Showing posts with label nicotine patch. Show all posts
Showing posts with label nicotine patch. Show all posts

Tuesday, April 18, 2017

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 MethodOne Method OnlyMultiple Methods



Gave up cigarettes all at once14.7%65%
Gradually cut back6.662
Partially substituted e-cigarettes1.135
Switched completely to e-cigarettes1.125
Used nicotine gum or patch0.825
Used Zyban or Chantix0.412
Switched to “mild” cigarettes0.320
Sought help – health professional0.215
Sought help – websiteless than 0.17
Sought help – telephone quitlineless than 0.17


All methods25.375

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).




Wednesday, May 13, 2015

Scaremongering Tactics Against Smoke-Free Tobacco Could Also Undermine Nicotine Medicines


Tobacco prohibitionists routinely cherry-pick data to put tobacco products in the worst possible light.  For example, crusaders have used calls to poison control centers to paint smokeless tobacco (here) and, more recently, e-cigarettes (here) as toxic time-bombs.  To underscore how deceptively simple and grossly misleading such scaremongering can be, I offer this demonstration of selective data analysis applied to nicotine medicines.

Opponents of safer smoke-free tobacco promote nicotine medicines as quit-smoking aids that are “safe and effective.”  In previous posts I have shown that nicotine medicines are not effective; their success rates are pitifully low (here and here). The question remains: Are nicotine medicines safe?

Data from the FDA Adverse Event Reporting System provides the starting point for a scaremonger case against nicotine medicines’ safety.  The FAERS is a collection of volunteered reports from consumers and health professionals, plus mandatory reports from manufacturers.  The dataset is difficult to use and interpret, so I worked with Joe Fuisz and Tom O'Connell of Vapor Tobacco Manufacturing LLC and Paul Danese of FDAble.com to prepare this analysis.

We looked at adverse events linked to nicotine medicines from 2007 to 2014, a period consistent with the availability of e-cigarettes.  Adverse events for e-cigarettes were also recorded by the FDA during this timeframe, however, those numbers may be underestimated, as e-cigs are not considered medicines by most consumers and health professionals.

During this period, there were 690 adverse events related to nicotine gum/lozenges, 2,006 related to patches, 1,123 for the spray and 28 for e-cigarettes.   

Table 1 illustrates the top 5 adverse events for each product.  It is not possible to make direct comparisons or to calculate rates, as these are individual reports, but it is noteworthy that “ineffective” was a top 5 adverse event for both gum/lozenges and patches.  The spray is commonly known to produce throat symptoms and cough, and nausea is also a frequent complaint for smokers who switch to smoke-free tobacco products.


Table 1. Top Five Adverse Events (Number) for Nicotine Medicines and E-Cigarettes, 2007-2014
Gum/Lozenges (690)Patches (2,006)Nasal Spray (1,123)E-Cigarettes (28)
Intentional drug misuse (243)Itching (396)Cough (96)Headache (6)
Nicotine dependence (216)Redness (395)Product quality issue (71)Nausea (5)
Administration error (86)Drug ineffective (368)Throat irritation (64)Dizziness (4)
Drug ineffective (65)Administration error (364)Nausea (63)Muscle spasms
Nausea (56)Nausea (199)Dizziness (47)Chest pain (3)

While the most common adverse events were not serious, the list of outcomes in the following table is worrisome at first glance.  There is no representation in the reporting system that the products “caused” the negative outcomes, but those aiming to trash nicotine medicines would make that linkage and issue press releases with hyperbolic safety warnings to drive their point home.  It’s that simple.


Table 2. Number of Serious Outcomes* for Adverse Events Related to Nicotine Medicines and E-Cigarettes, 2007-2014
OutcomeGum/LozengesPatchesNasal SprayE-Cigarettes
Congenital Anomaly0510
Disability47131
Hospitalization17101787
Life Threatening3736
Death61880

*Numbers are not mutually exclusive

Scaremongering is a despicable, yet all too common practice that undercuts legitimate scientific discourse, distorts public health policymaking and ultimately costs smokers’ lives.  Recreational use of nicotine in smoke-free delivery systems, like recreational use of caffeine, is relatively safe for consumers.  

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
1231616
3136.89.2
67.34.15.8



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.