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Mountain Vapor Blog

Welcome to the blog area of our site where we hope to keep you updated on the trends of the e-cigarette industry as well as product reviews.

English tobacco control plan embraces tobacco harm reduction – world first

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American experts call for risk-based reform of FDA regulation of tobacco and nicotine

July 14th, 2017

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IN MY VIEW: Campaign for Tobacco-Free Kids is Deliberately Lying to the Public

In a press release issued yesterday lamenting the passage by the House Appropriations Committee of a bill that grandfathers in existing e-cigarettes from the pre-market approval requirements of FDA vaping product regulations, the Campaign for Tobacco-Free Kids claimed that the bill strips the FDA of authority to review the public health impact of e-cigarettes.

Specifically, the Campaign for Tobacco-Free Kids stated that the bill:

"would “grandfather” e-cigarettes and cigars already on the market and exempt them from FDA review of their public health impact, including whether they appeal to kids." 

The Rest of the Story

The rest of the story is that the Campaign for Tobacco-Free Kids is lying. And I now believe that they are doing so deliberately with the specific intention of deceiving the public.

The truth is that the Bishop-Cole bill would not exempt e-cigarettes from FDA review of their public health impact. All it does is to prevent the FDA from requiring expensive and burdensome pre-market applications in order for e-cigarettes to remain on the market. The bill does nothing to take away the FDA's ability to review the public health impact of these products and to issue product standards, including restrictions on product flavorings, to protect the public's health.

For as long as I could, I tried to convince myself that the Campaign was just stretching the truth to protect its political interests and was not deliberately lying. While the Campaign was spreading misinformation, I did not necessarily believe that the Campaign lacked ethical integrity.

However, it is now clear to me that the Campaign for Tobacco-Free Kids is a organization that has neither scientific nor ethical integrity.

How do we know that the Campaign is deliberately lying? Well, later in the press release, the Campaign essentially admits as such. In trying to downplay the significance of a provision in the bill which requires the FDA to promulgate a standard regarding product flavorings within three years, the Campaign emphasizes that the FDA already has the authority to issue product standards, including standards to regulate flavorings. They state: "In one change this year, the House bill gives the FDA three years to develop a product standard addressing “characterizing flavors” in e-cigarettes. The FDA already has the authority under current law to issue such a product standard, so this provision does not provide the FDA with any new authority."

So any thought that the Campaign's false statement that the bill strips the FDA of its ability to review the impact of e-cigarettes was just an oversight is clearly laid to rest. The Campaign is fully aware that this is not the case and in fact makes this very argument in response to its opponents.

Furthermore, the Campaign for Tobacco-Free Kids is wrong on this point. The Bishop-Cole bill is significant because it requires the FDA to promulgate standards to regulate vaping product flavorings. The agency has had the authority to do so for 8 years, but has failed to issue a single product standard during that time. Thus, forcing the FDA to act within 3 years is a very significant impact of the Bishop-Cole legislation.

The bottom line is that I now believe the Campaign for Tobacco-Free Kids is intentionally lying, with a deliberate aim of deceiving the public and its constituents. It is no more ethical than many of our public health opponents. However, I view their dishonesty as more troubling because the Campaign has incessantly attacked the tobacco companies for lying to the American people. The Campaign should therefore be beyond reproach in its own statements to the public.
Original author: Michael Siegel
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FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (postscript)

by Carl V Phillips

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The Illogic of Condoning Vaping & Condemning Smokeless – Both Are Safer for Smokers



While many American tobacco researchers and policy experts have, of late, moved to endorse reasonable regulation of e-cigarettes and vaping, most persist in condemning smokeless tobacco products, which have been proven to be nearly harmless.  It is irrational to support one and prohibit the other, when both are legitimate harm reduction options for smokers.

The illogic of this dual position is displayed in the work of Dr. Dorothy Hatsukami, a prestigious tobacco researcher, author of 250 published articles (here) and recipient of tens of millions of dollars in NIH funding (available here,including $13 million to study reducing nicotine in cigarettes).  Dr. Hatsukami recently signed a letter to FDA Commissioner Scott Gottlieb (here) and published an article in Tobacco Control (here).

In the letter to the commissioner, Dr. Hatsukami applauded his “openness to the concept of tobacco harm reduction…There is already a considerable body of science and experience suggesting that a harm reduction approach…could yield substantial and highly cost-effective public health benefits…at this time we do not believe that the current regulatory framework for the low-risk nicotine products such as e-cigarettes and smokeless tobacco is appropriate or will deliver the substantial public health benefits we hope and expect FDA’s oversight will bring.”  The letter encouraged the FDA to regulate tobacco products according to risk and to “support informed choice through truthful communication of risk.”

However, in her Tobacco Control commentary, Dr. Hatsukami took a contrary view, fully endorsing the FDA’s proposed standard for NNN, which I have eviscerated hereand here.  She wrote, “If [FDA] puts the proposed rule into effect, it would be a significant and important step towards minimising the harms from smokeless tobacco use.”  Surprisingly, she asserted that “the risk for oral cancer is considerably higher for smokeless tobacco users,” and cited a federal study documenting that American men who dip or chew tobacco have no mouth cancer risk (here).

Notably, other signatories to the Gottlieb letter are genuine tobacco harm reduction advocates who have endorsed the substitution of smoke-free tobacco by smokers.  They include Clive Bates of the UK and Canada’s David Sweanor, who filed a comment (here) labeling the NNN rule “reckless and pointless.”  American signatories who are on record about the relative safety of smokeless are Sally Satel (hereand here), Kenneth Warner (hereand here), David B. Abrams (here) and Raymond S. Niaura (here). 




Original author: Brad Rodu
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IN MY VIEW: Position of Australian Medical Association (and Many U.S. Health Groups) on Vaping is Just Plain Evil

In a submission to the Australian government, the Australian Medical Association (AMA) argues that there is no evidence that e-cigarettes can help smokers quit, that e-cigarettes are harmful to health because they simply substitute one addiction for another, and that physicians must fight to prevent vaping from becoming an acceptable alternative to smoking.

According to an article published by the Australian Journal of Pharmacy: "Commenting on its submission to an inquiry into the devices, the AMA says it believes that there is currently no compelling evidence that e-cigarettes are successful in helping people to stop smoking. ... AMA President Dr Michael Gannon says that the growth in e-cigarette products internationally has provided sections of the tobacco industry with the opportunity to rebrand themselves as part of the effort to reduce smoking – but there is no evidence that e-cigarettes work as a deterrent. ... “E-cigarettes must not be allowed to be marketed with claims that they are a smoking cessation aid,” Dr Gannon says. “There is no such evidence. ... “We must not allow e-cigarettes to become a socially acceptable alternative to smoking.”"

The Rest of the Story

Up to this point, I have been criticizing many anti-tobacco groups for presenting false information about the relative safety and effectiveness of vaping and for supporting public policy that would harm the public's health. However, I have refrained from attacking the motives or intentions of these groups, assuming instead that they are simply misguided or uninformed about the scientific evidence.

That all changes today.

After reading the position statement of the Australian Medical Association, it is now clear to me that there is thinking going on in the anti-tobacco movement that is just plain evil.

Specifically, I am now convinced that in order to preserve a certain misguided ideology in tobacco control (the idea that addiction itself is unacceptable under any circumstances), anti-tobacco groups are willing to sacrifice the health and lives of smokers.

In other words, this really isn't about helping smokers and reducing the morbidity and mortality from smoking-related diseases. This is instead about protecting the world from the scourge of addiction itself, without regard to the impact of these statements and policies on the lives of smokers.

Smokers are literally being sacrificed for what is viewed as the "greater good," which is protecting the world from nicotine addiction.

To be blunt, the idea that anyone might actually derive enjoyment from, and health benefit from the use of nicotine is so unacceptable to anti-tobacco groups that it must be destroyed, even if that comes at the expense of smokers' lives.

I apologize, but this is just plain evil. This is not what public health and medicine are supposed to be about.

These groups are now admitting that they would rather not see smokers have a safer alternative that could save their lives. They do not want to see vaping become an alternative to smoking.

Think about that: They would rather smokers continue to smoke than to quit smoking if they are still deriving pleasure from nicotine. This equates to the position that they would rather see smokers die than save their lives but continue to derive pleasure from the use of nicotine.

This is a cruel position to take.

Many readers have inquired as to why the frequency of my posts have decreased recently. Part of that is of course due to the summer season. But a major part of it has been that I have been beset with a sense of utter frustration and disillusionment. I have realized that the ultimate goals of the modern anti-tobacco movement do not align with my goals and I fail to see any change in the movement, no matter how much I point out the incoherence of current tobacco policy. I can't think of a single anti-smoking groups that has revised or corrected its false statements on the health effects of vaping after being informed about the errors in their communications. It's not clear that anyone actually cares.

But today marks a turning point from even that level of frustration. Because it is now clear that we are not just dealing with scientific misinterpretation, poor communication, and misguided policy. We are dealing with cruel intent. And that is not something that some posts on a blog are able to change.
Original author: Michael Siegel
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Reckless and pointless at the same time – FDA proposes NNN standard for smokeless tobacco

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Sunday Science Lesson: toxicology and “the chains” in American football

by Carl V Phillips

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Comment on FDA's unreasonable smokeless tobacco rule - DUE by July 10th!

The deadline for commenting on an FDA rule regarding product standards for smokeless tobacco (ST) is Monday, July 10th, 2017.

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NIAAA Prostitutes Its Scientific Integrity and Helps Alcohol Industry Promote Drinking

In one of the greatest episodes of corruption of a U.S. governmental health agency during my career, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) has sold itself out to the alcohol industry by agreeing to accept $68 million for a shoddily-designed study intended to examine the potential health benefits of moderate drinking but without similarly assessing the potential risks.

According to the New York Times: "the National Institutes of Health is starting a $100 million clinical trial to test for the first time whether a drink a day really does prevent heart attacks. And guess who is picking up most of the tab? Five companies that are among the world’s largest alcoholic beverage manufacturers — Anheuser-Busch InBev, Heineken, Diageo, Pernod Ricard and Carlsberg — have so far pledged $67.7 million to a foundation that raises money for the National Institutes of Health, said Margaret Murray, the director of the Global Alcohol Research Program at the National Institute on Alcohol Abuse and Alcoholism, which will oversee the study."

The Rest of the Story

According to the New York Times article: "George F. Koob, the director of the alcohol institute, said the trial will be immune from industry influence and will be an unbiased test of whether alcohol “in moderation” protects against heart disease. “This study could completely backfire on the alcoholic beverage industry, and they’re going to have to live with it,” Dr. Koob said. “The money from the Foundation for the N.I.H. has no strings attached. Whoever donates to that fund has no leverage whatsoever — no contribution to the study, no input to the study, no say whatsoever.”"

What a bunch of crap!

The money has huge strings attached: namely, the money is to be used for a trial to examine the potential benefits of drinking! 

In other words, the alcohol industry doesn't need any further leverage because they have already won. They have succeeded in getting the NIAAA to spend 20% of its entire budget on a study which is designed to identify potential benefits of drinking. The study is not examining potential negative health effects of moderate drinking: namely, increased cancer risk, and especially breast cancer risk.

Very few people understand that the greatest influence that industry can have on research is not on the way the research is conducted, but on the topic of the research in the first place. The tobacco industry also funded research with "no strings attached." The tobacco industry completely divorced itself from the decisions of many of its funded scientists. However, the industry had already won because it essentially dictated the research agenda. The industry made decisions about what to fund and what not to fund. That is the true, critical point of leverage.

So, for example, the tobacco industry funded many studies on genetic causes of lung cancer, non-tobacco-related causes of cancer, etc., while funding few, if any, studies on the severity of nicotine addiction, nicotine addiction in youth, the exposure of youth to tobacco advertising, the positive impact of anti-tobacco regulations, etc. 

No strings attached? The strings have already been attached.

If the alcohol companies were willing to donate money to NIH that could be used for any purpose that an NIH researcher proposed, such as a study to examine the effects of increased alcohol taxes on reducing youth alcohol consumption, then one could say that there are no strings attached. But this money is clearly earmarked - and beyond that, earmarked for a study that is essentially designed to show some positive health effects of moderate alcohol consumption.

Dr. Koob's contention that this trial is an "unbiased" test is also laughable. How can it be unbiased when its major funder is the industry that markets the product under study? But the bias doesn't end there. It turns out that many of the investigators running the study have individual conflicts of interest with the alcohol industry. At my institution, such researchers would not even be allowed to be involved in a clinical trial in which they have a significant conflict of interest. Our general policy is that an investigator with a significant conflict of interest cannot conduct a clinical trial on a product made by the relevant company. We do allow conflicted investigators to conduct pre-clinical studies, such as laboratory research; however, the line is drawn definitively at the level of a clinical trial.

Just how strong are the conflicts of interest of the lead researchers for the study?

According to the New York Times article: "Harvard, the hub of the clinical trial, has a long relationship with the alcoholic beverage industry. In 2015 the university accepted $3.3 million from the Foundation for Advancing Alcohol Responsibility, a group founded by distillers, to establish an endowed professorship in psychiatry and behavioral science." 

In addition: "One of the trial’s principal investigators, Dr. Eric Rimm of the Harvard T. H. Chan School of Public Health, has acknowledged through various financial disclosures that he has been paid to speak at conferences sponsored by the alcohol industry and received reimbursement for travel expenses."

Moreover: "Dr. Diederick Grobbee, another principal investigator, who is based in the Netherlands and is in charge of clinical sites outside the United States, said in a telephone interview that he has received research money from the International Life Sciences Institute, an industry group that supports scientific research."

Furthermore: "In Baltimore, the trial will be run by Dr. Mariana Lazo-Elizondo of Johns Hopkins, who received research grants in 2013 and 2014 totaling $100,000 from the Alcoholic Beverage Medical Research Foundation. She declined to be interviewed."

And to add insult to injury: "The Barcelona study arm will be run by Dr. Ramon Estruch, who in February helped lead a “Wine & Health” conference in the wine region of La Rioja, Spain, that was supported by the wine industry. Dr. Estruch recently refused to disclose his financial conflicts of interest to The Journal of Studies on Alcohol and Drugs and has not responded to requests for comment."

It is clear that many of the principal investigators in the trial have personal conflicts of interest with the alcohol industry. And the lead investigator for the Barcelona study arm not only has severe personal conflicts of interest but has failed to disclose them, apparently despite numerous requests from the journal to do so. But his conflicts with Big Alcohol run deep. As I revealed in a 2016 column:

Dr. Ramon Estruch - is on the board of or receives money from three different research foundations, each of which is funded by alcohol companies. According to a published article: "Dr. Estruch reports serving on the board of and receiving lecture fees from the Research Foundation on Wine and Nutrition (FIVIN); serving on the boards of the Beer and Health Foundation and the European Foundation for Alcohol Research (ERAB)."

Well, it turns out that the Research Foundation on Wine and Nutrition is funded by alcohol companies.

And the Beer and Health Foundation is funded by the Spanish beer industry.

And the European Foundation for Alcohol Research acknowledges that it: "is supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production."

I have also previously discussed why Harvard's objectivity regarding this research has already been severely compromised (see: Harvard Medical School Teams Up with Makers of Bacardi Rum, Smirnoff Vodka, Jim Beam Bourbon, and Jack Daniels Whiskey, Providing Great PR at Bargain Rates).

The study design doesn't even pass the laugh test in terms of basic epidemiology. The study is excluding nondrinkers, who are the only people who really matter because they are the ones who would potentially benefit - or be harmed - by efforts to promote moderate drinking. People who are already drinking aren't the ones who would be most affected by such a campaign.

The study is also excluding problem drinkers. People who are already drinking, but are not problem drinkers, have already demonstrated that they are capable of moderate drinking. The real issue is what happens when you successfully convince a non-drinker to start drinking every day. This trial specifically avoids (and is designed to avoid) examining that research question. But that research question is really what is at the heart of any evaluation of whether promoting moderate drinking might have public health benefit.

Even the tobacco industry, to the best of my knowledge, never succeeded in persuading the prestigious NIH to accept industry funding for a study of interest to the tobacco companies. The tobacco companies had to resort to funding their own research bodies (e.g., the Council for Tobacco Research). But here, the NIAAA is giving the alcohol industry an unprecedented gift: the acceptance of industry money to conduct a clinical trial, under the pretense of being an objective government study.

The rest of the story is that by accepting this funding from the alcohol industry to support what is supposed to be an objective NIH research agenda, the NIAAA has compromised its scientific integrity, selling out to the alcohol industry and helping the industry to promote drinking. This is not the appropriate role of the NIAAA.

This clinical trial is tainted before it has even begun. Hopefully, its participants will be informed that the study is essentially a sham - that it is funded by the alcohol industry, which has -- in a dream come true scenario -- somehow gotten the NIAAA to agree to conduct a study that is designed only to examine potential positive health effects of moderate drinking, while ignoring (and not looking for) any serious potential risks, such as cancer.

The study investigators may not reveal this critical information to the human subjects in these trials; however, there are a number of public health groups that are planning to publicize this information so that the public is aware of this scam before it does real damage to the public's health. It has already done damage to the scientific credibility of the NIAAA specifically, and of government public health research in general.
Original author: Michael Siegel
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Drinking, Bingeing and Toking More Popular Than Smoking Among Teens in 2014



Teen smoking deservedly gets a great deal of attention from the media and public policymakers, but one government survey shows that teens consume alcohol and marijuana at far higher rates than cigarettes.

The National Surveys on Drug Use and Health (NSDUH), which I discussed last week (here), provide intriguing insights into use of licit and illicit products.

At left are 2014 NSDUH estimates of the numbers – and percentages by age – of Americans using cigarettes, smokeless tobacco, alcohol and marijuana in the past month. (Binge drinking is defined as consuming five or more drinks within two hours)  There were nearly 56 million smokers, 8.6 million smokeless tobacco users, 22.5 million marijuana users and a whopping 140 million drinkers.  There were actually more binge drinkers (61 million) than smokers. 

The following table shows the number of teens (12-17 years) and young adults (18-20 years) who used these substances in 2014.

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Numbers (millions) of Teens and Young Adults Who Were Past-Month Smokers, Smokeless Users, Drinkers, Binge Drinkers and Marijuana Users in 2014





Teens (12-17 yrs)Young Adults (18-20 yrsTotal




Smokers1.233.244.47
Smokeless Users0.500.661.16
Drinkers2.805.888.68
Binge Drinkers1.533.745.27
Marijuana Users1.852.774.62

There were some 1.2 million past-month smokers under 18, and about half a million underage smokeless users.  These numbers pale in comparison to those for alcohol.  There were 2.8 million drinkers under 18, and another 5.9 million between 18 and 20.  There were more underage binge drinkers (1.5 million) and marijuana users (1.85 million) than smokers.  The totals for marijuana, drinking and binge drinking are all greater than smoking.

Teenage smoking must be prevented, but teen abuse of alcohol and marijuana also requires attention.




Original author: Brad Rodu
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FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 3)

by Carl V Phillips

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FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 2)

by Carl V Phillips

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U.S. Can’t Decide How Many Adults Use Smokeless – 8.1 Million or 5.1 Million?



Federal officials routinely obfuscate on the subject of smokeless tobacco, and particularly on the number of smokeless users in the U.S.



The newest numbers are reported by Dr. Rachel Lipari and Mr. Struther Van Horn of the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA). They say, “In 2014, an estimated 8.7 million people aged 12 or older used smokeless tobacco in the past month.” (available here)  Their finding is based on data from the National Survey on Drug Use and Health (NSDUH).



That number included teens (Age 12-17 years).  When including only adults (18 and older), the NSDUH estimate is 8.1 million in 2014, which contrasts with a 2015 CDC-supported National Health Interview Survey (NHIS) adults-only estimate of 5.1 million. The 59% higher NSDUH number probably results from the use of different definitions.  NSDUH collects information on past-30 day use, whereas current users in NHIS is every day or some days.



The primary conclusion in the Lipari/Van Horn report is that “Smokeless tobacco is not a healthy alternative to cigarette smoking.”  This is a non sequitur, as the NSDUH survey includes no information on health. 



The government inconsistency also extends to smoking numbers, as I discussed previously (here, hereand here).  The NSDUH estimate of adult U.S. smokers for 2014 was 55.8 million, about 40% higher than the NHIS estimate of 40 million for that year.



It is time for federal officials to acknowledge the gross inconsistency of the government’s tobacco use estimates. In all likelihood, the higher NSDUH estimates, which reflect the fact that Americans use tobacco products more irregularly than every day or some days, are closer to reality than those based on the NHIS.





Original author: Brad Rodu
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Time for the Government of Sweden to get behind snus and tobacco harm reduction

One of the more puzzling things about snus is the reluctance of Sweden’s government to claim credit for what is by any standards an extraordinary public health achievement. So here I write to the relevant ministers requesting that they acknowledge Sweden’s success, show some leadership and promote the concept of tobacco harm reduction.  The challenge to the EU prohibition of snus brought by Swedish Match and New Nicotine Alliance provides an opportunity for the Government of Sweden to change its approach.  I wrote the following heartfelt plea, attaching the letter that 18 comrades sent sent to the European Commission: Lifting the unjustified European Union ban on oral tobacco or “snus” in the light of ongoing legal action hoping it might encourage a more constructive pro-health, pro-trade, post-enlightenment approach. 

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FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 1)

by Carl V Phillips

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Smoking May Harm Mental Health



Research has documented a strong link between smoking and various mental health disorders, including anxiety, depression, schizophrenia and bipolar disorder.  The CDC advises that about 20% of American adults had some form of mental illness in 2009-2011, and the smoking rate for that group was 36%, in contrast to 21% for all others (here).

There is certainly an association, but there are four distinct possibilities with respect to causality:

·       Mental health problems cause people to smoke.
·       Smoking causes mental health problems.
·       Both pathways exist.
·       Neither pathway exists.

My economist colleague Dr. Nantaporn Plurphanswat is the lead author of an innovative analysis that identifies a potential causal pathway for mental illness and smoking; the work appears in the American Journal of Health Behavior (abstract here).  Our co-author is University of Illinois professor Dr. Robert Kaestner.  We used data from people in almost all states participating in the federal Behavioral Risk Factor Surveillance System (BRFSS) from 2000 to 2010.  BRFSS collected information on smoking and asked participants “…for how many days during the past 30 days was your mental health [which includes stress, depression, and problems with emotions] not good?”

Recognizing that traditional approaches cannot identify a causal pathway between smoking and mental illness, Drs. Plurphanswat and Kaestner employed an instrumental variable approach, in which variation in smoking at the state level is strongly associated with cigarette excise taxes, but the excise taxes are completely unrelated to outcomes like mental health.  The IV analysis provides information on whether smoking leads to mental health problems, or vice versa.

Our results indicate that smoking may harm mental health: it is significantly associated with 14 or more days of poor mental health.  Most of the effect due to smoking is from large increases in the number of mentally unhealthy days and not by small increases among many smokers. 

The BRFSS data cannot tell us whether smoking is a form of self-medication practiced by those who suffer from specific mental health disorders.  However, our analysis confirms that smoking may contribute to anxiety, depression and emotional distress.  Thus, policies that reduce smoking may have a positive spill-over effect in improving mental health.


  

Original author: Brad Rodu
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A critical review of an Australian anti-vaping polemic

John Maynard Keynes: “when the facts change, I change my mind. What do you do sir?”

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Time to stop measuring risk as “fraction of risk from smoking”?

by Carl V Phillips

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Avoiding bureaucratic destruction of the US vaping market – proposals for a new approach by FDA

June 18th, 2017

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