Tuesday, December 22, 2009

Indications from Indy That Snus is a Viable Cigarette Substitute

Indianapolis is the quintessential Midwest American city, and it has served as a test market of Swedish-style snus by the two largest American cigarette manufacturers. In 2006 Philip Morris launched a test market for Taboka snus in Indy (in 2008 it was discontinued when Marlboro snus was launched). In 2007 Indy was one of several expansion markets for RJ Reynolds’ Camel Snus; that product went on to national distribution earlier this year.

Lois Biener and Karen Bogen, from the University of Massachusetts Center for Survey Research, analyzed data from the 2006-7 Indiana Adult Tobacco Survey, and their recently published study provides some valuable information.

Biener and Bogen reported that almost 20% of survey respondents throughout Indiana were aware of snus. Awareness among smokers statewide was 44%, which was 4.5 times higher than awareness among non-smokers.

Awareness among respondents in central Indiana (i.e. around Indianapolis) was 29%. More importantly, about 64% of male smokers in central Indiana had heard about snus, and 20% had tried it. This is evidence that Philip Morris and Reynolds were targeting adult male smokers in their test-market campaigns, and that the manufacturers were fairly successful.

Biener and Bogen also reported that risk perception played an important role in getting people to try snus. Respondents who correctly believed that smokeless tobacco is less harmful than cigarettes were almost 4 times as likely to try snus as those who had been misinformed about the differential risks. Unfortunately, this study revealed that 88% of all respondents had been misinformed, so they incorrectly believed that smokeless tobacco was just as dangerous as cigarettes.

Biener and Bogen offer some perceptive comments on the sad state of smoker misinformation:

“Both marketing and health education messages should include the information that all tobacco products are harmful and that abstinence from all tobacco products is the most healthful choice. At the same time, simply saying that smokeless tobacco is ‘not safe’ is not a sufficient stance for public health communications. There is a recognized continuum of risk along which various tobacco products can be placed, with low-nitrosamine smokeless tobacco products much lower on the risk continuum than combustible tobacco, although it is not harmless. Devising an effective way to inform the public about the continuum should be an important research priority, as currently consumers are woefully incorrect in their assessments of relative risk of various tobacco products. This state of affairs could result in people deciding not to give up smoking in favor of a product lower on the risk continuum because they assume that all tobacco products are equally harmful.”

Biener and Bogen mention that information about differential risks of smokeless and smoking have appeared in the media, and they cite a 2006 article by Kevin Helliker in the Wall Street Journal. That article remains the most well researched and best written description of tobacco harm reduction, and it can be found here.

Thursday, December 17, 2009

Monitoring the Truth About Tobacco Use in Children

The Monitoring the Future Study, based at the University of Michigan, just released its report on youth tobacco, alcohol and drug use in 2009. In October, I discussed previous findings from the MTF study.

With respect to alcohol use among 12th graders, the new report is very similar to that of the previous year. A whopping 44% of 12th graders had used alcohol, and 27% had been drunk during the past 30 days. Obviously, this put them at immediate and potentially life-threatening risk for alcohol poisoning, motor vehicle and other accidents.

The findings for cigarette use in 2009 were also similar to those from 2008; 20% of 12th graders had smoked in the past 30 days.

In 2009, smokeless tobacco use among 12th graders increased to 8.4% from 6.5% in 2008. At first glance, that appears to be a big jump, but MTF did not find it statistically significant. In fact, MTF did not mention smokeless tobacco in its press release. Despite a paucity of evidence, anti-tobacco fanatics have already decided who is to blame. John Spangler, a tobacco prohibitionist from Wake Forest University who has a National Cancer Institute grant to study smokeless tobacco use among college students, claims that increased marketing of smokeless tobacco likely has had some effect on teenagers.

Matt Myers, president of prohibitionist Campaign for Tobacco Free Kids, is certain that tobacco companies are to blame: “This increase coincides with the introduction of numerous new smokeless tobacco products and a big increase in smokeless tobacco marketing…These new products no doubt appeal to kids because they are easy to conceal, carry the names of youth-popular cigarette brands, and come in candy-like forms and flavors. More than 60 percent of smokeless marketing is spent on price discounts, including coupons, that make smokeless tobacco products more affordable and appealing to price-sensitive youth customers.”

Anti-tobacco fanatics have developed a brilliant strategy for dealing with ANY new research findings about tobacco use: If it’s good, take credit; if it’s bad, blame the industry.

This strategy has an intuitive appeal, and it pits the public health “angels” against the tobacco industry “demons.” But it doesn’t set a very good precedent for the application of scientific principles to public health policy. And it breaks down after applying even a small dose of common sense.

MTF also reported that past 30-day use of marijuana among 12th graders was higher in 2009 than use of cigarettes (20.6% vs. 20.1%). Perhaps anti-tobacco fanatics can answer this question: Which industry is responsible for marijuana use among children?

Any use of drugs, most importantly alcohol, among children is a major problem that should concern every American. We need to better understand the social and behavioral reasons why children experiment and adopt substance use, and we need interventions that are tailored to the relative impact of each substance on children’s health. With these rational guidelines, smokeless tobacco is at the bottom of the priority list.

Wednesday, December 9, 2009

Polycyclic Aromatic Hydrocarbons in Smokeless Tobacco: Much Ado About Snuffing

In August, I wrote about a report by a prohibitionist University of Minnesota group claiming that one pinch of smokeless tobacco is five times more dangerous than smoking. They reported that smokeless tobacco products contain PAHs, a complex family of chemicals that are formed during the incomplete burning of almost any product, including coal, oil, gas, wood or other organic matter.

The researchers, led by Irina Stepanov and Stephen Hecht, pitched these claims to national media at a press conference sponsored by the American Chemical Society. But they refused to share their results with other scientists, pleading that “we are in process of publishing a full paper on this study.”

That paper has just been published, and it has been pitched again to national media. Again, the headlines scream “high levels of toxins,” and Stepanov et al. portray the results in almost apocalyptic terms: “Our findings render PAHs one of the most prevalent groups of carcinogens in smokeless tobacco. Urgent measures are required from the U.S. tobacco industry to modify manufacturing processes so that the levels of these toxicants and carcinogens in U.S. moist snuff are greatly reduced.”

Are the PAHs really toxins? Are the levels really “high”? Are emergency measures really indicated?

Unproven toxins

Stepanov analyzed smokeless tobacco samples from the U.S. market for 23 PAHs, and the manuscript implies that all of these are proven cancer-causing chemicals (carcinogens). Not even close.

I compared Stepanov’s list with a database maintained by the authoritative International Agency for Research on Cancer. IARC has reviewed several hundred chemicals for cancer-causation, and it has classified them on the strength of the scientific evidence as (Group 1) Carcinogenic to humans, (Group 2a) Probably carcinogenic, (Group 2b) Possibly carcinogenic, and (Group 3) Not classifiable. Groups 2a and 2b are largely based on animal or laboratory studies with no direct human evidence. IARC is a recognized authority, but it is inclined to label chemicals as human carcinogens if there is even a shred of evidence.

Readers will be amazed at how many IARC Group 1 carcinogens are on Stepanov’s list: Exactly ONE. Her list included one chemical IARC calls “probable”, while eight agents are in the still less threatening category of “possible”. More importantly, twelve (over half!) are NOT EVEN CLASSIFIED. (I couldn't find the remaining chemical in any IARC list.)

Low, Low Levels

Stepanov not only misrepresented the number of carcinogens. She implied that levels were dangerously high, stating that “moist snuff can be considered an important source of human exposure to PAHs.” Her data contains virtually no evidence for this statement.

In order to discuss Stepanov’s data, I’ll have to give a short primer or review of the metric system weights. Let’s start with a reference weight 1 kilogram, which is about 2.2 pounds.

1 kilogram = 1000 grams
1 gram = 1000 milligrams
1 milligram = 1000 micrograms
1 microgram = 1000 nanograms

Stepanov reported PAH concentrations in nanograms per gram of (dry) tobacco. A nanogram is one trillionth of a kilogram, or one billionth of a gram, so we are talking about vanishingly small amounts.

A can of moist snuff contains about 30 grams of tobacco, but about 50% of this weight is water, so the effective tobacco content is 15 grams.

The most important PAH on Stepanov’s list is benzo(a)pyrene (BaP), the only IARC Group 1 carcinogen. In Stepanov’s ideal world, no one would consume BaP; but we live in the real world, in which a fundamental tenet of toxicology is: the dose determines the poison. Despite Stepanov’s rhetoric, the level of BaP is very low in her tests, at an average of 56 nanograms per gram. That means that a one-can per day user is potentially exposed to 840 nanograms of BaP per day.

What does this level mean? Fortunately, the federal Environmental Protection Agency (EPA) has information that provides perspective. It says that “BaP is commonly found … in cigarette smoke, in grilled and broiled foods, and … in some water sources.” According to a study published in the Journal of Agricultural and Food Chemistry, a person eating a char-broiled quarter-pound hamburger consumes about 400 nanograms of BaP. The EPA says that water can have 780 nanograms of BaP per gallon and still be acceptable. This means that someone who eats a quarter-pound burger and drinks a half-gallon of water may consume about as much BaP as a can-per-day moist snuff user.

The EPA gives guidance for consumption of 5 other PAHs on Stepanov’s list, which are available in this document from the CDC. In fact, it gives specific consumption levels of these chemicals which are “not likely to cause any harmful health effects.” Using this information, I have estimated the number of cans of moist snuff that can be safely consumed daily by a 110-pound man with respect to these 5 PAHs:

PAHStepanov’s Concentration (nanograms per gram)Number of Cans Per Day That Can Be Safely Consumed

I have been very conservative in developing these estimates. First, Stepanov used special solvents to get maximal extraction of PAHs from the samples; I have assumed that smokeless users consume those amounts, which is probably a serious overestimate. It is well known that PAHs are not very soluble in water, so it is likely that actual PAH consumption by smokeless users is much lower than the level reported by Stepanov.

One final comment: the EPA has estimated that on average, a person in the U.S. is exposed to about 3 milligrams of all PAHs every day. That’s 3 million nanograms. A person consuming a can of moist snuff per day is exposed to 174,000 nanograms, which is less than 6% of normal daily exposure.

No tobacco product is perfectly safe, but there is very little epidemiologic evidence that using smokeless tobacco, including American moist snuff, is associated with any cancer. Despite this, Stepanov and colleagues chemically characterize these products as major causes of cancer. Their rhetoric is not sustained by their data.

Thursday, December 3, 2009

European Experts Continue to Ignore the Swedish Miracle

A new study by cancer epidemiologists clearly provides evidence that snus use among men in Sweden is responsible for the lowest cancer death rate on the European continent. Surprisingly, the authors avoid drawing this obvious conclusion in both their article and their press release.

The study examined cancer mortality trends in 34 European countries over the period 1975-2004. It found that cancer deaths among men throughout Europe declined, mainly due to a drop in “lung and other tobacco-related cancers,” according to co-author Cristina Bosetti. The study shows that men in Sweden have the lowest death rates for lung cancer (less than 50% of the European Union rate) and for all cancers, while rates for Swedish women are at or above EU averages.

These findings are fully consistent with my recently published study of European lung cancer, which I discussed in a recent blog post.

The authors of the new study recognize that differences in cancer death rates among European countries reflect differences in smoking; they conclude that “further reduction of tobacco smoking remains the key priority for cancer control in Europe.” That’s perfectly true. But why did the authors ignore the only legitimate explanation of low cancer rates for Swedish men: the miracle of tobacco harm reduction?

It is important to point out that the difference in cancer rates between Swedish men and the rest of Europe is not a new finding. The first author of the current study, Carlo La Vecchia, is a prolific epidemiologist who previously published a study of cancer in Europe during the period 1955-1989. That study clearly shows that Swedish men have always had the lowest lung cancer rates on the continent.

When that study was published in 1992, there was little appreciation, either in Sweden or elsewhere, of the effect of snus use on smoking. But now there is a wealth of scientific literature on the Swedish miracle. When epidemiologists, tobacco researchers, policy experts and government regulators purposefully avoid talking about tobacco harm reduction, they put their reputations in jeopardy, to speak nothing of the lives of millions of smokers.

Wednesday, November 18, 2009

It’s a GAS, Take 34

November 19 is the date when American smokers are supposed to experience GAS, which is the American Cancer Society’s annual Great American Smokeout.

The American Cancer Society (ACS) has been producing GAS for 34 years, during which time it has refused to acknowledge that tobacco harm reduction is a legitimate public health option. That’s the main reason GAS is just a lot of hot air.

ACS has even criticized other medical organizations that want to tell smokers the truth. In 2007, the Royal College of Physicians, one of the world’s oldest and most prestigious medical societies, issued a comprehensive report reviewing and corroborating the impressive scientific foundation for tobacco harm reduction. The report 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.”

The response from the ACS and its vice president for epidemiology Michael Thun to this thoughtful treatise was a disservice to the millions of inveterate smokers in the U.S. who can not achieve complete abstinence from nicotine and tobacco.

Dr. Thun dismissed the existence of inveterate smokers as a “false assumption,” even though over 13 million Americans have died from smoking-attributable illnesses in the 34-year history of GAS. His solution is to provide all smokers with “sufficient counseling and treatment.”

“Counseling” consists of giving smokers behavioral coping skills. ACS instructs smokers who are in desperate need of nicotine to “Take a walk, go get a drink of water.” In 1991, the National Cancer Institute told physicians to help their patients quit smoking by advising them to: 1) ”Keep your hands busy- doodle, knit, type a letter,” 2) ”Cut a drinking straw into cigarette-sized pieces and inhale air,” and 3) ”Keep a daydream ready to go.” I’ve never met a smoker who could daydream himself out of craving for a cigarette, and I’ve never met a physician who passes along these ridiculous tips.

“Treatment” refers to pharmaceutical nicotine. In a prior post I discussed why these products fail to help smokers. They’re expensive, unsatisfying and most smokers have no interest in using them. If any other medication had the dismal 7% success rate of pharmaceutical nicotine products, the FDA would remove it from the market.

The grim reality is that Dr. Thun’s approach is grossly inadequate. According to the 2006 National Institutes of Health (NIH) Consensus Conference on Tobacco Use, “…fewer than 5 percent [of smokers] succeed [in quitting] in any given year. Effective tobacco cessation interventions are available and could DOUBLE OR TRIPLE SUCCESS RATES…” (emphasis added). This means that providing Dr. Thun’s “conventional treatments” to all 45 million American smokers would help fewer than 15% – no more than 7 million – to quit. Dr. Thun has no plan for the other 38 million adult smokers, except denying them life-saving information about safer smokeless tobacco products.

Dr. Thun understands the difference in risk between cigarettes and smokeless use; he served on a review panel for a National Cancer Institute-sponsored study which concluded that the health risks from the latter are at least 90% lower than those from smoking. However, he withholds this information from smokers because it might “postpone quitting.” He fears that smokeless will repeat the “fiasco of ‘Light’ and ‘Mild’ cigarettes,” which he characterizes as an industry-driven conspiracy. But that is only part of the story.

ACS played a prominent role in the fiasco, publishing research in 1976 showing that light cigarettes were indeed safer. ACS investigators wrote that “total death rates, death rates from coronary heart disease, and death rates from lung cancer were somewhat lower for those who smoked ‘low’ tar-nicotine cigarettes than for those who smoked ‘high’ tar-nicotine cigarettes.” The ACS made a mistake with light cigarettes, but the scientific evidence for smokeless tobacco is unequivocal.

Prohibitionists routinely stifle discussion by transforming every tobacco topic into a children's issue. Dr. Thun’s claim that “apple, peach, and mint” flavored smokeless tobaccos target children sets a new standard of insincerity. If he really believes that these are children’s flavors, Dr. Thun should campaign to eliminate them from alcoholic beverages, another cancer-causing adult-only consumer product. As with alcohol, tobacco manufacturers ought to be free to make their ST products appealing to adult tastes. Carping about flavored tobacco products is not responsible tobacco control; it is unwarranted harassment of adult consumers and the manufacturers who serve them.

Tobacco initiation by young people should be stopped in its tracks, but the relative safety and palatability of ST isn’t a children’s issue. The 8 million Americans who will die from smoking-related illnesses in the next 20 years are not children today; they are adults, 35 years and older. Preventing youth access to tobacco is vitally important, but the Thun/ACS position on tobacco harm reduction effectively condemns millions of smoking parents and grandparents to premature death. If any other consumer product was as dangerous as cigarettes, society would demand safer alternatives. It is
scandalous that the Cancer Society is not telling smokers the truth.

Monday, November 16, 2009

Tobacco Prohibition on American College Campuses

The pernicious and unmistakable march toward tobacco prohibition in the United States continues. It is especially depressing that many of the nation’s colleges and universities, institutions that promote themselves as bastions of tolerance and diversity, have implemented not just indoor smoking bans (which have a solid scientific rationale) and outdoor smoking bans (which have virtually no scientific rationale), but universal bans of all tobacco products.

Recently the University of Montana announced that it will impose a school-wide tobacco ban in 2011. The measure is the brainchild of a tobacco task force of misinformed public health activists such as Kari Harris, an associate professor of public health at the university. She said that the ban includes smokeless tobacco because just banning smoking would give students the message that it's safer to use other forms of tobacco. Harris concluded: “Is that the message we want to send?” Heaven forbid an institution of higher learning should provide students accurate information about tobacco use, one of the most important public health issues of our time.

University officials feigned concern over this draconian proposal. Linda Green, director of health enhancement at UM and a Tobacco Task Force member, said she expects - and wants - to hear plenty from students, even if it's outrage. “This is new territory for us… We want to hear their concerns,” she said.

Here are my concerns...

Why are university officials eager to ban smokeless tobacco, a product that is about as safe to use as an automobile?

How can the university enforce a ban on modern smokeless tobacco products, many of which are spit-free and invisible? Will campus police employ tobacco-sniffing dogs at security checkpoints? Will faculty and staff conduct random mouth checks before university lectures? How will the University of Montana resolve the inherent discrepancy between the tobacco ban and its policy on alcohol use (available here), a far more dangerous product?

A comprehensive national review of alcohol use among college students found that 42% (3.8 million) consumed 5 or more drinks on an occasion in the past month. Thirty-one percent of college students (2.8 million) admitted to driving under the influence of alcohol in the past year.

The review also found that over 500,000 college students are unintentionally injured every year because of alcohol and more than 600,000 were hit or assaulted by another drinking student. In total, over 1,700 college students died from alcohol-related motor vehicle accidents and other injuries.

Tobacco prohibition has been endorsed by many colleges and universities. The American College Health Association recommends that institutions of higher learning take the following position “because the improvements to health can be so significant”: Tobacco use is prohibited on all college and university grounds, college/university owned or leased properties, and in campus-owned, leased, or rented vehicles.”

For all the reasons noted above, and more importantly because alcohol consumption is illegal for about three-quarters of undergraduate college-age students, I asked the ACHA whether it had a position on alcohol. According to its communications coordinator, “ACHA does not have any recommendations or a position statement regarding alcohol use on campus.”

In summary, there is virtually no legitimate basis for American colleges and universities to prohibit the use of smokeless tobacco products. Furthermore, the imposition of tobacco bans are feel-good measures by and for health nannies, who neither have the means nor the fortitude to tackle far more important health risks facing our nation’s college population.

Monday, November 9, 2009

How Many Americans Smoke?

The U.S. Centers for Disease Control and Prevention (CDC), provider of “official” statistics on American smokers, has generally reported a downward trend in adult smoking. For example, in 1998 the CDC said 24.1% of the population (47.2 million adults) smoked. By 2005, the CDC said the number had declined to 20.9% (45.1 million).

Are CDC smoking estimates accurate?

UAB epidemiologist Philip Cole and I asked this question in a new study, published in the European journal Public Health. In contrast to the decline reported by the CDC, we found evidence from another federal source that the number of adult smokers in the U.S. has been stable for about a decade. In 2005, for example, the CDC estimate was 45.1 million smokers; our analysis revealed that number could be as high as 54.2 million.

The CDC Counts Smokers Using the National Health Interview Survey

The CDC uses two questions from the National Health Interview Survey (NHIS) to establish the smoking status of participants. The first question is, “Have you smoked at least 100 cigarettes in your entire life?” Subjects who answer “no” are never smokers, and those who answer “yes” are ever smokers. Ever smokers are asked a second question: “Do you now smoke cigarettes every day, some days, or not at all?” Respondents who answer “every day” or “some days” are current smokers; those who answer “not at all” are former smokers.

We Counted Smokers Using the National Survey on Drug Use and Health

We used the National Survey on Drug Use and Health (NSDUH), which is sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA). Although NHIS and NSDUH survey data on adult smoking have been available for many years, no government agency has ever directly compared them. The Office of Applied Studies at SAMHSA acknowledged differences in the two surveys, but it offered no explanation for the discrepancy.

NSDUH asks a 100-cigarette lifetime question that is identical to NHIS. But NSDUH does not ask about every-day or some-day smoking. Instead, it asks questions about smoking in the past 30 days, which the CDC counts as current smoking. If subjects reported that they had smoked on all 30 days we called them every-day smokers; if they had smoked on 1 to 29 days, we called them some-day smokers.

NHIS and NSDUH Surveys Show Different Pictures of American Smoking

We found that NHIS and NSDUH describe an increasingly divergent picture of smoking in the U.S. over the 1998-2005 period. In 1998, smoking prevalence in both surveys was 24%. By 2005, NHIS prevalence had declined to 21%. But the NSDUH estimate was 25%, suggesting no change. The difference is not trivial: NSDUH’s 4.5% higher estimate in 2005 amounted to 9.1 million more smokers than the NHIS estimate.

Higher smoking prevalence estimates in NSDUH are largely due to much higher estimates for some-day smoking. This is not surprising, because NSDUH surveys included as some-day smokers persons who smoked as infrequently as one day in the past month. In the 2005 NSDUH, one-quarter of 18-34 year old some-day smokers and almost one-third of 35+ year-old some-day smokers smoked only on 1 to 4 days in the past month. If these very occasional smokers had been subjects in the 2005 NHIS survey, perhaps they would not have been counted as smoking at all.

Our findings are consistent with a recent study of college students who smoked at least one cigarette in the past 30 days, 50% of whom denied being smokers. Among the deniers, about 70% smoked on only 5 or fewer days in the past month.

Cigarette smoking has been described in many government publications as “the single most preventable cause of disease and death in the United States.” But in order to estimate accurately the consequences of smoking, it is necessary for the government to count smokers accurately. It is surprising that the CDC counts smokers using only one source, the NHIS survey, and that little research has been conducted to assess its accuracy. Our study raises doubt about the CDC’s claim of a recent decline in smoking. Investigation of this discrepancy by federal survey administrators may lead to better surveys and an improved understanding of American smoking trends.

Thursday, October 29, 2009

Observations on a New Tobacco Harm Reduction Commentary

In August I discussed a comprehensive meta-analysis of smokeless tobacco use and cancer, which was published by Peter Lee and Jan Hamling in the prestigious journal BMC Medicine. Recently that journal published a commentary by David Timberlake and Jason Zell, professors at the University of California at Irvine. The article, available here, will be widely read and will likely promote lots of debate, so I will make some critical comments.

Timberlake and Zell attribute the origin of the “controversy” over the use of smokeless tobacco as a “potential substitute for cigarettes” to the “steep decline” in smoking among Swedish men “over the past two decades.” They conclude that “it is premature to state that the increased use of ‘snus’ is causally associated with tobacco substitution and the decline in morbidity.” Unfortunately, Timberlake and Zell have repeated a common misunderstanding of the Swedish data.

Most commentators describe the “Swedish experience” as a recent phenomenon. This is incorrect. Philip Cole and I published a study earlier this year in the Scandinavian Journal of Public Health and discussed in this blog, which examined lung cancer rates among men and women in all European Union countries for the past 50 years. We concluded “that snus use is inversely correlated with cigarette consumption among men in Sweden, resulting in the lowest [lung cancer mortality rates] in Europe for most of the past 50 years.” Thus, Timberlake and Zell are mistaken that it is “premature to state that increased use of ‘snus’ is causally associated with tobacco substitution and the decline in morbidity.” In fact, nothing else adequately explains the profound and sustained differences between very low lung cancer mortality in Swedish men compared with other EU countries over the past half-century.

Timberlake and Zell correctly observe that clinical trials are starting to address the efficacy of tobacco harm reduction. They describe a Danish quit-smoking trial that used smokeless tobacco as successful at 7 weeks and unsuccessful at 6 months, but they could have explained that the investigators urged subjects to be tobacco-free at 3 months. It is perfectly clear that smokeless tobacco will not be any better for smoking cessation than pharmaceutical nicotine (that is, terrible) IF the ultimate objective is complete nicotine and tobacco abstinence. This objective is the Achilles heel of the conventional quit-smoking mindset, and it is entirely unnecessary. The appropriate objective is for smokers to lead longer and healthier lives, and this can be accomplished by not forcing smokers to abstain completely from nicotine and tobacco.

Timberlake and Zell repeat anti-tobacco extremists’ claims that “[c]arcinogens in smokeless tobacco include high levels of nitrosamines, polycyclic aromatic hydrocarbons and other agents,” and they cite a monograph from the zealous International Agency for Research on Cancer. These contaminants are present in smokeless tobacco, but in miniscule concentrations that aren’t relevant to human health.

Trace levels of contaminants are in virtually every product that humans consume. For example, in 2000 Bruce Ames, a well known expert in carcinogenesis (cancer causation), published an article noting that roasted coffee contains thousands of chemical agents. At that time about 30 of them had been tested as carcinogens, and 21 were positive. Thus, even though coffee contains cancer-causing chemicals, there is no epidemiologic evidence that coffee is a significant risk factor for any cancer in humans who consume it. Similarly, although smokeless tobacco contains trace levels of carcinogens, the cancer risks among smokeless users are so low that they are barely measurable with modern epidemiologic methods.

Timerlake and Zell represent that Lee and Hamling observed “excess risk” for oropharyngeal cancer among smokeless tobacco users, but this is perplexing. As I noted in August, Lee and Hamling found no risk related to smokeless tobacco after adjustment for smoking and alcohol, two risk factors acknowledged by Timberlake and Zell.

In some sections Timberlake and Zell get on the anti-industry train, which may be attractive to anti-tobacco extremists but may not be entirely accurate. For example, they suggest that Philip Morris had a crystal ball as early as 1984 regarding the benefits of smokeless tobacco. This is just short of nonsense, because until 2005, none of the major cigarette manufacturers had ANY stake in smokeless tobacco. Prior to that, cigarette and smokeless manufacturers were absolute competitors, representing a lost opportunity for tobacco control advocates who failed to focus on the most harmful products (cigarettes and other combustible tobacco products).

Timberlake and Zell also appear to agree with the anti-industry complaint that it is “more interested in the dual use of tobacco products, rather than tobacco substitution.” It is true that some ads promote smokeless use during “times when you can’t smoke.” But the industry has been forced into a marketing corner so tight that it doesn’t have any other choice. With the idiotic warning present on smokeless products since 1986 (This product is not a safe alternative to cigarettes), a marketing campaign focusing on substitution would be a ticket to self-destruction. It is depressing to think that FDA regulation is likely to make a science-based switch-to-smokeless pitch even less likely.

I have been critical, but there is much to recommend Timberlake and Zell’s commentary. For the most part, they provide a balanced discussion of key issues, which is absent in many other published articles. With respect to the Lee-Hamling study, they correctly conclude that “the overwhelmingly null (i.e., zero) associations with cancer in this high quality analysis are provocative, if not compelling.” Regarding the gateway issue (the idea that smokeless tobacco use leads to smoking, especially among children), their interpretation is on target: “even if a gateway effect to smoking exists, which is doubtful, only a minority of smokeless-tobacco users would be affected.” They address the role of human papillomaviruses, another commonly forgotten risk factor in oral and pharynx cancer. Finally, they recognize that FDA regulation “may not be the sole determinant of harm reduction’s fate in the USA,” and they “anticipate that much of the debate will shift from the discussion of epidemiologic data to the discussion of the marketing, health communication and economics of smokeless tobacco.” When that happens, it will be long overdue.

Friday, October 23, 2009

Nonsense from the American Cancer Society

Last week, the New York City Council voted to ban all flavored tobacco products. While the ban excludes menthol cigarettes, it effectively prohibits many smokeless tobacco products that are vastly safer alternatives to cigarettes. This action means smokers who wish to quit without abstaining from nicotine will have fewer options available. That’s perfectly acceptable to tobacco prohibitionists, who claim that the law will prevent smoking by children, even though adolescent smokers overwhelmingly prefer unflavored cigarettes (see my post on flavored products, here).

On October 16, Jeff Stier, associate director of the American Council on Science and Health, wrote a commentary in the New York Post that was justifiably critical of the ban. Stier observed that smokeless tobacco and e-cigarettes “are noncombustible, eliminating almost all smoking risks. They could be a lifesaver; the only reason to crack down is the ideology of the public-health movement, which has decided that anything that has tobacco in it, or even looks like a cigarette, must be illegal, even for sale to adult smokers trying to stop smoking.” Stier concluded that these types of “government actions will do nothing to protect kids. The only effect is to promote the most dangerous form of tobacco use, smoking cigarettes.” Stier’s comments reflect ACSH’s position as a relentless opponent of smoking, but a strong supporter of tobacco harm reduction.

On October 22, the American Cancer Society responded to Stier with a letter to the Post from Clare Bradley, Chief Medical Officer of the Eastern Division. What Dr. Bradley said was pure nonsense.

Dr. Bradley claims that “using snus does not eliminate the risk of lung cancer. Smokers who use smokeless tobacco as a supplemental source of nicotine in an effort to quit smoking actually increase their risk of lung cancer.” Is it possible that a Cancer Society official actually believes that smokeless tobacco increases the risk for lung cancer?

Dr. Bradley’s prescription for smokers desperate to quit: “The best way to quit smoking is not to start.” She tells smokers who may not be able to accomplish that task that “nicotine-replacement therapy [NRT], when paired with a program to help change behavior, is a proven cessation method.”

What is “proven” about NRT is that it works for only 7% of smokers who try it.

By opposing tobacco harm reduction, the American Cancer Society is working against the health and welfare of smokers.

Monday, October 19, 2009

Misinformation from the American Dental Association

On October 9, the American Dental Association submitted a letter to the Food and Drug Administration in response to a federal register notice requesting public input on the role of the FDA in tobacco regulation. In the letter, available on the regulations.gov website, the ADA uses pseudo-scientific language to advocate for prohibition of all tobacco products, including smokeless tobacco. Following are some of the letter’s most absurd statements.

1. “We also ask that you begin your work by regulating industry assertions that smokeless tobacco is a healthier (or less harmful) alternative to cigarette smoking.”

While the ADA refers to “industry assertions” about the relative safety of various tobacco products, it ignores the growing number of independent health assessments from academia, public health organizations and other non-industry sources. The British Royal College of Physicians, the American Council on Science and Health and the American Association of Public Health Physicians have concluded that smokeless tobacco use is associated with a tiny fraction of the health risks of smoking.

The task of regulating “industry assertions” was intensively covered in the bill granting FDA regulatory control over tobacco. In fact, the agency was empowered to restrict any action that could “be reasonably expected” to result in “consumers believing” that an alternative tobacco product may have some health benefit vis a vis cigarettes. That’s not just regular commercial speech (e.g., advertisements), but ANY speech, and it’s one reason that several tobacco companies are suing in federal court to block this part of the law.

2. “Smokeless tobacco is not a healthy alternative to cigarette smoking; both products pose health risks. Compared with cigarettes, smokeless tobacco products are less likely to cause lung cancer but they are associated with oral (mouth) and pharyngeal (throat) cancers, as well as cancers of the stomach and pancreas (5,6,7,8).”

No one is suggesting that smokeless tobacco is a “healthy” alternative. The ADA is inappropriately manipulating the legitimate message of tobacco harm reduction.

At least the ADA admits that smokeless tobacco is “less likely” to cause lung cancer. In fact, the most comprehensive study of smokeless tobacco and cancer (previously discussed in this blog) revealed NO risk for lung cancer. Apparently, the ADA doesn’t consider the elimination of 125,500 deaths from lung cancer to be a sufficient public health gain to offset what it believes are risks from other cancers. That meta-analysis also proves that the ADA is wrong on the other cancers as well.

Note that three of the four numbered references supporting the ADA’s statements about other cancers were from the 1990s, when many experts mistakenly believed that smokeless products weren’t much safer than cigarettes. Either the ADA only reviewed selective scientific literature prior to 2000, or the organization chose to ignore irrefutable evidence supporting tobacco harm reduction. The fact is: If all U.S. smokers had instead used smokeless tobacco, cancers now attributable to smoking would plummet to around 1% of their current numbers.

3. “Researchers have found that adolescent boys who use smokeless tobacco products are highly likely to become cigarette smokers within four years (14).”

This is the ADA’s major rationale for its allegation that smokeless tobacco is a “gateway” to cigarette smoking. The reference is to a study by Scott Tomar, a staunch opponent of tobacco harm reduction at the University of Florida. Tomar’s theory has been disproven by Kozlowski and colleagues in published articles available here, here and here. These studies carefully examine datasets in order to determine whether ST or cigarettes were used first. They concluded that ST use plays no significant role in smoking initiation. The vast majority of smokers never used ST, and two-thirds of ST users either never smoked, or they smoked prior to using ST. That makes two-thirds of ST users ineligible to even be considered as gateway users.

It is not surprising that boys who use ST are more likely to become smokers, since experimentation with one tobacco product is closely linked to other similar behaviors. But opponents of harm reduction are deliberately confusing association with causation. Smoking among teenagers is also associated with alcohol use, drug use, risky driving, risky sex, bad grades and behavior problems, but it doesn’t cause them.

4. “That is one among many reasons former U.S. Surgeon General Richard H. Carmona classified the smokeless tobacco alternative as a ‘public health myth.’”

I am astounded that the ADA is still quoting the 2003 Congressional testimony of former Surgeon General Richard Carmona; he has virtually no credibility on this topic. I also testified at that hearing, and I was stunned by Carmona’s uneducated and completely inaccurate statements.

In his testimony, Carmona stated: “There is no significant scientific evidence that suggests smokeless tobacco is a safer alternative to cigarettes.” Carmona ignored decades of published research and the prestigious British Royal College of Physicians, who had reported a year earlier that smokeless tobacco products are “on the order of 10 to 1,000 times less hazardous than smoking”.

Carmona also testified that he wanted to ban tobacco products. Asked if he “would support banning or abolishing all tobacco products,” Carmona responded, “I would at this point, yes.” This marked the first time a Surgeon General had called for outright prohibition, and he sent would-be supporters running from the Hill. Even the Campaign for Tobacco-Free Kids, which has shown no interest in helping inveterate adult smokers, couldn’t support Carmona. Its spokesman commented that “We would all like to see a tobacco-free world…we can’t just take away their tobacco.” Bush administration officials responded quickly. “That is not the policy of the administration,” commented White House spokesman Scott McClellan, saying that Carmona’s comments represented only his views as a doctor.

The American Dental Association’s prohibitionist policy towards tobacco use is a disservice to dentists and their smoking patients; it denies them life-saving information about effective and vastly safer smokeless alternatives.

Friday, October 9, 2009

More Good News on Teen Smoking: Rates At or Near Record Lows

Last week I discussed my recently published study of smokeless tobacco use among adult men in the U.S. But what about tobacco use among children? It’s an important question. Earlier this year, when Congress gave the FDA regulatory authority over tobacco products, Chris Dodd (D- CT) told the Senate that the bill was “necessary…to protect our children and the public health from deadly tobacco products.”

Readers already know that smokeless tobacco doesn’t even come close to falling into the “deadly” category. In fact, the health risks (cancer, heart and circulatory disorders and all other tobacco-related illnesses) of long-term smokeless tobacco use are so small that they are barely measurable using modern epidemiologic methods.

Still, American media dwell on references to tobacco use among children, giving the impression that it is an escalating crisis. As Senator Blanche Lincoln (D- AR) put it, the FDA bill “would implement important marketing restrictions on tobacco products and especially on the marketing practices that have been shown to increase tobacco use among our Nation's young people.”

Let’s look at data behind those “increases” in tobacco use.

The title for this post was borrowed from a press release dated December 11, 2008 by Monitoring the Future, an authoritative source for information about tobacco use among children. MTF is a long-term survey-based study of the behaviors, attitudes and values of American high school students. It has been collecting information on smoking and smokeless tobacco use among grade 12 students since 1975. MTF, like other youth surveys, counts any child who has used a tobacco product within the past 30 days as a current user. Prevalence estimates using this definition are not understated; they tend to be higher than those using the adult definition, which counts only people using tobacco “every day or some days.”

Let’s start with 1998, the year of the Master Settlement Agreement, in which seven tobacco companies (including UST, the nation’s largest smokeless manufacturer) agreed to change the way tobacco products were marketed and pay the states an estimated $206 billion. Tobacco manufacturers agreed not to “take any action, directly or indirectly, to target Youth within any Settling State in the advertising, promotion or marketing of Tobacco Products, or take any action the primary purpose of which is to initiate, maintain or increase the incidence of Youth smoking within any Settling State.” We’ll end with 2008, the most recent year for which MTF data is available.

According to MTF, 8.8% of 12th graders were users of smokeless tobacco in the past 30 days (15.6% percent of boys and 1.5% of girls) in 1998. Ten years later, only 6.5% were current users (11.8% of boys and 1.0% of girls), a decline of 26%.

Smoking rates were also declining during this period. In 1998, 35.1% of 12th graders smoked cigarettes (36.3% of boys and 33.3% of girls). By 2008 the prevalence of smoking was 20.4% (21.5% for boys and 19.1% for girls). This means that smoking among high school seniors declined by 42% in the decade after the MSA.

It is informative to compare the 2008 rates of current smoking (20.4%) and smokeless tobacco use (6.5%) with usage rates for two other popular teenage drugs, alcohol and marijuana. A whopping 43% of 12th graders used alcohol, and 28% had been binge drinking; 19.4% of them had used marijuana, almost the same percentage as smoking.

Last year over four out of ten 12th graders reported drinking and two-thirds of drinkers had binged, putting them at immediate and potentially life-threatening risk for alcohol poisoning, motor vehicle and other accidents. In comparison, the cigarette smoking rate was about the same as that for smoking marijuana, and smokeless tobacco use was far lower.

Tobacco use among children is a relatively small problem, and shrinking virtually every year. More importantly, the issue of teen tobacco use is entirely irrelevant to tobacco harm reduction. Society has a genuine interest in stopping tobacco initiation among children. But it is disingenuous for tobacco prohibitionists to label every attempt to provide vastly safer smokeless substitutes to adult inveterate smokers as an attack on children. If prohibitionists have specific evidence that tobacco manufacturers are marketing to children, they should contact the appropriate state attorney general. Many states have an expedited process for policing and enforcing MSA provisions about targeting children. Otherwise, these allegations represent nothing more than hollow and specious diatribes.

Tobacco harm reduction isn’t a children’s issue. The 8 million Americans who will die from a smoking-related illness in the next 20 years are not children. They are adults who are at least 35 years old. Preventing youth access to tobacco is vitally important, but the issue should not be twisted to condemn cigarette-using parents and grandparents to premature death.

Friday, October 2, 2009

Smokeless Tobacco Use Among Men in the U.S., 2000 and 2005

Epidemiologist Philip Cole and I recently completed a study of smokeless tobacco (ST) users in the United States in 2000 and 2005, based on data from National Health Interview Surveys (NHIS), which are also used by the Centers for Disease Control and Prevention to estimate how many Americans smoke. Our manuscript was published in the Journal of Oral Pathology and Medicine.

Overall, we found that the percentage of American men who use ST is a low but stable 4%. Almost all ST users are white, about half are 25-44 years old, and the majority have up to a high school education. Eight out of ten ST users live in the South or the Midwest. Over 50% of ST users lived in small metropolitan and rural areas, while only 2% lived in metro areas with populations of 5+ million.

There was some good news: of the 4.1 million ST users in 2000, 1.1 million were former smokers. Only 120,000 of them had quit smoking by switching to ST; the other 980,000 had used other methods. However, at some point, these former smokers apparently made the decision that they wanted to remain smoke-free without abstaining entirely from nicotine and tobacco, so they became ST users. By 2005, the number of ST users who were former smokers had grown to 1.4 million. 

Although over a million ST users are former smokers, we also found that there were about three million smokers who were former ST users. This is the bad news, because these men have gone from very low risk ST to high risk cigarettes. This reflects the fact that most American smokers are not aware of the large difference in risk between ST use and smoking. For example, a 2003 survey found that while 80% of American smokers were aware of ST products, only 11% correctly believe that they are less hazardous than cigarettes. Another survey found that 82% of American smokers incorrectly believe that chewing tobacco is just as likely to cause cancer as is smoking cigarettes. A 2007 study of adult smokers in Australia, Canada, the UK and the U.S. found that only 13% correctly believed that ST is less hazardous than cigarettes.

In 2005, there were 1.4 million American men who were dual users of both cigarettes and ST products. These men consumed nicotine both from cigarettes and from ST, and the latter clearly resulted in lower consumption of the former. In both 2000 and 2005, every-day smokers who also used ST every day consumed significantly fewer cigarettes on average than exclusive smokers (13 cigarettes per day vs. 20 cigarettes). If these dual users knew that ST products were only 1% as hazardous as cigarettes, it is possible that many would have chosen to use only ST.

Many media reports have noted the sharp increases in sales of moist snuff over recent years. Our study revealed that increased snuff use among men between 2000 and 2005 is due in large part to a decline in the use of chewing tobacco, a long-term trend that has been apparent since the mid 1980s. These changes for chewing tobacco and snuff are in line with a report from the U.S. Department of Agriculture Economic Research Service showing that consumption of chewing tobacco in the U.S. decreased 20% from 49.4 million pounds in 2000, to 39.2 million pounds in 2005. In contrast, moist snuff consumption increased 28% over the same period, from 65.9 million to 84.5 million pounds.

Our study provides important information about American ST users, and it reveals that a large proportion of ST users are concurrent or former smokers. These findings should inform the growing discussion among health and policy experts about how ST can serve as a less hazardous cigarette substitute for inveterate smokers.

Friday, September 25, 2009

Banning Flavored Cigarettes…What’s Next?

Earlier this week the FDA implemented a ban on flavored cigarettes. According to FDA documents, the scientific basis for this action was essentially a 2008 study by Klein et al. in Nicotine and Tobacco Research.

Klein looked at the National Youth Smoking Cessation Survey (NYSCS), finding that 22-23% of smokers age 17-19 years had "used" flavored cigarettes, compared with 9-10% of smokers age 20-26 years and 11% of smokers age 25-39 years (the latter percentage is from another survey).

According to the manuscript, “most flavored cigarette users reported that they usually smoked a brand other than [a flavored one]. Over half of flavored cigarette users (51.1% in NYSCS…) reported use of a usual brand that was manufactured by Philip Morris,” a company that does not make flavored cigarettes. The report could have presented detailed information about use of flavored vs. non-flavored cigarettes; it didn't, probably because the information didn't sustain the authors' conclusion: “Uniquely flavored cigarette brands seem to be most attractive to the youngest smokers and should be prohibited.”

In summary, flavored cigarettes are used by, at most, 2 out of 10 young smokers and aren't even their usual brand, which is unflavored. The Klein report also provided no evidence that flavored cigarettes are tobacco initiation products among young smokers. Of course, anti-tobacco crusaders have two magical words for tobacco regulatory discussions: The children. Virtually any action can be portrayed as protecting youth, and providing a rationale for the action is entirely unnecessary.

Congress directed the FDA to remove flavored cigarettes, so the agency didn’t need to justify the ban. That was fortuitous, because but it appears the FDA had trouble producing a credible scientific rationale. The FDA’s action does serve one of the primary goals of the anti-tobacco crusade: make tobacco use a miserable experience. However, since smokers who occasionally enjoy flavored-cigarettes prefer unflavored brands most of the time, the ban is likely to have minimal to no effect on smoking prevalence. It’s the equivalent of banning wine coolers because they’re occasionally consumed by people who drink a quart of vodka daily.

The FDA “is currently examining options for regulating both menthol cigarettes and flavored tobacco products other than cigarettes.” The only “option” that will satisfy anti-tobacco extremists, who have been whining for years about flavored smokeless products, will be to broaden the ban.

Monday, September 21, 2009

Magnifying Smokeless Tobacco Risks By Cherry Picking Data: A Case Study

A month ago, I discussed in this blog the definitive study of cancer risks among smokeless tobacco users. This comprehensive meta-analysis, which produced a series of summary relative risks for cancer among smokeless tobacco users by systematically combining all of the primary epidemiologic studies, was completed by Peter Lee and Jan Hamling. They concluded that there is very little evidence that smokeless tobacco use is associated with any cancer.

The results in the Lee-Hamling study were surprisingly different from an earlier meta-analysis performed by Paolo Boffetta, an epidemiologist at the International Agency for Research on Cancer, and co-authors, which was published in the journal Lancet Oncology. The Boffetta team had produced relative risk estimates for cancers of the oral cavity and pharynx, esophagus and pancreas that were considerably higher than those from Lee and Hamling, as illustrated in the following table:

Cancer SiteBoffetta Relative Risk Estimate (95% CI) Lee-Hamling Relative Risk Estimate (95% CI)
Oral cavity/pharynx1.8 (1.1 – 2.9)1.36 (1.04 – 1.77)
Esophagus1.6 (1.1 – 2.3)1.13 (0.95 – 1.36)
Pancreas1.6 (1.1 – 2.2)0.99 (0.71 – 1.60)

Why did the Boffetta meta-analysis always produce higher risk estimates than the Lee-Hamling study if both were using essentially the same data? A commentary published by Lee and Hamling in the journal BMC Cancer provides the answer to that question. The answer is simple and disturbing.

First, let me give you some background information. Most primary epidemiologic studies report results for many different sets of circumstances. For example, a study about smokeless tobacco might report risk estimates for all users and these subgroups: current users, former users, exclusive users who never smoked, and users who also smoked. So it is important for investigators conducting meta-analyses to develop specific rules for combining estimates from different studies. Lee and Hamling developed rules and followed them systematically in their meta-analyses. In contrast, Boffetta did not specify any rules but appears to have followed one: Use only the highest risk estimate.

The Lee/Hamling commentary focused on the inherent contradictions in Boffetta’s approach, the best example of which is illustrated in the table below. There are two important primary epidemiologic studies on pancreatic cancer among smokeless tobacco users, one published in the Lancet and the other in the International Journal of Cancer. Each study provided risk estimates for exclusive smokeless users (i.e., those who never smoked) and for users who might also have smoked, as seen in this table:

Primary Study Journal, YearRisk Among Exclusive Users (95% CI)Risk Among Users +/- Smoking
Lancet, 20071.8 (1.1 – 2.9)0.9 (0.7 – 1.2)
Int J Cancer, 20050.85 (0.24 – 3.07)1.67 (1.12 – 2.50)

Lee and Hamling make it clear that they produced their summary estimates by either combining risks for exclusive users (i.e. 1.8 and 0.85), or risks for users who might have smoked (0.9 and 1.67). This is both logical and scientifically valid. But which estimates did Boffetta use? The highest, of course. For the Lancet study he used the estimate of 1.8 in exclusive users, but for the International Journal of Cancer study he used the estimate of 1.67 in smokeless users who might have smoked. His goal was to maximize the health risks from smokeless tobacco use, thereby feeding scaremongers who portray smokeless tobacco as deadly, despite decades of research to the contrary. The scientific term for this epidemiologic method is cherry picking.

This is just one example of the unscientific manner in which the Boffetta meta-analysis was conducted. The Lee/Hamling commentary describes many others.

According to its website, the International Agency for Research on Cancer places emphasis on “elucidating the role of environmental and lifestyle risk factors” in cancer development. The IARC should not condone the fabrication of estimates misrepresenting the scientific evidence that cancer risks from smokeless tobacco use in Sweden and the U.S. are minimal to nonexistent. Kudos to Peter Lee and Jan Hamling for documenting this travesty.

Monday, September 14, 2009

Wisdom From the Wall Street Journal

I have been engaged in tobacco harm reduction research for over 15 years; during this time I have discussed the subject with numerous journalists. Most of the subsequent news stories have been of marginal quality or even grossly inaccurate, because journalists rarely challenge spokesmen from the American Cancer Society or government health agencies who misrepresent smokeless tobacco as just as dangerous and just as evil as cigarettes.

The Wall Street Journal is the rare exception to the above. In 2006 and 2007, the Journal’s Pulitzer prize winning Kevin Helliker wrote a series of articles on tobacco harm reduction as a critical public health issue. Helliker challenged everyone he interviewed to fully substantiate their positions. The resulting articles remain quite simply the best media treatment on the subject. Two of his articles can be read here and here.

On August 31, R.J. Reynolds Tobacco Company and Lorillard, Inc. filed suit in U.S. district court in Bowling Green, Kentucky to block some of the provisions of legislation giving the FDA regulatory authority over tobacco products. On September 13, the Wall Street Journal editorialized on why the FDA legislation is flawed. One of the major points of the editorial, available here is that the legislation prohibits manufacturers from telling consumers that smokeless tobacco is safer than cigarettes:

“And there's also not much doubt that the new law hinders the ability of tobacco companies to communicate information to consumers, even when that information could lead to less harmful choices. Smokeless tobacco products aren't as dangerous as cigarettes because they contain fewer carcinogens and don't enter the lungs. Yet the law effectively prohibits companies from describing the relative health risks of different products. So a law that backers call a victory for public health actually prevents tobacco companies from informing consumers that switching to smoke-free nicotine products will reduce their health risks. Smokeless tobacco is not risk-free, but a public policy that pretends it is just as dangerous as lighting up is misleading and constitutionally suspect.”

The editorial concludes: “We sympathize with sincere efforts to reduce smoking. But imposing overly broad commercial speech restrictions that impede competition from safer alternatives is the wrong way to advance public health.”

Tuesday, September 8, 2009

Public Health Physicians to the FDA: Don’t Write Off Current Smokers

On August 29 the American Association of Public Health Physicians (AAPHP), which has served as the national voice of directors of state and local health departments and other public health physicians, released a letter to Lawrence Deyton, the new director of the FDA Center for Tobacco Products. Over the signatures of Joel Nitzkin, chair of the organization’s tobacco control task force, and AAPHP president Kevin Sherrin, the letter counseled Deyton to “save the lives of 4 million or more of the 8 million adult American smokers who will otherwise die of a cigarette-related illness over the next twenty years” by “making smokers aware of selected smokeless tobacco products (including but not limited to snus and electronic cigarettes) that promise to reduce the risk of tobacco-related illness by 99% or better for smokers who are unwilling or unable to quit.”

AAPHP concerns stem from the July 22 FDA “condemnation of electronic cigarettes,” which I covered in a previous post, available here. It appears that the FDA is poised to regulate e-cigarettes as drug delivery devices, which would remove these demonstrably safer cigarette substitutes from the market until they could be proven by manufacturers to be safe and effective, a burdensome process requiring as many as ten years of research and tens of millions of dollars. But the biggest losers of FDA e-cigarette mis-regulation would be the hundreds of thousands who are already using them to reduce cigarette consumption or quit smoking altogether.

The AAPHP outlined a simple and practical regulatory strategy for e-cigarettes: “We urge FDA to reclassify electronic cigarettes from a drug/device combination to a tobacco product. This will enable FDA to immediately regulate manufacturing and impose marketing restrictions during this initial period of FDA Tobacco Center development. This reclassification will eliminate pressure on the several hundred thousand current American users of electronic cigarettes to switch back to the much more hazardous conventional cigarettes.”

The letter, entitled “Don’t Write Off Current Smokers,” also encourages Deyton to consider smokeless tobacco as a harm reduction alternative for smokers. Nitzkin and Sherrin note that “this year, about 400,000 American adult cigarette smokers will die of a tobacco-related illness,” and “virtually all heart and lung disease from cigarettes, and an estimated 98% of the cancer mortality, are due to direct inhalation of fresh products of combustion.” They observe that “even though smokeless tobacco products represent about 20% of nicotine intake in the United States, the number of deaths per year from these products is too small for reliable estimates from the CDC.”

Nitzkin and Sherrin point out the futility of conventional quit-smoking approaches that emphasize pharmaceutical nicotine: “The only discussion of current smokers has been limited to encouraging use of pharmaceutical products to aid cessation. This has been touted as doubling quit rates – but without mentioning that this doubling is from about 3% to about 5% per year. In other words, this option fails 95% of smokers willing to try it, even under study conditions with optimal counseling.”

Last year the AAPHP became the first medical organization in the U.S. to formally adopt a policy of “…encouraging and enabling smokers to reduce their risk of tobacco-related illness and death by switching to less hazardous smokeless tobacco products.” The scientific manuscript on which that endorsement was based is available on the organization website here.

Nitzkin and Sherrin describe the singular goal of AAPHP as “doing everything in our power to reduce tobacco related illness and death.” Lawrence Deyton would be wise to make that the singular goal of the FDA tobacco center as well, and to make harm reduction a priority for the nation’s 45 million smokers.

Tuesday, September 1, 2009

Snus Use Lowers Risk for Multiple Sclerosis; Smoking Raises Risk

Multiple sclerosis (MS) is a chronic disease in which the immune system attacks and damages myelin, the substance that insulates nerves and facilitates transmission of electrical signals along the spinal cord, the mode by which the brain communicates with the rest of the body. It is a complicated disease, an excellent summary of which can be found here.

There are no definitive causes of MS; genetic and environmental factors may play a role. Several research studies indicate that smoking increases the risk for the disease by approximately 50% (RR = 1.5, 95% CI = 1.3 – 1.7).

Researchers at the Karolinska Institute of Environmental Medicine in Stockholm have just released a new study of tobacco use and MS, which was published in the September 1 issue of the journal Neurology. They compared tobacco use among persons diagnosed with MS (cases) with a group of controls derived from the Swedish population. This experimental design, called a population-based case-control study, is common in epidemiology.

Readers of this blog are familiar with relative risk (RR), which is used by some epidemiologic studies to measure the association of a risk factor and a disease. The measure of association in the present study was the odds ratio (OR), and its interpretation is essentially identical to the RR and is accompanied by a confidence interval (CI), which is the range within which the RR lies with 95% confidence.

Lead author Anna Hedstr̦m and her colleagues report that, compared with nonusers of tobacco, smokers had significantly elevated risks for MS. The OR for male smokers was 1.8 (CI = 1.3 Р2.5), and the OR for smoking women was 1.4 (CI = 1.2 Р1.7). The risk increased with the cumulative dose of smoking (measured in pack-years, that is, packs per day times years of smoking), which adds to the overall validity of the association. For example, compared to nonusers of tobacco, men who had up to 5 pack-years of smoking had an OR = 1.4 (CI = 1.0 Р2.0), while men who had 16+ pack-years of smoking had an OR = 2.9 (CI = 1.7 Р5.1).

In contrast to smoking, the study found that snus users had lower risks for MS than nonusers of tobacco. These lower risks were present among snus users of 5+ package-years who never smoked (OR = 0.4, not statistically significant) and who had smoked (OR = 0.3, CI = 0.1 – 0.9), the latter being statistically significant.

A previous study by the American Cancer Society showed that smokeless tobacco use may be protective for Parkinson’s Disease (a neurologic illness) (RR = 0.22, CI = 0.07 – 0.67). The Karolinska Institute study provides evidence that smokeless tobacco may provide protection for multiple sclerosis as well.

Wednesday, August 26, 2009

Minnesota Researchers to Smokeless Users: You’re Better Off Smoking!

In mid August the American Chemical Society, “the world’s largest scientific society,” held its national meeting in Washington, DC. The ACS has an impressive media machine, and on August 16 it was mobilized to promote a presentation entitled “Analysis of 21 polycyclic aromatic hydrocarbons in smokeless tobacco by gas chromatography-mass spectrometry,” by Irina Stepanov, a research associate at the University of Minnesota Masonic Cancer Center. The ACS media blitz included a press conference with Stepanov, which you can watch here.

Stepanov made some utterly incredible claims during her presentation, which were reported in an article published on the website of U.S. News & World Report under the headline “Chewing Tobacco No Safer Than Smoking”:

(1) “Tobacco users who think it's safer to dip snuff or chew tobacco than smoke are dead wrong, researchers say.”

(2) “A study has found that taking one pinch of smokeless tobacco delivers the same amount of polycyclic aromatic hydrocarbons (PAHs) as smoking five cigarettes.”

Let’s be perfectly clear: Irina Stepanov was asserting not only that smokeless tobacco is not safer than smoking, but that it is five times more dangerous than smoking!

Readers of this blog are familiar with the epidemiologic evidence linking smokeless tobacco use and cancer: almost a big fat zero. Numerous research studies have established that the cancer risks from using smokeless tobacco are so low that they are barely measurable.

Irina Stepanov made her claims about smokeless tobacco at a very public national meeting, and the American Chemical Society was an enthusiastic partner in promoting her research to the media. Surprisingly, after launching this unsubstantiated attack on smokeless tobacco, both Stepanov and the Chemical Society have refused to share her presentation with this researcher.

On August 19, I emailed Stepanov requesting a copy of her presentation. Her response on August 22 was bizarre: “We are in process of publishing a full paper on this study. So, the abstract is the only material that is available for sharing.”

That excuse for withholding her data is unprofessional. Researchers routinely provide copies of their public conference presentations to others in academia, regardless of the pendency of publication of fuller texts.

Refusal to share a conference presentation may violate the spirit, if not the letter, of the National Institutes of Health grants policy on data sharing. NIH funds Stepanov’s research group, the University of Minnesota and the Masonic Cancer Center, which also promoted Stepanov’s Chemical Society presentation. The NIH position is crystal clear: “It is NIH policy that the results and accomplishments of the activities that it funds should be made available to the public. PIs and grantee organizations are expected to make the results and accomplishments of their activities available to the research community and to the public at large.”

This episode is simply the latest in a series of attacks on smokeless tobacco by Minnesota anti-tobacco extremists. Almost the same approach and rhetoric were used in these 2007 articles in the New York Times and Fox News.

The main objective of this blog is to “examine and comment on the scientific foundation for tobacco policies and fallacies.” But that examination and commentary is contingent upon the scientific information being made available. In this case, Irina Stepanov, assisted by the American Chemical Society, has made a mockery of the long-standing tradition of open communication of scientific information.

Wednesday, August 19, 2009

Heart Attack and Stroke Risks from Smokeless Tobacco Use: Next to Nil

The International Agency for Research on Cancer (IARC) is a component of the World Health Organization with a mission “to identify the causes of cancer so that preventive measures may be adopted and the burden of disease and associated suffering reduced.” It is therefore not surprising that IARC staff have played a prominent role in exaggerating the cancer risks of smokeless tobacco use. The IARC anti- smokeless tobacco campaign has been led by Paolo Boffetta.

Boffetta, a cancer epidemiologist, departed from his field of expertise to complete (with co-author Kurt Straif) a review of the risks for heart attack and stroke among smokeless tobacco users in the U.S. and Sweden. The analysis has just been published by the British Medical Journal.

Boffetta reported that the summary relative risk (RR) for heart attack among smokeless tobacco users was 0.99, with a 95% confidence interval (CI) of 0.89 to 1.10 (For a discussion on how to interpret RRs and CIs, see my recent post). For stroke, Boffetta reported a minimal increase in risk (RR = 1.19) that was not statistically significant (CI = 0.97 – 1.47). Thus, the main finding in this study is that smokeless tobacco users have no excess risk of heart attack or stroke.

Given the importance of that conclusion, why did the researchers (in their BMJ abstract) and subsequent media coverage ignore it, focusing instead on fatal heart attack/stroke, one of two subgroups? It is because smokeless tobacco users had very small elevations in risk for the fatal events. For fatal heart attack the RR among smokeless users was 1.13 (CI = 1.06 – 1.21), and the RR for fatal stroke was 1.40 (CI = 1.28 – 1.54). Boffetta was unable to demonstrate that the excess risks were related to how much or how long smokeless tobacco had been consumed, two important characteristics that would have strengthened the validity of the findings.

There is a serious omission in this study. Boffetta divided all heart attacks and strokes into two subgroups, fatal and non-fatal. 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. But Boffetta provided no information about these subgroups, and the reason is obvious: it wouldn’t add to the health hysteria.

Here is the take-home message for smokeless tobacco users: You do not have elevated risks for heart attack and stroke. Although your risk for heart attack and stroke is the same as that of non-users of tobacco, there is a slight increased chance that, if one occurs, it could be fatal. This may be due to the effects of nicotine on the circulatory system, or it could be due to some other undiscovered factor that is associated with smokeless use. As Boffetta acknowledged, “the magnitude of the excess risk is small.”

In the article’s introduction, Boffetta wrote that smokeless tobacco “products have been proposed as an alternative to cigarettes and other smoking products under the claim of a smaller, or negligible, risk to health.” This study adds to the scientific evidence that, compared with cigarettes, the risks from smokeless tobacco are indeed vastly “smaller, or negligible.”