Wednesday, November 24, 2010

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


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.

Wednesday, November 17, 2010

American Evidence that Snus Is An Effective Substitute


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.

Wednesday, November 10, 2010

The CDC: Your Online Source for Incredible Tobacco Information


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.

Wednesday, November 3, 2010

Mayo Clinic Misinformation About Smokeless Tobacco


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.

Wednesday, October 27, 2010

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


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 DeathPercent 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.

Thursday, October 21, 2010

Snus Users and Smokers in Stockholm


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.

Wednesday, October 13, 2010

Noteworthy News From Norway: Snus is Superior Cigarette Substitute


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 (%)
18052
25523
38163
46253
57545
69050
77343

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.