The Illogic of Condoning Vaping & Condemning Smokeless – Both Are Safer for Smokers

While many American tobacco researchers and policy experts have, of late, moved to endorse reasonable regulation of e-cigarettes and vaping, most persist in condemning smokeless tobacco products, which have been proven to be nearly harmless.  It is irrational to support one and prohibit the other, when both are legitimate harm reduction options for smokers.

The illogic of this dual position is displayed in the work of Dr. Dorothy Hatsukami, a prestigious tobacco researcher, author of 250 published articles (here) and recipient of tens of millions of dollars in NIH funding (available here, including $13 million to study reducing nicotine in cigarettes).  Dr. Hatsukami recently signed a letter to FDA Commissioner Scott Gottlieb (here) and published an article in Tobacco Control (here).

In the letter to the commissioner, Dr. Hatsukami applauded his “openness to the concept of tobacco harm reduction…There is already a considerable body of science and experience suggesting that a harm reduction approach…could yield substantial and highly cost-effective public health benefits…at this time we do not believe that the current regulatory framework for the low-risk nicotine products such as e-cigarettes and smokeless tobacco is appropriate or will deliver the substantial public health benefits we hope and expect FDA’s oversight will bring.”  The letter encouraged the FDA to regulate tobacco products according to risk and to “support informed choice through truthful communication of risk.”

However, in her Tobacco Control commentary, Dr. Hatsukami took a contrary view, fully endorsing the FDA’s proposed standard for NNN, which I have eviscerated here and here.  She wrote, “If [FDA] puts the proposed rule into effect, it would be a significant and important step towards minimising the harms from smokeless tobacco use.”  Surprisingly, she asserted that “the risk for oral cancer is considerably higher for smokeless tobacco users,” and cited a federal study documenting that American men who dip or chew tobacco have no mouth cancer risk (here).

Notably, other signatories to the Gottlieb letter are genuine tobacco harm reduction advocates who have endorsed the substitution of smoke-free tobacco by smokers.  They include Clive Bates of the UK and Canada’s David Sweanor, who filed a comment (here) labeling the NNN rule “reckless and pointless.”  American signatories who are on record about the relative safety of smokeless are Sally Satel (here and here), Kenneth Warner (here and here), David B. Abrams (here) and Raymond S. Niaura (here). 

For Smoking Cessation, Camel Snus = Nicotine Gum

Camel Snus is equally effective as nicotine gum in helping smokers quit, according to a study funded by the National Cancer Institute (article here).     

Dr. Dorothy Hatsukami and colleagues at the University of Minnesota and the Oregon Research Institute recruited some 400 smokers who wanted to switch to snus or nicotine gum.  They randomized smokers to Camel Snus Winterchill, Robust (~2.5 mg. nicotine per pouch), Frost or Mellow (~1.5 mg), or nicotine gum (2 or 4 mg. nicotine).  Participants received free products for 12 weeks.  Overall, they visited the clinic 10 times over 26 weeks, where they filled out questionnaires and provided blood samples.  They also participated in counseling sessions using the NIH Clearing the Air Quit Smoking program that features conventional quitting tips (“Take a deep breath, clean something, make a move, start a new hobby, splurge on a massage”).  Study participants were paid $360 if they completed the program.

According to the authors, “The results showed no significant differences between those assigned to medicinal nicotine vs snus in amount of product use, levels of cotinine attained, the extent to which the product substituted for smoking and rates of avoidance of cigarettes or any nicotine containing products. Furthermore, there were no differences in suppression of withdrawal from cigarettes.”

In other words, snus was indistinguishable from nicotine gum in helping people avoid cigarettes.  

There was one confusing result.  The authors reported that “nicotine gum users reported more satisfaction and psychological reward from the product.”  However, after 26 weeks 14.9% of the snus group were still using only snus, and 11.6% were using both snus and cigarettes, which was significantly higher than gum users (6.0% and 6.8% respectively). 

This study is not cause for smoking cessation celebration.  Six months after the trial started, only 5.1% of gum users and 2.6% of snus users had continuously quit smoking (the difference was not significant).  The research does, however, demonstrate the fallacy of the claim that snus is unneeded because pharmaceutical nicotine is effective. 

Two years ago, I discussed a clinical trial showing that e-cigarettes were about as effective as nicotine patches in helping smokers quit (here). Now we have evidence that snus is just as effective as nicotine gum, even though success rates for both were abysmal.  The real take-away is that smokers should have access to all cigarette substitutes.

Minnesota Researchers’ #EpicFail – Trying for a Smokeless Tobacco/Cancer Link

Publishing a study of tobacco-specific nitrosamines in American smokeless tobacco products (abstract here), Dorothy Hatsukami and colleagues at the University of Minnesota called for the FDA to issue “regulations…to reduce levels of…NNK and NNN in smokeless tobacco products to the lowest levels possible.”  The authors make illogical and unscientific claims in their article and media interviews (here).

Claim 1: “The majority of smokeless tobacco users in the United States are not aware of …the tremendous variability in the levels of these chemicals across brands sold in this country.”  Tremendous variability?  Dr. Hatsukami reported that, with the exception of two products, the level of NNK+NNN varied from 0.64 microgram per gram of moist snuff to 3.89 micrograms (or, if you prefer, parts per million).   

Claim 2: “The higher the level of exposure the greater the risk for cancer.”  This statement is meaningless, as exposure to these agents has not been linked directly to human cancer.  The studies cited in the article involve SMOKERS, who are exposed to thousands of other toxins.  This is like claiming that golfers have a high risk for concussion, based on data from the National Football League.

The authors fail in their effort to make a cancer connection with a rat study from 1986, conducted by Dr. Hatukami’s colleague and coauthor, Dr. Stephen Hecht (here).  He exposed the mouths of 10-week-old rats to enormous doses of NNN and NNK daily for over 131 weeks.  The experiment was so aggressive that 86% of the rats died by trial’s end.  Not surprisingly, Dr. Hecht produced more tumors in the rats getting high doses.  Another result was entirely unexpected: In rats given the same massive NNN and NNK doses in snuff extracts, tumor production virtually disappeared. 

It appears that smokeless tobacco contains beneficial agents that virtually cancel out the negative effects of even massive doses of NNN and NNK.  That is probably happening with dippers and chewers, even though they are only exposed to minuscule levels of nitrosamines. 

I recognized this important smokeless attribute a decade ago, when I published a research study showing that commercial tobacco products have moderate-to-high antioxidant properties, much like fruits and vegetables (discussed here).

There is one bright spot in the Minnesota study. The authors acknowledge “The lack of association between snus use in Scandinavian countries to [sic] oral cancer.”  If only they and the broader scientific community would acknowledge that this profile also applies to modern American smokeless tobacco products. 

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 http://www.ncbi.nlm.nih.gov/pubmed/23239843 ), 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)	Satisfaction	Psychological Reward	Aversion	Relief	Ease of Use	Comfort	Dependence Concern
General Snus (3.4)	1.8	2.2	2.7	3.4	4.8	3.9	1.5
Camel Snus (1.8-2.0)	3.6	2.6	1.9	3.8	5.7	4.9	2.0
Marlboro Snus (0.1-0.4)	3.6	2.5	1.7	3.7	5.5	4.8	1.9
Stonewall (0.3-0.6)	3.3	2.4	1.9	3.6	5.8	5.6	1.8
Ariva (0.2)	3.4	2.4	1.6	3.5	5.9	5.4	1.8

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.