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E-cigarettes: The growing popularity of an unregulated drug delivery device

This post is not about vaccines (for a change).

However, I deem it appropriate to mention that one of the topics that I blog most frequently about is vaccines and how the antivaccine movement pushes pseudoscience and quackery based on its apparently implacable hatred of vaccines. (You’ll see why very shortly.) It seems almost as long as my interest in the topic since I first noticed that the antivaccine movement acquired its very own celebrity spokesperson in Jenny McCarthy, who at least since 2007 has been promoting outrageous quackery and pseudoscience associated with her antivaccine views. To her, vaccines are chock full of “toxins” and all sorts of evil humors that will turn your child autistic in a heartbeat and in general “steal” your “real” child away from you the way she thinks vaccines “stole” her son Evan away from her. Indeed, among other “achievements,” she’s written multiple books about autism in which vaccines feature prominently as a cause, led a march on Washington to “green our vaccines” and has been the president of the antivaccine group Generation Rescue for the last few years. None of this stopped ABC from foolishly hiring her to join the regular cast on The View beginning in a few short weeks.

Because I occasionally check on what Jenny McCarthy is up to, I noticed a couple of weeks ago that she had been hired to be a celebrity spokesperson for blu™ e-cigarettes. Here she is, hawking the blu™ Starter Pack:

Particularly odd to me is how the ad has Jenny McCarthy hawking blu™ e-cigarettes as a “sexy” way to smoke. She points out dramatically that, now that she is single, being a smoker is a big problem because, apparently, smoking itself is a big turnoff to a lot of men and she hates interrupting dates to have to go outside to catch a smoke. If you believe the commercial, blu™ e-cigarettes have completely revitalized Jenny McCarthy’s love life, apparently in the wake of her breakup with Jim Carrey a couple of years ago. Oddly enough, I didn’t see any mention of blu™ cigarettes as what I had frequently been told that e-cigarettes are meant for: To help a smoker quit smoking through nicotine replacement plus the behavioral queues of smoking. No, this ad portrayed e-cigs strictly as a “safer” and less offensive way to smoke. Like Matt Carey, I also could not escape the irony of the woman who rails against “toxins” in vaccines and described her struggles trying to stop smoking when she was pregnant now shilling for a device designed to be used to inhale a toxic substance (nicotine) into one’s lungs. On the other hand, she has in the past raved about how she absolutely “loves” Botox; so maybe it’s not so difficult to understand.

Jenny McCarthy’s decision to shill for an e-cigarette company “inspired” me to think that now is a good time to do a post on the evidence base behind e-cigarettes. After all, it’s been three and a half years since the topic has been covered here on SBM, last time by Steve Novella. In particular, I thought it a good time because I have been bombarded with huge amounts of e-cigarette spam e-mail lately. I’ve also noticed that a certain organization that represents itself as defending the public against health scares by countering them with science, namely the American Council on Science and Health (ACSH), is very high on e-cigarettes, even going so far as to praise Jenny McCarthy for being on the right side of science for a change. A quick search of the ACSH website for e-cigarettes reveals hundreds of posts about them, all uniformly either praising e-cigarettes as the greatest thing since sliced bread for “safer smoking,” harm reduction, and as an aid to smoking cessation or chastising anyone that has anything bad to say about them or any government entity that seeks to ban or tightly regulate them. Indeed, Gilbert Ross, MD, the executive and medical director at the ACSH, has even written posts for Forbes in which he accuses regulators who would restrict or ban e-cigarettes as being out to kill American smokers, a message echoed on the ACSH’s own website, in which apparently European Union regulators share the same homicidal urges towards European smokers that American regulators apparently exhibit towards theirs.

Rhetoric like what I saw in the articles to which I linked above tend to raise a huge red flag to me warning me that someone is laying down heapin’ helpin’s of grade-A BS. However, I don’t know for sure that that’s the case; it might not be. Maybe ACSH is right. On e-cigarettes, I have been and remain agnostic. After all, it’s not implausible to speculate that e-cigarettes might be a useful strategy to assist smokers in quitting as just another nicotine delivery system, nor is it implausible that they could be a safer means of “smoking” than cigarettes. On the other hand, let’s face it. E-cigarettes are, without a doubt, drug delivery devices designed to administer nicotine in a vapor, virtually identical in concept to nicotine inhalers already used for smoking cessation, but smaller and looking very much like cigarettes, making them more convenient and socially acceptable for use outside of the home. Yet, as of this writing nicotine inhalers are regulated by the FDA as a drug/device combination, while e-cigarettes are not. As a result, I view e-cigarettes as being in the same category as supplements. They are unregulated, and proponents make specific health claims for them, primarily (1) that they are safer than cigarettes and (2) that they are effective smoking cessation tools. This leads to the only question that matters to me in a health issue like this: What does the science show? The disappointing answer: Not a lot one way or the other.

E-cigarette facts and history

The effects of tobacco smoking result in enormous morbidity and mortality, through the various cancers caused by smoking, most prominently lung cancer, as well as chronic obstructive pulmonary disease (COPD), and cardiovascular disease resulting in heart attacks, limb loss, and strokes. Consequently, reducing harm from tobacco is a major public health challenge, and smoking cessation would result in an enormous decline in premature death and disability. Indeed, if smoking prevalence were reduced to zero, lung cancer, heart disease, and COPD prevalence would plummet. Various nicotine-delivery systems, such as nicotine patches and nicotine inhalers, have proven to be useful aids to smoking cessation.

E-cigarettes are the most common variant of a class of medical devices known as electronic nicotine delivery systems (ENDS), whose purpose is to vaporize nicotine, along with other substances used to affect the vapor consistency and flavor, and deliver it to the lungs of the user. Indeed, quite a bit of effort goes into making the vapor look like smoke, as can be seen in the video above. Each device typically consists of a tube made of plastic or other material in which there are housed a rechargeable battery, electronic controls, and an electronic vaporization system. Cartridges containing the liquid mixture to be vaporized are attached to the tube, and puffing on the e-cigarette results in the production of vapor, which is inhaled. Frequently, there is a light at the end of the tube that lights up when a puff is taken to simulate the lit end of a cigarette. One notes from Jenny McCarthy’s commercial that in the case of blu™ e-cigarettes this light is blue, for reasons that escape me.

Although Herbert Gilbert invented a device similar to what we know as electronic cigarettes in 1963, it was never marketed, and the first generation of e-cigarettes as we know them today was developed by a Chinese pharmacist, Hon Lik, in 2003 and patented soon thereafter. They were first introduced into the Chinese market in 2004 and reached the international market by 2006. It didn’t take long for a variety of manufacturers to start making them and promoting them as a “healthy alternative” to smoking or as an aid to smoking cessation. In a relatively short period of time, selling e-cigarettes has become big business; it’s been estimated that e-cigarette sales could reach $1.7 billion this year. That’s still a fraction of the $80 billion a year tobacco industry, but it’s a rapidly growing one. Moreover, many e-cigarette companies are owned by tobacco companies, something the ACSH applauds; for example, blu™ is owned by Lorillard.

According to e-cigarette manufacturers, the vapor inhaled from e-cigarettes does not contain tar or many of the toxic chemicals found in real cigarette smoke. The chemical mixture vaporized is typically composed of nicotine, propylene glycol, and other chemicals. Not all e-cigarettes use propylene glycol as the vaporizing agent (for example, blu™ e-cigarettes use vegetable glycerin instead), although many do, along with flavors designed to make the vapor more pleasant and attractive, such as menthol, vanilla, cherry, coffee bean, chocolate, apple, and, yes, various kinds of tobacco. This proliferation of flavors has led to concerns that e-cigarettes are attractive to children and could facilitate getting them hooked on nicotine or even serve as a “gateway” to real smoking.

Through a quirk of a ruling based on the 2009 Family Smoking Prevention and Tobacco Control Act, as long as manufacturers do not make health claims for them the FDA cannot regulate e-cigarettes as drug/device combinations, even though that’s what they clearly are. This is why you don’t see ads touting e-cigarettes as a smoking cessation aid, but rather as a “healthy alternative” to smoking. Here’s what happened. Between 2008 and 2010, the FDA quite reasonably determined that e-cigarettes are unapproved drug/device combinations. In response, Sottera, Inc., an e-cigarette manufacturer, challenged the FDA in court, and the U.S. Court of Appeals for the D. C. Circuit ruled in Sottera, Inc. v. Food & Drug Administration in 2010 that a jurisdictional line should be drawn between “tobacco products” and “drugs,” “devices,” and combination products. The court further ruled that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the act and are not drug/device combinations unless they are marketed for therapeutic purposes. For reasons that are unclear to me, the FDA declined to challenge the ruling, but retains the power under the Tobacco Control Act to add categories to the tobacco products it regulates after going through procedural steps that include a public comment process. As a result, the FDA plans to propose draft regulations for e-cigarettes this fall and put them out for public comment. Until such a time as the FDA finalizes regulations, however, e-cigarettes are unregulated by the FDA, although some states have banned them in public places, much as cigarette smoking is banned in public places in many states. This quirk of U.S. law has been the proverbial camel’s nose in the tent that opened the way for the currently booming e-cigarette business.

Are e-cigarettes safer than cigarettes?

Since the main claim being used to sell e-cigarettes right now is that they are safer than tobacco-containing cigarettes, that’s the first claim that needs to be examined. If you look at e-cigarette advertising, it’s hard not to feel a sense of déjà vu with respect to past tobacco company ads, complete with appeals to “freedom” (Jenny McCarthy’s ad uses that, among other common advertising ploys, such as the implication that you’ll have more sex if you use this product), celebrity endorsements (McCarthy again), and appeals to sophistication, freedom, equality and individualism. All of this is coupled with, of course, appeals to health, such as this ad for South Beach Smoke:

south-beach-smoke-e-cigarette

Indeed, e-cigarette advertising has been characterized as the “Wild, Wild West,” something out of Mad Men, and the “next great frontier” for ad agencies. It’s not hard to see why.

As I said earlier, it is not implausible that “vaping” (as inhaling e-cigarette vapor is commonly known) might be safer than tobacco cigarettes. After all, they don’t contain the tar and combustion products that cigarette smoke does, although most of them do contain the nicotine. There are nicotine-free e-cigarette cartridges for those who want the experience of smoking but not the nicotine. To me that seems like drinking decaffeinated coffee, something I’ve never been able to understand, but maybe that’s just me. Be that as it may, there really is a dearth of evidence one way or the other regarding the safety of e-cigarettes. The evidence that is out there, from my perusal of it, is of almost completely uniformly low quality. Particularly lacking are long-term studies of e-cigarette use, obviously because they’ve only been on the market for less than a decade and only skyrocketed in popularity beginning around five years ago. For instance, Odum et al pointed out that:

Most e-cigarette data on safety and efficacy are derived from the surveys of current or past e-cigarette users.14-18 The surveys have reported successful reduction in smoking and benign side effects, such as dry mouth, throat irritation, dry cough, vertigo, headache, and nausea (Tables 1). Most survey participants were male and from the Unites States, Europe, and Canada. Respondents were typically recruited by posting links on e-cigarette or smoking cessation Web sites and/or sending e-mails with survey links to consumers of ecigarettes[sic]. One survey18 recruited subjects by handing out questionnaires at an e-cigarette enthusiast meeting. Many of these surveys14,15,17,18 provided only descriptive analyses to understand the usage patterns and opinions of e-cigarettes along with baseline demographics such as previous quit attempts. One survey16 found a statistically higher amount of throat burning in current smokers versus former smokers and in e-cigarettes with nicotine versus e-cigarettes without nicotine. No differences were found for the side effect of dry mouth/throat.

I perused PubMed for data on e-cigarette safety, and I was appalled at the low quality of the studies out there. For instance, here are two more recent surveys compared to the review article I cited above. They tell us little or nothing more. Even surveys reporting adverse events are not particularly helpful. This Internet forum survey, for instance, has a built-in selection bias. Even though it tells us that there are a wide variety of reported effects from e-cigarettes, including cough, headache, panic, nausea, tremor, fatigue, reflux, throat and mouth irritation, burning, dermatitis, and elevated blood pressure, it’s hard to tell what the true prevalence of such reported symptoms are. Not surprisingly, given the uncontrolled nature of these studies, they showed that smokers generally liked e-cigarettes, think they help them decrease or quit smoking, and don’t cause any significant problems. It’s simply amazing how little hard data there are published. Moreover, most of these studies were prone to selection bias because they tended to recruit subjects from visitors to e-cigarette manufacturer websites and e-cigarette enthusiast blogs, and recall bias was certainly a concern given that these studies had no independent verification of smoking cessation. In other words, these surveys are pretty much useless.

In 2009, the FDA was concerned about the content of e-cigarettes and undertook an analysis of two leading brands of e-cigarette cartridges and found that one out of the 18 cartridges contained 1% diethylene glycol, an ingredient in antifreeze that is toxic to humans. Also noted were “certain tobacco-specific nitrosamines which are human carcinogens” in half the samples tested. Other findings included:

  • Tobacco-specific impurities suspected of being harmful to humans—anabasine, myosmine, and β-nicotyrine—were detected in a majority of the samples tested.
  • The electronic cigarette cartridges that were labeled as containing no nicotine had low levels of nicotine present in all cartridges tested, except one.
  • Three different electronic cigarette cartridges with the same label were tested and each cartridge emitted a markedly different amount of nicotine with each puff. The nicotine levels per puff ranged from 26.8 to 43.2 mcg nicotine/100 mL puff.
  • One high-nicotine cartridge delivered twice as much nicotine to users when the vapor from that electronic cigarette brand was inhaled than was delivered by a sample of the nicotine inhalation product (used as a control) approved by FDA for use as a smoking cessation aid.

These findings have been disputed. For instance, it has been pointed out that the tobacco-specific nitrosamines found by the FDA are present in e-cigarette vapor are present at much lower concentrations than in cigarette smoke and comparable to what is found in nicotine patches. Given that the only chemicals found in e-cigarettes that raise significant health concerns are tobacco-specific nitrosamines and diethylene glycol (believed to be a contaminant from the use of non-pharmaceutical grade polyethylene glycol), from the standpoint of the vapor, e-cigarettes probably are safer than regular cigarettes. A recent technical report from Igor Burstyn of Drexel University reports that the levels of contaminants e-cigarette users are exposed to are “insignificant, far below levels that would pose any health risk.” However, although it’s referred to in various places as a “study,” it really isn’t. It’s a review article, and it wasn’t even a peer-reviewed article, simply a “technical report” posted at the Drexel website and touted by press release. It was also funded by Consumer Advocates for Smoke-free Alternatives (CASAA), a group that promotes “reduced-risk” alternatives to cigarette smoking, including e-cigarettes. To be honest, given the funding source of this review and its lack of publication in a peer-reviewed journal — one blog comment hilariously states that the study “has been made public for peer review. As CASAA promised when fundraising, the researcher would not keep the study results a secret from the public during the review process” — I’m less than impressed, for obvious reasons. And for shame, ACSH, for promoting this piece of propaganda! If you think I’m being too hard on ACSH, then just imagine what its reaction would be if a supplement company pulled this sort of stunt, publishing a “technical report” that’s not peer-reviewed and promoting it.

Other studies have evaluated the effects of e-cigarette use on various measurable endpoints, such as plasma nicotine levels, heart rate, and expired carbon monoxide concentrations, but these were all short term studies using surrogate endpoints. Another study comparing tobacco cigarettes and e-cigarettes found that e-cigarette vapors produced smaller changes in lung function than tobacco smoke, but resulted in similar levels of nicotine in the blood as measured by the metabolite cotinine, while another study supports the observation of at least some adverse physiologic changes due to e-cigarette vapor. Specifically, use of an e-cigarette for 5 minutes was found to cause an increase in impedance, peripheral airway flow resistance, and oxidative stress among healthy smokers. On the other hand, this increase was small, and it is unclear what its clinical significance may be.

Given that e-cigarettes are too new for long-term studies to have been done, harm from the vapor can’t be ruled out, but it’s not unreasonable to provisionally conclude that it probably is less than tobacco smoke. The problem is that that’s a really low bar to clear, given how incredibly harmful tobacco-containing cigarettes are known to be, and says nothing about whether e-cigarettes are acceptably safe. The other problem, of course, is that that rigorous, well-conducted, long-term studies on e-cigarette safety are basically nonexistent. All we can do is extrapolate from surveys, chemical analyses, and generally low-quality data, and there’s a lot of uncertainty in doing so.

Are e-cigarettes effective smoking cessation aids?

The vapor is not the only issue with respect to e-cigarettes, though. They are, after all, intended as nicotine delivery devices, oddities in the law here in the US notwithstanding that classify them as tobacco products even though they contain no tobacco. Although manufacturers are not allowed to make the claim that e-cigarettes are useful smoking cessation aids, promoters of e-cigarettes as a harm reduction strategy, like the ACSH, are not nearly so shy about trumpeting such claims far and wide, even to the point of claiming that attempts to ban or strictly regulate e-cigarettes will “kill smokers,” presumably by robbing them of their one and only chance to quit smoking. It’s massive hyperbole, of course, because data are so lacking, and these are the claims that set my skeptical antennae a-twitchin’.

So what about nicotine? One concern the FDA reported was a highly variable nicotine delivery rate per puff from cartridge to cartridge of the same brand. (One notes at least one other study citing variable nicotine content in e-cigarette cartridges.) That suggests poor manufacturing processes and lack of standardization that are concerning. In addition, e-cigarettes appear to deliver less nicotine compared to FDA-approved nicotine inhalers, as measured by peak plasma concentrations after 10 puffs. According to manufacturers, these cartridges generally contain between 6 and 26 mg of nicotine, although there are cartridges on sale that contain as much as 45 mg of nicotine. In comparison, a typical cigarette generally delivers approximately 1 to 3 mg of absorbed nicotine. However, e-cigarette cartridges are not meant to be the equivalent of one cigarette; so a one-to-one comparison is difficult, as a typical cartridge is the equivalent of up to a pack of cigarettes, as many as 350 puffs.

When I perused PubMed looking for studies on the efficacy of e-cigarettes as a smoking cessation aid, I was no longer surprised to note an extreme paucity of them. There are to date no randomized double-blind controlled trials. Zero. Zip. Nada. In fact, I could find only two studies that weren’t in my opinion such dreck that they weren’t worth bothering to mention, and the larger and better designed of the two was essentially negative. First, there was a randomized, single-blind study by New Zealand researchers with a cross-over design in which subjects who smoked more than 10 cigarettes a day for at least one year who weren’t trying to quit used either a nicotine inhaler, a no-nicotine e-cigarette, a 16 mg nicotine e-cigarette, or their own cigarettes for a nine hour period. The results? The 16 mg e-cigarette and the nicotine inhaler produces a similar reduction in the desire to smoke compared to the no-nicotine e-cigarette. It was a small study, of course, and only looked at short-term surrogate outcomes. As such, it says little about the use of e-cigarettes as a smoking cessation aid other than that they might be useful.

More recently, there was a larger study of a similar design from an Italian group published in PLoS ONE. It was larger study (300 smokers) looking at three different strengths of a popular e-cigarette in Italy. Group A (n = 100) received 7.2 mg nicotine cartridges for 12 weeks; Group B (n = 100), a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; Group C (n = 100) received no-nicotine cartridges for 12 weeks. Subjects underwent nine visits during which cigarette use and exhaled carbon monoxide levels were measured. Interestingly, declines in cigarettes/day use and eCO levels were observed at each study visit in all three groups with no clear consistent differences between study groups in rates of smoking cessation and declines in cigarette use. There was no difference in adverse events either, including dry cough, mouth irritation, shortness of breath, throat irritation, and headache. In other words, it was a negative study, but that’s not how it was spun. Not surprisingly, the authors argued that e-cigarettes are useful adjuncts to smoking cessation.

My interpretation? There was no real control group, and this study suggests that it doesn’t matter whether there is nicotine in the e-cigarette or not. Moreover, there’s no way of knowing whether there was selection bias, and 40% of subjects didn’t show up for their last visit. From my perspective, the Hawthorne effect, in which the simple process of observation results in improvement in behavioral studies regardless of the intervention tested, could potentially account for this result. That’s why appropriate control groups are so essential. (I bet that if there were a no-intervention “observation only” group and a nicotine patch control group, there would have been a significant decline in smoking in those groups as well.) Sadly, the authors didn’t even mention that possibility.

As I said before, the question of whether e-cigarettes are a useful smoking cessation aid is a question that cries out for a decent randomized, double-blind controlled trial and a trial comparing them to conventional methods currently used for smoking cessation. As anyone who’s ever smoked or dealt with smokers know, smoking cessation is an incredibly difficult nut to crack. Even the treatments that work don’t work all that well. As far as e-cigarettes go, the best I could find was a proposed protocol from investigators in New Zealand for a randomized double-blind, placebo-controlled trial:

Design: Parallel group, 3-arm, randomised controlled trial. Participants: People aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking. Intervention: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. Participants randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Primary outcome: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups.

Which is what is desperately needed, a head-to-head comparison between e-cigarettes with nicotine, without nicotine, and nicotine patch alone. I hope these investigators succeed in getting this trial going and that it produces clearly interpretable data. This is a question that needs to be answered.

The bottom line

E-cigarettes started out as a promising idea that turned into a product that got away “into the wild,” so to speak, before being adequately studied. Originally conceived as a safer way for a smoker to get his nicotine fix, e-cigarettes have evolved into a fad driven by claims that they are much safer and promoted as such by e-cigarette companies and now by the big tobacco companies that are frantically buying up e-cigarette companies and/or introducing their own brands. Because, through a quirk in US regulatory law, they are currently unregulated, which has led to a proliferation of many, many brands of variable design and reliability. Although short term studies of e-cigarettes appear not to have found any evidence of significant harms, there are currently no solid long term data regarding the effects of inhaling the vapors produced by e-cigarettes. A recent review concluded that the vapors are likely safe, but did so based on primarily on a review of chemical analyses of e-cigarette vapor. A more recent analysis finds some toxic chemicals in e-cigarette vapor but at much lower levels than in tobacco smoke. Again, however, there are no long term epidemiological or observational data in actual humans using e-cigarettes.

Given that e-cigarettes are being touted as a replacement for smoking and thus presumably for long term use rather than short term use as a tool to quit smoking, this is a rather glaring problem. Moreover, we don’t know yet whether long term use of nicotine delivered in this manner is safe. Nicotine is, after all, an addictive drug whose use results in vasoconstriction, increasing heart rate and blood pressure, as well as inducing a combination of free radical production, vascular wall adhesion, and a reduction of fibrinolytic activity in the plasma that might be an indication of contributing to atherosclerosis. It might be safe delivered this way. It might not. We don’t know.

Despite all the uncertainty, on the one side we see anti-tobacco activists proclaiming e-cigarettes to be potentially harmful and gateway drugs to children leading to the use of real tobacco, while on the other side we see e-cigarette promoters (and I do count ACSH among that group) making concreted, absolutist statements that e-cigarettes are safe and effective aids to smoking cessation. The evidence base is such that both are overstating their cases, although I tend to conclude that the e-cigarette apologists are overstating their case more, given the apocalyptic rhetoric of regulators killing smokers. The hypocrisy of some of the rhetoric is astounding, attacking apologists for unregulated supplements for promoting them, while simultaneously blasting critics of…unregulated e-cigarettes! Meanwhile harm reduction advocates tout testimonials and selection bias-laden surveys as “evidence” that e-cigarettes definitely help smokers quit. Quite frankly, I don’t get it. Would the same people accept such low quality evidence in support of, say, supplements? Surveys routinely show that people love their supplements and believe them to improve their health. Accepting such low quality evidence for the efficacy of e-cigarettes is the same thing as accepting survey data as evidence for the efficacy of supplements, and it distresses me how many are either unable or unwilling to understand that.

I can understand provisionally concluding that e-cigarettes are safer than cigarettes (they likely are), but the evidence that e-cigarettes are an effective aid to smoking cessation is currently slim to non-existent, much less any evidence that they are more effective than nicotine patches or inhalers, as is sometimes claimed. Making definitive statements about the safety or efficacy of e-cigarettes is not an evidence-based stance. An evidence-based stance towards the question of whether e-cigarettes are an effective smoking cessation aid is, “We don’t know yet. Rigorous studies are desperately needed.” At least, that’s my story, and I’m sticking to it. As I said early on in this post, when it comes to e-cigarettes, I have been and remain agnostic, particularly in light of the massive advertising and promotional campaigns designed to sell them. To me, today, that is the correct science- and evidence-based stance. Show me some decent evidence, and I will change that stance.

I wonder whether the same can be said of some of the advocates attacking and promoting e-cigarettes.

Posted in: Cancer, Medical devices, Politics and Regulation, Public Health

Leave a Comment (166) ↓

166 thoughts on “E-cigarettes: The growing popularity of an unregulated drug delivery device

  1. Alia says:

    And then there is this story: http://www.rttnews.com/2143665/dj-ashba-almost-died-from-e-cigarettes.aspx?type=all
    I don’t claim it’s true, although it made quite an uproar over here. Certainly, unregulated amount of nicotine in e-cigarettes may be a problem.

    Anyway, I quite like e-cigarettes. I don’t smoke myself, I hate the stink of cigarette smoke and when some of my friends switched to e-cigarettes, I can sit with them and talk, and I do not have to throw all my clothes in the laundry (including overcoat) and wash my hair straight after getting home.
    On the other hand, there is a problem in the school I work. Smoking at school is of course strictly prohibited (by school regulation and by law). And then there are students who take out their e-cigarettes during recess and argue that since their are using nicotine-free cartridges, they should not be forbidden to do it. But how can I know whether it’s really nicotine-free?

  2. I LOVE my e-cigs. So I’ll state my bias up front. I was a pack a day smoker for about three years, until I started using e-cigs. I had tried quitting smoking many times, tried every type of smoking aid including medication and had no success. But since I started using e-cigs, I haven’t smoked a real cigarette in over a year.

    My feeling is: yeah, they might be less healthy than not smoking at all, but they have got to be healthier than smoking a pack of real cigarettes a day. (And yes, if I was presented with evidence that proved me wrong I’d have to re-evaluate, but so far that hasn’t happened.) So while it’s subjective personal anecdote, I feel better, and at least I’ve lost my smoker’s cough. (And my smoker’s odor!) I know common sense is often wrong, but at this point, with the lack of good studies, I’m gonna stick with the common sense that says nicotine vapor is not as harmful as a cigarette with all the byproducts and carcinogens. Subject to new evidence, of course.

    I am working on cutting down to no nicotine. I’ve already gone from the highest amount of nicotine available down two levels. The reason for this is I don’t think I can quit anytime soon, but I’d also like to be as healthy as possible, and I know nicotine is a poison. So if along with all the numerous cigarette poisons I’ve already cut out, I can get rid of another, that’s all for the good. It’s the physical sensation, holding something in my hand, in my mouth, the *inhale* (I went through several brands before I found the one I use now, because I couldn’t find one that duplicated that inhale sensation correctly).

    However, while I can’t quit, it also seems I can’t *start* smoking, either. I’ve been out of cartridges a couple times since quitting cigarettes, and only once I tried a real cigarette as a replacement. Couldn’t do it. It made me physically ill. I can’t even stand the smell anymore. So that’s good.

    Last thing: while I don’t have problems with them trying to regulate e-cigs to keep companies from making untrue claims or keeping them from children, I do have a problem with them banning e-cigs like cigarettes. I supported banning smoking from inside buildings and other areas crowded with people, but only because of the dangers from second hand smoke. I don’t care if it’s shown that e-cigs are unhealthy…unless there is a danger of second-hand smoke, it’s no one’s business what I put in my body. Now if a study shows that e-cigs can cause second-hand problems, okay, I also don’t have the right to hurt the people around me, but I’m gonna want to see that. A big reason people I know switched to e-cigs is so they can smoke in areas that would otherwise be forbidden–and you know what, if that ends up lowering the cancer and emphysema rate decades down the line, that can only be for the good.

    1. Erin N. says:

      My experience with e-cigs have been much the same as yours except I was a pack-a-day smoker for 15 years and have used e-cigs now for only 4 months. I too, have dropped down to low-level nicotine and can see myself drop to zero nicotine in the near future. I often say that these e-cigs take away everything even smokers hate about smoking. In the past, after a concerted effort to quit using any of the available quit options, I could still smoke a cigarette and after only a few puffs, could get right back into it. But just like your experience, when I recently tried a friend’s cigarette – sort of in a weird attempt to “remember” what it was like, my revulsion of said bummed cig was nearly violent. Another friend, only one month on e-cigs had a very similar reaction. I can’t ever see a time when I would ever smoke again. Another interesting area for study?

      In public areas where vaping is allowed, I have found that most non-smokers profess no irritation from the exhaled vapor and some even like the smell of some flavors. I think it interesting, however that more and more – anecdotally only: seem to be mostly composed of former smokers – are complaining about the smell and temporary haze that can happen in small places. I wonder if people are missing their superiority fix and complain because e-cigs offer a more acceptable way for smokers to enjoy a beer and a smoke, at the same time and while out with friends, and non-smoking people are losing the moral high ground they once lorded over us? That in itself seems to be an addiction for some!

      Congrats on your quitting and here’s to a stink-free life!

      1. I wonder if people are missing their superiority fix and complain because e-cigs offer a more acceptable way for smokers to enjoy a beer and a smoke, at the same time and while out with friends, and non-smoking people are losing the moral high ground they once lorded over us?

        Yep, I can see that. I have to say one of my favorite things is a cigarette with coffee and friends. But all the coffee shops in the last couple years have utterly banned smoking in the outside patios. Which made me sad, but now I get to have my smoke and coffee. A few times someone has come up and started to say, “You can’t smoke here.” And when I point out, hey, e-cig! Totally legal! No second-hand smoke! They look so let down. No opportunity to act superior! (Although one person did say, “You know those aren’t healthy for you.” I was like, okay, and? Did I ask for your unsolicited opinion? — well, I didn’t say that out loud, I’m kinda wimpy. But I thought it! And glared.)

        Congrats to you, too! Both my brother and my best friend smoke, and I’ve tried to get them try e-cigs, but they haven’t found a brand they like, that feels “real”. I tell ‘em to keep trying, it took several tries before I settled on NJOY, and they’re perfect for me. But the big expensive e-cig I bought on the internet was crap; I totally went back to smoking right away. ::shrug::

        1. Geekoid says:

          They can still ban you from the shop. I would.
          1) The advertising is designed to create young smokers,
          2) Young children will see you smoke, and will be more likely to smoke
          3) They aren’t really tested, so we don’t know what the second hand effects are, if any.

          1. Erin N. says:

            I get your point. I really do. I also totally agree with Dr. Gorski that because e-cigs aren’t tested, the medical community cannot advocate for their use and we have to wait for better studies. I get, too, that we don’t know if they are safe so it is kind of hard to argue for the free use of them in public places until we know the science. I do find it hard to advocate for them without sounding like an antivax-er or an alt-med advocate in that I’d be arguing for something that the science doesn’t support, and much of what those believers have consist of instinct, anecdotal evidence, and correlation without causation. What is true although, is that from the get-go, antivaxers didn’t have even a medically sound basis to begin with. It didn’t make sense that the harmless form of mercury sometimes found in vaccines could now harm a person (as was one of their earliest claims – I’ve been following this movement for nearly two decades now). At least with ecigs we largely have ingredients that have been studied, and used in medicine (the PG that is commonly used as the basis for the liquid is used in asthma inhalers) and their effects are known.

            The issue for me, as Erin B. has also indicated, is that they DO work. FINALLY getting off cigarettes has been literally a life-saver and because of that I do have an emotional investment in seeing them spread and accepted. And as we also stated, we are now repulsed by cigarettes after being confirmed regular smokers – nothing else I tried ever had this effect on me. There might actually be a prophylactic protection (again – totally an anecdotal observation, not even close to being a claim of truth) from smoking if one uses e-cigs.

            Your assertion that kids will become smokers by seeing adults vape is not a tested claim either, and we don’t know, but they could keep kids from ever smoking. Young people may begin vaping but if it turns out there isn’t much nicotine in vaping to begin with, then they won’t get addicted to that either. With antivaxers, it all started with vaccines that had been tested as safe, a possible correlation to autism was claimed, tests were conducted and found this was not true, and vaccines were given all the while because any proposed risk was still very small and on-balance, not as dangerous as not giving vaccines (a gross oversimplification I admit). With ecigs, one has a new, untested technology, that could be harmful, but quite reasonably way less harmful than smoking, and could lead to far fewer smokers. On balance, it seems to me to be the more win-able position. As there are no studies to support their use, no studies have come out to suggest they are harmful, either. Banning their use without the science, is no different than advocating their use without the science, but at least there is plausibility on the pro-vaper side.

            What I think most vapers are worried about, is that while we wait possibly years for the science to come in, laws will be written that make them illegal or as restricted as cigarettes and fewer smokers will be able to use them as an alternative to smoking. If the science comes in, and they are found to be safe for non-smokers and safer for smokers, antivaping laws will already be in place and we all know how hard it is to get a right back that was taken away. If the laws do stay on the books, or are continued to be banned after safety has been determined, then my earlier stated supposition that people are missing their superiority fix will be made true.

            1. This is indeed a very reasonable stance. And quite frankly, I come as close to supporting and endorsing e-cigs as I can without actually doing so. You cite most of the relevant reasons why. But the big issue I still have is that they are wholly unregulated. There are different ways of achieving the vaporizing effect ranging from heat to ultrasonic vibrations that can yield different products of inhalation beyond what is in the e-liquid. But the biggest issue is the e-liquid itself – that is also unregulated and I simply cannot be certain what the hell is or isn’t in the liquid. And for that reason alone I can’t see myself recommending to my patients that they take up e-cigs… except in perhaps the most seriously difficult of patients. But I can’t really say with any confidence that it will work beyond prior plausibility. Which, honestly, is fine except for the aforementioned (and legitimate, I think) concerns about the actual product itself. We certainly have an idea of the track record for Chinese safety.

              Also, I think it is not an unreasonable goal to actually stop people from smoking at all – whether e-smoking or r-smoking or whatever you want to call it. Even though it is likely less harm, it is certainly not no harm. And we saw how pervasive smoking can get despite how noxious it is. Can you imagine e-cigs becoming as pervasive? Nicotine itself is actually toxic. Get enough people vaping in a restaurant or cafe or whatever and it is not unreasonable to think that some level of harmful byproducts will build up.

              And believe me – I would love for this to work. My grandfather was hopelessly addicted to cigs. By the end he would smoke a pack or two a day, plus chew on the nicotine gum, sleep with the gum in his mouth, and STILL wake up at 2am to quickly burn one and go back to bed. All my life he literally BEGGED me to become a scientist who could invent something exactly like the e-cig. He died of lung cancer right about 2 years ago and I was not able to go see him or attend his funeral because I was away in med school.

              So I would love to see e-cigs be demonstrated effective, know the best ways to implement them, and advocate them as cessation aids for everyone who needs it. I need some data to back that up, but more importantly I need some basic safety regulations and quality controls so I don’t send my otherwise healthy but still smoking patient into renal failure because an e-liquid contained cadmium or something.

  3. I tend to advocate e-cigarettes to people I know who smoke due to the fact that I and others no longer have to deal with their smoke then. Since they eliminate second hand smoke are they at least safer for others? Are there any studies on vaping effects to near-by people?

    1. Lemmit says:

      Yes there is one study that I am aware of: http://www.ncbi.nlm.nih.gov/pubmed/23033998

      The conclusion: “For all byproducts measured, electronic cigarettes produce very small exposures relative to tobacco cigarettes. The study indicates no apparent risk to human health from e-cigarette emissions based on the compounds analyzed.”

      I cannot judge the science of this study and would be grateful for insights, though.

  4. stuastro says:

    Jenny Mc Carthy believes that vaccines are full of evil, nasty toxins, and yet she smokes E cigarettes. What the double standard?

    1. Who says she actually uses e-cigs? Just because she hawks them, doesn’t mean she uses them. Besides, all these years she’d been hollering about the “toxins”, she has been smoking actual cigarettes, full of dozens of real toxins. The hypocrisy is staggering.

  5. Stephen H says:

    Given the history of the tobacco industry, one is hesitant to accept any study that claims e-cigarettes are a “healthy choice”. They may be healthier than the old-fashioned cigarette, but unless and until that is properly studied no assumption should be made. There may be some totally unexpected issues with e-cigarettes that we just don’t yet know about – it has happened before.

    It reminds me of when I was a teenager, and my sister switched her habit to menthol cigarettes because “they’re better for you”. The industry managed to propagate that rumour very well thank you, and girls her age were happy to believe it.

  6. Is there a risk from second hand vapor using an e-cig?

    1. Lemmit says:

      Please take a look at this study: http://www.ncbi.nlm.nih.gov/pubmed/23033998

      It says there is none.

      1. Chris says:

        Who paid that company to perform that study?

        1. Lemmit says:

          I don’t know and it is not really relevant, as long as the science is sound. I, a bystander with no science training, can only look at secondary data:

          * the paper is published in a peer-reviewed magazine (http://informahealthcare.com/loi/iht)
          * none of the authors immidiately rings quackery alarms.

          So to the best of my knowledge the data is sound.

          Of course I’d be happy to have more studies to point at!

          1. Chris says:

            “I don’t know and it is not really relevant, as long as the science is sound.”

            If you read the paper rather than just the abstract, you would know the answer. And you cannot tell if the science is sound unless you read the paper.

            Unfortunately being in a peer reviewed journal does not always make it a good paper. There are lots of ways things can be wrong, and sometimes those that fund the research will tend to put certain data in a file drawer. That is why the end of articles include a conflict of interest statement, plus the funding source.

            You would have known that if you had read more of this blog. In particular the ones which are included in this search:
            http://www.sciencebasedmedicine.org/?s=conflicts+of+interest

            Some additional reading that would help you since you are not a scientist:

            Lies, Damned Lies, and Science: How to Sort Through the Noise Around Global Warming, the Latest Health Claims, and Other Scientific Controversies by Sherry Seethaler

            Snake Oil Science: The Truth About Complementary and Alternative Medicine by R. Barker Bausell Ph.D

            Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming by Naomi Oreskes and Erik M. M. Conway

        2. Becca says:

          It turns out that the senior author (S Babaian) is not a scientist, and is a member of the National Vapers Club. He has published no other articles that are indexed on PubMed. The first author is a scientific consultant who apparently was hired by the senior author to perform the study – he/she has one other published paper on ultrafine particle air pollution in Buffalo that was done in collaboration with researchers at Syracuse.

          Funding for this study was provided by the National Vapers Club in conjunction with e-cigarette retailers. If that doesn’t constitute a conflict of interest, I don’t know what does. This doesn’t negate their findings (e-cigarette vapors may indeed be harmless), but it does make this paper untrustworthy!

          For reference, here is the Declaration of Interest at the end of the paper (I have institutional access):
          “National Vapers Club (NVC) has spent more than 3 years educating people about electronic cigarettes. This research was necessary to have more thorough information to present to scientific and political bodies who are struggling with regulation of a new product about which there is very little published scientific data. Funding was obtained by fundraising events held by NVC as well as individual donations by NVC members, and in part by e-cigarette retailers who contacted NVC to offer contributions. Although NVC funded this study, it had no control over the results. The scientists and independent contractors hired by the principal investigator were entirely responsible for collecting, analyzing and interpreting the data. Prior to data collection, no author or independent contractor who worked on this project had any financial interest in the outcome of this study. Subsequent to data collection, S. Babaian became part owner in a retail e-cigarette company.”

          1. David Gorski says:

            This doesn’t negate their findings (e-cigarette vapors may indeed be harmless), but it does make this paper untrustworthy!

            I wouldn’t say “untrustworthy.” I would definitely say it’s less trustworthy, the same way that pharma-funded studies deserve more skepticism but don’t deserve to be rejected out of hand.

          2. Chris says:

            Thank you. That does put it in a different light. Though it may have all been above board, there still could be some data that slipped into file drawer purgatory.

  7. Kalind says:

    Thank you for this very thorough post on e-cigarettes. However, I need to point out a dichotomy here. While you have trashed ACSH and its pronouncements; nutriwatch.org, a site operated by Stephen Barrett, MD and Manfred Kroger, PhD lists ACSH as a resource for good advice under the sub heading “Antiquackery Web Sites”. It may be noted that both are co-authors of the book; Consumer Health: A Guide To Intelligent Decisions along with Dr. Harriet Hall. Further, they have ACSH on that list for quite a long time now. The problem with this for lay persons like me is that we are lulled into believing that we have found a science based answer to our questions and then like a bolt from the blue we get jolted and this generates many more doubts. This ACSH website also advocates the use of Snus/Snoos as a safer alternative to smoking. The debunking done by you raises doubts about the truth of this other claim too. This issue also compels us to suspect the content of other websites listed along with ACSH under the heading Anti-quackery web sites.Finally it boils down to this – unless it is on SBM it is probably not true..

    1. David Gorski says:

      The ACSH is a difficult problem, because it is often correct. However, I get into trouble when I criticize it because a lot of SBM supporters apparently don’t see the problems with ACSH that I do. Basically, I view ACSH as primarily an arm of industry, namely the pharmaceutical, food, chemical, and agribusiness industries. To the extent that those industries have a science-based opinion (vaccines or GMOs, for instance), the ACSH will be correct. However, it is very quick to attack any suggestion that environmental exposures (especially to chemicals from industry) might be harmful or that the food industry might be making products that are unhealthy. In the latter case ACSH often invokes “freedom” and castigates the “nanny state.” An example of the sorts of problems one sees with ACSH can be found in these posts:

      http://scienceblogs.com/insolence/2010/05/11/disingenuous-responses-to-straightforwar/

      http://scienceblogs.com/insolence/2010/05/10/the-presidents-cancer-panel-steps-into-i/ (In particular, check out the Daily Show segment about ACSH.)

      The one area ACSH has traditionally been good about is condemning tobacco. However, for some reason it seems to have latched on to e-cigarettes to a point that goes ridiculously beyond being evidence-based and become, let’s face it, a cheerleader for the e-cigarette industry. I’m on the ACSH mailing list, and hardly a week goes by without at least a couple of posts promoting e-cigarettes or attacking critics of e-cigarettes showing up in my e-mail. You can see it from the hundreds of posts that come up if you search the ACSH site for “e-cigarettes.” It makes me wonder whether there’s a financial tie. At the very least, there’s some sort of ideological link.

      1. Kalind says:

        I see. Thank you Dr. Gorski.

      2. arsawyer says:

        I’m always extremely confused after visiting the ACSH website. They appear to have a lot of really good content mixed in with really poorly written industry marketing. Why bother including this crap when you hired real scientists that know how to write? At one point someone thought it was a bright idea to give Michael Crichton an award because of his/their bizarre obsession with the awesomeness of DDT.

        http://acsh.org/2005/11/michael-crichton-accepts-award-from-acsh/

        1. David Gorski says:

          It’s all consistent with ACSH’s general anti-environmentalist stand in which any suggestion that industry could produce compounds that get into the environment and could potentially harm human health is arrogantly and contemptuously dismissed as “chemophobia,” no matter how reasonable, science-based, and nuanced the concern. So it’s no surprise at all that ACSH thinks banning DDT was one of the worst offenses against science ever. “The Daily Show,” as ever, was spot on in its take on ACSH when it comes to pesticides and its attacks on anyone criticizing the food industry:

          http://www.thedailyshow.com/watch/thu-may-14-2009/little-crop-of-horrors

          1. Chris says:

            Wait, what? My edible landscape garden is evil?

            I only did it because I had small kids and wanted to avoid toxic plants like castor bean and elephant ears, plus I have just wee bit of crazy of trying to grow things like peppers and tomatoes in Seattle (though that is working our fantastic this summer!).

            I also wanted to get my kids to learn where veggies came from, with hope they will eat them. Well the kid as a five year old who hid his baby carrots in the part of the wall where the stereo wires came out still needed to be coaxed to eat green stuff last night even though he is now 22 years old. But the youngest did go out today and pick basil to make pesto as her contribution to dinner at an overnight with friends.

            Also, I decided to not use the homemade pesticide made by soaking tobacco in water because it is just too toxic. Think about that.

  8. Peter Stigaard says:

    There is NO risk from second hand vapor…:

    • Comparison of the effects of e-cigarette vapor and cigarette smoke on indoor air quality:
    http://www.ncbi.nlm.nih.gov/pubmed/23033998

    Conclusion: ”For all byproducts measured, electronic cigarettes produce very small exposures relative to tobacco cigarettes. The study indicates no apparent risk to human health from e-cigarette emissions based on the compounds analyzed.”

    • Levels of selected carcinogens and toxicants in vapour from electronic cigarettes:
    http://tobaccocontrol.bmj.com/content/early/2013/03/05/tobaccocontrol-2012-050859.abstract

    Conclusion: We found that the e-cigarette vapours contained some toxic substances. The levels of the toxicants were 9–450 times lower than in cigarette smoke and were, in many cases, comparable with trace amounts found in the reference product.
    Our findings are consistent with the idea that substituting tobacco cigarettes with e-cigarettes may substantially reduce exposure to selected tobacco-specific toxicants

    • Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study:
    http://www.biomedcentral.com/1471-2458/11/786

    Conclusion: The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit

    • The Lancet Respiratory Medicine: Should e-cigarettes be regulated as a medicinal device?
    http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70124-3/fulltext

    Conclusions:
    “… nicotine intake from a non-smoked source is associated with low or no health risks.”
    “~ a safer alternative to cigarettes is likely to strengthen rather than weaken denormalisation of smoking.”
    “NRTs represent a classic example of the stifling effect of medicinal regulation.”
    “Excessive regulation of electronic cigarettes would protect the market monopoly of cigarettes”
    “The chemicals that make cigarettes dangerous are either absent in electronic cigarettes or
    present only in trace concentrations.”
    “… there is no credible risk that normally used electronic cigarettes can poison the user with
    nicotine.”
    “… in terms of market competition, electronic cigarettes are a consumer product competing with cigarettes.”

    1. David Gorski says:

      I cited some of the links you are touting. For example:

      Levels of selected carcinogens and toxicants in vapour from electronic cigarettes:

      http://tobaccocontrol.bmj.com/content/early/2013/03/05/tobaccocontrol-2012-050859.abstract

      Conclusion: We found that the e-cigarette vapours contained some toxic substances. The levels of the toxicants were 9–450 times lower than in cigarette smoke and were, in many cases, comparable with trace amounts found in the reference product.
      Our findings are consistent with the idea that substituting tobacco cigarettes with e-cigarettes may substantially reduce exposure to selected tobacco-specific toxicants

      Cited it, but didn’t discuss it in detail.

      Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study:

      http://www.biomedcentral.com/1471-2458/11/786

      Conclusion: The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit

      I discussed two similar studies to this one. One was by the same group and a much larger followup study to the one you cite above. I noted their lack of controls and how they are at best suggestive, not conclusive, evidence for e-cigarette efficacy in smoking cessation. I also noted how the larger followup trial was basically a negative trial. Think Hawthorne effect.

      Then there’s this one, which I didn’t cite:

      The Lancet Respiratory Medicine: Should e-cigarettes be regulated as a medicinal device?

      http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70124-3/fulltext

      I read it. However, I didn’t cite it because it’s nothing more than an opinion piece, and not a particularly good one at that. In particular, I find the argument that “NRTs represent a classic example of the stifling effect of medicinal regulation.” and “excessive regulation of electronic cigarettes would protect the market monopoly of cigarettes” to be particularly risibly bad arguments. The real argument they’re making is that regulation might force the e-cigarette industry to straighten up and fly right with respect to standardization and manufacturing practices, and they don’t like that one bit. Worse (to them), regulation might slow down the meteoric increase in profits that the e-cigarette industry has been enjoying over the last five years or so. I can’t help but note that the very same arguments tend to come up whenever tighter regulation of the supplement industry is proposed.

      1. I’m confused about the accusations several writers have mentioned concerning “lack of controls” in the two studies on smoking reduction that recruited smokers unwilling to quit. Most clinical trials use a group receiving a placebo as their control. In these trials, there was a group using an e-cigarette loaded with liquid that contains no nicotine.

        If in clinical trials of nicotine patches a group wearing a patch containing no nicotine served as a control, isn’t that a parallel situation to a no-nicotine e-cigarette?

        One writer stated that to count for anything, the researchers had to conduct a double-blind study having one arm that received no treatment at all. Hmmm…I suspect that it would be impossible for such a design to be double-blind…or even single-blind for that matter.

  9. Young CC Prof says:

    The idea that they are less harmful than cigarettes makes sense. A bunch of my smoking friends switched, and I’m glad for them. But e-cig users, you still need to stop doing it in places where you wouldn’t smoke, like next to me.

    Nicotine itself has harmful effects, including birth defects and delayed healing of bone injuries, and the vapor does escape. There’s a reasonable expectation of harm, we shouldn’t wait for more proof. The FDA should just say, “OK, they are a cigarette alternative, adults can buy them just as easily, but all the smoking regulations apply, including restrictions on advertising and use in public spaces.”

    1. A study (ClearStream) of bystanders’ blood in a closed cubicle with vapers shows 0 additional nicotine in their blood after 10 hours. So yes, FIRST-hand vaping might be a problem, compared to not smoking. But SECOND-hand, no. Nicotine is in potatoes, tomatoes, eggplant, and peppers. There is enough of it in these foods, especially peppers, to provide a protective effect against Parkinson’s Disease. The reason I said
      “additional” is because there is already nicotine in the blood of consumers of any of these 4 foods.

      Also, “nicotine” is often used as a synonym for “smoke” — simple sloppy thinking. I’m pretty sure carbon monoxide has more to do with small babies than nicotine does.

      I’ll accept “all the smoking regulations apply” only when it also applies to all hot foods and coffee, which have the same SECOND-hand effects as vaping. (Nicotine is also a lot like caffeine.) Go for it. Hope your town does not depend on tourist dollars.

      1. Young CC Prof says:

        Keep in mind, no one here is actually opposed to e-cigarettes. I think the world would be a healthier place if all smokers on the planet switched tomorrow. However:

        A rat study specifically examining the effects of nicotine in utero, without the other cigarette effects: http://www.ncbi.nlm.nih.gov/pubmed/1886540 (Wish I had a clean human study, but it would be pretty unethical, eh?) So the carbon monoxide may be a factor, but clearly nicotine is part of it.

        In this one, they broke rabbits’ bones and dosed the bunnies with small quantities nicotine: http://www.ncbi.nlm.nih.gov/pubmed/20805768. Delayed bone healing was seen.

        I could go on, but there’s proof of two harmful effects of nicotine alone. Can you get me a source for that study about second-hand vaping not delivering any measurable dose?

        Finally, call me crazy, but I think that allowing e-cigarettes to be used inside public buildings would be harmful _to the users,_ by enabling chain-vaping. Call me a nanny, but banning smoking in indoor public spaces got a lot of people to cut back and a few to quit. I don’t want to reverse that progress.

        1. Schripp T, Markewitz D, Uhde E, Salthammer T. Does e-cigarette consumption cause passive vaping? Indoor Air. 2012 Jun 2. http://www.ncbi.nlm.nih.gov/pubmed/22672560

          The researchers had subjects go into a 3 square meter chamber and smoke a traditional cigarette. They then cleared the chamber had a subject use an e-cigarette. They analyzed the exhaled smoke and the exhaled vapor. There no nicotine in exhaled smoke or in exhaled vapor. The only way they were able to detect any nicotine at all in exhaled vapor was to have the e-cigarette user exhale all the vapor into a jar. So maybe if you locked lips with an e-cigarette user and inhaled all of their exhaled vapor….

  10. “…To me that seems like drinking decaffeinated coffee, something I’ve never been able to understand…”

    Eek! No comparison at all! Nicotine has no flavor of it’s own (so far as I know), whereas coffee DOES. As I age, I get more sensitive to caffeine so have cut back slowly to mostly decaf, except for my morning first cup. I buy good, fresh beans, grind every cup’s worth and make a great full-bodied pour over (drip) decaf coffee that is every bit as tasty as its caffeine counterpart.

    It is totally possible to enjoy the robust flavor of coffee without getting “jazzed” on caffeine. That was fine when I was in college or when I had to be to work at 8 am and still felt half-asleep, but now caffeine just makes my jittery and too much makes it hard for me to use my hands without literally shaking for a couple hours after. Besides, decaf is not completely caffeine-free, so you do get some of the “benefits”. :-)

    Now I will go back and read the rest of this interesting post!

    1. Pareidolius says:

      I hear you Irene. But even decaf gets to me, so I switched to tea and now I’m limited to one cup in the morning. I’ve gone from mainlining caffeine for decades to barely being able to tolerate it since it causes jitters, palpitations and anxiety in me now. It must be genetic, since my dad had the same reaction to it. He did start drinking coffee again in his 80s and 90s however, so who knows? Maybe there’s hope for me yet.

      1. I don’t have ANY caffeine–tea, chocolate–nothing, after 2 pm for similar reasons. It’s strictly fizzy water after the single serving of wine or beer (measured portion) when hubby gets home.

        If I make it to 80, or even 90, I will sit all day and eat chocolate until I explode–and wash it down with good red wine and fine beer.

    2. Todrick says:

      you just argued against yourself…

      ” No comparison at all! Nicotine has no flavor of it’s own (so far as I know), whereas coffee DOES….

      …great full-bodied pour over (drip) decaf coffee that is every bit as tasty as its caffeine counterpart.”

      which would indicate that CAFFIENE, has no flavor of it’s own.

      Again, you reference a great analogy, non-vapers should reference when thinking of eCigarettes:

      Coffee = eLiquid
      Cup = eCigarette

      The analogy is incredibly strong…
      You have you product(that may or may not contain an addictive stimulant)
      and you have your method of delivery

  11. chadwickjones4 says:

    Ugh… But eCigs aren’t natural… Checkmate, McCarthy! ;-P

  12. Adam Acuo says:

    Based on the evidence in your article – it appears clear to me that e-cigs should remain unregulated and not subject to government regulation. As skeptics (and scientists) we should be cautious about handing over our freedom to bureaucrats, who are just as prone to getting things wrong (or being lobbied by the suppliers themselves) as we are. I am a non-smoker (I quit about a decade ago), I don’t “smoke” e-cigs (but I do drink decaffeinated coffee, and your aside on that was snarky and pretty lame) but I generally believe that adults should be free to make their own decisions and the civil court system can handle any fallout or liability that may arise from the claims of the manufacturers.

    1. duggansc says:

      I think his point is that the current methodology is insanely unregulated. Cigarette manufacturers have to employ quality control on their products and have oversight. Nicotine patches have to employ quality control and have oversight. E-cigs… you have absolutely no idea what you’re putting into your body. Yes, these are adults, but if you extend your argument out, that means that we shouldn’t maintain safety standards on car airbags because it’s adults driving and they understand the risks, that some airbags will explode violently and others contain trace contaminants that will result in the powder burn on your face developing into a nasty infection.

      1. Adam Acuo says:

        The idea that regulation by government is the only thing protecting us from evil business interests is as outdated as the argument that government bureaucrats somehow protect us from ourselves.

        1. David Gorski says:

          The idea that lawsuits for product liability will stamp out dangerous products is as outdated as the idea that the magic of the marketplace will somehow guarantee that products won’t be harmful.

        2. Sullivanthepoop says:

          The government is not the only one, but they do have the necessary resources to get the job done.

        3. Chris says:

          Yes. It was that pesky woman, a Canadian no less, that just refused to let Richardson-Merrell sell its product in the USA. Good grief, she actually wanted studies on the effects on babies just because it was to be prescribed to pregnant women.

          Oooh, the nerve of that woman.

          And to top it all off, President Kennedy gave her an award for not letting a good and proper pharmaceutical company sell their meds in the USA.

          Obviously the e-cig only lets pregnant women inhale “safe” nicotine. Right?

    2. Sullivanthepoop says:

      I agree that we need to be more careful about giving our freedom away, but in the case of e-cigs I do believe they are a drug delivery system and should be regulated like nicotine patches. In that they have to contain a market standard for content concentrations and manufacturing processes.

  13. Renate says:

    Still waiting for e-cigars. I would love my neighbour switching to those. The smoke of his cigars, which I can smell thanks to my love for an open bedroom-window, really gets annoying. I hate the smell of cigarettes, but his cigars I hate even more.

    1. Lemmit says:

      Why are you waiting? They are on sale since forever. Just google!

  14. Edward C. Holmes says:

    Several times over the past few months, in the USA and in several European countries, I have insidiously found myself coughing and in respiratory distress due to nearby e-cigarette use at restaurants and public spaces. Second-hand cigarette smoke, while not pleasant, does not cause my lungs to ache nor cause coughing for the next several hours as does the e-cigarette vapors.

    1. Todrick says:

      You are likely imagining things.
      A psychosomatic response to your perception of it’s ill effects.

      That or you are EXTREMELY sensitive to Propylene Glycol inhalation
      A very small minority is allergic to it… but what you describe would be an extreme reaction, In which case you should avoid concerts, clubs, theater performances, halloween haunted houses and any other event/location that uses fog machines(the fog is PG)

      1. Edward C. Holmes says:

        Yeah, I was imaging things. Yup, the psychosomatic response definitely due my prior lack of knowledge of and experience with vapor cigarettes. However, vapor cigarette use in public spaces is as offensive as cigarette and cigar smoke.

      2. Edward C. Holmes says:

        http://www.ama-assn.org//resources/doc/csaph/a10csaph6ft.pdf

        The contents of this report indicates all is not well with e-cigarettes:

        “Because E-cigarettes have not been thoroughly tested, one cannot conclude that they do not produce any harmful products, even if they produce fewer dangerous substances than conventional cigarettes. In fact, analysis of two brands of e-cigarettes found detectable levels of known carcinogens and toxic chemicals (i.e., diethylene glycol, an ingredient used in antifreeze, small amounts of tobacco-specific nitrosamines, and certain other tobacco-specific impurities that may be harmful). To date, most research on e-cigarette ingredients, safety, health effects, and use by current smokers has been funded by manufacturers.”

        1. Seriously? The American Medical Association is basing its opinion on a discredited 2009 lab report and ignoring all the research that has since been published? Here’s a nice collection, and you might forward this link to anyone you know who is an AMA member. http://casaa.org/Lab_Reports__ecigarettes.html

          And here’s a more reasoned opinion on the subject by Dr. Michael Siegel of the Boston School of Public Health: http://www.nytimes.com/roomfordebate/2013/08/20/the-ambiguous-allure-of-the-e-cig/with-e-cigarettes-whats-not-to-like

          1. weing says:

            Nicotene is a highly addictive drug and e-cigarettes are a drug delivery system. As with cigarettes, the nicotene saturates the receptors in the brain within seconds and, I presume, the level drops off just as with cigarettes. This is ideal for reinforcement of smoking and addiction. I do not think it should be glamorized with advertisement.

            Many states have legalized medicinal marijuana. The current delivery system results in inhaling tars and carbon monoxide. For this reason, I have problems recommending it to patients. We need an e-delivery system for it also.

          2. Edward C. Holmes says:

            By FRANCE 24 – Electronic cigarettes are “not as harmless” as manufacturers make them out to be and can “contain potentially carcinogenic elements”, a study by a French consumer magazine revealed on Monday. [August 26, 2013]

            E-cigarettes are more dangerous than thought and can cause cancer, the September edition of a French magazine has claimed.
            “Electronic cigarettes are far from the harmless gadgets they’re sold as by manufacturers,” wrote monthly magazine “60 Million Consumers” following a study of some 10 reusable and disposable e-cigarette models.
            “It’s not a reason to ban them, but to better control them,” said Thomas Laurenceau, chief editor of the magazine, which reports the findings of France’s national consumers’ institute (INC).
            The INC has relayed its findings to the authorities, Laurenceau told AFP.
            Laurenceau also criticised certain models for lacking safety caps because, he noted, the nicotine levels contained in the liquid content of electronic cigarettes could be lethal to children.
            The study claims to have employed an innovative method in detecting “a significant quantity of carcinogenic molecules” in the vapour of the cigarettes which, according to Laurenceau, have thus far gone undetected.
            “In three models out of ten, the levels of [carcinogenic compound] formaldehyde come close to those of a conventional cigarette,” he said.
            The highly toxic molecule acrolein was also detected in the vapours of e-cigarettes, “sometimes at levels even higher than in traditional cigarettes,” Laurenceau said.
            One million people use e-cigarettes in France, where smoking has been banned in public places since 2007.
            In May 2013, French Health Minister Marisol Touraine announced that the ban on smoking in public places would now be extended to cover electronic cigarettes.
            Some 73,000 people die from smoking-related illnesses in France each year.
            Unlike other European countries, the number of smokers has remained constant in the country despite price hikes on tobacco products and health-awareness campaigns.

          3. Edward C. Holmes says:

            http://casaa.org
            Does not appear to be a neutral, unbiased resource. One board member advocates smokeless tobacco use, which puts users at high risk for head and neck cancers.

            http://www.cancer.gov/cancertopics/factsheet/Tobacco/smokeless
            Key Points
            Smokeless tobacco is tobacco that is not burned. Smokeless tobacco is also known as chewing tobacco, oral tobacco, spit or spitting tobacco, dip, chew, and snuff/snus.
            Smokeless tobacco causes cancer and other diseases.
            Smokeless tobacco is not a safe substitute for cigarettes.

            The public does not want to be exposed to noxious chemicals in public spaces under any circumstances.

  15. Jay Gordon says:

    Thank you for this post. Parents ask me about these devices and I haven’t had a good answer. This helps immensely.

    1. stuastro says:

      Apart from what may or may not be the dubious claim that these things can assist in stopping people from smoking R cigarettes (that’s real cigarettes), it seems to me that this maybe a soft way into young people starting to smoke E cigs first and the moving on to nasty, evil, horrible, death causing real cigarettes. Perhaps E cigs are just an evil plot by “big baccy” to get children to start smoking. I certainly would not put it past “big baccy”, and for this reason alone, I would love to see them banned in the countries that have them. I have not comes across them here in good old Oz. No, not Kansas, Australia!

      1. Pam Distasio says:

        E-cigs made by Big Tobacco are a plot to win back all the customers they have lost to other, smaller e-cig manufacturers who beat them to it and stole their customers. BT is now playing ‘nice’ with the FDA to encourage heavy regulation ‘for the sake of the children’. Once that happens, that will put the smaller e-cig companies out of business, since they won’t be able to afford to comply. Most e-cig users will return to cigarettes, since BT’s e-cig products are so terrible. Once that happens, BT will dump the e-cig too. So, don’t worry about banning them, it will happen naturally.

      2. I don’t know…it’s been exactly the opposite in my (admittedly limited) experience. Most people I know who’ve found an e-cig that works for them have never gone back to real cigarettes. In fact, for many of us, even the thought is gross. As I said above, I tried smoking a real cigarette a while ago, when I was out of cartridges and needed a nicotine fix, and I couldn’t do it. Even the smell of my friends smoking makes me sick. I’ve never heard of anyone starting with e-cigs and moving to real cigarettes.

        Not saying it never happens, and there do need to be more studies. But I know I went from being a pack a day smoker (it was so bad that when I was in the hospital, my friend used to haul me in a wheelchair for a “walk” so I could go outside and have my smoke) to not having a cigarette in a year. And I’m lowering my nicotine intake to nothing. According to my last check-up, I’m a lot healthier, and I feel better (knowing that’s subjective).

        Also, I don’t smell! And that’s all for the good.

      3. Linda says:

        E cigarettes are a gateway away from smoking, not towards it. A much safer alternative to smoking and it has nothing to do with big tobacco. Although they are now cashing in as they are losing out to e cigs. They are not meant for smoking cessation, but a lot of smokers who use them, find they no longer want to smoke tobacco cigarettes. There are now over a million e cig users in the UK. It’s common sense that they certainly can’t afford to buy a good quality e cig as well as tobacco cigarettes which cost a fortune here.

      4. Todrick says:

        ” R cigarettes (that’s real cigarettes)”

        Just an FYI… many vapers call them ‘Analogs’

  16. Chris says:

    The biggest thing we can learn about this is:

    1. Ms. McCarthy should be ignored due to her hypocrisy, especially with anything that has to do with science. I do wish the best to her son, and hope he grows up healthy both physically and mentally (my oldest had seizures, developmental delays and other health issues).

    2. The best idea is to never start smoking, chewing, or have anything to do with tobacco products. It makes you do silly stuff like pay certain companies lots of your hard earned money to voluntarily suck toxins into your lungs. It is best to not support those industries.

    Though I have been tempted to buy loose tobacco to make homemade insecticide. Except that the “tobacco tea” is extremely toxic, and should be used carefully. Plus I like my ladybird beetles, parasitic wasps, spiders and bees that are in my garden. The homemade nicotine stuff is nasty to most living creatures. Think about that.

  17. WilliamLawrenceUtridge says:

    You like parasitic wasps? The very embodiment of Darwin’s objection to the existence of a just God? Your pragmatism is formidable :)

    1. Chris says:

      I especially like seeing the white mummified aphid bodies after the teeny tiny wasp has laid its eggs in them. Then after a while they turn into a white shell with a small hole that indicates the baby wasp has left.

      You can even buy them. I don’t have to, since I try not to kill the good bugs in my yard. Which is why I have never made tobacco tea, because that stuff is nasty.

      And if I don’t want to spray that in my yard, I would definitely not what to inhale it into my lungs.

    2. Every year some wasps (don’t know if they are parasitic–is that an adjective or a species name?) build a nest under my kitchen window awning. I watch it get bigger and bigger–they are so industrious!–until finally when they are swarming all over my kitchen garden, which is immediately adjacent to the outside door, I run in under the awning real fast, put a jar over the whole thing, and quickly move it to the far back yard. This year, a few just keep hanging around. Looking for the nest? Just confused?

  18. Lemmit says:

    I have been waiting for SBM to come back to this topic for a long time, but sadly I have to say the article was way below my expectations. It constantly confused claims with actual data and framed the whole discussion in a rant about a random anti-vaccine quack, which has _absolutely nothing to do_ with electronic cigarettes.

    What it boils down, the reason why millions of people are up in arms, is policy issues that are being made right now. Unless we find something awfully wrong with e-cigarettes, they have the potential to benefit public health on a scale that is hard to grasp. We are talking about the possibility of saving billions of lives world-wide(*). Science clearly points to e-cigarettes having the potential to be safer than cigarettes — the author seems to agree —, yet new policies being considered around the world aim for regulating e-cigarettes on the same level or even more than regular cigarettes.

    More often than not whole discussions end up pointing out that TSNAs have been discovered in some products, or that the contents of others don’t correspond to the label. These are isolated cases that can be easily resolved with sane regulation— if TSNAs can be eliminated in snus (look at the RCP doc linked to below), then they can be eliminated in e-vapour as well. And most vapers would be more than happy to have regulations that make sure the products actually meet the descriptions. Yes, that’s right — most vapers want electronic cigarettes to be regulated, so they can be sure they get the safest product possible. Regulated as anything we eat or drink is regulated, but not restricted like medicines.

    Again — fluctuations in the quality of certain products does not have any relevance to whether electronic cigaretets are _potentially inherently_ safer than regular cigarettes. All data points to this being the case. So to me the developing of new very restrictive policies ais absurd from standpoints of both science as well as common sense. Unfortunately I am not a scientist nor am I a politician, thus I will not argue the case further, but instead I want to point out some excellent reading material from the Royal College of Physicians: http://www.rcplondon.ac.uk/publications/harm-reduction-nicotine-addiction

    Be warned — it starts from the very beginning and covers a lot of real science on 250 pages. But is well worth the read! So much in fact, that I now strongly feel that no one should seriously deliberate larger issues surrounding electronic cigarettes — which are in fact issues of tobacco policy — without familiarizing themselves with this material. Again — the larger issue is not whether electronic cigarettes are safe (they are _not_, we know this already), but whether they are safer than regular cigarettes (they are, we know this already) and how we can use this knowledge to save lives by enacting policies that encourage users to switch to less hazardous forms of nicotine delivery. (Don’t get me started on snus!)

    Or in other words — it is a linguistic issue of being able to differentiate between positive, comparative and superlative.


    Most of them in third world countries where the smoking epidemic is rapidly spreading, as opposed to US/Europe et al, where it is in decline.

    1. David Gorski says:

      I see a lot of verbiage, but I don’t see anything there that calls my two central conclusions stated in this post into question:

      1. E-cigarettes are likely to be safer than tobacco cigarettes, at least in the short term, but that’s a mighty low bar to clear, given how harmful cigarettes are known to be. Because there are no good long term studies of e-cigarette safety, we don’t know if they’re sufficiently safe or not to recommend.

      2. There is no good evidence that e-cigarettes are more useful than (or even as useful as) existing smoking cessation aids in helping smokers quit. There is suggestive evidence that they might be efficacious as smoking cessation aids, but we have no idea if these mostly observational studies of self-reported outcomes will translate into hard evidence when tested in randomized clinical trials.

      In other words, we just don’t know whether e-cigarettes are safe, and we know even less whether they are effective smoking cessation aids. They might well be, but any claims made for them now are premature and not evidence-based.

      Now, as for your last statement:

      Yes, that’s right — most vapers want electronic cigarettes to be regulated, so they can be sure they get the safest product possible. Regulated as anything we eat or drink is regulated, but not restricted like medicines.

      Who cares? What vapers “want” does not change the fact that e-cigarettes are drug delivery devices designed to administer nicotine, the vagaries of US court rulings notwithstanding. If they’re being used for smoking cessation, they should be FDA-regulated as as drug/device combinations; i.e., as a medicine, just the same way that, for instance, other drug/device combinations like albuterol inhalers for asthma are regulated.

      Your arguments sound very similar to those of supplement manufacturers.

      1. Tom Gleeson says:

        The fact that nicotine is a drug is irrelevant, caffeine is a drug, is coffee a drug delivery system or cigarettes for that matter?
        As to evaluating the safety profile of e-cigs we can extrapolate from existing data on the ingredients. Nicotine we can safely say has a low risk profile in the absence of smoke. the flavorings need watching and PG is the big concern as we have no data at all on long term use.
        However long term use is something we cant do trials on expidently so a ‘suck it and see’ approach is all we can adopt. That or presume harm and restrict use to short term.
        The problem then is that we loose what may turn out to be the biggest advance in reducing smoking prevalence, a pries that is worth the small risk.
        You are right about the paucity of actual studies though,more needs to be done and funding is the big cost, until ecigs start turning over large sums of money studies will be scarce.
        E-cigs are not sold as nrt and imposing nrt rules on them would be counter productive. They do not treat or ameliorate any disease or illness.
        All they are is smoking replacements, ones that are less harmful than the product the replace. Low salt isn’t a medicine or low fat, no matter how you spin it.

        1. windriven says:

          “is coffee a drug delivery system or cigarettes for that matter?”

          No and yes. Coffee is an infusion, not a device. You are welcome to soak tobacco leaves in hot water and drink it down. You may find it rather toxic though. Cigarettes are designed to burn tobacco at a controlled rate for delivery to the lungs so in my estimation they would qualify as a device. Apparently the current interpretation of law does not agree with me.

          “However long term use is something we cant do trials on expidently (sic) so a ‘suck it and see’ approach is all we can adopt. ”

          Really? We have large numbers of people who desperately need new antibiotics, cancer drugs, and so forth; drugs far more important than nicotine. Shall we just jab ‘em and see what happens? Just because a trial can’t be conducted before you need your next fix is not a reason to abandon testing.

          “Low salt isn’t a medicine or low fat, no matter how you spin it.”

          Wrong again! Your analogy doesn’t hold as neither salt nor dietary fat are drugs.

          Personally, I don’t care if you smoke cigarettes, electronic cigarettes, joints or a crack pipe. Just don’t do it around me and don’t do it around anyone under the age of majority. In fact I would argue don’t do it in public at all unless and until you can demonstrate conclusively that second hand ‘vap’ (short for vapid?) is safe.

      2. Lemmit says:

        Here’s the gist of it:

        “Who cares? What vapers “want” does not change the fact that e-cigarettes are drug delivery devices designed to administer nicotine, the vagaries of US court rulings notwithstanding.”

        I respectfully disagree with your _opinion_ and point out that whether something is to be classified as a medical device or not, is not a matter of science, but of policy, law and public opinion. If electronic cigarettes are medical devices/medicines then regular cigarettes should rightfully be so as well, for they fall within your criteria. Just that you know — US is not the only country in the world where courts have clearly stated that the mere existence of nicotine in a product gives no grounds to call the device/product a medicine or apply medical standards to said products. The one I inhabit, Estonia, also recently saw the courts strike down down our State Agency of Medicines’ claim to that effect. And there are others.

        David — if you bear with me? — I do not know how these things are called in the medical profession, but I assume that if I say risk assesment, you understand my meaning. Am I correct to assume that in medicine, just as in every other field of life, risk and hazard is not a wanton entity, but is based on probabilities and the unknown is to an extent extrapolated from the known. Eg — when being more serious than on a blog, it is not entirely correct to simply say “electronic cigarettes can be dangerous” without suggesting a hypthesis about the possible mechanism and extent of said danger (something along the lines of: TSNAs in electronic cigarettes reach concentrations up to X, therefore, based on previous research, we can expect to see Y amount of tumors in users)?

        What you say about lack of research could not be more true — it is scarse, half of it is biased and crap and the other half is missing. But at the risk of being ridiculed more by my heroes of SBM — what I consider to cloud the whole issue is that those who would want to see similar regulations as govern cigarettes also apply to electronic cigarettes, are using even worse science than the proponents of these devices. I mean — gateway theories reek far and wide, and just as I pointed out above, simply stating that something might be dangerous is somewhat … simplistic. as grounds for highly restrictive regulations. Again keeping in mind that we are talking about risks compared to another product that is sold freely in every convenience store or gas station!

        The data is data, but there is a lot of shifting around of the burden of proof. To me banning everything that has not been proven safe is … not really viable. For, as you have pointed out yourself, nothing can ultimately be proven safe and thus at the end of the day, we have to make decisions based on risk assesments.

        1. David Gorski says:

          If e-cigarettes are not a drug/device combination, then what are they? Don’t quote me law. I’m talking from a logical, scientific and medical standpoint, what are they? Law resembles science and medicine often only by coincidence and often doesn’t resemble it at all, and in this case I think the law is an ass. Based on medicine and science, what are nicotine containing e-cigarettes, if not a drug/device combination whose sole purpose is to deliver a dose of nicotine to the lungs?

          Also note that I didn’t say I supported “gateway theories.” Although I did note that that is a concern, I intentionally did not give credence to them one way or another because there are no good data. Similarly, our “friend’s” attacks on me notwithstanding, I never argued that e-cig vapors are dangerous to non-vapers nearby. (It never ceases to amaze me how people like that don’t even bother to assess whether they talking points they want to use are needed before just dumping away.)

          As for risk assessments, you can’t really do a good risk assessment in the absence of data, can you? And you just agreed with me that the existing data regarding e-cigarette safety and efficacy suck. So how does one do a risk assessment? One can’t, until there are more data. I do think, however, there are more than adequate data to justify regulating these devices at least as tobacco products (even though I think it’s a contortion to call them that).

          1. Lemmit says:

            Thank you, David, for a polite reply, and please forgive me when I keep asking. Trolling my intention is not!

            As for what electronic cigarettes are, I will have to forgo the answer — I don’t want to play a game of semantics (trust me on this one, my education is in fact in semiotics). Also I did note your lack of endorsment for some specific theories and I dearly hope I never accused you otherwise!

            So, what I’d like to do is to point out the obvious — we do have some lab data on the chemical makeup of vapour and you have cited some of the studies yourself, without explicitly excluding them on grounds of sloppy science. For me, this one is rather telling: http://tobaccocontrol.bmj.com/content/early/2013/03/05/tobaccocontrol-2012-050859.abstract
            This one looks relatively straightforward as well:
            http://www.ncbi.nlm.nih.gov/pubmed/23033998

            The dose makes the poison, I have heard to no extent on this very blog! Therefore I am confused — providing the studies are sound (and if it turns out they are BS, I will immidiately rest my case and sprinkle ashes on my head!), then is this not enough for an initial risk assesment?

            Another question I have is about anecdotal evidence. I too can attest how, when I was still using electronic cigarettes, I could feel benefits of quitting regular cigarettes within hours and within a few weeks I could run up several flights of stairs without panting. These kinds of things.

            Now I am not saying anecdote is evidence, but surely what people report can be classified on some sort of a scale of trustworthiness, relevance, factuality. Somewhere in these very comments you brought the example of sworn testimonies about vaccination=autism by thousands of parents. Yes, we all use hyperbole, but is it not a completely different thing to ask smokers-cum-vapers about things like shortness of breath or specific measurable physical acts (climbing stairs, jogging, etc)? I mean — for vaccines+autism we know there is no causality as much as we can know anything in science. For e-cigarettes, however, we have reason to believe that inhaling dramatically less bad chemicals might lead to certain positive outcomes. So when people actually report these outcomes, how is it that we can dismiss the latter reports just as easily as we can dismiss the former ones? Is reporting bias really this awful!?

            And yes, I know all these purported benefits are short-term, but isn’t this were the risk _assesment_ comes to play. If we had exact longitudinal data, there would be no need for assesments, we’d be able to make definitive statements (like for vacines & autism). But data lacking, one has to extrapolate and guess to the best of available knowledge. Here, again, I fail to see anyone offering a sound hypothesis about the health risks of electronic cigarettes(*).


            * Relative to regular cigarettes. This is the mantra!

          2. Todrick says:

            “Based on medicine and science, what are nicotine containing e-cigarettes, if not a drug/device combination whose sole purpose is to deliver a dose of nicotine to the lungs?”

            Good Question… The answer get’s a bit complicated….

            First, That is not their sole purpose… if it was, there would be no visible vapor and flavoring wouldn’t matter. But it does. I’ve vaped flavorless and it’s boring and not very pleasurable… Also, it is possible to exhale no vapor, called “stealth vaping” also, boring and not as pleasurable.

            So when you take into account the flavor and pleasure derived from the act, in addition tot he addictive nature of the nicotine that they may OR may not contain.

            I guess they should be regulated like Coffee.
            It’s the only logical omparison… OK, maybe Carbonated Soft Drinks is a good one too.

            Certainly not a Medical device like an insulin pump or a tobacco product like Cigarettes.

            Both of those could only be seen as viable comparisons to people who have never vaped.

        2. David Gorski says:

          I guess they should be regulated like Coffee.
          It’s the only logical omparison… OK, maybe Carbonated Soft Drinks is a good one too.

          Uh, no. that doesn’t make sense at all. First, note that I specified “nicotine-containing” e-cigarettes, not nicotine-free e-cigs. You’re conflating the two. Even I would agree that nicotine-free e-cigs probably don’t need to be regulated as a medical device, but that’s not what I was talking about. Second, coffee is not consumed primarily as a medicine designed to decrease the use of a harmful and addictive product like tobacco. That’s a medical purpose. Third, coffee is not a vehicle for administering purified caffeine, as e-cigs are a vehicle for administering purified nicotine.

          So, no, I’m afraid your analogy doesn’t hold.

          1. Todrick says:

            “Uh, no. that doesn’t make sense at all. First, note that I specified “nicotine-containing” e-cigarettes, not nicotine-free e-cigs. You’re conflating the two. ”

            Then regulate like Caffeinated coffee.

            That analogy works fine.

            Coffee = eLiquid
            Cup = eCigarette

            The analogy is actually, incredibly strong…
            You have your product that contains an addictive stimulant
            and you have your method of delivery

            “Even I would agree that nicotine-free e-cigs probably don’t need to be regulated as a medical device, but that’s not what I was talking about.”

            So do you propose police carry Nicotine Test Kits?

            I know you may claim that policy and law is not the issue, but in this case the two cannot be separated, how can you regulate something you can’t identify?

            “Second, coffee is not consumed primarily as a medicine designed to decrease the use of a harmful and addictive product like tobacco.”

            Coffee IS consumed to self medicate withdrawal from Caffeine for many/most regular coffee drinkers.

            It’s not Nicotine’s fault that no one ever bothered to Smoke Tea leaves.

            That’s the issue… If smoking tea leaves gave you cancer(I’m pretty damn sure it would)… would people be calling for the regulation of Coffee?

            “Third, coffee is not a vehicle for administering purified caffeine, as e-cigs are a vehicle for administering purified nicotine.”

            ‘Purified’ is an interesting term.

            The alternative method of getting ‘un-purified’ nicotine, is to smoke… eCigarettes are possible only by extracting nicotine from the leaves.

            But you are perhaps mistaken anyway. Espresso is a form of coffee that greatly concentrates (‘purifies’) the caffeine content per ml.

          2. Chris says:

            Todrick: “Then regulate like Caffeinated coffee.”

            Hmmm. Well I actually give left over coffee to my roses (long with the spent grounds) to my roses, and it has not caused them any damage. I don’t think coffee or black tea will really harm the insects in my garden.

            Now contrast that to the fairly nasty insecticide you can make with some tobacco and water. It kills lots of bugs.

            Do you see a difference?

  19. nancy brownlee says:

    @ Chris- Nicotine is a cheap, effective pesticide, worth trying in some applications. When I had a big market garden, I soaked chewing tobacco in water overnight or longer, then used the strained juice to hand spray big, bothersome pests- like tomato hornworms. Very effective, very short-term contact poison. Rain or a sprinkle with the hose washed it away and in any case it broke down fast. That was years ago- decades- before BT was readily available.

    1. Chris says:

      I know. But it is not a selective pesticide and I don’t want to harm my neighbor’s honeybees. If anyone is afraid of bees and spiders, stay out my garden because there are lots of them!

  20. Bill Godshall says:

    If the real purpose of this piece was to objectively analyze the scientific and empirical evidence about consumer and public health risks and benefits of e-cigarettes, Gorski wouldn’t have started the article by citing Jenny McCarthy’s outrageous vaccine fear mongering past or by critiquing recent e-cig advertisements.

    But Gorski’s irrational bias against e-cigarettes permeates this entire article.

    The repeated daily inhalation of tobacco smoked (not the use of tobacco or nicotine) causes >99% of all tobacco attributable disease, disability, death and healthcare costs. That’s because cigarette smoking is more than 100 times more harmful than daily use of smokefree tobacco/nicotine products.

    Gorski wrote:
    “For reasons that are unclear to me, the FDA declined to challenge the ruling, but retains the power under the Tobacco Control Act to add categories to the tobacco products it regulates after going through procedural steps that include a public comment process.”

    The reason why the FDA failed to file a writ of certiori with the SCOTUS on April 25, 2011 is because at least five of the Justices (Roberts, Scalia, Alito, Thomas, Kennedy) would have ruled against the FDA had the SCOTUS agreed to consider the case. And the only thing worse than FDA losing a 13-0 decision in the US Court of Appeals would have been losing in the Supreme Court.

    Smokefree Pennsylvania and other public health groups (including ACSH, American Association for Public Health Physicians and Dr. Mike Siegel) and e-cigarette consumer consumer groups (including CASAA) filed an amicus brief with the DC Court of Appeals in 2010 opposing FDA’s import ban on e-cigs because it was unlawful, inhumane, unethical and totally irrational (as FDA’s action protected lethal cigarettes from market competition by far less hazardous smokefree e-cigs, and threatened the lives of vapers and smokers).

    In sharp contrast to Gorski’s criticism, the growing mountain of scientific and empirical evidence consistently indicates that e-cigarettes:

    - are 99% (+/-1%) less hazardous than cigarettes,
    - pose no risks to nonusers,
    - emit similar levels of constituents as FDA approved nicotine inhalers.
    - are consumed almost exclusively (i.e. 99%) by smokers and former smokers who quit by switching to e-cigs,
    - have never been known to addict any nonsmoker (or youth) to nicotine,
    - have helped several million smokers quit and/or sharply reduce cigarette consumption,
    - have replaced/reduced about 750 million packs of cigarettes in past five years,
    - are more effective than nicotine gums, lozenges and patches for smoking cessation and
    reducing cigarette consumption, and
    - pose fewer risks than FDA approved Chantix or Wellbutrin.

    While I strongly concur with Gorski desire for more research on e-cigarettes (and have been advocating for e-cig research and funding since 2007), the fact is that federal public health agencies (i.e. FDA, NIH, CDC and other DHHS agencies), drug industry funded anti tobacco groups (i.e. CTFK, ACS, AHA, ALA, Legacy) and smoking cessation researchers have rejected our many requests that they fund and/or conduct research on the impacts of e-cigarettes on smokers.

    Instead of conducting or funding useful research on e-cigs, Obama appointees at DHHS and the drug industry funded anti tobacco groups (who lied about e-cigarettes in 2009 in an unsuccessful attempt to scare the public and influence federal judges who were adjudicating the SE//NJOY lawsuit against FDA) have chose to continue making false and misleading fear mongering claims about e-cigarettes.

    In retrospect, had FDA been able to ban e-cigarettes (as then Deputy Commissioner Josh Sharfstein, a former Waxman staffer, insisted upon doing in spite of all the evidence supporting e-cigs), several million e-cigarette consumers would have smoked an additional 750 million packs of cigarettes, and the vast majority of them would still be smoking or be dead.

    Perhaps Gorski can explain why millions of smokers are better off smoking or dead than being alive and healthy vapers, as nobody at DHHS or any other e-cigarette prohibitionists have explained that inhumane and unethical policy.

    Regardless, since April 25, 2011 the FDA has restated its intent to regulate e-cigarettes as tobacco products by imposing the “deeming” regulation and by imposing additional regs on e-cigs.

    But the FDA and the news media refuse to acknowledge that the “deeming” regulation would ban all e-cigarettes (per Section 905(j) and Section 910 of the Tobacco Control Act), would prohibit e-cig companies from truthfully claiming that e-cigs “emit no smoke” (per Section 911), and would otherwise decimate the e-cigarette industry.

    Even if the FDA exempts e-cigarettes from these worst provisions in Chapter IX of the federal Tobacco Control Act, imposing the “deeming” regulation and additional regulations on e-cigarettes would likely ban 99% of e-cigarette companies and products, and basically give the e-cigarette industry to the existing oligopoly of Big Tobacco companies.

    Regarding the fear mongering claim that e-cigarette vapor harms nonusers (stated by those campaigning to ban e-cig use wherever smoking is banned) all of the following products and activities emit far more indoor air pollution than does an e-cigarette. But of course, none of the e-cigarette prohibitionists have called for bans or restriction on any of them.

    - plywood and other building materials
    - glues
    - paint
    - carpeting
    - furniture
    - appliances
    - cooking
    - every exhale by every smoker for more than an hour after smoking every cigarette
    - smoker’s clothes and hair
    - printers
    - photocopiers
    - computers
    - cleaning products
    - dry cleaned clothes
    - hair sprays
    - perfumes
    - nail polish and nail polish remover
    - air fresheners

    William T. Godshall, MPH
    Executive Director
    Smokefree Pennsylvania
    1926 Monongahela Avenue
    Pittsburgh, PA 15218
    412-351-5880
    smokefree@compuserve.com

    1. David Gorski says:

      In sharp contrast to Gorski’s criticism, the growing mountain of scientific and empirical evidence consistently indicates that e-cigarettes:

      If there’s such a “growing mountain” of scientific evidence indicating all these things, why, then, couldn’t I easily find it on PubMed? And don’t think I didn’t look hard for it. I did. I was shocked at the dearth of high quality scientific studies in the peer-reviewed medical and scientific literature, but, then, I did say that in my post, didn’t I? :-)

      - are 99% (+/-1%) less hazardous than cigarettes,

      In the short term. As I pointed out, there are no long term data. In the long term, we don’t know how much safer than tobacco cigarettes e-cigarettes are. Besides, as I’ve repeated, that’s a mighty low bar for safety, given how nasty tobacco cigarettes are.

      - pose no risks to nonusers,

      Unproven, but, then, you’re rebutting a claim I never made. That’s a logical fallacy known as a straw man argument. Actually, now that I reread your comment, it occurs to me: That’s a very high level claim to make. “No risk”? I mean, geez, nothing poses absolutely “no risk.” Everything has risk, even if that risk is very, very tiny and, based on how small it is, reasonably discounted. But that’s not what you said. What you said is “no risk.” You know what they say about who thinks in absolutes. (If you’re a Star Wars geek, as I am, you’ll know what I’m talking about. :-) )

      - emit similar levels of constituents as FDA approved nicotine inhalers.

      Then it should be no problem to get them FDA-approved, should it?

      - are consumed almost exclusively (i.e. 99%) by smokers and former smokers who quit by switching to e-cigs,

      Citation and evidence from peer-reviewed literature to support this statement, please?

      - have never been known to addict any nonsmoker (or youth) to nicotine,

      What’s with the straw man fallacies? Once again, you’re rebutting a claim I never made. Funny that. One suspects your comment might well be a cut ‘n’ paste job.

      - have helped several million smokers quit and/or sharply reduce cigarette consumption,

      Evidence from peer-reviewed medical journals to support this assertion, please. Even better, got any randomized controlled clinical trials to show e-cigarettes are effective for this purpose?

      - have replaced/reduced about 750 million packs of cigarettes in past five years,

      Evidence from peer-reviewed medical journals to support this assertion, please. Even better, got any randomized controlled clinical trials to show e-cigarettes are effective for this purpose?

      - are more effective than nicotine gums, lozenges and patches for smoking cessation and
      reducing cigarette consumption, and

      Evidence from peer-reviewed medical journals to support this assertion, please. Even better, got any randomized controlled clinical trials to show e-cigarettes are effective for this purpose?

      - pose fewer risks than FDA approved Chantix or Wellbutrin.

      Even if this is true, it is currently irrelevant, given that we don’t even know yet if e-cigarettes are efficacious as smoking cessation aids, and, if they’re efficacious, how efficacious.

      In retrospect, had FDA been able to ban e-cigarettes (as then Deputy Commissioner Josh Sharfstein, a former Waxman staffer, insisted upon doing in spite of all the evidence supporting e-cigs), several million e-cigarette consumers would have smoked an additional 750 million packs of cigarettes, and the vast majority of them would still be smoking or be dead.

      Repetition without evidence does not constitute science.

      Even if the FDA exempts e-cigarettes from these worst provisions in Chapter IX of the federal Tobacco Control Act, imposing the “deeming” regulation and additional regulations on e-cigarettes would likely ban 99% of e-cigarette companies and products, and basically give the e-cigarette industry to the existing oligopoly of Big Tobacco companies.

      Even if true, this is not evidence for the claims made for e-cigarettes. This is a policy question, not a question of science.

      Regarding the fear mongering claim that e-cigarette vapor harms nonusers (stated by those campaigning to ban e-cig use wherever smoking is banned) all of the following products and activities emit far more indoor air pollution than does an e-cigarette. But of course, none of the e-cigarette prohibitionists have called for bans or restriction on any of them.

      - plywood and other building materials
      - glues
      - paint
      - carpeting
      - furniture
      - appliances
      - cooking
      - every exhale by every smoker for more than an hour after smoking every cigarette
      - smoker’s clothes and hair
      - printers
      - photocopiers
      - computers
      - cleaning products
      - dry cleaned clothes
      - hair sprays
      - perfumes
      - nail polish and nail polish remover
      - air fresheners

      Excellent diversion! Of course I never made the claim that e-cigarette vapor harms nonusers. That’s at least three blatant straw man fallacies in your comment, although admittedly two are simply repetitions of the same straw man. Seriously, did you even bother to read my post? Look it over again. Here’s a hint: I never made that claim. In fact, I didn’t even discuss that claim.

      In any case, you say there’s a “growing mountain of evidence.” Funny that you didn’t see fit to directly cite any of it to support your assertions.

  21. I have quit smoking after 41 years. My health has improved dramatically in just about every way. I can breathe again, I have a new sense of smell and taste. I have gotten off of welbutrin.
    I can say in all honesty that e-cigarettes are the best thing to happen to me in years. I predict they will add years to my life.

    If you want a real idea of the safety of e-cigarettes ask one of the million or so ex-smokers that have switched to e-cigarettes. We are the ones who DO have something to lose.

    1. Becca says:

      Closer inspection of your first cluster of papers reveals that the (incredibly) productive Italian group including Caponnetto, Campagna et al. has a close relationship with a single e-cigarette manufacturer (Arbi Group SRL), who provided the materials for their randomized trial. Dr. Riccardo Polosa is even featured on the manufacturer’s website providing an endorsement of their product! Some quick googling brought me here: http://www.tobaccotactics.org/index.php/E-cigarettes:_Mixing_Research_and_Marketing

      This does NOT mean that their results are wrong. But the troublesome conflicts of interest combined with the inherent weakness in their trial design (low number of participants, large number lost to follow up, etc) means that the jury is still out. We need an independent scientist to do a robust trial, which is what Dr. Gorski is asking for in his post above.

      1. An independent scientist to do a robust trial, eh? That would be lovely, if Dr. Gorski is willing to volunteer. The independent scientist would need to be able to recruit a large number of smokers and have the funds to pay a staff to meet with subjects, distribute supplies, collect data, and compile results. He’d also have to invest in e-cigarette hardware and a year’s worth (or more, if possible) of liquid for each participant–maybe $200 per subject would cover it. And to be robust, we’d need to triple the number of subjects in the Italian study–say a total of 1,000 smokers. Not counting labor and incidentals, that’s about $200K to start. It often isn’t easy to find such generous and independently wealthy scientists.

        Maybe that’s why companies that want to prove something about their product hire independent researchers to conduct clinical trials. They also provide enough of whatever product is being tested to supply all the subjects in the study. You know, companies like Pfizer, GlaxoSmith Kline, etc. do this. And it is standard operating procedure for the researchers to insist in writing that the benefactor company makes no attempt to influence the results in any way.

        1. Becca says:

          As a clinical scientist myself, I am more than aware of the costs of performing clinical trials. Luckily that’s why we have institutions such as the NIH to fund these things! Companies that hire researchers to do these studies are doing so such that they get done quickly and the company can more aggressively market their product. It is not out of the goodness of their hearts or because they are worried about consumer safety.

          At this point, there is absolutely no incentive for e-cigarette manufacturers to do anything to prove safety and/or efficacy of their products – they are able to sell them under current regulations and make a profit, their only goals.

          1. I do not know of a grant from ANY government agency in any country that was available in 2011 for the purpose of conducting an e-cigarette clinical trial. I’m not sure there is such a grant available even today.

            In 2011 I attended the SRNT meeting in TX and the antipathy to e-cigarettes among the scientists and policy makers was palpable. When I stood up in an auditorium full of people and reported that I had quit smoking in March of 2009 using e-cigarettes, they told me that I must be a special case. I’ve heard they have mellowed some since then. I certainly hope so. But to read the Tobacco Control journal (especially the editorials), it looks to me like there are still many antis running the show. I hope I’m wrong.

        2. David Gorski says:

          Actually, it would be way more expensive than what Elaine describes to perform a study of the sort she has in mind. Think more in the range of $1-2 million to do such a study. The e-cigarettes and supplies would likely be the cheapest part of the trial.

          However, you don’t have to start out with such a large trial. A smaller randomized, controlled phase II trial would be a good starting point.

          In any case, nothing’s stopping interested scientists in the US from applying to the NIH for funding for such a clinical trial or for scientists elsewhere to apply for funding mechanisms in their own countries.

          1. I’ll be happy to pass along your suggestion to Dr. Polosa. He runs a large clinic in Sicily that treats asthma patients, and he learned about e-cigarettes from several of his patients. He became intrigued enough to want to study the potential of the products for helping smokers who can’t quit. He has seen more than his share of such people and I believe it breaks his heart.

            It upsets me to see him being accused of fraud. As far as I know, there were no such grants available when he began his studies, so he did the best he could.

            I suggested 1,000 subjects because people keep complaining that his study with 300 subjects was too small. So what’s a good number?

    2. windriven says:

      “I can say in all honesty that e-cigarettes are the best thing to happen to me in years. I predict they will add years to my life.”

      I can honestly say that quitting smoking is the best thing to happen to me in years. I predict it will add years to my life. And unlike electronic cigarettes it didn’t cost me a cent.

  22. Bill Godshall says:

    If Gorski prefers a document dump, the following case reports, user surveys and clinical trials consistently found that e-cigarettes are effective in helping smokers quit (including smokers who didn’t want to quit) and sharply reduced cigarette consumption.

    Caponnetto P, Polosa R, Auditore R, Russo C, Campagna D: Smoking Cessation with E-Cigarettes in Smokers with a Documented History of Depression and Recurring Relapses. International Journal of Clinical Medicine 2011, 2:281-284.

    Caponnetto P, Polosa R, Russo C, Leotta C, Campagna D: Successful smoking cessation with electronic cigarettes in smokers with a documented history of recurring relapses: a case series. Journal of Medical Case Reports 2011, 5:1-6.

    Etter J-F, Bullen C: Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction 2011, 106:2017-2028.

    Siegel M, Tanwar K, Wood K: Electronic cigarettes as a smoking-cessation tool: results from an online survey. American Journal of Preventive Medicine 2011, 40:472-475.

    Polosa R, Morjaria JB, Caponnetto P, Campagna D, Russo C, Alamo A, Amaradio M, Fisichella A. Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study. Intern Emerg Med. 2013 Jul 20. [Epub ahead of print]

    Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, Polosa R. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study. PLoS One. 2013 Jun 24;8(6):e66317.

    Polosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, Russo C. Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health. 2011 Oct 11;11:786.

    But instead of addressing any of my points about what we do know (and we know an awful lot) about e-cigarettes, Gorski further criticizes e-cigarettes and e-cigarette companies by diverting attention back to research that FDA, CDC, NIH and others have refused to fund or conduct.

    Besides, a lack of many clinical trials is not the same as the absence of evidence.
    Using Gorski’s rationale, since no clinical trials were conducted, there is no scientific evidence that parachutes can save a person’s life after jumping out of an airplane.

    When tens of thousands of people present testimony saying they quit smoking by switching to e-cigarettes, and when many survey’s (including some published in peer reviewed journals) confirm that many smokers have quit by switching to e-cigs, it is absurd to insist that they all must be lying unless/until a long term clinical trial is first conducted.

    But if Gorski wants prefers relying upon clinical trials (and ignoring all/most other evidence), lets look at the evidence on FDA approved nicotine gums, lozenges and patches.

    A meta-analysis found that an average of just 7% of those using over-the-counter NRT products remained cigarette free after six months, a 93% relapse rate.
    A meta-analysis of the efficacy of over-the-counter nicotine replacement, Hughes JR, Shiffman S, Callas P, Zhang Z, Tobacco Control, 2003, Vol. 12, 21-27. http://tc.bmjjournals.com/cgi/content/full/12/1/21?ijkey=5.ko5/Oz4yutl

    Another meta-analysis also found that 7% of smokers using NRT remained cigarette free after six months, and that just 2% remain cigarette free after 20 months (a 98% relapse rate).
    Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis, David Moore, Paul Aveyard, Martin Connock, Dechao Wang, Anne Fry-Smith, Pelham Barton, BMJ 2009;338:b1024
    http://www.bmj.com/cgi/content/full/338/apr02_3/b1024

    Another meta analysis of seven placebo controlled randomised controlled trials involving different NRT products found that just 6.75% of those receiving NRT had quit smoking after six months. Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis, David Moore, Paul Aveyard, Martin Connock, Dechao Wang, Ann Fry-Smith, Pelham Burton, BMJ 2009; 338:b1024
    http://www.sciencedirect.com/science/article/pii/S0306460311001572

    While supposedly double-blind clinical trials have found that NRT products double the chances of quitting when compared to using a placebo, skepticism has been raised about the accuracy and reliability of these studies, since it is likely that many participants who were assigned to placebos realized they were not getting nicotine.
    The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials, Mooney M, White T, Hatsukami D, Addictive Behaviors, 2004 Vol. 29, 673-684. http://whyquit.com/studies/NRT_Blinding_Failures.pdf
    Precessation treatment with nicotine patch significantly increases abstinence rates relative to conventional treatment, Jed E. Rose, Joseph E. Herskovic, Frederique M. Behm and Eric C. Westman, Nicotine & Tobacco Research 2009 11(9):1067-1075; doi:10.1093/ntr/ntp103.
    http://ntr.oxfordjournals.org/cgi/content/abstract/ntp103

    Skin patches appear to be ineffective smoking cessation aids for those who fail to quit smoking during their first use of NRT, as two published studies on the use of NRT skin patches to quit smoking after an initial failure with NRT found six-month smoking cessation rates of 0% and 1.4%, respectively.
    Recycling with nicotine patches in smoking cessation. Tonnesen P, Norregaard J, Sawe U, Simonsen K, Addiction. 1993 Apr;88(4):533-9.
    http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=8485431&query_hl=2
    Double blind trial of repeated treatment with transdermal nicotine for relapsed smokers. Gourlay SG, Forbes Q, Marriner T, et al. British Medical Journal, 1995, Vol. 311, No 7001 363-366.

    A survey of 500 U.S. smokers found only 16% agreed that NRT helps people quit smoking.
    Attitudes toward nicotine replacement therapy in smokers and ex-smokers in the general public. Etter JF, Perneger TV, Clinical Pharmocol Therapy 2001 Volume 69, 175-83.

    And a recent Gallup Poll found 48% of former smokers in US reported quitting “cold turkey”, 5% with nicotine patch, 3% with e-cigarettes, 2% with prescription drugs, 1% with nicotine gum.
    http://www.gallup.com/poll/163763/smokers-quit-tried-multiple-times.aspx?
    http://www.huffingtonpost.com/2013/08/04/quit-smoking-cigarettes_n_3684381.html

    Please note, however, that the vast majority (>90%) of former smokers in the US quit smoking more than 5 years ago, that nicotine gum has been on the market since 1984, nicotine skin patches since 1992, Wellbutrin since 1986 and Chantix since 2006.

    And while FDA approved drugs have been heavily promoted by drug companies, public health agencies, and drug industry funded anti tobacco groups as the only effective way to quit smoking, e-cigarettes have been demonized by those same health agencies and many industry and taxpayer funded groups, were unlawfully banned by FDA, and their use in public places has been banned by extremist state/local governments and employers.

    Bill Godshall

    1. David Gorski says:

      If Gorski prefers a document dump, the following case reports, user surveys and clinical trials consistently found that e-cigarettes are effective in helping smokers quit (including smokers who didn’t want to quit) and sharply reduced cigarette consumption.

      Are any of them randomized, placebo-controlled? Nope? Didn’t think so. BTW, I’ve read most of the articles you cite below.

      Caponnetto P, Polosa R, Auditore R, Russo C, Campagna D: Smoking Cessation with E-Cigarettes in Smokers with a Documented History of Depression and Recurring Relapses. International Journal of Clinical Medicine 2011, 2:281-284.

      A case series of two smokers in an open access journal I’ve never heard of that doesn’t even appear to be indexed on PubMed? Seriously?

      Caponnetto P, Polosa R, Russo C, Leotta C, Campagna D: Successful smoking cessation with electronic cigarettes in smokers with a documented history of recurring relapses: a case series. Journal of Medical Case Reports 2011, 5:1-6.

      OK, here’s one I didn’t read before writing this post. I’m not impressed. A case series of three smokers? I suppose that’s marginally better than a case series of two smokers, but you’re not impressing me.

      Etter J-F, Bullen C: Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction 2011, 106:2017-2028.

      Read it before I wrote my post. An Internet survey of users of e-cigarette websites and discussion forums? Seriously? How does dreck like this get published? Do the words “selection bias” mean anything to you? Did you bother to read my post, where I discussed briefly just why such surveys are not good evidence?

      Siegel M, Tanwar K, Wood K: Electronic cigarettes as a smoking-cessation tool: results from an online survey. American Journal of Preventive Medicine 2011, 40:472-475.

      I read it before I wrote my post. Another Internet survey, this time of first-time e-cigarette buyers? Do the words “selection bias” yet mean anything to you? How about the phrase “lack of control group”?

      Polosa R, Morjaria JB, Caponnetto P, Campagna D, Russo C, Alamo A, Amaradio M, Fisichella A. Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study. Intern Emerg Med. 2013 Jul 20. [Epub ahead of print]

      I read it, and, as I pointed out, I discussed two studies with similar design, which I chose to discuss rather than this one. Does the phrase “lack of adequate control group” mean anything to you? Does “lack of randomization” mean anything to you? I also notice that 17/40 subjects were lost to followup. That’s a very high number.

      Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, Polosa R. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study. PLoS One. 2013 Jun 24;8(6):e66317.

      My goodness. You didn’t read my post very carefully, did you? Not only did I read this study as part of my research, but I discussed this study in depth right in my post! Go back and look again. This was basically a negative study.

      Polosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, Russo C. Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health. 2011 Oct 11;11:786.

      I read this one, too, and didn’t include it because it was one of the less rigorous studies.

      Seriously, I get the feeling that you simply saw the title of my post, read the first few paragraphs, clutched your pearls because I started out talking about Jenny McCarthy becoming a spokesperson for e-cigarettes, and then regurgitated cut ‘n’ paste talking points and lists of studies, none of which have adequate control groups or are randomized controlled trials.

      But instead of addressing any of my points about what we do know (and we know an awful lot) about e-cigarettes, Gorski further criticizes e-cigarettes and e-cigarette companies by diverting attention back to research that FDA, CDC, NIH and others have refused to fund or conduct.

      Besides, a lack of many clinical trials is not the same as the absence of evidence.
      Using Gorski’s rationale, since no clinical trials were conducted, there is no scientific evidence that parachutes can save a person’s life after jumping out of an airplane.

      Do you really think I’m not intimately familiar with this article? I love the article and use it in my talks. (Take a look here if you don’t believe me, but you’ll have to watch a video of a talk I gave in DC last spring to get to it. I forget exactly at what point in the talk I cite this example, although I do know it’s slide #40.) Seriously, though. Search for the term “methodolatry” on this blog. See what I wrote about it. I understand clinical evidence, and I am not dogmatic about accepting, for example, epidemiological evidence or a confluence of lesser forms of evidence when randomized clinical trials are not available.

      When tens of thousands of people present testimony saying they quit smoking by switching to e-cigarettes, and when many survey’s (including some published in peer reviewed journals) confirm that many smokers have quit by switching to e-cigs, it is absurd to insist that they all must be lying unless/until a long term clinical trial is first conducted.

      How many logical fallacies do I see in this? At least two. There is a straw man arguent, given that I never said that the people giving these testimonials are lying. Indeed, funny that I just wrote about this today on my not-so-secret other blog. Let’s just put it this way. I am not accusing people of lying. I am, however, making a well-known observation, which I’ve liberally cut and pasted from there..

      In the evidence-based medicine (EBM) paradigm, observations begin with clinical observation. A careful clinical observation in which the patient’s history, diagnostic tests, treatments, and clinical course are carefully documented is basically an anecdote. (I realize I’ve been critical of EBM for ignoring prior plausibility and fetishizing the randomized clinical trial further above all other forms of clinical evidence than is deserved, but that doesn’t mean the general paradigm isn’t generally correct when prior plausibility is taken into account.) In EBM/SBM, anecdotes are not, straw men by quacks to the contrary, dismissed out of hand. Rather, they are useful as hypothesis generating observations, but they are not sufficient. The next step must be to test the hypotheses generated in more patients. This sort of observation can range from a case series (several anecdotes examined together for commonalities and differences) to retrospective observational studies, to a pilot study, which is usually a small study without a control group to test safety and look for indications of efficacy. It then takes a series of trials of increasing rigor to demonstrate that a treatment works. E-cigarettes haven’t climbed that ladder of rigor. They’re still stuck at the pilot study stage.

      As I like to say, the plural of “anecdote” is not necessarily “data.” The point is that in EBM/SBM it is fully understood that individual anecdotes can be profoundly misleading regarding the efficacy and safety of a therapy. Placebo effects, confirmation bias, regression to the mean, and any number of other confounders can provide the illusion of efficacy when there is none. Individual human observations and human memory are extremely fallible. You only have to consider the seemingly never ending testimonials for homeopathy, which is, quite literally, nothing (well, nothing more than water or water embedded in sugar pills). Similarly, if there is any treatment that is even more clearly nothing than homeopathy, it’s reiki. Reiki claims that healers known as reiki masters can channel the “universal energy” into a patient for healing effect. It’s nothing more than faith healing that substitutes Eastern mysticism for Christian beliefs.

      That’s why I do not consider testimonials to be sufficient. I can find hundreds of parents who swear that vaccines turned their children autistic and believe it with ever bit as much fervor as e-cigarette mavens believe that they could never have stopped smoking tobacco without their e-cigs. That doesn’t mean it is generally true that e-cigs are an effective smoking cessation aid.

      The other logical fallacy you use is the appeal to popularity. Just because something is popular doesn’t mean it works or is scientifically validated.

      The rest of your points are hardly worth addressing other than to say that the poor track record of other NRTs does not mean that e-cigarettes work. It means that we need to do better in creating more effective evidence-based smoking cessation aids. Whether e-cigarettes will be one of them, we just don’t know yet, your “document dump” and failure even to read what I wrote for comprehension notwithstanding.

      1. Well, I was all for promoting the idea of evidence-based medicine until I read Mr. Gorskis’s opinion which ADD UP TO saying that evidence-based medicine recommends continued smoking of combustibles until and unless all the gov’t and private orgs with policies against studying tobacco or nicotine change their policies and do a 20-year study.

        I don’t have that long.

        I’m also not going to give up my caffeine drug-delivery devices (coffee cups) or my ethanol drug-delivery devices (wine glasses) until someone tries prohibiting caffeine or alcohol….oh, wait.

        Go ahead and do medical recommendations to keep smoking. Just keep out of my legislature, congress, FDA, etc. The practice of medicine is not the same as the practice of life, and should no more control my life than my programming expertise would dictate totally different consumer computer choices than are now popular. As long as it is ONLY a recommendation, fine.

        1. WilliamLawrenceUtridge says:

          That’s a rather gross misrepresentation of what Dr. Gorski said. The recommendation is “don’t smoke” and has been for decades. The debate is over the relative benefits of e-cigarettes as a science-based harm-reduction device, as well as any actual harms associated with it at all – but no agency is urging people to take up e-cigarettes (bar, perhaps, the tobacco companies). I’m frankly amazed there is a debate, I had mentally substituted “nicotine inhaler” for much of my reading of the article, as the differences seem remarkably minimal. One has a light, the other doesn’t?

          Dr. Gorski’s recommendations do not, from my recall, ever state that e-cigarettes are the same thing as real cigarettes. Your attempt at a “health freedom” and “personal responsibility” rallying cry is unconvincing and deceptive, but is remarkably close to the party line toed by manufacturers and Big Tobacco. No black helicopters are swooping down to take your cigarettes, electronic or otherwise, it’s merely a discussion of whether e-cigarettes are worth the hype. Try reading the whole article.

          1. Read what the FDA can/is required to do with “Unregulated Drug Delivery Devices.”

          2. Lemmit says:

            > No black helicopters are swooping down to take your cigarettes, electronic or otherwise

            Yes they are. US is not the only country in the world. EU is debating new tobacco policies right now. There is a chance that e-cigarettes will be restricted more than regular cigarettes are. In my personal opinion this is absurd at best and criminal at worst. Science-wise, The Royal College of Physicians agrees.

          3. WilliamLawrenceUtridge says:

            Oh no! You’ll have to go to your doctor and get a prescription! Maybe that minor inconvenience will lead to you quitting completely! HEAVEN’S TO BETSY!!!

            The whole thing seems like a tempest in a teapot to me, simply not worth the heat or light generated. 100 comments in 3 days over a novelty variation of something that already exists? Why bother.

        2. David Gorski says:

          Well, I was all for promoting the idea of evidence-based medicine until I read Mr. Gorskis’s opinion which ADD UP TO saying that evidence-based medicine recommends continued smoking of combustibles until and unless all the gov’t and private orgs with policies against studying tobacco or nicotine change their policies and do a 20-year study.

          What is it with the propensity for straw man logical fallacies among e-cigarette fans? I mean, seriously. That one’s such a gross misrepresentation of what I wrote that it’s not worth responding to other than to point out that it’s a gross misrepresentation of what I wrote.

          Are people here starting to understand why I see so many parallels between e-cigarette promoters and the antivaccine movement as embodied by Jenny McCarthy? The two are made for each other. The sad thing is, the two represent positions with very different levels of evidence. It’s very clear that vaccines are safe and almost certainly do not cause autism; so the antivaccine movement is completely wrong on that. In contrast, it’s a legitimate open question whether e-cigarettes are safe and effective as a tobacco harm reduction strategy. Moreover, prior plausibility suggests a reasonable likelihood that they could be effective. Now if anyone would just do the right kinds of studies to figure it out one way or the other! Yet, when I say that we don’t know and more studies are definitely needed, e-cig aficionados attack me as though I’m trying to kill them. And, no, that’s not much of an exaggeration.

          Yes, there are many parallels between the e-cig boosters who have descended on this blog and the antivaccine movement. The sad thing is, I am agnostic with respect to e-cigs, as I’ve pointed out many times before. I’ll admit that right now I’m more skeptical and tend to doubt they are that great, but my mind could be easily changed by evidence and studies, if they are high quality. I have yet to see any such high quality evidence and studies about e-cigs, and it’s the people who could most benefit from a new, better tobacco harm reduction strategy who seem most opposed to actually studying e-cigs in a manner that would answer the questions about them once and for all.

          1. Every lawmaker or policy maker we talk to says the studies don’t count if we support or fund them. So…what do you propose we do?

          2. David Gorski says:

            Which studies were funded by “you” (“you,” I assume to mean the pro-e-cig activist movement)? If they’re any of the studies I discussed (and note how I didn’t even mention funding sources), then you should be demanding your money back.

          3. You’re thinking medically. I’m thinking legally. I’ve heard California Senator Corbett and others, at state, county, and city-level meetings, quote even the teensiest level of contribution towards ANY lab study or medical trial (which are NOT the same thing!) as though touch of money or support is enough, all by itself, to invalidate a study regardless of methodology. Starting with a simple lab result in New Zealand. Should the e-cigs company that asked for the lab analysis have refused to pay the bill?

  23. Lemmit says:

    Hmm, it seems comments here only go a few levels deep, so I am trying to reply to Chris, but have no idea where exactly this comment will end up.

    “If you read the paper rather than just the abstract, you would know the answer. And you cannot tell if the science is sound unless you read the paper.”

    Not necessarily. You are correct in that I haven’t read that paper, but even if I had, the specifics of the science might be absolutely beyond my understanding. So unfortunately yes, many times I simply do the due diligence I outlined above.

    Thank you for the pointers to books. I have been an avid reader of SBM and both abstracts (as well as contents) of stuff on pubmed for a while now. But as my budget is scarse, I cannot really go out and buy your recommendations, even though they’d fit my reading list nicely.

    Last but not least — I am not defending said study, nor condemning it. I would be thrilled however, if someone knowledgeable would offer insights. Our musings have not said anything substantial about the claims made there.

    1. The books that Chris listed should be easy to get from a library–ask about inter-library loan if you live in a small town or your library doesn’t have them for some other reason. You can also read through the archives of this blog and learn a great deal. The e-books sold here (not much for even a sparse budget) are good collections from the archives.

    2. Chris says:

      I do not own any of those books, I checked them out from the public library.

      “You are correct in that I haven’t read that paper, but even if I had, the specifics of the science might be absolutely beyond my understanding.”

      If you live near a university, especially a public one, you can ask their library if they have a subscription to that journal. Then get a temporary library card to read it there. My local library has terminals to read papers specifically for the public at the medical school library, and also at the engineering library.

      1. Chris, I could read full-length papers all day and not glean much that I could readily process and digest–I think that is Lemmit’s point as well. That’s why I read this blog (and others) and books like “Bad Science”, which includes a lot of information on logical fallacies and the different types of studies and their relative value. Oddly, I haven’t read the books you mention, but will go straight to the library tomorrow and get them. :-) Reading them will no doubt add to my seeming to others a pretentious science nerd with no respect for people’s “beliefs”.

        1. Chris says:

          The first two will help in reading the studies, and how to look for issues.

          The first one is actually quite short, and easy to read and understand. A video review is here.

          The second one is also quite a quick read, especially since the author does not take himself too seriously. Dr. Hall’s first post on this blog was a review of this book!

          Trust me, I used to also be confused by papers. But over the years I have learned how to read the studies, and learn what things to look for. I am not an expert, but I am much better than I was a few years ago.

          Actually, the third book is more of a slog. But you can guess why I included it in the list.

          Have fun at the library. Last week I picked up a book called Big Data, which is about the glut of information that is now available to us through the Internet. I have only read a few pages.

  24. Annie says:

    I am an avid vaper, but yes, I agree that some regulation should be in place. I live in a town of 20,000 people, and there are 3 “niquid” producers. These businesses are run out of people’s homes. It’s essentially bathtub science, or a less harmful meth house.

  25. Lemmit says:

    In contrast, it’s a legitimate open question whether e-cigarettes are safe and effective as a tobacco harm reduction strategy. Moreover, prior plausibility suggests a reasonable likelihood that they could be effective.

    But, but, but — David — this is the first time ever in this article or comments you say clear and loud that e-cigarettes have a reasonable likelihood in harm reduction. This is exactly what us nutcases and the Royal College of Physicians have been implying. With maybe words ill suited to the purpose?

    From this it is a logical leap to ask powers that be _not_ to restrict access to e-cigarettes more than regular cigarettes are regulated. For now. Because if true, benefits are huge while if not true, costs are not(*). This is all. It really is.

    (That and hoping that I finally nailed quoting here in comments)


    * compared to smoking regular cigarettes

    1. David Gorski says:

      But, but, but — David — this is the first time ever in this article or comments you say clear and loud that e-cigarettes have a reasonable likelihood in harm reduction. This is exactly what us nutcases and the Royal College of Physicians have been implying. With maybe words ill suited to the purpose?

      You misunderstand. Perhaps I was too fast and loose with SBM terms that regular readers are quite familiar with and know what I mean when I use them. “Prior plausibility” means only that the concept that using e-cigarettes for harm reduction is, from a scientific viewpoint, a reasonably plausible one. In SBM lingo, it means, more specifically, that there is a reasonable likelihood that a well-conducted clinical trial testing them will be positive. That’s all. Prior plausibility is necessary, but not sufficient, to justify doing a clinical trial and only says that the scientific question to be tested is plausible enough to be worth testing. (For example, homeopathy is so implausible as to be virtually impossible; so it is not worth testing in a clinical trial on basic science considerations alone.) In addition to prior plausibility, you also need preclinical data.

      So, when I say that e-cigarettes have a reasonable degree of prior plausibility as a tobacco harm reduction strategy, all I am saying is that they’re probably worth testing in a randomized controlled clinical trial, nothing more. I am not saying that I think they work. If I had sufficient evidence to think they work, I wouldn’t be so insistent on seeing a decent clinical trial.

      1. windriven says:

        David, I am loath to disagree on a fundamental definition but this brought me up short:

        “In SBM lingo, it means, more specifically, that there is a reasonable likelihood that a well-conducted clinical trial testing them will be positive.”

        There are many things that are scientifically plausible that don’t pan out; arguably more than do pan out.

        I wonder if a better definition would be that: scientific plausibility is generally a prerequisite to investing scarce resources in a well-conducted clinical trial. The absence of scientific plausibility renders the likelihood of a positive outcome vanishingly small.

  26. Lemmit says:

    Swamped by suggestions, thank you. Myself I usually use these simple solutions:

    1. google: “name of study” filetype:pdf
    2. write to authors and ask (I was surprised to see this work)

    But, Chris, my point about the study was not access (that had to do with books). Rather that sometimes reading != comprehending. So can I ask you whether you can say anyhing else about the study than pointing out funding bias (which does not automatically equal fake science). You can prod me to do my own reading to no end, but if you have read the study and found flaws with it, why not save both of us a bit of time instead?

    1. Chris says:

      Actually, you posted the study as if it was relevant. It is up to you to get and read it, and then answer the question.

      Though, typically I try to only cite papers that are free online. Which is pretty required for any federally funded research. What you do is go to PubMed.gov, and after doing a search, like http://www.ncbi.nlm.nih.gov/pubmed/?term=electronic+cigarettes+safety, click on the “Free full text available.” Which brings that list from 28 to 6, and I see some have been discussed above.

  27. Lemmit says:

    Umm, sorry everyone for creating a mess, but the Reply button ceased to do what it is supposed to do and somehow my latest comments ended up in a uniform pile :(

  28. nybgrus says:

    So it seems that this post came at a fortuitous time. I don’t think I am violating any sort of rules by saying that the student organization of my program, of which I am currently President, has taken on as our “signature outreach project” that of tobacco cessation.

    It seems that in Louisiana there was a separate legal settlement from the big tobacco fallout and that has left the state of Louisiana with the tidy sum of $287 million to use specifically for tobacco cessation purposes. This money can be used for everything related to it – from clinic fees, to doctor’s fees, to informational materials, drugs, counseling, research, everything – except for direct mass advertising of our clinic(s) and the fund itself.

    Since our students “work” for free, we can advertise since we don’t get paid for it. :-D

    As it stands right now, there exists only one clinic – at my institution – that operates with about 3 people on Thursdays from 4-8pm with in-house registration on Mondays and Tuesdays (so that physicians in the clinic can just refer down to us on those days to have their patients sign up). The plan is to expand to 3 clinics by the end of the year and 3 more next year.

    I just had a meeting with the head of The Trust at our institution and we will be getting formal training from Pfizer in cessation drugs, devices, and counseling so that we can then go out and staff registration booths, advertise and give information at local health fairs and sporting events that we volunteer at, and help run the clinic by doing H&P’s, writing notes, and putting in orders for our supervising physician to co-sign. The best part? All of this is 100% free to our patients, including the drugs themselves. Anything that is FDA approved for smoking cessation (and even off-label use) is covered.

    So where does today’s post come in? Well, I brought it up and it seems that our fund also covers research. And they like the idea of using our clinics as centers for prospective RCTs and we have the ability to do that – we have many PI’s available, students to help write and run protocols, our own IRB, and our own PubMed indexed journal. The only catch is that e-cigs are not covered since they are not FDA approved cessation devices. However, it seems there are other funds that would cover that and all other trial costs would be covered by The Trust.

    And now for the really best part. We have to spend all $287 million in the next 9 years. Otherwise, everything left over goes back to big tobacco. So we essentially have a ~$32 million per year budget and I would very much like to have a good chunk of that money go to robust research and at our meeting today that idea was met with significant enthusiasm.

    I also learned a few other interesting things. Firstly, it seems that the FDA cracked down and made flavored cigarettes illegal back in 2009 (cigars are still OK – the rule was for “paper wrapped” products). However menthol managed to slip by as an “additive.” So the FDA is currently trying to figure out what the heck to do with that. Which is partly why e-cigs have been pushed to the wayside, but, apparently, is very much on the FDA radar with money available for research opportunities on e-cigs, specifically in regard to using them as a smoking cessation device. Which is how we are currently planning on augmenting The Trust money for potential research opportunities. It seems that the completely unregulated use of e-cigs is going to come under some scrutiny at least.

    1. This is wonderful news…probably. If you allow ANY commercial OR advocacy group to dictate your methods, then not so much. However, since I have some suggestions I guess that means you’d have to be free to listen to suggestions from “the other side” also.

      There are areas where people are speculating (in both directions) like crazy, that I suspect the FDA doesn’t even plan to look at. Such as:

      In a study that lasts more than 3 months, I’d like to see differences between people who can choose their flavors from a wide variety as soon as they feel comfortable doing so,
      vs. people stuck with the menthol-or-not choice.

      I’d also like to see some of the groups in the study be trained to use more-sophisticated vaping devices such as the variable-voltage devices and the “clearos” — high-rated ones on forums.

      Also, group the flavors into groups (tobacco, menthol, fruit, sweets, coffee, booze, “other”) and see, after awhile, if that makes a difference in peoples’ attitudes regarding the taste of a combustable or their recidivism rates.

      I think the idea among scientists not familiar with the products is that an ecig is an ecig is an ecig. That is not something that should be taken as true before it is tested.

      1. We write our own protocols and amend them based on scientific merit and the likelihood of being able to answer the question we are asking.

        The problem with your proposed study design is that it is horrendously complex. Allowing free choice of anything willy nilly as you propose is simply adding too many variables and would inherently underpower the study. By limiting the options to a few well characterized ones we are much more likely to detect an effect. Your implicit argument is that limiting the choices would limit the size of the effect. No doubt that is correct. But if it takes the effect size down to something very small or zero, then adding in all that choice is just icing on a placebo cake anyways. Now in the case of addiction, placebo does indeed have prior plausibility for having some actual effect on the outcome being studied (since it is behavior and not an objective change). However, if that is the case then there is no legitimate case for nicotine to be in the e-cigs. In other words, we would be exploring the e-cig as a nicotine delivery device, not an elaborate placebo for people to futz around with and get distracted from their cigarettes. Plus, it would be a comparative effectiveness study comparing different methods of cessation. Having such a complex arm would make it horrendous to do the study or impossible to say where the effect actually is. Such is science.

        As for your second comment about the “sophisticated” vaping… that has some more merit and it may be worthwhile to do something like a PDSA cycle to determine what brand and combo of e-cig to use in the study. However, that has to be tempered with the realization that most people – particularly our demographic – would likely not be interested or capable (for myriad reasons) of taking the time to learn something particularly complex.

        I think the idea among scientists not familiar with the products is that an ecig is an ecig is an ecig. That is not something that should be taken as true before it is tested

        Certainly there are differences, but the reality is they are overall very similar. The idea would be to determine if there is same base level of effect in the general model idea of the e-cig. If there is none, then it becomes much less likely that a particular e-cig/e-liquid combo has any appreciable effect. Granted some people may really prefer XYZ and we used ABC and they just didn’t know they would like XYZ. But the idea is that with a large enough study we should capture some effect to demonstrate the principle is sound. Otherwise it all becomes special pleading that this specific combination actually works and the others do not at all.

        1. OK, there are ONLY a few differences between the prescription nicotine inhalers (already tested and proven) and the consumer product e-cigs that has everybody so excited.

          The inhaled nicotine delivery is already tested and proven safe and effective.

          The DIFFERENCES that remain untested are the flavorings, and to a lesser degree the carriers — vg vs pg. And the ability to control voltage (which takes 5 mins to learn, it only takes months to be interested in learning.)

          So, if all of that is placebo and the nicotine is safe and effective (already tested) and you’d be happy to have all the as-yet-untested ingredients freely available to inhale, what exactly needs to be tested?

  29. Lemmit says:

    > Actually, you posted the study as if it was relevant. It is up to you to get and read it, and then answer the question.

    Now you’re loosing the higher ground. Since when is it required to independently review and evaluate studies in peer-reviewd journals? Of course the study is relevant, it says so right there in the abstract. I linked to it, but never did I say it contains the uncontested truth.

    It is up to specialists in the field to tell us, mere mortals, whether it actually shows what it says. No matter how many times I would read a toxicology study, there’s slim chances that I’d be able to do better than the peer reviewers of the journal.

    Whether a study is freely available has nothing to do with its science value. Whether I have read a study has nothing to do with its science value.

    So can we please stop talking about me and turn this discussion back to the issue at hand — the study and the science within?

    1. Chris says:

      If you reference a study it is assumed that you actually read it!

      “So can we please stop talking about me and turn this discussion back to the issue at hand — the study and the science within?”

      Start by reading the above article and actually checking the links to the studies. Then you can ask about other papers that you have fully read.

  30. Chris says:

    Mere mortals are allowed access to medical school libraries. If you insist on citing a study, then at least make the effort to read it.

    “So can we please stop talking about me and turn this discussion back to the issue at hand — the study and the science within?”

    You are the one that kept posting that one study. It isn’t our fault that you did not find a way to read the whole thing. If you wish to discuss studies, read the links to “free online” studies posted in the above article.

    I am also a “mere mortal.” Just go to your local library and check out the books I suggested. What is difficult about that. I see lots of mortals at my local library. You should actually try it too.

  31. Linda says:

    E cigarettes are already well regulated here in the UK. They are regulated by trading standards and the EU as consumer products. The worst ones I have come across are the ones that are bought in supermarkets. These are ones we will likely end up with if they are to be regulated as medicines.

    They will work in the same way, have the same ingredients, although they’ll have less nicotine, but they will suddenly be safe to use as medicines but not as consumer products.

  32. Roger says:

    Regarding protocols, it is unlikely that you can design any that will show you the real picture of electronic cigarettes. Take the studies done by Dr. Eissenberg for instance. He initially did a study that found that electronic cigarettes do not deliver an appreciable amount of nicotine. We were discussing his study on the forums and he registered and joined our conversation. We eventually convinced him that his results were due to the way he designed the study. He was using an inadequate product matched to completely inexperienced users. Based on what he learned from talking to us he did another study. This time he recruited experienced users and let them use the product of their choosing. This time he found that the users were indeed getting appreciable amounts of nicotine, and in some cases approaching the same levels as provided by cigarette smoking.

    If you give an inexperienced user an inadequate product, with no choice of flavors, and no training/mentoring then you’ll be lucky to see a success rate that is much better than current NRT products. But if you give the user training/mentoring, the opportunity to find the right products and configurations that work for them, and a choice of any flavors they want, you’re going to find success rates that will blow your mind. My guess is around 80% of such people will successfully quit smoking by using electronic cigarettes.

    There are dozens of factors at play here that only a ex-smoking vaper can understand. Regardless, I applaud and encourage any efforts to study electronic cigarettes. Just know that if you want to learn more about what you’re studying, we vapers would be happy to help you out.

  33. Andrey Pavlov says:

    Well, that is the beauty of our situation. We not only have funds at our disposal but we actually HAVE to spend on average $32 million a year doing something with them. Pulling off a few million for a robust study seems very plausible to me. It will undoubtedly be long after I am gone from this institution, but I am doing my darndest to get the ball rolling. And I know that my institution in particular would be very supportive of such studies.

    As for the particulars, I won’t address them all individually, but there are some valid ideas out there. I won’t be in charge of the protocol so I can’t guarantee anything but obviously we’d endeavor to do a very good study. Perhaps adding some options in terms of flavor options and devices would be reasonable, along with education. There needs to be some standardization of course, and the results wouldn’t really be generalizable to ALL e-cigs, but it seems feasible.

    As for why an e-cig would (possibly) have more of an impact in quitting as purely a nicotine delivery system than the existing inhalers… that should be pretty obvious. A lot of the smoking addiction is about the ritual of it, in addition to the nicotine fix. Having something that better mimics an actual smoking experience will be psychologically more acceptable to someone than shifting over abruptly from an actual cig to an albuterol like inhaler. THAT is what we would be primarily testing since it is mostly untested to date. And why limiting it to no flavors and a single easy-to-use e-cig would be a reasonable (albeit not necessarily one that couldn’t be improved upon) protocol since we can reasonably expect that if THAT had good evidence for cessation that adding on other accoutrements would likely enhance, rather than detract from the effect.

  34. Cloudskimmer says:

    My concern is due to long ago reading “Licit and Illicit Drugs,” published by Consumer Reports. They maintained that drug addiction should be seen as undesirable by society and never glamorized. Making smoking inconvenient by banning it in public places has caused many smokers to quit, and made those places much better for all. That is why the commercial was so alarming: sexy, beautiful (though empty-headed) model stuffing the box into her bra. Tobacco companies used to claim that they didn’t try to attract and addict new smokers, only try to get others to change brands. This ad seemed to blatantly try and make sucking on a black stick with a blue light seem cool, sexy and desirable. Any good done by causing smokers to give up tobacco will be undone if new victims become nicotine addicts by using e cigarettes. That would be a definite down side of this new technology.

  35. ChrisL says:

    If e-cigarettes are simply another nicotine delivery system to aid smoking cessation, to avoid criticism that they are a gateway product to addict youths and lure them into becoming smokers:

    1) Eliminate the sexy advertisement. As noted by others, that type of messaging is easily construed as intending to entice.

    2) Limit sales by year of birth. If you are younger than the legal minimum age to buy cigarettes in your jurisdiction today, then why would you ever need access to e-cigarettes?

    For those who want latitude to allow e-cigarettes to be used by the 15-year-old smokers who are getting cigarettes by whatever means already, fine, change the year. But, just pick a year.

    1. ChrisL says:

      Before someone points out the problem… got carried aware there with the social engineering. Forgot that you’d have to limit/eliminate tobacco sales to those youths as they grew up and were allowed to start smoking legally. Drat.

  36. I absolutely agree with “eliminate the sexy advertisement.” The goal is to maximize the number of smokers that can be converted to a low-risk nicotine alternative. Therefore, the ads should target the age brackets of 25 to 44, which (according to CASAA’s most recent survey) represents 56% of the current consumers. The ad should also make crystal clear that the products are intended for current smokers.

    Given the prohibition against making any statements that the FDA could interpret as a health claim, the vendors’ hands are tied. They can’t say that their product is safer. They can’t even name the substances in smoke that are not present in vapor, because the Tobacco Act prohibits claims that a product reduces exposure to toxic substances.

    That doesn’t leave them with a very wide range of sales messages. I think they could get away with pointing out that there is less risk of fire, or that the products reduce the ugly cigarette butts…but I’m not even 100% sure that’s permitted. Those aren’t really attention grabbers, so I can understand why they decided to play the glamor angle.

    Maybe the government should wise up and ease up on the prohibitions against making a 100% truthful statement such as, “There is no tar in vapor.”

    CASAA supports limiting the age for purchase to match the legal age for purchase of tobacco. We struggled with the ethical issue of putting up barriers that prevents kids who smoke from purchasing a low-risk alternative that might save their health and lengthen their lifespan. But then we realized that if they are clever enough to get around age restrictions on buying real cigarettes, they will be clever enough to get around the age restrictions on the imitation cigarettes.

  37. Cole Durkee says:

    “..but the evidence that e-cigarettes are an effective aid to smoking cessation is currently slim to non-existent,..”

    But e-cigarettes are not being marketed as smoking-cessation devices. It’s only the e-cig shills using that argument to try to convince the gullible that e-cigarettes provide value.

    E-cigs are pure nicotine delivery devices, we all know that nicotine is as addictive as heroin.
    There’s no long-term profits to be made in changing “just” the smokers into e-cig addicts.

    E-cigs are a gold mine to their pushers, much better than any tobacco product. With e-cigs, there’s no need to continually find replacement smokers, less risk of lawsuits from causing cancer, less risk of social stigma from secondhand smoke, and currently much less regulation on them. They can make e-cigs appealing to kids with flavorings and package designs, advertise them anywhere, and sell them to anyone they please.

    That’s why the tobacco industry is moving into the market, and why there’s such a push on right now to convince the public that e-cigs are the answer to all of our problems.

    The only purpose behind e-cigs is to create long-term nicotine addicts for profit. No ethical healthcare professional should be endorsing such a product.

    Can you imagine society going back to the time when “most” of the population were nicotine addicts and smoked cigarettes? I predict that the percentage of nicotine addicts will be even worse if e-cigs are not banned, or required to become “prescription-only” products.

    1. I hear you saying, “E-cigarettes are bad because they don’t kill their consumers. It’s much better for nicotine addicts to get their well-deserved punishment–contracting COPD, other lung diseases, lung cancer, numerous other cancers, strokes and heart attacks. To reap their just punishment, they need to continue inhaling tar, particulates, carbon monoxide, and thousands of chemicals that are created whenever organic material is burned along with their nicotine. For that to happen, we need to get e-cigarettes banned. If we can’t get that to happen by sticking to the facts, we can lie and claim the products are marketed to non-smoking children, and that the reason why cigarette sales have fallen dramatically and why the 46 Million smokers in 2009 have been reduced to 43.6 Million smokers in 2011 has nothing whatsoever to do with the fact that 20% of smokers tried the products and that about 1 out of 4 were able to accept them as a complete replacement for all their smoked cigarettes and that many more were able to replace at least some of their smoked cigarettes.”

      I have two positive words to say about your theory: Yeah. Right.

      This is a case where two positives make a negative.

      If the FDA had succeeded in banning e-cigarettes back in 2009, I would have continued smoking for the last 4 years and 5 months. I have a sneaking suspicion that wheezing would still be keeping me awake at night, that I’d still have the “productive” morning cough, that my LDL cholesterol would still be 130 instead of less than 100, that I would still be unable to laugh out loud without going into an embarrassing coughing jag….and quite possibly that (after 45 years as a smoker) by now I’d be lugging around an oxygen tank with me…or worse.

      No ethical healthcare professional who has been dealing impotently for years with smokers who tried repeatedly and have been unable to quit, “Just keep smoking.”

      1. windriven says:

        “I hear you saying, “E-cigarettes are bad because they don’t kill their consumers. ”

        I don’t know what you hear Cole Durkee saying but you needn’t interpret what I’m saying:

        Regulating e-cigarettes as a medical device will not make them unavailable. It may make them more standardized. It may make them less hazardous.

        But more importantly the issue should be helping the addicts to break their addiction. If they don’t wish to quit, fine. Their business. I feel the same about mainlining heroin, actually. But I damned well don’t want to look at it and I don’t want my kids to look at it. Take your addiction behind closed doors.

        1. Due to the extremely effective propaganda campaign that has been waged over the last two decades by Tobacco Control extremists, the general public been taught to fear nicotine and to despise anyone who uses it in any form–even forms that carry ~99% lower health risks than smoking. Name calling and various forms of ostracism have been actively encouraged. So the next time you sneer at someone using a low-risk alternative to smoking, you might keep in mind that you’ve been brainwashed to feel and act that way.

          Why should the issue be more about “helping the addicts to break their addiction?” than about saving lives and preventing avoidable suffering? I’m beginning to see parallels between this situation and that of the people who were put to death in Salem as witches in the late 1600s by well-meaning citizens who only wanted to save their souls.

          “The harms associated with smoking stem primarily from the carcinogens in cigarette smoke, not from the nicotine itself…. available evidence suggests that nicotine is not in itself particularly harmful. Nor does it impair consciousness in the manner of other licit and illicit drugs; indeed it often enhances it.Thus, in contrast to recreational drugs such as alcohol, heroin or cocaine, tobacco’s main advantage is its compatibility with the requirements of everyday life.” –Kirsten Bell. “Tobacco control, harm reduction and the problems of pleasure.” Drugs and Alcohol Today, Volume 13, Number 2, 2013.

          When someone uses those recreational drugs, their purpose is usually escape from the worries of everyday life. People find nicotine useful because it improves their ability to concentrate, pay attention, and stay on task. In other words, the recreational drugs are used to forget about work. Nicotine is employed to enable better work performance. Indeed, for some people nicotine withdrawal can trigger confusion so severe that they would be as dangerous behind the wheel of a car as a heroin user or alcoholic would be when they are sated with their preferred drug.

          When the FDA wanted to “regulate” e-cigarettes as an “unapproved combination drug / drug delivery device” in 2009, the Agency stated that the products could not be sold until each brand and model had undergone the New Drug Approval process.

          An article on MedicineNet states, “It takes an average of 12 years for an experimental drug to travel from the laboratory to your medicine cabinet. That is, if it makes it. Only 5 in 5,000 drugs that enter preclinical testing progress to human testing. One of these 5 drugs that are tested in people is approved. The chance for a new drug to actually make it to market is thus only 1 in 5,000. Not very good odds.”

          In 2009, I didn’t have 12 years to wait for an effective way to stop inhaling smoke–nor does any smoker who has been incrementally damaging their lungs and cardiovascular system for decades. The next cigarette you light could be the one that tips the balance and drops you in your tracks from a heart attack or stoke, or that triggers an incurable cancer.

          So if being regulated as a medical devices were the ONLY legal way to market the drugs, the products that are being used today to help keep millions of former smokers from relapsing would be gone. And the continuing smokers would be denied access to the product that finally worked, after so many failed tries, for so many recent former smokers.

          Sadly, the product that finally emerged on the market would very likely be standardized to the point were it would be just as ineffective as the FDA-approved nicotine drugs available today. How ineffective is that? When used as directed to wean down and off nicotine altogether, the NRTs–nicotine, patches, gum, lozenges, inhalers, and nasal sprays–have an average success rate of about 5%. That’s a 95% failure rate. We can do better than that–much better than that. Even the FDA recognized that when they decided to change the labeling for the use of NRTs to remove limits on how long the products should be used and the warnings against smoking while using the products.

          1. windriven says:

            Wow, the tobacco industry is pulling out all the stops on this one, huh?

            You can temporize any way you’d like but nicotine IS A DRUG. You can wheedle and shuffle all you want but electronic cigarettes ARE A DRUG DELIVERY SYSTEM. Why are you so frightened of having your drug delivery system regulated? I have been a medical manufacturer for 25 years. Everything I make is FDA regulated. It can be a pain in the rear but in fact it leads to better and safer products.

            You are a nicotine addict. That’s OK. But I’ll say again: I don’t want my children exposed to your addiction, sucking away on your oral syringe in public

            “In 2009, I didn’t have 12 years to wait for an effective way to stop inhaling smoke”

            Yes you did. Quit. I did. After smoking 2 1/2 packs a day for years. When my wife became pregnant with our first child I put the last one out and I never lit the next one. It wasn’t easy, at least not for the first week or so. But it is not beyond the grasp of anyone. So don’t frame this as an issue of personal choice or lack of will power. You enjoy the nicotine rush. Enjoy at home.

          2. David Gorski says:

            Why should the issue be more about “helping the addicts to break their addiction?” than about saving lives and preventing avoidable suffering? I’m beginning to see parallels between this situation and that of the people who were put to death in Salem as witches in the late 1600s by well-meaning citizens who only wanted to save their souls.

            Seriously? You expect me to take you seriously after you make such a ridiculous, inflammatory, over-the-top, and, yes, just plain dumb analogy like this one? I hate to be so harsh, but in this case it’s hard to avoid.

        2. Linda says:

          The last place they should be is behind closed doors. It was seeing someone use and e cig in public that persuaded me to try them. The more smokers that switch, the better. If that annoys you, well tough. Adults should not be treated like children. Other peoples children are the responsibility of their parents. Not vapers.

          Nicotine is more like caffeine than heroin so I guess people who drink coffee are also addicts in your book.

          1. windriven says:

            “. The more smokers that switch, the better.”

            HAH!! The more smokers who QUIT, the better.

            There are three issues here. First is the electronic cigarettes are a sophisticated drug delivery system and need to be regulated by FDA. That is an issue of public policy. You don’t get to wiggle out of that because you are a pathetic drug addict.

            The second is whether you should be able to indulge your addiction in public. I vote no and I’ve already made this point clear to my state representative and my state senator in WA.

            And the third issue on which everyone seems to agree: tax electronic cigarette capsules just like cigarettes! And that, I suspect, is what you lackeys of the nicotine industry are really trying to avoid: paying for your addiction. Dream on, sucker. Every state legislature in the country looks at the plume of imitation, artificial, smoke-like haze pouring from your blow hole and they see dollar signs.

            That’s gonna make it harder to sell ‘vaping’ to the kiddies, isn’t it? You’re already creating a whole let of attractive words to make your addiction appear to be attractive so that BigNicotine can snag the next generation. You should be ashamed.

  38. Linda says:

    I’m not remotely ashamed. I’m also addicted to food and water. Your the one that has a problem with addiction, not me. I couldn’t give two hoots.

    As for kiddies, I have two grown up daughter and four grandchildren. I also worked with special needs children for many years, so I do think I have more experience with children than you. Should my grandchildren start smoking when they reach adolescence, my daughters are both non smokers, I would hope that e cigs are around for them to switch to.

    This blog should be about science and not some silly misguided puritan ideology. Most vapers research the science behind e cigs and conclude they are much safer than smoking. Most vapers know exactly what’s in their e cigs. E cigs are harm reduction.

    1. windriven says:

      Sorry Linda, food and water are necessities. Nicotine, not so much.

      “Should my grandchildren start smoking when they reach adolescence… I would hope that e cigs are around for them to switch to.”

      That is just execrable. You would prefer your grandchildren to be addicted to nicotine than not? Sad. Pathetic. But sort of a sad manifestation of addicts’ denial. And you don’t even wait for them to reach adulthood; adolescence is close enough. Explain if you can the distinction between your position and child abuse.

      “This blog should be about science and not some silly misguided puritan ideology.”

      My comments have nothing to do with puritanism. Nicotine is a drug. That is a scientific fact. An electro-mechanical drug delivery system is a medical device whether you like it or not. Nicotine addiction is a scientific fact. You and the other BigTobacco shills here are the ones suggesting it is just a lifestyle choice. So who is toeing the scientific line and who is spinning webs of bullcrap?

    2. windriven says:

      Linda said, “I’m not remotely ashamed.” Which just goes to demonstrate that some people are truly shameless.

  39. Andrey Pavlov says:

    Sorry but I had to chime in. You are the one with a clear ideological bias here.

    Food and water are not an addiction. They are required as a life sustaining intake. Nicotine is in absolutely no way required. The fact that you would even think such an analogy even remotely worth mentioning clearly belies your cognitive bias.

    Argument from authority about your own personal experience with kids is never a good idea, particularly when you have no idea what the actual experience of the other person is. You’d have egg on your face if you said that to lilady, for example. But in any event it is a ridiculously poor argument, especially if you are trying to feign science based thought.

    And lastly, your conclusion is not only clearly biased but certifiably untrue. You can’t have possibly researched the science behind e-cigs to know they are “much safer than smoking” since that research simply doesn’t exist. Which is the entire point of this particular post, in case you hadn’t noticed.

    Furthermore, you can’t possibly know exactly what is in your e-cigs since there is no rigorous regulation of the contents and we have some data to demonstrate that there is a lot in a lot of them that isn’t “supposed” to be there.

    So if you wish to have a philosophical discussion about addiction, public health, and cultural norms please do. But such ridiculous, aggressive, and absurdly obviously false ideologically based assertions serve no purpose except to allow people to discount you rather easily.

    1. windriven says:

      Sorry to walk on your food and water observation, Andrey. I wrote mine before reading yours. Great minds and all that…

  40. It doesn’t take a genius to figure out that if you remove the hazardous materials from something, that particular something is less likely to cause disease and death (e.g., removing asbestos from insulating materials). The absence of tar (because nothing is burned), carbon monoxide (again, because nothing is burned), of particles of partially burned paper and tobacco (ditto), and of the thousands of chemicals of combustion (ditto again), leaves only nicotine in common between e-cigarettes and traditional cigarettes. If the FDA were not convinced that nicotine itself is not terribly hazardous, the Agency would never have permitted the labeling and directions to be changed on NRTs to allow indefinite use and dual use.

    So the only way that e-cigarettes could be any more harmful than a medicinal nicotine inhaler would be if the chemicals used in the e-cigarette as the carrier and/or the flavoring were highly toxic. The two alternatives for a carrier liquid, propylene glycol (PG) and/or vegetable glycerin (VG) are Generally Recognized as Safe (GRAS). We know that 3 years of daily inhalation of PG did not harm children in a hospital ward, but I admit that I’m not familiar with the research on inhaled VG. We certainly don’t know what the health outcome might be for long term inhalation of large quantities of these two chemicals, but we do know that the health effects of switching from inhaling smoke to inhaling vapor begin within days and continue for at least 5 years. These include reduction in wheezing, coughing, and shortness of breath. There are more, but those will do for a start.

    The FDA began surveillance activities on e-cigarettes in 2009, asking the public to report any negative health problems with use of the products. There have been very few serious illnesses reported, and no way to prove that inhaling vapor was the cause of those illnesses. (Chen IL. FDA summary of adverse events on electronic cigarettes. Nicotine Tob Res. 2013 Feb;15(2):615-6. doi: 10.1093/ntr/nts145. Epub 2012 Aug)

    Contrast that with the huge number of illnesses, injuries, and fatalities reported by people using Chantix, one of the FDA-approved “safe” and “effective” smoking cessation drugs. Again, no way to prove that Chantix was the definite cause, but why so many cases? And why so few cases with e-cigarettes and NRTs? http://abcnews.go.com/Health/chantix-dangers-government-attention-study/story?id=14868835

    Current smokers can choose to take their chances with e-cigarettes, given the knowns and unknowns; or they can choose to take their chances with continued smoking for 10 or 12 more years, until a brand of e-cigarettes gains medicinal approval. Yes, yes, I know, since it’s been said so many times, “Or, they can choose to quit.” You’ll find that most of us former smokers who switched to an e-cigarette tried that. Not once, not twice, but multiple times until we began to believe that we would never be able to quit smoking. To many of us, finding e-cigarettes is truly an answer to a prayer.

    1. David Gorski says:

      You think that e-cigarettes are the “answer to a prayer,” but you have no hard evidence that they are. Let me remind you that there are parents out there of autistic children who are every bit as convinced that vaccines caused their children’s autism as you are that e-cigs are the “answer to your prayer” and helped you quit smoking. Careful studies showed that vaccines do not cause autism. Does that mean e-cigarettes don’t work as a smoking cessation aid? No. What it means is that we don’t know, and all your arguments are simply dancing around that simple fact. We don’t know. The science isn’t in. What we do know is based on pretty crappy studies.

      As I did the research for this post, I was shocked at how flimsy the evidence base for e-cigarettes. Going in, I really thought that it wouldn’t be so bad, my taking note of the subject because of Jenny McCarthy notwithstanding. And none of the e-cig advocates who’ve descended upon this post have managed to convince me that e-cigs aren’t a drug delivery device designed to administer nicotine. The problem is, they’re crappy and unreliable drug delivery devices, delivering highly variable doses that can’t be relied on. That’s why I came away from this post highly in favor of the FDA regulating e-cigarettes.

    2. windriven says:

      “The absence of tar (because nothing is burned), carbon monoxide (again, because nothing is burned), of particles of partially burned paper and tobacco (ditto), and of the thousands of chemicals of combustion (ditto again),”

      Exactly how credulous are you? You have no idea what besides nicotine is or isn’t in your electronic cigarettes. Tobacco companies treat tobacco with all kinds of unlabeled crap. So you are going to believe some skinky drug peddler that the stuff he’s selling you is pure? That’s rich!

  41. windriven says:

    “There have been very few serious illnesses reported, and no way to prove that inhaling vapor was the cause of those illnesses. ”

    Exactly the tactic that BigTobacco used for decades to legally peddle its drugs. You can’t prove it! Hahahahahaha!

    Well we did. It took years, but we did.

  42. stuastro says:

    I find it rather disturbing that a group of apparently intelligent people manages to post so many posts about smoking. To me, smoking in any form is disgusting. Sure it may be that e-cigs are less dangerous than real cigs, but my unscientific view is that they still have to present certain dabgers. As with real cigs, time will tell

  43. @windriven: Wow, just wow! I haven’t met anyone who wants to sell vaping to children. Why would they, when there’s a ready-made market of 43 million adult smokers who have bunches more money to spend than kids do? But I have met people (yes, in person) who make that false accusation, knowing there isn’t a shred of evidence to support it. Why? My guess is because they are morally outraged that anyone would choose to use a drug that is habit-forming. Funny, I have never seen this level of moral outrage aimed at people who stop at Starbucks every morning.

    And the fact of the matter is that nicotine is employed in the much the same way that caffeine is employed: To become more alert, to be able to concentrate, and to overcome the effects of fatigue. Both caffeine and nicotine have those effects which explains why so many long-haul truck drivers and people who work in demanding (but sometimes tedious) office jobs enjoy coffee and smoking so much. Now that there are less hazardous ways of delivering nicotine than smoking, they are no longer sentenced to a long illness and painful death as punishment for committing the sin of wanting to hold down a job, perform their duties adequately, and avoid killing people with their vehicle.

    By the way, are you equally outraged at former smokers who continue to chew Nicorette for years on end? Do you want them kept out of your sight, too? What if they were using an FDA-approved Nicotrol inhaler? The latter is not common because the products are so expensive. Likewise, long-term use of the patch is rare, mostly due to skin irritation.

    What would you say to your children if they saw someone wearing a nicotine patch or using a Nicotrol inhaler and asked about it? Would you say, “Don’t look at that person; that’s a dirty, filthy nicotine addict”? Or would you say, “That person is wearing the patch (using the inhaler) to help him stop smoking. That’s a good thing, because smoking is a very unhealthy and dangerous practice”? You can use any episode like this as a teaching moment. Do you teach them intolerance, or do you teach them tolerance, along with a health lesson?

    The explanation given for implementing “sin taxes” on smoking was that smokers get sick more often and cost society more. There is no logical reason to apply sin taxes to an alternative that is demonstrating health improvements in those who switch and that very probably will reduce smoking-related disease and death among users (see previous post regarding absence of hazardous ingredients found in smoke.) If in the future, evidence emerges showing that e-cigarette use harms users, apply a sin tax then. In the absence of such evidence, taxing smoke-free alternatives the same as smoking serves to encourage continued smoking (i.e., why change what you’re doing if it won’t do you any good?)

    In Sweden, smokers who switched to snus (finely cut moist snuff packaged in a teabag-like pouch) have no higher level of smoking-related diseases than smokers who quit nicotine altogether. http://www.ncbi.nlm.nih.gov/pubmed/23454227 In fact, it was evidence of this nature that convinced FDA to change the labeling on long-term use of NRTs.

    1. windriven says:

      “I haven’t met anyone who wants to sell vaping to children. ”

      How about adolescents. Meet Linda, above.

      “Funny, I have never seen this level of moral outrage aimed at people who stop at Starbucks every morning.”

      Funny, I’ve never seen people need to go to detox or wear patches when they want to quit Starbucks.

      “they are no longer sentenced to a long illness and painful death as punishment for committing the sin of wanting to hold down a job, perform their duties adequately, and avoid killing people with their vehicle”

      This made me laugh out loud! Outside of BigTobacco (or maybe even within it) I’ve never seen a job that requires smoking or nicotine infusions. To be “more alert, to be able to concentrate, and to overcome the effects of fatigue”, I’d suggest 8 hours of sleep.

      “[A]re you equally outraged at former smokers who continue to chew Nicorette for years on end”

      Couldn’t care less. Nicorette, Chicklets, Juicy Fruit – I have no idea what they’re chewing. Neither do my kids.

      “Do you teach them intolerance, or do you teach them tolerance”

      Tolerance is different from judgement. I teach my children both and the difference between them.

      “The explanation given for implementing “sin taxes” on smoking was that smokers get sick more often and cost society more.”

      Horsehockey. Sin taxes are used to raise money because some people just gotta have their sins and politicians just gotta have more money. Secondarily they’re used to regulate behavior because you can calibrate the taxes against the elasticity of demand. Lookin’ for that revenue generating sweet spot :-)

  44. stuastro says:

    Well there is one very big difference. I am not forced to share your coffee but I am forced to share your nicotine. I prefer to sleep with my window open. This is however not possible as the selfish unthinking smokers from 2 doors up insist on smoking in the street during the evening, which forces me to have to close my window in order to avoid the stink and the adverse health effects. And don’t try to tell me that they smoke in the street for the health of their children when they drive away smoking with children in the back seat of the car. In Australia it is illegal to smoke in a car containing children.

  45. Of course you are having problems finding scientific evidence that the products work as a smoking (i.e., nicotine) cessation aid. That is not their intended use. They are intended to serve as a replacement for smoking. As for your desire to see the FDA regulate them as a drug delivery device, that ship has sailed.

    The U.S. District Court for the District of Columbia ruled on January 14 2010, that the FDA could not regulate e-cigarettes as drug delivery devices (Civil Case No. 09-771 (RJL)). The FDA appealed, and on December 7, 2010, the U.S. Court of Appeals for the District of Columbia Circuit upheld the lower court’s ruling and granted the injunction being sought by the plaintiffs. The FDA appealed again, asking for a hearing in front of the full nine judge panel of the appellate court. The request was denied. At this point, the FDA’s only recourse would have been to ask the Supreme Court to hear the case. Apparently, the FDA decided not to spend any more taxpayers dollars pursuing the case. On April 25, 2011, the FDA announced that it would abide by the ruling. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm

    In his Opinion document in the lower court case, Judge Richard J. Leon wrote, “Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public. Furthermore, now that FDA has regulatory power over electronic cigarettes through the Tobacco Act, any harm to the public interest or to third parties caused by an injunction that merely forbids FDA from regulating electronic cigarettes as a drug-device combination is greatly diminished.”

    The FDA does plan to regulate the products, but as a tobacco product, not as a drug-delivery device. The judge pointed out that if, in the future, an e-cigarette manufacturer wanted to make health claims about their product, the FDA was free to regulate that product under the Food, Drug and Cosmetics act, requiring the product to go through the New Drug Approval process.

    It’s true that some of the products are crappy and unreliable. Unfortunately, I don’t believe the FDA plans to address those problems under the Tobacco Act. I suspect they have other things in mind. But the fact is that even the early models (most of which were crappy and unreliable) worked well enough as a substitute for some smokers to make a complete transition. Meanwhile, the products have evolved so that modern products are much less crappy and more reliable, and more and more smokers are managing to replace all their inhaled smoke with inhaled vapor.

    1. David Gorski says:

      You know what they say about the law: It’s an ass. Quite honestly, I don’t care what the court ruled. The law on this matter is wrong, and from a scientific standpoint its ruling was nonsensical. Just because the law as interpreted by the courts says e-cigarettes are not drug delivery devices doesn’t make it so on the basis of science and medicine. After all, courts ruled in the 1990s that silicone breast implants caused all sorts of horrible diseases. They don’t. I could list lots of rulings where the courts got the science wrong. Basically, court rulings and science tend to be related mainly by coincidence.

      BTW, one notes that you’ve shown no evidence that newer products are “much less crappy” or any more “reliable” than the old products.

      Bottom line: You are arguing on anecdotes and legalisms, not science. Indeed, what CASAA did with that silly “technical report” cum “study” from Igor Burstyn shows that.Seriously, I laughed when I read that blog comment justifying publishing a technical report on a website rather than in a peer-reviewed journal by saying that the study “has been made public for peer review. As CASAA promised when fundraising, the researcher would not keep the study results a secret from the public during the review process.” That was so incredibly lame and disingenuous that I ceased to take CASAA seriously as soon as I read that. I just imagine what the reaction would be if a supplement company pulled such a blatant stunt. Of course, e-cigarette companies are doing basically the same thing as many supplement companies.

  46. Nevertheless, right or wrong scientifically speaking, that legal ruling is binding upon the FDA. They have to enforce and uphold the law.

    The CASAA membership paid for the Burstyn study. That makes them the client. The client is entitled to inspect the work product and the researcher is free to publish the work product. There’s no law I know of that the researcher must keep the results a big secret before publication.

    I don’t know how to fulfill your desire for scientific evidence of “more reliable.” If you would settle for common sense, I might share with you that the first model I used (an RN4041) was about the size of a cigarette, and the battery would go dead after a few hours. You could recharge it, but after a month or so it would stop taking a charge, and you had to replace it at a cost of around $20. The next model I used (a 510) was about the same size, but the charge in the batteries lasted an entire day, reducing the expense and the hassle of carting around extra batteries. The last model I purchased has a significantly larger battery that holds a charge for three days. It uses a larger tank system which reduces the need to refill liquid so often. The early models only held about 1/10 of a teaspoon of liquid and the filler material soaked up and refused to vaporize about half of that. So you see, from the consumer’s viewpoint, there has been a continuous improvement in the hardware.

    This improvement would not have been possible if Ruyan had submitted its original model as a drug-delivery device.We would still have another 6 years to wait until it would be approved, and once the product was fielded, the manufacturer would not be able to respond to customer requests for improvement without going through FDA approval first. Imagine how such constriction would have affected the development and continuous improvement of other high-tech products such as computers, televisions, and cell phones.

    I’m sure you know that every vendor offers 0 nicotine liquids. So if the device isn’t being used to deliver a drug, is it still a drug-delivery device? Many consumers gradually reduce the nicotine concentration in their liquids and continue using the device after they get to 0 simply because they enjoy the hand to mouth motion, the sensation of inhaling, and the calming visual effect of the vapor itself. So you see, the situation is not as black and white as you imagine it to be.

  47. Linda says:

    Windriven.
    Adolescents do lots of things they shouldn’t do. If your children started smoking, would you tell them to quit or die. Because that’s what your saying to smokers. Tobacco shill? E cigs don’t contain tobacco.
    Andrey Pavlov.
    You obviously don’t use e cigs so why bother. As for me being aggressive, I do think you are trying to bully me. I know enough about e cigs to know they are safer than smoking. I do read research from independent doctors like Dr Michael Siegel and Dr Konstantinos Farsalinos.

    I’ll say again. In the UK, e cigs are regulated by UK trading standards and are covered by 17 different EU regulations. The nicotine is pharmaceutical grade and e cigs are restricted to eighteen and over as they should be.

    1. windriven says:

      @Linda

      “Adolescents do lots of things they shouldn’t do. If your children started smoking..,”

      Smoking needs to die along with the generation of wheezing geezers who still indulge in the addiction. No cigarettes, no problem.

      The fact that cigarettes in any form are still available for sale says everything about the political power of BigTobacco and nothing about science, ethics or common sense.

      The simple fact is that the tobacco industry needs to suck young people in. All drug dealers seem to understand that if you get ‘em young you sink the hook deep.

  48. Wow, this thread really blew up yesterday. I was extremely busy on rounds and have an entire day of conferences and lab work today so I’ll be busy today as well. Which means for the most part I’ll have to leave this to the other commenters who are pretty spot on. But a few points I can sneak in during my coffee.

    Legally binding means very, very little to us here. You should read Jann Bellamy’s posts. We here care about the science and the health effects of things and indeed often write about how incredibly wrong legal rulings are from those perspectives. So you can keep blathering on about it, but that is entirely irrelevant and in absolutely no way supports your stance. Period.

    Next, your improvement from a consumer standpoint also means absolutely nothing to us. Traditional Chinese Medicine herbals are often tainted with poisons and taste horrible. They could improve manufacturing processes to remove the added poisons and find a way to make it taste great. Consumers would love that. It wouldn’t change the science in question one iota (except to make us agree it is a little safer than before. So once again, why are you wasting your electrons transmitting completely irrelevant points?

    Waiting a longer time to have something useful approved is not a good reason. Just look at one of the more recent posts here about the brain surgeons who intentionally infected their patients with bacteria. Why? Because the basic sciences research and approval process would have taken too long. Sorry, but taking short cuts is almost universally a bad idea. And besides if it had been done from the start as a medical device it wouldn’t take that long. I have a friend who writes the code controlling a new diabetes pump. The company went from start up with him and 6 or 7 other guys to in the black to FDA approved device they are selling with a company of over 80 people in a total of about 6 years. And that is for an invasively implantable device. So, no, not totally irrelevant but nearly so and extremely flimsy no matter what.

    And having the option for a 0 nicotine liquid doesn’t matter. There are obviously plenty of nicotine liquids and that is the intended use. The other liquids are not the focus of the interest (though those certainly have some negative health effects as well). The point is that having a 0 nicotine fluid does not negate the fact that there are non-0 nicotine fluids to use the device as a drug delivery system. That would be like saying that there are needles and syringes used for insulin, so shouldn’t that negate the heroin use?

    So once again, if you are interested in discussing the actual science of the topic please do. But you and Linda just keep blathering nothing but ideological nonsense (well her more than you on the nonsense part) with no substance or relevance to the actual science and health effects of these products. I get that it helped you a lot and that you thoroughly enjoy it. Quite frankly, I hope that e-cigs can help a lot of folks in the same way. But in order for that to happen we need better data and better regulation in order to ensure the safety and proper usage of them. It’s really as simple as that.

  49. Andrey Pavlov.
    You obviously don’t use e cigs so why bother.

    Boy, if I had to do or experience everything I can advise my patients on I have a lot of trouble being a physician. What a ridiculous dismissal.

    You know enough about e-cigs to assume they are safer than cigarettes. I do too, by the way. So does Dr. Gorski. We actually both think there is good reason to believe that they may well be safer than cigarettes. But we aren’t blinded by ideology and love for the product to think we know that to be the case.

    And we also know many historical examples where assumptions have been spectacularly wrong. But even more relevant to this is we know how un-regulated (and particularly Chinese made and un-regulated) products can be a lot more dangerous than one would otherwise assume.

    Furthermore, what you completely ignore – or worse, don’t realize – is that the mechanism for vaporising the e-liquid varies quite a bit and indeed some of them do actually use plain old heat to burn the liquid into a vapor. Others use ultra sonic vibrations of a receiving pan to aerosolize the liquid. The former obviously flies in the face of your rant about how it simply must be safer than burning leaves and paper. What you don’t realize about the latter is that the high energy of ultra sonic vibrations can lead to combustion and has been demonstrated to do so.

    So get off your ideology horse and talk some science if you are interested. As I have said before, I actually want these things to succeed and be useful. But as someone who understands and practices science I also know the dangers of making assumptions and rushing to quickly to put things out to market. I also know the general dangers of addiction, regardless of how “safe” the delivery mechanism is. And I also know how dangerous nicotine in and of itself is.

    Which reminds me to close with a comment about your ridiculous analogy to caffeine and Starbucks. Nicotine =/= caffeine. Nicotine is vastly more toxic than caffeine. As Chris (I believe) pointed out, soaking tobacco leaves in water can be used as a rather effective pesticide. Dumping coffee on your plants doesn’t do diddly. The pharmacologic effects are significantly different as are the physiologic effects. They are not merely equivalent ways of perking up in the morning. And the level of physical addiction to nicotine is impressive. Ozzy Osbourne himself has said that he was able to quit heroin and cocaine more easily than cigs. So please, stop making really bad analogies that absolutely fall through without any deeper appreciation of the neuropharmacology and physiology behind what you are talking about.

  50. windriven says:

    “Nevertheless, right or wrong scientifically speaking, that legal ruling is binding upon the FDA. They have to enforce and uphold the law.”

    And in this statement lies the exactly correct strategy to choke (if you’ll pardon the expression) this off. We need to all encourage our lawmakers to immediately start taxing electronic cigarettes and tobacco water steeply and to prohibit smoking the things in public venues where cigarettes are prohibited.

    “This improvement would not have been possible if Ruyan had submitted its original model as a drug-delivery device.”

    How is this different from the thousands of device manufacturers who work under FDA scrutiny? Yet somehow everything from anesthesia masks to pacemakers to shunts have continuously improved. And with all due respect, those items are infinitely more valuable than your electronic cigarettes.

    “I’m sure you know that every vendor offers 0 nicotine liquids.”

    Yeah, I’m sure that is their biggest seller. People will spend money for a plastic tube and fake smoke. Or should I say ‘vap’. The Marlboro man is dead. Who today thinks that sucking on a cigarette makes them look fashionable or artsy or macho? I can only speak for myself but when I see someone smoking the only word that comes to mind is: loser.

  51. There is a widespread mistaken belief that smokeless tobacco (ST) causes oral cancer, but the evidence taken as a whole does not support this. Current research shows that all smoke-free alternative tobacco products pose a risk so low that it cannot be shown to be non-zero. NOTE: This applies to modern Western products, but not necessarily to Asian products which contain added non-tobacco plants.

    There are several types of ST products today that do not involve spitting, including snus (moist snuff packaged in a teabag-like pouch that is discarded in the trash after use) and dissolvable orbs, strips, and sticks. The orbs are nearly indistinguishable from Nicorette mini-lozenges. The public is not exposed to any chemicals, noxious or otherwise, through use of these products.

    In 2010, the FDA held a 2-day public workshop to consider whether to approve the use of NRTs as a long-term substitute for smoking. The decision hinged on the safety of nicotine, when separated from the safety (or lack thereof) of inhaling smoke. Since no studies have been conducted on long-term use of NRTs, Dr. Neal Benowitz, an expert on nicotine safety and toxicity, presented information on the health effects of long term use of smokeless tobacco based on decades of scientific research. “The lack of increase in common cancers in lifelong ST users indicates that nicotine is not a general cancer promoter,” he stated. Also, “Meta-analyses showing increased risk of MI and stroke in ST users are heavily weighted by CPS-I and CPS-II, which are older US studies with many methodologic problems. More recent Swedish studies and an NHANES study indicate minimal if any increased risk of CVD with ST.”

    Based on the evidence they heard, the FDA decided to allow not only use of NRTs indefinitely, but also to remove the restriction against smoking while using NRTs.

  52. geoff says:

    I stopped smoking in 2007 and started e-cigs. Slowly reducing, today I don’t use any nicotine, and only use it when I really choose to, i.e. if I want to kick back and relax, but the rest of the time it is like being a non-smoker. I smoked from the age of 14 till 30, and jumped on the e-cigs when I heard about it. I used to have to stand with the rest of the smokers at shelters at work, and never used it on trains etc. It saved my life. Today I put a little AZDA glycerin in and maybe a tiny vanilla & chocolate for flavor to bring back the old times…. once you know what nicotine is you are not addicted to it, even if you put on a patch or any other nicotine, trust me, I know- it is psychological unless it is over 2mg. Too bad they never sold 0.1-0.9mg I would have bought it! (Like a peace pipe!)

  53. This is true e cigarette have no restriction. Companies of e cigarette can make much profit . This is one of the main reason why big company come into the market for e cigarette. People are like it and accept it as best alternative of real cigarette.

    1. WilliamLawrenceUtridge says:

      C’mon, why should we believe you? Vampires don’t even need their lungs.

  54. Spot on with this write-up, I honestly think this amazing site
    needs much more attention. I’ll probably be returning to read through more, thanks for the information!

    1. WilliamLawrenceUtridge says:

      I don’t think you will be back, because I think you are a spambot.

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