Thursday, December 19, 2013

New Mantra in Tobacco Control Research: Reach Your Conclusions Before Conducting the Study

As 2013 draws to a close, I reflect on the lessons of the past year on The Rest of the Story. One of the most notable phenomena that has arisen this year is what appears to be the new mantra of tobacco control research, which I would describe as follows:

The purpose of tobacco control research is to demonstrate preconceived conclusions. If the research does not support those conclusions, make up some excuse or draw those conclusions anyway.

We have seen many examples in the electronic cigarette area where researchers have conducted studies that do not support their conclusions, but drew those conclusions anyway.

Today, I close the year by revealing an example of tobacco control research where the investigators conclude what they want to conclude, not letting the research findings get in the way.

The Rest of the Story

The headlines of a September 12 news article on MedPage Today were alarming: "Third-Hand Smoke Impacts Kids' Breathing." 

According to the article: "Third-hand smoke -- residue that remains on the skin, clothes, and furniture of smokers, even if they do their smoking out of the house -- still impacts children's breathing, researchers reported here. The risk of respiratory tract infections in children from infancy to 13 years of age more than doubled (OR 2.13, 95% CI 1.04-4.36, P=0.04) in households in which parents smoked cigarettes but claimed to smoke only outside, said Edward Dompeling, MD, professor of pediatric lung diseases at Maastricht University Medical Center in the Netherlands."

The results were from a cross-sectional study that examined the prevalence of secondhand and thirdhand smoke exposure among children living in households in South Limburg (The Netherlands) and respiratory symptoms among those children at a single point in time.

The results were reported at a conference in September, but were recently published in the Journal of Allergy & Therapy.

As reported above, the study found a significant association between thirdhand smoke exposure and respiratory symptoms.

There was just one problem. The study also examined the relationship between secondhand smoke and respiratory symptoms, but found no significant relationship. In fact, for kids who were exposed to secondhand smoke in utero and currently, the adjusted odds ratio for respiratory infections was 1.0, indicating no effect at all.

So the authors were left with the odd finding that secondhand smoke is not associated with respiratory symptoms, while thirdhand smoke increases respiratory problems. This finding is not plausible, since exposure to tobacco smoke is orders of magnitude higher in secondhand smoke compared to thirdhand smoke.

So how did the researchers handle this dilemma? Very simple. They simply dismissed the fact that the paper didn't find a relationship between secondhand smoke and respiratory effects as a methodological limitation. They argued that this finding was due to the cross-sectional nature of the study, sampling bias, or reporting bias. In other words, they simply assumed that the finding must be wrong.

That's fine, but how did they handle the finding of the relationship between thirdhand smoke and respiratory effects in the same paper? Did they also dismiss that finding, due to the cross-sectional nature of the study, sampling bias, or reporting bias?

The answer is no. Instead, they reported the significant association between thirdhand smoke and respiratory effects, warned the public about the need to eliminate thirdhand smoke exposure, apparently gave the newspaper reporter the impression that they had found that thirdhand smoke affects kids' breathing, and were quoted as stating that: "We have seen much the same thing with third-hand smoke causing irritation among children. When people think about harm caused by tobacco they are generally aware of smoking and second-hand smoke. Only recently are we finding that third-hand smoke as well can cause problems."

If you read the abstract of the study, you will see that the authors dismiss the findings regarding secondhand smoke, but accept the findings regarding thirdhand smoke.

The rest of the story is that these investigators apparently reached their conclusions prior to conducting the research. They concluded that secondhand smoke and thirdhand smoke both cause respiratory impairment. When their results showed that secondhand smoke was not associated with respiratory impairment but thirdhand smoke was, they simply concluded that the first finding was wrong but the second finding was correct.

So here is a matrix for how they apparently would have concluded under each of the four possible outcomes of their study:

1. Secondhand smoke and thirdhand smoke both related to respiratory symptoms: We conclude that both secondhand smoke and thirdhand smoke are associated with respiratory symptoms.

2. Secondhand smoke associated with respiratory symptoms, but thirdhand smoke not related: We conclude that secondhand smoke is associated with respiratory symptoms. The reason thirdhand smoke was not related to respiratory symptoms was most likely due to methodological limitations, such as the cross-sectional design, sampling bias, and reporting bias.

3. Secondhand smoke not associated with respiratory symptoms, but thirdhand smoke related: We conclude that thirdhand smoke is associated with respiratory symptoms. The reason secondhand smoke was not related to respiratory symptoms was most likely due to methodological limitations, such as the cross-sectional design, sampling bias, and reporting bias.

4. Neither secondhand smoke nor thirdhand smoke related to respiratory symptoms: We believe the reason we did not find an association between secondhand smoke or thirdhand smoke and respiratory symptoms is the methodological limitations of the paper, including its cross-sectional design, sampling bias, and reporting bias.

You see how it works?

Two More Electronic Cigarette Opponents Deny that Vaping is Any Safer than Smoking

It is becoming impossible for me to keep track of all the tobacco control advocates (electronic cigarette opponents) who are publicly denying that vaping is any safer than smoking. This, of course, amounts to making a public statement that we are not sure smoking is any worse than using non-tobacco e-cigarettes. It is an absurd, and demonstrably false claim.

This week, we can add two more electronic cigarette opponents to the list.

According to an article in the Portsmouth Herald, a New Hampshire pulmonologist is telling his patients, and the public, that cigarette smoking may not be any more dangerous than vaping.

The article quotes the physician as stating: "I get asked about this a lot, particularly by current smokers who are looking to quit. They feel this is a safer option and we cannot tell them that it is. We don't know the answer to that because the data is just not there."

According to the article, the pulmonologist is "concerned about the way e-cigarettes deliver nicotine and added he would never advocate their use as a way to quit smoking."

In other news, a Massachusetts anti-smoking group has informed the public that cigarette smoking is not any more dangerous than vaping. 

According to an article in the Metrowest Daily News: "“It’s dangerous to think of e-cigarettes as less dangerous than regular cigarettes,” Tami Gouveia, executive director of Tobacco Free Mass told a Daily News reporter."

The Rest of the Story

If this pulmonologist is informing his smoking patients that their smoking is not safer than switching to electronic cigarettes, then he is potentially committing malpractice, in my opinion. He argues that the "data is not there," but the data are there. There are many published and/or publicly available studies which document that vaping is much safer than smoking. I discussed one such study just yesterday.

Fortunately, it appears that his patients are more knowledgeable than him, as they are apparently under the correct impression that inhaling from a burning cigarette which produces tens of thousands of chemicals and more than 60 known carcinogens is, oh, say a little more dangerous than using a non-combusted product that contains no tobacco and merely heats a solution of nicotine and propylene glycol.

Tobacco Free Mass is also apparently telling the public that vaping isn't any safer than smoking. In fact, they are stating that it is dangerous to even think that vaping is safer than smoking.

It has become clear that many electronic cigarette opponents in the tobacco control movement really don't care about the science. They have a pre-existing opposition to electronic cigarettes on ideological grounds. So the actual facts don't matter. The truth must not get in the way of the ideology.

Apparently, quitting smoking is not the goal. You have to quit smoking the right way. And that way happens to be an extremely ineffective method, one with a 90% failure rate. But it does provide income to many anti-smoking groups, through their funding by the pharmaceutical companies that manufacture these largely ineffective drugs.

Anti-smoking advocates and groups continue to do tremendous damage. First, they are undermining the public's appreciation of the hazards of cigarette smoking. Second, they are discouraging many smokers who might quit using electronic cigarettes to continue smoking. And potentially, they are persuading ex-smokers who have quit using electronic cigarettes to return to smoking.

Why not? Based on the information being provided by a host of anti-smoking groups and advocates, you are no worse smoking than you are vaping.

It is difficult to continue calling these groups "anti-smoking" groups. They aren't really acting as if they want people to quit smoking. They're acting as if all they care about are the hand motions that look like smoking.

Stopping those hand motions won't save lives. But stopping the smoking will.

Wednesday, December 18, 2013

Anti-Smoking Advocates are Scaring the Public About Nicotine Exposure Due to Passive Vaping, But Failing to Reveal that Exposure is Less than 0.08 Cigarette Equivalents

Several anti-smoking advocates are using the results of a new study which documented that vaping may produce low levels of nicotine in ambient air to argue that electronic cigarettes are a significant health hazard to bystanders.

On his tobacco blog, Stan Glantz writes that a new study "shows e-cig users exhale nicotine and fine particles into the air where bystanders are breathing." While acknowledging that this study found that nicotine levels from vaping were 10 times lower than nicotine levels from smoking, Glantz nevertheless concludes that: "e-cigarettes should not be allowed anywhere that cigarettes are not allowed."

Guided by alarmist claims like that above, a number of news articles warned that exposure to secondhand vapor is dangerous to health. For example, a TIME article warned that electronic cigarettes pose a "second-hand risk."

Elsewhere, researchers warned that nicotine exposure from passive vaping could damage the heart. According to this article, a Brown University researcher warned that: "long-term consumption of nicotine by e-cigarette smoking is likely to increase the risk of developing atherosclerosis by stimulating invasion of vascular smooth muscle cells." In other words, this researcher is claiming that passive vaping can lead to heart disease because of the exposure to nicotine.

The Rest of the Story

There is one thing that none of these anti-smoking researchers or advocates are telling the public. Exactly how much nicotine is a bystander exposed to, according to this research?

Well, the answer of course depends on the concentration of vapers in the establishment. But let's take an extreme example: a smoky bar, filled with vapers, instead of smokers.

Assuming that the estimate from the study is correct, and that vaping produces 10 times lower the level of nicotine as smoking, then the estimate for the amount of nicotine inhaled by a bystander after 8 straight hours of exposure to a full room of vapers in a bar is which of the following? (In other words, how many cigarettes would a person have to smoke to get the same amount of nicotine as the bystander?)

A. 80 cigarettes
B. 8 cigarettes
C. 0.8 cigarettes
D. 0.08 cigarettes

The answer is ...

... D. 0.08 cigarettes

In order to inhale the equivalent amount of nicotine that would be inhaled by actively smoking one cigarette, a bystander would have to spend 12 days in a bar filled with e-cigarette vapor, at continuous exposure levels.

The reality is that right now, exposure to secondhand vaping is much lower than exposure to smoking in a smoky bar. A more realistic estimate is that a worker in a bar that allows vaping is exposed to at least 100 times lower exposure than with smoking (this assumes that the concentration of vapers in the bar is only one-tenth of that of smokers, averaged over the entire day).

Under these realistic conditions, even a full-time employee would be exposed to the equivalent amount of nicotine as actively smoking 0.008 cigarettes per day.

If that is the level of public health risk that warrants banning vaping in bars and restaurants, then there are a lot of other exposures that should be banned before touching vaping, based on these risk numbers.

To make it clear, I am not arguing that the door is shut and the case is over. Future research is still necessary to quantify the risks. I am simply pointing out that the actual evidence being used to support vaping bans - taken at face value - imply that advocates are alarming the public because bystanders may be exposed to about eight one-thousandths worth of the nicotine exposure in one cigarette if they spend a full day in a bar that allows vaping.

In my opinion, this makes a mockery of the scientific rigor of the movement and of the quality of evidence that we require before advocating for bans on personal behavior. Shouldn't we pride ourselves on a higher and more rigorous standard?

Tuesday, December 17, 2013

New Study Finds that Vaping Does Not Expose Bystanders to Carbon Monoxide or Volatile Organic Compounds

A new study published online ahead of print in the journal Nicotine and Tobacco Research reports the results of an experiment in which vapor from electronic cigarettes was generated in an experimental chamber, either by a machine or by human users. The investigators measured the levels of nicotine, carbon monoxide, and 11 volatile organic compounds.

There were two major study findings:

1. The electronic cigarettes did not produce detectable levels of carbon monoxide or any of the 11 volatile organic compounds, which included benzene, toluene, chlorobenzene, ethylbenzene, xylene, styrene, naphthalene, 1,2-dichlorobenzene, 1,3-dichlorobenzene, and 1,4-dichlorobenzene.

2. The electronic cigarettes did produce nicotine, but the levels were 10 times lower than those from tobacco cigarettes.

The study summarizes the results as follows: "The study showed that e-cigarettes are a source of secondhand exposure to nicotine but not to combustion toxicants. The air concentrations of nicotine emitted by various brands of e-cigarettes ranged from 0.82 to 6.23 µg/m3. The average concentration of nicotine resulting from smoking tobacco cigarettes was 10 times higher than from e-cigarettes (31.60±6.91 vs. 3.32±2.49 µg/m3, respectively; p = .0081)."

The study concludes as follows: "Using an e-cigarette in indoor environments may involuntarily expose nonusers to nicotine but not to toxic tobacco-specific combustion products."

The Rest of the Story

Because only three brands of electronic cigarettes were tested, these results should be viewed as preliminary. Nevertheless, this study does add to the literature suggesting that electronic cigarettes do not emit toxic chemicals at levels that pose any substantial risk to bystanders. Further research is certainly warranted, but at the present time, any risk from secondhand vaping appears to be minimal.

Because nicotine is highly absorbed in the upper respiratory tract, it is as yet unclear whether vaping in public places produces significant exposure to nicotine among nonsmokers. Also, this study was conducted in an experimental chamber and it is not clear what real-life nicotine exposure would be in situations where vapers are using electronic cigarettes in a public place.

However, we do know that the nicotine exposure with passive vaping  is much lower than that associated with secondhand smoke (which is quite low to begin with). Since it appears that the nicotine exposure associated with passive vaping is about 10 times lower than that associated with passive smoking, we are probably talking about miniscule levels of nicotine exposure.

Moreover, there is now no question that electronic cigarettes are much safer than smoking and secondhand vaping is much safer than secondhand smoking.

In light of this study, it becomes unfathomable that researchers from NYU have declared that vaping is more hazardous than smoking. And it becomes just as unfathomable that a number of anti-smoking researchers and groups continue to claim that there is insufficient evidence to show that vaping is less hazardous than smoking.

This research confirms that the following groups, which claim that we don't have enough evidence to determine that vaping is safer than smoking, are making unfounded, inappropriate, and damaging arguments (click on links to view the claims being made by each group):

American Legacy Foundation

Food and Drug Administration

American Lung Association

Tobacco-Free Coalition of Hancock County

Tobacco-Free Coalition of Delaware County

Southern Nevada Health District

This research also demonstrates how irresponsible is the advice that the World Health Organization and Department of Health and Human Services are giving smokers (i.e., "do not quit using electronic cigarettes").

Monday, December 16, 2013

Anti-Smoking Researchers Continue to Just Make it Up; Now Claim that Vaping is More Hazardous than Smoking

Several researchers who are apparently determined to show that electronic cigarettes are severe health hazards are publicly claiming that using electronic cigarettes is more hazardous than smoking, a conclusion which was widely disseminated through the media.

According to an article in this month's issue of NYU News, researchers at the NYU College of Dentistry have concluded that vaping is more hazardous than cigarette smoking.

According to the article: "Each nicotine cartridge in an e-cig can provide 200 to 400 puffs, equivalent to two to three packs of cigarettes. “Due to the frequency of puffing, depth of inhalation, and length of vaping,” says Li, “e-cig users may actually absorb higher concentrations of nicotine and other toxins than conventional tobacco smokers.”"

This conclusion has been widely disseminated through the media. For example, the headline of a Daily Mail article reads: "'E-cigarette Smokers Inhale MORE Nicotine and Toxins than Regular Smokers': Study Finds 'Users are Unknowingly Inhaling' a Host of Dangerous Chemicals."

According to that article: "People who smoke e-cigarettes may inhale higher concentrations of nicotine and of other toxins,say U.S researchers. ... Researchers at New York University found that due to the ‘frequency of puffing’ and ‘depth of inhalation’ e-cigarette smokers absorb higher levels of harmful chemicals than those who smoke traditional cigarettes. ... ‘Due to the frequency of puffing, depth of inhalation, and length of vaping,’ says Dr Xin Li, ‘e-cig users may actually absorb higher concentrations of nicotine and other toxins than conventional tobacco smokers.’"

The headline of an article in the University Herald reads: " E-Cigs Pose Greater Health Risk than Conventional Cigarettes, Study."

According to this article: "E-cigarette smokers should now think twice before taking a puff as they are more likely to inhale nicotine and toxins than the conventional cigarette smokers, according to a New York University study. Researchers said that due to the 'frequency of puffing' and 'depth of inhalation' e-cigarette smokers absorb higher levels of dangerous chemicals than those who smoke traditional cigarettes. Nicotine and other chemicals found in e-cigarettes are believed to be carcinogenic."

The headline of a New York Post article on Saturday read: "E-cigs May Deliver More Toxins Than Smoke, Researchers Say."

According to this article: "E-cigarette users may be getting higher concentrations of toxins than regular smokers because they inhale deeper and more frequently when they puff, NYU researchers say. Although they are often touted as a safer alternative, e-cigs, introduced in the States in 2007, haven’t been in use long enough to determine their health effects, said Dr. Deepak Saxena, of NYU’s College of Dentistry."

The Rest of the Story

It just gets worse and worse. For the past few weeks, I have revealed that many anti-smoking groups and researchers have publicly claimed that cigarette smoking may be no more hazardous than vaping. Those fallacious statements now seem benign, compared to the assertion being made by these NYU researchers.

They are not claiming that smoking is equivalent to vaping in terms of health effects. Instead, they are arguing that smoking is less harmful than vaping!

These researchers are actually telling the public that electronic cigarettes deliver higher concentrations of toxins to users than tobacco cigarettes deliver to smokers.

Can you imagine if a tobacco company made the same claim? The anti-smoking groups would condemn such a statement and go after the company. But no anti-smoking group will criticize these researchers because dissent is simply not allowed to be expressed in this movement.

The claim that Drs. Lin and Saxena are making is demonstrably false. The truth is exactly the opposite: electronic cigarettes deliver levels of toxins that are orders of magnitude lower than tobacco cigarettes. Most of the toxins in tobacco cigarettes are not present at all in electronic cigarettes. The few that are present have been shown to be present at much lower levels. For example, tobacco-specific nitrosamines, a major carcinogen in tobacco smoke, are present at up to 1,400 times lower a concentration in electronic cigarette vapor as in tobacco smoke.

The newspaper reporters appear to all be under the impression that Lin and Saxena's claim is based on a new study, presumably one that they conducted. However, I cannot find any such study. Nor is there any other published or publicly available study that has ever shown that the level of toxins in cigarette smoke is less than the level of toxins in electronic cigarettes.

In other words, it appears that these researchers are just making this up!

The NYU News article does indicate that Drs. Lin and Saxena will conduct a study in the future to assess the effects of vaping on DNA in cells in the oral cavity:

"Since the initial interaction of nicotine from e-cigs with the human body occurs first in the oral cavity, Saxena and Li will collect saliva and oral mucosa from College of Dentistry patients who are e-cig users to determine the relative abundance of oral bacteria and changes in DNA in these patients in order to compare them with the effects found among conventional cigarette smokers."

Unless these researchers are also fortune-tellers, they cannot possibly know what their study will find before actually conducting it. But apparently, this is not stopping them from drawing a definitive conclusion about the relative health effects of smoking compared to vaping. What is the point of conducting this research if the conclusion has already been drawn and disseminated to the public? Why bother spending the money? And how can NYU justify using human subjects for a research study that is not necessary, since they already "know" that smoking is less hazardous than vaping due to the lower levels of toxins?

Moreover, the NYU News article itself acknowledges that the conclusion of the future research has already been reached, since it states that this study will "determine the relative abundance of oral bacteria and DNA in these patients." So we already know that there will be a relative abundance of oral bacteria and DNA in these patients. What's the point of doing the study?

Sadly, this is just turning into a public health scientific disaster. And it gets worse every day. Before we're through, we are going to destroy our credibility. And it's not clear whether that credibility can be restored. As we've seen with other social movements, such as the animal rights movement and even the environmental and climate movements, once credibility is destroyed, it is very difficult to restore.

Finally, it is important to point out how damaging this misrepresentation of the science is to the public's health. It completely undermines decades of public health efforts to educate the public about the hazards of smoking. If smoking is safer than using a non-combusted product that contains no tobacco and has not been shown to cause any diseases, then the public may get the impression that smoking simply isn't as hazardous as previously believed.

No cigarette company would dare to make such a statement. But apparently, it is perfectly acceptable for anti-tobacco researchers to make precisely such a claim.

Thursday, December 12, 2013

My (Censored) Response to Stan Glantz's Contention that Electronic Cigarettes are Causing Youth to Smoke More Heavily

Last week, Stan Glantz used a new study, published online ahead of print in the Journal of Adolescent Health, to mislead the public into thinking that there is now evidence that electronic cigarettes are leading to smoking initiation and addiction among adolescents. In a statement accompanying the study, study author Stanton Glantz proclaimed that electronic cigarettes are "a new route to smoking addiction for adolescents."

He also wrote that: "Use of e-cigarettes is associated with heavier use of conventional cigarettes, which raises the likelihood that actual use of e-cigarettes may increase harm by creating a new pathway for youth to become addicted to nicotine and by reducing the odds that an adolescent will stop smoking conventional cigarettes."

As I pointed out previously, the problem is that Glantz took results from a cross-sectional study and misrepresented them as if they were derived from a longitudinal study. Moreover, he failed to heed his own warning, buried in the fine print of the paper, that: "Because the [survey] used cross-sectional data, the directionality of our findings cannot be established."

Specifically, the study was cross-sectional so it cannot conclude whether electronic cigarette use caused kids to smoke more or whether kids who smoked more were more likely to try electronic cigarettes (perhaps because they wanted to quit or cut down).

In response to Stan's statement on his blog, I submitted the following comment:

Stan,

You're better than this. You know full well that this is a cross-sectional study and that you cannot determine the direction of causality. It could well be that the reason for the higher prevalence of heavy smokers who use electronic cigarettes is simply that youths who smoke more heavily are more likely to use such products, perhaps because they are interested in quitting or cutting down. You cannot credibly conclude that the use of electronic cigarettes preceded the heavy smoking among these youth and that the e-cigarettes caused these kids to smoke more heavily.

I appreciate your caution and concern in embracing the use of electronic cigarettes for harm reduction among current smokers, but it seems to me that your arguments for caution -- and for regulating the sale and marketing of electronic cigarettes to youth - are strong enough that you don't need to draw unsupportable conclusions in order to put forward your case.

There are many legitimate concerns regarding the potential appeal of electronic cigarettes among youth. This truth alone should be sufficient. There is no need to stretch the truth by distorting the science.

Best regards,

Mike

Michael Siegel, MD, MPH
Professor, Boston University School of Public Health

The Rest of the Story

Unfortunately, Stan did not allow my comment to be posted in his blog comments section. It appears that Stan is only interested in promoting his own view and has no interest in allowing any dissenting viewpoints. That is certainly his right; however, why bother having comments on his blog? Why not just post his commentaries without a comment section. It seems to me that once you make a decision to allow reader comments, then you need to allow reader comments, unless they are inappropriate (e.g., use inappropriate language, contain defamatory statements, etc.). Censoring reader comments because you do not agree with them is not appropriate.

For those who have had the courage to venture into the comments section on my own blog, you have readily seen that I do not censor comments because they disagree with my personal viewpoint. In fact, the overwhelming majority of the comments do not agree with my viewpoints, especially on the issue of secondhand smoke and tobacco industry regulation. However, I still allow those comments. The only comments I have ever deleted from the blog are those which were inappropriate, either by virtue of foul language or defamatory or personal attacks.

There is no need for a blog to allow comments, but once you make a decision to do so, it seems to me that it is not appropriate to censor comments that don't agree with your viewpoint. What's the point of having a comment section if you censor the comments on that basis?

Sadly, Stan's misrepresentation of the conclusions that can be reasonably drawn from his study is leading to the widespread deception of many reporters and policy makers. His propaganda campaign is working. And by suppressing and censoring dissent, he is working to make sure that his propaganda is unopposed.

Fortunately, it doesn't take advanced epidemiology training to see through his smokescreen. Anyone with critical analytic abilities can see that there are two possibilities why heavy smokers are more likely to use electronic cigarettes. One is that electronic cigarette use causes people to smoke more. Another is that heavier smokers are drawn to electronic cigarettes, perhaps because they wish to cut down or quit.

In a cross-sectional study, you can't figure out which explanation is correct. Unless, of course, you are an anti-smoking researcher, in which case you can apparently just draw whichever conclusion is most supportive of your pre-determined position.

World Health Organization's Medical Advice to Smokers Who Failed to Quit Using Drugs: Public Health Malpractice

Last July, the World Health Organization publicly issued medical advice to smokers wishing to quit: do not use electronic cigarettes.

This remains the current medical advice from the World Health Organization regarding the use of e-cigarettes.

The World Health Organization's statement reads as follows:

"There are no scientifically proven instructions for using ENDS as replacements or to quit smoking. The implied health benefits associated with these claims are unsubstantiated or may be based on inaccurate or misleading information. When ENDS are used as cessations aids, they are intended to deliver nicotine directly to the lungs. ... Until such time as a given ENDS is deemed safe and effective and of acceptable quality by a competent national regulatory body, consumers should be strongly advised not to use any of these products, including electronic cigarettes."

The U.S. Department of Health and Human Services offers the same advice, although not worded quite as strongly: "There haven’t been any scientific studies that prove e-cigs actually help people to quit smoking. ... The bottom line is that we just don’t know enough about e-cigs, so we don’t recommend that you use them. There are other quit aids, with or without nicotine, that have been proven to be safe and effective at helping people quit smoking."

The Rest of the Story

Here's the problem: What is the official advice of the World Health Organization and the Department of Health and Human Services regarding the following patient?

J.B. is a 58 year-old male smoker who has smoked approximately one pack per day for 40 years, starting at age 18. He has tried to quit multiple times using nicotine replacement therapy, but failed. He has tried the nicotine patch six times, nicotine gum twice, and the nicotine inhaler once. He also tried Chantix, but had to discontinue after three days because he was feeling suicidal. His doctor advised him against trying Zyban. He has no history of heart disease and feels reasonably healthy, although he used to be able to jog 3 miles and now can only jog 2 miles before feeling shortness of breath. His blood pressure and cholesterol levels are normal, and there is no family history of heart disease or cancer. He reports that he has two close friends and one family member who recently quit smoking successfully using electronic cigarettes and he has expressed extreme interest in the product. He comes to you for advice on whether to give electronic cigarettes a try.

According to the World Health Organization, their advice for this patient is to try to quit using nicotine replacement therapy, even though he has failed 9 times! They would strongly discourage him from trying electronic cigarettes.

According to the Department of Health and Human Services, their advice for this patient is to try to quit using nicotine replacement therapy, even though he has already failed 9 times! They would discourage him from trying electronic cigarettes.

In my opinion, given the availability of electronic cigarettes and the observed success of these products among many smokers, the advice being given by the WHO and by DHHS is inappropriate. In fact, in my view, it represents public health malpractice.

If a doctor were to give this same advice to J.B., it would be completely inappropriate, and in fact, I think it would represent malpractice. A responsible physician would take into account the fact that this individual has failed to quit 9 times with NRT and would conclude that another trial of NRT is unlikely to be effective. The physician would see that the patient is extremely interested in and motivated by electronic cigarettes and has a support group around him that has used electronic cigarettes and is encouraging him to do the same. Certainly, a trial of electronic cigarettes may very well be warranted in this patient.

You can see from this example exactly why the medical advice being given by the WHO and DHHS represents public health malpractice.  

What makes these examples worse, and what truly makes them constitute malpractice, is that they not only provide bad advice without knowing the complete patient history, but they base that advice on false information.

The WHO claims that electronic cigarettes deliver nicotine "directly to the lungs." There is no evidence that this is true. In fact, electronic cigarettes produce an aerosol, much like nicotine inhalers, and it is likely that the overwhelming majority of the nicotine is absorbed in the upper respiratory tract, never making it down to the lungs. In fact, this is one of the reasons why vaping is not as satisfactory as smoking to many smokers.

The DHHS claims that there "haven’t been any scientific studies that prove e-cigs actually help people to quit smoking." This is also untrue. There are several studies which show that electronic cigarettes are helpful to many people in quitting smoking, although the results may not be as impressive as we would like to see. Nevertheless, a rigorous clinical trial demonstrated that electronic cigarettes are as effective as the nicotine patch. Unless the DHHS is prepared to argue that NRT is ineffective, it should not claim that electronic cigarettes are ineffective. Certainly, more data is needed before we can quantify the effectiveness of electronic cigarettes, but to say that there is no scientific evidence for the effectiveness of these products is just not truthful.

In my opinion, it is malpractice to provide medical advice to a patient without knowing the relevant aspects of that patient's history. Most physicians would agree that a doctor should not give medical advice without knowing the relevant history. But this is exactly what the WHO and DHHS are doing.

They are making blanket recommendations that people do not use electronic cigarettes without knowing the medical histories of these people. Perhaps they have tried to quit multiple times with NRT and have failed. Perhaps they have no interest in trying NRT. Perhaps they have decided that they will not quit unless they can use electronic cigarettes. Perhaps they have decided that electronic cigarettes are their only hope.

For such patients, the blanket advice from the WHO and from DHHS is still: We recommend that you not quit using electronic cigarettes. We recommend that you try NRT again, even though you have no interest in using it and will obviously not try again it given your history.

The central tenet of medicine and public health is "to do no harm." Both the WHO and DHHS are doing harm by disseminating inappropriate medical advice without adequate knowledge of the medical history of the people seeking that advice and based on information that is not factual. This, in my mind, is an example of public health malpractice.

Wednesday, December 11, 2013

First Study to Examine Passive Vaping Under Real-Life Conditions Finds No Chemicals of Concern in Room Air

In the first study of human exposure produced by passive vaping under real-life conditions, researchers from Italy and Greece found no chemicals of concern in room air while five electronic cigarette users vaped for a five-hour session in a 60 cubic meter closed room.

The researchers compared the constituents of room air during passive vaping to those present during passive smoking. During passive smoking, levels of chemicals were as follows (all in micrograms per cubic meter):

Nicotine: 34
Acrolein: 20
Polycyclic aromatic hydrocarbons: 9.4
Carbon monoxide: 11
Xylene: 0.2
Toluene: 1.7

The detected levels of these same chemicals during the passive vaping session were as follows:

Nicotine:0
Acrolein: 0
Polycyclic aromatic hydrocarbons: 0
Carbon monoxide: 0
Xylene: 0
Toluene: 0

(Romagna G, Zabarini L, Barbiero L, Bocchietto E, Todeschi S, Caravati E, Voster D, Farsalinos K. Characterization of chemicals released to the environment by electronic cigarettes use (ClearStream-AIR project): Is passive vaping a reality? Presented at the 14th Annual Meeting of the Society for Research on Nicotine and Tobacco, 2012, Helsinki, Finland.)

The Rest of the Story

These results should be viewed as preliminary, especially because only one brand of electronic cigarettes was tested. There could be variability between various brands, so no firm conclusions should be drawn until many brands of electronic cigarettes are tested under realistic exposure conditions.

Nevertheless, these results seem to suggest that electronic cigarettes at least have the potential to present little risk to bystanders. Not only can we say that there is currently no evidence that passive vaping is harmful, but we can now say that the first study to examine passive vaping under realistic conditions found no chemicals of concern in the ambient air.

One previous study (Flouris et al., 2013) did find an increase in serum cotinine levels in nonsmokers exposed to passive vaping; however, that study involved blowing air using an air pump into an experimental chamber. It did not involve the actual, real-life use of electronic cigarettes by humans. Also, that study measured only serum cotinine; it did not measure the levels of contaminants in the ambient air.

Stan Glantz and others have been using that study to argue that passive vaping is hazardous to bystanders. Of course, they ignore the results of the present study - the only one to be conducted under realistic conditions and to actually measure potentially hazardous chemical exposures. The finding that there were no detectable levels of nicotine, acrolein, polycyclic aromatic hydrocarbons, carbon monoxide, xylene, and toluene is inconvenient to Glantz's argument that electronic cigarettes are a significant health hazard to non-vaping bystanders.

Glantz and others also fail to inform the public that the Flouris et al. study -- which they tout as demonstrating the significant hazards of passive vaping - actually showed that exposure to electronic cigarette vapor in the experimental chamber for one hour had no effect on acute lung function of nonsmokers. This was in contrast to secondhand smoke, which adversely affects acute lung function.

The rest of the story is that there is no current evidence that passive vaping poses any significant threat to the health of bystanders. Thus, I do not see any public health justification for banning vaping in public places at the present time.

Tuesday, December 10, 2013

As New York Times Article Reveals, Quality of Scientific Analysis at Campaign for Tobacco-Free Kids Has Deteriorated

An op-ed column by Joe Nocera in the New York Times last Friday discusses the inane position of anti-smoking groups on electronic cigarettes.

Nocera writes: "You’d think that the public health community would be cheering at the introduction of electronic cigarettes. We all know how hard it is to quit smoking. We also know that nicotine replacement therapies, like the patch, haven’t worked especially well. The electronic cigarette is the first harm-reduction product to gain serious traction among American smokers. Yet the public health community is not cheering. Far from it: groups like the American Lung Association, the American Heart Association and the Campaign for Tobacco-Free Kids are united in their opposition to e-cigarettes. They want to see them stigmatized — like tobacco cigarettes. They want to see them regulated like cigarettes, too, which essentially means limited marketing and a ban on their use wherever tobacco cigarettes are banned." ...

"The reason to fear this resemblance, say opponents of electronic cigarettes, is that “vaping” could wind up acting as a gateway to smoking. Yet, so far, the evidence suggests just the opposite. Several recent studies have strongly suggested that the majority of e-cigarette users are people who are trying to quit their tobacco habit. The number of people who have done the opposite — gone from e-cigarettes to cigarettes — is minuscule. “What the data is showing is that virtually all the experimentation with e-cigarettes is happening among people who are already smokers,” says Michael Siegel, a professor at the Boston University School of Health. Siegel is a fierce critic of tobacco companies, but he’s also not afraid to criticize the anti-tobacco advocates when they stretch the truth. When we got to talking about the opposition to e-cigarettes in the public health community, he said, “The antismoking movement is so opposed to the idea of smoking it has transcended the science, and become a moral crusade. I think there is an ideological mind-set in which anything that looks like smoking is bad. That mind-set has trounced the science.” ...

"At that recent New York City Council meeting, one of the fiercest critics to testify was Kevin O’Flaherty of the Campaign for Tobacco-Free Kids. “If it walks like a duck and it talks like a duck and it sounds like a duck and it looks like a duck, it is a duck,” he said. Is this what passes for science when you oppose electronic cigarettes?"

The Rest of the Story

Sadly, the answer is yes. When it comes to groups like the Campaign for Tobacco-Free Kids and other similar anti-smoking groups, that is what passes for science.

This "science" is not very deep or thoughtful. Because electronic cigarettes look like cigarettes, they are therefore cigarettes and should be treated the same way as cigarettes. Sadly, many anti-smoking groups can't seem to get beyond that flawed logic.

While the Campaign for Tobacco-Free Kids talks about ducks, there are many scientists who have been conducting extensive research on electronic cigarettes, the components of e-cigarette aerosol, the effectiveness of e-cigarettes, and the potential use of these products as a gateway to smoking. But this science does not appear to matter to anti-smoking groups. The fact that electronic cigarettes look like cigarettes is all that matters.

It is important to remember that the Campaign for Tobacco-Free Kids called for a complete ban on electronic cigarettes. Had the Campaign had its way, these products would not presently be on the market and thousands of current ex-smokers would still be inhaling tobacco smoke every day. In December 2010, the American Heart Association was quoted as stating: "There is no scientific evidence that e-cigarettes are effective smoking cessation devices and, until they undergo rigorous evaluation by the Food and Drug Administration, they should be pulled from the marketplace." The Campaign for Tobacco-Free Kids shared this position.

In July 2009, the Campaign for Tobacco-Free Kids called for an outright ban on the sale and marketing of electronic cigarettes. The Campaign wrote: “We look forward to the FDA taking additional action to stop the marketing and sale of these unapproved products.”

While the Campaign can argue that they have changed their position, it is of little consequence, since their long-standing opposition to electronic cigarettes is clear.

The rest of the story is that groups like the Campaign for Tobacco-Free Kids have regressed into ideology-driven think-tanks that do almost no thinking, essentially just making them "tanks." The quality of their scientific analysis has deteriorated to the point that the New York Times is now highlighting the shallowness of their critical analytic capabilities.

But I should emphasize that it is not just the Campaign for Tobacco-Free Kids. A host of other anti-smoking organizations have gone down the same road. The science no longer matters. If something looks like smoking, its use cannot possibly be condoned, no matter how many lives it might be saving.

Monday, December 09, 2013

New York City Pulmonologist Tells Smokers that their Smoking May Be No More Hazardous than Using Tobacco-Free Electronic Cigarettes

When Will CDC and FDA Correct This Misinformation?

Adding to a long list of electronic cigarette opponents who are lying to the public, a New York City pulmonologist has publicly informed smokers that their cigarette smoking may be no more hazardous than using tobacco-free, non-combusted electronic cigarettes.

According to an Everyday Health article: "a pulmonologist at St. Lukes and Roosevelt Hospital in New York City was quoted as stating (referring to vaping): "There’s no way to say if it’s safer or not. Many people think they’re safer, but there’s no evidence. We can’t allow them, only to find out down the line they are as dangerous as cigarettes."

We have already established that if a tobacco company made the same statement, the CDC and anti-smoking advocates, including Stan Glantz, would be ready to pounce on the company for spreading such a dangerous lie.

However, when an anti-smoking advocate makes the same statement, these groups don't seem to care.

This is a particularly damaging falsehood, because it undermines years of public education about the severe hazards of smoking. The effect of these repeated claims is going to be the discouragement of smoking cessation. Why quit smoking if it may be only as dangerous as using non-tobacco electronic cigarettes? Apparently, the tobacco really doesn't add all that much risk. So why bother going through the difficult process of quitting?

The Rest of the Story

There is only one way to end this repeated string of public misinformation about the health effects of vaping. The CDC and FDA must correct their past mis-statements and must issue clear public statements that vaping is much safer than smoking.

Unfortunately, neither agency seems to be interested in correcting this misinformation.

I had discussions with the head of CDC's Office on Smoking and Health, urging him to make a clear statement on the CDC web site that electronic cigarettes are safer than tobacco cigarettes. Unfortunately, he showed no interest in informing the public about the truth by making a simple statement regarding the relative health effects of smoking vs. vaping.

Meanwhile, the FDA continues to spread this misinformation itself. Remember that back in 2009, the FDA directly informed the public that smoking may be no more hazardous than vaping. In an interview on NPR's Morning Edition, FDA spokeswoman Rita Chappelle stated: "We're concerned about the potential for addiction to and abuse of these products. Some people may mistakenly perceive these products to be safer alternatives to conventional tobacco use."

And as recently as this September, the FDA acknowledged that it does not want the public to think that cigarette smoking is any more hazardous than using a non-tobacco e-cigarette. According to an FDA spokeswoman, as quoted at WebMD: "We don't want the public to perceive them (e-cigarettes) as a safer alternative to cigarettes."

Unfortunately, the FDA web site still implies that vaping has no health advantages over smoking, claiming that: "consumers of e-cigarette products currently have no way of knowing ... if there are any benefits associated with using these products."

It is easy to see where health professionals like this New York City pulmonologist are obtaining their errant information.

Until the FDA and CDC correct this misinformation, health professionals are going to continue to provide false information to the public, and in the process, to undermine the public's appreciation of the hazards of smoking. 

Friday, December 06, 2013

CDC is Exaggerating the Problem of Electronic Cigarette Use Among Non-Tobacco Users

Previously, I discussed a CDC study which found a doubling of the prevalence of current electronic cigarette use among youth from 2011 to 2012. This report has been used to alarm the public and policy makers about the hazards of electronic cigarettes, with the CDC director claiming that these data demonstrate that e-cigarettes are serving as a gateway to a lifetime of youth addiction to smoking.

In my previous analysis, I pointed out that the CDC has been consistently leaving out an important part of the story: despite the doubling of electronic cigarette use, most of the current use is taking place among adolescents who already smoke cigarettes. The real concern would be if non-tobacco users were trying electronic cigarettes, becoming addicted to nicotine, and then progressing to cigarette smoking.

The Rest of the Story

Today, I report that the CDC's misrepresentation of its study results goes even deeper. Dr. Brad Rodu, Professor of Medicine at the University of Louisville, has revealed that the CDC has left out even more critical information.

In its report, the CDC noted that in 2012, 76.3% of middle and high school students who used e-cigarettes in the past month were smokers. Thus, 23.7% of students who currently used e-cigarettes were nonsmokers. However, Dr. Rodu's own analysis of the National Youth Tobacco Survey for 2012 shows that of these nonsmokers, more than half were actually using other tobacco products, such as smokeless tobacco or cigars. And of the remaining half who were not using other tobacco products, about half of that group had already experimented with smoking.

Thus, only 10.8% of electronic cigarette users were non-tobacco users with no previous tobacco cigarette use.

This means that the estimated prevalence of youth in the population who are current e-cigarette users but have never used tobacco products is only 0.25%.

This does not mean that the possibility of youth starting with e-cigarettes and progressing to smoking should not be a concern. What is does mean is that the CDC appears more interested in promoting a particular position on e-cigarettes than in providing the public with the facts.

There is little evidence regarding why youth are using electronic cigarettes. It is possible, for example, that many youth who are smokers or other tobacco product users may be trying electronic cigarettes in an effort to quit their tobacco use. If this is the case, then experimentation with electronic cigarettes could actually have a net benefit among youth. I emphasize that this is merely a hypothetical possibility. But the point is that we don't understand the reasons behind electronic cigarette use among youth. It does us no good to draw conclusions, as the CDC has done, without the proper evidence.

Dr. Rodu concludes: "CDC director Tom Frieden may wish to use his position as a bully pulpit to oppose e-cigarette use, but abusing the facts is inexcusable."

I agree, but would change the end of the sentence to emphasize that not providing the relevant facts is inexcusable.

To be sure, the issue of electronic cigarettes is a complex one, especially as it relates to youth experimentation with these products and how that changes the overall cost-benefit picture. There is room for debate on the issue and it actually helps ensure appropriate policy to have folks who force us to remain vigilant about the possibility that electronic cigarettes could serve as a gateway to established smoking. However, it does not do us a service for public health organizations to hide relevant facts from the public in order to promote a pre-established position. The best and most appropriate policy will come from a full consideration of the facts, not from the hiding of the facts.

Thursday, December 05, 2013

Politicians are Repeating CDC Propaganda, Word for Word, in Pushing Vaping Bans

What I have been predicting for the past few weeks is now coming true, as the CDC propaganda campaign about how electronic cigarettes are leading to a lifetime addiction to smoking is now being repeated - verbatim - by politicians who want to ban vaping in public places.

According to an article in the Orange County Register:

"On Tuesday night, the council voted 8-0 to have City Attorney Charles Parkin find ways to amend the City Code to regulate the trendy electronic cigarettes just like traditional tobacco products. ... “We’re not banning them, we’re not asking them to be sold in our city, what we’re asking for is a standard that we already enjoy with tobacco users,” said John Edmund, chief of staff for District 6 Councilman Dee Andrews, in a presentation to the council. ... “Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine,” Edmond said."

The Rest of the Story

When I presented on electronic cigarettes at the TMA conference in October, I criticized the CDC director for a series of statements indicating that electronic cigarettes are a gateway to youth smoking. I argued that there is no evidence to support such a conclusion and so the CDC director should not be telling the public that e-cigarettes are a gateway to a lifetime of addiction to cigarette smoking, as he was doing. The director of CDC's Office on Smoking and Health responded by arguing that the CDC director's comments were inconsequential, that few people saw these comments, that I was drilling down to dissect the comments inappropriately, and that no one was going to pay attention to them.

Today, we learn that politicians are now taking Dr. Frieden's statement - word for word - and using it as reputable evidence to support vaping bans.

Here is what the chief of staff to Councilman Andrews was quoted as saying:

"Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine."

And here is what CDC director Dr. Thomas Frieden stated:

"Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes."

Last week, I wrote: "At a recent TMA conference on electronic cigarettes, a CDC official defended Dr. Frieden's statement on the grounds that: (1) It was merely a "slip of the tongue"; and (2) it was inconsequential because very few people saw it. Apparently, this slip of the tongue, which was disseminated nationwide through more than 50 media outlets, will have no impact on local public health organizations. However, based on today's rest of the story, it appears that this unsupported statement may in fact be leading local public health practitioners to further disseminate this misleading information."

After today's story, I rest my case.

Tuesday, December 03, 2013

New York City Council To Consider Ban on Vaping in Parks Despite Lack of Evidence that This is a Significant Public Health Problem

Tomorrow morning, the New York City Council will hold a public hearing on a proposed ordinance that would ban vaping in public parks, as well as all other places where cigarette smoking is banned. The hearing will take place before the Committee on Health at 10:00 am.

The Rest of the Story

As a strong proponent of comprehensive workplace smoking bans that include bars, restaurants, and even casinos, I have long argued that to justify smoking bans, there must be strong evidence that smoking in the workplace and public places poses a significant hazard to nonsmokers. In fact, years ago, I testified before the New York City Council itself, speaking in support of the City's 100% smoking ban for bars and restaurants. I supported my testimony with abundant scientific evidence of the devastating health effects of secondhand smoke on the lives and health of bar and restaurant workers, including my own studies showing that bar workers face an increased lung cancer risk because of their high levels of secondhand smoke exposure. We even heard from actual bar workers who had suffered severe health effects due to their workplace exposure to tobacco smoke.

So what is the similar scientific evidence that exposure to a vaper in park poses a significant health threat to the public?

A comprehensive articulation of the evidence that vaping in parks poses a health threat to the public is presented on the following web page:

Comprehensive Articulation of Scientific Evidence that Vaping in Parks Poses a Health Risk to the Public

As it turns out, there is currently no evidence that "secondhand vaping" poses any significant health risk to bystanders. And there is certainly no evidence that secondhand vaping in a park poses any significant health threat.

Apparently acknowledging the lack of any scientific evidence that exposure to "secondhand" vapor from electronic cigarettes poses a significant public health problem, supporters of this ordinance have instead justified the proposal on other grounds. Specifically, they argue that the ordinance is necessary to protect children from seeing vapers, because by seeing someone using an electronic cigarette, it might lead a youth to experiment with electronic cigarettes, become addicted to nicotine, go on to become a cigarette smoker, and then suffer the consequences of a lifelong addiction to smoking.

The ordinance itself provides the following justification for its draconian interference with individual freedoms: "The use of electronic cigarette devices in places where smoking is prohibited may increase the social acceptability and appeal of smoking, particularly for youth, potentially undermining the enormous progress that has been made over the years in discouraging smoking, and could send a message to adults and youth that these potentially harmful products are in fact safe."

The ordinance argues that the prohibition on smoking in parks is necessary to "protect youth from observing behaviors that could encourage them to smoke."

City Health Commissioner Dr. Thomas Farley reiterated this same justification, telling the New York Post that electronic cigarettes "may introduce a new generation to nicotine addiction, which could lead to their smoking combustion cigarettes."

The same article notes that Speaker Christine Quinn offered the same justification, supporting the ban on electronic cigarette use in parks because "their use has exploded among kids."

But there are three major problems with this justification for this sweeping ban:

1. There is No Evidence that Electronic Cigarettes are a Gateway to Youth Smoking

First, there is no evidence that electronic cigarette use is leading to smoking addiction among youth. In fact, there is some evidence that this is not the case. Dr. Theodore Wagener and colleagues at the Oklahoma Health Sciences Center surveyed 1300 young college students and were able to find only one youth who initiated nicotine use with electronic cigarettes and went on to become a smoker.

A comprehensive summary of the current evidence that experimentation with electronic cigarettes leads to cigarette smoking among youth is presented on the following web page:

Comprehensive Summary of Current Evidence that E-Cigarette Experimentation Leads to Smoking

As you can see, the amount of evidence that supports the hypothesis that electronic cigarettes are a gateway to smoking is precisely the same as the amount of evidence that electronic cigarette use in public parks poses a threat to the health of nonsmoking bystanders.

2. If the Council Doesn't Want Youth to See People Vaping, Then Why Allow Vaping on Streets, Sidewalks, and Other Places?

If the City Council is serious about protecting youth from seeing someone use an electronic cigarette, then why limit the ban to public parks? Why not also ban vaping on the streets and sidewalks around those parks, and for that matter, on streets and sidewalks throughout the City? To be sure, parks are not the only place where youth see people vaping. If this is such a significant public health problem and there is truly a risk that a substantial proportion of youth are going to become addicted to smoking from seeing vapers in public, then why not simply ban vaping in public, period?

Either the supporters of this ordinance aren't as sincere about their concern for the health of children as they pretend to be, or even they realize that their contention that youth are going to see a vaper and then end up becoming a lifelong smoker is unsupported by any evidence.

3. The Purpose of Smoking Bans is to Protect Nonsmokers, Not to Prevent People from Seeing Smokers

The purpose of smoking bans, and their only justification, is to protect nonsmokers from exposure to the significant hazards associated with tobacco smoke inhalation. If the purpose of these laws were to prevent youth from ever having to see a smoker, then there would be no reason not to simply ban smoking in public. But public health advocates like myself never supported smoking bans on the grounds that the government had a substantial interest in making sure that no  youth ever sees someone smoking. We advocated smoking bans because of the scientific evidence that secondhand smoke kills tens of thousands of people each year.

Why It is Essential that Public Health Legislation Be Supported by Solid Scientific Evidence

If the City Council is concerned that youth might not understand what vapers are doing and may not understand that electronic cigarettes are not safe and should not be used by youth or by nonsmokers, then the Council should implement a public education campaign to achieve this end. In doing so, the Council might direct the Department of Health to emphasize to youth the tremendous hazards of cigarette smoking and explain that so many smokers want to quit that electronic cigarettes have been developed as a way to help them quit. This could be a great opportunity to teach kids how addictive smoking is by pointing out that many smokers can only quit if they use a product that simulates the exact behaviors of smoking.

However, to respond to this issue by enacting a law that is completely unsupported by scientific evidence is not only unjustified, but it undermines the very practice of public health. We in public health pride ourselves on only intervening in personal freedoms when there is scientific justification that such intervention is necessary to respond to a substantial public health problem. And we rely on scientific evidence to determine whether a substantial public health problem exists.

To deviate from this model by banning a behavior simply because we think it might have a particular effect, even though there is no evidence to support that contention, undermines the practice of public health. And it leaves us open to attack when there really is a substantial public health problem to which we need to respond with legislation that interferes with individual behavior.

When I testified at more than 200 city and town council meetings throughout the country in support of 100% smoke-free legislation, I was consistently berated by opponents, who argued that I was simply an anti-smoking zealot and that I would support banning smoking in public places even without evidence that it was a serious public health hazard. That charge was not true. However, by enacting this ordinance, the New York City Council would essentially be demonstrating that our smoke-free legislation opponents were right all along and that our movement is based on zealotry rather than on solid science.

According to CDC, the Fact that Some Nonsmoking Youth are Using Electronic Cigarettes Suggests that These Kids are Going on To Become Lifelong Smokers

If that seems like strange logic to you, then you have company. I do not understand the logic of extrapolating from the observation that some nonsmoking youth are experimenting with electronic cigarettes to concluding that these products are causing these youth to become addicted to smoking.

But sadly, this is precisely the logic that the CDC is using to try to convince the public that electronic cigarettes are a gateway to a lifetime of addiction to tobacco cigarettes.

According to the transcript of a CNN (nationally televised) interview with CDC's director in September, the observation that there are some nonsmoking youth who are experimenting with electronic cigarettes suggests that these products are leading to a lifetime addiction to smoking.

Based on the transcript, CDC's director told a national television audience that: "Well, if you start with e-cigarettes, there's a real likelihood that you'll become nicotine addicted, we found in CDC studies that 20 percent of middle school kids who used some -- who used e-cigarettes only used e-cigarettes, what that suggests to me, it's not proof, but what it suggests to me is that some kids are starting with e-cigarettes, getting hooked on nicotine and going on regular cigarettes and that's a real problem because those kids may well be getting condemned to a lifetime of nicotine addiction."

The Rest of the Story

What would suggest to me, as a scientist and 27-year tobacco control researcher, that "some kids are starting with e-cigarettes, getting hooked on nicotine, and going on [to] regular cigarettes" is evidence that some kids are starting with e-cigarettes and then going on to smoke real ones.

One would hope that our nation's leading prevention agency would demand that minimal level of scientific rigor before drawing a conclusion that would have profound implications for public health policy.

Those implications are so profound that if the CDC's conclusion were true, I would withdraw my support for electronic cigarettes as a smoking cessation strategy.

But it would be unwise (and possibly tragic) to base public health policy on the type of evidence that the CDC is using to scare the public into believing that electronic cigarettes are a gateway to a lifetime of cigarette addiction.

The fact that a number of nonsmoking youth -- even if it is a large number -- are experimenting with electronic cigarettes is concerning, but it in no way provides evidence that these youth are going on to become addicted to cigarette smoking. The only type of evidence which would support such a conclusion is longitudinal evidence showing that kids who initiate nicotine use with electronic cigarettes are going on to become cigarette smokers. That kind of evidence does not exist at the current time.

Many kids are chewing gum. But that provides no evidence whatsoever that these kids are initiating with chewing gum and then going on to try nicotine gum.

But this is precisely the nature of the evidence upon which the CDC is concluding that electronic cigarettes are serving as a gateway to a lifetime of cigarette smoking.

Monday, December 02, 2013

CDC and Glantz Misinformation Campaigns on Electronic Cigarettes are Working: Media Disseminating False Conclusions to Public

In recent weeks, I have exposed a repeated series of false or misleading statements being made by health and anti-smoking agencies, organizations, and advocates who are opposed to electronic cigarettes. The two most problematic aspects of this misinformation campaign are:

1. The CDC's propaganda regarding electronic cigarettes being a gateway to a lifetime of smoking addiction, despite the absence of any evidence to support this contention; and

2. Stan Glantz's propaganda that electronic cigarettes are a pathway to smoking addiction among youth, despite the fact that his study was a cross-sectional one and could not determine whether even a single youth started using electronic cigarettes and then progressed to established smoking.

A CDC official with whom I have been corresponding did not deny that the statement made by CDC regarding electronic cigarettes being a gateway to smoking addiction was misleading; however, he did downplay its significance, arguing that no one is paying attention to that statement.

Putting aside, for the time being, the attitude that it is acceptable for a federal agency to disseminate misinformation as long as no one pays attention, let's address the argument that no one is paying attention.

The Rest of the Story

Today, I present recent two newspaper headlines which make it clear that the two sets of propaganda outlined above - that from the CDC and that from Stan Glantz - are not merely being lost in the clutter, but instead, are resulting in widely read media stories that disseminate false conclusions to the public.

1. The CDC Propaganda Campaign

According to a New York Times article from last week, opponents of electronic cigarettes are arguing that electronic cigarettes are a gateway to smoking addiction among teenagers. The article states: "Opponents of e-cigarettes also argue that they are a gateway to conventional cigarettes, particularly for teenagers."

And who is the electronic cigarette opponent that the New York Times believes is arguing that these products are a gateway to cigarette addiction? It is the CDC.

According to the article: "The Centers for Disease Control and Prevention has found that the percentage of middle- and high-school students who use electronic cigarettes more than doubled from 2011 to 2012. In a statement with that report, Dr. Thomas R. Frieden, the C.D.C. director, said teenagers who used e-cigarettes could become addicted to nicotine and go on to smoke regular cigarettes."

Fortunately, the article does include a statement from the president of NJoy which makes it clear that there is no evidence to back up the CDC's assertion: "But Mr. Weiss, the NJoy executive, said: “There is no scientific data to support the argument that e-cigarettes are a gateway to smoking. On the contrary, there is a significant amount of research that indicates e-cigarettes can be a novel approach for moving smokers away from tobacco cigarettes.”"

However, it the CDC's word against NJoy's, and I believe most readers are going to trust the information they are getting from the CDC.

In this case, that information is untruthful, since there is no evidence that youth are becoming addicted to smoking from experimentation with electronic cigarettes. In fact, the only study to directly examine this hypothesis failed to find any evidence that this phenomenon is occurring.

Sadly, the CDC's informational campaign regarding electronic cigarettes is one of misinformation and deception.

2. The Glantz Propaganda Campaign

The headline of a Voice of America article last week reads: "Teens' E-Cigarette Use Promotes Heavy Tobacco Use."

According to this article: ""

Think about how damaging this headline is. Clearly, it is disseminating the conclusion that electronic cigarette use leads to heavy smoking among teenagers. If true, this would negate the tremendous smoking cessation benefits of electronic cigarettes for current smokers. Therefore, this conclusion has immense policy implications.

Disturbingly, the conclusion is false. There is no evidence to support the conclusion that electronic cigarettes are causing youth to smoke heavily. As I explained last week, Glantz's study was cross-sectional. The association between electronic cigarette use and heavy smoking could just as easily be explained by the hypothesis that youths who smoke heavily are more interested in electronic cigarettes, perhaps because they may be interested in quitting or cutting down on their tobacco use.

To be clear, this is not the reporter's fault. She is simply repeating what Dr. Glantz concluded in the propaganda material that he sent out to the media. Remember that in a statement accompanying his new study, Glantz proclaimed that electronic cigarettes are "a new route to smoking addiction for adolescents." He also represented his data as showing that: "kids who use e-cigs are less likely to have stopped smoking." And he wrote that: "Use of e-cigarettes is associated with heavier use of conventional cigarettes, which raises the likelihood that actual use of e-cigarettes may increase harm by creating a new pathway for youth to become addicted to nicotine and by reducing the odds that an adolescent will stop smoking conventional cigarettes."

In other words, this news article is a precise reflection of the Glantz propaganda campaign. Sadly, that campaign, like that of the CDC on the same issue, is one of misinformation and deception.

Tuesday, November 26, 2013

New Study Completely Misrepresents Findings to Mislead the Public About Role of Electronic Cigarettes as a Gateway to Smoking Initiation

A new study, published online ahead of print in the Journal of Adolescent Health, is being used by its authors to mislead the public into thinking that there is now evidence that electronic cigarettes are leading to smoking initiation and addiction among adolescents.

(See: Lee S, Grana RA, Glantz SA. Electronic cigarette use among Korean adolescents: a cross-sectional study of market penetration, dual use, and relationship to quit attempts and former smoking. Journal of Adolescent Health 2013; doi: 10.1016/j.jadohealth.2013.11.003.)

In a statement accompanying the study, study author Stanton Glantz proclaims that electronic cigarettes are "a new route to smoking addiction for adolescents."

He also represents his data as showing that: "kids who use e-cigs are less likely to have stopped smoking."

Glantz writes: "Use of e-cigarettes is associated with heavier use of conventional cigarettes, which raises the likelihood that actual use of e-cigarettes may increase harm by creating a new pathway for youth to become addicted to nicotine and by reducing the odds that an adolescent will stop smoking conventional cigarettes.”"

Glantz concludes: "We are witnessing the beginning of a new phase of the nicotine epidemic and a new route to nicotine addiction for kids."

The Rest of the Story

The rest of the story is that what we are actually witnessing is not the demonstration that electronic cigarettes are a route to smoking addiction for adolescents, but the twisting, manipulation, and misrepresentation of scientific data in order to mislead the public.

The problem is that Glantz is taking results from a cross-sectional study and misrepresenting them as if they were derived from a longitudinal study. Moreover, he is failing to heed his own warning, buried in the fine print of the paper, that: "Because the [survey] used cross-sectional data, the directionality of our findings cannot be established."

By examining the two major so-called "findings" of the study, you'll be able to see how Glantz is misrepresenting the study's actual findings.

1. "Kids who use e-cigs are less likely to have stopped smoking." 

This conclusion is scary, and if true, I would have to think seriously about whether to continue to support electronic cigarettes as a smoking cessation strategy. The statement suggests that in this study, smokers who used electronic cigarettes were less likely to have quit over time than smokers who did not use electronic cigarettes.

There's just one problem: this study did not follow any smokers over time.

Despite the author's insinuation that this was a longitudinal study and that smokers who used electronic cigarettes were less likely to have stopped smoking over time, the study was in fact cross-sectional. It was a snapshot of tobacco/e-cigarette use behavior at a single point in time.

In fact, it did not assess whether any of the respondents had quit smoking, because it did not determine whether youth who did not currently smoke were ever current smokers. A youth could have puffed one time on a cigarette at a party and never smoked again, yet this individual would be considered a "former smoker" in this study.

Because the study is cross-sectional, there are two - not one - potential explanations for the observed association.

One possibility is as Glantz concludes: it is possible that smokers who used electronic cigarettes were less likely to quit over time.

But there is a second possibility: it could be that kids who experimented with cigarettes but did not begin smoking were not interested in starting to use electronic cigarettes. In other words, the causation could work in the opposite direction. The reason for the observed association between the use of electronic cigarettes and a greater chance of  being a current than a "former" smoker could be simply that smokers are overwhelmingly more interested in electronic cigarettes than nonsmokers.

In fact, this is quite a likely possibility, as the study reports that current smokers are 66 times more likely than never smokers to be current electronic cigarette users.

In summary, the "actual" finding of the study is that there was an association between being a current as opposed to a former smoker and using or having used electronic cigarettes. But Glantz instead reports the interpretation that he apparently "wants" to believe: that kids who use e-cigs are less likely to have stopped smoking. He fails to inform readers of the equally likely (probably more likely) possibility that electronic cigarette use simply appeals much more to smokers than to kids who are not currently smoking.

2. "Use of e-cigarettes is associated with heavier use of conventional cigarettes, which raises the likelihood that actual use of e-cigarettes may increase harm by creating a new pathway for youth to become addicted to nicotine."

This conclusion is scary, and if true, I would have to think seriously about whether to continue to support electronic cigarettes as a smoking cessation strategy. The statement suggests that in this study, the use of electronic cigarettes caused smokers to smoke more, thus enhancing their addiction to cigarette smoking.

There's just one problem: this study was cross-sectional so it cannot conclude whether electronic cigarette use caused kids to smoke more or whether kids who smoked more were more likely to try electronic cigarettes (perhaps because they wanted to quit or cut down).

Once again, because the study is cross-sectional, there are two - not one - potential explanations for the observed association.

One possibility is as Glantz concludes: it is possible that the use of electronic cigarettes led smokers to significantly increase their cigarette use, and thus to enhance their nicotine and smoking addiction.

But there is a second possibility: it could be that kids who smoked more heavily were more likely to want to try electronic cigarettes, perhaps in an attempt to quit or cut down. In other words, the causation could work in the opposite direction. The reason for the observed association between the use of electronic cigarettes and a greater chance of  being a heavy smoker could be simply that heavier smokers are more interested in electronic cigarettes than lighter nonsmokers.

In fact, this is quite a likely possibility, as the study reports that current smokers who are trying to quit are much more likely to use electronic cigarettes.

In summary, the "actual" finding of the study is that there was an association between being a heavier smoker and using electronic cigarettes. But Glantz instead reports the interpretation that he apparently "wants" to believe: that electronic cigarettes are causing kids to smoke more. He fails to inform readers of the equally likely (probably more likely) possibility that electronic cigarette use simply appeals much more to heavier smokers, perhaps because they are trying to quit or cut down.

The Study Conclusion

Ultimately, the study and Glantz' statement conclude that electronic cigarettes are "a new route to smoking addiction for adolescents."

However, this is a cross-sectional study, and it did not find a single youth who started using electronic cigarettes and then went on to become a regular cigarette smoker. 

How then, can the study conclude that youths are starting with electronic cigarettes and then going on to be addicted to smoking?

The answer is simple: it can't. 

The study was cross-sectional so it cannot determine whether the dual users in the study had initiated with electronic cigarettes and then went on to smoke, or whether they initiated with smoking and then went on to try electronic cigarettes.

But that didn't stop the study authors from drawing this conclusion.

Why Continue to Do Tobacco Control Research?

As we go into the Thanksgiving holiday, I am seriously thinking about why there is a need to continue to do tobacco control research. If we are going to simply conclude what we want to conclude, regardless of the ability of the science to reach such a conclusion, then what's the point of doing the research in the first place?

A lot of money (in this case, taxpayer money) could have been saved if we had simply told Dr. Glantz: don't bother doing the study. Just come out with your pre-determined conclusion. It will save the government and the taxpayers a lot of money and you're going to reach this conclusion anyway, regardless of whether the study design allows you to draw such a conclusion.

Seriously: why not just have anti-smoking researchers save a lot of time and money by simply disseminating their conclusions about how evil electronic cigarettes are, without actually conducting the research? The money saved could go into a fund that would be used for tobacco control education and prevention programs. This would be a win-win-win. Electronic cigarette opponents could continue to disseminate their unsupported conclusions, since the actual results of these studies don't matter anyway, and as an added bonus, taxpayers save money and funds are generated to further reduce smoking rates.

The rest of the story is that the findings of this study have been misrepresented to support what appears to be a pre-determined conclusion. The study is cross-sectional, and as the authors themselves acknowledge, it does not permit the very causal conclusions that they have drawn. The scary findings about kids being less likely to quit and more likely to smoke more because of electronic cigarette use could simply be a reflection of the possibility that kids who smoke, and who smoke more heavily, are more attracted to electronic cigarettes, perhaps because they want to quit or cut down on the amount they are smoking.

Cambridge Public Health Department Follows the CDC's Lead, Claims that Electronic Cigarettes are a Gateway to a Lifetime of Tobacco Use

Following the lead set by CDC in telling the public that electronic cigarettes are a gateway to tobacco cigarette smoking, the Cambridge (Massachusetts) Public Health Department has proclaimed that e-cigarettes "are powerfully addictive and often serve as a 'gateway' to a lifelong tobacco habit."

In a memorandum to the City Manager, the Cambridge Public Health Department writes as follows:

"The manner in which tobacco companies have targeted younger groups also poses a long-term concern, as many younger individuals may not understand that e-cigarettes are powerfully addictive and often serve as a 'gateway' to a lifelong tobacco habit."

The memorandum recommends that the city tobacco ordinance be amended to ban the sale of electronic cigarettes to minors.

The Rest of the Story

I completely agree with this policy recommendation. However, I don't believe it was necessary to rely upon a false or unsupported statement to support this recommendation.

There is, in fact, no evidence that electronic cigarettes serve as a gateway to a lifelong tobacco habit. In fact, there is not even any evidence that electronic cigarettes serve as a gateway to a short-lived tobacco habit. The only study to examine this hypothesis found that electronic cigarettes are not currently serving as a gateway to cigarette smoking among young people.

Although more research needs to be done, it is safe to say that at the present time, the evidence suggests that electronic cigarettes are not a major gateway to smoking initiation among youth. At the very least, however, it is undeniable that there is no evidence to support the assertion that electronic cigarettes are leading to smoking among youth, much less a lifelong addiction to tobacco.

The larger part of this story is the question of how the public health department came to believe that electronic cigarettes are a gateway to a lifetime of smoking.

It is possible, and in fact, likely, that this local health department was simply reiterating material that was spewed out by the CDC in a widely circulated Associated Press story, which appeared in numerous newspapers and on television station sites, Dr. Frieden was quoted as stating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine." These articles also state that Dr. Frieden suggested the CDC survey data indicate that many kids experiment with e-cigarettes and then go on to smoke cigarettes.

It is certainly curious that the Cambridge Public Health Department's language mirrors that of Dr. Frieden.

According to the AP story: "health officials worry e-cigarettes could re-ignite teen cigarette use. They point to a finding in the study that 20 percent of middle school e-cigarette users had never tried conventional cigarettes. When the same question was asked of high school students, only 7 percent had never tried regular smokes. That suggests many kids experiment with the electronic devices and move on to cigarettes by high school, said CDC Director Dr. Tom Frieden. "In effect, this is condemning many kids to struggling with a lifelong addiction to nicotine," he said."

Fortunately, in the same article, there is an opposing quote from Dr. Kurt Ribisl from the University of North Carolina who pointed out that the survey results "don't prove that e-cigarettes are a gateway to smoking cigarettes." However, the CDC's point had already been made.

A quick Google search shows at least 52 different media outlets that disseminated this information, including the quote indicating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine."

At a recent TMA conference on electronic cigarettes, a CDC official defended Dr. Frieden's statement on the grounds that: (1) It was merely a "slip of the tongue"; and (2) it was inconsequential because very few people saw it.

Apparently, this slip of the tongue, which was disseminated nationwide through more than 50 media outlets, will have no impact on local public health organizations. However, based on today's rest of the story, it appears that this unsupported statement may in fact be leading local public health practitioners to further disseminate this misleading information.

Fortunately, in this case, the misleading information is not supporting a damaging public health policy. However, in other cases, it might well result in a policy that could harm the public's health.

In at least one other case, public health practitioners were explicit in noting that their hypotheses regarding electronic cigarettes and a lifelong addiction to smoking came directly from the CDC. In their op-ed piece published in the Spring Grove (MN) Herald, Shelton (CT) Herald, Los Angeles Daily News, and perhaps other local newspapers, writers from the American Lung Association tell us that: "We share the CDC's concern that children who begin by using e-cigarettes may be condemned to a lifelong addiction to nicotine and cigarettes."

Words matter, and the words spoken by the CDC matter even more than those of most health organizations. Many state and local health groups, like the Cambridge Public Health Department, look to the CDC for guidance on health science and policy issues. This is why it is particularly important for the CDC to get it right and not to disseminate false statements that mislead the public.

An associate professor of Pediatrics at the Ohio State University goes so far as to claim that: "a lifelong addiction to nicotine can start with one e-cigarette." We know that this professor relies heavily upon the CDC for his information because earlier in his article he cites the CDC's report on electronic cigarette use among youth. (By the way, he goes on to state: "Even if you assume that e-cigarettes are “cleaner” than tobacco, they still deliver a potent drug that can lead to lifelong dependence in many teenagers").

Meanwhile, the CDC's deceptive statements live on.

Just last week, a full eight weeks after the CDC's original statements, they are still being disseminated nationally through the media. An article on electronic cigarettes in Spry, dated November 21, reads: "According to a recent CDC report, the number of high school students who tried e-cigarettes rose from 4.7% in 2011 to 10% in 2012. In the report, CDC officials expressed concern about the potential for abuse and addiction inherent in e-cigarettes. “The increased use of e-cigarettes by teens is deeply troubling,” said CDC Director Tom Frieden, M.D., M.P.H. “Nicotine is a highly addictive drug. Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes.”"

I believe that it is now the CDC's responsibility to correct its previous statements and to make it clear to state and local public health practitioners that there is no evidence that electronic cigarettes are serving as a gateway to cigarette smoking among young people.