Tobacco Truth

The Dissolvable Deficit: FDA and CDC Must Fill Data Void

2012-01-25T13:57:00.000-05:00

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.

Discussing Dissolvable Smokeless Tobacco

2012-01-19T11:32:00.000-05:00

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.

E-Cigarettes Vary Widely

2012-01-12T13:30:00.000-05:00

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.

An Informative Study on Tobacco-Specific Nitrosamines

2012-01-04T07:43:00.000-05:00

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.

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

2011-12-29T19:28:00.000-05:00

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
Grizzly	11.1
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.

Allegations and Answers in Owensboro

2011-12-21T13:31:00.000-05:00

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

Karolinska Institute Study: Heart of Failure

2011-12-15T11:52:00.000-05:00

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

Tobacco Retailer Compliance High, Says FDA Data

2011-12-08T14:27:00.000-05:00

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	2,122	99
Arkansas	680	96
Arizona	818	94
Colorado	1,682	92
Idaho	323	99+
Illinois	950	93
Kansas	2,016	99+
Massachusetts	2,813	96
Maryland	1,477	99
Maine	3,137	99+
Missouri	1,033	88
Mississippi	3,419	94
New Jersey	1	--
Pennsylvania	1,813	94
Tennessee	829	96
Washington	1,305	93

All	24,418	96

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.

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

2011-11-29T16:05:00.000-05:00

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.

Tobacco Harm Reduction Debated in the Cincinnati Enquirer

2011-11-22T12:57:00.000-05:00

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.

How to Make the American Smokeout Great

2011-11-17T12:48:00.001-05:00

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

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

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

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

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

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

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

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

Switching from cigarettes to smoke-free tobacco is not an industry ploy; it’s endorsed by two prestigious medical organizations, the British Royal College of Physicians and the American Association of Public Health Physicians. The Royal College concluded “...that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.” (here)

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

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

Smoking Cessation Medicines Trigger Suicidal Behavior and Depression

2011-11-08T16:16:00.001-05:00

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

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

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

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

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

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

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

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

FDA Petition: End Smokeless Tobacco Misinformation

2011-11-02T12:19:00.000-04:00

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

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

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

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

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

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

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

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

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

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

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

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

British and Australian Smokers Attracted to Smoke-Free Substitutes

2011-10-26T14:37:00.000-04:00

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

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

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

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

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

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

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

New England Journal of Medicine Promotes Failed Policies for Smoking Control

2011-10-19T13:17:00.000-04:00

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

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

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

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

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

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

2011-10-11T13:33:00.000-04:00

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

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

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

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

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

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

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

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

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

British Government Endorses Tobacco Harm Reduction, E-Cigarettes

2011-10-05T13:23:00.000-04:00

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.

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

2011-09-28T15:01:00.000-04:00

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.”

Switch and Quit Owensboro (Kentucky)

2011-09-21T10:26:00.000-04:00

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.

How Many Americans Smoke?

2011-09-14T11:38:00.000-04:00

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.

Insights From E-cigarette Users

2011-09-07T09:20:00.000-04:00

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.

The Scientific Foundation for Tobacco Harm Reduction, 2006-2011

2011-08-31T11:16:00.000-04:00

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."

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

2011-08-24T18:09:00.000-04:00

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.

How to Use Smokeless Tobacco: A Primer for Smokers

2011-08-18T10:46:00.000-04:00

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 over do 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.

The Swedish Miracle Confirmed

2011-08-10T13:27:00.000-04:00

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
Snus	19	26	28
Cigarettes	20	12	7
Both	8	6	6

50 Year Olds
Snus	12	20	24
Cigarettes	21	16	11
Both	6	6	6

60 Year Olds
Snus	11	14	18
Cigarettes	17	14	13
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 Olds	41	49	60
50 Year Olds	26	37	44
60 Year Olds	23	26	31

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-Free	Baseline Snus	Baseline Cigarettes	Baseline Both
Follow-Up Tobacco
Tobacco-Free	93%	20%	29%	12%
Snus	4	74	13	45
Cigarettes	2	1	51	7
Both	Under 1	5	7	34

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.

CDC Propaganda Gets Wide Visibility; National Library of Medicine Assists

2011-08-03T12:41:00.000-04:00

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.

Snus Use and Gum Disease: No Association

2011-07-27T19:01:00.000-04:00

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 (%)
1983	9	29	62
1993	13	17	70
2003	17	14	69

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.

Switchers: Profiles of Pioneers

2011-07-20T09:07:00.000-04:00

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

Anti-Harm Reduction Tactics By The American Dental Association

2011-07-12T15:00:00.000-04:00

On June 24 the American Dental Association (ADA) continued its long assault on tobacco harm reduction in a news article on FDA cigarette warning labels (here). The dental group repeated its 2009 statement about smokeless tobacco substitution: “As a matter of public health, we have become increasingly alarmed by recent attempts to market smokeless tobacco as a healthier (or less harmful) alternative to cigarettes. Smokeless tobacco is not a healthy alternative to cigarette smoking; both products pose health risks.”

Under the guise of “public health,” the ADA continues to deny smokers information that smokeless tobacco is a satisfying and vastly safer substitute.

The ADA has a long history of undermining this lifesaving strategy. In 1994 I published the first two articles in the medical and scientific literature proposing that smokers switch to smokeless tobacco (here and here). At the time I was chairman of the oral pathology department at the University of Alabama at Birmingham School of Dentistry, and I was a member of the ADA. Nevertheless, the organization aggressively worked to destroy my reputation and my career.

On August 17, 1994 the president of the ADA wrote to the dean that my proposal was “naïve at best and irresponsible at worst,…a disservice to the faculty and the public at large. He called the “notion that smokeless tobacco is a safe alternative to smoking tobacco” a “deception,” and he urged the dean to “repudiate the advice being promulgated by Dr. Rodu in the strongest possible manner.”

The ADA letter was a thinly veiled request to silence me. I do not know if the dean responded, but I know that the ADA expanded its destructive campaign by trying to convince the local dental society to condemn me. However, in November 1994 Dr. Alvin Stevens, the local society’s president, published a letter supporting me in the nationally distributed ADA News. Dr. Stevens wrote that “Dr. Rodu’s message is simple and is backed up by published medical and dental data…statistically, the morbidity of smokeless tobacco use is dramatically and significantly less than the use of cigarettes…Dr. Rodu’s proposal is a viable and realistic option.”

Dr. Stevens concluded that “we think that it is a disservice to call a fellow dentist ‘irresponsible’ without acknowledging, recognizing or listening to his total message…”

The ADA encouraged my professional organization, the American Academy of Oral and Maxillofacial Pathology, to condemn me and my proposal. The president replied that “…it is not the role of the AAOMP to make public statements in support of or disagreement with any individual research that has been appropriately reviewed…”

The ADA also collaborated with the American Association of Oral and Maxillofacial Surgeons, which contacted all of their members, suggesting that they send a form letter under their signature to the local newspaper. The letter contained the false punchline: “Suggesting this switch is like telling someone to use a rifle instead of an Uzi.” In retrospect, we know now that the analogy would have been more accurate if the substitute was a water gun.

In the seventeen years since 1994, approximately 6.8 million Americans have died from diseases attributable to smoking. Yet, there is no evidence that officials at the ADA, or at other national health organizations, have even considered the hundreds of scientific and medical studies documenting the benefits of tobacco harm reduction.

One of the most frequently asked questions about tobacco harm reduction is: “Why don’t all health professionals recommend that smokers switch to smoke-free alternatives?” In addition to the widespread misperception about risks (documented here), health professionals are reluctant to draw the wrath of powerful national organizations that believe that the destruction of the tobacco industry is more important than the health of America’s smokers.

Taking Chances on Chantix

2011-07-05T16:10:00.000-04:00

The smoking cessation drug Chantix (generic name varenicline) has been associated with several potentially serious side effects. In 2009, the FDA issued a “boxed warning” for the product, based on this rationale: “Some people who have taken Chantix or Zyban to help them quit smoking have reported experiencing unusual behavior changes, have become depressed or have had their depression worsen, or have had thoughts about suicide or dying; some have attempted suicide either while using one of these drugs or after they stopped taking them.” (FDA advisory here).

Now a bigger warning flag has been raised. On July 4 a meta-analysis, published in the Canadian Medical Association Journal (available here), concluded that Chantix was associated with “an increased risk of serious adverse cardiovascular events,” based on an odds ratio of 1.72 (95% Confidence Interval = 1.09 – 2.71).

The FDA may have been aware of the new analysis; on June 16, 2011, the agency issued a drug safety announcement under this headline: “Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease.” (read it here ). It is a fascinating document.

First, what is a “certain cardiovascular adverse event”? The answer is important: a nonfatal heart attack (myocardial infarction). It is strange that the FDA titled the announcement so vaguely, when the report was primarily about the risk of heart attacks. The first time myocardial infarction is mentioned is halfway through the notice.

The announcement’s “Data Summary” section contains information upon which the FDA based its decision. The agency reviewed a clinical trial involving over 700 patients, about half of which (n = 355) received Chantix for 12 weeks, while the other half (n = 359) received a placebo. All had been previously diagnosed with stable cardiovascular disease (other than high blood pressure). Both groups “received smoking cessation counseling throughout the study,” so it appears that they got the best treatment available. The follow-up was complete at one year.

Of patients getting the placebo, only three, or 0.86%, suffered heart attacks. Seven, or about 2%, of the patients in the Chantix group had heart attacks. The numbers are small, so this result is not statistically significant. But the relative risk of heart attack in the Chantix group is 2.3, which was undoubtedly worrisome to FDA officials.

So what were the quitting rates? In the placebo group, only 7% were continuously abstinent at one year. That’s 26 out of the 359 who enrolled. This means that an astounding 93%, or 333 smokers, did not respond to “smoking cessation counseling.” In other words, the claim that safer tobacco substitutes are not needed because smoking cessation counseling works is utter nonsense.

In the Chantix group, the abstinence rate at one year was 19%. That represents 68 of the 353 smokers who started the study. Although the FDA says that this is “significantly higher” than the placebo group, 285 participants were still smoking. Tobacco harm reduction could help them, too.

Strangely, it appears that the FDA was trying to downplay the announcement; they did not identify the research source. In fact, the study was published in 2010 in Circulation (abstract here ), by first author Nancy Rigotti (Harvard) and, among others, co-author Neal Benowitz, who is a member of the FDA Tobacco Products Scientific Advisory Committee. The study was conducted in 15 countries. Pfizer, manufacturer of Chantix, sponsored the research and paid consultation fees to Rigotti and Benowitz.

Another oddity: the authors of the study were not concerned about the adverse cardiovascular events related to Chantix. Although they acknowledged that “trial size and duration preclude a definitive conclusion about [safety],” they asserted that “this study provides reassurance to physicians that varenicline appears to be safe to use in smokers with stable cardiovascular disease.” Given its June 16 warning, the FDA clearly disagrees with Rigotti and colleagues about the potential risks of Chantix.

In a previous post I discussed the American Heart Association’s rejection of smokeless tobacco as a substitute for cigarettes (here), based on almost no significant research findings; that position was also co-authored by Neal Benowitz. It is evident that some health professionals who reject tobacco harm reduction are willing to tolerate serious adverse events associated with the medicines they prescribe. If they accept relative risk for prescription drugs, why reject relative risk for tobacco products?

To the American Cancer Society: Fill in the Blanks

2011-06-29T09:19:00.000-04:00

In April, I wrote that the American Cancer Society (ACS) is withholding important information on the health risks of smokeless tobacco use (post here). Here’s how the ACS can fill in the blanks on the missing information.

In 1997 the ACS published death rates among non-smokers and smokers from their Second Cancer Prevention Study (CPS II), which the organization promoted as “the largest and most recent prospective study of smoking and disease.” (Available here). According to ACS at the time, “relative risk estimates from CPS-II already have been used extensively to estimate smoking attributable mortality in the United States, Latin America, and nearly 50 other developed countries.”

CPS II involved monumental effort. In 1982, ACS recruited almost 1.2 million Americans, and collected information on smoking, smokeless tobacco use and other lifestyle factors. During the next six years, it meticulously recorded deaths among participants, so that it could determine to what extent smoking and smokeless use influenced death rates

Death rates among smokers from CPS II are the basis for the entire American anti-smoking crusade. For 20 years, this data has served as the basis for estimates by the Centers for Disease Control of how many Americans die from smoking. As seen in the table, smoking is responsible for a two- to three-fold increase in death rates for male smokers compared with nonsmokers.

All Cause Mortality Rates (Deaths per 100,000 per year) Among Men Who Are Nonsmokers, Cigarette Smokers and Smokeless Tobacco Users, 1982-1988
Age (years)	Nonsmokers Rate	Smokers Rate	Relative Risk	ST Users Rate	Relative Risk

35-39	73	219	3.0
40-44	94	304	3.2
45-49	152	427	2.8
50-54	221	679	3.1
55-59	368	1,084	3.0
60-64	673	1,824	2.7
65-69	1,097	2,885	2.6
70-74	1,847	4,665	2.5
75-79	3,441	7,322	2.1
80+	5,467	10,448	1.9

Let’s interpret just one line in the table. Over the six year period, there were 368 deaths among 100,000 nonsmoking men who were 55-59 years at the start of the study. In contrast, there were 1,084 deaths among 100,000 smokers -- 2.95 times more (rounded to 3.0). That is a big difference.

But the table is incomplete. The Cancer Society has never released death rates among smokeless tobacco users for the period 1982-88. ACS has this information, but it refuses to release it. I believe that ACS is withholding death rates from smokeless tobacco use because they are not significantly different from those for nonusers.

The FDA should be required to address this appalling information gap. The agency mandates that smokeless tobacco packages carry this warning, among others: “This product is not a safe alternative to cigarettes.” It is outrageous that the FDA lacks hard data to support the statement. Potentially life-saving comparable risk information is being withheld from smokeless tobacco users, smokers and the FDA by the American Cancer Society.

A Nationwide Campaign Against Smokeless Tobacco

2011-06-24T10:35:00.000-04:00

Smokeless tobacco and e-cigarettes are being recognized as safer, satisfying cigarette substitutes by increasing numbers of American smokers. Tobacco prohibitionists appear to be countering with a national misinformation campaign aimed at dissuading smokers from switching to smoke-free alternatives.

Letters to editors and commentaries are appearing regularly around the country, over the signatures of local public health officials, physicians and other respected health figures. Many of these items share similar talking points, including the scourge of nicotine, misrepresented health risks, and baseless accusations of marketing candy-like products to kids. All of this is attributed to the tobacco industry, despite that sector’s regulation by the FDA.

There is another common thread: Most of the articles cite the Campaign for Tobacco-Free Kids as their source for the specious claims. Here is an example, written by Montana’s Lewis and Clark County health officer Melanie Reynolds and published in the Helena Independent Record (here).

To set the record straight, I wrote the following to the newspaper’s editor:

“It is clear that Melanie Reynolds’ commentary (Beware of tobacco…, June 15) promotes prohibition (‘We in public health recommend avoiding all tobacco products…’), but that goal does not justify its use of misleading and inaccurate information.

“Ms. Reynolds portrays these products as ‘dangerous,’ but she completely ignores decades of research documenting that smokeless tobacco use is 98% safer than smoking. While no tobacco product is absolutely safe, the majority of cigarette smokers are routinely misinformed – by government agencies and by anti-tobacco extremists – about the relative safety of smokeless products. Unlike cigarettes, smokeless does not cause lung cancer, heart disease or emphysema. Smokers rightfully worry about mouth cancer, but they should take comfort in the fact that the risk for mouth cancer with smokeless is far lower than it is with cigarettes. Statistically, smokeless users have about the same risk of dying from mouth cancer as automobile users have of dying in a car wreck. In fact, switching from cigarettes to smokeless provides almost all of the health benefits of complete tobacco abstinence.

“Ms. Reynolds repeats Tobacco-Free Kids’ flimsy allegations about children. If Lewis and Clark County health officials have evidence that tobacco manufacturers are marketing to children, these very serious charges should be directed to the Montana State Attorney General. Since the 1998 Master Settlement Agreement, tobacco manufacturers have been prohibited from directly or indirectly targeting children, and many states have an expedited process for policing and enforcing MSA provisions. Otherwise, these represent nothing more than hollow and specious diatribes.

“New smokeless products are for adult smokers, not children. The 8 million Americans who will die from smoking-related illnesses in the next 20 years are now adults who are at least 35 years old. Preventing youth access to tobacco is vitally important but should not be misused to condemn smoking parents and grandparents to premature death.

“Ms. Reynolds describes tobacco manufacturers as ‘devious’ for introducing vastly safer smokeless products, but this is irresponsible. If any other consumer product was as dangerous as cigarettes, society would demand safer alternatives, and it would be scandalous if consumers were denied them. Tobacco prohibitionists wish to do just that.”

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

On June 15 John Doran, Editor at the Independent Record, replied that he would “get [my letter] in as soon as we can.”

Weight! Quit Smoking Without the Gain

2011-06-16T20:19:00.000-04:00

It is well established in the scientific literature that smokers generally weigh less than nonsmokers, and that smokers who quit are at risk for weight gain. A recent article in the journal Science (abstract here) reported that nicotine activates specific nerve cells in the section of the brain called the hypothalamus. This interaction may be responsible for decreased appetite; it is different from nicotine’s trigger of reward and satisfaction in the brain. This complex research was conducted in mice, so the results will need confirmation in human studies. Still, they substantiate two dreaded downsides to quitting smoking: the loss of the powerfully rewarding and satisfying activity, and the gain of unwanted pounds.

We already know that switching from cigarettes to smokeless tobacco keeps smokers satisfied while giving them almost all of the benefits of complete tobacco/nicotine abstinence. But does switching keep the weight off?

In 2004, I published the first and only research article answering this question (abstract here). Along with colleagues from Umeå University in Sweden, I used a World Health Organization dataset to evaluate weight gain among nearly 3,000 men in Northern Sweden.

Weight Gain Over Nine Years Among Men in Northern Sweden
Tobacco Category	Average (lbs)
Nonusers (Referent group)	7.0
Smokers	5.1
Smokers who quit completely	15.0*
Smokers who switched to snus	7.9
Snus users	6.8
Snus users who quit completely	11.2*
*significantly elevated compared with nonusers

The big gainers were smokers and snus users who became completely abstinent from nicotine and tobacco. But snus users and smokers who switched to snus didn’t gain any more weight than nonusers. This is important news for smokers who are concerned about putting on pounds when attempting to quit smoking.

I also noted that the rate of overweight at the start of the study was 32% among those who didn’t use tobacco, 29% among smokers, and 42% for ex-smokers. These percentages are somewhat lower than other reports because our group defined overweight as a body mass index (BMI) of 27 or higher. The standard definition of overweight starts at a BMI of 25. For more information about BMI, go to this website at the federal National Heart Lung and Blood Institute.

Fear of gaining weight should not deter smokers from quitting. Research shows that a switch to smoke-free tobacco can leave them healthier with no added pounds.

The Truth About Federal Warnings on Smokeless Tobacco Products

2011-06-08T13:10:00.000-04:00

Cigarette smokers who are considering a switch to vastly safer smokeless tobacco are confronted with confusing government-ordered warning labels. Most would be surprised to learn that three of the four mandated warnings were fabricated by tobacco prohibitionists and codified into federal legislation in 1986 by a misinformed U.S. Congress. Despite their obvious flaws, the original warnings were re-confirmed in the 2009 Tobacco Act and a fourth was added.

Here are the underlying facts and fallacies related to the four warnings:

1. “This product can cause mouth cancer.” This warning was mandated in 1986, five years after Dr. Deborah Winn egregiously misinformed Americans about the magnitude and scope of mouth cancer risk from smokeless tobacco (discussed previously in this blog here and here). This warning is highly misleading. Contemporary American and Swedish smokeless products confer vanishingly small risk for mouth cancer. Now that the FDA has been given authority over the warnings, I hope the agency will provide comprehensive information about all health risks, as I did in this blog (here and here).

2. “This product can cause gum disease and tooth loss.” In 1986, prohibitionists were desperate to blame smokeless tobacco for causing something besides mouth cancer, but twenty-five years ago there was virtually no scientific evidence that smokeless tobacco was an independent risk factor for any dental problem. The same is true today. A comprehensive review of the subject was published by Kallischnigg and colleagues in BMC Oral Health in 2008 (available here). The risk for all dental problems is either very low or nonexistent among smokeless tobacco users.

3. “This product is not a safe alternative to cigarettes.” The purpose of this 1986 warning was to deceive smokers into believing that smokeless tobacco was just as dangerous as smoking. As I wrote in my 1995 book, For Smokers Only: How Smokeless Tobacco Can Save Your Life (link), this warning “is simply ludicrous…Not even potato chips or nature hikes are ‘safe.’ If we look at ‘safe’ to mean relatively safe or ‘safer,’ something the government warnings inanely avoid here, then use of smokeless tobacco products is far safer than cigarette smoking.”

To apply an absolute standard of safety to any product or activity is preposterous. It’s worse to use this standard to deny smokers access to life-saving smokeless products and information.

4. “Smokeless tobacco is addictive.” This was added in the 2009 legislation, and it’s the only warning with a legitimate scientific rationale. It is entirely appropriate for consumers to be warned that any product containing nicotine is addictive. But the warning also reinforces what switchers already know -- that smokeless tobacco can be a satisfying cigarette substitute precisely because it provides satisfying doses of nicotine.

Congress was misinformed in 1986, when it dictated the mouth-cancer, gum-disease and not-safe warnings for smokeless tobacco. In view of the extensive relative risk data published since then, Congress should have revised the warnings to reflect the facts, rather than just rubber-stamp them in 2009.

The FDA prides itself on being science-driven; that provides some hope that smokeless tobacco warnings will some day be appropriately and accurately revised. In the meantime, the mouth-cancer, gum-disease and not-safe warnings exaggerate and distort the vanishingly small health impact of smokeless tobacco. Medical ethics and principles of public health dictate that smokers and smokeless tobacco users should not be subject to such health-endangering deception.

The True Impact of Snus in Sweden: Smoking Cessation Up, Initiation Down

2011-06-01T11:05:00.000-04:00

It is a widely accepted myth that snus use among men in Sweden has only served as a quit-smoking aid. While my published studies from 2002 to 2005 (described here, here, and here) and many others (here, here, and here) have documented that male smokers in Sweden have used snus as a gateway to a smoke-free life, that is only part of the story.

Snus use has also played a valuable role in steering tobacco initiators away from more dangerous cigarettes. In 2005, I authored a study of tobacco use among Swedish boys and girls age 15-16, which was published in Tobacco Control (here). The results are impressive: “During the period 1989 to 2003, the prevalence of tobacco use [in Sweden] declined both among boys and girls. For boys, regular smoking declined after 1992 from 10% to 4%. Their snus use was about 10% in the 1990s but increased to 13% by 2003. Regular smoking among girls was 20% in early years and declined to 15%. Smoking among girls was always double that among boys. Patterns of occasional tobacco use were similar to those of regular use.”

I also observed that “…specific patterns of tobacco use differ strikingly between Swedish boys and their EU counterparts…In 2002 the World Health Organization reported that the average prevalence of daily smoking among 15 year old boys in 25 European countries (excluding Sweden) was 18%.7. In that report boys in Sweden had the lowest smoking prevalence of all countries (5.7%), at about one third of the EU average. The next highest prevalence was in Greece (9.2%). All other countries reported prevalences from 12% (Wales) to 27% (Lithuania). Thus, high prevalence of snus use by Swedish boys may be a factor in low smoking prevalence.

“In contrast, smoking rates among 15 year old girls in Sweden do not differ from those among girls in other European countries. In the 2002 WHO report smoking prevalence among Swedish girls was the fifth lowest in Europe (14%), but still close to the average for all other countries (19%, range 11% in Greece to 29% in Germany).”

I want to be absolutely clear: I strongly support all measures to keep tobacco away from children. However, a tobacco-free world, for adults and children, is as likely as an alcohol-free world was in 1920 (here). Teenagers will use tobacco, no matter what measures are taken to stop them. The remarkable story from Sweden is that most boys choose snus, the product their fathers use. This fact is well-received by health and policy professionals who understand that snus users lead lives that are virtually indistinguishable (in measures of years and health) from those of their abstinent peers.

Finally, the “Swedish Snus Experience” is not only about men. Recently, more women in Sweden are also using modern snus products (evidence here), which are spit-free and socially acceptable. This may represent the first time in recorded history that women have adopted a healthier behavior – from their husbands.

Tobacco Harm Reduction as the Basis for Tax Policy in Indiana & Kentucky

2011-05-25T13:22:00.000-04:00

On April 29, 2011, Indiana became the second state in the U.S. to officially recognize tobacco harm reduction. Governor Mitch Daniels signed into law HB 1004 (available here), which states: “The Indiana general assembly finds that the tax rate on smokeless tobacco should reflect the relative risk between such products and cigarettes.”

This is a landmark event. It sets the stage for the state to develop a rational excise tax policy for tobacco products -- something I have advocated since 2003. That year, I proposed that smokeless tobacco products and cigarettes should be taxed according to risk, in order to provide an economic incentive for smokers to transition from high risk/high tax cigarettes to very low risk/low tax smokeless products. My commentary was published by newspapers in Tallahassee and Tampa, Florida (here and here and St. Louis (here).

On March 23 of this year, I provided expert testimony at a hearing of the Indiana Senate Committee on Public Policy, which was considering HB 1405, a bill to appropriately classify dissolvable tobacco products. That legislation (here) was also passed by the legislature and signed by the governor. My prepared testimony is available here.

Indiana is the second state to recognize the roles that tobacco harm reduction and tobacco excise tax policy can play in promoting public health. In 2005, the Kentucky General Assembly passed and Governor Ernie Fletcher signed into law a bill recognizing that:

“increasing taxes on tobacco products should reduce consumption, and therefore result in healthier lifestyles for Kentuckians. The relative taxes on tobacco products proposed in this section reflect the growing data from scientific studies suggesting that although smokeless tobacco poses some risks, those health risks are significantly less than the risks posed by other forms of tobacco products. Moreover, the General Assembly acknowledges that some in the public health community recognize that tobacco harm reduction should be a complementary public health strategy regarding tobacco products. Taxing tobacco products according to relative risk is a rational tax policy and may well serve the public health goal of reducing smoking-related mortality and morbidity and lowering health care costs associated with tobacco-related disease.”

The idea of a rational risk-based tobacco tax is clearly gaining momentum in policy circles. Earlier this year, the National Center for Policy Analysis, a nonprofit, nonpartisan public policy research organization, issued a report titled “Taxing Tobacco By Risk.” That document, available on the NCPA website (here), discusses tobacco harm reduction as a basis for tax policy and concludes: “States that wish to pursue a consistent and science-based tobacco harm reduction strategy should examine the way in which they tax tobacco products and the amount of tax levied on these products.”

In 2003, I wrote: “When it comes to taxes there are no easy answers. But a rational tobacco tax strategy based on risk is as compelling as it is innovative, because it allows lawmakers to meet their fiscal responsibility while fulfilling their moral obligation to help smokers who are desperate to quit.”

Indiana and Kentucky have admirably adopted this compelling and innovative strategy; other states will be wise to follow.

Misinformation from the Dana-Farber Cancer Institute and the Massachusetts Dental Society

2011-05-18T12:59:00.000-04:00

The list of prestigious medical organizations that exaggerate and distort the risks of smokeless tobacco is growing longer. On May 12, the Dana-Farber Cancer Institute, “a principal teaching affiliate of the Harvard Medical School and… among the leading cancer research and care centers in the United States,” and the Massachusetts Dental Society, “a 5,000-member professional association… dedicated to improving the oral health of the public in the Commonwealth,” released demonstrably false information about smokeless tobacco risks (article here).

The Dana-Farber article says that these organizations “are partnering to spread the word that chewing tobacco, otherwise known as spit, dip, chew, or smokeless tobacco, is not a safe alternative to smoking.” Using an “absolutely safe” straw-man standard is now standard fare among smokeless prohibitionists.

The most egregious misinformation comes from Dr. David P. Lustbader, an oral surgeon: “Chewing tobacco is the most dangerous form of tobacco because it comes in contact directly with the oral mucosa.” Dr. Lustbader ignores the reams of medical literature irrefutably identifying cigarettes as “the most dangerous” of tobacco products.

Dana-Farber’s Dr. Marshall R. Posner does no better, saying, “Nicotine and the other tars in chewing tobacco change the cells throughout the mouth and tongue and lead to cancer.” First, nicotine does not “lead to cancer.” Second, nicotine is not a “tar.” Third, there are no “tars” in chewing tobacco. What was he smoking?

I emailed the director and associate director of media relations at the Dana-Farber Cancer Institute, detailing the misinformation in the press release and requesting a correction. No response or correction was forthcoming.

Dana-Farber (here) claims to “pursue excellence relentlessly and with integrity in all that we do, adhering always to the highest standards of conduct,” and the Massachusetts Dental Society is dedicated to “promotion of the highest professional standards.” These values are betrayed by the pernicious pronouncements about smokeless tobacco by their purported experts.

National Cancer Institute Funds Camel Snus Quit-Smoking Study

2011-05-11T11:42:00.000-04:00

Opponents of tobacco harm reduction have portrayed that public health strategy as a marginal approach to smoking cessation that is neither legitimate nor credible. Finally, that specious position may be convincingly undermined, by no less an authority than the National Cancer Institute. The NCI is funding a study, based at the Medical University of South Carolina, that will evaluate the impact of Camel Snus in a nationwide randomized clinical trial among 1,250 smokers who are not motivated to quit.

The trial will run for one year, although the grant is active until 2016 (description here); the NCI has provided over $400,000 for the current fiscal year. The research is being directed by Matthew Carpenter, a psychiatrist at MUSC who previously published a pilot study demonstrating that Ariva and Stonewall dissolvable tobacco products are effective cigarette substitutes (described in this blog last January, here).

As with any clinical trial, outcomes will depend on the trial’s design; so far, few details are available. Will participants be provided with accurate information about the vastly lower health risks of Camel Snus? The answer isn’t clear, because the public description of the trial uses ambiguous terms. For example, Carpenter states that “a comprehensive risk profile [for smokeless tobacco] remains unclear”, despite numerous epidemiologic studies documenting minimal risks. In addition, he states, “The tobacco industry has developed a number of novel smokeless tobacco products that are purported to offer reduced health risks as compared to conventional cigarettes.” This implies that “reduced health risks” are unsubstantiated industry allegations; in fact, they are established scientific fact.

Carpenter describes the trial: “A population-based, nationwide sample of smokers will be proactively recruited through established methods, consented to enroll in a telephone-based cessation induction trial, and randomized to either a) provision of Camel Snus, or b) not.”

We don’t know how smokers will be recruited or enrolled, but we do know they will be randomized to receive Camel Snus, or not. While it is routine to offer one “treatment” in a clinical trial, this presents many problems when the outcome is a behavior. How do you study a product that is already available in stores nationwide? Will smokers who don’t receive Camel Snus be denied a product that is 98% safer than cigarettes? Will smokers who receive Camel Snus know its name? Will the products be provided free, or will smokers have to buy them? Which flavor of Camel Snus will be used? What happens if participants prefer another flavor, or prefer another smokeless product?

Previously, Carpenter found that Ariva and Stonewall had great potential as smoking cessation aids, but now only Camel Snus is being tested. If this trial is not a success, it may mean only that smokers are not enamored of Camel Snus.

Despite these questions, this trial is a landmark development for tobacco harm reduction. Its funding by the National Cancer Institute sends an unequivocal message that informing smokers about safer smokeless substitutes is ethical, credible and worthy of serious consideration.

Huffington Post Suppresses Tobacco Truth

2011-05-04T11:17:00.001-04:00

In his Huffington Post blog on April 18, Dr. Glenn Braunstein penned “Chew on This: The Real Dangers of Smokeless Tobacco.” (available here) Dr. Braunstein is professor and chairman of the Department of Medicine at Cedars-Sinai Medical Center in Los Angeles.

The “dangers” he described are demonstrably fictitious. Compounding this offense, Dr. Braunstein subsequently violated HuffPo blog moderating rules by removing my April 19 reasoned and fact-driven comment, which read:

“It is regrettable that Dr. Braunstein used the Huffington Post to misinform Americans about smokeless tobacco.

“Dr. Braunstein: ‘Contrary to popular belief, ingesting [smokeless] tobacco carries risks just as serious and severe as smoking.’ This ignores numerous scientific studies documenting that smokeless tobacco use is 98% safer than smoking. Smokeless does not cause lung cancer, heart disease or emphysema, and the risk for mouth cancer is far lower than with cigarettes. Statistically, smokeless users have about the same risk of dying from mouth cancer as automobile users have of dying in a car wreck.

“Dr. Braunstein goes even further, suggesting that ‘…ingested tobacco may be even more dangerous than cigarettes...’ because of nicotine. This is grossly misleading. All tobacco products have roughly the same nicotine content and produce about the same blood levels. More importantly, nicotine does not cause any smoking-related disease.

“Dr. Braunstein’s comments are at odds with the viewpoint of prominent tobacco research and policy professionals. A group of leading tobacco experts in 2004 concluded: … ‘[smokeless] products pose a substantially lower risk to the user than do conventional cigarettes. This finding raises ethical questions concerning whether it is inappropriate and misleading for government officials or public health experts to characterize smokeless tobacco products as comparably dangerous with cigarette smoking.’

“The established scientific and medical literature on tobacco harm reduction clearly refutes the major objections raised by Dr. Braunstein concerning modern smoke-free tobacco products.”

My comment appeared just long enough on HuffPo to elicit a supporting comment from another reader: “I agree with Dr. Rodu. I'd like to see Dr. Braunstein's reponse to Dr. Rodu's points, though we probably won't. As a dentist, I encourage those who use smokeless to quit, but not by giving them false information. The information in this article is very very misleading.”

According to Dr. Braunstein’s HuffPo biography, he is an endocrinologist with an interest in the treatment of thyroid cancer and in male and female reproductive endocrinology; he has no apparent expertise in tobacco issues. His blog entry on the subject closely aligns with smokeless tobacco misinformation issued in the past by the leading tobacco-prohibitionist organizations (Campaign for Tobacco Free Kids and others).

HuffPo says on its site that its mission is “to promote an open and transparent conversation.” But allowing Dr. Braunstein to erase a fair and factual rejoinder to his unfounded remarks violates that tenet, and disserves the public interest.

Kudos to the FDA: E-Cigarettes Are Tobacco Products

2011-04-26T15:57:00.002-04:00

On April 25, the FDA abandoned its claim that e-cigarettes are drug delivery devices. In an open letter published on the agency’s website (here), Tobacco Center Director Lawrence Deyton and Drug Center Director Janet Woodcock acknowledged that e-cigarettes are tobacco products and would be subject to regulations under the 2009 Tobacco Act. This is consistent with the January 2010 decision by federal judge Richard Leon (discussed here).

This is a victory on several counts for smokers and for our nation’s public health. First, the FDA decision guarantees that e-cigarettes, which have helped many smokers quit, will remain on the market.

Second, as the Deyton-Woodcock letter indicates, FDA regulation of e-cigarettes will subject them “to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for ‘new tobacco products’ and ‘modified risk tobacco products.’” These requirements will promote the marketing of safe and quality-controlled products.

Finally, this decision could allow pharmaceutical companies to reposition nicotine medicines as recreational alternatives to cigarettes. Today, these products are sold with a therapeutic claim for smoking cessation, but they are expensive, unsatisfying and FDA-approved only for temporary use (10-12 weeks). That accounts for their dismal success rate of only seven percent among smokers (evidence here). I believe pharmaceutical companies should enter the recreational nicotine market with products that satisfy smokers indefinitely and are cheap enough to compete directly with cigarettes. Clearly, the tobacco industry is poised to compete in this new market -- Reynolds American owns Niconovum (here) and British American Tobacco recently formed Nicoventures (here).

In my 1995 book “For Smokers Only” (description here), I shared my perspective on recreational nicotine smokers:

“Smokers derive a lot of pleasure from smoking tobacco. You may be reading this book because you or your loved one actually enjoys lighting up a cigarette and taking several deep puffs. A smoke may be especially welcome when you are in a stressful situation or when you need to relax. Or you may enjoy smoking when you need to concentrate on a difficult problem at work or at home. Cigarette smoking can activate that mental pressure-relief valve, which is followed by the feeling that the problem can be solved, the crisis will pass. These feelings are real, and not just a figment of your imagination.

“Many tobacco opponents claim that these sensations are not truly pleasurable, but are merely the satisfying of induced cravings and avoidance of withdrawal symptoms. One of the big advantages of the smokeless tobacco solution is that it addresses either view of smoking equally well. That is, it doesn't matter if you are a smoker who is unwilling to quit because you enjoy tobacco, or if you are unable to quit because of nicotine craving and withdrawal. Because in either case you recognize the potential life-shortening effects of this nicotine delivery system. In either case the smokeless tobacco solution can work for you.”

Smoking has been the problem; smoke-free tobacco and nicotine can be the solution. In making the right call on e-cigarettes, the FDA has facilitated that solution.

Nicotine Delivery and Satisfaction: Snus is Superior

2011-04-20T19:59:00.000-04:00

In a small, but impressive, clinical study just published in Nicotine & Tobacco Research, Drs. Erik Lunell and Margareta Curvall demonstrate that snus is a superior substitute for delivering satisfying nicotine doses to smokers (abstract here). Dr. Curvall is a scientist employed by Swedish Match.

Lunell and Curvall recruited 15 smokers (9 men, 6 women) who had never used snus or nicotine gum to use two snus 1-gram snus products (in packets) and 4-milligram nicotine gum during three visits to a clinic in Helsingborg, Sweden. The subjects abstained from smoking for 12 hours the night before each visit.

The researchers measured the amount of nicotine in the used products and found that a higher proportion was extracted from the gum than from the snus products. This is understandable, because the gum was chewed, while the snus was simply placed under the upper lip. Nevertheless, blood nicotine levels from snus were higher after 30 minutes than those from the gum, and the increases were also faster for snus. The snus products took less time than the gum to deliver the maximum nicotine level (37 versus 46 minutes), but the differences were not statistically significant.

The most important finding was that the snus products had higher subjective scores than the gum for overall “product strength” (also referred to as “head rush”, “buzz” or “hit”). This means that the snus products were more enjoyable than the gum, even though all products reduced the craving or urge to smoke to about the same extent. Another interesting finding is that snus resulted in significantly less mouth and throat burn than the gum five minutes after use.

Lunell and Curvall concluded “that Swedish snus produces a higher maximum blood nicotine concentration, in shorter time and with a quicker onset of ‘head rush’ in smokers naïve to snus, compared with the 4 mg [nicotine] chewing gum in spite of a smaller ingested dose…The quicker onset of ‘head rush’ and supposedly higher satisfaction from snus may partly explain the widespread use of snus in Sweden in attempts to stop smoking.”

This study is additional proof that smokeless satisfies smokers.

Smoking Gun: Manipulating Definitions

2011-04-12T16:28:00.000-04:00

A report just published in Nicotine & Tobacco Research (abstract here) draws an obvious conclusion: How surveys define cigarette smokers and smokeless tobacco users influences the prevalence rate of dual use (consumption of both products).

Robert Klesges and colleagues used information obtained from Air Force recruits to show that if dual users are defined as using both products daily (a narrow definition), prevalence of dual use will be low. However, if dual users are defined as using either product once in the past month (a broader definition), prevalence of dual use will be high.

It is not surprising that Dr. Klesges found that defining tobacco use influences survey results. In 2001, he co-authored a study (with first-author C. Keith Haddock, abstract here; hereafter called Haddock-2001) that perfectly demonstrates how definitions can be manipulated to produce desirable results. Haddock-2001 purported to show that smokeless tobacco use is a gateway to smoking among Air Force recruits; it has been widely cited in American prohibitionist attacks on smokeless tobacco. In fact, its results are based on manipulation of definitions.

Haddock-2001 studied 14,340 men (average age, about 20 years) who had never smoked when they reported to Air Force basic training in 1995 and 1996. After one year, Dr. Haddock followed up with 7,865 subjects, finding that 1,099 of them were smoking. That’s a 14% smoking initiation rate among 20-year old men after one year in the Air Force! At one year, Haddock-2001 also found that, compared with recruits who had never used tobacco before basic training, recruits who were current smokeless users were 2.33 (95% Confidence interval = 1.84 – 2.94) times more likely to be smoking.

First, how did 14% of first-year never-smoking Air Force recruits start smoking? It turns out that this number is grossly inflated. In 1999, Drs. Klesges and Haddock had published a study of these same recruits (abstract here; hereafter called Klesges-1999), in which they reported that only 8% of never smokers had started to smoke after one year in the Air Force.

The discrepancy between Haddock-2001 and Klesges-1999 is due to differences in the category definitions of smoking, summarized in this table.

Different Definitions of Smokers in Klesges-1999 and Haddock-2001
Category	Klesges-1999	Haddock-2001(%)

At Enrollment

Never Smoker	Never smoked a cigarette	Never Smoked regularly

Experimental Smoker	Smoked on one or two occasions, never regularly	Not mentioned
Ex-smoker	Smoked regularly, but quit	Smoked regularly, but quit
Current Smoker	Smoked regularly, at least one cigarette per day	Smoked regularly, at least one cigarette per day

At One Year

Current Smoker	Smoked even a puff in last 7 days	Smoked even a puff in last 7 days

At enrollment, Klesges-1999 identified a group of “experimental smokers,” 26% of whom became smokers at the one-year follow-up. But Haddock-2001 never mentioned experimental smokers, which means that they were in the “never-smoking” group at enrollment; that significantly accounts for the 14% initiation rate, instead of the 8% rate found in the Klesges-1999 report.

It is likely that many Haddock-2001 smokeless tobacco users were also experimental smokers. The only apparent reason to eliminate the experimental smoker category and effectively shift those subjects to the never-smoking category was to bolster the case for labeling smokeless tobacco use as a gateway to smoking.

Dr. Haddock also defined current smoking differently at enrollment than after one year of follow-up. Good practice in scientific investigation is to establish definitions and stick with them throughout a research project. As the table shows, Haddock-2001 defined a current smoker at enrollment as smoking at least one cigarette per day, but then defined a current smoker at one-year as someone who smoked even a puff in the last 7 days.

The manipulation of smoking definitions in Haddock-2001 casts considerable doubt on its claim that smokeless tobacco use is a gateway to smoking.

American Cancer Society Withholds Important Information About Tobacco Use and Risk

2011-04-06T10:18:00.000-04:00

Last week, I discussed how the American Cancer Society (ACS) misinforms Americans about the risks of smokeless tobacco use (here). The ACS is also withholding important information that has profound implications for FDA regulation of smokeless tobacco.

I wrote to ACS president John Seffrin in September 2010, asking the organization “to fully and publicly disclose important information from its Cancer Prevention Study II (CPS-II) regarding the health risks associated with tobacco use. Notwithstanding the fact that this information has been in the possession of the ACS for years, it has not been made public. The tobacco regulatory and research community, as well as the American public, need access to this information in order to validate significant differences in the health risks associated with smokeless tobacco use compared with smoking in the U.S.”

I noted that the ACS has released highly selective bits of information about smoking and smokeless tobacco use:

“The ACS has provided the Centers for Disease Control and Prevention (CDC) with risk estimates for cigarette smokers, which are derived from a 6-year follow-up of CPS-II. For many years the CDC has used these risks to estimate that smoking kills 400,000 Americans every year. Although these estimates serve as the cornerstone for federal government actions regarding smoking, there is no way to validate them, because the ACS has never published the risks or released the CPS-II data on which they are based.

“In addition to smoker risk estimates, the ACS must release complete risk estimates for smokeless tobacco users and smokers who switched to smokeless tobacco. Previous ACS releases have been highly selective and incomplete, and none are directly comparable because the ACS used different follow-up intervals. As I noted, the ACS provided unpublished risk estimates derived from a 6-year follow-up of CPS-II for smokers. For smokeless tobacco users, ACS investigators have published risk estimates using an 18-year follow-up of CPS-II; for switchers, ACS and CDC investigators have together published risk estimates using a 20-year follow-up.”

I explained why this information was important for FDA regulation:

“There are compelling reasons why the ACS should release this information. Officials at the U.S. Food and Drug Administration (FDA), which now has regulatory authority over tobacco products, may not be aware that the health risks from smokeless tobacco use are vastly lower than those from smoking. Earlier this year, Lawrence Deyton, director of the FDA Center for Tobacco Products, Principal Deputy Commissioner Joshua Sharfstein and Commissioner Margaret Hamburg authored a commentary about tobacco regulation for the New England Journal of Medicine, in which smoking and tobacco use were used synonymously. These physicians wrote that ‘tobacco use causes more than 400,000 deaths in the United States annually…,’ and they described ‘tobacco products’ as ‘the leading cause of preventable death in the United States.’ If the ACS and the FDA are committed to reducing the morbidity and mortality from tobacco use, the first critical step must be to recognize that all forms of tobacco use are not equally risky. That critical issue was overlooked in the New England Journal of Medicine commentary.

“When FDA officials characterize all tobacco products as equally lethal, they are effectively denying smokers lifesaving information about safer cigarette substitutes. A 2004 study, in which ACS Vice President Emeritus Michael J. Thun participated, concluded that ‘…smokeless tobacco products pose a substantially lower risk to the user than do conventional cigarettes. This finding raises ethical questions concerning whether it is inappropriate and misleading for government officials or public health experts to characterize smokeless tobacco products as comparably dangerous with cigarette smoking.’ ”

I strongly urged the ACS to end its misinformation campaign by releasing ALL of its risk data:

“The public health is not well served when information that can save lives is buried and/or ignored. The selective and incomplete provision of risk information by the ACS is contrary to its public health mission and will only serve to hamper the FDA from undertaking an independent assessment of this issue in pursuit of its overarching mission: reducing the harm associated with tobacco use.

“I urge the ACS to release comparable risk estimates for male smokers, smokeless tobacco users and switchers in CPS-II for all three follow-up periods, 6-years, 18-years and 20-years. In addition, the ACS should release the CPS-II data, so that the risk estimates for all tobacco users can be validated by external scientists. I would be happy to meet with ACS officials to discuss this request.

“Dr. Deyton has confirmed that the FDA’s ‘objective is to use the best available science to develop and put into action effective public health strategies to reduce the enormous toll of illness and death caused by tobacco products.’ I strongly urge you to release these data and risk estimates, which constitute the best available science distinguishing the health risks related to smoking from those related to smokeless tobacco use. Because this matter has implications for future regulatory actions by the FDA, I have sent copies of this letter to relevant FDA officials.”

The ACS response was written by Chief Medical Officer Otis W. Brawley on December 1, 2010. He explained why the ACS would not share its data:

“[The ACS] have not found it productive to share the CPS-II data with researchers supported by the tobacco industry, because of their repeated misuse and misrepresentation of the data.”

I have conducted research on tobacco harm reduction for almost 20 years; published numerous studies in professional journals; written dozens of articles in the general media; and given hundreds of lectures. No one has ever accused me of misusing or misrepresenting any data.

The ACS continues to misinform Americans, and especially American smokers, about the vast difference in health risks related to smoking versus smokeless tobacco use. This is vitally important because the CPS-II survey is the only source for comparable information about the health risks from smoking and smokeless tobacco use.

FDA regulation of tobacco should not compromised by the withholding or selective release of critical data by the American Cancer Society.

More Misinformation About Smokeless Tobacco From the American Cancer Society

2011-03-30T13:17:00.000-04:00

American Cancer Society (ACS) investigators have just published results of a study on alcohol consumption and the development of pancreas cancer in the Archives of Internal Medicine (abstract here). Led by Susan M. Gapstur, the study found that, compared with never alcohol drinkers, consumers of three or more drinks per day had an elevated risk of pancreas cancer mortality. The higher risk was statistically significant for never smokers (Relative risk, RR = 1.36, 95% Confidence Interval, CI = 1.13 – 1.62) and for ever smokers (RR = 1.16, CI = 1.06 – 1.27). They did not detect higher risks for beer or wine drinkers, but only for consumption of liquor.

The article discussed the public health implications of the research:

“Alcoholic beverage consumption—a modifiable lifestyle factor—is causally related to several cancers, including oral cavity, pharynx, larynx, esophagus, liver, colorectum, and female breast. Findings from the prospective study presented herein strongly support the hypothesis that alcohol consumption, in particular heavy intake, also is an independent risk factor for pancreatic cancer, the fourth most common cause of cancer mortality in the United States. These results underscore the importance of adhering to the following guideline for cancer prevention by the American Cancer Society: ‘If you drink alcoholic beverages, limit consumption.’”

Thus, while the ACS acknowledges that alcohol is associated with considerable cancer risks, its advice to consumers emphasizes moderation. Historically, moderation has played no role in ACS messages to tobacco users: quit now and abstain completely and permanently.

The ACS web page on smokeless tobacco (available here) was revised on December 16, 2010; it is replete with misinformation, especially about cancer risks. Following are the cancers that the ACS claims, with no supporting data, are caused by smokeless tobacco use, followed by the actual scientific evidence derived from the most comprehensive study ever published (read about it here).

American Cancer Society Claim	Actual Scientific Evidence
Mouth, tongue and throat cancer	Not significantly elevated, RR = 1.07 (CI = 0.84-1.37)
Esophagus cancer	Not significantly elevated, RR = 1.13 (CI = 0.95-1.36)
Stomach cancer	Not significantly elevated, RR = 1.03 (CI = 0.88-1.20)
Pancreatic Cancer	Not significantly elevated, RR = 1.07 (CI = 0.71-1.60)

RR = Relative Risk.

Scientific evidence shows clearly that smokeless tobacco use only slightly elevates cancer risks, if at all. The reported elevations are so small that they are not statistically significant; in other words, they may have occurred purely by chance. It is also important to point out that small RRs (those under 2) should not be seen as reliable. The National Cancer Institute advises: “Relative risks or odds ratios less than 2 are viewed with caution,” because they “are sometimes difficult to interpret.”

Next week I will discuss ACS intransigence with respect to refusing to provide information in its possession about the health risks related to tobacco use.

The Price of Prohibition: Illicit Tobacco Trade

2011-03-22T19:38:00.000-04:00

I recently discussed Tacit Incremental Prohibition – Tobacco Elimination, or TIP-TOE (here). A new report from the United States Government Accountability Office (GAO) provides important lessons about how prohibitive policies have created a thriving illicit tobacco industry (read the report here).

The report highlights New York City, where the cost of a pack of name-brand cigarettes is a prohibitive $13.00. Here is a breakout of where that money goes:

Cigarettes at $13 Per Pack: Where the Money Goes
Who	How Much ($)	Percent (%)
Manufacturers	4.91	38
Tobacco Farmers	0.06	< 1
States (Master Settlement)	0.56	4
Local Govt. (Sales Tax)	0.61	5
Local Govt. (Excise Tax)	1.50	12
State Govt. (Excise Tax)	4.35	33
Federal Govt	1.01	8

Manufacturers, who produce, package, ship and market the cigarettes, get 38% of the purchase price. Everyone else, including local, state and federal governments, get the lion’s share. New York taxes are so high, compared to those in other states, that they have spawned a major, lucrative illicit cigarette industry. GAO breaks out the key elements:

1. Smuggling genuine and counterfeit cigarettes from foreign countries to the U.S. For example, in January the Customs and Border Protection announced that more than 22,000 cartons of counterfeit Marlboros were intercepted at the Los Angeles/Long Beach seaport complex after being shipped from China (story here).

2. Unlicensed manufacturers, located in northern New York on land controlled by the St. Regis Mohawk tribe, can produce a carton of cigarettes that sells for $20 in New York. This region is also the source for the contraband cigarettes that comprise half of all consumption in Ontario and 40% in Quebec (article here). A recent article describes the impact of illicit cigarette sales throughout Canada (here).

3. Diverting cigarettes during distribution and retail to avoid local and state taxes. “According to federal and state law enforcement officials, there are many different types of diversion schemes at the wholesale and distribution level of the supply chain. [Alcohol, Tobacco and Firearms] officials stated that criminal organizations may purchase state excise tax-paid cigarettes from wholesalers in a state with low state excise taxes, like Virginia, and illegally transport those cigarettes for resale in a state with higher excise taxes, like New York, to capitalize on state excise tax differentials.” The GAO reports that just one carton (10 packs) of cigarettes travelling from Richmond, VA to New York City will avoid $55.50 in taxes.

We can only guess at the huge scale of economic activity related to contraband cigarettes. Every so often, authorities announce a large seizure, such as one on March 8 at the Ontario-Quebec border involving six million cigarettes (here).

Excessively high taxes are irrational and counter-productive. New York should follow Kentucky’s rational risk-based tobacco tax policy, enacted in 2005, which bases excise taxes for cigarettes and smokeless tobacco products on differential risks. It recognizes that “[t]he relative taxes on tobacco products…reflect the growing data from scientific studies suggesting that although smokeless tobacco poses some risks, those health risks are significantly less than the risks posed by [cigarettes]…Taxing tobacco products according to relative risk is a rational tax policy and may well serve the public health goal of reducing smoking-related mortality and morbidity and lowering health care costs associated with tobacco-related disease.”

Chemical Analysis of Camel Dissolvables Reveals Tobacco, Flavors and Sweeteners

2011-03-16T13:20:00.000-04:00

In 2009, R.J. Reynolds test-marketed dissolvable tobacco products in Indianapolis. Chemists at Indiana University-Purdue University Indianapolis, led by Christina Rainey, have just published the results of an extensive chemical analysis of Camel Orbs, Sticks and Strips in the Journal of Agricultural and Food Chemistry (abstract here).

Using several extraction methods, Rainey et al. documented that Camel Orbs, Sticks and Strips contain tobacco, flavors and sweeteners:

1. Tobacco: Measuring the nicotine content of the products, the researchers findings were similar to those reported in Reynolds’ product literature: 1 mg. per Orb, 3.1 mg. per Stick and 0.6 mg. per Strip.

2. Flavors: Rainey et al. found menthol, ethyl citrate, cinnamaldehyde, coumarin, vanillin and carvone. Readers will immediately recognize menthol, cinnamon and vanilla flavors. Carvone is a flavor component of spearmint, caraway and dill, so it also has a long history of use in foods (more here). Ethyl citrate is a derivative of citric acid (lemons and limes); it is a food additive.

Rainey et al. claim that “coumarin is a harmful ingredient and causes liver damage in rodents…and has been banned as a flavor additive to food.” This statement is misleading, as it implies that coumarin is a dangerous chemical that has been added to the dissolvables.

It is true that coumarin is toxic to the liver of rats, but this is due to the fact that rats process this agent via an enzyme system that humans lack. Extrapolating rat liver damage to humans is specious.

It is true that the FDA prohibits adding coumarin to human food (here). Why was it found in Camel dissolvables? It is well known that coumarin is present in some varieties of cinnamon; Rainey et al. found coumarin only in an Orb flavored with cinnamon (more information about coumarin is available here). In 2008, scientists from Germany found coumarin in bakery products and breakfast cereals flavored with cinnamon (here). Should Orbs be considered as dangerous as cinnamon buns and breakfast cereal?

3. Sweeteners: Xylitol and/or sorbitol, non-caloric sweeteners used in many products, were found in all three Camel dissolvables.

4. Others: Rainey et al. note that Orbs contain palmitic and stearic acid, food-grade additives that probably aid in the physical properties of the product (e.g., shape and texture). Strips contain glycerin, a food additive that helps products retain moisture.

In summary, smokers who switch to Camel Dissolvables are consuming smoke-free tobacco products that are consistent with government standards for human foods.

Tacit Incremental Prohibition - Tobacco Elimination (TIP-TOE)

2011-03-09T11:03:00.002-05:00

Outright prohibition of psychoactive substances has proven futile, time and again. The disastrous consequences of U.S. prohibition of alcohol (1920 to 1933) and marijuana (ongoing) are well documented (examples here and here). Zealous prohibitionists have now targeted nicotine, using a strategy I call Tacit Incremental Prohibition - Tobacco Elimination, or TIP-TOE. Their aim is to employ an escalating series of legislative and regulatory controls in order, over time, to remove all tobacco products from the marketplace.

TIP-TOE has been promoted by a cadre of individuals using the cover of reputable organizations, including the Mayo Clinic (here), the American Cancer Society (here), the American Heart Association (here), the federal Centers for Disease Control (here) and the National Cancer Institute (here). The principals believe that a world without nicotine is both desirable and achievable, yet they are not courageous enough to demand outright prohibition. Instead, they’ve implemented the subtle TIP-TOE strategy of chipping away at consumer rights and industry initiatives. Several elements of their campaign were in view in recent weeks.

On February 15, Senators Frank Lautenberg (D, NJ) and Dick Durbin (D, IL) urged Major League Baseball commissioner Bud Selig and players’ association director Michael Weiner to ban smokeless tobacco in their sport. At the obvious prodding of TIP-TOE advocates, the senators pressed for a “solution” to a “problem” that doesn’t exist, as I discussed in a previous blog entry (here).

Another TIP-TOE initiative is the move to ban flavored tobacco products, an issue I addressed over a year ago (here). A bill in the Washington legislature (HB 1246, here) would ban flavored smokeless tobacco products and all dissolvable products. A Utah bill (HB 170, here) would ban flavored smokeless tobacco products and electronic cigarettes.

These TIP-TOE bills are especially egregious. They would ban tobacco products that are almost risk-free, while assuring continued market dominance by vastly more hazardous cigarettes.

Using TIP-TOE tactics, tobacco prohibitionists are sprinting toward a public health disaster.

Unbalanced FDA Guidance on Substantial Equivalence

2011-03-02T11:22:00.001-05:00

On January 5, the FDA issued “guidance” concerning an important provision of the Tobacco Act – the demonstration of substantial equivalence for tobacco products. This post will explain why the provision might result in a regulatory nightmare for tobacco harm reduction by threatening existing smokeless products and completely inhibiting new-product innovation. Intrepid readers might wish to read the entire 17-page document (here).

According to the Act, any tobacco product in the American market on February 15, 2007 – a seemingly arbitrary date – is not subject to FDA review. For any product that was changed or introduced between February 15, 2007, and March 22, 2011, manufacturers are required to submit a 905(j) report by March 22, assuring the FDA that the product is “substantially equivalent” to a predicate product that was on the market February 15, 2007.

What information does the FDA require in 905(j) reports? Under normal circumstances, a federal agency would interpret legislation by formulating proposed regulations, submitting them for public comment, and eventually publishing final regulations. However, because the FDA is under pressure to get this equivalence provision into place, the agency issued a guidance document which says, “In the future, FDA intends to initiate a rulemaking that would establish requirements and standards for substantial equivalence.” For now, the guidance only “provides recommendations on the form and content of section 905(j) reports.”

According to the FDA, “guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.” (emphasis in original)

The FDA “suggests” that manufacturers submit a vast amount of information in 905(j) reports, including side-by-side comparisons of each new product with its predicate with respect to:

1. Ingredients and their levels

2. Design features and other materials; description of the heating source and composition (these mostly apply to cigarettes)

3. Harmful and potentially harmful constituents. The Tobacco Products Scientific Advisory Committee has started to develop this list of over 100 agents (see this document).

In addition to these basic requirements, manufacturers may need to submit “additional data.” The FDA guidance elements for additional information relating to consumer perception, clinical, abuse liability and toxicology data are so sweeping that I include them verbatim:

4. “Consumer Perception Studies - data comparing consumer perceptions with respect to the new tobacco product and the predicate that could affect initiation, cessation, frequency of use, patterns of use, smoking behavior, and perceptions of harm or addictiveness.”

5. “Clinical data - data comparing the biomarkers of exposure and biomarkers of potential harm and human toxicity of the new tobacco product as compared to the predicate tobacco product …Your report should include a summary of all studies conducted. In addition, your pivotal studies should be submitted and include: final approved study protocols, statistical analysis plans, any modifications to the study(ies), raw data, analysis platforms, and full reports.”

6. “Abuse liability data - data comparing the abuse liability of the new tobacco product to the predicate tobacco product ... Abuse liability can be assessed by a battery of studies, such as animal models of conditioned place preference, drug discrimination and self-administration, and human behavioral pharmacology studies that assess self-administration and subjective effects of the new tobacco product.”

7. “Toxicology data - data comparing the toxicity of the new tobacco product to the predicate tobacco product ... Comparisons between the new tobacco product and the predicate tobacco product can be assessed by a battery of studies, including nonclinical studies such as in vitro and in vivo mutagenicity and clastogenicity studies, general toxicology studies that include hematological, clinical chemistry, and histopathological endpoints, toxicology studies designed to specifically address cardiac, respiratory, and reproductive/developmental toxicity and studies to assess the carcinogenic potential.”

If you have read this far, you may suspect that the agency is pursuing an anti-tobacco agenda. Even if the FDA’s “guidance” is not binding or “legally enforceable,” the agency’s “current thinking” on this issue is clear: Require tobacco manufacturers to spend millions of dollars to keep their existing tobacco products on the market, and prevent the introduction of new products. If the FDA upgrades its guidance to binding regulations, it could strangle the tobacco industry. It would not be surprising if most U.S. cigarette and smokeless products have been altered in some manner since February 15, 2007; any such changes would subject their manufacturers to the onerous new data-production regulations.

Will consumers be any safer for all the corporate and government expense? Will such sweeping regulations dissuade companies from attempting to introduce new and safer smokeless tobacco products?

Last week, R.J. Reynolds and Altria made separate announcements about test markets of dissolvable tobacco products (here). Reynolds announced it will resume test markets in Denver and Charlotte of Camel Orbs, Strips and Sticks, products that had been tested in Columbus, Indianapolis and Portland, Oregon, in 2009-2010. In March, Altria will introduce in Kansas Marlboro and Skoal Smokeless Tobacco Sticks, which are 2.5-inch-long wooden sticks coated with finely milled tobacco.

These are exciting developments, demonstrating that cigarette manufacturers are committed to offering smokers vastly safer smoke-free options. It would be a public health tragedy if the FDA used equivalence criteria to deny smokers these products, thus assuring the continued market dominance of deadly cigarettes.

Terrific News From Tobacco Retail Inspections in Indiana and Mississippi

2011-02-23T15:19:00.001-05:00

Last week the Indiana Tobacco Retailers Inspection Program announced that 96% of tobacco retailers in the state were compliant with laws restricting tobacco products to minors (story here). This is the highest compliance rate since the program’s inception in 2000, when the rate was 59%.

Indiana’s outstanding results are similar to those from FDA compliance checks in Mississippi, announced in early January by the agency (here). Of the 493 Mississippi tobacco retailers that were inspected, only 25 had violations. In other words, 95% of stores in that state are not selling tobacco to minors. This compliance rate is much higher than even a few years ago. To the agency’s credit, FDA issued stern warning letters to the remaining violators.

I have been critical in the past of FDA Center for Tobacco Products actions (here, here and here), but these are positive developments. Point-of-sale is a legitimate place for enforcement actions by state and federal agencies. The FDA indicates that it will expand the compliance checks to all 50 states during the upcoming fiscal year.

Still, these actions will have little impact on major suppliers of tobacco to underage users -- adult friends or relatives who legally purchase tobacco products and then provide them to teens. According to a study published in 2004, (abstract here), 65% of teen smokers obtained cigarettes in just that way. That is probably why the 2010 Monitoring the Future Survey found that 75% of 10th graders reported that it was "fairly easy" or "very easy" to get cigarettes.

Stopping underage access to tobacco is a critical national priority, but non-compliant retailers are no longer a significant source for teenagers. This key fact invalidates the allegation by Matt Myers and other zealots that tobacco manufacturers are targeting kids with harm reduction products like dissolvables (here). The allegation is fatuous if children don’t have access to tobacco products.

Misrepresentation of Snus Use in Karolinska Institute Studies

2011-02-15T14:10:00.000-05:00

As I documented in a previous blog entry, Karolinska Institute (KI) studies on the health effects of snus use have profoundly influenced regulatory action worldwide, but those studies are compromised by important, troubling and unresolved discrepancies. Following is evidence that KI investigators misrepresented snus use among the revolving-door cohort in multiple journal articles.

From 1971 to 1974, 135,000 Swedish construction workers were enrolled in a health program that served as the basis for epidemiologic follow-up studies investigating associations between many risk factors and diseases. The first report, claiming that snus use had risks for cardiovascular diseases, was published by Gunilla Bolinder (abstract here); subsequent studies variously included and excluded this group, prompting me to label it the “Bolinder Revolving-Door” cohort (here).

There are many other problems with the KI studies that are technical in nature, but one deserves special mention because it is so basic and egregious. It involves the definition of snus use.

When conducting epidemiologic research, it is critically important to classify subjects according to current or former exposure to a risk factor; there are often large differences in risk in these groups. For example, current smokers have higher risks for heart attacks than former smokers. Sometimes, researchers don’t collect information on current and former use, in which case they designate subjects as “ever-users” and “never-users.” The ever-never classification is not nearly as informative as current-former-never classification.

In her 1994 publication, Dr. Bolinder clearly stated that she investigated cardiovascular diseases among “present” (i.e., current) snuff users. Keep in mind that Bolinder’s cohort probably had “former” users of snus, but she didn’t mention them.

Now, fast-forward to 2007, when Maria-Pia Hergens published a study of snus use and heart attack among construction workers (abstract here). As I mentioned previously, Hergens excluded the Bolinder cohort, and this was her reason: “During the period 1971–1974 exposure information on snuff use was limited to ever or never use.” (emphasis added)

Thus, Bolinder claimed that she studied “present” (i.e., current) snus users in her cohort, but in 2007 Hergens said the only information available in the Bolinder cohort was ever or never use. To make matters more interesting, Gunilla Bolinder was a co-author on Hergens’ publication.

Did the Bolinder Revolving-Door Cohort have current snus users or ever snus users? The Bolinder and Hergens-Bolinder descriptions of snus use are not only conflicting but irreconcilable; one of them is a gross misrepresentation.

Last year, I described a 30-year misinformation campaign in the United States, almost entirely based on Dr. Deborah Winn’s misrepresentation of dry powdered snuff in her influential 1981 New England Journal of Medicine report (my entry here). Winn exaggerated and conflated the risks of a rarely used smokeless product (dry powdered snuff), and attached those risks to popular chewing tobacco and moist snuff products, which have virtually no risks (evidence here).

The credibility of the KI studies is contingent on the resolution of their many significant discrepancies. It would be a public health travesty if the KI misrepresentation persisted as the basis for a Winn-style misinformation campaign in Sweden and throughout the world.

The Revolving-Door Cohort at the Karolinska Institute

2011-02-09T13:29:00.000-05:00

The Karolinska Institute (KI) in Stockholm is Sweden’s premier medical research institution, and among the most well known and respected in the world. For several years a group of researchers in the KI’s Department of Medical Epidemiology and Biostatistics has published numerous studies of the health risks related to snus use.

As I stated in a recent commentary published in Sweden (link here), “the health risks identified in the KI studies are the raison d’être for the ban on snus in the E.U. (except Sweden), but it has also had a profound impact on tobacco regulation in the U.S. and other countries,” making access to snus difficult or impossible.

The KI studies have profoundly influenced regulatory actions all over the world, but they are compromised by important, troubling and unresolved discrepancies that KI researchers have refused to address. This post describes the biggest problem in detail.

The KI studies are based on over 300,000 male Swedish construction workers who enrolled in a health program from 1971 to 1992, including roughly 135,000 workers who were enrolled in the program during the 1971-1974 period. This group is important, because there are potentially serious questions about the adequacy of tobacco use information for these workers. In fact, the information is so questionable that KI researchers have included and excluded them in a revolving door fashion in published analyses over the last several years.

The story goes back to 1994, when KI investigator Gunilla Bolinder and colleagues reported that snus use was a risk factor for cardiovascular diseases. (abstract here). In that study Dr. Bolinder studied only the construction workers from the 1971-74 group (hereafter, the “Bolinder” cohort). That report, one of only a few linking snus use with heart disease and stroke, had some obvious but inexplicable technical problems, which I raised in a 1995 letter to the editor of the journal (here). Dr. Bolinder did not resolve these problems.

Fast-forward 13 years to 2007, when KI investigators Luo et al. published a high profile study in The Lancet finding that snus use was a risk factor for pancreas cancer (here). In their analysis, Luo et al. excluded ALL of the workers in the Bolinder cohort “because of ambiguities in the coding of smoking status” of participants. In other words, Luo tossed out the 135,000 workers of the Bolinder cohort. The justification for these exclusions was an “unpublished” observation by Zendehdel, another KI investigator.

I published a letter to the editor of The Lancet (here) observing that, if the Bolinder cohort was deficient, then the validity of the Bolinder study was suspect. Luo et al. responded that perhaps the exclusions were not warranted (here), citing a KI study that was about to be published. That study, which found that snus use was associated with esophageal and stomach cancer, included the Bolinder cohort (here). The lead author on that study was Zendehdel.

Confusing? Absolutely. First, KI researchers cited Zendehdel as the justification for excluding the Bolinder cohort, but then Zendehdel included the Bolinder cohort in his published study.

To illustrate how many times KI researchers have subjected the Bolinder cohort to revolving door treatment, here is a list of publications.

The Bolinder Revolving Door Cohort At the Karolinska Institute
Year	First Author	Journal	Disease	Bolinder Cohort In/Out
1994	Bolinder	American Journal of Public Health	Cardiovascular	In
2005	Odenbro	British Journal of Cancer	Skin cancer	In
2007	Luo	Lancet	Pancreas cancer	Out
2007	Odenbro	British Journal of Dermatology	Melanoma	In
2007	Fernberg	Cancer Research	Leukemia	In
2007	Hergens	Journal of Internal Medicine	Heart attack	Out
2008	Zendehdel	International Journal of Cancer	Gastrointestinal cancer	In
2008	Hergens	Epidemiology	Stroke	Out
2008	Hergens	Journal of Internal Medicine	Hypertension	Out
2010	Carlens	American Journal of Respiratory and Critical Care Medicine	Inflammatory Diseases	Out
2011	Nordenvall	International Journal of Cancer	Colon-rectal cancer	In

This is unacceptable from a scientific perspective, but there are many other problems. For example, it appears that Dr. Bolinder’s definition of snus use was inconsistent with later definitions. I’ll have more to say about this in a future post.

Why Doesn't the Karolinska Institute Want To Disclose How They Conducted Their Research On Snus?

2011-02-07T10:14:00.000-05:00

On February 7, Dagens Industri, Sweden’s prestigious business newspaper, published my commentary on snus misinformation emanating from the Karolinska Institute, Sweden’s premier research institution. The commentary is available in Swedish (here); the English version of my submission follows. I will post a detailed description of the Karolinska Institute misinformation in a few days.

Published in Dagens Industri, February 7, 2011

Many research studies from Sweden have not found any health risks from snus use, but researchers at the Karolinska Institute have produced a series of reports, based on a large cohort of Swedish construction workers, that emphasize very small risks for esophagus and pancreas cancer and fatal heart attack and stroke.

The KI reports do not change these indisputable scientific facts: the health risks from the use of Swedish snus are so low that they are difficult to measure with modern epidemiologic methods. Snus use by Swedish men has resulted in the lowest rates of smoking-related diseases and deaths in Europe for the past sixty years.

However, the KI studies have obvious technical problems and contradictions, and I have documented these concerns in medical journals. For example, in 1994 Dr. Gunilla Bolinder studied 135,000 Swedish construction workers who had enrolled in a health program from 1971 to 1974. She found that snus users had elevated risks for cardiovascular diseases.

But in 2007 another KI study excluded the 1971-74 workers because of “ambiguities” in tobacco use. Then another KI-study in 2008 included them.

These problems are unacceptable from a scientific perspective, and I gave the KI researchers several opportunities to resolve them. There was no response.

Over two years ago I asked KI researchers for access to the construction worker data so that their findings could be validated. In the past the KI has given data to American researchers while fully protecting the identity of the participants. But the KI refused my request.

I was at an impasse with the KI from a scientific perspective, so I pursued the matter in the administrative court as a last resort. The court ruled that the data is a matter of public record, and it encouraged KI to make a thorough and comprehensive assessment of which data can be disclosed. But the institute has twice failed to comply with the court’s instructions, and it has provided no reasonable explanation for its intransigence.

KI – which in this respect is a Swedish authority – recently decided that I should be granted partial access to the data. But not digitally – which is customary – but only via pieces of paper. In addition KI will remove information about health conditions, i.e. the very information that I want to validate! This means that I would get hundreds of thousands of pages of worthless paper, for which KI has the right to invoice me.

This cannot be seen as anything but pure obstruction, and KI’s position is that its research is exempt from validation.

Researchers at KI have more than implied that I am running the errands of the tobacco industry. That is of course not the case. For years my university has accepted unrestricted funding from tobacco manufacturers including Swedish Match. This is very common in the U.S., as well as in Europe. We would never – nor would KI – let our funding direct the focus or results of our research.

Personally I have conducted tobacco research for two decades, and I developed a deep understanding of Swedish snus as a visiting scientist at the University of Umeå in 2002.

At first glance this matter appears to be just a minor dispute between a sole American professor and a prestigious and powerful Swedish research institute. I would argue the issue is bigger than that.

The health risks identified in the KI studies are the raison d’être for the ban on snus in the E.U. (except Sweden), but it has also had a profound impact on tobacco regulation in the U.S. and other countries.

It would be a tragedy if snus restrictions and prohibitions were improperly based on exaggerated or fictitious health risks. As a result, millions of inveterate smokers outside Sweden might never know that snus is a much safer substitute for cigarettes.

KI’s position is counter to the scientific and ethical principles of data sharing among medical institutions. These principles require that scientific results are open to challenge by other scientists to determine their accuracy and integrity.

The best solutions for scientific debates are not found in the courts. I therefore hope that KI decides to follow the practices of the world of medical research. If the KI does not release the data, it risks damaging its outstanding international reputation.

Professor Brad Rodu
University of Louisville, U.S.A.

New Study: Smokeless Tobacco is NOT Associated with Pancreatic Cancer

2011-02-02T10:20:00.000-05:00

A new study documents that smokeless tobacco use is not associated with increased risk for pancreatic cancer. The study, from the International Pancreatic Cancer Case-Control Consortium and lead author Paolo Bertuccio of Milan, Italy, was published in Annals of Oncology (abstract here). It is a collaborative analysis of 6,000 cases of pancreatic cancer from 11 studies in North America and Europe.

With only 130 pancreatic cancer cases among ever smokeless tobacco users, the odds ratio (OR) is 0.98 (95% Confidence Interval, CI = 0.75 – 1.27). Twenty-three cases among exclusive users of smokeless tobacco produced an OR of 0.62 (CI = 0.37 – 1.04), which was almost significant for a PROTECTIVE EFFECT. Smokeless users who were also cigarette smokers had an OR of 1.36, which was not statistically significant (CI = 0.94 – 1.96) but confirms other studies that showed higher pancreatic cancer risks for smokers.

(The odds ratio is the measure used for case-control studies. Its interpretation is similar to that used for relative risks, which was discussed in this post.)

The importance of this study is hard to overestimate. First, it provides additional evidence that smokeless tobacco users are not at risk for pancreatic cancer. More importantly, it directly addresses a persistent question about the integrity of previous studies.

In September 2009, I described in detail the results of two meta-analyses of cancer risks among smokeless tobacco users (read my description here). The first report, published in 2008 by Paolo Boffetta and colleagues in Lancet Oncology, concluded that smokeless users had an increased risk for pancreatic cancer (RR = 1.6, CI = 1.1 – 2.2). But that study used cherry-picked data in an unscientific manner to artificially raise the cancer risks. The second study, by Peter Lee and Jan Hamling, using a more scientifically credible and valid approach, reported an RR for pancreatic cancer of 0.99 (CI = 0.71 – 1.60).

The results from the current study are in close agreement with the Lee-Hamling estimate, and at odds with the Boffetta estimate, which Bertuccio clearly acknowledges:

“Our results on smokeless tobacco use are in broad agreement with a recently published meta-analysis of all published data on the issue [Lee-Hamling], which reported NO EXCESS RISK OF PANCREATIC CANCER in case-control studies. They are, however, at variance with those from another meta-analysis [Boffetta], based mainly on data from two Nordic cohort studies, which suggested that smokeless tobacco is associated with an increased risk of pancreatic cancer.” (emphasis added)

Bertuccio actually cited a different Lee-Hamling publication (abstract here), but the data from this study is identical to the Lee-Hamling meta-analysis.

The Bertuccio study is significant because it endorses the Lee-Hamling analysis and clearly refutes the Boffetta analysis. But there is another, profound aspect to this report: Paolo Boffetta is a co-author. Thus, Dr. Boffetta is finally acknowledging that his 2008 meta-analysis was wrong.

American consumers have been deceived for decades by the myth that smokeless tobacco confers high risk for oral cancer (here ). Because of the misguided 2008 Boffetta meta-analysis, smokeless tobacco opponents have built a second unscientific line of attack around the issue of pancreatic cancer.

Regulatory authorities worldwide should now acknowledge that use of modern American and Swedish smokeless tobacco products is not a risk factor for cancers of the oral cavity or pancreas.

Federal Appeals Court to FDA: E-Cigarettes Are Tobacco Products, Not Medicines

2011-01-26T12:12:00.002-05:00

One month ago a federal appeals court affirmed Judge Richard Leon’s decision requiring the FDA to regulate e-cigarettes as tobacco products, rather than as drug-delivery devices, as the agency had attempted to do. This week the appellate court rejected the FDA’s request to review the decision, so the only remaining option for the agency is to appeal to the Supreme Court (here).

The FDA had decided that e-cigarettes were being sold without sufficient evidence of safety and efficacy – the expensive and time-consuming regulatory challenge that all drug manufacturers must address. The agency had begun seizing shipments, triggering the suit.

As I noted one year ago (here), Judge Leon found that the 2009 “Tobacco Act applies to ‘tobacco products,’ which Congress defined expansively as ‘any product made or derived from tobacco that is intended for human consumption’…Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product – whether traditional or not – that is sold for customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in effect, serves as an implicit acknowledgment by Congress that FDA's jurisdiction over drugs and devices does not, and never did, extend to tobacco products, like electronic cigarettes, that are marketed in customary fashion for purely recreational purposes.”

The reaction from nicotine prohibitionists has been predictable. Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the decision “wrong on the law, wrong on the facts…” and he urged “the government to appeal this ruling.”

Why is Mr. Myers so upset? According to the New York Times, he was a primary author of the Tobacco Act (link here). The legislation placed “any product made or derived from tobacco that is intended for human consumption” under FDA control.

It is wonderful irony that the courts have interpreted Myers’ legislation to free a potentially broad array of recreational nicotine products from drug regulation. It is also a dramatic, positive development for tobacco harm reduction, public health and millions of inveterate smokers, effectively accomplishing what I first advocated in 1995 – deregulation of nicotine. (link here)

This week I was interviewed about the e-cigarette issue by www.AllTreatment.com, which focuses on ways of making treatment and recovery more accessible to anyone struggling with addiction. That interview is available here.

New Study Documents the Health Effects from Snus Use: Almost Zero

2011-01-19T12:02:00.000-05:00

A detailed review of epidemiologic studies regarding snus use has just been published online by Regulatory Toxicology and Pharmacology (abstract here). Author Peter Lee, a UK epidemiologist, concludes: “Using snus is clearly much safer than smoking. While smoking substantially increases the risk of cancer and cardiovascular diseases, any increase from snus use is undemonstrated, and if it exists is probably about 1% of that from smoking.”

Dr. Lee confirms what I have been asserting since 1994: Smokeless tobacco use is 99% less hazardous than smoking, and the magnitude of risk, if it exists, is difficult to measure using modern epidemiologic methods.

Lee reviewed the evidence from over 150 studies covering many diseases. Previously, he published separate meta analyses involving smokeless tobacco use and all cancers (abstract here), dental problems (abstract here), pancreas cancer (here), oral cancer (here), and circulatory diseases (here).

The hallmark of Lee’s analytic approach is to use all of the published evidence in a systematic and unbiased manner. This is in direct contrast to anti-tobacco advocates like Dr. Paolo Boffetta, who cherry pick the data and use only numbers that confirm their pre-existing belief that smokeless tobacco causes disease. Pancreas cancer is an excellent example.

In 2008, Boffetta published a meta analysis (abstract here) in which he claimed that snus use is a risk factor for pancreas cancer. He cited two studies, one from Norway (here) and another from Sweden (here). The Norway study reported a risk increase among all snus users (Relative Risk = 1.7, Confidence Interval = 1.1 – 2.5) but not for a subset of snus users who were never smokers (RR = 0.9, CI = 0.2 – 3.1). The Swedish study reported exactly the opposite: There was virtually no risk among all snus users (RR = 0.9, CI = 0.7 – 1.2), but the subset of snus users who never smoked had an increased risk (RR = 2.0, CI = 1.2 – 3.3).

Dr. Boffetta chose only to use the elevated risks, even though they were from different groups. As Lee points out, “For pancreatic cancer, Boffetta cited only the increases for never smokers from the [Swedish] study and for the whole population from the [Norwegian] study, not mentioning the lack of increase for the whole population for the construction workers and for never smokers for the Norway cohorts.”

It is important to note Dr. Boffetta was an author of both studies; that makes his selective use of data from them even more objectionable.

Another issue raised by Lee about another Boffetta meta analysis (here) claiming that snus use is a risk factor for fatal – as opposed to non-fatal – heart attack and stroke. In a 2009 blog post, I noted that Boffetta’s claim was questionable (here): “Boffetta found that smokeless users had no significant risk for all heart attacks and strokes but had elevated risks for fatal cases. It logically follows that smokeless users probably had LOWER risks for NON-FATAL heart attacks and strokes.” Lee echoes my concern: “Anyway, an association for fatal cases but not for all cases seems unlikely unless implausibly snus protects against non-fatal cases.”

Finally, Lee reviewed epidemiologic studies to answer this question: Does snus encourage initiation of smoking or discourage quitting? His conclusion: “There is no good evidence that introducing snus in a population would encourage smoking initiation or discourage cessation.”

This is an especially important point, because RJ Reynolds has just launched a campaign encouraging smokers to switch completely to Camel Snus (article here). While apparently in full compliance with FDA tobacco regulations, the ads have enraged prohibitionists like Matt Myers, who said that Reynolds should “stop its insidious marketing of tobacco products in ways that seek to discourage smokers from quitting and keep them hooked on nicotine...The ads are trying to take advantage of people trying to end all uses of tobacco.”

Myers is wrong about many things. Most smokers are not trying to achieve abstinence, but they are interested in enjoying tobacco in a safer manner. As Dr. Lee documents, snus is a vastly safer cigarette substitute.

Scientific Evidence Supporting FDA Regulatory Action of Menthol Cigarettes: Essentially Nil

2011-01-12T10:37:00.000-05:00

In March, the FDA Tobacco Products Scientific Advisory Committee (TPSAC) is scheduled to release recommendations for agency regulation of menthol cigarettes. This is a highly charged issue, racially, politically and legally. Additionally, the TPSAC recommendations and any subsequent regulations will be harbingers of the FDA’s future handling of smokeless tobacco and tobacco harm reduction.

Dr. Lawrence Deyton, director of the FDA Center for Tobacco Products, has stated that the FDA’s “objective is to use the best available science to develop and put into action effective public health strategies to reduce the enormous toll of illness and death caused by tobacco products.” (here)

Last year, the “best available science” on menthol was reviewed by the American Council on Science and Health, a science-driven organization that has been anti-smoking for decades. I was an expert reviewer of that report (available here), which concluded that any differences in health effects from smoking menthol versus non-menthol cigarettes are inconsequential.

The ACSH report used the available scientific evidence to answer a series of questions:

1. Does cigarette mentholation affect initiation, dependency, and cessation?

ACSH: “Overall, the evidence summarized in this section does not suggest that mentholated cigarettes are associated with any independent reduction in age of starting to smoke (‘starter product for youth’), increase in cigarette consumption or dependency (‘greater addiction potential’)… Data from the Federal Trade Commission in 2006 indicate that the menthol percentage of the total cigarette market has been remarkably stable over the last 35 years. If menthol cigarettes were more addictive than non-menthol, or otherwise increased likelihood of usage, then menthol’s share of market would have steadily increased over the last 35 years.”

2. Does mentholation affect the metabolism and clearance of nicotine and other smoke constituents?

ACSH: “Although there are only a few studies, cigarette mentholation does not appear to have any major effects on either the absorption of nicotine and smoke, or the metabolism and elimination of tobacco smoke constituents.”

3. Does cigarette mentholation affect smoking behavior?

ACSH: “Taken as a whole, the data presented here are inconsistent with the idea that mentholation may affect how a cigarette is smoked so as to increase uptake of toxic smoke constituents through a ‘unique stimulatory sensation.’”

4. Could menthol cigarettes be claimed [by manufacturers] to be “healthier”

ACSH: “Any such health claims without rigorous substantiation would instantly attract the attention of numerous regulatory authorities, such as the Federal Trade Commission. Since these authorities have continued for decades to allow the sale of mentholated cigarettes, it is safe to assume that mentholated cigarettes do not differ in any substantial way from non-mentholated cigarettes in terms of generalized health claims.”

5. Does mentholation of cigarettes affect other smoke constituents, and is the subsequent toxicology any different?

ACSH: “The in vitro and in vivo toxicological properties of mentholated and non-mentholated cigarettes appear to be virtually identical.”

6. Does menthol affect airway patency?

ACSH: “…[M]enthol does not ‘help the poison go down,’ since if this were the case there would be substantial increases in the various biomarkers of smoke exposure, which is clearly not the case.”

7. Does mentholation increase the risk of lung cancer in smokers?

ACSH: “It appears to be very unlikely from the cumulative evidence that cigarette mentholation increases the risk of lung cancer, and may even protect from it.”

8. Does mentholation increase the risk of other diseases?

ACSH: “Overall, available epidemiological data on cancers other than lung cancer do not suggest any important pathogenic role of cigarette mentholation…Incidences of other diseases do not seem to differ between smokers of mentholated and non-mentholated cigarettes, and mortality rates are similar.”

The ACSH report also comments on the societal consequences of a menthol cigarette ban:

“An FDA ban of menthol in cigarettes would affect 25% of the near 50 million U.S. smokers. The affected smokers are largely minorities who have a strong preference for mentholation, and the arbitrary removal of this choice by the FDA would almost certainly result in the rapid establishment of a black market, possibly accompanied by ‘do-it-yourself’ attempts to modify non-menthol cigarettes through potentially more risky attempts at ‘home mentholation.’ Neither of these scenarios represents the actions of a society dedicated to the factual, unbiased, and scientific assessment of the biological effects of consumer products.”

The bottom line: There is essentially no published scientific evidence for any FDA regulatory action that restricts or removes menthol cigarettes from the American market.

Camel Dissolvables and Anti-Tobacco Dissembling

2011-01-05T10:32:00.001-05:00

On December 20, R.J. Reynolds Tobacco Company announced that it was discontinuing Camel Dissolvable test marketing in Indianapolis, Columbus, Ohio and Portland, Oregon (here). The response from Matthew Myers (here), president of the Campaign for Tobacco-Free Kids, speaks volumes about the U.S. anti-tobacco crusade’s faulty logic.

According to Myers, “The Camel dissolvable products appeal to children in that they are easily concealed and colorfully packaged, shaped and flavored to resemble mints or gum.” He ignores the fact that dissolvables are tobacco products and are thus subject to a complete sales prohibition to anyone under 18 years in all 50 states.

Myers also blamed tobacco manufacturers for an increase in smokeless tobacco use by children: “Most troubling, the most recent data on youth tobacco use, included in the Monitoring the Future Survey released just last week, shows a significant increase in smokeless tobacco use among high school students. Among 12th graders, 8.5 percent used smokeless tobacco in 2010, a 39 percent increase since 2006…The increase in smokeless tobacco use also comes as some smokeless manufacturers have sought to portray their products as a less hazardous alternative to cigarettes.”

Myers’s use of the Monitoring the Future Survey was very creative. Why use 2006 as a comparison year? Because in 2006, smokeless tobacco prevalence was unusually low – in fact, the lowest in the 25-year history of the survey. This makes the 8.5 percent prevalence in 2010 seem like a substantial increase. Actually prevalence was 8.4% in 2009 and 1999, and even higher before that.

It is disingenuous for Myers to blame manufacturers for tobacco use by teenagers. While it’s true that 8.5% of 12th graders used smokeless tobacco and 19.2% smoked cigarettes in 2010, 21.4%, smoked marijuana. What industry does Myers hold responsible for marijuana use among children?

Teenage substance use fluctuates, which permits zealots to cherry-pick findings for dramatic, but highly misleading, story lines. If tobacco use is down, zealots take credit; if tobacco use rises, they blame industry.

Gandhi said an error does not become truth by reason of multiplied propagation, nor does truth become error because nobody sees it. Tobacco opponents continue to dissemble on harm reduction and the risks associated with smokeless tobacco. But the facts endure, and they will continue to sustain a transformation in nicotine and tobacco use.

Quit-Smoking Medicines and Episodes of Violence

2010-12-29T14:01:00.001-05:00

A new study published in Public Library of Science One (available here) reports that two drugs widely prescribed to help smokers quit -- varenicline (brand name Chantix) and bupropion (brand names Wellbutrin and Zyban) - are associated with thoughts or acts of violence towards others.

The study was conducted by Thomas Moore at the Institute for Safe Medication Practices, and colleagues from Harvard and Wake Forest Universities. Moore et. al. analyzed data from the FDA Adverse Event Reporting System, extracting all serious adverse event reports for drugs with 200 or more cases received from 2004 through September 2009. The researchers focused on homicide, homicidal ideation, physical assault, physical abuse and violence related symptoms. They reported the number of events, as well as proportional reporting ratios (PRRs), which allows for comparison of the proportion of violence events for each medicine with the proportion from all other evaluable drugs (those in wide clinical use with adequate post-marketing surveillance).

Moore found that “among 484 evaluable drugs, 31 drugs met the study criteria for
a disproportionate association with violence, and accounted for 1527/1937 (79%) of the violence cases…Varenicline has the largest number of reported violence cases (n = 408), [and] the highest proportion of violence cases (PRR= 18.0).”

The PRR for varenicline was so high that it was in a class all by itself. As Moore and colleagues noted, “We have previously examined varenicline’s association with serious psychiatric symptoms including aggression/violence [references omitted]. The aggression/violence case series for varenicline was consistent with these data but revealed other features that may or may not occur in cases attributed to other drugs. These features include early onset of psychiatric symptoms (usually within a few days), a senseless act of aggression/violence directed at anyone who happened to be near by, and resolution of the symptoms upon discontinuation.”

Moore also found that bupropion, an antidepressant prescribed to aid smoking cessation, was also associated with violence, although at a much lower rate (35 episodes, PRR = 3.9). As he and his associates note, “bupropion is indicated for both depression and as an aid to smoking cessation, so those results are not limited to the smoking cessation population.”

Moore also studied pharmaceutical nicotine, which was associated much less frequently with violent episodes (11 cases, PRR = 1.9).

Tobacco prohibitionists like the American Cancer Society often claim that tobacco harm reduction is unnecessary, since medicines represent the gold standard for smoking cessation. This study demonstrates that the gold standard is substantially tarnished. At a minimum, the Cancer Society should update its website discussion of smoking cessation (here). The current version promotes varenicline and bupropion, but fails to mention the drugs’ possible side effect of violent behavior.

POTUS Puffing?

2010-12-22T10:00:00.002-05:00

On December 10, White House press secretary Robert Gibbs was asked pointed questions about whether President Obama had quit smoking. Gibbs responded by saying, “I've not seen or witnessed evidence of any smoking in probably nine months,” which prompted an optimistic headline in the Washington Post: “Obama Kicks His Smoking Habit.” But after watching the video of Gibbs’ actual comments (available here), one is left with the impression that the press secretary was practicing plausible deniability; he never actually said President Obama had quit smoking.

Two and a half years ago, in June 2008, I wrote to then-Senator and presidential candidate Obama, encouraging him to consider practicing tobacco harm reduction. I also submitted my letter to the Chicago Tribune, which published it on June 22. The text of that letter (also available here) is as relevant to millions of Americans, and very likely the President, as we move into 2011 as it was two years ago:

An Open Letter To Barack Obama

Dear Senator Obama:

I viewed with great interest your recent comments about your struggle to quit smoking. As a professor of medicine at the University of Louisville with a long-term research program focused on tobacco use and its consequences, I strongly believe that your discomfort is entirely unnecessary; your dependency on cigarettes can readily be resolved.

First, understand that you are not alone. Some 25 million adult Americans are inveterate smokers – that’s about 50% of all who smoke. They are unable or unwilling to stop using tobacco and nicotine. For them, conventional quit-smoking tactics, which require abstinence, simply don’t work.

A growing number of public health experts – including Britain’s Royal College of Physicians, one of the world’s oldest and most prestigious medical societies – believe that inveterate smokers could benefit from alternative tobacco products that are effective quit-smoking aids and vastly safer substitutes for cigarettes.

The Royal College has observed that “smokers smoke predominantly for nicotine” and “nicotine itself is not especially hazardous.” You probably appreciate that nicotine is among the most powerful of addictive substances. But nicotine doesn’t cause any smoking-related disease. In fact, nicotine itself is about as safe as caffeine, another addictive drug consumed safely by millions of Americans.

Research and consumer experience show that smokers can obtain satisfying doses of nicotine from smoke-free (and spit-free) tobacco products. Available as small packets or pellets of tobacco that are placed inside the upper lip, modern smokeless tobacco products can be used invisibly in all social settings, including stressful press conferences.

Most importantly, smokeless tobacco products are 98% safer than smoking. While no tobacco product is completely safe, the majority of cigarette smokers are routinely misinformed – by government agencies and by anti-tobacco extremists – about the relative safety of smokeless products. Unlike cigarettes, smokeless does not cause lung cancer, heart disease or emphysema. Smokers rightfully worry about mouth cancer, but they should take comfort in the fact that the risk for mouth cancer with smokeless is far lower than it is with cigarettes. Statistically, smokeless users have about the same risk of dying from mouth cancer as automobile users have of dying in a car wreck.

In fact, switching from cigarettes to smokeless provides almost all of the health benefits of complete tobacco abstinence.

Substituting satisfying and vastly safer sources of nicotine for cigarettes is called “tobacco harm reduction”. Tobacco harm reduction has worked in Sweden, where men have 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.

A colleague and I recently published research, based on an analysis of the federal government’s National Health Interview Survey, documenting that tobacco harm reduction has also worked for American smokers.

The Royal College characterized harm reduction as “a fundamental component of many aspects of medicine and, indeed, everyday life, yet for some reason effective harm reduction principles have not been applied to tobacco smoking.” It concluded, “If nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.”

Senator, your genuine desire to quit tobacco altogether is commendable. But if you find this goal unachievable, like millions of inveterate smokers, I urge you to switch to smokeless tobacco for your physical and emotional wellbeing. In doing so, you can provide inspiration for American smokers, and you can effect a profound positive change in the nation’s public health. Yes, you can.

Sincerely,

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

Snus Not Linked to Colorectal Cancer

2010-12-15T14:40:00.001-05:00

Researchers from the Swedish Karolinska Institute have published a study in the International Journal of Cancer showing that snus use is not a risk factor for cancers of the colon, rectum and anus among Swedish men (abstract here).

Caroline Nordenvall, from the Department of Medical Epidemiology and Biostatistics, and colleagues studied over 300,000 male Swedish construction workers who enrolled in a health program from 1971 to 1992. The workers were followed for up to 37 years, and Nordenvall calculated the relative risks (RRs) for cancer of the colon, rectum and anus among smokers and snus users.

Compared with non-users of tobacco, smokers had RRs of 1.08 (95% Confidence Interval = 0.99 – 1.19) for colon cancer and 1.16 (CI = 1.04 – 1.30) for rectal cancer. These are very small increases, and only the latter is statistically significant. The RR for anal cancer among smokers was 2.41 (CI = 1.06 – 5.48). Although smoking has been implicated for many years as a risk factor for anal cancer, the sexually transmitted human papillomaviruses are known causes of this malignancy. Information on sexual behavior or venereal infections, not found in this study, might affect Nordenvall’s risk estimate for smoking.

Snus users did not have significantly elevated risks for any of these cancers. The RRs were 1.08 (CI = 0.91 – 1.29) for colon cancer, 1.05 (CI = 0.85 – 1.31) for rectal cancer and 0.61 (CI = 0.07 – 5.07) for anal cancer.

Nordenvall concluded her study with the following: “Our results from a large and homogenous cohort of Swedish male construction workers with up to 37 years of
follow-up do not convincingly support an important role of tobacco use in the etiology of colorectal cancer. As expected, an increased risk of anal cancer was associated with smoking.”

Distorting Tobacco Facts to Sway Major League Baseball

2010-12-09T09:20:00.002-05:00

Tobacco prohibitionists have for many years pressed Major League Baseball (MLB) to ban player use of smokeless tobacco. Despite decades of misinformation from advocates like Joe Garagiola (example here), many ballplayers still use smokeless products. The U.S. Congress entered the fray in April, when House Health Subcommittee Chairman Henry Waxman convened a hearing to browbeat baseball executives for failing to implement a ban. Witnesses pitched a barrage of misinformation. I responded in this blog (here and here).

More misinformation flowed on November 19, when the presidents of ten organizations dedicated to tobacco prohibition called on the commissioner and the director of the MLB players’ association to ban smokeless tobacco use. Their rationale for a ban was wholly unscientific; earlier this week I wrote the commissioner and the MLB association to set the record straight. The text of my letter follows:

December 6, 2010

Mr. Allen H. (Bud) Selig
Commissioner
Major League Baseball
245 Park Avenue, 31st Floor
New York, NY 10167

Mr. Michael Weiner
Executive Director
Major League Baseball Players Association
12 East 49th Street, 24th Floor
New York, NY 10017

Dear Commissioner Selig and Mr. Weiner:

On November 19, 2010, the presidents of ten organizations dedicated to tobacco prohibition wrote you “…to urge Major League Baseball and the Major League Baseball Players Association to prohibit the use of all tobacco products, including smokeless tobacco, by players, coaches, managers, and other team personnel, at all Major League Baseball venues.” The letter (available here, hereafter referred to as Myers et al.) contains distorted and inaccurate statements about the health risks of smokeless tobacco.

I am a professor of medicine, and I hold an endowed chair in tobacco harm reduction research at the University of Louisville. I have conducted research for two decades on the health effects of smokeless tobacco use, and I believe you are entitled to know what tobacco research and policy experts consider an indisputable scientific fact: the health risks from smokeless tobacco use are so low that they are difficult or impossible to measure with modern epidemiologic methods.

Myers et al. make unsupported allegations that smokeless tobacco causes a litany of cancers. They cite no scientific evidence for their claims, because the risks are either barely measurable or completely nonexistent. In 2009, a comprehensive analysis (Reference 1) of all available epidemiologic studies documented that smokeless tobacco users do not have significantly elevated risks for ANY of the cancers listed by Myers et al.

Myers et al. also claim that “Tobacco use is the number one preventable cause of death in the United States.” This is grossly misleading, as it combines smoking’s dramatic fatality figures with the far more benign use of smokeless tobacco (2). For example, the U.S. Centers for Disease Control and Prevention estimate that over 400,000 Americans die every year from smoking-attributable diseases (3), but the comparable number attributed to smokeless tobacco use is so low that the CDC has never attempted to provide an estimate. American Cancer Society Vice President Emeritus Michael J. Thun participated in a 2004 study concluding that “…smokeless tobacco products pose a substantially lower risk to the user than do conventional cigarettes. This finding raises ethical questions concerning whether it is inappropriate and misleading for government officials or public health experts to characterize smokeless tobacco products as comparably dangerous with cigarette smoking.” (4)

The use of smokeless tobacco may be a legitimate topic of discussion between Major League Baseball and the Major League Baseball Players Association. However, the facts about smokeless tobacco vs. cigarettes should not be twisted to satisfy an anti-tobacco agenda or to influence public health policy.

Please do not hesitate to contact me if you would like more factual information on this important subject.

Sincerely,

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

References

1. Lee PN, Hamling JS. Systematic review of the relation between smokeless tobacco and cancer in Europe and North America. BMC Medicine 7: 36, 2009. Available here.

2. Rodu B, Godshall WT, 2006. Tobacco harm reduction: an alternative cessation strategy for inveterate smokers. Harm Reduction Journal 3:37. Available here.

3. Centers for Disease Control and Prevention. Smoking-attributable mortality, morbidity, and economic costs (SAMMEC). Available here.

4. Levy DT, Mumford EA, Cummings KM, Gilpin EA, Giovino G, Hyland A, Sweanor D, Warner KE. The relative risks of a low-nitrosamine smokeless tobacco product compared with smoking cigarettes: estimates of a panel of experts. Cancer Epidemiology Biomarkers and Prevention 13: 2035-2042, 2004.

A Medical Association in Denial on Smokeless Tobacco

2010-12-01T13:06:00.001-05:00

A few weeks ago I highlighted misinformation about smokeless tobacco from the Mayo Clinic (here). The foolishness continues, this time from the American Academy of Otolaryngology - Head and Neck Surgery (here). Commonly called Ear, Nose and Throat specialists, or ENTs, these physicians are often involved in the treatment of oral and throat cancers. Regrettably, the Academy and spokesman Dr. Daniel Deschler are perpetuating myths about smokeless tobacco and harm reduction.

“Using smokeless tobacco products, like chew, is not a safe way to quit or a healthier alternative to smoking,” says Dr. Deschler in an Academy press release. He asserts that smokeless tobacco users run the same risks of gum disease, heart disease, high blood pressure, and addiction as cigarette users, but an even greater risk of oral cancer. Only one of these claims is true: Smokeless users are just as addicted to nicotine as smokers, and that is exactly why smokeless is an excellent alternative to cigarettes.

The reality is that smokeless users have almost no risks for gum disease, heart disease or high blood pressure. They certainly don’t have “an even greater risk for oral cancer” than smokers. This gross misstatement should not be made by a physician-spokesman for a professional medical society. As I have documented many times, the oral cancer risk for smokeless use is barely measurable in most epidemiologic studies, and negligible when compared with smoking.

Is the American Academy of Otolaryngology - Head and Neck Surgery deliberately misleading the public? In an effort to correct websites that had false and misleading information about smokeless tobacco, tobacco harm reduction colleagues at the University of Alberta sent a detailed letter to the Academy describing misinformation on its site and explaining why it was potentially harmful to inveterate smokers (read about it here). The organization never responded.

Patients believe their doctors make decisions based on sound science, not on moral judgments. Physicians and organizations that mischaracterize medical facts violate the sacred trust upon which our health care system is based. The American Academy of Otolaryngology - Head and Neck Surgery should correct its message.

The Consequences of Tobacco Prohibition and Misinformation in the U.S. Air Force

2010-11-24T09:36:00.002-05:00

A new study about tobacco use among Air Force recruits, before and one year after basic training, has been published in the American Journal of Public Health (abstract here). The authors include two vocal tobacco opponents, Dr. Robert C. Klesges of the University of Tennessee (Memphis) and Dr. Jon O. Ebbert of the Mayo Clinic.

Dr. Klesges looked at tobacco use among airmen (an Air Force term used for both men and women) who made up a control group in a large study combining universal forced tobacco abstinence during 6 weeks of basic training and an “intervention” consisting of tobacco prevention or cessation. The results from the large study were published in 2006 (I refer to it as Klesges I, the abstract is here; I refer to the current study as Klesges II).

Klesges classified recruits based on their tobacco habits prior to basic training (baseline): nonusers of tobacco, smokers, smokeless users and dual users. In addition, he described tobacco prohibition:

“During basic military training, there is a total tobacco ban…and the prohibition is strictly enforced. At the beginning of basic military training, airmen are searched and all tobacco products are confiscated. Tobacco products are considered ‘‘contraband’’ along with alcohol, drugs, weapons, and chewing gum. The airmen recruits are required to maintain a ‘money list’ (i.e., a list of all serial numbers for all their money), which is checked regularly by basic military training instructors. Airmen are under constant supervision, and there are no tobacco products accessible even during those rare occasions when airmen are not supervised. An honor code is established early in basic training so that if a recruit breaks the rules, fellow airmen are duty bound to report the infraction. Finally, the punishment for tobacco use during basic military training is severe. In virtually all cases, the airman is ‘recycled’ (forced to repeat some or all of basic training), a possible sanction that few airmen dare risk.”

That is serious tobacco prohibition, and perhaps Klesges et al. hoped that none of the 5,225 Air Force recruits would be using tobacco 12 months later. That didn’t happen.

Klesges reported that 11% of recruits who were nonusers at baseline were smoking 12 months afterwards. As he admitted in Klesges I, “the smoking prevention program had no impact on smoking initiation.” So airmen started smoking in large numbers despite boot-camp tobacco prohibition and prevention programs.

In Klesges II, the main focus was on the 6% of smokers at baseline who were dual users afterwards. He classified this transition as harm escalation, which is an appalling misrepresentation of reality. It is scientifically established that smokers who switch to dual use smoke fewer cigarettes and have lower health risks (described here).

Other data in Klesges II were informative. Fewer than 1% of baseline smokers were smokeless users at follow-up, but 15% of baseline smokeless users were dual users and 14% were smokers at follow-up. In addition, 42% of dual users at baseline were smokers at follow-up. Thus, the transition from smokeless to cigarettes was more common than from cigarettes to smokeless. How did this happen? This is strong evidence that tobacco users in the Air Force are not properly informed about the risks of smoking and smokeless use. Unfortunately, they are making very bad decisions based on misinformation.

A big concern with this study is that the numbers don’t add up, compared with Klesges I. That study started with 7,974 airmen, compared with only 5,225 airmen in this study. In Kleges I, there were 312 smokeless users at baseline, but in Klesges II, there were only 193 (38% fewer). In Klesges I dual use was not a tobacco category, so we have no idea how it classified those 249 airmen from Klesges II. In short, reconciliation of different numbers between Klesges I and II is impossible, which is an indicator of low quality and inconsistency.

Klesges concludes that “[harm] escalation is a possible unintended consequence of promoting smokeless tobacco as a harm reduction strategy for smokers.” He is wrong. Harm escalation is the unintended consequence of not telling smokers and smokeless users the truth about the health risks.

American Evidence that Snus Is An Effective Substitute

2010-11-17T09:25:00.001-05:00

Scientists from the University of Minnesota Tobacco Use Research Center have just published the results of a clinical trial from 2006-7 showing that RJ Reynolds’ Camel Snus and Philip Morris’ Taboka (a precursor of Marlboro Snus) were viable substitutes for cigarettes. The trial was conducted by Michael Kotlyar and colleagues; the results are published in Cancer Epidemiology and Biomarkers (abstract here).

Kotlyar recruited smokers who were interested in quitting, and assigned them to use one of three products: 4 milligram nicotine gum or lozenge, Camel Snus or Taboka (participants had a choice of various flavors for each product). Participants used only 1 or two products per day during a one-week sampling period; for the next four weeks, they used the product at least 6 to 8 times daily. During week 5, participants were required to reduce consumption of the substitute; by the end of that week they had to be completely tobacco- and nicotine-free.

There were several interesting results. First, all participants in all groups had a reduction in exhaled carbon monoxide, clearly demonstrating that they smoked less than before the study. Participants in all groups had a reduction in the urine concentration of two chemicals that are considered carcinogens, abbreviated here as NNN and NNAL. The reductions were statistically significant except for NNN in Camel Snus users (p = 0.07).

Overall craving and withdrawal scores decreased over the 4 weeks in all groups, with no differences between the groups.

Continuous abstinence rates over the 4 treatment weeks varied from 33% (Taboka) to 43% (Camel Snus). Two weeks after the treatment ended, 39% of the Taboka group, 47% of the Camel Snus group and 56% of the nicotine group were not smoking, but these percentages dropped to 23%, 31% and 33% respectively after ten weeks of complete abstinence.

One possible reason for the precipitous drop in the smoke-free percentages was the insistence on abstinence after 4 weeks. If this philosophy prevails, it will guarantee that smokeless products are no more effective than pharmaceutical nicotine, which has a documented failure rate of 93% (evidence here).

There is evidence that the FDA is starting to think about offering smokers “long-term” nicotine substitution (review a symposium on the topic was held on October 26-27 here), which is a strategy I called “nicotine maintenance” in 1999 (here). I recommend that readers look at the FDA presentations, especially the one by Neal Benowitz (here). He indicates that the best information about the long-term risks of nicotine come from the epidemiologic studies of Swedish snus use.

There were other interesting aspects of the Minnesota study. The Taboka group smoked significantly more than those using nicotine or Camel Snus. It is possible that Taboka, which had very low nicotine levels, simply didn’t satisfy smokers.

A total of 1,159 smokers responded to advertisements for the study. According to the researchers, 800 “were able to be reached and were screened over the telephone,” and 429 qualified and were interested in participating. Another 212 did not show up for the orientation. The attrition didn’t stop there: 211 smokers were enrolled in the study but only 130 were randomized to one of the three groups. Just 80 participants completed the 4-week treatment period and the one-week transition to abstinence.

These numbers represent one of the biggest challenges of clinical trials, especially in the field of risky behaviors like smoking. The 80 participants who completed the study represent only 6.9% of the smokers who originally responded, so they are an especially motivated group. That has been one of the problems with quit-smoking trials: It is impossible to generalize their results because they are from a highly selected population that is not representative of smokers in general.

In the past, I have criticized the Minnesota group for publishing biased and distorted studies about smokeless tobacco (here and here). But this is a fair and balanced report of the potential for smokeless tobacco as a substitute for cigarettes.

The CDC: Your Online Source for Incredible Tobacco Information

2010-11-10T13:53:00.001-05:00

The U.S. government is battling tobacco and tobacco users, based to a great extent on misinformation promulgated by the Centers for Disease Control and Prevention (CDC). The CDC bills itself as “Your Online Source for Credible Health Information,” but two recent reports clearly demonstrate that the agency is deliberately deceiving Americans about fundamental facts concerning tobacco use.

Last week, the CDC published an article in the Morbidity and Mortality Weekly Report (MMWR) about the dual use of smokeless tobacco and cigarettes among men and women in the U.S. (available here). The data was from the 2009 Behavioral Risk Factor Surveillance System (BRFSS), an on-going telephone health survey tracking U.S. health conditions and risk behaviors yearly since 1984.

The information in the CDC report was routine: Smokeless tobacco use was highest in Wyoming and West Virginia (9 percent), and lowest in California (1 percent). Smoking rates were highest in Kentucky, West Virginia and Oklahoma (about 26 percent), and lowest in Utah (10 percent), California (13 percent) and Washington (15 percent).

Still, CDC director Dr. Tom Frieden used the results to rejoin the attack, with a special focus on smokeless products: “Tobacco use is the leading preventable cause of death in this country and unfortunately smokers are also using smokeless tobacco. If you smoke, quitting is the single most important thing you can do to improve your health. Use of smokeless tobacco may keep some people from quitting tobacco altogether. We need to intensify our anti-tobacco efforts to help people quit using all forms of tobacco.”

This week, with the help of the Wall Street Journal (here), the CDC turned its attention back to cigarettes, with the claim that smoking rates stopped declining several years ago. Here’s the lead:

“Many cash-strapped U.S. states are slashing budgets for tobacco-prevention programs, raising alarms among public-health groups as the nation's progress toward getting adult smokers to quit has stalled. The adult smoking rate was 20.6% in 2009, the same as a year earlier and largely unchanged since 2004, according to the Centers for Disease Control and Prevention.”

The basis for these numbers was the 2009 National Health Interview Survey (NHIS)(available here), which reported that the prevalence of smoking has been “largely unchanged” for the past several years, at just above 20%. But what about the BRFSS (discussed above)? What does that survey say about smoking rates?

For 2004, BRFSS reported the prevalence of current smoking as 20.9%, about the same as the NHIS. But for 2009, according to BRFSS, smoking prevalence had dropped to 17.9%. That’s a whopping decline of 14% in just 5 years!

One year ago I discussed in this blog how different federal surveys report contrasting data on smoking in the U.S. (here). We now have a brilliant example of how the CDC creates a consistent anti-tobacco narrative by cherry-picking data from what are essentially conflicting datasets. The public, and government budgeting officials, would be better served by a CDC that focused on reporting and explaining the unvarnished facts, free of any social behavioral bias.

Mayo Clinic Misinformation About Smokeless Tobacco

2010-11-03T11:30:00.001-04:00

For many years, tobacco “experts” at the Mayo Clinic have tarnished the institution’s name by fabricating misinformation about smokeless tobacco. In a 2004 article about such tactics (available here), I noted that the Mayo website contained this irresponsible, unprofessional and demonstrably false statement: “…smokeless tobacco, also called spit tobacco, has health risks just as severe or even more severe as those associated with cigarette smoking.”

Last week, Jennifer A. Kern, a Mayo Clinic behavioral counselor and former smoker, published a quit-smoking blog entry for the official Mayo Clinic web site, in which she invented new health risks related to smokeless tobacco use (here).

Ms. Kern begins with an explicit acknowledgment that smokeless tobacco is an effective substitute for cigarettes: “Those of us who live in the north are moving into the cooler seasons…it's not uncommon to see people switching tobacco products in order to stay indoors while still getting their nicotine fix. Some folks put down cigarettes and pick up smokeless tobacco products such as chewing tobacco and snuff instead.”

Ms. Kern doesn’t like smokers switching to vastly safer smokeless products, so she tries to convince them not to do so by invoking a “just-as-harmful” theme: “Smokeless tobacco products carry carcinogens, or cancer-causing chemicals, just like cigarettes do.”

Next, Ms. Kern turns to outright fabrication: “In fact, a variety of cancers that can be caused by smokeless tobacco use include: mouth and gum, larynx (voice box), esophagus, and salivary gland, as well as non-oral cancers like pancreas, kidney and penile cancer.”

My readers know that a comprehensive meta-analysis published in 2009 found that smokeless tobacco use is not associated with cancers of the mouth and gum, larynx, esophagus, pancreas or kidney (for a full discussion, click here). But what about salivary gland and penile cancer?

For salivary gland cancer, Ms. Kern may have misread a story involving Tony Gwynn, a former major league baseball player. In early October, Gwynn was diagnosed with cancer of the parotid salivary gland (described here), and he commented that “I haven't discussed that with the doctors yet, but I'm thinking it's related to dipping.” Apparently Gwynn and Ms. Kern are unaware that no epidemiologic studies have linked smokeless tobacco use and salivary gland cancer.

Ms. Kern’s most bizarre claim is that smokeless tobacco use causes penile cancer. According to the National Cancer Institute, penile cancer is extremely rare, occurring in only 1,250 American men each year (here). Penile cancer is strongly related to human papillomavirus infections and lack of circumcision (here). Maybe Ms. Kern was referring to a 1995 report linking penile cancer and smokeless use in India (here), but Swedish and American products have not been implicated in numerous epidemiologic studies.

Someone should counsel Ms. Kern and her employer about the public health imperative of sticking to the facts.

Good News You Never Knew About Life Expectancy in the U.S.

2010-10-27T11:42:00.001-04:00

The National Center for Health Statistics in May released final data on life expectancy and deaths in the U.S. for the year 2007 (read it here). It is an extraordinary report, because it further documents that Americans continue to live longer and healthier lives, year after year.

Compared with 2006, the age-adjusted death rate from all causes declined 2.1% in 2007. This is an extraordinary single-year decline, and it was driven by impressive reductions in five of the top 10 causes of death, as noted in the table.

Top Ten Causes of Death, and Percentage Change from 2006 to 2007

Cause of Death	Percent Change From 2006
1. Heart Diseases	- 4.6
2. Cancer	- 1.3
3. Stroke	- 3.2
4. Respiratory Diseases	+ 0.7
5. Accidents	+ 0.5
6. Alzheimer’s Disease	+ 0.4
7. Diabetes	- 3.4
8. Influenza/pneumonia	- 9.0
9. Kidney Diseases	None
10. Blood Infection	None

Heart disease, accounting for about one-quarter of all American deaths, declined almost 5% in 2007, and stroke deaths dropped by over 3%. Deaths from cancer were down over 1%, and there were impressive declines for diabetes (-3.4%) and influenza/pneumonia (-9%). These aren’t just one-year wonders; declines have been occurring for 20 to 30 years.

Chances are that you knew nothing about these incredible statistics. That’s because the federal government and most health organizations cast every health issue as a crisis. They argue that Americans are in poor health and are being killed by obesity, as well as chemicals in our food and in our environment. They portray our health care system as ineffective. They don’t want you to know the truth: death rates for most major diseases continue to plummet.

The long-term decline in smoking is playing a role, especially in the impressive reductions in heart disease, cancer and stroke rates. But many Americans are also eating healthier foods, and using preventive medications like aspirin and statins (that lower cholesterol levels) to reduce risks. And the health care system is providing ever-improved treatments.

I offer the following example to illustrate that the decline in American death rates over the past couple decades is truly astounding: let’s compare 2007 with 1987. In 2007, the nation’s age-adjusted death rate for all causes was 760 deaths per 100,000, and a total of 2,423,712 Americans died. Just twenty years earlier, the age-adjusted death rate was 970, about 28% higher than 2007 but still far lower than in previous decades. If the 1987 rate had been effective in 2007, there would have been 669,000 more deaths!

The average life expectancy at birth for the U.S. population in 2007 was the highest in history at 77.9 years, an increase of 0.2 year over the 2006 number. In other words, every American gained almost 2½ months of life expectancy in just one year! This is irrefutable evidence that our health and social system, despite its limitations, has sustained remarkable advances in the prevention and treatment of most life-threatening diseases, extending and improving the lives of millions of Americans.

Snus Users and Smokers in Stockholm

2010-10-21T13:44:00.001-04:00

A new study published in Biomed Central Public Health (available here) describes the socioeconomic and lifestyle characteristics of snus users and smokers in Stockholm County, Sweden. Based on a 2006 survey of 35,000 residents, it was authored by Karin Engström and colleagues at the Department of Public Health Sciences at the Karolinska Institute. In addition to providing interesting information about snus users, this study has important implications for Karolinska Institute claims about the link between snus use and cancer.

Among men, 17% were exclusive snus users, 11% smoked and 2.4% were dual users. Among women, cigarette smoking was dominant (15%), while snus use and dual use were only 3.1% and 0.5% respectively. Given this, I will focus on the findings for men.

It is noteworthy that the prevalence of snus use was highest among men less than 35 years old. This means that young men in Stockholm strongly prefer snus, a lifestyle choice that will have little or no effect on their health as they age.

Snus users were somewhat more likely to have lower education levels than nonusers of tobacco, a trend that was even stronger among smokers. Smokers were also more likely to be unskilled and skilled workers in the very low income group, while snus users were more evenly distributed among all occupational classes and across all income levels.

One of the more interesting results concerned alcohol consumption. Risky alcohol consumption was defined as 14 standard drinks per week; the survey also asked about weekly or monthly binge drinking. Snus users and smokers were more likely to practice risky consumption than nonusers (odds ratios = 1.8 – 1.9), and they were more likely to have weekly binge-drinking episodes (ORs around 3.1).

This information on alcohol abuse among snus users is important, because a Karolinska epidemiology group, led by Olof Nyrén, published studies suggesting that snus use is associated with a small risk of pancreatic, stomach and esophageal cancer (abstracts here and here) among workers in the Swedish construction industry. Alcohol abuse is a strong risk factor for esophageal cancer and may be linked to stomach and pancreas cancer; this makes it a confounder with respect to snus use. In other words, if snus users are more likely to be alcohol abusers, then some of the cancers attributed to snus might instead be caused by alcohol. In many modern epidemiologic studies, standard procedures are used to account for confounders. In this case, to accurately separate the risks due to snus use from those due to alcohol abuse.

But the construction worker studies had no information on alcohol consumption, so alcohol abuse could not be ruled out as a competing risk factor. The lack of information about alcohol in these studies is a serious deficiency that raises questions about the validity of Nyrén’s claims.

In summary, men in Stockholm from all income levels and all occupations prefer snus over cigarettes. The impact of this preference on their health is so small that it is barely measurable by modern epidemiologic methods. Furthermore, snus users, like smokers, are more likely to abuse alcohol, which may be a distinct risk factor for some cancers that has not been evaluated in previous Karolinska Institute reports on snus use.

Noteworthy News From Norway: Snus is Superior Cigarette Substitute

2010-10-13T09:44:00.002-04:00

In 2008, the European Commission released a report entitled “Health Effects of Smokeless Tobacco Products.” (available here). Except for one small part discussing tobacco harm reduction (Section 3.8, pages 111-118), most of the report was very negative, even denying that snus use has had any effect on smoking in Sweden and Norway.

The report concluded: “It is difficult to envision any significant impact of snus use on smoking cessation in Norway…” This was especially baffling, as Figures 19-22 (pages 42-43) show clearly that increased snus use over the last 20 years was concomitant with decreased smoking.

The Commission report also surprised Dr. Karl Erik Lund, a respected tobacco researcher with SIRUS, the Norwegian Institute for Alcohol and Drug Research. Lund has 20 years experience in tobacco research and has authored more than 85 journal articles in the fields of tobacco epidemiology, evaluation and prevention. This year, he published landmark studies showing unequivocally that snus use has had a profound impact on smoking in Norway.

Lund’s current study was published in Addiction (abstract here). He compared quit rates, defined as the percentage of ever smokers who are now former smokers, among snus users and never users in seven previously published Norwegian surveys.

Lund Survey No.	Quit Rate- Snus Users (%)	Quit Rate- Never Snus Users (%)
1	80	52
2	55	23
3	81	63
4	62	53
5	75	45
6	90	50
7	73	43

As seen in the table, the quit rates for snus users were always higher than for those who had never used snus; the results are statistically significant for all surveys except number 4. This is compelling evidence that snus has played a powerful role in smoking cessation among Norwegians. As Lund notes, it is consistent with the Swedish evidence. Equally important, it is consistent with evidence I have published from federal surveys in the U.S. (discussed in this March blog post).

Earlier this year, Lund published evidence in Nicotine & Tobacco Research that Norwegian men preferred snus over ALL other methods to quit smoking (abstract here).

The SIRUS survey asked 3,583 former or current smokers age 20-50 years what method they used when they last tried successfully (former) or unsuccessfully (current) to quit. Snus was used by 32% of all respondents, making it the most popular method by far. Other methods that enjoyed modest popularity were nicotine gum (18%), self-help material (12%), and the nicotine patch (10%). Nicotine inhaler, Zyban, Champix, telephone quit line, and help from health care professionals were also included in the survey, but they had negligible usage rates.

Lund reported an adjusted odds ratio (AOR) to indicate effectiveness of products compared with nicotine gum, the reference product. For quitting completely, the AOR for snus was 2.7, meaning that it was nearly three times more effective than gum. Snus was also three times more effective than nicotine gum in “greatly reducing cigarette consumption” among continuing smokers (AOR = 3).

Lund observed: “Of those smokers who reported that they had tried to quit by using snus, 62.4% reported that they still used snus at the time of the survey, either daily (43.8%) or occasionally (18.6%)…In comparison, only 9.5% who had used nicotine chewing gum or nicotine patches at the last attempt to quit were still using these medicinal nicotine products at the time of the survey.” In other words, snus was effective precisely because it was a satisfying and enjoyable substitute, rather than an unsatisfying and distasteful temporary medication. This represents the fundamental advantage of a recreational approach to smoking cessation, compared to treating smokers’ nicotine addiction with medications. Smokers aren’t sick; they just want to have safer alternatives.

There is no question that snus is an effective and PERMANENT nicotine substitute for many former smokers. This is important, because a dominant theme in the U.S. is that quit-smoking methods must all eventually lead to permanent nicotine and tobacco abstinence. Given that the outcome measure for all smoking cessation trials in the U.S. is complete abstinence, it is no wonder that most cessation methods are deemed failures. For successful tobacco regulation, the FDA must break the public health community’s addiction to abstinence promotion. Unfortunately, the FDA is still focused on abstinence (here).

Norwegian authorities have a more realistic and rational strategy. Lund and colleagues noted that in 2009, the Norwegian Health Directorate “agreed that health care personnel can recommend snus in individual cases of inveterate smokers.” It is refreshing that the directorate recognizes that saving smokers’ lives is more worthy and achievable than simply breaking the chain of tobacco addiction.

Imagining Tobacco Without Nicotine

2010-10-06T13:03:00.002-04:00

In June, I called attention to the unscientific proposal by two FDA tobacco advisory committee members, Drs. Jack Henningfield and Neal Benowitz, to radically reduce nicotine in cigarettes in order to force smokers to quit and prevent children from starting to smoke (read my post here). They are now the co-authors of another thinly veiled call for reducing nicotine to “non-addictive levels” in cigarettes, just published in the journal Tobacco Control (abstract here).

Henningfield and Benowitz are joined by fellow committee member Dr. Dorothy Hatsukami, the National Cancer Institute’s Dr. Cathy Backinger (read about her previous pronouncements here), FDA staffer Dr. David Ashley, and Mitch Zeller, a lawyer. Zeller works for a consulting firm employed by GlaxoSmithKline, the pharmaceutical manufacturer that last week called on the FDA to ban dissolvable tobacco products (read about it here). According to Dr. Elizabeth Whelan of the American Council on Science and Health, “GSK is clearly trying to protect its own market…” by eliminating tobacco products that it perceives as competition with its medicinal nicotine products.” (For insights on medicinal nicotine’s dismal track record, see my previous blog post).

The Tobacco Control article is an urgent call for research that would inform policy decisions regarding reduced nicotine cigarettes. Here are the questions these “six leading tobacco research and policy experts” (as they describe themselves in their press release) want answered about reducing cigarette nicotine content:

"What is the nicotine threshold dose(s) for addiction…? What are the effects of reduced nicotine cigarettes on the brain in adult smokers and in adolescents…? What is the extent of compensatory smoking…and what interventions can be used to minimize compensatory smoking, such as making nicotine available through less hazardous delivery systems (e.g. nicotine replacement therapy)…? What are the effects of reduced nicotine cigarettes in subpopulations (consumers who smoke for self-medication purposes such as those with comorbidity or who are severely addicted)…and how can negative consequences be mitigated? What would be the public’s reaction…? How could we frame the message and educate the public…? What are the potential unintended consequences from reduced nicotine cigarettes, how can [the consequences] be determined and monitored, and what needs to be done to mitigate against negative consequences?"

In other words, these “experts” can’t even define a threshold dose for nicotine addiction, and they are clueless about the effects of radically reducing nicotine in cigarettes. Yet, their press release (here ) makes nicotine prohibition sound like the perfect solution. Dr. Hatsukami ignored all those important questions, proclaiming in the release that “Reducing the nicotine in cigarettes to a level that is non-addicting could have a profound impact on reducing death and disability related to cigarettes and improving overall public health.” It appears that she has already reached conclusions before the research is performed.

Lawyer Zeller was even more fanciful: “Imagine a world where the only cigarettes that kids could experiment with would neither create nor sustain addiction.”

Unfortunately, it doesn’t take an active imagination to appreciate the disaster that would result from radical reduction (prohibition) of nicotine in cigarettes. One need only look at the nation’s reaction to alcohol prohibition, as chronicled by Daniel Orient in his outstanding book, Last Call (description here).

In 1914, U.S. per capita beer consumption was 20 gallons. In anticipation of alcohol prohibition, launched in 1920 by the 18th Amendment to the Constitution, breweries produced an alcohol-free drink, informally called near beer. Six months into prohibition, sales of near beer plummeted, and brewers turned to a more attractive and profitable alternative: malt syrup, the key ingredient for making beer. It was sold in grocery stores across the nation, and it spawned a mini-industry offering filters, bottles, bottle stoppers, and most importantly, yeast. It is not a coincidence that California vineyards survived Prohibition in a similar manner. Millions of Americans legally consumed alcohol during Prohibition by making their own beer and wine.

The prohibitionists’ response to home brewing was to call for more prohibition. In 1925, Wayne B. Wheeler, a key prohibition architect (profiled here), asked one of his friends in Congress if “the time is ripe to prohibit the sale and distribution of these malt syrups and malt supplies.” Orient writes, “It wasn’t, nor would it ever be.”

Near beer, which tasted like real beer, didn’t sell precisely because it didn’t provide alcohol, an addictive drug with benefits. Today, neo-prohibitionists, with little research and a lot of imagination, are trying to sell Americans on near cigarettes that are devoid of addictive but rewarding nicotine.

Is the time ripe for such foolishness, especially when smokers have increasing access to vastly safer smokeless alternatives? It isn’t, nor will it ever be.

Does Dual Use Jeopardize Smokeless Tobacco’s Role in Harm Reduction? Absolutely Not

2010-09-29T14:14:00.000-04:00

One year ago, I briefly discussed the “dual use” of cigarettes and smokeless tobacco by men in the U.S. (post here). Dual use is the object of persistent complaints by American tobacco control extremists. For example, in 2002, Dr. Jack Henningfield, currently a member of the FDA tobacco products scientific advisory committee, was first author of a commentary describing theoretical adverse consequences of dual use (citation here). Despite his concerns, Henningfield acknowledged that “There are virtually no data that currently exist on the safety of such use or the degree to which such use will foster the perpetuation of smoking or contribute to reduced overall smoking…The issue warrants further study.”

That study has now been done, and the results have been published online in Nicotine & Tobacco Research (abstract available here). In a review of 17 published research studies that had data on the health risks from dual use versus those from smoking, almost all of which have appeared since 2002, Kimberly Frost-Pineda and colleagues conclude that “…there are not any unique health risks associated with dual use of smokeless tobacco products and cigarettes, which are not anticipated or observed from cigarette smoking alone.” The authors further commented that “some data indicate that the risks of dual use are lower than those of exclusive smoking.”

Frost-Pineda and colleagues also found evidence from both American and Swedish longitudinal studies that dual users were more likely than exclusive smokers to quit smoking, but less likely to become completely tobacco-abstinent. For example, one American study (abstract here) found that 11% of dual users were tobacco-abstinent after 4 years of follow-up, compared with 16% of exclusive smokers. However, 80% of exclusive smokers were still smoking at the 4-year follow-up, while only 27% of dual users were smoking; 44% were still dual users and 17% were exclusive smokeless users. The differences between smokers and dual users in Swedish follow-up studies are even more impressive.

This excellent review will present major problems for Henningfield and other FDA panelists, including Greg Connolly, Dorothy Hatsukami, Jonathan Samet and Neal Benowitz, because they have established solid records opposing tobacco harm reduction. Samet, the panel’s chair, summed up this opposition in a 2009 article in the Journal of the American Medical Association (citation here ): “Snus, a moist snuff that is low in tobacco-specific nitrosamines, has received particular attention because it has been widely used in Sweden, apparently with little increase in risks for cancer and cardiovascular disease. However, there is concern that strategies to introduce lower-risk products will diminish efforts to promote prevention and cessation.”

For over 40 years, “prevention and cessation” efforts have largely failed. But tobacco prohibitionists continue to focus on those objectives, while raising a host of largely theoretical concerns about the substitution of smokeless tobacco for cigarettes. Now, scientific research shows that the “problem” of dual use is not a problem at all.

A final note: The authors of the dual use study are employees of Altria Client Services, which is owned by the parent company of Philip Morris and U.S. Smokeless Tobacco. They should be complimented for this contribution to the scientific literature on tobacco harm reduction. The editors of Nicotine and Tobacco Research deserve kudos for reviewing and publishing this manuscript.