Pfizer has recalled all lots of anti-smoking treatment Chantix due to high levels of cancer-causing nitrosamines, reports Reuters.
Pfizer paused distribution in June and asked wholesalers and distributors last week to stop use and distribution immediately.
Patients taking Chantix are in no immediate risk, according to the company, but they should consult healthcare providers about alternative treatment options.
The FDA approved Chantix in 2006 as a quit-smoking aid.
Vaping studies often contain a lot of modal verbs like can, could, may and might. For example, an updated study on e-cigarettes for smoking cessation by the Cochrane Review suggest that vaping “could” help smokers quit using deadly combustible cigarettes.
The Cochrane study looked at 50 studies that took place in the US, the UK, Italy, Australia, New Zealand, Greece, Belgium, Canada, Poland, South Korea, South Africa, Switzerland and Turkey. The review found that e-cigarettes “could” be the answer many smokers are looking for according to an article in The New Strait Times.
Among the key findings were that smokers were likely to stop smoking for at least six months by switching to a vaping device with a nicotine e-liquid as compared to nicotine replacement therapy (such as gum and patches), nicotine-free vaporizers or behavioural support.
The researchers, made up of multiple independent and internationally-renowned healthcare experts, found that vaping with a nicotine e-liquid can help 10 in 100 people to stop smoking, compared to only 6 in 100 people who have tried using nicotine-replacement therapy or vaping nicotine-free e-liquids. Only an estimated 4 in 100 who try to quit without support, or those who rely only on behavioural support, are likely to succeed.
They also did not detect any clear evidence of serious harm from vaping a nicotine e-liquid.
Jamie Hartmann-Boyce from the Cochrane Tobacco Addiction Group said there is an increase in evidence of smoking cessation through the use of e-cigarettes compared to the last review in 2016.
“The randomised evidence on smoking cessation has increased since the last version of the review and there is now evidence that electronic cigarettes with nicotine are likely to increase the chances of quitting successfully compared to nicotine gum or patches,” said Hartmann-Boyce, the lead author of the review. “While there is currently no clear evidence of any serious side effects, there is considerable uncertainty about the harms of electronic cigarettes and longer-term data are needed. Scientific consensus holds that electronic cigarettes are considerably less harmful than traditional cigarettes, but not risk-free.”
In contrast, a recent study from the University of California San Francisco (UCSF), led by Richard Wang, determined that that e-cigarettes do not lead smokers away from addiction. Wang also claims that e-cigarettes “could” increase a users risk of disease. “If the use of consumer device products is not associated with increased smoking cessation, there is no health benefit,” he said. “Also, as people who smoke add e-cigarettes to their smoking, their risk of disease could increase.”
Wang worked with fellow UCSF researcher Sudhamiyi Bhadriraju and disgraced former UCSF researcher Stanton Glantz, who has recently had multiple studies retracted for what has been labeled by fellow scientists as “explicit dishonesty.”
This latest study was based on the collection of 64 trials in which participants were examined. All of them are e-cigarette users, according to an article on Explica.com.
“In observational studies you are asking people about the use of the devices they bought themselves. But they did it without specific guidance to quit smoking,” says Wang. “In a randomized trial, you test a product, treating it as a therapy or drug to quit.”
Wang then goes on to say there “may” be a cessation effect. “When certain electronic devices are treated as medicines, there may actually be a smoking cessation effect,” explains Wang. “But it has to be balanced against the risks of using cigarettes.”
More smokers could turn to reduced-risk products like e-cigarettes after the U.K.’s menthol ban becomes enforceable today, new research suggests.
The study by TobaccoIntelligence shows that many retailers are planning to use the shelf space previously occupied by menthol cigarettes for alternatives such as vapour and heated tobacco products.
David Palacios, from TobaccoIntelligence, said: “The opportunities to convert menthol smokers to less risky alternatives are substantial.
“In the UK alone, for example, it is estimated that 1.3 million people currently using menthol cigarettes will need to find an alternative product.”
France has banned the online sale of nicotine products and limited their sale in pharmacies, after researchers suggested that nicotine may play a role in protecting against coronavirus.
The new rules cover products like nicotine gum and patches, designed to help people stop smoking. Last week, data from a Paris hospital indicated that smokers were statistically less likely to be admitted for treatment for Covid-19, according to an article on BBC.com.
Trials are set to continue in France.
France has reported nearly 22,000 coronavirus-related deaths since the start of the outbreak earlier this year. The authorities are planning to gradually lift the lockdown from 11 May.
What are the new nicotine restrictions?
The French government says people will only be allowed to buy one month’s supply of these products. The aim is to stop people putting too much nicotine into their bodies, in the hope of protecting themselves against coronavirus, and also to protect the supply for people who need it, says the BBC’s Lucy Williamson in Paris.
What’s the background to this?
The run on nicotine products was sparked this week after researchers noticed the low number of smokers among those hospitalised with Covid-19. The theory that nicotine could play a role in blocking the virus is due to be tested at a hospital in Paris, using nicotine patches.
The government’s chief health official said the study was interesting but warned that smoking killed 75,000 people a year in France. The official also warned that smokers who did become infected with coronavirus tended to have more serious symptoms.
No matter who you are, it’s notoriously tough to quit smoking. But it’s even harder if you’re a woman.
A new study with 200 patients corroborated a plethora of earlier research that concludes it’s harder for women than men to stop smoking. Researchers at the University of Toronto found that women experience more anxiety and depression, which may interfere with their desire and ability to quit smoking.
But another new study has encouraging news for women who switch to e-cigarettes.
That research found that smokers—and particularly women—who switched to e-cigarettes enjoyed a significant improvement in their vascular health within one month of switching.
A 2019 study of more than 200 patients at St. Michael’s Hospital in Toronto supports earlier evidence that gender is the biggest factor in the odds of successfully quitting smoking.
This study found that women were roughly 50 percent less likely than men to quit smoking. Researchers said the biggest reason was because women are more likely to have mood disorders; 41 percent of women in the study suffered from anxiety or depression compared to only 21 percent of men.
Beth Abramson, an associate professor of medicine at the University of Toronto and the study’s senior author, said depression and other mood disorders need to be addressed in women who smoke and especially those with a history of heart disease and stroke.
A propensity toward anxiety and depression is not the only factor making it more difficult for women to quit smoking.
The female brain also reacts differently to nicotine, according to epidemiological data that shows women’s brains are more sensitive than men’s brains to nicotine’s deleterious effects.
Although hard-pressed to determine the exact mechanisms underlying women’s greater sensitivity to developing nicotine dependence, researchers from the University of California at Irvine point to “gonadal hormone-mediated sexual differentiation of the brain,” particularly during the perinatal and adolescent periods.
Exposure to nicotine during these developmental periods can produce long-lasting, sex-dependent changes in neuronal structure and function, they concluded.
The study, published in 2017 by the National Center for Biotechnology Information, stresses that there are important age and sex differences in nicotine’s effects and opines that preclinical research into tobacco dependence include these factors.
Other studies conducted at the University of Pittsburgh School of Medicine conclude that women benefit less from nicotine-replacement therapy (NRT) relative to men.
“Smoking cessation treatment for women must address several other issues that often emerge, and these are most likely to require behavioral counseling tailored to these problems,” said Kenneth A. Perkins, who authored the study.
“These issues include concern about bodyweight gain, restrictions on medication use in pregnant smokers, variability in mood and withdrawal as a function of menstrual cycle phase, harnessing social support to foster abstinence, and the possibility that smoking-associated environmental cues may be more influential in smoking behavior in women than men,” he said.
It’s a well-documented fact that most people, and particularly women, are concerned about gaining weight after they quit smoking. There’s good reason for their concern: Researchers estimate that people gain about 10 pounds on average after they quit smoking.
No woman is happy gaining weight, even when she knows that quitting smoking is vital for her health in the long run.
The reason that weight gain is associated with quitting smoking is because nicotine is a stimulant as well as an appetite suppressant.
That’s one of the key factors behind the growth in e-cigarettes; instead of quitting their daily oral habit or nicotine intake, the former smoker is simply quitting the thousands of chemicals in traditional cigarettes, including over 60 known carcinogens. While nicotine is highly addictive, it is not a carcinogen.
Multiple studies confirm that even if you gain weight, it’s still much better to quit smoking, as it lowers the risk of cardiovascular disease. Research has found that quitters who gain a few pounds still have about a 50 percent lower risk of heart disease than smokers.
The same reduction in risk holds true for people with diabetes. That may come as a surprise given that gaining weight can worsen or contribute to an onset of diabetes.
That’s why researchers and physicians would agree that it’s important to counsel women that some weight gain is to be expected after quitting cigarettes. That is, unless she chooses not to quit cold turkey and switches to e-cigarettes, which makes her less likely to substitute nicotine with food at the times when she used to smoke.
This type of gender-specific counseling and education could also make a dent in the quit rates for women who smoke.
Different women choose many different paths to quitting smoking. One of the more popular methods that’s prescribed by doctors is the drug Chantix, or varenicline.
However, both men and women run the risk of experiencing this drug’s serious side effects.
A 2018 study conducted by the Yale Specialized Center of Research found that Chantix was 46 percent more effective in women at the outset. Although after one year, the results were equally effective among women and men. The study’s author hypothesized that sex differences in the brain’s nicotine receptor system may be a key factor why Chantix was at least initially more effective for women.
However, Chantix has been associated with at least 2,748 adverse events—14.8 percent of all cases—including 293 suicides, 490 attempted suicides and many other cases involving self-injurious behavior or homicidal ideation. The Institute for Safe Medicine Practices, a nonprofit medication watchdog, concluded that Chantix was responsible for more reports of serious drug adverse events than any other drug in the U.S.
Not surprisingly, these adverse events spurred thousands of lawsuits by families of loved ones who suddenly and inexplicably committed suicide while on Chantix. In March 2013, Pfizer, the drug’s maker, settled 80 percent of these lawsuits out of court for an estimated $273 million.
Yet the differences between how the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the media are handling e-cigarettes versus the drug Chantix (varenicline) are dramatic.
While the FDA drafts increasingly strict enforcement policies for e-cigarettes, it removed the “black box” warning on Chantix that cautioned consumers of the risk of suicide and a host of psychiatric problems, including depression and mania, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety and panic.
Regardless of one’s age, it’s becoming easier to buy and take Chantix. In July 2019, Indiana joined 11 other states where anyone can pick up a box of Chantix without a doctor’s prescription.
A simple search on the CDC website for Chantix and you’ll get only 66 results versus more than 2,200 for e-cigarettes that mention “pulmonary disease,” “lung injury” and “youth tobacco use,” even though e-cigarettes contain no tobacco. Similarly, the FDA website also only lists 78 results in a search for Chantix, and the top result is an update on the September 2016 decision to remove the black box warning.
“I think Chantix should be recommended by public health officials as a Plan E smoking cessation remedy after cold turkey, e-cigarettes, smokeless tobacco and NRT, since Chantix poses far greater risks than these four other smoking cessation methods combined,” said Bill Godshall, founder and executive director of Smokefree Pennsylvania.
For years, it was thought that women were less likely to suffer the same negative consequences as men who smoked. A 2013 study published in The New England Journal of Medicine debunked that notion. After examining data from more than two million women in the U.S., the author, Richard Peto of Oxford University, concluded, “If women smoke like men, they die like men.”
“There was a big gap in our knowledge,” said Tim McAfee, director of the CDC’s Office on Smoking and Public Health. “This sort of puts the nail in the coffin around the idea that women might somehow be different or that they suffer fewer effects of smoking.”
Lung cancer is the second most common form of cancer but by far the leading cause of cancer deaths in both men and women. In 2018, over 234,000 new cases of lung cancer—121,680 men and 112,350 women—were diagnosed. More than 154,000 people died of the dreaded disease, including 83,550 men and 70,500 women.
Lung cancer claims the lives of more women than breast cancer, ovarian cancer and uterine cancer combined. Although lung cancer deaths dropped steadily in men since 1990, these cancers continued to rise in women.
The fact that women tend to start smoking at a younger age, smoke more cigarettes and continued to smoke in the 1960s and 1970s when men were quitting are the primary reasons behind the dramatic increase in lung cancer deaths among women.
While advances in treatment and management helped decrease the number of cancer deaths among women, the notable exception is lung cancer. And although it’s more difficult to identify the causal agents of breast cancer, there’s an obvious correlation between smoking and lung cancer.
Add alcohol into the mix, and women take an even greater risk, according to a European study that followed a group of 380,000 people over age 40 for around 12 years. The mortality rate was anywhere from 1.5 times to 3 times higher for smokers than for people who never smoked.
And although there were no differences between men and women when only the amount they smoked was taken into account, these risks changed dramatically when alcohol was thrown into the mix. In that case, the mortality rate was 3.88 times higher among women who smoked more than 26 cigarettes and drank more than 30 grams of alcohol a day.
“Women who consume excessive amounts of alcohol have a significantly higher risk from tobacco use than those who consume little or no alcohol,” the authors concluded.
But there’s still good news for former smokers. Former smokers who quit before they turn 35 can gain most if not all of that decade back, and even those who wait until middle age to kick the habit can add about five years back to their life expectancies.
Nicotine exposure during pregnancy is never advised—whether the mother smokes regular cigarettes, e-cigarettes or even uses nicotine patches or gums. Ample research has shown that nicotine use during pregnancy doesn’t just increase morbidity and mortality in the neonatal period, it also increases risk of sudden infant death syndrome and can have lifelong consequences.
However, research published in November 2019 in The Journal of the American College of Cardiology shows that women who switch to e-cigarettes at other times in their lives can enjoy significant health benefits, including a major improvement in vascular function.
Smokers, particularly women, demonstrated substantial improvement in their vascular health within one month of switching from traditional cigarettes to e-cigarettes, leading researchers to conclude that switching was an important and significant harm reduction measure.
Interestingly, the researchers found no difference in vascular effects between those who used e-cigarettes with nicotine and e-cigarettes without nicotine. The authors hypothesized that “early improvement appears to be unrelated to the abstinence from nicotine but rather from other toxic material produced by combustion” in conventional cigarettes.
In summary, women are at greater risk than men of the deleterious effects of smoking. Yet, quitting is even harder for women for a variety of physiological and psychological reasons.
But if “first do no harm” is truly the health community’s mantra, then we need to do a better job educating women on the best alternative to quitting tobacco altogether.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
By Marina A. Murphy
The popularity of e-cigarettes these days means that you can buy them almost anywhere: online, in general retail or in specialist vape shops. But new research shows that where you buy your e-cigarettes may not only determine the price you pay for them or what selection you have to choose from, but also the likelihood that you will be a successful quitter—that is, whether you’ll be successful at quitting smoking if you are a smoker.
Scientists at the University of California conducted a two-year survey1 of vapers and concluded that those who buy their e-cigarettes from vape shops or online are far more likely to give up smoking than those who get their e-cigarettes in general retail. This proved to be true regardless of how heavy a smoker they had previously been, whether they had intended to give up smoking in the first place and their willingness to use medicinal products like nicotine-replacement therapies.
The researchers say that given the influence the place you purchase your e-cigarettes may have on your ability to quit, regulators should consider how the rules they make might impact smokers’ access to different options for vapor products. For example, in March this year, the U.S. Food and Drug Administration (FDA) said that it was going to ban the majority of e-cigarette flavors in general retail but not online or in specialist vape shops.
The question then becomes whether limiting the choices of vapers who shop in general retail puts these vapers at a disadvantage in terms of their likelihood to quit smoking, compared with those who buy in specialist shops or online (who have more choices).
The University of California study involved 1,600 vapers and was conducted between 2014 and 2016. During this time, researchers collected information on smoking and quitting behavior and primary choice of place of purchase.
Survey results revealed a number of differences between vape shop customers and retail customers. Vape shop customers were more likely to use open systems. Retail customers were more likely to use FDA-approved cessation aids. A total of 92.8 percent of vape shop customers used open systems compared to only 17.3 percent in retail customers.
Vape shop customers were also more likely to vape daily. More than half of vape shop customers were daily vapers whereas only one in five retail customers were daily vapers.
Previous studies found a correlation between daily vaping and using open systems with smoking cessation. This would seem to be borne out here, as vape shop customers were also more likely to have quit smoking. Among those smoking 12 months prior to the survey, smoking cessation rates were higher for vape shop and internet customers at 22.2 percent and 22.5 percent, respectively, than for retail customers at 10.7 percent.
The researchers point out that previous studies have depended mainly on data from retail stores, which accounted for only 30 percent of purchases in 2016. They say that further studies must therefore include a broader range of purchase channels.
Marina A. Murphy is head of scientific media relations at British American Tobacco.
By Chris Howard
Put yourself in the shoes of a smoker who is trying to quit. You’ve tried various quit-smoking products, such as nicotine patches, gums and prescription medications. None have worked. Your friend tells you how vaping with flavors works, so you decide to give e-cigarettes a try.
You stop at a convenience store, seeking a vapor product that meets your needs. Surprisingly, the flavors that seemed so appealing are nowhere to be found. You never liked menthol, and tobacco reminds you of the cigarettes you hope to avoid. Like many smokers, you’re anxious about leaving cigarettes behind and your ability to quit. This latest obstacle makes quitting seem impossible (again). What happens next? You buy another pack of cigarettes and promise to try again another day.
The reality is that smokers don’t get to count on “another day.” Each cigarette increases the smoker’s risk of developing a smoking-related illness that will inevitably lead to a lower quality of life or worse—premature death.
The vapor industry shares the U.S. Food and Drug Administration’s (FDA) goal of ensuring e-cigarettes are used only by adults. That said, the FDA should consider a variety of more reasonable options to curb youth access without jeopardizing e-cigarettes’ harm reduction potential.
Codify marketing standards: Many adult-oriented industries employ voluntary codes of conduct to govern marketing practices. The FDA should seek consensus standards prohibiting marketing practices directed at youth. The Vapor Technology Association (VTA), which advances the interests of 800-plus manufacturers, wholesalers, small-business owners and entrepreneurs of the vapor industry, has already enacted such standards (see https://bit.ly/2Ozbfyn), which are mandatory for membership. Most, if not all, vapor companies would likely embrace objective, FDA-accepted parameters as reasonable ways to reduce youth e-cigarette access.
Revamp enforcement scheme: Undoubtedly, the FDA is resource-constrained and overwhelmed by age-verification requirements for vapor products. That said, even if the FDA could act on every violation, the current scheme allows a retailer to sell tobacco products to a minor five times within a 36-month period before the FDA can stop them from selling tobacco for 30 days. Revamping the current enforcement policy to provide for stricter and more consistent penalties would enable the FDA to use agency resources more effectively and deter bad actors from breaking the law.
Enhance restrictions for online purchases: Some online retailers are already implementing two-factor authentication and other measures to curb youth access to vapor products—measures rightly considered by the FDA. Such online purchase restrictions should continue to be developed, strengthened and exercised in order to eliminate youth access to vapor products.
Work with schools: Nearly every anecdotal news report involves a teenage student’s exposure to e-cigarettes. Given that schools are also seeking tools to combat this issue, the FDA should work more closely with school districts to provide resources and training that helps teachers identify the signs of youth e-cigarette use and how to stop it. The FDA’s current “The Real Cost” campaign is the right approach to assist teachers and educate youth, but unfortunately the messaging is riddled with inaccuracies about health effects that could deter smokers of combustible cigarettes from switching to vapor products.
Analyze the impact of higher minimum purchase age: Some states have increased the minimum purchase age for e-cigarettes to 21. The FDA should analyze purchase and use patterns in these states to assess any reduction in straw sales and youth usage rates resulting from increased purchase age requirements.
The decisions the FDA makes affect millions of adults who rely on vapor products for harm reduction. Restricting the availability of flavors is a radical measure that places unnecessary obstacles for adults obtaining products of their choice. In many ways, the proposed restrictions may actually help combustible cigarettes.
For these reasons, the FDA’s proposed flavor ban should be a last resort.
Chris Howard is vice president, general counsel and chief compliance officer at E-Alternative Solutions.
By Marina A. Murphy
A study has shown that a combustible cigarette smoker’s decision to switch to vaping is a deliberate one and not something that happens by chance.
Smokers of combustible cigarettes who successfully switch to vaping go through a very specific deliberation process that contrasts with the rather passive process by which smokers are thought to initiate cigarette smoking.
The authors of the study say that we could use what we learn about this decision-making process to develop communication strategies that might stimulate more smokers who would otherwise not have considered using e-cigarettes to give them a try. These communication strategies could, for example, provide would-be vapers with information on the risks of smoking and the health benefits of switching to e-cigarettes.
“There is significant evidence that e-cigarettes are one of the most effective quitting aids for smokers, yet this information is not always getting to the people who need it or indeed to the health professionals who should be advising them,” says Pooja Patwardhan, a general practitioner and the medical director of the Centre for Health Research and Education (CHRE) in the U.K. “Understanding the decision-making process used by those who have successfully made the switch to e-cigarettes would certainly go some way towards changing this,” she says.
This study is thought to be the first to examine the decision-making process of vapers. It explored if and how vapers, smokers, and nonusers differ in their knowledge and attitudes regarding e-cigarettes and whether they use what knowledge they do have to consider the pros and cons of vaping. The results were published in The International Journal of Environmental Research and Public Health.1
The researchers from the National Institute for Public Health and the Environment as well as Maastricht University, both located in the Netherlands, conducted several focus group interviews with vapers, smokers and nonusers. The results reveal differences between vapers and smokers in the knowledge they have about e-cigarettes, their attitudes toward e-cigarettes and their views on the harmfulness of continuing smoking.
In general, vapers were more knowledgeable about e-cigarettes than smokers or nonusers. Smokers and nonusers did have information about e-cigarettes, but when asked, vapers could provide far more detailed information. Vapers reported seeking out information on e-cigarettes in order to make the decision to take up vaping in the first place. Typically, they sought information on product characteristics, ingredients of e-liquids and legislation regarding e-cigarettes. When asked how informed they felt about e-cigarettes, smokers and nonusers stated that they did not search for information about e-cigarettes and that they didn’t know much about them. By contrast, vapers felt very informed.
Another important difference between vapers, smokers and nonusers is in their attitude toward e-cigarettes. Successful switchers (vapers) are generally very positively predisposed toward e-cigarettes, emphasizing positive aspects like the varieties of flavors available and the adjustability of nicotine levels. Vapers tended to be negative about smoking. By contrast, smokers tended to be negatively predisposed toward e-cigarettes, in general mentioning that vaping was “weird,” but were positive about cigarette smoking. Regardless of the negative health effects associated with smoking, smokers said that they really enjoy smoking.
Another important difference between vapers and smokers was in their perception of the health risks. Vapers perceived smoking to be harmful to health but did not perceive any health risks with vaping. Smokers’ on the other hand, while acknowledging that smoking is harmful, did not understand how smoking causes smoking-related diseases and perceived that these diseases were only something that they needed to worry about in the distant future. Nonusers perceived both smoking and vaping to be addictive behaviors, so they indulged in neither.
This study showed that vapers make a conscious decision to seek out and deliberate information with which to make the decision to vape. Smokers and nonusers, by contrast do not consciously deliberate information to make the decision not to vape.
The authors suggest that insights into the conscious decision-making process of vapers who switched from smoking combustible cigarettes could be used to stimulate smokers to consciously deliberate vaping, despite the fact that, initially at least, they might consider it to be “weird.”
“Surely one of the most important steps in stimulating a smoker to consider switching to vaping is to ensure that their health practitioners have all the information they need to help them in the first place,” says Patwardhan. “That is why we at CHRE are developing an education and outreach program designed to bring doctors in the U.K. up-to-date on the latest policy recommendations so that they can clearly communicate with smokers on the range of services and devices available to help them in their attempts to stop smoking.”
Marina A. Murphy is a scientific communications and engagement expert with more than 20 years of experience, including 10 years in the tobacco sector.
By Marina A. Murphy
Smokers who hang out with vapers are about 20 percent more likely to try to quit tobacco, according to research that puts paid to the idea that e-cigarettes and vaping renormalize smoking.
The study, which was conducted by researchers at University College London (UCL) over a period of 3.5 years and involved almost 13,000 participants, found that smokers who regularly spend time with vapers are likely to have tried an e-cigarette themselves. They are also highly motivated to quit and are likely to have already made attempts to stop smoking. By contrast, smokers who hang out with other smokers are not motivated to stop smoking.
While there is a lot of support for e-cigarettes, given that they are likely to be significantly safer than smoking and do not harm bystanders, some skeptics still believe that the sight of people puffing away on their e-cigarettes is likely to encourage smoking.
This is the first study to assess the impact of other people’s vaping on smokers’ desire to quit and the likelihood that they will try to do it.
The authors of this study say that their findings offer no evidence that spending time with vapers discourages smokers from quitting and should offer reassurance in terms of the public health impact of e-cigarettes.
“It is becoming increasingly more commonplace for smokers to come into contact with vapers, and some concerns have been raised that this could ‘renormalize’ smoking in England and undermine smokers’ motivation to quit,” said lead author Sarah Jackson of the Institute of Epidemiology & Health Care at UCL.
Kruti Shrotri, a tobacco control expert at Cancer Research U.K., which funded the study, said, “So far, there hasn’t been much evidence about whether e-cigarettes might make smoking tobacco seem normal again. So it’s encouraging to see that mixing with people who vape is actually motivating smokers to quit. As the number of people who use e-cigarettes to quit smoking rises, we hope that smokers who come into contact with them are spurred on to give up tobacco for good.”
The study, which was published in BMC Medicine, used data from 12,787 smokers who participated in the Smoking Toolkit Study, which analyzed smoking patterns in England between November 2014 and May 2018. Participants were asked whether anyone other than themselves used an e-cigarette regularly in their presence, whether they were motivated to quit smoking and whether they had made any attempts to quit.
The results showed that smokers who were regularly exposed to vapers (as opposed to other smokers) were around 20 percent more likely to report both a high current motivation to quit and to have made a recent attempt to quit.
Around one-quarter of smokers in the study said they regularly spent time with vapers. Of these, around one-third had tried to quit smoking in the previous year—a higher rate than was observed among smokers who did not regularly spend time with vapers.
It is thought that a key driving factor in the differences between smokers who hang out with vapers and those who don’t is that smokers who spend time with people who vape are simply more likely to give vaping a try themselves.
Marina A. Murphy is a scientific communications and engagement expert with more than 20 years of experience, including 10 years in the tobacco sector.
By Timothy S. Donahue
It was bad. The U.S. Food and Drug Administration’s (FDA) attempt at an unbiased hearing to discuss cessation methods for youth addicted to e-cigarettes and other tobacco products did not accomplish its goal. The Jan. 18 meeting, called the Public Hearing on Eliminating Youth Use of Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies, was little more than an attack on the vapor industry that continued to propagate misconceptions.
The meeting opened with a speech by FDA Commissioner Scott Gottlieb, who told attendees that the focus of the gathering was the potential role that drug therapies may play in the broader effort to eliminate e-cigarette and other tobacco product use among young people as well as the appropriate methods for evaluating such therapies.
Gottlieb said the hearing was in response to statistics from the National Youth Tobacco Survey (NYTS) released by the FDA and U.S. Centers for Disease Control and Prevention (CDC) showing that more than 3.6 million middle school and high school students were current (past 30 days) e-cigarette users in 2018—an increase of more than 1.5 million students since 2017. He also said that the survey showed youth who use e-cigarettes are also using flavored products more often than last year.
“This past November, the [CDC] reported that smoking rates among adults reached an all-time low in 2017; 14 percent of adults reported cigarette smoking ‘every day’ or ‘some days,’ marking a 67 percent decrease since 1965,” he said. “Sadly, this progress is being undercut—even eclipsed—by the recent dramatic rise in youth vaping. A few years ago, it would have been incredible to me that we’d be here discussing the potential for drug therapy to help addicted youth vapers quit nicotine.”
There is a large body of research on adult smoking cessation; however, the methods to treat adolescents and teens who are addicted to vaping are not well understood, according to Gottlieb. “There is little information about how drug or behavioral interventions might support youth e-cigarette cessation as well as youth tobacco use more generally,” he said. “The data and other information presented at today’s hearing will be vitally important to helping the FDA and other stakeholders begin to address these information gaps.” The data never came.
The first speaker, Bonnie Halpern-Felsher, a professor of pediatrics at Stanford University, was one of the only speakers to even mention nicotine-replacement therapies (NRTs) for youth. She said that there are currently no approved NRTs for youth. “Therefore, there is no evidence of their effectiveness when used off label,” she said. “Clearly, we need much more research … we need some evidence, so that’s the first thing we need to consider.”
She then added that there are additional “pharmacological events” to consider, going as far as calling on the FDA to ban all flavors in vapor products and claiming there is no evidence that flavored vapor products help adult smokers quit. Speaking to a five-member panel, as well as attendees, Halpern-Felsher also said the FDA needed to stop companies from saying vapor products in general help adults quit smoking combustible cigarettes when “there is no clear evidence that is the case, and, instead, it’s just attracting young people.” Of course, the FDA already bans vapor companies from making cessation claims.
The claims made by Halpern-Felsher contradicted the statements made by Gottlieb moments earlier. Gottlieb told attendees that he believes e-cigarettes present an important opportunity for adult smokers to transition off of combustible products and onto nicotine-delivery products that may not have the same level of risk associated with them.
“The FDA’s plan was founded on the principle that what primarily causes the death and disease from tobacco use isn’t the nicotine in these products but rather the harmful chemicals associated with cigarette combustion,” he said. “But we also know that nicotine isn’t a benign substance. We know that initiation to and addiction to nicotine by neversmokers—predominantly youth and young adults—raises its own set of public health concerns.”
Halpern-Felsher also asked the FDA to eliminate all ads for all flavors and ban companies from saying e-cigarettes are safe or safer (also banned by the FDA). “We all hoped that to be true [that e-cigarettes help adult smokers quit smoking combustible cigarettes], but the evidence isn’t playing out …. In most of the [cases] when adults were using electronic cigarettes, they tend to not be able to quit smoking and, if anything, tend to use both cigarettes and e-cigarettes, therefore increasing the amount of nicotine they are using,” said Halpern-Felsher, who provided no evidence to support her claims.
Susan Tanski, speaking for the American Academy of Pediatrics, reiterated that there is no data available for NRTs for youth use. She called on the FDA to quickly fund studies to better understand adolescent e-cigarette addiction, while also quickly identifying effective interventions for this population of e-cigarette users. “Indeed, the very issue of nicotine dependence and adolescent e-cigarette use is also likely to be a challenge, and researchers may need support in measuring dependency in a consistent way,” she said. “There have not been any trials for e-cigarette cessation with NRTs.”
Oddly, Tanski also stated that improvements to current NRT products, “such as changes to flavors that make them more palatable to youth, may help improve” compliance and effectiveness. Ironically, she also supported a ban on flavors in vapor products.
Another speaker explained how it was wrong for Gottlieb to say things, such as vaping is safer than smoking, while vapor companies could not make the claim. Lauren Lempert, a researcher with the University of California San Francisco’s Center for Tobacco Control Research and Education, said that “the FDA’s own statements characterizing e-cigarettes as less harmful nicotine-delivery devices have been misunderstood by kids to suggest that e-cigarettes” would help them stop smoking combustible cigarettes.
“The less harmful claims made [by] the FDA have not been substantiated. In fact, if e-cigarette companies made these very same claims, they would be illegal,” she said. “The problem is these companies have been repeating them in their ads … messages that say something is for adults only actually have the reverse effect of attracting youth and do more harm than good.”
Lempert called for the removal of all e-cigarettes from the market that have not survived the premarket tobacco product application (PMTA) process (which would mean all e-cigarettes), a ban of all flavors of e-liquids, the prohibition of all internet sales (because “evidence has shown there is no age-verification scheme that is effective”), a ban of cessation claims from all companies and the prohibition of all ads that target youth. Jennifer Folkenroth, speaking for the American Lung Association, made nearly the same statements as Lempert.
Points raised by vapor industry supporters seemed to fall on deaf ears. Spike Babain, technical analysis director for the New York State Vapor Association, drew attention to how the NYTS doesn’t specify whether a vape pen is used for nicotine or marijuana—it notes only that a vaporizer has been used. She also noted that the NYTS asked whether youth used a hookah pen and lumped the non-nicotine product in with nicotine use. She was asked a question about data but didn’t answer the question.
Bill Godshall, founder of Smokefree Pennsylvania, stated that most youth who vape are not using nicotine. He also noted that most youth who vape are 18 years old and can legally purchase vapor products in most states. He pointed out that the FDA and CDC have been characterizing all vapor use as nicotine consumption whereas a significant share of that figure may have in fact been marijuana use, given that nine of 10 states with the highest reported e-cigarette use among teens have legalized marijuana in some form. Godshall presented a plethora of data, such as that the 2017 NYTS found that 49.8 percent of sixth-graders to 12th graders who ever used an e-cigarette reported using an e-cigarette containing THC, marijuana, wax or hash oil, up from 38 percent in 2016.
“Scott Gottlieb and the FDA rely upon NYTS data on marijuana vaping, experimental and occasional e-cigarette use, and vaping by smokers, former smokers, and 18 and over adults to falsely claim youth nicotine vaping is an epidemic and threatens to ban/restrict more vapor product sales to adults,” he said. “Marijuana vaping has skyrocketed among teens—as with adults—in recent years.”
Some speakers appeared unaware of how the tobacco industry is regulated. Daniel Hussar, a professor at the Philadelphia College of Pharmacy at the University of the Sciences, suggested that vapor products should be available only by prescription. “Nicotine is a drug. The FDA recognizes that,” he said. “Yet nicotine-containing products are routinely available even to the youth [to whom] they are not supposed to be sold.”
Hussar said nicotine is no different when delivered through an electronic-delivery system. “Why has the FDA not made these devices available only by prescription?” he asked. “If the FDA does not comply with its own regulations and policies, why should anyone else feel they should need to comply?” However, in 2007, Njoy won a lawsuit against the FDA that prevented the agency from regulating e-cigarettes as a drug. The decision requires the agency to regulate vapor products in the same way it does other tobacco-derived products.
Other speakers took the opportunity to highlight products that could help address the FDA’s concerns. Jack O’Toole, president of FreshAir Sensor, for example, explained how his smoke detector-like device could be placed in a teen’s bedroom and would sound an alarm when someone in the bedroom was vaping. Two other presenters discussed the “SKY Bio-Psycho-Social Program for Youth Empowerment,” which teaches those addicted to nicotine other methods of stress relief, such as taking deep breaths.
Don Seibert, founder of Smokenders, discussed his web-based quit-smoking program that boasts a 60 percent success rate. “We do it now by a video class each week and daily action steps the student uses,” said Seibert. “We guarantee they quit smoking, or they get their money back.” The company is soon starting a Vapenders program to address teen vaping. Seibert added that he had no data on whether his program would work with youth vapers. Another speaker said that she put her teen in a 30-day, in-house drug treatment program to help him stop vaping. She then stated that “he no longer vapes because he knows he will have to go back to the treatment facility.”
Gottlieb closed his speech by saying that he had met with senior executives from the five largest e-cigarette manufacturers, and he would be calling some of them back to meet again. Those companies had previously given the FDA written commitments about the steps they would take to stop youth use of their products.
“Are they living up to what were very modest promises? We all need to ask ourselves that question,” Gottlieb said. “But the major marketers of these products don’t seem to fully understand the scope of this challenge, or they don’t seem to be fully committed to their own stated commitments to curtail this youth use …. It matters if the e-cig makers can’t honor even modest, voluntary commitments that they made to the FDA. It informs how we shape our regulatory policies and our enforcement activities.”
The FDA is not dependent on voluntary action. Gottlieb said that unless youth use is lowered, the debate will change to one of whether flavored products should continue to be marketed at all without going through the PMTA process. “It could be ‘game over’ for some [of] these products until they can successfully traverse the regulatory process,” he said. “I think the stakes are that high. And [it] would be a blow for all of the currently addicted adult smokers who, I believe, could potentially benefit from these products.”
As for learning more about the potential role that drug therapies may play in helping youth addicted to nicotine, the FDA is still where it was before the start of this hearing.
