1. The Anti-Tobacco Activists Know that their Ulterior Motives are Flawed, and so they take advantage of a Complex Debate
Prof Stan Glantz and several of his colleagues submitted a public comment to the FDA docket regarding a “Report to Congress on Innovative Products and Treatments for Tobacco Dependence". Glantz and his colleagues made note of the fact that electronic cigarettes were successfully ruled by The US Courts in 2010 to be excluded from FDA regulations, and regulated as "tobacco products" specifically because electronic cigarettes were not being marketed with therapeutic claims.
However, companies such as Sottera (owner of NJOY), and SFATA (an ecig trade association founded by V2cigs), are claiming that their products are "treatments for nicotine dependence". This was criticised by TVECA, another ecig trade association that wishes to keep electronic cigarettes classified as tobacco products. Glantz argues that if electronic cigarette companies are marketing their products with therapeutic claims, the FDA should regulate electronic cigarettes as drug devices under the Food Drug and Cosmetic Act. Glantz also believes the FDA should restrict consumer advocate associations from making such claims, essentially aiming to stifle free political speech.
This is a very deceitful and insidious move by Glantz in attempt to restrict public access to knowledge about the usefulness of electronic cigarettes.
For decades, anti-tobacco activists and Governments have worked hard and spent a lot of money on social engineering, attempting to de-normalize the activity of tobacco smoking. Glantz's number one dilemma with electronic cigarettes, as has been argued by many anti-tobacco activists and the World Health Organization, is that the mere appearance of electronic cigarette usage looks likes tobacco smoking. Electronic cigarette usage, despite an overwhelming number of individual testimonies claiming that it has been beneficial in smoking cessation, is therefore perceived by the anti-tobacco activists to be a severe threat to their efforts to de-normalize tobacco smoking. Anti-tobacco activists, when arguing this point, often attempt to persuade public opinion by using emotional claims regarding the persuasion of children to use electronic cigarettes, at which they ultimately lead to their "gateway to tobacco smoking" fallacy.
This argument by anti-tobacco activists is nothing less than absurd. As Michael Ryan, co-director of E-Lites, pointed out in a recent interview whilst holding up a glass of water;
"if somebody sees me drinking a glass of water, does that mean they're going to go out and drink a glass of vodka because it looks like it?"
The reality is that electronic cigarette use does not normalize tobacco smoking. It normalizes electronic cigarette use.
Glantz understands that his main argument against electronic cigarettes is flawed, and hence has no real foundation to argue against electronic cigarette use. So instead, Glantz is taking advantage of the internal dispute within the electronic cigarette industry over whether electronic cigarettes should be classified as medical devices or tobacco products. He is seeking to use this unresolved debate to his advantage in hindering the spread of public knowledge of electronic cigarettes as a safe and effective alternative to tobacco smoking, and prevent further growth of the industry and public consumption.
If electronic cigarettes are classified as medical devices, then, as Glantz claims, they will have to undergo extensive longitudinal studies. It was speculated by Prof Carl Phillips that possibly;
"Glantz’s real motive is that a longitudinal study would take much longer than clinical trials, and he just wants to stall"
Glantz also makes the outrageous claim that due to the overwhelming individual submissions to the FDA by electronic cigarette users about their use of the devices for smoking cessation, the companies that sold them their products, and political associations that aided their use, are engaging in false advertisement - that the publication of personal testimonies on successful smoking cessation by electronic cigarettes is not free political speech - it is commercial speech which can be regulated.
Glantz has essentially argued that the electronic cigarette users who have submitted their personal testimonies to the FDA, are merely pawns of the electronic cigarette industry and consumer advocate associations, brainwashed into falsely believing that the products they use are of benefit to their health.
If electronic cigarettes are classified as tobacco products, then they could be subject to strict regulations, including the banning of nicotine liquids (loose juice) and on-line sales, which would have a devastating impact of the industry. Companies that primarily sell via retail stores and sell only prefilled, non-refillable cartomizers wont be affected to the same extent. It should be noted that most of the companies that TVECA represent are companies that would not be affected by strict restrictions of the Tobacco regulations.
Either way, Glantz seeks to benefit by preserving his ideology that the only way to cease tobacco smoking is to use Nicotine Replacement Therapies (NRTs) or quit cold turkey - a very false and dangerous perception of the tobacco smoking epidemic.
2. There is no useful "Placebo" for Electronic Cigarettes
If one were to look closely at Glantz's reasoning that there is no scientific evidence that electronic cigarettes aid in smoking cessation, they would see that his grasp of science is indeed tenuous.
This week Glantz came under heavy criticism by two prominent pro-Tobacco Harm Reduction Public Health Professors, Micheal Siegel and Carl V Phillips, when he publicly announced that he believes that individual testimonies by electronic cigarette users are not evidence of electronic cigarettes as useful in smoking cessation. He has also begun censoring commentary from his university blog by individuals who contradict his arguments with their personal accounts on how electronic cigarettes have aided them in tobacco smoking cessation.
In his distorted reasoning Glantz references the "Placebo effect", indicating that since no studies have been conducted to test whether electronic cigarettes are more effective than the apparent 'placebo control' of the electronic cigarette, then there is no evidence yet that electronic cigarettes do work as smoking cessation aids.
Glantz then continued ;
"If and when there are high quality longitudinal studies showing that e-cigarettes as actually used actually help people quit smoking conventional cigarettes, I will modify my opinions on e-cigarettes as cessation aids"This comment clearly demonstrates Glantz's lack of understanding about electronic cigarettes in aiding smoking cessation, and quite possibly science in general. Professors Phillips and Siegel wrote extensively on Glantz's referencing of a placebo control for testing electronic cigarette effectiveness.
Phillips wrote ;
"...while [clinical studies] are great for studying people’s biology under fairly simple circumstances (e.g., for assessing most disease treatment options), they are generally quite poor for studying anything else, like behavior. Something like smoking cessation involves the effects of countless complicated real-world factors that are absent from an artificial clinical setting"Phillips also makes note of what a placebo actually is, and explains the Hawthorn effect ;
"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..."
"..In clinical studies where some subjects are just given a sugar pill, 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."Phillips also makes note that the Hawthorn effect would have most likely affected clinical studies of NRT products ;
"in the real clinical studies, extra cessation ... 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."and noted that ;
"both placebo and Hawthorne effects are much more likely when the outcome of interest is decision-based rather than biological"Phillip's also points out that Glantz was most likely confusing the placebo effect with the Hawthorn effect, and was claiming that electronic cigarette use in aid of smoking cessation was being subject to the same false postives as is thought to occur in NRT clincal trials.
Nevertheless, as Phillips mentions, that in NRT trials, people do become abstinent for a finite time at a much higher rate than smokers on average. But the effect is basically the same for those people on the NRT placebo.
And here lies the major difference between clinical testing of NRTs and Electronic cigarettes. Since NRTs are a chemical treatment, testing whether a particular drug being admistered affects a particular behaviour, the subject being tested can be given a treatment that did not contain the subtance (i.e a placebo).
With electronic cigarettes, you cannot administer a placebo control.
Electronic cigarette usage is far more complex than the administration of a drug. Electronic cigarette usage is behavioural and involves multiple factors such as the placing of a physical object in the mouth, the inhalation and exhaltion of visible gas, the sensation of warm air in the mouth, the sensation of a throat hit, taste, smell, and obviously arm and hand movements. You cannot provide a fake alternative to test the effectiveness of this activity in smoking cessation.
In essence, the subjects cannot be tricked in the same manner that they can in an NRT trial.
3. Electronic cigarette use involves a number of factors, each as essential as each other
Of course, nicotine is a major aspect of electronic cigarette use, however, what most anti-tobacco/anti-ecig activists appear to be completely unaware of, is that apart from it's stimulative effects, nicotine contributes to another major and essential aspect of electronic cigarette use.
Part of the smoking simulation is what is called the “throat hit”. It is the very brief sensation at the back of the throat as a person inhales the vapor or smoke. The science behind throat hit is still obscure. It may be caused by the sensation of the nicotine chemical reacting with the tissue lining of the Pharynx (back of the throat). Alternatively, it may be caused by the forcing of vaporised nicotine molecules into tighter spaces of the lower respiratory track (larynx and Trachea). In either case, the “throat hit” is an essential and critical aspect of a successful electronic cigarette product.
Nicotine is very much the main contributer to throat hit. An e-juice containing zero milligrams of nicotine will produce absolutely no throat hit. As as a result, an electronic cigarette e-juice containing a zero nicotine could never be used as placebo control in a clinical setting.
There are, however, products on the market that have attempted to mimic the throat-hit provided by nicotine. These include FlavourArt’s Flash, Totally Wicked' Diablo Loco, and Hangsen's Throat Hit E Liquid. It is suspected that these products use Capsaicin (chemical responsible for Chili spiciness) as their main component. Some electronic cigarette users have reported that Pure Grain alcohol can also be used to achieve a simulated nicotine-like 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 flavor of the vapor, with some users claiming they can taste the peppery-ness of the Capsaicin.
Hence, as of yet, no suitable placebo exists to test whether nicotine has to be an essential part of electronic cigarette use. If a suitable throat hit replacement were to be designed or discovered, the stimulant effects of nicotine consumed via electronic cigarettes could be tested in double blind placebo controlled experiments. As of now, since only nicotine can provide the desired throat hit that electronic cigarette users desire, nicotine is therefore essential to electronic cigarette use.
The topic of nicotine alone is beside the point of this particular discussion, and in any case, the anti-tobacco/anti-ecig activist's real problem with electronic cigarettes use is the appearance of it, rather than the substance being consumed.
What's actually being questioned here is the evidence for electronic cigarette usage as a whole, as being effective in smoking cessation. As noted previously, electronic cigarette use involves a number of factors. Each factor is as essential as each other to making what is essentially electronic cigarette use. Factors such as flavor, cloudiness of the vapor exhaled, temperature of the vapor, as well as nicotine concentration, all make up what is essentially electronic cigarette use.
Most importantly, each factor's involvement varies depending on the product and/or user self-set ups. Even the color of the electronic cigarette device can be considered an essential part of the use. In other words, Personal Customization is vital for electronic cigarettes to work, which is why it is critical that products such as liquids containing various levels of nicotine (aka "loose juice"), various flavorings, various refillable cartridge types, and various battery types must remain available to consumers.
4. What is Currently being Tested?
This post is not to make light of what clinical studies could provide. As one of Phillips' responders (Rory Morrison) wrote;
"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, ..... which method is the one for a commissioner...to recommend? the one with the most success stories? the one with the best-written ones? the most entertaining ones?"
Further, as Siegel noted ;
"Obviously, we also need clinical studies that document the cessation rates and the amount of smoking reduction achieved with electronic cigarettes. But to deny that the case reports are part of the overall scientific evidence is to ignore the science"
Indeed, a clinical study (pg16) funded by Health Research Council of New Zealand is being conducted on electronic cigarettes. In this study, 653 Participants are being tested, whereby 290 participants will use electronic cigarettes containing 16mg/ml cartridges, 290 participants will use 21mg nicotine Patches, and 73 will use electronic cigarettes with cartridges containing 0mg nicotine, all over a 12 week period. The participants will be using electronic cigarette devices and cartridges provided by PGM International Ltd, which means they are most certainly using the Elusion 510 model.
Participants included in this study are smokers of 10 or more cigarettes per day, and who have been smoking for longer than one year. They are people over the age of 18 and who want to quit smoking. The primary test for smoking cessation of the participants will be by the measuring of carbon monoxide level exhaled, which is a marker for evaluating smoking abstinence. However, as a secondary measurement, self reports of continuous abstinence at 1, 3 and 6 months after quit day will be recorded.
This secondary measurement of electronic cigarette usage is interesting. In criticism of Glantz's claim that personal testimonies of successful smoking cessation with electronic cigarettes are not scientific evidence, Siegel writes ;
"While case reports are obviously not the highest standard of scientific evidence, they are undeniably a valid form of scientific evidence. In the case of electronic cigarettes, the fact that millions of vapers are using these products with success is undoubtedly a valid piece of scientific evidence that these products are useful as alternatives to smoking"
Is this study actually a good test for electronic cigarette efficacy in smoking cessation? It is probably not the kind of study that tests electronic cigarettes to their full potential as most electronic cigarette enthusiasts would explain. The key challenges listed in this study include frequent battery failure and participant withdrawal from the trial. Most electronic cigarette enthusiasts would suspect that these challenges are due to the quality design of PGM's Elusion e-cigarette device. It might be speculated that perhaps the withdrawal of participants from the trial could be due to insufficient knowledge about electronic cigarettes, media publications falsely exaggerating the dangers of electronic cigarettes based on unpublished non-peer reviewed studies, and even a dislike of the electronic cigarette flavoring, battery charge time, and throat hit sensation - particularly in the sample of participants using the 0mg cartridges.
Understandably, in order keep all samples consistent for testing purposes, Personal Customization of the electronic cigarettes is not part of this study, so as mentioned above, essential aspects of electronic cigarette use are not being properly tested.
However, it is a start. This is the only electronic cigarette efficacy trial to be embarked upon to date. By early September 2012, more than 50% of
participants had been randomized. Prior to this study, there had been one published pilot study showing that 54% of smokers were able to quit smoking or to cut down their smoking by more than half. This is contrary to Glantz's claim that "such studies simply do not exist".
5. The False Dichotomy
The whole topic of 'evidence for the efficacy of electronic cigarettes as a smoking cessation aid' is clearly obscure. As noted in a previous forum post, aside from studies that show the electronic cigarette vapor contains only minuscule amounts of toxins, and a few important medical studies on a small sample number of patients showing that electronic cigarettes are significantly safer than tobacco cigarettes, individual testimonies are perhaps the strongest evidence we have.
However, some may question the need for electronic cigarettes to be proven as smoking cessation aids in the first place. They may also ask why the devices and nicotine containing liquids can't simply be regulated as their own form of recreation product, just as caffeine or alcohol is.
There really is no need for electronic cigarettes and nicotine liquids to be classified as either a tobacco or medical product. This is a false dichotomy constructed by the anti-tobacco groups, and those who seek to profit by falsely labeling the behavior of tobacco smoking as a disease in and as itself.
As Carl Phillips notes;
Smoking causes disease, of course, but it is obviously a consumer behavior, not a disease.
Pharmaceutical NRT producers, particularly, profit from this, both with the sale of their cure for this disease, as well as by politically hindering the growth of their market competitors; the electronic cigarette industry.
There is really no need for electronic cigarettes to be proved as smoking cessation product. Smoking cessation is actually a product of electronic cigarette usage. Only in the false conception that tobacco smoking is a disease, does the electronic cigarette's smoking cessation property become a therapeutic device, and therefore subject to regulations imposed on therapeutics.
Perhaps it's not the numerous absurd and trivial arguments spouted by the anti-tobacco/anti-ecig activists that we should be focusing on, but the underlying cultural propaganda on which they survive. Their entire approach to solving the tobacco smoking epidemic is founded on a misconception, a lie, and it is this foundation that should be attacked, rather than the trivial arrows they keep firing at us.