Tobacco harm reduction
Tobacco harm reduction (THR) is a public health strategy to lower the health risks associated with using nicotine, as an example of the concept of harm reduction, a strategy for dealing with the abuse of other drugs. Smoking tobacco is widely acknowledged as a leading cause of illness and death. However, nicotine itself is not very harmful, as inferred from the long history of use for nicotine replacement therapy products. Thus, THR measures have been focused on reducing or eliminating the use of combustible tobacco by switching to other nicotine products, including:
- Cutting down (either long-term or before quitting smoking)
- Temporary abstinence
- Switching to non-tobacco nicotine containing products, such as pharmaceutical nicotine replacement therapies or currently (generally) unlicensed products such as electronic cigarettes
- Switching to smokeless tobacco products such as Swedish snus
- Switching to non-combustible organic or additive-free tobacco products
It is widely acknowledged that discontinuation of all tobacco products confers the greatest lowering of risk. However, approved smoking cessation methods have a 90% failure rate, when used as directed. In addition, there is a considerable population of smokers who are unable or unwilling to achieve abstinence. Harm reduction is likely of substantial benefit to these smokers and public health. Providing reduced-harm alternatives to smokers is likely to result in lower total population risk than pursuing abstinence-only policies.
The strategy is controversial: proponents of tobacco harm reduction assert that lessening the health risk for the individual user is worthwhile and manifests over the population in fewer tobacco-related illnesses and deaths. Opponents argue that some aspects of harm reduction interfere with cessation and abstinence and might increase initiation.
The concept of tobacco harm reduction was established in 1976 when Professor Michael Russell wrote: "People smoke for nicotine but they die from the tar" and suggested that the ratio of tar to nicotine could be the key to safer smoking. Since then, the harm from smoking has been well-established as being caused almost exclusively by toxins released through the combustion of tobacco. In contrast, non-combustible tobacco products as well as pure nicotine products are considerably less harmful, although they still have the potential for addiction.
Debates on tobacco harm reduction tend to be geographically defined arguments, because of the varying legal, moral, and historical status of tobacco, and the different types of tobacco products and use in different cultures around the world. For instance, cigarette smoking is the dominant form in the United States, while use of cigars, pipes, and smokeless tobacco is limited to a much smaller population. Anti-smoking advocacy efforts and widespread popularization of the negative health effects of smoking over the last few decades have led to restrictions in the sale and use of tobacco products. Despite this, tobacco in all its forms has remained a legal product in most societies. A notable exception is the European Union, where the most dangerous products (cigarettes) are available but smokeless tobacco products, which are far less hazardous, are banned. The exception is Sweden, where there is a long tradition of smokeless tobacco use among men.
In October 2008 the American Association of Public Health Physicians (AAPHP) became the first medical organization in the U.S. to officially endorse tobacco harm reduction as a viable strategy to reduce the death toll related to cigarette smoking. Joel Nitzkin, MD wrote: "So if we can figure that the nicotine in the e-cigarettes is basically a generic version of the same nicotine that is in prescription products, we have every reason to believe that the hazard posed by e-cigarettes would be much lower than one percent, probably lower than one tenth of one percent of the hazard posed by regular cigarettes."
In the United States, tobacco controllers and other anti-smoking advocates are opposed to harm reduction approaches. They are generally motivated by an irrational hatred of tobacco and substantial financial ties to the pharmaceutical industry. Anti-tobacco extremists have successfully lead a disinformation campaign resulting in the widespread use of misleading health claims aimed at preventing smokers from learning about the lifesaving potential of harm-reduction approaches.
Cigarette manufacturers have attempted to design safer cigarettes for almost 50 years, but results have been marginal at best. Filters were introduced in the early 1950s, and manufacturers were selling low-yield cigarettes by the late 1960s. Initially it was thought that these innovations were harm reducing. For example, in 1976 investigators at the American Cancer Society published research concluding that light cigarettes were safer. The study authors wrote that "total death rates, death rates from coronary heart disease, and death rates from lung cancer were somewhat lower for those who smoked 'low' tar-nicotine cigarettes than for those who smoked 'high' tar-nicotine cigarettes."
It has been established that use of Swedish and American smokeless tobacco confers only 0.1% to 10% of the risks of smoking, though smokeless products in India and Asia contain higher levels of contaminants and thus confer greater risks. Two respected medical groups believe that smokeless tobacco may play a role in reducing smoking-attributable deaths. In 2007, Britain's Royal College of Physicians concluded "...that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved."
In the United States, a study based on National Health Interview Survey data found that 73% of smokers who switched to smokeless tobacco as part of their latest quit attempt were successful in quitting smoking. In the same study, smokers who used pharmaceutical nicotine products in their most recent quit attempt had success rates between 0 and 35%.
Scandinavian snus is a moist form of smokeless tobacco which is usually placed under the upper lip, and is not smoked or swallowed. A 2014 report commissioned by Public Health England on another avenue for tobacco harm reduction, electronic cigarettes, said snus "has a risk profile that includes possible increases in risk of oesophageal and pancreatic cancer, and of fatal (but not non-fatal) myocardial infarction, but not COPD or lung cancer." The report examined the case of snus as "a unique natural experiment in the impact of a socially accepted, non-medical, affordable and easily accessible reduced harm product on the prevalence of tobacco smoking". They concluded that "Although controversial, the Swedish natural experiment demonstrates that despite dual use and primary uptake of the reduced-harm product by young people, availability of reduced-harm alternatives for tobacco smokers can have a beneficial effect. While snus is not likely to become a legal or indeed politically viable option in the UK, this data proves the concept that harm reduction strategies can contribute to significant reductions in smoking prevalence."
Based on the mounting evidence that the health risks of Swedish snus are far lower than those of combustible tobacco products, in August 2014, Swedish Match (a manufacturer) filed a Modified Risk Tobacco Product (MRTP) application with the FDA Center for Tobacco Products (CTP). The MRTP application seeks to modify the warning labels on smokeless tobacco products such that they reflect the evidence of reduced-harm compared to smoking. Among the proposed labeling changes, the MRTP application requests replacing the current warning, "This product is not a safe alternative to cigarettes," with this text: "No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."
Electronic cigarettes are battery-powered devices that deliver vaporized propylene glycol or vegetable glycerin (or a mixture of both) and nicotine when users inhale while using them. Electronic cigarettes are a promising harm reduction technology because they deliver nicotine without the dangerous chemicals in tobacco smoke, while remaining attractive to smokers. While the eventual regulatory status of e-cigarettes in many countries remains uncertain, public health advocates view electronic cigarette as having a valid place within tobacco harm reduction strategy. Public health researchers in the UK estimated that 6,000 premature smoking-related deaths per year would be prevented for every million smokers who switched to e-cigarettes. Since currently approved smoking cessation methods have a 90% failure rate, the use of e-cigarettes as a prominent THR modality is likely to substantially reduce tobacco-related illness in the United States, with the potential to save 4.8 million lives over the next 20 years. Their usefulness in tobacco harm reduction as a substitute for tobacco products is unclear, but in an effort to decrease tobacco related death and disease, they have a potential to be part of the strategy.
In 2015 Public Health England, a government agency, released a report stating that e-cigarettes are estimated to be 95% less harmful than smoking. They also found that as well as stopping smoking entirely, reducing harm from smoking was a main motivation with users, and concluded that "such efforts should be supported but with a long-term goal of stopping smoking completely." In a policy statement released with the report, Public Health England said that "PHE looks forward to the arrival on the market of a choice of medicinally regulated products that can be made available to smokers by the NHS on prescription."
Propellant-based nicotine delivery
An alternative nicotine delivery platform based on existing asthma inhaler technology is under development by a UK-based healthcare company, Kind Consumer Limited. The technology is currently under development and the company has submitted a Marketing Authorisation Application to the UK MHRA for licensing of the technology as an approved nicotine containing product. The technology is under licence to Nicoventures Limited a subsidiary of British American Tobacco who are responsible for the launch and commercialisation of the technology as an approved nicotine replacement therapy product.
Nicotine pyruvate technology
Philip Morris International bought the rights to a nicotine pyruvate technology developed by Jed Rose at Duke University. The technology is based around the chemical reaction between nicotine acid and a base which produces a nicotine pyruvate vapour for inhalation. It has undergone preliminary clinical evaluation which has shown delivery of nicotine to the lungs.
Smokers remain confused about tobacco harm reduction. In a 2004 survey, about 80-100% of participants incorrectly perceived low-yield cigarettes as harm-reducing, while 75-80% mistakenly believed that switching to smokeless tobacco conferred no risk reduction.
Similar confusion exists about electronic cigarettes. In the UK, research commissioned by the anti-smoking charity Action on Smoking and Health found that in 2015, compared to the year before, "there has been a growing false belief that electronic cigarettes could be as harmful as smoking". Among smokers who had heard of e-cigarettes but never tried them, this "perception of harm has nearly doubled from 12% in 2014 to 22% in 2015." The charity expressed concern that "The growth of this false perception risks discouraging many smokers from using electronic cigarettes to quit and keep them smoking instead which would be bad for their health and the health of those around them."
In 2015 a report commissioned by Public Health England noted, as well as the UK figures above, that in the US belief among responders to a survey that vaping was safer than smoking cigarettes fell from 82% in 2010 to 51% in 2014. The report blamed "misinterpreted research findings", attracting negative media coverage, for the growth in the "inaccurate" belief that e-cigarettes were less harmful than smoking, and concluded that "There is a need to publicise the current best estimate that using EC is around 95% safer than smoking".
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A carefully structured Tobacco Harm Reduction (THR) initiative, with e-cigarettes as a prominent THR modality, added to current tobacco control programming, is the most feasible policy option likely to substantially reduce tobacco-attributable illness and death in the United States over the next 20 years.
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The need for more appealing, licensed nicotine products capable of competing with cigarettes sensorially, pharmacologically and behaviourally is considered by many to be the way forward.
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Hiding THR from smokers, waiting for them to decide to quit entirely or waiting for a new anti-smoking magic bullet, causes the deaths of more smokers every month than a lifetime using low-risk nicotine products ever could.
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Switching to ST compares very favorably with pharmaceutical nicotine as a quit-smoking aid among American men, despite the fact that few smokers know that the switch provides almost all of the health benefits of complete tobacco abstinence.
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It is important that interpretation of the evidence and communication with policy makers and the public is not distorted by a priori judgements.
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