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Do Smokers Quit After Hospital Cessation Trials? Don’t Count on It, or Them



Do smokers lie about quitting?  A new study analyzes smokers’ self-reports of their smoking habits six months after their participation in quit-smoking clinical trials.

Several years ago, researchers recruited sick smokers at a group of hospitals – the Consortium of Hospitals Advancing Research on Tobacco, or CHART – and conducted federally-supported smoking cessation trials.  Now Taneisha Scheuermann et al. in the journal Addiction (abstract here) examine the post-trial results, focusing on levels of cotinine, a nicotine breakdown product, in trial participants’ saliva.

Hospitals in six cities provided 5,827 smoking patients with a variety of quit-smoking interventions.  Six months later, 4,206 of those subjects completed a survey, with 1,708 reporting that they had not smoked in the past seven days.  Nearly 10% of them reported using pharmaceutical nicotine, e-cigarettes or other tobacco harm reduction products in the past seven days; those subjects were among the 530 excluded from the Scheuermann analysis.  Self-described non-smokers were offered $50 to $100 in exchange for saliva samples, but only 923 participants responded; of those, 822 supplied usable samples.

Scheuermann used a standard saliva cotinine cutoff of 10 nanograms per milliliter: participants below this level were considered to be not smoking, while those at or above were still smoking.

Of the 822 participants who reported 7-day abstinence, 347 (42.2%) were dissembling, as their saliva cotinine levels indicated they were smoking. 

That so many individuals failed to quit evidences a fact that tobacco prohibitionists often ignore: The vast majority of smokers are unable or unwilling to quit.  The 475 verified quitters constituted roughly 8% of the 5,827 patients who started the trials – a percentage that is consistent with the quit rate among the general population.  Also note that these smokers were recruited during a hospitalization, when their focus on health issues might have increased their motivation to quit.

Treating smokers as social outcasts may influence their decision to lie about the results of their quit attempts.

The CHART study was supported from 2009 to 2014 by five NIH grants costing taxpayers $15.5 million.     

Original author: Brad Rodu
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The War on Nicotine begins

by Carl V Phillips

...
Continue reading
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Center for Tobacco Products is Lying to the Public About Youth Tobacco Use

This month, the FDA's Center for Tobacco Products (CTP) updated a chart purporting to show trends in youth tobacco use over the past 5 years.

Here are the facts (i.e., the "true" facts) displayed in the chart:

1. Youth cigarette use (among high school students) dropped by a huge amount from 2011 to 2016.
2. Cigar use dropped substantially from 2011 to 2016.
3. Pipe use dropped substantially from 2011 to 2016.
4. Smokeless tobacco use dropped slightly from 2011 to 2016.
5. Hookah use was essentially the same in 2011 and 2016.

Given those facts, here is the key question:

What happened to overall use of tobacco among high school students during the time period 2011-2016?

It doesn't take any fancy math or statistics to figure out that overall tobacco use among high school students must have declined substantially from 2011 to 2016. Since youth cigarette use dropped by a huge amount, cigar use dropped substantially, pipe used dropped substantially, smokeless tobacco use didn't change  much, and hookah use didn't change much, it stands to reason that overall tobacco use went down substantially. There is no way that youth tobacco use went up or even stayed the same from 2011 to 2016 because it dropped substantially for three categories of use but didn't change much in the other two categories.

The Rest of the Story

But that is not what the Center for Tobacco Products chose to tell the public.

Here is what the Center for Tobacco Products titled the chart:






















The CTP chose to tell the public that there was no significant decline in overall tobacco use over the past 5 years. However, as I showed above, that is simply not true. Youth tobacco use declined substantially.


So how does CTP justify this dishonesty?


It plays a trick on the public. It classifies e-cigarette use as a form of tobacco use and includes e-cigarette use in the totals for overall tobacco use. Since there was a huge increase in e-cigarette use from 2011 to 2016, CTP is able to completely undermine the fact that there was a dramatic drop in youth smoking, cigar use, and pipe use by adding youth who experimented with e-cigarettes. 


This is dishonest and inaccurate because e-cigarette use is not a form of tobacco use. The truth is -- and CTP knows this -- that e-cigarettes do not contain tobacco. In fact, the whole point of e-cigarettes is that they are an alternative to using tobacco. 

The rest of the story is that the Center for Tobacco Products is lying to the public. This is unfortunate because it risks losing the public's trust. It is also unfortunate because this deception could have deleterious public health effects, as misinforming people to think that e-cigarettes contain tobacco may dissuade many smokers from quitting and may even induce many ex-smokers to return to smoking. On top of all of this, it is - in my view- unethical to lie to the public, even if the aim were to discourage us from engaging in a potentially harmful behavior. I think the public deserves to know the truth. Someone has to start telling them the rest of the story. 


Note: Thanks to Clive Bates for alerting me to the deceptive headline in this dishonest communication. 

Original author: Michael Siegel
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Teen Smoking Unconnected to Cinematic Smoking



In a July report (here), the CDC Office on Smoking and Health asserted the following about tobacco use in movies:

“The Surgeon General has concluded that there is a causal relationship between depictions of smoking in the movies and the initiation of smoking among young persons.”

“…the decline in the total number of tobacco incidents [in top-grossing movies] has not progressed since 2010.”

“Reducing tobacco incidents that appear in youth-related movies would prevent the initiation of tobacco use among young persons.”

“An R rating for movies with tobacco use could potentially reduce the number of teen smokers by 18%...”

Responding, Guy Bentley published an excellent commentary noting that any connection between smoking in movies and among teens is illusory (here).  I provide statistical evidence of this by analyzing the CDC report’s numbers together with smoking prevalence rates among high school seniors for the same years.  The resulting chart fails to support any of the above claims. 

The number of tobacco incidents per year in top-grossing movies varied from 1,600 to 3,300 over 25 years, 1991-2016, except for a couple years around 2005.  Smoking among high school seniors plummeted continuously after 1996.  There appears to be no connection between the two data sets.

The report clearly lacks objectivity.  It was authored by CDC staffer Michael Tynan; Jonathan Polansky, founder of the advocacy firm Onbeyond and creator of the Smokefree Movies campaign (here); Kori Titus and Renata Atayeva from Breathe California Sacramento Region (here), an organization that “…has been fighting for…tobacco-free communities [otherwise known as prohibition] since 1917…”; and Stanton Glantz, faculty member of the University of California, San Francisco, and long-time tobacco opponent.  Polansky, Titus and Glantz acknowledge grant support from the Truth Initiative as their only conflict of interest.

Note that the tobacco incident numbers were collected by “Youth volunteers between the ages of 14-22… trained to analyze tobacco content in films…Their data is posted weekly on our sister website SceneSmoking.org and is used by university-level researchers and public health professionals across the globe….”  This underlying data does not appear to be publicly available.  The link to SceneSmoking was not functional and redirected to Breathe California Sacramento. 


 
Original author: Brad Rodu
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Negligible Evidence of Radical Nicotine Reduction Benefit



An August 17 commentary in the New England Journal of Medicine (here) by FDA Commissioner Scott Gottlieb and Center for Tobacco Products Director Mitchell Zeller raises some concern about the agency’s new tobacco regulation strategy.

The piece touches on “less harmful tobacco products,” which Commissioner Gottlieb wrote favorably about earlier (here), but it includes descriptors – “potential” (four times) and “conceivable” (once) – that suggest the authors are not convinced that e-cigarettes are truly lower-risk. Smokeless tobacco, already demonstrated to be vastly safer than cigarettes, isn’t mentioned.

In their commentary, the FDA officials advocate for radical nicotine reduction (RNR) in cigarettes. 

RNR is a variation on a failed concept: supply-side elimination of popular products.  Full-on cigarette prohibition was adopted, then jettisoned, in 12 states from 1899 to 1909 (here). During Prohibition a decade later, brewers tried to market an alcohol-free product called near beer (here).  That bombed just as badly as Vector Group’s RNR cigarettes in 2003 (here).  Any new RNR products will likely be rejected as well, causing smokers to seek out higher-nicotine-level products, licit or otherwise.

Despite a significant expenditure of taxpayer dollars on RNR research, this approach has not been demonstrated to reduce adult smoking. For example, a $29 million clinical trial by Dr. Neal Benowitz, reported in 2015, produced dismal results (my review here).

The FDA commissioner and his co-author remain optimistic: “A recent 6-week study by Donny et al. showed that cigarettes with lower nicotine content reduced nicotine exposure and dependence, as well as the number of cigarettes smoked, as compared with cigarettes with standard nicotine levels.”  They are referring to another 2015 report (here), but that study’s results were unimpressive as well.

Dr. Eric Donny recruited 840 smokers uninterested in quitting, and randomly provided them with one of seven types of cigarettes to use for 6 weeks: their usual brand, a full-nicotine study cigarette and five others with varying low nicotine levels (2% to 33% of the full-nicotine cigarette).  Subjects were paid up to $835 for 10 clinic visits, which probably contributed to a 92% completion rate.

While it was not surprising that smokers using reduced nicotine cigarettes had lower nicotine levels in their urine, most of the low-nicotine smokers (73-81%) admitted that they smoked three or four “wildcat” cigarettes (products not distributed as part of the study) on 24-35% of days in the trial.

There was little consistency regarding changes in dependence.  On the Wisconsin scale, smokers in all groups had lower scores after six weeks than at baseline, with only one of the reduced nicotine groups significantly lower than the full-nicotine group.  On the Fagerström scale, three low-nicotine groups were significantly lower than the full-nicotine group, but the changes from baseline were not impressive.  In other words, it is not clear if the low-nicotine cigarettes reduced dependence.

The number of cigarettes smoked in the Donny study is interesting.  At baseline, every group was smoking about 15 cigarettes per day.  Although Commissioner Gottlieb and Mr. Zeller imply that low-nicotine groups smoked fewer cigarettes at the end of the study, they actually averaged 15-16 cigarettes per day.  Smokers of usual-brand and full-nicotine cigarettes smoked 21-22 per day after six weeks, an increase of 6-7.  Perhaps Donny contributed to this increased consumption by providing full nicotine cigarettes for free.

Like the Benowitz study, the Donny study does not prove that reduced-nicotine cigarettes produce meaningful benefits for smokers.

It should be noted that the Donny study was supported by $93.3 million in grants from the National Institute on Drug Abuse and the FDA.


Original author: Brad Rodu
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My Testimony for Electronic Cigarette Hearing in Windham, New Hampshire

Attorney Fred Kelly Grant conducted a very nice interview with me regarding electronic cigarettes which will be submitted as testimony for an e-cigarette informational hearing in Windham, New Hampshire. Fred did a great job of asking questions that covered the gamut of important scientific and regulatory issues, so I hope this will be a good resource to provide a solid background on this issue.
Original author: Michael Siegel
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Government-Funded Researchers Continue to Misrepresent Smokeless Tobacco Cancer Risks



The American Journal of Epidemiology in October 2016 published a report by Annah Wyss of the National Institute of Environment Health Science and 20 government-funded coauthors.  It revealed that American men had ZERO mouth cancers associated with dipping or chewing tobacco (Odds Ratio, OR = 0.9), while women, who mainly use powdered dry snuff, had a 9-fold elevated risk (here). 

After trying for several months to correspond with the authors, I wrote to the journal editor.  My letter was accepted, and the authors were invited to reply.  The journal published both items on August 4 (here).

Here is my letter.  Because the references are important, I provide links to the sources.


“In the article… Wyss et al. omit key information that would likely yield critical insights about their most important result.

“Wyss et al. reported that ever use of snuff among never cigarette smokers was associated with head and neck cancer (OR = 1.71, [95% Confidence Interval] CI: 1.08, 2.70), based on 44 exposed cases and 62 exposed controls.  The OR among women ever snuff users (8.89, CI: 3.59, 22.0, based on 20 exposed cases and 12 controls) was an order of magnitude higher than that in men (0.86, CI: 0.49, 1.51, based on 24 exposed cases and 50 controls). 

“The striking difference between women and men reflects completely different snuff exposures.  It is widely known that in the southern U.S. women primarily use powdered dry snuff, whereas men throughout the U.S. use moist snuff.  Powdered dry snuff use is associated with excess oral cancer risk in four previous studies (Reference 2), all of which were cited by Wyss (3, 4, 5, 6).  In contrast, moist snuff is associated with minimal to no risk in eight previous studies (2).

“Wyss and colleagues are knowledgeable about the use of powdered dry snuff by women and its cancer risk; one was first author of a 1981 study reporting that “[t]he relative risk [for oral and pharyngeal cancer] associated with snuff dipping among white [women] nonsmokers [in North Carolina] was 4.2 (95 per cent confidence limits, 2.6 to 6.7).” (4)  Subjects in that study had exclusively used powdered dry snuff.  

“Wyss et al. used pooled data from 11 US case-control studies located throughout the U.S.  They have information to confirm that the 20 female [powdered dry] snuff users with cancer were from study sites in the Southern U.S., whereas the 24 male [moist] snuff users were from more diverse locations.  This information is not available from the 12 publications cited by Wyss et al. as data sources.  Six publications had insufficient information about exposed and unexposed cases and controls (i.e. no specificity with respect to smokeless tobacco type, gender, and/or smoking), three reported no results related to any smokeless tobacco product and three did not mention smokeless tobacco at all.

“Wyss et al. should provide in tabular form the number of exposed and unexposed cases and controls separately for never smoking men and women from each of the 11 source studies.  This information is routinely provided in publications of pooled analyses, and it is available in the existing data and results files.”



In their response, Dr. Wyss and her coauthors provided additional results, per my request.  While they confirmed no risks among men who dip, their conclusion about women was grossly inaccurate: “Snuff use was strongly associated with elevated [head and neck cancer] risk in both Southern women…and non-Southern women.”

In Southern women, the risk was quite high (OR = 11.25) and statistically significant, but with a wide 95% confidence interval (2.14 – 59.07), owing to the fact that the OR was based on only 26 cases.  In non-Southern women, the OR was even higher, at 15.91, but this was based on a mere 6 cases.  While statistically significant from a technical perspective (CI = 1.20 – 211.43), the CI is so large and unstable that the estimate is virtually meaningless.

Dr. Deborah Winn of the National Cancer Institute knows that powdered dry snuff is the only smokeless product with mouth cancer risk (evidence here, here, hereand here); she published a study in 1981 that falsely implicated dip and chew.  Even though Dr. Winn co-authored the new report, the authors’ only comment on powdered dry snuff was, “we cannot comment on whether snuff users – female or male, Southern or non-Southern – in our analysis used dry or moist snuff.”

To be clear, numerous studies since 1981 have demonstrated that the huge difference in mouth cancer risk between women and men is attributable to powdered dry and moist snuff.  Yet federally funded researchers continue to misrepresent these established facts in order to sustain the fiction that all smokeless products are hazardous.

 
Original author: Brad Rodu
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American Heart Association Still Clings to Alternative Facts: Claims that Smoking is No Safer than Vaping

Scientists like myself are often frustrated by "denialists" who refuse to acknowledge global warming, disseminate false information about adverse effects of vaccines, or - historically - failed to acknowledge the severe health effects of cigarette smoking. But I never expected this denialism to be coming from within my own movement in public health.

Today, it appears that the American Heart Association is still taking a public denialist stance with regards to the health benefits of quitting smoking by switching to vaping. Despite overwhelming scientific evidence that vaping is much safer than smoking and that quitting smoking by switching to electronic cigarettes has dramatic and immediate health benefits, the American Heart Association is still clinging to the false message that smoking may be no safer than vaping.

According to an article appearing today in The Daily Mail:

"Dr Aruni Bhatnagar, director of the American Heart Association's Tobacco Research and Addiction Center, added: 'We just don't know if moving to e-cigarettes is good enough to reduce the harm.'"

As the Daily Mail is not necessarily a trustworthy source (note the headline that a single e-cigarette can potentially lead to a heart attack), I confirmed this quote with other sources. The same quote appeared in the San Diego Union-Tribune two weeks ago. It seems clear that the American Heart Association, through its Tobacco Research and Addiction Center, is still clinging to the belief that smoking may be no more hazardous than vaping. Furthermore, the American Heart Association is disseminating this false information to the public.

The Rest of the Story

The American Heart Association's claim that quitting smoking by switching to electronic cigarettes does not reduce the harm of cigarette smoking flies in the face of overwhelming scientific evidence that switching from smoking to vaping leads to an immediate improvement in respiratory symptoms and improves lung function. Improvement in spirometry measurements was observed even in dual users, but was most substantial in smokers who switched completely to e-cigarettes. Remarkably, respiratory symptoms improved in patients with chronic obstructive pulmonary disease (COPD) who switched to electronic cigarettes.

In addition to improving respiratory health, e-cigarettes also lower carcinogenic risk compared to smoking, as they deliver many fewer and much lower levels of carcinogens. 

The American Heart Association's claim is not only false, but it is potentially damaging. If smokers believe this false information, they may decide that there is no reason to quit smoking using e-cigarettes. Or, even worse, ex-smokers who quit using e-cigarettes may return to smoking. After all, if it is not clear that vaping reduces harm compared to smoking, then what's the point of vaping? You might as well enjoy the real thing.

I'm surprised that cigarette companies haven't jumped on the opportunity to use the American Heart Association's endorsement of smoking:

"We at Philip Morris believe the public should heed the advice of respected public health organizations. According to the American Heart Association, we just don't know if quitting smoking by switching to e-cigarettes reduces the harm. So if you're thinking of trying to quit smoking by switching to vaping, don't bother. There's no certainty that it will reduce your health risks. But it will certainly decrease your enjoyment of the tobacco smoking experience."
Original author: Michael Siegel
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It's Official: Anti-Tobacco Groups Willing to Throw Away the Lives of Smokers to Promote Radical Ideology

For months, I have been arguing that the major anti-tobacco groups in the United States have been waging a war against electronic cigarettes that is motivated not by a pure concern for the public's health, but by an ideological opposition to the idea that anyone could get pleasure from nicotine in whatever form -- even if they are improving their health and saving their life.

Today, the American Thoracic Society (ATS) made it official.

In a letter to the editor published in the Washington Post, the American Thoracic Society confirmed what I have been suggesting for months.

The vice chair of the American Thoracic Society’s Tobacco Action Committee essentially confirmed that the ATS is willing to throw away the lives of smokers in order to promote the radical ideology that no one should derive pleasure from nicotine in any form, even if it is a life-saving switch from deadly cigarettes to very low-risk e-cigarettes.

In the letter, Dr. Enid Neptune writes: "As a physician who treats patients devastated by tobacco-caused lung disease, I was concerned by the Aug. 5 editorial “Breaking nicotine’s grip,” which embraced Food and Drug Administration Commissioner Scott Gottlieb’s plan for regulating tobacco products. The commissioner seems unconcerned about switching one form of nicotine addiction with another. Nicotine in any form is bad for your health, adversely affecting neurological and cardiovascular systems and reproductive health. Evidence shows that nicotine can be a gateway drug. ... The FDA’s job is to protect youths from all types of tobacco and nicotine addiction, not to negotiate which types of nicotine addiction it will allow."

The title of the letter is: "The FDA’s new plans could just switch one form of nicotine addiction with another."

The Rest of the Story

The writer makes a great point. We should never promote the idea of people switching from one addiction to another. And it is not the concern of public health what health risks are associated with any form of addiction. All addiction is bad and our job in public health is to make sure that no one, anywhere, at any time, is addicted to any substance.

For example, when heroin addicts are treated with methadone or bupenorphine, the physician is just substituting one addiction for another. These physicians seem unconcerned about switching one form of nicotine addiction with another. Opiates in any form are bad for your health, adversely affecting neurological and cardiovascular systems and reproductive health. Evidence shows that opiates can be a gateway drug and there is a great risk of overdose with any opiate. The job of physicians is to protect people from all types of opiate addiction, not to negotiate which types of opiate addiction they will allow.

OK - I was being facetious. But this demonstrates the insanity of the argument that the e-cigarette industry should be decimated through burdensome regulations because vaping is just another form of nicotine addiction and all nicotine addiction is equally evil.

I, and fortunately the new FDA Commissioner, strongly reject this radical ideology. Risk does matter. Addiction is a public health problem not because the concept of someone being addicted to a substance is severely damaging, but because the addictive substance carries severe health risks. Switching from a high-risk addictive substance to a low-risk addictive substance is not a zero-sum game. It is a critical and life-saving intervention. Just as methadone maintenance programs have saved thousands of lives from heroin-associated morbidity and mortality, electronic cigarettes are saving thousands of lives from smoking-associated disease and death.

While this writer speaks only for the American Thoracic Society, it is clear to me that this is indeed the underlying philosophy of all the major anti-tobacco groups, and even of many health departments and agencies, including the Centers for Disease Control and Prevention and the state health departments in California, Vermont, and Washington (to name a few).

Fortunately, Commissioner Gottlieb has rejected this philosophy, strongly and definitively. Public health is about saving lives, not fighting for some ideological principle of no addiction to any substance, regardless of how low-risk the product might be or how the product might be saving a life by switching someone to a much safer form of drug delivery.

Of course we need to restrict the sale and marketing of vaping products to youth and educate them about the health risks of all types of nicotine products, including real cigarettes and fake ones. But discouraging youth from using e-cigarettes should not come at the expense of wiping out 99% of the e-cigarette market, depriving millions of former smokers of the product they are using successfully to stay off tobacco cigarettes, and risking tens of thousands of these former smokers returning to cigarette smoking because their vaping products are taken off the market.
Original author: Michael Siegel
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E-Cigarettes: The Case for Regulatory Restraint



Debate over FDA regulation of e-cigarettes often degenerates into bitter argument and ad hominem attack.  In contrast, a point/counterpoint presentation in the Journal of Policy Analysis and Managementis calm, thoughtful and enlightening.

The case for stringent FDA regulation (citations here and here) is presented by Kurt Ribisl, a professor at the University of North Carolina, along with graduate students Andrew Seidenberg and Elizabeth Orlan (hereafter RSO).  Cornell University Professor Donald Kenkel makes the case for light regulation (here and here).

Describing the problem – “Smoking is estimated to result in 480,000 deaths per year in the United States” – Kenkel underscores a death toll that has not changed in 20 years, despite increasingly harsh anti-smoking policies.  Tobacco prohibitionists frequently cite this horrid data, but they rarely support vastly safer alternative products like e-cigarettes, referred to by Kenkel as “perhaps the most revolutionary product innovation in the market…”

Kenkel puts the risk differences in striking contrast.  He notes that if Britain’s health authorities are correct that vaping is no more than 5% as hazardous as smoking, then a world in which all smokers vape would suffer only 24,000 deaths attributable to e-cigarettes, compared to 480,000 actual deaths due to smoking.  This projection is similar to that in my 1994 publication (here), where I estimated 6,000 deaths among an imagined 46 million smokeless tobacco users – a mere 2% of the 419,000 actual deaths from smoking.

RSO acknowledge that vaping is less risky than smoking, but they reject the 5% estimate, arguing that it “lacks empirical basis, as it came from a multicriteria decision analysis model developed from one meeting of 12 people. This type of expert opinion is at the bottom rung of the evidence hierarchy…”  That is true, but the North Carolinians offer no counter-estimate.  Kenkel suggests that even if the e-cigarette risk was as high as 10% as that of smoking – which is highly implausible, the result “would still be a revolutionary public health gain.”

RSO “supports regulating e-cigarettes less stringently than combustible tobacco products,” however that position is not fully reflected in their policy recommendations.  As Kenkel notes, they still call for “restrictions on flavors, advertising and marketing restrictions, taxes, bans on indoor vaping, and mandatory product warnings.” 

Using “the conceptual framework of economics,” Kenkel brings a refreshing perspective to e-cigarette use: “the key question is whether vaping and smoking are substitutes or complements… if they are complements, a policy that encourages vaping will increase smoking… If they are substitutes, a policy that encourages vaping will cause consumers to substitute vaping products for combustible cigarettes and thus reduce smoking.”

Kenkel finds that “Accumulating evidence suggests that vaping is a substitute for smoking,” and he concludes: “Policies to encourage vaping could facilitate such a revolutionary change in the U.S. market for tobacco products.”

Government and insurance incentives are worth considering, says Kenkel: “the benefits of reducing smoking could also justify a more activist policy approach. Taxing cigarettes and subsidizing a substitute good are alternative approaches to correct market and individual failures in the cigarette market. Many private and public health insurance plans provide generous coverage for one class of substitute goods—nicotine replacement products approved as smoking cessation aids. The same rationale might support subsidies for vaping products.”

Observing that vaping is “an existential threat to the market for combustible cigarettes, unless their spread is restricted by government regulation,” Kenkel seems to be in sync with new FDA Commissioner Scott Gottlieb, who has signaled a lighter approach toward e-cigarette regulation.



Original author: Brad Rodu
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New Study Provides Strong Empirical Support for New FDA Approach to Tobacco Product Regulation

A new study published in the journal Tobacco Control reports that the modeled cancer risk associated with vaping is less than 1% of that associated with smoking and is only slightly higher than, if not comparable to the cancer risk associated with nicotine replacement therapy (NRT). In select circumstances, electronic cigarettes produced high levels of aldehydes but only when the voltage was cranked up to excessive levels. Thus, under conditions of normal use, this study finds that tobacco-free e-cigarettes present a drastically reduced carcinogenic risk compared to tobacco cigarettes.

The study methods were as follows: "The cancer potencies of various nicotine-delivering aerosols are modelled using published chemical analyses of emissions and their associated inhalation unit risks. Potencies are compared using a conversion procedure for expressing smoke and e-cigarette vapours in common units. Lifetime cancer risks are calculated from potencies using daily consumption estimates."

The results were as follows: "The aerosols form a spectrum of cancer potencies spanning five orders of magnitude from uncontaminated air to tobacco smoke. E-cigarette emissions span most of this range with the preponderance of products having potencies less than 1% of tobacco smoke and falling within two orders of magnitude of a medicinal nicotine inhaler; however, a small minority have much higher potencies. These high-risk results tend to be associated with high levels of carbonyls generated when excessive power is delivered to the atomiser coil. Samples of a prototype heat-not-burn device have lower cancer potencies than tobacco smoke by at least one order of magnitude, but higher potencies than most e-cigarettes. Mean lifetime risks decline in the sequence: combustible cigarettes much greater than heat-not-burn, which is much greater than e-cigarettes (normal power), which are greater than or equal to nicotine inhaler."

The study concludes that: "Optimal combinations of device settings, liquid formulation and vaping behaviour normally result in e-cigarette emissions with much less carcinogenic potency than tobacco smoke, notwithstanding there are circumstances in which the cancer risks of e-cigarette emissions can escalate, sometimes substantially. These circumstances are usually avoidable when the causes are known."

The Rest of the Story

This study should put to rest any doubt within the tobacco control movement about whether vaping greatly reduces health risk compared to smoking. Numerous anti-tobacco groups and health departments have repeatedly asserted that vaping is no less hazardous than smoking, but this claim is false, and the present study adds significantly to the already substantial evidence that vaping is orders of magnitude safer than smoking. The anti-tobacco groups and health agencies that have made such statements should immediately correct them and issue retractions to alert the public to these important findings.

These results add strong empirical support to the new FDA approach to tobacco products, announced one week ago by FDA commissioner Dr. Scott Gottlieb, which emphasizes the regulation of tobacco products and e-cigarettes based on the wide differential in their health risk. It makes no sense to lump e-cigarettes in the same basket as tobacco cigarettes, given their drastically different health risks. However, that is precisely what the FDA was doing prior to Dr. Gottlieb's appointment as the new commissioner. Now, the agency is taking a much more sensible and evidence-based approach.

While this study does find that there are conditions under which e-cigarettes can be made to produce rather high levels of certain hazardous chemicals -- most notably aldehydes -- these conditions involve jacking up the voltage to excessive levels that typically produce dry puff conditions, something that vapers would almost certainly detect immediately and not tolerate. Nevertheless, the results do suggest that FDA safety standards related to the maximum allowable voltage or coil temperature may be warranted.
Original author: Michael Siegel
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FDA’s New Vision for Tobacco Harm Reduction



U.S. Food and Drug Administration Commissioner Scott Gottlieb on July 28 fully endorsed tobacco harm reduction. In a speech (here), he clearly defined the problem: “[I]t’s cigarettes that are the primary cause of tobacco-related disease and death.” 

Dr. Gottlieb cited facts about nicotine, emphasizing its addictive qualities and the need to keep children away from all tobacco products. He also made one critical distinction:

“[T]he nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.  Yes, it got them all addicted and kept them addicted for the long term.  And it got most of them addicted when they were still teenagers.  But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine.”

This has been one of my principle themes for over two decades.

Dr. Gottlieb called for reduction of nicotine in cigarettes to non-addictive levels, an idea that I criticized in my 1995 book, For Smokers Only (updated version here) and more recently in my blog (hereand here).  However, I was critical because advocates of nicotine fadeout were deluded in thinking it would work in the absence of viable tobacco substitutes.  Unlike them, Dr. Gottlieb embraces the harm reduction component: “…we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels.  And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them…”

The new commissioner underscored the value of less harmful products: “I also hope that we can all see the potential benefits to addicted cigarette smokers, in a properly regulated marketplace, of products capable of delivering nicotine without having to set tobacco on fire.  The prospective benefit may be even greater for the subset of current cigarette smokers who find themselves unable or unwilling to quit.”

Note two key phrases above: (1) “less harmful forms [of tobacco], efficiently delivering satisfying levels of nicotine, are available for adults who need or want them;” and (2) “…current cigarette smokers who find themselves unable or unwilling to quit.”

I used the latter words in 1994 to describe my vision for a new approach to smoking control:

“In a review of the avoidable causes of cancer, Doll and Peto observed that ‘No single measure is known that would have as great an impact on the number of deaths attributable to cancer as a reduction in the use of tobacco or a change to the use of tobacco in a less dangerous way.’  Unfortunately, the second part of this observation has not received attention.  Because smokeless tobacco causes far fewer and considerably less serious health effects than does smoking, it should be promulgated as an alternative to cigarettes for smokers unable or unwilling to overcome their nicotine addiction.” (article here, emphasis added)

Dr. Gottlieb’s use of “unable or unwilling” acknowledges the effectiveness of tobacco harm reduction, without judging smokers. 

This theme is repeated in Dr. Gottlieb’s closing: “A renewed focus on nicotine can help us to achieve a world where cigarettes no longer addict future generations of our kids; and where adults who still need or want nicotine can get it from alternative and less harmful sources.  FDA stands ready to do its share.”

Many of the commissioner’s talking points are virtually identical to the policies I have researched and advocated for two decades.  Dr. Gottlieb notes the rancor in this field, saying, “…there’s the ongoing divisive debate around the pros and cons of e-cigarettes.  Precious little progress has been made as competing camps dig in on the benefits and risks of a harm reductionist approach to this new technology.  Both sides are convinced that they’re right, but we’ve seen little progress, and virtually no common ground.”  He encouraged “…participants from all sectors in the ongoing harm reduction debate…to take a step back and work together to reach greater common ground.”

I applaud Dr. Gottlieb’s leadership on this issue and offer my support in turning his vision into reality.




Original author: Brad Rodu
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New FDA Commissioner Saves the Day: Embraces Harm Reduction Strategy for Tobacco Control

On Friday, the new FDA Commissioner - Dr. Scott Gottlieb - saved the day for the public's health by officially embracing a harm reduction approach to tobacco control. Commissioner Gottlieb announced a new approach to the regulation of tobacco products that, unlike the FDA's previous strategy, acknowledges the vastly different risks of tobacco cigarettes compared to electronic cigarettes and proposes to regulate each product in alignment with its risk level.

Previously, the FDA had simply lumped e-cigarettes into the exact same category as tobacco cigarettes and in fact, regulated e-cigarettes much more stringently. The FDA previously required e-cigarettes to complete burdensome and expensive pre-market applications just to remain on the market, a process from which all cigarettes were exempted. The old approach would have destroyed about 99% of the existing vaping product market, leading to a major reduction in smoking cessation in the U.S. and with that, an increase in smoking-related morbidity and mortality.

Instead, the FDA will now delay the implementation of the pre-market application requirement for e-cigarettes while seeking ways to ease the expense and burden of the process. At the same time, the FDA will - for the first time - actually set safety standards for e-cigarettes so that the benefits of these products can be realized while minimizing potential harms. And, to top it all off, the agency will consider - also for the first time - actually setting a safety standard for real cigarettes that would require the reduction of nicotine to non-addictive levels if that is found to be technologically and practically feasible.

Commissioner Gottlieb also, for the first time, tied implementation of a harm reduction approach based on vaping products to the idea of making combustible cigarettes less addictive through substantial nicotine reduction, thus reducing the demand for real cigarettes but at the same time, making a viable alternative available to smokers to help ease them through the transition to the tobacco-free, smoke-free cigarettes.

Dr. Gottlieb emphasized that while nicotine is largely responsible for the addictive potential of cigarettes, the nicotine itself is not what kills smokers. As he stated: "the nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.  Yes, it got them all addicted and kept them addicted for the long term.  And it got most of them addicted when they were still teenagers.  But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine."

Commissioner Gottlieb unveiled his vision of " a world where cigarettes lose their addictive potential through reduced nicotine levels.  And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them."

Specifically, the strategy outlined by Commissioner Gottlieb involves the following:

1. Implementation of the requirement for pre-market applications for electronic cigarettes will be delayed until 2022, giving vaping product manufacturers another four years to remain on the market and to prepare the necessary application materials.

2. New guidance for the pre-market applications will be developed, which will presumably greatly simplify the requirements and reduce the burden and expense of preparing these applications.

3. Safety standards for electronic cigarettes will be developed, addressing issues such as battery safety, e-liquid ingredients, and flavorings.

4. The agency will examine the effectiveness and feasibility of requiring a reduction of nicotine levels in real, tobacco cigarettes to a non-addictive level.

5. Ideally, the reduction of nicotine levels in real cigarettes would be paired with the development and promotion of electronic cigarettes and vaping products as a viable alternative to smoking.

The Rest of the Story

This is truly a great day for public health. For the first time since 2009, when the FDA began regulating tobacco products, we now have a rationale approach to their regulation. This approach explicitly acknowledges the differential in risk between smoking and vaping and proposes to regulate these products according to the level of risk they present. It acknowledges that while nicotine is a critical contributor to the addiction potential of tobacco products, it is not what actually kills smokers. It aims to maximize the benefits of electronic cigarettes while minimizing their harms by both embracing e-cigarettes for harm reduction and easing their ability to stay on the market and setting safety standards to make these products as safe as possible. Finally, it aims to reduce the attractiveness of cigarettes and facilitate a transition from combusted to non-combusted nicotine products by reducing the addictive potential of cigarettes, thus promoting a shift to safer forms of nicotine delivery.

More than anything else, the greatest contribution of this new approach is that it is evidence-based, rather than based on ideology or political concerns. Instead of punishing smokers by depriving them of potentially life-saving alternatives, it embraces the idea of giving them much lower-risk choices that have already been shown to help millions of smokers quit.

The greatest risk to successful implementation of this sensible approach comes from the anti-tobacco groups themselves. Already, the Campaign for Tobacco-Free Kids is complaining about the pre-market tobacco application deadline extension for e-cigarettes. In a statement released Friday by the Campaign, it attacked the agency for attempting to save the e-cigarette industry, arguing that: "it is a serious error for the FDA to significantly delay critical deadlines for complying with the FDA’s 2016 rule establishing oversight of electronic cigarettes, cigars and other previously unregulated tobacco products. This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight."

This complaint is complete crap. There is nothing in the deeming regulations that directs the agency to eliminate "kid-friendly" flavors. To do that, the agency would almost certainly have had to formally consider the issue and make a decision regarding the overall public health impact of such a restriction. It would have also had to carefully consider exactly how to define "kid-friendly" flavors. It is almost inconceivable that such a decision would have been made arbitrarily through the process of approving or denying pre-market tobacco applications. Moreover, in the approach outlined by Dr. Gottlieb on Friday, he specifically stated that the agency would examine the issue of "kid-friendly" flavors and make a decision about whether and how to implement such a policy. In contradiction with the Campaign's false claims, the FDA has full authority and oversight over e-cigarette flavorings and can regulate these flavorings completely independently of the pre-market application process.

It is great to see this major change in the FDA's approach to the regulation of tobacco products and especially, to see the shift from an ideologically-driven approach to an evidence-based one. It is time for the anti-tobacco groups to make such a change as well. The ideological crap that is coming out of these groups has to end. Frankly, that crap is the greatest threat to the successful implementation of the sensible, evidence-based public health approach to tobacco control that the FDA has now embraced. 
Original author: Michael Siegel
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Huge FDA announcement on future tobacco and nicotine strategy

July 28th, 2017

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IN MY VIEW: American Lung Association Guilty of Public Health Malpractice

Yesterday, researchers from the University of California, San Diego published a landmark paper in the BMJ (British Medical Journal) which reported that for the first time in 15 years, the smoking cessation rate among adults in the U.S. has increased. The researchers tie this unprecedented increase in the smoking cessation rate to the availability of electronic cigarettes. The paper reports that the advent of electronic cigarettes was associated with a significant increase in the population smoking cessation rate. It also finds that smokers who use e-cigarettes are more likely to quit smoking than those who do not.

Combined with abundant existing research, the findings of this study make it clear that among adult smokers, electronic cigarettes have had a huge public health benefit. They have increased the number of quit attempts as well as the proportion of successful quit attempts. The reason for this is clear: many smokers have trouble quitting not simply because of nicotine addiction, but because of addiction to the physical, behavioral, and social aspects of smoking. None of these are addressed by existing FDA-approved cessation methods, but they are specifically addressed by e-cigarettes, which replace almost all aspects of the smoking experience other than the tar, smoke, and high levels of 60+ carcinogens and 10,000+ toxins.

It is also clear that smokers who are able to quit using e-cigarettes have greatly improved their health. Even dual users have improved their health, as lung disease risk drops with a decline in cigarette consumption, albeit not as much as quitting entirely. There is also a decline in cancer risk, although again, not as much as quitting altogether. (There is probably not a significant decline in heart disease risk among dual users).

One would think that public health groups would hail this study and, if making recommendations to smokers, advise them to quit any way they are able to, including with the use of e-cigarettes if that works for them. 

But no ... that's not the case with many health groups. One in particular -- the American Lung Association -- is still urging smokers not to quit using e-cigarettes. Instead, they are urging smokers to only use FDA-approved methods that are clearly not going to work for many smokers. And if you are one of those smokers, the American Lung Association would apparently rather that you continue smoking than try to quit by switching to vaping.

While many public health researchers affirmed the value of electronic cigarettes for many adult smokers, an article on the new study in the San Diego Union-Tribune quoted the American Lung Association as continuing to advise smokers not to try to quit using e-cigarettes. There was no qualifying clause, so the American Lung Association is giving this advice even to those smokers who are unable to quit using FDA-approved drugs.

According to the article: "People who had tried e-cigarettes in the previous 12 months were significantly more likely to have quit smoking traditional cigarettes than in previous years. The quit rate remained virtually the same for those who didn’t try e-cigarettes. ... “It’s important to remember that no e-cigarette has yet been found by the FDA to be safe and effective in helping smokers quit,” said Erika Sward, the American Lung Association’s assistant vice president of national advocacy."

The Rest of the Story

The American Lung Association's advice is tantamount to a physician telling a smoker who has failed to quit multiple times using FDA-approved drugs and who expresses interest in e-cigarettes that she should not try vaping and instead should stick to the failed methods in which she has no interest. This is precisely the advice that the American Lung Association is giving to America's smokers. And it is inappropriate and health-damaging advice. I view it as a form of public health malpractice.

Most physicians will advise smokers to quit in whatever way they are able to. Quitting smoking is so difficult, and individuals are so different in what works for them, that physicians should not take any reasonable options off the table. It is one thing for a physician to make recommendations about what methods are most effective based on the evidence. But it is quite another for a physician to tell a patient for whom those methods have failed to continue hitting their head against a wall, rather than trying a new, promising method in which the patient has expressed interest and which has worked successfully for millions of other smokers. This is exactly the medical advice that the American Lung Association is giving.

In my opinion, the American Lung Association should either correct this misinformed and dangerous advice or it should get out of the business of making medical recommendations altogether. With this advice, the American Lung Association is doing far more harm than good. The central principle of medicine and public health is "to do no harm." The American Lung Association is violating this core principle.

The rest of the story is that the American Lung Association is guilty of public health malpractice because despite clear evidence that e-cigarettes have helped millions of smokers quit, it continues to advise smokers not to use this method to quit. Apparently, the American Lung Association is more concerned that smokers quit "the right way" than that they quit. Smoking is apparently a moral issue, not merely a health issue, and if you quit the wrong way, you apparently haven't paid the proper penance for your addiction.
Original author: Michael Siegel
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Government’s Abstinence from Smokeless Truth Detailed by Wall Street Journal



The Wall Street Journal on July 21 reported what readers of this blog already know: “Many scientists agree that…smokeless tobacco, including chewing and dipping tobacco, is significantly less harmful than cigarettes.  But rather than encouraging the country’s 37 million smokers to switch to less-risky products, U.S. health officials have so far stuck with an abstinence-only message to the public.”

Journalist Jennifer Maloney underscored the government’s withholding of relative risk information about smokeless tobacco: “Online fact sheets published by the Centers for Disease Control, the Food and Drug Administration and the National Cancer Institute list multiple health risks associated with smokeless tobacco…but give no indication it is less harmful than cigarettes. ‘There is no safe form of tobacco,’ the cancer institute says on its website.”

Scientific research says otherwise.  Although it is impossible to prove absolute safety, dozens of epidemiologic studies over three decades have documented that health risks among American chewers and dippers are not significantly elevated.  Last year, a government study failed to find any mouth cancer risk among men who chew or dip (here). 

The CDC claims that it is unable to provide risk estimates for smokeless users (here, hereand here).  Yet researchers from Altria produced them from CDC data; these are seen in the chart above (source here).  Smokeless users’ risks were comparable to those of nonusers of tobacco, whereas smokers had twice the risk of dying.

That Altria was able produce these dramatic results from CDC’s data underscores the government’s refusal to acknowledge the scientific truth about smokeless tobacco’s reduced harm profile. That is irresponsible and contrary to public health interests.

Federal health officials told Maloney, “more research needs to be done on the potential population-level consequences of broadcasting the fact that some tobacco products are safer than cigarettes.” 

Such facts should not be withheld from the American public.  Here is the consequence of public health officials’ persistent obfuscation and mendacity:

There were 8.1 million smokeless users in 2014, according to the National Survey on Drug Use and Health (NSDUH) (here), and 41% of them were also smokers.  This means that 3.36 million Americans are equally comfortable and satisfied using nearly harmless chew or dip, and smoking, which is deadly.  Government data shows that smokers have no idea that they are needlessly putting their lives at risk (here).  Federal agency leaders are aware of the differential risks, but choose not to push that potentially life-saving information to the public. 

The Wall Street Journal is to be applauded for helping to expose this transgression.





Original author: Brad Rodu
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Yet Another Group of Anti-Tobacco Researchers Encourage Lying to Kids About Relative Health Effects of Vaping and Smoking

It seems that honesty has disappeared as a core principle in tobacco control. Today, I report that yet another group of tobacco control researchers is bemoaning the fact that many youth understand the relative health effects of vaping and smoking and is encouraging lying to kids instead.

In a paper published in Tobacco Prevention and Cessation, investigators from the University of Louisville examined YouTube videos promoting electronic cigarettes. They found that one of the major selling points for vaping in these videos was the claim that using e-cigarettes is safer than smoking and switching from cigarettes to e-cigarettes can therefore improve health. However, here is how they report this finding and how they describe its implications:

"Our findings extend similar conclusions in related work: that the majority of YouTube videos promoting e-cigarettes demonstrate the social benefit and acceptability of e-cigarettes in part by claiming that using e-cigarettes is safer and healthier than consuming traditional tobacco products. This comparison perpetuates a narrative that e-cigarettes are safe because they are “healthier” or “safer” than other traditional tobacco products. Promoting a product by claiming that it is better than a hazardous substance, like traditional tobacco, only has merit when targeting cigarette users who are considering quitting or cutting back. Given that scientific information about safety is largely inconclusive, claims using words like “safer” to describe e-cigarettes could contribute to confusion about the overall safety of these products, especially among youth. A recent analysis found that 34.2% of youth believe that e-cigarettes are less harmful than traditional cigarettes, and 45% are not sure. Furthermore, e-cigarette use among youth who did not use traditional cigarettes was more likely when they perceived e-cigarettes to be less harmful than traditional cigarettes."

The paper concludes that: "There is a need for “anti” e-cigarette videos on YouTube, especially ones targeted at youth, to more accurately convey current scientific understanding about the safety of these products."

The Rest of the Story

To be clear, this paper is suggesting that e-cigarette promotional videos are inaccurately asserting that vaping is safer than smoking. The paper calls for anti-vaping videos that "more accurately" convey scientific understanding about the safety of these products, condemning videos that claim that e-cigarettes are safer than real, tobacco cigarettes.

In other words, the paper is clearly calling for public health practitioners to lie to our nation's youth by telling them that vaping is no safer than smoking or by hiding the fact that vaping is much safer than smoking.

Ironically, the paper argues that telling kids the truth - that vaping is safer than smoking - is creating "confusion" because a recent analysis showed that one-third of youth believe that e-cigarettes are less harmful than traditional cigarettes. How is that confusion? What the paper calls "confusion" is actually the truth.

The investigators appear to be upset that many youth have a correct understanding of the relative safety of vaping compared to smoking.

A core principle of public health is honesty. Another core principle of public health is transparency. And a key element of health communication is telling the truth. We do not mislead, deceive, or lie to the public in order to promote health behavior change. That is what we have incessantly attacked the tobacco companies for doing. Deceiving people is not a valid or appropriate strategy in public health.

But the rest of the story is that many tobacco control practitioners are encouraging precisely such a strategy. They can't stand the fact that youth may have a correct understanding of the relative health effects of vaping compared to smoking, and they want youth to be lied to in order to confuse them or even worse, deceive them into thinking that vaping is actually just as hazardous as smoking.

While the overall goal of this dishonesty may be valid - trying to discourage kids from vaping - the means being urged to reach this end are inappropriate. In public health, we do not lie to the public to promote our agenda. That's what the tobacco companies used to do. And there is no excuse for us to sink to that level.
Original author: Michael Siegel
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Challenging the prohibitionists – submissions to Australian parliamentary inquiry into e-cigarettes

July 21st, 2017

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Simple Simon would refuse to meet the pieman

by Carl V Phillips

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United Kingdom Doubles Down on Support for Tobacco Harm Reduction



The United Kingdom Department of Health’s new position statement (here), “Towards a Smokefree Generation,” is, as Clive Bates wrote (here), “probably the first significant government policy paper anywhere that recognises and pursues the opportunities of tobacco harm reduction, rather than defining these technologies as a threat to be suppressed.  For that, the Department of Health and its allies deserve considerable credit.”



Indeed.



British health authorities have been telling smokers the truth about vaping since 2011 (as I have noted here, here, hereand here), and British smokers have listened – the UK’s vaping population has ballooned to 2.9 million (here), while smoking has significantly declined.  In fact, a Public Health England official recently reported (here) that the UK smoking rate is now the second lowest in the European Union, after SWEDEN!



Meanwhile, the U.S. persists in advocating for a “tobacco-free society” and a “tobacco endgame,” demonizing smoke-free products with untruths and giving continuing life to urban anti-vaping myths.  The UK paper underscores this stark contrast.



“Towards a Smokefree Generation” sets forth the facts about e-cigarettes’ relative safety:



“… the evidence is increasingly clear that e-cigarettes are significantly less harmful to health than smoking tobacco.”



The UK Department of Health promises to help smokers make the switch:



“The government will seek to support consumers in stopping smoking and adopting the use of

less harmful nicotine products. Public Health England has produced guidance for employers

and organisations looking to introduce policies around e-cigarettes and vaping in public and

recommend such policies to be evidence-based.”



The paper dismisses the unfounded claim that second-hand vapor is a health threat:



“Public Health England recommends that e-cigarette use is not covered by smokefree legislation and should not routinely be included in the requirements of an organisation’s smokefree policy.”



Additionally, the document invites the introduction of new tobacco harm reduction products, an apparent reference to products like Philip Morris International’s heat-not-burn iQOS:



“… there has been the development and very recent introduction of novel tobacco products that claim to reduce the harm of smoking. We welcome innovation that will reduce the harms caused by smoking and will evaluate whether products such as novel tobacco products have a role to play in reducing the risk of harm to smokers.”



Concluding, the UK pledges:



“Public Health England will continue to provide smokers and the public with clear, evidence based and accurate information on the relative harm of nicotine, e-cigarettes, other nicotine delivery systems and smoked tobacco, to enable informed decision-making.”



American health authorities, are you listening?





Original author: Brad Rodu
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