How to Make the American Smokeout Great

This commentary was published by the Cincinnati Enquirer on November 17 (available here).

The American Cancer Society’s 36th annual Great American Smokeout is November 17. After 35 years, we might expect to see better results. There are still 45 million smokers in the U.S., and 440,000 smoking-related deaths every year, according to the CDC (Centers for Disease Control and Prevention). The toll is 7,400 in Kentucky, nearly 18,000 in Ohio.

The Smokeout could be “Great” if the ACS and other public health institutions were more honest with smokers. For years, these organizations have perpetuated the myth that the only way smokers can save themselves is to quit tobacco. Tobacco abstinence has proven not only unachievable for the vast majority of smokers, but also unnecessary.

Nicotine, like caffeine, is addictive but otherwise relatively harmless. Nicotine’s benefits include improved concentration, enhanced performance of some tasks, and elevated mood. Tobacco smoke, however, containing thousands of toxic agents, is a dangerous nicotine delivery system, conferring risks for cancer, cardiovascular disease and emphysema.

Eliminate the smoke, and you eliminate virtually all the risks.

That is the essence of tobacco harm reduction, a public health strategy that educates smokers about vastly safer sources of nicotine, including smokeless tobacco and e-cigarettes.

Decades of medical research have proven that smokeless tobacco use is at least 98% safer than smoking. No tobacco product is absolutely safe, but the ACS and other tobacco prohibitionist organizations cherry-pick scientific studies for isolated epidemiologic findings to make exaggerated claims about health risks. They ignore the overwhelming scientific evidence documenting little or no risk from smokeless tobacco use. In fact, all health risks from smokeless tobacco, including the risk of oral cancer, are so low as to be barely measurable. Statistically, a user has about the same risk of dying from smokeless tobacco as an automobile user has of dying in a car accident.

It’s time to tell smokers the truth. The ACS grudgingly acknowledges on its website that “[smokeless tobacco] is less lethal than smoking cigarettes.” (here) The organization’s chief epidemiologist served on a review panel for a National Cancer Institute study that concluded “…[smokeless] products pose a substantially lower risk to the user than do conventional cigarettes.” (here) Still, the ACS objects to smoke-free product substitution by smokers.

Switching from cigarettes to smoke-free tobacco is not an industry ploy; it’s endorsed by two prestigious medical organizations, the British Royal College of Physicians and the American Association of Public Health Physicians. The Royal College 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.” (here)

Tobacco harm reduction has saved many lives in Sweden, where men smoked less and used more smokeless tobacco over the past century than in any other Western country. The result: Swedish men have the lowest rates of lung cancer – indeed, of all tobacco-related deaths – in the developed world. If the rest of the European Union smoked at the rate of Swedish men, there would be 272,000 fewer dead smokers in the EU each year. (here )

Tobacco harm reduction can also work in the U.S., if the ACS and other health organizations start telling smokers the truth about safer cigarette substitutes. The ACS message for this year’s Smokeout is “Help create a world with less cancer and more birthdays.” That’s the basic theme of tobacco harm reduction: If you’ve tried and failed to stop smoking, make the switch to any smoke-free tobacco product and enjoy a healthier, longer life.

Smoking Cessation Medicines Trigger Suicidal Behavior and Depression

Anti-tobacco extremists say that safer tobacco products aren’t necessary because FDA-approved medicines are effective. They ignore scientific evidence of those medicines’ paltry success rate (pharmaceutical nicotine works for only 7% of smokers), and of their significant side effects. For example, varenicline (Chantix) and bupropion (Zyban) carry FDA black-box warnings concerning depression and suicidal or self-injurious behavior.

A study published in PLoS One (here) concludes that “Varenicline shows a substantial, statistically significant increased risk of reported depression and suicidal/self-injurious behavior. Bupropion for smoking cessation had smaller increased risks.” The study’s first author is Thomas Moore from the Institute for Safe Medication Practices; his coauthors are from medical schools at Wake Forest, Harvard and Johns Hopkins Universities.

Moore et al. looked at cases of depression or suicidal/self-injurious behavior in the FDA Adverse Event Reporting System from 1998 to 2010. As a negative control for short-term medication, they compared behavioral episodes during varenicline and bupropion use to those during use of three common antibiotics. Because quitting smoking has also been associated with behavioral problems, Moore also used pharmaceutical nicotine as a “cessation” control.

Compared with antibiotic use, varenicline users were 37 times more likely to experience depression or suicidal/self-injurious behavior (odds ratio, OR = 37, confidence interval, CI = 28-49). The OR for bupropion was 13 (CI = 9-17), and the OR for nicotine was 4.3 (CI = 3.1-6.2).

Compared with nicotine (which controlled for behavioral problems due to quitting smoking), the OR for varenicline was 8.4 (CI = 6.8-10.4) and the OR for bupropion was 2.9 (CI = 2.3-3.7).

Moore also discussed other safety concerns: “While suicidal/self-injurious behavior and depression appear to be prominent side effects of varenicline, they are by no means the only safety issues. Varenicline has been associated with aggression and violence in three studies and carries a warning about this behavior. Its effect on vision, cognition, and motor control and other risks have led to its being banned for airline pilots, air controllers, military pilots and missile crews, and restricted for truck drivers. Varenicline is also associated with an increase in the risk of serious cardiovascular events. In addition, it is associated with hypersensitivity, angioedema and potentially life-threatening severe cutaneous adverse events [references omitted].”

Moore warns doctors prescribing varenicline about “…the value judgment of how to weigh the possible benefits of 52 weeks of smoking abstinence for 1 or 2 out of every 10 patients treated against the risk of less frequent adverse events such as violent and suicidal behavior that can have immediate, catastrophic and irreversible effects on self, family, and career. In the meantime, safer alternatives now exist and should be preferred.”

Unwritten is that one of those safer alternatives is smoke-free tobacco. While no tobacco product is absolutely safe, smoke-free alternatives deliver satisfying doses of nicotine, which is an important modulator of mood, well-being, and other behavioral performance measures.

FDA Petition: End Smokeless Tobacco Misinformation

The federal government requires the printing of three fallacious warnings on smokeless tobacco (ST) products . As I noted in an earlier post (here), one of the warnings – “This product is not a safe alternative to cigarettes” – is especially deceptive; it implies that smokeless tobacco is just as dangerous as smoking.

On July 28, RJ Reynolds filed a citizen petition with the FDA, challenging this warning (here). Reynolds requested that the agency change the text to:

“No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

The petition states, “the public has been misinformed by the public-health and tobacco-control communities – including government health agencies – about the relative risks presented by cigarettes and ST products. A significant part of that affirmative misinformation is the challenged warning, which has appeared in other contexts before its inclusion in the [Tobacco Control Act] in 2009. Government-mandated warnings on ST products reach audiences beyond the purchasers of these products, through press reports, websites of and publications by organizations that follow the Government’s lead, word of mouth and otherwise. The challenged warning has been on ST products since February 1987, undoubtedly, it has contributed to the widespread misunderstanding, including among smokers, that ST products present as much risk to health as cigarettes do.

“FDA should not participate in further perpetuation of that misinformation by retaining the text of the challenged warning. When advising the public, and when requiring others to advise the public, about the relative risks of cigarettes and ST, the Government should, in suitably brief form, tell the whole truth, not mislead by telling only part of the truth.”

The petition documents, with scientific and legal evidence, the inaccuracy of the warning, which has been required since 1987. One of the strongest arguments is that it perpetuates the common misperception, documented in several published studies (including ours, here), that ST is equally or more dangerous than cigarettes. As a result, the warning “may lead some consumers to simply continue smoking after failed attempts at abstinence because they will be resigned to the belief that the use of [ST products] is just as harmful as smoking.”

The petition notes that the 2009 Tobacco Act gave the FDA authority to change the warnings in order to “promote greater public understanding of the risks associated with the use of smokeless tobacco products,” while “the current misleading warning affirmatively fosters public misunderstanding of those risks.” (Emphasis in original.)

I have lectured on tobacco harm reduction for over 17 years; one of the most common objections from opponents is that Americans can’t handle the truth that the health risks of smokeless tobacco are barely measurable. Because consumers might make bad decisions, health professionals are encouraged to perpetuate a lie.

The Reynolds petition destroys this specious argument. Its concluding paragraphs are exceptionally powerful, so I reproduce them here:

“One way or another, sooner or later, the public will learn the truth about the relative risks presented by cigarettes and ST products. When that truth becomes widely known, what will the members of the public think of the public-health authorities who had deceived them into believing that there is no relevant difference between the risks presented by cigarettes and those presented by ST products? And how much will their trust in public-health authorities on other matters – e.g. diet, exercise, alcohol – have been undermined by the deception about tobacco?

“[Sissela] Bok’s overall conclusion [from the book, Lying: Moral Choice in Public and Private Life, here] is that, for many reasons, lying to provide a benefit for the recipients of the lie is wrong. Her final words are: ‘Trust and integrity are precious resources, easily squandered, hard to regain. They can thrive only on a foundation of respect for veracity.’ For FDA, an agency whose mission is to be accomplished through the application of sound scientific principles and whose statutory charge here is to promote the greater public understanding of the risks associated with the use of ST products, there can be only one answer. Tell the whole truth.”

The Reynolds petition is scientifically credible and morally compelling. The FDA must correct the egregious misinformation that it requires on one fourth of all ST products sold in the U.S.

British and Australian Smokers Attracted to Smoke-Free Substitutes

A study published in Harm Reduction Journal (here) concludes that there is “an untapped interest in the use of substitutes to reduce the harmfulness of smoking…The greater the range of products on offer, the more smokers are likely to try a product to quit.”

The study’s lead author is Ron Borland at Australia’s VicHealth Center for Tobacco Control. His coauthors are from the University of Nottingham in the UK, and Roswell Park Cancer Institute in Buffalo, New York.

Thirty-four smokers in the UK and 31 in Australia were recruited; each received a variety of smoke-free substitutes for “short term use (less than 1 week).” In the UK, 15 smokers preferred nicotine lozenges, 9 preferred Oliver Twist (here), one liked both products and 8 liked neither. Smokers in Australia were sent more products, and 17 tried all of them. Six favored Oliver Twist, 5 liked nicotine lozenges, 2 preferred Swedish snus (here) and one favored Stonewall/Ariva dissolvables (here); three smokers didn’t like any of the smoke-free alternatives.

Borland and colleagues reported that there was “considerable interest in using [pharmaceutical nicotine and smokeless tobacco] as a means of quitting smoking or as a long-term substitute for smoking.” They added that “the greater range of options provided, the more likely we are to find one that will be acceptable to any given smoker, thus increasing the potential pool of those who might be helped” and they advocated sampling to get “the participant to choose the product they wanted to use longer term” as a “sensible and viable approach for encouraging more than minimal use of substitute products.”

The authors reasonably write that smokers should try a variety of smoke-free substitutes, but they add an unrealistic caveat -- “we should not allow for-profit companies to directly market them to consumers, rather they should be available from a not-for-profit source.”

Borland and colleagues conclude that “…many smokers are interested in reducing the harmfulness of their smoking behaviour. Smokers deserve to know what the differential risks of potential alternatives are, and to be supported to make the choices that are in their long-term best interests, which is to quit nicotine altogether, but failing that use the least harmful form of nicotine they find acceptable.”

Many smokers are interested in harm reduction, but too many are dying every year – 15,000 in Australia, 80,000 in the UK and 400,000 in the US – because they don’t have truthful information about vastly safer cigarette alternatives.

New England Journal of Medicine Promotes Failed Policies for Smoking Control

The New England Journal of Medicine on September 29 published a commentary (here) promoting “total abstinence” with behavioral therapy and medicines, a strategy that has failed to help over 90% of smokers who tried to quit. The article, by Michael Fiore and Timothy Baker of the University of Wisconsin, reflects the nation’s dual obsession with smoking as a disease and nicotine- and tobacco-abstinence as the only cure.

Fiore and Baker use the terms “smoking” and “tobacco use” synonymously. They write, “more than 30% of deaths from cancer, 90% of cases of COPD and 30% of cases of cardiovascular disease in the United States are attributed to tobacco use…Tobacco use remains the chief avoidable cause of death in the United States…”

That is demonstrably false. Tellingly, in the next sentence they drop the phrase “tobacco use” and correctly use the word “smoking.” I have previously described the unfortunate consequences of such deliberate misinformation (here).

While Fiore and Baker advise health professionals to “note the effectiveness of seven FDA-approved medications for smoking cessation,” they acknowledge that a meta-analysis documented that the abstinence rate for nicotine medicines was a mere 9% at six months -- a 91% failure rate. Despite these dismal statistics, Fiore and Baker use the words “effective” or “effectiveness” at least 10 times in describing quit-smoking medicines. Interestingly, they write that patients don’t use medicines because they believe them to be “dangerous” and “ineffective.” Although smokers incorrectly believe that nicotine medicines are dangerous, they are correct in believing that they are largely ineffective.

Anti-tobacco extremists and most journal editors continue to ignore the scientific evidence for tobacco harm reduction, but some medical journals are putting it front and center (here). It is unfortunate that the New England Journal of Medicine devoted 10 pages to a misleading abstinence-only screed.

International Sports Monitoring Agency: Nicotine, Smokeless Tobacco May Enhance Performance

The World Anti-Doping Agency (WADA), an international agency composed and funded by sport organizations and governments, on September 27 announced it will “monitor the effects nicotine can have on performance when taken in oral tobacco products such as snus,” starting in 2012 (here). This followed publication of a report from the agency’s laboratory on over 2,000 urine samples from athletes in 43 sports. The report, by François Marclay and colleagues at the University of Lausanne in Switzerland, is abstracted here.

The research measured exposure to and active use of nicotine by athletes. While the prevalence of active use was only 15%, the authors noted high prevalence in some sports, included in this table:

Active Nicotine Consumption Among Athletes
Sport (No. of samples)	Active Consumers (%)
American football (19)	56
Basketball (24)	25
Biathlon (38)	18
Bobsleigh (38)	31
Football (soccer) (205)	19
Gymnastics (48)	29
Ice hockey (108)	32
Rugby (25)	28
Skating (41)	20
Skiing (143)	26
Volleyball (46)	20
Wrestling (31)	32

Marclay wrote that these results provide “alarming evidence” about nicotine consumption among athletes. But the report had no information about the athletes who were tested, and the number of samples was minuscule. For example, Marclay’s claim that 56% of American football players actively used nicotine was based on only 19 samples. There are over a million football players at the high school level in the U.S., thousands at the college level, and hundreds in the NFL, and there are 18 other countries with American football leagues. The most alarming aspect of this report is that it made sweeping claims based on very little evidence.

Marclay wrote that “…smokeless tobacco is a very attractive drug from a doping perspective, considering the performance enhancement pharmacological properties of nicotine and the absence of direct adverse effects on the respiratory tract.” Nicotine “exhibits a variety of pharmacological properties sought-after by consumers,” and it “results in vigilance and cognitive function enhancement together with relaxation, reduced stress, mood modulation and lower body weight.”

These effects are well known among tobacco users, but Marclay cited no authority for the claim that these properties enhance performance to an extent that justifies prohibition in sports. In fact, Marclay acknowledged that “the frontier between recreational consumption and use for doping purpose is difficult to ascertain with social drugs, including nicotine, caffeine or tetrahydrocannabinol (THC)[marijuana].” Would Marclay and WADA ban caffeine along with nicotine?

In trying to tie smokeless tobacco to performance enhancement, Marclay offered a startling non-sequitur: “Since smoking may be responsible for noticeable respiratory effects and numerous health threats detrimental to sport practice at top level, likelihood of smokeless tobacco consumption for performance enhancement is a hypothesis of very serious concern.” Simply put: Smoking is very bad, so smokeless tobacco must be a performance enhancer. The association of these two very different products in this manner defies logic.

Marclay was especially concerned about athletes involved in winter sports. Citing his own work (abstract here), he wrote that “a recent study on the 2009 Ice Hockey World Championships brought alarming findings as active nicotine consumption before or/and during the games was highlighted for about half of the athletes.”

If WADA rules eventually that smokeless tobacco and nicotine enhance athletic performance, it will refute tobacco prohibitionists’ persistent claim that tobacco provides no tangible benefits to consumers. As I have written (here), “It’s time to be honest with the 50 million Americans, and hundreds of millions around the world, who use tobacco. The benefits they get from tobacco are very real… It’s time to abandon the myth that tobacco is devoid of benefits, and to focus on how we can help smokers continue to derive those benefits with a safer delivery system.”

British Government Endorses Tobacco Harm Reduction, E-Cigarettes

The British Cabinet Office’s Behavioural Insights Team (BIT), or the “nudge unit”, as the year-old high-level group is called, strongly endorsed tobacco harm reduction in its first annual report (read the report here).

The BIT’s mission is “to find intelligent ways to encourage, support and enable people to make better choices for themselves.” The unit reported that “smoking remains the biggest preventable cause of death in the U.K., killing over 80,000 a year in England alone,” and that “treating smoking-related diseases costs the [National Health Service] £2.7 billion each year in England.”

BIT observed: “A review by the [British] Medicines and Healthcare products Regulatory Agency concludes that ‘nicotine, while addictive, is actually a very safe drug.’ BIT is working with [the U.K. Department of Health] on how to encourage smokers to substitute to safer but nonetheless appealing sources of nicotine, noting that products that produce a fine vapour appear to reproduce the pleasant ‘hit’ without the harms associated with smoking.”

This statement is remarkable. It confirms what I have been reporting for over 17 years: Nicotine, “while addictive, is a very safe drug.” BIT observes that nicotine is a recreational drug that can be used safely, like caffeine and alcohol, and notes that there are efforts to get smokers to substitute “safer but nonetheless appealing sources of nicotine”. E-cigarettes are cited as potentially effective substitutes because of their behavioral attributes.

This positioning by such a high-level entity should significantly advance tobacco harm reduction initiatives on a global scale. U.S. regulatory authorities, in particular, should take note. For the British government, the challenge now is to translate concepts into practical applications. Although e-cigarettes are widely available in the UK, snus and other smoke-free products remain under an EU ban. As awareness of the benefits of tobacco harm reduction increases, British smokers will rightfully demand access to the full range of smoke-free products that are available in Sweden and the U.S.