by Carl V Phillips
[This is a continuation of yesterday’s post on this topic and will probably not make much sense if you have not read that one.]
I will pick up the analysis with a thoughts that came up in the comments (h/t to the comment by “mav” in particular): On the topic of whether Glantz is a liar, it is possible that he genuinely believes his absurd claims about how mere imagery of smoking is what causes people to benefit from nicotine/tobacco, and that he might have genuinely humanistic concern about the harm such images would cause. (I.e., on that count, he is not the calculated corporate liar that dominates the tobacco control industry leadership.) But then, it might also be that he is so worried about e-cigarettes creating such imagery (despite most of the decent e-cigarettes not looking much like cigarettes) that he is motivated to lie about e-cigarettes specifically.
There was also the observation that a single reported example of an exploding e-cigarette battery or contamination of the e-cigarette liquid is considered by the anti-harm-reduction activists to be true and worth repeatedly reporting. So obviously they do understand the concept that a single observation is often adequate scientific evidence of a particular claim. This argues in favor of the explanation that they are consciously lying when they deny the usefulness of personal success stories of how e-cigarettes caused someone to quit smoking. If a personal testimonial of an exploding battery constitutes evidence, then countless testimonials about smoking cessation certainly do.
One of the reasons that both of these are so compelling is the plausibility of the claim. Batteries (in all devices, whether they cost $5 or $200 million) do occasionally fail catastrophically, especially if someone uses the wrong kind. Thus, it is not at all surprising that a few batteries have burned or exploded. The e-cigarette is purpose-built for smoking cessation. Thus, it is not at all surprising that e-cigarettes have caused lots of people to quit smoking. There are many other examples of how to use prior knowledge in our scientific reasoning: Since nicotine is derived from tobacco, we would expect to find a miniscule (inconsequential) trace of other molecules that occur in plants — e.g., TSNAs — in the nicotine that is used in NRTs or e-cigarettes, and indeed it has been found. This contrasts with, say, a study of e-cigarette vapor that finds tobacco smoke combustion products that we do not expect to find; in that case, the explanation is probably sloppy lab procedure and equipment that was contaminated by previous analyses of smoke.
So for something that is easily predicted to be true, apart from the empirical evidence, we only need a little bit of empirical evidence to convince us that it is indeed true. That evidence is valuable, though, no matter how strong the theory is. So, recent efforts by smokeless tobacco manufacturers to bring new products to the American market have almost certainly caused some smokers to quit, but absent a bit of evidence to confirm success, it is not unreasonable to consider that conclusion less than definitive. This relates back to the light switch point from the previous post: We have strong reason to believe that the switch on the wall and not, say, the fact that it is 8:00 is what causes the lights to be on, so when our switch-flipping experiment seems to confirm that, we can be confident of the claim.
This does bring up the one bit of possible doubt about personal experiments: What if someone is quite sure about a particular cause and effect, but they are wrong? You only need to wander through the internet for a few minutes to find examples where this is pretty clearly the case. But how could someone possibly be wrong about their smoking cessation? Glantz tries to make up such a story by claiming “placebo effect”.
Glantz is in good company in clearly not understanding what this concept even means. Most people who talk about placebo effects or placebo controls clearly do not understand what they are talking about. So to explain…
The concept of a placebo, as part of a scientific inquiry, only makes sense with specific reference to context, and needs to be separate from similar but quite distinct effects. When a placebo is referred to without a research context, it generally refers to an actual treatment method, in which someone is cured of a disease by intentionally tricking them into believing they are receiving a treatment with known benefits. This is a good thing when it works, obviously. To the extent that the word is interpreted this way, then for someone to quit smoking due to the placebo effects of e-cigarettes means that they quit smoking due to e-cigarettes. Success! (Michael Siegel wrote more about this observation yesterday.)
But that brings up the issue of what the word means in a research context, and that, rather than the intentional medical use of a placebo, is presumably what Glantz was referring to. What would it mean for an e-cigarette to work as a placebo, rather than because… well, rather than what? This points out that the concept of an experimental placebo has to refer to a specific characteristic of an intervention, and not the intervention in general. Someone might wonder if the nicotine delivery from an e-cigarette really matters much, or whether the device and action itself is causing most of the effect — i.e., whether the nicotine content was merely a placebo. In that case, the placebo control would consist of a nicotine-free e-cigarette that the subject did not know was nicotine-free. The placebo would still be something real, as most placebos are, but not real in one specific sense. But this would obviously not constitute a placebo if the question were “is the act of mimicking smoking useful for cessation?” The concept of a placebo in research only makes sense when we consider the question that is being asked.
To further complicate it: In clinical studies where some subjects are just given a sugar pill (Glantz’s example of what a placebo is), there is perhaps some placebo effect. However, this is actually probably dwarfed by the “Hawthorne effect”, the tendency of people to behave differently just because they know they are being studied, regardless of whether anything is being done to them. (Ironically, the Hawthorne experiment that it is named after probably actually demonstrated as much of a placebo effect as anything, but that is another story. The concept is clearly right even though the name is wrong.) When smoking cessation studies are performed, and it is found (as is pretty much always the case) that the NRT or other intervention had the same effect as a placebo, most of the effect is probably Hawthorne and not placebo. That is, the cessation success rate is elevated for both groups not so much because of a placebo effect, but because people who are being studied are more likely to behave in different ways.
Indeed, I have long believed that the following intervention would have approximately the same success rate as NRT in clinical trials (or the placebos that have the same effect): Have a reasonably attractive member of the opposite sex approach a smoker and say “I am from <organization> and we are very interested in finding out how many people are quitting smoking this year and how they are doing it. Would you mind if I get contact information for you and check back in six months to see if you have quit?” In both that scenario and in the real clinical studies, extra cessation (in excess of the population average rate) would mostly result from people who had been seriously thinking about quitting one of these days, and who — because they know that someone is watching them to see if it happens right now — go ahead and do it. (We were actually considering doing that experiment when I was in Alberta, but did not manage to get it started.)
It should be obvious that both placebo and Hawthorne effects are much more likely when the outcome of interest is decision-based rather than biological. That is, occasionally someone actually overcomes biological disease due to the power of belief, but it is much more likely for someone to choose an action because of their belief. Indeed, people only take volitional action because of belief. So talking generically of a placebo (rather than specifically, as with the nicotine-free e-cigarettes) when the outcome is behavioral actually makes no sense. It seems likely that Glantz was confusing the Hawthorne effect, which occurs in study settings, with the placebo effect. He was probably trying to suggest that since the placebo group in clinical trials quit at the same rate of those who received “FDA approved”-type interventions, that maybe that was also occurring with e-cigarettes. But since he was talking about people making personal decisions in their normal lives and not in a study, there was probably almost no Hawthorne effect (there might have been a bit, if a friend who turned someone on to e-cigarettes was monitoring their success, but not much).
As I said, Glantz is in good company in not understanding this. Well, I should say he is in a lot of company — the widespread failure to understand this among people who claim to be experts is not really forgivable. When someone refers to a placebo effect, without actually identifying what specific aspect of an intervention is being replaced with a placebo, it is yet another example of someone understanding just enough about how to do science to create confusion rather than knowledge.
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I wish you’d have mentioned there are reports that ”the exploding battery” was an unprotected non-rechargeable battery from Radio Shack. And you can’t ban roll your own cigarettes just because it very much looks like a marijuana joint.
Hmm… but what if Stan Glantz actually has a “Clap On, Cry Off” mechanism for his lights? Then every time he saw an Antismoking commercial on TV he would clap and his lights would come on. Every time he saw a character smoke on TV he would cry and his lights would go off. He’s not very bright unfortunately and if he sees a character with an e-cig he responds the same way. And, since he’s still very young mentally, he’s likely afraid of the dark, so when the lights would go off he would spend a lot of time crying, and thus spend even MORE time in the dark.
Sitting in a dark room surrounded by Vapers he keeps seeing these scary little red and blue and green and yellow lights going on and off and that makes him even MORE scared and then he has MORE crying and his lights stay off even LONGER!
Poor Stan… no WONDER he doesn’t like e-cigs!
this comment isn’t so much placebo-related but more to do with the concept of controlled trials and why they would still be useful for e-cigs in some contexts (despite the difficulties in conducting: cost, rapid changes in devices outpacing how quickly evidence can be gathered etc).
in the UK, a lot of stop smoking support is provided through the publicly funded healthcare system, NRT type products are subsidised (to the point of being completely free in Scotland).
in an ideal world, we would always want anybody who presents at a healthcare system and says ‘I would like to stop smoking, what can you offer?’ the best option, for as cheap as possible. in the future, the provider of the service could have options like e-cigs to choose from.
the planners of this service will want to know quite precise estimates of effectiveness, and the person who holds the budget will want to know precise estimates of cost-effectiveness. hence controlled trials of e-cig devices against what we currently consider appropriate to subside and provide (NRT) to gather this stuff is still useful, because no other type of evidence would be accepted (or, really, possible, to get such data).
I know there’s a big thing about e-cigs not being a medical ‘treatment’ (which is causing all the grief in Europe at the moment), however some people who could benefit from THR approaches will be more likely to use these kind of devices if the get the official stamp of approval to some extent as well – otherwise they’ll be reluctant to try.
Clinical trials are certainly more relevant to administered behavioral interventions than they are to what happens in the wild, so that helps, but only somewhat. It is those clinical trials that are the excuse for those clinics to offer worthless NRTs, after all. It is true that they would almost certainty find that e-cigarettes worked more often than current interventions, which theoretically would (if honestly interpreted) lead to e-cigarettes being recommended over the alternatives. But it would still not be possible to predict what would really happen very well — there would still be a Hawthorne effect.
The benefit would mostly take the form of science theater (or, rather, I suppose, theatre) rather than scientific information — doing something that pretends to be useful science, purely for the purpose of facilitating a political decision because it so happens that those who are in political power think that is what you need to do. Or maybe we could call that placebo science. From the real scientific perspective, it would still not be particularly informative.
a very droll way of putting it of course, however I don’t agree.
rather than being a big giant everybodyinwhitecoats type trial, a pragmatic trial with people already attending these type of clinics would be relatively easy, and they wouldn’t be receiving that much more attention than they would anyway (aside from agreeing to be involved involved in research of course, a Hawthorne effect, but you could assess how large that was from a matched sample of otherwise similar people attending the clinic not doing the trial). so you’d get a decent estimate of real world effect, in this setting.
also, just having lots of success stories is enough to assess that something works, but is not that useful in quantifying how well it works, or how well it works compared to something else, on the whole. I could go and collect a few thousand success stories about how people have used NRT and succeeded. I could also go out and gather stories of people who’ve tried e-cigs, gone off them, gone back to NRT instead and found success (yes, they do exist, including people I’ve suggested e-cigs to, but who decided they weren’t for them in the long run).
in that case which method is the one for a commissioner (or anybody) to recommend? the one with the most success stories? the one with the best-written ones? the most entertaining ones? obviously this is sillyness when we could just do a decent pragmatic trial and have the answer relatively quickly instead.
as quick addition, Carl, you probably know this, but others might be interested that a trial sort of like this is going on at the moment in NZ, according to an abstract from a recent conf pg 16
I think what you are proposing is basically “do exactly what it is we want to learn the effects of, and see what happens”. Now *that* is a good research method. As I said, and artificial trial tells us a bit about what would happen in the somewhat similar artificial clinical setting where someone in a white coat is telling people what they should do. Just running the clinic is better, obviously. Neither is very informative about what happens in the normal parts of the world, though.
The obsession with knowing how often something works seems to be primarily an obstacle construed by the ANTZ with no legitimate purpose. There is no conceivable way that recommending / allowing advertising of / etc. e-cigarettes would keep someone from quitting smoking. It does not crowd out any other option. So if it works, let it work. If you want to know how often it works under circumstances in which is promoted, promote it and see what happens. There worst case outcome is that “only” 1% of smokers switch to it (still making it more useful than NRT weaning).
Placebo blows a gasket when one with experience, beyond the myths and assumptions of non smokers or anti smokers, actually evaluates the situation. People who try e-cigs are not being tricked or treated for a medical condition by others. They choose consciously to compare one product with another, to see how the new product stacks up. Not unlike someone who simply tries a new cigarette brand, hoping to find something milder or smoother, to enhance their enjoyment. You can’t bring placebo into the discussion legitimately, unless you are talking about using a product such as the patches or nicotine candy which are unfamiliar to the user, because these products are completely different than smoking and involve completely different actions of administration. An unfamiliar product in comparison, could only succeed as a treatment; by a placebo effect or as legitimately effective, or a combination of the two, which result in an total quit rate that exceeds the normal success rates without them.
As we all well know, the patches and candy fail miserably, in totality of placebo effectsd and efficacy, they fail much more often than the rate of success without them. E-cigs are popular because they actually have a rate of success that exceeds the quit levels seen without them. Half of those who use them switch and half continue to smoke. All are still using a product that pleases them. Thus placebo effects are misplaced as a possible reason for their success. Only because people are making a conscious choice with full disclosures available. A choice between two products as a test of preferences, which does not require trickery or deceptions. No one is carrying a piece of candy around in their mouth all day, terrified to swallow, or selecting a new spot to place a patch, because the last two or three spots haven’t healed yet. Forcing themselves to endure things that are not pleasant only because they are determined to quit smoking, and believe they have no other choices. People who use e-cigs, chewing tobacco, or or snus for that matter are not medicating themselves. They are simply assessing apples to apples and making a choice by preferences, of which product they enjoy the most.
It is definitely true that it would be difficult to find a placebo-type substitute (where subjects do not realize something is missing) for the aesthetic and motion aspects of an e-cigarette. It is still possible to do it with the chemistry, though. And, of course, it is possible to compare e-cigarettes to some other intervention, it just that one could not pretend that the subjects were having similar experiences, as you say. That is all the more reason that Glantz’s knee-jerk jump to “placebo” is incredibly naive (or a calculated lie — still not sure).
NRTs in trials owe almost all of their success to the placebo and Hawthorne effects, which are not trivial — people in those trials (including those on the placebos) do become abstinent (for a while) at a much higher rate than smokers on average. But the effect is basically the same for the placebo. I agree that there is a huge difference between people making choices and being assigned a “therapy” by some authority figure. That is why I actually gave Glantz props for not demanding clinical trials, which are a lousy way to assess people’s real-life choices.
Carl, you wrote, “That is why I actually gave Glantz props for not demanding clinical trials, which are a lousy way to assess people’s real-life choices.”
They may be a lousy way, but they ARE widely accepted as the gold standard though, true? My guess is that the ONLY reason Glantz doesn’t demand the clinical trial route is that he probably strongly believes he would lose. So I give him no props at all on it — quite the reverse. If you deliberately abandon the scientific method in those instances where you think the science is likely to go against your wishes then you are NOT a scientist: you’re the antithesis of a scientist.
Well, in fairness to myself, I did allow the possibility that he said that because it served his purposes and not because he really understood. I specifically identified the possibility that he was trying to stall — because the observational study would take a long time. But you are right that another possibility is that he actually realizes — as the rest of us do — that the trials would not come out the way he wants. Perhaps he even knew that his proposed longitudinal study would be useless for the reasons I pointed out in the previous post, and was really constructing an even deeper lie. I still lean toward the theory that he does not know what he is talking about, though, if only because most people involved in epidemiologic studies do not understand epidemiology.
Picture telling a group of people that they are enrolled in a placebo trial to test a stop smoking device. keeping in mind all the promotions, of the highly addictive qualities of cigarettes and how difficult it will be to quit. Many in the group have attempted to quit in the past and are familiar with the experience, heightened by the hype the same way the somatic effect of second hand smoke intensified peoples awareness of the smoke, as a negative product in place of the neutral product that existed in the past. How many of those given a placebo would not realize they were receiving a placebo? True some would remain determined to quit and succeed regardless however the majority of this portion of the group, would simply walk away and smoke. The evidence that patches and candy doubles your chances of quitting compared to placebo was always corrupt and only a venue to great ads that tell people that these products double your chances of quitting however studies not funded by the manufacturers, remain almost entirely consistent revealing the success rates are well below the success rates, when you quit without them. meaning in my opinion these products actually do harm yet remain on the shelf as Medicine because of the deeply rooted payola effect of drug companies and their connections to medicine and dominance of research funding which leaves researchers with little choice but to temper their opinions, in connection to their primary income sources.
The use of nicotine is a very tricky subject in the vaping world. Part of the smoking simulation is what is called the “throat hit”. It is the very breif sensation at the back of the throat as a person inhales the vapour or smoke. The science behind throat hit is still obscure.
Some claim is it a chemical-tissue mechanism, while others claim it is the forcing of thick air (vapour or smoke containing nicotine) into tighter spaces (larynx and alveolar of the lungs).
Either way, the “throat hit” is an essential part of a successful vaping product. Thousands of youtube vaping reviews on electronic cigarettes and ejuices always, and I literally mean always, have a segment describing the throat hit quality of the reviewed product. The acroynym “V.T.F” is commonly reported on, standing for “Vapour volume”, “throat hit” and “Flavour”. See this picture for fake sendup of Vaping’s most popular reviewer : http://i.imgur.com/YVaqJ.jpg
Nicotine is very much the main contributer to throat hit. An ejuice with 0mg/ml of nicotine will produce absolutely no throat hit, and as result, could never be used as placebo control.
However, there are products on the market that have attempted to mimic the throat-hit provided by nicotine. For example, FlavourArt’s Flash. FlavourArt doesnt say what they use in this product, but it is suspected that they use Capsaicin, which is also believed to be the main component of another “throat hit simulator” called Diablo Loco made by Totally Wicked. These products come in 10 to 30ml quantities and only a few drops are needed to be added to a 10mL ejuice mix to reach the desired effect. Others have reported that you can use Pure Grain alcohol to achieve a simulated throat hit.
Reviews of all these products however have not been very positive, as they appear to be providing more of a chemical burn sensation rather than the very unique kind of throat hit that nicotine provides. They also affect the flavour of the vape, with some claiming they can taste the peppery-ness of the Capsaicin.
In my most honest opinion, I admit that I don’t actually know whether I am addicted to nicotine or the throat hit. The lack of a suitable placebo for a nicotine-vaping experiment limits me from answering this question. What I am certain of is that vaping doesn’t not work for me (and most vapers) unless there is a throat hit.
My prediction is that the first person to design (and patent) a suitable replacement molecule to produce a nicotine-like throat hit that can be dissolved in PG/VG, and does not affect the flavour of the vape, will become a very rich person in a very short time – not only because they may have stumbled upon what could be the Holy Grail of tobacco smoking cessation, but because their innovation would be one of the most useful placebo control tools for nicotine-inhalation related research.
A comparison exposure in an experiment does not necessarily need to be a perfect imitation of the exposure that is being tested, since subjects seldom use them side-by-side. However, it is true that you are testing the effect of everything that is different, that which you intended to be different and anything else that was unintentionally different as a result. So it would be a mistake (a common one!) to claim that any difference in response is definitely due to the one factor that was intentionally different and not those that were unintentional.
I’d be hesitant to play with either Capsaicin or Grain Alcohol as a substitute for nicotine. By itself nicotine is (in my nonmedical opinion at least) relatively harmless. It’s not a primary Class A Carcinogen (whereas ethyl alcohol “consumption” is) and I don’t think it’s a “tissue irritant” in the same way that Capsaicin is. We don’t know what decades of concentrated exposure by inhalation of either of these would mean. I’ll freely grant that I’d give odds that the alcohol was safer than regular tobacco smoke, but I wouldn’t be as sure about the Capsaicin. I wouldn’t give odds for either one being safer than nicotine though — at least in terms of lifelong use (short-term, as in switching to vaping as possibly successful quit-smoking alternative and then eventually giving up vaping as well, would be a different story.)
As noted, I don’t really know anything of any medical research for either one other than the Class A designation of alcohol (It should also be noted though that alcohol is thought to be a fairly *weak* carcinogen as such things go. It gets beefed up when combined with smoking, but on its own I don’t think it’s been shown to be that bad … probably on the order of using snus or somesuch. Carl, any ideas on that last thought?)
I don’t really have any intention to replace nicotine with another substance as I understand it’s safety, but I am eager to know with what my
dependence is on. I am aware of the known nootropic effects of nicotine, and it would be silly of me to disregard them. I would expect that if I were vaping “Chemical Y”, I would certainly feel it, in my concentration, my depression/mood, and motivation. However, I think the only way to be certain would be to test it.
Other than my own curiosity, I think the only reason I have interest in it is due to the politics surrounding nicotine.
In Australia, it is illegal to sell or even supply people with nicotine (unless you are a tobacco company or pharmeceutical company – and strangely enough, if you happen to be someone’s cat or dog). But it is not illegal to import nicotine.
Hence, Australian vapers must purchase nicotine from overseas, (often in bulk and at higher concentrations), which is then used to mix with flavourings purchased from Australian e-cig vendors. The overseas import of nicotine also raises the cost of vaping for Australians significantly, but we learn to organise our shipments to cut down on shipping fees.
There is regularly talk on the Australian vaping forums about the “Dooms Day” when the Australian Government will decide one day to begin intercepting nicotine imports.
In these discussions, people often raise ideas, such as stock piling large volumes of pure nicotine (which is fact dangerous if you have children and something that UK and US Vapers have the luxury of not having to do), extracting nicotine from tobacco leaf (which is in fact very dangerous – I try to avoid pure nicotine liquids).
But the discussions often lead to finding a suitable throat-hit replacement.
Bare with me, I do have a little trouble digesting this. :-)
So imagine an experiment using two electronic cigarettes.
One e-cig contains 20 mg/mL nicotine, 25% Glycerin, 75% Propylene Glycol (we’ll leave flavour out of this equation for now – although that is still a very important factor).
The other e-cig contains X mg/mL of chemical Y, 25% Glycerin, 75% Propylene Glycol.
Chemical Y is the yet to be discovered substance that provides a nicotine-like throat hit simulation.
X is the concentration that has been determined by reviewers to have the most similar throat hit simulation to 20mg/ml nicotine (I see a flaw with this specifically, but difficult to describe it)
The cartridges are identical, and are shuffled whilst blindfolded, and only one is handed to me.
I then vape this solution for a week, and determine whether I was able to to consistently vape – maybe measure the amount of liquid I went through, and note down certain experiences I had during vaping.
I then have my liquid tested to determine which solution I was in fact vaping. I do this for several weeks.
Could this experiment provide useful information as to whether I am dependent on nicotine, or to the sensation of throat hit?
Mav’s comment just gave me an idea. Given the superficial similarities between caffeine and nicotine, have they ever tried vaping with caffeine in the vapor? Is that possible?
It’s been tried. :-)
Caffiene is very hard to dissolve in Glycol or Glycerin. Those vendors who sell vaping liquids that supposedly give you a “kick” of caffeine actually have very little caffeine in their ejuices.
It’s dissapointing. It would have went lovely in my coffee flavoured vapes.
The trouble (or at least part of it) with attempting to use caffeine instead of nicotine is that it takes a much larger dose of caffeine to produce the desired psychostimulant effects and e-cigarettes use very small amounts of liquid. A single cup of regular black coffee may contain 200mg of caffeine which means that you’d have to use an entire 1ml cartridge with 20% caffeine to consume the same amount. Not only would it be rather difficult to use an entire cartridge in the same amount of time someone can drink a cup of joe, a 20% solution would probably taste terrible.
Thanks for the informative responses regarding the caffeine idea! Sounds like it’s a no-go. :> I’ve never been a caffeine fan myself in any event. I may be a low down chocoholic, but I don’t do coffee, and probably average about a six-pack of cola per month.
Well, the researchers would label you “noncompliant” (for shame! :-), which is an infantalizing term borrowed from medicine to describe people who make their own decisions rather than obeying, because you did that research rather than following the rules of their experiment. But to answer your real question, assuming the non-nicotine e-cigarette was a perfect mimic, then this would tell us whether nicotine really mattered to you or not. If you did not resume smoking or otherwise seek nicotine while using placebo nicotine (i.e., no nicotine) it would suggest that the nicotine did not matter much to you.
That would leave open several possibilities: the throat hit mattered; other aspects of e-cigarette use mattered; or you would have been just fine using nothing at all. We would not know for sure that the throat hit was the key to the experience (unless you told us, of course!). The “nothing at all” possibility is what Glantz believes to be true — or probably more likely, is pretending to believe in order to support his political position.
By the way, the better protocol in terms of testing the placebo effect, if it were allowed, would be to not do that randomization in front of you, but to actually tell you that you were getting a nicotine solution even though you were not. That would distinguish between the biological effect of nicotine and you just thinking that you desire nicotine.
“We would not know for sure that the throat hit was the key to the experience”
Could this be tested by adding a third vaping solution to the experiment? ; i.e an ejuice containing zero nicotine, which provides absolutely no throat hit at all. Even if you were to tell me that there is nicotine in the juice – I would certainly know that it didn’t, and prefer not to vape it.
As I replied to MJM, I am aware of the known nootropic effects of nicotine, and it would be silly of me to disregard them. I would expect that if I were vaping “Chemical Y”, I would certainly feel it, in my concentration, my depression/mood, and motivation. However, I think the only way to be certain would be to test it.
Glantz’s view on this, as well as the garbage that is spewed from the Allan Carr Institute which claims that I’m not really dependent on nicotine, but that it is some kind of an “illusion”, is simply something I cannot accept. I’m happy to partake in an experiment to see for certain, but I strongly doubt that my use of nicotine is some kind of mental misconception. Politically, as a Libertarian, I tell both Glantz and the Allan Carr Institute to simply get lost and leave me alone.
Thank You for this discussion. And thank You for the work you do. If you don’t mind, after more comments by your readers are posted, I might summarise/link this article and the comments and begin a discussion on the topic on the Aussie Vaping forum. There are many people there that like to discuss these kinds of topics specifically.
To be clearer, I meant that the third vaping solution added to the experiment would be one with neither nicotine, nor the throat-hit simulating substance. This would provide no throat hit and determine whether thraot hit was a factor.
You are welcome, and yes, please do publicize this. As you can see, there are now three posts and >30 comments in this little series.
Yes, you could definitely do a trial with the additional option. You would probably end up with four (2×2) not three: with and without nicotine x with and without throat hit.
But that (and what you go on to write) brings up the complexities of the “placebo” question again. If it does not seem to matter whether there is nicotine, then this is pretty good evidence that you only think nicotine is driving you (and I agree that this is very unlikely for all but a few people). But if the throat hit seems to matter, it might be that it is deeply existentially important to you, or it just might be that you think it matters a lot (but, say, could learn to be happy without it in just a few days if you tried) but you cannot help but notice it. That is, it is hard to really do the placebo comparison if it is obvious to you whether you are getting the real thing or not (in the jargon, when the study is not blinded as to which arm you are in).
That is the same reason that it would not be possible to do a placebo test for the motion/action side of using an e-cigarette. Indeed, since the effects are based on immediate self-observable sensation, it arguably makes no sense to even speak of a placebo. I believe that Michael Siegel, when writing about this, made the point that the you could call that entire effect a placebo if you wanted, but it would still be what it was and it would still work.
So to summarize, yes you can definitely design a trial that adds or removes any particular part of the exposure. But if that is part of the user-observed experience, it makes little sense to distinguish “really likes it” from “thinks he likes it”.
So in essence, the experiment being suggested, using the 4 different vaping solutions, is more of a test for the need for nicotine (and therefore a side issue to this article’s topic), and that the experiment I’m suggesting is not really testing “electronic cigarettes” per se.
To paraphrase your comment (hopefully correctly), it’s impossible to have a placebo control for “electronic cigarette use”. If you’re not picking up an actual physical device, placing it your mouth, sucking in air, and blowing air out, then this would immediately be aware to the subject, in a similar way to myself immediately being made aware of the difference if a vaping solution didn’t provide a throat hit in the hypothetical nicotine/throat hit experiment.
As Siegel pointed out, “what Stan is calling a “placebo effect” would be the mechanism by which smokers are quitting using electronic cigarettes”.
In other words, whatever the situation, no matter whether nicotine is part of the equation or not (that’s a another topic all together), the fact remains that, the “use of electronic cigarettes” are keeping people away from tobacco smoking.
If I’ve got this right, then as far as I can see, Glantz’s entire comment on electronic cigarettes would have to be the most rediculous thing I’ve ever read.
Individual testimonies certainly has to be one of the the most important factors in this debate.
Yes, I believe Siegel’s point is basically that it makes no sense to even discuss whether this is a placebo effect because there is really no room for such a distinction. I totally agree.
The funny thing is that 90% of medicine works this way: We are not quite sure exactly why this treatment works while a variation one that seems like it should work does not. But it does work, so we will just do it. The ANTZ want to disallow that, though, because they only want people to quit “their way” (which seems to mean, in particular, to not be happy about it).
I just now saw this ;
Glantz is taking advantage of the “Tobacco Product” vs “Medical Product” debate, and using his false reasoning to get them banned. What are the chances that the FDA will accept his lie?
I’ll reference the following forum post for the background to the “Tobacco product – medical product” debate that is dividing the e-cig manufacturing industry (in case some readers are not aware of it)
Actually, there may be some re-inventing of the wheel going on here. The nic-lowering/removal experiments have already been pretty widely done in the field with regular cigarettes and I believe the upshot was that smokers either don’t accept the brands or end up smoking more or more intensely for the nicotine. I believe also that the tobacco companies did a fair amount of research on what we’re calling “throat hit” back during the time when they were first introducing True, Carlton, and Merit. The early Trues had very little “sensation” of smoke and most smokers didn’t care for them. Later Trues and the newer Merit both had much “harsher” smoke that gave more of that sensation — I believe in an attempt to deliver the “throat hit” while still being able to be lower in tar and nicotine.
For those old enough to remember the scent of cigarettes back in the 60s/70s, it was quite different than what you’ll usually smell today with many filter brands, and I believe it was less offensive to most nonsmokers. The change in scent seemed to parallel the TC’s attempts to make milder cigarettes “taste” more like stronger ones (i.e. deliver more of the “throat hit” sensation).
And of course, over the years you’ve also had things like totally de-nicotinized tobacco and even lettuce-leaf cigarettes.
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Whether the the ‘fact’ that people find it easier to stop smoking using ecigs be due to a placebo effect (no matter how misused the word is) or as a result of the nicotine inhaled, ought to be good news for Public Health. If people stop smoking, they stop smoking, which is the aim of Public Health.
But an important points is: “Is smoking cessation the aim of the Tobacco Control Industry?” The answer to that question is not a definite “Yes”. One of the reasons for saying that is that we often read Advocates claiming that ecigs ‘have not been proven to be safe’. But in what sense is the word ‘safe’ being used? It seems that they often mean ‘in a mechanical sense’ (witness the quoting of the instance where the chap <may have used the wrong type of battery). If that is the reason, then, surely, the mechanical unsafety is not a matter for Public Health. If the unsafety concerns the vapours, then, surely, the burden of proof should lie with those who say that ecigs are or may be unsafe. For example, ecigs have been in use for some years now. Has there ever been a case of physically harm reported by doctors or hospitals? If there are harmful by-products of the warming and breathing of the warmed liquids vapours, what are they and what is the dosage and what is the likelihood of harm from long term use? Merely claiming that there MAY POSSIBLY be harm sometime in the future is not sufficient for banning ecigs, and that is the reason that the EU Tobacco Control Directive is iniquitous.
But vapers should not think that reasoned arguments will prevail. They will not. It is likely that the Zealots will find a way to get the production of e-liquids outlawed.
Nicely put. I agree that those arguments will not prevail with the ANTZ (and thus not the CTP). I think they do work fairly well as soon as normal people are involved in the discussion, however. Look for my post on that theme soon.
“One of the reasons for saying that is that we often read Advocates claiming that ecigs ‘have not been proven to be safe’.”
Which brings up an interesting question: Is such a standard generally applied elsewhere? E.G. If I come up with a new “thing” out there (sorry, having a hard time coming up with some decently analogous examples) that might make some activity safer and that a good number of reasonable and responsible people would argue was quite likely to be MUCH safer … does it have to be *proven* to be “absolutely safe” before it is approved for the market? And how can anything be “proven to be absolutely safe” without a huge amount of experiential/epidemiological evidence that can only be gathered through millions of people using the thing over a period of decades or even generations?
Then there’s also the question of defining “safer” in terms of being safe for the user vs. being safe for the population. Adding a mild poison to all alcoholic beverages that killed one person out of a thousand wouldn’t ordinarily be thought of as making them “safer,” but what if the poison tasted like dead monkey’s turds so everyone stopped drinking? The end result would be fewer “alcohol-related deaths” and so it could be argued that it’s added to safety. Or what if something was developed that made alcoholic drinks taste better, thereby leading more people to drink and rot their livers, but at the same time reduced the effects that caused people to have accidents while driving drunk?
That last example may be more in lines with how the Antismokers are treating e-cigs: they’re afraid that e-cigs will result in people engaging in a very mildly “unsafe behavior” while without e-cigs they engage in no such analogous behavior at all. Of course that sort of thinking stems from their fanatical belief that they can actually “eliminate” smoking or bring it down to a level of just a few percentage points in the population. I think most Free Choice activists would argue that such a thing is unlikely to happen.
What should be questioned is a government’s right to intervene with a ban in place of a sign, and if such a right exists within their authority, how they justify the selectivity of those “safety” interventions restricting them to what serves the political agenda of the day. Every day we hear about someone burning down their own house with a torch while repairing the plumbing or slicing their wrists with a razor blade. Safety resides in the hands of the user and people are still deemed trust worthy enough [so far] to use these products and suffer the consequences of their own actions. Within the regime of safety could you prove a car [OMG it’s got a Hemi !!!] or even a bicycle was safe?
Although you can still sue McDonald’s if your coffee is too hot. Yet no concern from the nanny state in the first example, because they have not been shown how to serve their budgetary concerns, by attacking the consumer home renovation business. Although taxing of fast foods is well seeded in the scientific puppy mill, as an excellent hopeful for stealing other people’s money.
The undermining of personal autonomy [treating us all as defenseless children] with controls in the form of terrorist interventions, with an intent, to form divided communities deliberately, is only just, more repugnant, than the theft of property rights, by an entirely under-discussed redefinition of “Public spaces” tucked into the fine print of every smoking ban, which most of the majority screaming for comfort, have yet to realize. Just as the seat-belt imposed a right [Duty?] of government bureaucracies to reign supreme over personal judgements and choices in eliminating trust of our own self defense. “Public Spaces” could well be the ticket to the eventual elimination of property rights and surely will serve as an excuse, for illegal search and seizures in the collection of evidence, in a criminal trial at some point in the immediate future. If you have nothing to hide?…, will be the reasoning, however personal rights are your only defense [not against each other] against governments, which if you have any concept of where this is all going, these moves pretty well make any constitutional document, about as valuable as the paper it is written on. Especially now that PDF documents and green [the color of money] movements are replacing even that.
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I came across this article recently and felt anyone else who had not read this, really should.
In regards to Glanz’s preferred Gold Standard choice of evaluation weapons, [at least when it suits his banter] the explanation of how to achieve deliberately corrupted results below the radar, is quite well explained. Along with many other sources of fables and scientific misconduct we have seen played out, for far too many years.
Always for the money.
Kevin, thanks for the comment. I agree that there are lots of ways to intentionally corrupt epidemiology — indeed, that is what much of my scientific work has focused on — and that Glantz and other ANTZ are particularly bad about that. (Hey! “Stanton Glantz hates science”) The problem with essays like the one you post (and there are a lot of them out there, in many forums) is that the authors do not quite understand how epidemiology works when it works correctly, and so their criticisms are about half right and half wrong.
One common misunderstanding is that there is any gold standard for evaluating the effects of behavioral exposures. About the closest we have to that are “natural experiments”, when one population just does not do something, for some reason that is mostly unrelated to their health (e.g., the cultural appreciation of snus in Sweden). Clinical intervention trials are a reasonably gold-ish standard for measuring the effects of clinical interventions (though still far from gold, as I have noted earlier in this series). Individual testimonials are gold evidence that an intervention sometimes works, but cannot measure how often.
My understanding of epidemiologist is that; it is an attempt to find a two dimensional spot within a multidimensional space. Logic suggests that we should miss that mark far more often than we hit it. “The science is settled” crowd are outrageous and fraudulent, when attaching politics to science, within such a narrow tract of understanding. What is inexcusable is the sight of so many within the scientific and Public Health Community standing silent while the public is being deceived and driven by artificial fears.
These are the dark days of science and movement forward, in search of legitimate cures for diseases, beyond the cult activities of treating us all as a disease, will only happen after the frauds and lies are revealed.
Leaving us what? And trusting whom?
I have long taken the position that epidemiology currently fails as a science because people in the field (excepting a few of us, of course, but not all that many) do not engage in any self-policing. That is, they do not bother to respond to those who are turning the science to junk by misusing it for political ends. There really is no longer much of a public health community — they have been crowded out by the “public health” community, people who have misappropriated that term but who cannot be said to really be pursuing it.
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