Monday, July 21, 2014

In the Face of Contrary Evidence, the CDC Still Denies that Electronic Cigarettes Can Help Anyone to Quit Smoking

In her article on CDC's "Tips from Former Smokers" anti-smoking campaign, Nancy Wride of Elements Behavioral Health made an interesting observation. On its web site describing a variety of possible strategies to quit smoking, the CDC does not list electronic cigarettes. Wride therefore asked the CDC why electronic cigarettes are not included on its web site as a potential smoking cessation aid.

The CDC's response:

"while we have heard from some former smokers who say e-cigarettes helped them quit, there is not yet any conclusive scientific evidence that e-cigarettes can work as a cessation aid."

The Rest of the Story

In other words, what the CDC is saying is:

"While we have heard from former smokers who say e-cigarettes helped them quit, we have to ignore their statements because we just can't bring ourselves to admit that something which looks like a cigarette could possibly be a good thing and could have positive benefits like helping a smoker get off of tobacco cigarettes."

The CDC's statement is wrong on its face. If there is reputable evidence from former smokers that e-cigarettes helped them quit smoking, then there is indeed conclusive scientific evidence that e-cigarettes "can work" as a cessation aid.

In fact, there are literally thousands of testimonials from ex-smokers as well as thousands of identified ex-smokers in surveys who testify that for them, e-cigarettes did work as a cessation aid. There is no legitimate scientific debate over whether e-cigarettes can work as a cessation aid. They can work, and they have worked for literally thousands of smokers.

Since the CDC admits, in the first part of its statement, that e-cigarettes have indeed worked as a cessation aid for some former smokers, it is clearly lying in the second part of its statement, in which it claims there is no scientific evidence that e-cigarettes can work as a cessation aid.

Why is the CDC unable to tell the truth? Why can't the agency even issue a statement that is internally consistent on this issue? Why is the CDC ignoring the wealth of evidence that it admits exists, which shows that many ex-smokers have used electronic cigarettes effectively as a smoking cessation aid?

One possible answer appears in Wride's column. She writes:

"So why doesn’t the CDC include e-cigarettes among its cessation and quitting tips? “The real reason is that they don’t condone anything that looks like smoking, even if it delivers none of the smoke and even if it delivers no nicotine,” Siegel said. “It is the ideology of the smoking action that they oppose.”"

In a recent column in Forbes magazine, Jacob Sullum reviews some of the evidence which demonstrates that many former smokers have quit smoking successfully using electronic cigarettes as a cessation aid. Sullum writes:

"The new survey [published by the E-Cigarette Forum] ... provides further evidence that e-cigarettes help smokers quit... . Eighty-nine percent of the respondents reported that they had smoked at least 10 cigarettes a day before they started vaping, and 88 percent said they were not currently smokers. Those findings are similar to the results of another survey focusing on people who participate in online vaping forums, reported last April in the International Journal of Environmental Research and Public Health. That study, which included more than 19,000 vapers from around the world, found that almost all of them (99.5 percent) were smokers when they started vaping. Four-fifths of them had stopped smoking completely, while the rest had reduced their cigarette consumption, on average, from 20 to four per day."

"It should be emphasized that neither of these studies was designed to capture a representative sample of all vapers. Instead they focus on the most enthusiastic among them, whom you would expect to have had especially satisfying experiences with e-cigarettes. The high success rates in these surveys therefore are unlikely to be seen among the broader group of smokers who try to quit with e-cigarettes, let alone among smokers who merely try the product out. But these surveys do indicate that e-cigarettes have helped many smokers quit."

"It borders on bizarre that critics like [West Virginia Senator Jay] Rockefeller continue to question the existence of those former smokers, even while arguing that e-cigarettes should be restricted or banned based on the entirely hypothetical risk that vaping will lead to smoking among teenagers who otherwise never would have tried tobacco."

The CDC is even worse. It actually acknowledges the existence of these former smokers, but still argues that there is no evidence that electronic cigarettes have helped any smokers quit.

Clearly, the actual scientific evidence doesn't matter to an agency that is being guided purely by ideology and which has come to a pre-determined conclusion that e-cigarettes are evil. Today's story demonstrates how a strong pre-existing schema, propped up by ideology, leads to such preposterous scientific statements such as arguing that although many ex-smokers have used e-cigarettes successfully as a cessation aid, there is no evidence that any ex-smokers have used e-cigarettes successfully as a cessation aid.

Wednesday, July 16, 2014

Acquisition of Lorillard Demonstrates that Reynolds American Agrees that Democratic Senators are Full of Hot Air

For several months, a group of Democratic senators - led by Dick Durbin (D-IL), Richard Blumenthal (D-CT), and John Rockefeller (D-WV) - have been blasting the e-cigarette industry for using flavors in their products. This group of senators has called for a ban on flavorings in e-cigarettes, supposedly because of their sincere interest in curtailing "marketing tactics aimed at luring children and teenagers into ... nicotine addiction."

The Rest of the Story has called their bluff, pointing out that what these senators really mean is that they want to stop tactics (flavored e-cigarettes) aimed at luring children into fake cigarette addiction, but not tactics (flavored cigarettes) that are aimed at luring children into actual cigarette addiction. These same senators either supported the menthol exemption to the flavored cigarette ban and/or have failed to introduce or sponsor legislation that would ban menthol flavoring from cigarettes.

In other words, these politicians are full of hot air. They are pretending to be truly concerned about the health of children, but in reality, they are simply trying to score an easy political victory. They want to have the appearance of protecting children from nicotine addiction, while not actually having the courage to stand up against Big Tobacco and pull the plug on menthol. The truth is that they are spineless and disingenuous. Children's health is not their true aim; political victory is.

The Rest of the Story

The acquisition of Lorillard by Reynolds American demonstrates that Reynolds shares my view of these politicians as being merely full of hot air. Specifically, the acquisition shows that Reynolds is confident that these politicians will not push the FDA to ban menthol, nor will they introduce Congressional legislation that would ban menthol cigarettes. The chief asset that Reynolds is acquiring, after all, is Newport. If Reynolds truly believed that there was any risk that Senator Durbin would back up his words with action, then it would never had made this deal. If Reynolds had any real fear that the FDA were going to ban menthol, the acquisition would not have occurred.

One thing we can learn from this deal, then, is that the future of menthol cigarettes is bright and rosy. Even after ditching Blu, the acquisition of Camel and Newport was viewed to be worth billions. Clearly, Reynolds is counting on a continuing profitable market for menthol cigarettes.

I agree with Reynolds' reasoning. The Congress has made its intent clear: menthol cigarettes were exempt from the flavoring ban because there is no real intent among the Congressmembers to actually put a dent in cigarette sales. The Family Smoking Prevention and Tobacco Control Act was window dressing, disguised as a strong anti-smoking measure, but actually doing almost nothing to tackle youth smoking. And the FDA, in five years of jurisdiction over cigarettes, has done next to nothing to reduce youth smoking or to set standards that would make cigarettes safer.

It is safe to say that neither Congress nor the FDA has the guts to actually take on Big Tobacco and ban menthol. At the end of the day, the federal regulation of cigarettes is all about making it look to the public like the federal government has the problem under control. In reality, our government is spending more time trying to keep electronic cigarettes off the market then it is trying to reduce cigarette smoking or to make it safer.

At the end of the day, we can thank politicians like Senator Durbin for providing such a high valuation for Newport that the acquisition became profitable. If these senators actually meant what they are telling the public, then no one would want to touch Newport with a ten foot pole.

Tuesday, July 15, 2014

Pennsylvania Legislators Calling on Smokers to Fund Public Education for Philadelphia Children

"Support public education: Buy cigarettes."

That might as well be the slogan for T-shirts that come out of the Pennsylvania legislature's solution to the problem of adequately funding Philadelphia's public schools.

Faced with a $93 million budget deficit for Philadelphia's school system, state legislators have decided to ask smokers to make up the budget deficit by providing extra tax revenue to support public education.

According to an article in the Philadelphia Inquirer: "The tax, anticipated to bring in $1.6 million per week, could raise $45 million this year and $83 million in the first full year. The Philadelphia School District has a $93 million budget deficit."

The Rest of the Story

I have no problem with a $2 per pack cigarette tax in Philadelphia to reduce smoking rates and to fund an aggressive anti-smoking campaign that would also provide money for research to prevent and treat smoking-related diseases and subsidize the treatment of smoking-related diseases. However, the idea of making public education permanently dependent upon continued high sales of cigarettes is bordering on insane.

For one thing, it puts the government in the business of promoting smoking. It removes any incentive for the legislature to support any strong actions to reduce smoking. Were that to happen, the Philadelphia school system would go under. Does it not seem somewhat perverse that in order to support public education for Philadelphia children, we need to hope that people continue to smoke at high rates?

The Pennsylvania governor and legislators are grown adults, and they should be able to deliver a budget that finds $93 million to fund the Philadelphia School District without tying that funding permanently to cigarette smoking. They should be forced into a closed chamber and not allowed to come out until they come up with the needed funding in a way that doesn't force smokers to shoulder the burden of supporting public education and tie such funding to continuing high rates of smoking.

Hint: The solution isn't too difficult. Pennsylvania corporations are enjoying $2.4 billion in annual tax breaks. Closing a fraction of those loopholes would fully fund the Philadelphia school system.

Friday, July 11, 2014

Disgrace of the Year: Leading Lung Health Groups Call for Ban on Fake Cigarettes, But Want Real Ones to Remain on the Market

Yesterday, a group of international lung health organizations issued a position statement on electronic cigarettes, which called for a ban (or severe restrictions) on these products until more is known about their health effects. In contrast, these organizations did not express any problem with real tobacco cigarettes remaining on the market, even though they kill millions worldwide each year, and electronic cigarettes are not known to have killed a single person ever.

According to a press release from the American College of Chest Physicians: "Experts from the world’s leading lung organizations have released a position statement on electronic cigarettes, focusing on their potential adverse effects on human health and calling on governments to ban or restrict their use until their health impacts are better known."

"Produced by the Forum of International Respiratory Societies (FIRS), the position statement will be presented July 9 at a meeting hosted by FIRS and the NCD (Noncommunicable Disease) Alliance, “Shared Drivers, Shared Solutions: NCDs, Lung Health and Sustainable Development.” ... FIRS, established in 2001, is an organization composed of the world's leading international respiratory societies working together to improve lung health globally, including the American College of Chest Physicians (CHEST), the American Thoracic Society (ATS), the AsociaciĆ³n Latinoamericana del Thorax (ALAT), the Asian Pacific Society of Respirology (APSR), the European Respiratory Society (ERS), the International Union Against Tuberculosis and Lung Disease (The Union), and the Pan African Thoracic Society (PATS)."

The Rest of the Story

This has to be one of the most disgraceful moves of the year by any medical or public health group. Even the multinational tobacco companies do not have the gall to promote a ban on electronic cigarettes so that their deadly tobacco cigarettes will not be threatened by this potentially substantial competition. In fact, the position of these supposed lung health groups is far more extreme than any Big Tobacco position, as the tobacco companies have entered the e-cigarette business and are not using their lobbying power to try to remove these products from the market. Sadly, it is these lung health groups that apparently want electronic cigarettes taken off the market so that deadly tobacco cigarettes can maintain their monopoly on smokers.

Despite strong evidence that vaping is much safer than smoking, that e-cigarettes do not contain any tobacco or involve any combustion, that tens of thousands of smokers are successfully using these products to quit smoking or cut down substantially on the amount they smoke, and that smokers with obstructive lung disease who switch to electronic cigarettes experience and immediate improvement in their respiratory symptoms, it appears that the American College of Chest Physicians and its partner organizations in FIRS would rather see tens of thousands of vapers return to cigarette smoking than to maintain a much healthier, smoke-free or greatly smoke-reduced lifestyle.

Apparently, the American College of Chest Physicians would rather that smokers die from the known risks of tobacco cigarettes than greatly improve their health by switching to electronic cigarettes, which has unknown long-term risks - although they are certainly orders of magnitude safer than real cigarettes. At least the smokers will know what they're dying from.

Some knowledgeable analysts have predicted that if promoted, electronic cigarettes could actually replace nearly half of the combustible tobacco cigarette market. This would be the greatest public health achievement of my lifetime. Sadly, the American College of Chest Physicians and its partners do not want to see this happen. They would rather stick with the status quo, where smokers will continue to die in the millions each  year, but at least they will not be taking any "unknown" risks.

What is so scary to these lung groups about the prospect of so many smokers quitting or cutting down substantially on their smoking? A cynic might say that it would cause these physicians to lose a huge number of patients. That these groups are trying to protect their own payment streams is as rational an explanation for their behavior than any science- or public health-based explanation I can ponder.

The truth is that these groups are stuck - trapped in a blinding ideology in which science plays absolutely no role and positions are based on pure, raw emotion. And the emotion against anything which looks like a cigarette is apparently so strong that it drowns out even the most solid evidence of the life-saving potential of a product that resembles smoking but delivers nicotine with only a minute fraction of the dangerous chemicals, and which, with proper manufacturing, appears to deliver only one chemical of any significant health concern.

The rest of the story is that the FIRS groups have committed a disgraceful act, which, if their advice is adopted, will result in a substantial increase in the number of smokers and with that, an increased amount of disease and death.

Tuesday, July 08, 2014

Outstanding Commentary on the Folly of Anti-Smoking Groups' Opposition to Electronic Cigarettes

Tony Newman, the media relations director for the Drug Policy Alliance, has written a cogent piece which is a must-read for anyone who has been following The Rest of the Story and its exposition of the strong opposition to vaping from numerous (supposedly) anti-smoking advocates and groups.

I can't add anything to this fine piece, so I'll leave it for readers to examine. I'll just close with the final paragraph of Newman's piece, which summarizes the situation incisively:

"Anti-smoking advocates have become so used to demonizing smoking and so afraid of giving an inch that they are waging a war against a practice that is actually accomplishing the goal of reducing or eliminating people's smoking. They should know better than most that a tool that may help millions of people stop smoking cigarettes should be celebrated and embraced -- not restricted and stigmatized."

Monday, July 07, 2014

Maryland Hospital Will Not Hire Ex-Smokers, If They are Still Using Electronic Cigarettes

Anne Arundel Medical Center in Annapolis wants to encourage smokers to quit, but only in the way the hospital says they should quit. Specifically, smokers who successfully quit smoking using electronic cigarettes will not be eligible for employment if they are continuing to use e-cigarettes to stay smoke-free. Moreover, smokers who are currently attempting to quit using e-cigarettes will not be eligible for employment, no matter how successful they might be in quitting or cutting down using these products.

Starting next July, Anne Arundel Medical Center will not hire anyone who uses nicotine in any form. According to an article in the Baltimore Sun: "Anyone who wants a job next year at Anne Arundel Medical Center — whether as a surgeon or security guard — will have to prove they don't smoke or use tobacco.
The Annapolis hospital's new hiring policy might be controversial, but it is legal in Maryland and more than half of the United States. ... Anne Arundel Medical Center, like a growing number of health systems, universities and other businesses, will require a urine test for nicotine use for all applicants starting next July. The policy ... covers not only cigarettes, but cigars, pipes, snuff and e-cigarettes."

The Rest of the Story

This is not a public health policy. It is a moral crusade.

If it were a public health policy based on some sort of health principles, then it certainly would not penalize ex-smokers who quit using electronic cigarettes. In contrast, it would actually reward these individuals for having quit smoking and perhaps saved their lives.

It the policy were based on health principles, then it certainly would not exempt current employees. Clearly, the hospital doesn't care that much about the health principle, since it will continue to employ smokers with no questions asked.

If the policy were based on health principles, it would encourage smokers to quit, and therefore, it would reward smokers who are trying to quit using nicotine patches, nicotine gum, or electronic cigarettes, rather than exclude these individuals from employment.

If the policy were based on health principles, then it would certainly include other behaviors, such as those related to obesity, which have large health care costs and which set a "bad example." It would certainly include alcohol use as well.

The rest of the story is that this is not an employment policy based on health principles. Instead, it is part of a moral crusade against a particular health behavior (i.e., a vice) which is being punished in a discriminatory fashion.

Thursday, July 03, 2014

"Groundbreaking" Legislation in New Jersey Provides No Human Health Protection While Sacrificing the Health and Lives of Casino Workers

According to an article in the Sand Paper, the New Jersey state legislature has passed legislation that would ban smoking in all state parks and beaches, with no exceptions. Smoking would also be banned in municipal parks, but localities would be allowed to designate 15% of the park as a smoking area.

According to the article: "“The bill first has to be signed by Gov. Christie,” said Karen Blumenfeld, executive director of Global Advisors on Smokefree Policies. ... “This law is nationally groundbreaking as New Jersey will become the first state in the United States to require that all state, county and local parks, recreation areas and beaches be 100 percent smoke-free,” said Blumenfeld. “It provides for consistent, uniform healthful environments from town to town.  New Jersey is ready for a 100 percent smoke-free parks and recreation areas policy statewide. ... One hundred percent smokefree parks and recreational areas also generate health, environmental and economic health benefits. It normalizes smokefree environments where children engage in recreational activities, reducing the likelihood they’ll start smoking.” She said there is no safe level of secondhand smoke even outdoors, especially for children and seniors. “Studies show outdoor smoke levels can be as high as indoor smoking-permitted locations,” said Blumenfeld."

The Rest of the Story

I doubt that the smoke levels in New Jersey parks were anything like the levels that are being experienced by the tens of thousands of the state's casino workers.

Vince Rennich is a casino floor worker who at age 47 was diagnosed with lung cancer due to 25 years of heavy exposure to secondhand smoke, which he described as working in "a modern-day coal mine." "A good majority of the time, I'm surrounded in a cloud of smoke," he said.

While New Jersey anti-smoking groups and policy makers pat themselves on the back for what they claim is "groundbreaking" public health protection, New Jersey remains one of the two worst states in the country in terms of failure to protect a huge segment of its workers - casino workers - from the devastating health effects of heavy and chronic secondhand smoke exposure.

While the new law may provide for "consistent, uniform healthful environments from town to town," it doesn't do so if that town is named "Atlantic City."

In my opinion, New Jersey has no business pretending that achieving "100 percent smoke-free parks and recreation areas" is some sort of huge public health victory when the reality is that thousands of its casino workers continue to suffer disease and disability from exposure to high levels of secondhand smoke.

Banning smoking in public parks and beaches may have environmental benefits, but in terms of human health, there is no evidence that these policies are actually addressing any substantial public health problem. In contrast, the problem of secondhand smoke exposure in New Jersey's casinos is truly a life and death issue.

The rest of the story is that New Jersey lawmakers and anti-smoking groups should be ashamed of celebrating the "groundbreaking" human health protection represented by eliminating all wisks of tobacco smoke in public parks while doing nothing to eliminate the literal clouds of smoke that enshroud the state's casino workers who are simply trying to make a living and support themselves and their families, but have to breathe in high levels of carcinogens in order to make a living.

I'm sure those casino workers will sleep well at night knowing that never again will they have to walk by a smoker in a park.

In Ironic Twist, Glantz is Acting as Tobacco Front Group While Defamed "Front Groups" are Trying to Make Cigarettes Obsolete

Sometimes, reality isn't what it seems. And once in a rare while, it is exactly the opposite. That is the case in today's Rest of the Story.

Yesterday, I revealed that Dr. Stan Glantz has accused electronic cigarette associations of being front groups for Big Tobacco, insinuating that they are masquerading as grassroots vapers' groups but in reality are working to protect Big Tobacco profits.

Today, I show that ironically, it is Dr. Glantz who is working to protect Big Tobacco profits, while the electronic cigarette groups are working to make cigarettes obsolete.

The most telling point is Dr. Glantz's opposition to legislation that classifies electronic cigarettes as being separate from tobacco products. The electronic cigarette associations have been lobbying local and state governments not to classify e-cigarettes as tobacco products. This makes perfect sense because they are not tobacco products. They contain no tobacco. They are orders of magnitude safer than cigarettes and should not be treated in the same category for regulatory purposes.

Obviously, it is to the great disadvantage of cigarette profits to have e-cigarettes classified and treated separately. For example, if e-cigarettes are taxed as heavily as cigarettes, then cigarettes are protected from competition and have a huge market advantage. If e-cigarette use is not allows in the same places where smoking is allowed, then cigarettes also are protected from competition and gain a huge market advantage.

By opposing the classification of e-cigarettes as tobacco products, the e-cigarette associations have been everything they can to avoid regulations that treat these products in the same way. The reason is simple: such regulations would give cigarettes a huge competitive advantage in the market place. Laws that categorize e-cigarettes the same way as tobacco products are essentially protective legislation for tobacco cigarettes. By fighting such a classification, e-cigarette associations are doing what they can to reject the idea of this protective legislation so that they can gain the upper hand on cigarettes and eventually, make these products obsolete.

Ironically, Dr. Glantz (and numerous anti-smoking groups) are supporting the protective legislation. Which raises the question: Who is acting more as a Big Tobacco front group? The e-cigarette associations, which are fighting protective legislation for tobacco cigarettes, or Glantz and the anti-smoking groups, which are trying to get protective legislation ensconced in every state throughout the country, so that cigarette profits are protected nationwide?

Wednesday, July 02, 2014

More Defamatory Accusations from Glantz: This Time, Vaper Associations are Attacked

Vapers Club, Vapers Forum, Vapers Place, Utah Vapers, Consumer Advocates for Smoke-free Alternatives Association, Tobacco Vapor Electronic Cigarette Association

What do all of these organizations have in common?

According to Dr. Stan Glantz, they are all tobacco front groups because they "bear an uncanny resemblance" to front groups that the tobacco industry historically formed to oppose clean indoor air legislation.

Dr. Glantz writes: "It turns out that ABC spiked a second documentary, prepared for its documentary program Turning Point, "Tobacco Under Fire." The first segment, which deals with advertising, is mostly of historical interest (to show that we have actually made some progress, although nothing close to most other countries, which have ad bans). The second segment, dealing with how the tobacco companies create front groups, however, is highly relevant today, since the "grassroots" vaper associations bear uncanny resemblances to what the tobacco companies did in (generally ineffective) efforts to organize smokers to oppose clean indoor air laws and other tobacco control policies."

In other words, the efforts of grassroots organizations like these vaper associations are not genuine displays of the opinions of vapers. Instead, these organizations are merely front groups created by the tobacco industry in order to have the appearance of a grassroots group, but actually intended to lobby for the tobacco industry's interests.

The Rest of the Story

Fortunately, Dr. Glantz is living in the past. While it is quite true that the tobacco companies used to form front groups to masquerade as genuine grassroots organizations in order to oppose smoke-free laws, the fact that Big Tobacco acted this way in the 1980s and 1990s does not mean that any organization that supports electronic cigarette use in 2014 is a Big Tobacco front group.

In fact, the accusation is a defamatory one because it is intended to harm the credibility of these groups and it is not based on any careful attempt to present the truth.

Nearly all of the vaper groups and associations are genuine grassroots organizations that truly represent the interests of the vaping community, not Big Tobacco. The accusation makes no sense even on its face - these groups are trying to replace tobacco cigarettes with electronic ones. Why would Big Tobacco fund groups that are trying to make tobacco cigarettes obsolete?

This is just another example of the defamatory tactics that a number of electronic cigarette opponents are using to try to discredit these products and their potential role in public health.

Monday, June 30, 2014

Researcher at UCSF Tobacco Research Center Involved in Unethical Facebook Research

A scientist who is currently with the UCSF Center for Tobacco Control Research and Education (home of Dr. Stan Glantz) is part of a research team that conducted an unethical experiment on hundreds of thousands of Facebook users, whose Facebook news feed content was manipulated without their informed consent in order to try to trigger their emotions.

The purpose of the experiment was to determine whether manipulation of an individual's Facebook news feed by blocking either positive or negative emotional content could affect the mood and emotional expression of that person. In short, the experiment sought to determine whether emotion is "contagious."

The paper defends its ethical standards by arguing that it "was consistent with Facebook's Data Use Policy, to which all users agree prior to creating an account on Facebook, constituting informed consent for this research."

Regarding the engagement of Facebook users in research, Facebook's Data Use Policy states the following:

"We use the information we receive about you in connection with the services and features we provide to you and other users like your friends, our partners, the advertisers that purchase ads on the site, and the developers that build the games, applications, and websites you use. For example, in addition to helping people see and find things that you do and share, we may use the information we receive about you: ... for internal operations, including troubleshooting, data analysis, testing, research and service improvement."

The policy also states: "We give your information to the people and companies that help us provide, understand and improve the services we offer. For example, we may use outside vendors to help host our website, serve photos and videos, process payments, analyze data, conduct and publish research, measure the effectiveness of ads, or provide search results."

The Rest of the Story

This research violates basic ethical standards of informed consent for two reasons:

1. The subjects did not consent to participate in the study.

In fact, the subjects had no idea that they were part of an experiment involving artificial manipulation of their news feed for the purposes of potential inducing happiness or sadness as part of a research study. This potential use of their Facebook account is simply not mentioned in the Data Use Policy. The policy states that the information provided by users may be used for research purposes. It also states that the information may be shared with outside vendors to conduct research. However, nowhere does the policy state that users agree to intentional manipulation by Facebook staff for research purposes.

In other words, while the policy allows Facebook to collect and use user information for research purposes, it does not allow Facebook to conduct interventions in which it manipulates feeds shared with users in order to try to control their emotions as part of a research experiment.

Thus, before even getting to the issue of informed consent, the subjects in this research did not even consent to the research in the first place.

2. The subjects did not provide informed consent for their participation in the research.

Contrary to the assertion of the authors of this paper, simply being aware that the information one provides to Facebook may be used for research purposes does not constitute informed consent. The fact that users agreed to a Data Use Policy which notes that information may be used for research purposes does not, as the authors state, "[constitute] informed consent for this research."

In order to represent informed consent, there are several other elements which must take place. These are explained best by Professor James Grimmelmann over at The Laboratorium:

"The standard of consent for terms of service is low. But that “consent” is a legal fiction, designed to facilitate online interactions. (See Nancy Kim and Margaret Jane Radin’s books for more.) It’s very different from informed consent, the ethical and legal standard for human subjects research (HSR). The Federal Policy for the Protection of Human Subjects, a/k/a the Common Rule, requires that informed consent include:
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject; …
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Facebook’s actual Data Use Policy contains none of these, only general statements that “we may use the information we receive about you … for internal operations, including troubleshooting, data analysis, testing, research and service improvement.” and “We give your information to the people and companies that help us provide, understand and improve the services we offer. For example, we may use outside vendors to … conduct and publish research.” Neither of these comes close to a “description of the procedures to be followed” or a “description of any reasonably foreseeable risks or discomforts,” and the Data Use Policy doesn’t even attempt to offer a contact for questions or an opt-out."

It is clear, then, that this study violated the principles of informed consent, as subjects did not provide informed consent prior to being enrolled in the research.

There is a provision for waiver of informed consent; however, the conditions for such a waiver were not met because: (1) the level of risk was not minimal; (2) the waiver did affect the rights and welfare of the subjects; (3) the research could still practicably have been carried out with informed consent; (4) subjects were not provided with information after the study to explain what occurred.

An Unethical Experiment

Because this research was funded by the federal government (by the Army Research Office, according to Cornell), it is subject to the human subjects research requirements. In addition, the involvement of two researchers at academic (federally-funded) institutions requires that the research be approved by an Institutional Review Board. Apparently, the research was approved by an academic IRB, a decision which I publicly question, for the above reasons.

The rest of the story is that despite the Common Rule and the intense efforts to try to prevent human subject violations in research, there are still occasional studies which find their way through the cracks. This is one bad example. It is an example of an unethical experiment that should never have been approved by an IRB in its current form because it blatantly violates the ethical principles of both consent and informed consent.

Friday, June 27, 2014

New Survey of Adult Vapers Finds that 75% Use Non-Tobacco Flavors; Flavoring Ban Would Likely Cause Massive Migration Back to Tobacco Cigarettes

A number of policy makers - including several prominent U.S. senators - have called for a ban on e-cigarette flavorings in order to reduce their appeal to youth. Unfortunately, a new survey conducted among 10,000 adult vapers at E-Cigarette Forum suggests that such a ban would lead to a massive migration of adult vapers back to real, tobacco cigarettes.

The survey found that 74.4% of adult vapers most often use non-tobacco flavors, with the majority of these preferring fruit or dessert-related flavors. Only 22.9% prefer tobacco flavoring, and an additional 2.7% prefer tobacco flavoring combined with menthol. Fruit- and dessert-flavored electronic cigarettes represent approximately half of the market among the users surveyed.

The Rest of the Story

This survey has two major implications for public health regulation.

First, the results demonstrate that many adults - in fact the majority of them - do prefer flavored e-cigarettes. Thus, it cannot be assumed that just because an electronic cigarette company markets flavored products, it is intentionally trying to recruit youth users. This is a flaw that many anti-smoking advocates and groups have fallen into. Because the market appears to be dominated by flavored products, it does not logically follow that any company which is marketing flavored e-cigarettes is trying to attract kids to vaping.

Second, the results suggest that a ban on flavorings in e-cigarettes would have devastating consequences for the public's health. Specifically, it would likely cause a massive migration of vapers back to the severely toxic, real, tobacco cigarettes, and with that transition, all of the associated adverse health sequelae.

A further reason not to ban flavorings in e-cigarettes is that youth who experiment with these flavored products are almost certainly much less likely to progress to smoking. It is difficult to imagine a youth transitioning from a cherry e-cigarette to a Marlboro. In a sense, flavored e-cigarettes may actually be protective of youth transitioning from vaping to smoking. The tastes are so vastly different, and the e-cigarette use probably accustoms youth to a flavored taste that they are just not going to get with a real cigarette.

For all of these reasons, I believe that the current evidence does not support the FDA placing a ban on flavorings in electronic cigarettes. Such an action would, ironically, have devastating overall consequences for the public's health, both among youth and adults.

Thursday, June 26, 2014

Glantz/Chapman: Twisting the Facts to Support Pre-Determined Conclusions

Yesterday, I reported that Drs. Stan Glantz and Simon Chapman issued defamatory attacks against Lorillard for running an inappropriate blu e-cigarette commercial (the robot sex ad). The truth is that Lorillard had nothing to do with the ad, which was produced in 2010, well before Lorillard acquired blu.

The Rest of the Story

Today, I reflect on what this story demonstrates about the scientific bias that is apparent in the anti-smoking movement, particularly among researchers like Dr. Glantz, who has repeatedly misinterpreted scientific studies in order to skewer electronic cigarettes.

What the story demonstrates is that Dr. Glantz has a pre-determined set of conclusions about electronic cigarettes and the tobacco companies' role in inappropriately marketing these products to addict a new generation of kids. When presented with information, he jumps to an immediate interpretation and conclusion that supports his pre-determined schema. Instead of exercising critical judgment and objective evaluation of the evidence, he immediately twists the facts to support his pre-existing position. Dr. Glantz is just one example of a phenomenon that characterizes a number of researchers and tobacco control groups that are vehement opponents of electronic cigarettes for ideological, rather than valid scientific reasons.

In psychology, this phenomenon is known as confirmation bias. A 2010 Boston Globe article describes this phenomenon and explains how when people are affected by this bias, they twist new facts that run counter to their position in order to fit with their pre-determined conclusions, rather than change their positions in line with the new information. 

In the article, Joe Keohane writes:

"Recently, a few political scientists have begun to discover a human tendency deeply discouraging to anyone with faith in the power of information. It’s this: Facts don’t necessarily have the power to change our minds. In fact, quite the opposite. In a series of studies in 2005 and 2006, researchers at the University of Michigan found that when misinformed people, particularly political partisans, were exposed to corrected facts in news stories, they rarely changed their minds. In fact, they often became even more strongly set in their beliefs. Facts, they found, were not curing misinformation. Like an underpowered antibiotic, facts could actually make misinformation even stronger." ...

“The general idea is that it’s absolutely threatening to admit you’re wrong,” says political scientist Brendan Nyhan, the lead researcher on the Michigan study. The phenomenon — known as “backfire” — is “a natural defense mechanism to avoid that cognitive dissonance.”

For this reason, I am discouraged about the possibility that people like Dr. Glantz and Dr. Chapman will change their minds about the potential utility of e-cigarettes if further evidence accumulates to demonstrate the benefits of these products. The science is simply not going to matter to them. Hopefully, the science will matter to the FDA.

Wednesday, June 25, 2014

Glantz and Chapman Falsely Accuse Lorillard of Using Robot Sex Ad to Promote E-Cigarette Use

On his tobacco blog, Dr. Stan Glantz links to a quite inappropriate advertisement for blu electronic cigarettes, attacking Lorillard for using this approach to promote e-cigarette use. He claims that this is part of Lorillard's ongoing strategy, accusing Lorillard of stooping to this low tactic to recruit youth to vaping. The ad depicts a robot having sex with a woman and then afterwards shunning a cigarette and offering an e-cigarette instead.

On his Twitter feed, Dr. Simon Chapman also attacked Big Tobacco for running this ad, accusing Lorillard of "viraling" this ad "to teens."

Of course, I agree with both Dr. Glantz and Dr. Chapman that the ad is quite inappropriate.

The Rest of the Story

The problem is that Lorillard did not create this ad, had no part in its development, and is not running the ad now. In fact, Lorillard has absolutely nothing to do with the ad.

The truth is that the ad was created independently as part of a viral video contest. Apparently, blu did not do anything to dissociate itself from the ad. However, the ad was produced in 2010, two years before it was purchased by Lorillard. Thus, Lorillard had nothing to do with the ad.

The rest of the story, then, is that Glantz and Chapman are making a false accusation.

How, then, do they get away with this?

The answer is that in the anti-smoking movement, you don't need to be honest and truthful. As long as your intentions are good, you can get away with lying and with making false and defamatory accusations. The ends are all that matter, and if you use defamatory means to reach those ends, it's perfectly acceptable.

I, too, was disturbed by this ad and was going to write a blog post attacking it. However, it was quite apparent to me that this is not something that Lorillard would run. So before jumping to attack Lorillard, I did a little research and confirmed that it was not a Lorillard ad. In fact, it wasn't even really a blu company ad, since the company did not produce it (although they still had some association with the ad and did not disavow any relationship with it). My colleagues - Glantz and Chapman - were so excited about the opportunity to attack Lorillard for promoting e-cigarettes to youth that they failed to exercise even a minimum of due diligence in checking the facts first. (The complete story is here).

In law, there is a term used to refer to what Glantz and Chapman are doing here. It is called defamation.

As much as I condemn this advertisement, I also condemn the defamatory tactics that Glantz and Chapman are using to falsely accuse Lorillard of producing the ad.

Tuesday, June 24, 2014

New Study Shows that E-Cigarettes, Unlike Real Ones, Do Not Adversely Affect Acute Heart Function

A new study published yesterday in the journal BMC Cardiovascular Disorders reports that unlike real cigarettes, electronic cigarettes do not adversely affect acute heart function.

(See: Farsalinos KE, et al. Acute effects of using an electronic nicotine-delivery device (electronic cigarette) on myocardial function: comparison with the effects of regular cigarettes. BMC Cardiovascular Disorders 2014, 14:78.)

In the study, investigators examined measures of acute heart function using echocardiography among 36 smokers and 40 vapers, before and after using either a cigarette or e-cigarette. The researchers found that cigarette smoking adversely affected acute heart function. Electronic cigarette use had no effect on any of the measures examined.

The results were summarized as follows:

"This is the first study to examine the acute effects of electronic cigarette use on myocardial function. No adverse effects on LV [left ventricular] myocardial function were observed after using electronic cigarette with nicotine-containing liquid for 7 minutes. On the contrary, significant changes in diastolic function parameters were found after smoking 1 tobacco cigarette."

The authors conclude as follows:

"This study provides the first clinical evidence that electronic cigarettes have less acute adverse effects on myocardial function when compared to tobacco cigarettes."

The Rest of the Story

This study adds to the abundant evidence that electronic cigarette use is much safer than smoking.

Given that abundant evidence, it is inappropriate for many anti-smoking advocates and groups to continue to tell the public that we don't yet know whether vaping is safer than smoking.

Sadly, the FDA itself - in its proposed deeming regulations - concluded that we do not yet know enough to determine whether vaping is any more dangerous than smoking. I find it horrific that the FDA - the agency which is going to supposedly be using science to make informed, evidence-based decisions regarding tobacco products - is not sure that cigarette smoking is any more hazardous than the use of fake cigarettes that contain no tobacco, involve no combustion, produce no secondhand smoke, have much lower levels of carcinogens, and have been found to acutely improve the health of smokers who switch to them.

With that conclusion, the FDA has unfortunately destroyed its scientific credibility. It has demonstrated that it will be ideology, and not science, that dictates the regulation of tobacco and nicotine-containing products in this country. 

The rest of the story is that the next time you hear an organization claim that vaping may not be any safer than smoking, you will know that the group has no scientific credibility. It's just sad to think that the FDA is one of those groups.

Monday, June 23, 2014

How Do Senator Jay Rockefeller and his Commerce Committee Colleagues (Barbara Boxer and Richard Blumenthal) Sleep at Night?

Last Wednesday, the Senate Committee on Commerce, Science, and Technology held a hearing on the marketing of electronic cigarettes. Several senators, including Jay Rockefeller (D-WV), Barbara Boxer (D-CA), and Richard Blumenthal (D-CT) harshly attacked the two electronic cigarette company executives who testified before the committee, calling them liars who are doing harm to the public and comparing them to the Big Tobacco executives of the past.

According to an article at "In a hearing Wednesday afternoon that harkened back to the famous congressional Big Tobacco hearings two decades ago, Senators on the Commerce, Science and Transportation Committee eviscerated electronic cigarette executives Jason Healy, CEO of blu eCigs (owned by tobacco company Lorillard), and Craig Weiss, CEO of NJOY, leaders of the two leading e-cig brands."

The harshest questioning came from Senators Richard Blumenthal, Barbara Boxer, and Jay Rockefeller:

"I think we have seen this movie before," Senator Richard Blumenthal said. "It is called big nicotine comes to children near you and you are using the same kinds of tactics and promotions and ads that were used by big tobacco and proved so effective." ...

"At the end of her time to question, Boxer said: “Mr. Healy and Mr. Weiss, you can con yourself. But we don’t know if this product gets people off cigarettes yet, so don’t think you are doing some great mission. Don’t say you care about kids,” said Senator Boxer. “Don’t be a part of this, because you’ll regret it.”"

"But the harshest words came from Senator Jay Rockefeller (D- West Virginia), who said to the executives: “I’m ashamed of you. I don’t know how you go to sleep at night. I don’t know what gets you to work in the morning except the color green of dollars. You are what is wrong with this country.”"

The Rest of the Story

Actually, it is the behavior of Senator Rockefeller that is what is wrong with this country. And it is Senator Rockefeller who should not be able to sleep at night.

There is a part of this story that was not revealed at the hearing, and it is time to reveal it now at the Rest of the Story.

While Senator Rockefeller attacks the electronic cigarette companies for targeting kids with flavored products that he claims is going to addict and harm them, he is hiding from the public the truth:

1. There are, in fact, thousands of kids who are becoming addicted to flavored nicotine products which are going to eventually kill them. 

2. Those products are not electronic (fake) cigarettes.

3. Those products are real tobacco cigarettes.

4. Those products are menthol-flavored cigarettes.

5. In 2009, Senator Rockefeller sponsored and supported legislation that protected menthol cigarettes by exempting them from the flavored cigarette ban in the Family Smoking Prevention and Tobacco Control Act.

Thus, the rest of the story is that Senator Rockefeller protected Big Tobacco and helped them to continue to see the color green of dollars by voting to exempt menthol cigarettes from legislation that banned every other flavor. In other words, he sold out to Philip Morris, agreeing to this exemption that would allow Big Tobacco to continue to addict America's children with flavored cigarettes. Nearly 50% of youth smokers in the U.S. become addicted to smoking via menthol cigarettes.

The bottom line is that Senator Rockefeller is a typical politician and a classical hypocrite. He is also completely disingenuous. Were he truly committed to protecting kids from addiction to flavored tobacco products, he would never have sold out to Philip Morris by sponsoring and supporting legislation that exempted menthol from the cigarette flavoring ban. Even now, if he truly cared about the actual health of children, instead of attacking the e-cigarette industry, he would have devoted his time and energy to crafting and sponsoring legislation to ban menthol from cigarettes.

The truth is that Senator Rockefeller pretended to be committed to protecting the health of our nation's children, but instead, he was actually protecting Big Tobacco profits by exempting menthol from the flavoring ban. The Tobacco Act banned every imaginable flavor that was not actually being used in cigarettes (e.g., cherry, strawberry, banana, and pineaple), yet it exempted the one flavor (menthol) that was actually being used to addict children to a lifetime of smoking - a greatly shortened lifetime for many of them.

This is actually what is wrong with our country: politicians who pretend to be acting in the public's interest but who are actually acting in interest of our nation's largest and most profitable corporations.

And it is not the CEOs of Blu or NJOY who shouldn't be able to sleep at night, it is Senator Rockefeller. How can he sleep each night, knowing that his actions are responsible for thousands of kids who, in the past four years, have become addicted to menthol cigarettes because he failed to act responsibly and are eventually going to die prematurely because of his sellout to Philip Morris?

Senator Boxer also has no business excoriating the e-cigarette executives as she, too, sold out to Big Tobacco by supporting the legislation which exempted menthol from the cigarette flavoring ban. And she, too, has failed to sponsor legislation - now or any time in the past four years - that would correct the problem now by banning menthol cigarettes.

Senator Blumenthal is also a phony and a hypocrite as he, too, has failed to sponsor legislation to ban menthol cigarettes (he was not a Senator in 2009 so did not vote for the original menthol exemption).

Beyond the blatant hypocrisy of Senators Rockefeller, Boxer, and Blumenthal, they are also wrong in their assertion that blu and NJOY are heavily marketing their products to kids. In fact, the evidence suggests otherwise.

The most telling point is that blu does not offer its disposable products in flavors other than tobacco (classic) or menthol. Note that the disposable products are the ones that are relevant to children because they are the cheapest and most likely to be used by kids. It is very unlikely that kids are going to unleash the money required to purchase the charging kit. Blu offers rechargeable starter kits that do contain flavorings, but does not offer the disposables in flavors other than tobacco or menthol. Kids would have to shell out a minimum of $70 for the starter kit.

Here are the available electronic cigarette flavors offered by blu:

a. Classic tobacco
b. Menthol

a. Classic tobacco
b. Menthol
c. Java jolt
d. Cherry crush
e. Vanilla
f. Pina colada
g. Peach schnapps

In contrast to Senator Rockefeller's assertion, blu is actively avoiding the marketing of candy-flavored electronic cigarettes to children, as it is not offering candy-flavored disposable electronic cigarettes. This is perhaps the clearest signal that blu is not marketing flavors to children. It should be obvious to the senators, if if they put any thought into the issue, that the best way to judge blu's intentions is to examine the differences between their starter kit flavors (the ones which require you to shell out 70 bucks) and their disposable flavors (the ones which kids are most likely to use). In fact, while the starter kit flavors do include candy varieties, the disposables do not. This is a clear sign that Lorillard is not interested in offering candy-flavored electronic cigarettes to the youth market.

In fact, Blu was already offering these candy-flavored varieties prior to its acquisition by Lorillard. It is understandable while Lorillard maintained these flavors, since it wouldn't want to lose existing Blu customers. But it is telling that Lorillard chose not to extend this candy-flavored approach over to its disposable e-cigarette segment. If the senators' assertion was correct, then Lorillard would most certainly be selling candy-flavored disposable electronic cigarettes.

Similarly, NJOY does not appear to be marketing to kids. The most telling point is that in its internet sales, the company does not sell flavored e-cigarettes (only traditional tobacco and menthol). And of course, if NJOY were after kids, it would certainly offer the flavored varieties online, since kids are more easily able to obtain these products online, where age verification is not required, than in-store, where it is.

The truth, in fact, is that NJOY's explicit value proposition is that it is trying to eviscerate the combustible cigarette market. While NJOY has the courage and values to stand up and work for the decimation of combustible cigarettes, that is something which Senators Rockefeller, Boxer, and Blumenthal do not have the fortitude to do. Instead, they have supported the institutionalization and protection of the tobacco cigarette market and are doing everything they can to protect real cigarettes from potential competition from far safer, fake ones.

How can they sleep at night?

Wednesday, June 18, 2014

Gateway Hypothesis for Electronic Cigarettes All But Destroyed: Data Show Youth Smoking at All-Time Low

Organizations that oppose electronic cigarettes, such as the CDC and FDA, and anti-smoking advocates who oppose these products, like Dr. Stanton Glantz, have been arguing that electronic cigarettes are a gateway to youth smoking. The CDC has gone so far as to claim that its own survey demonstrates that youth are starting with electronic cigarettes and then moving on to smoke real tobacco cigarettes. The CDC has warned the public that e-cigarettes lead to a lifetime addiction to smoking among our nation's children.

Fortunately, there is a simple way to evaluate this hypothesis, at least on a preliminary basis, prior to waiting for the results of longitudinal studies. Enough youth are experimenting with electronic cigarettes, and the increase in youth e-cigarette use has been dramatic and sustained enough, that if the gateway hypothesis were correct, we would be starting to see an increase in smoking prevalence among youth due to the many new smoking initiates that were converted from e-cigarette experimentation to smoking.

The Rest of the Story

The rest of the story is that new data from the CDC itself show that the smoking rate among U.S. high school students dropped significantly in 2013, reaching the lowest level in the history of the survey (the Youth Risk Behavior Survey), which began in 1991.

Despite the tremendous proliferation of e-cigarette experimentation among youth, with a doubling of use from 2011 to 2012 alone, the CDC data show that youth smoking prevalence (among high school students) fell dramatically, from 18.1% in 2011 to 15.7% in 2013. This is a 13.3% decline in smoking prevalence over a two-year period. It is also the largest drop in youth smoking prevalence measured by this survey over the past decade.

These data all but destroy the gateway hypothesis. They demonstrate that at the current time, the evidence simply does not support the assertion that the proliferation of e-cigarette use among youth is leading to increased smoking initiation. Electronic cigarettes are not leading to a lifetime addiction to cigarette smoking among our nation's youth.

Tuesday, June 17, 2014

New Study Demonstrates Why FDA's Proposed Regulatory Approach to E-Cigarettes Makes No Sense

A new study published today in the journal Tobacco Control demonstrates why the FDA's proposed regulatory approach for electronic cigarettes makes no sense. In fact, the new research shows why the FDA's approach would be a complete bureaucratic nightmare, while not actually protecting the public's health.

(See: Zhu S-H, et al. Four hundred sixty brands of e-cigarettes and counting: implications for product regulation. Tobacco Control. Published online ahead of print on June 17, 2014.)

In this study, the authors study attempted to determine the number of electronic cigarette products on the market, both in terms of the number of different brands and the number of different flavors. Using comprehensive internet searches, the researchers found as follows:

"By January 2014 there were 466 brands (each with its own website) and 7,764 unique flavors. ... Newer brands offered more flavors per brand (49 vs. 32) ... ."

The Rest of the Story

The basic framework that the FDA has proposed to regulate e-cigarettes is that every product on the market (except a very few that were already on the market as of February 2007) must submit a new product application. These applications must demonstrate to the FDA that the introduction of the product to the market is appropriate for the public's health.

Because products are substantially equivalent only if they pose no different issues of public health, and because flavorings can affect product efficacy and safety, it is probable that every different flavor of every different brand must submit a separate application. Thus, at a minimum, there are going to be at least 466 x 49 applications, or 22,834 required applications.

The FDA's Center for Tobacco Products simply does not have the capacity to review 22,000 new product applications. After all, it has taken more than 4 years for the agency to even begin to process the more than 3,500 substantial equivalence applications submitted by tobacco companies, and as of this date, there are still thousands of those applications pending. It is easy to see that the proposed deeming regulations would create a bureaucratic nightmare.

Moreover, the proposed regulations do nothing to directly regulate product safety. For years to come, we would still have exploding batteries, leaking cartridges, and packaging that is not child-proof. After all, it is going to be a minimum of one year before the regulations are promulgated, another two years before the applications are due, and probably 5-6 years before the 22,000 new product applications can be processed (and that is only if the FDA acts in an unprecendentedly speedy fashion). So we're talking 8-9 years before we see any meaningful safety improvements.

Instead of this insane regulatory approach, the FDA should scrap the requirement for product applications and should simply promulgate basic safety standards that ensure minimum, uniform requirements for product safety. If the agency allows for a 12-month grace period, we could expect to see these requirements actually take effect within two years.

The safety standards should focus on the following issues:

1. Battery safety and overcharge protection;
2. Packaging (leak-proof cartridges and child-proof containers);
3. Basic manufacturing standards;
4. Pharmaceutical-quality ingredients in e-liquids;
5. Quality control for stated nicotine levels; and
6. Regulation of heating temperature and protection against overheating and dry puffs.

In addition to ensuring basic safety, such regulations would also address issues such as the presence of formaldehyde in some e-cigarette brands and would regulate the product to minimize the known harmful by-products which have been identified in some e-cigarettes. These by-products are avoidable. We know this because some brands on the market (such as Vuse and NJOY) have been tested and shown to have no detectable/quantifiable levels of any hazardous byproducts.

As the agency learns more about these products in all their diversity, the basic safety standards could be enhanced.

I can only hope that this new study will help the FDA realize the folly of its proposed approach to electronic cigarettes and develop a new set of regulations that directly set standards for the safety of the product.

Monday, June 16, 2014

Tony Gwynn Dies of Oral Cancer Almost Certainly Caused by Smokeless Tobacco

Many tobacco control advocates have asked me why, as a harm reduction supporter, I am always talking about the use of electronic cigarettes to help people quit smoking, rather than the use of smokeless tobacco products.

Tony Gwynn's tragic death at age 54 from repeated smokeless tobacco use is the reason why. While it is not common, traditional smokeless tobacco use is clearly associated with oral cancer. In addition, there is little evidence that as marketed and used in the United States, these products are helping a substantial proportion of smokers to stay off cigarettes.

For these reasons, I believe that electronic cigarettes are a much more viable option as a harm reduction approach for smoking cessation.

Glantz Asserts that Pulmonary Effects of Smoking May Be No Worse than those of Vaping

In a comment submitted to the FDA, Dr. Stan Glantz has asserted that in terms of pulmonary effects, the use of electronic cigarettes may not be any less hazardous than smoking conventional cigarettes.

Of course, this is the same thing as stating that cigarette smoking may be no worse than vaping in terms of its effects on pulmonary function.

Dr. Glantz writes: "Evidence that e-cigarette aerosol has the same effects on an important measure of lung function as cigarette smoke undermines the assumption that e-cigarettes are uniformly less risky than conventional cigarettes."

This assertion is based on a new study which found that electronic cigarette use, like smoking, results in reduced levels of exhaled nitric oxide. As Dr. Glantz writes:

"The paper, "Short-term effects of electronic and tobacco cigarettes on exhaled nitric oxide," by Sara Marini, et al, just published in Toxicology and Applied Pharmacology (Volume 278, Issue 1, 1 July 2014, Pages 9–15), reports important data showing that nicotine e-cigarettes, non-nicotine e-cigarettes, and conventional cigarettes all have similar effects of depression of exhaled nitric oxide."

Based on this single study, Dr. Glantz concludes: "the FDA must be extremely careful about assuming that e-cigarettes uniformly pose less risk than conventional cigarettes."

Stated another way, Dr. Glantz is cautioning the FDA against assuming that e-cigarettes are safer than conventional cigarettes in terms of their effects on lung function.

The Rest of the Story

In my opinion, Dr. Glantz's conclusion from this study is unscientific, illogical, and extremely damaging and destructive to the FDA's consideration of this issue as well as to the public's appreciation of the severe hazards of cigarette smoking.

Dr. Glantz is simply wrong. There is abundant evidence which demonstrates that while vaping does cause some degree of respiratory irritation (and probably triggers a bit of inflammation), it is far safer than smoking and has far less of an effect on lung function.

In fact, in a study by Flouris et al., the investigators found that real cigarettes, but not the fake ones, had a significant detrimental effect on pulmonary function, measured by spirometry. This study documents that while active smoking has immediate, clinically meaningful effects in reducing lung function, electronic cigarettes do not.

The study found that: "Neither a brief session of active e-cigarette smoking (indicative: 3% reduction in FEV1/FVC) nor a 1 h passive e-cigarette smoking (indicative: 2.3% reduction in FEV1/FVC) significantly affected the lung function (p > 0.001). In contrast, active (indicative: 7.2% reduction in FEV1/FVC; p < 0.001) but not passive (indicative: 3.4% reduction in FEV1/FVC; p = 0.005) tobacco cigarette smoking undermined lung function."

The main study finding was as follows: "The assessment of lung function demonstrated that neither a brief session of active e-cigarette smoking nor a 1 hour passive e-cigarette smoking session significantly interfered with normal lung function. On the other hand, acute active and passive tobacco cigarette smoking undermined lung function, as repeatedly shown in previous studies."
The study concluded that: "e-cigarettes generate smaller changes in lung function but similar nicotinergic impact to tobacco cigarettes."

In order to draw the conclusion that Dr. Glantz drew in his comment, one would have to completely ignore this study. Obviously, Dr. Glantz has done exactly that. He has based his comment on one narrow study and ignored the rest of the literature.

But it doesn't end there.

The Marini study demonstrates that electronic cigarettes do lead to a reduction in exhaled nitric oxide, which suggests that they have a mild respiratory irritant effect and induce some inflammation in the airways. This is a finding which has been reported previously in a number of studies. It is not surprising because propylene glycol is known to be a mild respiratory irritant.

But what is the clinical meaning of this effect? In order to find that out, one needs to conduct studies with longer-term end points.

Well, Polosa et al. have conducted exactly such a study. They examined the changes in asthma symptoms among smokers who continue to smoke versus those who switch to electronic cigarettes. These investigators reported that in contrast to real cigarettes, the fake ones result in actual harm reversal. Lung function, asthma control, and asthma symptoms were significantly improved among patients who switched from regular cigarettes to electronic cigarettes. These improvements were even observed among patients who became dual users of both real and fake cigarettes.

It is clear from the overall evidence that electronic cigarettes are not as risky as tobacco cigarettes in terms of acute effects on lung function. On this issue, Dr. Glantz's comment is simply wrong.

The very idea that one would extrapolate from a study finding that vaping, like smoking, reduces exhaled nitric oxide levels to the conclusion that smoking may be no more hazardous than vaping in terms of its acute pulmonary effects defies scientific logic. It also shows a misunderstanding, or at least a misinterpretation of the meaning of exhaled nitric oxide findings.

The finding of reduced exhaled nitric oxide is an indication that an exposure is causing some sort of inflammatory effect on cells lining the respiratory tract. It doesn't mean anything more or less than that. You can't take two exposures - each of which causes respiratory tract inflammation - and make the statement that the effects of both exposures are equal. Risk posed by an exposure depends on many other factors, including the degree of inflammation induced, the reversibility of the effect, the nature of the exposure, the chronicity of the exposure, etc.

To understand how ridiculous Dr. Glantz's extrapolation is, consider some of the other exposures that also cause reductions in exhaled nitric oxide:

1. Taking an exam

When students take their final exam in my course, they are all experiencing acute effects on their respiratory tracts. In fact, if you were to measured their exhaled nitric oxide levels, you would find that there is a significant reduction, just as is observed with smoking.

In fact, this is precisely what Trueba et al. demonstrated in a study of changes in exhaled nitric oxide levels in 41 healthy college students. 

Would one therefore conclude that taking an exam is just as risky, in terms of respiratory effects, as smoking a cigarette? Apparently, Dr. Glantz would draw such a conclusion. But it is easy to see why this is an inappropriate conclusion. And we would never disseminate messages to the public that smoking is no more hazardous than taking an exam.

Can you imagine if the tobacco companies used the same logic as Dr. Glantz? They would, according to his scientific reasoning, be perfectly honest in communicating to the public statements like this:

"Smoking is not uniformly more hazardous than simply taking an exam."

"In terms of acute effects on respiratory function, active smoking is exactly equivalent to the effects of taking a math test."

"Smoking is no more hazardous than taking an exam in terms of its acute respiratory effects."

To be completely honest, Trueba et al. actually found that not only did taking an exam affect nitric oxide levels, but it also produced decreases in lung function measured by spirometry. This is something that has not been observed for electronic cigarettes. 

2. Feeling sad

Trueba et al. also found that higher depressive mood was associated with greater reductions in exhaled nitric oxide.

Using Dr. Glantz's reasoning, the cigarette companies would be perfectly honest in putting out headlines stating:

"Smoking no worse on the lungs than feeling a little sad."

"By improving symptoms of depression, smoking may actually enhance respiratory health."

You can see the quality of the scientific reasoning we are dealing with.

Hopefully, the FDA will not be swayed by this nonsense.

It is worth noting that the conclusions which Dr. Glantz is disseminating are destructive because they undermine decades of public education about the severe hazards of smoking. If the public thinks that smoking is only as risky as vaping, then it is likely that many smokers will decide to continue smoking rather than quitting using electronic cigarettes. And many ex-smokers who have quit with electronic cigarettes may return to smoking, thinking that they might as well since they are not getting any definite health benefit from having made the switch.

Thursday, June 12, 2014

UCSF Scientists Tell FDA They are Not Sure Smoking is Any More Dangerous than Vaping

In a comment submitted to the FDA regarding its proposed e-cigarette deeming regulations, a trio of UCSF scientists argue that it is premature to declare that there is a continuum of risk among nicotine-containing products, including tobacco cigarettes and electronic cigarettes.

They write: "The idea of a “spectrum of risk” or “continuum of risk” among tobacco and nicotine delivery products is logical. However at this time it is a hypothesis lacking sufficient empirical evidence to use as a basis for regulatory decisions. ... The FDA should not predicate regulatory actions on the assumption that any tobacco or nicotine delivery product is substantially safer than another until the improved safety profile has been demonstrated by a substantial body of peer-reviewed scientific research."

They conclude: "Taken together, these studies demonstrate unequivocally that products and devices that deliver respirable particles and nicotine are inherently dangerous. The “Spectrum of Risk” is an unproven hypothesis with potentially deadly effects on the public health. FDA should not deem any tobacco or nicotine product to be safer than another, until it is proven to be safer through a substantial and consistent body of peer-reviewed scientific research."

The Rest of the Story

These scientists are arguing that it is premature to declare that there is any difference in risk between a tobacco cigarette, which burns tobacco, and an electronic cigarette, which contains no tobacco and involves no combustion, but merely heats nicotine in a solution of propylene glycol and glycerin.

In other words, they are telling the FDA that at the present time, they cannot conclude that cigarette smoking is any more harmful than vaping.

What a damaging and irresponsible public statement to make!

They are essentially telling smokers that they are perhaps just as well off continuing to smoke cigarettes as switching to electronic cigarettes because we are not sure that the e-cigarettes are any safer.

We have an epidemiological term for what we would call it were a physician to make precisely such a statement to a patient: ...

... malpractice.

There is absolutely no question that vaping is safer than smoking and that smokers who switch to electronic cigarettes are improving their health. To suggest otherwise is scientifically irresponsible, in my opinion. It undermines years of public education about the dangers of cigarette smoking. Even Big Tobacco would not claim that their products are as safe as non-combusted, non-tobacco-containing, electronic cigarettes.

However, these UCSF scientists are making precisely such a claim.

These researchers conclude, in the same comment, that electronic cigarettes cause heart disease, heart attacks, and pulmonary disease. There is inadequate evidence for any of those assertions.

The ultimate irony is that while these researchers do not believe there is sufficient evidence to conclude that smoking is any more harmful than vaping, they do believe there is enough evidence to conclude - already - that vaping causes heart disease, heart attacks, and pulmonary disease. Even the most hardened e-cigarette opponents, including Glantz himself, have not gone that far.

Wednesday, June 11, 2014

Glantz and Colleagues Support Government Suppression of the Truth about Electronic Cigarettes

In a submission to the FDA regarding the proposed deeming regulations, Stan Glantz and colleagues have called on a government ban on truthful speech by electronic cigarette companies: namely, stating that electronic cigarettes are safer than tobacco cigarettes. The authors of this comment want the FDA to expressly prohibit electronic cigarette companies from informing consumers that vaping is safer than smoking.

In fact, one of the complaints in the comment is that "E-cigarette companies are marketing e-cigarettes as healthier alternatives to cigarette smoking."

Glantz believes that informing consumers that e-cigarettes are safer than smoking will increase the appeal of e-cigarettes to youth, and on that basis, he wants the truth to be suppressed. The comment recommends that FDA ban "indirect health claims," which presumably means claims that e-cigarettes are safer than real cigarettes.

The Rest of the Story

It is perfectly reasonable for the government to intervene to prevent companies from making false or misleading claims to the public. Even severe infringement of free speech by corporations may be justified in the case of preventing the deception of consumers. However, there is little justification for prohibiting companies from telling consumers the truth, and there is no justification for suppressing the truth when those facts are the most pertinent information that the consumer needs to know in order to make an informed decision about using the product.

There is little question that electronic cigarettes are much safer than tobacco cigarettes (even Glantz himself admits that). And further, there is little question that the most important piece of information consumers need in deciding whether to continue to smoke real cigarettes or switch to the fake ones is that the fake ones don't contain or burn tobacco and are therefore much safer than the real tobacco cigarettes.

Why would we want to suppress the provision of this information to the public? And what justification is there for a government-mandated suppression of the truth?

While I agree with Stan on virtually every aspect of the regulation of cigarette marketing, we part ways when he advocates the suppression of the truth. 

Tuesday, June 10, 2014

It's Official: Big Pharma is Lobbying Against Electronic Cigarettes

I have long argued that tobacco control advocates who have financial ties to Big Pharma must disclose these ties if they opine about national strategies for electronic cigarette regulation because these ties represent a conflict of interest. My argument was based on the premise that electronic cigarettes represent a major form of market competition with pharmaceutical cessation aids and that drug companies therefore have a financial interest in seeing electronic cigarettes squashed.

Today, I reveal that this speculation about pharmaceutical financial interests in the demise of e-cigarettes was not just speculation, but it has now been confirmed.

According to an article in the London Times, GlaxoSmithKline - a major player in the pharmaceutical smoking cessation industry - has lobbied vigorously on behalf of stringent electronic cigarette regulation in the European Union. Specifically, a leaked memo apparently showed that Glaxo was telling policymakers that electronic cigarettes could be a gateway to smoking and that these products should be regulated as medicines, not as a type of nicotine or tobacco product.

According to the article: "One of the world’s biggest pharmaceutical companies has warned lawmakers that electronic cigarettes could act as a “gateway to tobacco”. The leaked correspondence from GlaxoSmithKline, whose nicotine patches, gums and lozenges are being undermined by the burgeoning e-cigarette market, reveals the opposition from the pharmaceutical industry to impending regulation of e-cigarettes across the European Union. The pharmaceutical industry wants medicines licences to be mandatory for e-cigarettes, as they are for nicotine products. Instead, the EU is set to introduce a system in which e-cigarette companies can opt in for medicines regulation or be regulated in a similar way to traditional cigarettes."

Christopher Snowdon reported the details of the story here back in February. He wrote:

"This is a blatant attempt at rent-seeking by an obvious vested interest. We know that the pharmaceutical industry has been lobbying hard to hamper the growth of e-cigarettes so it comes as no surprise to find Glaxo using the tired old gateway argument. The truth is that e-cigarettes will only "seriously disadvantage" the NRT market if they work better as quitting aids. In my experience—and the experience of countless other people—e-cigarettes are much better substitutes for smoking. If they were really a "gateway" to smoking, e-cigarettes would be good for companies like Glaxo as they would create more smokers (NRT companies need there to be smokers just as much as cigarette companies do)."

Snowdon also noted that the UK National Smoking Cessation Conference was funded by GlaxoSmithKline and Pfizer. He wrote:

"As usual, both these companies are main sponsors of the conference—apparently there is no problem having corporations that are vociferously opposed to the most promising development in smoking cessation paying for a conference about smoking cessation."

The Rest of the Story

Financial interests in Big Pharma must now be recognized as conflicts of interest for any organization or individual who is offering opinions about national strategy, policy, or regulations regarding electronic cigarettes. Therefore, the authors of all scientific articles regarding electronic cigarettes must disclose any financial interests with pharmaceutical companies. Furthermore, organizations must also disclose any financial ties to Big Pharma when they offer recommendations regarding electronic cigarette policy.

Unfortunately, there have been numerous violations of this disclosure standard, as several commentators on electronic cigarette policy have failed to disclose their Big Pharma ties in published articles. I have highlighted many of these stories on my blog, but for one demonstrative example, see my column on failed disclosures by an individual and an organization in the New York Times debate on electronic cigarettes.

Another inexcusable conflict of interest is the fact that Mitch Zeller, the director of the FDA's Center for Tobacco Products and therefore the chief author of the proposed electronic cigarette regulations, came to the FDA directly from a consulting job with GlaxoSmithKline and therefore has a severe conflict of interest regarding the electronic cigarette issue.

Moreover, several former members (and one current member) of the FDA's Tobacco Products Scientific Advisory Committee have (or have had) financial conflicts of interest with Big Pharma, and thus are not in a position to offer opinions about national tobacco product regulation in the context of this expert advisory panel.

And finally, it appears that most of the national tobacco control conferences continue to be funded by pharmaceutical companies. There is no way that these conferences can be objective about smoking policy, especially regarding electronic cigarettes and smoking cessation, when they are funded by Big Pharma.

Monday, June 09, 2014

IN MY VIEW: Why Electronic Cigarette Flavors Probably Prevent Youth from Taking Up Smoking

Recently, Stan Glantz and colleagues called for a ban on electronic cigarette flavorings. Other anti-smoking groups have also urged the FDA to implement a ban on the use of flavors in electronic cigarettes. I have already explained why such an intervention makes no sense because it essentially represents a ban on electronic cigarettes, prevents brand differentiation, and greatly decreases the appeal of these products, thus forever protecting the market share of tobacco cigarettes. Today, I explain why the flavors in electronic cigarettes probably play a role in deterring youth smoking. Thus, I provide another argument for why the FDA should not ban electronic cigarette flavors.

The Rest of the Story

The argument being made by the CDC, as well as many other anti-smoking groups and advocates, is that electronic cigarettes are a gateway to youth smoking. In other words, youth who have never smoked before are going to try electronic cigarettes, become addicted to nicotine, and then move on to tobacco cigarette smoking.

This argument might have some plausibility if electronic cigarettes were "starter cigarettes." In other words, if electronic cigarettes were much milder versions of tobacco cigarettes, with milder tobacco flavor, then it might be expected that youth could advance from an electronic cigarette to a real one. Electronic cigarettes with tobacco or menthol flavoring, for example, might be expected to get kids used to the taste of a tobacco cigarette and thus to promote cigarette smoking initiation.

However, is the same thng true of a flavored e-cigarette?

Based on the experience of vapers, there is strong and compelling evidence that the flavors lead vapers away from tobacco taste, not towards it. Vapers consistently report that the use of the flavors helps them lose their taste for tobacco and makes it more difficult for them to return to cigarette smoking.

One would expect a similar experience with youth e-cigarette experimenters. Once they get used to the sweet flavors of electronic cigarettes, it is hard to fathom that they could then be drawn to the harsh taste of tobacco. It is difficult to imagine a youth switching from a gummy bear flavored e-cigarette to a Marlboro.

In fact, it could well be that flavored electronic cigarette use inhibits youth smoking by making it much less likely that a youth is going to enjoy his or her first experience with real tobacco cigarettes. The oral and respiratory tracts that are used to fruit or candy flavors are most likely not going to be able to tolerate or enjoy the harsh taste and sensation of a tobacco cigarette. For this reason, it is entirely conceivable that the use of electronic cigarettes might actually be a deterrent to cigarette smoking.

However, this deterrent effect - if present - depends upon the availability of flavored electronic cigaretttes. If only tobacco and menthol e-cigarettes were to be allowed on the market, this deterrent effect could no longer take place.

For this reason, the FDA should think long and hard before jumping into a decision to ban the flavors in electronic cigarettes. It is possible that despite encouraging experimentation among some nonsmoking youth, flavored electronic cigarettes may actually have a net positive effect on the public's health by serving as an overall deterrent to youth smoking.

In the absence of data demonstrating that flavored electronic cigarettes are serving as a gateway to youth smoking, there is no public health justification for a ban on flavors in electronic cigarettes, and such a measure could cause more public health harm than good.

Friday, June 06, 2014

Glantz and Colleagues Essentially Call for a Ban on Electronic Cigarettes: Banning Flavors Would Ban All Existing E-Cigarettes

Stan Glantz and several colleagues have submitted a comment to the FDA calling for a complete ban on the use of flavors in electronic cigarettes.

The authors write: "FDA should immediately under the current rulemaking establish a product standard prohibiting flavors in e-cigarettes... ."

The Rest of the Story

The rest of the story is that Glantz and colleagues are essentially calling for a ban on all existing electronic cigarettes. Why? Because every electronic cigarette contains flavors. In fact, the presence of flavors is the only distinguishing characteristic of different brands of e-liquids or cartridges.

The ingredients of virtually every electronic cigarette liquid on the market are:

1. Nicotine
2. Propylene glycol and/or glycerin
3. Flavors

That's it! That's basically all there is.

For example, let's take a look at the ingredient list for some of the major e-cigarette brands on the market:

VUSE: nicotine, PG, VG, water, flavorings
Blu: nicotine, PG, VG, water, citric acid, flavorings
Mark Ten: nicotine, PG, VG, flavorings
V2: nicotine, PG, flavorings
LOGIC: nicotine, PG, water, flavorings
NJOY: nicotine, PG, VG, flavorings

Virtually every electronic cigarette consists of nicotine, PG and/or VG, and flavorings, plus or minus a little water and perhaps citric acid. It is the flavor that makes the brand. In most cases, even the "tobacco"-flavored electronic cigarettes contain flavorings.

It's easy to see that a ban on flavors is essentially a ban on electronic cigarettes. It would ban virtually every electronic cigarette currently on the market. Moreover, it would mean that there could only be one type of electronic cigarette liquid, which would have to contain just nicotine and propylene glycol and/or glycerine, and there would be no way for different liquids to distinguish themselves. The product would completely lose its appeal to smokers and the cigarette market would be protected forever.

Such a regulatory action would remove the ability of companies to market their products and would eliminate the taste and appeal of the product, handing the entire cigarette category over to Big Tobacco.

In my opinion, a ban on flavors in electronic cigarettes would completely destroy the electronic cigarette market. If the FDA is going to ban the flavors in e-cigarettes, then it might as well just ban the product entirely.

Why would public health practitioners like Dr. Glantz and his colleagues support an action that will end the great electronic cigarette experiment and permanently hand the entire cigarette market over to Big Tobacco?

If any of my readers can find out, please let me know because it is baffling to understand why a long-time anti-smoking advocate like Stan would want to protect cigarettes from the most serious competition they have ever faced. If this flavoring ban is enacted, Stan will have the rare role of being not only the hero of the tobacco control movement but the hero of the cigarette promotion movement as well.

Tuesday, June 03, 2014

Northampton Board of Health Positions Itself for Hypocrite of Year Award

Last week, the Northampton (MA) Board of Health enacted regulations to strengthen its smoke-free air law. Specifically, the Board of Health extended the smoking ban to include: (1) all public parks and athletic fields; (2) all private clubs; and (3) the use of e-cigarettes in all public places, including parks.

It may sound like a strong, courageous action from a Board of Health that is being guided by the solid, consistent principle that all nonsmokers should be protected from exposure to secondhand smoke, period.

The Rest of the Story

Not exactly.

While the Board of Health was "courageous" enough to ban smoking at all private clubs, it was not "courageous" enough to similarly ban smoking at the city's own public club -- the Garden House Banquet Hall at Look Park.

Hidden in the regulations is an exemption that allows for a designated smoking area at the Garden House Banquet Hall, even though that area is located in Look Park, which is a municipal park at which the regulations supposedly ban smoking.

In other words, this is a special exemption put in place for what are clearly political, rather than public health purposes.

And what might those political purposes be?

Well, consider that by banning smoking at all private clubs but creating an exemption for the city's Banquet Hall, it could potentially establish a competitive advantage for the city-owned facility over private facilities in competition for business from people looking for venues for celebrations.

Fortunately, the fine print in the regulations did not escape the attention of the ACLU, which is challenging this special interest exemption.

The ACLU is also challenging the inclusion of electronic cigarettes in the regulations, as it seems absurd to ban the use of e-cigarettes in all parks, given the lack of any evidence that vaping in a park poses any substantial public health threat.

The Northampton Board of Health may not have created public health regulations that have any consistency or science base. However, they have created an excellent entry for the 2014 Hypocrisy of the Year Award.