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Advice on using over-the-counter nicotine replacement therapy.

Jonathan Foulds, MA, MAppSci, PhD
Surveys have shown that many smokers (incorrectly) do not believe that nicotine replacement therapy helps smokers to quit. Many also believe NRT can cause cancer (again incorrectly). Unfortunately the labeling on the NRT product packaging also uses very cautious language that reinforces the idea that NRT can be dangerous. For examples, the long list of precautions regarding co-occurring medical problems, the advice to use low doses unless you are a heavy smoker, and the advice against using the NRT if you smoke or use another NRT, all feed the perception that NRT is dangerous and should be avoided if at all possible.

Partly because of these miscommunications to the public, only a fraction of those trying to quit smoking use an effective smoking cessation aid and even fewer use it in an optimal manner for smoking cessation. In order to help improve this situation, Professor Lynn Kozlowski (University of Buffalo) and a group of experts in smoking cessation have produced a paper discussing these issues, and (importantly) providing a consensus statement on the most effective way to use NRT. The summarized version of the agreed-upon advice to consumers is provided below:



1. NRT is one good tool to help you quit smoking. But NRT can’t do all the work for you—you have to help—and it is not the only tool to help you stop smoking.


2. Don’t worry about the safety of using NRT to stop smoking: NRT is a safe alternative to cigarettes for smokers.


3. Do be cautious about using NRT while pregnant.


4. NRT is less addictive than cigarettes and it is not creating a new addiction


5. Stop using NRT only when you feel very sure you can stay off cigarettes.


6. If the amounts of NRT you are taking do not help you stop smoking, talk with your health care provider about using (1) more NRT, (2) more than one type of NRT at the same time, (3) other smoking cessation medicines at the same time, or (4) telephone or in person advice on quitting tips.


7. If NRT helps you stop smoking, but you go back to smoking when you stop using NRT, you should seriously think about using NRT again the next time you try to stop smoking.


8. Make sure you are using the gum or lozenge in the best way:
o Chew the gum slowly – fast chewing doesn’t allow the nicotine to be absorbed from the lining of the mouth and can cause nausea.
o Don’t drink anything for 15 minutes before and nothing while you are using nicotine gum or the lozenge so your mouth can absorb the nicotine.
o Make sure you get the right amount of nicotine – people who smoke more than 10 cigarettes per day should use a 4mg piece of gum or lozenge.


9. Make sure you are using the patch in the best way:
o If you can’t stop having a few cigarettes while using the patch, it is best to keep the patch on. Don’t let a few slips with cigarettes stop you from using the patch to quit smoking.
o You may need to add nicotine gum or lozenges to help get over the hump or you may need to use more than one patch at a time. Talk to your healthcare provider about this.


10. If the price of NRT is a concern, try to find “store brand” (generic) NRT products which are often cheaper than the brand name products.

11. Do whatever it takes to get the job done—it is not a weakness to use medicine to stop smoking.

Adapted from: Kozlowski LT, .Giovino GA, Edwards B, DiFranza J, Foulds J, Hurt R, Niaura R, Sachs DPL., Selby P, Dollar KM., Bowen D Cummings KM, Counts M, Fox B, Sweanor D, Ahern F. Advice on using over-the-counter nicotine replacement therapy- patch, gum, or lozenge- to quit smoking. Addictive Behaviors (in press).

Some of these pieces of advice contradict some of the advice given on the product packaging (e.g. suggestion to combine NRTs and to continue use until confident of quitting). However, this advice is based on the latest research evidence and the clinical expertise of 16 experts on tobacco treatment.

You can read the full paper and a Spanish translation of the key points at:
http://proyectovidanofume.org/publication.htm

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When is the best time to quit smoking?

Jonathan Foulds, MA, MAppSci, PhD
Most of us are familiar with the statistic that in countries like the USA, UK, Canada and Australia (and many other developed countries) approximately 70% of current smokers say that they would like to quit smoking. An even greater proportion typically state that if they had their time again, they would choose never to start smoking.

However, if you ask them when they plan to quit, most give a time frame over 6 months in advance, but expect to have quit within 2 years. So we see a lack of urgency combined with an understanding that it would be a big mistake to let it drag on for much longer. The big problem, however, that the average smoker who stated 10 years ago, “I want to quit, but its not a good time right now, - I’ll definitely do it within the next 2 years” is still smoking today. What this means is that smokers tend to put off quitting for much longer than they plan to, and if they try to wait for “the right time” there is a very large chance that they end up waiting until the worst time – after the diagnosis of a serious illness caused by smoking.

A report by Professor Martin Jarvis and colleagues at University of London commented on the “delusion gap” between smokers’ expectations (53% expecting to be quit in 2 years) and reality (only 6% actually quitting in that time frame).

One of the reasons people often give for putting off a quit attempt is that they have too much stress in their life. Unfortunately, people who have stress now are fairly likely to continue having stress in the future. Cigarettes add to many of the most common stresses (financial problems, health problems etc) and the evidence is very clear that people who smoke are not less stressed than people who don’t. In fact, if you follow a group of smokers who successfully quit for 6 months the typical finding is that they report being less stressed as an ex-smoker than they did as a smoker. So stress is probably not a great reason for delaying quitting.

Another reason people sometimes have for delaying (often supported by psychologists like myself) is the belief that you need to do a lot of planning and preparation before trying to quit. Professor Robert West (University of London) recently published an interesting study that seemed to argue against that idea. Based on a survey of almost 2000 smokers and ex-smokers he found that almost half of the most recent quit attempts were made rather spontaneously (i.e. they made up their mind to try to quit on a day without prior planning on previous days), and perhaps more surprisingly, those who claimed to have made a quit attempt without any prior planning were twice as likely to still be quit at least 6 months later, compared with those planning ahead!

Now the tricky bit here is in interpreting what this means. No-one (or at least not the authors of the article, nor most of the commentators including myself) think this means that it is detrimental to plan your quit attempt. But what it does suggest that if you find yourself suddenly convinced by some thought, experience, or something you saw on TV, that now is the time to quit, then don’t talk yourself out of it by reasoning that you need to take time to plan. Go with the flow, get rid of your cigarettes and follow your instincts there and then.

So (perhaps predictably), the best answer to the question posed in the title is “right now”!


The paper by Professor Jarvis and colleagues can be found at: http://www.bmj.com/cgi/content/full/324/7337/608

The paper by Professor West and colleague can be found at:
http://www.bmj.com/cgi/content/full/332/7539/458

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Tobacco Use Around The World

Jonathan Foulds, MA, MAppSci, PhD
A reader from Australia requested some comparative information on tobacco use around the world. By far the best source of such information is a superb book called, “The Tobacco Atlas” (2nd Edition) written by Dr. Judith Mackay, Dr. Michael Eriksen, and Dr. Omar Shafey. Large parts of the book are available online via the link below, but I’ll try to summarize the parts I found most interesting.

The most striking thing is the enormity of it. Taking cigarettes alone, global cigarette production continues to increase dramatically, from 1,686 billion cigarettes in 1950 to 5,604 billion in 2002. The magnitude of tobacco consumption in Asia generally and China in particular is mind-boggling. More than 300 million men smoke in China (70% of men) – more than the entire population of the United States, and they consume 30% of the world’s cigarettes each year. The other striking factor is that in many countries in the world (particularly Asia, Africa and the Middle East) smoking is largely a male past-time, with male smoking rates about 10 times those in women.

Because of these marked sex differences in smoking in some countries, around a billion men smoke and around 250 million smoke around the world. It is largely the high smoking rates among women in North America and Europe that causes the overall smoking rates in these countries to be relatively high – in most other countries male smoking is higher but female smoking is much less common. In fact the only country in the world that has had consistently higher female than male cigarette smoking rates over the past 10 years is Sweden. Sweden has the lowest male smoking rates in Europe, and is the only member of the European Union that allows the sale of smokeless tobacco. More men now use smokeless tobacco than smoke in Sweden.

In countries like the UK, USA and Australia there is a clear linear relationship between smoking rates and education/socioeconomic status, with smoking rates being much higher in the poorest, least educated sections of society. However, it is not like that across the globe. For example, in southern European countries such as Greece, female university students are more likely to smoke than young women not attending university. Amazingly in some countries (e.g. Turkey and Bulgaria) the smoking rates are higher among health professionals than in the general population. In China 57% of male doctors smoke!

The China National Tobacco Corporation is the biggest tobacco company in the world, having a monopoly in China as part of the Chinese government, and therefore having about a third of the global tobacco market. Then there are 5 major multinational tobacco companies with significant global market shares: Altria (Philip Morris): 17.6%, British American Tobacco (15.1%), Japan Tobacco Inc (9.5% including recent take-over of Gallaher Group PLC), Imperial Tobacco Group (3.6%) and Altadis (2%). In 2004, Philip Morris sold $57 billion worth of cigarettes in over 160 countries. Interestingly, in 2003, 851 billion cigarettes were reported as being exported around the world but only 664 billion were reported as being imported. Unless we are exporting to aliens on another planet, almost 200 billion cigarettes went “missing” in the process!

And to return to our Australian colleague, in fact Australia is one of the world leaders in tobacco control, with an adult smoking prevalence of around 17.6% (as compared with around 26% in UK and around 22% in USA). I often hear Americans return from vacation in Europe commenting on how “everyone” smokes over there. However, it depends which part of the USA one lives in whether smoking rates are much lower. In Utah and California smoking rates are much lower than most countries in Europe, but in Nevada and Kentucky smoking rates are higher than in many European countries.

For those of you with an interest in global tobacco, I’d strongly recommend taking a look at The Tobacco Atlas.
http://www.cancer.org/docroot/AA/content/AA_2_5_9x_Tobacco_Atlas.asp

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Reductions in teen smoking.

Jonathan Foulds, MA, MAppSci, PhD
One of the most fascinating and unexplained changes in smoking habits that has taken place in the United States was the dramatic reduction of cigarette smoking among African American youth since the 1970s. The “Monitoring the Future” study has documented clearly that in 1975, smoking prevalence was very similar across ethnic/racial groups of teenagers, with 38% of white teens smoking, 37% of African American teens smoking and 36% of Latino youth smoking cigarettes in 1977. However, by 1985, smoking prevalence had halved among African American teens (18%) but remained high in whites (31%) and Latino youth (26%). By 1992 the differences had become even more marked, with only 9% of African American youth smoking, compared with 32% of white youth and 25% of Latino youth. Although smoking declined in young people of all backgrounds since 1998, these ethnic/racial differences largely persist. So the proportion of African American teens who smoke was cut by more than three quarters over 15 years, and yet no-one appears to know how it happened. Suggestions have ranged from increased price-responsiveness among African American teens (during a period involving increases in price of cigarettes), the possibility that African American youth could be using other substances instead. However, this last idea is based more on stereotypes than data: illegal drug use has also fallen in African American youth over the same time frame, and in 2006 a smaller proportion of African American high school seniors had used an illicit substance in the past year, as compared with whites or Latinos.

So this rather dramatic reduction in smoking by African American youth occurred prior to the major funded campaigns that followed the master Settlement Agreement in 1998, and is largely unexplained. If you think you have an explanation, please tell me!

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Cigarette Brand Preferences: start young and focus on 3 brands.

Jonathan Foulds, MA, MAppSci, PhD
When you look at the cigarette counter at a supermarket or even a chain pharmacy you will typically see a wall of cigarettes and advertising placards touting dozens of types of cigarettes. However, although there are actually hundreds of different brands, and at least 25 different brands that are widely available, sales of cigarettes focus very much on just a few brands.

This is particularly noticeable in children, for whom almost all the sales focus on just 3 brands (can you guess what they are?). The other thing that is very noticeable is how brand preferences vary dramatically by ethnic/racial groupings. A massive ongoing study run by University of Michigan called, “Monitoring the Future” has been tracking youth smoking and other substance use over many years and has produced some fascinating data. For example, it has found that 65% of white youth smokers smoke Marlboro (as do 60% of Latino and only 8% of African American youth smokers), whereas 75% of African American kids who smoke prefer Newport (a mentholated brand), which is smoked by only 12% of whites and 20% of Latino youth smokers. The only other brand with any recognition in 1998 was Camel, which was smoked by 9% of white youth smokers. The full breakdown as of 1998 can be seen at:
http://www.monitoringthefuture.org/data/tables/cigbrands/table1.html

These patterns persist in smokers aged 12 or over (including adults) in a national survey carried out in 2005, with whites and Latinos preferring Marlboro, and African Americans preferring Newport. The main (fairly small) differences in that study were increased market penetration among African Americans for the “Kool” brand (11%, also a menthol), and increased market share for “discount” brands (eg Doral and Basic). The most recent data can be found at: http://www.oas.samhsa.gov/2k7/cigBrands/cigBrands.htm

If you would like to know why brand preferences are concentrated in this way, then visiting the website: www.trinketsandtrash.org may give you a clue. This site contains a collection of tobacco advertising and memorabilia and is a good tool for tracking the activities of vector in this epidemic: the tobacco industry.

I’d be interested in hearing your reasons for your brand preferences and if any ads influenced you.

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Higher nicotine intake per cigarette by African American smokers: is it a menthol effect?.

Jonathan Foulds, MA, MAppSci, PhD
There are some quite large differences in tobacco use between the different racial and ethnic groups in the United States. One of the most consistent findings is that African American and Latino smokers smoke fewer cigarettes per day than non-Latino whites. For example, in a large study reported by Dr Richard O’Connor and colleagues in the American Journal of Epidemiology, in daily smokers aged over 24 years, African American smokers averaged around 12 cigarettes per day, whereas non-Latino whites smoked an average of around 18 cigarettes per day. Mexican-Americans smoked only 8 or 9 cigarettes per day on average.

However, this study also included a measure of blood cotinine – the main metabolite of nicotine and a good index of total nicotine intake. African American smokers had much higher cotinine concentrations (253 ng/ml) than white/non Latino smokers (208 ng/ml) and Mexican American smokers (94 ng/ml). So the estimated cotinine per cigarette was much higher (33) for African Americans, than both non-Latino whites (15) or Mexican American smokers (17). While there is some evidence that these differences in cotinine levels may relate to metabolic differences, they also appear to be due to real differences in nicotine intake per cigarette, as indicated by higher levels of exhaled carbon-monoxide.

A similar pattern was recently reported among 900 young adult smokers (aged 18-26), among whom whites averaged over 15 cigarettes per day but African Americans, Latinos and Asian smokers averaged 10-11 cigarettes per day. However, African American smokers had blood cotinine levels that were much higher than other groups, and an average cotinine level per cigarette that was more than twice that of non-Latino whites.

Part of these differences in nicotine intake per cigarette may relate to differences in the types of cigarettes smoked by different subgroups. Around 80% of African American smokers smoke a mentholated brand of cigarettes, compared to 25% for non-Latino whites. Menthol stimulates cold receptors and so cools the harshness of cigarette smoke on the throat, enabling a larger inhalation per puff.

If African Americans are inhaling more nicotine per cigarette, this would suggest that they may have increased absorption of other toxic chemicals. The habitual intake of more nicotine from fewer cigarettes may also produce a stronger addiction to cigarettes. Further evidence that is consistent with this idea emerged last year in a paper published in the New England Journal of Medicine which reported a higher rate of lung cancer, and lower rate of “ex-smokers” among African American and Native Hawaiian smokers. Interestingly, Native Hawaiians also have a strong preference for mentholated brands (65-80%). Putting together all of the evidence on this leads me to believe that people who smoke menthol cigarettes are likely to inhale more smoke per cigarette, be more addicted, and be at greater risk of smoking-caused diseases (all other things being equal). These effects are likely to be more marked in people who have had to restrict their cigarette consumption due to the expense of cigarettes, restrictions on smoking in public places or other factors (e.g. those affecting young people, or pregnant smokers). It also seems likely that the tobacco industry has targeted their marketing of menthol brands at groups they perceive as having less disposable income, because the industry knows that menthol cigarettes can get the customer addicted on fewer cigarettes per day.

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Is nicotine replacement therapy effective in the “real world”?

Jonathan Foulds, MA, MAppSci, PhD
Over a hundred double-blind randomized placebo-controlled trials have evaluated the efficacy of nicotine replacement therapy for smoking cessation, and the results are very clear: use of NRT almost doubles the smokers’ chances of successfully quitting. Five years ago, a paper published in the Journal of the American Medical Association by Professor John Pierce and colleagues claimed that since becoming available over-the-counter, NRT was no longer effective. This study was based on retrospective recall of quit attempts by respondents to a large survey in California. Many researchers questioned the validity of the findings, partly based on evidence that smokers are more likely to forget unaided failed quit attempts, and partly because smokers who choose to use NRT tend to be more addicted than those choosing to quit on their own, and the Pierce study was not able to adequately measure this.

Since then, a number of studies have been published that shed more light on this issue. A more recent study by the same research group found that use of a pharmacological aid (NRT or bupropion) is more effective than no aid in households with either no other smokers or a smoke-free policy. This result was an interesting demonstration of the interaction between effects of a medication and the environment in which it is used. It also suggests that effectiveness of NRT has little to do with whether it is prescribed by a doctor or purchased over the counter. However, this study still relied on retrospective recall and so some doubts about recall accuracy remain.

Further light was shed on this issue in a study by Miller and colleagues published in the Lancet in 2005. They reported on a large scale distribution of free nicotine patches (via a telephone quitline) to over 34,000 people in New York City. Six months later they followed up a randomly selected sample of participants, and also a sample of people who called the quitline but did not receive patches due to mailing errors. They found that 33% of those receiving patches had quit 6 months later, as compared with only 6% among those not receiving them. This suggests that nicotine patches are effective when used along with very low intensity support.

Very recently, Professor Robert West and Xiaolei Zhou have reported in the journal, Thorax, the results of a multinational prospective study of over 3,605 smokers attempting to quit. This study found that those using NRT were about twice as likely (8% vs 4%) to remain continuously abstinent six months later. This study, like the New York City patch study, supports the findings from randomized clinical trials and demonstrates that smokers making a self-initiated quit attempt without additional behavioral support are twice as likely to remain abstinent for at least six months if they use NRT as compared with trying without NRT. Nicotine replacement therapy is therefore an effective aid to smoking cessation in the “real world”.

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Whats the problem with Accomplia/rimonabant (Zimulti) the weight-loss drug that also helps you quit smoking?

Jonathan Foulds, MA, MAppSci, PhD
Rimonabant is the name of a drug that has been developed as an aid to weight loss in people who are obese. It is a novel cannabinoid receptor blocker – basically giving an effect a little bit like the opposite of the “munchies” reported by people after smoking cannabis. The drug was eagerly awaited in the United States, especially after publication of fairly impressive trial data on weight loss and lipid profile in three major medical journals and launches of the drug in Europe and South and Central America. There have also been numerous media reports that this “wonder drug” also helps people to quit smoking. Strangely, none of the trials of the drug for smoking cessation have been published, although some of the results have been presented at scientific meetings.

Then in early 2006, the FDA did not approve rimonabant. Instead, it issued an "approvable" letter to the parent company (Sanofi-Aventis) for weight loss, and a "non-approvable" letter for smoking cessation. Undisclosed requirements were apparently placed on Sanofi before final approval for the weight loss indication is granted. Until recently everyone was very tight lipped as to what the problem was. However, on June 13th an advisory committee met to review the data on rimonabant. While they accepted the fairly good data on weight loss, they were concerned about increased rates of psychiatric symptoms and voted 14-0 not to approve the drug until there is additional data on rimonabant’s safety profile. The 20mg dose (which is most effective for weight loss) was associated with approximately double the rate of psychiatric symptoms, including suicidality.

The full FDA briefing documents for that meeting are available online at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4306b1-00-index.htm . However, it now seems fairly clear that this drug will not be approved in the U.S. in the very near future, and its next chance will be on completion of another large trial that is currently underway for weight loss. The company is adding more detailed measurement of psychiatric symptoms into the ongoing trials and will be able report on these results in a couple of years. Of course, rimonabant is the first of this new class of drugs to reach the market (at least in other countries), and the evidence of its weight loss effects (and possible effects on smoking cessation) will encourage pharma companies to develop new medicines based on similar molecules and mechanisms of action. The first of these drugs to be found effective for both weight loss and smoking cessation, (without serious side-effects) will likely be a “blockbuster” drug. In the mean time it will be interesting to hear from colleagues in Europe and South America whether this drug appears successful for weight loss and/or smoking cessation, and whether those concerning side effects are a problem in those countries.

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Which nicotine replacement therapy?

Jonathan Foulds, MA, MAppSci, PhD
Nicotine replacement therapy (NRT) is the name given to FDA-approved medicines containing nicotine that are used to reduce nicotine withdrawal symptoms and cravings and to help smokers quit. Currently there are 5 main types: patch, gum, lozenge, nasal spray and inhaler. These latter two (nasal spray and inhaler) are only available via prescription in the United States, although they are available over-the-counter in many other countries (e.g. UK).

Each type of NRT has its own advantages and disadvantages. The patch is by far the most commonly used NRT, largely because it is the easiest to use, requiring only a single patch application per day. Another advantage of the patch is that its side effects are usually mild – primarily mild skin irritation and itching. The main disadvantage is that there is nothing one can do with the patch to increase the dose when you feel the need for more nicotine.

The gum and the lozenge are broadly similar in terms of dose (each available in 2mg and 4mg formats) and route of administration. The main challenge facing the gum chewer is to adopt a “chew and park” style, such that you chew the gum a few times to release a peppery taste (nicotine) and then park it in the side of your mouth for a few minutes before chewing again. The labeling on the gum suggests that people who smoke less than 25 cigarettes per day should use 2mg (rather than 4mg) and the labeling on the lozenge states that those who don’t smoke within 30 minutes of waking in the morning should use the 2mg lozenge. In practice many clinicians have learned that this labeling (especially the gum) is a recipe for under-dosing and advise all but the lightest smokers to use the 4mg formulation of each product. To get a real benefit from these products you need to use enough. Most users only take 3 or 4 per day in response to cravings. You can get a far greater benefit by taking one per hour (to prevent cravings and withdrawal symptoms) plus another whenever you have a breakthrough craving.

I described the nicotine nasal spray in some detail a few days ago. It appears to be particularly helpful for heavy addicted smokers who are willing to persevere despite the initial nasal irritation. Make sure you have some Kleenex handy when you first try the spray. The initial doses sting and will make you sneeze. But, just as with smoking, you will get used to it within a few days, and within a week will probably like it!

The inhaler‘s main advantage is that it enables the smoker to continue with a similar hand/mouth habit, but it helps to gradually wean them off nicotine. The main thing to note is that one puff on a cigarette delivers a similar amount of nicotine to ten puffs on the inhaler. This means that in order to obtain a therapeutic dose, the ex-smoker has to be puffing on the nicotine inhaler almost all the time. We recommend puffing on the inhaler for 20 minutes out of ever waking hour. Again, people who get into that regular use habit early on tend to do very well with the inhaler.

Some years ago Professor Peter Hajek and colleagues at the University of London conducted a randomized trial comparing the nicotine patch, gum, nasal spray and inhaler. In practice they all had similar quit rates (around 20-25% complete abstinence 3 months later), although women did better on the inhaler than the gum and men were the opposite. Prior to their quit attempt, participants were shown videos describing each NRT and were then allowed to rate their preferences. They were each then randomly allocated to one product. This meant that some people were allocated the product that was their first preference, whereas most were not. However, at the end of the study the smoking cessation outcomes were similar for those receiving their preferred NRT versus those being randomly allocated to a less preferred NRT. Also, people came to prefer the product they were given after they had used it for a week.

One final thing to consider is that the products differ in the risk of inducing dependence. It is extremely rare for someone to have any difficulty coming off the patch (which typically have a built-in reduction plan, involving using smaller sized patches over 4 weeks). However, some people (about 5-10%) find themselves using the gum, inhaler or lozenge long term (i.e. over 3 months and possibly continuing for years). The nicotine nasal spray has the highest dependence potential, with around 10-15% of those who use it continuing use after 3 months. The risk of becoming dependent is related to the speed of nicotine delivery from the product (spray fastest, but still slower and lower dose than a cigarette, whereas the patch delivers nicotine very slowly). It also seems to be related to how addicted the person was to their cigarettes. Thus people who smoked over a pack a day and smoke within 30 minutes of waking in the morning (or wake at night to smoke) are more likely to become a long term user of their NRT product. However, in the placebo-controlled trials these were precisely the people who were much less likely to succeed in quitting if they received the placebo. The thing to remember here is that it is much better to be a long term user of an NRT product delivering only nicotine, than a continuing user of a product that delivers a higher dose of nicotine plus 4000 other toxic chemicals (i.e. a cigarette).

Recently a group of experts in the treatment of tobacco addiction got together to produce a consensus statement guiding consumers on the most effective ways to use NRT to help them quit smoking. You can find a copy of the paper and the summary (in both English and Spanish) at: http://proyectovidanofume.org/publication.htm

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Its time for pictorial warnings on cigarette packs.

Jonathan Foulds, MA, MAppSci, PhD
Virtually everyone knows that smoking is bad for health. But smokers typically don’t give much thought to the effects on their own health until they have been smoking for years. They also tend to be less aware of effects other than lung cancer (e.g. cardiovascular effects, effects on reproductive health etc). Health warnings first appeared on the side of US cigarette packs in 1965, stating that, “Cigarette smoking may be hazardous to your health.” The labels on U.S. cigarettes have not changed since 1984 and appear in small black and white print on the side of cigarette packs. Can you remember what they say? (most people can’t).

Messages given in small print on the side of the pack clearly lack salience and persuasive power compared with more colorful, larger messaging placed on the front of the packs. An expert panel commissioned by the National Academy of Sciences described the current warnings as “woefully deficient.” In an effort to help smokers be more clear about the health effects of cigarettes, many other countries around the world (including Australia, Belgium, Brazil and Canada) have introduced larger pictorial health warnings on cigarette packs.

You can view the pictorial health warnings from other countries around the world at:
http://www.smoke-free.ca/warnings/default.htm . These warnings provide quite a contrast to those in use in the United States, and may even help increase a smoker’s motivation to quit simply by viewing them online.

Some recent studies indicate that current U.S. warnings are woefully ineffective at getting the attention of smokers, communicating health risks or motivating smokers to quit, whereas the type of pictorial warnings used in Canada are much better. David Hammond and colleagues at University of Waterloo in Canada examined Canadian smokers’ reactions to the pictorial warnings in Canada. Over 90% of smokers had read the new warnings and those who read them, thought about and discussed the new Canadian warnings were more likely to have quit, made a quit attempt, or reduced their smoking three months later. Dr Ellen Peters and colleagues from University of Oregon recently compared US warnings with those in Canada. A majority of both smokers and non-smokers endorsed the use of Canadian-style warnings in the United States.

A bill currently pending in Congress would give the U.S. Food and Drug Administration (FDA) authority to require major changes in U.S. cigarette pack health warnings and require that they cover at least the top 30 percent of the front and back of cigarette packs. The legislation would also allow the FDA to increase the warning size to 50 percent of the front and back panels and adopt graphic or pictorial warnings, as Canada and several other countries have already done. Some countries also include the toll-free number for the national Smokers Quitline next to the warning. Its time to upgrade the health warnings on cigarette packs in the United States to include pictorial warnings and the national quitline number (1-800 QUIT NOW).

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Can quitting smoking trigger depression?

Jonathan Foulds, MA, MAppSci, PhD
Adolescent smokers are more likely than non-smokers to subsequently develop depression, and adult smokers are more likely to have either current depression or a history of depression than adult non-smokers. So although some have suggested that tobacco may have some component that “medicates” depression, the evidence for this is not at all clear. But for the smoker who has previously suffered a major depressive episode it is reasonable to wonder whether stopping smoking might increase the risk of suffering another episode of depression.

Depression is one of the most common and most unpleasant of all illnesses. It is characterized by feeling consistently sad, hopeless and pessimistic for more than 2 weeks (usually much longer), and often involves sleep disturbance, fatigue and changes in appetite. Perhaps most importantly, major depression is a risk factor for both attempted and completed suicide. So anyone who has ever suffered from major depression may understandably be very reluctant to do anything that may increase the risk of feeling that bad again. Remembering that low/depressed mood (which is not the same as full blown depression) is one of the symptoms of nicotine withdrawal, one can understand why someone with a history of depression would become concerned when they experience the onset of depressive symptoms after quitting smoking. Some studies find that people with a history of depression have a lower quit rate when they try to quit smoking, compared to those without such a history. One reason for this may be that onset of depressive symptoms raises the concern that a major depressive episode may return and triggers a return to smoking. However, a critical question is whether such fears are justified. Can quitting smoking increase the risks of onset of major depression?

Professor John Hughes, of the University of Vermont recently reviewed all the published studies providing evidence relevant to this question. The rate of major depression in the year after successfully quitting varied considerably across studies, from as low as 1% to as high as 31%. There was fairly consistent evidence that people with a history of major depression were more likely to have another episode after quitting, but this is not surprising as people with a prior history of depression are more likely to have another episode regardless of whether they quit smoking or not. Two studies by Professor Stan Glassman at Columbia University found that depression occurred more frequently in people with a history of depression who succeeded in quitting smoking compared with those who continued to smoke. In his review, Professor Hughes commented that none of the studies provided conclusive evidence and that there was a high risk of “publication bias”. This refers to the tendency for studies that don’t find a difference/effect to be less likely to be published. So what can we conclude from all this?

It looks likely that having a history of major depression is associated with slightly greater difficulty quitting smoking, and an increased risk of recurrence of depression in the months/years after quitting smoking. It remains uncertain whether quitting smoking can actually trigger an occurrence of depression, although it is clear that the majority (69-99%) of people who quit (even those with a history of depression) do NOT experience major depression within a year of quitting.
But how might this affect the choice of treatment, particularly for those with a history of depression? If I had a close relative who wanted to quit smoking but had a history of major depression, my advice would be as follows:
1. To ensure that you get the best advice and support, attend a treatment center with staff who have been trained to provide tobacco treatment, including access to medical staff with experience providing the range of tobacco treatment medications.
2. To increase the chances of successfully quitting AND preventing unpleasant withdrawal symptoms make sure you use an adequate dose of medication approved for smoking cessation. For the heavy smoker that should involve discussing with the doctor the potential advantages of combination therapy, such as Zyban (bupropion), plus the nicotine patch, plus one of the acute dosing nicotine replacement therapies (nicotine gum, lozenge, inhaler or nasal spray).
3. Make use of all the counseling support services available – ideally combining attendance at regular group or individual appointments, plus registering with a smoking cessation website (e.g. www.quitnet.com ), plus use of a telephone quitline.
4. Don’t start reducing the prescribed medication until you are feeling very confident about maintaining abstinence from tobacco and have discussed it with your prescriber. As a rule of thumb, don’t consider reducing your prescribed smoking cessation medications until you have had fourteen consecutive days with no cravings, withdrawal symptoms or near lapses.
5. Stay engaged in counseling for at least a few months (and ideally longer) after you have come off your smoking cessation medications. This could be as simple as scheduled monthly appointments or telephone calls, but even this relatively infrequent contact during months 4-12 after quitting smoking will help maintain focus on abstinence and will enable the counselors to monitor symptoms and treat as required.

Now all of this may sound like a great deal more work than people typically plan on when they try to quit smoking. It is. But I would remind my relative that this is a difficult but life-saving behavior change they are about to embark on. One likely to add ten healthy years to their life. Its well worth the effort both to successfully quit and to look after ones mental health in the process.

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Nicotrol Nasal Spray: an effective treatment for the heavy smoker.

Jonathan Foulds, MA, MAppSci, PhD
Of all the nicotine replacement products, the one that’s used least frequently is the nicotine nasal spray (brand name Nicotrol). This may be partly because it requires a prescription, and partly because it initially causes some nasal side-effects. But in my experience this can be a very useful smoking cessation aid – particularly for the more addicted smoker.

Like other nicotine replacement products, you start using the spray on the day you quit smoking. One dose (a squirt up each nostril) delivers approximately 1mg of nicotine, although the typical blood nicotine level achieved by a single dose is around 6ng/ml – about half the concentration delivered by a cigarette.

In order to deliver a good dose of nicotine with just a couple of squirts, the concentration of nicotine in the spray is quite high. Unfortunately this means that the initial sensation in the nose is quite similar to that caused by sniffing pepper (a burning sensation, causing sneezing and watering of the eyes). This is probably the main reason the spray is not widely used. This is a pity because these side effects usually calm down within a couple of days. By the end of the first week nicotine nasal spray users have usually learned to like it and find that it provides rapid relief of craving for a cigarette. Numerous placebo-controlled trials have shown that the spray is effective in relieving nicotine withdrawal symptoms and cravings. These studies have also found that the spray was particularly helpful to heavier smokers, who were more than 5 times more likely to quit smoking successfully with the nicotine nasal spray as they were with a placebo spray containing no nicotine.

The main advantages of the spray are that it delivers a good hit of nicotine more rapidly than any other nicotine replacement therapy. The main disadvantage is the initial nasal irritation. Although needing a prescription presents an extra hurdle to getting this medication, it also means that the Nicotrol spray is more frequently covered by health insurance than the “over-the-counter” products like the gum, lozenge or patch. If you are the type of smoker who really enjoys smoking and feel that you need the stimulant effects of nicotine, or if you smoke within 30 minutes of waking each morning (or in the middle of the night), then the nicotine nasal spray may be the thing for you. Because it gives a more rapid nicotine hit than the other products, slightly more users (around 10% of those who try it) become dependent on it and want to use it for longer than 3 months. Clearly longer term use of a nicotine nasal spray is much less harmful than continued use of nicotine plus over 4000 chemicals from cigarettes.

The nicotine nasal spray is certainly worth considering if you’ve tried another NRT, (e.g. the patch) and felt it didn’t really provide enough craving relief, or if you tried Chantix and couldn’t take it due to nausea. If you are a particularly heavy smoker you may even want to discuss with your doctor the (“off-label”) option of combining the nasal spray with Zyban (bupropion) and/or the nicotine patch. You can find published descriptions of outcomes from such combination treatments on the Tobacco Dependence Program’s website at: http://www.tobaccoprogram.org/staffarticles.htm
(see papers by Williams & Foulds, 2007; Steinberg, Foulds & colleagues, 2006 and Williams, Ziedonis & Foulds, 2004).

If you’ve tried the nicotine nasal spray, why not post your experience so others can learn from it?

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Get rid of all your tobacco

Jonathan Foulds, MA, MAppSci, PhD
When trying to help smokers to quit, one naturally has to respect each individual’s preferences and beliefs about the best way to do it. But there are a few pieces of advice on which we can be pretty clear. One of them relates to the importance of getting rid of all your tobacco.

Not keeping cigarettes around when you are trying to quit sounds so obvious, but many smokers making an unassisted quit attempt keep some of their cigarettes or just don’t bother to carefully find and get rid of all their cigarettes. Even among smokers attending a specialist treatment clinic, around one in ten hang on to at least one cigarette after their target quit date arrives. When asked why, the answer is often something like, “just in case”. When asked, “just in case what?”, the answer is usually “just in case I feel I really need one.” Of course there will be times when you think you really need one, and perhaps the main thing that will stop you from smoking one will be that you don’t have one handy.

Sometimes smokers say that they’ll feel calmer knowing they have a cigarette nearby. But in my experience the availability of tobacco serves to stimulate cravings rather than reduce them. I’ve known smokers who have almost turned their house upside down during a quit attempt, trying to find that one cigarette that they remembered was in an old coat pocket, or the back of a drawer. Urges to smoke occur frequently during the first weeks of a quit attempt, but they are usually brief – from a few seconds to 5 minutes. Focusing attention on something else and keeping busy helps reduced the length, frequency and severity of cravings. But having cigarettes around or even just the knowledge that one is available somewhere in the house can trigger cravings and make it harder to refocus your thoughts on something else.

It is important to be thorough about this prior to your quit day. That means more than making sure you have either finished or thrown out your current pack. It also means making sure there are none in your car, workplace, closets, old clothes and down the back of the sofa! It involves having a good think about where any cigarettes might be available, prior to the quit day and disposing of them, along with any matches or lighters you still have.

Disposing thoroughly is also important. A half-full pack in the trash can start to seem mighty tempting after a few hours. Similarly giving what is left of your carton of cigarettes to your partner or neighbor to “look after” doesn’t cut it. Its too easy to pop round and say, “Remember that carton I gave you, can I have just one back?” Any remaining cigarettes should be scrunched up, soaked in water and put in a garbage bag along with all the other rotting food, and then the garbage bag placed out in the trash can. By thoroughly disposing of your tobacco and avoiding tempting situations where cigarettes are available, you will reduce your cravings and significantly increase your chances of successfully quitting.

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Why did Philip Morris’s new smokeless tobacco product (“Taboka”) deliver almost no nicotine?

Jonathan Foulds, MA, MAppSci, PhD
Recently I mentioned that Philip Morris (biggest selling US cigarette manufacturer) plans to test-market a new smokeless tobacco product called “Marlboro Snus” in Dallas. In 2006 the company tested a similar product, which they called “Taboka” in Indianapolis. The company presented some information to health professionals at a meeting in Boston last year, and some of the details were rather puzzling (to me at least).

The kind of smokeless tobacco that has proven to be rather successful in Sweden, and is referred to as “snus” (Swedish for snuff) is a moist snuff, typically containing about 50% water. It is typically alkaline (ph around 8) and can deliver a dose of nicotine comparable to a cigarette. However, Taboka is a dry tobacco product (about 12% moisture content), is less alkaline (which impairs nicotine delivery) and in fact delivers almost no nicotine (certainly not enough to be enjoyable for a smoker).

To give you a sense of typical nicotine deliveries by different tobacco products, when a smoker smokes a cigarette their blood nicotine concentration typically increases by 10-20 ng/ml within 10 minutes. When a smokeless tobacco user uses a typical dose of loose snuff (eg General Snus or Copenhagen snuff) they can get an increase in blood nicotine levels of around 8-16 ng/ml within 15-20 minutes. But when people used a Taboka sachet their blood nicotine concentration only increased by 1-2 ng/ml.

So why is the biggest tobacco company in the United States, with hundreds of research scientists at its disposal, and decades of experience in selling nicotine in a stick, apparently trying to launch a product that doesn’t deliver anything close to an adequate dose of its key ingredient? In all honesty I don’t know the answer. But here’s my theory:

Philip Morris may know fine and well that an almost nicotine-free smokeless tobacco product is about as useful to consumers as a chocolate teapot. Philip Morris may also know precisely what level of nicotine delivery is required to provide “satisfaction” (satisfaction is tobacco-industry speak for addictiveness and is virtually interchangeable with nicotine delivery). Philip Morris has by far the largest share (around 50%) of the US cigarette market. Philip Morris wants the status quo to continue. It therefore may not want lots of smokers switching from its deadly cigarettes to a much less harmful smokeless product. But it doesn’t want to run the legal risk of losing a court case on the basis that it needlessly caused people to die of lung cancer when they could have sold tobacco products that don’t cause lung cancer (smokeless tobacco doesn’t cause lung cancer, and snus doesn’t even cause oral cancer, unlike cigarettes). So how do they minimize risks? Firstly by supporting a bill in Congress that will allow the FDA to regulate tobacco in a way that makes it more difficult to launch new products that claim to be less harmful than regular cigarettes (Philip Morris supports the current FDA regulation bill – the only major tobacco company to do so). Secondly, they claim to have spent millions of dollars trying to get smokers to switch to a less harmful smokeless product, but unfortunately find that smokers don’t really like the much less harmful (and less addictive) smokeless product they offered. So the product dies a death, smokers keep smoking one of the dozens of varieties of lethal Marlboro cigarettes, and the company can claim in court that they tried, but smokers really just want to keep puffing on their yummy cigarettes.

So am I suggesting that Philip Morris may have created a product that was specifically designed to fail? Yes. Just as surely as it would appear that way if the Ford Motor Company launched a new pollution-free car, but gave it square wheels. One would have to assume that they would know better. In these scenarios either Philip Morris and Ford are completely stupid (and I don’t think that’s very likely) or they have a different agenda – one that requires the new product to fail.

Phillip Morris have not yet revealed whether their new Marlboro Snus product delivers a better hit of nicotine than Taboka did. If at least one of their new “snus” products doesn’t deliver at least 3-4 times the nicotine dose as Taboka, I am going to stick with the view that this test market launch is also intentionally designed to fail.

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Marlboro Snus: What is it?

Jonathan Foulds, MA, MAppSci, PhD
Yesterday Philip Morris USA, the tobacco company that has around 50% of the total market for cigarettes in the USA, announced the launch a new product: “Marlboro Snus,” in a test market in the Dallas/Fort Worth area. So what type of product it this?

As this particular brand of snus won’t be launched until August we can’t yet tell much of the details of the product (e.g. how much nicotine it delivers or how much it will cost) so lets talk about what “snus” is generally, and why the biggest cigarette manufacturers in the US are test marketing an entirely different type of product.

Snus (pronounced “snooss”) is the Swedish word for snuff, and is a form of moist ground smokeless tobacco, that is usually sold in “sachet” form – each sachet looking like a small tea-bag. Each sachet is placed in the mouth (usually under the upper or lower lip) for about 30 minutes and the nicotine and tobacco taste is absorbed via the lining of the mouth. The main difference between snus products and other smokeless tobacco already available in the United States, is that snus is produced using a process like pasteurization in which it is heated with steam. This kills most of the microbes that can produce cancer-causing chemicals in tobacco. Traditional smokeless products like Skoal and Copenhagen are not pasteurized but are fermented - a process that facilitates the development of cancer-causing chemicals. So snus does not appear to cause oral cancer. Clearly smokeless products also don’t cause lung cancer or respiratory diseases like emphysema either. That’s not to say that snus is entirely safe. Long term use can cause white patches to appear on the lining of the mouth and erosion of the gum where it is placed, and decades of use may increase risks of pancreatic cancer and cardiovascular disease (e.g. stroke and heart attacks). The nicotine from this product will also harm the unborn baby when used by a pregnant woman. So neither snus nor any other form of smokeless tobacco is recommended for anyone who currently doesn’t smoke. But because the health risks from snus are much lower (about 90% lower) than from smoking this may be a step in the right direction for the smoker who wants to keep using tobacco but wants to avoid most of the health risks.

Other companies are also test marketing snus products in the US. For example, Reynolds are launching Camel Snus, and Swedish Match are marketing “Exalt” in the US. So why are the big tobacco companies starting to test-market this product? The most likely reason is that they are aware that indoor smoking bans are sweeping the country, making it more hassle to be a smoker. They know that for a proportion of smokers the hassle of going in and out of nicotine withdrawal and being blamed for inflicting their smoke on other people makes it just not worth it, and will prompt many smokers to quit each year. I think they see snus as a way to get smokers to use their smokeless product in smoke-free environments, (so avoiding nicotine withdrawal and social stigma) but to continue smoking their cigarette brand in places where it is allowed. Clearly if smokers who would otherwise have quite continue to use both cigarettes and snus, this is a bad outcome for public health.

The use of the brand name “Marlboro” for their snus product suggests that the company may be serious about selling this product, and also suggests an intent to link it to their cigarette brands.

For those interested in quitting smoking, the best advice is to use one or more FDA-approved smoking cessation medications and enrole in counseling with a smoking cessation specialist.

If you are interested in learning more about snus, and the effects it has had on smoking in Sweden, click on this link: http://www.tobaccoprogram.org/staffarticles.htm
, scroll down to the papers by Foulds and colleages (2003) on “The Effect of smokeless tobacco (snus) on smoking and public health in Sweden” and the paper by Ramstrom & Foulds (2006). These are both available as pdfs for free from this site.

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Think you don’t really smoke for nicotine?

Jonathan Foulds, MA, MAppSci, PhD
When talking to smokers about why they smoke, I quite often hear people say something like, “I don’t really smoke for the nicotine..I just like the ritual, the taste and the feel of the smoke hitting the back of my throat…its not an addiction for me… its just a habit , a little pleasure all to myself. I don’t think it’s really a drug effect…more just the time to sit and relax and take some deep breaths without thinking about my worries.”

Now I agree that there may be a few smokers out there who are really not inhaling very much nicotine, or can go a week or more without smoking and not miss it at all. But these are a tiny minority of smokers (fewer than 5%) and it’s possible to identify them with a few questions about their cigarette consumption and experiences when not smoking (see prior posts). But for more than 95% of the smokers reading this article, the primary reason for smoking is for the psychological effects of the drug, nicotine, provided by smoking.

Every time a smoker inhales a puff of cigarette smoke, the smoke is carried to the lungs, absorbed directly into the blood and carried via the arterial circulation to the heart and the brain. That clump of smoke contains a high concentration of nicotine, which reaches the brain within 15 seconds of each puff. On reaching the brain, nicotine binds to certain types of receptors (nicotinic acetylcholine receptors), which then cause a cascade of other effects, including the release of the “reward neurotransmitter” – dopamine, in some of the parts of the brain that are particularly sensitive to reinforcement and emotional regulation. Other effects include a mild stimulant effect, that can be measured as an increase in heart rate, and a speeding of the brain’s electrical activity. This effect is also associated with a slight improvement in focused attention and tasks like driving late at night. We know that all of these (and some other) effects are caused by nicotine because they don’t occur when people smoke cigarettes that don’t contain nicotine, and likewise they don’t occur in laboratory rats given placebo (no drug) injections rather than nicotine.

Some of these effects are quite subtle, particularly after the first cigarette of the day. The smoker is typically not aware that their brain waves have speeded up, and they don’t usually experience a very noticeable “high” or intoxication that can be caused by numerous other addictive drugs. But the reinforcing effect on the brain and the occasionally noticeable feeling of satisfaction or “buzz” from the cigarette, which are caused directly by nicotine, become associated with the behavior of opening a cigarette pack, lighting a cigarette, inhaling the smoke and feeling that hit at the back of the throat as it goes down to the lungs. You may have heard of the famous experiments conducted by Ivan Pavlov, the Nobel Prize-winning Russian scientist at the beginning of the 20th century. He was initially interested in studying the functioning of the gastric system in dogs. This involved ringing a bell, presenting the dog with some food and then measuring the amount of saliva produced by the dog in response to the food. Pavlov quickly noticed that while a new experimental animal would initially only salivate when given food, after a few pairings of the bell with the food, the dogs would salivate simply in response to the bell. This very fundamental type of learning is called “classical conditioning” and it helps us to understand why smokers say they believe they really just enjoy the ritual or the feeling of the smoke hitting the back of their throat. The ritual of opening the pack, and the sensation of the smoke hitting the back of the throat were not satisfying the first time you did them. But after smoking a few packs, that ritual is like the bell for Pavlov’s dogs. It is a perfect predictor that in a few seconds, nicotine will reach the brain, and stimulate the release of dopamine in the reward center. Just as Pavlov’s dogs really get to like the sound of the bell, and start salivating as soon as they hear it, so the smoker really gets to like the ritual of lighting a cigarette. The main difference is that unlike Pavlov’s dogs, people can ring the bell themselves (by buying a pack and lighting up). The whole ritual becomes self-reinforcing, and this is strengthened by the fact that when a smoker goes for a day or two without the ritual, they start to experience unpleasant withdrawal symptoms, that are then relived by smoking. The ritual or habit is strengthened to the point that the smoker has cravings and urges to smoke when they havn’t done so for a few hours. This is an addiction, and happens to be caused by the effects of nicotine.

If you really don’t think it’s the nicotine then try switching to a brand of nicotine-free (zero nicotine, not “low”) cigarettes for a week. They provide the whole ritual, minus the nicotine. In fact you may find that at first the nicotine-free cigarettes help reduce cravings and seem to fulfill the same needs as your regular cigarettes. But within the first week or so the “extinction” process will take place – just as happened with Pavlov’s dogs if he kept ringing the bell but didn’t follow it up immediately with food. The dog learns that the bell is no longer associated with food and salivates less and less over time when the bell is rung. After a while the smoker realizes that these nicotine-free cigarettes aren’t doing it for them any more. By that time they are also experiencing nicotine withdrawal symptoms. This is why almost no smokers smoke nicotine-free cigarettes. They are missing the key ingredient.

As my former PhD supervisor, Professor Michael Russell, once put it, “If it wasn’t for the nicotine in cigarettes, people would be no more likely to smoke than to blow bubbles.”

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