Wednesday, January 28, 2015

Anti-Smoking Groups' Propaganda Campaign is Working: Policy Maker Says that "Hundreds of Thousands" of Vapers Will Die

Today brings evidence that not only is the misinformation coming from many electronic cigarette opponents unethical because it violates the public health principles of transparency and honesty, but the propaganda campaign is actually working.

In a Reuters article from Monday, state Senator Mark Leno is quoted as stating: "Whether you get people hooked on e-cigarettes or regular cigarettes, it’s nicotine addiction and it kills. We're going to see hundreds of thousands of family members and friends die from e-cigarette use just like we did from traditional tobacco use."

The Rest of the Story

There is absolutely no evidence to support the contention that e-cigarettes are going to kill hundreds of thousands of vapers. In fact, there is currently no evidence that e-cigarette use carries with it any mortality risk. Clearly, this policy maker is under the mistaken belief that e-cigarette use is as harmful as smoking.


Where could he possibly have gotten that idea?


Let's see .... could it be? ........SATAN?! (apologies to those who did not get the Church Chat reference)


The answer appears to be much simpler. He most likely got this ridiculous idea from the propaganda campaign being waged by electronic cigarette opponents. Over the past few days and months, I have documented one story after another of major anti-smoking groups and agencies disseminating the false claim that vaping is no more hazardous than active smoking. This propaganda has come from reputable health agencies and groups, including the FDA, the American Lung Association, the American Thoracic Society, and the American Legacy Foundation, as well as from numerous physicians and public health practitioners. It should therefore come as no surprise that policy makers are picking up on this, believing it, and then relying on it to formulate e-cigarette policy.


Making matters even worse, some of this misrepresentation and deception is occurring in the presence of severe financial conflict of interests which are being hidden from the media and the public.

Where is the error in simply being honest and truthful to American consumers?

Tuesday, January 27, 2015

New Head of Office of Medical Products and Tobacco at FDA Has History of Pharmaceutical Consulting

It appears that the FDA is following a pattern in seeking new directors and office heads. It is apparently looking to those who have financial conflicts of interest with Big Pharma. I have already discussed how Mitch Zeller - the head of the Center for Tobacco Products - came to FDA directly from a pharmaceutical consulting company. Yesterday, it was announced that the new head of the Office of Medical Products and Tobacco at FDA will be Dr. Robert Califf.

The press release describes Dr. Califf as follows:

"During his career, Dr. Califf has led many landmark clinical studies, and is a nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research. He is one of our nation’s leaders in the growing field of translational research, which is key to ensuring that advances in science translate into medical care. He was a member of the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market and of the IOM’s Committee on Identifying and Preventing Medication Errors. In addition, he served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Currently, he is a member of the IOM Policy Committee and liaison to the Forum in Drug Discovery, Development, and Translation."

The Rest of the Story

Despite the seemingly exhaustive review of Dr. Califf's many highly recognized roles, there is one small piece of information that was not provided.

It turns out that Dr. Califf has a strong conflict of interest by virtue of his long history of grant funding and consultancies for Big Pharma. These are precisely the companies he will now be regulating.

In a recent article published in the journal Metabolism, Dr. Califf is a co-author of a manuscript that reported the results of a clinical trial which tested the efficacy of two pharmaceutical agents in treating metabolic syndrome. The manuscript notes that: "The NAVIGATOR study was supported by Novartis, Inc., and was designed by an academic executive committee in collaboration with the sponsor."

In addition to this pharmaceutical funding, Dr. Califf also disclosed personal conflicts of interest with Big Pharma: "RMC has received consulting fees from Bayer, Bristol-Myers Squibb, CV Sight LLC, DSI-Lilly, Gambro, theHeart.org, Janssen, Kowa, Novartis, Pfizer, Regeneron, and Roche." He also acknowledged that: "his institution has received research grants from Bristol-Myers Squibb, Novartis, Amylin, Merck, Schering-Plough, Scios, Johnson & Johnson, and Eli Lilly."

It does appear to me that there is a question about whether there might be a conflict of interest for a scientist with a substantial number of personal conflicts of interest with Big Pharma to be brought in to head a department which is involved directly in the regulation of those very pharmaceutical companies.

It may be that Dr. Califf has to recuse himself from varous decisions that directly affect these particular companies. However, the list of companies is so long that there may not be all that many drug reviews that do not pose a conflict of interest. Perhaps more concerning than this individual case is the pattern that seems to be emerging. Do we really want a rotating door between the FDA and the pharmaceutical industry and its consultants?

Yet Another Public Health Practitioner Publicly Claims that Smoking is No More Hazardous than Vaping

In what is becoming a daily occurrence, yet another public health practitioner has publicly claimed that smoking is no more hazardous than vaping.

In a letter to the editor published in the New York Times, Joshua Muscat - a professor of public health sciences at the Penn State College of Medicine - writes:

"The biggest concern about e-cigarettes is their potential to increase nicotine addiction among young smokers, especially children, who would not normally try tobacco. It is not likely that e-cigarettes are safer, because their use may lead to increased and not decreased tobacco smoking in young people."

The Rest of the Story

Whether e-cigarettes lead to smoking among young people or not is irrelevant to the issue of whether e-cigarette use is safer than smoking. Moreover, there is no evidence that e-cigarette use leads to increased smoking among young people. If anything, there is some evidence pointing in the other direction. But the main point is that it is simply not true that vaping is as hazardous as smoking.

By disseminating to the public the falsehood that vaping is just as harmful as smoking, medical and public health practitioners are actually discouraging many smokers from quitting. They may even be causing many ex-smokers, who quit using e-cigarettes, to return to active smoking. After all, if vaping is no safer than smoking, then what's the point of using e-cigarettes? You're better off smoking and getting the full enjoyment of the experience.

Michael Shaw notes the absurdity of the position of many public health practitioners in a column published at Health News Digest. He writes: "The FDA approved products--patches, gums, and drugs--help "boost" that to about one in ten, an abysmal "success" rate of 10 percent. Yet, the official line, from the FDA and the CDC on down, is "stick with the FDA-approved methods; don't even try anything else!" Chief among that "anything else" are e-cigarettes, loved by users--because they do help you quit--but almost unanimously hated by officialdom. ... However, there are powerful forces against e-cigarettes, including the proverbial strange bedfellows. ... As to the strange bedfellows, e-cig opponents include many public health departments, disease trade associations, and a host of smoking cessation groups.  Why on earth should the American Lung Association be against e-cigs?"

That is a great question. Why are so many public health and anti-smoking groups against a product that is helping many smokers quit? But more importantly, why are so many public health and anti-smoking practitioners telling lies about the scientific evidence regarding the relative safety of vaping vs. smoking.

There is certainly room for a healthy debate about the appropriate role that e-cigarettes should play in public health promotion and the regulations that are necessary to maximize the potential benefits while minimizing the risks of these products. However, there is no room for lying to the public about the science.

ADDENDUM: Dr. Gil Ross has an excellent column in the Daily Caller which highlights the misinformation being disseminated by the California Department of Health Services. Note particularly this important point: "the official line, from the FDA and the CDC on down, is “stick with the FDA-approved methods; don’t even try anything else!” This amounts to advising desperate, addicted smokers to “quit, or die,” given the 90 percent failure rate of these products."

Monday, January 26, 2015

American Thoracic Society Physicians Claim There is No Evidence Smoking is More Hazardous than Vaping

In statements that even the tobacco industry would not make, two physicians with the American Thoracic Society have publicly claimed that there is no evidence smoking is any more hazardous than the use of non-tobacco-containing, non-combusted e-cigarettes.

In a letter to the editor in the New York Times, Dr. Frank Leone - a pulmonologist who is chair of the American Thoracic Society's Tobacco Action Committee - claims that there is no evidence that e-cigarettes are safer than real cigarettes. In fact, he claims that it is too early to even suggest that e-cigarettes are likely to be much safer than smoking.

Dr. Leone writes: "There is not sufficient evidence to conclude that e-cigarettes are a safer alternative to regular cigarettes or that e-cigarettes actually help smokers quit. ... it is too early to suggest labeling saying 'it is likely that e-cigarettes are much safer than smoking.' That isn't reassurance; it's a marketing tactic."

Meanwhile, in an article in the Journal of the National Cancer Institute, Dr. Dona Upson - a member of the Tobacco Action Committee of the American Thoracic Society - also claims that there is no evidence vaping is any less hazardous than smoking.

Dr. Upson is quoted as stating that: "we just don’t have any good, solid data showing harm reduction versus tobacco products."

The Rest of the Story

These are shocking claims, given that e-cigarettes contain no tobacco and merely heat and aerosolize a solution of nicotine, propylene glycol, and glycerine, while cigarettes burn tobacco at very high temperatures, producing more than 10,000 chemicals which include more than 60 human carcinogens.

The statements are also shocking given the fact that a multitude of data now demonstrate that e-cigarettes are less toxic than tobacco cigarettes, including studies showing that asthmatic smokers who switch to e-cigarettes experience dramatic improvement in their symptoms, that the levels of virtually all carcinogens are much lower in e-cigarette aerosol than in tobacco smoke, and that unlike smoking, vaping does not cause endothelial dysfunction or decrements in spirometric pulmonary function tests.

And the statements are even more shocking given that the tobacco companies themselves have acknowledged that smoking is much more hazardous than vaping. Obviously, it would be quite advantageous for the tobacco companies to lie to the public and repeat the claim that these physicians are making. But the tobacco companies are not doing that. Ironically, they are the ones telling the truth about the relative hazards of smoking vs. vaping.

Adding to the shock, Dr. Leone states that there is not evidence to even suggest that e-cigarettes are likely to be less hazardous than smoking. In other words, he is claiming that it is not likely that smoking is any more hazardous than vaping. Based on the existing scientific evidence, I view that claim as being patently false.

It is not clear exactly what the American Thoracic Society's Tobacco Action Committee is smoking, but whatever it is, they are undermining years of public education about the severe hazards of smoking. They are also discouraging quit attempts by smokers and helping to protect the cigarette market, as the hysterical information they are disseminating may well scare some vapers into returning to smoking and may discourage smokers from quitting who might well have quit using e-cigarettes.

On the bright side, I at least applaud Dr. Leone for speaking out against hospital policies that refuse employment to e-cigarette users.

This story once again demonstrates how ideology, and not science, has taken over in the tobacco control movement.

Friday, January 23, 2015

Confirmed: Formaldehyde Study Conducted Under Implausible Conditions; Conclusions Invalid

Using information on type of atomizer studied in the recent New England Journal of Medicine article which claimed that vaping produces formaldehyde levels that pose a greater cancer risk than active smoking, Dr. Konstantinos Farsalinos has confirmed that the conditions used in the study (at the 5 volt level) were implausible.

The study reported finding high levels of formaldehyde in the aerosol of electronic cigarettes, leading the authors to conclude that the cancer risk associated with vaping is higher than that associated with smoking. The formaldehyde was not detected at the low voltage setting (3.3V), but was detected in large quantities at the high voltage setting (5.0V).

It turns out that the atomizer had a resistance of 2.1 ohms. At a voltage of 5 volts, the power delivered would be about 12 watts. This is clearly in the red zone, where the atomizer coil may be damaged or burned and the e-liquid would definitely be overheated. This would create an extremely unpleasant taste, and no vaper could tolerate more than one puff under these conditions (known as "dry puff" conditions).

The Rest of the Story

The implications of this story are that the conditions used in the high voltage setting in the study were implausible. Thus, the cancer risk estimation in the study is invalid, as is its conclusion that vaping poses a higher cancer risk than active smoking because of the high levels of formaldehyde.

To borrow an apt analogy from Dr. Farsalinos, it is like totally charring a piece of meat, detecting high levels of carcinogens, and then concluding that people who eat meat are at a very high risk of developing cancer. While it is absolutely accurate that there are high levels of carcinogens in charred meat, no one eats meat under such conditions, so the cancer risk estimation is completely invalid.

If you overheat an atomizer, it is going to result in aldehyde formation. This is because at very high temperatures, propylene glycol degrades (is oxidized) to form formaldehyde due to incomplete combustion. This process is enhanced with the presence of metals.

While the high voltage conditions were implausible, the low voltage conditions were not. Thus, the only valid conclusion from the study is that at low voltage conditions, the atomizer tested did not produce any detectable levels of formaldehyde.

Unfortunately, the alarmist (and incorrect) conclusions of this study have already been widely disseminated in the media. Even if the information is corrected, it appears that the damage is done.

I believe that the damage is substantial because many smokers will now become convinced that there is no advantage to switching from tobacco cigarettes to electronic cigarettes. This will discourage many smokers from quitting. It also may cause some vapers to return to cigarette smoking, since they may be convinced that smoking is no worse for their health.

It is difficult to imagine even the tobacco companies of old disseminating such a false conclusion about the relative "safety" of smoking. What the authors concluded is that smoking is safer than vaping, at least in terms of carcinogenic risk. While the tobacco companies undermined conclusions about the hazards of smoking, I don't recall them ever stating that smoking was as benign as a behavior for which no serious adverse effects had been observed. Regardless, my point is simply to emphasize the magnitude of the fallacious conclusion of this study and the damage that it has already done to the protection of the public's health.

Wednesday, January 21, 2015

New Study Reports High Levels of Formaldehyde in Electronic Cigarette Aerosols

A new study released today by the New England Journal of Medicine reports finding high levels of formaldehyde in the aerosol of electronic cigarettes, leading the authors to conclude that the cancer risk associated with vaping is higher than that associated with smoking.

(See: Jensen RP, Luo W, Pankow JF, Strongin RM, Peyton DH. Hidden formaldehyde in e-cigarette aerosols. New England Journal of Medicine 372;4, January 22, 2015.)

The study examined the aerosol produced by a tank system electronic cigarette. The aerosol was collected and analyzed for formaldehyde. Two voltage settings were used: low (3.3V) and high (5.0V).

The main finding was that at low voltage, no formaldehyde was detected, but at high voltage, high levels of formaldehyde were detected. Using these levels, the authors extrapolate to derive an overall lifetime cancer risk from vaping, which they claim is higher than that from cigarette smoking.

The Rest of the Story

There's just one problem with the study, but this problem renders its conclusion invalid.

The conditions used to study the e-cigarette aerosol at the high voltage setting were unrealistic and under such conditions, a vaper would never be able to use the product. This is because the wattage being used was so high that the vaporizer was overheated (for a conventional e-cigarette it would likely damage or burn the coils), creating a horrible taste which a vaper could not tolerate. This is sometimes referred to as the "dry puff phenomenon."

Based on calculations by Dr. Konstantinos Farsalinos from data provided in the article, the resistance was no higher than 1.7 ohms. At a voltage of 5.0V, the wattage would be 14.7W. That is in the "red zone" where the vaporizer is being overheated and where, for a conventional e-cigarette, the coils would likely be damaged or burned.

Essentially, what this study demonstrates is that if you overheat a vaping system, it will produce high levels of formaldehyde. However, such conditions are not realistic, as they could not be tolerated by an actual vaper. Therefore, extrapolating from this study to a lifetime of vaping is meaningless.

On the other hand, the study does demonstrate a very important point. It is entirely feasible to produce an electronic cigarette or vaping system that does not deliver any measurable amount of formaldehyde. At the low voltage setting, no formaldehyde was detected. Rather than scaring people about the dangers of vaping and alarming them to the "fact" that vaping raises their cancer risk above that of smoking, we should instead be regulating the voltage and temperature conditions of electronic cigarettes so that the problem of formaldehyde contamination is completely avoided.

As I have argued before, instead of wasting its time and resources setting up a bureaucratic nightmare, where thousands of different products must submit pre-marketing applications, the FDA should simply promulgate basic safety standards. And one of those standards should set maximum voltage and temperature conditions for these products. That would minimize the health risks while maximizing the benefits.

ADDENDUM: Dr. Farsalinos has corrected me and pointed out that it is really the coil temperature, not the voltage, which needs to be controlled and regulated. 

California Department of Health Services Lies to the Public About Electronic Cigarettes

The California Department of Health Services (CDHS), under a grant funded by the Centers for Disease Control and Prevention (CDC), has produced a brochure entitled "Protect Your Family from E-Cigarettes: The Facts You Need to Know."

Here are some of the "facts" being disseminated by the CDHS:

1. "The aerosol is a mixture of chemicals and small particles that can hurt the lungs just like cigarette smoke."

2. "E-cigarettes are just as addictive as regular cigarettes."

3. "People can become addicted to nicotine from e-cigarettes and they may start using regular cigarettes."

4. "Studies show that e-cigarettes do not help people quit smoking cigarettes."

The Rest of the Story

The California Department of Health Services is lying to the public. Here is a brief analysis of each statement and an evaluation of its validity:

1. "The aerosol is a mixture of chemicals and small particles that can hurt the lungs just like cigarette smoke."

EVALUATION: Unsupported by scientific evidence

While it is true that there are a small number of chemicals in the aerosol of many electronic cigarette brands and there are certainly small particles, at present there is no evidence that these small particles can hurt the lungs just like cigarette smoke. In fact, there is strong evidence that electronic cigarette use does not produce the kinds of decrements in lung function observed with cigarette smoking.

2. "E-cigarettes are just as addictive as regular cigarettes."

EVALUATION: A lie

It has been quite convincingly shown that electronic cigarettes are not nearly as addictive as regular cigarettes. The nicotine delivery from e-cigarettes is quite poor and inconsistent in most brands. The delivery of nicotine from e-cigarettes is much lower than in regular cigarettes. Patterns of use of the product, especially among youth, demonstrate that the addictive power of e-cigarettes is much lower than that of tobacco cigarettes.

3. "People can become addicted to nicotine from e-cigarettes and they may start using regular cigarettes."

EVALUATION: Unsupported by scientific evidence

It has not yet been demonstrated that people can become addicted to nicotine from e-cigarettes. Certainly, people who are already addicted to nicotine from smoking may remain addicted to nicotine when they switch to electronic cigarettes. But there is as yet no evidence that nonsmokers who try e-cigarettes are at significant risk of becoming addicted to nicotine. More importantly, there is no evidence that people who start out with e-cigarettes are progressing to cigarette smoking. In fact, existing studies have failed to find more than a couple of youths who have started smoking after having been introduced to nicotine for the first time through e-cigarettes.

4. "Studies show that e-cigarettes do not help people quit smoking cigarettes."

EVALUATION: A lie

In fact, the opposite is true. Studies show that e-cigarettes do help people quit smoking. The existing studies suggest that e-cigarettes are about as effective as nicotine replacement therapy. It is possible that newer products are more effective for smoking cessation, but at very least, we can say that these products do help many people quit smoking.

While I commend the California Department of Health Services for putting out a pamphlet that warns parents that e-liquids are poisonous and urges them to keep these products away from young children, I condemn the Department for blatantly lying to the public. In their apparent zeal to demonize electronic cigarettes, the California Department of Health Services has crossed the line into unethical public health conduct, breaking one of the key principles: communicate honestly with the public.

That federal revenue is being used to support the dissemination of these lies makes this conduct even more egregious. I urge the CDC to cancel this contract with CDHS on the grounds that the Department is violating basic public health ethics by lying to the public.

Tuesday, January 20, 2015

Physician Recommends that Middle-Age Lifelong Nondrinkers Should Be Told to Start Drinking, But Hides Conflict of Interest With Big Alcohol

In the most recent issue of the journal Alcoholism: Clinical and Experimental Research, a physician counsels all doctors to promote moderate alcohol use (one drink per day) among middle age, lifelong nondrinking patients. The author, Dr. Emanuel Rubin, is a pathologist at Thomas Jefferson University in Philadelphia.

(See: Rubin, E. (2014), To Drink or Not to Drink: That Is the Question. Alcoholism: Clinical and Experimental Research, 38: 2889–2892. doi: 10.1111/acer.12585.)

The major conclusion of the article is as follows: "The strongest evidence for a beneficial effect of moderate alcohol intake is the documented reduction in all cause mortality and cardiovascular disease. Indeed, the protection against coronary artery disease is comparable to that produced by the administration of statins. In this context, alcoholic beverages do not require a prescription, are far cheaper, and are certainly more enjoyable. Although a physician's advice to a patient should always be individualized, including a consideration of a person's genetic background, the overwhelming evidence suggests that physicians should counsel lifelong nondrinkers at about 40 to 50 years of age to relax and take a drink a day, preferably with dinner. The “black swan” predicts that the risk/benefit ratio is highly favorable."

I don't know who the "black swan" is but he appears not to be a very good scientist. Calling "comparable" the scientific evidence linking statins to an improvement in heart disease risk with that linking moderate alcohol intake to lower cardiovascular disease mortality is scientifically unsound. The link between statin use and decreased cardiovascular disease is based on several double-blind, placebo-controlled, clinical trials, while the link between moderate alcohol intake and lower cardiovascular disease risk is based on observational studies that are plagued by the problems of selection bias and confounding.

People who do not drink at all are very different from those who drink moderately, and in ways that could influence heart disease risk. For example, there are often medical reasons why people don't drink alcohol. A number of medications recommend that alcohol not be used while on them. If these medical conditions and medications are associated with cardiovascular disease risk, which is highly plausible, then this would confound the relationship between observed heart disease risk and alcohol intake.

Moreover, even if it were true that a drink a day reduced heart disease risk, it does not necessarily follow that advising lifelong non-drinkers to start drinking would create net public health benefits. Since these are people who have not consumed alcohol for 20 to 30 years of adulthood (and perhaps not in childhood as well), it is quite possible that their ability to limit their alcohol intake once they start is not sufficient to keep them at only one drink per day. One of the reasons they are not drinkers may in fact be that they have a family history of alcoholism and are predisposed to alcoholism. A large increase in the number of drinking adults may well lead to an increase in youth alcohol use, since parental drinking is a known risk factor for underage drinking. Thus, for many reasons, Dr. Rubin's advice is premature and ill-advised.

The Rest of the Story

But that's not what this post is about.

This post is about the failure of the author to disclose a significant conflict of interest with Big Alcohol.

According to a 2011 report, Dr. Rubin was at one time a member of the Medical Advisory Council of the Alcoholic Beverage Medical Research Foundation (ABMRF), which is heavily funded by the alcohol industry.  Dr. Rubin is also listed as having been a recipient of grant funding from ABMRF (from 1987-1991 and in 1993). Dr. Rubin also served as an expert witness for Philip Morris on several occasions during the period 1991-2000. During this time, the Miller Brewing Company was owned by Philip Morris.

Moreover, it appears that the conflict of interest with Big Alcohol is indeed current, as Dr. Rubin himself lists himself as being a consultant to the Medical Advisory Board of ABMRF. He lists the relationship as "Current Consultantships - Medical Advisory Council, Alcoholic Beverage Medical Research Foundation 1992-present."

Clearly, Dr. Rubin has a conflict of interest by virtue of his relationship with Big Alcohol, including having been the recipient of grant funding from an alcohol industry foundation and having served on the board of that alcohol industry foundation.

However, nowhere in the article can I find any disclosure of this conflict. 

I can't even find a disclosure of this conflict in a 2004 article in Atherosclerosis that reports the results of a study designed to identify potential benefits of alcohol consumption.

And in a 2013 article that reports the results of an investigation into potential benefits of alcohol consumption, the conflict of interest disclosure statements reads: "No potential conflicts of interest were disclosed."

Interestingly, Dr. Rubin testified that the research conducted by the Council for Tobacco Research (CTR) was of high scientific quality and that the scientific review adhered to widely recognized scientific standards. As the CTR was recently found by a federal court to be part of a vast conspiracy of fraud and deceit by the tobacco industry, Dr. Rubin's testimony in these tobacco cases sheds doubt on his scientific objectivity and judgment.

But the most serious issue here is not the poor medical advice. All physicians are entitled to their opinions. What they are not entitled to do, however, is to issue national recommendations on an issue as important as alcohol use if they have severe financial conflicts of interest, especially if they fail to reveal those conflicts.

The conflict of interest disclosure guidelines for the journal (Alcoholism: Clinical and Experimental Research) seem pretty clear. The guidelines require the disclosure of "any potential sources of conflict of interest," and they do not limit the disclosure to only a certain number of years. Here is the full disclosure requirement guideline:

"Conflict of Interest: This publication requires that all authors disclose any potential sources of conflict of interest. Any interest or relationship, financial or otherwise, that might be perceived as influencing an author's objectivity is considered a potential source of conflict of interest. These must be disclosed when directly relevant or indirectly related to the work that the authors describe in their manuscript. Potential sources of conflict of interest include but are not limited to patent or stock ownership, membership of a company board of directors, membership of an advisory board or committee for a company, and consultancy for or receipt of speaker's fees from a company. The existence of a conflict of interest does not preclude publication in this journal."

"If the authors have no conflict of interest to declare, they must also state this at submission. It is the responsibility of the corresponding author to review this policy with all authors and to collectively list in the cover letter to the Editor, in the manuscript (in the footnotes, or Conflict of Interest or Acknowledgements section), and in the online submission system ALL pertinent commercial and other relationships."

The rest of the story is that this commentary deceives readers by failing to disclose the fact that the author was the recipient of grant funding from an alcohol industry foundation and that he served on a board of that foundation. It also fails to disclose that the author is currently a consultant to the board. Surely, these conflicts are relevant to the ability of readers to properly evaluate the validity of the article's recommendations. I suspect that there are thousands of readers of this article who would be very surprised to find out "the rest of the story."

Monday, January 19, 2015

Rest of the Story Expanding to Cover Alcohol

The Rest of the Story will be expanding to cover alcohol as well as tobacco. I am becoming increasingly aware of parallels between the two fields of public health, including issues regarding hidden conflicts of interest and biased reporting of science. I'll kick the week off tomorrow with an alcohol story, to be followed by another later in the week. I expect that tobacco will remain the main focus.

Tuesday, January 13, 2015

Local Health Officials Lie to the Public; Claim that Smoking is No More Hazardous than Vaping

Local health officials in Franklin County, Kentucky are lying to the public, claiming that cigarette smoking is no more hazardous than using electronic cigarettes. According to an article in the Frankfort State Journal written by two public health officials associated with the Franklin County Health Department:

"One claim of those selling e-cigs is that they are not as harmful as cigarettes; however, this is untrue."

The Rest of the Story

It is quite ironic that health department officials, rather than tobacco industry executives, are the ones who are lying to the public and telling them that smoking is not as hazardous as previously thought. It is ironic that health officials, and not the tobacco industry, are the ones who are undermining the public's appreciation of the serious health hazards associated with cigarette smoking.

If any tobacco company came out with the statement that smoking is not any more hazardous than e-cigarettes, I can assure you that anti-smoking groups all over the country would be attacking those companies and probably bringing them to court for prosecution under RICO, consumer protection statutes, and civil lawsuits. Yet here we have a situation where numerous public health officials are lying to the public, making this precise claim, but so far as I know, not a single mainstream tobacco control organization has called them on it.

Other than the ACSH, Smokefree Pennsylvania, and the Rest of the Story, I'm not aware of any other tobacco control organizations that have publicly acknowledged that many of our colleagues in public health are lying to the public.

It is worth emphasizing that lying is unethical generally, but it is also a specific violation of the ethical code of public health.

These groups should be forced to retract their statements and apologize to the public for the damage they have done to the public's health.

Monday, January 12, 2015

Why are Anti-Smoking Groups Recommending a Smoking Cessation Drug That Has Been Linked to Hundreds of Sudden Deaths?

Numerous health and anti-smoking groups continue to recommend the use of a smoking cessation drug, despite the fact that this drug has been linked with hundreds of sudden deaths.

The drug is Chantix, and the sudden deaths were suicides.

The Vancouver Sun revealed this Saturday that in Canada over the past seven years, Chantix has been linked to 30 suicides, 44 deaths, and more than 1,300 episodes of suicidal ideation or suicide attempts, depression, and aggressive behavior.

According to the article: "Numbers on the deaths and other side-effects come from a Health Canada database where doctors, pharmacists and drug companies report bad side-effects experienced by patients taking pharmaceuticals. But Health Canada admits on its website that side-effects are under-reported, and experts say the database could represent as little as one per cent of the patients who suffer complications.
“A small proportion of the adverse reactions that have occurred on this drug in Canada would be in the adverse reaction database. Essentially it is spontaneous, voluntary reporting,” said Barbara Mintzes, a pharmaceutical drug expert at the University of B.C."

"Even the incomplete numbers, though, are a concern, she said. When someone taking an anti-depressant attempts suicide, it’s initially not clear whether that’s caused by the pre-existing depression or the drug; but in the case of Champix, people are taking the drug to stop smoking — not for a mental health condition. “You are looking at a lot of deaths, suicides and attempted suicides, and suicidal ideation in a population that you would have no reason to think would be otherwise at high risk of suicide,” said Mintzes, an associate professor in the Faculty of Medicine’s School of Population and Public Health."

The article also revealed that in 2012, the British Columbia ministry of health fired eight scientists who were doing research on Chantix. Also that year, the health ministry cancelled an independent review of Chantix, allegedly because it didn't want the serious adverse effects associated with this drug to go public. A leaked email written by the co-director of the health ministry's drug evaluation unit stated:

"We’ve decided to keep (the review of) smoking cessation in-house, sorry about that. It’s getting political and we aren’t sure anyone wants to see a published evaluation."

The Rest of the Story

Imagine that there were reports linking the use of electronic cigarettes to hundreds of sudden deaths. Unquestionably, health and anti-smoking groups would be calling for the removal of e-cigarettes from the market. At very least, they would not be recommending the use of e-cigarettes for smoking cessation. How then can these groups recommend the use of Chantix?

This reveals the hypocrisy and bias of these anti-smoking groups. They recommend that smokers use Chantix, despite its having been linked with hundreds of sudden deaths, but they discourage smokers from using e-cigarettes, which have so far not been linked to any serious adverse health effects.

Moreover, there is a black box warning on Chantix which alerts patients to the potential for serious health effects, including suicidal ideation and suicide attempts. Given that warning, how can these anti-smoking groups continue to recommend the use of the drug?

It isn't this recommendation alone that troubles me. It is the hypocrisy of the anti-smoking groups. If e-cigarettes were linked to even a fraction of the sudden deaths to which Chantix has been linked, there is no way that these groups would be recommending the use of e-cigarettes.

Whether Chantix is causally linked to suicide is not relevant to my point because if e-cigarettes were linked - by anecdotal reports - to sudden deaths, even without definitive evidence of a clear causal connection, anti-smoking groups would not be recommending the use of this smoking cessation device. But under precisely the same conditions, they are recommending the use of Chantix.

I believe there are three major reasons for the hypocrisy and bias that we see being displayed.

First, there is a strong ideology in the anti-smoking movement against anything that even looks like smoking, regardless of the benefits and health effects of the product. Anti-smoking groups simply cannot recommend a behavior that looks like smoking, regardless of how many lives it might save.

Second, there is a strong pre-existing bias against electronic cigarettes. Anti-smoking groups have reached the pre-determined conclusion that e-cigarettes are evil, and no amount of scientific evidence of the net public health benefits of these products will cause the groups to change their mind.

Third, most of the major anti-smoking groups receive significant funding from Big Pharma, and Pfizer - the maker of Chantix - is a major donor to these groups. This creates an obstacle to anti-smoking groups publicizing the potential dangers of Chantix because they don't what to bite the hand that feeds them. However, this financial conflict of interest is hardly ever disclosed when these groups make their public recommendations against the use of e-cigarettes and for the use of Chantix.

The apparent actions of the British Columbia health ministry are a rather extreme demonstration of these severe biases. But we must remember that even by merely discouraging the use of e-cigarettes, anti-smoking groups are causing public health harm because they are opposing a bona fide strategy for smoking cessation that helps many smokers who would not be able to quit using traditional methods.

Thursday, January 08, 2015

Alaska Health Department Airs First Pro-Smoking Television Ad Since 1970

Since 1970, the television airwaves have been clear of pro-smoking advertisements. That is, until recently, when the Alaska Department of Health and Social Services began running a television spot that undoubtedly promotes smoking by strongly discouraging smokers who might otherwise quit from using electronic cigarettes. The commercial will likely also cause ex-smokers who have quit via electronic cigarettes to return to cigarette smoking. Worst of all, the commercial lies to the public by attributing to electronic cigarette diseases for which there is no evidence of an association with vaping.

The text of the commercial reads as follows:

"What's in an e-cig cloud? ... Nicotine, just like the other cigarettes. Ultrafine particles that can lead to asthma. Embalming fluid. Ugh. Lead. Doesn't that cause brain damage? Nail polish remover. ... Don't let Big Tobacco cloud your judgment."

The Alaska state health department also provides a fact sheet which implies that electronic cigarettes are no safer than real cigarettes. The health department justifies this conclusion based on a single study, which tested the effect of electronic cigarette vapor on bronchial cells in cell culture.

The Rest of the Story

There is no doubt that this commercial is extremely misleading and that it contains false information. It is designed to scare people so much about the health effects of vaping that they essentially view these products as no different from tobacco cigarettes in terms of health risk. The ultimate effect of this campaign is that many smokers in Alaska who might otherwise have quit smoking or cut down substantially by switching to electronic cigarettes will be dissuaded from doing so. Moreover, many ex-smokers who successfully quit via the use of electronic cigarettes may well return to smoking, since it appears from the commercial that e-cigarettes are not better for your health than tobacco cigarettes.

Let's start with the information that is outright false. The commercial implies that electronic cigarettes can cause "asthma" and "brain damage." This is an outright lie. There is absolutely no evidence that electronic cigarettes cause asthma or brain damage. In fact, Dr. Riccardo Polosa and colleagues have shown that electronic cigarettes actually improve symptoms of asthma in smokers who either completely or even partially switch to these products. No study has ever shown that electronic cigarettes cause brain damage. What we do know is that switching to electronic cigarettes can substantially improve the health of smokers.

Now let's move to the information that is downright misleading. Telling the public that electronic cigarettes contain embalming fluid and nail polish remover is misleading because it belies the fact that e-cigarettes merely contain small amounts of the main components of those products. Someone who uses an electronic cigarette is not inhaling embalming fluid any more than someone who purchases a new sofa is inhaling embalming fluid.

To demonstrate how misleading and damaging this commercial is, consider the very same commercial applied to nicotine gum:

"What's in nicotine gum? ... Nicotine, just like cigarettes. And 4-(methylnitro-samino)-1-(3-pyridyl)-1-butanone, a powerful carcinogen that causes lung cancer. N-Nitrosonornicotine. Doesn't that cause esophageal cancer? Don't let Big Pharma cloud your judgment."

The above commercial text is just as scientifically valid as that provided by the Alaska health department. However, if the Department aired such a commercial, it is very clear that such a campaign would be terribly misleading. It would also be terribly damaging, because it would likely scare people who might otherwise quit using nicotine gum not to proceed with their quit attempt. And it might dissuade people who have already quit using nicotine gum from continuing the gum use, which could likely lead to their returning to smoking.

If the tobacco industry put out such an advertisement, there is no question that we in public health would be condemning the campaign and arguing that it is a pro-smoking campaign. Anti-smoking groups would likely try to have the commercial pulled off television on the grounds that it is pro-smoking and thus violates the intent of the 1970 ban on television advertising of cigarettes.

Now consider the very same commercial applied to the nicotine inhaler:

"What's in a nicotine inhaler? ... Nicotine, just like cigarettes. Nickel, a metal which has been shown to cause cancer, respiratory failure, and heart disorders. Lead. Doesn't that cause brain damage? Don't let Big Pharma cloud your judgment."

Once again, the commercial text is just as scientifically valid as that provided by the Alaska health department. However, if the Department aired such a commercial, it is very clear that such a campaign would be terribly misleading. It would also be terribly damaging, because it would likely scare people who might otherwise quit using a nicotine inhaler not to proceed with their quit attempt. And it might dissuade people who have already quit using the nicotine inhaler from continuing the inhaler use, which could likely lead to their returning to smoking.

And once again, if the tobacco industry put out such an advertisement, there is no question that we in public health would be condemning the campaign and arguing that it is a pro-smoking campaign. Anti-smoking groups would likely try to have the commercial pulled off television on the grounds that it is pro-smoking and thus violates the intent of the 1970 ban on television advertising of cigarettes.

We could even run a similar commercial about the nicotine patch:

"What's in a nicotine patch? ... Nicotine, just like cigarettes. 4-(methylnitro-samino)-1-(3-pyridyl)-1-butanone, a powerful carcinogen that causes lung cancer. And doesn't that also cause lung immunosuppression? Don't let Big Pharma cloud your judgment."

Another untruthful aspect of the campaign is its denial that smoking is any more hazardous than vaping. Can you imagine if the tobacco industry made such a claim on a web site? The anti-smoking movement would be up in arms. How dare the tobacco industry undermine years of education about the hazards of cigarette smoking by telling the public that smoking may be no more hazardous than using an electronic cigarette. But this is exactly what the Alaska health department is doing.

My colleague Stan Glantz has praised the campaign, urging all other states to air the same commercial. However, I can't possibly condone a campaign that lies to the public, significantly misleads its audience, undermines years of public education about the health hazards of smoking, and has the effect of promoting smoking by discouraging smokers who would otherwise have quit using e-cigarettes not to do so. 

Tuesday, January 06, 2015

Latest UK Data Suggests Substantial Benefits of Electronic Cigarettes for Smoking Cessation

According to an article in The Guardian, electronic cigarettes were the fastest growing item in terms of supermarket sales in the UK in 2014: "E-cigarettes were the fastest-growing product in British supermarkets last year as consumers shrugged off the controversy over vaping. Sales of electronic cigarettes – or vapourisers – across the largest grocers rose 49.5% in 2014, despite clamour from health groups to ban the devices."

Data from the Smoking Toolkit Study (STS) show that there was a dramatic rise in the use of electronic cigarettes among adults in England that began in 2012 and continued through 2014. Contemporaneous data from the STS show that the period 2012-2014 marked a sudden reversal in the trend of declining annual smoking cessation rates.

From 2007-2011, annual quit rates declined steadily from 6.7% to 4.6%. But suddenly in 2012, things turned around. The quit rate jumped to 6.2%, remained at 6.1% in 2013, and rose further to 7.5% in 2014.

Moreover, the same trend was observed in the proportion of smokers trying to quit each year.

And to top it off, the same trend was observed in the proportion of smokers trying to quit who reported success in their quit attempt.

Of course, these is merely an ecological analysis. However, the pattern of these trends seems far too striking to be explained alternatively. The working hypothesis, it seems, should be that electronic cigarettes have played a major role in enhancing smoking cessation in the England, both by stimulating quit attempts and improving success in those quit attempts.

The Rest of the Story

The irony of this story is that policy makers in the UK wanted a virtual ban on electronic cigarettes, and health groups and many anti-smoking advocates in the U.S. favor policies that would put a huge dent in the growth of the electronic cigarette market (at the expense, of course, of increased tobacco cigarette sales).

This is probably the most profound example in my career of public health groups supporting policies that are antithetical to the overall goals of public health. Therefore, it warrants a careful examination of the reasons why anti-smoking groups are promoting such policies. Our search for these answers will continue at The Rest of the Story over the next few months.

The rest of the story is that the existing evidence suggests that electronic cigarettes are producing substantial public health benefits but causing very little in the way of public health harms. Based on the data available at the present time, I think it is safe to conclude that electronic cigarettes are having a very large net positive impact on the public's health. Unfortunately, anti-smoking groups are doing everything they can to negate this public health success story.

Monday, January 05, 2015

2014 Anti-Smoking Myth of the Year Award Goes to CDC, Dr. Stan Glantz, and Dr. Michael Fiore

The Rest of the Story is pleased to announce the recipients of the 2014 Anti-Smoking Myth of the Year Award. This year's award goes to:
  • The Centers for Disease Control and Prevention (CDC);
  • Dr. Stan Glantz; and
  • Dr. Michael Fiore
for publicly spreading the myths that electronic cigarettes have been found to be a gateway to smoking among youth and that electronic cigarette experimentation leads to a lifelong addition to nicotine.

The CDC was first to the punch, with its director misrepresenting cross-sectional CDC survey data as conclusive evidence that electronic cigarettes are a gateway to smoking. Specifically, CDC Director Dr. Thomas Frieden stated:

"What we are doing first is tracking, and we are seeing some very concerning trends. Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes."

In addition, Dr. Frieden was quoted as stating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine."

The Office on Smoking and Health (where I used to work) vigorously supported these statements and failed to offer any public corrections. Nor am I aware of any other CDC corrections or retractions of these claims.

More recently, Dr. Stan Glantz began disseminating the conclusion that e-cigarettes are a gateway to smoking. In an article published in USA Today, he stated definitively that electronic cigarettes are a gateway to smoking. He was quoted as stating: "There's no question that e-cigarettes are a gateway to smoking."

And even more recently, Dr. Michael Fiore rang in the new year with a public statement that electronic cigarettes can lead youth to a lifetime addiction to nicotine. He was quoted as stating: "One of the biggest concerns about e-cigarettes is that they will serve as a gateway drug to lifelong nicotine dependence and all of the harms we know result from cigarette smoking. We know that the adolescent brain is very sensitive to nicotine. Use of e-cigarettes, with its exposure to nicotine, puts these adolescents at risk of lifelong nicotine addiction."

The Rest of the Story

As I have repeatedly pointed out, there is absolutely no existing evidence that electronic cigarettes are a gateway to smoking among youth or that electronic cigarette experimentation is leading youth to a lifetime of addiction to nicotine. In fact, the only evidence to date suggests that among U.S. youth, electronic cigarettes are not a gateway to smoking and e-cigarette experimentation does not appear to lead to regular (greater than weekly) use, much less to a lifetime of addiction.

President John F. Kennedy once said: "The great enemy of truth is not the lie--deliberate, contrived, and dishonest--but the myth--persistent, persuasive, and unrealistic." Here indeed, the repeated statements of the CDC and a number of prominent anti-smoking researchers have effectively created a myth, one that has become persistent and persuasive, even though it lacks evidence. And as a result, the media and in turn, policymakers, are accepting this myth as truth and making poor policy decisions because of it.

Interestingly, what President Kennedy went on to say in that 1962 speech relates perfectly to the manner in which the anti-smoking movement is dealing with the scientific question of whether e-cigarettes are a gateway to smoking.

Kennedy went on to say: "Too often we hold fast to the cliches of our forebears. We subject all facts to a prefabricated set of interpretations. We enjoy the comfort of opinion without the discomfort of thought."

This is precisely what is occurring in the tobacco control movement. We are holding fast to the cliches of the fast (i.e., the knowledge that smokeless tobacco can act as a gateway to cigarette use). We are subjecting all evidence to a prefabricated set of interpretations. Even cross-sectional evidence is being interpreted as showing that youth are starting with e-cigarettes and then progressing to active smoking. The CDC and some anti-smoking researchers are enjoying the comfort of expressing their conclusions about the gateway hypothesis without having to actually "think" (i.e., to actually analyze and interpret the scientific evidence that bears directly on this question).

I will close as President Kennedy did: "The stereotypes I have been discussing distract our attention and divide our effort. These stereotypes do our Nation a disservice, not just because they are exhausted and irrelevant, but above all because they are misleading--because they stand in the way of the solution of hard and complicated facts. It is not new that past debates should obscure present realities. But the damage of such a false dialogue is greater today than ever before... ."

Monday, December 22, 2014

Senator Durbin Asks Attorneys General to Violate the Constitution and Misinterpret the Master Settlement Agreement to Reign in Electronic Cigarettes

I am all for regulating the marketing of electronic cigarettes so that it does not target youth. However, I submit that measures to accomplish this should represent legitimate (i.e., constitutionally valid) government actions.

Last Friday, Senator Dick Durbin (D-IL) and Representatives Henry Waxman (D-CA) and Frank Pallone (D-NJ) sent a letter to all the state Attorneys General requesting that they define electronic cigarettes as "tobacco products" under the Master Settlement Agreement (MSA) and thereby, they claim, make e-cigarettes subject to the advertising restrictions that the MSA poses on tobacco manufacturers.

The letter states: "we believe you could take a significant step in the battle against tobacco use by classifying e-cigarettes as cigarettes under the Master Settlement Agreement (MSA) with the tobacco companies. ... we are writing to urge you to consider using your authority under the MSA to take immediate actions against the efforts of e-cigarette companies to target youth."

The letter also states: "We believe e-cigarettes meet all the criteria for the definition of cigarette (and tobacco product) in the Master Settlement Agreement. .. They contain "tobacco, ... in any form" because their key ingredient is nicotine, which is produced from tobacco leaves."

The Rest of the Story

Stan Glantz has praised this action of these politicians. I, on the other hand, condemn it.

Why? Because, very simply, it is unconstitutional. It clearly violates the rights of electronic cigarette companies. Specifically, it makes the electronic cigarette companies parties to a contract that they didn't sign. The government cannot do that. No one can do that. A contract is an agreement that is approved by the participating parties. A contract between these parties cannot tell other parties what they may or may not do. The Master Settlement Agreement was signed by the Attorneys General and several participating manufacturers (mainly, the large tobacco companies). It cannot set rules for other companies that were not parties to the agreement.

Moreover, these politicians are completely misinterpreting the Master Settlement Agreement. They misinterpret the MSA in two ways.

First, e-cigarettes are clearly not "cigarettes" as defined by the MSA. In order to be classified as a cigarette under the MSA, a product must contain tobacco. However, e-cigarettes do not contain tobacco. The politicians try to get around this by arguing that because they contain nicotine, they contain tobacco, as nicotine is derived from tobacco. But this argument flies in the face of basic rules of statutory construction. If the intent of the MSA was to define all nicotine-containing products as tobacco products, then it would not have been necessary to include the additional clause specifying that tobacco products must not only contain nicotine, but also contain tobacco.

Second, even if the Attorneys General redefine electronic cigarettes as tobacco products, that does not make the e-cigarette companies subject to the marketing restrictions in the MSA. The marketing restrictions only apply to "participating manufacturers." Because e-cigarette companies are obviously not "participating manufacturers," they cannot be subject to the MSA's marketing restrictions, regardless of how "tobacco products" are defined.

The rest of the story is that e-cigarette opponents like Stan Glantz and these politicians are so zealous about demonizing electronic cigarettes that they are willing to violate constitutional principles and basic legal rights of companies in order to achieve their aims.  

Canadian Survey Suggests that Electronic Cigarettes are a Useful Smoking Cessation Tool

A national public opinion survey of 2,154 adult Canadians taken by the Forum Poll found that among smokers who used electronic cigarettes primarily as a smoking cessation tool, 24% had quit smoking.

The study concluded that: "many vapers are trying to quit smoking tobacco, and between a quarter and a third are successful at this. So, it appears e-cigarettes don't represent the trojan horse they are painted as, and may be a very useful smoking cessation aid."

The Rest of the Story

It seems fortunate that a large number of smokers in Canada have ignored Health Canada's advice not to use electronic cigarettes. The health agency had advised smokers "not to purchase or use electronic smoking products, as these products may pose health risks and have not been fully evaluated for safety, quality and efficacy by Health Canada." Had all smokers taken Health Canada's advice, it appears that as many as one quarter of them who otherwise would have quit would instead still be smoking. It is ironic and unfortunate that a national health agency put out advice which runs contrary to the best interests of the public's health.

Due to differences in the legal status of e-cigarettes in the U.S. and Canada, these results cannot be extrapolated to the U.S. In Canada, the sale of nicotine-containing e-liquids was banned, although use by individuals is still legal. Therefore, it is possible that smokers in Canada who use electronic cigarettes are particularly motivated to quit smoking. This could, in part, explain the high observed smoking cessation rate in the survey.

I doubt that anti-smoking advocates and groups who oppose e-cigarettes will pay any heed to the results of this survey, as they appear not to be concerned with the actual scientific evidence, but instead, appear to have already drawn their conclusions. Nevertheless, if enough evidence accumulates to show that e-cigarettes are helping many smokers to quit, eventually it will be impossible for public policy makers to deny that e-cigarettes are a bona fide smoking cessation tool, despite the propaganda being disseminated by the anti-smoking groups.

Of note, the survey found that among those who are unsuccessful in quitting using e-cigarettes, about half have reduced the amount that they smoke. Thus, e-cigarettes may be benefiting those who fail to quit by reducing the damage done to the lungs and by decreasing the level of their addiction to smoking.

Also of note, 70% of smokers surveyed who had used e-cigarettes to try to quit reported that these products were somewhat or very effective in helping them quit. Despite the pre-determined conclusions of many anti-smoking groups, consumers seem to be indicating that these products can work.
Although penetration of e-cigarettes is not that high now, those using them are the young, and this behaviour is bound to become more popular. It appears, contrary to authorities' fears, that vaping is not a gateway to tobacco smoking, and many people who never smoked enjoy e-cigs for the flavours, not the nicotine. On the other hand, many vapers are trying to quit smoking tobacco, and between a quarter and a third are successful at this. So, it appears e-cigarettes don't represent the trojan horse they are painted as, and may be a very useful smoking cessation aid

Read more at: http://poll.forumresearch.com/post/197/two-thirds-using-e-cigs-to-quit-one-quarter-to-one-third-are-successful/
Copyright ©Forum Research Inc.
Although penetration of e-cigarettes is not that high now, those using them are the young, and this behaviour is bound to become more popular. It appears, contrary to authorities' fears, that vaping is not a gateway to tobacco smoking, and many people who never smoked enjoy e-cigs for the flavours, not the nicotine. On the other hand, many vapers are trying to quit smoking tobacco, and between a quarter and a third are successful at this. So, it appears e-cigarettes don't represent the trojan horse they are painted as, and may be a very useful smoking cessation aid

Read more at: http://poll.forumresearch.com/post/197/two-thirds-using-e-cigs-to-quit-one-quarter-to-one-third-are-successful/
Copyright ©Forum Research Inc.
Although penetration of e-cigarettes is not that high now, those using them are the young, and this behaviour is bound to become more popular. It appears, contrary to authorities' fears, that vaping is not a gateway to tobacco smoking, and many people who never smoked enjoy e-cigs for the flavours, not the nicotine. On the other hand, many vapers are trying to quit smoking tobacco, and between a quarter and a third are successful at this. So, it appears e-cigarettes don't represent the trojan horse they are painted as, and may be a very useful smoking cessation aid

Read more at: http://poll.forumresearch.com/post/197/two-thirds-using-e-cigs-to-quit-one-quarter-to-one-third-are-successful/
Copyright ©Forum Research Inc.

Friday, December 19, 2014

New Study Refutes Claim that Electronic Cigarettes are a Gateway to Smoking

A new study published in the American Journal of Preventive Medicine refutes the claim that electronic cigarettes are a gateway to smoking.

(See: Meier EM, Tackett AP, Miller MB, Grant DM, Wagener TL. Which nicotine products are gateways to regular use? First-tried tobacco and current use in college students. American Journal of Preventive Medicine 2015; 48(S1):S86-S93.)

The paper reports the results of an online survey of 1,304 undergraduate students at a large university in Oklahoma. The mean age of respondents was 19.6 years. Students were asked to report:

(1) the first nicotine-containing product they used (cigarettes, smokeless tobacco, electronic cigarettes, hookah, or NRT); and

(2) all of the nicotine-containing products that they current use.

Thus, the study was able to ascertain the proportion of students who had initiated nicotine use with electronic cigarettes and went on to become smokers (and remained smokers at the time of the survey).

The two most important findings of the study were as follows:

(1) Of the 1,304 students, only 3 reported having first tried electronic cigarettes and currently being a smoker. There were 59 students who had initiated with electronic cigarettes, so the proportion of these students who progressed to smoking and were currently smoking was 5.1%. In contrast, 18.6% of students who initiated nicotine use with smokeless tobacco progressed to smoking and were currently smoking.

(2) Of the 59 students who initiated nicotine use with e-cigarettes, only 1 was currently using e-cigarettes, and this student reported only occasional use of these products.

The authors conclude that: "ETPs were the first product tried by some students (n=59), 78% of whom first tried e-cigarettes. Interestingly, only one of these students was still using an ETP at the time of the study, and this was reported as occasional use of e-cigarettes. This may suggest that the uptake potential of current ETPs is limited among youth. This finding is supported by the fact that all dissolvable tobacco products have been taken off of the market by tobacco companies owing to poor uptake of these products.29 Moreover, given the timing of data collection, it is likely that students who first tried e-cigarettes tried a first-generation device, which anecdotally is considered to be much less effective in delivering nicotine than newer models.30 In addition, only one student who initiated with an ETP (1.7%) was a daily user of any tobacco product (i.e., conventional cigarettes), compared to the 10% and 21% of current daily tobacco users who first tried conventional cigarettes and SLT, respectively. Though this finding should be interpreted with caution, it potentially indicates that current ETPs are not necessarily strong gateways to regular tobacco use."

The Rest of the Story

This is the first study designed to actually answer the question of whether electronic cigarettes are a gateway to smoking because it is the first one to assess whether e-cigarette use preceded or followed cigarette use. It is inexplicable why some tobacco control advocates (Stan Glantz) and public health agencies (the CDC) had already concluded that e-cigarettes are a gateway to smoking in the absence of a single study that actually examined this question.

This study found only three students, in a sample of 1,300, who had initiated nicotine use with e-cigarettes and progressed to smoking. Moreover, only one of the students who initiated nicotine use with e-cigarettes was still using e-cigarettes, and only occasionally.

These findings refute the claim that electronic cigarettes are a gateway to smoking. Moreover, they suggest that the addictive potential of electronic cigarettes is quite low. The results support my contention that the public health consequences of e-cigarette experimentation among youth are not as dire as is being claimed by anti-smoking groups and health agencies. The current evidence does not support the conclusion that e-cigarette experimentation is a significant cause of nicotine addiction and subsequent uptake of smoking among youth.

There is one major caveat with this research. The sample consisted of college students and at the time many of them were in high school, e-cigarette use was not as popular. Also, most of these students probably initiated with first generation e-cigarette products, which do not deliver nicotine as effectively as more recently introduced products. Thus, to definitively answer the gateway question, we need a similar study among younger youth.

Despite this limitation, the rest of the story is that based on the current available evidence, there is no basis for concluding that e-cigarettes are a gateway to smoking. The CDC should immediately retract its claim that these products are a gateway to smoking to ensure that public policy is formulated based on science, rather than ideology.

Thursday, December 18, 2014

Cochrane Review Concludes that Electronic Cigarettes Appear to Be Effective for Smoking Cessation and Reduction, Although Further Research is Necessary

The first Cochrane review of the effectiveness of electronic cigarettes has concluded that there is enough evidence to declare that these products are effective for smoking cessation and reduction.

(See: McRobbie H, Bullen C, Hartmann-Boyce J, Hajek P. Electronic cigarettes for smoking cessation and reduction. The Cochrane Library. Published online on December 17, 2014. DOI: 10.1002/14651858.CD010216.pub2.)

The authors describe their study inclusion criteria as follows: "We included randomized controlled trials (RCTs) in which current smokers (motivated or unmotivated to quit) were randomized to EC or a control condition, and which measured abstinence rates or changes in cigarette consumption at six months or longer. As the field of EC research is new, we also included cohort follow-up studies with at least six months follow-up. We included randomized cross-over trials and cohort follow-up studies that included at least one week of EC use for assessment of adverse events."

The results of the study were as follows: "Participants using an EC were more likely to have abstained from smoking for at least six months compared with participants using placebo EC (RR 2.29, 95% CI 1.05 to 4.96; placebo 4% versus EC 9%; 2 studies; GRADE: low). The one study that compared EC to nicotine patch found no significant difference in six-month abstinence rates, but the confidence intervals do not rule out a clinically important difference (RR 1.26, 95% CI: 0.68 to 2.34; GRADE: very low). A higher number of people were able to reduce cigarette consumption by at least half with ECs compared with placebo ECs (RR 1.31, 95% CI 1.02 to 1.68, 2 studies; placebo: 27% versus EC: 36%; GRADE: low) and compared with patch (RR 1.41, 95% CI 1.20 to 1.67, 1 study; patch: 44% versus EC: 61%; GRADE: very low). Unlike smoking cessation outcomes, reduction results were not biochemically verified. None of the RCTs or cohort studies reported any serious adverse events (SAEs) that were considered to be plausibly related to EC use."

The authors conclude: "There is evidence from two trials that ECs help smokers to stop smoking long-term compared with placebo ECs. However, the small number of trials, low event rates and wide confidence intervals around the estimates mean that our confidence in the result is rated 'low' by GRADE standards. The lack of difference between the effect of ECs compared with nicotine patches found in one trial is uncertain for similar reasons. ECs appear to help smokers unable to stop smoking altogether to reduce their cigarette consumption when compared with placebo ECs and nicotine patches, but the above limitations also affect certainty in this finding. In addition, lack of biochemical assessment of the actual reduction in smoke intake further limits this evidence. No evidence emerged that short-term EC use is associated with health risk."

The Rest of the Story

There is clearly a need for further research in this area, and the authors make it clear that they have low confidence in their conclusions because of the limited evidence. However, it does appear that at the current time, there is evidence that electronic cigarettes can be useful for smoking cessation and reduction and that they are probably at least as effective as other FDA-approved therapies. In addition, there is no evidence that these products cause any serious adverse side effects, at least in terms of short-term use.

These conclusions refute the statements being made by a number of tobacco control researchers and advocates that electronic cigarettes actually inhibit smoking cessation. And they also refute statements by some health agencies that there is no evidence that electronic cigarettes have any usefulness for smoking cessation.

There is an urgent need for a high-quality clinical trial of electronic cigarettes in the United States, especially since more conclusive information is necessary to inform the FDA as it prepares and implements regulations. I developed a protocol for such a study, but was unable to secure funding from electronic cigarette companies to conduct the study. Hopefully, someone will be able to secure funding. I am happy to share my protocol with any researchers who are interested in potentially conducting such a study.

Wednesday, December 17, 2014

IN MY VIEW: Why Hysteria Over Youth E-Cigarette Use is Overblown; And Why it May Not Normalize Smoking

In response to the release of the 2014 Monitoring the Future data, which show that more youth are experimenting with electronic cigarettes than smoking (in terms of past 30-day use), many anti-smoking groups have sounded the alarm. More specifically, these groups have told the public that these data demonstrate that e-cigarettes are normalizing smoking. As Sabrina Tavernese explains in her New York Times article: "Health advocates say the trend for e-cigarette use is dangerous because it is making smoking seem normal again." For example, the American Academy of Family Physicians argued that these data show that e-cigarette use is normalizing smoking.

I have already explained how anti-smoking groups are missing the most important finding from the Monitoring the Future study: that despite the dramatic increase in e-cigarette experimentation, youth smoking prevalence declined substantially and is at its lowest level in decades. This demonstrates that e-cigarettes are not a gateway to smoking, as has been claimed by the CDC and by some tobacco control advocates, led by Stan Glantz.

Thus, it turns out that the concern of anti-smoking groups that e-cigarettes will normalize smoking is misplaced. In fact, the evidence seems to suggest just the opposite. It may well be that e-cigarettes are de-normalizing smoking by actually diverting some youth who would otherwise have smoked to e-cigarettes, or by diverting some youth smokers to vaping. What e-cigarette use is normalizing is the use of electronic cigarettes, not the use of tobacco cigarettes. The anti-smoking groups fail to see this because they have drawn pre-determined conclusions based on their ideology, and they are not able to look objectively at the actual scientific evidence.

While the health groups got the story wrong, fortunately, Sabrina Tavernese got it right: "Health advocates say the trend for e-cigarette use is dangerous because it is making smoking seem normal again. They also worry it could lead to an increase in tobacco smoking, though the new data do not show that."

Today, I reveal another important finding of the recent surveys on electronic cigarette use that has been entirely ignored and which should lessen our concern about the public health implications of e-cigarette experimentation among youth.

The Rest of the Story

Another important finding of the recent surveys, which has been completely ignored, is the finding that despite the large number of youth who are experimenting with e-cigarettes, only a very small proportion are actually using these products regularly, in a way that could plausibly cause significant harm. Wills et al. found that although 29% of high school students had experimented with e-cigarettes, only 2% were using them more than once a week. This means that only 7% of all high school e-cigarette experimenters are vaping more than once a week, which should lessen concerns that these products are causing significant health harm.

The truth is that e-cigarettes pose little acute health harm. Almost all the potentially adverse health effects of e-cigarette use are related to long-term use (over a period of many years). The potential acute health effects are basically two-fold: (1) these products could potentially be a gateway to smoking; and (2) these products could addict kids to nicotine, causing prolonged use of e-cigarettes which could cause neurological damage.

As I discussed above, concern #1 does not appear to be a problem. And based on the Wills et al. data, it does not appear that #2 is currently a major problem either. The data suggests that despite the dramatic rise in e-cigarette experimentation, youth are not becoming addicted to these products. The pattern of e-cigarette use is almost entirely sporadic, with 93% of users vaping no more than once in an entire week. It is not clear that use of e-cigarettes at this level - only once a week - poses any significant health harms.

My point is that the public health significance of youth e-cigarette use may very well be positive, rather than negative. It is possible that these products have caused very little health harm, while at the same time, diverted many youth from smoking to vaping. We know that smoking experimentation quickly leads to addiction. But e-cigarette use does not appear to have the same level of addictiveness. Possibly because of the much lower and inconsistent nicotine delivery, these products do not appear to be creating e-cigarette addicts (among youth).

If it is true that e-cigarettes are diverting some youth away from smoking, then it is actually the case that e-cigarette use among youth is having a positive net effect on the public's health. Even if this is not the case, it appears that e-cigarette use among youth is having very little public health impact, thus meaning that the benefits of e-cigarettes for adults (smoking reduction and cessation) far outweigh the costs for youth.

Let me close by making one point very clear. I am not arguing that e-cigarette use among youth is not a concern, that youth e-cigarette use should be allowed or promoted, or that measures should not be taken to discourage e-cigarette use among youth. I support bans on the sale of e-cigarettes to minors, restrictions on advertising and marketing that is directed at youth, programs to educate youth about e-cigarettes, programs to discourage kids from using e-cigarettes, and most importantly, FDA regulations that require child-proof packaging on e-cigarettes and stronger warnings about the potential risks of nicotine (especially acute poisoning).

Nevertheless, it is critical that we get the science right. And as of today, the science suggests that: (1) e-cigarettes are not a gateway to smoking among youth; and (2) e-cigarettes may well be de-normalizing smoking rather than promoting it.

Tuesday, December 16, 2014

Glantz Tells Public There is No Question that E-Cigarettes are a Gateway to Smoking, But Today's Monitoring the Future Data Show the Opposite

In an article published yesterday in USA Today, Dr. Stanton Glantz states definitively that electronic cigarettes are a gateway to smoking. He was quoted as stating: "There's no question that e-cigarettes are a gateway to smoking."

The article highlights the findings of two new studies showing that rates of electronic cigarette use among youth continue to rise dramatically. According to the article: "About 25% of high school students in Connecticut and 29% of teens in Hawaii have used e-cigarettes, according to separate studies. About 18% of the Hawaii teens and 12% of the Connecticut high school students had used e-cigarettes in the past month. Both studies were done in 2013. Those rates are much higher than the latest data from the Centers for Disease Control and Prevention, which found 4.5% of high schoolers and 1.1% of middle schoolers had used e-cigarettes in the past 30 days in 2013. Authors of the Hawaii study, published online Monday in Pediatrics, note that e-cigarette use has grown exponentially among kids, doubling every year since 2009."

Today, the University of Michigan released data from the 2014 Monitoring the Future study which confirm that among a national sample of 8th, 10th, and 12th grade youth, rates of electronic cigarette use are between 9% and 17%. The prevalence of past 30-day use of electronic cigarettes was 8.7% among 8th graders, 16.2% among 10th graders, and 17.1% among 12th graders.

The Monitoring the Future study also found that the prevalence of cigarette smoking decreased substantially in all three groups. For 8th graders, the prevalence of past 30-day smoking dropped from 4.5% to 4.0%; for 10th graders, current smoking prevalence dropped from 9.1% to 7.2%, and among 12th graders, smoking prevalence dropped from 16.3% to 13.6%. In 2014, cigarette smoking was at its lowest level in decades.

The most dramatic declines in smoking occurred between 2011 and 2014. For 8th graders, smoking prevalence dropped from 6.1% to 4.0%; among 10th graders, smoking prevalence dropped from 11.8% to 7.2%; and among 12th graders, smoking prevalence dropped from 18.7% to 13.6%. However, the decline in smoking from 2013 to 2014 was by far the most substantial year-to-year decrease during this period.

The Rest of the Story

It is clear that experimentation with electronic cigarettes among youth has increased dramatically from 2011 to 2014. But despite this dramatic increase, the prevalence of current smoking among youth decreased dramatically. And the sharpest decline in smoking occurred concurrently with the largest increase in electronic cigarette use.

Dr. Glantz's conclusion - that electronic cigarettes are a gateway to smoking - just doesn't hold up in light of these data. If electronic cigarettes were serving as a major gateway to smoking, then we wouldn't expect to see such dramatic declines in smoking concurrent with dramatic increases in electronic cigarette experimentation. If anything, these national data suggest that electronic cigarettes may actually be serving as a deterrent to smoking by diverting kids who might otherwise try smoking over to a non-tobacco nicotine product. Even if it is the case that kids who might not have tried smoking are experimenting with e-cigarettes, this is very different from claiming that e-cigarettes are a gateway to smoking.

Furthermore, there simply are no studies to support the conclusion that e-cigarettes are a gateway to smoking. The only existing evidence suggests that e-cigarettes are not serving as a major gateway to smoking. Thus, Glantz has drawn a conclusion that is simply unsupported by any evidence.

Glantz now joins the CDC in disseminating the unsupported conclusion that e-cigarette experimentation is a gateway to smoking. One unfortunate consequence of public health agencies or researchers spreading this misinformation is that we risk losing our credibility, not just on the issue of electronic cigarettes, but on other issues as well. If we are not credible with respect to our opinions on electronic cigarettes, then why should the public trust us when we comment about tobacco cigarettes?

Sadly, this story simply adds to the long list of examples of the degradation in the rigor of science in the tobacco control movement.

Sunday, December 14, 2014

CDC Makes Startling Proclamation: Electronic Cigarette Aerosol is Not as Safe as Clean Air

For the past two years, the Centers for Disease Control and Prevention (CDC) has been on a crusade to demonize electronic cigarettes. The agency has falsely claimed that its survey data demonstrate that electronic cigarettes are a gateway to cigarette smoking among youth. The agency has fabricated evidence that ex-smokers are in large numbers being driven back to smoking because of electronic cigarettes. The agency has scared the public by noting that rates of experimentation with electronic cigarettes doubled among youth, but failed to mention that almost all regular e-cigarette users were smokers or users of other forms of tobacco.

Now, the CDC is trying to dissuade the public from believing that vaping is safer than smoking. However, the worst thing the agency is able to say about the hazards of electronic cigarettes is that they are not as safe as "clean air."

In a December 12 MMWR article on electronic cigarettes, the CDC writes that some "contend that ENDS [electronic cigarettes] emit fewer toxins than combustible tobacco... . However, ENDS aerosol is not as safe as clean air."

The Rest of the Story

There are two striking things about these CDC statements.

First, it is extremely misleading to write that some groups "contend" that electronic cigarettes emit fewer toxins than combustible tobacco. By framing it in this way, the CDC is giving the impression that it does not agree with this contention, or at least, that the evidence is not clear.

However, there is abundant evidence that what these groups "contend" is the documented scientific truth. There is abudant evidence that electronic cigarettes emit fewer toxins than combustible tobacco, and no reputable scientist would argue otherwise. But by framing this as merely a contention, the CDC is insinuating that we don't actually know that electronic cigarettes emit fewer toxins.

Why would the CDC want to suggest to the public that we don't actually know that electronic cigarettes deliver fewer toxins that tobacco cigarettes? To me, this indicates a desire to demonize these products. Otherwise, why should the CDC be scared to tell the public the truth: that electronic cigarettes are much safer than tobacco cigarettes? And this isn't even going that far. It's merely acknowledging that e-cigarettes deliver fewer toxins than tobacco cigarettes.

Frankly, the CDC is using what we previously would have referred to as "tobacco speak." This is the way that the tobacco companies historically would frame their statements about the health effects of smoking. They would say things like: "Some public health officials contend that smoking causes ... ." Why is CDC now stooping to this level?

The second striking thing about the statement is that apparently, the worst thing the CDC can say about the adverse health effects of electronic cigarettes is that these products are not as safe as inhaling "clean air."

If that's the worst thing the CDC can say, then electronic cigarettes are apparently not that hazardous, or at least there is not currently any evidence to support the contention that they pose major hazards. Besides, you could say the same thing about any airborne exposure, including exposure to FDA-approved products. For example, you could correctly state that "aerosol from nicotine inhalers is not as safe as clean air."

Actually, it depends on how you define clean air. If you define it as simply being outdoor air, then it may not even be true that electronic cigarette aerosol is not as safe as "clean air." After all, in many urban areas, there are high levels of pollution in outdoor air. This air pollution has been associated with adverse cardiac and respiratory effects. So it is entirely possible that for some urban dwellers, their "clear air" is actually more hazardous than inhaling e-cigarette aerosol.

The rest of the story is that the CDC continues to misrepresent scientific evidence in order to demonize electronic cigarettes. If you didn't know any better, you might think that the agency has been paid by Big Tobacco to undermine the public's appreciation of the severe hazards associated with cigarette smoking and that it is trying to preserve, rather than decimate, the combustible tobacco market.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.