Pharmaceutical Nicotine and Chantix: 93% Failure Rate Reconfirmed

A study published in the European Journal of Internal Medicine indicates that pharmaceutical nicotine and Chantix (varenicline) had 93% failure rates at two inner city academic health center clinics with predominantly Medicaid patients (abstract here). 

First author Dr. Ranjit Dhelaria from Baystate Medical Center in Springfield, MA, was joined by coauthors from Tufts University in Boston and Allegheny General Hospital in Pittsburgh .

Dhelaria and colleagues reviewed the medical records of 371 patients who received prescriptions for nicotine or Chantix.  The subjects averaged 43 years of age, and had been smoking some 16 cigarettes per day for 22 years.  Forty-four percent had a history of mental illness; drug abuse and alcohol abuse were also prevalent (24% and 12% respectively).

The overall quit rate was 7.0%, with no difference between nicotine and Chantix.  This information was self-reported by the subjects and not verified, so the actual rate may have been even lower.  A 93% failure rate for pharmaceutical nicotine was first published in a review nine years ago (here).  Dhelaria and colleagues note that these real-world quit rates are much lower than those reported in clinical trials, which are typically designed to enroll highly motivated participants. 

The authors make two dubious statements. First, they imply that patient counseling can dramatically affect smoking cessation: “Providing a brief period of counseling (three minutes or less) has been shown in clinical trials to augment rates of abstinence by approximately 30%...”  In fact, such “augmentation,” if fully effective, would have only increased their 7.0% success rate to 9.1% -- a resounding failure still.

Under “Learning Points,” the authors write: “Varenicline and nicotine replacements were equally effective for smoking cessation.”  Use of the term “effective” for substances that fail in 93 out of 100 cases is inane.

Public health policy should not promote six-dollar-a-day pharmaceuticals with dismal performance records, while demonizing OTC smokeless tobacco products with scientifically established records of success… all in the pursuit of largely unachievable tobacco abstinence.   

Smokeless Tobacco Labeling Matters: Impact of Warnings and Relative Risk Info

A study published in Nicotine & Tobacco Research (abstract here) reveals “high levels of appeal for ST [smokeless tobacco] among young adult Canadian cigarette smokers,” despite the fact that “more than one quarter (28%)…were unaware that using ST is less harmful than smoking.”  The lead author was William E. Callery at the University of Waterloo in Ontario, with co-authors from Roswell Park Cancer Institute and the Ontario Institute for Cancer Research.

Callery and coworkers recruited 611 Canadian smokers age 18-30 years old to participate in an online survey viewing photographs of four ST packages (duMaurier snus, Marlboro snus, Copenhagen moist snuff and Ariva dissolvable tobacco), altered to contain a mix of text or pictorial health warning labels tested by Health Canada, the federal health agency.  The ST packages were also altered to contain relative health risk messages that truthfully explained the difference in risk between ST products and cigarettes.

Callery  et al. found that “43.6% of respondents indicated that they were likely to try at least one of the ST products”; the preferred product was Ariva.  The pictorial warning labels significantly reduced the likelihood of trying the ST products, while the relative risk messages doubled the prospect of trial.  In other words, picture warnings increased the scare factor, while relative risk messages increased the chances of switching.

The young adults came in to the study grossly misinformed about the relative risks of ST products.  Callery observed that “between 30% and 47% of respondents incorrectly believed that ST and cigarettes are equally harmful, and a small proportion incorrectly believed that ST is more harmful than cigarettes.”  As one might expect, warning labels enhanced the misperceptions, while participants who saw the truthful relative risk messages “had higher odds of reporting correct beliefs about the health risk of ST compared with cigarettes.”

Callery and coworkers concluded that their study showed “relatively high levels of appeal for ST products and openness to trying ST products among young adult cigarette smokers in Canada.  Further research is needed to determine if the high level of openness to trying ST found in this study will translate into actual use and, if so, whether increased ST use might alter cigarette consumption.  The current study also suggests that pictorial warnings on ST products increase overall perceptions of risk and discourage use as intended.  However, pictorial warnings also exacerbated the false belief that smokeless products are equally as harmful as conventional cigarettes.  Regardless whether ST products serve as a harm-reduction product at the population level, greater efforts should be undertaken to promote more accurate perceptions of [the relative health risks] between tobacco products.”

The Canadian findings directly relate to tobacco regulation in the U.S.  The FDA should act on the petition filed nearly a year ago to change the misleading warning that smokeless tobacco “is not a safe alternative to cigarettes.” (discussed here)  Furthermore, the U.S. Centers for Disease Control, the National Cancer Institute and other federal agencies should “promote more accurate perceptions of [the relative health risks] between tobacco products.” 

In short, tell smokers the whole truth.

Health Fraud at FDA.gov

The FDA Center for Tobacco Products on June 27 launched a new consumer web page entitled “Health Fraud” (here).  The page implies that statements about comparative risks among tobacco products are inherently fraudulent:

“Claiming less harm or reduced risk of disease from using tobacco products misleads consumers to think that these products are safe to use.  FDA considers these kinds of claims to be health fraud.”

Is the FDA suggesting that my 18 years of peer-reviewed work, and the findings of many other respected academicians and various U.S. and international medical societies are fraudulent?  

In 1994, epidemiologist Philip Cole and I published a study in Nature, one of the world’s most prestigious scientific journals (citation here), concluding that “…the average remaining life expectancy of a 35-year old smokeless tobacco user is 45.92 years, only 0.04 year less than that of a non-user.  This 15-day reduction in life expectancy is in sharp contrast to the 7.8 years lost by smokers.”  We noted, “…abstinence is not the only approach to reducing tobacco-related mortality: for smokers addicted to nicotine who would not otherwise stop, a permanent switch to smokeless tobacco could be an acceptable alternative to quitting.”

In the nearly two decades since, the scientific foundation for tobacco harm reduction has expanded enormously.  How, then, can the FDA justify its new post:

“To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.” (emphasis in original)

FDA take note: The above statement is demonstrably false and intentionally misleads consumers.  It should be removed, immediately.

Snus Use: No Heart Attack Risk

A new snus study from Sweden, the largest ever conducted, reports that snus use is not associated with heart attacks.  Researchers crunched data for 130,361 men never smokers followed for a total of 2.3 million years in eight separate Swedish cohort studies. 

Lead author Jenny Hansson, a research assistant at the Karolinska Institute in Stockholm (here), worked with 15 collaborators from the Institute, Sweden’s Umeå, Uppsala and Lund Universities, and the University of Milano-Bicocca in Italy.  The study was published in the European Journal of Epidemiology (abstract here).

Compared with never users of tobacco, the hazard ratio (HR, similar to relative risk, adjusted for age and body mass index, BMI) for heart attack among current snus users was 1.03 (95% Confidence Interval = 0.92 – 1.15). 

Hansson and colleagues also reported that HRs were not elevated with higher levels of snus consumption or longer duration.  These are important findings, as they confirm that even a high consumption level (1 can per day) or a long history of snus use (20+ years) does not confer heart attack risk.

Risk of Heart Attack Among Snus Users, According to Consumption Level and Duration
Group	Hazard Ratio (95% CI)
Non-Current Users (Referent)	1.00
Current Snus Users
< 4 cans per week	1.02 (0.90 – 1.16)
4-6 cans per week	0.94 (0.64 – 1.38)
7+ cans per week	1.17 (0.79 – 1.72)
< 20 years	0.96 (0.80 – 1.14)
20+ years	1.10 (0.95 – 1.27)

The researchers also collected information on subjects who died within one year of a heart attack.  They observed, “Current snus users had a higher probability of dying as compared to non-users (p < 0.05), and this excess occurred during the first 24 h[ours].”  However, they did not provide any other information on this point (e.g. number of deaths), so it’s significance is unclear.  In addition, they wrote, “The 28-day case fatality among snus users was 1.28 ([CI] = 0.99 – 1.68), adjusted for age and BMI, based on 97 cases.”  This was not statistically significant, and the authors note that “…this relationship may be due to confounding by socioeconomic or life style factors.”  Other than the 24-hour and 28-day points, there appears to be no difference in the death rate among snus users versus nonusers for the year following a heart attack.

Hansson and colleagues conclude: “These findings, based on the largest sample to date, do not support any relationship between use of snus and development of [heart attacks].”