Thursday, August 29, 2013

Measuring Smokers’ Preferences for Smokeless Tobacco Products

Most of America’s 45 million smokers have never considered switching to a smokeless tobacco product.  They have plenty of options, but we have little information about smokers’ product preferences.

A new study gauges smokers’ perceptions of five smokeless products: General Snus from Swedish Match, Camel Snus from Reynolds, Marlboro Snus from Phillip Morris, and Stonewall and Ariva dissolvable pellets (which are no longer marketed) from Star Tobacco. 

The study, appearing in Nicotine & Tobacco Research (abstract here ), was authored by Dorothy Hatsukami, a tobacco researcher from the University of Minnesota and former member of the FDA Tobacco Products Scientific Advisory Committee, and colleagues from Roswell Park Cancer Institute and the Oregon Research Institute. 

Dr. Hatsukami recruited 97 smokers interested in quitting.  After not smoking for five hours, the subjects sampled each of the five products on separate days over a two-week period (brand names were hidden).  They then answered 21 questions about satisfaction, psychological reward, aversion (dizziness, nausea, other bothersome side effects), relief of craving/withdrawal, ease of use, comfort and dependence concerns.  Answers were based on a Likert scale ranging from 1 (not at all) to 7 (extremely); 4 is neutral.  At the end of the sampling period they were asked to pick a product to use during two weeks of smoking abstinence. 

Average Smokers’ Scores For Smokeless Tobacco Products During Sampling Period
Product (Nicotine Content, mg)SatisfactionPsychological RewardAversionReliefEase of UseComfortDependence Concern
General Snus (3.4)
Camel Snus (1.8-2.0)
Marlboro Snus (0.1-0.4)
Stonewall (0.3-0.6)
Ariva (0.2)

Average scores for the products are seen in the table.  Camel and Marlboro snus had the highest scores for satisfaction and relief of craving/withdrawal, even though they had vastly different levels of free nicotine, the form that is readily absorbed in the mouth.  The dissolvable products scored highest for ease of use and comfort.

Smokers’ individual product scores were correlated with their preferred product for the smoke-free period.  Camel snus was picked by the largest percentage (28%), followed closely by Stonewall and Ariva (24% each), and Marlboro snus (23%).  No one picked General snus, probably because of its high nicotine content, which accounted for higher aversion scores.   

The research leaves a few questions unanswered.  Information on cigarette and smokeless consumption during the smoke-free period was collected, but not reported.  Two-thirds of the subjects in this study were female, but the authors did not comment on the effect of gender on the scores.  Women have considerably different perceptions of smokeless tobacco than men.

These shortcomings aside, the Hatsukami study provides valuable data on smokers’ preferences for various smoke-free products.

Wednesday, August 21, 2013

A Tainted Legacy

On August 19 David Abrams and Julia Cartwright wrote an article for the Huffington Post entitled “What’s Wrong With This Picture.” (here).

Dr. Abrams and Ms. Cartwright are what’s wrong with this picture.  They represent the Legacy Foundation, a billion dollar enterprise (here) aimed at “Helping people live longer, healthier lives without tobacco” (here).  This prohibitionist crusade is fueled by exaggerated claims of tobacco risks and gateway fantasies. 

For example, they write that “smokeless tobacco or ‘chew’ can also cause a long list of disfiguring and deadly oral cancers.”  This is false, as attested to in in the Legacy fact sheet on smokeless tobacco (here)*, which lists no specific health risks for those products. 

Asserting that “newer products have unknown risks and require more research,” Abrams and Cartwright ignore decades of research documenting that smokeless tobacco products produce barely measurable health risks. 

The writers of the column praise the European Union’s inclination to ban tobacco products, including snus, in every country except Sweden.  Yet they should know that snus use has been directly associated with record low smoking rates among men in Sweden: they smoke less and use more smokeless tobacco than in any other developed country.  And they have the lowest rates of lung cancer -- indeed, of all smoking-related deaths -- in the developed world.

Abrams and Cartwright claim that children are confused about “which products are candy and which ones are the real deal.”  This is a red herring.  The sale of tobacco products to children is prohibited in every state; FDA monitoring reveals that the vast majority of retailers are compliant (here).  If Legacy has evidence that tobacco manufacturers are marketing to children, those serious charges should be directed to states’ attorneys general.  Since the 1998 Master Settlement Agreement, tobacco manufacturers have been prohibited from directly or indirectly targeting children.  Legacy should produce evidence and file a complaint; otherwise their accusations are specious.

Abrams and Cartwright write that smoking “…robs us of more than 440,000 lives, $96 billion in healthcare costs and an additional $97 billion in lost productivity costs each year.”  Yet their prohibitionist prescription would rob 45 million American smokers of vastly safer smoke-free alternatives.  The eight million Americans who will die from a smoking-related illness in the next 20 years are not children, they are today adults.  Preventing youth access to tobacco is important, but that can be accomplished without condemning to premature death those parents and grandparents who are current smokers.

*The publication date of this post was August 21, 2013.  On August 27 Legacy produced a new smokeless tobacco fact sheet and gave it a new web address.  The new fact sheet lists no specific health risks for smokeless tobacco use.

Wednesday, August 14, 2013

Fabricating a Smoking Gateway

A Harvard School of Public Health report claims, according to Reuters, “Most young people in the U.S. who use newer smokeless tobacco products are smoking cigarettes.” (here).  In fact, the article, published in Pediatrics (abstract here), contains no specific information on cigarettes.

It is common knowledge that a high proportion of U.S. smokeless tobacco (ST) users – both men and boys – also smoke, as I have previously discussed in this blog (here and here).  So the main message of this study, that youth ST users are also smokers, is not new. 

The study, led by tobacco prohibitionist Dr. Gregory Connolly, could be seen as having one purpose – to fuel the campaign against tobacco harm reduction.  The journal article and the attendant media coverage are tainted by unscientific bias. 
The authors observed that 72% of ST users also “smoke,” a finding that the media reported as smoking cigarettes.  The authors, however, defined a smoker as anyone using any of these combustible products on one of the past 30 days: cigarettes, cigars, pipes, bidis, kreteks, roll-your own, flavored cigarettes, clove cigarettes, flavored cigars, or hookah/waterpipe.  Results were reported for this entire group of “combustible” products, not for cigarettes alone. 
The inclusion of the other products is just one of several tactics to maximize the percentage of ST users who smoked.  Another was the definition of a tobacco user: For all forms, it was anyone who used the product on at least one day in the past 30 – a broadly inclusive definition.

The most disturbing part of the media coverage of this study is the use of its results to attack tobacco harm reduction.  There is nothing in these findings that is damaging, or even relevant, to tobacco harm reduction, but it is clear that Dr. Connolly was campaigning to insert gateway the speculation – the fictitious idea that ST use causes smoking.  I have dealt with it previously (here).  According to Reuters, Dr. Neal Benowitz, “…who was not involved in the current research, noted that studies have shown use of smokeless tobacco among U.S. youth can indeed be a gateway to cigarette smoking.”
This is nonsense.  Dr. Benowitz cannot cite even one legitimate study showing that ST is a gateway to smoking.  Few cross-sectional or longitudinal surveys in the U.S. or Sweden have specific information on the order in which ST and cigarettes were first used – data that is required to demonstrate that ST use causes smoking.  ST users may also smoke, but this does not mean that ST use causes smoking.  Two studies (here and here) that have examined the causal pathway document that ST use may be protective against smoking.
Why do so many ST users smoke?  Dr. Connolly’s study, ironically, gives us a clue, as he notes that 67% of all ST users wrongly believe that all tobacco products are equally harmful.  (Ninety-two percent of nonusers of ST share the same mistaken view.)
American children, like their parents, are routinely misinformed about the risks of ST use and smoking.  Journal reviewers and editors, as well as journalists, should view biased and shallow research with a more critical eye.

Thursday, August 8, 2013

Federal Officials Endorse Impossibly High Standard for E-Cigarettes

NPR host Diane Rehm on August 5 discussed “Smoking in America Today” with Dr. Tim McAfee, Director of Office of Smoking and Health at the Centers for Disease Control and Prevention; Mitch Zeller, Director of Center for Tobacco Products at the FDA; Dr. Thomas Glynn, Director of Cancer Science and Trends at the American Cancer Society; Michael Felberbaum, journalist covering tobacco for the Associated Press; and Craig Weiss, President and CEO of e-cigarette maker NJOY (program available here).

The federal officials and Dr. Glynn held essentially identical views on e-cigarettes, providing a strong signal that FDA regulation is likely to be burdensome or even punitive.

Early in the program, Rehm asked about relative risk: “Is there any evidence whatsoever from the public health community regarding electronic cigarettes and whether they are in fact safer than tobacco products?”

The CDC’s McAfee gave an extended answer, starting with: “Well, there’s several different ways that we’re thinking about this, we think it’s an incredibly important question.”  Important, but unanswered, as Dr. McAfee shifted to the familiar cigarette mantra: “… we need to focus on the harm that’s caused by cigarette smoking, and ways to get smokers to quit and to prevent nonsmokers from starting.”  As for e-cigarettes, “.. the challenge is that we don’t yet know how e-cigarettes are going to completely fit into that.  The availability of a cigarette alternative that does deliver nicotine without also delivering harmful by-products of combustion… could this play a beneficial role in reducing tobacco-related death and disease?  This would be especially true if a large number of smokers successfully switched completely to e-cigarettes, either permanently or as a transition phase to nicotine abstinence.”

Dr. McAfee expressed concern that alternative tobacco products might foster dual use, prevent smoking cessation and serve as a gateway to smoking for new users and former smokers. “… The other alternative is that the availability of e-cigarettes could result in harm by increasing the initiation of cigarette use among youth and young adults or by delaying quitting among smokers who, rather than switching, engage in dual use, which currently looks like that’s the majority situation.  People are using them in situations where it’s hard to smoke cigarettes.  And we see ex-smokers think ‘Hey, maybe I can go back to e-cigarettes,’ and that re-kindles their nicotine addiction.  And they actually start smoking cigarettes themselves.”    

Regulator Zeller returned to these themes later in the program.  He alluded to, but never quite acknowledged, the vast difference in risk between traditional and electronic cigarettes: “The thing that’s most interesting about e-cigarette is that we look at individual-level risk, what is the risk, say, to a current smoker who would be otherwise unable or unwilling to quit, if that person completely substituted all of their conventional cigarettes for an e-cigarette, that’s individual-level risk.”

However, he made clear that FDA regulation isn’t about individual smokers: “… Policy is going to be made here at the population level, and there’s population-level harm.  Who is actually using these products?  And how are they being used?  Tim [McAfee] talked about this earlier.  Are current smokers going to be less inclined to quit, and more likely to engage in what we call dual use of both the combustible version and the electronic version?  Are kids going to start using e-cigarettes?  These are the kinds of questions that we have that ultimately comes down to behavior, and right now we have far more questions than answers.”

I discussed in 2010 scientific evidence documenting that a population-level evidentiary standard was “unattainable” (here).  I also said that the standard was unprecedented.  The FDA has regulatory authority over other consumer items – food, cosmetics, drugs, medical devices and vaccines.  FDA regulations assure that drugs, medical devices and vaccines provide the intended medical benefit.  Far more importantly, they assure that all of these products are safe to consume.  The FDA does not traditionally compromise individual safety with a population standard.

Today, the FDA also regulates tobacco products.  One of these (the cigarette) is highly toxic, killing over 400,000 Americans every year.  When the FDA asserts regulatory authority over e-cigarettes, it would be criminal to use an arbitrary population standard to deny American smokers access to these products.