Wednesday, April 30, 2014

Spurred On By CDC/Glantz Propaganda, Two U.S. Senators Claim that Electronic Cigarettes are a Gateway to Smoking

In separate statements yesterday, Senators Richard Blumenthal (D-CT) and Charles Schumer (D-NY) publicly claimed that electronic cigarettes are a gateway to smoking.

In an article in the New Haven Register, Senator Blumenthal was quoted as stating: "These products are essentially a gateway to smoking. ... E-cigarettes are the new Joe Camel."

In a CBS New York article, Senator Charles Schumer was quoted as stating: "Instead of being harmless, e-cigarettes are actually a gateway to conventional smoking, particularly for kids. That's the problem."

Both senators appear to be regurgitating information they probably heard as a result of propaganda produced by CDC and by Stan Glantz.

The CDC concluded, from a cross-sectional survey showing that youth who use e-cigarettes are almost exclusively smokers, that vaping is a gateway to smoking addiciton. However, this study could not determine whether the e-cigarette use preceded or followed the tobacco cigarette use.

Glantz's research also generated widespread media headlines announcing that electronic cigarette use is a gateway to smoking, even though his study was also a cross-sectional one and he himself admitted that one cannot determine whether smokers in his study might have started smoking first and tried electronic cigarettes second. 

The Rest of the Story

The assertions by the CDC, by Stan Glantz, by Senator Blumenthal, and by Senator Schumer are completely unsubstantiated by actual scientific data. In fact, there is no scientific evidence to support the conclusion that they have all disseminated to the public: that electronic cigarettes are a gateway to smoking.

The most recent data that examined this issue, reported yesterday by researchers in the UK, found that in Great Britain, electronic cigarettes are not serving as a gateway to smoking. These researchers concluded that: "There is no evidence of regular electronic cigarette use among children who have never smoked or who have only tried smoking once."

The study found that very few neversmokers try electronic cigarettes and that of those who do, virtually none go on to become regular users: "Of those who had never smoked a cigarette, 99% reported never having tried electronic cigarettes and 1% reported having tried them “once or twice.”"

The rest of the story is that despite the public statements of the CDC, Stan Glantz, and two U.S. senators, current evidence does not support the conclusion that electronic cigarettes are a gateway to smoking. Why, then, are public health agencies, anti-smoking researchers, and politicians disseminating these unsupported conclusions to the public?

Quite simply, they are spreading misinformation to the public because the truth just doesn't support their ideological opposition to electronic cigarettes. When the science doesn't back up your position, then you are left with the need to lie to the public or to mislead people in order to support your position.

The evidence that electronic cigarettes are contributing substantially to the protection of the public's health is so strong that opponents are unable to counter this evidence with science or with factual arguments. Instead, they have to resort to a campaign of misinformation. Senators Blumenthal and Schumer, spurred on by the CDC, are conducting just such a campaign.

Tuesday, April 29, 2014

FDA Tells Researchers and the Public that It is Not Sure Cigarette Smoking is any Worse than Vaping

As I revealed yesterday, the FDA - supposedly committed to using the most rigorous science to regulate the continuum of nicotine-delivery products - stated in its proposed electronic cigarette deeming regulations that it is not sure that vaping is any less hazardous than cigarette smoking. In fact, the deeming regulations suggest that it is a problem that many consumers perceive vaping to be less hazardous than smoking. Moreover, the regulations make it clear that electronic cigarette companies will not be allowed to tell their customers that their products are any safer than real cigarettes, thus hiding the truth from the public and essentially requiring companies to implicitly lie to consumers.

Today, I reveal that it is not only in its proposed deeming regulations that the FDA has acknowledged its lack of knowledge that smoking is more hazardous than vaping. The FDA explicitly states that it is unsure that smoking is more hazardous than vaping in the scientific literature itself.

In a Tobacco Control article by the Center for Tobacco Products at the FDA, the agency states: "While e-cigarette aerosol may contain fewer toxicants than cigarette smoke, studies evaluating whether e-cigarettes are less harmful than cigarettes are inconclusive."

Later in the article, the FDA reiterates its position: "while the inhaled compounds associated with e-cigarettes may be fewer and less toxic than those from traditional cigarettes, data to establish whether e-cigarette use as a whole is less harmful to the individual user than traditional cigarettes are not conclusive."

The Rest of the Story

Yet again, the FDA has made it eminently clear that it is not sure that cigarette smoking is any more hazardous than vaping.

This is particularly disturbing, as five years have passed and numerous studies have been published since the FDA originally told the public that cigarette smoking may be no more hazardous than using non-tobacco, non-combusted electronic cigarettes.

If the FDA doesn't have the evidence needs at the current time to conclude that smoking is more dangerous than vaping, then what kind of evidence will it take?

And how can we explain the FDA's failure to appreciate that smoking is much more hazardous than vaping? It is not based on solid scientific reasoning. Instead, it appears to be based on either politics or ideology.

And that, more than anything else, is what scares me about the FDA's approach to the regulation of cigarettes and electronic cigarettes.

This scientific folly highlights the absurdity of having the FDA now approving cigarettes, but threatening to take a huge number of the electronic ones - which contain no tobacco - off the market.

Since the Family Smoking Prevention and Tobacco Control passed, the FDA has done nothing little to warn the public about the risks of cigarette smoking, but as we see today, through its actions and statements on electronic cigarettes, is actually undermining the public's appreciation of the severe health hazards associated with conventional cigarette smoking.

The Tobacco Act has created a situation where by statute, the FDA must approve deadly cigarettes for sale and consumption in the United States, but where the very same FDA is threatening to remove from the market many brands of devices which are actually helping perhaps hundreds of thousands of people to keep off of cigarettes.

When, five years after it was clear to most knowledgeable scientists that electronic cigarettes were safer than real cigarettes, the FDA continues to tell the public that cigarette smoking may be no more hazardous than vaping, you know we have serious problems with tobacco control in this country.

Monday, April 28, 2014

Federal Agency that Regulates Cigarettes is Not Sure Smoking is Any More Hazardous than Vaping

The most damaging revelation in the FDA's proposed deeming regulations is the fact that the agency is not sure that smoking is any more hazardous than vaping.

This is worth repeating: the nation's federal regulatory agency with jurisdiction over cigarettes is not sure that smoking - which kills more than 400,000 Americans each year - is any more dangerous than vaping, which involves no tobacco and no combustion and has not been shown to cause any harm. The FDA is not convinced that inhaling nicotine plus tens of thousands of chemicals and more than 60 known human carcinogens is any worse than inhaling nicotine plus propylene glycol and low levels of a few other chemicals.

To make matters worse, the deeming regulations would prohibit electronic cigarette companies from informing their consumers that vaping is less hazardous than smoking. In fact, e-cigarette companies would not even be allowed to inform consumers that electronic cigarettes are free of tobacco, or that they have much lower levels of a number of carcinogens and are free of thousands of harmful chemicals that are present in tobacco smoke.

In the deeming regulation proposal, the FDA states: "Many consumers believe that e-cigarettes are "safe" tobacco products or are "safer" than cigarettes. FDA has not made such a determination and conclusive research is not available."

Clearly, the FDA does not believe that there is sufficient evidence at the present time to conclude that cigarette smoking is any more hazardous than vaping. 

Futhermore, one of the problems noted in the deeming regulations is the fact that: "The vast majority of the respondents who were aware of these products indicated that they believed e-cigarettes were less harmful than traditional cigarettes...".

Once again, the FDA is stating that smoking may not be any more hazardous than vaping.

The Rest of the Story

Frankly, I find it horrific to learn that the FDA - the agency which is going to supposedly be using science to make informed, evidence-based decisions regarding tobacco products - is not sure that cigarette smoking is any more hazardous than the use of fake cigarettes that contain no tobacco, involve no combustion, produce no secondhand smoke, have much lower levels of carcinogens, and have been found to acutely improve the health of smokers who switch to them.

Fortunately, the vast majority of the public appears to have better scientific judgment than the FDA and to recognize that cigarette smoking is far more hazardous than the use of an electronic nicotine delivery system that merely aerosolizes nicotine from a propylene glycol solution that is completely free of any tobacco or any combustion.

While the FDA sees the problem as being that the public believes electronic cigarettes are safer than smoking, I believe the problem is that the FDA fails to grasp the clear science and to appreciate that cigarette smoking is far more hazardous than vaping.

Is this really the way we want our federal health agencies to treat cigarettes? As a product that is of such little concern that it may be no more harmful than the combination of nicotine and propylene glycol in an electronic cigarette?

Is this the message we want going out to smokers? That their smoking is perhaps no more dangerous to them than if they quit smoking and instead used a product that only delivers nicotine without the tens of thousands of other chemicals, including more than 60 known human carcinogens?

The FDA is essentially saying that ex-smokers who have quit smoking using electronic cigarettes might as well revert back to smoking, since the Agency is not aware that vaping is any less hazardous than smoking. Is this the kind of scientific-based advice that we think is appropriate to be coming from a federal health agency?

With this disregard for the basic principles of science, the FDA is undermining literally decades of public education about the severe hazards of cigarette smoking. The FDA is negating the benefits we have accrued from the tobacco companies halting their own undermining of the public's appreciation of smoking's hazards because the agency is now doing that work for the tobacco companies.

The rest of the story is that this assertion by the FDA - that cigarette smoking may be no more hazardous than vaping - appears to be more politically-based than science-based. President Obama, in his inaugural address, called for a return of science to public policy. He asked that science be restored to its rightful place. However, the assertion that cigarette smoking is not known to be any more harmful than inhaling the aerosol produced by heating a solution of nicotine and propylene glycol is hardly something that can be viewed as science-based. Especially when e-cigarette vapor has been extensively characterized and shown to be far less toxic than cigarette smoke.

If the FDA is not sure that removing all of the carcinogens from cigarettes - and reducing their concentrations to no more than trace levels - is going to make "smoking" safer (even forgetting the fact that there is no smoke and no combustion associated with vaping), then one has to ask whether the FDA is basing its positions only on science, and not on any political or ideological concerns.

Think of it this way: Individual X has smoked 2 packs per day for 30 years. She has tried, unsuccessfully, to quit smoking using the nicotine patch and nicotine gum. Finally, she has successfully quit smoking using electronic cigarettes.

What the FDA is stating is that it does not believe that it would be any worse for individual X to resume cigarette smoking than for her to remain an ex-smoker by continuing to vape. The FDA is stating that it is aware of no evidence to suggest that returning to cigarette smoking would be an unwise decision for this individual.

That sounds like something the tobacco industry would say if asked to comment about electronic cigarettes. And to its credit, even the tobacco industry has not made any such statement.

Instead, the federal government has helped protect the tobacco market by making this unscientific statement for them.

Is this really the kind of pure scientific expertise - unclouded by any ideological or political concerns - that we want to be making the critical decisions about how to regulate tobacco products which are killing hundreds of thousands of Americans each year?

While the deeming regulations pretend to acknowledge that there is "a continuum of nicotine-delivering products" in terms of their health risks, the truth is that the agency fails to acknowledge that the most hazardous product along that continuum - cigarettes - are any more hazardous than the least dangerous product (non-tobacco electronic cigarettes).

If this is the kind of "scientific" reasoning that is going to guide the nation's decisions on how to handle tobacco products which are killing hundreds of thousands of Americans each year, then we may actually be better off reverting back to the "wild, wild west" that Stan Glantz keeps talking about. At least in that wild west, consumers are able to make reasonable judgments about the relative safety of different products. In the FDA-regulated "east," consumers are going to be kept hidden from even the most basic truths: that electronic cigarettes do not contain tobacco and that they are much safer than the real thing.

Thursday, April 24, 2014

FDA Gives Huge Gift to Combustible Tobacco, and to Cancer

With the release of its deeming regulations, the FDA is poised to give a huge gift to combustible tobacco and to the diseases and death caused by cigarettes. If promulgated as is, the regulations will be devastating to the public's health by protecting the combustible cigarette market at the expense of the introduction and promotion of much safer alternative products that would otherwise have the potential to substantially reduce lung disease, heart disease, stroke, and cancer.

There are two major aspects of the deeming regulations that deal a devastating blow to the public's health:

1. Electronic cigarette companies cannot inform consumers that these products are safer than cigarettes, and they cannot even tell the public that they are free of tobacco.

2. The regulations put a huge, if not insurmountable, obstacle in the way of new and innovative electronic cigarette products.

The Rest of the Story

I will address each of these two provisions of the deeming regulations, showing why they represent a devastating blow to the public's health and a huge gift for combustible cigarettes and in turn, for cigarette-related disease and death.

1. Electronic cigarette companies cannot inform consumers that these products are safer than cigarettes, and they cannot even tell the public that they are free of tobacco.

The deeming regulations subject electronic cigarettes to section 911 of the Family Smoking Prevention and Tobacco Control Act, which prohibit the marketing of tobacco products as modified risk products without the approval of the FDA. Specifically, what this means is that electronic cigarette companies cannot tell consumers the simple truth: that their products are safer than tobacco cigarettes. They cannot even tell consumers that the intended purpose of these products is to provide a safer alternative to smoking.

This means that 99% of the electronic cigarette companies currently on the market are going to have to change the way they market their products. They are going to be forced to implicitly lie about their products by pretending that providing a safer alternative to smoking has nothing to do with why they are marketing these innovative devices.

According to the deeming regulations, electronic cigarettes cannot inform consumers that the electronic cigarette "presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products" (which includes cigarettes). In other words, the marketing of electronic cigarettes will need to be based on the false pretense that e-cigarettes are not intended as a safer alternative to smoking.

This is a disaster not only because it hides from consumers knowledge that these products are safer than cigarettes, but because it forces electronic cigarette companies to rely on other advertising pitches, such as portraying the use of these products as being sexy or attractive, boasting about how these products can be used in places where smoking is not allowed, or portraying these products as fancier types of cigarettes. This is going to make it more difficult to deter young people from picking up these products because it becomes more difficult for them to understand the true purpose and meaning of electronic cigarettes.

I cannot think of a regulatory provision that would be more favorable to combustible cigarettes than to ban any potential competitor products that are not made from tobacco and do not involve combustion from informing consumers that these products are safer alternatives to smoking. This is literally a huge gift to the combustible cigarette market and therefore, it is devastating to the public's health. It is going to increase disease and death. This is absolutely the opposite of what the FDA should be doing in these regulations.

To highlight the absurdity of this aspect of the deeming regulations, it means that electronic cigarette companies will not be allowed to even claim that their product is free of tobacco. The law states that a tobacco product manufacturer cannot claim that "the tobacco product or its smoke does not contain or is free of a substance." In other words, an electronic cigarette company cannot claim that its electronic cigaretes do not contain, or are free of, tobacco.

If a company were to make such a claim, it would constitute a reduced exposure claim, which is prohibited under section 911. To make matters worse, such a claim can only be approved by the FDA if the company shows that if consumers hear that the product is free of tobacco, they will not be led to believe that the product is safer. In other words, to simply make the truthful and uncontroversial claim that your electronic cigarettes are free of tobacco, you would have to first demonstrate that consumers will not interpret the absence of tobacco as indicating that the product is any safer. But we know for a fact that consumers will interpret (and should interpret) the absence of tobacco as an indication that vaping is safer than smoking. Therefore, the deeming regulations place a de facto, permanent ban on electronic cigarette companies making the simple claim that their products do not contain tobacco.

While it is theoretically possible that an electronic cigarette company could some day get a full reduced risk claim approved, the regulatory burden is extreme. Not only would the company have to show that the product is safer than smoking, but the company would also have to demonstrate that the product will not deter smokers from quitting and will not introduce youth to the use of nicotine. The studies required would be substantial. For most companies, the costs would be prohibitive. It would take many years before any company could even have a reasonable chance of getting such an application approved and by then it will be too late for the market to continue to expand.

Moreover, what scientific evidence is the FDA looking for in order to approve a simple claim that electronic cigarettes are safer than tobacco cigarettes? If the overwhelming current evidence is not sufficient, then no evidence will ever be sufficient because there is no further research that is necessary in order to draw this conclusion. It doesn't take a rocket scientist to figure out that a product which burns tobacco and produces tobacco smoke with more than 10,000 chemicals including more than 60 carcinogens and causes more than 400,000 deaths per year is more harmful than a product which merely heats and aerosolizes nicotine from a solution of propylene glycol.

The rest of the story is that by applying section 911 to electronic cigarettes, the FDA is forcing electronic cigarette companies to implictly lie to its consumers by hiding from them the undeniable truth that electronic cigarettes are much safer than tobacco cigarettes. This removes the most critical element of potential marketing competition from combustible cigarettes.

For the combustible cigarette market, this is a dream come true. In fact, it seems too good to be true because it is a supposedly public health protection agency that is issuing this immense market protection.

2. The regulations put a huge, if not insurmountable, obstacle in the way of new and innovative electronic cigarette products.

In order to introduce a new electronic cigarette product to the market, the manufacturer will have to demonstrate that the product is beneficial to the public's health. This does not simply mean that one must demonstrate that the product is safer than cigarettes. The applicant also needs to show that the introduction of the product into the market will not deter smokers from quitting or encourage youth to start using the product. At the present time, there is a substantial body of opinion among tobacco control experts that electronic cigarettes do not reduce population risk. Therefore, how can we expect that a manufacturer could demonstrate, at the level of proof required, something which most tobacco control experts do not even agree with?

In other words, the deeming regulations place an insurmountable obstacle in the way of new and innovative products. This is disastrous because it is new products which are essential to continue to drive the market forward. It is the new products which will be safer and more effective. It is the new products that are critical to allowing electronic cigarettes to some day seriously challenge or overtake the combustible market.

However, the deeming regulations take away both the prospect of innovation and the incentive to introduce new products. Essentially, these regulations freeze the current market of electronic cigarettes, or at least of those electronic cigarettes which were most like the products already on the market in 2007.

FDA's Proposed Electronic Cigarette Deeming Regulations: The Good, the Bad, and the Ugly

This morning, the FDA finally released its draft deeming regulations for electronic cigarettes. Here is my initial take on these draft regulations from a public health perspective. I have divided my analysis of the 241 pages of provisions into three sections: the good, the bad, and they ugly.

The Good

1. The regulations ban the sale of electronic cigarettes to minors, both in person and via the internet.

The ban on the sale of electronic cigarettes to minors is a critical aspect of the proposed regulations. If properly enforced, it will help keep these products out of the hands of minors. An additional benefit of this provision is that it will obviate the need for every city and town council in the nation to enact its own e-cigarettes sales restrictions.

2. The regulations do not ban the sale of electronic cigarettes to adults via the internet.

A ban on the sale of electronic cigarettes to adults via the internet would have been devastating to the bulk of the electronic cigarette market and would have placed an immediate limit on the potential for growth in this market.

3. The regulations do not ban the use of flavorings in electronic cigarettes.

Many anti-smoking groups and advocates have been pushing for a ban on the use of flavorings in electronic cigarettes. Such a ban would have devastated the industry, as the flavors are a key aspect of what makes these products competitive with tobacco cigarettes. In addition, the flavors make e-cigarettes distinct from tobacco cigarettes and make it much less likely that people who switch to these products will return to regular cigarettes. In addition, youth who use flavored electronic cigarettes are most likely less inclined to initiate smoking because once they are accustomed to the flavors, cigarettes would seem extremely harsh.

4. The regulations do not ban or restrict e-cigarette advertising or marketing to adults.

Many anti-smoking groups and advocates have been calling for a ban on all e-cigarette advertising. This would of course have been devastating to the industry and would have given tobacco cigarettes an unfair advantage in the marketplace. The FDA decided to defer any decision on marketing restrictions at this time. It is likely that the agency will revisit this issue in the future, but with more time, the FDA can craft marketing restrictions that balance the desire to protect youth from this advertising with the need for e-cigarette companies to be able to reach adult consumers.

5. The regulations do not immediately pull any e-cigarette products from the market.

One of my fears in advance of the release of the regulations was that they would require substantial equivalence determinations for most products currently on the market an would pull some products from the market pending such determinations. Instead, the agency decided to allow all existing products to remain on the market, giving them two years to apply for FDA approval. In addition, new products can enter the market for the next two years without pre-approval from the agency.

If a product submits an application for a new product approval or substantial equivalence determination within the allotted 24-month period, it will not be taken off the market while the review of the application is pending.

The Bad

1. The regulations do not limit the marketing of electronic cigarettes to youth.

There does need to be some restriction on the marketing of electronic cigarettes to youth. The FDA deferred a decision on marketing restrictions at this time. However, it is important that the agency does revisit this issue and that it craft restrictions that carefully balance  the desire to protect youth from this advertising with the need for e-cigarette companies to be able to reach adult consumers.

2. 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.

3. 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.

The Ugly

1. The regulations apply section 911 (the modified risk product provisions) to electronic cigarettes.

This is a complete disaster and is not in the interest of protecting the public's health. In fact, this provision is going to harm the public's health. It is going to require manufacturers to implicitly lie about the intended purpose and relative safety of their products.

Sadly, the agency concluded that it is not sure that e-cigarettes are any safer than tobacco cigarettes. The FDA states: "Many consumers believe that e-cigarettes are "safe" tobacco products or are "safer" than cigarettes. FDA has not made such a determination and conclusive research is not available."

That the FDA is not sure whether smoking is any more hazardous than vaping does not say a lot for the agency's scientific standards.

This provision is going to undermine the public's appreciation of the health hazards of smoking and prevent companies from telling consumers the truth: that e-cigarettes are a lot safer than tobacco cigarettes.

In addition, this is going to force companies to rely on other methods to pitch their products, such as using sexy models, emphasizing that e-cigarettes can be used where tobacco cigarettes are allowed, and relying on celebrity endorsements. The FDA is literally forcing e-cigarette companies to lie about their products and instead of pitching them as safer alternatives to smoking, to pitch them with non-health-related benefits.

Under this provision, an electronic cigarette company cannot even inform consumers that the product does not produce smoke because such a claim would be considered a "reduced exposure" claim under the Tobacco Act.


Overall Summary

All in all, the deeming regulations are a disaster. However, they are not as much of a disaster as they could have been. The positive side is that internet sales, marketing to adult consumers, and flavors are still allowed and that no products will immediately be taken off the market. The negative side is that new products will require pre-approval, virtually every product on the market will require a substantial equivalence determination (if not a new product approval), and that manufacturers will be forced to implicitly lie about the intended purpose and relative safety of the product by not being allowed to correctly point out that these products are much safer than tobacco cigarettes.

At the end of the day, while there are some positive aspects to these regulations, it is clear that science is not playing much of a role in the process. That does not bode well for the potential of electronic cigarettes to seriously challenge the combustible tobacco market, and thus to save hundreds of thousands of lives.

FDA's Electronic Cigarette Deeming Regulations Expected Today

Per rumor only, I am expecting the FDA electronic cigarette deeming regulations to be released today. It will take me some time to digest and analyze them, but as soon as I do, I will provide a summary and commentary on their implications.

Huge Survey of Dedicated Electronic Cigarette Users Confirms that Quitting Smoking or Greatly Reducing the Amount Smoked are the Main Reasons for Vaping

A huge survey of more than 19,000 dedicated electronic cigarette users - mostly users of rechargeable units or mods - confirms that concerns about the health effects of smoking and a desire to quit smoking or cut down substantially on the amount smoked are the primary reasons for vaping among this population.

(See: Farsalinos KE, et al. Characteristics, Perceived Side Effects and Benefits of Electronic Cigarette Use: A Worldwide Survey of More than 19,000 Consumers. International Journal of Environmental Research and Public Health 2014, 11, 4356-4373; doi:10.3390/ijerph110404356.)

The study confirms that a huge number of people - at least 16,000 have successfully quit smoking using electronic cigarettes and among dedicated e-cigarette users who are not able to quit smoking completely, the reduction in cigarette consumption is dramatic: from an average of 20 cigarettes per day down to just 4 cigarettes per day.

The study concludes as follows: "The results of this worldwide survey of dedicated users indicate that ECs are mostly used to avoid the harm associated with smoking. They can be effective even in highly-dependent smokers and are used as long-term substitutes for smoking. High levels of nicotine are used at initiation; subsequently, users try to reduce nicotine consumption, with only a small minority using non-nicotine liquids. Side effects are minor and health benefits are substantial, especially for those who completely substitute smoking with EC use. Further population and interventional studies are warranted."

The Rest of the Story

Because this study is based on recruitment of e-cigarette users from online vaping forums, the results must be interpreted cautiously. This is not a representative sample of smokers who try electronic cigarettes. Instead, it is a selective sample of dedicated electronic cigarette users. Thus, the proportion of respondents who succeeded in quitting is not relevant to the general population of smokers who try to quit using electronic cigarettes.

Nevertheless, the study does provide valid data about the patterns of use of cigarettes and reasons for use of e-cigarettes among this particular population of highly dedicated vapers. Perhaps the most important finding is that huge numbers of ex-smokers succeeded in quitting and are keeping themselves off cigarettes by vaping. Second, huge numbers of smokers have succeeded in drastically reducing their cigarette consumption and lowering their addiction level by using these products. Third, the overwhelming stimulus for use of these products is the concern about the health effects of tobacco cigarettes and the desire to quit or cut down substantially. Finally, huge numbers of smokers who switched to electronic cigarettes have experienced dramatic acute improvements in their health.

Based on these results, I do not believe it is reasonable for anti-smoking advocates to continue to argue that electronic cigarettes have not been shown to help with smoking cessation. The results of this study make it clear that for many thousands of people, electronic cigarettes are an effective smoking cessation aid.

Wednesday, April 23, 2014

New Article Argues that Hospitals Denying Employment to Smokers is Not Consistent with Principles of Medicine

In an article published online ahead of print in Academic Medicine, physicians Thomas Huddle, Stefan Kertesz, and Ryan Nash argue that policies by which hospitals or health care systems deny employment to smokers are inconsistent with the traditional values of medicine.

(See: Huddle T, Kertesz S, Nash R. Health care institutions should not exclude smokers from employment. Academic Medicine 2014; 89.)

Here is the crux of their argument:

"We suggest that smoker ban proponents are mistaken when they maintain that smoker bans in health care institutions uphold professional norms in those institutions. Health care workers are expected to foster their patients’ healthy behaviors through respectful alliances with them, a posture articulated in the study of motivational interviewing. But health does not stand above care among the norms of medical practice; in fact, the latter is more important. Health care workers exemplify an ethic of care, including care for those whose ill health might be their own doing. Although there may be a case for having patients “take responsibility” for their health at the level of purchasing insurance, we do not consider individuals’ responsibility for their illnesses as disqualifying them from receiving care. Nor should we. This stance, which does not allow a person’s bad choices to influence our responses to his or her needs, is utterly at odds with employee smoker bans, which assign the moral status of the activity to the actor and label both as unwelcome. These bans reflect a moralization of health, characteristic of late-20th-century middle and upper class life, in which virtuous health behaviors serve as a marker for a “secular state of grace.” Whatever the merits of this moralization, its manifestation in smoker bans seems incompatible with mercy, charity, and even—insofar as such bans diminish the employment prospects of the poor—with social justice."

The article concludes:

"In the case of smokers, health care institutions ought to hire them freely and then encourage them to quit smoking. The message actually conveyed by an employee smoker ban to smokers is unlikely to be one of an affirmation of health; it is far more likely to be received as a personal affront or rejection. Such a message is incompatible with who we are as physicians and health care professionals. We believe that an institutional identity allied to the profession of medicine should be sufficient to rule out employee smoker bans for such institutions."

The Rest of the Story

The authors of this important and sentinel piece provide a cogent argument against smoker hiring bans. They compellingly argue that such bans violate the values and principles of medicine itself, by which care is provided to all who seek it, and moral status is not conveyed on the basis of health status or behavior.

Indeed, the moralization of health is a disturbing trend and is perhaps the greatest threat posed by workplace smoker bans.

Tuesday, April 22, 2014

Anti-Smoking Groups and Policy Makers Attack Big Pharma for Targeting Kids with Flavored Nicotine Replacement Products

A group of Congressmembers today released a report that criticizes pharmaceutical companies for targeting kids with candy-flavored nicotine replacement products. In addition to using appealing flavors, the report says, the pharmaceutical companies are attracting youth by using social media, sponsorship of youth-oriented events, and television and radio advertisements that reach substantial youth audiences. The report, entitled "“Gateway to Addiction? A Study of Nicotine Replacement Product Manufactureres and Marketing to Youth," is the first investigation of tactics used by pharmaceutical companies to market nicotine gum and nicotine lozenges to youth.

The major finding of the report was that pharmaceutical companies are marketing nicotine gum and lozenges in flavors that could be appealing to children and teens. Among the flavored brands of nicotine gum and lozenges cited in the report are:
  • Fruit Chill
  • Cinnamon Surge
  • Cherry
  • Orange
  • Fresh Mint
  • Extreme Chill
  • White Ice Mint
  • Spearmint Burst
The report includes pictures of product images and advertisements that appear to showcase the sweet, fruit flavorings of these products.

For example:
  • The Nicorette Fruit Chill package includes an image of fruits: pineapple, strawberry, banana, and orange.
  • An advertisement for Nicorette Fruit Chill uses the tagline: "Quitting is no vacation. But it can taste like one."
  • Nicorette's Spearmint Chill brand mimics the taste, flavor, and marketing image of youth-popular Wrigley's spearmint gum.
  • The image used on the Nicorette Fruit Chill package is almost identical to that of Trident spearmint gum, which also shows a variety of fruits.
The report also documents how pharmaceutical companies are using sponsorships of motor sports - particularly, the sponsorship of racing cars - to associate these products with youth-popular activities and events that have large youth audiences. The report includes photos, such as:
Perhaps the most damning finding of the report is the marketing of Nicorette toy race cars, a tactic that the lawmakers say can only be targeted at young children and intended to create positive associations with Nicorette in children as young as 2 and 3 years-old. The lawmakers included in the report multiple images of Nicorette toy race cars:
  • Nicorette Cinnamon Surge toy race car
  • Jeff Gordon's Nicorette Cinnamon Surge Chevy toy race car
The report also noted that popular stars, such as Jessica Simpson, have been endorsing the use of nicotine gum. Simpson - a former teen-pop sensation - told a national television audience that she was addicted to Nicorette gum, even though she had never smoked a cigarette in her life. Simpson told Jay Leno: "The first time I ever chewed a piece of Nicorette gum one of my close friends’ mother gave it to me. I think she thought she was giving me a piece of regular gum. I was chewing it and it was like a party in my mouth. It was like fireworks and 'Oh my god, I’m talking a million miles per hour and I love this gum and what kind of gum is this? I have to have this gum.'"

In citing Jessica Simpson's nationally televised testimonial to Nicorette, the report warned that "flavored nicotine replacement products may be a gateway to a lifetime of youth addiction to nicotine and tobacco."

The report concludes by calling on the Food and Drug Administration to remove candy-flavored NRT products from the market and to regulate the marketing of NRT so that it does not appeal to or target youths.

The Rest of the Story

Yes, this is satire. But it makes the point that the very same arguments that the lawmakers are using to implicate electronic cigarettes in targeting youth could be made to implicate nicotine replacement products such as nicotine gum and lozenges.

The rest of the story is nicely summarized by Jacob Sullum in a Reason.com column. He concludes:

"According to the Smoking Toolkit Study, e-cigarette use in England has been rising since 2011, when the survey began. Meanwhile, the percentage of smokers who reported quitting in the previous year rose from 4.6 percent in 2011 to 6.2 percent in 2012. The cessation rate was 6.1 percent last year and 8.7 percent in the first quarter of this year. During the same period the success rate of smokers who tried to quit rose from 13.7 percent to 21.4 percent. Those numbers suggest the real promise of e-cigarettes—not as a nefarious plot to hook teenagers on nicotine but as a harm-reducing alternative to smoking. If the FDA follows Durbin's advice, it will ban most e-cigarette flavors, making the switch less appealing to smokers who prefer the prohibited varieties, and restrict e-cigarette advertising, making smokers less aware of a competing product that could literally save their lives."

Monday, April 21, 2014

American Cancer Society Sells Out Its Principles for Money

In a press release last month congratulating CVS for its decision to stop selling deadly cigarettes, the American Cancer Society (ACS) wrote that: "policies that restrict access to tobacco products, reduce exposure to tobacco advertising, and limit the places that people smoke have a direct effect on reduced smoking rates, especially among youth. And that’s what makes this move so significant: community pharmacists play a key role in health and wellness and CVS Caremark has taken a bold step to demonstrate its commitment to healthy lifestyles and the prevention of disease."

Given that position, you might think that the American Cancer Society would be critical of Walgreens, arguably the largest remaining pharmacy chain which still sells deadly cigarettes, which kill more than 400,000 Americans each year. And naturally, you might expect that the ACS would criticize Walgreens on its web site and that it would point out the hypocrisy of this corporation selling medications to treat heart and lung disease at the same time it is selling the consumer product which is most responsible for causing these very diseases.

But no ... there is no criticism of Walgreens on the ACS web site. Instead, the American Cancer Society offers nothing but praise for this corporation. In fact, the ACS goes so far as to highlight Walgreens as a corporation that is "making a difference," giving it its own call-out page to help promote Walgreens' sales.

The American Cancer Society goes so far as to provide a special profile of Walgreens and to tell its members that Walgreens is making huge contributions to the protection of the public's health. Apparently, the ACS even provided Walgreens with a special award for its contibutions to public health.

What the ACS does not tell its readers is that Walgreens is full of hypocrisy: despite its pretentions that it is committed to the public's health, it continues to sell cigarettes; this is the single most devastating thing that this corporation could possibly do to decimate the public's health. But the American Cancer Society's profile of Walgreens is curiously silent on this issue. The ACS is trying to hide this from the public.

The American Cancer Society actually goes as far as calling Walgreens "a leader in the fight against cancer."

The Rest of the Story

Sadly, through its hypocrisy, the American Cancer Society has removed itself from being a "leader in the fight against cancer." Because a leader in the fight against cancer would never praise, award, and cite as a leader in the cancer fight a corporation which is selling deadly cigarettes that are killing hundreds of thousands of Americans each year. Walgreens' products are causing decimation, destruction, and suffering to families throughout the country. No - Walgreens' is no leader in the fight against cancer. Walgreen's is profiting off people getting cancer. That is sick and disgusting. It is not something to be rewarded. And it is certainly not an example of leadership in fighting cancer. On the contrary, Walgreens is causing cancer through the sale of its products.

The American Cancer Society's failure to recognize this, and its thinly-veiled efforts to hide the truth from the American public, are even more disgusting because while Walgreens is a corporation whose goal is to make money, the American Cancer Society is supposed to be fighting cancer.

After Peter Bach exposed the blatant hypocrisy of the ACS in his stinging New York Times piece, the ACS responded not by publicly blasting Walgreens for selling cancer-causing products, but instead, praised the corporation and further highlighted its financial contributions to the Society.

Clearly, the ACS has been bought off by the money that Walgreens is contributing. The Society cannot even stop praising Walgreens for its donations in a letter to the editor which is purportedly defending itself against the accusation that it is accepting donations from Walgreens!

The rest of the story is that the American Cancer Society has sold itself out for money. It has sacrificed its principles and betrayed its mission in order to not offend a corporation which is one of the chief contributors to the cancer epidemic.

On its web site, the ACS kisses up to the Chief Executive Officer of Walgreens, claiming that he truly believes that: "Being in the business of dispensing products and services to help people live well, stay well and get well means getting behind efforts to prevent disease, not just treat it."

This is complete crap. If the CEO of Walgreens truly believed that his corporation should get behind efforts to prevent disease, then the first thing he would do is stop selling the product that is the number one preventable cause of disease in the nation. If he were sincere, he would stop selling cigarettes.

That the American Cancer Society is promoting this crap on its web site is disgusting. It shows how low this organization has sunk and how little integrity it has left. Very little now separates the ACS from Walgreens. Both are selling out the public's health in order to make a buck. But at least Walgreens' is a corporation whose primary goal is to make money. The American Cancer Society is supposed to be fighting cancer.

According to the ACS itself: "A few months after Wasson took over as CEO in 2009, Walgreens received the first American Cancer Society Corporate Impact Award for Excellence in recognition of efforts by the company and employees to help create a world with less cancer and more birthdays."

If Walgreens were truly interested in helping create a world with less cancer and more birthdays, it would stop selling cigarettes. Period.

Today, I want to give my own award out. It goes to the American Cancer Society for the most blazen act of hypocrisy by an anti-smoking organization in 2014. And the engraving on the plaque will state: "To the American Cancer Society: for selling out its principles for corporate donations."

Friday, April 18, 2014

IN MY VIEW: Why Attacking Tobacco Companies for Giving their Cigarette Brands Color Labels Makes No Sense

Earlier this week, I discussed an article published in the journal Tobacco Control and a blog commentary on the article, in which a set of anti-smoking researchers attacked the cigarette industry for complying with the law. The article and commentary criticize tobacco companies for changing their labeling of "light" and "ultra-light" cigarette brands by removing these terms and instead, giving the brands different colors to differentiate them. The study found that manufacturers removed the "lights" labels, as required by law, and substituted colors for the banned descriptors. The study concludes that the tobacco companies circumvented the law and argues that these brands should be labeled by the FDA as "adulterated" and pulled from the market.

In my blog post, I argued that the cigarette companies cannot possibly be found in violation of the law for using alternative names for their products when the law specifically allowed those products to remain on the market.

My argument was echoed in a response to the article by Steven Pinkerton, a public health researcher from the Medical College of Wisconsin, who pointed out that: "the major tobacco companies demonstrated 100% compliance with the law by eliminating all terms specified in the FSPTCA [Family Smoking Prevention and Tobacco Control Act]--the use of colour terms to designate sub-brands is not regulated by the FSPTCA."

In their reply to this response, the authors of the study clarify their reasoning for attacking the cigarette companies, even though they merely complied with the law:

"The findings demonstrated that manufacturers did not simply remove descriptors, to be in compliance with the law, but introduced new color-coded brand name descriptors which smokers were able to recognize and easily identify the formerly labeled "lights" brands. We did not examine the use of colors themselves, which may be protected by the First Amendment, but rather the use of color terms. The marketing materials examined make explicit the fact that the use of substituted color terms in brand names is similar to the dropped "descriptors, so that consumers will continue to recognize these brands as "lights"."

The Rest of the Story

The study authors attack the cigarette companies for substituting another term in the brand name for their products after removing the offending terms ("lights," "ultra-lights," "mild," etc.). But what they fail to acknowledge is that in order to comply with the law, the cigarette companies had no other choice. Had they simply removed the offending descriptor, this would have resulted in their having four or five brands with the exact same name, preventing consumers from having any way to distinguish these brands. Such a result would have effectively removed these brands from the market, which was clearly not the intent of Congress. Had Congress intended to remove these brands from the market, it would have simply banned these brands altogether.

Without adding a descriptor of some sort, the cigarette companies would not have been able to distinguish their sub-brands. For example, Marlboro "Lights" would now be called "Marlboro." Marlboro "Ultra-Lights" would now be called "Marlboro." And Marlboro "Milds" would now be called "Marlboro." Thus, there would be three brands on the market, all called simply "Marlboro," and consumers would have no way of telling them apart.

Let's suppose that Altria had decided to simply call these brands Marlboro A, Marlboro B, and Marlboro C. Consumers would have still learned which letter corresponded to which product, and if you conducted a study, you would find that despite banning the "lights" terms, consumers still recognized which product corresponded to which earlier brand name. By the reasoning of the study authors, this would have represented a circumvention of the law and resulted in the companies being attacked for evading the law.

The point is that there was no way for the cigarette companies to comply with the law, other than to change the banned descriptors to a new term. And no matter what term they chose, consumers would have figured out which brand was which. Moreover, the law did not specify or imply that the companies were prohibited from informing consumers which brand was which. 

In other words, it is time to acknowledge that the law was flawed. It is not the cigarette companies that are to blame for the fact that consumers still understand which brand is which. The law is to blame. If the intent of Congress were to ban any brand that might mislead consumers, then the Congress should simply have banned these brands, requiring them to be pulled from the market. 

But that wasn't the intent of Congress, or of the anti-smoking groups which supported the Family Smoking Prevention and Tobacco Control Act. The intent was to gain a political victory by making it look like they were doing something to protect the public's health, when in truth, they weren't actually doing anything to make cigarettes safer. If anything, they were putting obstacles in the way of transforming the tobacco market into one that is safer.

Instead, the law created a huge bureaucracy full of red tape and sluggish approval processes such that there are still close to 3500 substantial equivalence applications stacked up in a pile somewhere, and the FDA is so overburdened that it cannot even issue electronic cigarette regulations in a reasonable amount of time.

The failure of the Family Smoking Prevention and Tobacco Control Act does call for criticism. But that criticism should not be leveled at the colors Gold, Silver, and Blue. The criticism should be directed at the anti-smoking groups and politicians who sold out the health of the public for political gain.

Thursday, April 17, 2014

Anti-Smoking Advocate Claims that Inhaling Small Amounts of Nicotine Can Be Deadly

In an April 2 press release, anti-smoking advocate John Banzhaf, a law professor at George Washington University and former director of Action on Smoking and Health (ASH), claims that inhaling even small amounts of nicotine can be deadly. He also tells the public that breathing in tobacco smoke for only 30 minutes raises a nonsmoker's risk of a fatal heart attack to that of a long-time smoker's. And to top it off, he claims that inhalation of propylene glycol can cause seizures.

According to the press release:

"Nicotine, even when inhaled in small amounts by nonsmokers, can be deadly. That's why the CDC has warned that nonsmokers seated in the no-smoking sections of restaurants, and inhaling only the nicotine in the small amount of smoke which drifts to their table, nevertheless increase their risk of a heart attack to that of a smoker in as little as 30 minutes."

Also according to the release:

"Experts have warned that propylene glycol should not be inhaled because it can cause respiratory irritation, convulsions, and gastrointestinal distress."

The Rest of the Story

All of these claims are false or highly misleading.

First, the inhalation of nicotine is not deadly. While Banzhaf seems to imply that even the acute inhalation of nicotine is deadly, even if we take his statement to mean that the long-term inhalation of nicotine is deadly, it is still unsupported by scientific evidence. It is not the nicotine which makes cigarette smoking and secondhand smoke deadly; it is the tar, or the other components of the smoke. If what Banzhaf is saying were true, then would he not want to demand that the FDA take nicotine inhalers off the market. After all, if inhaling small amounts of nicotine can be deadly, then surely we would not want anyone to be using a nicotine inhaler.

Second, it is not true that breathing in tobacco smoke for 30 minutes raises a nonsmoker's risk of a heart attack to that of a smoker. The truth is that an otherwise healthy nonsmoker is not going to suffer a heart attack as a result of 30 minutes of exposure to secondhand smoke. A nonsmoker's risk of a heart attack from breathing tobacco smoke for 30 minutes is not the same as that of a smoker. It is actually zero. You are not going to have a heart attack if you don't have coronary artery disease; and 30 minutes of exposure to secondhand smoke is not going to clog your coronary arteries.

Third, the inhalation of propylene glycol from an electronic cigarette is not a cause of seizures. Would we not have expected to have heard reports of seizures from electronic cigarettes by now, given that more than 2 million Americans are using this product and it has been in widespread use across the world for the past 3 years?

I don't understand the point of this scare-mongering. But its effects are to undermine the public's appreciation of the severe health effects of smoking and potentially to promote a return to cigarette smoking among ex-smokers who achieved cessation using electronic cigarettes. Thus, these public statements are not only false but they are damaging as well.

Moreover, statements like these are going to eventually undermine or destroy the scientific reputation of the tobacco control movement. There is only so much of this we can tolerate before the public begins to dismiss everything we say.

Sadly, very few advocates in the tobacco control movement are willing to call other anti-smoking practitioners or groups on this kind of nonsense. And that is exactly what allows this to continue.

Wednesday, April 16, 2014

Anti-Smoking Researchers Attack Tobacco Companies for Complying with the Law

In a strange and ironic twist, in an article published in the journal Tobacco Control and a blog commentary on the article, a set of anti-smoking researchers are attacking the cigarette industry for complying with the law.

The article and commentary criticize tobacco companies for changing their labeling of "light" and "ultra-light" cigarette brands by removing these terms and instead, giving the brands different colors to differentiate them.

The results of the study were as follows: "Manufacturers substituted “Gold” for “Light” and “Silver” for “Ultra-light” in the names of Marlboro sub-brands, and “Blue”, “Gold”, and “Silver” for banned descriptors in sub-brand names."

The study concludes that the tobacco companies circumvented the law and argues that these brands should be labeled by the FDA as "adulterated" and pulled from the market.

The Rest of the Story

The truth is that Bill Godshall and I predicted, years ago, that the anti-smoking groups' were full of baloney in promising that the FDA legislation would protect children and adults. Bill and I predicted that exactly this scenario would unfold: the cigarette flavoring ban would have no effect because no cigarettes were actually affected by the ban (menthol cigarettes are exempt) and the "lights" ban would have no effect because cigarette companies would start using coloring to convey the differences between "lights" and other brands.

Instead of whining about the tobacco companies evading the FDA tobacco law by using colors to denote the brands formerly known as "lights" or "milds," the Campaign for Tobacco-Free Kids and the other major anti-smoking groups should be apologizing to its constituents and to the public for knowingly crafting legislation that would not accomplish its declared purpose.

The Campaign for Tobacco-Free Kids, along with the American Heart Association, American Lung Association, and American Cancer Society pulled one over on the American people by declaring that the legislation that the Campaign crafted in negotiations with Philip Morris would put an end to descriptors relating to "light" or "mild" cigarettes.

These groups agreed to and supported legislation would specifically did not remove these brands from the market. Instead, the legislation simply mandated that these descriptor terms not be used after June 21, 2010.

As the tobacco companies are no longer using these descriptor terms, they are in compliance with the federal law. They cannot possibly be found in violation of the law for using alternative names for their products when the law specifically allowed those products to remain on the market.

If it was the anti-smoking groups' intention to remove these products from the market, then they should have made sure that the legislation removed these products from the market. But given that they did not do that, these groups cannot stand up today and pretend that the problem is the tobacco companies circumventing the law. The problem is the law itself, and the fact that it expressly permits the companies to rename and repackage the products formerly known as "lights" or "milds." Thus, these anti-smoking groups have no one to blame but themselves.

It is not that the tobacco companies are evading the law; it is that the law is so weak that it allowed these products to remain on the market, as long as they simply changed their names to terms that do not directly convey the same meaning.

The Campaign for Tobacco-Free Kids argued that the tobacco companies and retailers not be allowed to tell consumers that the renamed products are the same as the former products. But this would have been an unconstitutional restriction of free speech. Unless the renamed product is banned, or the descriptor used is in violation of the law because it directly infers that the cigarette is safer, then I'm afraid that the companies are in compliance with the law and the anti-smoking groups are going to have to respect that.

You see, the problem is that the anti-smoking groups were willing to talk the talk, but not willing to walk the walk. They wanted to pass legislation in order to say that they had done something. They wanted to be able to tell their constituents that they accomplished something. You see, that's good for donations.

But when it really came down to it, these groups weren't willing to actually put any meat in the legislation. That's why they merely banned the descriptors, rather than banning the products. That's why they banned the flavorings that are never used, rather than the menthol which is used by millions. That's why they gave the FDA authority to lower the nicotine in cigarettes, but not remove it. That's why they gave the FDA authority to regulate tobacco sales to minors, but not to increase the legal age of purchase or outlaw the sale of tobacco in any particular type of retail establishment. And that's why they are pushing the FDA to outlaw electronic cigarettes and dissolvable tobacco products, but not touch the real ones.

I'm sorry, but the words "gold," "silver," "orange," "red," "green" and other colors do not imply levels of harm. In fact, there are existing cigarettes on the market with the names "gold" or "silver" and these products are not accused of implying different levels of health risk. The only reason why these color names imply different risk level is that people know they are the replacement names for the former "light" or "mild" cigarettes.

The Campaign for Tobacco-Free Kids, and the FDA, cannot simply rewrite the law because it was crafted improperly. They have to live within the statute, and within the constitution. And unfortunately, the anti-smoking groups screwed up (albeit intentionally). In other words, the tobacco companies are not evading the law. They are following the law.

You see, no matter what term a tobacco company uses to rename its product, it is going to be known that the name is the new name for whatever the product's old name was. No matter how bland and non-descriptive the new name is, it is still going to infer the same attributes as the old name.

Thus, if it had been the intent of Congress to eliminate this problem, Congress would have chosen to simply mandate the removal of these "light" products from the market. But Congress did not do that.

The rest of the story is that the anti-smoking groups are whining loudly because they need to: they need to cover up their own indiscretion -- negotiating and supporting a bill with no teeth, while misleading the public about the strength of the bill and its effects. In other words, unless the anti-smoking groups shift the blame over to the tobacco companies, then the fact that these groups lied to the American people is going to become clear.

Tuesday, April 15, 2014

New York State Senator Wants to Ban Most Electronic Cigarettes, While Keeping the Toxic Real Ones

New York State Senator Kemp Hannon has introduced legislation that would ban most electronic cigarettes, including both the rechargeable and modular types, while keeping toxic tobacco cigarettes on the market.

Senate Bill 6939 would ban the sale of all electronic cigarette liquids. Under the proposed law, an e-liquid is defined as "A LIQUID COMPOSED OF NICOTINE AND OTHER CHEMICALS, AND WHICH IS SOLD AS A PRODUCT THAT MAY BE USED IN AN ELECTRONIC CIGARETTE."

By this definition, it would be illegal to sell not only the e-liquids used in modular electronic cigarettes, but also the refill cartridges used in rechargeable electronic cigarettes. Thus, this legislation would remove from the market a huge chunk of the electronic cigarettes that are currently sold in New York State. Only disposable electronic cigarettes would remain, and it is unclear if even these would be allowed to be sold, since they do contain "a liquid composed of nicotine and other chemicals" that is "used in an electronic cigarette." Thus, it is conceivable that this legislation would ban the sale of all electronic cigarettes in the state of New York.

The Rest of the Story

If the goal here were to simply protect children and infants from accidentally ingesting nicotine, then Senator Hannon could simply have introduced legislation to require childproof packaging and warning labels on these products. Instead, it appears that the goal is actually to protect the sale of cigarettes in New York by eliminating competition from a rapidly proliferating smoking cessation product that is projected to give tobacco cigarettes a run for their money.

It makes no sense, from a public health perspective, to ban a product which is almost uniformly used by smokers in an effort to quit smoking or significantly reduce the amount of cigarette consumption, while at the same time, to sanction the sale of the real thing: deadly cigarettes. What Senator Hannon is saying is that he would rather have smokers continue to smoke cigarettes than quit smoking with the aid of a much safer alternative product.

If Senator Hannon were truly committed to protecting the health of children in New York, he would propose banning the sale of cigarettes, which are the primary source of nicotine poisoning among New York residents. Why ban the non-tobacco cigarettes which are helping thousands of smokers get off cigarettes, while leaving the real ones on the market to continue to kill New York residents?

This bill would serve to protect the profits of Big Tobacco. Most troublesome is the fact that it would protect the sale of the most toxic market segment - combustible cigarettes - at the expense of a smoking cessation product that has been shown to be much safer to users. 

Senator Hannon is not alone in this craziness. The Israeli Health Ministry has proposed a complete ban on the sale of electronic cigarettes.

The benefits of electronic cigarettes are clear: they help many smokers to quit smoking. They are especially advantageous to smokers who have failed to quit using traditional methods. Taking these products off the market is essentially condemning many smokers to continued smoking by taking away a viable option for them to try to kick the addiction.

The proposed policies in New York State and Israel would severely harm the public's health by causing many vapers to go back to cigarette smoking. What justification is there for a law that we know would harm the public's health? 

Monday, April 14, 2014

ANR Apparently Decides to Keep Defamatory Statement on Its Web Site

Last week, I revealed that Americans for Nonsmokers' Rights (ANR) is making defamatory statements on its web site about electronic cigarette companies, claiming that all of them are owned by Big Tobacco and that Mistic, in particular, is a tobacco-owned company that is distributing misinformation based on a Harris Interactive survey it commissioned.

On the site, ANR makes the following claim: "A recent survey conducted by Harris Decima, a Harris Interactive company, for Mistic e- cigarettes purports to document public support for use of e-cigarettes in in a variety of places, including airplanes, workplaces, sporting events, restaurants and bars, and more. But the survey should be looked at skeptically, inasmuch as, historically, research funded by the tobacco industry tends to yield results favorable to the industry's position. One only needs to refer to the landmark Department of Justice case against the tobacco companies to know their history of disseminating misinformation designed to protect industry profits."

I argued as follows:

"This statement insinuates that Mistic is a tobacco company. The statement refers to the survey as "research funded by the tobacco industry" and reminds readers of the history of the dissemination of misinformation by "the tobacco companies." I read this as a clear assertion that Mistic is a tobacco company, or owned by a tobacco company.

To the best of my knowledge, this assertion is false. I do not believe that Mistic is a tobacco company. I believe that Mistic is an electronic cigarette company, and I do not believe that Mistic is owned by any tobacco company. Thus, I believe that this accusation is false.

Because ANR is falsely accusing Mistic of being part of Big Tobacco, I am afraid that ANR is making a potentially defamatory statement. The false accusation appears to be malicious, as it ties Mistic to the historical fraud and conspiracy for which the tobacco companies were found guilty in the Department of Justice lawsuit. The accusation also appears to represent a blatant disregard for the truth, since there is absolutely no reason to even think that Mistic is owned by Big Tobacco, and because ANR does not list Mistic in its list of e-cigarette brands that are owned by tobacco companies. Thus, it appears that ANR is aware that Mistic is just an independent e-cigarette company."


The Rest of the Story

Today, it has become apparent that ANR has no intention of retracting or clarifying its defamatory statement attacking Mistic E-Cigarettes, accusing it of being owned by Big Tobacco, and claiming that it is putting out misinformation similar to the historical fraudulent actions of the tobacco industry. I wrote my colleagues at ANR to inform them about the inaccuracy in their public accusation, but received no response. Moreover, the claim remains on ANR's website, unchanged.

Unless ANR has evidence that Mistic is owned by Big Tobacco, I believe that ANR may be in serious legal trouble. ANR is now aware, for certain, that its claim that Mistic is a tobacco company is false. So any continuation to make this claim on its web site is most definitely a blatant disregard for the truth. And there is no doubt that it is being done with malicious intent.

But the question is: why even take this chance? Why is there a need to rely upon defamatory and false statements to promote the public's health? Why isn't telling the truth good enough for ANR?

To be sure, ANR could simply have suggested that any poll commissioned by a company should be questioned because there is a potential bias. There was no need to claim that Mistic is actually a tobacco company and that Big Tobacco's history of fraud therefore applies to Mistic. Moreover, there was no need to claim that all electronic cigarette companies are tobacco companies. ANR could simply have stated that some electronic cigarette companies are owned by tobacco companies.

I just do not understand why ANR finds it necessary to lie in order to make its point. Couldn't ANR just tell the truth? There are enough truthful reasons for the public to be cautious about electronic cigarettes that lies are not necessary.

While I didn't highlight this in my earlier post, ANR makes another false statement on its site. It claims that electronic cigarette companies are calling what comes out of their products a "vapor" rather than an "aerosol" because they are trying to connote "reduced harm." ANR then calls this a "tobacco industry tactic," implying that the electronic cigarette companies are acting in a fraudulent manner.

If the electronic cigarette companies are acting fraudulently, then I guess so am I. If you review my blog, you will find that I referred to what comes out of electronic cigarettes as a vapor until quite recently. It wasn't until several months ago that I learned that it is actually an aerosol rather than a vapor. I wasn't using a tobacco industry tactic; I was simply using the term that was most commonly used, and I was using the term that I believed was correct. I don't have any reason to believe that electronic cigarette companies were doing anything different. Moreover, it is not fraudulent for these companies to try to connote reduced harm. Electronic cigarettes are undeniably less harmful than real cigarettes.

Ironically, while ANR is attacking the electronic cigarettes in general, and Mistic in particular, for spreading "misinformation," the rest of the story is that it is ANR that is spreading the misinformation. Moreover, not only is ANR spreading misinformation, but it is doing so in an intentionally malicious way, while blatantly disregarding the truth.

Were I still on the ANR Executive Board, I would be very concerned about a potential lawsuit. Fortunately, I am no longer on that Board. And it was in anticipation of a problem like this that I resigned. I took my leave from ANR when I learned that the organization cared more about attacking its opponents than about telling the truth. I left when I realized that ANR was not interested in the truth, but was obsessed with smearing its perceived enemies and was willing to use defamatory attacks to achieve this end.

At the end of the day, if you need to lie in order to make your point, it seems to me that you need to go back and reassess your position. I think today would be a good day for ANR to go back to the drawing board.

Thursday, April 10, 2014

New Data from England Suggest that Electronic Cigarettes are Helping to Accelerate Smoking Cessation, Not Hinder It

In contrast to the claims of many anti-smoking advocates, led by Stan Glantz, new evidence from England suggests that electronic cigarettes are helping to accelerate smoking cessation, rather than hinder it.

(See: West R, Brown J, Beard E. Trends in electronic cigarette use in England. Smoking Toolkit Study. London: University College London, April 4, 2014.)

According to this study, the prevalence of electronic cigarette use in England was very low in 2011, but it took off in 2012 and has continued to climb steadily through the first quarter of 2014. The key finding from the study is that the annual rate of smoking cessation (that is, the percentage of current smokers who quit smoking during the past year), which had reached a low of 4.6% in 2011, increased markedly to 6.2% in 2012, 6.1% in 2013, and 8.7% for the first quarter of 2014, concomitant with the dramatic rise in electronic cigarette use among these smokers.

The proliferation of electronic cigarettes in England has also been associated with a dramatic increase in the proportion of smokers who tried to stop in the past year (from 33.5% in 2011 to 40.3% in 2014) and an increase in the success rate for smokers who tried to quit (from 13.7% in 2011 to 21.4% in 2014).

The proliferation of electronic cigarettes was also associated with an acceleration in the decline in smoking prevalence.

Taken together, these data suggest that the widespread use of electronic cigarette among smokers in England has advanced the degree of smoking cessation.

The authors conclude that: 
  • "Evidence does not support the view that electronic cigarettes are undermining motivation to quit or reduction in smoking prevalence"; and
  • "Evidence conflicts with the view that electronic cigarettes are undermining tobacco control or ‘renormalizing’ smoking, and they may be contributing to a reduction in smoking prevalence through increased success at quitting smoking."
The Rest of the Story

Opponents of electronic cigarettes have spent most of their time speculating about the negative impact of these products. They have argued that electronic cigarettes undermine the motivation to quit, normalize smoking, and undermine years of tobacco control efforts. However, a look at the actual scientific evidence suggests that this is not the case at all. Quite the opposite, it appears that electronic cigarettes are enhancing the process of smoking cessation among active smokers.

This evidence needs to be confirmed in other countries, but it does suggest that electronic cigarettes could play a role in helping to facilitate or enhance smoking cessation, rather than detract from it. In contrast to the arguments of opponents, vaping does not appear to renormalize smoking, but to further de-normalize it.

Wednesday, April 09, 2014

Contrary to Claims of Many Anti-Smoking Advocates, New Study Shows that Electronic Cigarettes Decrease Nicotine Addiction

Many anti-smoking groups and advocates have been opposing electronic cigarettes on the grounds that these products perpetuate or even increase nicotine addiction, rather than decreasing it. But a new study presented at the 2014 annual conference of the Society for Research on Nicotine and Tobacco (SRNT) provides evidence that nicotine addiction levels are actually decreased, not increased, in smokers who have switched to electronic cigarettes.

(Jonathan Foulds PhD, Susan Veldheer MS RD, Jessica Yingst, Shari Hrabovsky RN MSN. Comparison of dependence on electronic cigarettes and regular cigarettes in a large sample of e-cig users. Penn State University College of Medicine, Department of Public Health Sciences, Hershey, PA.)

Dr. Foulds and colleagues developed a 10-question scale to assess nicotine dependence and administered it to a sample of 2,368 current electronic cigarette users. Subjects were asked to fill out the scale to assess the level of their addiction while smoking, and then again to assess the level of their current addiction using electronic cigarettes.

The main results were as follows: "In the survey of e-cig users, dependence on e-cigs was significantly lower than it had been on cigarettes (8.6 v 14.9). ... Current e-cig users are significantly less dependent on e-cigs than they were on cigarettes prior to switching."

The Rest of the Story

While the study must be viewed as providing only preliminary evidence and further confirmation is necessary, this is important research because it suggests that contrary to the assertions of many anti-smoking advocates, switching from tobacco cigarettes to electronic cigarettes decreases rather than increases the level of addiction to nicotine. Smokers who make the switch are less addicted and feel better prepared and better able to quit completely.

Since Dr. Foulds' addiction scale correlates significantly with actual quitting behavior, one would expect that these results would eventually translate into higher rates of complete nicotine cessation in smokers who switch to electronic cigarettes.

These results, while preliminary, provide initial evidence that electronic cigarettes may serve not only as a means of helping smokers to quit, but also of helping them to eventually become free of nicotine addiction.

Hopefully, Dr. Foulds and his group will next repeat the study using a sample of dual users (electronic cigarettes and regular cigarettes) to determine whether or not dual users experience a similar reduction in their overall level of smoking addiction.

Tuesday, April 08, 2014

Americans for Nonsmokers' Rights Spreading False Information About Health Effects of Electronic Cigarettes

According to a "fact sheet" on the Americans for Nonsmokers Rights (ANR) web site, short-term use of electronic cigarettes impairs lung function and can cause difficulty breathing:

"Short term use of e-cigarettes has been shown to increase respiratory resistance and impair lung function, which may result in difficulty breathing."

The citation provided to back up this assertion is a study by Vardavas et al. (Vardavas, C.I.; Anagnostopoulos, N.; Kougias, M.; Evangelopoulou, V.; Connolly, G.N.; Behrakis, P.K., "Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide," Chest 141(6): 1400-1406, June 2012.).

The Rest of the Story

The rest of the story is this study actually found no effect of electronic cigarette use on pulmonary function tests, indicating that there was no clinically significant observable effect of vaping on lung function. Specifically, the study found "no differences between basic pulmonary measurements" between the two groups, demonstrating that acute exposure to electronic cigarette vapor did not affect FEV1, FVC, PEF or MEF50 and MEF75."

In contrast to what ANR is stating, the study found no effect of e-cigarettes on lung function, as measured by spirometry. This is in contrast to tobacco smoking, which does have effects on lung function that can be measured using spirometric testing. While previous research indicates that active smoking and even secondhand smoke exposure can affect acute lung function as measured by spirometry, the study demonstrated that electronic cigarette use led to no impairment of lung function detectable via spirometric testing.

What the study did show was subclinical evidence of impaired lung function, meaning that the observed (measurable) lung function was unchanged, but that there was evidence of physiologic effects consistent with some bronchial inflammation. What is not known is whether this acute bronchial inflammation has any significance in the long-term. The presence of bronchial inflammation may be a result of propylene glycol having a respiratory irritant effect. But this does not necessarily mean that long-term exposure would lead to any adverse effect on lung function. More research is necessary to clarify that point.

The authors acknowledge this: "We must state though that while the differences within our study are of statistical significance, the clinical changes may be too small to be of major clinical importance."

Despite this, ANR tells the public not only that vaping impairs acute lung function, but that it can cause difficulty breathing. This is an outright lie. There is absolutely no evidence that vaping causes clinical respiratory impairment to an extent that leads to difficulty breathing. In fact, the available evidence overwhelmingly demonstrates that smokers who switch to electronic cigarettes experience a marked improvement in their respiratory symptoms.

Unfortunately, ANR is so determined to attack electronic cigarette use that it has abandoned scientific integrity and is spreading misinformation to the public. While ANR has every right to advocate against the use of electronic cigarettes, it should not do so based on false and misleading information.

The reason I resigned from the ANR Executive Board was that the organization told me that it placed a higher value on its political objectives than on scientific integrity. This story illustrates that ANR continues to operate on this unethical strategy.

Monday, April 07, 2014

Americans for Nonsmokers' Rights Disseminating Misleading and Potentially Defamatory Statements About Electronic Cigarette Groups

In a document entitled "Electronic Cigarettes: Advocacy and Research Updates," and an accompanying "fact" sheet, Americans for Nonsmokers' Rights (ANR) insinuates that all electronic cigarette companies are actually owned by Big Tobacco, that several e-cigarette trade associations/lobbying groups are actually tobacco industry front groups, and that Mistic E-Cigarettes specifically is owned by a tobacco company.

Here are the three claims, an analysis of what they insinuate to the public, and an explanation of why they are false, misleading, and potentially defamatory:

1. "E-cigarette companies ARE tobacco companies!" (capitalization and exclamation point are original to the document)

This statement insinuates that all electronic cigarette companies are tobacco companies. Had ANR wished to convey the assertion that some e-cigarette companies are tobacco companies, it could and should have stated: "Some e-cigarette companies are tobacco companies." The omission of the word "some," along with the capitaliation of the word ARE and the exclamation point at the end of the claim combine to construe to the reader that all e-cigarette companies are tobacco companies; that is, that they are one and the same.

This assertion is demonstrably false. While it is true that there are a total of about seven e-cigarette brands that are owned by Big Tobacco, the overwhelming majority of electronic cigarette companies have nothing to do with tobacco companies. There are estimated to be more than 250 e-cigarette brands on the market. Therefore, the overwhelming majority of electronic cigarette companies are completely independent from tobacco companies.

2. "Remember the National Smokers Alliance, Philip Morris' phony grassroots network? How about all those "studies" looking at public support for or economic impact of smokefree laws? They're back: There are three national e-cigarette "trade associations" one of which, Smoke Free Air Trade Association (SFATA), has several board members with ties to Big Tobacco. Also, two new statewide front groups, Oklahoma Vapors Advocacy League (OVAL) and Iowans for Alternatives to Smoking and Tobacco (IAST), have popped up and are providing testimony in favor of e-cigarette use. A lobbyist for IAST has also lobbied for Philip Morris."

This statement insinutates that like the National Smokers Alliance, the Smoke Free Alternatives Trade Association (SFATA), Oklahoma Vapors Advocacy League (OVAL) and Iowans for Alternatives to Smoking and Tobacco (IAST) are actually Big Tobacco front groups. The statement emphasizes the ties of two of SFATA's Board members to Big Tobacco, as well as the fact that a lobbyist for IAST has lobbied for Philip Morris. Thus, the insinuation is that these are all Big Tobacco front groups and they are not being honest about their true funding from tobacco companies.

This assertion is very misleading, if not outright false. All of these groups readily acknowledge that they are trade associations whose members are electronic cigarette manufacturers or retailers. Moreover, none of these groups, to the best of my knowledge, is funded by Big Tobacco. They are independent trade associations that were organized by and are run by electronic cigarette companies or retailers, not by tobacco companies. 

3. "A recent survey conducted by Harris Decima, a Harris Interactive company, for Mistic e- cigarettes purports to document public support for use of e-cigarettes in in a variety of places, including airplanes, workplaces, sporting events, restaurants and bars, and more. But the survey should be looked at skeptically, inasmuch as, historically, research funded by the tobacco industry tends to yield results favorable to the industry's position. One only needs to refer to the landmark Department of Justice case against the tobacco companies to know their history of disseminating misinformation designed to protect industry profits."
  
This statement insinuates that Mistic is a tobacco company. The statement refers to the survey as "research funded by the tobacco industry" and reminds readers of the history of the dissemination of misinformation by "the tobacco companies." I read this as a clear assertion that Mistic is a tobacco company, or owned by a tobacco company.

To the best of my knowledge, this assertion is false. I do not believe that Mistic is a tobacco company. I believe that Mistic is an electronic cigarette company, and I do not believe that Mistic is owned by any tobacco company. Thus, I believe that this accusation is false.

Because ANR is falsely accusing Mistic of being part of Big Tobacco, I am afraid that ANR is making a potentially defamatory statement. The false accusation appears to be malicious, as it ties Mistic to the historical fraud and conspiracy for which the tobacco companies were found guilty in the Department of Justice lawsuit. The accusation also appears to represent a blatant disregard for the truth, since there is absolutely no reason to even think that Mistic is owned by Big Tobacco, and because ANR does not list Mistic in its list of e-cigarette brands that are owned by tobacco companies. Thus, it appears that ANR is aware that Mistic is just an independent e-cigarette company.

The Rest of the Story

I am very familiar with the tactics of ANR because I served on the ANR Executive Board for several years. The reason I resigned from the ANR Executive Board was that they told me they were more concerned with the political impact of their statements than worrying about whether their statements might be defamatory. Thus, the potentially defamatory statements that ANR is currently making about electronic cigarette companies and groups appear to be in line with its long-standing philosophy of using unethical tactics to smear, attack, and defame what it views to be its enemies.

Although I agree with most of the overall goals of ANR in terms of reducing the public's exposure to secondhand smoke, I denounce its tactics of disseminating false and misleading information to the public and especially, trying to smear its declared enemies with false, misleading, and defamatory attacks.