Why Can’t Smokers Quit: Part II

 

Last week I introduced our new study of persistent smokers in five waves of the FDA’s Population Assessment of Tobacco and Health (PATH) Study.  I explained that menthol cigarettes and vaping had almost no effect on persistent smoking or quitting in this population, which was followed for about six years.  This week I’ll discuss some differences that distinguish persistent smokers from quitters.

Over 85% of persistent smokers puffed every day, a much higher rate than among smokers who quit in the following wave.  For example, in Wave 1, 87% of persistent smokers puffed every day, compared with 52% among quitters at Wave 2.  More persistent smokers smoked 21+ cigarettes per day, smoked within 30 minutes of waking up in the morning, and had a higher objective measure of nicotine addiction than quitters.

Fewer persistent smokers tried to quit completely in all waves, compared with those who quit.  For example, in the first wave, 19% of persistent smokers reported they had tried to quit completely during the past 12 months, compared with 30% of those who quit by the next wave and stayed smoke-free for the rest of the study.  As many as 22% of persistent smokers had stopped for a month or longer at Wave 2, compared with 42% of quitters. 

Persistent smokers’ lack of quitting success may have been due to their experiencing more adverse symptoms, including anxiety, restlessness, difficulty concentrating or sleeping, feeling depressed and/or weight gain.  Quitting cold turkey is unpleasant, and some smokers may not be able to exist comfortably when nicotine-abstinent.  Persistent smokers were honest about their likelihood to succeed: Only 31% were optimistic in Wave 1, compared to 60% of quitters.

In the previous post, I described our less-than-impressive findings with respect to quitting with e-cigarettes, but in subsequent waves, both persistent smokers and quitters showed decreased use of any quit aids.  In fact, the percentage of all smokers who reported using no aid at all increased during the study.  In our analysis, we looked at all aids, including nicotine replacement therapy (NRT) and prescription medicines such as Chantix, varenicline, Wellbutrin, Zyban, and bupropion; and others, such as family and friends, counseling and self-help material. 

In summary we wrote, “Compared with smokers who became and stayed quit, [persistent smokers] were more likely to smoke every day, have higher measures of nicotine dependence and have more adverse effects of nicotine withdrawal.  They were less interested in cessation, less likely to make a quit attempt and less confident that the attempt would be successful.  While [vapor products] and menthol are topics of current debate, neither played a prominent role in continued smoking or quitting.” 

None of these findings are new.  The reasons smokers can’t quit have been known for a long time, but our study demonstrates that these characteristics persisted throughout the six-year PATH follow-up.  Let’s consider what this means.

During our study period 2013-2018, 2.9 million Americans died from a smoking-related illness.  Over 40% of persistent smokers in our study were age 45+ years when they enrolled, so they were at risk of becoming a mortality statistic.  Another 42% were 25-44 years old, the perfect time for them to quit.  It is tragic, therefore, that the sponsor of the PATH survey, the FDA, is slow-walking reviews of smoke-free cigarette substitutes, in keeping with its ultimate goal of eliminating the entire tobacco and nicotine market.

It is long past time for FDA to alter its prohibitionist crusade and, instead, focus on truly protecting the health of persistent smokers.

 

 

CDC: E-Cigarettes More Popular Than FDA-Approved Quitting Aids

Cigarette smokers prefer e-cigarettes to FDA-approved quit methods, according to a research brief authored by the CDC Office on Smoking and Health, RTI International and the University of North Carolina (here).

Using a nationally representative online survey of 15,943 adult smokers who tried to quit during the past three months, they found that 75% used one or more methods to quit, and 25% used only one method, as shown below.

Weighted Prevalence (%) of Methods Used By 15,943 Adult Smokers Who Attempted to Quit in Past 3 Months
Quit Method	One Method Only	Multiple Methods
Gave up cigarettes all at once	14.7%	65%
Gradually cut back	6.6	62
Partially substituted e-cigarettes	1.1	35
Switched completely to e-cigarettes	1.1	25
Used nicotine gum or patch	0.8	25
Used Zyban or Chantix	0.4	12
Switched to “mild” cigarettes	0.3	20
Sought help – health professional	0.2	15
Sought help – website	less than 0.1	7
Sought help – telephone quitline	less than 0.1	7
All methods	25.3	75

E-cigarettes were far more popular single quit aids for partial or complete substitution (2.2%), compared with nicotine patches/gum (0.8%) or other prescription medicines (0.4%).  They were also more popular when more than one aid was used.

Of note, telephone quitlines were rarely used.  The government has poured millions of dollars into this mini-industry, yet quitlines were used by a mere 0.02% (unweighted, n=3) of smokers as single quit aids in this study.

Participants here were current smokers.  A similar analysis performed on former smokers will show even more impressive effects from vaping.

Despite the current study’s evidence of vaping’s popularity among smokers, the authors’ summation was understated: “Given that our data show that e-cigarettes are more commonly used for quit attempts than FDA-approved medications, further research is warranted on the safety and effectiveness of using e-cigarettes to quit smoking.”

The fact is that the CDC has documented with real-world data that e-cigarettes are preferred smoking cessation aids, negating the argument that evidence is merely “anecdotal” (here). 

Our government should adopt the UK Royal College of Physicians’ position that “the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco.” (here).  In Britain e-cigs have been the leading quit-smoking aid since 2013 (here, page 46).

Smoking Cessation Medicines Trigger Suicidal Behavior and Depression

Anti-tobacco extremists say that safer tobacco products aren’t necessary because FDA-approved medicines are effective. They ignore scientific evidence of those medicines’ paltry success rate (pharmaceutical nicotine works for only 7% of smokers), and of their significant side effects. For example, varenicline (Chantix) and bupropion (Zyban) carry FDA black-box warnings concerning depression and suicidal or self-injurious behavior.

A study published in PLoS One (here) concludes that “Varenicline shows a substantial, statistically significant increased risk of reported depression and suicidal/self-injurious behavior. Bupropion for smoking cessation had smaller increased risks.” The study’s first author is Thomas Moore from the Institute for Safe Medication Practices; his coauthors are from medical schools at Wake Forest, Harvard and Johns Hopkins Universities.

Moore et al. looked at cases of depression or suicidal/self-injurious behavior in the FDA Adverse Event Reporting System from 1998 to 2010. As a negative control for short-term medication, they compared behavioral episodes during varenicline and bupropion use to those during use of three common antibiotics. Because quitting smoking has also been associated with behavioral problems, Moore also used pharmaceutical nicotine as a “cessation” control.

Compared with antibiotic use, varenicline users were 37 times more likely to experience depression or suicidal/self-injurious behavior (odds ratio, OR = 37, confidence interval, CI = 28-49). The OR for bupropion was 13 (CI = 9-17), and the OR for nicotine was 4.3 (CI = 3.1-6.2).

Compared with nicotine (which controlled for behavioral problems due to quitting smoking), the OR for varenicline was 8.4 (CI = 6.8-10.4) and the OR for bupropion was 2.9 (CI = 2.3-3.7).

Moore also discussed other safety concerns: “While suicidal/self-injurious behavior and depression appear to be prominent side effects of varenicline, they are by no means the only safety issues. Varenicline has been associated with aggression and violence in three studies and carries a warning about this behavior. Its effect on vision, cognition, and motor control and other risks have led to its being banned for airline pilots, air controllers, military pilots and missile crews, and restricted for truck drivers. Varenicline is also associated with an increase in the risk of serious cardiovascular events. In addition, it is associated with hypersensitivity, angioedema and potentially life-threatening severe cutaneous adverse events [references omitted].”

Moore warns doctors prescribing varenicline about “…the value judgment of how to weigh the possible benefits of 52 weeks of smoking abstinence for 1 or 2 out of every 10 patients treated against the risk of less frequent adverse events such as violent and suicidal behavior that can have immediate, catastrophic and irreversible effects on self, family, and career. In the meantime, safer alternatives now exist and should be preferred.”

Unwritten is that one of those safer alternatives is smoke-free tobacco. While no tobacco product is absolutely safe, smoke-free alternatives deliver satisfying doses of nicotine, which is an important modulator of mood, well-being, and other behavioral performance measures.

Quit-Smoking Medicines and Episodes of Violence

A new study published in Public Library of Science One (available here) reports that two drugs widely prescribed to help smokers quit -- varenicline (brand name Chantix) and bupropion (brand names Wellbutrin and Zyban) - are associated with thoughts or acts of violence towards others.

The study was conducted by Thomas Moore at the Institute for Safe Medication Practices, and colleagues from Harvard and Wake Forest Universities. Moore et. al. analyzed data from the FDA Adverse Event Reporting System, extracting all serious adverse event reports for drugs with 200 or more cases received from 2004 through September 2009. The researchers focused on homicide, homicidal ideation, physical assault, physical abuse and violence related symptoms. They reported the number of events, as well as proportional reporting ratios (PRRs), which allows for comparison of the proportion of violence events for each medicine with the proportion from all other evaluable drugs (those in wide clinical use with adequate post-marketing surveillance).

Moore found that “among 484 evaluable drugs, 31 drugs met the study criteria for
a disproportionate association with violence, and accounted for 1527/1937 (79%) of the violence cases…Varenicline has the largest number of reported violence cases (n = 408), [and] the highest proportion of violence cases (PRR= 18.0).”

The PRR for varenicline was so high that it was in a class all by itself. As Moore and colleagues noted, “We have previously examined varenicline’s association with serious psychiatric symptoms including aggression/violence [references omitted]. The aggression/violence case series for varenicline was consistent with these data but revealed other features that may or may not occur in cases attributed to other drugs. These features include early onset of psychiatric symptoms (usually within a few days), a senseless act of aggression/violence directed at anyone who happened to be near by, and resolution of the symptoms upon discontinuation.”

Moore also found that bupropion, an antidepressant prescribed to aid smoking cessation, was also associated with violence, although at a much lower rate (35 episodes, PRR = 3.9). As he and his associates note, “bupropion is indicated for both depression and as an aid to smoking cessation, so those results are not limited to the smoking cessation population.”

Moore also studied pharmaceutical nicotine, which was associated much less frequently with violent episodes (11 cases, PRR = 1.9).

Tobacco prohibitionists like the American Cancer Society often claim that tobacco harm reduction is unnecessary, since medicines represent the gold standard for smoking cessation. This study demonstrates that the gold standard is substantially tarnished. At a minimum, the Cancer Society should update its website discussion of smoking cessation (here). The current version promotes varenicline and bupropion, but fails to mention the drugs’ possible side effect of violent behavior.