Kaiser Permanente to Smokers: “Say No to E-Cigarettes…Light Incense or a Candle Instead”

Kaiser Permanente, the health care consortium that insures over 10 million Americans, is telling its members, “say no to e-cigarettes…here are 3 good reasons to give them a thumbs down.”  Those reasons, straight from the prohibitionist playbook, are outdated, irrelevant, deceptive and irresponsible.

Reason #1: “Safety concerns.”  KP mentions a six year old FDA study that reported traces of diethylene glycol and tobacco-specific nitrosamines in some e-cig liquid samples.  As I explained, “the FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, using methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years.”  Not only is the study outdated and irrelevant, subsequent studies have failed to find diethylene glycol in e-cig liquids.

Reason #2: “No convincing evidence they will help you quit.”  As I reported earlier this year, ignoring medical literature is not just irresponsible, it’s laughable: There are legions of former smokers who credit e-cigarettes with life- and breath-saving benefits. 

Reason #3: “What’s proven to work still works.”  KP advises that “the most effective way to quit is to use a combination of FDA-approved medications (like the nicotine patch, gum, lozenge, or bupropion) and counseling support,” which works for about 7% of smokers in the general population.  KP urges smokers to use these coping measures to “fight the urge”:

• ·       Take 10 deep breaths and hold the last one while lighting a match. Exhale slowly and blow out the match. Pretend it's a cigarette and crush it out in an ashtray.

• ·       Take a shower or bath.

• ·       Learn to relax quickly and deeply. Visualize a soothing, pleasing situation and get away from it all for a moment. Concentrate on that peaceful image and nothing else.

• ·       Light incense or a candle instead of a cigarette.

• ·       Try crossword puzzles, needlework, gardening, or household chores. Wash your hands, do the dishes, or try new recipes.

• ·       Brush your teeth and use mouthwash.

KP’s e-cigarette advice violates its mission “to improve the health of our members and the communities we serve.”

Reality Bites the Dust in New Smokeless Tobacco Study

It’s surprising what passes for “science” in some journals today.  Chemical Research in Toxicology has published a study from the University of California’s Berkeley and San Francisco campuses making this extraordinary claim: “Children living with smokeless tobacco [ST] users may be exposed to carcinogenic tobacco-specific nitrosamines [TSNAs] via contact with contaminated dust and household surfaces.”

The research was an offshoot from a larger effort looking for an environmental cause of childhood leukemia.  Families who participated in the study were divided into three groups: non-users of tobacco, smokers and ST users.  The contents of dust bags from their household vacuum cleaners were analyzed for NNN and NNK, two TSNAs that are considered to be causes of cancer.

Almost every household – even those with no tobacco users – had NNN and NNK in their dust, but researchers found “higher” levels of these agents in every gram of dust from an ST home – about 5 to 10 nanograms.  Keep in mind that a nanogram is one billionth of a gram, and a gram is less than four one-hundredths of an ounce. 

Each gram of moist snuff contains about 5-10 micrograms of NNN/NNK, about 1,000 times higher than the dust in this study (see my previous blog entry).  At one can a day (32 grams), the typical ST user is exposed to 32,000 times more NNN and NNK than the hypothetical child who eats a gram of dust every day.  It is well established that long-term use of ST even at that level is not associated with a significant increase in risk for ANY cancer.      

The California exposure data may be accurate, but the findings are of no practical consequence, other than to serve as fodder for hyperbolic anti-tobacco claims.

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. 

What’s the Takeaway from Snus?

A new study from British American Tobacco scientists answers that fascinating question, providing valuable information for consumers and regulators. 

Snus contains nicotine and other constituents that make tobacco satisfying, but it also contains contaminants, albeit in vanishingly small amounts.  It is useful to know how much of these constituents users extract and consume during typical use.

Dr. Helena Digard and colleagues published their research in Chemistry Central Journal (abstract here).  They recruited 21 male snus users in Sweden to use four 1-gram pouched snus products for one hour.  They then compared constituent levels in the used pouches with levels in unused pouches from the same package. 

The researchers found that the percentage extraction of constituents from snus was fairly consistent, even though they were present in concentrations that differed by almost a million-fold.  For example, users extracted about one-quarter of the available salt (sodium and chloride), which was present in milligram quantities in the snus pouches.  Also present in milligram quantities was propylene glycol, the solvent used in many e-cigarettes, of which about 30% was extracted; a third of the available nicotine was consumed.

Several constituents, including ammonium (28% extracted), nitrate (27%), and flavorings (19-30%), were present in microgram quantities (one thousand times smaller than milligrams).  Tobacco-specific nitrosamines were present in nanogram quantities (one millionth of a milligram); about 36% were extracted.

This study’s results were reasonably consistent with those from research published in 2012 by John Caraway and P.X. Chen of Reynolds American (abstract here), although the latter work showed somewhat lower extraction of TSNAs and slightly higher extraction of nicotine.  As Nigard et al. acknowledged, there is wide variation in the percentage of extraction among different snus users and even by a single user on different occasions.

A Reasonable Draft Report on Dissolvable Tobacco

When Congress passed the 2009 Tobacco Act, it directed the FDA to study the issue of dissolvable tobacco products (DTPs). After meetings in July 2011 and last month, the Tobacco Products Scientific Advisory Committee (TPSAC) released a draft report summary (available here). In general, the draft is a reasonable and even-handed discussion of available information on DTPs.

The Tobacco Act required TPSAC to review and provide recommendations to the FDA regarding “the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children.”

The report contains some positive statements. First and foremost, “TPSAC members concurred that available evidence supports a conclusion that DTPs are likely to be associated with far lower disease risks than cigarettes.” The committee appropriately acknowledges the much lower risk profile of DTPs compared with cigarettes.

Lower risk was also noted earlier in the draft: “Based on information on TSNAs [tobacco-specific nitrosamines], nicotine, and studies of cancer risk of SMTs [this acronym was not defined, but the context suggests that it refers to smokeless tobacco], exclusive use of DTPs should be less hazardous than either cigarettes or SMTs now marketed in the United States.”

Although the overall message is affirmative, it is not clear how the committee concluded that DTPs “should be less hazardous” than “SMTs now marketed in the United States.” As I have documented (here and here), TSNA levels in all popular American smokeless products are minuscule. There is no way to prove that DTPs are safer than smokeless products now marketed in the U.S., because the latter have risk profiles that are barely elevated, if at all.

The report makes some reasonable comments about the overall population effects of dissolvable tobacco. Referring to the report’s flow chart (that contains errors and is unclear), “[t]he TPSAC framework indicates several ways that DTPs could reduce the disease burden caused by tobacco use: decreasing the number of smokers, if availability of DTPs increases successful cessation, and decreasing the risk of tobacco caused disease, if availability of DTPs sufficiently reduces cigarette smoking or use of other types of SMT.”

However, the report also suggests that DTPs could cause population harm, “by either increasing the number of tobacco users or reducing cessation,” which are persistent but speculative concerns within the tobacco control community. First, because the risks of DTP use are, at most, about 2% of the risks of smoking, the increase in users would have to be over 50-fold to increase population harm. The reduced-cessation concern is also not evidence-based. Currently, cessation is abysmal among American smokers; fewer than 5% quit in any given year. Furthermore, a study published in 2010 (discussed by me here) documented that that there is “no evidence that smokeless tobacco (Ariva or Stonewall) undermines quitting. To the contrary, readiness to quit (in the next 1 month and within the next 6 months) significantly increased among smokers who used a smokeless tobacco product relative to those who continued to smoke conventional cigarettes.” This is unmistakable evidence that DTPs don’t deter smokers from quitting.

The TPSAC report concludes with recommendations for additional product testing, surveillance and research; I heartily concur with the call for improved surveillance. As discussed recently in this blog (here), there is a deficit of information in federal surveys on smokeless tobacco use in general, and especially on newer products like dissolvables and e-cigarettes. Adequate information is a necessary prerequisite for meaningful regulatory action.

An Informative Study on Tobacco-Specific Nitrosamines

Last week, I noted that University of Minnesota researchers, arguing for additional reductions of tobacco-specific nitrosamines (TSNAs) in moist snuff products (here), complained that “No evidence has been found that Conwood [a Reynolds company] and USST [United States Smokeless Tobacco, an Altria company] took any meaningful steps to reduce the relatively high levels of NNN and NNK in their products.” (The lead author was Stephen Hecht.)

The Hecht allegations are another false alarm, as a new study in Food and Chemical Toxicology (abstract here) provides evidence that, “…since 1997, average TSNA levels have declined by approximately half in USST moist smokeless tobacco products.” The authors, including lead author Michael Fisher, are from Altria.

Fisher et al. provide valuable information about how agricultural and production practices influence TSNA development. They collected samples from thousands of bales of tobacco over the past 15 years, and discovered that “…there is a general relationship between average rainfall during the tobacco curing season and TSNA in cured tobacco.”

Moist snuff is primarily made from dark-leaf tobacco, grown in western Tennessee and western Kentucky, and barn-cured in late-summer and autumn with smoke from hardwood fires. Fisher et al. show that the most important factors in TSNA formation are humid and/or moist curing conditions. Excess nitrogen fertilizer is also a factor, although tobacco needs high concentrations of nitrogen in order to thrive. As Hecht et al. pointed out in their article, American moist snuff has marginally higher TSNA levels than Swedish snus, which is also made with dark-leaf tobacco that is air cured. This suggests that fire curing may also play a minor role in TSNA formation.

In the past manufacturing may have also played a small role in TSNA formation, when particular bacterial strains used some of the nitrogen (in the form of nitrate) to form nitrite. The nitrate-reducing bacteria may be present in harvested tobacco, and in fermentation facilities, but in 2005 USST initiated strict sanitation practices and other programs to inhibit these bacteria. This resulted in TSNA levels in finished products that were consistent with the levels found in the incoming leaf.

As I have noted previously, TSNA levels in moist snuff products from Altria and Reynolds are at historically low levels. This study documents that TSNA levels are mainly influenced by weather conditions during the curing process. Furthermore, it is important to emphasize that there is no evidence that current TSNA levels are associated with ANY significant cancer risks.

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

I discussed a year ago the tempest-in-a-teapot issue of tobacco specific nitrosamines (TSNAs) in smokeless tobacco products (here). TSNAs are contaminants found only in tobacco, and they are present in vanishingly small concentrations – mainly in the single-digit parts-per-million range. “Regardless of current TSNA levels,” I wrote, “anti-tobacco extremists will call for reductions.”

Last month, the University of Minnesota’s Stephen Hecht, Irina Stepanov and Dorothy Hatsukami (a member of the FDA Tobacco Products Scientific Advisory Committee) published a letter in Tobacco Control (here), demanding TSNA reductions. This, despite the fact that their data showed that TSNA levels in moist snuff products from Altria and Reynolds were at historically low levels in 2010. I have commented on this group’s anti-smokeless-tobacco articles before (here and here).

Hecht et al. list the levels of NNN and NNK in several Altria and Reynolds brands:

NNN + NNK Levels in Moist Snuff and Snus, in Parts Per Million (ppm), Dry Weight
Brand	NNN+NNK (ppm)
Altria
Copenhagen	5.6
Copenhagen Long Cut	5.8
Copenhagen LC Wintergreen	4.6
Skoal Long Cut Straight	4.9
Skoal Long Cut Wintergreen	5.2
Skoal Bandits Wintergreen	5.2
Marlboro Snus Rich	0.7
Marlboro Snus Spearmint	0.9
Marlboro Snus Peppermint	0.8
Marlboro Snus Mild	0.8
Reynolds
Grizzly	11.1
Kodiak Wintergreen	5.1
Camel Snus Frost	1.5
Camel Snus Mellow	1.7

These NNN and NNK levels are lower, across the board, than those of moist snuff products from the 1980s and 1990s, which I documented in a review article in 2004 (here). Epidemiologic studies from the 1980s and 1990s show that oral cancer risks among moist snuff users were minimally elevated, if at all, when those higher level products were being used.

While Hecht and colleagues assert that “smokeless tobacco is carcinogenic to humans, causing oral, pancreatic and esophageal cancer,” a comprehensive study of cancer risks among smokeless users (here) documented no significant risk for any of these cancers. There is virtually no evidence that current TSNA levels are associated with ANY significant cancer risks. Reducing current levels cannot lower an immeasurable cancer risk.

The article by Hecht et al. indicates that the authors are comfortable with TSNA levels in Marlboro and Camel snus, and that they view these products as acceptable cigarette substitutes. Perhaps Drs. Hecht, Stepanov and Hatsukami will now endorse them in this manner.