Electronic Nicotine-Delivery Systems for Smoking Cessation


Abstract

Background

Electronic nicotine-delivery systems — also called e-cigarettes — are used by some tobacco smokers to assist with quitting. Evidence regarding the efficacy and safety of these systems is needed.

Methods

In this open-label, controlled trial, we randomly assigned adults who were smoking at least five tobacco cigarettes per day and who wanted to set a quit date to an intervention group, which received free e-cigarettes and e-liquids, standard-of-care smoking-cessation counseling, and optional (not free) nicotine-replacement therapy, or to a control group, which received standard counseling and a voucher, which they could use for any purpose, including nicotine-replacement therapy. The primary outcome was biochemically validated, continuous abstinence from smoking at 6 months. Secondary outcomes included participant-reported abstinence from tobacco and from any nicotine (including smoking, e-cigarettes, and nicotine-replacement therapy) at 6 months, respiratory symptoms, and serious adverse events.

Results

A total of 1246 participants underwent randomization; 622 participants were assigned to the intervention group, and 624 to the control group. The percentage of participants with validated continuous abstinence from tobacco smoking was 28.9% in the intervention group and 16.3% in the control group (relative risk, 1.77; 95% confidence interval, 1.43 to 2.20). The percentage of participants who abstained from smoking in the 7 days before the 6-month visit was 59.6% in the intervention group and 38.5% in the control group, but the percentage who abstained from any nicotine use was 20.1% in the intervention group and 33.7% in the control group. Serious adverse events occurred in 25 participants (4.0%) in the intervention group and in 31 (5.0%) in the control group; adverse events occurred in 272 participants (43.7%) and 229 participants (36.7%), respectively.

Conclusions

The addition of e-cigarettes to standard smoking-cessation counseling resulted in greater abstinence from tobacco use among smokers than smoking-cessation counseling alone.

Are Nicotine Patches and E-Cigarettes Safe in Pregnancy?


Guidelines consistently advise that the best thing a pregnant woman can do is to stop smoking. Now, new research has found that regular use of nicotine replacement products to assist smoking cessation is not associated with adverse events or poor pregnancy outcomes.

“Using nicotine products to stop smoking during pregnancy appeared safe,” Professor Peter Hajek of the Wolfson Institute of Population Health, Queen Mary University of London, and lead researcher of the study told Medscape News UK.

The scientists found that pregnant women who stopped smoking cigarettes and used e-cigarettes and nicotine patches had infants with significantly higher birth weight than smokers, and “not different from abstainers not using nicotine”. The researchers wrote that they “did not detect any risks to pregnancy” from e-cigarettes or nicotine patches used by smokers trying to quit.

The study was funded by the National Institute for Health and Care Research (NIHR) and led by scientists at Queen Mary University of London. It was published in the journal Addiction.

Current Guidance

The prevalence of smoking during pregnancy has been decreasing over time. The smoking rate for pregnant women at the time of birth fell to 9.1% in 2021-2022, the lowest annual rate on record. In 2022-2023, the prevalence had dropped slightly further to 8.8%, but was still higher than the government’s target of 6%.

A landmark review in 2015 led by King’s College London and commissioned by Public Health England found that e-cigarettes had the potential to reduce smoking. It also found that nearly half the population (44.8%) did not realise that e-cigarettes or vapes were much less harmful than smoking. 

Both the Royal College of Obstetricians and Gynaecologists (RCOG) and the NHS currently recommend that pregnant women stop smoking completely, ideally before the fact.

They also suggest that nicotine replacement therapy (NRT) can be an effective aid for pregnant women who want to stop smoking. NICE points out in its recommendations on treating tobacco dependence in pregnant women that “any risks from using NRT are much lower than those of smoking”. 

In 2019, the Royal College of Midwives released a position statement that stated that “E-cigarettes contain some toxins, but at far lower levels than found in tobacco smoke. If a pregnant woman who has been smoking chooses to use an e-cigarette (vaping) and it helps her to quit smoking and stay smokefree, she should be supported to do so”.

Still, Professor Tim Coleman, Smoking in Pregnancy research group, University of Nottingham, who was also involved in the study, said in a press release that “some clinicians are reticent about providing NRT or e-cigarettes in pregnancy”.

Hajek explained that, in animal studies, chronic forced large doses of nicotine led to a range of adverse pregnancy outcomes. This has led to caution among some healthcare professionals. However, he said that studies have shown that this does not translate to self-regulated nicotine doses in humans. 

Building a Foundation of Evidence

Knowledge gaps remain, though. A Cochrane review in 2020 concluded that there was no evidence that NRT had positive or negative impacts on birth outcomes. In 2021, a systematic review concluded that NRT seemed to be associated with higher risk of infantile colic at 6 months similar to that associated with smoking during pregnancy. It also found an association with higher risk of attention-deficit/hyperactivity disorder. The review did not find associations were reported between the use of NRT during pregnancy and other infant health disorders or major congenital anomalies.

In 2023, a study suggested that aerosols from e-cigarettes may contain several newer, potentially toxic compounds, including some known developmental toxicants that may adversely impact both the mother and foetus. However, the authors found that research was limited, with large knowledge gaps regarding the effects of e-cigarette use on maternal and foetal health and birth outcomes.

Hajek said that vapes are more effective for smoking cessation than NRT, but the impacts of their extended use is currently unclear.

NICE emphasises that most smoking-related health problems are caused by other components in tobacco smoke, not by the nicotine.

“The harms to pregnancy from smoking, in late pregnancy at least, seem to be due to other chemicals in tobacco smoke rather than nicotine,” Hajek explained.

Hazel Cheeseman, deputy chief executive at Action on Smoking and Health told Medscape News UK: “Given the significant risks of smoking during pregnancy, it is vital that pregnant smokers are supported to stop.” She said the new study added to the evidence that e-cigarettes are safe and effective for use by pregnant women to quit smoking. 

“There are widespread misperceptions about the risks of nicotine in pregnancy. While smoking is deadly, nicotine on its own does not cause the same harms. These findings should provide reassurance that vaping products and nicotine replacement therapy do not increase the risk of harms during pregnancy and can be safely recommended for smoking cessation,” said Cheeseman.

What Do We Know About E-cigarettes?


E-cigarettes are known by many different names, and sometimes people find it hard to understand what is really known about these devices. Here we address some of the common questions people ask about e-cigarettes.

What are e-cigarettes?

E-cigarettes are known by many different names, including e-cigs, electronic nicotine delivery systems (ENDS), alternative nicotine delivery systems (ANDS), e-hookahs, mods, vape pens, vaporizers, vapes, and tank systems.

E-cigarettes are available in many shapes and sizes. They can look like cigarettes, cigars, pipes, pens, USB flash drives, or may be in other forms.

E-cigarettes include a battery that turns the device on, a heating element that heats the e-liquid and turns it into an aerosol of tiny particles (sometimes called a “vapor”), a cartridge or tank that holds the e-liquid, and a mouthpiece or opening used to inhale the aerosol.

E-cigarettes do not contain tobacco, but many of them contain nicotine, which comes from tobacco. Because of this, the Food and Drug Administration (FDA) classifies them as “tobacco products.”

What is vaping?

The use of e-cigarettes is often referred to as “vaping” because many people believe e-cigarettes create a vapor, which is then inhaled. But in fact, e-cigarettes produce an aerosol made up of tiny particles, which is different from a vapor.

How do e-cigarettes work?

E-cigarettes heat a liquid – called e-liquid or e-juice – to turn it into an aerosol (sometimes called a “vapor”). E-cigarette users inhale this into their lungs.

Do e-cigarettes contain nicotine?

The e-liquid in most e-cigarettes contains nicotine, the same addictive drug that is in regular cigarettes, cigars, hookah, and other tobacco products. However, nicotine levels are not the same in all types of e-cigarettes, and sometimes product labels do not list the true nicotine content.

There are some e-cigarette brands that claim to be nicotine-free but have been found to contain nicotine.

What is in the aerosol (“vapor”) of an e-cigarette?

Although the term “vapor” may sound harmless, the aerosol that comes out of an e-cigarette is not water vapor and can be harmful. The aerosol from an e-cigarette can contain nicotine and other substances that are addictive and can cause lung disease, heart disease, and cancer.

Again, it is important to know that most e-cigarettes contain nicotine. There is evidence that nicotine harms the brain development of teenagers. If used during pregnancy, nicotine may also cause premature births and low birthweight babies.

Besides nicotine, e-cigarettes and e-cigarette vapor typically contain propylene glycol and/or vegetable glycerin. These are substances used to produce stage or theatrical fog which have been found to increase lung and airway irritation after concentrated exposure.

In addition, e-cigarettes and e-cigarette vapor may contain the chemicals or substances listed below.

  • Volatile organic compounds (VOCs): At certain levels, VOCs can cause eye, nose and throat irritation, headaches and nausea, and can damage the liver, kidney and nervous system.
  • Flavoring chemicals: Some flavorings are more toxic than others. Studies have shown that some flavors contain different levels of a chemical called diacetyl that has been linked to a serious lung disease called bronchiolitis obliterans.
  • Formaldehyde: This is a cancer-causing substance that may form if e-liquid overheats or not enough liquid is reaching the heating element (known as a “dry-puff”).

The FDA does not currently require testing of all the substances in e-cigarettes to ensure they are safe. It’s also hard to know exactly what chemicals are in an e-cigarette because most products do not list all of the harmful or potentially harmful substances contained in them. Some products are also labeled incorrectly.

It’s important to know the US Centers for Disease Control and Prevention (CDC) has stated that sometimes e-cigarette products are changed or modified and can have possibly harmful or illegal substances from unknown sources. You can read more about this statement on the CDC newsroom page.

What are the health effects of e-cigarettes?

E-cigarettes are still fairly new, and more research is needed over a longer period of time to know what the long-term effects may be. The most important points to know are that the long-term health effects of e-cigarettes are still unknown, and all tobacco products, including e-cigarettes, can pose health risks to the user.

For more information, see Health Risks of E-cigarettes.

The American Cancer Society is closely watching for new research about the effects of using e-cigarettes and other new tobacco products. (See “What is in the aerosol (“vapor”) of an e-cigarette?” and “Do e-cigarettes contain nicotine?)”

What is known about the use of e-cigarettes by youth?

No youth, including middle schoolers and high schoolers, should use e-cigarettes or any tobacco product. (See “What is in the aerosol (“vapor”) of an e-cigarette?”)

It is important to know that most e-cigarettes contain addictive nicotine. There is evidence that nicotine harms the brain development of teenagers.

Some studies have shown that vaping by some youth may be linked to later use of regular cigarettes and other tobacco products. Using e-cigarettes may play a part in some kids or teens wanting to use other, more harmful tobacco products.

The FDA has the authority to regulate all tobacco products, including e-cigarettes. The FDA is working on several options to prevent youth access to e-cigarettes.

Does e-cigarette use cause cancer?

Scientists are still learning about how e-cigarettes affect health when they are used for long periods of time. It’s important to know that the aerosol (“vapor”) from an e-cigarette contains some cancer-causing chemicals, although in significantly lower amounts than in cigarette smoke.

Can e-cigarettes explode?

There have been reports of e-cigarettes exploding and causing serious injuries. Usually the explosions are caused by faulty batteries or because the batteries were not handled as they should be. Visit the Food and Drug Administration website for safety tips to help avoid an e-cigarette battery explosion.

Is exposure to secondhand e-cigarette aerosol harmful?

Although e-cigarettes do not give off smoke like tobacco cigarettes, they do expose people to secondhand aerosol or “vapor” that may contain harmful substances. Scientists are still learning about the health effects of being exposed to secondhand e-cigarette aerosol.

The smoke-free and tobacco-free policies at schools, businesses, healthcare institutions, and other organizations should also cover e-cigarettes. This will help non-users avoid being exposed to potentially harmful e-cigarette aerosol.

Can e-cigarettes help people quit smoking (known as smoking cessation)?

E-cigarettes are not currently approved by the FDA as aids to help stop smoking. This is because there’s just not enough research or evidence yet. On the other hand, there is a large body of evidence clearly showing that FDA-approved medications are safe and effective ways to help people quit smoking, especially when combined with counseling.

Some people who smoke choose to try e-cigarettes to help them stop smoking. Stopping smoking clearly has well-documented health benefits. But switching to e-cigarettes still exposes users to potentially serious ongoing health risks. It’s important to stop using all tobacco products, including e-cigarettes, as soon as possible both to reduce health risks and to avoid staying addicted to nicotine. If you’re having trouble quitting e-cigarettes on your own, get help from your doctor or from other support services, such as your state quitline (1-800-QUIT-NOW) or the American Cancer Society (1-800-ACS-2345).

People who have already switched completely from smoking to e-cigarettes should not switch back to smoking (either solely or along with e-cigarettes), which could expose them to potentially devastating health effects.

Some people who smoke choose to use both cigarettes and e-cigarettes at the same time on an ongoing basis, whether they are trying to quit or not. This is known as “dual use.” The dual use of e-cigarettes and tobacco cigarettes can lead to significant health risks because smoking any amount of regular cigarettes is very harmful. People should not use both products at the same time and are strongly encouraged to completely stop using all tobacco products.  

Where can I find more information about e-cigarettes?

To learn more about e-cigarettes, here are resources from the American Cancer Society and the FDA.

High levels of synthetic cooling agents in e-cigarettes may exceed safety thresholds


“We were concerned that menthol and synthetic compounds or artificial compounds that are similar to menthol are also in e-cigarettes,” Sven-Eric Jordt, PhD, associate professor in anesthesiology and associate professor of pharmacology and cancer biology at Duke University School of Medicine, told Healio during the American Thoracic Society International Conference. “These compounds have the same cooling effect as menthol. We wanted to see what the levels are, how much is added to the e-cigarettes and whether there might be some concerns about toxicity in these compounds. They are permitted for use in foods, but we don’t know their safety when you inhale them in tobacco products. Some international regulatory organizations have issued threshold values for raising toxicity concerns.”

E-cigarettes do not improve smoking cessation, survey finds


The use of e-cigarettes as a smoking cessation method did not significantly prevent relapse or successful termination, according to survey findings published in Tobacco Control.

“This is the first survey in which e-cigarettes were less popular as a smoking cessation aid than FDA-approved pharmaceutical aids,” John P. Pierce, PhD, a distinguished professor at the Herbert Wertheim School of Public Health and Human Longevity Science at UC San Diego and UC San Diego Moores Cancer Center, said in a press release. “Not only were e-cigarettes not as popular, but they were associated with less successful quitting.”

Recent former smokers who reported cigarette abstinence used
Chen R, et al. Tob Control. 2022;doi:10.1136/tobaccocontrol-2021-056901.

Pierce and colleagues evaluated data from the nationally representative PATH cohort study to determine the effectiveness of e-cigarettes as a smoking cessation aid from 2017 — when sales for nicotine e-cigarettes increased in the U.S. — to 2019. The analysis included 3,578 participants who were established smokers in 2016 with a recent quit attempt and 1,323 recent former smokers.

E-cigarette use

Between 2016 and 2017, there was a more than 40% growth in sales for e-cigarette products in the U.S., according to the researchers.

In 2017, 12.6% (95% CI, 11.3-13.9) of smokers who recently attempted to quit reported using e-cigarettes as a cessation aid (8.7% e-cigarettes only, 3.2% e-cigarettes and nicotine replacement therapy/pharmaceutical aid, 0.5% e-cigarettes and other tobacco products, and 0.2% three or more products). This marked a decline from 17.4% in 2016, according to Pierce and colleagues.

Only 2.2% (95% CI, 0-4.4) of recent former smokers said they switched to a high nicotine e-cigarette. These products were most often used as a cessation aid by respondents aged 18 to 50 years compared with those aged older than 50 years. Also, non-Hispanic white individuals, those who attended college, those with higher incomes and daily smokers were more likely to report using e-cigarettes.

Other cessation aids

Meanwhile, 2.5% (95% CI, 1.9-3.1) of respondents reported using a non-e-cigarette tobacco product as a cessation aid and 20.6% (95% CI, 18.9-22.3) used a nicotine replacement therapy or pharmaceutical aid only. The researchers reported that most respondents (64.3%) attempted the “cold turkey” method, in which no products were used.

Smoking cessation

Among respondents who reported cigarette abstinence, 18.6% (95% CI, 16-21.2) said they did not use any aids. In contrast, a lower proportion (9.9%; 95% CI, 6.6-13.2) said they used e-cigarettes.

The results further showed that e-cigarettes were associated with lower abstinence rates at 12 or more months compared with pharmaceutical aids (adjusted risk difference [aRD] = 7.3%; 95% CI, 14.4 to –0.4) or any other method (aRD = 7.7%; 95% CI, 12.2 to –3.2), according to Pierce and colleagues.

Although the finding was insignificant, the researchers also noted that respondents who switched to e-cigarettes appeared to have a higher relapse rate than those who did not switch to e-cigarettes or other tobacco products. By 2019, nearly 60% of recent former smokers who used e-cigarettes daily had resumed cigarette smoking.

While randomized clinical trials show improved cessation with e-cigarettes, they are often not conducted under “optimal conditions” and do not reflect “the effectiveness of the product in community settings,” Pierce and colleagues wrote.

An epidemic

“There is good evidence that [e-cigarettes] have become the initiation product of choice for adolescents,” Pierce told Healio. “The Surgeon General has labeled this an epidemic. Some are concerned that this effect on teens may be wiping out all of the successes in tobacco control over the past 3 decades.”

When talking to patients about smoking cessation, “clinicians can correct patient misperceptions that e-cigarettes will make their quit attempt more successful,” he said.

According to Pierce, individuals who smoke are advised to mix and match approved cessation aids. As an over-the-counter option, nicotine replacement therapy is the most popular aid, he said. It is often used in combination with varenicline or Zyban (bupropion hydrochloride, GlaxoSmithKline), he added.

In September, Pfizer voluntarily recalled all lots of its varenicline product Chantix “due to the presence of unacceptable N-nitroso-varenicline levels,” according to the FDA. The agency approved a generic version of varenicline (Par Pharmaceutical) in August.

References:

Adoption of e-cigarettes for smoking cessation in 2017 low and ineffective. https://ucsdnews.ucsd.edu/pressrelease/adoption-of-e-cigarettes-for-smoking-cessation-in-2017-low-and-ineffective. Published Feb. 7, 2022. Accessed Feb. 11, 2022.

Chen R, et al. Tob Control. 2022;doi:10.1136/tobaccocontrol-2021-056901.

Endo launches first and only generic version of Chantix (varenicline) tablets in the United States. https://investor.endo.com/news-releases/news-release-details/endo-launches-first-and-only-generic-version-chantixr. Published Sept. 22, 2021. Accessed Feb. 16, 2022.

FDA updates and press announcements on nitrosamine in varenicline (Chantix). https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix. Published Sept. 17, 2021. Accessed Feb. 16, 2022.

Laboratory analysis of varenicline products. https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-analysis-varenicline-products. Published Aug. 23, 2021. Accessed Feb. 16, 2022.

E-cigarettes linked to greater odds for prediabetes


E-cigarette use was associated with greater odds for prediabetes among U.S. adults, according to findings published in the American Journal of Preventive Health.

“CDC has reported that people who smoke traditional cigarettes are 30 to 40% more likely to get type 2 diabetes,” Shyam Biswal, PhD, a professor in the department of environmental health and engineering at the Johns Hopkins Bloomberg School of Public Health, told Healio. “This is due to nicotine and chemicals in cigarette smoke, which hampers the action of insulin. The use of e-cigarettes in the younger population is on the rise and these products have nicotine and many chemicals. From this and several other studies, there is enough evidence that e-cigarettes are not harmless. Clearly, use of e-cigarettes increases the odds of prediabetes.”

Odds for prediabetes among U.S. adults compared with individuals who never used e-cigarettes
Zhang Z, et al. Am J Prev Med. 2022:doi:10.1016/j.amepre.2021.12.009.

Biswal and colleagues analyzed 2016 to 2018 data from the Behavioral Risk Factor Surveillance System, a nationally representative health survey of U.S. adults. In total, the analysis included self-reports from 600,046 respondents. Among the cohort, 28.6% of respondents were aged younger than 35 years, 50.4% were women, 67.7% were non-Hispanic white and 12.2% were non-Hispanic Black.

The results were based on two models: one adjusted for age, sex, race and BMI and the other adjusted further for education level, physical activity, medical history of heart disease, cancer, depressive disorder, COPD and asthma, cigarette use, use of smokeless tobacco products and blood sugar tests in the past 3 years.

Overall, an average of 10.9% (95% CI, 10.7-11.1) of respondents who reported never using e-cigarettes had prediabetes compared with 9% (95% CI, 8.6-9.4) of current users, 9.2% (95% CI, 8.4-10.1) of former users and 5.9% (95% CI, 5.3-6.5) of e-cigarette users who never smoked combustible cigarettes. In addition, Biswall and colleagues reported that 9.3% (95% CI, 9.1-9.6) of respondents who never smoked combustible cigarettes had prediabetes compared with 13.4% (95% CI, 13-13.7) of current smokers and 10.2% former and dual smokers (95% CI, 9.8-10.7).

The ORs for prediabetes were 1.22 (95% CI, 1.10-1.37) among current e-cigarette users and 1.12 (95% CI, 1.05-1.19) among former e-cigarette users compared with respondents who never used e-cigarettes, according to the fully adjusted model. Moreover, the ORs for prediabetes were 1.54 (95% CI, 1.17-2.04) among sole e-cigarette users and 1.14 (95% CI, 0.97-1.34) among dual users compared with respondents who never used e-cigarettes or combustible cigarettes.

“Prediabetes is reversible with lifestyle management,” Biswal said. “Considering the results, quitting e-cigarettes has to be a key part of lifestyle management.”

Among those attempting to quit smoking combustible cigarettes, previous research has shown that the use of e-cigarettes for smoking cessation did not significantly prevent relapse or successful termination, Healio reported.

“More and more evidence is piling up that e-cigarettes are not safe,” Biswal said. “I think there is sufficient evidence for doubling down on public health measures to prevent the initiation and use of e-cigarettes, at least amongst youth.”

References:

Chen R, et al. Tob Control. 2022;doi:10.1136/tobaccocontrol-2021-056901.

E-cigarettes do not improve smoking cessation, survey finds


The use of e-cigarettes as a smoking cessation method did not significantly prevent relapse or successful termination, according to survey findings published in Tobacco Control.

“This is the first survey in which e-cigarettes were less popular as a smoking cessation aid than FDA-approved pharmaceutical aids,” John P. Pierce, PhD, a distinguished professor at the Herbert Wertheim School of Public Health and Human Longevity Science at UC San Diego and UC San Diego Moores Cancer Center, said in a press release. “Not only were e-cigarettes not as popular, but they were associated with less successful quitting.”

Recent former smokers who reported cigarette abstinence used
Chen R, et al. Tob Control. 2022;doi:10.1136/tobaccocontrol-2021-056901.

Pierce and colleagues evaluated data from the nationally representative PATH cohort study to determine the effectiveness of e-cigarettes as a smoking cessation aid from 2017 — when sales for nicotine e-cigarettes increased in the U.S. — to 2019. The analysis included 3,578 participants who were established smokers in 2016 with a recent quit attempt and 1,323 recent former smokers.

E-cigarette use

Between 2016 and 2017, there was a more than 40% growth in sales for e-cigarette products in the U.S., according to the researchers.

In 2017, 12.6% (95% CI, 11.3-13.9) of smokers who recently attempted to quit reported using e-cigarettes as a cessation aid (8.7% e-cigarettes only, 3.2% e-cigarettes and nicotine replacement therapy/pharmaceutical aid, 0.5% e-cigarettes and other tobacco products, and 0.2% three or more products). This marked a decline from 17.4% in 2016, according to Pierce and colleagues.

Only 2.2% (95% CI, 0-4.4) of recent former smokers said they switched to a high nicotine e-cigarette. These products were most often used as a cessation aid by respondents aged 18 to 50 years compared with those aged older than 50 years. Also, non-Hispanic white individuals, those who attended college, those with higher incomes and daily smokers were more likely to report using e-cigarettes.

Other cessation aids

Meanwhile, 2.5% (95% CI, 1.9-3.1) of respondents reported using a non-e-cigarette tobacco product as a cessation aid and 20.6% (95% CI, 18.9-22.3) used a nicotine replacement therapy or pharmaceutical aid only. The researchers reported that most respondents (64.3%) attempted the “cold turkey” method, in which no products were used.

Smoking cessation

Among respondents who reported cigarette abstinence, 18.6% (95% CI, 16-21.2) said they did not use any aids. In contrast, a lower proportion (9.9%; 95% CI, 6.6-13.2) said they used e-cigarettes.

The results further showed that e-cigarettes were associated with lower abstinence rates at 12 or more months compared with pharmaceutical aids (adjusted risk difference [aRD] = 7.3%; 95% CI, 14.4 to –0.4) or any other method (aRD = 7.7%; 95% CI, 12.2 to –3.2), according to Pierce and colleagues.

Although the finding was insignificant, the researchers also noted that respondents who switched to e-cigarettes appeared to have a higher relapse rate than those who did not switch to e-cigarettes or other tobacco products. By 2019, nearly 60% of recent former smokers who used e-cigarettes daily had resumed cigarette smoking.

While randomized clinical trials show improved cessation with e-cigarettes, they are often not conducted under “optimal conditions” and do not reflect “the effectiveness of the product in community settings,” Pierce and colleagues wrote.

An epidemic

“There is good evidence that [e-cigarettes] have become the initiation product of choice for adolescents,” Pierce told Healio. “The Surgeon General has labeled this an epidemic. Some are concerned that this effect on teens may be wiping out all of the successes in tobacco control over the past 3 decades.”

When talking to patients about smoking cessation, “clinicians can correct patient misperceptions that e-cigarettes will make their quit attempt more successful,” he said.

According to Pierce, individuals who smoke are advised to mix and match approved cessation aids. As an over-the-counter option, nicotine replacement therapy is the most popular aid, he said. It is often used in combination with varenicline or Zyban (bupropion hydrochloride, GlaxoSmithKline), he added.

In September, Pfizer voluntarily recalled all lots of its varenicline product Chantix “due to the presence of unacceptable N-nitroso-varenicline levels,” according to the FDA. The agency approved a generic version of varenicline (Par Pharmaceutical) in August.

References:

Adoption of e-cigarettes for smoking cessation in 2017 low and ineffective. https://ucsdnews.ucsd.edu/pressrelease/adoption-of-e-cigarettes-for-smoking-cessation-in-2017-low-and-ineffective. Published Feb. 7, 2022. Accessed Feb. 11, 2022.

Chen R, et al. Tob Control. 2022;doi:10.1136/tobaccocontrol-2021-056901.

Endo launches first and only generic version of Chantix (varenicline) tablets in the United States. https://investor.endo.com/news-releases/news-release-details/endo-launches-first-and-only-generic-version-chantixr. Published Sept. 22, 2021. Accessed Feb. 16, 2022.

FDA updates and press announcements on nitrosamine in varenicline (Chantix). https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix. Published Sept. 17, 2021. Accessed Feb. 16, 2022.

Laboratory analysis of varenicline products. https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-analysis-varenicline-products. Published Aug. 23, 2021. Accessed Feb. 16, 2022.

E-Cig Harms Outweigh Benefits, Study Finds


Vaping creates more cigarette smokers than quitters

The harms that electronic cigarettes currently pose to non-smoking teens and young adults far outweigh the potential benefits to adult smokers who want to give up conventional cigarettes, according to findings from a newly published risk analysis.

The risk model by Samir Soneji, PhD, of Dartmouth-Hitchcock Norris Cotton Cancer Center, Lebanon, N.H., and colleagues found that in a single year, 2,070 adult smokers would successfully kick the habit using e-cigarettes (albeit with a wide 95% confidence interval).

But the model also estimated that e-cigarette use among non-smoking teens and young adults would lead to 168,000 new smokers.

The study, published in PLOS ONE, concluded that e-cigarette use currently represents more harm than benefit at the population level.

“The model suggests that the harms to kids are substantial in magnitude, while the promised benefits for smokers wanting to quit are not very robust,” Soneji told MedPage Today.

He said the study is among the first to attempt to quantify the balance of harms and benefits associated with e-cigarette use.

The researchers used census counts, national health and tobacco use surveys, and recent e-cigarette studies to calculate the expected years of life gained or lost from e-cigarette use on smoking cessation among current smokers and transition to long-term cigarette use among never smokers in a 2014 population cohort.

Using these data, the team performed stochastic simulation using the Monte Carlo model.

The investigators assessed three outcomes:

  • Additional number of current cigarette smokers who will quit smoking through the current use of e-cigarettes and abstain from smoking for ≥7 years, compared with those who do not currently use e-cigarettes
  • Additional number of adolescents and young adults who will initiative cigarette smoking through the ever use of e-cigarettes and eventually become daily cigarette smokers at age 35-39, compared with those who never used e-cigarettes
  • Total number of expected years of life gained or lost across all these population subgroups

The estimates based on the modeling were as follows:

  • A total of 2,070 additional current cigarette smoking adults ages 25-69 (95% CI -42,900 to 46,200) would quit smoking in 2015 and remain continually abstinent from smoking for ≥7 years through the use of e-cigarettes in 2014
  • A total of 168,000 additional never-cigarette smoking adolescents ages 12-17 and young adults ages 18-29 (95% CI 114,000-229,000) would initiate cigarette smoking in 2015 and eventually become daily cigarette smokers at age 35-39 through the use of e-cigarettes in 2014
  • E-cigarette use in 2014 would lead to 1,510,000 years of life lost (95% CI 920,000-2,160,000), assuming an optimistic 95% relative harm reduction of e-cigarette use compared with cigarette smoking
  • Assuming an approximately 75% relative harm reduction, the model estimated -1,550,000 years of life lost (95% CI -2,200,000 to -980,000); assuming an approximately 50% harm reduction, the model estimated -1,600,000 years of life lost (95% CI -2,290,000 to -1,030,000)

Although electronic cigarette use is widely accepted as being safer than smoking combustible cigarettes, there is now strong evidence that their use by teens and young adults increases smoking risk, Soneji noted.

“There have now been about a dozen studies from different countries consistently showing about a threefold increased risk of smoking initiation among kids who vape. What is even more concerning is that the risk appears to be greatest among kids who are otherwise at low- or moderate-risk of starting smoking.”

He said the current, population-level risk balance could shift if e-cigarettes are adequately regulated to make them unattractive and unavailable to teens, while optimizing their effectiveness as reduced-harm products for smoking cessation.

“Ten million smokers tried to quit last year. Half tried to quit cold turkey, which is a very ineffective way to quit. E-cigarettes may have some advantages over currently available nicotine-replacement therapies, in that, like cigarettes, they deliver nicotine through inhalation.”

FDA to Shift Tobacco Regulatory Focus


Federal officials today announced a dramatic shift in tobacco policy, vowing to slash nicotine levels in combustible cigarettes to non-addictive levels while delaying key regulatory action on electronic cigarettes until the summer of 2022.

In a Friday morning media call, FDA Commissioner Scott Gottlieb, MD, made it clear that the agency now considers e-cigarettes to be less harmful than conventional cigarettes and a potential tool for smoking cessation, and that it will move forward with regulation of the products with this view in mind.

Under the revised timeline for newly deemed tobacco products, applications for newly-regulated combustible tobacco products, such as cigars, pipe tobacco and hookah tobacco, would need to be submitted to the FDA by Aug. 8, 2021, and product applications for e-cigarettes currently on the market would be required by Aug. 8, 2022.

The new enforcement policy does not affect provisions of the regulatory rule that are already in place, such as mandatory age and photo-ID checks for e-cigarettes and other newly regulated tobacco products. It will also not affect future deadlines for other provisions of the deeming rule.

Gottlieb said the FDA is ready to move forward with efforts to require tobacco companies to reduce nicotine levels on combustible cigarettes to non-addictive levels, but he gave no timeline for this.

He said the evidence shows that the greatest dangers from tobacco come from smoking it. Although nicotine itself is not harmless, Gottlieb said, its most important harm is that it addicts people to smoking.

“We believe that in a world where we are rendering combustible cigarettes no longer addictive, we can take a more balanced approach to some of the newer innovations that might have the potential to help current combustible cigarette smokers transition to products that might be less harmful,” he said. “And our regulatory process will help determine whether, in fact, those products are less harmful.”

A press release issued Friday stated that the agency plans to issue an Advance Notice of Proposed Rulemaking (ANPRM) “to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.”

During the media call, Mitch Zeller, JD, who directs the FDA’s Center for Tobacco Products, said the ongoing debate in public health about whether e-cigarettes are harmful or helpful is a distraction.

“I think all sides would hopefully look at what we are doing as advancing and promoting public health, and acknowledging that there is a continuum of risk, and there are more and less harmful ways for nicotine to be delivered. In a properly regulated marketplace there is an appropriate place for the least harmful forms of nicotine delivery, whether its medicinal nicotine products or electronic cigarettes.”

“This is an opportunity to re-frame the debate,” he added. “Yes, we need to ask some tough questions about the benefits and potential risks of any new technology, but these questions should be asked through re-framing.”

Where smokeless tobacco products fit into the “continuum of risk” scheme was not addressed directly.

Eric Lindblom, JD, former director of the FDA Center for Tobacco Products’ Office of Policy, was highly critical of the FDA’s action to delay regulatory action on e-cigarettes, calling it “seriously troubling” in a press statement.

“If the FDA were truly concerned about protecting the public health, the agency would not extend the deadlines at all, or it would at least extend the deadlines only for those e-cigarettes and cigars that meet certain minimum standards and only for those smaller tobacco companies that might not have sufficient resources to meet the existing deadlines,” he said.

Lindblom currently directs the Tobacco Control and Food & Drug Law Program at Georgetown Law’s O’Neill Institute for National & Global Health Law in Washington, D.C.

He was also highly skeptical of the FDA plan to seek input on the proposed reduction of combustible cigarette nicotine levels through an ANPRM.

“FDA Advanced Notices of Proposed Rulemaking have, so far, been where good tobacco control ideas go to die or be delayed,” he said, noting that the agency has issued previous ANRPMs on control measures such as banning menthol-flavored cigarettes, with no action being taken.

“If FDA were serious about reducing nicotine levels, it could quickly issue a proposed rule now to get all the comments they would need before issuing a final rule and start saving some lives.”

Gottlieb also vowed to seek public comment through ANPRMs to further explore the role of flavors, including menthol, in attracting kids and teens to tobacco products.

The American Thoracic Society applauded the action in a statement issued Friday afternoon, while expressing concern about FDA’s role in tobacco regulation moving forward.

“While we are encouraged that FDA Commissioner Gottlieb indicated the agency intends to develop new regulations on flavored tobacco products that appeal to children and adolescents and consider banning menthol, we are concerned about the agency’s intent on tobacco regulation overall, including the signaling of potential regulatory exemptions for premium cigars. The ATS will continue to monitor the FDA’s progress to ensure the best possible outcome for children and adults,” the statement read.

Karolinska Institute finds 10 puffs on e-cigarettes increases risk of heart disease.


  • Vaping has gained popularity across the globe as a substitute to smoking
  • But studies have cast doubt on the assumption they are almost harmless
  • Scientists at the Karolinska Institute in Stockholm have been researching
  • Just ten puffs on an e-cigarette can ‘start the heart disease ball rolling’

A decade ago, e-cigarettes were nothing more than a novelty. The battery-powered devices, which heat up a liquid containing nicotine and flavouring so it can be inhaled as a vapour, were dismissed by many as little more than a passing fad.

Now they are everywhere. Almost three million people use e-cigarettes in Britain today, drawn in by the seductive proposition they can happily puff away without damaging their health. The legion of users here grows daily.

So-called ‘vaping’ is also gaining popularity across the globe, encouraged by doctors who believe it is far safer than smoking real cigarettes.

Not surprisingly, tobacco giants, keen to defend their profits, are getting in on the act by buying up brands and creating their own products. But now a growing number of studies has cast serious doubt on the rosy assumption that e-cigarettes are an almost harmless alternative to smoking. And the latest research is truly worrying.

'Vaping' is gaining popularity across the globe, encouraged by doctors who believe it is far safer than smoking real cigarettes

‘Vaping’ is gaining popularity across the globe, encouraged by doctors who believe it is far safer than smoking real cigarettes

Scientists at the world-renowned Karolinska Institute in Stockholm have discovered that just ten puffs on an e-cig is enough to trigger physiological changes that, in the words of one leading expert, ‘start the heart disease ball rolling’.

This study follows others which have found that – just like ‘real’ cigarettes – e-cigs raise blood pressure and promote a hardening of the arteries.

Separate research indicates that the food additives used to flavour the vapour could be dangerous when heated and inhaled.

And another hotly disputed study, published earlier this year, even suggested that those who vape are 28 per cent less likely to quit tobacco than those who do not.

Despite all this, a number of medical organisations in the UK strongly support encouraging smokers to switch from tobacco to e-cigarettes.

Public Health England has issued a statement saying the devices are ‘around 95 per cent less harmful than smoking’. And only last week the Royal College of GPs told its 52,000 members to advise those trying to give up smoking to switch to e-cigarettes.

However, critics of this approach are unconvinced by such enthusiasm.

Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine, said: ‘Many health organisations across the UK have significant concerns about promoting e-cigarettes to smokers.

‘We simply can’t know what their effect will be on health, if used over the long term, because they have not been around long enough.

‘To me, it would be sensible to take a precautionary approach and regulate them as much as possible.’

And Dr Filippos Filippidis, lecturer in public health at Imperial College, London, said: ‘We don’t know whether we may start to see diseases emerge in ten or 20 years’ time associated with some of the ingredients. We urgently need more research into the devices.’ His warning is particularly pertinent because it took decades for the link between tobacco and lung cancer to emerge.

It became clear only thanks to the pioneering work of statistician Sir Richard Doll in the 1950s – work that has saved millions of lives.

In the Karolinska study, published in the journal Atherosclerosis, Swedish researchers took 16 occasional smokers of cigarettes and asked them to each take ten puffs on an e-cigarette.

Within the first hour, there was a ‘rapid rise’ in levels of a type of cell indicating damage to the inner lining of blood vessels, called endothelial progenitor cells or EPCs, said the scientists. This increase, they wrote ‘was of the same magnitude as following smoking of one traditional cigarette’.

This ‘very short exposure to e-cigarette vapour… may indicate an impact on vascular integrity leading to future atherosclerosis’ – better known as hardening of the arteries.

SO IS VAPING THE SAFE ALTERNATIVE?

YES…

By Prof John Britton

We should not let studies rightly highlighting the potential dangers of e-cigarettes blind us to the fact that these devices are much, much safer than smoking tobacco.

For a smoker, moving to e-cigarettes brings a huge health benefit. The decision should be a no-brainer. When you smoke a cigarette you inhale not only nicotine but also more than 4,000 highly toxic chemicals, including carcinogens. And you inhale many of them in fairly high concentrations. So there’s nothing better you can do for your health than to quit smoking. Let’s be clear: e-cigarettes are not harmless and we shouldn’t be complacent. E-cigarette vapour contains toxic chemicals, and tiny particles that can harm lungs and blood vessels.

But in terms of the harm they cause, they simply aren’t in the same league as smoked tobacco.

Levels of EPCs only returned to normal 24 hours later.

Professor Joep Perk, a heart specialist and spokesman for the European Society of Cardiology, said: ‘It really surprises me that so little vapour from an e-cigarette is needed to start the heart disease ball rolling.

‘It’s worrying that one e-cigarette can trigger such a response.’

So will long-term use of e-cigs cause heart disease? That remains to be seen. But the Swedish team noted that the average user takes 230 puffs a day – raising the prospect that prolonged use could cause serious damage.

Nor is this study alone. In August, a team at the University of Athens Medical School claimed that puffing on an e-cigarette for half an hour led to similar levels of stiffness in the aorta – the main artery – as smoking a tobacco cigarette. Both activities raised blood pressure, too.

Study leader Professor Charalambos Vlachopulos said at the time: ‘E-cigarettes are less harmful [than smoking tobacco] but they are not harmless.

‘I wouldn’t recommend them as a method of giving up smoking.’

New research is coming thick and fast. Last month, an American study found teenagers who used e-cigarettes were 71 per cent more likely to suffer bronchitis.

On Friday, another study claimed just one puff contained up to 270 times the safe level of toxic chemicals called aldehydes.

But it is a study in the journal Lancet Respiratory Medicine – which found e-cig users were 28 per cent less likely to quit tobacco smoking than those who didn’t vape – that has perhaps caused the most dispute. This finding matters because the vast majority of e-cig users are those trying to quit tobacco.

Co-author Stanton Glantz wrote: ‘While there is no question that a puff on an e-cigarette is less dangerous than a puff on a conventional cigarette, the most dangerous thing about e-cigarettes is that they keep people smoking conventional cigarettes.’

His findings have been leapt on by e-cig sceptics, who frequently quote the headline result.

But e-cig advocates have dismissed it as unscientific and even ‘grossly misleading’.

Peter Hajek, of the Tobacco Dependency Research Unit at Queen Mary, University of London, said it looked only at current smokers who had used e-cigarettes in the past – ignoring ex-smokers who had given up tobacco thanks to the devices.

This study follows others which have found that – just like 'real' cigarettes – e-cigs raise blood pressure and promote a hardening of the arteries

Advocates of getting smokers to swap tobacco for e-cigarettes now fear their simple message – that switching saves lives – is getting lost in a cloud of confusion.

Smoking claims the lives of 93,000 people in the UK every year – accounting for almost one in every five deaths – as it significantly increases the risk of killer diseases including cancer, heart disease, and a lung condition called chronic obstructive pulmonary disorder.

Professor John Britton, director of the UK Centre for Tobacco and Alcohol Studies at Nottingham University, said: ‘The decision to switch should be a no-brainer… There’s nothing worse you could do for your health than smoke.’

And e-cigarettes did help 18,000 people quit smoking last year, according to research by University College London and Cancer Research UK.

Scientists such as Dr Britton believe that, despite the lurking dangers of e-cigarettes, they could deliver huge benefits to the country’s overall health.

SO IS VAPING THE SAFE ALTERNATIVE?

NO…

By Prof Martin McKee

Do we know what the long-term effects of regular e-cigarette use will be on human health? No – because they haven’t been around long enough.

But the evidence that is accumulating causes me very considerable concern.

For a start, nicotine is more dangerous than previously thought. It negatively affects the developing brain, helps cancer spread by encouraging the growth of blood vessels around tumours, and increases the risk of dangerous heart rhythms in those who have just had a heart attack. The flavourings in e-cigs – usually food additives – might have been tested for safety in terms of ingestion though the gut, but taking them in through the lungs after heating is completely different.

Vaping is almost certainly safer than smoking tobacco. But the limited evidence suggests using e-cigs actually reduces the chance of a smoker quitting tobacco.

To that end, a group of 13 health bodies, led by Public Health England and including Cancer Research UK, the Royal College of Physicians and Faculty of Public Health, issued an unprecedented ‘consensus statement’ in July supporting the principle that smokers should be encouraged to switch.

They wrote: ‘We all agree that e-cigarettes are significantly less harmful than smoking.

‘One in two lifelong smokers dies from their addiction.

‘All the evidence suggests that the health risks posed by e-cigarettes are relatively small by comparison, but we must continue to study the long-term effects.’

They concluded: ‘The public health opportunity is in helping smokers to quit, so we may encourage smokers to try vaping.’

Yet this position is ‘out of step’ with opinion in the US and Europe, according to Prof McKee and Dr Filippidis, where health bodies are far more cautious.

Dr Filippidis said: ‘Only time will tell who is right, but my personal opinion is that some more caution would be prudent until the evidence is more clear.

‘Very soon, major tobacco companies will enter the market with their own e-cigarettes or similar products that promise harm reduction.

‘I would feel very uncomfortable promoting products created by companies which have caused so much death and pain.

‘I don’t think we could trust them with our people’s health.’

Watch the video.URL:http://www.dailymail.co.uk/news/article-3997474/E-cigs-incendiary-truth-Just-10-puffs-increases-risk-heart-disease-make-smokers-likely-quit.html#v-3749975288001