Wednesday, December 17, 2014

IN MY VIEW: Why Hysteria Over Youth E-Cigarette Use is Overblown; And Why it May Not Normalize Smoking

In response to the release of the 2014 Monitoring the Future data, which show that more youth are experimenting with electronic cigarettes than smoking (in terms of past 30-day use), many anti-smoking groups have sounded the alarm. More specifically, these groups have told the public that these data demonstrate that e-cigarettes are normalizing smoking. As Sabrina Tavernese explains in her New York Times article: "Health advocates say the trend for e-cigarette use is dangerous because it is making smoking seem normal again." For example, the American Academy of Family Physicians argued that these data show that e-cigarette use is normalizing smoking.

I have already explained how anti-smoking groups are missing the most important finding from the Monitoring the Future study: that despite the dramatic increase in e-cigarette experimentation, youth smoking prevalence declined substantially and is at its lowest level in decades. This demonstrates that e-cigarettes are not a gateway to smoking, as has been claimed by the CDC and by some tobacco control advocates, led by Stan Glantz.

Thus, it turns out that the concern of anti-smoking groups that e-cigarettes will normalize smoking is misplaced. In fact, the evidence seems to suggest just the opposite. It may well be that e-cigarettes are de-normalizing smoking by actually diverting some youth who would otherwise have smoked to e-cigarettes, or by diverting some youth smokers to vaping. What e-cigarette use is normalizing is the use of electronic cigarettes, not the use of tobacco cigarettes. The anti-smoking groups fail to see this because they have drawn pre-determined conclusions based on their ideology, and they are not able to look objectively at the actual scientific evidence.

While the health groups got the story wrong, fortunately, Sabrina Tavernese got it right: "Health advocates say the trend for e-cigarette use is dangerous because it is making smoking seem normal again. They also worry it could lead to an increase in tobacco smoking, though the new data do not show that."

Today, I reveal another important finding of the recent surveys on electronic cigarette use that has been entirely ignored and which should lessen our concern about the public health implications of e-cigarette experimentation among youth.

The Rest of the Story

Another important finding of the recent surveys, which has been completely ignored, is the finding that despite the large number of youth who are experimenting with e-cigarettes, only a very small proportion are actually using these products regularly, in a way that could plausibly cause significant harm. Wills et al. found that although 29% of high school students had experimented with e-cigarettes, only 2% were using them more than once a week. This means that only 7% of all high school e-cigarette experimenters are vaping more than once a week, which should lessen concerns that these products are causing significant health harm.

The truth is that e-cigarettes pose little acute health harm. Almost all the potentially adverse health effects of e-cigarette use are related to long-term use (over a period of many years). The potential acute health effects are basically two-fold: (1) these products could potentially be a gateway to smoking; and (2) these products could addict kids to nicotine, causing prolonged use of e-cigarettes which could cause neurological damage.

As I discussed above, concern #1 does not appear to be a problem. And based on the Wills et al. data, it does not appear that #2 is currently a major problem either. The data suggests that despite the dramatic rise in e-cigarette experimentation, youth are not becoming addicted to these products. The pattern of e-cigarette use is almost entirely sporadic, with 93% of users vaping no more than once in an entire week. It is not clear that use of e-cigarettes at this level - only once a week - poses any significant health harms.

My point is that the public health significance of youth e-cigarette use may very well be positive, rather than negative. It is possible that these products have caused very little health harm, while at the same time, diverted many youth from smoking to vaping. We know that smoking experimentation quickly leads to addiction. But e-cigarette use does not appear to have the same level of addictiveness. Possibly because of the much lower and inconsistent nicotine delivery, these products do not appear to be creating e-cigarette addicts (among youth).

If it is true that e-cigarettes are diverting some youth away from smoking, then it is actually the case that e-cigarette use among youth is having a positive net effect on the public's health. Even if this is not the case, it appears that e-cigarette use among youth is having very little public health impact, thus meaning that the benefits of e-cigarettes for adults (smoking reduction and cessation) far outweigh the costs for youth.

Let me close by making one point very clear. I am not arguing that e-cigarette use among youth is not a concern, that youth e-cigarette use should be allowed or promoted, or that measures should not be taken to discourage e-cigarette use among youth. I support bans on the sale of e-cigarettes to minors, restrictions on advertising and marketing that is directed at youth, programs to educate youth about e-cigarettes, programs to discourage kids from using e-cigarettes, and most importantly, FDA regulations that require child-proof packaging on e-cigarettes and stronger warnings about the potential risks of nicotine (especially acute poisoning).

Nevertheless, it is critical that we get the science right. And as of today, the science suggests that: (1) e-cigarettes are not a gateway to smoking among youth; and (2) e-cigarettes may well be de-normalizing smoking rather than promoting it.

Tuesday, December 16, 2014

Glantz Tells Public There is No Question that E-Cigarettes are a Gateway to Smoking, But Today's Monitoring the Future Data Show the Opposite

In an article published yesterday in USA Today, Dr. Stanton Glantz states definitively that electronic cigarettes are a gateway to smoking. He was quoted as stating: "There's no question that e-cigarettes are a gateway to smoking."

The article highlights the findings of two new studies showing that rates of electronic cigarette use among youth continue to rise dramatically. According to the article: "About 25% of high school students in Connecticut and 29% of teens in Hawaii have used e-cigarettes, according to separate studies. About 18% of the Hawaii teens and 12% of the Connecticut high school students had used e-cigarettes in the past month. Both studies were done in 2013. Those rates are much higher than the latest data from the Centers for Disease Control and Prevention, which found 4.5% of high schoolers and 1.1% of middle schoolers had used e-cigarettes in the past 30 days in 2013. Authors of the Hawaii study, published online Monday in Pediatrics, note that e-cigarette use has grown exponentially among kids, doubling every year since 2009."

Today, the University of Michigan released data from the 2014 Monitoring the Future study which confirm that among a national sample of 8th, 10th, and 12th grade youth, rates of electronic cigarette use are between 9% and 17%. The prevalence of past 30-day use of electronic cigarettes was 8.7% among 8th graders, 16.2% among 10th graders, and 17.1% among 12th graders.

The Monitoring the Future study also found that the prevalence of cigarette smoking decreased substantially in all three groups. For 8th graders, the prevalence of past 30-day smoking dropped from 4.5% to 4.0%; for 10th graders, current smoking prevalence dropped from 9.1% to 7.2%, and among 12th graders, smoking prevalence dropped from 16.3% to 13.6%. In 2014, cigarette smoking was at its lowest level in decades.

The most dramatic declines in smoking occurred between 2011 and 2014. For 8th graders, smoking prevalence dropped from 6.1% to 4.0%; among 10th graders, smoking prevalence dropped from 11.8% to 7.2%; and among 12th graders, smoking prevalence dropped from 18.7% to 13.6%. However, the decline in smoking from 2013 to 2014 was by far the most substantial year-to-year decrease during this period.

The Rest of the Story

It is clear that experimentation with electronic cigarettes among youth has increased dramatically from 2011 to 2014. But despite this dramatic increase, the prevalence of current smoking among youth decreased dramatically. And the sharpest decline in smoking occurred concurrently with the largest increase in electronic cigarette use.

Dr. Glantz's conclusion - that electronic cigarettes are a gateway to smoking - just doesn't hold up in light of these data. If electronic cigarettes were serving as a major gateway to smoking, then we wouldn't expect to see such dramatic declines in smoking concurrent with dramatic increases in electronic cigarette experimentation. If anything, these national data suggest that electronic cigarettes may actually be serving as a deterrent to smoking by diverting kids who might otherwise try smoking over to a non-tobacco nicotine product. Even if it is the case that kids who might not have tried smoking are experimenting with e-cigarettes, this is very different from claiming that e-cigarettes are a gateway to smoking.

Furthermore, there simply are no studies to support the conclusion that e-cigarettes are a gateway to smoking. The only existing evidence suggests that e-cigarettes are not serving as a major gateway to smoking. Thus, Glantz has drawn a conclusion that is simply unsupported by any evidence.

Glantz now joins the CDC in disseminating the unsupported conclusion that e-cigarette experimentation is a gateway to smoking. One unfortunate consequence of public health agencies or researchers spreading this misinformation is that we risk losing our credibility, not just on the issue of electronic cigarettes, but on other issues as well. If we are not credible with respect to our opinions on electronic cigarettes, then why should the public trust us when we comment about tobacco cigarettes?

Sadly, this story simply adds to the long list of examples of the degradation in the rigor of science in the tobacco control movement.

Sunday, December 14, 2014

CDC Makes Startling Proclamation: Electronic Cigarette Aerosol is Not as Safe as Clean Air

For the past two years, the Centers for Disease Control and Prevention (CDC) has been on a crusade to demonize electronic cigarettes. The agency has falsely claimed that its survey data demonstrate that electronic cigarettes are a gateway to cigarette smoking among youth. The agency has fabricated evidence that ex-smokers are in large numbers being driven back to smoking because of electronic cigarettes. The agency has scared the public by noting that rates of experimentation with electronic cigarettes doubled among youth, but failed to mention that almost all regular e-cigarette users were smokers or users of other forms of tobacco.

Now, the CDC is trying to dissuade the public from believing that vaping is safer than smoking. However, the worst thing the agency is able to say about the hazards of electronic cigarettes is that they are not as safe as "clean air."

In a December 12 MMWR article on electronic cigarettes, the CDC writes that some "contend that ENDS [electronic cigarettes] emit fewer toxins than combustible tobacco... . However, ENDS aerosol is not as safe as clean air."

The Rest of the Story

There are two striking things about these CDC statements.

First, it is extremely misleading to write that some groups "contend" that electronic cigarettes emit fewer toxins than combustible tobacco. By framing it in this way, the CDC is giving the impression that it does not agree with this contention, or at least, that the evidence is not clear.

However, there is abundant evidence that what these groups "contend" is the documented scientific truth. There is abudant evidence that electronic cigarettes emit fewer toxins than combustible tobacco, and no reputable scientist would argue otherwise. But by framing this as merely a contention, the CDC is insinuating that we don't actually know that electronic cigarettes emit fewer toxins.

Why would the CDC want to suggest to the public that we don't actually know that electronic cigarettes deliver fewer toxins that tobacco cigarettes? To me, this indicates a desire to demonize these products. Otherwise, why should the CDC be scared to tell the public the truth: that electronic cigarettes are much safer than tobacco cigarettes? And this isn't even going that far. It's merely acknowledging that e-cigarettes deliver fewer toxins than tobacco cigarettes.

Frankly, the CDC is using what we previously would have referred to as "tobacco speak." This is the way that the tobacco companies historically would frame their statements about the health effects of smoking. They would say things like: "Some public health officials contend that smoking causes ... ." Why is CDC now stooping to this level?

The second striking thing about the statement is that apparently, the worst thing the CDC can say about the adverse health effects of electronic cigarettes is that these products are not as safe as inhaling "clean air."

If that's the worst thing the CDC can say, then electronic cigarettes are apparently not that hazardous, or at least there is not currently any evidence to support the contention that they pose major hazards. Besides, you could say the same thing about any airborne exposure, including exposure to FDA-approved products. For example, you could correctly state that "aerosol from nicotine inhalers is not as safe as clean air."

Actually, it depends on how you define clean air. If you define it as simply being outdoor air, then it may not even be true that electronic cigarette aerosol is not as safe as "clean air." After all, in many urban areas, there are high levels of pollution in outdoor air. This air pollution has been associated with adverse cardiac and respiratory effects. So it is entirely possible that for some urban dwellers, their "clear air" is actually more hazardous than inhaling e-cigarette aerosol.

The rest of the story is that the CDC continues to misrepresent scientific evidence in order to demonize electronic cigarettes. If you didn't know any better, you might think that the agency has been paid by Big Tobacco to undermine the public's appreciation of the severe hazards associated with cigarette smoking and that it is trying to preserve, rather than decimate, the combustible tobacco market.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Thursday, December 11, 2014

First Meta-Analysis of Existing Studies Concludes that Electronic Cigarettes are Effective for Smoking Cessation

A meta-analysis of the existing studies which examined the effectiveness of electronic cigarettes for smoking cessation has concluded that these products are indeed effective. The study abstract, which was published on the Circulation website, was presented at an American Heart Association conference.

The study concluded as follows: "Six studies were selected, including two randomised controlled trials, two cohort studies and two cross-sectional studies, and included 7,551 participants. Meta-analyses included 1,242 participants on whom complete smoking cessation data was available. Of these, 224 (18%) reported smoking cessation after using nicotine-enriched e-cigarettes for a minimum period of six months. Use of such e-cigarettes was positively associated with smoking cessation with a pooled Effect Size of 0.20 (95% CI 0.11-0.28). Nicotine filled e-cigarettes were more effective in achieving cessation compared to those without nicotine (pooled Risk Ratio 2.29, 95% CI 1.05-4.97). Use of e-cigarettes was also effective in reducing smokers’ daily cigarette consumption."

The Rest of the Story

This meta-analysis reports, as its primary outcome variable, the proportion of smokers using e-cigarettes who quit successfully at six months (or longer). The authors found that 18% of all the smokers using e-cigarettes in the combined studies had quit after six months. This provides preliminary evidence that e-cigarettes do appear to be modestly effective for smoking cessation and that they certainly compare equally or favorably to existing FDA-approved drugs.

In contrast, a previously published meta-analysis of the effectiveness of FDA-approved smoking cessation drugs focuses on the pooled odds ratios. In fact, the study does not even report the absolute cessation rates. Thus, the fact that the study was funded by Pfizer unfortunately appears to be creating a bias in result reporting, as the authors are hiding the key piece of information that readers need to understand whether these drugs are really effective, or whether they are just better than placebo, which has a dismal cessation rate. (None of the authors of the e-cigarette meta-analysis reported any conflicts of interest.)

Remember that a drug can produce an odds ratio of 2, yet represent an 8% cessation rate compared to a 4% cessation rate. Moreover, in these clinical trials, the subjects who received placebo were likely to have known that their medication was inactive and may have suffered a huge initial disappointment which would have resulted in very dismal success rates.

Because this is just an abstract and has not yet been peer-reviewed, its results should be viewed as preliminary. Nevertheless, the conclusion of the study casts doubt on the many anti-smoking groups and advocates who continue to argue that there is no evidence that electronic cigarettes have efficacy in smoking cessation.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Sunday, December 07, 2014

Required Reading: Michael Marlow's Commentary on the FDA's Proposed Deeming Regulations

Everyone involved in the debate over electronic cigarettes must read Dr. Michael Marlow's commentary on the FDA's proposed deeming regulations. According to his Mercatus Center biography, Dr. Marlow is "an affiliated senior scholar at the Mercatus Center at George Mason University and professor of economics and distinguished scholar at California Polytechnic State University, San Luis Obispo."

(See: Marlow ML. Regulating a less unhealthy cigarette: The FDA's treatment of e-cigarettes jeopardizes public health. Regulation. Fall 2014.)

In his commentary, Dr. Marlow argues that in its proposed deeming regulations, the FDA has completely skewed its cost-benefit analysis by failing to recognize the dramatic negative effect its burdensome regulatory requirements for electronic cigarettes will have on the public's health by virtue of the suppression of the e-cigarette market that these regulations will cause.

Dr. Marlow writes: "This article argues that the FDA jeopardizes public health by not developing an appropriate benefit-cost analysis of the proposed rule. The FDA “anticipates,” without quantifying, substantial benefits from reducing harm by regulating e-cigarettes and non-cigarette tobacco products. The FDA also does not adequately assess costs that appear likely from its suppression of the e-cigarette market. The evolving literature on e-cigarettes strongly suggests they help smokers to quit smoking. The proposed rule endangers public health by pushing e-cigarette manufacturers to focus efforts toward developing attributes unrelated to improved public health, thereby promoting combustible tobacco use and reducing the number of smokers who would use e-cigarettes to quit or reduce cigarette consumption. Public health would worsen because e-cigarettes are a safer alternative to tobacco cigarettes."

Dr. Marlow carefully articulates the adverse consequences to the public's health that would occur if the FDA's proposed deeming regulations are adopted. These regulations, he argues, would result in the suppression of the e-cigarette market, a stifling of product innovation, a contraction of the overall e-cigarette market with limitation of consumer choices and increased product costs, and an increase in youth e-cigarette use due to the prohibition of honest claims that e-cigarettes are safer than combustible tobacco products.

Dr. Marlow concludes that: "The FDA needs to develop a regulatory strategy that fully considers the potential benefits that smokers receive from e-cigarettes and the many unintended adverse effects on public health associated with how this proposed regulation slows the evolution of a promising harm reduction tool."

The Rest of the Story

This commentary very nicely summarizes many of the major points that I have tried to make here at the Rest of the Story over the past months. Like Dr. Marlow, I have argued that the proposed deeming regulations would suppress the e-cigarette market, stifle innovation, and contract the overall market by reducing the number of players as well as consumer choices. The burdensome requirement for a new product application for virtually every e-cigarette product on the market will almost certainly drive most e-cigarette companies and shops out of business. The net effect of this disruption of the industry will be a reduction in the rate at which smokers switch from combustible cigarettes to the much safer electronic ones. Thus, the net effect of the proposed regulations would be a strongly negative impact on public health.

In addition, Dr. Marlow nicely articulates the argument I have previously made that by disallowing companies from truthfully informing their customers that these products are safer than tobacco cigarettes and may be helpful in smoking cessation, the result will be that companies have no option other than marketing these products as having benefits unrelated to health, such as looking cool and sexy and allowing smokers to inhale nicotine in places where smoking is not allowed. The net effect of this suppression of the truth will be an increase in youth e-cigarette use, as honest marketing of e-cigarettes based on their health benefits would have far less appeal to youth.

Instead of the burdensome requirements that the FDA is proposing, I believe that the agency should take a different approach which recognizes the vast difference in risk between tobacco and electronic cigarettes, which embraces the harm reduction potential of e-cigarettes, and which enhances the progression of the nicotine market away from combustible products.

Specifically, the FDA should:
  1. Scrap the requirement that e-cigarette products must submit new product applications.
  2. Instead, simply promulgate uniform safety standards that all products must meet.
  3. These standards should include:
    • child-proof packaging;
    • quality assurance of nicotine levels;
    • battery and charging safety;
    • voltage and/or temperature regulation to avoid the formation of carbonyl compounds like formaldehyde;
    • manufacturing standards such as those set out by AEMSA;
    • banning the use of diacetyl as a flavoring; and
    • soldering restrictions to prevent the presence of metals in e-liquid.
       4. Explicitly allow companies to truthfully inform their customers that these products are intended to aid   in smoking cessation and that these products are much safer than tobacco cigarettes.
The last thing we need is the creation of a monstrous bureaucracy in which the FDA will have to review literally thousands of new product applications, including hundreds of applications - in some cases - from a single company. The FDA has not demonstrated how such a process, which is unduly burdensome, which actually benefit the public's health. Instead, the agency should simply mandate the safety standards that all companies must follow. This minimizes the bureuacracy, limits the economic and time burden on small companies, allows the market to continue to expand rather than contract, encourages innovation, and directly regulates the factors that will most affect product safety.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Wednesday, December 03, 2014

Anti-Smoking Groups Succeed in Undermining the Public's Appreciation of the Hazards of Smoking

New data reported by Clive Bates and presented in Joe Nocera's New York Times column about electronic cigarettes reveal that there has been a major change in the public's appreciation of the severe hazards of smoking in the past three years:

According to these sources, in 2010, 80% of the public believed that smoking was more hazardous than using non-tobacco-containing, non-combustible electronic cigarettes.

However, in 2013, only 60% of the public believed that smoking was more hazardous than using non-tobacco-containing, non-combustible electronic cigarettes.

This is bad news for public health, as it indicates that within three years, the public's appreciation of the severe hazards of smoking has been undermined. Twenty percent of the public has been convinced that smoking is no more hazardous than inhaling aerosol from a device which involves no combustion and contains no tobacco.

The Rest of the Story

Who is responsible for this undermining of the public's appreciation of the health hazards of smoking?

Historically, it was the tobacco industry which used public relations activities to undermine the public's appreciation of smoking's health hazards.

Sadly, it was not the tobacco industry which is responsible for today's bad news. Instead, I believe that it is clearly the result of a strong propaganda campaign by the anti-smoking groups.

For the past three years, the mainstream anti-smoking groups, as well as federal agencies including the FDA and the CDC, have been disseminating the message that electronic cigarette use is harmful and they have largely hidden from the public the fact that vaping is much safer than smoking. In addition, a number of anti-smoking groups and advocates have actually been spreading misinformation about the health hazards of vaping and the relative hazards of smoking compared to vaping.

As a result of these information campaigns, it is now clear that the public's appreciation of the health hazards of smoking has been undermined, as there has been a substantial decline in the proportion of the public which correctly believes that smoking is more hazardous than vaping.

This is not just a friendly debate about the potential role of electronic cigarettes as a tobacco control strategy. This is now a situation where the mainstream anti-smoking groups are actually doing tangible and demonstrable public health harm by completely distorting the relative risks of smoking compared to vaping and as a result, undermining the public's appreciation of the hazards of smoking.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Tuesday, December 02, 2014

U.S. House Members Urge FDA to Change Grandfather Date in Proposed Deeming Regulations

Speaker of the House John Boehner, along with the House Majority Leader Kevin McCarthy and Chair of the Energy and Commerce Committee Fred Upton, have sent a letter to the FDA and Center for Tobacco Products urging that the proposed deeming regulations be changed. Specifically, they have requested that the FDA change the grandfather date of February 15, 2007 to either April 25, 2014 (the date the deeming regulation was published) or to the effective date of the final deeming regulation.

The representatives' concern is that with the proposed grandfather date, it will be virtually impossible for current electronic cigarette products to claim substantial equivalence to a predicate product. Therefore, virtually every electronic cigarette company will need to file a new product application, which is a burdensome and expensive undertaking. The net result could be the removal of thousands of electronic cigarette products from the market.

The letter asks the FDA to change the grandfather date "to ensure that these innovative products are not snuffed out by overly burdensome regulations."

According to the letter: "As a practical matter, many newly deemed products could be removed from the market. ... [T]he cost and barriers surrounding a new product submission would largely prevent new entries, posing an unwarranted regulatory barrier to innovation. ... This is a critical issue, and we request that manufacturers of newly deemed tobacco products have the same market entry opportunities as manufacturers of cigarettes and other currently regulated tobacco products. ... Any final provision on this issue should ensure equity among all regulated tobacco products and encourage innovation while achieving the purpose of the law."

The Rest of the Story

I agree with the request that is being made in this letter. However, I would go further and recommend that the FDA not require new product applications for any products. Doing so stifles innovation and makes it difficult if not impossible for newer products that may be safer and more effective to enter the market.

These comments are similar to those expressed by Altria Client Services, Lorillard, and the American E-Liquid Manufacturing Standards Association.

They also echo my initial comments about the proposed deeming regulations, when I wrote:

"The regulations require pre-approval (or substantial equivalence determinations) for all new electronic cigarette products."

"This provision is going to present a huge obstacle to innovation in this category. The newer products tend to be safer and more effective, so it makes no sense to allow the older products to remain on the market while requiring pre-approval for the newer and better products. The implications of this regulation is going to depend on the evidence that the agency requires to approve these applications. A stringent interpretation of the regulations will put a huge dent in electronic cigarette innovation and could limit the expansion of the market. In addition, this provision is going to place an undue burden on smaller companies and give a huge advantage to larger companies, including the tobacco companies that have entered the e-cigarette market."

"The regulations require pre-approval or substantial equivalence determinations of almost all existing electronic cigarette products."

"This provision is going to wreak havoc with the industry. The agency is determined that it cannot extend the grandfather date beyond 2007. This means that any product not on the market as of 2007 (which includes almost all electronic cigarette products) must either obtain a new product approval or a substantial equivalence determination. Given the snail's pace at which the FDA has processed cigarette substantial equivalence determinations, this could result in a literal quagmire of pending applications for the more than 250 brands of e-cigarettes currently on the market."

(Thanks to Greg Conley for the tip.)

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Monday, December 01, 2014

Boulder City Council Considering Legislation to Ban Vaping in Wide-Open Outdoor Areas

The Boulder (Colorado) City Council is considering legislation that would extend the city's smoking ban to include parks and open spaces and ban vaping in all the places where smoking is banned. Thus, the ordinance would ban vaping in all parks and open spaces. Specifically, vaping would be banned in the following outdoor areas:
  • the downtown business improvement district;
  • all parks and parkland;
  • all open spaces and mountain parks property; and
  • on any trail or multi-use path.
What is the city's justification for considering a ban on vaping in these wide-open outdoor areas? What is the evidence the city presents to justify such a draconian measure?

If you read the city's fact sheet on electronic cigarettes, you'll find out that the city does not name a single health problem that has been shown to be caused by exposure to "secondhand vapor." Instead, the worst thing that the city health department can say about secondhand vaping is this:

"ENDS [electronic cigarettes] aerosol has consistently been demonstrated to contain more than water."

The Rest of the Story

When the worst thing that can be said about the potential public health hazard of exposure to exhaled e-cigarette aerosol is that the aerosol has been shown to contain more than water, you know that you are dealing with a flimsy justification for this proposed policy.

This is truly a draconian policy. There is no scientific justification for banning smoking in wide-open outdoor spaces; there is absolutely no scientific justification for banning vaping in these places. It isn't even clear whether vaping indoors poses any significant hazards to the public. Certainly, vaping outdoors poses no substantial public health risks.

Beyond the lack of any public health justification for this vaping ban, the policy is flawed because it would likely discourage many smokers from quitting smoking via electronic cigarettes. It might even encourage some vapers to return to cigarette smoking. It is possible, then, that this policy could have negative net public health benefits.

Hopefully, the Boulder City Council will choose not to include vaping in this expanded smoking ordinance.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Wednesday, November 19, 2014

Proof of Concept Study Shows Great Promise for Second Generation Electronic Cigarettes

Riccardo Polosa and colleagues have just published a six month pilot study, in which 50 smokers who were not interested in quitting were provided with a second generation electronic cigarette (personal vaporizer). The specific product was the EGO/CE4 model. Participants were also provided with chargers and e-liquids throughout the study period.

At six months, a sustained 50% or greater reduction in cigarette consumption was observed in 15 subjects (30%), with mean consumption dropping from 25 cigarettes per day to 6 cigarettes per day. Of these 15 subjects, 7 (14% of the total sample) experienced a sustained reduction of 80% or more in their cigarette consumption, with their mean consumption dropping to just 3 cigarettes per day.

Also at six months, smoking abstinence was reported by 18 subjects (36% of the sample).

Therefore, in total, 33 subjects, or 66%, were either able to quit smoking or cut down on the amount they smoke by at least 50%.

The Rest of the Story

This is a small pilot study and there is no control group or randomization of subjects, so it must be interpreted cautiously. Nevertheless, considering that these were smokers who expressed no interest in quitting, the finding that two-thirds either quit or cut down by more than 50% is encouraging.

This study also demonstrates some of the complexities of studying the effectiveness of electronic cigarettes. There are a wide range of products on the market with different abilities to effectively deliver nicotine and to produce a full vapor that delivers a sufficient throat hit to satisfy many smokers. It may be that the effectiveness of these products could improve over time, as inefficient products are replaced with ones that are better able to satisfy the needs of smokers.

This is why the FDA's proposed deeming regulations make no sense. They would prohibit the introduction of new products into the market, keeping the older and antiquated products going and stifling innovation. The process to get a new product approved is complex and involves showing that the product is beneficial to the public's health. I interpret this as meaning that a new product would have to conduct a clinical trial that shows the effectiveness of the particular product whose approval is being sought. This barrier is a huge one.

This would be unfortunate because the quality and effectiveness of electronic cigarettes appear to be increasing over time. Why would the FDA want to stifle innovation and essentially force the market to be stuck with the less effective products? This is not a recipe designed to maximize the number of smokers who successfully quit smoking. If anything, it is a recipe designed to protect traditional cigarette sales.

Hopefully, the FDA will reconsider this provision of the deeming regulations and will remove it from the final regulation. Innovation in this industry should be encouraged and promoted, not stifled.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Thursday, November 13, 2014

New CDC Study Reveals that Youth Smoking has Declined Despite Tripling of Electronic Cigarette Use Among High Schoolers

A new study released today by the CDC reports that although electronic cigarette use has doubled among middle-school students and tripled among high school students, there was a marked reduction in cigarette smoking in both groups from 2011/12 to 2013.

During this time period, current e-cigarette use among middle-school students increased from 0.6% to 1.1%. At the same time, current cigarette smoking declined from 4.3% to 2.9%.

Among high school students, current e-cigarette use increased from 1.5% to 4.5%. Concurrently, current cigarette smoking dropped from 15.8% to 12.7%.

The study also reported that there were very few never smokers who were currently using electronic cigarettes.

The Rest of the Story

The finding that despite a tripling of current e-cigarette use among high school students, the smoking prevalence among this group dropped substantially suggests that electronic cigarettes are not serving as a major gateway to cigarette smoking among youth.

Although the CDC has been disseminating to the public its contention that electronic cigarettes are a gateway to youth smoking, it has yet to produce a shred of evidence that this is the case. In fact, it has not identified a single youth who started with electronic cigarettes and then progressed to cigarette smoking.

Nevertheless, the CDC director stated last year that: "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes."

Given the absence of evidence that e-cigarette use is a gateway to smoking and the lack of any documentation that kids are starting out with e-cigarettes and then progressing to cigarette smoking, it seems that the CDC should correct its earlier statement and apologize for letting it sit out there in the media for more than a year.

It is doing damage because policy makers are accepting this unsupported statement as the truth, and are using it as the basis for stringent regulations of electronic cigarettes which may end up causing more public health harm than good. The benefits of electronic cigarettes in terms of helping smokers to quit or cut down needs to be weighed against the harms in terms of potentially recruiting new smokers or e-cigarette addicts. However, so far there is no evidence that either of these phenomena are occurring.

Certainly, we need to continue to carefully monitor the situation and to conduct research to clearly identify the trajectory and time course of electronic cigarette and tobacco cigarette use among youth. But as a start, we need our public health agencies to be honest with us about the facts. Distorting the science to create more compelling stories or to fulfill predetermined conclusions is not appropriate.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Tuesday, November 11, 2014

New State Study Shows Dramatic Reduction in Youth Smoking Despite Sharp Rise in E-Cigarette Use

New data out of Minnesota shows that despite a marked increase in e-cigarette use among Minnesota teenagers, there was a corresponding dramatic decline in tobacco cigarette smoking.

According to the report: "The 2014 Minnesota Youth Tobacco Survey found that the percent of high school students who smoked cigarettes in the past 30 days dropped from 18.1 percent in 2011 to 10.6 percent in 2014."

At the same time: "12.9 percent of high school students used or tried an electronic cigarette in the past 30 days. The survey found that 28 percent of high school students reported ever having tried an e-cigarette."

The Rest of the Story

These findings add further evidence that electronic cigarettes are not currently serving as any kind of major gateway to cigarette smoking. Despite massive levels of experimentation with electronic cigarettes, youth smoking rates are falling dramatically. This pretty much rules out the hypothesis that e-cigarettes are a major gateway to smoking.

Stan Glantz has reviewed additional evidence which documents rather dramatic increases in electronic cigarette use in the past few years, some of which is occurring among nonsmokers. However, these data actually add to the evidence that e-cigarettes are not a major gateway to smoking because they demonstrate that this experimentation, even among nonsmokers, is occurring at a time when smoking rates among youth have fallen to historic low levels.

Bottom line: There is no evidence at the current time that electronic cigarettes are serving as a gateway to smoking among youth.

Unfortunately, the lack of evidence did not stop the CDC director from proclaiming publicly that e-cigarettes are a gateway to youth smoking. And sadly, I am not aware that the director has made any sort of retraction, correction, or apology.

Meanwhile, the bogus conclusion that youth electronic cigarette use is a major risk for increased youth smoking continues to deceive policy makers throughout the country and risks the formation of inappropriate and unsupported state and federal policies regarding electronic cigarettes.

Despite all the attention to the hypothetical risks of electronic cigarettes, which so far have not been shown to pose any substantial risk to young people, the policy makers remain silent about menthol cigarettes, which - according to the Minnesota report - are currently smoked by 44% of youth smokers. This is not a hypothetical risk. This is not a slight chance of progression to smoking. These are kids who are already smoking and most likely already addicted to smoking. And half of these kids who continue to smoke over a lifetime will die prematurely of this addiction.

But nobody in the anti-smoking movement seems to care. It appears that we just can't stand hypothetical or unknown risks. But known epidemics of disease and death are just fine.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Thursday, November 06, 2014

New Study Suggests that Menthol Cigarettes May Be Worse for Lung Health; Policy Makers Respond by Calling for Ban on Flavored Electronic Cigarettes

I'm not much kidding in making that connection. If there is any flavor in tobacco products that is contributing toward youth addiction and ultimately, disease, it is menthol. Menthol cigarettes are preferred by nearly 50% of youth smokers. And menthol is the one flavoring that was exempt from prohibition under the Family Smoking Prevention and Tobacco Control Act.

Who was responsible for that exemption? Ironically, the policy makers who are currently calling for a ban on flavorings in electronic cigarettes.

Despite the lack of evidence that electronic cigarettes are leading to any tobacco use among youth, and despite the strength of the evidence that menthol cigarettes make up about 50% of the tobacco cigarettes that youth do smoke, it makes absolutely no sense for policy makers to call for a ban on flavorings in electronic cigarettes, but not to demand a similar policy for the menthol in cigarettes.

Unfortunately, this is exactly the state of affairs among the leading politicians who supported the Family Smoking Prevention and Tobacco Control Act and who are now switching their attention over to electronic cigarettes, which they are treating like a far greater scourge on the health of our nation's children.

The new study found that menthol smokers had higher rates of hospitalization for chronic lung disease. Beware, however. There were major differences between the populations of menthol and non-menthol smokers in this study, and I do not personally feel that the study controlled adequately enough for these differences to be able to attribute the observed health differences specifically to the presence of menthol.

Similarly, I have long argued that a policy which aims to ban menthol because menthol cigarettes pose a greater health risk than non-menthol cigarettes is flawed from the start, because the scientific evidence doesn't support such a judgment.

In fact, the reason for the flavorings ban in the Tobacco Control Act is not that flavored cigarettes are any more hazardous, but that - hypothetically - youth would be more attracted to such products. But on that basis, not only should menthol cigarettes have been banned, but all flavorings that are added to cigarettes should have been banned as well. In other words, the policy made little sense and was internally and externally inconsistent from day one.

Now is the time for the politicians to put up or shut up. Either back up your supposed concern for kids' health by sponsoring legislation to ban menthol and all flavorings in cigarettes, or cut the crap about the need to ban the flavorings from e-cigarettes in order to end the scourge that these flavors are having on our nation's children.

Tuesday, November 04, 2014

Anti-Smoking Groups and Politicians are Way Off the Mark in Accusing Altria and Reynolds American of Targeting Children with their E-Cigarettes

In recent months, a host of anti-smoking groups as well as several leading politicians in Congress and at the state level have attacked the Big Tobacco companies - including Reynolds American and Altria - for targeting their electronic cigarette products to children.

While it may sound like a great sound bite, it fits the mantra of tobacco control, and it may be consistent with historical practices of these tobacco companies in marketing cigarettes to youth, there is much more here than meets the eye. As much as the anti-smoking groups might like, things are not that simple.

Specifically, this claim by anti-smoking groups and politicians is demonstrably false. And by continuing to make this false accusation, it detracts from the anti-smoking groups' legitimate complaints against a small number of e-cigarette companies that do appear to be crossing the line.

The Rest of the Story

In their complaints, the anti-smoking groups and politicians have specified the ways in which e-cigarette companies are targeting kids. First, according to these groups, the use of candy and fruit-flavored products is a sure sign of youth targeting. Second, selling their products over the internet is an attempt to recruit youth customers, since it is much easier for underage customers to purchase over the internet than to purchase in face-to-face sales in brick-and-mortar facilities. Third, electronic cigarette companies are targeting kids by offering disposable products at cheap prices.

Let's now examine Reynolds American's e-cigarette product (Vuse) and Altria's product (Nu Mark) to see how they fare on each of these youth targeting criteria:

VUSE
Candy and fruit flavors: None. Only tobacco and menthol.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

NU MARK
Candy and fruit flavors: None. Only tobacco and menthol.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

Not only is there a lack of evidence that Vuse and Nu Mark are not targeting youth, but there is very strong evidence that these products are not targeting youth. 

Nevertheless, I am not aware of any mainstream tobacco control group which has so much as acknowledged that Vuse and Nu Mark are indeed being responsibly marketed toward adult smokers. 

My readers know that I can certainly dish out criticism when it is warranted. But at the same time, I feel it is important to be discriminating, and to withhold criticism unless it is warranted and backed up by adequate evidence. 

Unfortunately, the anti-smoking groups and politicians seems incapable of such discrimination. Everything is black and white, and there is no need to actually examine the scientific evidence. 

Except that the rest of the story is that for Vuse and Nu Mark, it isn't black and white. It's exclusively classic tobacco and menthol.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Monday, October 27, 2014

Study Suggests that Telling Smokers the Truth About Electronic Cigarettes Could Enhance Smoking Cessation

Last week, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research, which reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation. The study found that intensive electronic cigarettes users at baseline were six times more likely to quit smoking after a two-year follow-up period compared to intermittent or non-users.

One additional important finding of this study deserves mention.

The study found a difference in the reasons for starting e-cigarette use between triers (those who only vaped one or two times), intermittent users, and intensive users (those who vaped daily for at least one month).

Among the intensive users, the overwhelming majority (87.6%) reported that they were vaping because of health concerns: they were concerned about their own health and/or wanted to quit smoking or cut down on the amount that they smoked.

Among the intermittent users, this percentage was only 53.6%, and among the triers, it was only 55.2%. Other major reasons given among the triers and intermittent users were vaping where smoking is not allowed and avoiding exposing others to tobacco smoke.

Overall, then, the most intensive users -- who were also more likely to quit successfully -- tended to be smokers who were using electronic cigarettes specifically with a health purpose in mind (usually, quitting smoking). There were fewer "ancillary" reasons for use among these intense users.

As the authors concluded: "those who did not progress to extended daily use of e-cigarettes were using them for reasons other than the desire to quit smoking."

The Rest of the Story

This highlights one of the major problems with the proposed regulation of e-cigarettes, as well as the way many anti-smoking groups are treating these products.

First, in terms of proposed regulation, the FDA's proposed deeming regulations would prohibit companies from telling the truth about their products. Companies could not point out that electronic cigarettes produce no smoke, nor could they truthfully make the point that these products are much safer than cigarettes. Beware of making a therapeutic claim, they could not point out that the primary purpose of these products is for smoking cessation. In short, the proposed regulations would prohibit companies from marketing these products truthfully: the companies would have to pretend that improving health has nothing to do with why these products exist or why one would want to use an e-cigarette instead of a real one.

This is absurd, and it needs to be changed in the final regulations. First, companies should be explicitly allowed to point out that these products contain no tobacco smoke. Second, companies should be allowed to truthfully inform consumers that vaping is much safer than smoking. Third, companies should be allowed to make a certain set of claims regarding smoking cessation. They should not be allowed to market these products as nicotine delivery devices or with the purpose of treating nicotine dependence or addiction (since these are diseases/conditions). But instead, they should be allowed to truthfully note that the primary intention of these products is to get smokers off of cigarettes. They should also be allowed to inform consumers that many smokers have successfully quit smoking using e-cigarettes. The FDA should allow this subset of claims to be made without running afoul of the Food, Drug, and Cosmetic Act (i.e., without having to reclassify their products as drugs and therefore pull them off the market while submitting a new drug application).

Second, in terms of the statements of anti-smoking groups, they should stop criticizing electronic cigarette companies for making truthful claims, such as that these products have helped many people quit smoking or that these products are much safer than tobacco cigarettes. By discouraging these types of truthful claims, the anti-smoking groups have in fact backed the e-cigarette companies into a corner: all they can do without arousing the ire of the anti-smoking groups is to market e-cigarettes as a glamorous or sexy form of tobacco use, or as a product that can be used where smoking is not allowed. This is exactly how we don't want these products to be marketed.

The rest of the story is that it isn't as simple as condemning electronic cigarette companies for using marketing that seems to appeal to young people, or which casts vaping as being glamorous or sexy. The companies have been boxed into a corner. And the ones boxing them into that corner are us! By us, I mean public health groups and agencies.

It is time to not only allow, but to encourage the truthful marketing of electronic cigarettes. Based on the current research, such an approach would actually aid the public's health by encouraging more serious vapers who would have a higher likelihood of making the complete switch from tobacco cigarettes to the much safer electronic ones.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Thursday, October 23, 2014

Unlike Data from U.S., Data on Youth Electronic Cigarette Use in Poland is Concerning

A new set of cross-sectional surveys of e-cigarette use among Polish students ages 15-19 was just published in the Journal of Adolescent Health.

(See: Goniewicz ML, et al. Rise in electronic cigarette use among adolescents in Poland. Journal of Adolescent Health 2014; 55:713-715.)

Like its U.S. counterpart (the National Youth Tobacco Survey), the survey from Poland found a dramatic increase in experimentation with electronic cigarettes during the period 2010/11 - 2013/14. Experimentation increased from 16.8% to 62.1%.

Different from the U.S. study, however, the Poland study found very high rates of current use of electronic cigarettes, which rose from 5.5% to 29.9%.

Most alarming, and completely different from results observed in the U.S., the prevalence of cigarette smoking during the study period increased substantially, rising from 23.9% to 38.0%.

The Rest of the Story

In and of itself, the increase in electronic cigarette experimentation in Poland is to be expected. However, there are two aspects of the data which are alarming.

First, not only did experimentation rise, but the rates of current use of electronic cigarettes are substantially higher than they are in the U.S. This suggests that not only are Polish youth trying these products, but the products seem to have more of a "stick" factor than they do in the U.S.

Second, and more alarming, is the finding that the dramatic increase in electronic cigarette use is occurring in the presence of a substantial increase in cigarette smoking. This is completely unlike the situation in the U.S., where the dramatic rise in experimentation with electronic cigarettes has been associated with a decline in youth smoking to its lowest level in recent history.

As the authors point, out the combination of the dramatic increase in e-cigarette experimentation, the high prevalence of current e-cigarette use, and both in the setting of a substantial increase in smoking prevalence do not appear to be consistent with the hypothesis that the use of electronic cigarettes among youth in Poland is displacing tobacco cigarettes.

Of course, this is only a cross-sectional study so it is premature to conclude that it is the electronic cigarette use that caused the observed increase in smoking. There are many other factors which could be at play. Nevertheless, these are the type of data which would cause me concern should they appear in U.S. surveys.

There are three major takeaways from this story.

First, having seen what concerning data about e-cigarette and cigarette use among youth would look like, this should be reassuring to public health advocates in the United States, where the data look very different and do not support the conclusion that e-cigarettes are serving as any sort of gateway to cigarette smoking.

Second, it may be that country-specific policies are necessary to regulate e-cigarettes, as the products being used and the use and popularity of the products may differ from country to country. A one size fits all approach may not make sense for such a complex phenomenon with an incredible diversity of types of products.

Third, comparing how different anti-smoking groups present the results of these findings along with those of the U.S. findings should be instructive in terms of identifying potential biases.

Those who report both the U.S. findings and Poland findings as demonstrating the gateway effect of youth moving from e-cigarettes to smoking (i.e., Glantz, Dutra, etc.) are clearly biased towards presenting the negative effects of e-cigarettes, rather than the truth.

Those who report both the U.S. findings and Poland findings as great news that should spare us concerns about the use of electronic cigarettes among youth are clearly biased towards electronic cigarettes and downplaying potential risks.

Those who report the U.S. findings and Poland findings differently (with the Poland findings showing reason for concern and the U.S. findings not ringing alarm bells about any significant gateway effects) are probably presenting a much more balanced and nuanced (and less biased) picture of the scientific data.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Wednesday, October 22, 2014

New Research Suggests that Banning E-Cigarette Flavors Could Have Tragic Consequences

As I noted yesterday, one of the most central tenets of medicine and public health is "to do no harm." Research out of the Center for Survey Research at the University of Massachusetts Boston suggests that policy makers and anti-smoking groups which are supporting bans on e-cigarette flavors - such as one proposed in New York City - would be violating this principle, causing tragic consequences by promoting smoking to a significant proportion of the population.

Monday, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research, which reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation. The study found that intensive electronic cigarettes users at baseline were six times more likely to quit smoking after a two-year follow-up period compared to intermittent or non-users.

However, the survey included a very useful question for all smokers who had tried, intermittently used, or intensively used electronic cigarettes but discontinued e-cigarette use for some reason and returned to smoking. Specifically, these smokers were asked to name the most important reasons why they returned to cigarette smoking.

The number one reason given by smokers for stopping electronic cigarette use was the taste of the product. More than one-third (35.0%) of triers reported that taste was a major factor in their discontinuation of vaping.

Very few intensive users and only a small number of intermittent users listed taste as an important consideration in discontinuing vaping. This suggests that taste is a critical aspect of the vaping experience which largely explains whether a smoker will progress to more intensive and perhaps more advanced use of these products, which are associated with a higher likelihood of smoking cessation.

The Rest of the Story

What does this mean?

It means that if electronic cigarette flavors are banned, the percentage of smokers who progress to regular e-cigarette use will plummet. Moreover, the benefits of e-cigarettes in terms of promoting smoking cessation will be largely negated. Worst of all, thousands of smokers who would otherwise have been likely to reduce their cigarette consumption or perhaps quit with e-cigarettes will instead return to cigarette smoking or never give e-cigarettes the light of day.

Simply, it would be a public health tragedy that would cost countless lives.

It would, of course, also be a huge boon for combustible cigarette profits.

Proponents of these flavoring ban proposals have failed to present a cost-benefit analysis demonstrating that these enormous costs of basically decimating the e-cigarette market would be offset by a reduction in harm to youth who are picking up e-cigarettes because of the flavor and suffering serious health consequences (presumably as a result of initiating smoking). In fact, the current evidence base does not suggest that the use of flavored e-cigarettes is causing any net harm. If anything, it appears that youth e-cigarette use might be associated with some amount of smoking reduction among youth smokers.

It is critical that before policy makers, whether in New York City or at the FDA, take the draconian step of banning electronic cigarette flavors, they demonstrate that such a measure's public health benefits would outweigh its harms. The current evidence demonstrates that the opposite is the case. There would be very little public health benefit at the expense of tragic consequences to ex-smokers, who would return to smoking in huge numbers, and to current smokers, who would continue to smoke combustible cigarettes rather than make a potentially successful quit or reduction attempt using e-cigarettes.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Tuesday, October 21, 2014

New Research Suggests that Anti-Smoking Groups' Propaganda About Electronic Cigarettes' Harms is Causing Tragic Consequences

One of the most central tenets of medicine and public health is "to do no harm." Research out of the Center for Survey Research at the University of Massachusetts Boston suggests that many anti-smoking groups are violating this principle, causing tragic consequences by promoting smoking to a significant proportion of the population.

Yesterday, I discussed a study, just published online ahead of print in the journal Nicotine & Tobacco Research, which reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation. The study found that intensive electronic cigarettes users at baseline were six times more likely to quit smoking after a two-year follow-up period compared to intermittent or non-users.

However, the survey included a very useful question for all smokers who had tried, intermittently used, or intensively used electronic cigarettes but discontinued e-cigarette use for some reason and returned to smoking. Specifically, these smokers were asked to name the most important reasons why they returned to cigarette smoking.

Sadly, the third most common reason given by smokers was concern over the health effects of electronic cigarettes. Nearly one-third (29.3%) of smokers who discontinued e-cigarette use and returned to exclusive smoking listed concern over the health effects of vaping as a very important reason for stopping e-cigarette use.

This is unfortunate because despite the propaganda being disseminated by many anti-smoking groups, vaping is much safer than smoking and there is no legitimate health concern that should lead a smoker to choose tobacco cigarettes over fake, tobacco-free ones.

I find it truly tragic that a substantial proportion of smokers who have used e-cigarettes - perhaps as many as one-third - have fallen for the propaganda of many anti-smoking groups and have discontinued their cessation or reduction attempts and returned to full-time cigarette smoking because of a concern about their health. This is completely irrational, as there is no question that switching to electronic cigarettes is much safer than continuing to smoke, and that even a major reduction in smoking has positive respiratory health consequences.

Where are these smokers getting the irrational and completely unfounded idea that a concern about their health should lead them to switch completely from vaping to smoking? The answer - and here is the sad part of the story - is that these smokers are almost certainly getting this false information from a host of supposedly "anti-smoking" groups which, as documented on The Rest of the Story over the past years, have been spreading false and misleading propaganda about the relative health effects of electronic cigarettes compared to tobacco cigarettes.

No later than yesterday did Stan Glantz again disseminate hysterical propaganda designed to scare people into thinking that the nicotine in electronic cigarettes causes heart attacks, despite the lack of any direct evidence that this is the case, and despite the fact that most scientists are unsure that the nicotine in cigarette smoke contributes to heart attacks. While Glantz provides the caveat that: "there are not yet direct evidence on the effects of e-cigarettes on the sympathetic nervous system," this is likely to be lost, given that the headline reads: "Reasons to worry about e-cig induced heart attacks."

I don't mean to single Stan out because he is joined by a host of supposedly "anti-smoking" groups. But the irony is that these groups, by disseminating propaganda that is demonstrably resulting in vapers deciding to switch completely back to smoking, are actually helping to promote cigarette smoking. Thus, it is uncomfortable to continue to refer to these organizations as "anti-smoking" groups. I do not question their intentions. However, when the effects of their actions are to promote smoking, then something is wrong.

And something needs to change. Right away.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Monday, October 20, 2014

New Cohort Survey Study Shows that Intensive E-Cigarette Use Greatly Increases Chances of Quitting Smoking; Also Shows Need for a Clinical Study

A new study, just published online ahead of print in the journal Nicotine & Tobacco Research, reports the results of a population-based survey of smokers followed up after two years to determine whether e-cigarette use was associated with higher or lower rates of smoking cessation.

(See: Biener L, Hargraves JL. A longitudinal study of electronic cigarette use in a population-based sample of adult smokers: association with smoking cessation and motivation to quit. Nicotine & Tobacco Research, 2014; doi:10.1093/ntr/ntru200.)

A baseline survey conducted in the Dallas and Indianapolis metropolitan areas in 2011/2012 identified 1,374 smokers who agreed to be re-contacted. Of these, 695 were successfully re-contacted in 2014. At the baseline interview, all respondents were current smokers and their use of electronic cigarettes was assessed. At the follow-up interview, smoking cessation was defined as abstinence from cigarettes for at least one month.

Smoking cessation rates were compared between intensive e-cigarettes users at baseline (daily use for at least one month), intermittent users (use more than once or twice but not daily for a month or more); and non-users (use no more than once or twice).

The chief finding was as follows: "Logistic regression controlling for demographics and tobacco dependence indicated that intensive users of e-cigarettes were 6 times as likely as non-users/triers to report that they quit smoking (O.R. 6.07, 95% C.I. 1.11, 33.2). No such relationship was seen for intermittent users."

The Rest of the Story

This is very important research, because it demonstrates that the intensive use of electronic cigarettes is associated with greatly increased rates of smoking cessation, even among a sample of dual users (i.e., all users were smokers at baseline).

However, the study also shows that for a number of reasons, many smokers do not become intensive e-cigarette users, and these individuals do not appear to gain any benefit from e-cigarettes in terms of smoking cessation. Trying to identify the factors that impede progression to more intensive electronic cigarette use could help to discover ways to make e-cigarettes more appealing and more likely to lead to more regular and sustained use. This would in turn increase the value of these products for smoking cessation.

One difficulty in interpreting the results of the study is that different levels of use may correspond with different levels of motivation to quit. For example, it may be that intensive users are more likely to be using e-cigarettes as part of an explicit quit attempt, while intermittent users are more or less experimenting with the products or using them for some other reason. This means that the results of any survey study must be interpreted strictly with respect to the nature of the use of the product in that specific sample.

This problem explains why two previous survey studies have found that e-cigarette users had lower chances of quitting. In those studies, many of the users were likely those who were not highly motivated to quit and who were not even making a quit attempt.

This is one major reason why a clinical study of the effects of e-cigarettes on smoking behavior is so critical. There is simply no other way to equalize the levels of motivation to quit and reasons for wanting to use an alternative product.

Interestingly, this study did not find a consistent relationship between electronic cigarette use and motivation to quit. Thus, even when one measures motivation to quit explicitly, it is not clear that controlling for this variable is adequate to account for differences between groups.

What does this all mean? It means that while survey research continues to be valuable, especially when it carefully defines and compares different subsets of e-cigarette users and attempts to focus on users who are explicitly making quit attempts, there are still major limitations with this methodology that cannot be overcome. We no doubt need many more survey studies to help elucidate the complex behavioral effects of  electronic cigarettes on smoking behavior. However, we also need a clinical study in which smokers at exactly the same level of motivation to quit are compared - that is, we need a randomized study in which the behavioral effects on smoking with e-cigarettes are identified and compared with another product such as NRT.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Wednesday, October 15, 2014

Why a Randomized Behavioral Study is Essential to Understanding the Potential Benefits of Electronic Cigarettes

Some of the researchers and advocates who opposed our crowdfunding campaign to raise money for a randomized behavioral study of the effects of electronic cigarettes on smoking behavior argued that randomized clinical trials (RCTs) are simply not appropriate to study e-cigarettes because they cannot simulate the real-life situation, where smokers have many choices of different types of products, can engage with social networks, and can experiment over time, change products, advance from one type of product to another, etc.

Instead, these advocates argued that surveys are the best way to study the potential benefits of e-cigarettes. Surveys measure the real-life situation of how e-cigarettes and vapor products are actually used.

According to the argument, surveys produce valid results, while RCTs produce invalid results.

The Rest of the Story

Unfortunately, it's just not that simple.

The above argument is convenient for advocates who want to suppress "negative" or "unfavorable" findings by discouraging RCTs - which they believe will "underestimate" the effectiveness of e-cigarettes for smoking cessation and encouraging survey studies - which they believe will show the effects of vapor products in all their possible glory. However, the argument carries with it a lack of scientific validity.

The truth is that there are major advantages and disadvantages of both surveys and clinical trials to examine the potential benefits of electronic cigarettes. Both types of study designs have inherent biases which can produce results that are more "favorable" or "unfavorable." This is why the methodology of published research needs to be examined so carefully. It is not so simple as to dismiss RCT evidence and accept survey evidence. One needs to consider the strengths and limitations inherent in both approaches. And at the end of the day, the only defensible approach, I believe, is that both types of studies are necessary, and we must carefully interpret and synthesize the findings from studies of multiple designs, using the totality of the evidence to make final judgments about the benefits of electronic cigarettes.

This is why I find it so troubling that some major voices in the e-cigarette community are arguing that RCTs should not be conducted and only survey studies are of value.

The randomized study provides a number of important benefits that can never be realized in a survey study. Most importantly, the RCT can equalize between study groups the known and unknown confounding variables that may lead to invalid study results.

For example, one of the major problems in some of the previous survey studies of electronic cigarettes (the ones cited by Stan Glantz, for example) is that they fail to control for a major confounder: the level of a smoker's addiction to smoking and motivation to quit. Some of the studies that Glantz has cited to show that e-cigarettes are ineffective for smoking cessation compare users of e-cigarettes and non-users of e-cigarettes. In two of these studies, those who did not use e-cigarettes had higher quit rates.

The problem is that the smokers who used e-cigarettes were likely more heavily addicted and more resistant to quitting. The reason they tried e-cigarettes was probably related to their failure to quit smoking using other types of therapy, such as NRT or other drugs. E-cigarettes, after all, are not generally the first smoking cessation approach that a smoker will try.

The impact of this confounding is that it will bias the results towards finding that e-cigarettes are much less effective than other approaches. In fact, this is exactly what happened and it is the reason why the evidence that Glantz and others are citing to support their contention that e-cigarettes hinder smoking cessation is invalid.

The beauty of a randomized study is that it can equalize the levels of smoking addiction, reasons for wanting to quit, and motivation to quit across groups. In addition, it equalizes other confounders, including unknown confounders which could affect the study results. There is no way for a survey study to accomplish this.  Thus, to simply throw out the RCT is quite unscientific, in my opinion. It throws out one of the most valid pieces of evidence that is necessary to make an informed judgment about the effect of these products: the differences in effectiveness of the products under conditions in which confounding cannot throw off the results.

A second major advantage of a clinical trial is that it can examine the potential effectiveness of interventions in which the use of a product is promoted for use among smokers who are interested in quitting. A survey cannot do this, because it can only examine the use of products under current conditions. It provides no information on what would happen if the product was actively promoted to a group of smokers, as it is in a clinical trial.

A third major advantage of a clinical trial is that conditions are controlled as carefully as possible, minimizing potential biases. Both sampling and measurement bias are greatly reduced, if not eliminated. In contrast, survey studies are generally subject to significant sampling and measurement bias.

There are some specific problems with survey studies that could lead to an overestimation of the benefits of electronic cigarettes. One major problem is that a survey study of the use of advanced vapor products would result in a severe bias towards finding a high level of effectiveness of these products. The reason? By the time smokers advance to use products like open-ended systems, they have already experienced success, fulfillment, and enjoyment with vaping. In other words, limiting the sample to users of advanced vapor products filters out the majority of e-cigarette users, who do not experience great success and therefore don't go on to the more advanced products.

Although the survey approach described above would lead to "invalid" results, I would never argue that survey studies should be thrown out and that we should only be conducting RCTs. My point is that there are strengths and limitations of various study designs, and causal inference is enhanced by having research evidence from multiple study designs. On balance, the strengths and weaknesses balance each other out, leading to a much greater ability to draw valid conclusions.

Neither the survey approach or the RCT approach is perfect. Both have major strengths and significant limitations. The best way to proceed is to conduct both types of studies and to synthesize the results across study designs, keeping in mind the methodological strengths and limitations of each individual study. Only by looking at this totality of the evidence can we draw valid scientific conclusions.

And this is why when some responded to our proposal for a randomized behavioral study by arguing that such an approach was invalid and that we should do a survey instead, I viewed those responses as being unscientific and unsound. Instead, I believe what is truly behind these draconian opinions (draconian because they would throw out an entire line of potential evidence) is a bias towards electronic cigarettes. I'm not arguing that it is a conscious bias. It may be subconscious. But I don't believe that any objective scientist would argue for completely throwing out a randomized clinical study design and relying solely on survey evidence to draw conclusions about the effectiveness of a product such as electronic cigarettes.

Finally, while it is true that the typical RCT is limited because it does not simulate the real-life situation where smokers can choose between different products, change products over time, and engage in social networks to support their vaping, the study we had proposed would have allowed for all of these things. We would have given smokers a wide range of products to choose from and allowed them to experiment with different products and make changes if they desired, and we would have referred them to a number of vaping web sites and support groups. In fact, we had decided to include a training and information session with an actual vaper as part of the study. This would still not have simulated the real-life situation exactly, but it would have significantly helped to make the study more meaningful by making it more similar to what happens in "real life."

I believe that such a modified, randomized clinical study is essential to add another line of evidence with which to evaluate the potential benefits of electronic cigarettes. Yes, there are limitations to RCTs, but it makes no sense to throw out the baby with the bath water.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Tuesday, October 14, 2014

New Study Finds No Benefits to Use of Over-the-Counter NRT for Smoking Cessation

A new study published in this month's issue of Mayo Clinic Proceedings casts doubt on the effectiveness of over-the-counter NRT for smoking cessation.

(See: Kotz D, Brown J, West R. Prospective cohort study of the effectiveness of smoking cessation treatments used in the "real world." Mayo Clinic Proceedings 2014; 89:1360-1367.)

The study - a prospective cohort study of 1560 adult smokers who were surveyed at baseline and 6 month follow-up and made at least one quit attempt between the two interviews - compared the quit rates for the use of prescription medication with specialist behavioral support, prescription medication with brief advice from their physician, over-the-counter NRT, and none of these (no use of medication).

The main outcome measure was sustained abstinence from the last quit attempt to the time of the survey. The analysis controlled for demographic variables as well as baseline level of cigarette dependence.

The results were as follows: "Compared with smokers using none of the cessation aids, the adjusted odds of remaining abstinent up to the time of the 6-month follow-up survey were 2.58 (95% CI, 1.48-4.52) times higher in users of prescription medication in combination with specialist behavioral support and 1.55 (95% CI, 1.11-2.16) times higher in users of prescription medication with brief advice. The use of NRT bought over the counter was associated with a lower odds of abstinence (odds ratio, 0.68; 95% CI, 0.49-0.94)."

Regarding the use of over-the-counter NRT, the study concludes: "The most frequently used form of treatment, NRT bought over the counter, appears to be associated with reduced success rates."

The Rest of the Story

This study adds to the growing evidence that while NRT is more effective than placebo in clinical trials, the real-life use of NRT is not necessarily associated with improved cessation outcomes. In this study, the researchers found that the use of over-the-counter NRT was actually associated with lower smoking cessation rates than quit attempts that did not involve the use of any medication.

The authors suggest that the reason for the failure of over-the-counter NRT in real life, but its effectiveness in clinical trials, is most likely the fact that in the clinical trials, there is intensive intervention outside of the drug, including instructions on how to use the medication, multiple study visits to help maintain adherence with medication use and the quit attempt, and consistent, long-term monitoring. As the authors argue: "This is a different situation from the real-world setting of our study in which smokers use the medication in an uncontrolled yet more realistic fashion."

The authors note that these findings are consistent with their earlier study, in which "NRT bought over the counter was equally associated with the success of quitting than not using treatment ... (adjusted odds ratio, 0.96; 95% CI, 0.81-1.13)."

Another possible reason why NRT is effective in clinical trials but may not be nearly as effective in real-life settings is that the clinical trials are not truly blinded. Many subjects receiving placebo are immediately aware that they are not receiving nicotine replacement and have a higher tendency to quickly give up on their quit attempt in frustration that they were assigned to the placebo arm of the study.

While the study did find a benefit of prescribed smoking cessation medication, especially in combination with specialist behavioral intervention, the reality remains that the most common form of NRT usage is over-the-counter purchase outside the setting of intensive behavioral intervention or physician advice and guidance. Thus, the "real world" effectiveness of NRT is brought into serious question by the results of this study.

In the context of their previous study showing that "real life" use of electronic cigarettes is associated with enhanced smoking cessation rates compared to the use of NRT, it appears that the existing evidence from survey studies suggests that electronic cigarettes may actually be more effective than NRT in real-life circumstances (i.e., outside the context of clinical trials).

I believe that what is needed urgently are randomized behavioral studies that directly compare electronic cigarettes head-to-head against over-the-counter NRT.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.

Thursday, October 09, 2014

New UK Advertising Rules for E-Cigarettes Prohibit Companies from Telling the Truth About Their Products

The UK's Committee of Advertising Practice (CAP) has announced new rules, effective on November 10, which restrict electronic cigarette advertising.

According to CAP:

"In summary, the rules state:
  • Ads must not be likely to appeal particularly to people under 18, especially by reflecting or being associated with youth culture
  • People shown using e-cigarettes or playing a significant role must neither be, nor seem to be, under 25
  • Ads must not be directed at people under 18 through the selection of media or the context in which they appear
  • Ads must not encourage non-smokers or non-nicotine users to use e-cigarettes
  • Ads must make clear that the product is an e-cigarette and not a tobacco product
Ads on TV and radio will be subject to scheduling restrictions to reduce the chance of e-cigarette advertisements being seen or heard by children. Furthermore, unless manufacturers obtain an authorisation for their product from the Medicines and Healthcare products Regulatory Agency, ads for e-cigarettes cannot convey health benefits or claim that they are ‘safer’ or ‘healthier’ than smoking tobacco."

The Rest of the Story

While many of these restrictions are reasonable, the final restriction mentioned - the prohibition on electronic cigarette companies claiming that these products are safer than tobacco cigarettes - is both inappropriate and devastating to the public health interest.

The restriction is inappropriate because it prohibits companies from simply telling consumers the truth about the relative safety of their products. Arguably, this is the single most important piece of information that every consumer needs to know. Keeping consumers in the dark about the relative safety of electronic cigarettes vs. tobacco cigarettes does not serve any public health interest. In fact, it does just the opposite.

By blocking e-cigarette companies from telling the truth to consumers, CAP has completely undermined the very purpose of electronic cigarette marketing. The only reason these products are on the market and being used extensively in the first place is that they are much safer than regular cigarettes. If they weren't safer than cigarettes, there would be no justification for these products to even remain on the market. Moreover, they would not have become so popular among smokers because no one is going to switch to a product that delivers less nicotine unless it has health benefits.

The relative safety of e-cigarettes over tobacco cigarettes is their primary selling point.

Destroying this selling point helps no one except for the UK's cigarette companies, which stand to enjoy a bigger run of profits due to CAP's stupidity.

The major purpose of regulating advertising in the first place is to prohibit companies from deceiving consumers. But by precluding companies from telling consumers the truth, the CAP's regulations actually ensure that consumers are deceived. There is no legal nor public health justification for this campaign of deception. It protects cigarette profits at the expense of the lives and health of UK citizens.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

Wednesday, October 08, 2014

New York City Council Considering Ban on Flavored Electronic Cigarettes

According to an article in the New York Daily News, New York City councilman Costa Constantinides (D-Queens) yesterday introduced legislation that would ban the sale of all flavored electronic cigarettes.

According to the article: "Councilman Costa Constantinides (D-Queens) will introduce legislation Tuesday to ban the fruity flavors, saying they entice kids to start puffing on the devices. “These flavors are direct marketing to children,” Constantinides said. “They appeal to children, and we’re taking them out of that market.” ... “These guys are not in the quitting business. They’re in the addiction business,” Constantinides said."

The Rest of the Story

Actually, these "guys" are in the quitting business, not the addiction business. The overwhelming majority of electronic cigarette users are people who are already addicted to cigarette smoking. And the reason they are using these products is because they want to overcome their addiction to smoking. They want a safer product that can help them get off cigarettes, or at least to greatly reduce their cigarette consumption in order to protect their health. Very few never smokers are regular electronic cigarette users, and there is at present no evidence that the use of electronic cigarettes leads to nicotine or smoking addiction in anyone who was not already a tobacco user.

Banning the sale of flavored electronic cigarettes would be tantamount to a ban on virtually all electronic cigarettes. In reality, virtually every electronic cigarette product is flavored. Even the "tobacco" type of electronic cigarette is actually a flavored product, since flavorings are generally used to create that "tobacco" taste. Otherwise, the only ingredients in electronic cigarettes are nicotine, propylene glycol, and glycerin.

Councilman Constantinides' desire to take flavored electronic cigarettes off the market may be motivated by a legitimate desire to protect kids from addiction, but the reality is that his proposal would greatly increase smoking addiction in New York City by removing from the market a product that is helping thousands of New Yorkers to eliminate their smoking addiction or at least to greatly reduce the level of that addiction.

Jacob Sullum provides an excellent review of the literature on this topic, pointing out that there is very strong data to demonstrate that the flavors are what attract many smokers to try to quit using electronic cigarettes. You have to read his whole column, but to summarize:

"Whether or not they appeal to minors, the flavors that offend him appeal to adults who switch from smoking to vaping. In a survey conducted by E-Cigarette Forum last summer, three-quarters of adult vapers favored flavor categories other than tobacco, including fruit (31 percent), bakery/dessert (19 percent), and savory/spice (5 percent). Sales data from Palm Beach Vapors, a chain of 14 stores that sell vaping equipment and liquids to adults only, confirm that supposedly juvenile flavors are popular with adults. Last fiscal year, only two of the chain's top 19 sellers were tobacco flavors. They finished 18th and 19th, far below flavors such as strawberry, watermelon, and cinnamon."

Sullum concludes: "Critics like Constantinides and Sen. Jay Rockefeller (D-Va.), guided by little more than their own idiosyncratic tastes, want to decree which flavors adult vapers may consume, even at the cost of deterring smokers from quitting. "Studies show that e-cigarettes, particularly flavored kinds, are effective at helping smokers move away from combustible cigarettes," says Gregory Conley, president of the American Vaping Association. "The AVA supports common-sense regulation of its products, such as New York City's existing ban on [sales] to minors. But adults are free to make their own choices." For now."

Hopefully, the New York City Council will vote down this proposal. If policy makers are interested in protecting kids from electronic cigarettes, they should focus on regulating the sale and marketing of these products - just as we do with the real cigarettes. It makes no sense to ban the entire product category, especially when we know these products are helping many smokers quit or cut down and when there is no evidence that the use of these products is causing youth to become addicted to smoking, or even to e-cigarette use itself.

The saddest part of the story is that while Councilman Constantinides is so concerned about youth "addiction" that he is willing to ban electronic cigarettes, he expressed no similar desire to ban the real ones. That's not public health leadership. It's political cowardice, and hypocrisy.


Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.