Anti-Tobacco Advocate Argues that Cigarettes Should Remain More Freely Available to the Public than Fake Electronic Ones Without Any Tobacco

I remember years ago when a colleague was pressuring a chain of stores to stop selling candy cigarettes. While I certainly agreed that stores shouldn't sell candy cigarettes, I asked my colleague a question: "Why are you asking the store to stop selling the fake cigarettes but to continue selling the real ones?" That made no sense to me.

Now, in a story that is quite similar, an anti-tobacco advocate is arguing that steps should be taken to make sure that real, deadly, tobacco cigarettes remain much more readily available to the public than fake ones which have not been shown to cause any substantial harm and which are actually helping thousands of people to quit smoking.

In a commentary published in the journal Tobacco Control, Dr. Simon Chapman argues that electronic cigarettes are a tobacco industry ploy to keep people smoking, that reducing smoking has no health benefits, and that real cigarettes should remain more readily available to the public than the fake ones.

(See: Chapman S. Should electronic cigarettes be as freely available as tobacco cigarettes? No. Tobacco Control 2013; doi: http://dx.doi.org/10.1136/bmj.f3840. Published 14 June 2013.)

One of the key arguments made in the commentary is that there is no health benefit to reducing the amount one smokes -- even if the reduction is substantial (e.g., greater than 50%). Chapman argues that: "importantly, cutting down cigarettes rather than quitting confers little if any health benefit, so dual use may be as bad as continued smoking in terms of health outcomes."

The Rest of the Story

If a physician made the same claim to a patient that Dr. Chapman is making, it would - in my opinion - constitute medical malpractice. Why? Because the statement is blatantly false and runs contrary to both medical science and widespread clinical experience. It is blatantly untrue that a major reduction in cigarette consumption confers no health benefits to a patient. In contrast, there are immediate and important health benefits.

Now obviously, cutting down is not nearly as beneficial as quitting entirely, but the statement made in this commentary is not that quitting is better than cutting down. The statement is that cutting down substantially has no health benefits.

But, wait, you say. Dr. Chapman cites research which found no health benefits associated with smoking reduction. Well, there are two problems. First, the paper did not look at all of the important health outcomes. For example, it does not report on whether smoking reduction improved patients' respiratory symptoms. In other words, did it improve their lives? Second, the paper did not have sufficient power to detect the health benefits that might accrue with smoking reduction. So even though some of the relative risks are not statistically significant, they are substantially less than 1.0 and probably represent an important health benefit. With a larger sample size, the study would likely have found these benefits to be statistically significant.

The first benefit that is unequivocally related to smoking reduction is an improvement in respiratory symptoms. That alone makes the statement false. Now the reduction in respiratory symptoms may not necessarily translate into a measurable improvement in lung function, but there is almost certainly a health benefit in terms of respiratory symptoms. This is an important health benefit because it improves people's lives. If they can actually climb up a flight of stairs, which they couldn't before, then how can one argue that they have not experienced any health benefit?

The second benefit that is almost certainly related to smoking reduction is a decreased risk of lung cancer. Even the research that the commentary cites as showing no health benefit actually shows that smokers who reduced their consumption were less likely to die of lung cancer. The relative risk was 0.66. This means that their lung cancer risk declined by one-third. That is a substantial decline. While the relative risk was not statistically significant, this was likely due to the low power of the study.

Importantly, other research - with a more appropriate sample size - has documented a reduction in lung cancer risk associated with smoking reduction. For example, a study published in the Journal of Clinical Oncology which had a sample size almost 10 times higher than the study which found the non-significant relative risk of 0.66 found a very similar reduction in lung cancer risk, but the reduction was statistically significant.

The study results were as follows: "For lung cancer, patients who reduced from heavy to moderate smoking and from heavy to light smoking (< 10 cigarettes/d) had significantly decreased risks based on multivariable-adjusted HRs (HR = 0.72, 95% CI, 0.49 to 0.89; HR = 0.63, 95% CI, 0.46 to 0.84, respectively)." This means that smokers who reduced their consumption were able to decrease their risk of lung cancer by one-third.

This is hardly evidence for a lack of any health benefit from smoking reduction.

This paper concludes that: "Smoking reduction was associated with a significant decrease in the risk of lung cancer...".

The third benefit that may be related to smoking reduction is a slowing of the progression of chronic lung disease. The research cited in the commentary did not even examine whether smoking reduction lowers the risk of death from chronic obstructive lung disease. So even from that research alone it is not appropriate to conclude that there are no health benefits associated with smoking reduction.

The upshot of this advice is that many patients who are unable to quit smoking but might well be able to reduce the amount that they smoke may decide that it's not worth the bother. If there are no health benefits, then why bother reducing consumption?

Well, perhaps the greatest health benefit of reducing cigarette consumption is that it makes it easier, ultimately, to quit smoking. There is no question that reducing smoking is often a behavior that lies along the pathway from heavy smoking to quitting. It is easier to quit smoking for someone who smokes a half pack per day than for someone who smokes three packs per day.

My point is not that smoking reduction should be the focus of tobacco control efforts. Readers will remember that last week I highlighted a recent chapter I wrote which emphasizes the importance of jolting smokers into spontaneous, cold turkey cessation. And in fact, I cited Dr. Chapman's important work in this area. He has been a pioneer in challenging the dogma of the tobacco control movement. I should make it clear that I have the greatest admiration for Dr. Chapman.

However, on this particular issue, I sense that there is some sort of ideological barrier that is slanting his take on the issue. The point of this post is to demonstrate that in opining about electronic cigarettes. Dr. Chapman has misrepresented the science on the benefits of smoking reduction. In doing so, he has negated any health value associated with switching from smoking to vaping for smokers who are not able to completely make the switch.

I challenge Dr. Chapman to actually speak to vapers who have made the switch, but are still maintaining some cigarette use, and ask them to report whether it is indeed true that they have not experienced any improvement in their respiratory symptoms. We know from speaking to many vapers that there is unquestionably a health benefit associated with switching from real cigarettes to fake ones, and that this benefit accrues even among those who are unable to achieve a 100% substitution of non-tobacco cigarettes for tobacco cigarettes.

The rest of the story is that once again, here is an example of an electronic cigarette opponent who seems more guided by ideology than by the facts. I understand that anti-tobacco advocates have a hatred for the act of cigarette smoking and for the tobacco companies. But we can't let that hatred blind ourselves to the scientific facts. And the fact is that vaping has improved the lives of hundreds of thousands of smokers and ex-smokers. To take this away from them, or even to make it more difficult for other smokers to experience these benefits, would be a public health tragedy.

At the end of the day, I would much rather that the public has easier access to fake cigarettes than to the real ones.

The Cleveland Clinic: Unethical By Its Own Standards

By its own standards, the Cleveland Clinic is acting unethically by supporting behavior that ultimately leads to death.

How is the Cleveland Clinic supporting behavior that leads to death?

Well, it's doing it in two ways:

1. By continuing to employ smokers, which increases health care costs, threatening our "sustainability as a nation."

2. By continuing to employ overweight individuals, which drives up health care costs, threatening our "sustainability as a nation."

The Rest of the Story

It is not me who opined that hiring employees who exhibit unhealthy behaviors is unethical. It is the Cleveland Clinic! In an op-ed piece, the physician who chairs the Wellness Institute at the Cleveland Clinic wrote:

"Is it ethical for employers to hire smokers? The practice fosters ill health and makes America less competitive in an international marketplace. The expense of healthcare in the United States represents more than 18 percent of the gross domestic product, more than in any other country. It threatens our sustainability as a nation, squeezing out education and defense. Therefore, we must do everything we can to bring down costs while improving quality. Tobacco use accounts for one in every five deaths each year in the U.S.To us, supporting a habit that ultimately leads to death would be unethical. In 2006, we began offering free smoking cessation to our employees; the following year we offered the same throughout Northeast Ohio. In 2008, we stopped hiring smokers, a natural progression."

So the Cleveland Clinic itself apparently believes that it is unethical to hire smokers. Well, then, the Cleveland Clinic is, by its own admission, engaging in unethical behavior because it employs smokers. In fact, 6% of its workforce smokes. Why is the Cleveland Clinic continuing to engage in this unethical behavior? Sure, the Cleveland Clinic has stopped hiring new employees who smoke, but ethics does not know the difference between an existing employee and a new one. If it is unethical to employ a smoker, then it is unethical to employ a smoker. There is nothing stopping the Cleveland Clinic from firing existing smokers who do not quit within a reasonable amount of time.

Moreover, by its own admission, the Cleveland Clinic is unethical in supporting another behavior that leads to death: overeating and under-exercising. Overweight and obesity are severe health risks that lead to billions of dollars in health care costs. To be sure, obesity is driving up health care costs in the same way as smoking. Some estimates put the costs of obesity as rivaling those of smoking.

So why is the Cleveland Clinic supporting these unhealthy behaviors which can lead to death by continuing to employ overweight and obese individuals?

While businesses that refuse to hire smokers can make a legitimate argument that they need to reduce health care costs. if they implement smoker-free policies for this reason then they are simply engaging in discrimination and bigotry. But the Cleveland Clinic is not just engaging in discrimination and bigotry. It is also engaging in the basest form of hypocrisy: telling the world that it has higher ethical standards than most, but not actually living up to the ethical standards it espouses.

The Cleveland Clinic tells us that it is unethical to employ smokers, but then it goes ahead and continues to employ smokers. The Cleveland Clinic tells us that hiring people who engage in unhealthy behavior is unethical, and then it goes ahead and continues to hire people who overeat and under-exercise to the point that their obesity threatens their health and lives.

The Cleveland Clinic is not just serving as a model for employment discrimination and bigotry. It is serving as a model for hypocrisy and political cowardice. They are not even willing to stand up for what they say they believe in.

This is politics, not public health.

The appropriate way for employers to deal with problems such as smoking and obesity is not to discriminate against smokers or overweight individuals in their hiring practices, but to offer comprehensive employee health and wellness programs with state-of-the-art initiatives to promote healthy behavior.

Worksite health promotion is a central aspect of public health. Employment discrimination is not.

Campaign for Tobacco-Free Kids Wants to Tie Childhood Education to Future High Levels of Smoking; Undermines National Tobacco Control Funding

In a destructive move that will have negative repercussions for future funding of tobacco control programs, the Campaign for Tobacco-Free Kids has turned its back on the state-of-the-art in tobacco control and instead, is pushing for a cigarette tax increase that will further reduce incentives for the government to reduce cigarette use.

In a letter to the editor published in the New York Times, the Campaign for Tobacco-Free Kids supports President Obama's proposal to increase the federal cigarette excise tax by 94 cents in order to fund early childhood education programs. The revenues would be used to help expand pre-school programs. None of this money would be allocated for tobacco control or even other health-related programs.

The Rest of the Story

The state-of-the-art in tobacco control is the use of cigarette tax increases to fund comprehensive tobacco control programs. This is precisely what California did in 1989, and this is specifically why California has been so successful in reducing smoking prevalence. Unfortunately, this model is not being used any more, largely because the Campaign for Tobacco-Free Kids turned its back on this model. Instead, the Campaign decided to, in knee-jerk reflex fashion, support any and all cigarette tax increases, regardless of their underlying purpose or the use of the resulting revenue.

Why is it that so few states are funding their anti-smoking programs at adequate levels? Part of the answer, believe it or not, is the actions of the Campaign for Tobacco-Free Kids.

In the late 1990s, the Campaign made a decision to support increasing state cigarette taxes without tying those tax increases to smoking-related spending. The Campaign initiated campaigns throughout the country to increase cigarette taxes, but did not insist that the revenues be allocated for treatment of smoking-related diseases, research to prevent or cure smoking-related diseases, or anti-smoking education and prevention programs.

As a result, numerous tax increases were enacted with no tie to smoking-related programs. Thus, the public learned to dissociate the two. The public also learned to distrust policy makers because they failed to see the tobacco revenues being used for smoking-related purposes. They saw the revenues simply being plopped into the general fund.

Largely because of this, it is now very difficult to pass any cigarette tax increase as the public trust is not there. Moreover, the idea of using cigarette taxes for smoking programs has all but disappeared.

It is my belief that in no small way, the Campaign for Tobacco-Free Kids is responsible for the devastation of statewide tobacco control in the United States. The low allocation of state budget resources - especially cigarette tax revenues - for anti-smoking programs is very much the Campaign for Tobacco-Free Kids' doing.

In addition to undermining funding for tobacco control programs, this policy has the disastrous effect of permanently tying the provision of pre-school education to continued high rates of cigarette smoking.

In the future, what would happen if smoking rates dramatically drop? The answer is that pre-school education programs would have to be cut because of declines in cigarette tax revenue. Thus, the President's proposal creates a situation in which the maintenance of pre-school education becomes dependent on continued high rates of cigarette smoking.

This has several perverse effects. One is that it takes away any incentive for the federal government to substantially cut cigarette smoking. Doing so would result in de-funding pre-school education and who would want to do that? A second effect is that it creates a government dependence on cigarette smoking for one of the most critical services that the government provides: pre-school education.

Essentially, this proposal would allow smokers to boast that it is thanks to them that our nation's 4 year-olds are being educated. Can you imagine bumper stickers like: "Support Pre-School Education: Smoke Early and Often," or "I Support Kids: I Smoke."

This is how perverse the effects of the proposed tax would be.

Should the Congress increase the cigarette tax? Well, it depends on the purpose of the tax increase. If the money is used to fund pre-school education, then no. It makes no sense, it makes this essential program dependent on continued high rates of smoking, it removes the incentive for the government to substantially reduce smoking rates, it undermines the principle of spending tobacco revenues on tobacco control, and it is unfair to smokers to have to shoulder the burden of funding pre-kindergarten education programs.

But if the money were to be used specifically for anti-smoking programs, then it would truly become a win-win situation. The tax would not only decrease cigarette consumption but would provide much-needed funding for tobacco control. It would be fair to smokers, because much of the revenue would be used to directly benefit smokers, such as finding more effective treatments for smoking-related diseases and providing specific services to smokers. Moreover, if the revenues decline over time, the program needs less money because there are fewer smokers.

This is what the Campaign for Tobacco-Free Kids should be supporting, not balancing our federal budget on the backs of smokers.

New Article Reveals Massive Deception about Effectiveness of NRT, Need to Shift Toward Abrupt Cold Turkey Cessation Approaches

In a book chapter published last week by Future Medicine, I reveal how the public has been massively deceived about the true effectiveness of nicotine replacement therapy (NRT) and identify the need to shift focus toward the use of abrupt, cold turkey strategies for smoking cessation.

(See: Siegel M. Intervention for smoking cessation: from randomized controlled trial to real world. In: Polosa R, Caponnetto P, eds. Advances in Smoking Cessation. London: Future Medicine, 2013: 54-66.)

The chapter begins by citing a recent Cochrane review of the effectiveness of NRT for smoking cessation. It points out that in this "comprehensive" review, the pooled relative risk of smoking cessation associated with pharmacotherapy is given (1.8). The authors conclude that NRT and other drugs are effective for smoking cessation because they double quit rates compared to placebo.

However, what the review does not reveal is the absolute cessation rate achieved with NRT or other drugs. It turns out that the actual success rate - not provided in the article - was only 12.5% for studies that validated quitting biochemically. Thus, as my article states: "the treatment that this review recommends for all patients has a dismal 87.5% failure rate."

But the story does not end there. In real-life, as opposed to clinical trial settings, the quit rate associated with NRT use is only about 10%. I therefore conclude that: "Due to the low success rates for pharmacotherapeutic approaches to smoking cessation, the value of this strategy for smoking cessation is limited."

The article goes on to question a key theoretical assumption in the treatment of smoking dependence: that quitting smoking occurs in stages, according to the Transtheoretical Model (also called the Stages of Change model). I point out a number of studies which document that spontaneous, unplanned quitting is more effective than gradual, planned quit attempts. Some researchers, including Dr. Robert West, have called for the abandonment of the Transtheoretical Model for use in smoking cesation. Following West, I conclude that: "In practice and as supported by a growing body of literature, there is little support for the Transtheoretical Model as a valid description of typical smoking cessation behavior. ... Smoking cessation programs and policies therefore need to lessen their reliance upon the Transtheoretical Model and become open to alternative models which allow for sudden, spontaneous, unplanned behavior that does not require a gradual progression through various stages of change."

I cite the important work of Dr. Simon Chapman who has argued that there is too much of an emphasis in tobacco control on pharmacotherapy, to the almost complete neglect of cold turkey cessation: "Chapman and Mackenzie argue that the majority of successful quitters do so unaided or 'cold turkey,' without the help of pharmacotherapy. Furthermore, they argue that the tobacco control movement has become overly focused on the use of pharmaceutical approaches, neglecting the evidence base which consistently shows that the overwhelming majority of successful quitters have done so cold turkey."

The article also questions the assumption that smoking addiction is solely addiction to nicotine, arguing that the physical, behavioral, psychological, and social aspects of smoking contribute heavily to its addictiveness. This explains why NRT and other forms of pharmacotherapy are so ineffective and why electronic cigarettes represent such a promising approach: "They address not only the pharmacological, but also the physical and even the social aspects of smoking addiction. Placing a nicotine patch does nothing to simulate smoking behavior and there is no social aspect to the behavior. In contrast, electronic cigarettes closely mimic cigarette smoking and they can be used with other people in social settings. Future approaches to smoking cessation must treat smoking addiction more holistically, recognizing that it entails far more than merely a dependence on nicotine."

There are two major recommendations of my article:

1. "Rather than relying on the Transtheoretical Model and focusing on pharmacotherapy or counseling, the basis for an effective smoking cessation program should be an aggressive, hard-hitting, high exposure, anti-smoking media campaign that jolts smokers into quitting, regardless of their previous stage of readiness to quit."

2. "Instead of focusing solely on nicotine replacement, nicotine vaccines, or pharmacologic agents that bind to nicotine receptors, smoking cessation treatment approaches must address the behavioral aspects of smoking addiction in addition to its pharmacological component. The prototype for such a strategy is the electronic cigarette... ."

The Rest of the Story

I sincerely hope that this chapter will help to facilitate a paradigm shift in the tobacco control movement in terms of our strategies to promote smoking cessation.

A Changing World: All Three Major U.S. Tobacco Companies Have Now Entered the Electronic Cigarette Market

Reflecting massive changes in the U.S. tobacco space, all three major U.S. tobacco companies - Altria, Reynolds American, and Lorillard - have all entered the electronic cigarette market.

Lorillard had previously acquired Blu, but last week's announcement that R.J. Reynolds will introduce Vuse e-cigarettes in Colorado in July and this week's announcement that Altria will introduce MarkTen e-cigarettes in Indiana in August mean that all three companies will have entrants in the electronic cigarette market.

The Rest of the Story

There is now no question that the major cigarette companies are actively engaged in transforming the cigarette market, with a shift towards much less hazardous tobacco products. This shift has already resulted in a significant reduction in cigarette consumption, but the declines in smoking should grow as these alternative products begin to penetrate into brick-and-mortar retail stores, rather than just mall kiosks and the internet.

Ironically, the only groups which are opposing this transformation - which may result in a great reduction in cigarette-related morbidity and mortality - are the anti-smoking groups, which simply can't handle the fact that vaping looks like smoking and are not willing to actually examine the evidence that electronic cigarettes, in their seven years on the market, have not resulted in youth smoking initiation or even regular e-cigarette use among nonsmokers.

All three of the major tobacco companies are now officially in the business of harm reduction and are devoting a substantial amount of resources to promoting smoking cessation via the use of electronic cigarettes. On the other hand, anti-smoking groups are largely opposed to the use of electronic cigarettes and have called for their removal from the market. They, along with the FDA, are actively discouraging smokers from trying to quit using these products and are scaring smokers who have quit using electronic cigarettes into discontinuing the use of these devices and instead, returning to smoking.

In addition to being a strange but true ironic twist, I view this as being a major embarrassment for the anti-smoking movement.

Is it not unfortunate that we in tobacco control are the last to adopt the idea of harm reduction to help protect the health of millions of smokers who - let's face it - are not going to quit smoking? Is it not a disgrace that Big Tobacco is now promoting a form of smoking cessation that we in tobacco control are discouraging?

The entrance of the cigarette companies into the electronic cigarette market offers five distinct advantages that I believe in the long run will enhance the e-cigarette market:

1. The entrance of the tobacco companies into the electronic cigarette space now means that a substantial amount of resources - not previously available - can be devoted to marketing the product and making the public aware of electronic cigarettes, something which has previously been quite slow to develop. It is unfavorable for the e-cigarette industry that even six years after introduction of this product, consumers are still largely unaware of the very existence of the product. Even tobacco control experts remain confused about the differences between a cigarette and an electronic cigarette. Already, the entrance of the tobacco companies into the market has resulted in substantial publicity and media attention which is helping to educate the public about these products. 

2. The entrance of the tobacco companies into the electronic cigarette space now means that the industry has the resources to conduct the types of studies that may be required in order to obtain FDA approval for various important marketing claims that will ultimately be pivotal for the industry. While it is unclear whether the FDA will apply section 911 to electronic cigarettes (I have urged the agency not to do so), if it does there is no chance that any of the smaller electronic cigarette companies could possibly produce the research required to meet the heavy burdens of that statute. At least there is now a chance. Even if the FDA does not apply section 911 to electronic cigarettes, the entrance of tobacco companies into the market will help facilitate the conduct of important research into the safety and effectiveness of electronic cigarettes that can help inform the development of rational public policy regarding these products.

3. The entrance of the tobacco companies into the electronic cigarette space creates a formidable force that the FDA must now deal with and which has the resources to apply pressure to the agency to promote a reasonable approach to electronic cigarette regulation.

4. The entrance of the tobacco companies into the electronic cigarette space helps the entire industry by establishing an entity that can introduce the most stringent and appropriate quality control measures and help address concerns such as:

• the presence of diethylene glycol in some cartridges;
• unpredictable delivery of nicotine; 
• inaccurate nicotine levels on cartridges;
• exploding batteries;
• leaky cartridges, etc.

Anti-smoking advocates will no longer be able to argue that we have no idea what electronic cigarettes are or what they contain or how or where they are made. In addition, the tobacco companies will be able to educate the FDA and provide the agency with ideas about specific aspects of the manufacturing process that could be incorporated into sensible regulations that would help set high standards for the entire industry.

5. Perhaps most importantly, the entrance of the tobacco companies into the electronic cigarette space may help transform the market by shifting it from an internet and mall kiosk business into a more traditional retail store operation. Already, the cigarette companies have developed arrangements with retail stores to carry their products. This could potentially lead to a more traditional market in which these products are available at brick-and-mortar stores, not just on the internet or at mall kiosks.

New Study Shows that Electronic Cigarette Vapor is Much Less Cytotoxic than Cigarette Smoke

A new study from researchers in Italy and Greece, under the direction of senior author Dr. Konstantinos Farsalinos, reported last week in the journal Inhalation Toxicology that vapor from electronic cigarettes was found to be much less cytotoxic (damaging to cells) than tobacco smoke.

(See: Romagna G, Allifranchini E, Bocchieto E, Todeschi S, Esposito M, Farsalinos KE. Cytotoxicity evaluation of electronic cigarette vapor extract on cultured mammalian fibroblasts (ClearStream-LIFE): Comparison with tobacco cigarette smoke extract. Inhalation Toxicology 2013; 25(6):354-361.)

The study examined the effect of electronic cigarette vapor from 21 different brands compared to cigarette smoke on the growth of fibroblasts in cell culture. This is a laboratory test that detects whether or not a substance causes cell damage and therefore inhibits cell growth.

At the highest dilution, 20 of the 21 brands of electronic cigarette showed no signs of cytotoxicity. One brand showed evidence of cytotoxicity at the highest dilution but not at any lower dilutions. Even at this high dilution, the cytotoxicity was more than two orders of magnitude lower than that of cigarette smoke. In contrast, cigarette smoke was cytotoxic up until the third level of dilution.

The study reports the findings as follows:

"The main result of our study is that the vapor from only 1 of the 21 EC [electronic cigarette] liquids examined had cytotoxic effects on cultured fibroblasts according to protocol definition. CS [cigarette smoke] extract had significant cytotoxic effects, and fibroblast viability was significantly lower at all extract concentrations compared to EC vapor extracts."

The study concludes:

"This study indicates that EC vapor is significantly less cytotoxic compared to tobacco CS."

The Rest of the Story

This study adds further evidence that electronic cigarette use is much safer than cigarette smoking. There is absolutely no scientific basis for anti-smoking advocates to continue arguing that vaping is simply another form of smoking. This should put that argument to rest. Completely.

The one electronic cigarette brand that did show evidence of cytotoxicity was a "coffee-flavored" brand. Dr. Farsalinos and colleagues point out that it is quite likely that the cytotoxicity resulted from the flavoring, rather than the electronic cigarette liquid components generally used in most brands, as processing of coffee beans has been shown to lead to degradation products that exhibit cytotoxicity. They also point out that even for this brand, "the cytotoxic effect ... was found only at the highest extract concentration, and, even at this concentration, fibroblast viability was 795% higher compared to CS extract."

Nevertheless, the results do suggest that studies are necessary to make sure that flavorings or other additives in electronic cigarette liquids are not harm-producing. This is an area that the FDA could address in its regulatory oversight of these products.

The rest of the story is that we now have additional scientific evidence that vaping is much safer than smoking. We already knew that vaping greatly lowers the carcinogenic risk associated with cigarette smoking. Now we know that vaping greatly lowers cytotoxicity as well. There is strong evidence that vaping lowers both the carcinogenic risk and lung disease risks associated with cigarette smoking.

It is simply untenable for anti-smoking groups and policy makers to continue the argument that vaping is simply another form of smoking. There is a world of difference between the two. And that difference might just be that between life and death for hundreds of thousands of electronic cigarette users.

German Cancer Research Center Corrects Inaccurate Statement About Glycerine Causing Lipoid Pneumonia

In response to my blog post revealing an inaccurate statement in the German Cancer Research Center's report on electronic cigarettes, the Center has corrected the statement.

The original statement was: "Glycerine may cause lipoid pneumonia on inhalation." As I pointed out, this is not possible, because glycerine is an alcohol and lipoid pneumonia is associated with the aspiration of oils.

In response, the Center corrected this statement in its online version of the report to read: "Inhaled glycerine-based oils may cause lipoid pneumonia."

The Center also let me know that the incorrect statement was a mistake, rather than a deliberate attempt to mislead readers.

The Rest of the Story

I applaud the German Cancer Research Center for correcting this inaccurate statement. As I pointed out, the statement was particularly damaging, because it gave the impression that glycerin, which is widely used in almost every brand of electronic cigarettes, can potentially cause this serious adverse outcome. The effect could have been to discourage smokers from trying electronic cigarettes and potentially, to encourage governments to ban the product. So I thank the German Cancer Research Center for correcting this important mistake.

However, there is still a problem with the Center's conclusion, in my opinion. I simply do not think that a single case report is enough to justify a conclusion that electronic cigarettes pose any significant risk of lipoid pneumonia, especially when even this single case report was unable to document that the case was attributable to the use of an electronic cigarette.

To be very clear, I have no problem with the Center stating that there was a published case report in which the authors attributed a case of lipoid pneumonia to the use of an electronic cigarette. However, the report goes beyond this. It also includes a bullet point - which is essentially a summary or conclusion statement - that asserts to readers that electronic cigarettes can cause lipoid pneumonia because of the presence of "glycerine-based oils."

First, I believe it is misleading to use the term "glycerine-based" oils. By including the term "glycerine," I'm afraid that many readers will misinterpret the assertion to mean that glycerine itself may cause lipoid pneumonia. Why even include the word "glycerine"? Almost all oils are "glycerine-based" so the term is redundant and unnecessary. It creates confusion between the real potential cause - the possible presence of oils in some electronic cigarette brands - and the substance present in almost all electronic cigarettes which does not cause lipoid pneumonia: glycerine.

Second, I do not believe this conclusion is scientifically justified. It is based on just a single case report and if you carefully consider the details of the case report, it becomes clear that this report cannot definitively attribute the case to oils inhaled from an electronic cigarette.

The report does not document the specific brand of electronic cigarette used, nor does it document the ingredients of that electronic cigarette. Thus, it is not even clear whether the electronic cigarette brand contained oils as an ingredient or not. The author of the paper is not able to provide that information, so it is premature and inappropriate - I believe - to draw the conclusion that the case was attributable to something that we don't even know for sure was present in that particular brand of electronic cigarettes.

According to the paper: "Recent evaluation of the nicotine solution and vapor content of e-cigarettes found primary components of propylene glycol, glycerin, and nicotine. Other chemicals identified in trace amounts include N-nitrosamines, diethylene glycol, polycyclic aromatic hydrocarbons, anabasine, myosmine, and β-nicotyrine. ... Vegetable glycerin is often added to the nicotine solutions used in e-cigarettes to make the visual smoke when the solution is vaporized."

None of the chemicals mentioned in this case report could cause lipoid pneumonia. While I am not arguing that it is impossible that the presence of oils in some electronic cigarette brands could hypothetically cause lipoid pneumonia if aspirated, it seems clear that this report fails to even document that there were oils present in the specific brand of electronic cigarettes used by the patient.

In the absence of such documentation, I don't see how the report can definitively attribute the lipoid pneumonia to the use of electronic cigarettes.

There is even a third possibility. The patient in question reported that her home was fumigated with chemicals two weeks prior to her presentation in the hospital. Exposure to fumigation chemicals has been associated with the development of lipoid pneumonia, possibly because some of the fumigation chemicals used are oils or oil-based.

Again, I have no problem with the report speculating that the use of an electronic cigarette that may have used an e-liquid that contained oils could potentially have caused lipoid pneumonia in this particular patient. However, I do not believe this justifies a conclusion that electronic cigarettes cause lipoid pneumonia and I think that the use of the term "glycerine-based oils" is misleading.

Nevertheless, I applaud the German Cancer Research Center for correcting the mistake about the potential cause of lipoid pneumonia in a patient who used electronic cigarettes.

The Problem with the Tobacco Control Movement: Ideology Has Overtaken Science

According to a DNA India article, the health minister of France supported her call for a ban on vaping in public places and a ban on e-cigarette advertising by asserting that using an electronic cigarette is the same thing as smoking.

According to the article: "The Italian health ministry's top advisory body has recommended a ban on the smoking of electronic cigarettes in public places and their sale to pregnant women and minors. The recommendation by the ministry's Superior Health Council came after France's Health Minister Marisol Touraine said she was planning simiar restrictions. 'Smoking an e-cigarette is smoking,' she stated."

The Rest of the Story

Nothing could be further from the truth.

The truth is: "Smoking an e-cigarette is a step towards quitting smoking."

This is the bare fact that so few in the anti-smoking movement seem to appreciate.

The importance of this story is that it illustrates precisely what is wrong with today's anti-smoking movement. Instead of being driven by science, as it was in the past, it is now being driven by ideology. This ideology is so skewed that using a non-tobacco device resembling a pen that vaporizes a solution of nicotine and propylene glycol without any combustion or smoke production is considered equivalent to cigarette smoking.

That using an e-cigarette is considered to be the same thing as smoking is emblematic of the victory of ideology over science in today's anti-smoking movement. The science clearly tells us that vaping is not smoking and that in fact, vaping is a method of quitting smoking. But the ideology is telling many anti-smoking advocates that because it looks like smoking, vaping actually is smoking.

I explained yesterday how a tobacco control researcher - Dr. Glantz  - is so much guided by ideology instead of the science on this issue that he called a study which did not evaluate the effectiveness of e-cigarettes for smoking cessation a "good study" of the effectiveness of e-cigarettes for smoking cessation.

Apparently, the ideology against a behavior that looks like smoking is so strong that most anti-smoking advocates are incapable of condoning such a behavior, even if it is saving lives.

The upshot of this is that the anti-smoking movement is doing everything in its power to protect cigarette sales from the threat of e-cigarettes. Even the cigarette companies are hoping to shift some of the cigarette market toward e-cigarettes. Not so with the anti-smoking groups. And that's a tragedy.

Researcher Continues to Use Bogus Data to Support Non-Efficacy of E-Cigarettes; Even Study Authors Admit Study Cannot Be Used to Evaluate E-Cig Efficacy

In my recent KQED radio discussion with Dr. Glantz about proposed California legislation to ban electronic cigarette use in public places, Dr. Glantz again cited data from a recent study by Vickerman et al. to support his contention that e-cigarettes are less effective than NRT for smoking cessation.

I have already explained in detail why the data from the Vickerman study cannot be used to assess the effectiveness of e-cigarettes for smoking cessation. Briefly, instead of estimating cessation rates among a cohort of smokers who made quit attempts using these products, the study analyzed cessation rates of a large number of smokers who had previously tried to quit using e-cigarettes but failed, and then called a quitline because they had failed and wanted to try again. Then, they compared the quit rate among these smokers to that among smokers without such a history of a failed quit attempt using electronic cigarettes.

In other words, this study did not estimate quit rates among smokers trying to quit using e-cigarettes. Instead, it estimated quit rates among many smokers who were not using e-cigarettes in their quit attempt at all!

The truth is that many of the electronic cigarette users in the study did not use electronic cigarettes in their quit attempts! According to data provided in the paper, a full 28% of the sample of electronic cigarettes did not use these products in their quit attempts.

It should be clear to readers that this study was poorly designed to investigate the efficacy of electronic cigarettes.

The Rest of the Story

Concerned that Dr. Glantz was misrepresenting the results of their study, the authors of the study - who are at Alere Wellbeing - publicly admitted that the study was never intended to assess the effectiveness of electronic cigarettes and that the data should not be used for this purpose.

The Alere Wellbeing blog states very clearly: "The recently published article by Dr. Katrina Vickerman and colleagues has been misinterpreted by many who have written about it. It was never intended to assess the effectiveness of the e-cig as a mechanism to quit."

Imagine that a tobacco company was concerned about the threat of electronic cigarettes to its profits and wanted to publicly disseminate a conclusion that electronic cigarettes are less effective than NRT for smoking cessation. A new study comes out, published in a reputable journal, that is not designed to evaluate the efficacy of electronic cigarettes for smoking cessation. It neither can nor should be used to gain information about the rate of successful cessation using e-cigarettes. But the tobacco company uses these data anyway, telling the public on a radio show that this study shows how ineffective electronic cigarettes are.

Without a doubt, anti-smoking advocates would view the behavior of this tobacco company as fraudulent. The company would be viewed as misleading the public, misrepresenting the results of research, and trying to pull the wool over the eyes of the people.

There is a reasonable discussion that can be conducted regarding the wisdom of banning vaping in public places. However, if we use bogus data to support a pre-determined position, this is no longer a scientific discussion.

It is clear to me that Dr. Glantz has a pre-determined opinion about electronic cigarettes and that this ideology is dictating his agenda, which is now blind to the actual scientific evidence. He is judging studies not based on their scientific rigor, but on whether their "findings" are "favorable" to his opinion. This is a perfect example of this. Here we have a study which, as the authors themselves admit, sheds no light whatsoever on whether electronic cigarettes are effective for smoking cessation. Yet Dr. Glantz used this study to publicly declare that e-cigarettes are less effective than NRT, a gross misrepresentation that deceives the public.

Dr. Vickerman herself explained that her results do not in any way indicate that electronic cigarettes are less effective than NRT, stating: "It may be that callers who had struggled to quit in the past were more likely to try e-cigarettes as a new method to help them quit. These callers may have had a more difficult time quitting, regardless of their e-cigarette use."

By the way, this is a study that Dr. Glantz called a "good study" on "the use of e-cigs for cessation."

Finally, I need to clarify another misrepresentation by Dr. Glantz. He stated on his blog that my main argument against the proposed California ban on vaping in public places is that this would harm vapers by decreasing electronic cigarette use. He states: "Mike's essential argument was that any restrictions on "life saving" e-cigarettes would discourage their use for smoking cessation."

This is not my argument. My argument is that the bill is not justified because there is no scientific evidence that vaping poses a substantial health risk for bystanders. My opinion is that we should not base coercive health legislation on pure speculation. I believe that we need solid scientific evidence of a public health hazard before we enact coercive legislation. 

Therefore, if there were evidence that vaping was harmful to bystanders, I would support a ban on vaping in public places, even if this would also discourage vapers from using these products to quit smoking. The point of my emphasizing this detrimental aspect of the legislation was simply to emphasize that while the bill offers no known benefits, it does create substantial harm. But I would support the legislation if there were known risks posed by passive vaping that would be minimized with such legislation.

French Government Would Rather that Smokers Continue to Smoke Instead of Switching to Electronic Cigarettes

Yesterday, I criticized a recently announced French policy that would ban vaping in public places. Today, I address a different aspect of the proposal: a ban on the advertising of electronic cigarettes.

According to the health minister, not only will vaping in public places be banned, but so will the advertising of electronic cigarettes. The new regulations include a "blackout on media advertising" of electronic cigarettes. Thus, the government will extend its current ban on tobacco advertising on television, radio, the internet, and print media to electronic cigarettes.

The Rest of the Story

By placing a ban on the advertising of electronic cigarettes, the French government is saying that it wants to put electronic cigarettes at a disadvantage in terms of recruiting customers. In other words, France is going to take an extreme, intrusive measure to protect tobacco profits. Obviously, this measure is going to reduce electronic cigarette use. Apparently, the French government would rather that people use real cigarettes that kill them instead of fake ones that cause little recognized harm and help thousands of French smokers to quit smoking and save their lives.

The most unfortunate part of this story to me is that anti-smoking advocates are supporting this measure. For example, Stan Glantz expressed his support for both aspects of the French policy on his blog. While I disagree with Stan's support of a ban on vaping in public places because there simply is no existing evidence that vaping poses a significant harm to bystanders, I can at least understand his position. However, I do not understand his support for a complete ban on the advertising of electronic cigarettes.

There is simply no valid basis to ban the advertising of electronic cigarettes at the current time. How anti-smoking advocates can place these devices in the same category as tobacco cigarettes is beyond me. With all due respect, this policy is going to result in increased disease and death. It is going to reduce the sales of electronic cigarettes and increase the consumption of tobacco cigarettes. What is the rationale for anti-smoking advocates to support a measure that is going to significantly harm the public's health?

French Health Ministry to Ban Electronic Cigarette Use in Public Places Based on Uncertainty and Pure Speculation

According to a Reuters article, France is set to ban electronic cigarette use in public places even though it is not aware of any scientific evidence that these products harm bystanders. Apparently, France will ban electronic cigarette use in these places simply because of uncertainty over the precise nature of potential, unproven risks.

The other justification given for banning vaping in public places is that it mimics smoking and COULD lead to smoking initiation: "'This is no orlarldinary product because it encourages mimicking and could promote taking up smoking,' said Touraine, who announced her plans at a news conference."

According to the article: "France will ban electronic cigarette smoking in public places by imposing the same curbs enforced since 2007 to combat tobacco smoking, Health Minister Marisol Touraine said on Friday. Amid mounting global concern over the public health implications of so-called e-cigarettes, Touraine said they faced the same fate as traditional ones: a ban on smoking in public spaces and sales to minors and a blackout on media advertising. ... The near-odorless electronic alternative - battery-driven devices that allow users inhale odorless nicotine-laced vapor rather than smoke - are gaining ground in no-go zones such as bars, cafes, trains, waiting rooms and offices. A government-commissioned report said this week that around 500,000 people in France had turned to e-cigarettes, which are designed to look like cigarettes although some come in different colors, and recommended a crackdown on public use."

The Rest of the Story 

My feeling is that the government should not use coercive interventions – such as bans – unless there is strong scientific evidence that a substantial public health problem exists. So far, I have seen no data to suggest that “passive vaping” represents any significant hazard. I think there needs to be more than just pure speculation for the government to take coercive action. The French government presents absolutely no evidence that secondhand vaping represents a public health threat.

The second justification given for the vaping ban is that it might encourage mimicking and could - hypothetically - promote smoking initiation. But again, there is absolutely no evidence that this is the case. Two large studies have had difficulty finding any substantial number of youth nonsmokers who regularly use electronic cigarettes, despite their presence on the market for at least six years and despite the fact that youth experimentation with this product has already occurred.

Pure speculation should not stand as a valid basis for coercive government action, in my opinion.
 
The same justification used by the French government - pure speculation - is also being used by Dr. Stan Glantz to promote a ban on electronic cigarette use in public places in California. On a KQED radio segment about California legislation to ban e-cigarette use in public places, Dr. Glantz defended the legislation by speculating that there "might" be a slight risk associated with these products. But he presented no evidence that as actually used, they pose any threat to bystanders.

In my opinion, these efforts to pass coercive legislation based on pure speculation - devoid of any scientific evidence of risk or harm - undermine the integrity of public health. What these anti-smoking advocates - such as Dr. Glantz - are admitting is that they would support 100% smoke-free laws even if there were no scientific evidence that secondhand smoke is harmful.

I'm not willing to adopt that position. My support for smoking bans is based on the substantial scientific evidence demonstrating that it is a significant public health hazard that is causing suffering, disease, and death.

Dr. Glantz' and others' support for banning vaping in public places without any evidence of risk or harm undermines the integrity of public health because it indicates that we would be willing to ban smoking in public places even in the absence of evidence that it is harmful. I believe that there needs to be a higher standard for coercive government action.

New Cochrane Review of Smoking Cessation Drugs Hides the Truth from Readers

A new, comprehensive, 51-page review of multiple meta-analyses summarizing the effectiveness of nicotine replacement therapy (NRT) and other drugs for smoking cessation concludes that these drugs are highly effective in helping smokers quit.

(See: Cahill K, Stevens S, Perera R, Lancaster T. Pharmacological interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database of Systematic Reviews 2013, Issue 5. Art. No.:CD009329.DOI: 10.1002/14651858.CD009329.pub2.)

The review was extensive, covering hundreds of studies and tens of thousands of subjects: "The authors combined the findings of existing Cochrane reviews on the subject, using all the available data from across the individual reviews. In total, they collected evidence from 267 studies, which together involved a total of 101,804 people. The studies covered a wide variety of licensed and unlicensed smoking cessation medications, comparing the treatments with placebo, and the three main treatments with each other. If a person stopped smoking for six months or longer, this was considered a successful quit attempt."

The study results were summarized - correctly - by one news outlet, as follows: "Participants were 80% more likely to quit when using a single NRT or taking bupropion compared to those using a placebo. Those using varenicline as well as an NRT had two to three times greater odds."

The Rest of the Story

If I gave my students an assignment to review the scientific evidence on the effectiveness of NRT and other drugs for smoking cessation and they handed in this comprehensive, 51-page review, I would not be able to give them a passing grade on the assignment.

Why not?

Because the article leaves out the single most important piece of information that the review should provide. It fails to answer the single most important research question:

What was the success rate for these products?

How could any review of this topic claim to be "comprehensive" when it doesn't answer the most basic question: What percentage of people who use NRT or other drugs to quit smoking are successful? If the paper doesn't provide the answer to that question, how can we consider it to be a solid review of the scientific evidence on this topic? That's why I would have to give a student passing in such a paper a failing grade.

This review reports only the relative risk of smoking cessation with NRT/drugs, not the absolute prevalence of abstinence following treatment. Knowing that the relative risk for cessation associated with NRT compared to placebo is 1.8 doesn't actually answer the question of whether these drugs are effective.

Suppose you went to the doctor for pneumonia. She prescribed an antibiotic and told you that the antibiotic is 500 times more likely than placebo to cure your infection. Sounds great, right? But suppose that the absolute cure rate with placebo for bacterial pneumonia is only 0.001%. That would mean that this antibiotic has a success rate of 0.5%. This means it will work only 5 out of 1,000 times. Your proper course of action is not to fill your prescription for this antibiotic with a relative risk of 500 compared with placebo but to head to your lawyer's office to file malpractice papers.

Well, sadly, this is the precise error that this review commits. It reveals the relative risk of treatment but hides from the reader any information about the absolute success rates. In other words, it doesn't actually tell us whether these treatments work or not!

The truth is that placebo success rates are only about 5%, so at best, use of NRT in real world settings produces about a 10% long-term quit rate.

How can a treatment with a 90% probability of complete failure be considered effective?

Instead of concluding that "Participants were 80% more likely to quit when using a single NRT or taking bupropion compared to those using a placebo," the review could have just as easily concluded that "Participants using NRT or taking bupropion had a 90% chance of failing to quit smoking."

To me, a 90% failure rate is not the hallmark of an "effective" medication.

Alere Wellbeing is Still Making Misleading Advertising Claims About the Effectiveness of Its Quit for Life Smoking Cessation Program

On its web site, Alere Wellbeing boasts that its Quit for Life smoking cessation program has a "47% quit rate."

For those unfamiliar with quit rates for smoking cessation programs, this is a phenomenal rate of success, dwarfing that of any other program.

The Rest of the Story

If only it were true.

If this blog were a PolitiFact fact checker, Alere Wellbeing's claim would get a rating of ...

... FALSE.

Or more properly, a rating of: "Liar, Liar, Pants on Fire."

It is not clear on what scientific basis Alere Wellbeing makes its claim, but presumably it comes from a study in which its own study team reported about a 41% quit rate for the program. However, this is based on the assumption that every smoker who was not successfully followed up was a quitter. Obviously, this is an unreasonable assumption. In an intent-to-treat analysis (which is the appropriate one to use), the quit rate was only 20.5%. It it were being honest, Alere Wellbeing would advertise a quit rate of 21%, instead of 47%.

If one cherry picks from the literature, the highest quit rate I can find - based on an intent to treat analysis - is 33% from this study.

In more realistic settings, such as this study of the Quit for Life program in actual routine use in Florida, the quit rate was only 16% (and that was only for three months).

Importantly, the web site does not indicate that the 47% figure is from a responder analysis, rather than an intent-to-treat analysis. This is highly misleading, and in my mind, fraudulent.

In my view, this is fraudulent marketing, because it the company is knowingly providing a quit rate that is invalid -- essentially by definition the true quit rate is substantially lower than that which is being advertised. And presumably, the company knows this.

I find it interesting that the FDA is going to great lengths to take electronic cigarette companies to task for suggesting that these devices can help smokers quit (when there is abundant evidence that numerous vapers have found the product to be effective for smoking cessation), yet the FDA is silent in the face of this fraudulent marketing for medication- and counseling-based smoking cessation.

If any fraudulent claims are being made about smoking cessation programs, they are not coming from electronic cigarette companies but from Alere Wellbeing, which is marketing an "FDA-approved" smoking cessation approach. Perhaps, to protect the public, the FDA should focus a little more attention on commercial smoking cessation service providers.

For Some, Electronic Cigarettes are the Only Hope for Life

Last week, I received a stirring testimonial from an ex-smoker who quit smoking using electronic cigarettes. His story is typical of so many similar stories I have heard directly from vapers. I wanted to share it as an example of the way in which these products have given hope to so many people.

The story is that this long-time smoker developed liver cancer and was not allowed onto the transplant list because he was unable to get off of cigarettes. Despite trying the "recommended" therapies, he was just unable to quit. This in spite of the refusal of the medical provider to offer him the potentially life-saving transplant until he is able to successfully quit smoking for a sustained period of time.

Well he tried a product that is not recommended by anti-smoking groups and the FDA: electronic cigarettes. He was finally able to quit successfully and very soon will be put on the transplant list and enabled to receive that life-saving liver.

The Rest of the Story

This is exactly the type of miraculous, hope-filled story that many anti-smoking groups and advocates want to put to an end.

Authors of Electronic Cigarette/Quitline Article Fail to Disclose Significant Conflict of Interest

Two weeks ago, I discussed a new study that appeared online ahead of print in the journal Nicotine & Tobacco Research. The study reported on the efficacy of electronic cigarettes in smoking cessation. However, instead of estimating cessation rates among a cohort of smokers who made quit attempts using these products, the study analyzed cessation rates of a large number of smokers who had previously tried to quit using e-cigarettes but failed, and then called a quitline because they had failed and wanted to try again. Then, it compared the quit rate among these smokers to that among smokers without such a history of a failed quit attempt using electronic cigarettes. In other words, this study did not estimate quit rates among smokers trying to quit using e-cigarettes. Instead, it estimated quit rates among many smokers who were not using e-cigarettes in their quit attempt at all! I showed, further, that the results of this study are being misused by anti-smoking advocates to argue that electronic cigarettes are not effective for smoking cessation.

Today, I reveal that the authors of the study hid a significant conflict of interest that I believe should have been reported.

At the end of the article, under the section entitled "Declaration of Interests," the article states: "None declared." Thus, the authors are denying that there are any relevant conflicts of interests related to this work.

The Rest of the Story

The truth is that there are two major financial conflicts of interest that the authors are apparently hiding and which should have been disclosed.

Note, first, that the authors are employed by (and the study funded by) Alere Wellbeing, a company which provides commercial smoking cessation services, including the administration of state tobacco quitlines which tend to use the Quit for Life program. This program relies heavily upon the use of nicotine replacement therapy (NRT and other drugs), but shuns the use of electronic cigarettes.

First, the article reports cessation rates among callers to six state tobacco quitlines. What the article does not make clear is that these programs are run by Alere Wellbeing, which has contracts (i.e., it receives lots of money) to administer these programs. Moreover, Alere Wellbeing has a vested interest in reporting high levels of success with its programs. Obviously, if its evaluations were to report low smoking cessation rates, states would be less likely to contract with Alere Wellbeing for smoking cessation services. Thus, the company (and these authors) has a strong financial conflict of interest: the company makes money and its profits are dependent upon reporting high levels of success with its services.
 
That this conflict of interest was not reported in the paper is mind-boggling to me. It is difficult for me to think of a conflict that would be more severe or more significant than this one. If this is not a conflict of interest, then I don't know what is!

Not only is there the threat that states could turn to other commercial programs if Alere reports low cessation rates, but states as a whole might put less money into these types of programs if they don't work very well. In fact, Alere Wellbeing readily acknowledges that state funding cuts represent a significant threat to profits, writing:

"Future reductions in state spending on existing preventative care programs could reduce our net revenues, net income and cash flows. Due to budgetary shortfalls, many states are considering, or have enacted, cuts to existing preventative care programs. These cuts have included, or may include, elimination or reduction of coverage for some or all of our preventative care programs. For example, in 2011, several states reduced their funding of smoking cessations programs provided by our Alere Wellbeing business. During 2011, approximately 58% of the net revenue of our Alere Wellbeing business was derived from sales to state governments. Continued state budgetary pressures could lead to further reductions in funding for our services which, in turn, could have a material adverse effect on our financial position and operating results."

Elsewhere in its annual report, Alere reiterates that its revenue depends upon continued levels of state funding for quitline services: "Wellness net product sales and services revenue from our Alere Wellbeing business, formerly known as Free & Clear, has been negatively impacted as a result of the continuation of decreased funding under certain states’ quitline programs."

Clearly, this is a conflict of interest that should have been reported in the article.

We are not just talking about small potatoes here. In its annual report, the intangible asset value acquired from the acquisition of Free & Clear (now Alere Wellbeing) from customer relationships is listed at $36 million. Don't you think it would be of importance to journal readers to understand that this article is evaluating a service that is provided by the company for which these authors work? How would readers react if they found out that the article is hiding the fact that the services being evaluated in the paper are worth perhaps $36 million to the company that is sponsoring the study?

As if this first conflict were not enough, there is a second major conflict of interest. Alere Wellbeing's business depends upon producing data showing that its services are effective. But the business also depends on the absence of significant competition. Electronic cigarettes represent what is probably the greatest potential competition to existing smoking cessation services. Thus, this also represents a significant conflict of interest that should have been disclosed.

The journal Nicotine & Tobacco Research is very clear that all competing interests must be disclosed. The journal puts no qualifications on this reporting: all competing interests are to be reported. The journal's guidelines state: "...all authors must disclose any competing interests in a Competing Interests section."

To make it eminently clear, this article does specifically report on the effectiveness of the services provided by Alere Wellbeing. In Table 2, the article provides the 7-month quit rates (30-day abstinence) for quitline callers. It turns out that this figure was 27%. It should be easy for readers to see that this figure has significant financial implications for Alere Wellbeing.

Say, for example, that the article had reported a 7-month quit rate of only 6%. This would suggest that the services provided are quite ineffective and would obviously have negative potential financial implications for the company. How can this possibly not be considered a significant competing interest?

Now to be clear, I am not arguing that the authors have intentionally or unintentionally altered their data or analyses to come up with this 27% figure. In fact, I am not actually arguing that there was any conscious bias present. My point is simply that there is undeniably a competing interest present and that it should have been reported.

In the absence of this disclosure, the rest of the story is that this article hides a significant conflict of interest that journal readers should have been made aware of. Hopefully, this error will be corrected in an erratum statement in a subsequent journal issue.


DOCUMENTATION THAT THE ARTICLE REPORTS ON SERVICES PROVIDED BY THE SPONSORING COMPANY

According to the article, the data presented come from six state quitlines: Connecticut, Louisiana, Nebraska, North Carolina, South Carolina, and Texas.

The article does not disclose that the sponsoring company makes money off of these quitlines and therefore has a financial interest in reporting a high 7-month quit rate in this study.

Below is documentation that the quitlines in each of these states are administered, or have been administered, by Alere Wellbeing (formerly Free & Clear):

Connecticut
"Connecticut Quitline is funded by the Connecticut Department of Public Health and administered by Alere Wellbeing, a commercial tobacco treatment provider."

Louisiana
"The Louisiana Tobacco Quitline, 1-800-QUIT-NOW, is a free, confidential, 24-hour helpline that links individuals who want to quit using tobacco with trained Quit Coaches®. The Quitline is funded by the LTCP and The Louisiana Campaign for Tobacco-Free Living; it is administered by Free & Clear, Inc."

Nebraska
"©2013 Alere, Inc. All rights reserved."

North Carolina
"©2013 Alere, Inc. All rights reserved."

South Carolina
"The Quitline is a contractual partnership between the S.C. Department of Health and Environmental Control and Alere Wellbeing, Inc., a Seattle-based tobacco treatment and behavioral health provider with vast experience running quitlines across the nation."

Texas
"Funder of quitline services: Texas Department of State Health Services

Operator of counseling services: Alere Wellbeing"

A Failing Grade: Massachusetts Spends Less than 1% of Cigarette Revenues on Tobacco-Related Programs

Massachusetts was once a leader in the tobacco control movement. In 1992, voters approved a ballot initiative - Question 1 - which increased the excise tax on cigarettes by 25 cents per pack and allocated the revenues towards a comprehensive statewide tobacco control program. In its heyday, the program funded education, prevention, research, and treatment programs to the tune of more than $50 million per year. The state's anti-smoking media campaign alone - at $13 million per year - was responsible for cutting the smoking initiation rate among Massachusetts adolescents in half.

Thanks to a trio of governors who subverted the voters' intentions in passing Question 1 - William Weld, Jane Swift, and Mitt Romney - the program was decimated: it was cut by more than 95% and now exists in merely skeleton form at about $4.5 million per year.

An article in Monday's Lowell Sun reveals that despite having one of the highest taxes on cigarettes in the nation, Massachusetts spends less than a paltry 1% of cigarette revenues on tobacco control programs. Thus, the state has gone from having a model tobacco control program to having a mere skeleton of a program. Accordingly, progress in reducing youth and adult smoking in the Commonwealth has been stunted.

According to the article, the state receives a whopping $815 million per year from tobacco taxes and Master Settlement Agreement payments, yet allocates less than 1% of these funds for tobacco control. And although the administration has proposed a further $1 per pack cigarette tax increase, none of the resulting revenue would be devoted to tobacco-related programs.

The Rest of the Story

The decimation of the Massachusetts Tobacco Control Program corresponds directly with the initiation of the Campaign for Tobacco-Free Kids' new strategy of promoting and supporting any and all cigarette tax increases, without an insistence that a substantial proportion of the revenue be allocated for tobacco control. In my opinion, it was the Campaign for Tobacco-Free Kids that destroyed the previous wisdom in the movement that cigarette tax revenue allocated to comprehensive statewide tobacco control programs was the model and should be pursued in all states.

I have pointed out a number of reasons why this change in tobacco control strategy was destructive, in addition to its having resulted in the states realizing that they no longer needed to worry about allocating cigarette tax money towards cigarette prevention, education, research, and treatment programs. First, for the majority of lower-income smokers, tax increases will result not in smoking cessation, but in continued smoking at a greater expense and at a higher proportion of overall income. This may have adverse consequences -- and even adverse health consequences -- and may be particularly problematic for the families and children of lower-income smokers, who may actually suffer as a result of these policies.

Second, these policies make essential government programs dependent upon continued high levels of cigarette consumption for their solvency.

Third, they create a financial partnership between the states or the federal government and Big Tobacco.

Fourth, they reduce (if not eliminate) the incentive for state legislatures to enact any policy that would actually make a serious dent in smoking prevalence, because such policies would severely harm the budget, which (now) relies upon cigarette sales to fund its most essential programs and services.

It was the Campaign for Tobacco-Free Kids that developed the mindless mantra that using cigarette taxes to fund essential government programs is a "win-win-win" proposition. But as I have argued:

"These are not win-win-win propositions. There is a win, but unless the policy is properly crafted, that win comes at the expense of a number of losses: regressivity, lack of fairness, increased burdens upon lower-income populations, increasing health disparities, a government dependence upon continued cigarette consumption to fund critical programs, an unhealthy fiscal partnership between the states and Big Tobacco, and the elimination of any incentive to enact meaningful tobacco policies that would actually make a serious dent in smoking prevalence. The cigarette tax policies may actually be making it more difficult - if not impossible - for the more effective non-price policies to be implemented."

What is the solution? How can tobacco control be restored at the state level?

The problem is not going to be resolved until the Campaign for Tobacco-Free Kids ends its knee-jerk support for all cigarette tax increases and withdraws its support from proposals unless they allocate a substantial portion of the revenues to comprehensive statewide tobacco control programs.

Inane Statement of the Year: South Carolina Anti-Smoking Advocates Claim that Completely Discontinuing Smoking is Not the Same as Quitting Smoking

What's the definition of quitting smoking?

A simple question, you might think.

But apparently not so simple to anti-smoking advocates in South Carolina, who have come up with quite a strange definition of their own.

Take this scenario:

A 56-year old man, who has smoked 2 packs per day for 35 years and has unsuccessfully tried to quit using nicotine patches and gum tries electronic cigarettes in an attempt to quit smoking. He succeeds and is able to go from smoking about 40 cigarettes per day to smoking 0 cigarettes per day. In fact, he quits smoking and is abstinent from cigarette smoking for twelve months.

Question: Has this individual quit smoking?

A. Yes
B. No

Most reasonable people would answer A. Yes, this smoker went from smoking 2 packs per day to smoking 0  cigarettes per day. He has not smoked for 12 straight months. So yes, of course, he has successfully quit smoking.

Not so, according to some anti-smoking advocates in South Carolina. They argue that since he continues to vape, he has not quit smoking. He is still a smoker in their eyes.

The Rest of the Story

According to an article in the Times and Democrat (Orangeburg, SC), two anti-smoking advocates in South Carolina believe that if someone quits smoking using electronic cigarettes, she has neither quit smoking nor discontinued tobacco use:

"Melissa Watson, a Columbia health counselor ... believes e-cigarettes, while potentially helpful from solely a harm reduction standpoint, are not useful in actually kicking the habit. She said the problem with e-cigarettes is they are designed to simulate smoking, while the commonly used nicotine gums and patches are not. “What’s the end goal?” she asked. If the patient intends to fully quit tobacco use, she said, e-cigarettes are not the way to go."

So Watson is saying that if someone successfully quits smoking using e-cigarettes, she has not actually quit smoking, even though she no longer uses any combusted tobacco product, or any tobacco product for that matter. Watson argues that this ex-smoker is still a tobacco user, even though there is no tobacco in the electronic cigarette.

But that's not the end of the story.

According to the article: "Dr. Scott Strayer of the University of South Carolina Medical School shares a similar opinion. He noted that no studies yet prove that e-cigarettes are healthier or helpful in quitting. A former smoker of 15 years, Strayer said quitting is about “behavior change.” This can be difficult to achieve when still reliant on smoking something, even if it is electronic."

So again, Dr. Strayer as well believes that if a 40 pack-year smoker quits by using non-tobacco electronic cigarettes, he has not actually changed his behavior. He hasn't achieved the desired behavior change (which was quitting smoking).

So much for reason and logic.

Now you can see the problem we are facing in public health. The ideology against the physical act of holding something that looks like a cigarette is so strong that some anti-smoking advocates don't even recognize that someone who has quit smoking using electronic cigarettes has quit smoking. These anti-smoking advocates don't even appear to understand that a person who quits smoking using electronic cigarettes is no longer using tobacco.

Apparently, what bothers these advocates is the simple act of doing a behavior that looks like smoking.

It is also disheartening to see that Dr. Strayer is not convinced that smoking is any more hazardous than vaping. Hopefully, he is not telling his patients what he apparently told the Times and Democrat: that there is no evidence that cigarette smoking is any more hazardous than using a non-tobacco, non-combustion product that has been demonstrated to have levels of carcinogens that are orders of magnitude lower than cigarettes and which have been demonstrated not to impair acute lung function.

Any physician who advises his patients not to try to quit smoking using an electronic cigarette because they may not be improving their health by quitting in this way is not only committing malpractice, in my opinion, but she also needs a remedial course in basic chemistry and toxicology.

There is plenty of room for debate about the appropriate role for electronic cigarettes in smoking cessation strategy. However, if opponents of electronic cigarettes can't even acknowledge that someone who quits smoking using electronic cigarettes has indeed quit smoking and no longer uses tobacco, then there is no basis for rational, scientific discussion.

German Cancer Research Center Lies about Health Effects of Electronic Cigarettes to Scare Users and Unfairly Influence EU Directive

According to the German Cancer Research Center, the inhalation of glycerin can cause lipoid pneumonia. Lipoid pneumonia is a form of pneumonia - lung inflammation - in which lipids (oils) accumulate in the bronchial tree. It can be caused by exogenous factors, such as the inhalation of oils.

A report on electronic cigarettes from the German Cancer Research Center states: "Glycerine may cause lipoid pneumonia on inhalation."

This is a serious assertion because if true, then the use of electronic cigarettes would be quite unsafe. Glycerin is a common component of a huge majority of electronic cigarettes on the market and it is inhaled in significant quantities by electronic cigarette users. If this inhalation of glycerin could cause lipoid pneumonia, then electronic use would be unduly risky. In fact, if the German Cancer Research Center's assertion is true, I would have to reverse my recommendation that these products are a viable alternative for smoking cessation.

The major purpose of the release of this report by the German Cancer Research Center was to influence the upcoming European Union deliberations on its proposed tobacco product directive. The initial draft of that directive bans electronic cigarettes. Based in part on its conclusion that the inhalation of one of the most common ingredients in electronic cigarettes causes lipoid pneumonia, the report recommends that electronic cigarettes be banned, unless they are shown to be safe in clinical trials. However, if it is true that glycerin inhalation causes lipoid pneumonia, then these products would not (and should not) ever be approved as smoking cessation drugs or devices.

The Rest of the Story

Since I've noted that if the inhalation of glycerin causes lipoid pneumonia I would discontinue my support for electronic cigarettes as a smoking cessation product and since the German Cancer Research Center asserts that glycerin does cause lipoid pneumonia, I suppose it is time for me to make a major announcement:

I hereby withdraw my support of electronic cigarettes as a viable and relatively safe smoking cessation product.

Cancel that.

Because there is a rest of the story.

The rest of the story is that the German Cancer Research Center is lying.

It is not true that glycerin causes, or can cause, lipoid pneumonia. In fact, it is impossible for glycerin inhalation to cause lipoid pneumonia.

The reason?

Lipoid pneumonia is caused by the inhalation of oils. But glycerin is not an oil!

Basic chemistry tells us that glycerin is an alcohol. Specifically, it is a polyol, which is a compound with multiple hydroxyl groups. The hydroxyl group (OH) is the hallmark of an alcohol. Oils, on the other hand, are characterized by the presence of either a carboxyl group (COOH) or a sterol. The bottom line is that glycerin is not an oil, but an alcohol.

In fact, glycerin is soluble in water and alcohol, but not in oil. This is because of the three hydroxyl groups.

If glycerin was in fact a cause of lipoid pneumonia, the FDA would not have approved its widespread use in medications such as cough syrups, expectorants, and mouthwashes, because of the risk that accidental aspiration of these products could cause lipoid pneumonia.

It will be interesting to see if the German Cancer Research Center corrects this serious error. It is particularly serious because it is the difference between electronic cigarettes being relatively safe and electronic cigarettes being absolutely unsafe and unsuitable for use.

Of course, if the German Cancer Research Center's statement were true, we would have seen many cases of lipoid pneumonia in vapers by now because there are millions of people who inhale glycerin daily from these products. 

It is theoretically possible that lipoid pneumonia could result from an electronic cigarette product that used oils in its formulation. For example, a product that used essential oils in a flavoring or fragrance would introduce a real - although still very small - risk. It is certainly legitimate to ask regulators to ensure that oils are not used in these products. However, the contention that glycerin itself does or can cause lipoid pneumonia is a manufactured lie.

It is unfortunate that this report is providing such extreme misinformation in an apparent attempt to influence the European Union's consideration of the tobacco product directive. It would be a shame if the EU were to ban electronic cigarettes because of this absolutely false information.

This appears to be another example of an anti-smoking organization which is manipulating the truth (i.e., lying) in order to promote its apparently pre-determined, ideology-based opposition to electronic cigarettes.

If the German Cancer Research Center wanted to do one thing to prevent cancer, it would start by embracing this product - which has the potential to save thousands of lives - as an alternative to smoking and a viable harm reduction strategy. Instead of being regulated as pharmaceuticals (which would result in a de facto ban of the product), they should be regulated as alternative (much safer) nicotine delivery products.


(Special thanks to Dr. Konstantinos Farsalinos for scientific insights that I incorporated into this post.)

Sacrificing Children's Health for Politics: American Cancer Society Sinks to a New Low

Yesterday, I revealed that the American Cancer Society is actually opposed to legislation that would ban the sale of electronic cigarettes to minors, noting how odd this position is, as even the electronic cigarette industry supports such measures. In trying to explain the possible reason for the ACS opposition to such a simple, common sense public health policy, I shared Dr. Carl Phillips' hypothesis that the ACS actually wants kids to be unprotected from e-cigarette sales so that these products appear to be a greater problem, leading the FDA to ban or heavily restrict the products even for adults.

Dr. Phillips theory: "It might sound over-the-top to suggest that ACS et al. would sacrifice the children in pursuit of their real goals, but I have not thought of or heard any other explanation for the behavior that has been observed."

Today, I reveal that the American Cancer Society has admitted that Dr. Phillips is correct. This is no longer just a theory. This is a bona fide explanation for the ACS position on this issue. And the ACS admits it.

The Rest of the Story

Senate Bill 1209 in Arizona is a very simple measure that does nothing other than add electronic cigarettes to the list of tobacco products whose sale to minors is prohibited. In Arizona, the sale to youth of cigarettes, cigars, cigarillos, smokeless tobacco products, and hookah is already prohibited. This legislation would do nothing other than to add electronic cigarettes to the ban. It doesn't change state law in any other way.

There is absolutely no reason, from a public health perspective, why it should remain legal to sell electronic cigarettes to minors. Virtually no one opposes this common sense measure. The electronic cigarette companies are on board and many already restrict access to their web sites and/or have very clear statements that their products are not intended for minors.

Why in their minds would any group actually want children to have access to electronic cigarettes?

The perverse answer is that the American Cancer Society is afraid that the widespread passage of state laws prohibiting the sale of electronic cigarettes to minors will hinder its efforts to place stringent restrictions on the availability of these products for adults. The ACS wants to get rid of the whole category of products ... period. But if the sale of e-cigarettes to minors is banned in most states, then it becomes much more difficult to argue that e-cigarettes remain a threat to the health of children, an argument that is critical to the ACS in its efforts to get these products off the market or severely restricted.

The ACS tips its hand in an April 22 letter to an Arizona state senator, a letter which opposes Senate Bill 1209. The reason for this opposition is that by banning the sale of electronic cigarettes to minors, "it sets the stage for tobacco companies to claim they are protecting children via this legislation...". In other words, the ACS opposes this bill because it doesn't want companies to be able to claim that they have helped address the potential problem of youth e-cigarette use by statutory sales restrictions. The ACS actually wants the sale of e-cigarettes to minors to remain unregulated so that it can convince the FDA that e-cigarettes are a major problem: their sale to minors is unregulated and thus the risk of youth taking up vaping is very high. This argument is essential in getting the FDA to take extreme action against all use of electronic cigarettes. If youth truly are protected from e-cigarette sales, then the problem will not appear to be as severe.

In other words, the ACS is working to make sure that sales of e-cigarettes to minors remain a problem, giving it ammunition in its desire to essentially get rid of these products altogether. And why does the ACS oppose all e-cigarette use? Again, they tip their hand: "The use of these products by adults could have a serious negative impact on the social norms around smoking especially around children."

Thus, the ACS opposition to e-cigarettes is ideological: they can't stand the idea of a behavior that looks like smoking, even if that behavior is helping to save thousands of lives.

Sadly, in its letter, the ACS demonstrates that it is willing to say anything for political purposes, even if they make assertions which contradict other statements they have made:

On its web site, the ACS asserts as follows: "We do know that e-cigarettes can lead to nicotine addiction, especially in young people who may be experimenting with them, and may lead kids to try other tobacco products, many of which are known to cause life-threatening diseases."

So according to the ACS, we have the scientific evidence needed to conclude that e-cigarettes can lead to nicotine addiction in young people who are experimenting with them.

However, in its letter to the Arizona Senate, the ACS claims: "Very little is known about the use of electronic smoking devices by youth...".

Well, which is it?

In the former statement, the ACS' goal is to scare the public about how much of a threat electronic cigarettes pose to minors. So they manufacture evidence (which doesn't exist) to show that these products are leading to nicotine addiction among young people.

In the latter statement, the ACS' goal is different. Here, they want to convince the Arizona Senate that e-cigarette use among youth is not a problem, negating the need for this new legislation. So the ACS now claims that there is no evidence that youth are actually using these products.

It is unfortunate enough that the American Cancer Society is sacrificing scientific integrity and honesty for political purposes. But it is despicable that the organization would sacrifice the health of children, and use them as pawns in a political game.