Thursday, December 29, 2011

Low Nitrosamine Levels in Altria and Reynolds Moist Snuff Products, say Minnesota Researchers

I discussed a year ago the tempest-in-a-teapot issue of tobacco specific nitrosamines (TSNAs) in smokeless tobacco products (here). TSNAs are contaminants found only in tobacco, and they are present in vanishingly small concentrations – mainly in the single-digit parts-per-million range. “Regardless of current TSNA levels,” I wrote, “anti-tobacco extremists will call for reductions.”

Last month, the University of Minnesota’s Stephen Hecht, Irina Stepanov and Dorothy Hatsukami (a member of the FDA Tobacco Products Scientific Advisory Committee) published a letter in Tobacco Control (here), demanding TSNA reductions. This, despite the fact that their data showed that TSNA levels in moist snuff products from Altria and Reynolds were at historically low levels in 2010. I have commented on this group’s anti-smokeless-tobacco articles before (here and here).

Hecht et al. list the levels of NNN and NNK in several Altria and Reynolds brands:


NNN + NNK Levels in Moist Snuff and Snus, in Parts Per Million (ppm), Dry Weight
Brand NNN+NNK (ppm)
Altria
Copenhagen 5.6
Copenhagen Long Cut 5.8
Copenhagen LC Wintergreen 4.6
Skoal Long Cut Straight 4.9
Skoal Long Cut Wintergreen 5.2
Skoal Bandits Wintergreen 5.2
Marlboro Snus Rich 0.7
Marlboro Snus Spearmint 0.9
Marlboro Snus Peppermint 0.8
Marlboro Snus Mild 0.8
Reynolds
Grizzly11.1
Kodiak Wintergreen 5.1
Camel Snus Frost 1.5
Camel Snus Mellow 1.7

These NNN and NNK levels are lower, across the board, than those of moist snuff products from the 1980s and 1990s, which I documented in a review article in 2004 (here). Epidemiologic studies from the 1980s and 1990s show that oral cancer risks among moist snuff users were minimally elevated, if at all, when those higher level products were being used.

While Hecht and colleagues assert that “smokeless tobacco is carcinogenic to humans, causing oral, pancreatic and esophageal cancer,” a comprehensive study of cancer risks among smokeless users (here) documented no significant risk for any of these cancers. There is virtually no evidence that current TSNA levels are associated with ANY significant cancer risks. Reducing current levels cannot lower an immeasurable cancer risk.

The article by Hecht et al. indicates that the authors are comfortable with TSNA levels in Marlboro and Camel snus, and that they view these products as acceptable cigarette substitutes. Perhaps Drs. Hecht, Stepanov and Hatsukami will now endorse them in this manner.

Wednesday, December 21, 2011

Allegations and Answers in Owensboro

A letter published in the Owensboro Messenger-Inquirer on December 12 challenged the veracity and ethics of the Switch and Quit Owensboro campaign (described here). The letter, authored by a former administrator of the Kentucky oral/dental health program, reflected the hostility towards tobacco harm reduction that is common among dental organizations (previously described here and here).

The Messenger-Inquirer published this response from me on December 19:

To the Editor,

Dr. Jim Cecil’s December 12 letter criticizing Switch and Quit Owensboro contained serious inaccuracies.

Dr. Cecil states that smokeless tobacco products “are known to cause” a number of diseases. In fact, research shows that the health risks from smokeless use are so minuscule that they are barely measurable, and they are a tiny fraction of the health risks associated with smoking. Dr. Cecil suggests that smokers only be told about “FDA-approved smoking cessation aids,” but those products succeed with only 7% of smokers. Smokeless tobacco works as a cigarette substitute because it satisfies nicotine cravings; it is also more affordable and more widely available than nicotine medicines.

Dr. Cecil incorrectly states that “there is no scientific evidence that smokeless tobacco can help a smoker quit!” Numerous scientific studies published in prestigious medical journals document that smokeless tobacco is an effective quit-smoking tool. These studies are summarized in two comprehensive reviews in Harm Reduction Journal (here and here).

Rather than being an industry ploy, as Dr. Cecil implies, Switch and Quit embodies a smoking cessation concept that has been endorsed by the esteemed British Royal College of Physicians (among others), which found “...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.” (available here)

Dr. Cecil believes it is “unconscionable” and “unethical” to inform smokers about vastly safer smoke-free tobacco products. Consider this fact: If all American smokers instead used smokeless tobacco, over 430,000 lives would be saved each year. The Switch and Quit campaign is consistent with the highest medical and ethical standards.

Brad Rodu
Professor of Medicine
Endowed Chair, Tobacco Harm Reduction Research
University of Louisville

Thursday, December 15, 2011

Karolinska Institute Study: Heart of Failure


I have described in detail (here, here, and here) studies from Stockholm’s Karolinska Institute (KI) that have driven smokeless tobacco regulation worldwide. These studies contain important and troubling discrepancies that KI researchers have refused to address. Rather, they continue to defy international scientific principles of data sharing, which stipulate that scientific results are open to challenge by other scientists to determine their accuracy and integrity.

Some of the same KI researchers, led by Gabriel Arefalk, recently authored another study, alleging that snus use causes heart failure (here). The article was published in the European Journal of Cardiovascular Prevention and Rehabilitation.

As in the past, KI focused on snus users in the Swedish Construction workers cohort. This time, construction workers who were snus users didn’t have a significantly higher risk for heart failure than nonusers. But the researchers also analyzed the Uppsala Longitudinal Study of Adult Men (ULSAM), reporting that snus use “was associated with a more than doubled risk for subsequent heart failure” in this group.

It appears that the ULAM analysis was tailor-made to produce the desired result, and it is evident that the KI researchers employed highly unorthodox methods. I attempted to draw attention to these serious problems by submitting a letter to the journal editor. My submission was rejected, “on grounds that this commentary is a re-review of the analyses of the paper.” Ignoring my systematic description of the study’s deficiencies, the editor suggested that I “obtain data and write another scientific paper for the journal.” This is particularly ironic, since I have tried for three years to obtain data from KI.

Following is my letter to the European Journal of Cardiovascular Prevention and Rehabilitation.

To the Editor:
Study of Snus Use and Heart Failure: Problems Requiring Resolution


The article by Arefalk et al. (1) reported that snus use was “a significant predictor of heart failure” among 70 year-old men in the Uppsala Longitudinal Study of Adult Men (ULSAM) (hazard ratio, HR = 2.09, 95% confidence interval, CI = 1.00 – 4.39). However, there are numerous problems that raise questions about the validity of the findings.

Among the 78 snus users at baseline, 62 (79%) were current smokers; in the referent group of 998 snus non-users, only 175 (18%) were current smokers. The large difference in smoking makes it extremely unlikely that the results were fully adjusted for current smoking, which is an important confounding factor (2). This problem was compounded by the authors’ highly unorthodox adjustment procedure.

The authors apparently did not utilize conventional categories of current, former and never smoking, even though it was clearly possible to do so according to the ULSAM questionnaire (3). Instead, they stated that “[s]moking was adjusted for by using a current smoking dose variable [none, < 10 or > 10 cigarettes per day] as well as a pack-year variable [never, < 33 and > 33 pack-years].” But this created a major problem: the 504 former smokers were combined with the 335 never smokers in the current smoking dose variable, and they were combined with the 237 current smokers in the pack-years of smoking variable (Table 1, Column labeled Total Sample). Thus, in the authors’ adjusted models former smokers were simultaneously pooled both with never smokers and with current smokers, two groups that ought to be mutually exclusive.

Although Arefalk et al. failed to define or categorize current and former smokers in the ULSAM cohort, the latter group appeared in the discussion: “…we performed a secondary analysis…further subdividing former smokers into those who quit smoking less than vs. more than 10 years before baseline.” Mentioning former smokers in the last third of the discussion without ever defining them is incomprehensible. In addition, the authors’ 10-year cut-point for smoking cessation was different from the 5-year cut-point in the questionnaire (3). The authors need to provide a complete explanation of the analysis that they employed.

Arefalk et al. reported that there were 78 snus users, which is consistent with the number on the ULSAM website (questionnaire item Z480, “Do you use snus?”; yes, n=79)(3). They also described 237 current smokers (167 moderate and 70 heavy), which was consistent with responses to the question asked during a euglycemic hyperinsulinemic clamp investigation, “Do you smoke?” (Z085; yes, n=245), but not with responses to the questionnaire item “Do you smoke?”(Z158; yes, n=173) (3). It would be helpful to understand the differences in these responses.

Arefalk et al. also estimated the risk of heart failure among snus users in the Swedish Construction Workers Cohort (CWC), and they evaluated the effect of dose among the 75 current snus users with heart failure (Table 4). They concluded that “[n]o clear dose-response relationship was observed…” In contrast, Arefalk et al. reported that “the limited sample size did not permit the study of dose-response relations” in the ULSAM cohort. This important information, which was available for the 14 snus users with heart failure (3), may be very informative even if it was inadequate for a formal analysis. For example, perhaps all 14 cases of heart failure were among users of very low doses. Arefalk et al. should not withhold this information.

There were numerous formatting errors in the tables. For example, in Table 1 the variables Diabetes prevalence, ECG-left ventricular hypertrophy, Body mass index, Office systolic blood pressure and Antihypertensive medication use were listed under Pack-years of smoking, and the variables Myocardial infarction before baseline and Myocardial infarction during follow-up were listed under Alcohol use. There were similar errors in Table 4.

Arefalk et al. concluded that they “observed an increased risk for subsequent heart failure” among male snus users in the ULSAM, but the conclusion is neither legitimate nor persuasive until the authors resolve the fundamental questions about the analysis.

References

1. Arefalk G, Hergens M-P, Ingelsson E, Ärnlöv J, Michaëlsson K, Lind L, Ye W, Nyrén O, Lambe M and Sundström J. Smokeless tobacco (snus) and risk of heart failure: results from two Swedish cohorts. European Journal of Cardiovascular Prevention and Rehabilitation 2011, DOI: 10.1177/1741826711420003 (here).

2. Dunlay SM, Weston SA, Jacobsen SJ, and Roger VL. Risk factors for heart failure: a population-based case-control study. American Journal of Medicine 2009; 122: 1023-1028 (here).

3. ULSAM-70 Questionnaire and Response Statistics (here).

Brad Rodu
Professor of Medicine
Endowed Chair, Tobacco Harm Reduction Research
University of Louisville

Thursday, December 8, 2011

Tobacco Retailer Compliance High, Says FDA Data

The Food and Drug Administration issued a press release on November 10 (here), titled “FDA acts to protect children from illegal tobacco sales.” It advises that “most retail establishments inspected by the FDA have been found to be in compliance with the law” restricting sales of tobacco to minors. The release focused on warning letters sent “to more than 1,200 retailers, the majority of which respond to violations relating to selling tobacco to minors, as part of its ongoing effort to reduce tobacco use among children.”

FDA Commissioner Margaret A. Hamburg is quoted: “It should worry every parent that 20 percent of U.S. high school students smoke cigarettes…Retailers are vital partners in the FDA’s efforts to prevent tobacco use among kids.”

What the FDA didn’t report is that in most states, retailer compliance is outstanding. I downloaded the raw data from the agency’s website and noted compliance statistics for the available states:


FDA Tobacco Retail Compliance Inspections in 16 States
State Number of Inspections Compliance Rate (%)
Alabama 2,12299
Arkansas 68096
Arizona 81894
Colorado 1,68292
Idaho 32399+
Illinois 95093
Kansas 2,01699+
Massachusetts 2,81396
Maryland 1,47799
Maine 3,13799+
Missouri 1,03388
Mississippi 3,41994
New Jersey 1--
Pennsylvania 1,81394
Tennessee 82996
Washington 1,30593
All 24,41896

Retailers in all states combined showed a 96% compliance rate, with every state except Missouri above 90%. Retailers in Alabama, Idaho, Kansas, Maryland and Maine demonstrated compliance rates of at least 99%.

As I noted in an earlier post (here), the principal suppliers of tobacco to underage users are adult friends or relatives, according to a 2004 study (abstract here).

The FDA should continue to monitor retailers, but when it comes to children’s access to tobacco, retailers are clearly not the major problem.

Tuesday, November 29, 2011

Carcinogens in Coffee and Smokeless Tobacco: Truths & Half-Truths

If a health official announced, “The use of coffee, which contains 21 known human carcinogens, is not harmless,” she would be correct... but not entirely so.

A leading expert in carcinogenesis, Bruce Ames, authored a scientific manuscript in 2000 reporting that 21 known carcinogens are found in coffee (abstract here). Roasted coffee contains thousands of chemicals in addition to addictive caffeine. Some of these agents have been shown in laboratory experiments to cause cancer. Professor Ames also reported that humans consume carcinogens every day in foods and beverages that are considered “safe”; the carcinogens are present in such minuscule quantities that they play no significant role in the development of human cancer. He wrote:

“Naturally occurring pesticides that are rodent carcinogens are ubiquitous in fruits, vegetables, herbs, and spices. Cooking foods produces about 2000 milligrams per person per day of burnt material that contains many rodent carcinogens and many mutagens… In a single cup of coffee, the natural chemicals that are known rodent carcinogens are about equal in weight to a year’s worth of synthetic pesticide residues that are rodent carcinogens, even though only 3% of the natural chemicals in roasted coffee have been adequately tested for carcinogenicity.”

Here are some of the cancer-causing agents in coffee: Acetaldehyde, benzaldehyde, benzene, benzofuran, benzo(a)pyrene, caffeic acid, catechol, 1,2,5,6-dibenzanthracene, ethanol, ethylbenzene, formaldehyde, furan, furfural, hydrogen peroxide, hydroquinone, isoprene, limonene, 4-methylcatechol, styrene, toluene, xylene. And there are still about a thousand chemicals that haven’t been tested.

While this is a scary list, health officials are not calling for a ban on coffee. They know that epidemiologic studies show that coffee, while not absolutely harmless, is quite safe to consume.

Let’s get back to that statement at the beginning of this entry. In fact, a Daviess County (Kentucky) health department official was quoted in a news report, saying, “The use of smokeless tobacco, which contains 28 human carcinogens, is not harmless.” She was commenting on Switch and Quit Owensboro, a public health campaign that tells smokers the truth about vastly safer smoke-free cigarette substitutes (here).

The health department official was parroting a commonly used but almost meaningless factoid about smokeless tobacco. It is used by the CDC (here), the National Cancer Institute (here), the American Lung Association (here), and many state agencies (example here ).

The factoid is essentially meaningless because numerous epidemiologic studies have established that cancer risks associated with smokeless tobacco are so low that they are barely measurable.

Coffee contains 21 carcinogens and smokeless tobacco contains 28; both have high levels of an addictive drug (caffeine and nicotine, respectively). Neither coffee nor smokeless tobacco is absolutely safe, but informed public health practitioners know that the health risks with either are minimal. The real risk is in misleading smokers with partial truths.

Tuesday, November 22, 2011

Tobacco Harm Reduction Debated in the Cincinnati Enquirer

The Cincinnati Enquirer published my guest column last week (here), on the occasion of the Great American Smokeout.

The following day, Dr, Nagla Abdel Karim, an assistant professor at the University of Cincinnati College of Medicine, authored a column criticizing the Owensboro Switch and Quit campaign (here). Her piece illustrates the misinformation that dominates discussion of tobacco harm reduction. Dr. Karim’s statements are worthy of further discussion.

Dr. Karim accurately described Switch and Quit as “an advertising campaign encouraging smokers in Kentucky to make the switch to smokeless tobacco… citing a decreased risk for cancer.” But then she makes a demonstrably false statement: “Unfortunately, this simply isn’t true.”

Is it possible that Dr. Karim believes that the cancer risks from smokeless tobacco are the same as those from smoking? A recent study (here) estimated how smokeless tobacco use might have changed cancer deaths in 2005, a year in which 104,737 American men died from cancers directly attributable to smoking. If all smokers had instead used smokeless tobacco, the number would have been 1,102. The risks from smokeless tobacco are so low that, even if ALL American men were users, there would have been only 2,298 cancer deaths, or 2.2% of the number attributable to smoking.

Dr. Karim wrote that smokeless tobacco “users are at a higher risk for gastrointestinal cancers. This isn’t supposition,” she continued, “it’s been scientifically proven through research studies examining the health effects of smoking and smokeless tobacco.”

She is mistaken. A comprehensive meta-analysis (discussed in detail here) found that smokeless tobacco users had the following relative risks (RR, compared with never users):

Esophagus: RR = 1.13 (CI = 0.95-1.36)
Stomach: RR = 1.03 (CI = 0.88-1.20)
Pancreas: RR = 1.07 (CI = 0.71-1.60)
All Digestive Tract: RR = 0.86 (CI = 0.59-1.25)

It is important to emphasize that there are no elevated risks in this list.

Dr. Karim wrote that a 2007 American Cancer Society study showed that smokers “…who had switched to spit tobacco had a higher rate of death from lung cancer, coronary heart disease and stroke than those who quit using tobacco entirely.”

These claims cannot be validated because the Cancer Society refuses to release the underlying data (discussed here). This is contrary to worldwide medical data sharing practices. Since lung cancer, coronary heart disease and stroke are strongly associated with smoking, the data might show that some Cancer Society “switchers” were actually still “smokers”, undercutting the findings.

Finally, Dr. Karim acknowledges how hard it is to achieve abstinence, and she refers smokers to the government’s abstinence-only website (here). On the homepage is a reference to behavioral tips that are supposed to help smokers when they are desperate for a cigarette -- “being active (walking, jogging, exercising, etc.) drinking water, thinking about something else, and making arts and crafts.”

It is unfortunate that health professionals are invested in worthless behavioral tips for one of the most powerful of human addictions. However, I wholeheartedly agree that smokers should start “thinking about something else,” including switching to satisfying and vastly safer cigarette substitutes.

I would welcome the opportunity to debate this important public health issue with Dr. Karim at a University of Cincinnati College of Medicine forum.

Thursday, November 17, 2011

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.

Tuesday, November 8, 2011

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.

Wednesday, November 2, 2011

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.

Wednesday, October 26, 2011

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.

Wednesday, October 19, 2011

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.

Tuesday, October 11, 2011

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.”

Wednesday, October 5, 2011

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.

Wednesday, September 28, 2011

State-Wide Smoking Bans: Little to No Impact on Heart Attack Deaths

My research group just published a study documenting that the implementation of state-wide smoking bans in California, Utah, Delaware, South Dakota, New York and Florida had little or no immediate measurable effect on deaths from heart attack (acute myocardial infarction, AMI). The study was published in the Journal of Community Health (here).

Nicholas Peiper, Phil Cole and I studied the AMI death rate in those states before and after smoking bans were implemented, comparing those rates to historical and national trends. The results are illustrated in the figure.

The state-wide bans had no effect in California, Utah, Delaware or South Dakota (the AMI death rate actually increased almost 9% in South Dakota during the target year). But after bans in Florida and New York in 2003, AMI death rates declined 9% and 12% respectively, which exceeded the expected declines based on historical trends in those states. However, they were not significantly different from the 10% decline in the 44 states that did not have smoke-free ordinances in 2004.

Since 2004 several published reports have claimed that smoking bans in small cities result almost immediately in reductions in heart diseases. For example, in Helena, Montana hospital admissions for acute myocardial infarction (AMI) declined 40%, from 40 before to 24 after implementation of a smoke-free ordinance (here). In Pueblo, Colorado, AMI admissions dropped 27%, from 399 before to 291 over a 1.5-year period following a ban, and the authors reported that the decline occurred “within months” of implementation (here). In Bowling Green, Ohio, hospital admissions for ischemic heart disease and heart failure fell from 36 before to 22 after a ban (here), and in Monroe County Indiana, hospital admissions for AMI among non-smokers declined from 17 before to 5 after a ban (here).

But there are two problems with these claims. First, it’s dangerous to make big claims based on tiny numbers. Phil Cole and I presented evidence that the Helena and Pueblo findings “are consistent with random variation because of the small number of observations on which they are based.” (here).

Second, none of the previous reports accounted for the long-term downward trend in heart disease in the U.S. In our study smoking bans might have taken the credit for the 9% decline in Florida and the 12% drop in New York if the historic drop in AMI that occurred throughout the U.S. in 2004 was ignored. The figure above shows the impressive decline in American heart attack deaths since 1991.

We concluded that “Smoke-free ordinances may serve public health objectives by providing non-smokers with indoor environments that are free from irritating and potentially harmful pollutants. However, this study does not provide evidence that these ordinances result in a measurable immediate reduction in AMI mortality of the magnitude claimed by reports based on very small incident numbers.”

Wednesday, September 21, 2011

Switch and Quit Owensboro (Kentucky)

A University of Louisville public health initiative is reaching out to thousands of adult smokers in Owensboro, encouraging them to quit with assistance from the unlikeliest of sources — tobacco. The “Switch and Quit Owensboro” campaign is based on scientific evidence that switching from cigarettes to smoke-free tobacco products provides almost all of the health benefits of complete tobacco abstinence.

Switch and Quit Owensboro is the first community-based quit smoking program based on principles of tobacco harm reduction. Switching to a safer form of tobacco that satisfies smokers’ addictive desire for nicotine helps smokers quit cigarettes, and gain longer and healthier lives.

The campaign includes print, radio, billboard, social media and cinema public service messages. It is aimed primarily at adult inveterate smokers -- those who are unable or unwilling to quit using conventional approaches that emphasize total tobacco abstinence.

At the start of the campaign, an astounding 15,000 cartons of cigarettes were sold per week in Owensboro/Daviess County. Cigarette sales should decline when smokers learn about safer, satisfying smoke-free substitutes. Visit the campaign website here.

Switch and Quit Owensboro is a program of the University of Louisville James Graham Brown Cancer Center, which is committed to the prevention and treatment of cancer. The campaign aims to prevent the estimated 220 smoking-related deaths that occur in Owensboro and Daviess County, Kentucky every year.

Wednesday, September 14, 2011

How Many Americans Smoke?

Surprisingly, the answer is either 45.3 million or 52.7 million in 2010, depending on which federal agency does the counting. This wide variance underscores the discordant findings from government smoking data.

National statistics on smoking are provided by two federal surveys, the National Health Interview Survey (NHIS) and the National Survey on Drug Use and Health (NSDUH). I have conducted research on the differences between these two surveys (here) and I previously wrote a blog on the topic (here).

Federal officials released fresh data from both surveys last week, making the discrepancies even more stark.

The Office on Smoking and Health at the Centers for Disease Control and Prevention (CDC) counted 45.3 million American smokers, using the NHIS (available here). This number has not changed much in over 20 years. In 1990, the CDC reported that there were 45.8 million adult smokers. But as the U.S. population has grown, the percentage of smokers has declined. In 1990, smokers made up 25.5% of the adult population; by 2010, prevalence had declined to 19.3%.

The CDC notes that, “If current patterns continue, smoking prevalence is projected to fall to approximately 17% in 2020, and the national Healthy People objective to reduce smoking prevalence to < 12% will not be met.” That’s an understatement. In 1998, the government set 2010 as the target for 12% smoking prevalence (available here). That proved to be a pipedream, and the 2020 goal will prove equally unattainable. One is reminded of Albert Einstein’s definition of insanity: doing the same thing over and over again and expecting different results.

Last week, the Substance Abuse and Mental Health Services Administration, which administers NSDUH, released “selected” 2010 survey information (here). They estimated the number of smokers at a whopping 70 million, including teenagers, but they did not break out the number of adult smokers. The 2009 NSDUH survey reported 52.7 million adult smokers; the 2010 estimate likely will be similar.

It is unacceptable that two federal surveys differ by over 7 million in their adult smoking counts. Even worse is the way the government uses the divergent data to spin different stories about smoking. They use the lower NHIS numbers to boast about declining smoking rates, which they attribute to higher taxes and smoking bans. They use the higher NSDUH numbers to argue for even more onerous anti-tobacco measures.

My research (here) has explored why the NHIS and NSDUH estimates are so divergent. I have called for officials to investigate and resolve these problems so that national tobacco policy can be guided by accurate smoking data.

Wednesday, September 7, 2011

Insights From E-cigarette Users

When e-cigarette enthusiasts held a Vapefest in Philadelphia in March, Jonathan Foulds, a tobacco researcher at the Penn State University College of Medicine in Hershey, collected information from 104 attendees, using a 55-question survey. Dr. Foulds is the lead author on the resulting manuscript, published by the International Journal of Clinical Practice (abstract here).

About three quarters of the users were men, with an average age of 34 years; almost 80% had not used a traditional tobacco product in the past 30 days. The average duration of smoking was 16 years, and they had smoked an average of 25 cigarettes per day. The average number of quit attempts was nine. Nearly two thirds of e-cigarette users had unsuccessfully tried FDA-approved smoking cessation medications, and three quarters had tried to quit “cold turkey.” Over half had used e-cigarettes for over one year. Most participants planned to continue using e-cigarettes for at least another year; they reported that the average weekly cost was about $13.

The event attendees were e-cigarette enthusiasts, so it is not surprising that few of them used major brands that are widely available in convenience stores (such as NJOY and Smoking Everywhere). These brands have rechargeable batteries and replaceable cartridges. Instead, there was a preference for brands that have larger batteries with an extended life expectancy (eGo, Joye and Riva); the most experienced users preferred even more exotic hardware (Omega, Silver Bullet, Helix).

The findings are informative but not necessarily representative of e-cigarette users generally. However, it is likely that Philly Vapefest participants were inveterate smokers who, by switching to a form of smoke-free tobacco, substantially reduced their risk of contracting a smoking-related illness. Foulds and colleagues acknowledge that “the health risks from smoking are large and are known with certainty. Comparatively, the health risks from e-cig use are likely much smaller (if any) and temporarily switching to e-cigs will likely yield a large health benefit.” However, they inexplicably conclude that “current smokers who are interested in quitting smoking should be strongly directed towards evidence-based treatments (counseling, and approved medicines like nicotine replacement, bupropion or varenicline), rather than to e-cigs.”

Foulds and colleagues write that “we do not know enough about e-cigs to recommend them to patients.” Still, they must know that the “evidence” for evidence-based treatments is not compelling. Nicotine medicines have a 93% failure rate (here), and bupropion and varenicline are fraught with potentially serious side effects (here).

Many health professionals wrongly believe that smoking is an illness requiring treatment. In fact, smoking is a lifestyle choice – albeit an addictive and risky one – for which people need satisfying and safer substitutes. This is the core philosophy of tobacco harm reduction, and of this blog.

Wednesday, August 31, 2011

The Scientific Foundation for Tobacco Harm Reduction, 2006-2011

In 2006, the American Council on Science and Health (ACSH) became the first American scientific organization to formally endorse tobacco harm reduction. Their position was based on a Harm Reduction Journal review article (available here), authored by me and William Godshall, director of Smoke-Free Pennsylvania.

Over the past five years, interest in tobacco harm reduction has expanded exponentially, with a concomitant increase in the number of published studies. ACSH asked me to review and analyze influential contributions to the scientific and medical literature, and to discuss issues that continue to stimulate debate. My review, “The Scientific Foundation for Tobacco Harm Reduction, 2006-2011,” has just been published by the Harm Reduction Journal (available here).

Numerous epidemiologic studies and subsequent meta-analyses confirm that smokeless tobacco (ST) use is associated with minimal risks both for cancer and for myocardial infarction; a small increased risk for stroke cannot be excluded. Studies from Sweden document that ST use is not associated with benign gastrointestinal disorders or with chronic inflammatory diseases. Although any form of nicotine should be avoided during pregnancy, the highest risks for the developing baby are associated with smoking. It is documented that ST use has been a key factor in the declining rates of smoking and of smoking-related diseases in Sweden and Norway. For other countries, the potential population health benefits of ST are far greater than the potential risks.

In follow-up studies, dual users of cigarettes and ST are less likely than exclusive smokers to achieve complete tobacco abstinence; however, they are also less likely to be smoking. The health risks from dual use are probably lower than those from exclusive smoking.

E-cigarette users are not exposed to the many toxicants, carcinogens and abundant free radicals formed when tobacco is burned. Although laboratory studies have detected trace concentrations of some contaminants, pending FDA regulation of e-cigarettes as tobacco products is likely to remedy this issue. There is limited evidence from clinical trials that e-cigarettes deliver only small doses of nicotine compared with conventional cigarettes. However, e-cigarette use emulates the cigarette handling rituals and cues of cigarette smoking, which suppresses craving and withdrawal that is not entirely attributable to nicotine delivery.

I will end this post with the same quote that ended my review. It is from the outstanding policy paper “Tobacco harm reduction: how rational public policy could transform a pandemic,” by David Sweanor, Philip Alcabes and Ernest Drucker, published in the International Journal of Drug Policy in 2007 (available here):

"The relative safety of ST and other smoke-free systems for delivering nicotine demolishes the claim that abstinence-only approaches to tobacco are rational public health campaigns...Applying harm reduction principles to public health policies on tobacco/nicotine is more than simply a rational and humane policy. It is more than a pragmatic response to a market that is, anyway, already in the process of undergoing significant changes. It has the potential to lead to one of the greatest public health breakthroughs in human history by fundamentally changing the forecast of a billion cigarette-caused deaths this century."

Wednesday, August 24, 2011

E-Cigarettes - No Toxic Effects from Inhaled Propylene Glycol Aerosol

One of the key ingredients in many e-cigarette liquids is propylene glycol (PG), described by Wikipedia (here) as a “colorless, nearly odorless, clear, viscous liquid with a faintly sweet taste…” The entry also explains that PG is used “as a moisturizer in medicines, cosmetics, food, toothpaste, shampoo, mouth wash, hair care and tobacco products…, in smoke machines to make artificial smoke for use in firefighters' training and theatrical productions” and “as a moisture stabilizer (humectant) for snus” among many other applications.

A new study provides valuable information about the toxicological profile of inhaled PG aerosols in laboratory animals; it also provides an excellent general review of the agent. The authors are Michael Werley, a scientist at Altria, and colleagues from Charles River Laboratories (Scotland), WIL Research Laboratories, Battelle Memorial Institute and Virginia Commonwealth University. It was published in the journal Toxicology (abstract here).

The investigators exposed rats and dogs to high concentrations of PG aerosol for up to 28 days, followed by comprehensive systemic evaluations, especially involving the respiratory system.

They report, “In general, these studies confirmed the relatively low toxic potential of [aerosol] PG, administered by various dose routes, including the inhalation route…in the dog, no histopathological effects on the [larynx, trachea and lung] tissues were observed.” The investigators noted decreases in some assessments of red blood cells in dogs treated for 28 days, but “these effects were not clinically significant in the dog and had no effect upon their activity of health”, and “the values still within the normal historical ranges for dogs of this age, strain and sex.”

Werley and colleagues added that, “overall, PG inhalation exposure in rats and dogs produced quite limited toxicological findings, and allowed us to conclude that [aerosol] PG exposures could be conducted safely in man by the inhalation route…”

This study assessed the effects of short-term exposure to PG vapor, but the effects of long-term (months or years) exposure are unknown and unknowable. However, it provides valuable information for e-cigarette users and policy makers. First, even high concentrations of PG vapor don’t have any measurable harmful effects, which is fully consistent with its designation by the FDA as “generally recognized as safe” as a food additive for all food categories up to 2% (here). Just as important, there will be no impact on bystanders from “second-hand” exposure to e-cigarette vapor, if it occurs at all.

Thursday, August 18, 2011

How to Use Smokeless Tobacco: A Primer for Smokers

This blog is devoted to correcting myths and misconceptions about tobacco harm reduction. Here is some practical advice on to make the switch to smoke-free tobacco products.

1. Pick the right product. Choose a pouch -- a small “teabag” containing tobacco and flavors -- or try one of the other products from this list and decide which works best for you. There are many options, so don’t be discouraged if one product doesn’t fit your lifestyle or taste.

2. If you’re using a pouch, put it in the right place. Place it under your upper lip, near the corner of your mouth. Most smokeless tobacco users put products behind their lower lip – a practice that generates tobacco juice and leads to spitting. In Sweden, snus users tuck the product behind their upper lip, where it’s spit-free and invisible. Simply pop a pouch in your mouth and move it in place with your tongue. Alternatively, pull your upper lip out with your fingers and position the pouch. At first, the pouch will feel like a cannonball. Look in the mirror, and you’ll see that it’s hardly noticeable.

3. Get your nicotine buzz, but don’t overdo it. When you inhale cigarette smoke, you get an immediate nicotine kick. The effect from smokeless tobacco takes longer, but slower nicotine uptake also means slower nicotine decline. One- or two-pack-a-day smokers who switch often need to use only 4 or 5 smokeless pouches… saving money.

Light and ultra light smokers might get too much nicotine from some smokeless products. Choose one that’s satisfying but not overwhelming.

At first, use the smokeless product for only a few minutes. You’ll learn how much time you need to get tobacco satisfaction.

4. Expect the unexpected. You might feel minor burning where you place the tobacco, and your throat might get irritated. This is from the nicotine, and it’s normal. Sipping some water or a beverage can help. You may get the hiccups, feel dizzy or experience an upset stomach, but these minor symptoms will quickly disappear.

5. Stick to the switch. Although some smokers make the transition quickly, smoke-free tobacco products don’t automatically “cure” you of wanting another cigarette. These products will make it easier to quit and they’ll make those cravings less intense, but they don’t entirely replace the smoking ritual. If you’ve smoked for years, breaking the habit can still be a challenge.

Remember, it’s the smoke that kills. Stay committed to being smoke-free.

Wednesday, August 10, 2011

The Swedish Miracle Confirmed

Investigators from Umeå University and the Karolinska Institute in Sweden have just published a study of tobacco use among the population (40, 50 and 60 year-olds) of Västerbotten County in Northern Sweden over the period 1990 to 2007 (abstract here). The results confirm the findings from earlier published reports (here, here and here), that snus use has been a major influence in low smoking and high cessation rates among Swedish men, and more recently among Swedish women.

This table, adapted from the publication, lists the prevalence (%) of men who used snus, cigarettes, or both products during each period of the study.


Prevalence (%) of Tobacco Use Among Men in Västerbotten County, 1990-2007
1990-95 1996-2001 2002-07
40 Year Olds
Snus192628
Cigarettes2012 7
Both 8 6 6
50 Year Olds
Snus122024
Cigarettes211611
Both 6 6 6
60 Year Olds
Snus111418
Cigarettes171413
Both 3 3 4

It clearly shows the transition from cigarettes to snus. Men of all ages made the switch, but the findings are most impressive for 40 year olds: snus use rose from 19% in 1990-95 to 28% in 2002-07, while smoking dropped from 20% to 7%.

Women also made the switch. In 1990-95, 31% of 40 year old women smoked, and only 2% used snus. By 2002-07, 12% smoked and 12% used snus.

The following table, also adapted from the publication, shows that many men used snus to quit smoking.


Percentage of Men Former Smokers Who Were Current Snus Users
1990-95 1996-2001 2002-07
40 Year Olds414960
50 Year Olds263744
60 Year Olds232631

Once again, the switch was most impressive among 40 year olds. In 1990-95, 41% of former smokers were using snus. By 2002-07 that figure was 60%. Although the percentages were smaller among women former smokers, they were still impressive. In 2002-07, 30% of 40 year old former smokers were using snus -- 16% among 50 year olds, and 7% among 60 year olds.

The study also looked at tobacco use among participants 10 years after they enrolled in the study (Baseline). Here is a breakdown of those results.


Tobacco Use Among Men After 10 Years
Baseline Tobacco-FreeBaseline SnusBaseline CigarettesBaseline Both
Follow-Up Tobacco
Tobacco-Free93%20%29%12%
Snus4741345
Cigarettes21517
BothUnder 15734
Note: Stable use in bold

The important message here is that only 51% of smokers were still lighting up after 10 years, while 29% were tobacco-free, and 13% were using snus. Dual use was even more unstable, with 45% using snus at follow-up. Once again, these findings are similar to previously published research (here).

These results clearly show that snus use has played an important role in low smoking rates. Despite this, the researchers who produced the data argue to the contrary. They write, “If this was a randomized trial it would definitely refute the argument that snus use reduces smoking prevalence…our data is not in support of the claim of smoking reduction of snus…on a population level, snus has played a small role in the decision process to quit smoking.”

The researchers’ anti-tobacco sentiments are clearly at odds with the evidence. Their data simply proves, once again, the reality of the Swedish Miracle. Their jarring analysis underscores the disconnect between the fact-based science of tobacco harm reduction and the obfuscating politics of tobacco prohibitionism.

Wednesday, August 3, 2011

CDC Propaganda Gets Wide Visibility; National Library of Medicine Assists

The CDC’s dangerously misleading position on smokeless tobacco has been given fresh exposure, thanks to a widely syndicated July 28 news brief from the writers at Health Day (here). Among a broad range of media and web sites republishing the hit piece was the federal government’s National Library of Medicine (here) -- an agency that purports to provide “trusted health information” that is “authoritative,” “reliable” and “up-to-date.” Their seeming endorsement of this anti-tobacco propaganda belies their credibility.

Following is the Health Day screed, interspersed with my factual statements in bold.

Health Tip: Smokeless Tobacco Isn't a Safe Alternative

CDC: It can cause cancer, oral health issues and nicotine addiction

(HealthDay News) -- Some people may think smokeless tobacco is a safer alternative to cigarettes, but experts at the U.S. Centers for Disease Control and Prevention want to nip that idea in the bud.

The CDC acknowledges that it wants to get rid of a concept that is scientifically proven and has the potential to save millions of lives.

The CDC mentions these health issues that can stem from smokeless tobacco use:
Cancer, notably oral cancer.

The oral cancer risk from modern smokeless products is not “notable” at all. It’s insignificant, as documented previously in this blog (here).

Tooth decay, gum disease, receding gums and other oral health problems.

There is “virtually no scientific evidence that smokeless tobacco was an independent risk factor for any dental problem.” It is beyond comprehension that the CDC continues to spew misinformation about dental problems that don’t exist. See my blog entry (here).

If you're pregnant, increased risk of complications, including preeclampsia, low birth weight and premature birth.

This is the only sentence in the release that comes close to being accurate. As I documented previously (here and here), smokeless tobacco use may present risks to the developing baby. All forms of nicotine should be avoided during pregnancy, but the highest risks for a developing baby are associated with maternal smoking.

Fertility problems in men, including abnormal sperm and lower sperm count.

This appears to be another stretch of CDC officials’ imagination. A search of the medical literature reveals two studies relating to smokeless tobacco use and infertility. One, published in 1987 (here), concluded that “tobacco use by chewing or smoking is not associated with impaired semen quality in males selected from an idiopathically hypofertile population.” A second study (here) found some problems among smokeless users in India, data related to a form of tobacco that is neither relevant nor applicable to use of modern Swedish or American smokeless products.

Addiction to nicotine and increased likelihood of becoming a cigarette smoker.

Smokeless tobacco is addictive, and an excellent substitute for cigarettes, but the allegation that smokeless use is a gateway to smoking is a complete fabrication, as I discussed previously (here).

By providing such gross distortions of the truth to smokers and the media, the CDC and NLM undermine their institutional credibility. The public expects these agencies to offer accurate information about infectious diseases, injuries, vaccination, health statistics and more. CDC Director Thomas Frieden ought to be outraged over the distortions and fabrications being promulgated by his personnel.

Wednesday, July 27, 2011

Snus Use and Gum Disease: No Association

Swedish investigators have just published a study in the Journal of Clinical Periodontology documenting “no significant association between gingivitis, [periodontal pockets] and periodontal disease experience and snus use.” (abstract here). The authors are Anders Hugoson from Jönköping University and Margot Rolandsson from Karlstad University.

The study was based on 1,500 residents of Jönköping who took part in detailed dental health exams in 1983, 1993 and 2003. Hugoson and Rolandsson supervised teams of dentists who collected information on the number of teeth, plaque index, presence of inflammation of the gingiva (gum tissue), periodontal pocket depth, gum recession, calculus, and x-ray examination. The findings were used to classify participants according to the presence and severity of gum, or periodontal, disease. The results were adjusted for factors that might influence the development of periodontal disease, such as age, gender, and socioeconomic class (education, employment and marital status).

In comparison to nonusers of tobacco, smokers were more likely to have severe periodontal disease (odds ratios, OR = 3.0 – 6.5, which were statistically significant). The authors note, “Numerous epidemiological studies have demonstrated that of all the risks identified, cigarette smoking may be the most strongly associated with periodontitis.”

Severe periodontal disease among snus users was about as common as among nonusers of tobacco (OR = 0.8, not statistically significant). This is in essential agreement with a comprehensive review published by Kallischnigg and colleagues in BMC Oral Health in 2008 (available here). Furthermore, it suggests that the federally mandated smokeless tobacco warning, “This product can cause gum disease and tooth loss,” is not relevant to snus, if it is scientifically credible at all.

Hugoson and Rolandsson provide information on tobacco use for each year of the study. Following is the breakdown for men:


Proportion of Men in Jönköping Who Are Snus Users, Smokers and Nonusers
Year Snus Users (%) Smokers (%) Nonusers (%)
198392962
1993131770
2003171469

The prevalence of snus use among men doubled from 9% in 1983 to 17% in 2003, while the prevalence of smoking was cut in half, from 29% to 14%.

This study provides more evidence that use of snus by Swedish men has resulted in real benefits to their general and oral health.

Wednesday, July 20, 2011

Switchers: Profiles of Pioneers

The scientific rationale for switching from cigarettes to smokeless tobacco was indisputable in 1994 when I published my first two articles on tobacco harm reduction (here and here). But had anyone ever made the switch from combustible to smoke-free tobacco?

The answer, according to a 1993 report from the federal Centers for Disease Control and Prevention (available here), was a resounding YES. The report estimated that there were 5.3 million smokeless users in the U.S., and that one-third of them, or 1.7 million, were former smokers.

My research group established contact with a small number of switchers, and in 1995 we published a manuscript about them (citation here). Their average age was 50, but some were as young as 27, and some as old as 77. They were blue and white collar, women and men. Their cigarette smoking experience varied considerably, with an average smoking history of 48 pack-years. (A pack-year is a measure of exposure to cigarettes obtained by multiplying the number of packs smoked daily by the number of years smoked). Some had recognized early on that cigarette smoking was a future health threat -- they had only 3 pack-years; others made the switch with an astounding 156 pack-years behind them.

In my book, For Smokers Only (link), I shared the stories of switchers we had met. The following is an excerpt.

The people depicted below are real pioneers. They are former smokers who, for various and sometimes very personal reasons, decided on their own, without any medical assistance or support, that smokeless tobacco was a safer alternative to cigarette smoking. These profiles in courage can serve as models for those of you who may be impressed by the facts, the stats and the logic in this book, but who need a personal touch to bring the book's message to heart.

Each one of the former smokers below has shared his or her medical and personal story with researchers in my program.

Clint

Clint is a 55 year old manager of maintenance operations for a national transportation firm. He started smoking when he was 17 years old and consistently smoked a pack of cigarettes a day for the next 34 years. Clint had occasionally tried to quit. In 1985 he successfully quit smoking for an extended period of time, but soon found himself again smoking up to two packs per day.

In August 1988 Clint started experiencing pain in his lower chest and stomach area. When it did not go away, he decided to drive to the hospital for evaluation. To calm his nerves on the way, he had what turned out to be his last cigarette. Clint was suffering a heart attack.

During his hospitalization the doctors were blunt. Smoking was a big factor in the attack. To continue to smoke was to run the risk of another attack -- one that might not be as mild. For Clint this was enough of an incentive to quit for good. However, the need to smoke persisted. He seemed to be longing for nicotine every minute of every hour of every day. Finally, after a year and a half of continuous craving, he started using smokeless tobacco.

Clint's story is not uncommon from several standpoints. First, a health problem resulting from smoking made a sudden appearance. Second, he continued to experience craving long after he quit, long after the physical effects of nicotine were out of his system. This is not unusual. Many smokers enrolled in our program have quit in the past for as many as several years, but the need for nicotine did not subside. Smokeless tobacco had completely satisfied that craving.

Carl

Carl is a retired machinist who remembers smoking when he was 10 years old. For forty years he averaged two packs a day. He smoked unfiltered Camel cigarettes for 30 years, but switched to a filtered brand when he started to experience breathing problems. When his breathing started to get considerably worse, Carl consulted a doctor. The diagnosis: emphysema. The solution: stop smoking. The outcome if he didn't: a maddeningly slow death by suffocation. Carl made the decision to quit. He tried prescription nicotine gum, but it was of no help. He knew he had to try something else soon or he would break down and resume smoking. He tried smokeless tobacco.

That was twelve years ago. His lung deterioration was slowed, and, most importantly, he is convinced that without smokeless tobacco he would still be smoking, or be six feet under.

Marian

Marian is a 77 year old who smoked a pack of cigarettes every three or four days for decades. When she was 72 she developed a cough that scared her. Looking for a way to continue enjoying tobacco without harming her grandchildren (even by bad example), she hit upon the idea of trying discreet little packets of moist snuff. For the past five years Marian has been successfully substituting smokeless tobacco for cigarettes.

Wendell

Wendell is a 50 year old farm manager. He had smoked non-filtered cigarettes for 14 years when, at the young age of 35, he started experiencing severe shortness of breath, a bad cough, and numerous sinus infections. Wendell thought he could beat these problems by switching to a pipe. However, he fell into a common trap for cigarette smokers who switch to cigars or a pipe. Because a cigarette smoker gets used to the nicotine jolt obtained through inhaling the smoke, the tendency is to continue inhaling when smoking a cigar or pipe. NO SMOKE IS HEALTHY, and cigar and pipe smoke can be very irritating when inhaled.

After six years of pipe smoking, Wendell decided he'd better quit altogether. After just one week of climbing the walls, he went back to the tobacco aisle and tried smokeless tobacco. Today, 15 years later, Wendell remains smoke-free and cough-free.

Rick

Rick is 52 years old and works as a technician for a major electronics manufacturer. He started smoking when he was 20, and for the next 29 years he consistently consumed between two and four packs daily. Rick had several close calls with another "occupational risk" of the habit. He had dozed off several times with a cigarette in his hand, coming very close to starting a major house fire. (Each year in the United States, smoking is the cause of fires that kill one thousand, three hundred people.)

Rick tried to quit tobacco altogether when he quit smoking. But he frequently craved the nicotine he was missing, even though he got over the queasy disorientation of the physical withdrawal symptoms within the first week.

After three months of constant craving, he started using smokeless tobacco. For the past three years he has been sleeping better, knowing that he won't wake up with a problem in his lungs or a burning cigarette in his hand.

Dan

Dan is a 38 year old non-commissioned officer in the army. He started smoking when he was 16 years old. After smoking 2 packs per day for 12 years, Dan started developing shortness of breath. He saw the handwriting on the wall and made an overnight switch to smokeless tobacco.

Like many successful participants in my quit-smoking program, Dan did not experience a moment of physical or psychological withdrawal after giving up his cigarette habit. He had not read about the relative safety of smokeless tobacco, but he intuitively knew that it had to be healthier than pouring fumes into his body.

John

John is a 66 year old who owns a small business. He had been smoking 3 packs of cigarettes per day for 52 years. Four years ago doctors told him that he had hardening of the arteries, a blood vessel condition that is complicated by smoking. He switched to smokeless tobacco as soon as he realized, to his surprise, that dipping snuff gave him the same satisfaction he got from cigarettes.

Dr. Lee R.

Dr. Lee R. is a health professional in rural Alabama. He started when he was 20 years old, smoking one and a half packs per day for 26 years. Like many other smokers, his entire breathing apparatus started to rebel. Dr. R. started wheezing, especially at night. In addition, he had shortness of breath, a persistent cough, and irritated sinuses and eyes. Dr. R.'s medical training had not been forgotten; these were ominous signs of more serious problems ahead if he didn't quit. He quit for 3 months, suffering continuous craving like so many other former smokers. Then he discovered smokeless tobacco, and for the last ten years he has been looking and feeling better.

Dr. R. tried to convince smoking friends and relatives to make the switch. He worked on his brother for years, but was not able to convince him to make the transition. His brother has since died from lung cancer.

If you’re a switcher, share your story. It might inspire other smokers who are struggling to manage one of the most powerful of human addictions. Submit a comment to this post, or send me an email -- brad.rodu at louisville.edu