Tobacco Truth

Last week I made the case that the CDC was largely responsible for the information void related to smokeless tobacco use. (here). Staff from the CDC Office on Smoking and Health have published a report documenting that many adults in the U.S. are not even aware of snus and dissolvable tobacco, and they are mostly clueless about differential health risks of these products versus cigarettes.

Annette Regan was the first author of this study, published in the American Journal of Preventive Medicine (abstract here). She and her colleagues analyzed several thousand responses to the 2009 ConsumerStyles and HealthStyles Surveys conducted by Synovate Inc. The results are representative of the U.S. population.

Regan et al. wrote that “44% of [American adults] had heard of Camel or Marlboro snus…” but only “5.4% of adults reported trying snus and 1.8% used snus currently.” Only 10% of adults were aware of dissolvable tobacco, only 0.5% had tried it and a scant 0.3% currently used it.

Awareness and use of snus and dissolvables are modest, but the beliefs about risks were, well…unbelievable. Here is what respondents thought about the health risks of snus and dissolvables, compared with cigarettes:

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What American Adults Think About the Health Risks of Snus and Dissolvable Tobacco SnusDissolvableMore harmful than cigarettes8%7%Just as harmful50%39%Less harmful5%4%Unsure37%50%
It is astounding that only tiny fractions of American adults (5% and 4%) are correctly informed that snus and dissolvables are less harmful than cigarettes. It is even more remarkable that Regan et al. did not even comment on this. Instead, they resorted to the same old mantra:

“All tobacco use is harmful; however, uptake of some of these products may pose unique health concerns. For example, snus and dissolvable tobacco products are marketed for use by cigarette smokers in places where smoking is not permitted. These discrete smokeless tobacco products can be used to deal with nicotine cravings while circumnavigating smokefree policies, and as a result deter smoking-cessation attempts. Because smoking cessation would result in substantial health benefıts, this behavior would be detrimental to health.” (references omitted)

Regan et al. don’t acknowledge that Americans are misinformed, and they perpetuate the misinformation by repeating that “all tobacco is harmful.” They opine that snus and dissolvables keep people smoking, but that is ridiculous. Their study shows that it is misinformation that keeps smokers from switching to lifesaving alternatives.

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) held a public hearing January 18-20 on dissolvable smokeless tobacco products. The information gleaned there will help inform a congressionally mandated report on the subject, due March 23.

The proceedings (agenda here) underscored the dearth of information on dissolvable tobacco use. Committee members repeatedly observed that there is no reliable data on who uses these products and in what context. Are dissolvables temporary or permanent substitutes for cigarettes? Do they promote tobacco initiation among teenagers?

These are legitimate questions for which we need definitive answers. One problem is that dissolvables from major manufacturers have only been in limited markets since 2009, when RJ Reynolds test-marketed Camel Orbs, Strips and Sticks in Indianapolis, Columbus and Portland, Oregon. Testing was discontinued early last year, but Reynolds later launched the products in Denver and Charlotte. In 2011, Altria introduced Skoal and Marlboro Sticks in Kansas. A smaller player, Star Tobacco, has sold Ariva dissolvable tobacco since 2001.

It is not surprising that we know next to nothing about dissolvable tobacco use; little is known about smokeless tobacco use generally, despite the fact that some 6 million U.S. adults consume these products. This information deficit can be blamed on the federal government, and specifically on the Centers for Disease Control and Prevention (CDC).

Each year, the CDC publishes detailed information on U.S. smoking prevalence, based on the annual National Health Interview Survey. What about smokeless tobacco? It turns out that the CDC has only produced detailed smokeless tobacco information twice in the last decade, in 2000 and in 2005, when the NHIS included a special supplement sponsored by the National Cancer Institute. There is a lot of information in these supplements, as I documented in 2009 publication (abstract here).

There has been growing discussion over the past decade about smokeless tobacco as a substitute for cigarettes. The U.S. House of Representatives in 2003 held a hearing titled “Can Tobacco Cure Smoking: A Review of Tobacco Harm Reduction” (my testimony here). It should have been a wakeup call for government officials to collect more information on smokeless tobacco use. Instead, there is evidence that NHIS staff decided to collect less.

In addition to smokeless tobacco information, the 2000 NHIS also collected information on the techniques used by smokers during their last attempt to quit. This data proved that tobacco harm reduction with smokeless tobacco was working. As I noted in a published study (abstract here):

“An estimated 359,000 men switched to smokeless tobacco in their most recent quit attempt. This method had the highest proportion of successes among those attempting it (73%), representing 261,000 successful quitters (switchers)… Switching to ST compares very favorably with pharmaceutical nicotine as a quit-smoking aid among American men, despite the fact that few smokers know that the switch provides almost all of the health benefits of complete tobacco abstinence. The results of this study show that tobacco harm reduction is a viable cessation option for American smokers.”
If the 2000 NHIS survey proved that tobacco harm reduction was viable, what did the 2005 NHIS survey show? Absolutely nothing. NHIS removed the switch-to-smokeless option from the 2005 survey, despite the huge explosion in awareness of and discussion about tobacco harm reduction.

Today, the TPSAC committee is preparing to make important decisions concerning tobacco harm reduction... lacking basic information about smokeless tobacco use and with no current data about transitions between cigarettes and smoke-free products.

This information deficit is unacceptable. The FDA Center for Tobacco Products, generously funded by fees from tobacco manufacturers, must act. At a minimum, it should fund annual use of the 2000 NHIS smokeless tobacco supplement – with appropriate revisions for e-cigarettes – in every annual survey, in order to collect unbiased information about use of smoke-free tobacco products.

When Congress gave the FDA regulatory authority over tobacco in 2009, it directed the agency to evaluate dissolvable smokeless tobacco. This week the FDA Tobacco Product Scientific Advisory Committee is holding hearings, and this has prompted a media blitz by anti-tobacco extremists.

Thomas J. Glynn, the director of science and trends for the American Cancer Society, issued a strange statement (here): “At this point, we don't know the full range of what is in them.”

Dr. Glynn may not be aware that dissolvable tobacco has been analyzed extensively (discussed here), and we do know what is in them: tobacco, flavors, non-caloric sweeteners and a few food-grade additives.

Two months ago Dr. Glynn authored an “Expert Voices” blog post titled “Here Come the Dissolvables” (here), in which he included some reasonable comments about dissolvable tobacco and one demonstrably false statement. ACS describes the blog as providing “timely insight on cancer topics from experts.” I have previously discussed other statements from Dr. Glynn (here).

ACS, at last, acknowledged that smokeless tobacco use is less hazardous than smoking. Dr. Glynn: “Certainly, as with all smokeless tobacco products, [dissolvable tobacco] will be less lethal than smoked cigarettes…” He added that “smokers should certainly continue to be made aware of that.”

A few paragraphs later, Dr. Glynn repeated the smokeless-is-safer theme: “…there is little doubt that, if all smokers in the U.S. suddenly switched from smoked cigarettes to smokeless tobacco – and stayed switched – we would see far fewer cancers and less heart disease 20 years from now…” He again noted, “smokers should continue to be made aware of the reduced, but by no means empty, threat posed by smokeless tobacco…”

Unfortunately, Dr. Glynn didn’t acknowledge ACS’s refusal to educate smokers about vastly safer smokeless tobacco, or the organization’s refusal to release critical information about the relative safety of smokeless tobacco (here).

Dr. Glynn made a passing reference to my research when he said, “Some proponents of smokeless tobacco, including dissolvables, make the argument that smokeless tobacco is as much as 98% less harmful than smoked cigarettes.” Later he opined that the “‘98% less harmful’ figure is suspect,” though he provides no evidence to support his suspicion.

Glynn’s core position remained prohibitionist. “It would be irresponsible,” he wrote, “for the public health community to urge [smokers to switch to smokeless tobacco] because there is also no evidence that smokers won’t just end up using both forms of tobacco, rather than using only smokeless – or better yet, quitting altogether.”

It is disappointing that Dr. Glynn repeatedly disrespected smokeless users by using the term “spit tobacco”. I previously reported this inappropriate and unprofessional practice to the ACS president (here), and I had been told that it had been discontinued.

Dr. Glynn made a demonstrably false statement when he predicted that “…if all smokers in the U.S. suddenly switched from smoked cigarettes to smokeless tobacco – and stayed switched…we would also see an increased number of oral cancers…”

The risk for oral cancer among smokeless tobacco users is much lower than the risk among smokers. In fact, since 1990, no epidemiologic study has reported any significantly elevated risk among smokeless users.

It is almost certain that a large-scale permanent switch from cigarettes to smokeless tobacco would not only result in a significant reduction in the number of oral cancers, it would substantially reduce all smoking-related diseases.

Investigators from the University of California Riverside have published a study underscoring the wide variation in performance of e-cigarette brands, including Liberty Stix (here), Crown Seven (here), Smoking Everywhere (here), and VapCigs (here).

Tests conducted by Monique Williams and Prue Talbot measured airflow rates required to produce an aerosol, and the number of puffs available per unit, among other things (abstract here).

They reported, “Significant variation was found among e-cigarette brands in the airflow rate required to produce aerosol,…in aerosol density, and in the manner in which e-cigarettes performed over time….Consumers and researchers should be aware that e-cigarettes vary in performance across brands and within models from the same brand, that some brands will require harder inhalation to use than [combustible] cigarettes, and that aerosol density varies between puffs which may affect nicotine delivery.”

This research followed work published last year (abstract here), in which Williams, Talbot and first author Anna Trtchounian used a smoking machine to compare the puffing characteristics and smoke/aerosol densities of Liberty Stix, Smoking Everywhere, Crown Seven and NJOY (here) with those of combustible cigarettes. They found that most e-cigarettes required a much higher vacuum for puffing than commercial cigarettes, and that the vacuum required for Liberty Stix was the lowest of all tested products. In addition, puff strength had to be increased as puff number increased. They also found considerable variation in the maximum number of puffs delivered by the products, which ranged from 177 (Smoking Everywhere) to 313 (NJOY). In the current study, Smoking Everywhere also delivered only 160 puffs, while VapCigs delivered 250 and Crown Seven delivered 400 (no results were presented for Liberty Stix).

There are numerous e-cigarette brands available in retail stores, shopping mall kiosks and online; starter-pack prices range from about $20 to $100. Smokers should be aware of the variability among and within brands, so they won’t reject this cigarette alternative on the basis of one e-cigarette experience. Smokers should talk with consumers who have made the switch; learn about e-cigarette options and observations on the Internet; and try several products, if necessary, to find one that is satisfying.

While e-cigarettes vary widely, they are capable of improving and extending the lives of cigarette smokers.

Last week, I noted that University of Minnesota researchers, arguing for additional reductions of tobacco-specific nitrosamines (TSNAs) in moist snuff products (here), complained that “No evidence has been found that Conwood [a Reynolds company] and USST [United States Smokeless Tobacco, an Altria company] took any meaningful steps to reduce the relatively high levels of NNN and NNK in their products.” (The lead author was Stephen Hecht.)

The Hecht allegations are another false alarm, as a new study in Food and Chemical Toxicology (abstract here) provides evidence that, “…since 1997, average TSNA levels have declined by approximately half in USST moist smokeless tobacco products.” The authors, including lead author Michael Fisher, are from Altria.

Fisher et al. provide valuable information about how agricultural and production practices influence TSNA development. They collected samples from thousands of bales of tobacco over the past 15 years, and discovered that “…there is a general relationship between average rainfall during the tobacco curing season and TSNA in cured tobacco.”

Moist snuff is primarily made from dark-leaf tobacco, grown in western Tennessee and western Kentucky, and barn-cured in late-summer and autumn with smoke from hardwood fires. Fisher et al. show that the most important factors in TSNA formation are humid and/or moist curing conditions. Excess nitrogen fertilizer is also a factor, although tobacco needs high concentrations of nitrogen in order to thrive. As Hecht et al. pointed out in their article, American moist snuff has marginally higher TSNA levels than Swedish snus, which is also made with dark-leaf tobacco that is air cured. This suggests that fire curing may also play a minor role in TSNA formation.

In the past manufacturing may have also played a small role in TSNA formation, when particular bacterial strains used some of the nitrogen (in the form of nitrate) to form nitrite. The nitrate-reducing bacteria may be present in harvested tobacco, and in fermentation facilities, but in 2005 USST initiated strict sanitation practices and other programs to inhibit these bacteria. This resulted in TSNA levels in finished products that were consistent with the levels found in the incoming leaf.

As I have noted previously, TSNA levels in moist snuff products from Altria and Reynolds are at historically low levels. This study documents that TSNA levels are mainly influenced by weather conditions during the curing process. Furthermore, it is important to emphasize that there is no evidence that current TSNA levels are associated with ANY significant cancer risks.

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:

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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.

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

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

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:

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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.

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.

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.

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.

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.

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.

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.

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.