he's conducted research for over 30 years in smoking prevention, cessation, nicotine addiction, and the impact on various public health policies on smoking behavior. His studies often focus on harm reduction strategies, particularly in relation to e-cigarettes and other nicotine and tobacco products. His work has contributed to the understanding of smoking behavior and to the development of effective tobacco control policies. We also have our other esteemed colleague, Dr. Arielle Selya, who is a behavioral scientist. She'd be well known to all of you at GFN and consultants specializing in tobacco harm reduction. Through her primary role as a senior scientist at Pinney Associates, she supports dual labs and the scientific and regulatory efforts through behavioural study protocols, statistical methodology and scientific publishing strategy and execution. Dr. Selye also serves as a scientific consultant to the Global Forum on Nicotine. She received her PhD in neuroscience at Rutgers University and prior to becoming a consultant, spent a decade in academia studying adolescent substance use and addiction. In addition to being a prolific contributor to the scientific literature, with over 70 scientific publications to her name, Dr. Selye is also actively engaged in both post-publication critiques of published research and in communicating scientific findings to broader audiences on social media, such as Twitter, Substack, and YouTube, et cetera. So without any further ado, I am going to invite Jean-Francois, who has warned me that I need to slow down, I speak too fast, and I promised him I will do that. So Jean-Francois, if you'd like to come to the podium here.



03:14 - 24:14


[Jean-François Etter]


Thank you very much, Garrett, and good morning, ladies and gentlemen. Thank you to the organiser for inviting me. Can you please project the presentation? So I was challenged by the organizers to speak about the ethical issues around prohibition. I start by saying that I do not have any conflict of interest in the field. So prohibition is not anymore a marginal approach to this field. If you look at this position paper on tobacco harm reduction published by the World Health Organization last year, you can see that they start by saying that government can best protect health by implementing measures that includes, and the first line in the list is a ban of manufacturing, distributing, non-combustible products and enforcing those prohibitions rigorously. So this is the WHO policy right now, and it's followed with effects. Several countries don't just ban selling, but also using these products, e-cigarettes in particular. I've listed a few of them here, it's only examples, where users can face heavy fines or even prison for using these products. And other large countries, some of them are listed here as examples. prohibit selling e-cigarettes. Now you also have partial bans, like, for instance, in Australia, where e-cigarettes are available only by prescription. Japan bans nicotine-containing e-liquids. Disposable vapes are banned in many countries. It will be illegal in the UK next year to sell tobacco to people born after 2008. and to sell vapes to people under 18. And many countries also ban flavors in the liquids, as you know. So the ethical question here is, given then most of the harm come from the combustion, not the nicotine itself, and that some smokers have great difficulty quitting smoking or just will not stop quit smoking, then is it ethical to deny them access to low-risk alternative while cigarettes remain widely available and are not subject to similar bans? So let's examine this using the basic principles of bioethics and public health ethics, which are the respect for persons and their dignity and their autonomy, the principle of beneficence and non-maleficence, the principle of justice and, in the public health perspective, social justice. So let's start by acknowledging that in the field of nicotine and tobacco, The user's autonomy is limited by nicotine dependence, so it may undermine their ability to make autonomous decisions. In particular, vulnerable people, like people with mental health issues who have great difficulty or greater difficulty than other people to quit smoking or illicit drug users, or vulnerable and marginalized population where there is a high smoking prevalence, a social pressure to smoke, and it's people who have more difficulty stopping using the substance. Of course, at the core of the debate is young people and the risk for them to become addicted to nicotine or to tobacco. And I think we all agree that it's necessary to protect them through measures that are effective, proportionate, and ethical and that respect their dignity and autonomy. A corollary of the autonomy principle is the duty to inform. People are treated with respect when they are given choices based on accurate information. So the duty of ourselves, the professionals in the field, public health professionals, is to provide truthful information about the products and to inform them also of the relative risks, I think, An important element is to always compare the risks with the relevant comparator, which in many cases is smoking, not just not using the products. You have two relevant comparators, not using the product and smoking. The relative risks should be presented. But prohibition are often based on false assumptions. They are often accompanied by misinformation or information that emphasize the absolute risks or just the presence of the toxic substance without a relevant comparator to cigarette smoke. For an example, the EU Health Commissioner, Oliver Varelier, said that he is 100% sure that e-cigarettes, heated tobacco and nicotine pouches are just as harmful as cigarettes, that the person in charge of health at the EU Commission. If you take the same WHO paper on harm reduction, which was published last year for the COP, the Conference of the Parties of the Framework Convention, You can read in this document that all tobacco, nicotine, and related products both have risks, including risk of addiction. But the problem with this statement is that it lets the reader think that all products are equally harmful. And in this sense, it is a misleading statement. So withholding information is clearly a violation of the duty to inform because then users are denied the opportunity to make informed choices and autonomous decisions based on their own preferences and values. And I think a grave consequence of this is also that people understand that this is not true, and then it undermines the public's trust in health authorities, in the EU Commission or WHO, for instance. And, well, we are facing an epidemic of Ebola, for instance, and if people lose trust in one field, they may also lose trust in WHO in other fields, too. Prohibition, of course, is also... a way to deny users the opportunity to choose autonomously, and it's paternalist also. It assumes that people are incapable of making autonomous choice, so this undermines their dignity. I think the prohibition is like the nuclear option. There are many, many other ways that are less restrictive to achieve the public health goals. We'll come to this later. The principles of beneficence and non-maleficence. If you ban non-combustibles but do not ban cigarettes, then the only thing you do is that you change the user's preference, the market preferences, and you give a competitive advantage to cigarettes. And then it perpetuates smoking and causes more harm than good. The logic of prohibition is quit or die. It's a very harsh logic that completely lacks compassion. It lacks compassion for the people who have difficulty quitting smoking, in particular the vulnerable groups who will be most impacted by these measures and by enforcement by authorities. So it's hard to believe that these prohibitions have as their primary goal the protection of public health. Rather, they're motivated by other objectives, preventing nicotine use by young people, which could be a valid objective, but also a moral aversion against nicotine, or just political and strategic and electoral considerations, ideology. And because they are founded in ideology, because they are very ideological, these bans are not proportionate, and harm reduction is a more pragmatic approach. Could you please send the next slide? It doesn't work. Technical team, please give me the next slide. Okay, I'll continue with my paper. Excuse me. So, yeah, I'll continue with it, never mind. So the effectiveness of prohibition, is it effective? It worked at least. Well, it may work. Use uptake may decline in some cases, but not always. Not always. And not in particular when illicit products are easily available. And we see that the illicit market is thriving under prohibitions. Or not when there are innovations. The field is very innovative. New products come up all the time, so it's easy for people to get the products anyway. And if you want to prohibit a product, then strong enforcement is necessary. with all its negative consequences. And at the core, in this field, at the core of the definition of nicotine dependence or addiction, there's compulsive use, use in spite of negative consequences. So demand will not disappear. People will continue to use addictive products. We have decades of experience in this field showing the negative consequences of prohibitions. In the US, for instance, oh, thank you very much. It's easier with the slides. In the US, for instance, retail sales data shows that almost all e-cigarettes, 86% of e-cigarettes sales are for illegal products. Almost all the market was given to the illicit market. In Australia, for instance, you have a tough war between criminal gangs who control the e-cigarette and tobacco market. They burn each other's shops. This is a tobacconist after an arson attack. It's a billion dollar industry wiping out legitimate businesses. Here, another arson attack in Australia. In Mexico, as it was discussed yesterday, the drug cartels now control the vape market, so it's a new source of income and influence for them and a new possibility for them to corrupt political decision makers. In Brazil, for instance, At the border with Paraguay and Argentina, the same routes, the same cartels, the same routes are used to introduce illegal drugs and vapes in the country. So... And the list of adverse consequences goes on. If there's a ban, there's no regular oversight, no quality control. Products may contain illicit ingredients. Vulnerable groups are the most affected, both by over-policing, enforcement by authorities, and the criminality. So many adverse consequences. And also, it stifles innovation. In other fields of drug addiction, harm reduction approach were implemented at least since the late 1980s, early 1990s, when there were no treatments for AIDS. Then needle exchange programs, supervised injection sites, or even medical prescription of heroin programs were implemented with popular support in spite of the moral and ideological opposition to this program. In Switzerland, for instance, where the population vote for almost everything, repeatedly in the past 30 years, people have voted in favor of these needle exchange or supervised injection sites and medical prescription of heroin. It has popular support, but if you prohibit a product, then you stifle innovation and you favor cigarettes over the innovations. Also, I think when People say, well, let's apply the precautionary principle. Then they may think, well, we'll ban the product. That's the necessary consequence of a precautionary principle. But no, it's a completely incorrect application of this principle. The European Union has a structured approach to this precautionary principle that says that, first, in case of uncertainty, then we need the fullest possible scientific examination. of the situation. We shall examine the cost and benefits of action and inaction. This evaluation and the writing of the regulation should be done with the participation of all interested parties, including the consumers. Measures should be proportional to the chosen level of protection. Measures should be non-discriminatory. Comparable situations should be treated similarly. And measures should be consistent with action taken in the past in similar situations. They should be reversible. Much of the time, the bands are not reversible. They should be reversible if data and new scientific studies show that they have negative consequences, and the burden of proof should be assigned. the regulation should say who should bring the proof, either the consumers or the producers or the government, but the burden of proof should be assigned. So this is the correct application of the precautionary principle, and if it was correctly implemented, certainly measures other than bans would be implemented. Now, at the core of this debate is the situation of young people. We all agree that they require special protection because they may be immature or inexperienced and may not be able to make autonomous decisions as adults do. So, as in other contexts, they require stronger protection than adults do. But there are a range of less restrictive measures and more ethical measures than bans. Educational measures, the classical taxation proportional to risk, marketing restrictions, environmental measures like vapor environment or approaches that use peer influence, Product regulation, pre-market authorization, access measures like age verification, retail licensing, structural measures that decrease the risk factors in the first place like vulnerability, poverty, better health care, smoking cessation support. And also an important point is the monitoring of the situation, the surveillance of the pattern of use, the products, the new products, the innovation, the industry behavior and the marketing, the health effects, the illicit trade, all of this should be monitored. And I'm not sure, for instance, that the French who banned nicotine pouches have put in place the necessary monitoring to make sure that the inevitable transfer of the market to the existing criminal gangs who already control the illicit market of drugs in neighborhoods where the police does not even enter in some big cities in France will not just hand over the market to them. The gateway theory, at the center of this fear about young people is the gateway theory, the theory which we spoke, Ariel and Mr. Shapiro spoke a few minutes ago, that says that people will start vaping and then get addicted to nicotine and then start smoking. It's a controversial theory, even in the case of cannabis leading or not leading to heroin use. For over half a century, this theory has always been controversial because it is a causal theory. And scientifically, it's very hard to prove a causal relation. In particular, in the absence of experimentation, you cannot randomly assign young people to vape or not vape. So it's difficult to prove or disprove it. And anyway, the data are also compatible with the common liability model, a model that says that the same risk factors, the same vulnerabilities lead people to either vaping or smoking because the two behaviors are so similar. then they share the risk factors. The justice principle, who bears the cost of prohibition? The smokers, of course, the legitimate manufacturers who are wiped out of the market, the consumers who are exposed to unregulated products, the populations victim of criminal gangs like in Australia, Mexico, The disadvantaged groups that have the highest smoking prevalence and that are the most affected by enforcement. So we may also ask, who bears the responsibility for the unintended consequences? For instance, in Australia, a recent document shows that the government was warned and was aware of the negative consequences of the ban, but they chose to proceed anyway. So when governments and the proponents of bans spread misinformation, when they were warned but chose to proceed anyway, then who's going to hold them accountable? And are they ever going to be held accountable for that? So to conclude, BANs run counter to the core principles of bioethics. A better approach would prioritize reducing disease and be pragmatic rather than ideological. Respect autonomy, provide accurate information, a very important point. Education is a great part of it. Use the least repressive measure to achieve goals. Be open to innovation. apply the precautionary principles, and I think look also for compromises. The field is so divided that if we don't reach a compromise, we are unlikely to achieve a result. Thank you very much for your attention.



24:24 - 24:43


[Garrett McGovern]


Thank you very much for that, Jean-Francois. That was an excellent look at the impacts of prohibition and what we can do to avert this. I'm going to bring Arielle to the stage. As I said, I've done my introduction, so with no further ado, Arielle, I'll let you get your slides up and get moving.



24:56 - 45:47


[Arielle Selya]


Good morning, everyone. If you could pull up my slide deck, the other deck. No, this is the wrong slide deck. It should be My own one. Hopefully they have a copy of it. There you go. Perfect. Thank you. Okay, good morning. If you don't know me, I'm Arielle Celia. By way of disclosures, I work for Penny Associates. We consult for Juul. I advise to GFN. But mainly today I'm talking about my extensive kind of side experience reviewing the new literature and critiquing it and pointing out the common flaws in this body of research. When the organizers first asked me to be on this panel, I didn't really know what I should talk about because I don't specifically focus on prohibition issues, and I don't really focus on the ethical issues. But the more I thought about it, the more I realized that this does really relate to a lot of the issues that I'm seeing with flaws in the scientific literature. And I'm going to frame this as a harm versus harm reduction mindset. This relates to prohibition. I think in many cases there's an ethical rationale for either endorsing a harm mindset versus a harm reduction mindset. But once a mindset takes hold in the body of research, this can affect scientific integrity and kind of compromise the scientific quality there, which also, of course, has ethical implications. So my assumptions on this is that I'm not always talking about full prohibition, but the problems that I see in the literature are evident well before it gets to the point of prohibition. So the distinction I'm making here is between a harm mindset where you take a safer product like e-cigarettes and you're only focused on what can go wrong, what are the health harms from this, what are the addiction harms, what are the harms to youth, versus a harm reduction mindset where you're saying, well, is it better than the alternative, which is probably cigarette smoking? Not everybody is going to go down the spectrum, obviously, but I think it starts with something more justifiable. Like, for example, taxes do have a justifiable evidence base for if you increase cigarette taxes to an extent, it can reduce demand. But it doesn't continue that. If you keep increasing taxes, it doesn't continue to reduce demand. You get diminishing returns at some point. You can see this in places like Australia, where a legal pack of cigarettes costs like $50 and is available for $7 to $10 on the illicit market. At some point, you hit diminishing returns. And then the tendency in the literature that I see week after week is that almost all papers end with a conclusion to either for stricter regulation, for more enforcement, more bans, more regulation. So I think it's kind of a slippery slope towards the end of prohibition. Whether or not it ends at full prohibition is a different story, but the problems I think emerge with a more broad harm mindset. Last year, for my Michael Russell oration, I talked about research incentives and how the academic funding and publishing incentives kind of created and perpetuate the problems that we see in the literature. And in particular, I identified the need to conform with funding agency priorities as a primary driver of low quality and anti-THR research. And I think that's where the harm mindset has originated in a lot of cases. Research funders, in large part, set the questions worthy of being asked. The NIH historically has been more focused on the harm side rather than harm reduction. I believe NIH has softened up a little in recent years. But the other minor funders of academic research, especially in the US, such as Bloomberg, American Heart, American Lung, they're all very anti-e-cigarette. So when funders are more often focused on harm rather than harm reduction, this determines the study design, the research questions being asked, how you define variables, what statistical analyses you do, and what conclusions you draw. And I thought, let's go through an example of research on e-cigarette flavor bands. So from a hypothetical point of view, the research question in the harm mindset is really focused on what are the possible harms and like harms of e-cigarettes. And in the context of flavor bans, this translates into, well, how can we reduce e-cigarette use among youth? One idea is to ban flavors. So the harm mindset will only look at the direct intended effect of that policy. Whereas harm reduction mindset, It's a broader take on what's the overall risk profile. How do flavor bands affect the overall patterns of tobacco and nicotine consumption? For study design, often the harm mindset will just be focused on youth vaping prevalence as the main direct intended effect. And it'll often involve low quality types of studies such as just a before and after. What was youth prevalence doing before the flavor ban versus after? If there's a decline, it's often interpreted in favor of the ban, of course, even if it's not particularly strong evidence. The harm reduction literature more often, not always, but more often relies on natural experiment type, which in the absence of being able to run randomized experiments is probably the best, highest quality possible evidence. So what I mean by that is in the US, for example, you have 50 states that can each do their own thing. Some of them have passed flavor bans, others have not. So the idea is you compare places that decided to pass a flavor ban with with similar states that didn't and you evaluate the effect. Not gonna go through all of this line by line, but essentially I think you get the idea. The harm mindset is really only focused on what can we do to reduce harms of e-cigarette use versus harm reduction is broader and it includes considering possible unintended and harmful effect. Running through some examples in the recent literature on e-cigarette flavor bans. I've got some good examples and bad examples here. So first up we have a flavor ban analysis in Finland, and the main findings there in terms of prevalence was that current vaping was 2% both before the ban and after the ban. So no obvious effect here of the flavor ban, but the conclusions supported the flavor ban anyway because they did kind of a, A different analysis, they spun it by looking at the profile of current, former, and never use, and since they found changes before and after the ban, they concluded that the flavor ban had some kind of effect, even though it wasn't really detectable at the population level. Also, people continued to use flavor de-cigarettes after the ban in large numbers, so really no detectable effect of the policy, but the conclusion supported the policy anyway. Next, there was a paper in the US looking at flavor bans across US states. This analysis focused on the fact that e-cigarette sales decreased by 30% to 94% across states, which they concluded a success of the flavor ban. But the big missing question is what happened with cigarette smoking? This wasn't even examined in the paper, yet this is a well-known indirect harmful consequence of flavor bans. Another paper in New Jersey actually did look at effects on cigarette and cigar sales, and they did find a short-term increase following the e-cigarette flavor ban. So the ban shifted some of the consumption away from flavored e-cigarettes and towards cigars and cigarettes. And the authors kind of remained neutral. They didn't seem particularly concerned about the unintended effects, and they said, well, this was only a short-term effect. We need more research on long-term effects. But if you already have a short-term effect of harm, how long do you need to go before it makes somebody question the value of that policy? A more recent paper in the Netherlands after a flavor ban found that 40% of youth and young adults either reduced or quit their vaping entirely. That included 22% who quit. Yet in the same study, they reported that 6% of all participants started smoking because of the e-cigarette flavor ban. And the conclusions are still in favor of the flavor ban, and I think what they're doing is maybe weighing the 6% against the 22% and saying, well, the 22% is bigger. But that assumes that there's a trade-off, an equal trade-off in terms of harm, and of course there's not. Any small increase in cigarettes can quickly undermine any public health gains by a reduction in vaping. So this paper is a situation where they're ignoring the harm to support the policy anyway, so it's keeping with the mindset in spite of the evidence. Couple more quick examples. The pro-harm reduction side is not immune to these problems either. So the first one is a recent study in South Korea that looked at product substitution between cigarettes, e-cigarettes, and heated tobacco products. They used kind of a quasi-experimental or natural experiment analysis, but there was no natural experiment in Korea. It was just national level estimates and correlating with time series. So really weak evidence. It was the right... conclusion in my opinion, but for the wrong reasons and not backed up by their science. Finally is some of the high-quality or that I hold in high regard, some of the work from Friedman, Pesco, Lieber, looking at natural experiment variation across the US. So it was almost, I think, 400 localities in several states that enacted flavor bands. And they looked at both the direct effect and the indirect effect. For the direct effect, flavor bands did decrease e-cigarette sales, but for every fewer e-cigarette pods sold, 11 to 15 additional cigarettes were sold. So again, a harmful unintended consequence, but this is valuable because it looks at the big picture and doesn't just support the policy despite the evidence. Harm mindset dominates current research. This is mostly my own opinion, but this was backed up by a recent conference presentation that somebody sent me on Twitter, where they took, looks like almost 900 papers on novel tobacco and nicotine products. and they broke it out by whether it was industry funded or not. And those two pie charts look very different, which is to some extent reasonable. The industry studies were more likely to conclude in favor of these products, and the academic studies were completely the opposite. But what was really interesting to me is that if you look within each group at the percentage that publishing a conclusion that goes against their own best interest, 12% of the industry studies came out against the new products, which is kind of interesting. And if you add up the comparable number on the academic side was the 0.7% up there and the 7.9%, so that's about 8.6%. Slightly higher in the industry group, publishing against their best interests, so it kind of raises the question, who is the biased one here? Bringing it back to ethics and prohibition, I think ethics in part drives the research mindset, but once a research mindset dominates the field, as is the case we have now, it invites and allows unethical research practices to perpetuate. So this can show up in the form of unchecked confirmation bias when a researcher is interpreting their results, dismissing or downplaying documented harms, and this goes unchecked by peer reviewers, journal editors, and colleagues because they're kind of blind when they have the same mindset. It's really important to have cross communications, and that goes for our side as well. So we're not susceptible to the confirmation bias. But unfortunately, a lot of papers that I see are choosing the research mindset that they started out with over the evidence in their papers. And of course, low quality research, which can happen in both sides, has ethical implications for public health. So restricting access to less harmful products, as Jean-Francois just argued, is an unethical issue. And policies that create unintended but not unpredictable consequences. Another couple of other ethical related topics that I wanted to include here is related to, the first one's related to IRB mission creep. So if any researchers in the room will know that before you do any research on human subjects or animal subjects, you need to secure ethical approval. And there's good reasons for this because there have been really unethical experiments in the early 20th century. So this is to protect against that, and it's mostly been successful, but there's also mission creep. So as IRB boards see fewer and fewer submissions with glaring ethical issues, they are more inclined to nitpick over the remaining issues that are there, because they feel like they have to comment on something. And then in controversial fields like this one, IRBs can sometimes act as gatekeepers of the status quo mindset. An example that I have to deal with is I analyze, for a lot of my work, public survey data from CDC. These are publicly available data. Anybody in the world can download and analyze them. But if I want to publish them, I have to ask an IRB permission. The NIH, a few years ago, set exemption categories specifically to reduce the burden on IRBs in cases that clearly just don't count as interacting with a human participant and exposing them to risks of the study. The exemption category four here is what applies to me, which is you don't have any identifying information. All you have is their survey responses. There's no way to connect it back to a person. And from my perspective, I think it's pretty clear that the de-identified surveys from the CDC fall into this category. But if I want to publish in certain journals, and here's an example of instructions to authors, even secondary data analyses of publicly available data sets require formal exemption by an IRB. So you still have to submit an IRB application anyway. for them to decide what's clearly on the NIH's website, that this is not human subjects research. On the other hand, it's not balanced. So when I think of over micromanaging human subjects research with minimal risk research, on the animal side of things, things are completely different. So they seem to rubber stamp these animal studies that have little to no value for human research. I asked co-pilot for some examples of this. These animals and the nicotine addiction and, like, vapor exposures and secondhand smoke exposures, there's a lot of suffering for the animals. It's hard to get them addicted to nicotine in the first place, from what I understand. It requires restraint, restricting their food and water, prolonged exposure to nicotine vapor, and in much higher doses and for longer periods than a human user would choose to experience. The method of delivery is not even comparable in some of the studies. So IRBs tend to rubber stamp these articles while over-scrutinizing the public health research. And the motivation for animal research is supposed to be that we're making the animal suffer so that humans can achieve a benefit from it. And in some cases, that's justified. I'm not blanket anti-animal research, but in the case of nicotine exposure, when the exposures are not even relevant to human consumption or human clinical outcomes, not only is there no value, but it seeks to feed a lot of the alarmism in the media and in the studies out there. So if anything, it's harming humans as well. Another ethical gray area is this research that exposes youth to vaping ads to see what features are attractive and should be banned. Among these researchers, there's a nearly unanimous belief that marketing exposure is a strong driver of youth use. That may be the case, it may not be the case. I haven't seen super convincing evidence because I don't think they account for, or they always account for like pre-existing interest from the participants. But in any case, some of these studies even involve young non-users who have never used nicotine. It involves exposing them to e-cigarette advertising content, either real or hypothetical. and looking at what features of the ad will make them more interested in e-cigarettes. But aren't they worried about the harmful effects, or worse, that their research might be misused for purposes that they wouldn't approve of? And what's the point of doing this when advertising is already heavily restricted? Another help from co-pilot, I asked if any of these studies that expose young non-users to marketing exposure, have they discussed any of the ethical implications? And the short answer, this may or may not be correct, but I certainly haven't seen it. No evidence in the paper that this ethical tension has been discussed. There's no way for me to know whether the IRB flagged this, but it didn't make it into the publication or into the public sphere. Okay, wrapping everything up, ethics in part drives the mindset, whether it's harm versus harm reduction. And my thinking here is that prohibition is at the extreme end of the harm mindset, but the problems start well before it gets to that point. Dominance of either mindset can compromise the quality of the research. So in the harm dominance mindset, which I believe we're currently in, there's excessive focus on any measurable harms without putting them into context against cigarettes or against established safety thresholds. In a theoretical world where harm reduction dominance, that might be bad too because the focus, as I think about it, might be on more incremental products being safer, like this is slightly safer than the other one, without really keeping track of the absolute risk. So the absolute risk could be ignored if that were the case. But currently, about 70%, think back to those pie charts I showed you from the conference presentation, the current mindset dominates with about 70% of overall articles being anti-nicotine and tobacco product. Ethical implications of this are that it allows questionable or unethical research practices to go unchecked. It allows ethical gatekeeping of the status quo mindset. And it maintains the harm mindset, in some cases, despite the opposing evidence that's published in the very paper. And articles as a whole, as I've been following the literature for several years now, they almost always call for increasing regulation. So where will it end? Hopefully not in prohibition. But if it does, this is especially important why research integrity is so needed, because it's an extreme measure of prohibition. And you have to have it backed by really, really strong evidence, which is not there in my view. Thank you. These are my socials if you want to follow me more.



45:47 - 47:19


[Garrett McGovern]


So thank you very much, Jean-Francois and Arielle, for those wonderful talks. If you can take a seat here, Arielle. Yep. And Jean-Francois. Yeah, if you sit just this seat here. Yeah, exactly, those two. And what we're going to do is just have some questions I'm going to pose to the speakers, and then hopefully we've got a lot of time. I think we've got till 11, so we'll have the chance to open it up to the audience to ask them some questions too. So listen, that was fascinating, as always. I'm going to ask, maybe open the question to Arielle first. And I suppose the question, you've touched on this very much in your talk about how do we balance the kind of inestimably lower risk of noncombustible products against this sort of absolute goal, which is tobacco control and who of nicotine cessation. I suppose you could call it harm reduction versus harm elimination. How do you see that kind of playing out, or what's your views on that?



47:19 - 48:18


[Arielle Selya]


Yeah, it seems like there's shifting goalposts because the whole reason for tobacco control was because smoking is still the number one primary cause of preventable death. But with so much of the harm now being taken away by noncombustible products, the conversation has kind of shifted. I see this in other sub areas, too, where a few years ago it used to be controversial still to say at the main academic conferences that switching to e-cigarettes is harm reduction. Now it's kind of accepted, but the hesitation is backed up to dual use. So I see this as the same sort of shifting goalposts where harm is no longer a reliable condition. direct concern, except for some, like, oh, we don't know about 30-year outcomes, long-term health outcomes are not in yet. But with emerging evidence, it's becoming less of a defensible position. So I think it's shifted now to nicotine overall.



48:19 - 49:06


[Garrett McGovern]


Yeah, I suppose to maybe put this to you, Jean-Francois, I mean, you put up a very interesting slide in your talk about where the WHO talked about tobacco, smoking, nicotine, And the kind of inference, if you read that, is that these are comparable harms. And we know very, very well that they are not. They are vastly different harms. But the public and anybody reading that document would think, oh, these are equally harmful. I suppose from my own point of view, the whole idea of harm elimination is nonsense. There's no harm elimination. anywhere in the world. What's your sense of this? When are we going to get a change where harm reduction will be accepted, I suppose?



49:08 - 50:12


[Jean-François Etter]


I don't know. But yes, the WHO documents recently and their policy is really appalling. For instance, they are now presenting harm reduction as a tobacco industry plot and tobacco harm reduction proponents as like useful idiots who just help the tobacco industry, in the best case or in the worst case, as having conflict of interest with the tobacco industry. And they now want to fight tobacco harm reduction, the tobacco industry plot, by using Article 5 of the Framework Convention, which says that the FCTC policies should be completely independent from the industry. So it's a dishonest move, I think, because harm reduction is present in Article 1 of the FCTC, but they just ignore it. So, yes, not very optimistic in this field.



50:13 - 50:43


[Garrett McGovern]


I suppose the other question I was going to ask you, Jean-Francois, is what happens when we're seeing it already, but what happens if ultimately they get their way and they heavily restrict safer you know, non-combustible products, and they have a free market for combustible products. I mean, what is the likely outcome of that, number one? And I suppose number two is, should the policymakers be held accountable for the negative outcomes that happen as a result of those policies that they so are passionate about?



50:44 - 51:42


[Jean-François Etter]


What's happened and what is going to happen, for instance, in France, and they were warned about it, is that this just hands over the market to criminal gangs and to the illicit market with all the negative consequences, including over-policing. Because the corollary of prohibition what they call a whole of society or whole of government approach. It means justice, police, repression, all the repressive measures. So a whole range of negative measures, negative impacts for the population. Now, will they ever be held accountable? They should, in particular if they were warned. But accountability should be proportional. It should be intellectually honest and fair. But I don't see any accountability for the moment. So they get away with it, largely.



51:44 - 51:49


[Garrett McGovern]


Yeah. Any comments there on that, Ariel?



51:49 - 52:21


[Arielle Selya]


Yeah, I think it's... I agree with everything you said. And yeah, it's just frustrating to see so much evidence come out. It's not unexpected that banning e-cigarette flavors will increase smoking. And the more extreme measures, such as complete prohibition, it's no surprise that there's an illicit market. This has been well documented. But they just think it's going to be different this time for some reason. And it's really frustrating to see, because the evidence was there.



52:23 - 52:55


[Garrett McGovern]


I suppose Arielle is going to ask you another question, which is about, do you see the right to choose non-combustible products, safer nicotine products, as a human right? you know consumers be able to and smokers be able to choose for themselves and if so if that's the case where do policymakers come in in terms of regulation I mean is it a free-for-all or do policymakers have a role where do you see that balance trying to get that balance right



52:55 - 53:44


[Arielle Selya]


Yeah, I definitely think it's a human right to allow somebody to access products, even combustible cigarettes. Back when I was a postdoc, I didn't really ever believe in the coercive measures. I think it's public health's job to educate people about the risk. Since working in the space, I've learned a lot from consumers. So shout out to Richard Pruin and Skip Murray out there. They've talked about how using safer nicotine products has helped them with their ADHD symptoms. Richard Pruin talks about how he tried traditional psych meds and had horrific side effects. Nicotine's the only thing that worked for him. Who are public health people to tell somebody how they can manage their own internal state? As long as they're informed of the risks and there's appropriate consumer protections in place, I think everybody should be able to access the products.



53:45 - 53:50


[Garrett McGovern]


No, excellent. Jean-Francois, are you in agreement with that, do you think, basic human rights? What do you think?



53:51 - 54:18


[Jean-François Etter]


Yes, it is a human rights issue. In particular, as I said, in countries where smoking prevalence is decreasing, then you have a population of smokers with a high proportion of people with mental health issues or vulnerabilities. And the impact falls disproportionately upon them. So it's clearly a human rights issue in this.



54:18 - 55:06


[Garrett McGovern]


No, I agree. I suppose I was going to ask you, Jean-Francois, about the whole youth use kind of issue. Because it seems to me that internationally, when policies are made, particularly restrictive policies, they tend to be driven by this concern of the youth. We use very sort of inflated, hyperbolic language like epidemic, youth epidemic use, and nicotine in the developing brain. How do you think we can get the balance right between protecting youth, on one hand, and making sure that the people who need these products, i.e. the smokers, can get ready access. So how can we balance this in a way that maybe will please everybody? I mean, I'm being altruistic here, but I just wondered, do you think there's a way of doing this to get this right?



55:06 - 57:36


[Jean-François Etter]


Yes, it's actually a challenge. Maximizing use protection risks harming current smokers, and mortality in the next years and decades will occur in people who already smoke today. And because the market is changing so rapidly, young people may not take up smoking as former generations did. The answer, I think, depends on every country. It's different. It's really different. If you look at the statistics of vaping and smoking, it's different. In Switzerland, for instance, young people have taken up vaping, but smoking has not decreased that much. In the UK, it changed over time. You have the fantastic toolkit study, which showed that smoking decreased, but then started to stabilize or even increase. In the US, it's different. So it's different in every country. You cannot generalize. And you cannot use these historical trends. You cannot interpret them as causal. So the situation and the response is implementing all the measures which I listed previously. but adapting them to the local situation, and I think involving users and representative of users in the policymaking process. It's extremely important, I think, that every stakeholder is consulted, takes part in the decision, and that we reach compromise. In Switzerland, contrary to other countries, we have a strong... political tradition of compromise because the countries historically was divided by religion, countryside versus cities, Protestant versus Catholic, French speaking versus German speaking. So there's a strong tradition of reaching a compromise, which perhaps explains why Switzerland was a pioneer in harm reduction approaches starting in the 1990s with drug injection sites, needle exchange program, heroin prescription. But in the field of tobacco harm reduction, it's not the same. The big public health, you know, the enemy used to be big tobacco, but now we have also to tackle big public health. They are against tobacco harm reduction, largely. Not all of them, but.



57:37 - 57:40


[Garrett McGovern]


Yeah. Do you agree with that, Arielle?



57:40 - 57:41


[Arielle Selya]


Yep.



57:41 - 58:18


[Garrett McGovern]


Yeah. So I was going to ask you, Arielle, maybe about taxation on safer products. I mean, we know from the research long established over many decades that lower income countries and lower income populations within countries have the highest smoking prevalence. What's your view on taxation in terms of this? Because it seems to me that if taxation is very high on these products or there at all, it's going to negatively impact more disproportionately those people who are impoverished. What's your sense of that?



58:18 - 58:40


[Arielle Selya]


Right, yeah, it's definitely a much bigger financial burden on people. Taxes do have some evidence base for deterring use, but it doesn't work for everybody and it only works to a certain extent. And as Australia is experiencing right now, if you increase taxes too much, it incentivizes the illicit market, because you can get those for a fraction of the price.



58:42 - 58:45


[Garrett McGovern]


What's your sense, Jean-Francois? Taxation?



58:46 - 58:59


[Jean-François Etter]


Taxation, yes, should be proportional to risk, and you have the whole range of measures that are also effective and that can avoid the nuclear option of prohibition.



59:00 - 59:43


[Garrett McGovern]


I was going to ask you, actually, Jean-Francois, about the precautionary principle. This is a thing that has been very familiar to us over many years, over many decades. But the precautionary principle seems to be very much the focus. When does the precautionary principle become unethical? I mean, how long do you wait for this harm, which may turn out to be phantom harm? How long do you wait and deny people these safer alternatives? Because that seems to be what people are saying, policymakers, they're saying, look, we just don't know what the outcome of these things is. If we don't know what the outcome is going to be, we're better off banning these products. So do you think the precautionary principle in terms of safer nicotine products is unethical?



59:45 - 61:26


[Jean-François Etter]


First, When people speak about the proportionary principle, they may conclude that the consequences of applying it is to ban the product. It's not the case. It's not the case. Well, it's reasonable in the context of uncertainty to take protective measures, in particular when confronting an industry that has a history of misconduct. But I think the European approach to the precautionary principle is very useful and should be implemented. Banning is really the most extreme option, but in the case of uncertainty, we should first gather the best possible scientific evidence. evaluate the consequences of action and inaction, just doing nothing, letting the market actually change. And the field is so innovative that probably, hopefully, just the innovation, the technological innovation will change everything, like in other fields, in communication, transportation, et cetera. Applying the precautionary principle means also taking proportional measures, proportional to the level of protection, involving all stakeholders, having reversible measures, and not discriminating between products. If you ban something, then also ban cigarettes. Otherwise, you just shift the market towards cigarettes. You agree with that, Ariel?



61:26 - 61:41


[Arielle Selya]


Yeah, I agree. Regulation should definitely be in proportion to risk. Any regulation that affects appeal, price, access has an unintended consequence.



61:42 - 62:39


[Garrett McGovern]


Yeah, absolutely agree. I suppose I'm going to ask something, Ariel. You touched on this, and it's a great question to ask you because of the work you do. It seems to me that the scrutiny maybe peer review of a lot of scientific papers is lacking. I mean, there's a lot of stuff. I mean, yourself and Clive every week, you know, do the updates. And I mean, the amount of, we call them OMG, the guys call them OMG, oh my God, studies are double OMGs, is incredible. And I just wonder, do you know what we might be able to do? What could be done to tighten this up so that the quality of research, because I'm not just in this area, I work in drug harm reduction, and I just, Just to me, anyway, just my perception is that papers, I remember there was a time when really good papers would get rejected. They would go, no, the methodology isn't up to scratch. Get back to the drawing board. How can we improve this? It seems to me to have got really bad.



62:40 - 65:01


[Arielle Selya]


It's really bad, and I don't know how to, it's such a massive scale problem, I'm not sure how to start reining it in. For sure, papers get published anyway now. If I see a really flawed paper come across my desk, I always debate, should I try to rescue this paper, should I just reject it? And the problem is if I recommend rejection, it's gonna get published elsewhere probably as is, and then it'll be out there on the scientific record where it's immensely more difficult to get it retracted or corrected. A couple ideas to start bringing this back. I think researchers need to be forced to do this. Researchers respond to incentives, right? So I think if journals start requiring better practices, and I have a whole list, dual use is one of my pet peeves right now, where the claim that dual use is worse than exclusive smoking. I can rebut that. I know exactly why all those studies are flawed. And I have a list, if any journal editor out there wants my advice on how to improve these studies, I have a list of better ways of analyzing this that can paint a different story. And then I also think of academics at institutions. Institutional initiatives can start to overcome this too. So in annual review, every faculty member everywhere is reviewed on an annual basis, like at least until they get tenure, then it's every couple of years. But they respond to incentives there too. So right now they're responding to incentives to get grants and publish. And both of those things, like with funding agencies being with a harm mindset, that creates some of these issues. needing to publish along with the grants that creates more papers out there that are of the harm mindset. I think if universities started requiring or incentivizing something like an adversarial collaboration where they have to have somebody with a different opinion and work with them, come up with a pre-designed research and analysis plan and pre-register, okay, if the results show this, it's going to support this hypothesis. If they show this, they'll support the other hypothesis. I think that can be a really good tool for having blind spots checked out by an opposing viewpoint.



65:01 - 65:10


[Garrett McGovern]


Excellent, excellent idea. Jean-Francois, research, is it not what it used to be? Could it be better, stronger, more scrutinized?



65:11 - 65:54


[Jean-François Etter]


I don't know. I mean, I've been in the field for 30 years, and there's always been poor research. There's such pressure upon people to publish. Not everyone who publishes has been properly trained. But it's more biased, definitely. I've clearly seen a division in the field and more biased science to the point where you just need to read the name of the authors to know their conclusions. You don't even need to read the conclusion. So, yeah, it's pretty bad. And then you have garbage in, garbage out of meta-analysis, and it's getting worse and worse.



65:54 - 66:27


[Garrett McGovern]


It's getting worse. I was going to ask you, actually, Jean-Francois, the sort of production, manufacture, and sale of electronics. The kind of opponents really, I mean, many of the opponents, certainly in my country, will say things that are not actually true. But I wonder, is it that important? Who sells these products? Who manufactures them? So the big thing is that if it's the tobacco industry that are doing this, that's evil. It's a bit less evil if it's independent vaping companies, etc. Does it matter? Do you think it matters who sells these products, other than the optics of it?



66:27 - 68:15


[Jean-François Etter]


Forget the optics. It matters a lot, of course. It matters a lot. But you don't have good guys and bad guys. You know, there's pros and cons on each side. The tobacco industry, of course, has a history of misconduct. And they also continue to push cigarettes. They have a strong... political influence. They are very good at lobbying, at obtaining harsh regulations that only they can survive. So they eliminate the competition this way. But on the other hand, they also conduct very good research. They invest a lot in R&D. They are very innovative. And the smaller companies, yes, they are very innovative. I visited e-cigarette factories in China a few years ago, and I was very impressed by how young the CEOs are, how competitive they are. Innovations come from the competition between these guys. But on the other hand, Some of the smaller companies have conducted irresponsible marketing to reduce, they supply the illicit market, and some of them produce products of inferior quality. So it's not a matter of who produces something, it's a matter of the outcome. And here, I think it's particularly important to monitor the market, to have... surveillance of the market of the new products and their safety like implementing safety standards for instance looking at marketing strategies do they target smokers or do they target young people and the illicit market also should be documented so it's more important I think to focus on the outcome than to focus on the identity of the manufacturer



68:16 - 68:50


[Garrett McGovern]


Yeah, I totally agree with you. Would you agree with that, Ariel? It matters that the products are safe and that they're well produced. Because one of the things I would say is the tobacco industry get criticized for selling safer products. I mean, that's illogical. I mean, they know the direction of traffic. They know that it is moving in an upward trajectory away from combustibles. Why should we fear the tobacco industry selling them? This idea that they tricked us all those years ago, they're tricking us again. What's your sense of this?



68:50 - 69:33


[Arielle Selya]


I think it goes back to a deeply ingrained harm versus harm reduction mindset. Because in the harm mindset, you think the comparison is often to not using any product. And they think that the massive declines in combustible cigarette smoking would have happened anyway, and that the rise in noncombustible products is offsetting that or undermining that. But I don't buy into that, because there's a fairly stable proportion of nicotine prevalence use when you're including all products. It's just you shift, population shift between different products. But that's not their mindset. Their mindset is that if this goes away, the alternative is that nobody would use nicotine.



69:34 - 70:23


[Garrett McGovern]


Yeah, no, I absolutely agree with you. I was going to ask you actually, Ariel, about flavors. I mean, I kind of know, you know, from hearing you talk before, what your view is on this. But one of the things that we often see is the countries go steaming in to getting rid of flavors in the idea that they're going to protect youth and leave only tobacco flavors. And I suppose the question I would ask, not so much the obvious question about flavors, but maybe how can policymakers be more informed before they go steaming in? They go steaming in. They make these regulations. And we know what the outcomes are. And the research would show that you get an uptick in smoking prevalence and less of the products are used. How can we inform policymakers more so that they understand the, we call it unintended, although When does an unintended consequence become unintended? I mean, when you keep doing it, it's predictable, isn't it?



70:23 - 71:24


[Arielle Selya]


Yeah, exactly. Yeah, the research has always been there. I guess I don't know how to get through to policymakers, because I think the flavors is linked to the youth use, and that's an emotional issue for a lot of people. They want to protect youth, which is reasonable, and that's important to make sure that young people are not accessing products. But at the same time, they're ignoring adult adults who like flavors too. If you look at the side-to-side list of flavors for youth and adults, it's essentially the same. There's minor differences, but overall, youth and adults like fruit flavors. That's the most common. The FDA came out with guidance recently on PMTA submissions in the US, and they recommended spice, coffee, tea flavors. Those flavors existed for a time, and almost nobody uses them, including among adults. So it's important to get the whole picture.



71:25 - 71:51


[Garrett McGovern]


Jean-Francois, what do you think? How do we kind of inform policymakers more before they make very radical changes? Because I think the general feeling, I mean, I've talked to many people from vape companies, I've talked to consumers, you know, you're going to obliterate that industry of tobacco flavor. The very, very flavor they're trying to get away from is the only flavor they can access. How can we, what can we do to policymakers to tell them this is not a good idea? What do you think we can do?



71:51 - 73:21


[Jean-François Etter]


It's not just a matter of information. I think they've been informed. There's so much information. The information is available. And perhaps we've not been good enough at communicating it. Yes. And we are divided also. When you speak to policymakers, for them, it's very simple. If a demand comes from anywhere in the population, then the people who carry the demand should be united. But we are divided. And so nothing moves forward politically because the field is so divided. And also, the scientific evidence or the information is just one element in the political process and not the most important one. In the UK, for instance, I think it's remarkable how they use government-sponsored scientific documents to establish a policy. In Switzerland, it's not the case. The political process is complex and obscure sometimes. We don't have many scientists in the parliament. We have many lawyers. The two professions that are best defended is the lawyers and the agriculture, the farmers. They are very politicized and very active politically at the local level, at the national level. But there are few doctors in the parliament, few scientists. They're not interested enough in the struggles of policymaking to be influential.



73:22 - 73:46


[Garrett McGovern]


Yeah. Well, I'm going to open it to the floor. We're doing really good. I think we've got another 15, 16 minutes left. So anyone in the audience would like to ask a question? We have this gentleman here. We've got a few people. So if you can bring the roving mic. We've got Mark over here as well. Is that working? Howard Schmidt?



73:55 - 75:30


[Norbert Schmidt]


Now it works, okay. Norbert Schmidt, I'm consumer here. I have an ethical question about information presentation. There are two facts, scientific facts about nicotine. One is that it's anti-inflammatory effects and It also is angiogenic, so it reduces the impact of the immune system and it promotes the growth of blood vessels. Usually, anybody would consider that positive effects, but I've heard it framed as it compromises the immune system. Well, yes, technically it's true, and it promotes the growth of tumors. Well, technically true too, but that's with almost every substance that is anti-inflammatory and anti-ogenic. How is this ethical communication of information?



75:30 - 75:37


[Garrett McGovern]


Anyone want to take that one up? A nice easy question to start.



75:40 - 76:06


[Arielle Selya]


I guess I'll just react that this aligns with the harm versus harm reduction framework because in the harm dominant mindset you focus on any little possible harm and don't have the larger context of how does this compare to other acceptable behaviors or substances or what's the alternative.



76:07 - 76:11


[Garrett McGovern]


And yeah, Mark, do you want to come in? And then I'm going to.



76:12 - 78:40


[Mark Tyndall]


Yeah, I'm Mark Tyndall from Canada. Really enjoyed both of your talks and I have A question for both of you, and it's kind of the same theme, and it's, is it too late? So as far as the research goes, I believe strongly that we wanna collect evidence, but it's so biased because if you have a journal that's already come out very strongly against harm reduction and very strongly against any kind of liberation of nicotine access, it's very unlikely they're gonna publish a study that goes against that. So, for instance, the Canadian Medical Association Journal has come out very strongly with their editorial reviews against that, and if I had the most excellent study that was favoring vaping as harm reduction, it would never get published in that journal, and I think many, major journals have already stated their position and would not ever publish anything that goes against the narrative they've said. So maybe Ariel could comment on that. And then as far as being too late with the prohibition, if we allow these illegal markets to already be well established, As we kind of push back on the current restrictions and want to get more access for people, it may be too late. If 86% of American vapors are already getting illegal markets, the people selling those are quite invested in that. And even if tomorrow we had every option for people, from a commercial market, they would be more expensive, they would be taxed, there would be more regulation. So the illegal market could always undercut that. And I really feel it's really going to be difficult now in markets to shift that back because they already have their clientele, they already have products out there, and they're going to fight like hell to hold on to that. I did a project, a safe supply project in Vancouver, handing out hydromorphone, and the biggest threat to that program wasn't the people that I was helping, it was the dealers who felt that I was cutting, taking away some of their clients, because they relied on that, and I think the same kind of process could happen with the illegal market.



78:42 - 79:21


[Arielle Selya]


Yeah, great question. It does seem overwhelming in the literature when there's so much bad research out there. And then, like you mentioned, it goes into meta-analyses, so it's garbage in, garbage out. But I do see signs of hope. I try to be optimistic about this. And I am starting to see people that were previously hostile to harm reduction now kind of quietly change their mind and endorse it. They don't always... acknowledge that they've changed their opinion or come around, but all of a sudden it seems more acceptable to talk about e-cigarettes for harm reduction in some circles.



79:23 - 82:51


[Jean-François Etter]


Yes, I would add that you're perfectly right. Once the market is handed over to criminal groups, it's going to be very hard to come back. And so it's irresponsible, I think, to ban these products because It's already written. What's going to occur in France, for instance, is already written. But about the division in the field, the fact that some journals will never accept to publish some papers or some conferences do not accept presentations from people who are not from the right side. I think we have to go back to the root causes of this division, and it's not just a scientific division. I mean, the scientific differences are just one element in the equations, and there are many other causes of this division. There are ideological and moral aversion towards nicotine, also biased leadership. Bloomberg funding of WHO is a good part also of the explanation. And if you consider that the WHO leadership is important in this field, because many countries do not have the scientific resources to reassess the situation every time. implement the recommendation of the WHO. Where does it come from, this position of the WHO? Well, perhaps from bias in the leadership of the FCTC and the No Tobacco Group, Bloomberg Funding, but also it comes from the General Assembly. The General Assembly of the WHO is where the decisions are made. And there you have very large countries in the South. They have a quite different situation. They have different smoking prevalence, sometimes very low, like in sub-Saharan Africa. They have different demographics, more young people. They have different functioning of the state. The state may be weaker and less able to implement a policy, more vulnerable to corruption. The informal market may be bigger, so it only reinforces the illicit market if you lower this product. So they have a quite different situation, and we should not, I think, impose the views developed in the countries where most of the research is conducted, high-income countries, to lower-income countries. use the easiest way of implementing the WHO recommendation because they don't have the resources locally. But an important point would be to develop capacity in the field of tobacco harm reduction and research in lower and middle income countries so that countries like Brazil, for instance, or India may change their mind. And then the General Assembly may move a little bit. And then the leadership also may move. It may take time, but we don't speak enough about the problem in lower- and middle-income countries. Many representatives of these countries are here. We heard them yesterday. It was quite interesting. It's also an important element.



82:51 - 83:02


[Garrett McGovern]


Now, I'm going to take the question from this gentleman here. We have a question over here and a question down here. But I'm going to take this question, and there's an online question that I'm going to put to the presenters that they can see here.



83:06 - 83:24


[Patrik Strömer]


Thank you. Patrick from Sweden. I was wondering about the research on smoking and cigarettes. Are we done there, or do we know enough? And the second question is, why does not any country ban cigarettes instead of the alternatives?



83:26 - 84:14


[Arielle Selya]


Yeah, good question. I also feel like we pretty much know enough about cigarette smoking that maybe we don't need more research, but I'm sure some people would disagree with me. I actually, before I, as a junior faculty member, I was starting to get bored myself with the topic of researching adolescent smoking and risk factors and I only stayed in the field because e-cigarettes started getting traction and then I changed my mind with about the gateway. So then it became like an interesting controversy where not a lot is known. So I kind of agree with you and I'd share the frustration that cigarettes are never, cigarettes are still always legally available. Not that I think banning them would work because there's obviously an illicit supply there too.



84:15 - 84:54


[Jean-François Etter]


I would add that good research starts with a good question, a question that helps in a public health perspective, that helps decision makers, that helps clinicians, consumers, manufacturers. The good research question is a question that is helpful. So are there... No more helpful questions would be... The market is changing so rapidly. The technology is so innovative that there are a lot of good, original, and useful research questions to be addressed, I think.



84:55 - 85:24


[Garrett McGovern]


I'm just going to take the online question. I might take this gentleman, and there is one down the back. Fascinating from both presenters. I would like to ask both of them, What will be their approach to reaching out and creating constructive dialogue with those who oppose harm reduction? That's a very, very interesting question. I've often asked that myself. Any thoughts on that? How do we bring the anti-harm reduction people, can we bring them into the room and convince them of our wisdom, or are we wasting our time?



85:24 - 86:14


[Jean-François Etter]


I think that we should refer to Thomas Kuhn, as Brent Stafford suggested yesterday in a discussion. He said that scientific revolutions occur also because older scientists die and they are replaced by younger scientists, but people never change their mind. So, yeah, it's a possibility. I think the... The change will come from the technology, from the market, from the success. The new products, the pouches, for instance, are so successful. It's a strong market force that hopefully is going to wipe out the opposition. I hope so. I have great faith in innovation and technology to change the situation, but people will not change their mind.



86:15 - 86:23


[Garrett McGovern]


Yeah, good stuff. We have a question here. This gentleman, yeah. And then we're going to take, I think, the last questions up here.



86:23 - 87:24


[Joe Koesterich]


I don't think there's... Great, thank you. Joe Koesterich from Australia. Two prongs is the question. Number one, to what extent is the precautionary principle just an excuse? I mean, we don't see the precautionary principle invoked, for example, with puberty blockers, and we didn't see it invoked in other events at the start of the decade, sorry. And number two, you spoke, Ariel, about people going against their interests. It raises the question of what are their interests? And I think the problem, and maybe we do need a revolution, because science used to be about my current thoughts are wrong and need to be proved right. And I'm not sure if it was Einstein who was attributed to him, a thousand experiments can't prove me right, one can prove me wrong. And it seems we've morphed into it's all about reinforcing what we already believe, which I suppose raises the question, is that salvageable or do we need an entirely new paradigm?



87:27 - 88:09


[Arielle Selya]


Yeah, no, that's a great question because science is, many scientists now have made their career on getting funding from a certain agency to pursue certain types of questions. So there's direct incentives in terms of keeping the same research track, securing future funding. There is a self-interest there that I think is as much of a conflict of interest as what I have, but it's not usually treated as such. And then there's the reputational issue, too. If you've built your whole career arguing a certain case, it can be risky to change your mind, and so that's a disincentive.



88:11 - 88:20


[Garrett McGovern]


Yeah. I think last question. We've got a couple of minutes left. We've done really well on time. I'm going to take this one at the back of this lady here.



88:22 - 89:40


[Maria Papaioannoy-Duic]


Hi, my name's Maria. I'm from Canada. My question is about biohacking and nicotine and the growing trend of that. So we're looking at the World Health Organization, and they have quietly, loudly, whatever you want to say, a goal of reducing nicotine to 5 by 40. So that means 5%. What we're also seeing online is a growing population of biohackers or influencers and doctors who support the idea and the notion that nicotine helps with your health. which I tend to believe that. So we're looking at human behavior, which tends to grow a lot quicker and move along faster, and we can see that through vaping and nicotine pouches. What happens if we go the way of, I do believe, India, who removed all nicotine products? except for cigarettes, are we going to end up having a reversal and seeing the increase of people smoking? And I want to be very clear, most people are not using vaping products or nicotine pouches to biohack. They're using the patch. But what happens if those also start getting removed? Because we should have autonomy to take care of our health, whichever way we see fit.



89:43 - 90:35


[Jean-François Etter]


Well, it's very clear that if you remove lower-risk products but cigarettes remain available, people will just use cigarettes. They need nicotine. In the 16th century, when tobacco was introduced in Europe, at the time when people traveled by foot and on horseback, It's spread across Europe in a few years or a few decades only, and we're never going to get rid of it because it also has positive effects. It helps concentration and focus, and it relieves withdrawal symptoms. So I have little... I can't predict that we'll get rid of it. We just need to allow users to use it in the less toxic way possible.



90:37 - 90:48


[Garrett McGovern]


I'm going to let one question, because I really love Roberto Sussman, and I think you should be allowed to ask a question. It's over the time, Roberto, but we're going to make an exception. No, no, you ask a question. Yep.



90:52 - 92:01


[Roberto Sussman]


On science, like sometimes it is very difficult to disentangle what is sloppiness and ignorance from an ethical misconduct, because ethical misconduct is an intention. And sometimes, and I've been working a lot on criticizing different types of research, especially on emissions and so on, and also animal models. What I notice is that the authors are really ignorant. But I don't know to what degree is there a boundary between an ethical breach and simply sloppiness. And I understand that there is an ecosystem that is favoring harm. And maybe these authors are just following because of their own academic interest, and they're just following this thread. But can you identify one case when there was an intention, an ethical breach in this ecosystem, in this context?



92:04 - 92:42


[Arielle Selya]


Yeah, that's a good question, because I try to give people the benefit of the doubt, and sometimes when I peer review papers, I'll point out if their introduction is biased, and a lot of the times the response is, oh, sorry, we didn't mean to do that. Here's the references you asked us to include. So I think that's probably the... majority of the middle, but there are a handful of bad actors, I would say, that it seems like, when I read their papers, I always try to give the benefit of the doubt, but sometimes it's so skewed and so selective that it is more likely intentional.



92:46 - 92:51


[Garrett McGovern]


I'm gonna bring this session to a close. I'd like you to put your hands together for the two great speakers.