The hosts, together with a panel representing scientists, consumers and other stakeholders will review a selection of scientific papers, published in the past 12 months, on nicotine and THR-related issues, identifying the best and worst examples.
GFN 2024 Panel Discussion #3 - hosted by Clive Bates with panellists: Arielle Selya, Gizelle Baker and Roberto Sussman.
Transcription:
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Clive Bates: We have an absolutely excellent panel this morning. We've got Roberto Sussman, Ariel Selyab, PD Associates, Giselle Baker from PMI. Your job is what, Gizelle?
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Gizelle Baker: I am the head of Global Scientific Engagement.
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Clive Bates: Excellent. Okay, good. But above all, we've got the audience, okay? And we're aiming to have a lot of audience participation this morning. So... Just as a kind of warm-up, well, let me explain. One of the things that we want to get out of this is that Ariel and I are going to take away the feedback from this session, and we're going to use it to shape a kind of user's guide to terrible science. which is really gonna be aimed at advocates, companies, individuals, organizations, who are confronted by terrible scientific arguments, or pseudo-scientific arguments, and our sort of guide to what's going on behind them. And this is gonna be built out of our, Ariel and I now do a sort of weekly review of all the science coming out on PubMed, and it's the themes that we see over and over and over again. These papers are now quite easy to read because they all basically make the same mistake. And so we're trying to go and distill that wisdom into what I hope will be a GFN publication or a preprint or something. But the main thing is we want to test it and challenge it with this audience and this panel, okay? So the very first thing we're going to start off with is a sort of group exercise where I would like the panel first and then members of the audience to just give me or give us the most annoying scientific statements or assertions or arguments that you hear. And what I want to do is get the whole lot on the table, all the stuff that we hear about, teenage brains, Ivali, gateway effects, you name it. And I'd just like to do this in a sort of rapid-fire way. So if we're going to start with a panel, could I start with maybe Ariel? You go first, and then we'll go to the audience.
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Arielle Selya: Is this on?
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Clive Bates: Yeah, okay. So think, or I'll just pick on people if there's no hands. Okay.
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Arielle Selya: Gateway is the main thing for me. This is what my academic research had been on before I joined Penny into Gateway. And we hear the quote, I think they've gone away from saying e-cigarette use causes youth to smoke. They've been a little more subtle about it, but now we hear the same talking point that youth who use e-cigarettes are three times more likely to smoke cigarettes.
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Clive Bates: Oh my God, possibly the most annoying argument of all time. So that's a very good one to start on. Roberto?
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Roberto Sussman: Third-hand smoke. It's a ghost. It's nonexistent. Well, it exists, but you know, a molecule is always here and there. Second-hand smoke equated to the particles, the killing particles that go into the children's lungs. And again, this is where my expertise lies. And it has also annoyed me because I'm a user. Very good. All right, you've got two minutes left.
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Clive Bates: Giselle, your nomination for annoying science. Remember, everyone thinking, thinking, thinking. What are you going to say?
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Gizelle Baker: I'm going to go one step away from what they're claiming. It's the use of the word may or could, especially when you throw that in front of the word association, which by definition is a may, to imply that there is actual risk. But an association means there may be risk. But what does may have an association mean? That there is risk? A double negative?
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Clive Bates: Yeah. brilliantly annoying, the use of associations and then tentative conclusions about associations that are then reproduced as policy recommendations as if they are causal. That is something that's so pervasive it's untrue, but well spotted. Right, who wants to go first in the audience? Gentleman at the back. Gentleman at the back, then Norbert, then Matt. Okay, and if you're down there in that corner, I can't really see anything. And same in that corner over there. So you need to move, stand up, jump up, wave or something because there's massively bright lights in those two corners. Okay.
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Alexandro Lucian: In Brazil, we have often saying, including in national television organizations, saying that one vape, not exactly one cartridge, just one vape is equal to 100 cigarettes.
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Clive Bates: Oh, my God. Yes.
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Alexandro Lucian: Yes.
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Clive Bates: Yes. A direct hit. OK. All right. Go. Who's next? Stand up, please.
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Cecilia Kindstrand: Thank you. I would like to put it to the policy side. Sorry, Cecilia, Swedish Match. On the policy side, which I think is sort of, they use that product category X, Y, or Z has adverse health risks, and they base it upon science, and then they don't say what adverse health risks are.
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Clive Bates: Okay. Can you think of a specific?
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Cecilia Kindstrand: Just generally... generally adverse health risks, but there are other stuff. Snooze increases the risk of cleft. Nicotine increases the risk of ADHD.
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Clive Bates: Yeah, okay, got it, right, okay. Right, Norbert.
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Norbert Zillatron Schmidt: During the recent tax consultations, The German Cancer Research Institute, very well known for their economic prowess, uttered a statement, uttered in their statement, there is no evidence that increasing taxes invariably leads to a black market.
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Clive Bates: Yeah, okay. Invariably, interesting, yeah. Okay. All right. John fell and then down here.
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Jonathan Fell: You might find this cheating, but one that I find particularly frustrating is we don't know the long-term effects.
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Clive Bates: Oh, my God. Yes. Yes. Yes. That's a direct hit. Yeah. Okay. Okay. I can't, hang on a minute, come on, there's too many. All right, yeah, down here. Sorry, this one, lady with the, all right, lady with the white here. Yeah, stand up if I point to you. All right, okay, wait, wait, wait, wait, wait, wait, wait, wait. There's plenty of time, come on.
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Libby Clarke: Libby Clark, Imperial Brands. Causation, when it's actually an association, and when you look at the odds ratios, possibly not even that.
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Clive Bates: Okay, yes. Things that are claimed to be causal when they're associations, which they will never use the word correlation, because everybody knows that correlation is not causation. So that's a really good one. Down here, there we go. Don't forget to say your name.
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Carmen Escrig: The last one in the Spanish press. Carmen from Spain. The last one in the Spanish press. Adolescents who are now vaping will develop cancer in 15 years.
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Clive Bates: Just say it again.
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Carmen Escrig: Adolescents who are now vaping will develop cancer in 15 years. The last one in all Spanish press.
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Clive Bates: There's an interesting variation on that one, which is it took 50 years to discover that cigarettes cause cancer, and therefore everything's unknown for the next 50 years associated with vapes, which I think is the same sort of argument. Yeah, somebody there, yeah, you take that, and then we'll go to the back of the room, three in a row there.
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Diego Verrastro: Everyone needs to be fast, please, go. Yes, it's very fast. I'm Diego Verrastro, I'm physician from Argentina, and I'm doing my practice with my vape in my hand, but I'm doctor, I'm consumer. And the patients told me, hey, doctor, be careful. Your vaping is worse than smoke. Okay. And the patient is a smoker. You know that?
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Clive Bates: Okay, this is a really important one. Obviously, it's not a scientific statement, but it has become normalized now. Maybe five years ago, one Californian crank was willing to say, that vaping and smoking are equally dangerous. Now it's a very common trope in the academic world. Okay, we're going to go to the back. Okay, there's like three hands up there. Three, one, two, three, really quickly. Go fast.
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Miguel Okumura: Miguel Okumura from Brazil. Vaping nicotine causes EVALI.
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Clive Bates: Okay. Yep. That is everywhere. Even now. Yes, go on. You've got the mic.
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Person from audience: One vape cause EVALI.
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Clive Bates: So there's a bunch of stuff about the nonsense of Avali. Got that. Okay. There's a couple behind you. Go. Come on.
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Ignacio Leiva: There is no proof that cigarettes help you quit smoking.
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Clive Bates: Yeah. That's a big WHO one. Insufficient evidence. But that's when you set the evidence bar like infinitely high. Yep.
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Heneage Mitchell: H, fact Asia. Erectile dysfunction. Okay.
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Clive Bates: All right. That's enough about you. What about the science issues? Okay.
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Maria Papaioannoy: This is one sentence from the minister that is the health critic in Canada. It is important to note that vaping is associated in numerous clinical studies with serious negative health impacts including addiction, harm to brain development, seizures, increased risk for tobacco and substance use, mental health problems, pulmonary and cardiovascular disease, unintentional injuries, decreased breathing, and difficulties with concentration.
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Clive Bates: Excellent, okay. I might need an email for that one, okay, but that was very good. And that is interesting, that is very typical of the introductory paragraphs we now see in so-called academic papers. So yes, let's come forward a bit down here. This gentleman has had his hand up for a while. Yes, you.
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John de Miranda: John de Miranda, United States. Nicotine is poison.
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Clive Bates: Okay, nicotine is poison, yes. Yes, if you drink a lot of it, it's definitely true. Okay. Okay, Mark, do you want to hand it to Mark there at the front?
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Mark Dickinson: Mark Dickinson. I'll go with two, if I may. One is comparing nicotine-containing products and looking at toxins, but not comparing it with cigarette smoke or environmental standards and claiming that because you can measure something, it's potentially dangerous. The second is, I'll offer, is making a link between vaping and mental health illness and and a complete discounting of the fact that people might be self-medicating mental health problems with nicotine.
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Clive Bates: So that's a direction of causation issue, and assuming that the direction is in the way that's adverse to vaping. Okay. Right. Alex has had his hand up for a while. My God, there's so much.
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Alex Wodak: Alex Wodak, Australia. Yeah. the consumption of nicotine in children and adolescents has negative impacts on brain development, leading to long-term consequences for brain development and potentially leading to learning and anxiety disorders. That's a quote from WHO.
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Clive Bates: Oh, is it? We'd have definitely seen that in all the generations of nicotine users who grew up as smokers. They walk amongst us, these zombies, so yes, that is obviously a piece of nonsense. But yes, we should definitely address that. Okay, let's see. Yep, there. Oh, I need to go over to the other side. I'm sorry.
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Natalia Mendoza: Okay, so I'm Natalia from Mexico, and it says a recent study in the U.S. revealed that vaping consumers have 19% more chances of developing heart failure.
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Clive Bates: Oh, my God. Okay. All right, yeah. Actually, let's get a quick comment on that from Gisela. Okay.
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Gizelle Baker: That study looked at congestive heart failure following three years in a prospective manner, meaning they asked people if they used e-cigarette at the beginning of three years and didn't have congestive heart failure, and then measured at the end without asking what they did, without considering how long they had done it, when they started doing it, and used congestive heart failure, which is an outcome of cardiovascular disease to predict the onset of cardiovascular disease. So everything about that study is wrong.
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Clive Bates: Okay, that's a good conclusion to that section. All right, Ben, hang on. Gentleman there.
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Person from audience: So new studies, recent studies have shown that nicotine is far more contagious than we previously thought.
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Clive Bates: Contagious?
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Person from audience: Or dangerous.
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Clive Bates: Dangerous, okay.
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Person from audience: Or harmful.
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Clive Bates: Okay, harmful.
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Person from audience: They could vary that kind of words.
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Clive Bates: Okay.
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Person from audience: But it's always recent studies and new evidence.
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Clive Bates: Yeah, okay. So new evidence that you've never seen. Okay, all right. Ben, please. Yeah. And then Martin.
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Bengt Wiberg: This was just two weeks ago. All British newspapers, snooze cause oral cancer. And it's proven it reduces oral cancer.
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Clive Bates: Okay. All right. Martin Cullip. And then at the back. Oh, okay. Hand it to Martin. He's been waiting a while. Oh, thank you.
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Martin Cullip: I get frustrated at the conflation between harm and addiction. So you'll see loads of articles say, it's said that vaping is far less harmful than smoking, but it contains nicotine, which is highly addictive.
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Clive Bates: Okay, and that word addiction is contested in its meaning, and it's laden with value judgments and stigma and so on, so yes. Gentleman standing up, I think it's Kurt at the back there. In the dark.
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Kurt Yeo: Hi, yes, Kurt from South Africa. We've seen a lot of selection bias in our research, which is used to pass off as an entire population group.
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Clive Bates: Okay, just explain what you mean. Give me an example of what you mean. Say what you actually mean by that.
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Kurt Yeo: Basically what they say is that the youth vaping is increasing rapidly in South Africa, but they're selecting the high-income schools and not accounting for all the low-income schools. So it's a minority of the population group in that age cold. Okay.
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Clive Bates: All right, good. Any more? We'll wind this up in a minute. All right. Okay, that's it. Just you, yeah.
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Person from audience: Stand up. Sorry, just quickly. Go on, yeah. Conflating the argument between the hypothetical risk of the gateway effect and adults quitting smoking.
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Clive Bates: Yeah. All right. It's a gateway thing. Okay, the guys down there, it's like three in a row down there.
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Barnaby Page: The indiscriminate use of the word epidemic and sometimes even pandemic.
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Clive Bates: Okay, epidemic, yes.
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Thomas Nahde: Thomas Nahde, Imperial Brands, flavours in e-cigarettes are particularly toxic to the users.
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Clive Bates: Okay, right, that's a good one. All right.
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Colin Mendelsohn: My one was just, we found in mice. Therefore, we must ban this.
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Clive Bates: Yeah. There's a whole category, I think, around rodent studies, cell studies, in vitro studies, and even computational in silico studies, where gigantic liberties are taken and then projected into actual human effects. I think we can all be... Down at the front here, we're going to wrap this up in a minute. You can all email. Oh, yeah. Okay, sorry. I've got you next time. Go.
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Chase Wallace: Chase Wallace from the United States. There are government campaigns against vaping that always focus on you can be inhaling toxic metals into your lungs with vaping, like nickel, chromium, and lead, which may or may not be true, but they don't mention at all the things you're inhaling when smoking tobacco. So it's definitely a focus on the lesser evil.
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Clive Bates: So there's two issues there, really. Compared to what? And also, how much? You know, if you've got a couple, you're probably all breathing in a couple of molecules of molybdenum right now, for all I know. You know, so again, it's a dose thing and a comparator thing. Down in the corner has been waiting like a million years, going...
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Carolina Garcia-Canton: Carolina Garcia-Canton from BAT. I'm going to go simpler. Gently heating a substrate or aerosolizing a liquid is producing smoke. Therefore, it's combustion. And of course, we can apply artificial intelligence to all those molecules to see how much toxicants we can produce with 900 degrees.
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Clive Bates: Right. Okay. This is a prominent WHO argument that, you know, the definition of smoke, which is stretching to allow policies that are designed to tackle smoke to stretch into things that don't produce smoke. I think that's probably where you're getting that from. Okay, good. Alex, and then perhaps the last one. Vaping has created a new generation of addicts All right, that's a very good one. Okay, now, I think the interesting thing here, as it relates to some of the discussion we had yesterday, is when anybody starts using nicotine, is that a net nicotine user, or is there just an underlying demand for nicotine amongst certain people who will smoke, vape, use pouches, use snus, whatever? And the assumption often is that if somebody takes up vaping, that's a sort of net loss. So I think, again, it's what's the counterfactual? What's the world without vaping look like? And how many of the kids that take up vaping would otherwise be taking up smoking? And that's something that never really gets any airtime and in some jurisdictions is ignored completely. Okay, I think we'll call that quiz. That was very well done. Give yourselves a round of applause for that. I thought it was very good. Very good, very good. All right, if anybody has any extra thoughts as we go through this, Ariel and I are going into the next phase now, and we're going to present our 10-part framework, which we will definitely have to modify, I think, in order to... in order to incorporate all the stuff that has come in. But we want to just give you a sense of where we're heading with this. Now, does anyone in command and control over there have a thing for changing the slides over? Because we've got a slide present. Huh? Oh, sorry, okay, right, okay. Let me just, we'll have to swap ourselves around on this. Thank you, that's great, okay. So... Can we have the slides up that we have for this session? Oh good, very good, okay. So we're gonna do this guide in which we're gonna, are these working? Are these or should I use this? Is this working? Oh, yes, it is. Great. OK. Right. OK, so we've got this sort of 10-part framework, but I think we'll probably end up with a 15-part framework by the time we've had all the feedback. So I want to quickly go through this. This is our 10-part framework. No need to take that in now. We're going to go into each of these individually. So let me start with toxic. And this has picked up a whole load of things, which is when you say something is toxic, it's not the same as saying you can detect a potentially toxic element in it. The dose matters. And we've known this for several centuries. If you've just got a few... you know, nanograms of something in the substance, not necessarily toxic. So, and I think we've got to think in terms of meaningful, in my reviews I always call it how material is this? How much should somebody concerned with public health be bothered about this? And I think in this we also include the in vitro studies where they are projecting enormous risks from animal or cell studies. We also have to remember, and I think this is something that people forget, it's not a very popular argument, but these are pictures from smoking epidemiology. So this is about smoking. And these curves... are premature mortality or mortality curves. And the bottom dark blue one is how likely you are to die if you're a continuing smoker by a given age. So along the bottom it's age. So you see that gap opens up from about the age of 40. Now, if you quit before the age of 40, which is the chart in the top right hand corner, you avoid nearly all of the, I mean almost all, very close to all, the premature mortality risks associated with smoking. Now, the flip side of that is that the body is actually very resilient. And you can smoke for quite a long time. As long as you give up before you're 40, you're mostly okay. But that means that people can be subject to around 25 years of... exposure to all the high concentrations of toxicants in cigarette smoke and still not suffer these sort of lifetime differences. And that's why we see big differences between conclusions drawn from epidemiology, which actually measures mortality over time, and sort of detailed studies, clinical studies on sort of exposure, because they don't really reflect the degree of resilience that there is. Right, are you doing the next one? You're doing the next one. Oh, I am? Okay. So, yes, sorry, I'm doing the next one. So this is the second part here. And this is really calculations about risk. And this is the repeated assertion that X, Y, Z, smoking, pouches, snooze, whatever, are not a safe alternative to smoking or just not a safe alternative to anything. Now, this is a really unhelpful risk communication. It's not an appropriate way of thinking about huge differences in risk. And that's a snooze pouch there. The Americans forced them to put that warning on, yet there's nothing in that that communicates that the risks are two orders of magnitude or greater than... than the risks of smoking. So misuse of risk communication and risk-based statements that are, they are true, it's probably true that that's not a safe alternative, but deeply misleading. True but misleading statements. Okay. Ariel, I think this is yours. This was picked up by a lot of the comments earlier. You go on.
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Arielle Selya: Okay, then the next one is all the disease studies, all the studies of e-cigarette use and some health outcome. There's two basic flaws that are there in almost all of the studies. There is a handful of studies that make an honest attempt at looking at this. but let me start with one that I don't even really count as the two things, is that these are mostly observational studies, so they're not experimental, so therefore, just by its nature, the ability to say it's a causal relationship is very limited, but even aside from that, there was a paper that came out recently subject to some criticism looking at e-cigarette use and myocardial infarction. A couple of fundamental flaws with most of these studies are, number one, that it doesn't rule out cases where the outcome occurred before people even started using e-cigarettes. And once you take those out, then the association sometimes disappears, but it's very unreliable in any case when you have, unless you take efforts to eliminate the observations like that where e-cigarette use started afterwards. There's also an element of reverse causality there, possibly, because if somebody's really sick from cigarette smoking and that motivates them to quit to improve their health, then they're more likely to use e-cigarettes, but they're also more likely to have been sick to begin with. The other issue is that most people who use e-cigarettes have a history of smoking. So you don't know whether any health conditions are caused by the prior cigarette smoking history versus the e-cigarette use. And the analysts often treat this, they say, oh, we're controlling for cigarette smoking history. But usually this is very crude. They're only controlling for whether or not you currently smoke. They're not controlling for the cumulative exposure across the lifetime, which is really essential. Yet because they treat this as a control variable, they then attribute anything remaining to e-cigarette use when more likely it's caused by the prior cigarette smoking.
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Clive Bates: Okay, should we just pause here? If there's any feedback so far from the panel, any thoughts from the panel on what we've seen, things that need to be added into just these first three sections. Why don't you go, Robert, pick up a mic.
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Roberto Sussman: There is something absent here, and it's the eternal claim that flavors attract kids. and it has very strong policy implications, but it is, everybody's attracted to flavors. Kids, it is not fair to think that kids will not be attracted to nice flavors, but it's the driving force.
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Clive Bates: Okay, so we have a slot for this at point six. in our framework is inappropriate causal assertions. So we're concentrating on health and toxicity at the moment. You, I think, previously raised the whole issue of secondhand aerosol, secondhand smoke, thirdhand smoke, thirdhand aerosol. Presumably there's fourthhand aerosol that somebody in California is working on right now. Are there any other aspects here?
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Gizelle Baker: Well, I think it's about risk communication and why you would use absolute risk versus relative risk. And coming up through an epidemiological education, you learn very early that if you want to prevent something from happening, you need to speak in absolute risk. It will kill you. It has a carcinogen in, so therefore it can cause cancer, therefore it's deadly. Absolute. where if you want to change behavior and you want people to do something they're not willing to do, you speak in relative terms because it's encouraging. And that use of it to try and drive a behavior in public health, I think, is something that touches on all of these.
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Clive Bates: Okay, so that's an interesting nuance on, if you're trying to get a more subtle behavior change, you have to use more subtle messaging. Exactly. Okay, very good. Can I add something very quickly?
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Roberto Sussman: Yeah, in terms of many, many of the studies that look at emissions, and it generalizes also in other issues, they take the most extreme possibility of a system and assume there is normal usage. And this, for example, in a car, like a car can go 200 kilometers per hour. It's possible for a car. But who drives at that speed? So if you look at security of cars, you have to look in the ranges of parameters where it is used.
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Clive Bates: Absolutely right. So people taking a vaping device, cranking it up to maximum, sticking it into a machine, and measuring the toxic but uninhalable stuff that comes out of it. You might as well look at the nutritional value of burnt toast, driving a car at 100 kilometers per hour in first gear. That's what it's telling you. All right, let's have any from the audience. Ben? Everybody quick now. Ben?
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John de Miranda: I'd like to comment on the not safe. I and Atakan Befritz were personally witness when a Karolinska Institute professor was banning a doctor who was making his thesis saying that snus should not be compared to smoking. It should be compared to no nicotine use at all. And those having quotations in their theses with doctors who have written about this, they should have a red star mark.
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Clive Bates: Okay, so there's a point there about relative and absolute risk. And I think also in society we don't aim for zero risk. absolute risk. We aim for acceptable risk. And we don't, you know, if people say that, you know, bacon or cheese are not particularly healthy foods, we don't have a lengthy discussion about which is the more unhealthy. And we just say, actually, those risks are acceptable in diet. I really think, sorry, go on. You were going to say something? Yes.
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Roberto Sussman: We'll say it. The reference, like when a neumologist says it is important when you're evaluating risks to have a reference, a reference with a consensus. When a neumologist says our lungs were made to breathe fresh air, I would like to, and I have said it to oncologists, that means Dr. X is planning to move 150 kilometers away in some corner. See, the reference is important. Fresh air and no use and safe, all these things have to be given proper references or else they are useless.
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Clive Bates: One thing I just wanted to ask Giselle as well. I mean, one of the things that these, when people find, you know, we find a few molecules of chromium or something like that, isn't that often a comment on the detection equipment? Which I assume, I don't know about this, but from a lab point of view, that this stuff is becoming more sensitive all the time, and therefore things that weren't detectable 10 years ago are detectable now.
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Gizelle Baker: It's two things. One, that they increased sensitivity of the analysis, but the fact is if you don't design the sensitivity for that specific compound, you can't measure it. So if you don't go looking for a compound, you won't find it.
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Alexandro Lucian: Okay. We've got a gentleman here. Recently, I was in a Senate hearing, and a friend of mine, a toxicologist, remember everyone that choline that is sometimes presented in e-cigarettes is a level one carcinogenic according to international standards, but it's also present in the meat on the everyday barbecue. So that is something like absolute and relative risk.
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Clive Bates: Excellent. And there's a variation of that, which contains a class 2B carcinogen, which means there's no evidence that it is a carcinogen, it's just that somebody thinks it might be. So that's an IARC definition. Alex, and then we'll move on to the next few in this series, which I think are all being done by Ariel.
00:34:22 --> 00:35:15
Alex Wodak: Thank you. Look, I think this is a terrific exercise and I congratulate all of you and the program organizers for putting this on. And I may be jumping several steps ahead, but I think that And what I like about this is we're actually critically examining what people with very different views are saying. But there's another dimension to this that needs to happen somehow by someone, and that is looking at the the population traction of these statements and to some extent that can be done by literature analysis how often a thing is said but also there has to be a kind of focus group type study that looks and sees which of these really make a difference.
00:35:15 --> 00:36:52
Clive Bates: Okay I think that's a very interesting point because What I think you see is what I call a sort of accretion of alarm that happens, that right at the back, at the beginning, the scientific paper, there'll be a bunch of caveats that say, no, no, no, the headline that we've presented you with isn't actually true. Then there'll be a press release from the university publicity department which says, aha, look at this headline. And then there'll be something in the press which is, oh my god! Everybody stop vaping! Which is essentially deliberate. It starts at the beginning, and the papers are written in such a way that that outcome in the press is predictable. And the scientists will blame the newspapers, but it's not the newspapers to blame, it's the scientists to blame. And I think that is... how that science is shaped to get alarmist headlines and therefore to win the sort of notoriety and the prestige of the original authors. And the most extreme example of that, I think, was the formaldehyde paper in 2015, where absolutely disreputable use of reporting there, claiming that vapes were going to cause two and a half times the rate of cancer or something. It's completely outrageous. Right, I think, unless there's anyone who has an absolutely burning one, we will move on. Ariel, I think, has the next three, because they're sort of similar in some ways. They're related. So, over to an actual expert.
00:36:53 --> 00:39:27
Arielle Selya: Okay, the next two have to do with behavioral studies. So first is RCTs. So we see the claim everywhere that e-cigarettes are being advertised as effective for smoking cessation, and there's no evidence that they are. There's not sufficient evidence that they are. There is sufficient evidence and Cochrane says so. So I think the case is closed on that one. I don't think anybody can really reasonably deny any longer that e-cigarettes are effective for smoking cessation. But I also want to make a broader point is that even when in many places where e-cigarettes are accepted as harm reduction, it's only in the context of cessation. And I'm going to show a slide from some of the work that I've done at Penny with Juul. Switching with ENDS on the left-hand side here has a completely different time response than quitting smoking with NRT. So the point here is that cessation is not the only way that e-cigarettes can have a harm reduction effect. Many of you in the audience are accidental switchers and that's a lot of what I think explains this because to use NRT and to be in a formal cessation pathway, you have to make the a priori decision that I'm gonna quit, here's my quit day. You go and seek NRT or some other prescription or some other aid if you're going to. Sometimes you do cold turkey but the point is that you ahead of time, you're intending to quit, and that's the intention. And that kind of fails more and more over time, whereas with accidental switching and with ends use and use as an alternate consumer product, it's gradually displacing, and it's often accompanied by a period of dual use. And success rates for switching increase over time, in contrast to NRT. So this is another point that bothers me, where kind of the only acceptable use of e-cigarettes is for cessation, but it's much wider than that. And the big difference here is reach, really, because only, according to PATH data, only about 10 to 15 percent of people who smoke are ready to quit in the next 30 days. So what about the other 80%? Even if NRT is 100% effective, it can only reach about 15% of people who smoke, whereas e-cigarettes could potentially reach a lot more. There's also some good research out of the PATH team, the PATH study in the US, showing that even among people that never intend to quit smoking, those who do try e-cigarettes have very high odds of eventually switching.
00:39:28 --> 00:41:07
Clive Bates: Ariel, can I just butt in on this? Because I think this is a really important point. Everybody goes... RCT is the gold standard. RCTs are not really designed to capture the effect of consumer products in the ways that Ariel has been describing. There are other ways as well. First of all, the studies generally end well before vapes have had their full effect. And you can see that the vaping cessation rate rises, the classic cessation rate falls. There are other things as well. RCTs generally randomize. That's the point of them. And therefore, they don't let users choose what they're actually going to do. And choice and volition plays a really important part in the success of vapes. Users go into a marketplace and choose what they actually want. And I think the other big thing that's missing, I think you're alluding to it at the end there, is an RCT doesn't tell you how many people are willing to follow that path. The perfectly effective product that no one wants to use isn't really any use to anyone. So you have to have both popularity and effectiveness for a big public health impact. And RCTs don't capture that effect. And they certainly don't capture the accidental quitters. Generally, people who don't want to, you can design them to do this, but most of the RCTs don't capture people who drift into vaping as an alternative to smoking that they use at certain times and then go on to quit smoking. That's not what an RCT generally does. Is that fair?
00:41:07 --> 00:41:50
Gizelle Baker: Yeah, absolutely. Can I give a statistical nerdy answer as well? As a statistician, the one thing when you move from pharma over to the tobacco research that I look at from a randomized control study is its external allocation, which goes to your lack of choosing. But it goes one step further, which is then when you analyze them, everybody wants to see an intent to treat. And an intent to treat gives you a very wrong expectation of your outcome because what drives non-compliance is completely assuming external allocation when it's an internal choice. So the statistics that they give at the end are actually invalid.
00:41:51 --> 00:41:57
Clive Bates: Okay. One quick point because we don't know. I'm allowed to interrupt, but you're not, so go on.
00:41:58 --> 00:42:14
Roberto Sussman: One quick point, the definition of abstinence. Like, for example, in my case, I occasionally smoke, so I would fail. I would be a failure for randomized quantum trials, but what I do is very representative. Many people do that.
00:42:15 --> 00:42:38
Clive Bates: Okay, so that's a really... This is the sort of... classification of dual use as if it's one thing where it could be somebody who smokes once a month and vapes the rest of the time or somebody who smokes all the time and vapes once a month to mess around at a party that they're totally different behaviors they're captured in the same way you know in the trial results often let's get back to Arielle working through this framework next one
00:42:39 --> 00:44:09
Arielle Selya: Okay, next, there was a criticism a few years ago about, well, even if e-cigarettes are effective in RCTs, where's the population level evidence that they're making an impact? There is a lot of population level evidence. And first I'll talk about youth with the gateway. So this is from a paper I did where it's a simulation model where I say, okay, if the gateway were true, what would smoking trends look like versus what do they actually look like now? And the point here is that it's hard to measure gateway because you can't directly observe what youth would have been doing in a world without e-cigarettes. So we have to come up with ways to estimate this using trend modeling from before e-cigarettes appeared. So that's what I'm doing in this paper. And essentially the lesson here is that it takes quite a large diversion effect to explain the actual population level trends. Doesn't necessarily prove diversion, because again we can only sort of indirectly estimate, but it does show that the predictions of Gateway are very inconsistent with real world population level trends. And then extending this to adult age groups, there's kind of a patterning by age where the age groups that, or not necessarily age, but any other stratification of the population you can think of, the groups that take up e-cigarette use in greater numbers have a larger drop in smoking compared to what we might expect based on the pre-existing trends.
00:44:10 --> 00:44:35
Clive Bates: All right. As another element to this that I want to raise here, which is what you see is a rapid decline in smoking coincided with a rapid rise in vaping, and then the tobacco control people say, ah yeah, well that's tobacco 21, or that's our plain packaging measure. So is that something that, you know, that sort of false, like causal claim, like it feels like theft of success or something like that?
00:44:35 --> 00:44:57
Arielle Selya: Yes, yeah, thank you for bringing that up. My response to that is that this general trend is consistent across countries, across many other countries that didn't have equivalent legislation at the same exact time. It's also consistent in retail data, and pretty much any way you look at cigarette trends and project them in the future, it's a very robust finding across settings.
00:44:58 --> 00:45:12
Clive Bates: Ariel, what about the one that you hear, which is, yeah, yeah, yeah, randomized controlled trials, not the real world. The population trends don't bear out that e-cigarettes are making any difference at all. Where do you come down on that?
00:45:12 --> 00:45:34
Arielle Selya: I mean I would show them this exact type of result because there is a detectable drop in cigarette smoking that's pretty robust and it correlates with the degree of uptake in different populations. So there is an RCT effect but there's also a larger population effect that extends beyond the cessation.
00:45:34 --> 00:45:46
Clive Bates: I'd also note that if you said, okay, well, show us the population effect with NRT or Varenicline or conventional tobacco, they'd be like, yeah, well, we've got a randomized controlled trial that covers that.
00:45:46 --> 00:45:47
Arielle Selya: Right, yeah, that's a good point.
00:45:48 --> 00:45:51
Clive Bates: All right, do we want to do the next one and then go to the team?
00:45:53 --> 00:48:06
Arielle Selya: Okay, so the next one is getting a little more abstract in terms of inappropriate conclusions of causality. So back to Gateway, since we just looked at that. There's a tendency, even if, I think the researchers are pretty careful at not explicitly claiming causality, but where causality sneaks in is in May, as you talked about, Giselle, and also in the implications or recommendations that they make at the end of the paper. There was a recent paper on e-cigarette use and asthma, and they were careful to avoid explicitly claiming causality. And they even said, oh, we can't establish causality. But then in the implications, they say, we need to reduce e-cigarette use to prevent earlier onset of asthma. And that recommendation only makes sense if they are assuming that it's a causal relationship. So that's where the causality sneaks in. And then another thing that didn't get raised this morning in the session is social media. I'm gonna raise this as another example of inappropriate causality. There's a ton of social media studies analyzing self-reported exposure to e-cigarette advertising and e-cigarette use or susceptibility have a separate brand on susceptibility that I won't even get into today. But with social media and self-reported exposure, there's all sorts of other explanations. It's interpreted like the authors fundamentally usually say, we need to crack down on social media. We need to have more social media restrictions and more marketing restrictions with the assumption that it's going to reduce e-cigarette use. It doesn't really account for, number one, selection bias, attentional bias, where youth who are already using these products or are interested in using these products are more likely to recall seeing such content. And also the direct nature of social media. They're not passive consumers like they are in the form of mailers or television ads. Social media, you have an active role in what accounts you follow, the algorithm then feeds it back to you and shows you more of what you've already expressed interest in.
00:48:08 --> 00:48:13
Clive Bates: All right. Should we pause at that point? Where are we up to?
00:48:13 --> 00:48:14
Arielle Selya: Number six.
00:48:14 --> 00:48:30
Clive Bates: Number six. Okay. Yeah. Let's have any comments from the panel first on this stuff. It's more like populations, things, big trials, drawing inferences from trends and all of that. Any comments on this?
00:48:30 --> 00:48:56
Gizelle Baker: Well, I think what I always find interesting is that they pit one against another. So even if you have both, it seems like as long as you act a little bit appalled by the fact that somebody would conclude something, it means it's not true. So they have a randomized study, but that doesn't show this. OK, but there's the population study in an observational manner that does. And you're like, yeah, but that's not randomized.
00:48:57 --> 00:49:30
Clive Bates: Okay. All right. So there's a kind of... I mean, I think the right way to... Nothing's ever totally conclusive, but the right way is to get a sense of the totality of the evidence. And that includes things that, you know, like... randomized control trials, population studies, observational studies, even testimony, which most people say, well, that's just anecdote. But actually, if you get 10,000 anecdotes, that's actually very compelling evidence. So let's go to the audience now. Sorry.
00:49:30 --> 00:49:51
Roberto Sussman: I just wanted to comment that sometimes in observational studies, especially related to Gateway, there are some very dirty statistical tricks. They have been identified. Essentially, it's hiding part of the sample and manipulating the samples to get what you need.
00:49:53 --> 00:50:07
Clive Bates: All right, let's get some comments from the audience. Let's start with Norbert here, then we'll go to the... Anybody in the... Yes, at the back there in a minute. Wait a minute. Wait, wait, wait, wait, wait. Okay, Norbert, go. We'll just go around and then to her.
00:50:07 --> 00:50:34
Norbert Zillatron Schmidt: Norbert Schmidt, German consumer. What bugs me most is the same people who claim thousands of testimonials by consumers are just irrelevant anecdotes. The same people... if somebody reports some illness. Yes, absolutely.
00:50:34 --> 00:50:35
Clive Bates: I'm with you. Okay.
00:50:35 --> 00:50:37
Norbert Zillatron Schmidt: And claims it on vaping.
00:50:37 --> 00:50:37
Clive Bates: Yeah.
00:50:39 --> 00:50:41
Norbert Zillatron Schmidt: Important case study.
00:50:41 --> 00:50:52
Clive Bates: I vaped and then had a seizure. And that's it. That's the news sorted out. I completely agree. That's brilliant. Okay. Do you want to take the mic and then we'll go to there and then we'll go to the back corner over there.
00:50:52 --> 00:52:01
Nicoleta Turliuc: Hello. I'm Nicoleta from Romania. And... Yes, stand up. And I want to say that... We can relativize, relativization of the science can be done, but there are some perils in that. In my opinion, random control trials are golden standards because it measures the effect of the intervention. We are made in a population, smoking population in this case, and the problem with random control trials probably are related to the fact that we cannot control very well the variables. even in these control trials the problems are with the control of the variables we are using and in the interpretation and these are the main problem for a good science researchers I think just to draw in case anyone missed that really important here is the concept of external validity so you run a trial how well does it
00:52:02 --> 00:53:03
Clive Bates: actually reflect and represent the phenomenon in society that you are trying to measure, which is generally not randomized, not controlled, and not time limited in the form of a trial. And I think the best example of poor external validity is actually the trials that purport to show that reduced nicotine cigarettes will reduce the sort of disease consequences of smoking because they are not measuring or in any way modeling the real world in which there would be illicit supply, there would be switching between smoking and smoking cigarettes and smoking other types of tobacco products and so on. So unless the trial is set up to represent the real world phenomenon, which is an economic marketplace disturbed by regulation in that case, then it's not actually measuring or examining the thing that you are interested in scientifically. So I think we should really focus.
00:53:03 --> 00:53:22
Alexandro Lucian: That's a really good point. Let's go to the back. When Ariely was talking about RCT studies, she mentioned dual use. And I remember that nobody here commented about something that often happens in Brazil, that dual use is worse than just smoking. Right, right. OK, you can comment on that.
00:53:22 --> 00:53:57
Arielle Selya: Yeah, thank you so much for bringing up that point. That's really important. And this is comparing apples and oranges because people who dual use are usually, they smoke more heavily to begin with. So it's comparing apples and oranges there. But really, if you look at within an individual person at the point when they started e-cigarette use, I have a paper on the Juul purchaser study showing this. the majority of people substantially reduce their baseline cigarette consumption. So I agree with you. There's a lot of alarmism about dual use, but it's based on statistical tricks.
00:53:58 --> 00:54:26
Clive Bates: And the dual users might be different kind of people. They might be more dependent. You know, so the way that some of these things are compared, if you compared all dual users with non-dual users, you might find that they're consuming more nicotine and more toxicants. But if you compared one user over time going from smoking to dual use, you'll see a different picture. So it depends how you actually examine these things. Gentleman at the back there. Let's get the mic on.
00:54:31 --> 00:55:18
Person from audience: It's done. So I'm Claude from PMI. I mean, we can blame the scientists. We can blame the media. And we can blame the governments for a lot of stuff. But one part that's quite awful we don't criticize is the actual journalists who publish the original studies. Because many of these studies are published in quite quite prominent journals actually and a lot of the statistics the thing we see here is things you learn the first week in a statistical course or the first week in a course of trial designs and to me it's really puzzling that reviewers don't spot these things things goes straight through the review process, then they are published, and then the spin starts. So I think this is really, really strange, and to me, I don't understand.
00:55:18 --> 01:01:47
Clive Bates: Yeah, I agree with you. I think we're going to come back and look at the reasons, if we get time, we're going to look at the reasons why this bad science happens in the sort of next section after we've got through these 10 points. I'm going to carry on now, just be mindful of the time. We are moving through. But don't forget, any of this can be picked up later or separately with us, okay? I'm going to go next, I think. Fall off. Right. Where's our slides gone? OK. Right. Oh, that was the point of the causation one there, was that youngsters who listen to loud music are at risk of drugs, alcohol and sex, as if loud music is the main cause of those things. Obviously, this is a common liability issue. Anyway, let's go. Policy recommendations. This is where scientists Move ahead from basic science to drawing policy recommendations. And I would say we should think in terms of there being three types of science, really. You could probably extend it to four or five. But let's just say there's observation, which is understanding what is actually happening in the world, characterizing different trends, different behaviors, understand how much toxic exposure do you have. Then the second type is interpretation. Why is that happening? What are the causal drivers? What is creating these effects that we are observing? And then the third type is intervention, which is what is the science of intervention? What do we know about intervening to change that behavior or that exposure or anything? And the problem you see is that a lot of scientists don't understand the differences between these three. So they'll do an observational study. They'll say, oh, look, more young people use flavors. which is a true statement. And then at the end of it, they'll say, and therefore ban flavors, which is an intervention question. And of course, when you study interventions, you're really moving into economic territory. You're moving into what happens in a market or what do suppliers do? How does an illicit trade react? How do companies react? What do consumers do to work around? So you have to be mindful of unintended consequences. You have to have insights into trade-offs. Are we going to do something that has a minor benefit for young people but is catastrophically bad for adults and so on? So one of the things that I find so annoying is observational or interpretive papers that jump around. to a policy conclusion, okay? And you see this. It's almost like, oh, I did a load of work, and now I can say something about policy, as if it's obvious. But policymaking's a discipline in its own right, and it's not straightforward. It's generally economically based, and it's usually about the behavioral economics or the functioning of markets. This is one example I've got here. This is an extremely detailed presentation given by someone from the Netherlands. After 33 slides, they end up with this, which is a list of flavor ingredients that they say should be permitted on the Dutch market. And it's not very many, and they're all designed to produce tobacco flavors. Check out the next slide in this presentation. Oh, what other things that could go wrong? And then suddenly they're talking about, well, DIY, flavoring, mixing, less attractive as a smoking cessation thing, decreased ends use but more cigarette use, increased illicit markets. And she gives this presentation, puts that slide up, and then moves on. Doesn't even comment on it, OK? Yet, those are the issues. It's not the first 33 slides working out what chemicals you are allowed or not allowed to create a tobacco-only environment. It's those things are the policy questions. It just basically ignored those. So that's an example of what I'm talking about. Questions not asked. Is that me or you? That's you, isn't it? Okay, yeah, all right. Questions not asked. I'm going to carry on on this one. So the very, very first stage of science is what do we actually study, okay? And a variation of that is what do the funders fund and what do the journals want to publish? And that's a massive filter, okay? So I'll give you some examples here. Let's start with this one. Why is there a demand for nicotine? How many papers can you lay your hands on easily that explain why people use nicotine? How much of it is there? setting out this, this is my model of why there is a demand for nicotine. How much of that do you actually see? But let me suggest some others. There's been an amazing change in the rate of cigarette consumption in Japan, okay? Are the skies above Tokyo dark with the planes of tobacco control researchers flying into Narita Airport to study that? No, they are not. They're not interested. Same with the snus experience in Sweden. Don't want to study that in detail with a few honorable exceptions. There's very little interest in New Zealand and the incredible experience that's been achieved with Maori smoking, but there's a lot of upset about some endgame measures that have been cancelled by an incoming government. So these are the sort of issues that I think just never hit the science. Do you want to add something? OK. OK.
01:01:48 --> 01:02:46
Arielle Selya: I'll add a couple of my own. I agree with all of that. A lot of what I see in the weekly literature reviews is kind of, which it's linked to the last point as well on unintended consequences, especially with policy. So there's a lot of studies, and I'll give a shout out to one of the science lab sessions from yesterday. I think it was a JTI session that reviewed, did a scoping review of papers on flavor bands. And of 23 papers that they found on flavor bans, only five of them looked at unintended consequences. And that's really the most important part of it. Most policies will have their directly intended effect, but there's all these off effects that in many cases when you're talking about using a reduced harm product versus the unintended consequence of going back to smoking, that's a lot more... a lot bigger of an effect on overall health, and that really needs to be examined.
01:02:47 --> 01:05:54
Clive Bates: Exactly. And a number of, you know, you quite often see, well, we did this intervention on e-cigarettes, like we banned flavors in San Francisco, for example. And the paper will come back saying, oh, look, the sales of flavored e-cigarette products in shops in San Francisco has gone way down. Big win for the policy. Except they didn't look at what happened to smoking. They didn't look what happened to illicit trade, cross-border trade. buying over the internet or anything. They didn't study the full phenomenon. They asked a very narrow question and answered it, and that's quite typical. All right, next. I think... Yeah, sorry, I meant to say as well, you know, things like vaping cessation papers, you know, you have to ask the question. If you're doing public policy, one of the things that you always ask is, what's the cost-effectiveness? And for there to be cost-effectiveness, there has to be substantial health gains. And for there to be substantial health gains, there has to be substantial ill health associated with vaping. So, you know... When you're talking about spending public money, are you really doing it in a wise and sensible way? So that's just another area where you see incomplete policy analysis. Okay. Right, oh no, it's the tobacco industry. So this is the sort of strategy that I think kind of caricatures the tobacco industry by suggesting that people like Giselle are like these fat old men from the, this is a congressional hearing back in 1994, I think, But there's a constant evocation of that model of big tobacco without ever really understanding what the tobacco industry is. And I'm first to be sceptical about the industry, but... I think we have to accept that since around 2000, when there was a massive amount of litigation, when there was danger, jeopardy for the execs that they'd end up in jail for racketeering, they were running the black market and things like that, they were genuinely doing terrible things. They have taken fright and have cleaned up their act to some extent. They also now have these alternative offerings, reduced-risk products, which they're trying to promote as alternatives to cigarettes. That's a very different industry to the one that we had in... We have to be realistic about that. It doesn't mean that we are naive about it or that we're not skeptical about it, but it's a very different thing. And using documents from 1954 to sort of understand the behavior of the industry now I think is inappropriate. But I'm going to come to Giselle, and I'm going to put the blunt question to you. The tobacco industry has an absolutely terrible reputation. Why should we trust its science?
01:05:55 --> 01:06:35
Gizelle Baker: And I'm going to give not a tobacco industry answer, but a science answer, is science isn't based on trust. And I hate that question, because it's not about trust. It's about open, it's about sharing, and it's about having an audience on the other side that will interrogate the data and come to their own conclusions. Where there should be absolutely no trust or maybe even mistrust is when the data isn't shared, when methods aren't available, and it doesn't matter what industry or lack of industry you come from, if you don't make your methods and your data available so that they can be interrogated, that's where misinformation comes from.
01:06:36 --> 01:06:43
Clive Bates: Brilliant. And I really do agree. Do you want to say something? You're a scientist. Go. Hello?
01:06:44 --> 01:09:13
Roberto Sussman: Hi. Yes, I would like to talk from outside the industry. And I have professionally... collaborated with co-authors in Italy and France to make a revision of studies, the methodology, the assumptions, the results, et cetera. And we have looked at industry studies. We have also looked at the quotation mark independent. And I can say that it is true what Giselle is saying that industry, When you read an industry study, you find everything, everything. You can really reproduce or replicate the study if you want. And I have also been a referee of papers that criticize the industry. For example, one paper would try to expose PMI on the issue of ICOS by saying, well, PMI published this study on whatever, doesn't matter the subject. And then, these are six independent studies that obtained, some of them a similar result, some of them another result. But these six studies were not replicating TMI studies. So what they were claiming is wrong. Because if you study certain type of cells exposed to icosarosol, and then you study other type of cells, this is a different experiment with different assumptions. So it is not a counter to the industry study. And here is the question I pose. to people who question the industry. Why don't you replicate them? I am a scientist and I have replicated studies in astrophysics and cosmology because the results were wrong or questionable and I replicate them. I show that they were invalid or whatever and an amount of my publications are like this. So I would ask people in tobacco control, If you do not trust the industry, go and replicate them. This is the only way that you could prove your point that research from industry is deceptive. Otherwise, it's just rhetoric.
01:09:14 --> 01:12:59
Clive Bates: Fantastic. Brilliant. I agree completely with it. I really love Giselle's point here. Science not as an act of trust. I think one way of describing science is organized skepticism. this Mertonian ideal, in which actually it's all about scepticism combined with openness. So the right approach to science is intense scepticism, but not unreasonable, declaration of interests and conflicts of any type. which includes prior policy positions and motivated reasoning from tobacco control groups and academics. And then this openness in which you expose everything to examination and replication. And that's the right way to go about it. So I think it's a really nice way of putting it. And then finally... Yeah, shifting goalposts. All right, what are we actually trying to achieve? All this science is being done to a particular end, and I thought it would be fun just to list out all the things I have seen that people appear to be trying to achieve. Okay, I'm not going to go through them one by one, but this is the list of things. of all the different things that people could be aiming to do. Are they trying to eliminate tobacco, smoking, disease, nicotine, effects on kids, and if so, why, secondhand exposure? Are they non-smokers rights activists who just hate being in the presence of other people and so on? In the good old days, when I started in the tobacco control field in 1997, you could basically say all of the above. Cigarettes were pretty terrible. The industry was terrible. All of these things were together. But now you can't. You can't say all of that because if you pursue the end of nicotine use, you may be increasing the harm because you're not pursuing harm reduction options. If you go mad on kids, you might be hurting adults. If you focus on vaping uptake, you might be overlooking the diversion of young people away from smoking by vaping, those sorts of things. So the landscape now is much, much more complicated in terms of what people are trying to achieve. And often in the literature, it's unclear. And they are not explicit about what they're trying to achieve. So you see implicit goals in the science and implicit views about what everyone is trying to achieve. You know, people will just say, we're trying to reduce vaping. And then they will... They're not really asking, well, might that increase smoking? Or how far are we allowed to go with that? Does it matter if we mislead people about risks, for example, if it gets us that goal? And we see a lot of that. Uncritical acceptance of goals without really articulating them. So... I'm going to stop there. That's our sort of ten-point framework. Can I just take... Let's take any points that we've got on the last few first, which I think we started on policy records, the last four, and then we'll just look at the framework as a whole. We're probably not going to get more than a few minutes to talk about why is the science so bad, but let's go. I'm just going to sit down. Do you want to do it? All right, get some hands up. Yes, down here please.
01:13:04 --> 01:13:38
Yvonne Khoo: I'm Yvonne from PMI. So with regards to policy recommendations, I know regulators readily accept RCT as an evidence for most other subjects, but when it comes to regulation of alternative nicotine delivery products, is it about time that clinical researchers rethink methods in clinical trials, not only RCT, but to rethink how they can design clinical trials in order to challenge regulatory acceptance of these products.
01:13:43 --> 01:14:08
Arielle Selya: Yeah, that's a good question. I think one of the challenges, at least in the US regulatory system, is that everything has to be on a per product basis. So it's not sufficient to show that e-cigarettes as a category are displacing cigarettes or are effective. It has to be a particular product. So I think that's one of the challenges that I'm not quite sure how to get around at the moment.
01:14:08 --> 01:14:42
Clive Bates: You've just reminded me of a massively annoying thing that we didn't mention earlier, which is, well, e-cigarettes might work well in the United Kingdom, but they don't necessarily work well in Vietnam. And it's like, well, therefore, we need to replicate the entire evidence base for everybody in Vietnam or every subpopulation. And actually, that's a ridiculous way of looking at things. There's some commonalities between human beings here. even across the whole globe. Okay, any other comments from the panel? Let's go to the back there, someone's got their hand up, I can't see who it is. There you go.
01:14:42 --> 01:14:54
Maria Papaioannoy: I have a question. How do we combat bad science? Because, here's the thing, bad science in Canada from a man named Oh, God, I forgot what his name is.
01:14:54 --> 01:14:55
Clive Bates: Neil Collishaw? I don't know.
01:14:55 --> 01:14:59
Maria Papaioannoy: Oh, no. The David guy from the University of Guelph.
01:14:59 --> 01:14:59
Clive Bates: Oh, yes.
01:15:00 --> 01:15:01
Maria Papaioannoy: David Hammond, thank you.
01:15:01 --> 01:15:02
Clive Bates: David Hammond, yeah.
01:15:02 --> 01:15:21
Maria Papaioannoy: That started us off on this entire youth vaping epidemic. And it was bad science. It was retracted. He went away for a while. Now he's back. We are still catching up on that. And then when I'm looking at the bad science for the flavour ban, that's our ingredient list in Canada.
01:15:22 --> 01:15:22
Norbert Zillatron Schmidt: Yeah.
01:15:22 --> 01:15:30
Maria Papaioannoy: How do we combat that with our politicians? Because our politicians are now forcing our regulators to make bad decisions.
01:15:31 --> 01:16:03
Clive Bates: Okay, this was going to be the sort of next phase of our discussion. Let's move on to that. Anyone's free to add any further comments on our 10-point framework. But I think that is an interesting question. So let's hear from the panel views on what should be done. And I think Giselle alluded to some of this, like open science, you know, so on. Let's start with Ariel, and then Roberto, and then you.
01:16:04 --> 01:17:00
Arielle Selya: Sure, so I think this goes into, it touches on the whole what's wrong with academic publishing and the causes of it, but I think briefly post-publication criticism is becoming more important. It's too easy for a paper, peer reviewers don't always do their job thoroughly, but peer reviewers are under time pressure. It's hard to catch everything wrong with an article without analyzing the raw data yourself. And I think peer reviewers can't be counted on catching all of this. And if something's rejected from a top tier journal, it gets bumped, it gets published eventually somewhere. And even papers that have been published in very, unreliable journals, let's say, have gotten huge press coverage. So I think having, like, PubHere is a great platform for that. Post-publication criticism, I think, is becoming more important for stuff that eventually gets published.
01:17:00 --> 01:17:46
Clive Bates: I mean, the extreme form of unreliable journal is conference abstract, isn't it? Conference abstract plus press release. You know, everybody should be on standby every time there's an American Thoracic Society conference, because there's always a stupid abstract and a stupid press release. Roberto, do you want to comment on how... Post-publication review, the David Hammond paper you're talking about there wasn't retracted, it was corrected. And there's a big difference there, because it was corrected to the point where the original conclusions no longer held any water based on the data, but the original conclusions were left in place. So there was a big failing of the BMJ with that paper, in my opinion. But, yeah...
01:17:47 --> 01:18:29
Roberto Sussman: Yeah, as Ariel said, it is part of global science because there's a massive production of articles in all disciplines. And the paradigm of the referee, the peer review referee, it is overburdening them. And also there are some social cultural attitudes like publish or perish. So all these things exist in all sciences. I am aware of it. I pass through it every day. But what is the difference with tobacco nicotine science politics?
01:18:29 --> 01:18:30
Clive Bates: Yeah.
01:18:30 --> 01:19:05
Roberto Sussman: Like... If you add this problem, this endemic problem, if you add politics, then we see what we have. There is a clearly identified political agenda. And science, if you have this fantasy, science is objective. Galileo is looking at the stars and so on. No, science is cooperative. Science has funding, has jobs, has institutions, and it is affected by political agenda. And we have a political agenda.
01:19:06 --> 01:19:37
Clive Bates: And I think so is peer review. Peer review is also politicized. You will find that choice of peer reviewer is essentially a rubber stamping exercise. They're not looking for the problems, they're looking for publication. Or filtering out, that's why I never bother with academic publishing. I just know that somebody's gonna get to peer review it and they're gonna block it and it'll take forever and I'll get upset. So I never bother with it. Giselle, your view on things that could be done to fix science.
01:19:38 --> 01:20:16
Gizelle Baker: I think one of the biggest problems in science is funding. We have very limited options in funding sources. And when the funding sources come with an agenda, then you're driving where the science will go because you can't get funded for something that would go against the agenda. And I think when you look at it, you've got NIH, which is going to find the people who are going to do the studies. And if that's your main source or you want any option to get it, and tenure is going to depend on getting NIH funding, and NIH funding is not going to fund somebody who took money from the tobacco industry, it all goes back up to funding.
01:20:16 --> 01:20:40
Clive Bates: Yeah, and I think NIH, which is, I think, probably by far the largest funder in the world, actually has an explicit objective of securing a tobacco-free society. Which in the way the Americans use the word tobacco means nicotine-free society. So you're not going to get a lot of stuff that's very positive about it. You do get some, but you're not necessarily going to be, they're not going to be institutionally inclined to that.
01:20:41 --> 01:20:48
Gizelle Baker: Exactly, especially if you have to think that this may be my last funding if I conclude something that goes in the wrong direction.
01:20:48 --> 01:21:35
Clive Bates: Yeah, and you look at the professional history of someone like Brad Radu, who was one of the first, I mean, a truly extraordinary pioneer in the field, bringing the information on smokeless tobacco and the fact that there was no mortality penalty among smokeless tobacco users in the United States. What happened to him? ostracized, criticized, shunned, and driven out of publicly funded research and in the end has to take an unrestricted grunt from U.S. tobacco. And then he's demonized for that. So there are those sort of funding and career threats that affect people in this field. Do you want to comment?
01:21:36 --> 01:22:33
Roberto Sussman: Yeah, together with funding, it's demographics. Like when you are outside of the mainstream political agenda, Then there are two groups outside in our particular case. One group is industry, and the other group is a bunch of Don Quijotes trying to hit the mills. We are very few. And on the other side, NHI-funded, FDA-controlled, tobacco center, and European Union, public health, You have armies of people who work full time on this, and we are very few. And that is why some people go to industry, because sometimes industry is the only way you can do research, otherwise you are isolated. This is a problem of being outside of the mainstream agenda that is affecting the science. I think that was your experience.
01:22:33 --> 01:22:58
Arielle Selya: Yeah, that was my experience. I was in academia for 10 years. I was always a prolific publisher, but the problem came with getting grants. And I'm not going to say that if it were only for this factor, I would have been a successful grant awardee. But I would get comments from my reviewers for having the wrong opinion on e-cigarettes. And that certainly worked against me to some effect.
01:22:58 --> 01:23:29
Clive Bates: All right, we're going to close. We're running towards the end now. I just want a quick blast of why. Why is there so much bad science? And is it abnormal in this discipline compared to other disciplines, like physics, for example? So let me get some quick questions from the panel, quick thoughts on the panel about why things are so bad. Why is there so much bad science? Really quick, though. Roberta, you go first. And what's it like compared to physics?
01:23:30 --> 01:24:10
Roberto Sussman: Oh, it's completely different. Well, physics also has conflicts of interest and interest and dogma, etc. But it's very different. It is day and night. It's completely different, the procedure, etc. But what I would like to mention is that what we are seeing, and it is known, it has been said, it is the reaction of a very conservative technocracy against an innovation, against a disruptive technology. And from here, from From this point, everything follows. Okay. Ariel, your views?
01:24:10 --> 01:24:28
Arielle Selya: I think there's a lot of bad science because academics respond to publishing incentives. There's a pressure to publish a lot, and they have to gain funding and comply with the priorities of the funding agencies. And I actually don't think tobacco research is the only bad one. Nutrition research is just as bad in my experience.
01:24:29 --> 01:24:49
Clive Bates: Okay, so that's a set of economic incentives. From Roberto, it's essentially a disruption of a career and a livelihood pattern that's essentially an existential threat if there's no harm to these products. Your view, Giselle?
01:24:49 --> 01:25:21
Gizelle Baker: Well, I'm going to say I don't think it's just the tobacco industry. I think it happens when there is organized agenda behind another point of view. So I think you can go back in history and look at the Yudkin versus Keyes, sugar versus fat. When you put money and you put systematic, organized, an agenda driver on the other side and you don't consider that to be a conflict of interest, you end up in a situation where you end up censoring the other side of the argument and considering that the win.
01:25:22 --> 01:26:10
Clive Bates: That's a really good point. There is a wall of money behind anti-vaping and anti-tobacco harm reduction that affects the views of the medical society. They're all taking money for this. Medical societies, the professional bodies, the activist groups, they're all creating a cultural environment that is hostile to tobacco harm reduction. And the science, to some extent, is reflecting that environment and the norms that are being established in that environment. We're going to finish very soon, but any final comments from the audience, please? Why is there so much bad science? Has anybody got a big picture view on this? Bloomberg. Bloomberg, that's probably true. Okay, sir, go on, let's get a mic.
01:26:10 --> 01:26:30
Barnaby Page: Thank you. Ian Fair, an independent consultant in the UK. Has science lost its fundamental principle of hypothesis testing? And scientists should be trying to prove themselves incorrect, but instead all they want to do is prove themselves correct and prove the dogma.
01:26:30 --> 01:26:32
Clive Bates: Do you want to quickly on that?
01:26:33 --> 01:26:36
Arielle Selya: Yeah, I do see a lot of evidence for confirmation bias. I agree with that.
01:26:37 --> 01:26:39
Clive Bates: All right, any final... Do you want to...
01:26:39 --> 01:27:05
Roberto Sussman: Yeah, very quickly, that's true. It is the end, the regulatory policy is already decided. So you have to try to find resources that are consistent with this previously designed policy. It is the opposite of physics. In physics, it's absolutely, it's the inverted pyramid, yes.
01:27:06 --> 01:27:19
Clive Bates: Okay, I'm gonna finish now, and I want just a suggestion for actionable things. What can people actually do here? Who's gonna go first? Giselle, you go first. What can people do?
01:27:20 --> 01:27:23
Gizelle Baker: I think what people can do is read beyond the headline.
01:27:25 --> 01:27:30
Clive Bates: Okay, I think that's good. And that's basically maintaining skepticism.
01:27:30 --> 01:27:34
Gizelle Baker: Maintaining skepticism and don't stop with the headline.
01:27:34 --> 01:27:35
Clive Bates: Okay, Arielle?
01:27:36 --> 01:27:41
Arielle Selya: Use our 10 guidelines or whatever we come up with. Read the literature and post pub peer comments.
01:27:42 --> 01:27:50
Clive Bates: Yeah, post pub peer comments. So get involved in post-publication peer review if you can and if you want to. Don't feel you need to, though.
01:27:52 --> 01:28:47
Roberto Sussman: Double-check. Don't take the first one. Double check. And find the sources. If you find the sources, even if you do not understand them, find the sources and be skeptical if they are, as Clive said, conference proceedings. Do not trust any article that says a very impressive effect, et cetera, et cetera. A story somewhere published. if the reference of that study is not cited. Just minimal skepticism values, minimal measures of skepticism already make a difference. And ask your peers, your friends, to do that, to do that. And it's not only in science. People should be like that in everything, in politics, in economy, et cetera. I have one final piece of advice, then we'll stop.
01:28:48 --> 01:30:06
Clive Bates: Tell your story. If you're a vaper and if you've had direct experience of this, you, your families, everything, in some ways, the case study of a successful person going from smoking to vaping or not vaping or whatever, in many ways that enters the brain in a different hemisphere and it resonates emotionally and with empathy Whereas in the science side of the brain, people are fighting each other to a standstill with graphs and odds ratios and claim and counterclaim. But in politics, the emotional, the empathy counts for a great deal. So never, ever feel that you can't compete in a world of claims that are scientific. Because if you've been a vaper, you have direct experience, and that counts in a big way in politics. Okay, so I think with that, if you don't mind, we will wrap up this session. For everyone who contributed, please give everyone who contributed a round of applause. And the panel and everybody, I thought that was great. At some unspecified date in the future, Arielle and I will come back with a synthesis of all of this, hopefully not too far, and hopefully before the next one.