Source: California Department of Health Services - Suggested citation: Robins R, ed. The Seduction of Harm Reduction: Proceedings from the September 2004 Summit. Sacramento, CA

By Jonathan Foulds, PhD, Associate Professor and Director of the Tobacco Dependence Program University of Medicine and Dentistry of New Jersey, School of Public Health

The focus of Dr. Foulds' talk was whether there is a health benefit to switching to smokeless tobacco. He acknowledged that he faced an uphill battle to convince the California Department of Health Services, Tobacco Control Section (TCS), that there is anything particularly good about smokeless tobacco, but his main aim was to give a rationale for nicotine maintenance and to show how, in one particular country, smokeless tobacco has had a potentially positive impact on tobacco-caused death and disease.

Before continuing, he mentioned that he has never had any financial or other links with the tobacco industry. In the past, he has received grants or honoraria from pharmaceutical companies involved in tobacco treatment, and he has provided testimony for plaintiffs in litigation against tobacco companies. His current support comes mainly from the New Jersey Department of Health and Senior Services.

Dr. Foulds agreed that the term "nicotine maintenance" is probably a more precise and preferable one than "harm reduction" as it describes the strategy rather than the desired outcome. While there is considerable doubt whether harm reduction is likely to be the end result of strategies often discussed under that heading, "nicotine maintenance" is a clear and accurate description of one strategy. The important context that one has to think about when talking about nicotine maintenance is that, right now, nicotine maintenance is the norm for tobacco users (i.e., in any one year, the vast majority of tobacco users continue to use nicotine on a regular basis). So, the real issue centers around whether we would improve health by switching some people from smoking to a form of nicotine maintenance that is markedly less likely to kill them or cause serious harm to their health.

Why not just stay with the dichotomy of cigarettes vs. quitting, with brief use of nicotine replacement therapy (NRT) if necessary?

1. Many people are not ready to give up nicotine use, and currently the most toxic form of nicotine delivery (cigarettes) is perceived as their only option. They consider smokeless tobacco, gum, and other NRT products as unappealing gimmicks. They believe that cigarettes are the preferred way to get nicotine.

2. Less than 10% of daily smokers in the U.S. are preparing to quit in the next month, and around 60% are not planning to try in the next six months. This percentage has remained stable throughout the 1990s.

Because that is not a particularly encouraging situation, should alternative strategies be considered? Perhaps, but these alternatives raise several problems. Dr. Foulds pointed to Interval, an existing nicotine maintenance product, as an example. Although certainly less harmful than cigarettes, its delivery of pure nicotine is very low; it probably would not satisfy a smoker. In addition, the public health community is correct to be concerned about how these products would be marketed; they may not have the desired impact. Yet, these products exist. The tobacco control community needs to be honest with the public as to their relative harmfulness versus the dominant nicotine delivery products, which are cigarettes.

Inhalation of the products of combustion is what distinguishes the most harmful products from other products that are markedly less harmful:

• Nothing that involves the inhalation of combustion products is likely to be markedly less harmful.
  
• Combustion creates an unavoidably toxic cocktail, so products such as Omni, Eclipse, and Advance would not be markedly less harmful. These products all carry the risks of decreasing cessation rates and giving people a false sense of safety with very little if any public health gain.
  
• Nicotine delivery products that do not require inhalation of combustion products or that do not deliver concentrations of toxic chemicals that could plausibly cause death and disease on the scale of cigarettes, such as nicotine replacement therapies and potentially low nitrosamine smokeless tobacco products, would be considered markedly less harmful.

There are three main options for nicotine maintenance:

• Encourage development of nicotine replacement therapies that are more acceptable to consumers, with higher nicotine delivery and more aggressive marketing in terms of cessation and nicotine maintenance. This would mean putting these products right next to tobacco and giving consumers a choice.
  
• Encourage marketing of low nitrosamine, high nicotine smokeless tobacco products such as snus for the purpose of nicotine maintenance.
  
• Both of the above

It is important to keep this discussion in the context of smoking-related morbidity and mortality: 442,000 people die from smoking-related diseases each year, and 12.7 million people suffer annually with serious smoking-related diseases, mainly chronic respiratory diseases.

With that in mind, Dr. Foulds posed a difficult question: Is there a public health benefit to switching to smokeless tobacco? He first looked at the benefit to the individual:

• There are no respiratory risks to the individual who uses smokeless tobacco.
  
• The cardiovascular risks are much less than smoking (much less than 50%).
• There are no or minimal cancer risks from some products with low nitrosamine concentrations.
  

So, for the individual, it is clear that switching to smokeless tobacco is likely to be much less harmful than continuing to smoke but with some excess risks (primarily cardiovascular) over complete nicotine abstinence. In some populations, such as pregnant women, there are much more serious risks, in which case any nicotine consumption should be strongly discouraged (although even in this population, which is extremely unlikely to be open to switching to smokeless, the health risks from smokeless are likely to be lower than from continued smoking). However, "given that smokeless eliminates all of the risks of lung disease caused by smoking, and has substantially lower risks of almost all other tobacco-caused disease," said Dr. Foulds, "I think it's what you call a no-brainer."

To discuss the use of smokeless tobacco at a population level, Dr. Foulds presented some data from Sweden, where they use a smokeless tobacco product known as snus (the Swedish word for snuff).

Swedish snus is characterized by the following:

• Moist fine-ground oral tobacco predominantly from air-cured dark tobacco
  
• Manufactured by a pasteurizing-like heating process (without any fermentation as is used in most manufacturing procedures for American snuff)
  
• Tobacco-specific nitrosamine (TSNA) content < 5 mg/kg (1/5 the content of American snuff)
  
• Benzo(a)pyrene (BaP) content < 10 µg/kg
• Its high pH (7.8-8.5) facilitates nicotine absorption; it can be purchased loose or portion-packed (similar to small tea bags).
  

Swedish snus differs from smokeless tobacco used in the U.S. in the following ways:

• It is stored refrigerated.
  
• It adheres to well-established standards for toxin content.
  
• Its TSNA levels do not increase with length of time in storage.
  
• It shows low TSNA content and low mutagenic activity compared to smoked tobacco.

Dr. Foulds listed the following health effects of snus:

• It causes nicotine dependence (similar to cigarettes), which he sees as a necessary characteristic of a nicotine maintenance product in order for it to be capable of helping significant numbers of people switch from cigarettes.
  
• It causes oral lesions/gum recession (only some of which are reversible), but not oral, gastric, or head/neck cancer.
• It may increase cardiovascular risks but less than cigarettes. (Three studies find no increase; one finds increased myocardial infarction risk relative to non-tobacco users; all find a lower risk than cigarettes).
  
• It is certainly harmful to the unborn fetus (though less so than cigarettes).
  
• It does not cause respiratory disease or lung cancer.
  

In looking at the health effects from snus use, one can look at the standardized lung cancer rates in Sweden as compared to its neighbor Norway. From 1960 to 1980, the lung cancer rates of men in Sweden and Norway were very similar. Beginning in 1980, however, the lung cancer rates of Swedish men began to drop, but not so for Norwegian men. That is not to say that snus is entirely responsible; decreased smoking is certainly the direct cause. But it is clear that smoking decreased and snus use increased among men over that time period. It is also clear that the reduction in lung cancer in men occurred despite stable tobacco use but with a growing proportion of tobacco use being attributable to snus use rather than smoking.

One can also look at the risk of myocardial infarction in men and women in Sweden from 1987 to 1995. The rate dropped significantly more for men than for women during the same period of time in which snus use was increasing. Sweden has a relatively low rate of oral cavity cancer, as well.

One can also look at data from the European MONICA study, which is a large study looking at heart disease, with cross-sectional surveys in many European countries. One of the study's centers is in northern Sweden. When researchers looked at the data there, it was consistent with the idea that men in particular were switching from cigarette smoking to snus use.

Data on cigarette consumption confirm that snus is used almost exclusively by men. In 1970, daily cigarette use was 42% among men, but as of 2003, the daily smoking prevalence rate was down to 14%. Smoking has come down in women as well, probably as a result of Sweden's very good tobacco control program. Their program focuses very much on reducing smoking among women, particularly pregnant women. Even so, Sweden is unique in that the smoking prevalence rate has fallen even more in men than in women, largely because of snus use.

This a key point in interpreting the Swedish data: Sweden is the only country in the European Union where snus is available legally; it is banned in the rest of the European Union. Furthermore, Sweden is the only country in the European Union (and possibly the world) in which male daily smoking prevalence has not only dropped faster than female smoking but has dropped far below the female smoking rates and continues to do so. While it is correct to applaud the excellent tobacco control work in Sweden, which discourages tobacco use in both sexes, the most likely explanation for the unusually positive trend in male smoking is that a significant proportion (around 30%) of Swedish men have given up smoking by using snus instead.

One of public health's greatest concerns is that many young people will take up snus or that it may be a gateway to cigarette smoking. Data indicate that the youth daily smoking prevalence rate has been very stable in Sweden over the past 20 years, at around 11% for boys age 16 and 16% for girls age 16, despite the fact that boys have had a much higher and increasing rate of snus use.

There is no evidence that snus is a gateway to smoking; if anything, it is just the opposite-snus use may be associated with quitting smoking. In a recent survey, 30% of men who had quit smoking had used snus to quit. Of those snus users, two-thirds of them continued to use snus after they quit smoking, thereby fitting into the definition of nicotine maintenance. Swedish men who have used snus are more likely to abstain from smoking.

Dr. Foulds stated these conclusions about snus use:

• Snus delivers much smaller quantities of toxins than smoked tobacco and smaller quantities than most other types of smokeless tobacco.
  
• Snus is not harmless but is markedly less harmful to health than smoked tobacco.
  
• Snus is almost as addictive as cigarettes, enabling a significant proportion of male smokers to transfer their dependence from smoking to smokeless.
  
• Swedish men who have quit smoking using snus have reaped the health benefits.
  
• The improvement in smoking prevalence and health status has been greater in Swedish men than in Swedish women, or men in other countries. At least part of this is attributable to widespread snus availability, marketing, and use by men in Sweden.
  
• Snus is therefore a concrete example of a reduced harm product that has been demonstrated to reduce net harm to health.
  
• It is possible (though not certain) that other similar products (NRT, Ariva) could have a similar beneficial effect, so long as they could compete with cigarettes on nicotine delivery, marketing, price, and other factors.

Dr. Foulds finished his presentation with some comments about the TCS draft document:

1. "First do no harm" is not a reasonable standard. Most healthcare policies or interventions involve a risk of doing some harm but are approved if it is perceived that the likely benefits will outweigh the likely harms. For example, most medicines have side effects, and many have potentially serious harmful effects, yet we don't refuse to use them in case some harm occurs. Rather, we try to ensure that clinicians and consumers are adequately and accurately informed about the potential benefits and possible dangers. The key is to give the public an informed choice on the risks and benefits. "Do no harm" is not a legitimate reason to make no changes or fail to look at alternatives to the status quo. The status quo gives cigarettes preferred status as the "norm" for nicotine maintenance and that in itself is causing enormous harm.

2. There is not necessarily a contradiction between smoking cessation strategies and nicotine maintenance strategies. It is all in the way the message is delivered and to whom. Tobacco control programs can still have as their main clear message, "The best thing you can do for your health is to stop smoking." However, when asked about the relative risks from nicotine maintenance (including low nitrosamine smokeless tobacco) versus continued smoking, we should be prepared to give an honest answer that reflects the scientific evidence. Low nitrosamine smokeless tobacco products should remain an alternative in the marketplace for those few who cannot or will not quit tobacco use right away, particularly as a preferable and less harmful alternative to the dominant product, cigarettes.

3. Contrary to what the draft paper says, snus use in Sweden is a concrete example of nicotine maintenance producing a net public health benefit.

To summarize, one way of accelerating the rate of smoking cessation and the consequent improvement in public health may be to create a regulatory framework that makes it much harder to market traditional cigarettes (or any product involving inhalation of combustion products) and easier to market markedly less harmful nicotine delivery products, including low nitrosamine smokeless tobacco.

Other excerpts on comments by Dr. Johnathan Foulds:

Jonathan Foulds went on to say that epidemiological studies have found that low nitrosamine smokeless tobacco does not contribute significantly to heart disease or acute cardiovascular events. In Sweden, the use of low nitrosamine snus has not been associated with oral cavity cancer. "As you know, the Surgeon General made a statement that said smokeless tobacco is just as dangerous as cigarettes, which based upon the scientific data, I would regard as inaccurate.

…I think we can agree that there's no such thing as a safe cigarette. Anything combustible is bad; the best thing to do is stop smoking. We also need to be aware of the blatant conflict of interest in terms of states that rely so heavily on tobacco taxes to balance their budgets."

Over 95% of the harms to health caused by tobacco are caused by smoking cigarettes. We can continue to be very clear and aggressive in our opposition to cigarettes, and in trying to reduce cigarette smoking, without throwing out the potential of a non-smoked nicotine delivery system as an aid to smoking cessation.

"I'm not promoting smokeless tobacco. I'm suggesting that there are forms of smokeless tobacco that are much less harmful than other forms of smokeless tobacco, and that probably all forms of smokeless tobacco are less harmful than cigarettes."

I stated at the meeting that there appeared to be confusion as to whether the main aim was to reduce tobacco-caused death and disease, to reduce tobacco use, to oppose the tobacco industry as a whole, to reduce nicotine use, or some other goal. The optimal strategies will be different according to the overall goal, and these goals are not synonymous. Cigarettes of all types do much more harm to health than high carcinogen smokeless tobacco, which does much more harm than low carcinogen smokeless tobacco, which does more harm than nicotine replacement, which does a net good even under the most pessimistic assumptions.

My recommendation is therefore that the draft proposal address these different types of products dfferently, based on the massively different harms to health that these products cause. By lumping many different products together, and by making recommendations that effectively make it harder for the public to get the least harmful (actually beneficial) products (NRT by prescription only) than the most harmful (cigarettes-widely available OTC from government shops), the draft is unlikely to benefit public health and runs a serious risk of having harmful unintended consequences.

Jonathan Foulds also asserted that there is a group of people who can be defined as those who cannot or will not quit. "What would you call the millions of people who began smoking in adolescence and die in middle age of a smoking-related disease? Aren't they people who didn't or couldn't quit?"

Jonathan Foulds also challenged the idea that smokers who do not quit lack sufficient motivation, pointing to participants in clinical trials who say they are highly motivated, have to jump through many administrative hoops, answer extensive questionnaires, complete several physicals, and get the best treatment money can buy, yet only 25% of them are successful in their quit attempts six months out. He suggested John Pierce might be neglecting the "teensy weensy factor of nicotine addiction."

Other Relevant Commentary:

Steven Schroeder continued with another point: 44% of cigarettes are consumed by people with serious psychiatric and substance abuse problems. The assumption in all the presentations has been of the rational smoker. But, many smokers are not rational; they are self-medicating. He asked the panel what their recommendations were for that population.

John Pierce did not accept Steven Schroeder's figure of 44%, saying he did not think it was a huge problem.

Mike Cummings said that when New York's psychiatric facilities became smoke-free, having NRT products available helped, and that most of the problems came from the staff, not the patients.

Jonathan Foulds: If clean nicotine was widely accepted to be a major cause of mortality from heart attacks, strokes, and cancer, then I would have greater agreement with a number of the recommendations. However, that is simply not what the science suggests.

Among the best evidence on this at a population level comes from studies of smokeless tobacco use in Sweden. Here we have very large numbers of people taking nicotine along with a number of other carcinogens (but without smoke) for decades, and the epidemiology suggests no increased risk of myocardial infarction or stroke (with one study finding an intermediate risk of MI, lower than that from smoking). TCS should consult with those who specialize on this topic (e.g., Benowitz, et al).

Edward Anselm

Nicotine is an antidepressant and is used for mood modification and cognitive enhancement in a broad range of treatable psychiatric conditions. To offer nicotine to the general smoking population is to mask a large number of treatable psychiatric conditions. The exclusive focus on nicotine is unfortunate as there are other agents shown to be effective in smoking cessation. Depressed patients now get lifelong treatment with anti-depressants; that is not harm reduction, that is appropriate and effective medical treatment.

A psychiatric condition can only be diagnosed by its phenomenology. When the patient is taking medications, depression, OCD, ADDS, and even anxiety-related conditions are difficult to diagnose. Remove the cigarettes, caffeine, and all other drugs and you can make a good diagnosis. When I offer this insight at conferences, the head bobbing by the clinicians who treat smokers begins.