Wednesday, September 25, 2013

Population-Level Proof: Snus Saving Swedish Smokers’ Lives as Tobacco Consumption Declines

New research confirms earlier findings demonstrating that widespread snus use is tied to reduced rates of smoking.

A decade ago I worked with scientists from Sweden’s Umeå University to publish the first scientific evidence that smokeless tobacco (“snus” in Swedish) played an impressive role in low smoking rates among Northern Swedish men from 1986 to 1999 (here and here).  We published another study showing that in 2004 smoking among women also declined as a result of increased snus use (here).

I am the lead author on a new study documenting that snus continues to play a role in low Swedish smoking rates.  That work, based on 2009 data, was just published in the Scandinavian Journal of Public Health (here), with coauthors Drs. Jan-Håkan Jansson and Mats Eliasson from Umeå University.

The chart on the left illustrates the most interesting finding from this study: Snus continues to play a role in low smoking rates among both men and women, but all tobacco use, including that of snus, is declining.  Critics of tobacco harm reduction charge that snus and other safer smoke-free substitutes are a gateway TO smoking, and thus will lead to a negative population effect.  The data from Sweden is conclusive.  As we wrote, “…tobacco harm reduction is not contrary to overall reductions in tobacco use at the population level.”

We also documented the direct role snus plays in smoking cessation.  From our study: “The prevalence of former smoking was 27% for men and 31% for women in 2009. Among men, only 27% of former smokers were never snus users, 39% were current snus users and 34% were former snus users. Among women former smokers, 70% never used snus, 19% were current users and the remainder were former snus users.”

Snus’s impact was seen in the smoking quit rate, which is the percentage of former smokers among ever smokers (current + former smokers).  “The smoking quit rate among men was 71%; 52% were ever users of snus and 19% were never users.  This was consistent with earlier surveys (reference here). The quit rate among women was 72%, which was considerably higher than previous years, reflecting increases in both ever users of snus (21%) and never users (51%).”

I have noted in this blog that American policymakers insist on population-level proof that vastly safer smoke-free products do not increase tobacco use (here and here).  This study provides that proof: snus promotes low rates of smoking in Sweden and is also compatible with reductions in all tobacco use.

Wednesday, September 18, 2013

Nicotine Safety

I have asserted for some 20 years that nicotine, while addictive, is otherwise without significant adverse health effects outside of pregnancy.  It is, in other words, safe to consume.  In my 1995 book, For Smokers Only, I compared nicotine to caffeine (here), another addictive drug used safely by millions of people. 

Scientific evidence of nicotine’s safety, however, is hard to document, despite the fact that it is one of the most comprehensively studied drugs.  The problem is that drug safety is primarily established by the absence of adverse effects.  Owing to tobacco prohibitionists’ persistent demonizing of nicotine, only a small number of medical researchers have come forward to express positive views on nicotine safety.

At a 1997 United Nations roundtable on the social and economic aspects of smoking reduction through the use of alternative nicotine delivery systems, nicotine and tobacco experts came to the following conclusions:

"Turning to the long-term use of nicotine replacement, the major causative factors for [tobacco-related diseases] are the carcinogens, carbon monoxide and other toxins contained in tobacco smoke, rather than nicotine per se."

"...long-term use of nicotine replacement appears to be safe and may be necessary for some highly dependent smokers"

"Nicotine per se does not substantively contribute to most of the medical complications of tobacco use...Long-term nicotine use is not of demonstrated harm, with the possible exception of use during pregnancy...Scientific research indicates that nicotine is not a carcinogen."

"There is a widely held misconception that nicotine is implicated in [tobacco-related diseases].  To date, there is still no definitive evidence that nicotine directly contributes to human disease, but several areas of concern remain." (Neal Benowitz, nicotine pharmacologist and member of the FDA Tobacco Products Scientific Advisory Committee)

"The main cause of death with some addictive drugs, e.g. heroin, is exposure to the toxins of the drug delivery system rather than the drug itself; this also applies to nicotine." (Jack Henningfield, tobacco harm reduction opponent and former member of the FDA Tobacco Products Scientific Advisory Committee)

Ken Warner, a well-respected tobacco economist at the University of Michigan, wrote about tobacco harm reduction in Nicotine &Tobacco Research in 2002 (abstract here):

"Although the evidence is not yet definitive, the best scientific judgment to date is that,
outside of pregnancy, long-term use of nicotine, in the doses at which people self-administer it, does not pose substantial risks to health.”  He cited Neal Benowitz’s 1998 book entitled “Nicotine Safety and Toxicity” (available here). 

Finally, Mitch Zeller commented on the spectrum of risks related to various forms of nicotine delivery in a Tobacco Control article published in 2009 (abstract here):

"There is a very pronounced continuum of risk depending upon how toxicants and nicotine, the major addictive substance in tobacco, are delivered. Cigarette smoking is undoubtedly a more hazardous nicotine delivery system than various forms of noncombustible tobacco products for those who continue to use tobacco, which in turn are more hazardous than pharmaceutical nicotine products.  There is potential for an ever-wider range of consumer-acceptable alternatives to the cigarette for smokers who will not otherwise cease their dependence on nicotine."

Zeller, now director of the FDA Tobacco Products Center, acknowledges nicotine’s safety and tobacco harm reduction’s potential.  One hopes that FDA’s regulatory actions will ensure that all Americans are equally well-informed.

Wednesday, September 11, 2013

E-Cigarettes = Nicotine Patches for Smoking Cessation, Clinical Trial Shows

Newly published research shows that e-cigarettes are about as effective as nicotine patches in helping smokers quit. That should (but won’t) silence critics who insist that e-cigarettes are unproven and that medicinal nicotine products are the only scientifically valid cessation aids.

At New Zealand’s University of Auckland, Dr. Christopher Bullen and colleagues compared quit rates among 657 smokers treated for 12 weeks with nicotine e-cigarettes, nicotine-free e-cigarettes, or 21-mg. nicotine patches.  Their randomized study was published in the Lancet (abstract here).   

Bullen and colleagues reported continuous abstinence from smoking at 1, 3 and 6 months after the participants’ quit day.  Here is a summary of the main results:

Continuous Smoking Abstinence (%) Among Smokers Treated With Nicotine E-cigarettes, Nicotine-Free E-cigarettes and Nicotine Patches
Follow-Up (months)Nicotine E-cigarettesNicotine-free E-cigarettesNicotine Patches

There were no significant differences between any of the treatments in any time period.  In other words, e-cigarettes were just as effective as nicotine patches in helping smokers quit – keeping in mind that “effective” here is only a roughly seven percent quit rate (here).  At one-year follow-up, the gold standard for cessation trials, the results would be even worse. 

This new study adds to a growing body of evidence supporting the effectiveness of e-cigarettes (here, here, and here).

A seven-percent solution is not very impressive, but if the real objective is to improve the health of smokers, the products might not be the problem.  Rather, fault may lie with the clinical trial model, in which smoking is the “illness,” 12 weeks of NRT or e-cigarettes or snus is the “therapy,” and nicotine/tobacco abstinence is the only targeted “outcome.”  Most people consider smoking a lifestyle choice, not an illness; they aren’t seeking treatment, and they are unwilling or unable to abstain.  The biggest challenge, therefore, isn’t to offer more quitting options, it is to alter the design of clinical trials to accommodate smokers’ preferences and incorporate the principles of tobacco harm reduction.  Changing the targeted outcome from nicotine/tobacco abstinence to smoking abstinence would permit ex-smokers to use alternative products at satisfying doses, indefinitely if they choose.   

Blocking the path to accomplishing this smoke-free objective is the bizarre demand by tobacco-prohibitionists that companies seeking FDA approval for harm reduction products must first prove that they will not cause population-level effects (discussed here).  Peter Hajek addressed this challenge in a Lancet commentary accompanying the Bullen study: “There is an obvious source of evidence as to whether use of e-cigarettes leads to an increase or reduction in tobacco smoking: the trajectories of sales of e-cigarettes and tobacco cigarettes.  If growing sales of e-cigarettes coincide with increased sales of tobacco cigarettes, tobacco control activists arguing for restriction of e-cigarette availability would be vindicated.  If traditional cigarette sales decline as e-cigarette sales increase, it would suggest that e-cigarettes are normalising non-smoking and that it is in the interest of public health to promote and support their development rather than try to restrict it.”

Hajek makes a legitimate case for using market data as the primary indicator of e-cigarettes’ public health impact.  An accelerating decline in cigarette consumption will confirm the positive public health impact of an e-cigarette revolution.

Thursday, September 5, 2013

Irresponsible E-Cigarette Theatrics from Federal Officials

The anti-tobacco movement continues to ignore evidence that millions worldwide have switched from smoke to vapor.  Witness today’s press release (here) from the Centers for Disease Control and Prevention (CDC): “There is no conclusive scientific evidence that e-cigarettes promote successful long-term quitting.”  Yet in the absence of proof, extremists insist that e-cigarettes are a gateway to smoking for teenagers.  A new CDC report adds fuel to that gateway fire in the nation’s media. 

The report (available here) uses information from the 2011 and 2012 National Youth Tobacco Surveys (NYTS).  In 2012, 2.8% of high school students used an e-cigarette in the past 30 days, compared with 1.5% of students in 2011.  Over 80% of e-cigarette users also had smoked cigarettes in the past 30 days. 

There is no information in the CDC report or in the NYTS relating to gateway.  The NYTS asks teenagers at what age they first smoked a cigarette.  However, since the teens were not asked at what age they first used e-cigarettes, gateway analysis is impossible.  Still, that didn’t stop CDC Director Tom Frieden from speculating: “Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes.”

The report’s findings are hardly surprising.  The market for e-cigarettes is rapidly expanding, and youths who smoke cigarettes will also experiment with vapor products.  Yet federal officials’ headline-ready comments put the findings in apocalyptic terms.  Dr. Tim McAfee, director of the CDC Office of Smoking and Health, said, “These dramatic increases suggest that developing strategies to prevent marketing, sales, and use of e-cigarettes among youth is critical.” 

The report is an unabashed pitch for FDA e-cigarette regulation, which is likely coming in October.  Mitch Zeller, director of the FDA’s Center for Tobacco Products, also exaggerated the findings to justify FDA action: “These data show a dramatic rise in usage of e-cigarettes by youth, and this is cause for great concern as we don’t yet understand the long-term effects of these novel tobacco products…These findings reinforce why the FDA intends to expand its authority
over all tobacco products and establish a comprehensive and appropriate regulatory framework to reduce disease and death from tobacco use.”

Zeller, a respected authority on tobacco use, knows that cigarettes cause 99% of “disease and death from tobacco use.”  Here, he deliberately conflates the risks of smoke-free and combustible tobacco products in the context of teenage use.

Federal authorities should restrict youth access to all tobacco products, but it is unacceptable for them to characterize e-cigarettes as gateway products when they are, in fact, helping to eliminate the smoking plague.