Wednesday, January 30, 2013

Massachusetts Governor is Proposing $1 Increase in Tax on Cigarettes with No Increased Funding for Anti-Smoking Programs and Campaign for Tobacco-Free Kids is SUPPORTING It; Now You Can See the Problem

According to a Reuters article, Massachusetts governor Deval Patrick has proposed a $1 per pack increase in the state cigarette tax (bringing it from $2.51 to $3.51 per pack), with all funds placed into the general fund in order to fund education and transportation projects. Apparently, none of the additional revenues would be earmarked for the state's anti-smoking program, which has been decimated from $54 million in its heyday to just $4.5 million in 2013. And none of the additional revenues would be earmarked for treatment of smoking-related diseases.

This despite a new report from the New England Center for Investigative Reporting which revealed that the Commonwealth of Massachusetts has diverted 99% of all its tobacco revenues to something other than the tobacco-related purposes for which they were originally intended.

According to an article in the North Andover Eagle-Tribune: "Millions of dollars originally intended for smoking cessation programs in Massachusetts have been diverted to offset budget deficits, leaving the state struggling to fund quit-smoking hotlines, treatment programs and anti-tobacco advertising, the New England Center for Investigative Reporting has found. The cutback in smoking cessation programs comes at a time when more than 9,000 Massachusetts residents die annually from smoking-related diseases and yearly health care costs associated with treating tobacco-related illnesses in the state have risen to $3.9 billion, according to the Centers for Disease Control. ...

“Roughly 99 percent of all the tobacco dollars that come into the state are used for something else,” said Stephen Shestakofsky, recently retired executive director of Tobacco Free Massachusetts, an anti-tobacco advocacy group. He was referring to the nearly $254 million in tobacco-related legal awards given to Massachusetts in 2012. More than $561 million in tobacco taxes was also collected, bringing the state’s total tobacco tally to just over $815 million, the CDC reports. Of that $815 million in tobacco money, only about $4.2 million will be spent in 2013 on smoking cessation and prevention programs in Massachusetts, state health officials said."

The Rest of the Story

The worst part of the story is that the Campaign for Tobacco-Free Kids (and apparently other anti-smoking groups as well) support the proposal.

In a statement issued last week, the Campaign for Tobacco-Free Kids called the proposal a "win-win-win" solution. And nowhere in its statement did it even suggest that part of the revenues should be used to bolster the state's anti-smoking campaign, which is at an embarrassingly low level.

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.

Not only is it devastating strategically to raise these taxes without tying the money to anti-smoking spending, but it also isn't fair. Why should smokers, who are disproportionately lower income, be singled out to bear the burden of helping the state pay its transportation debts? Why should smokers, who are disproportionately of lower education, be singled out to shoulder the burden of paying for educational improvements? Especially when smokers paying the taxes do not benefit directly from the resulting programs.

In contrast, when tax revenue is used to fund treatment for smoking-related diseases and research to help find better treatment or a cure for smoking-related disease, then at least those bearing the burden of the tax can potentially benefit from the programs that the revenue is funding.

Tuesday, January 29, 2013

New Study Reports Decline in Heart Attacks After Smoking Ban, But There Was No Decline in Heart Attacks After Smoking Ban

A new study published last week in PLoS ONE reports that a partial smoking ban enacted in Spain in 2006 resulted in an 11% decline in heart attack incidence and an 18% decline in heart attack mortality rates in six counties in northern Spain.

(See: Aguero F, et al. Impact of a partial smoke-free legislation on myocardial infarction incidence, mortality and case fatality in a population-based registry: the REGICOR study. PLoS ONE 2013; 8(1): e53722. doi:10.1371/journal.pone.0053722.)

The study compared the incidence and mortality rates for acute myocardial infarction for the four years prior to the partial smoking ban (2002-2005) with those during the first three years after implementation of the law (2006-2008). The law banned smoking in workplaces, but exempted hospitality establishments including bars and restaurants. The data were collected from a population-based heart attack registry, covering six counties in northeast Spain served by a single tertiary care hospital with a coronary care unit.

The paper used a negative binomial regression to model the annual rates of heart attack incidence or mortality, with an indicator variable corresponding to whether the data were from before or after the partial smoking ban.

The results were reported as follows: "In the post-ban period, AMI incidence and mortality rates significantly decreased (relative risk [RR] = 0.89; 95% confidence interval [CI] = 0.81–0.97 and RR = 0.82; 95% CI = 0.71–0.94, respectively)."

The conclusion was: "The 2006 Spanish partial smoke-free legislation was associated with a decrease in population AMI incidence and mortality, particularly in women, in people aged 65–74 years, and in passive smokers. These results clarify the association between AMI mortality and the enactment of a partial smoke-free legislation and reinforce the effectiveness of smoking regulations in preventing CHD."

The results were disseminated widely through the media. The press release boasted that: "Implementation of smoke-free legislation reduces the number of acute myocardial infarctions by 11 percent."

The Rest of the Story

There's just one problem with this study concluding that the partial smoking ban implemented in 2006 reduced the number of heart attacks by 11% (and the number of heart attack deaths by 18%):

The data show that there was no decrease in heart attacks or heart attack deaths following the smoking ban.

One can easily see this in Figure 1 of the paper. There was indeed a decline in heart attack incidence and mortality in northeast Spain during the study period, but the decline occurred prior to the smoking ban, not after it. There was in fact little or no change in heart attack incidence or mortality after implementation of the smoking ban.

The data speak for themselves:

Here are the heart attack incidence rates for 2005 (immediately before the ban) and 2008 (after the ban):

Before: 173.35
After: 175.15

Here are the heart attack hospitalization rates for 2005 (immediately before the ban) and 2008 (after the ban):

Before: 144.90
After: 142.71

Here are the heart attack mortality rates for 2005 (immediately before the ban) and 2008 (after the ban):

Before: 37.58
After: 39.57

As you can easily see from the data reported in the paper, heart attack incidence and mortality rates were almost the same after the partial smoking ban as they were immediately prior to the ban.

What's quite clear is that the heart attack rates were dropping significantly during the baseline period, from 2002-2005. From 2005-2008, they remained relatively steady. Therefore, a negative binomial regression is going to "pick up" an "effect" of the smoking ban, that is not at all due to the smoking ban. Instead, this detection of an 11% "decline" in heart attacks is simply a reflection of the secular decline that occurred during the baseline period. If you just use data from 2005 for the pre-ban period, this effect will completely disappear!

This is hardly surprising, since the ban was hardly a "ban." It simply eliminated smoking in office-type workplaces, but it didn't get rid of smoking in bars or restaurants. Since most people were already working in smoke-free offices in 2005 anyway, and because the law didn't apply to bars and restaurants, one would not have expected to observe any decline in heart attacks to begin with. I find it surprising that the study authors actually expected to see such an effect.

But the most significant aspect of this story is that the paper is reporting a conclusion based on data which demonstrate the opposite. The paper reports that heart attacks declined after the smoking ban, but the data show that heart attacks did not decline after the smoking ban.

This is yet another study on the acute cardiovascular effects of smoking bans that reports exactly the opposite of what the study data demonstrate. It appears that anti-smoking researchers are so determined to find an effect of smoking bans on heart attacks that they will manufacture conclusions that simply are not consistent with the reported data.

In most of the public's eyes, a change from 173 to 175 is not an 11% decline, but the minds of anti-smoking researchers, it is. After all, we're working for a good purpose, and so it's perfectly acceptable to manipulate the data with statistical models so as to find an effect that doesn't really exist.

Monday, January 28, 2013

Problem is Not that Electronic Cigarette Companies are Making False Claims; Problem is that Anti-Smoking and Health Groups Are

Many anti-smoking groups and advocates have expressed grave concern that electronic cigarette companies are widely misleading the public about the scientific truths regarding these products. Accordingly, they have called for strict regulation of these claims, with some groups calling for prohibition of these statements. For example, Stan Glantz on his blog last week expressed concern about "false advertising" claims being made by electronic cigarette companies. According to Glantz and others, electronic cigarette companies are falsely claiming that their products may be helpful in smoking cessation, and immediate measures are necessary to protect the public from this false advertising.

Since there is in fact strong evidence that electronic cigarettes may be useful in smoking cessation, these claims do not represent false advertising. Whether they represent therapeutic claims is debatable, and I have already explained why I do not believe that a smoking cessation claim, in and of itself, is a therapeutic claim.

There is, however, a large number of entities that are grossly misrepresenting the scientific evidence, widely misleading the public, and often lying about the scientific facts regarding electronic cigarettes. Who are they?

Not the electronic cigarette companies, but anti-smoking and health groups.

The Rest of the Story

A review of 10 of the most popular electronic cigarette brand web sites revealed that not a single one of these companies is making a smoking cessation claim for its products, not a single one is making any drug claims, and each company offers a specific disclaimer making it clear that the product is not approved for any purposes by the FDA and that it is not intended for smoking cessation nor to cure, treat, or prevent any disease or condition:

Blu Cigs: "blu e-cigs® electronic cigarettes are not a smoking cessation product and have not been evaluated by the Food and Drug Administration, nor are they intended to treat, prevent, or cure any disease or condition."

V2 Cigs: "V2 Cigs products are not marketed for use as a smoking cessation product. Just like traditional tobacco cigarettes, V2 Electronic Cigarettes are not approved by the American FDA. ... Our products do not treat, diagnose, or cure any disease, physical ailment, or condition."

Safe Cig: "This product is sold for recreational use only. Our products are neither intended nor marketed as a quit smoking aid or cessation device. ... Electronic Cigarettes and Cigars are not FDA approved. Statements made about our products are not intended to diagnose, treat, cure or prevent any disease. Electronic cigarettes and cigars are not FDA approved."

Green Smoke: "This product is sold purely for recreational purposes - it is not a smoking cessation product and has not been tested as such."

NJOY: "NJOY products are not a smoking cessation product and have not been tested as such.  This product and the statements made within have not been evaluated by the US Food and Drug Administration or any other international health or regulatory authority, unless otherwise noted in NJOY’s materials. These statements and NJOY products are not intended to diagnose, treat, cure, or prevent any condition, disorder, disease or physical or mental conditions and should not be used as a substitute for your own physician’s advice."

Johnson Creek: "Johnson Creek Original & Red Oak Smoke Juice is not a smoking cessation product and has not been tested or guaranteed as such. Johnson Creek Original & Red Oak Smoke Juice has not been evaluated by the Food and Drug Administration nor is it intended to treat, prevent or cure any disease or condition."

South Beach Smoke: "Our products do not treat, diagnose, or cure any disease, physical ailment, or condition. If you are allergic to nicotine or any combination of inhalants, if you are pregnant or breast-feeding, or if you have a heart-condition, diabetes, high blood pressure or asthma, consult your physician before using South Beach Smoke nicotine products. Just like traditional tobacco cigarettes, South Beach Smoke Electronic Cigarettes are not approved by the American FDA." 

Premium Electronic Cigarette: "Premium Ecigarette does not market or intend its product to be used as a quit smoking aid or a cessation device.  Premium Ecigarettes are not intended to diagnose, treat, cure or prevent any disease."

Vapor Couture: "Our products do not treat, diagnose, or cure any disease, physical ailment, or condition. ... Vapor Couture products are not marketed for use as a smoking cessation product. Just like traditional tobacco cigarettes, Vapor Couture Electronic Cigarettes are not approved by the American FDA."

Crown 7: "The FDA will regulate e-cigarettes under its authority to regulate other tobacco products. The FDA has in the past detained or blocked incoming shipments of e-cigarettes from overseas manufacturers on the basis that e-cigarettes are unapproved drug delivery devices that must pass through the FDA's New Drug Application (NDA) process before they can legally be sold. Two e-cigarette importers and distributors, Smoking Everywhere, Inc. and Sottera, Inc., brought a lawsuit against the FDA and sought a preliminary injunction to prevent the FDA from regulating e-cigarettes as a drug delivery device and from stopping the importation of e-cigarettes into the U.S. while the case is ongoing. The e-cigarette distributors argued that because their products use nicotine derived from tobacco, e-cigarettes should be regulated as "tobacco products," subject to much more limited restrictions that do not require pre-approval by the FDA. The United States District Court for the District of Columbia granted the preliminary injunction. This ruling was affirmed by the United States Court of Appeals for the District of Columbia Circuit in December 2010.22 In April of 2011, the FDA decided it will not seek further review of this decision, but rather will regulate e-cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act in accordance with the court's opinion. In September 2009, the FDA announced that it will continue to bring enforcement actions against e-cigarette companies that make unsubstantiated health claims about their products.
E-cigarette sales are also subject to state law. Various state attorneys general have brought lawsuits alleging that e-cigarette distributors have violated state law by selling to minors or making unsubstantiated health claims."

In fact, the only misleading statement on any of these web sites is the assertion that "like tobacco cigarettes," the FDA has not approved electronic cigarettes. Actually, the FDA has approved tobacco cigarettes, which are statutorily legal and officially approved by the agency.

In contrast, just in the last few weeks, numerous anti-smoking and health groups have made misleading or blatantly false scientific claims about electronic cigarettes:

1. The Malaysia Health Ministry has apparently communicated that electronic cigarettes are more hazardous than the real ones: "The Health Ministry has urged smokers who have switched to electronic cigarettes to refrain from using liquid nicotine as it was more hazardous. Its minister Datuk Seri Liow Tiong Lai said liquid nicotine was a controlled drug under the Poisons Act 1952. ... Liow said it was safe if smokers used the e-cigarettes without nicotine to slowly quit the habit. “But adding liquid nicotine can make the e-cigarettes more harmful than the normal cigarettes,” he said...".

2. A German health official apparently also communicated that electronic cigarettes can cause more harm than smoking: "They are billed as a healthier alternative to smoking, yet experts now warn that electronic cigarettes may be more damaging than the habit they replace. ... To vaporise the nicotine solution, the chemical propylene glycol is put into the cartridges, and accounts for up to 90 per cent of their content. This can cause ‘acute respiratory system irritation’, claims Dr Elisabeth Pott, director of the Federal Centre of Health Education in Cologne, Germany, who has studied e-cigarettes."

3. The Department of Health in the Phillippines apparently has communicated that electronic cigarettes cannot be helpful in quitting smoking: "Electronic cigarettes (e-cigarettes), increasingly popular among young Filipinos, are not advisable for those who want to quit smoking, the Department of Health (DOH) warned last week. Anthony Leachon, DOH consultant for non-communicable diseases, e-cigarettes could not help a person who wants to stop smoking. 'Electronic cigarettes are not advisable since you don’t kick the habit. You can easily go back to smoking,' said Leachon. He said if a person wants to quit but can’t do it on his own, he should consult a doctor for proper counseling and medication. Maricar Limpin, executive director of the Framework Convention on Tobacco Control Alliance Philippines, has expressed concern over the proliferation of e-cigarettes. Limpin warned that e-cigarettes give a false sense of security because these are being marketed as something that would help one quit smoking 'when, in fact, there is no evidence to prove that.'"

4. The Canadian Lung Association is warning smokers not to use electronic cigarettes to quit smoking because they contain carcinogens and anti-freeze, harm the lungs, are marketed to and appeal to kids, and may be a gateway to smoking: "For National Non-Smoking Week, the Canadian Lung Association encourages people who want to quit smoking to use scientifically proven methods and to avoid gimmicky unproven methods, like electronic cigarettes. "Don''t be fooled by e-cigarettes. These electronic devices could be potentially harmful to lung health and are not an approved quit smoking aid by either Health Canada or the U.S. Federal Drug Administration," says Margaret Bernhardt-Lowdon, a tobacco issues spokesperson for the Canadian Lung Association. ... "People who use e-cigarettes inhale unknown, unregulated and potentially harmful substances into their lungs," says Dr. Theo Moraes, a medical spokesperson for the Canadian Lung Association and an assistant professor at the University of Toronto. ... E-cigarettes may contain ingredients that are known to be toxic to humans including carcinogens and diethylene glycol, a toxic chemical used in antifreeze. In initial lab tests, the U.S. Food and Drug Administration found detectable levels of carcinogens and toxic chemicals in two leading brands of e-cigarettes and 18 various cartridges. ... The Canadian Lung Association is greatly concerned that e-cigarettes with candy-like flavours, such as chocolate and vanilla, are being marketed and sold to youth. "We are afraid that e-cigarettes, if not regulated, may lead more young people to start smoking," says Dr. Moraes, who is also a staff respirologist at The Hospital for Sick Children in Toronto. "These products have candy-like flavours, which appeal to children and teenagers and can be bought by those under the age of 18. We are also concerned that e-cigarettes may lead kids to try other tobacco products."

The statements being made by these health officials are far more concerning than the statements being made by electronic cigarette companies, which are largely truthful. In contrast, the statements being made by these health officials are either misleading and deceptive or outright false. 

If public health policy makers and federal health officials want to ensure that the public receives truthful information about the health risks of smoking and electronic cigarette use, then the place to start is not with the electronic cigarette companies, but with anti-smoking and health groups which are deceiving and lying to the public because they simply don't like the idea of a behavior that looks like smoking actually helping to save lives.

Thursday, January 24, 2013

New Study Purports to Show that Graphic Cigarette Warning Labels Cause Smokers to Quit

"Graphic Warnings on Cigarette Packets Proven to Drive Smoker Quit Rate"

Thus reads the headline of a news article about a recent study on graphic warning labels published in PLOS ONE.

The conclusion of the study itself reads: "Policies that establish strong pictorial warning labels on tobacco packaging may be instrumental in reducing the toll of the tobacco epidemic, particularly within vulnerable communities."

The news article quotes one of the study authors as emphasizing that: "mandating strong pictorial warnings is an effective and efficient way to communicate the risk of tobacco use."
The Rest of the Story

What is the scientific evidence upon which these headlines and conclusions are based?

Take a guess from the following options:

A. A study that demonstrated an increase in quit rates among smokers following implementation of graphic warning labels.

B. A study that demonstrated an increase in quit attempts among smokers following implementation of graphic warning labels.

C. A study that demonstrated an increase in the intention to quit among smokers immediately after purchasing cigarettes with graphic warning labels on their packages.

D. A simulation study of responses of smokers to graphic or text messages displayed on a computer, completely divorced from the actual context of buying cigarettes, and without any demonstration of an actual effect on behavior.

If you guessed D, then you are correct.

Surprisingly, after reading these headlines and conclusions, I found that the scientific evidence upon which these conclusions were based is about the weakest possible evidence imaginable. There was no attempt to determine whether graphic warning labels affect actual smoking behavior. Nor was there an attempt to examine the impact of graphic warning labels in the actual context in which they are viewed: after the purchase of cigarettes.

While interesting, I do not find that this study adds much to the evidence on the impact of graphic warning labels. It merely shows that under experimental conditions, computer images that correspond to graphic warnings on cigarette packs stimulate a greater cognitive response than text-based messages. This is hardly surprising, nor is it evidence that graphic warning labels will be effective in stimulating smoking cessation in real life conditions.

The fact is that people are very poor at predicting their actual behavior, especially for addictive behaviors such as smoking. It is easy for a smoker to report an increased intention to quit after seeing a computer image, but whether that translates into the smoker quitting after seeing that image on a cigarette pack after actually purchasing those cigarettes is not clear. It is certainly not appropriate to take this evidence and conclude that graphic warning labels are "instrumental in reducing the toll of the tobacco epidemic" or that this intervention is an "effective and efficient" one.

It certainly appears to me that the investigators have a pre-determined agenda: a desire to show that graphic warning labels are effective. I cannot think of another reason why they would translate the weak scientific evidence in this study into a conclusive statement that graphic warning labels are "instrumental in reducing the toll of the tobacco epidemic." There is currently no solid scientific evidence to support this contention, and in fact, there is considerable evidence that this is not the case.

I believe that in tobacco control, the science should drive the policy agenda, not the other way around. Unfortunately, we are seeing too many examples of the opposite these days. What we need is evidence-based policy, not policy-driven evidence.

Wednesday, January 23, 2013

New Study on Electronic Cigarette Use Among Youth Fails to Find a Single Nonsmoking Youth Who Has Even Tried an Electronic Cigarette

In a newly published article in the Journal of Adolescent Health, Pepper et al. report the results of an online survey of 228 adolescent males, ages 11-19, to assess awareness, willingness to use, and actual use of electronic cigarettes.

The results were reported as follows: "Only two participants (< 1%) had previously tried e-cigarettes. Among those who had not tried e-cigarettes, most (67%) had heard of them. Awareness was higher among older and non-Hispanic adolescents. Nearly 1 in 5 (18%) participants were willing to try either a plain or flavored e-cigarette, but willingness to try plain versus flavored varieties did not differ. Smokers were more willing to try any e-cigarette than nonsmokers (74% vs. 13%; OR 10.25, 95% CI 2.88, 36.46). Nonsmokers who had more negative beliefs about the typical smoker were less willing to try e-cigarettes (OR .58, 95% CI .43, .79)."

The article concludes: "Given that even experimentation with e-cigarettes could lead to nicotine dependence and subsequent use of other tobacco products, regulatory and behavioral interventions are needed to prevent “gateway” use by adolescent nonsmokers."

In an accompanying commentary entitled "Electronic Cigarettes: A New Nicotine Gateway?" Dr. Rachel Grana of the Center for Tobacco Control Research and Education expresses alarm because "18% of the sample endorsed being susceptible to trying e-cigarettes." On this basis, she concludes that: "Additional action should be taken to ensure e-cigarettes are not sold to youth and their appeal to youth and nonsmokers is minimized, such as enacting restrictions on health claims, explicit celebrity endorsements, and the elimination of the flavors."

The Rest of the Story

These two articles are a perfect example of the profound disconnect between the scientific evidence and the policy agenda in the modern tobacco control movement.

Here we have two papers which sound the alarm about the terrible problem of youth use of electronic cigarettes and about the hazards of e-cigarettes serving as a gateway to nicotine addiction. But what did the study actually show?

It showed that not a single nonsmoking youth could be found, among a sample of 228 male adolescents, who actually uses or has ever even tried an electronic cigarette. And only two smoking youth could be found who have tried the product.

This is a striking finding which puts to bed the contention of many anti-smoking groups and advocates that electronic cigarettes appeal heavily to youths and serve as a gateway to nicotine addiction. The finding quite strongly answers the question posed by Dr. Grana, in the negative.

Yet instead of emphasize this important finding, the articles try to scare the public about the scourge of electronic cigarettes among our nation's youth, citing the rather meaningless finding that 18% of youths would be willing to try an electronic cigarette. Most adolescents are willing to try anything. This finding means nothing. The important finding is that in contrast to popular belief among anti-smoking advocates and researchers, the electronic cigarette is simply not popular among adolescents. In this particular sample, not a single nonsmoking youth could be found who has even so much as tried the product.

The first sentence of the paper's discussion reads as follows: "Although few adolescent males in our national sample had tried e-cigarettes, around two-thirds were aware of them." This is an odd way to summarize the results. I would have stated it in exactly the opposite way: "Although two-thirds of the adolescent males in our national sample were aware of electronic cigarettes, only two had ever tried them."

This is a striking finding. Adolescents are widely aware of these products, but they are not using them. And they are not even experimenting with them. Clearly, this is a product which is not particularly appealing to adolescents. They much prefer the real thing. Just as they prefer "real" jeans to imitation ones and "real" name-brand sneakers to imitation ones.

To be sure, public health practitioners and policy makers need to stay vigilant and monitor the use of electronic cigarettes. And measures to prohibit the sale of electronic cigarettes to minors are certainly justified. But the rest of the story is that there simply is no evidence to suggest that electronic cigarettes are appealing to, or popular among youth. Measures suggested by Dr. Grana - such as prohibiting flavors, outlawing celebrity endorsements, or banning truthful claims about the relative safety of these products - are not justified or warranted.

But I don't think most anti-smoking groups or advocates care about the actual evidence. They've already made up their minds. Vaping looks too much like smoking. So forget about the fact that not a single nonsmoking youth could be found who has even tried the product. The advocates must continue to follow the party line and warn about the danger of electronic cigarettes as a gateway to nicotine addiction. Never mind that the gateway just doesn't exist.

Tuesday, January 22, 2013

Usefulness in Smoking Cessation or Reduction is Not Necessarily a Therapeutic Claim; Electronic Cigarette Companies Should Be Allowed to Tell the Truth

In his blog post last Thursday, Stan Glantz argued that electronic cigarette companies should not be allowed to claim that these products can be useful for smoking cessation or reduction because such claims would represent "therapeutic" or "drug" claims and therefore put the products under the jurisdiction of the Food, Drug, and Cosmetic Act (FDCA).

Glantz wrote: "The fact that the e-cigarette companies and their trade association have been encouraging their consumers to submit public comments to a docket about smoking cessation products can be read no other way than the e-cigarette companies and their trade association are promoting their products as having therapeutic benefit." He goes on to opine that such "therapeutic" claims render e-cigarettes subject to the FDCA, which would of course require them to either be removed from the market or to stop making these claims.

While Glantz' opinion seems, at first glance, to be a reasonable one, closer inspection reveals that it is not sound because a claim that electronic cigarettes can help a smoker to reduce or eliminate cigarette use by substituting for cigarettes is not a therapeutic claim.

The Rest of the Story

What is a therapeutic claim? Under the Food, Drug, and Cosmetic Act, it is defined as: "Promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body will cause the product to be considered a drug under the FD&C Act, section 201(g)."

The key point is that in order to be making a therapeutic claim, one either has to claim that the product will treat or prevent a disease or claim that the product will affect the structure or a function of the body.

A. Is Smoking a Disease?

Is claiming that electronic cigarettes can aid in smoking cessation a claim that these products can treat or prevent a disease? That depends on whether smoking is a disease.

Smoking itself is not a disease, but a behavior. Just as eating unhealthy food is not a disease, but a behavior. Or as not exercising is not a disease, but a behavior. Or as drinking alcohol is not a disease, but a behavior.

In and of itself, a claim that electronic cigarettes can aid in smoking cessation is therefore not a therapeutic claim.

As long as electronic cigarettes are marketed as an alternative to cigarettes which may help the user cut down or eliminate cigarette use, then it is simply claiming that it may affect a health behavior, rather than that it will treat or prevent a disease.

Consider the following scenarios:

1. An apple orchard decides to promote consumption of its apples by putting out advertisements which claim that buying apples from this orchard will help consumers to improve their diet and reduce their consumption of junk food. Does the FDA have jurisdiction over such claims under FDCA?

Of course not. The apple orchard is not claiming that is products (apples) will prevent or treat any disease. It is merely arguing that eating its apples is a healthy behavior. What is being claimed is that these products will improve health behavior, not that these products will treat or prevent a disease?

If the orchard claimed that eating its apples would reduce the risk of heart disease, then that could be interpreted as a therapeutic claim because it is claiming that its product will prevent a disease. But a simple claim that eating these products will improve one's diet is a behavioral claim, not a therapeutic one.

If we applied Stan's reasoning, then the apple orchard would have to stop making this claim. One can easily see, I believe, that Stan's argument does not hold.

2. I decide to sell a calendar that includes inspirational pictures of people exercising. It also contains reminders on certain days of the week to remind people to exercise on those days. I send out a flyer, advertising my calendar, in which I claim that this calendar may help people to exercise more often. Is that a therapeutic claim?

Of course not. Lack of exercise is not a disease. It is a behavior. I am not claiming that my calendar will treat or prevent any disease. I am only claiming that my calendar could influence one's health behavior. But again, by Stan's argument, this is a therapeutic claim and renders my calendars subject to the FDCA.

3. I conduct an educational program about alcohol, inviting people to come learn about the potential harms of alcohol use. At the program, I offer for sale a booklet that I claim can help people reduce their alcohol use. Do I need FDA approval to sell my booklet?

Of course not. It is only claiming to help people alter their behavior. It is not making a therapeutic claim. But again, by Glantz' reasoning, since it is claiming to affect a health behavior, it is indeed a therapeutic claim and would not be allowed.

I have demonstrated that in and of itself, claiming that electronic cigarettes may be useful in smoking cessation is not a therapeutic claim. Of course, the companies must refrain from claiming that the use of electronic cigarettes will reduce the risk of disease (that would be a therapeutic claim). But as long as they restrict their marketing to claims that these products may influence smoking behavior, then the claim is not a "therapeutic claim."

B. Is a Smoking Cessation Claim One that the Product Will Affect the Structure or Function of the Body?

It depends. Specifically, it depends on the mechanism by which the company is claiming smoking cessation will be achieved. If the mechanism involves any alteration of the structure or function of the body, then the claim could be interpreted as a therapeutic one. However, if the company is not claiming that the structure or function of the body will be affected, then it is not a therapeutic claim.

Suppose that an electronic cigarette company markets its products by boasting that they are intended to deliver nicotine with the goal of relieving symptoms of nicotine withdrawal and therefore making it possible for the smoker to quit smoking. If the primary intended purpose of the device is to deliver nicotine in order to prevent withdrawal symptoms by occupying nicotine receptors, then this type of marketing claim could be interpreted as a therapeutic claim.

This is, in fact, the reason why NRT products are regulated under FDCA. These products are specifically designed and intended to affect the structure and function of the body. They are designed to bind to nicotine receptors and prevent nicotine withdrawal, thus aiding the smoking cessation process. Similarly, Chantix is designed as a nicotine agonist. It works by altering the structure and function of the body.

However, suppose that an electronic cigarette company markets its products not by intending that the product's purpose is to prevent nicotine withdrawal symptoms during quit attempts, but instead, by simply intending that the product's purpose is to serve as an alternative to cigarette smoking. Suppose that the marketing of the product is focused on providing an alternative to cigarette smoking that does not involve tobacco or combustion. Then it is not making a therapeutic claim because it is not claiming that this product is intended to affect the structure or function of the body.

Summary of My Argument

There is no such disease or medical condition as smoking dependence. Smoking is not a medical disease or condition, it is simply a behavior. Smoking isn't any more of a disease as is bungee jumping or eating Vienna Fingers. What is a medical condition is nicotine dependence and nicotine withdrawal. These are conditions clearly defined in the DSM-IV.

I have acknowledged, above, that if the primary intended use of electronic cigarettes is to treat a disease or medical condition, then they are subject to FDA jurisdiction under FDCA. This means that if a company claims that electronic cigarettes are designed specifically to help smokers quit by treating nicotine dependence, then the product can be regulated as a drug. However, what if the company markets the product merely as a smoking alternative? In that case, the product is not a drug and cannot be regulated under FDCA.

Now let's take a middle ground case: suppose a company states that electronic cigarettes are a smoking alternative that may help smokers to quit smoking. In that case, are the electronic cigarettes being marketed to treat any medical condition? If the intent of the manufacturer is for the consumer to simply switch over to electronic cigarettes, then I believe the answer is no. Smoking dependence is not a medical condition. So if the primary objective is to get the consumer off of cigarettes, then no therapeutic claim is being made.

In fact, unless an electronic cigarette company is making a specific claim that its products will treat nicotine dependence by eliminating the symptoms of nicotine withdrawal - and that is the primary aim or use of the product - then I believe that it is making no therapeutic claim and that its products cannot be regulated under FDCA.

In other words, simply stating that electronic cigarettes may help smokers quit smoking is not, in my opinion, a therapeutic claim.

As long as the primary intent of the electronic cigarette company is to maintain the customer on its products, then it is not treating nicotine dependence, and I do not believe it is making a therapeutic claim. If the purpose of the product were to help someone get over the hump of quitting smoking and then discontinue use of the product, that would be a different story. But that's not the way I see most electronic cigarettes being marketed.

The rest of the story is that the world is not as simple as Stan would like us to believe. A smoking cessation claim, in and of itself, is not necessarily a therapeutic claim. The situation is a lot more nuanced than that.

In my opinion, electronic cigarette companies should be allowed to truthfully inform consumers that their products may be useful for smoking cessation, as long as these claims are made within the general framework of marketing electronic cigarettes as an alternative to tobacco cigarettes. Such claims are not therapeutic claims as defined by section 201g of the FDCA.

Thursday, January 17, 2013

When You Don't Like the Evidence, Make Up Bogus Scientific Explanations to Dismiss It: Anti-Smoking Mantra, Part 3

The fact is that literally tens of thousands of smokers have found electronic cigarettes to be a viable alternative to smoking and have used these products to either quit smoking or cut down on the amount that they smoke. The experiences of these smokers, documented by the skyrocketing sales of electronic cigarettes and the projections by financial analysts that these products could make a serious dent in the cigarette market provide an important element of scientific evidence that electronic cigarettes are an effective tool for smoking reduction or cessation.

This creates a problem for anti-smoking researchers and advocates who have already reached a pre-determined conclusion that electronic cigarettes are harmful to public health - a conclusion guided by their ideology which dictates that even the hand motions associated with smoking are scornful and must be frowned upon.

One approach to this quandary was demonstrated this week by Stan Glantz, who argued that all of these personal stories about smokers quitting using electronic cigarettes are invalid pieces of evidence because these smokers are quitting because of the "placebo effect" rather than because of the electronic cigarettes.

The Rest of the Story

That the evidence provided by tens of thousands of smokers quitting or cutting down on the amount they smoke due to electronic cigarettes is invalid because it merely demonstrates a "placebo effect" is a completely bogus scientific explanation for this evidence, and is a contrived effort to dismiss the evidence.

To explain away this evidence as merely demonstrating a placebo effect is a meaningless exercise in bogus science, as well as a distortion of the meaning of the placebo effect.

There are essentially two aspects to a "placebo effect" that Stan is invoking to explain the widespread effectiveness of electronic cigarettes in helping smokers quit or cut down.

First, Stan could be arguing that the effect of these devices is not due to the nicotine delivery, but to a placebo effect, because vapers believe they are inhaling nicotine. In other words, the argument would be that these smokers would have quit smoking anyway, even if the electronic cigarettes didn't deliver any nicotine.

If that explanation is correct, then electronic cigarettes are an even more promising strategy for smoking cessation than is currently believed. It would mean that zero-nicotine electronic cigarettes would be effective for smoking reduction or cessation. It would mean that electronic cigarette companies could avoid FDA regulation entirely by simply producing cartridges without nicotine.

Second, Stan could be arguing that it is not necessarily the electronic cigarette that is inducing smoking cessation, but that any product which is held and used like a cigarette would be effective in achieving this result.

If that explanation is correct, then electronic cigarette manufacturers have discovered the single most effective approach to smoking cessation in existence. In essence, what Stan is calling a "placebo effect" would be the mechanism by which smokers are quitting using electronic cigarettes. Far from negating the effect of these products on smoking cessation, such an explanation demonstrates precisely why they are so effective: because the vaping process mimics smoking behavior so well.

This is in fact a major reason why electronic cigarettes are so effective. But to call it a "placebo effect" is a distortion of the concept and is rather meaningless.

The bottom line is that Stan has stopped making valid scientific arguments, and is now simply blowing smoke because he apparently cannot find any valid reasons to dismiss the overwhelming evidence that these products have helped tens of thousands of smokers to either quit smoking or cut down on the amount that they smoke.

I believe that Stan is blinded by ideology: the idea that something which looks like a cigarette and is used in the same way could be a life-saver is simply not within the scope of possibility of many anti-smoking researchers and advocates. For Stan and many other anti-smoking researchers, this ideology is so powerful that it is precluding an objective consideration of the scientific evidence.

I highly recommend that readers spend some time digesting Dr. Carl Phillips' commentary on this issue. Carl explains much better than I ever could why Stan's argument about the "placebo effect" is bogus.

Wednesday, January 16, 2013

The New Anti-Smoking Mantra - Part II: When You Don't Like the Evidence, Delete It

Yesterday, I reported that Stan Glantz acknowledged that when he sees evidence of the effectiveness of electronic cigarettes presented by individuals who have used these products successfully, he chooses to ignore it. Today, I have realized that the story is even worse. Not only is Stan refusing to consider such scientific evidence, but he is refusing to allow ex-smokers who have quit using electronic cigarettes to post comments on his blog reporting their success. This would be tantamount to my deleting all comments from smokers who tried to use electronic cigarettes but failed.

As a long-time blogger, I understand the issues related to whether to allow or disallow certain comments. It is certainly appropriate to censor comments that violate basic ethical norms, such as comments that are defamatory, use inappropriate language, contain personal attacks, etc. It is also appropriate to censor comments that are off-topic, repetitive, or excessively long. However, I believe it is inappropriate to censor comments simply because you don't agree with their viewpoint. And it is definitely inappropriate to censor comments from individuals because you don't like the implications of their personal experiences and want to cover up the truth.

Stan is essentially admitting that his blog is not about presenting an objective evaluation of the scientific evidence but instead, is about spouting tobacco control propaganda. That's fine - it's certainly his prerogative to use his blog as a propaganda instrument. However, he should stop pretending that he is an objective scientist and that his blog is either objective or science-based.

Look - there are many comments on my blog with which I strongly disagree. But unless the comments are defamatory, I do not delete them. I don't see the harm done by allowing people to express their opinions, no matter how strongly I might disagree with them. Some of the most important advances in science have actually come from vehement disagreements and sometimes, these advances have resulted from people questioning accepted dogma.

Even more importantly, I will not delete any comments by individuals sharing their personal experiences. In fact, such comments are very helpful because they provide examples of people's actual experiences on the issues being discussed. I certainly wouldn't delete personal experiences because I don't like the implications.

I won't repeat here my discussion of why personal testimonials about their experiences with electronic cigarettes do in fact constitute important scientific evidence about the effectiveness of these products. I will, however, refer readers to an excellent commentary by Dr. Carl Phillips, who points out that in some ways, personal testimonials provide a type of evidence that is not available from clinical trials.

As Dr. Phillips wrote: "Glantz’s claim that these posts are not informative brings us to his profound lack of understanding of the science he claims expertise in. ... Those testimonials are the real scientific evidence, not the vague statistics that Glantz proposes collecting.  Any real scientist would recognize this.  It turns out that the statistics he wants to collect offer us little or no information about what we want to know — what switchers would have done without e-cigarettes.  It is that kind of information that is not scientifically useful.  The testimonials, on the other hand, are a rich source of scientific information about smokers who did not quit (they would probably say “could not quit”) until they found e-cigarettes.  These testimonials represent useful scientific experiments."

The rest of the story is that unfortunately, the modern tobacco control movement is losing its scientific objectivity. There is a pre-determined agenda, based on firmly entrenched ideology - which cannot be challenged, and evidence that goes against that agenda must be either ignored or buried, or both.

Tuesday, January 15, 2013

When You Don't Like the Evidence, Ignore It: The New Anti-Tobacco Mantra

Anti-tobacco groups, researchers, and advocates who have a pre-existing bias against electronic cigarettes and who have already made up their minds that these cigarette-like substitutes are evil are faced with a perplexing problem: how to respond to the personal stories of literally hundreds of thousands of vapers who have successfully used these products to quit smoking or to cut down substantially on the amount that they smoke.

This is a major problem for these anti-tobacco researchers and advocates because they must continue to assert that there is no evidence electronic cigarettes are helpful in smoking reduction or cessation. Once the acknowledge that electronic cigarettes are useful for smoking cessation or reduction, then their ideological opposition to these products becomes untenable.

So how to respond to the fact that more than 2.5 million smokers in the United States find these products helpful in their efforts to quit smoking or to cut down on the amount that they smoke? How to respond to the hundreds of thousands of personal testimonials of vapers who have succeeded in using these alternatives to cigarettes?

To me, this would seem like a vexing problem. After all, you can't simply ignore this evidence, can you?

The Rest of the Story

Yes - you can ignore the evidence! This is the modern-day anti-tobacco movement and in 2013, ignoring the scientific evidence is perfectly acceptable in the movement.

Yesterday, a leading anti-tobacco researcher - Dr. Stan Glantz - admitted that his approach to the evidence that millions of smokers are using electronic cigarettes successfully as an alternative to the real ones is very simple:

Ignore it.

Yesterday, Dr. Glantz wrote, on his tobacco blog, that smokers who have succeeded in quitting smoking using electronic cigarettes have not actually demonstrated the usefulness of the electronic cigarette. Instead, he argues, they have simply experienced a placebo effect.

In a column entitled "Why I don't post personal testimonials about e-cigarettes on by blog," Dr. Glantz explains that: "There is a long and well-developed literature about the placebo effect where people think a treatment worked when, in fact, it was no better than a sugar pill. Personal testimonials about the benefits of e-cigarettes do not constitute scientific evidence that they are effective ways to quit smoking."

In this case, Dr. Glantz' argument makes no sense because a placebo-type effect is precisely how the electronic cigarette works. In other words, the electronic cigarette works by simulating a real one. The similarity of the electronic cigarette to a real cigarette is the precise mechanism of action by which electronic cigarettes work. The issue of a "placebo" effect is only relevant as far as the question of whether the vaper is quitting because of the nicotine in the e-cigarette or the behavioral aspects of e-cigarette use.

Moreover, while case reports are obviously not the highest standard of scientific evidence, they are undeniably a valid form of scientific evidence. In the case of electronic cigarettes, the fact that millions of vapers are using these products with success is undoubtedly a valid piece of scientific evidence that these products are useful as alternatives to smoking. This evidence is not the only piece of evidence we need. Obviously, we also need clinical studies that document the cessation rates and the amount of smoking reduction achieved with electronic cigarettes. But to deny that the case reports are part of the overall scientific evidence is to ignore the science.

And if you are willing to ignore part of the science, why should anyone believe that you are not going to ignore other parts of it? We've already established that Dr. Glantz is willing to ignore some of the scientific evidence regarding electronic cigarettes. Now it just remains to be seen how much of the scientific evidence he will choose to ignore. To be honest, it's not clear to me that clinical trials would sway his opinion, regardless of their results.

After all, there has already been one published trial, showing that an amazing 54% of smokers were able to quit smoking or to cut down their smoking by more than half. And this result was achieved among smokers who were not motivated to quit. Dr. Glantz is apparently ignoring this evidence as well. He writes that: "such studies simply do not exist."

The truth is that one such study does exist and Dr. Glantz is ignoring it. Obviously, these results need to be replicated in other studies with larger sample sizes, but you can't simply pretend that the study was never done.

The question may occur to my readers: What would I do if I received testimonials from smokers who tried electronic cigarettes and failed to quit smoking or to cut down on the amount they smoke? Would I simply ignore these testimonials or find some bogus reason to dismiss their experiences?

Absolutely not. Such personal experiences are part of the scientific evidence that must be considered. In fact, there are a large number of smokers who try electronic cigarettes and simply do not find them to be a satisfactory substitute. This is important evidence that becomes a part of the totality of evidence that I consider when rendering scientific judgments. I don't simply ignore evidence because "I don't like it."

At this point, I have to admit that I'm not at all surprised that a prominent anti-smoking researcher would choose to simply ignore scientific evidence about electronic cigarettes that doesn't comport with his preconceived ideology. What does surprise me, however, is that he readily admits it and that he would feature such an acknowledgment on his blog.

If you are going to ignore scientific evidence that you don't like, why would you readily admit to it? And why would you voluntarily publicize your dismissal of scientific rigor on your own blog?

Monday, January 14, 2013

Top 5 Reasons Why an FDA Deeming Regulation for Electronic Cigarettes Could Be a Public Health Disaster

Under the Family Smoking Prevention and Tobacco Control Act of 2009, the Food and Drug Administration (FDA) has the authority to issue a regulation deeming "other" tobacco products (beyond cigarettes and smokeless tobacco) to be subject to FDA jurisdiction. The FDA has announced that it is preparing such deeming regulations for electronic cigarettes.

As I see it, the FDA has two options. First, it can issue a deeming regulation that simply makes electronic cigarettes subject to all the provisions of chapter IX of the Tobacco Control Act, including the new product provisions, modified risk provisions, etc.

Second, the FDA could carve out a special regulatory framework for electronic cigarettes, different from that mandated by Congress for cigarettes and traditional smokeless tobacco products.

I have argued that the FDA should choose the second option and regulate electronic cigarettes under a separate and specific framework that is different from that used for products that contain tobacco. It is essential that products which do not contain tobacco be regulated differently than products which actually contain tobacco, even if the former products meet the definition of "tobacco products" under the Act.

Here, I outline the top 5 reasons why a deeming regulation that makes electronic cigarettes - which contain no tobacco - subject to the same rules that govern cigarettes and smokeless tobacco products would be a public health disaster.

The Rest of the Story

1. Requiring Approval of New Products Under the Act Would Prevent Safer and More Effective Products from Entering the Market

Electronic cigarettes are relatively new products and even within the past year or two, substantial advances have been made that have improved the safety and effectiveness of these products. For example, most of the electronic cigarette juice used to be manufactured overseas; now, there are U.S. companies which manufacture the juice under very tightly controlled conditions. Advances have also been made in terms of making electronic cigarettes more similar to active smoking, and therefore more effective for smoking cessation.

If electronic cigarettes are made subject to the new products provision of the Tobacco Act, there will no longer be an opportunity for further advancement. Such a move by the FDA would freeze the current market and would ensure that the least effective products remain the only ones on the market. It would preclude the development of better and more effective electronic cigarettes and e-liquids, thus hindering the ability of these products to play an increasingly important role in getting people off of cigarettes. In my view, this would be a public health disaster because these products are the single most promising intervention that could potentially save millions of lives by successfully capturing a substantial portion of the existing and future tobacco cigarette market.

2. Adopting the Substantial Equivalent Requirements for Electronic Cigarettes Could Result in the Removal of Many Products from the Market

Strictly speaking, a deeming regulation could potentially make electronic cigarettes introduced into the market after 2007 subject to a requirement that they apply for a substantial equivalence determination, something that might be impossible under the current framework that the FDA has established for such determinations as they apply to tobacco cigarettes. This would be a disaster because it would remove many brands of electronic cigarettes from the market and could result in a large number of vapers returning to cigarette smoking.

3. Adopting the Substantial Equivalent Requirements for Electronic Cigarettes Would Cause Massive Confusion and Could Create a Black Market

A deeming regulation that made electronic cigarettes introduced into the market after a certain date subject to a requirement that they apply for a substantial equivalence determination would create massive confusion. It is not clear, for example, what constitutes the "product." Is it the tube? Is it the battery? Is it the charger? Is it the e-liquid? Is it the cartridge? Is it all of the above? What if a cartridge contains no nicotine? Would such a deeming regulation mean that all e-liquid introduced in the U.S. after a certain date would have to be taken off the market? Would the e-cigarette device itself have to be taken off the market? This is an incredibly complex set of issues and could cause massive confusion.

In addition, as explained in #1 above, there have been many advancements in electronic cigarette devices and liquids. Taking off the market many of the newer products and juices would force vapers to revert back to the less effective products. This would almost certainly result in many vapers deciding to return to cigarette smoking.

Furthermore, if FDA chooses this approach, it could result in a black market for certain products, especially the e-liquid cartridges. Already, many vapers are stocking up on e-liquids so that they will be able to continue vaping should this occur. I can easily see the development of a black market for these products.

4. Adopting the Modified Risk Product Provisions for Electronic Cigarettes Would Force Companies to Hide the Truth from Consumers

Although there is abundant scientific evidence that using electronic cigarettes is much safer than smoking, companies could not inform their customers of the truth. Doing so would make their products a modified risk product, and therefore they cannot make such claims without approval (a process that may be impossible, given the way the modified risk rules have been written). Even telling consumers that electronic cigarettes do not contain tobacco and therefore eliminate most of the thousands of chemicals present in tobacco cigarettes would constitute a modified risk claim, and could not be made if they suggest to consumers that vaping is safer than smoking (which of course is exactly what this fact would and should suggest).

Ironically, the modified risk provisions of the Tobacco Act - if applied to electronic cigarettes - would accomplish exactly the opposite of their intended purpose. They are intended to prevent companies from deceiving consumers about the risks of tobacco products. If applied to electronic cigarettes, they would ensure that consumers are deceived about those risks.

5. A Deeming Regulation that Makes Electronic Cigarettes Subject to Chapter IX Would Force Companies to Hide from Consumers the Truth about the Potential Usefulness of These Products in Smoking Cessation and Reduction

A regulation that simply deems electronic cigarettes subject to chapter IX provisions could potentially preclude electronic cigarette marketers from mentioning that these products may be useful for smoking cessation, because such a claim might be interpreted as a drug claim and therefore put the product under the realm of the Food, Drug, and Cosmetic Act. What is needed is a guidance from the agency which makes it clear that a simple statement of the truth - that these products may be helpful to smokers in quitting or cutting down on the amount they smoke - will not be interpreted as a drug claim.


The bottom line is that a deeming regulation that makes electronic cigarettes subject to chapter IX of the Family Smoking Prevention and Tobacco Control Act, rather than carving out a specific and separate regulatory framework for this product that contains no tobacco, would constitute a public health disaster. It would hinder the development of safer and more effective products, force many vapers to return to cigarette smoking, cause massive confusion, create a black market, and force companies to deceive their customers about the health risks and usefulness of these products.

There is no justification for regulating a product that contains no tobacco in a way that is identical to products that actually contain tobacco. If the FDA has any ability to see the big picture with regards to the public's health, it will avoid this disastrous pitfall.

Thursday, January 10, 2013

FDA Will Issue Proposed Regulations for Electronic Cigarettes in April

According to a Troutman Sanders article, the Obama administration has announced that the FDA will issue proposed regulations for electronic cigarettes (as well as cigars, pipe tobacco, and other tobacco products) this April. While the Family Smoking Prevention and Tobacco Control Act created a regulatory framework for cigarettes and smokeless tobacco, it did not establish provisions for other types of tobacco products. The FDA intends to fill this gap by issuing regulations for these other products.

The Rest of the Story

There are several critical aspects of the regulation that I will be closely watching with regard to the regulation of electronic cigarettes. These provisions of the proposed regulations will have a major impact on whether or not electronic cigarette companies will be able to continue to make these products available to millions of smokers and ex-smokers who are using them and whether they will be able to tell the truth about the safety and intended use of the products.

Issue #1: Will the FDA Require a Substantial Equivalence Determination for Electronic Cigarettes?

This is a potentially dicey issue. If the FDA requires that electronic cigarettes introduced into the market after 2007 apply for a substantial equivalence determination, it could create massive havoc. After all, most of the electronic cigarette brands on the market were introduced after 2007. If the FDA simply adds electronic cigarettes under the existing regulatory framework, hundreds of electronic cigarette brands will be taken off the market and those companies will have to apply for a substantial equivalence determination before they can start selling them again. Given the fact that the FDA has been extremely slow with its current substantial equivalence applications and the fact that most electronic cigarette companies are small, this could essentially put an end to hundreds of electronic cigarette companies and brands.

Issue #2: Will the FDA Apply the Modified Risk Provisions to Electronic Cigarettes?

Doing so would be a public health disaster because it would mean that electronic cigarette companies could not tell the truth about their products to consumers. It would mean that these companies would have to hide the fact that electronic cigarettes are much safer than regular cigarettes. In other words, it would force these companies to hide important, truthful facts from the consumer. It would prevent the companies from being honest. Thus, applying the modified risk provisions to electronic cigarettes would be a mistake, as it would not serve the interests of the public's health.

Issue #3: Will the FDA Clarify What is Meant by a Therapeutic Claim for Electronic Cigarettes?

It is very clear that electronic cigarettes cannot market themselves as a drug or medical device that is intended to treat nicotine dependence. However, I do not believe it is clear that marketing electronic cigarettes for smoking cessation would represent making a therapeutic claim. After all, smoking is not a disease, but a behavior.

If I were to sell a special calendar that I contended would help increase the frequency with which people exercise, that would not be a therapeutic claim. I would not need FDA approval to sell my calendars. Yet the purpose of the calendars is to change a health behavior. It would not be considered a therapeutic claim because failing to exercise is not a disease. It is a behavior that puts one at risk of disease, but it is not a disease itself.

In the same way, why should it be considered a therapeutic claim if I contend that my product can help smokers quit? What makes NRT or Chantix claims drug claims is that these products are intended to specifically treat nicotine dependence, which is recognized by the DSM-IV as a medical disease. The purpose of these products is to affect nicotine receptors and treat the problem of nicotine dependence. In contrast, electronic cigarettes are alternatives to smoking that are not primarily intended to treat nicotine dependence, but to provide a satisfactory alternative to smoking. I do not believe that electronic cigarette companies should be precluded from telling consumers that these products may be useful for smoking cessation.

My Recommendations

Here is a summary of my recommendations to the FDA for regulating electronic cigarettes:

1. In general, I would not put electronic cigarettes under the provisions of the Tobacco Act as it relates to cigarettes and smokeless tobacco. Instead, I would create a new, specific regulatory framework that applies uniquely and specifically to electronic cigarettes.

2. In accordance with #1, electronic cigarettes should not be subject to the substantial equivalence provisions, new product approval provisions, or modified risk product provisions for tobacco cigarettes.

3. All electronic cigarette companies should be required to do the following. Existing products would be granted a reasonable amount of time to furnish the required information. New products would have to submit the information prior to entering the market.

a. Register their company and products with the FDA.
b. Provide a list of the product ingredients, by brand.
c. Provide an analysis of the components of the electronic cigarette cartridges and vapor.
d. Demonstrate the absence of diethylene glycol in their cartridges (or presence at a level of below 0.1%).
e. Demonstrate that labeled nicotine levels correspond to the actual nicotine levels in the cartridges.
f. Demonstrate that levels of nicotine in cartridges labeled as "zero" are zero.
g. Demonstrate the safety of the battery.
h. Provide labeling that warns consumers against manipulating the battery/charger system.
i. Confirm procedures for not selling the product to minors.

4. Electronic cigarette companies would be permitted to truthfully inform consumers that these products are safer than tobacco cigarettes, are free of smoke, are free of tobacco, and do not involve combustion. They would be permitted to compare levels of constituents between electronic cigarettes and tobacco cigarettes. None of these truthful claims would require any sort of approval or designation as a reduced risk product.

5. Electronic cigarette companies would be permitted to inform consumers that these products have been found to be useful by many smokers in reducing cigarette consumption or quitting. These would not be considered therapeutic claims as long as companies do not state or imply that the products are intended to specifically treat nicotine addiction.

6. The FDA should create a priority research program that focuses on the following critical issues:

a. Battery safety
b. Diethylene glycol testing and an understanding of why diethylene glycol was present in some brands
c. Health effects of electronic cigarette use
d. Effectiveness of electronic cigarettes in reducing or eliminating smoking
e. Short and long-term effects of inhalation of propylene glycol
f. Mechanisms by which chemicals such as formaldehyde are created and methods to reduce or prevent its formation.
g. Differences in the chemicals produced in e-cigarette vapor using propylene glycol vs. glycerine as an excipient
h. Development of other excipients for nicotine vaporization that will minimize the presence of formaldehyde or any other volatile organic compounds.

Wednesday, January 09, 2013

Sometimes it Takes a Novelist to Articulate the Most Insightful Perspective: Lionel Shriver on Electronic Cigarettes

In an op-ed piece published in The Guardian this Saturday, novelist Lionel Shriver expresses better than I have ever seen the stupidity of the anti-smoking groups' opposition to electronic cigarettes and articulates the underlying ideological reasons for this opposition.

Shriver writes: "With e-cigs, it seems you haven't "really quit", even if you've really quit tobacco, the very substance that sheepish smokers yearn to eschew. In desperation, rabid anti-smokers deride e-cigs as stupid-looking and pathetic. Apparently we're in danger of "renormalising smoking" after having lavished endless initiatives on making smoking socially unacceptable among all but a sad, quivering few."

"Nonsense. If electronic cigarettes became a socially acceptable norm, lung cancer and emphysema rates would plummet. The trouble is that smokers have been demonised medically and morally: not merely bad for public health, but bad, full stop. E-cigs neatly separate the rational, research-backed concern for the health consequences of tobacco from a purely cultural revulsion for a "filthy" habit marking you as evil."

"For anti-smoking fanatics, e-cigs must be enraging. They can't clamber on to that handsome high horse, because what's to get upset about? Those plastic vapour sticks aren't gunking anyone's lungs or even stinking up the drapes. And those dreadful cheats seem to be enjoying themselves! They're getting away with something horrid scot-free! It isn't fair! They should get cancer! Imagine the dizzy swoon of indignation deprivation: what's upsetting is there's nothing to get upset about." ...

"You want real evil? What's truly evil is attempting to deny people addicted to a profoundly damaging substance the opportunity to transfer that addiction to a product most medical professionals rate as 99% harmless. The gathering European opposition to electronic cigarettes is the result of kneejerk cultural prejudice, puritanical vindictiveness, corporate collusion, and the unconscionable greed of tax authorities that won't be able to heap the same punitive, confiscatory, opportunistic duties on a product that doesn't hurt anyone."

The Rest of the Story

For once, I have very little to add because Shriver has said it so well and so insightfully. I would only emphasize three points:

1. Shriver is quite correct that among anti-smoking circles, switching from tobacco cigarettes to electronic cigarettes is not considered quitting smoking. Apparently, it is not the health effects of smoking which distinguish the behavior, but the hand motions.

2. The widespread concern among anti-smoking groups that the use of electronic cigarettes will normalize smoking is inane. What it actually normalizes is smoking cessation. And it de-normalizes cancer and lung disease.

3. As I have written extensively, it is indeed "evil" (that is, contrary to the protection of the public's health) to deny smokers the availability of a product that can help them save their lives. I have termed this "public health malpractice."

Tuesday, January 08, 2013

West Springfield Board of Health Considering Banning the Sale of Electronic Cigarettes, But Keeping the Real Ones

According to an article in the Springfield Republican, the West Springfield Board of Health is considering a regulation that would ban the sale of electronic cigarettes in the town. Unlike laws in other cities which ban the sale of electronic cigarettes to minors, this proposed regulation would ban all sales of electronic cigarettes in the town. Such sales would be allowed only if and when the FDA officially "approves" these products. If the Board of Health enacts this regulation, West Springfield would become the first locality in the U.S. to ban the sale of electronic cigarettes.

Although the draft regulation mentions only a ban on the sale of electronic cigarettes to minors, a letter from the Director of Public Health to tobacco sellers refers to an outright "ban on the sale of e-cigarettes." A knowledgeable source told the Rest of the Story that the Board is indeed considering a ban on the sale of electronic cigarettes, not only to minors but to adults as well.

The rationale for the Board's proposed ban on the sale of electronic cigarettes is not clear, since there is nothing in the preamble of the draft regulation that mentions electronic cigarettes or why they pose a danger to the public's health.

The Rest of the Story

I believe that enactment of this regulation would be a serious mistake. There is strong evidence that electronic cigarettes are much safer than tobacco cigarettes. These products contain no tobacco and do not involve combustion. Multiple studies have confirmed that there are only a few chemicals present beyond the nicotine, and so far, only trace or low levels of potentially concerning constituents have been detected - levels which are much lower than in real cigarettes. Users of these products generally report an immediate and dramatic reduction in respiratory symptoms. Moreover, there is strong evidence that electronic cigarettes can be effective in smoking cessation and that they may actually be more effective than traditional nicotine replacement products such as nicotine patches, gum, or lozenges.

So why would the Board of Health want to ban the sale of these products?

There is a legitimate concern about the potential for youth to get their hands on these products, and that concern warrants the regulation of the sale of electronic cigarettes to minors. But why ban the sale of this smoking cessation aid to adult smokers who are trying to quit?

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 the Board of Health would be saying, if it enacts this regulation, is that they would rather have smokers continue to smoke cigarettes than quit smoking with the aid of a much safer alternative product.

If the West Springfield Board of Health were truly committed to protecting the health of its residents from the dangers of cigarette smoking, it would address the problem head on by simply banning the sale of cigarettes. Why ban the non-tobacco cigarettes that have not been shown to be hazardous and which are helping thousands of smokers get off cigarettes, while leaving the real ones on the market to continue to kill West Springfield residents?

I have published extensively on this topic, co-authoring studies which review the safety and effectiveness of electronic cigarettes, demonstrate the widespread use of electronic cigarettes to quit smoking, and discuss the reasons why electronic cigarettes are essential as a harm reduction strategy in tobacco control. These articles, as well as multiple commentaries on this blog, address each of the concerns expressed by the FDA about these products and show that the agency has not presented an objective picture of the relative safety and efficacy of electronic cigarettes.

Briefly, my research with Zachary Cahn was the first to comprehensively review the scientific evidence about the safety and effectiveness of electronic cigarettes and was published in the Journal of Public Health Policy. After reviewing 16 laboratory studies of the constituents of electronic cigarettes, we conclude that electronic cigarettes are much safer than the real ones and therefore show tremendous promise in the fight against tobacco-related morbidity and mortality. Banning these products from the market would benefit the tobacco companies at the expense of the public’s health.

The FDA and major anti-smoking groups keep saying that we don’t know anything about what is in electronic cigarettes. The truth is, we know a lot more about what is in electronic cigarettes than regular cigarettes. Our review shows that carcinogen levels in electronic cigarettes are up to 1,000 times lower than in tobacco cigarettes. No other constituents have been detected at levels that are of significant health concern. Thus, using electronic cigarettes (also called vaping) appears to be much safer than smoking. Taking these products off the market would force thousands of vapers to return to cigarette smoking. Why would the FDA and the anti-smoking groups want to take an action that is going to seriously harm the public’s health? The only ones who would be protected by a ban on e-cigarettes are the tobacco companies, as these new products represent the first real threat to their profits in decades.

Regarding the relative safety of electronic cigarettes, the study concludes that “few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns. Although the existing research does not warrant a conclusion that electronic cigarettes are safe in absolute terms and further clinical studies are needed to comprehensively assess the safety of electronic cigarettes, a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products.”

The study also reviews preliminary evidence that electronic cigarettes can be effective in suppressing the urge to smoke, largely because they simulate the act of smoking a real cigarette. The fact that bothers the anti-smoking groups the most – that vaping looks like smoking – is precisely the fact which appears to make e-cigarettes an effective tool for smoking cessation.

Regarding the effectiveness of electronic cigarettes for smoking cessation, the study concludes as follows: “Although more research is needed before we will know how effective electronic cigarettes are at achieving smoking abstinence, there is now sufficient evidence to conclude that these products are at least capable of suppressing the urge to smoke.” There is also reason to believe that they offer an advantage over traditional nicotine delivery devices, the study argues, because smoking-related stimuli alone have been found capable of suppressing tobacco abstinence symptoms for long periods of time.

The article concludes: "The evidence reviewed in this article suggests that electronic cigarettes are a much safer alternative to tobacco cigarettes. They are likely to improve upon the efficacy of traditional pharmacotherapy for smoking cessation." While more research is needed, the article concludes that electronic cigarettes show promise as a harm reduction strategy and that removing them from the market would substantially harm the public’s health.

I hope that the West Springfield Board of Health will consider this research and these arguments before it makes a decision that I believe will harm, rather than protect, the public's health.

Monday, January 07, 2013

Providence (Rhode Island) and Wakulla County (Florida) Claim to Want to Protect Kids from Addiction to Tobacco by Banning Flavored Products; But Both Exempt the Leading Flavored Tobacco Product of Choice Among their Kids

Recently, the city of Providence (Rhode Island) and the county of Wakulla (Florida) implemented ordinances that ban the sale of flavored tobacco products, except in a few locations where minors are not allowed. The Providence law, which went into effect last Thursday, bans the sale of flavored tobacco products in all stores except cigar bars. The Wakulla county law, which goes into effect on February 1, bans the sale of flavored tobacco products except in stores that are not open to minors.

Policy makers in both localities are boasting that these laws will protect kids from addiction to tobacco and will significantly reduce the rate of youth tobacco use:

The Providence mayor and city council boasted that the law would "curb tobacco use among youths" and "protect our youth from initiating the dangerous addictive habit of tobacco use."

The Wakulla County Board of Commissioners boasts that: "Through this ban Wakulla joins other communities on the frontlines of public health, helping to reduce the prevalence of teen tobacco use. Flavored tobacco is tobacco products like cigars, cigarettes, snuff, chewing tobacco, smokeless tobacco products and blunt wraps that have had artificial or natural flavors added to them. In 2009, the FDA banned the sale of candy flavored cigarettes across the country, but other existing and new tobacco products were left exempt to be handled by future action. According to Tobacco Free Florida over the last few years the emergence of new flavored tobacco products, presented in colorful and playful packaging and backed by hefty marketing budgets, have parents, teachers, health advocates, physicians, and communities rightly concerned. Flavored tobacco appeals to younger audiences. In Florida, one in six kids between the ages of 11 and 17 has ever tried flavored tobacco. The tobacco industry’s own documents show that these sweet tobacco products are designed to get children to start using tobacco products. Taking these products out of stores where our kids shop is a huge step forward towards keeping our youth tobacco free."

The Providence ordinance specifically mentions a number of flavors that are prohibited:
  • fruit;
  • chocolate;
  • vanilla;
  • honey;
  • candy;
  • cocoa;
  • dessert alcoholic beverage;
  • herb;
  • spice; and
  • concepts such as spicy, arctic, ice, cool, warm, hot, mellow, fresh, and breeze.

The Rest of the Story

What policy makers in Providence and Wakulla County are not telling the public is that these laws exempt the one flavor that is overwhelmingly popular among kids in their jurisdictions: menthol.

In fact, about 50% of youth smokers in middle school prefer menthol flavored cigarettes. And about 81% of African American middle school smokers prefer menthol flavored cigarettes. There are 1.3 million youth menthol smokers in the U.S., making menthol the single and overwhelmingly most popular flavored tobacco product among our nation's youth, including those in Providence and in Wakulla County.

So while politicians in Providence can boast that youth in that city will not have access to chocolate, vanilla, honey, and cocoa tobacco products, the ordinance does nothing to actually address the most popular flavored tobacco product that Providence youth are actually using: menthol cigarettes. And to the best of my knowledge, the Wakulla County ordinance does not include menthol cigarettes either.

Even worse, the Providence ordinance goes further to protect the financial interests of tobacco companies. It also exempts mint and wintergreen flavorings, which are the most prevalent flavors in the smokeless tobacco products actually used by Providence youth. So youth in Providence can continue to use their mint and wintergreen Skoal and Copenhagen, while the non-existent honey, vanilla, and chocolate smokeless tobacco products are taken off the market.

One might ask why it is that if policy makers in Providence aimed to "curb tobacco use among youths" and "protect our youth from initiating the dangerous addictive habit of tobacco use," they chose to exempt the primary flavored tobacco products that youth are actually using.

The answer is quite simple: the true aim was not to "curb tobacco use among youths" and "protect our youth from initiating the dangerous addictive habit of tobacco use," but to score a political victory without having to actually put a dent in tobacco sales and thus alienate tobacco companies or engender any serious political opposition.

The rest of the story is that the primary aim of these policy makers appears to be protecting the sales of the most popular and important flavored tobacco products among youth tobacco users, so as not to threaten the profits of cigarette and smokeless tobacco companies.

It is difficult to find a sincere desire to "curb tobacco use among youths" and "protect our youth from initiating the dangerous addictive habit of tobacco use" when one reads the fine print of the ordinance and considers the rest of the story.