Thursday, April 25, 2013

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.

Thursday, April 18, 2013

The American Cancer Society’s Anti-Tobacco Campaign Ignores Its Own Research

The American Cancer Society continues to misinform smokers about vastly safer options.  With chapters in nearly every county across the nation, the ACS is a powerful tobacco harm reduction opponent.

Since it cannot argue against tobacco harm reduction on the facts, the ACS resorts to false and deceptive claims.  For example, last week the House Consumer Protection Committee of the Illinois General Assembly scheduled a hearing on tobacco harm reduction.  Heather Eagleton, Illinois Director of Public Policy and Government Relations for the ACS Cancer Action Network, issued a press release replete with false statements; it was reported in a popular capitol blog that previewed the event (here).

False Statement 1.  “This is a new twist on the old tobacco marketing campaigns of the 1960s, 1970s, and 1980s that falsely promised health benefits to be derived from filtered, ‘light’, and ‘less tar’ tobacco product alternatives that were ‘more safe’ versus ‘less safe.’ These ‘harm reduction’ messages were false then and are false now.”

Ms. Eagleton is apparently unaware that the ACS was responsible for some of the “false promises.”  In 1976 (here)  and in 1979 (here), the organization documented and promoted the health advantages of light cigarettes compared with full-flavor brands.  The ACS president said in the latter year that “findings of the new study suggest a way for smokers to reduce their lung cancer risk by switching to low tar-nicotine cigarettes if they find it impossible to quit entirely.”

False Statement 2.  “There is research, however, to show these products cause cancer of the mouth, pancreas and esophagus, as well as other serious health conditions.”

This is a completely false assertion by Ms. Eagleton.  It ignores the 2009 results of the most comprehensive analysis of relevant research (discussed here).  More importantly, Ms. Eagleton ignores research from her own organization.  In 2005, ACS investigators published results from the first and second Cancer Prevention Studies (abstract here), two of the largest studies of smokeless tobacco use and deaths in the U.S.  Here are the ACS-reported noteworthy risks for smokeless tobacco users:

Relative Risks (95% Confidence Interval) of Death From Selected Diseases Among Smokeless Tobacco Users in the American Cancer Society’s Cancer Prevention Studies (CPS)
All Cancers1.07 (0.95 – 1.20)1.19 (1.02 – 1.40)
−Oropharynx2.02 (0.53 – 7.74)0.90 (0.12 – 6.71)
−Digestive system1.26 (1.05 – 1.52)1.04 (0.77 – 1.38)
−Lung1.08 (0.64 – 1.83)2.00 (1.23 – 3.24)
−Urinary system0.97 (0.77 – 1.22)1.15 (0.85 – 1.56)
−Other cancers0.90 (0.71 – 1.14)1.49 (1.04 – 2.14)
Cardiovascular diseases1.18 (1.11 – 1.26)1.23 (1.09 – 1.39)
Respiratory diseases1.28 (1.03 – 1.59)1.11 (0.84 – 1.45)
Emphysema1.86 (1.12 – 3.06)1.28 (0.71 – 2.32)

First, note that the excess risk for oral cancer among smokeless tobacco users in both ACS studies was ZERO.  In fact, there was only one death from oropharyngeal cancer among smokeless users in CPS-II, compared with 45 deaths among nonusers of tobacco.  ACS staff certainly would have spotlighted increases in cancers of the pancreas or esophagus; this report never mentions these cancers, which is virtual confirmation that risks weren’t increased.

There are some elevated risks in this table.  For example, smokeless users in CPS-I had slightly increased deaths from digestive system cancers, and CPS-II smokeless users had small increases for other cancers and cardiovascular diseases.  The reasons for these findings are obvious: CPS-I smokeless users had significant elevation in emphysema, and CPS-II users had a two-fold elevation in lung cancer, both of which are caused by smoking.  So, while the ACS tried to study exclusive smokeless users, the subjects were also smoking.

In summary, the ACS harm reduction messages were false then and are false now. The organization continues to deny almost 60 million American tobacco users truthful information about smokeless tobacco and e-cigarettes.  Tobacco users, and their families and friends are responsible for at a portion of the nearly $900 million the ACS collects in contributions annually (here).  They, and the public at large, deserve more honest and forthright public health messaging from such an influential organization.

Friday, April 12, 2013

Dual Use, Double Standard

Tobacco harm reduction opponents have myriad rationales for withholding from smokers vital information about safer products.  One common objection is that smokers will become dual users (of both cigarettes and smoke-free substitutes), and never achieve abstinence. 

While scientific evidence (here) rebuts such dual use allegations, tobacco opponents are not dissuaded.  They further claim that safer tobacco products simply aren’t necessary, given the availability of nicotine medicines; those, however, work for only seven percent of smokers (here and here). 

Interestingly, nicotine medicines are used concurrently by a small percentage of smokers.  A 2003 study reported that 10% of smokers in the GlaxoSmithKline “Committed Quitters” program were dual users at 12 weeks after enrollment, and 2% were dual users at 24 weeks (here).

There are several differences between smoke-free tobacco products (like snus and e-cigarettes) and over-the-counter pharmaceutical nicotine products:

  • Smoke-free tobacco is affordable; pharmaceutical nicotine is expensive
  • Smoke-free tobacco is perceived as recreational; pharmaceutical nicotine is seen as medicine
  • Smoke-free tobacco delivers nicotine/tobacco satisfaction; pharmaceutical nicotine does not

Smoke-free tobacco and pharmaceutical nicotine are identical in one respect: They are both candidates for dual use with cigarettes.  Criticizing the former while giving a pass to the latter is an unacceptable double standard.

Friday, April 5, 2013

Misperceiving Nicotine Health Risks

My research group published survey data in 2010 documenting that a highly educated population (faculty at the University of Louisville) misperceived the health risks of smokeless tobacco use compared with smoking (discussed here).  Half of survey participants incorrectly believed that smokeless tobacco use confers general health risks that are equal to or greater than smoking; the misperception rate for oral cancer risk was 86%.

In a new study, we measure misperceptions of nicotine.  My co-authors are Dimple Patel and Nicholas Peiper, graduate students in public health at the University of Louisville; the article appears in Addiction Research and Theory (abstract here).  

Our study quantifies risk perceptions of cigarette smoking and nicotine use with respect to general health, heart attack/stroke, all cancer and oral cancer among full-time faculty. We compare the results from faculty on the health science campus with those in schools not related to health.  

We find that “the majority [of faculty] incorrectly categorized nicotine as moderate or high risk for all health domains, which is contrary to expert assessments.”

Our findings confirm that misperception of nicotine is widespread.  As we note, “Several surveys previously documented smokers’ misperceptions of nicotine’s risks. In 2001, a nationally representative survey of American smokers revealed that two thirds incorrectly believed that nicotine causes cancer, and 65% believed that nicotine patches confer the same or higher risk for heart attack as cigarettes (here). A majority of smokers also believe that reducing nicotine in cigarettes reduces harm (here). A 2009 survey involving smokers in Norway and Sweden reported exaggerated perceptions of harm from nicotine and NRT products (here). It found that 55% of smokers incorrectly regarded nicotine as being a relatively large to very large part of cigarette harm, and 59% wrongly believed that long-term use of nicotine from patches or gum is almost as harmful as smoking. Smokers in Minnesota had strong misperceptions that nicotine was the cause of heart attack, stroke, lung cancer, and oral cancer.”(here)

We write that “The FDA, which since 2009 has had regulatory authority over both tobacco and pharmaceutical nicotine, could serve as an educational resource for correcting misperceptions about the health effects of nicotine.  In fact, there is evidence that the agency is looking at its options. In October 2010, the FDA Center for Drug Evaluation and Research conducted a workshop on the risks and benefits associated with long-term use of pharmaceutical nicotine products (information here). It is clear from the presentations that almost all participants believe that the health risks from long-term nicotine use are minimal to negligible. In addition, a presentation by Dr. Dorothy Hatsukami from the University of Minnesota addressed the importance of educating the public to correct misperceptions about pharmaceutical nicotine use.”

That workshop was held two years ago, but the agency has been slow to take the simplest steps concerning nicotine.  As I wrote three years ago (here), the FDA never responded to New York State Health Commissioner Richard Daines’s 2008 petition requesting minor revisions in package labeling and sale of nicotine that would greatly expand consumer awareness and availability.  But the FDA has allowed Niconovum, a pharmaceutical nicotine company affiliated with Reynolds American, to sell 10-packs of its Zonnic nicotine gum to compete directly with cigarettes (website here).

On April 1 the FDA removed the 12-week limit on pharmaceutical nicotine products (here).  This is a message to smokers that nicotine is not the problem, and it may also signal the agency’s recognition that a small percentage of former smokers use nicotine for months, even years, after quitting.    

We conclude: “Nicotine is not the cause of any of the diseases associated with smoking.  There is an immense disconnect between the scientific and medical facts about nicotine and the perception of highly educated people, including health professionals… Our study documents that health education initiatives are still needed to minimize and/or eliminate these misperceptions and to inform smokers about noncombustible nicotine products that are vastly less hazardous than smoking.”