Smoking and Using E-Cigarettes? Moffitt Cancer Center Wants You To Be “Forever Free”

“Do e-cigarettes actually help people quit smoking?”  The Moffitt Cancer Center in Tampa, Florida, is recruiting smokers who vape (i.e., dual users) for a clinical trial that, according to spokesman Vani Nath Simmons (here), aims to answer that question.  Researchers will be using federal grants to convince smoker-vapers to quit smoking, and possibly to quit vaping, by sending them self-help booklets.

The researchers, led by Thomas Brandon, Ph.D., have long been interested in providing smokers low-cost self-help interventions for quitting and preventing relapse.  They mail study participants booklets called “Forever Free,” teaching them “how to resist urges to smoke.”  The researchers have published the results of several trials, each of which involved minor variations in design and frequency of booklet mailings.  Here are some results:

Results Of Moffitt-Based Clinical Trials Employing Self-Help Booklets
Publication, date	Main Outcome	Main Result
Addiction, 2015	Relapse prevention	No effect
American Journal of Preventive Medicine, 2015	Abstinence	Booklets better
Nicotine & Tobacco Research, 2016	Relapse prevention	No effect
Journal of Consulting and Clinical Psychology, 2000	Relapse prevention	Booklets better

The first study was conducted in Britain; the next two, in the U.S., were supported by National Cancer Institute grants totaling about $5 million over the period 2009-2013.  According to the American Journal of Preventive Medicine report, the booklets helped smokers abstain in one cessation trial.  They were mailed to smokers at two rates, standard (8 booklets over 12 months) or intensive (10 over 18 months with other mailings on alternate months).  The control group only received one booklet at the beginning of the trial.  At 24 months, 19% of this group reported that they hadn’t smoked in the past week.  The non-smoking rate was 24% in the control group and 30% (significantly higher) in the intensive group.

In 2000, Dr. Brandon reported that former smokers who received booklets had lower relapse rates than smokers who had access to a telephone hot line (12% vs. 35%). 

Dr. Brandon has been quoted noting the relative merits of e-cigarettes compared to cigarettes (here), and Moffitt spokesman Simmons acknowledged, “We can say that it is very unlikely that they [e-cigarettes] are as harmful as regular tobacco cigarettes because you aren’t being exposed to the tar and the cancer-causing chemicals.” 

In the current trial, the booklets are modified specifically for vapers, as reflected in the title, “If You Vape: Guide to Quitting Smoking”.  However, the formal description of the study, as filed with the NIH (here), includes among its objectives producing tobacco abstinence among subjects and terminating “their e-cigarette use as per traditional nicotine replacement therapy (NRT).”  One hopes that this study will not embrace the disease-treat-cure model for influencing consumer behavior (here and here).

Note: This post was updated with additional information on July 29, 2016.

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.

Dual Use and Smoking Suppression

Norway has proven that the Swedish tobacco experience can be duplicated in other countries where smokeless tobacco is used (discussed earlier here and here).  Karl Erik Lund, from the Norwegian Institute for Alcohol and Drug Research, and Ann McNeill from the University of Nottingham in the UK, have profiled male dual users (of snus and cigarettes) in Norway in a new report published in Nicotine & Tobacco Research (abstract here).

Drs. Lund and McNeill use Norwegian survey data to show that dual use has been relatively stable at 4-7% over the 25-year period from 1985 to 2010, during which exclusive snus use increased from 3% to 12% and exclusive smoking dropped from about 50% to 20%.  While U.S. tobacco prohibitionists argue that dual use will be problematic if smokers are educated about safer smokeless products, dual use has not been a public health issue in Sweden or Norway.

Another finding in the Scandinavian research is that dual users smoked fewer cigarettes than exclusive smokers (57 vs. 80 per week).  I also reported this fact in my landmark Swedish study published ten years ago (abstract here), and I documented this finding among American dual users (abstract here). 

One finding not discussed by Lund and McNeill was that among all Norwegian men surveyed from 2005-2010, 5.3% were former smokers and current snus users, while only 3.3% were former snus users and current smokers.  This shows that snus was more of a gateway FROM smoking than the reverse.  This contrasts with U.S. experience, where more male smokeless users transition to smoking (documented by me here).  It appears that Norwegian men are better informed about the relative risks of  snus use and smoking, resulting in healthier decisions.

Lund and McNeill conclude: “The increase in snus use among men in Norway has not been paralleled by an increase in dual use of snus and cigarettes.  The prevalence of smoking—the far most dangerous form of nicotine uptake—is quite low among men who use snus everyday but generally quite high among men who use snus on a less-than-daily basis. Use of snus also seemed to lower cigarette consumption.  Dual use did not lessen plans to quit smoking within 6 months but increased expectancies of being smoke-free 5 years into the future.”

The Scientific Foundation for Tobacco Harm Reduction, 2006-2011

In 2006, the American Council on Science and Health (ACSH) became the first American scientific organization to formally endorse tobacco harm reduction. Their position was based on a Harm Reduction Journal review article (available here), authored by me and William Godshall, director of Smoke-Free Pennsylvania.

Over the past five years, interest in tobacco harm reduction has expanded exponentially, with a concomitant increase in the number of published studies. ACSH asked me to review and analyze influential contributions to the scientific and medical literature, and to discuss issues that continue to stimulate debate. My review, “The Scientific Foundation for Tobacco Harm Reduction, 2006-2011,” has just been published by the Harm Reduction Journal (available here).

Numerous epidemiologic studies and subsequent meta-analyses confirm that smokeless tobacco (ST) use is associated with minimal risks both for cancer and for myocardial infarction; a small increased risk for stroke cannot be excluded. Studies from Sweden document that ST use is not associated with benign gastrointestinal disorders or with chronic inflammatory diseases. Although any form of nicotine should be avoided during pregnancy, the highest risks for the developing baby are associated with smoking. It is documented that ST use has been a key factor in the declining rates of smoking and of smoking-related diseases in Sweden and Norway. For other countries, the potential population health benefits of ST are far greater than the potential risks.

In follow-up studies, dual users of cigarettes and ST are less likely than exclusive smokers to achieve complete tobacco abstinence; however, they are also less likely to be smoking. The health risks from dual use are probably lower than those from exclusive smoking.

E-cigarette users are not exposed to the many toxicants, carcinogens and abundant free radicals formed when tobacco is burned. Although laboratory studies have detected trace concentrations of some contaminants, pending FDA regulation of e-cigarettes as tobacco products is likely to remedy this issue. There is limited evidence from clinical trials that e-cigarettes deliver only small doses of nicotine compared with conventional cigarettes. However, e-cigarette use emulates the cigarette handling rituals and cues of cigarette smoking, which suppresses craving and withdrawal that is not entirely attributable to nicotine delivery.

I will end this post with the same quote that ended my review. It is from the outstanding policy paper “Tobacco harm reduction: how rational public policy could transform a pandemic,” by David Sweanor, Philip Alcabes and Ernest Drucker, published in the International Journal of Drug Policy in 2007 (available here):

"The relative safety of ST and other smoke-free systems for delivering nicotine demolishes the claim that abstinence-only approaches to tobacco are rational public health campaigns...Applying harm reduction principles to public health policies on tobacco/nicotine is more than simply a rational and humane policy. It is more than a pragmatic response to a market that is, anyway, already in the process of undergoing significant changes. It has the potential to lead to one of the greatest public health breakthroughs in human history by fundamentally changing the forecast of a billion cigarette-caused deaths this century."

The Consequences of Tobacco Prohibition and Misinformation in the U.S. Air Force

A new study about tobacco use among Air Force recruits, before and one year after basic training, has been published in the American Journal of Public Health (abstract here). The authors include two vocal tobacco opponents, Dr. Robert C. Klesges of the University of Tennessee (Memphis) and Dr. Jon O. Ebbert of the Mayo Clinic.

Dr. Klesges looked at tobacco use among airmen (an Air Force term used for both men and women) who made up a control group in a large study combining universal forced tobacco abstinence during 6 weeks of basic training and an “intervention” consisting of tobacco prevention or cessation. The results from the large study were published in 2006 (I refer to it as Klesges I, the abstract is here; I refer to the current study as Klesges II).

Klesges classified recruits based on their tobacco habits prior to basic training (baseline): nonusers of tobacco, smokers, smokeless users and dual users. In addition, he described tobacco prohibition:

“During basic military training, there is a total tobacco ban…and the prohibition is strictly enforced. At the beginning of basic military training, airmen are searched and all tobacco products are confiscated. Tobacco products are considered ‘‘contraband’’ along with alcohol, drugs, weapons, and chewing gum. The airmen recruits are required to maintain a ‘money list’ (i.e., a list of all serial numbers for all their money), which is checked regularly by basic military training instructors. Airmen are under constant supervision, and there are no tobacco products accessible even during those rare occasions when airmen are not supervised. An honor code is established early in basic training so that if a recruit breaks the rules, fellow airmen are duty bound to report the infraction. Finally, the punishment for tobacco use during basic military training is severe. In virtually all cases, the airman is ‘recycled’ (forced to repeat some or all of basic training), a possible sanction that few airmen dare risk.”

That is serious tobacco prohibition, and perhaps Klesges et al. hoped that none of the 5,225 Air Force recruits would be using tobacco 12 months later. That didn’t happen.

Klesges reported that 11% of recruits who were nonusers at baseline were smoking 12 months afterwards. As he admitted in Klesges I, “the smoking prevention program had no impact on smoking initiation.” So airmen started smoking in large numbers despite boot-camp tobacco prohibition and prevention programs.

In Klesges II, the main focus was on the 6% of smokers at baseline who were dual users afterwards. He classified this transition as harm escalation, which is an appalling misrepresentation of reality. It is scientifically established that smokers who switch to dual use smoke fewer cigarettes and have lower health risks (described here).

Other data in Klesges II were informative. Fewer than 1% of baseline smokers were smokeless users at follow-up, but 15% of baseline smokeless users were dual users and 14% were smokers at follow-up. In addition, 42% of dual users at baseline were smokers at follow-up. Thus, the transition from smokeless to cigarettes was more common than from cigarettes to smokeless. How did this happen? This is strong evidence that tobacco users in the Air Force are not properly informed about the risks of smoking and smokeless use. Unfortunately, they are making very bad decisions based on misinformation.

A big concern with this study is that the numbers don’t add up, compared with Klesges I. That study started with 7,974 airmen, compared with only 5,225 airmen in this study. In Kleges I, there were 312 smokeless users at baseline, but in Klesges II, there were only 193 (38% fewer). In Klesges I dual use was not a tobacco category, so we have no idea how it classified those 249 airmen from Klesges II. In short, reconciliation of different numbers between Klesges I and II is impossible, which is an indicator of low quality and inconsistency.

Klesges concludes that “[harm] escalation is a possible unintended consequence of promoting smokeless tobacco as a harm reduction strategy for smokers.” He is wrong. Harm escalation is the unintended consequence of not telling smokers and smokeless users the truth about the health risks.

Does Dual Use Jeopardize Smokeless Tobacco’s Role in Harm Reduction? Absolutely Not

One year ago, I briefly discussed the “dual use” of cigarettes and smokeless tobacco by men in the U.S. (post here). Dual use is the object of persistent complaints by American tobacco control extremists. For example, in 2002, Dr. Jack Henningfield, currently a member of the FDA tobacco products scientific advisory committee, was first author of a commentary describing theoretical adverse consequences of dual use (citation here). Despite his concerns, Henningfield acknowledged that “There are virtually no data that currently exist on the safety of such use or the degree to which such use will foster the perpetuation of smoking or contribute to reduced overall smoking…The issue warrants further study.”

That study has now been done, and the results have been published online in Nicotine & Tobacco Research (abstract available here). In a review of 17 published research studies that had data on the health risks from dual use versus those from smoking, almost all of which have appeared since 2002, Kimberly Frost-Pineda and colleagues conclude that “…there are not any unique health risks associated with dual use of smokeless tobacco products and cigarettes, which are not anticipated or observed from cigarette smoking alone.” The authors further commented that “some data indicate that the risks of dual use are lower than those of exclusive smoking.”

Frost-Pineda and colleagues also found evidence from both American and Swedish longitudinal studies that dual users were more likely than exclusive smokers to quit smoking, but less likely to become completely tobacco-abstinent. For example, one American study (abstract here) found that 11% of dual users were tobacco-abstinent after 4 years of follow-up, compared with 16% of exclusive smokers. However, 80% of exclusive smokers were still smoking at the 4-year follow-up, while only 27% of dual users were smoking; 44% were still dual users and 17% were exclusive smokeless users. The differences between smokers and dual users in Swedish follow-up studies are even more impressive.

This excellent review will present major problems for Henningfield and other FDA panelists, including Greg Connolly, Dorothy Hatsukami, Jonathan Samet and Neal Benowitz, because they have established solid records opposing tobacco harm reduction. Samet, the panel’s chair, summed up this opposition in a 2009 article in the Journal of the American Medical Association (citation here ): “Snus, a moist snuff that is low in tobacco-specific nitrosamines, has received particular attention because it has been widely used in Sweden, apparently with little increase in risks for cancer and cardiovascular disease. However, there is concern that strategies to introduce lower-risk products will diminish efforts to promote prevention and cessation.”

For over 40 years, “prevention and cessation” efforts have largely failed. But tobacco prohibitionists continue to focus on those objectives, while raising a host of largely theoretical concerns about the substitution of smokeless tobacco for cigarettes. Now, scientific research shows that the “problem” of dual use is not a problem at all.

A final note: The authors of the dual use study are employees of Altria Client Services, which is owned by the parent company of Philip Morris and U.S. Smokeless Tobacco. They should be complimented for this contribution to the scientific literature on tobacco harm reduction. The editors of Nicotine and Tobacco Research deserve kudos for reviewing and publishing this manuscript.