Thursday, February 28, 2013

Imagining Tobacco Without Nicotine: Chapter 2

A February 23 Winston-Salem Journal article about Mitch Zeller, the new director of the FDA Center for Tobacco Products (here), reported that “Brad Rodu, a professor of medicine at the University of Louisville and a smokeless-tobacco advocate, said he is concerned that Zeller’s work with GlaxoSmithKline could create a regulatory bias against manufacturers’ smokeless products.  He urged the FDA to take an open-minded approach to smokeless innovations, ‘especially when smokers have increasing access to vastly safer alternatives.’”

That’s only part of the story. 

Over two years ago, I critiqued an article in Tobacco Control that I labeled “another thinly veiled call for reducing nicotine to ‘non-addictive levels’ in cigarettes” (my blog post is here). 
Zeller was one of the authors of that article.  In the press release from the University of Minnesota (still available here), Zeller commented: “Imagine a world where the only cigarettes that kids could experiment with would neither create nor sustain addiction.”

I said then that … “it doesn’t take an active imagination to appreciate the disaster that would result from radical reduction (prohibition) of nicotine in cigarettes.”  Zeller and his coauthors did not understand the effects of radically reducing nicotine in cigarettes. Yet, they make nicotine prohibition sound like the perfect solution for the nation’s 45 million smokers.

I am less concerned that Zeller used to work with GlaxoSmithKline than I am with the possibility that he might steer the FDA to reduce nicotine levels in tobacco products to the nonaddictive level in GSK’s nicotine medicines.  Those levels, the data show, don’t satisfy smokers and result in a 93% failure rate for smoking cessation (discussed here).

Wednesday, February 20, 2013

Smoking, But Not Smokeless Tobacco, Associated with Past-Year Psychiatric Disorders

Compared with the general population, smokers have elevated rates of psychiatric problems, and affected smokers tend to consume more cigarettes, inhale more deeply and quit less often (evidence here, here and here).  A new study confirming this link concludes that “smokeless tobacco is not significantly associated with psychiatric morbidity…”

The principal investigator of the study, which was published in Social Psychiatry and Psychiatric Epidemiology (abstract here), is Nicholas Peiper, a doctoral student in epidemiology at the University of Louisville; I am honored to be a co-author. 

Peiper analyzed data from the 2005 to 2008 National Survey on Drug Use and Health (NSDUH).  In addition to detailed information on tobacco use, the survey also measures past-year serious psychological distress and major depressive episodes using clinically validated instruments, and past-year anxiety disorder with proxy items.  Results were adjusted for other potential factors for these disorders, including age, race/ethnicity, education, income, marital status, diabetes and other illnesses, substance/alcohol abuse and pregnancy. 

Odds Ratios For Serious Pyschological Distress (SPD), Major Depressive Episode (MDE) and Anxiety Disorder (AD) Among Current Smokers, Smokeless Tobacco Users and Dual Users, NSDUH 2005-2008
SmokersSmokeless UsersDual Users
SPD1.14 (0.99 – 1.31)0.71 (0.55 – 0.91)0.86 (0.65 – 1.14)
MDE1.21 (0.99 – 1.48)0.88 (0.66 – 1.19)1.15 (0.82 – 1.63)
AD1.53 (1.17 – 2.00)1.21 (0.79 – 1.87)1.73 (1.13 – 2.65)
SPD1.60 (1.45 – 1.77)0.95 (0.51 – 1.77)2.24 (1.10 – 4.58)
MDE1.43 (1.26 – 1.63)0.38 (0.13 – 1.10)1.68 (0.71 – 3.98)
AD1.83 (1.56 – 2.14)0.99 (0.35 – 2.81)2.76 (1.09 – 7.00)

Both male and female smokers were more likely than never tobacco users to have experienced past-year serious psychological distress, major depressive episodes or anxiety disorders.  Smokeless users were less likely to experience psychological distress (statistically significant in men) and depressive episodes.  Female and male dual users were significantly more likely to experience anxiety; female dual users also experienced more psychological distress.

It is evident that tobacco harm reduction can be an effective adjunct to the management of patients with psychological problems.  We conclude: “considerable efforts should focus on addressing differential tobacco risks in treatment settings, as those with psychiatric morbidity suffer a disproportionate share of smoking-attributable morbidity and mortality.” 

Wednesday, February 13, 2013

Making the European Case for Snus

The Parliament magazine, which covers European Union news, politics and public policy, just published a special supplement on snus. The supplement, underwritten by the Swedish Food Federation and the Swedish Food Worker’s Union, documents the travesty of the EU snus ban, with articles by Velvet Glove, Iron Fist author Chris Snowdon; Swedish members of the European Parliament Christopher Engström and Christofer Fjellner; Director of the Norwegian Institute for Alcohol and Drug Research Karl Lund; Swedish ministers for trade and children and the elderly Ewa Bjorling and Maria Larsson; Swedish Institute for Tobacco Studies’ Lars Ramström, and others. 

The supplement is available on The Parliament website (here); a PDF version can be obtained from my SmokersOnly website (here).  I also contributed the following article to the publication.

Imagine this news story: “As Sweden celebrates the fifty-third anniversary of the seat belt as a standard accessory in Volvos, the European Commission health directorate reiterated its seatbelt ban for all other EU countries.  ‘All automobiles are dangerous; seat belts have not been proven to make cars safer and may promote riskier driving,’ said the EU health commissioner.  Opposition in Sweden is led by the Karolinska Institute, which has documented rare fatalities among those wearing the devices…”

Today this story is unimaginable.  Seat belts are a proven harm reduction measure, preventing deaths and injuries from auto accidents.  Why does the EC embrace seat belts and still ban another proven Swedish harm reduction measure, snus? 

Snus is a 200-year old tobacco product.  When placed in the mouth, it delivers nicotine and tobacco satisfaction, like cigarettes, but without the smoke.  Nicotine is not the major cause of any disease; it is no more harmful than caffeine, which is addictive but safely consumed in coffee, tea and cola drinks. 

Smoke kills.  In contrast, studies from Sweden show that snus has minuscule health risks that are barely measurable with modern epidemiologic tools.  This applies even to mouth cancer, for which snus poses virtually no risk.  The EU removed the cancer warning on snus packages in 2001.

For 50 years, men in Sweden have smoked less and used more smokeless tobacco than in any other developed country, resulting in the lowest rates of lung cancer -- indeed, of all smoking-related deaths.  The Swedish snus experience is not only about men; increasing numbers of Swedish women are using spit-free, socially acceptable snus products.

The EU ban on vastly safer snus is contributing to smokers’ deaths.  In a published study, I found that if EU men smoked at the Swedish rate, 274,000 smoking-attributable deaths would be avoided every year. 

The EU ban is largely based on health risks identified in Karolinska Institute (KI) studies, which have also had a profound impact on tobacco regulation around the globe.  These studies have obvious technical problems and contradictions that I have documented in medical journals.  The KI refused to respond to or resolve them.  Three years ago, I asked the researchers for access to their data so that their findings could be validated.  My request was refused, despite the fact that KI had shared research data with other investigators. Scientific results must be open to challenge to determine their accuracy and integrity.

It is a tragedy that the EU ban on snus is based on exaggerated, fictitious or outlier health risks that mask the true harm reduction value of this product. 
EU tobacco experts wrote in 2003: “Through the [snus] ban, the EU is actively preventing smokers having access to a product at least 90% less dangerous than cigarettes, but that is clearly an effective substitute for at least some people (and for many people in Sweden).  It is important to consider where the EU draws its moral (and legal) authority to make such ‘life-or-death’ choices on behalf of its citizens—especially as, on the basis of Swedish evidence, it appears to be making the wrong choices.”

Almost ten years later, EU smokers are still facing avoidable premature deaths.  It is inhumane for the EC to continue to deny them the tobacco equivalent of seat belts.

Wednesday, February 6, 2013

FDA: Adverse Events Related to E-Cigarettes Are Almost Nonexistent

The FDA Center for Tobacco Products’s Dr. Ii-Lun Chen describes in Nicotine and Tobacco Research (citation here) adverse events related to e-cigarettes reported to the agency from 2008 to the first quarter of 2012.  

Adverse Events Reported to the FDA for E-cigarettes and Other Tobacco Products
YearE-cigarettesOther Tobacco Products
Up to 2008117
1st Quarter 201292

Dr. Chen notes: “…approximately half of all tobacco-related [adverse event] reports [since the late 1980s] concern electronic cigarettes, the first of which was submitted in 2008.”  A look at details of the events reveals that few reflect legitimate e-cigarette health impact.

Some “serious” complaints variously involved hospitalization for pneumonia, congestive heart failure, disorientation, seizure, hypotension, possible aspiration pneumonia, second-degree burns (from a battery explosion), chest pain and rapid heartbeat, possible infant death from choking on a cartridge, and loss of vision.  The single burn case may have been related to an e-cigarette, as there have been media reports of rare battery-related incidents (here).  The infant choking death, while tragic, implicates irresponsible adults who put children in proximity of ingestible objects; it is not an e-cigarette health issue.  All of the other “serious” complaints were nonspecific and probably unrelated to the product.

Dr. Chen reports that “…other e-cigarette complaints include concerns about false advertising, headache/migraine, chest pain, cough/sputum, nausea/vomiting, dizziness, feeling sick, confusion/stupor, sore throat, shortness of breath, abdominal pain, pleurisy, blurry vision, and sleepy/tired.”  He correctly adds, “Of note, there is not necessarily a causal relationship between AEs reported and e-cigarette use, as some AEs could be related to pre-existing conditions or due to other causes not reported.”

E-cigarettes are relatively new products, so it is not surprising that adverse events have surfaced in the form of “…voluntary communications from consumers, health care professionals, and concerned members of the public.” 

The bottom line is: Among millions of e-cigarette users, credible adverse events are almost nonexistent.