Alere Wellbeing is Still Making Misleading Advertising Claims About the Effectiveness of Its Quit for Life Smoking Cessation Program

On its web site, Alere Wellbeing boasts that its Quit for Life smoking cessation program has a "47% quit rate."

For those unfamiliar with quit rates for smoking cessation programs, this is a phenomenal rate of success, dwarfing that of any other program.

The Rest of the Story

If only it were true.

If this blog were a PolitiFact fact checker, Alere Wellbeing's claim would get a rating of ...

... FALSE.

Or more properly, a rating of: "Liar, Liar, Pants on Fire."

It is not clear on what scientific basis Alere Wellbeing makes its claim, but presumably it comes from a study in which its own study team reported about a 41% quit rate for the program. However, this is based on the assumption that every smoker who was not successfully followed up was a quitter. Obviously, this is an unreasonable assumption. In an intent-to-treat analysis (which is the appropriate one to use), the quit rate was only 20.5%. It it were being honest, Alere Wellbeing would advertise a quit rate of 21%, instead of 47%.

If one cherry picks from the literature, the highest quit rate I can find - based on an intent to treat analysis - is 33% from this study.

In more realistic settings, such as this study of the Quit for Life program in actual routine use in Florida, the quit rate was only 16% (and that was only for three months).

Importantly, the web site does not indicate that the 47% figure is from a responder analysis, rather than an intent-to-treat analysis. This is highly misleading, and in my mind, fraudulent.

In my view, this is fraudulent marketing, because it the company is knowingly providing a quit rate that is invalid -- essentially by definition the true quit rate is substantially lower than that which is being advertised. And presumably, the company knows this.

I find it interesting that the FDA is going to great lengths to take electronic cigarette companies to task for suggesting that these devices can help smokers quit (when there is abundant evidence that numerous vapers have found the product to be effective for smoking cessation), yet the FDA is silent in the face of this fraudulent marketing for medication- and counseling-based smoking cessation.

If any fraudulent claims are being made about smoking cessation programs, they are not coming from electronic cigarette companies but from Alere Wellbeing, which is marketing an "FDA-approved" smoking cessation approach. Perhaps, to protect the public, the FDA should focus a little more attention on commercial smoking cessation service providers.

For Some, Electronic Cigarettes are the Only Hope for Life

Last week, I received a stirring testimonial from an ex-smoker who quit smoking using electronic cigarettes. His story is typical of so many similar stories I have heard directly from vapers. I wanted to share it as an example of the way in which these products have given hope to so many people.

The story is that this long-time smoker developed liver cancer and was not allowed onto the transplant list because he was unable to get off of cigarettes. Despite trying the "recommended" therapies, he was just unable to quit. This in spite of the refusal of the medical provider to offer him the potentially life-saving transplant until he is able to successfully quit smoking for a sustained period of time.

Well he tried a product that is not recommended by anti-smoking groups and the FDA: electronic cigarettes. He was finally able to quit successfully and very soon will be put on the transplant list and enabled to receive that life-saving liver.

The Rest of the Story

This is exactly the type of miraculous, hope-filled story that many anti-smoking groups and advocates want to put to an end.

Authors of Electronic Cigarette/Quitline Article Fail to Disclose Significant Conflict of Interest

Two weeks ago, I discussed a new study that appeared online ahead of print in the journal Nicotine & Tobacco Research. The study reported on the efficacy of electronic cigarettes in smoking cessation. However, instead of estimating cessation rates among a cohort of smokers who made quit attempts using these products, the study analyzed cessation rates of a large number of smokers who had previously tried to quit using e-cigarettes but failed, and then called a quitline because they had failed and wanted to try again. Then, it compared the quit rate among these smokers to that among smokers without such a history of a failed quit attempt using electronic cigarettes. In other words, this study did not estimate quit rates among smokers trying to quit using e-cigarettes. Instead, it estimated quit rates among many smokers who were not using e-cigarettes in their quit attempt at all! I showed, further, that the results of this study are being misused by anti-smoking advocates to argue that electronic cigarettes are not effective for smoking cessation.

Today, I reveal that the authors of the study hid a significant conflict of interest that I believe should have been reported.

At the end of the article, under the section entitled "Declaration of Interests," the article states: "None declared." Thus, the authors are denying that there are any relevant conflicts of interests related to this work.

The Rest of the Story

The truth is that there are two major financial conflicts of interest that the authors are apparently hiding and which should have been disclosed.

Note, first, that the authors are employed by (and the study funded by) Alere Wellbeing, a company which provides commercial smoking cessation services, including the administration of state tobacco quitlines which tend to use the Quit for Life program. This program relies heavily upon the use of nicotine replacement therapy (NRT and other drugs), but shuns the use of electronic cigarettes.

First, the article reports cessation rates among callers to six state tobacco quitlines. What the article does not make clear is that these programs are run by Alere Wellbeing, which has contracts (i.e., it receives lots of money) to administer these programs. Moreover, Alere Wellbeing has a vested interest in reporting high levels of success with its programs. Obviously, if its evaluations were to report low smoking cessation rates, states would be less likely to contract with Alere Wellbeing for smoking cessation services. Thus, the company (and these authors) has a strong financial conflict of interest: the company makes money and its profits are dependent upon reporting high levels of success with its services.
 
That this conflict of interest was not reported in the paper is mind-boggling to me. It is difficult for me to think of a conflict that would be more severe or more significant than this one. If this is not a conflict of interest, then I don't know what is!

Not only is there the threat that states could turn to other commercial programs if Alere reports low cessation rates, but states as a whole might put less money into these types of programs if they don't work very well. In fact, Alere Wellbeing readily acknowledges that state funding cuts represent a significant threat to profits, writing:

"Future reductions in state spending on existing preventative care programs could reduce our net revenues, net income and cash flows. Due to budgetary shortfalls, many states are considering, or have enacted, cuts to existing preventative care programs. These cuts have included, or may include, elimination or reduction of coverage for some or all of our preventative care programs. For example, in 2011, several states reduced their funding of smoking cessations programs provided by our Alere Wellbeing business. During 2011, approximately 58% of the net revenue of our Alere Wellbeing business was derived from sales to state governments. Continued state budgetary pressures could lead to further reductions in funding for our services which, in turn, could have a material adverse effect on our financial position and operating results."

Elsewhere in its annual report, Alere reiterates that its revenue depends upon continued levels of state funding for quitline services: "Wellness net product sales and services revenue from our Alere Wellbeing business, formerly known as Free & Clear, has been negatively impacted as a result of the continuation of decreased funding under certain states’ quitline programs."

Clearly, this is a conflict of interest that should have been reported in the article.

We are not just talking about small potatoes here. In its annual report, the intangible asset value acquired from the acquisition of Free & Clear (now Alere Wellbeing) from customer relationships is listed at $36 million. Don't you think it would be of importance to journal readers to understand that this article is evaluating a service that is provided by the company for which these authors work? How would readers react if they found out that the article is hiding the fact that the services being evaluated in the paper are worth perhaps $36 million to the company that is sponsoring the study?

As if this first conflict were not enough, there is a second major conflict of interest. Alere Wellbeing's business depends upon producing data showing that its services are effective. But the business also depends on the absence of significant competition. Electronic cigarettes represent what is probably the greatest potential competition to existing smoking cessation services. Thus, this also represents a significant conflict of interest that should have been disclosed.

The journal Nicotine & Tobacco Research is very clear that all competing interests must be disclosed. The journal puts no qualifications on this reporting: all competing interests are to be reported. The journal's guidelines state: "...all authors must disclose any competing interests in a Competing Interests section."

To make it eminently clear, this article does specifically report on the effectiveness of the services provided by Alere Wellbeing. In Table 2, the article provides the 7-month quit rates (30-day abstinence) for quitline callers. It turns out that this figure was 27%. It should be easy for readers to see that this figure has significant financial implications for Alere Wellbeing.

Say, for example, that the article had reported a 7-month quit rate of only 6%. This would suggest that the services provided are quite ineffective and would obviously have negative potential financial implications for the company. How can this possibly not be considered a significant competing interest?

Now to be clear, I am not arguing that the authors have intentionally or unintentionally altered their data or analyses to come up with this 27% figure. In fact, I am not actually arguing that there was any conscious bias present. My point is simply that there is undeniably a competing interest present and that it should have been reported.

In the absence of this disclosure, the rest of the story is that this article hides a significant conflict of interest that journal readers should have been made aware of. Hopefully, this error will be corrected in an erratum statement in a subsequent journal issue.


DOCUMENTATION THAT THE ARTICLE REPORTS ON SERVICES PROVIDED BY THE SPONSORING COMPANY

According to the article, the data presented come from six state quitlines: Connecticut, Louisiana, Nebraska, North Carolina, South Carolina, and Texas.

The article does not disclose that the sponsoring company makes money off of these quitlines and therefore has a financial interest in reporting a high 7-month quit rate in this study.

Below is documentation that the quitlines in each of these states are administered, or have been administered, by Alere Wellbeing (formerly Free & Clear):

Connecticut
"Connecticut Quitline is funded by the Connecticut Department of Public Health and administered by Alere Wellbeing, a commercial tobacco treatment provider."

Louisiana
"The Louisiana Tobacco Quitline, 1-800-QUIT-NOW, is a free, confidential, 24-hour helpline that links individuals who want to quit using tobacco with trained Quit Coaches®. The Quitline is funded by the LTCP and The Louisiana Campaign for Tobacco-Free Living; it is administered by Free & Clear, Inc."

Nebraska
"©2013 Alere, Inc. All rights reserved."

North Carolina
"©2013 Alere, Inc. All rights reserved."

South Carolina
"The Quitline is a contractual partnership between the S.C. Department of Health and Environmental Control and Alere Wellbeing, Inc., a Seattle-based tobacco treatment and behavioral health provider with vast experience running quitlines across the nation."

Texas
"Funder of quitline services: Texas Department of State Health Services

Operator of counseling services: Alere Wellbeing"

A Failing Grade: Massachusetts Spends Less than 1% of Cigarette Revenues on Tobacco-Related Programs

Massachusetts was once a leader in the tobacco control movement. In 1992, voters approved a ballot initiative - Question 1 - which increased the excise tax on cigarettes by 25 cents per pack and allocated the revenues towards a comprehensive statewide tobacco control program. In its heyday, the program funded education, prevention, research, and treatment programs to the tune of more than $50 million per year. The state's anti-smoking media campaign alone - at $13 million per year - was responsible for cutting the smoking initiation rate among Massachusetts adolescents in half.

Thanks to a trio of governors who subverted the voters' intentions in passing Question 1 - William Weld, Jane Swift, and Mitt Romney - the program was decimated: it was cut by more than 95% and now exists in merely skeleton form at about $4.5 million per year.

An article in Monday's Lowell Sun reveals that despite having one of the highest taxes on cigarettes in the nation, Massachusetts spends less than a paltry 1% of cigarette revenues on tobacco control programs. Thus, the state has gone from having a model tobacco control program to having a mere skeleton of a program. Accordingly, progress in reducing youth and adult smoking in the Commonwealth has been stunted.

According to the article, the state receives a whopping $815 million per year from tobacco taxes and Master Settlement Agreement payments, yet allocates less than 1% of these funds for tobacco control. And although the administration has proposed a further $1 per pack cigarette tax increase, none of the resulting revenue would be devoted to tobacco-related programs.

The Rest of the Story

The decimation of the Massachusetts Tobacco Control Program corresponds directly with the initiation of the Campaign for Tobacco-Free Kids' new strategy of promoting and supporting any and all cigarette tax increases, without an insistence that a substantial proportion of the revenue be allocated for tobacco control. In my opinion, it was the Campaign for Tobacco-Free Kids that destroyed the previous wisdom in the movement that cigarette tax revenue allocated to comprehensive statewide tobacco control programs was the model and should be pursued in all states.

I have pointed out a number of reasons why this change in tobacco control strategy was destructive, in addition to its having resulted in the states realizing that they no longer needed to worry about allocating cigarette tax money towards cigarette prevention, education, research, and treatment programs. First, for the majority of lower-income smokers, tax increases will result not in smoking cessation, but in continued smoking at a greater expense and at a higher proportion of overall income. This may have adverse consequences -- and even adverse health consequences -- and may be particularly problematic for the families and children of lower-income smokers, who may actually suffer as a result of these policies.

Second, these policies make essential government programs dependent upon continued high levels of cigarette consumption for their solvency.

Third, they create a financial partnership between the states or the federal government and Big Tobacco.

Fourth, they reduce (if not eliminate) the incentive for state legislatures to enact any policy that would actually make a serious dent in smoking prevalence, because such policies would severely harm the budget, which (now) relies upon cigarette sales to fund its most essential programs and services.

It was the Campaign for Tobacco-Free Kids that developed the mindless mantra that using cigarette taxes to fund essential government programs is a "win-win-win" proposition. But as I have argued:

"These are not win-win-win propositions. There is a win, but unless the policy is properly crafted, that win comes at the expense of a number of losses: regressivity, lack of fairness, increased burdens upon lower-income populations, increasing health disparities, a government dependence upon continued cigarette consumption to fund critical programs, an unhealthy fiscal partnership between the states and Big Tobacco, and the elimination of any incentive to enact meaningful tobacco policies that would actually make a serious dent in smoking prevalence. The cigarette tax policies may actually be making it more difficult - if not impossible - for the more effective non-price policies to be implemented."

What is the solution? How can tobacco control be restored at the state level?

The problem is not going to be resolved until the Campaign for Tobacco-Free Kids ends its knee-jerk support for all cigarette tax increases and withdraws its support from proposals unless they allocate a substantial portion of the revenues to comprehensive statewide tobacco control programs.

Inane Statement of the Year: South Carolina Anti-Smoking Advocates Claim that Completely Discontinuing Smoking is Not the Same as Quitting Smoking

What's the definition of quitting smoking?

A simple question, you might think.

But apparently not so simple to anti-smoking advocates in South Carolina, who have come up with quite a strange definition of their own.

Take this scenario:

A 56-year old man, who has smoked 2 packs per day for 35 years and has unsuccessfully tried to quit using nicotine patches and gum tries electronic cigarettes in an attempt to quit smoking. He succeeds and is able to go from smoking about 40 cigarettes per day to smoking 0 cigarettes per day. In fact, he quits smoking and is abstinent from cigarette smoking for twelve months.

Question: Has this individual quit smoking?

A. Yes
B. No

Most reasonable people would answer A. Yes, this smoker went from smoking 2 packs per day to smoking 0  cigarettes per day. He has not smoked for 12 straight months. So yes, of course, he has successfully quit smoking.

Not so, according to some anti-smoking advocates in South Carolina. They argue that since he continues to vape, he has not quit smoking. He is still a smoker in their eyes.

The Rest of the Story

According to an article in the Times and Democrat (Orangeburg, SC), two anti-smoking advocates in South Carolina believe that if someone quits smoking using electronic cigarettes, she has neither quit smoking nor discontinued tobacco use:

"Melissa Watson, a Columbia health counselor ... believes e-cigarettes, while potentially helpful from solely a harm reduction standpoint, are not useful in actually kicking the habit. She said the problem with e-cigarettes is they are designed to simulate smoking, while the commonly used nicotine gums and patches are not. “What’s the end goal?” she asked. If the patient intends to fully quit tobacco use, she said, e-cigarettes are not the way to go."

So Watson is saying that if someone successfully quits smoking using e-cigarettes, she has not actually quit smoking, even though she no longer uses any combusted tobacco product, or any tobacco product for that matter. Watson argues that this ex-smoker is still a tobacco user, even though there is no tobacco in the electronic cigarette.

But that's not the end of the story.

According to the article: "Dr. Scott Strayer of the University of South Carolina Medical School shares a similar opinion. He noted that no studies yet prove that e-cigarettes are healthier or helpful in quitting. A former smoker of 15 years, Strayer said quitting is about “behavior change.” This can be difficult to achieve when still reliant on smoking something, even if it is electronic."

So again, Dr. Strayer as well believes that if a 40 pack-year smoker quits by using non-tobacco electronic cigarettes, he has not actually changed his behavior. He hasn't achieved the desired behavior change (which was quitting smoking).

So much for reason and logic.

Now you can see the problem we are facing in public health. The ideology against the physical act of holding something that looks like a cigarette is so strong that some anti-smoking advocates don't even recognize that someone who has quit smoking using electronic cigarettes has quit smoking. These anti-smoking advocates don't even appear to understand that a person who quits smoking using electronic cigarettes is no longer using tobacco.

Apparently, what bothers these advocates is the simple act of doing a behavior that looks like smoking.

It is also disheartening to see that Dr. Strayer is not convinced that smoking is any more hazardous than vaping. Hopefully, he is not telling his patients what he apparently told the Times and Democrat: that there is no evidence that cigarette smoking is any more hazardous than using a non-tobacco, non-combustion product that has been demonstrated to have levels of carcinogens that are orders of magnitude lower than cigarettes and which have been demonstrated not to impair acute lung function.

Any physician who advises his patients not to try to quit smoking using an electronic cigarette because they may not be improving their health by quitting in this way is not only committing malpractice, in my opinion, but she also needs a remedial course in basic chemistry and toxicology.

There is plenty of room for debate about the appropriate role for electronic cigarettes in smoking cessation strategy. However, if opponents of electronic cigarettes can't even acknowledge that someone who quits smoking using electronic cigarettes has indeed quit smoking and no longer uses tobacco, then there is no basis for rational, scientific discussion.

German Cancer Research Center Lies about Health Effects of Electronic Cigarettes to Scare Users and Unfairly Influence EU Directive

According to the German Cancer Research Center, the inhalation of glycerin can cause lipoid pneumonia. Lipoid pneumonia is a form of pneumonia - lung inflammation - in which lipids (oils) accumulate in the bronchial tree. It can be caused by exogenous factors, such as the inhalation of oils.

A report on electronic cigarettes from the German Cancer Research Center states: "Glycerine may cause lipoid pneumonia on inhalation."

This is a serious assertion because if true, then the use of electronic cigarettes would be quite unsafe. Glycerin is a common component of a huge majority of electronic cigarettes on the market and it is inhaled in significant quantities by electronic cigarette users. If this inhalation of glycerin could cause lipoid pneumonia, then electronic use would be unduly risky. In fact, if the German Cancer Research Center's assertion is true, I would have to reverse my recommendation that these products are a viable alternative for smoking cessation.

The major purpose of the release of this report by the German Cancer Research Center was to influence the upcoming European Union deliberations on its proposed tobacco product directive. The initial draft of that directive bans electronic cigarettes. Based in part on its conclusion that the inhalation of one of the most common ingredients in electronic cigarettes causes lipoid pneumonia, the report recommends that electronic cigarettes be banned, unless they are shown to be safe in clinical trials. However, if it is true that glycerin inhalation causes lipoid pneumonia, then these products would not (and should not) ever be approved as smoking cessation drugs or devices.

The Rest of the Story

Since I've noted that if the inhalation of glycerin causes lipoid pneumonia I would discontinue my support for electronic cigarettes as a smoking cessation product and since the German Cancer Research Center asserts that glycerin does cause lipoid pneumonia, I suppose it is time for me to make a major announcement:

I hereby withdraw my support of electronic cigarettes as a viable and relatively safe smoking cessation product.

Cancel that.

Because there is a rest of the story.

The rest of the story is that the German Cancer Research Center is lying.

It is not true that glycerin causes, or can cause, lipoid pneumonia. In fact, it is impossible for glycerin inhalation to cause lipoid pneumonia.

The reason?

Lipoid pneumonia is caused by the inhalation of oils. But glycerin is not an oil!

Basic chemistry tells us that glycerin is an alcohol. Specifically, it is a polyol, which is a compound with multiple hydroxyl groups. The hydroxyl group (OH) is the hallmark of an alcohol. Oils, on the other hand, are characterized by the presence of either a carboxyl group (COOH) or a sterol. The bottom line is that glycerin is not an oil, but an alcohol.

In fact, glycerin is soluble in water and alcohol, but not in oil. This is because of the three hydroxyl groups.

If glycerin was in fact a cause of lipoid pneumonia, the FDA would not have approved its widespread use in medications such as cough syrups, expectorants, and mouthwashes, because of the risk that accidental aspiration of these products could cause lipoid pneumonia.

It will be interesting to see if the German Cancer Research Center corrects this serious error. It is particularly serious because it is the difference between electronic cigarettes being relatively safe and electronic cigarettes being absolutely unsafe and unsuitable for use.

Of course, if the German Cancer Research Center's statement were true, we would have seen many cases of lipoid pneumonia in vapers by now because there are millions of people who inhale glycerin daily from these products. 

It is theoretically possible that lipoid pneumonia could result from an electronic cigarette product that used oils in its formulation. For example, a product that used essential oils in a flavoring or fragrance would introduce a real - although still very small - risk. It is certainly legitimate to ask regulators to ensure that oils are not used in these products. However, the contention that glycerin itself does or can cause lipoid pneumonia is a manufactured lie.

It is unfortunate that this report is providing such extreme misinformation in an apparent attempt to influence the European Union's consideration of the tobacco product directive. It would be a shame if the EU were to ban electronic cigarettes because of this absolutely false information.

This appears to be another example of an anti-smoking organization which is manipulating the truth (i.e., lying) in order to promote its apparently pre-determined, ideology-based opposition to electronic cigarettes.

If the German Cancer Research Center wanted to do one thing to prevent cancer, it would start by embracing this product - which has the potential to save thousands of lives - as an alternative to smoking and a viable harm reduction strategy. Instead of being regulated as pharmaceuticals (which would result in a de facto ban of the product), they should be regulated as alternative (much safer) nicotine delivery products.


(Special thanks to Dr. Konstantinos Farsalinos for scientific insights that I incorporated into this post.)

Sacrificing Children's Health for Politics: American Cancer Society Sinks to a New Low

Yesterday, I revealed that the American Cancer Society is actually opposed to legislation that would ban the sale of electronic cigarettes to minors, noting how odd this position is, as even the electronic cigarette industry supports such measures. In trying to explain the possible reason for the ACS opposition to such a simple, common sense public health policy, I shared Dr. Carl Phillips' hypothesis that the ACS actually wants kids to be unprotected from e-cigarette sales so that these products appear to be a greater problem, leading the FDA to ban or heavily restrict the products even for adults.

Dr. Phillips theory: "It might sound over-the-top to suggest that ACS et al. would sacrifice the children in pursuit of their real goals, but I have not thought of or heard any other explanation for the behavior that has been observed."

Today, I reveal that the American Cancer Society has admitted that Dr. Phillips is correct. This is no longer just a theory. This is a bona fide explanation for the ACS position on this issue. And the ACS admits it.

The Rest of the Story

Senate Bill 1209 in Arizona is a very simple measure that does nothing other than add electronic cigarettes to the list of tobacco products whose sale to minors is prohibited. In Arizona, the sale to youth of cigarettes, cigars, cigarillos, smokeless tobacco products, and hookah is already prohibited. This legislation would do nothing other than to add electronic cigarettes to the ban. It doesn't change state law in any other way.

There is absolutely no reason, from a public health perspective, why it should remain legal to sell electronic cigarettes to minors. Virtually no one opposes this common sense measure. The electronic cigarette companies are on board and many already restrict access to their web sites and/or have very clear statements that their products are not intended for minors.

Why in their minds would any group actually want children to have access to electronic cigarettes?

The perverse answer is that the American Cancer Society is afraid that the widespread passage of state laws prohibiting the sale of electronic cigarettes to minors will hinder its efforts to place stringent restrictions on the availability of these products for adults. The ACS wants to get rid of the whole category of products ... period. But if the sale of e-cigarettes to minors is banned in most states, then it becomes much more difficult to argue that e-cigarettes remain a threat to the health of children, an argument that is critical to the ACS in its efforts to get these products off the market or severely restricted.

The ACS tips its hand in an April 22 letter to an Arizona state senator, a letter which opposes Senate Bill 1209. The reason for this opposition is that by banning the sale of electronic cigarettes to minors, "it sets the stage for tobacco companies to claim they are protecting children via this legislation...". In other words, the ACS opposes this bill because it doesn't want companies to be able to claim that they have helped address the potential problem of youth e-cigarette use by statutory sales restrictions. The ACS actually wants the sale of e-cigarettes to minors to remain unregulated so that it can convince the FDA that e-cigarettes are a major problem: their sale to minors is unregulated and thus the risk of youth taking up vaping is very high. This argument is essential in getting the FDA to take extreme action against all use of electronic cigarettes. If youth truly are protected from e-cigarette sales, then the problem will not appear to be as severe.

In other words, the ACS is working to make sure that sales of e-cigarettes to minors remain a problem, giving it ammunition in its desire to essentially get rid of these products altogether. And why does the ACS oppose all e-cigarette use? Again, they tip their hand: "The use of these products by adults could have a serious negative impact on the social norms around smoking especially around children."

Thus, the ACS opposition to e-cigarettes is ideological: they can't stand the idea of a behavior that looks like smoking, even if that behavior is helping to save thousands of lives.

Sadly, in its letter, the ACS demonstrates that it is willing to say anything for political purposes, even if they make assertions which contradict other statements they have made:

On its web site, the ACS asserts as follows: "We do know that e-cigarettes can lead to nicotine addiction, especially in young people who may be experimenting with them, and may lead kids to try other tobacco products, many of which are known to cause life-threatening diseases."

So according to the ACS, we have the scientific evidence needed to conclude that e-cigarettes can lead to nicotine addiction in young people who are experimenting with them.

However, in its letter to the Arizona Senate, the ACS claims: "Very little is known about the use of electronic smoking devices by youth...".

Well, which is it?

In the former statement, the ACS' goal is to scare the public about how much of a threat electronic cigarettes pose to minors. So they manufacture evidence (which doesn't exist) to show that these products are leading to nicotine addiction among young people.

In the latter statement, the ACS' goal is different. Here, they want to convince the Arizona Senate that e-cigarette use among youth is not a problem, negating the need for this new legislation. So the ACS now claims that there is no evidence that youth are actually using these products.

It is unfortunate enough that the American Cancer Society is sacrificing scientific integrity and honesty for political purposes. But it is despicable that the organization would sacrifice the health of children, and use them as pawns in a political game.

American Cancer Society Opposes Banning the Sale of Electronic Cigarettes to Minors

In 2013, everyone is sensible enough to believe that the sale of e-cigarettes to minors should be prohibited.

Most public health advocates agree.

The tobacco companies agree.

Even the electronic cigarette companies agree.

However, there is apparently one group that believes e-cigarettes should continue to be available to minors and which opposes the ban on the sale of e-cigarettes to youth:

The American Cancer Society.

The Rest of the Story

As reported by Dr. Carl Phillips over at his tobacco harm reduction blog, the American Cancer Society is leading the fight to prevent the sale of electronic cigarettes to minors. Dr. Phillips cites testimony given by the American Cancer Society in opposition to a provision in state legislation in Rhode Island that would have prevented the sale of electronic cigarettes to youth under 18 years of age.

An excerpt of the ACS testimony follows:

"Good afternoon, Chairman.  I’m Susan Roberts.  I am the State Director of Governmental Relations and Advocacy for the American Cancer Society Cancer Action Network.  And again, I want to reiterate what my former colleague testified to, that we really appreciate that the chairman has taken a look at protecting our youth here in Rhode Island. We do have some concerns about this bill, and we also recognize that you realize that this bill has an identity crisis.  It looks like a Trojan horse to us.  I mean, it is coming to us saying that it’s protecting youth, and, in fact, what it’s really doing is circumventing some things we didn’t really get into a little bit today:  FDA regulation of these products. ... So that is of great concern because right now, FDA is looking at these products to figure out how safe and effective they really are, and we want to wait. ... It’s essential that we wait until we get guidance from FDA before we even put in any kind of ban for the products for youth."

So let's get this straight. We need to wait before we protect youth from electronic cigarettes. We have to wait before we ban the sale of these products to minors. The ACS, in other words, wants - for the time-being - for electronic cigarettes to remain freely available to youth.

So why is the ACS one of the only groups in the nation to oppose banning the sale of e-cigarettes to minors?

I can think of no better answer than the one Dr. Phillips offers: "This really leaves only one apparent explanation that we can think of for the policy of trying to stop states from banning e-cigarette sales to minors:  The American Cancer Society and their allies prefer that more children use e-cigarettes because that would look bad for e-cigarettes. It is fairly clear that their political faction is trying to bring about a ban or similar crippling restrictions on adult access to e-cigarettes."

So the rest of the story is, that as Dr. Phillips puts it: "It might sound over-the-top to suggest that ACS et al. would sacrifice the children in pursuit of their real goals, but I have not thought of or heard any other explanation for the behavior that has been observed."

Anti-Smoking Advocate Uses Bogus Research to Deny Overwhelming Scientific Evidence on Electronic Cigarettes

On his tobacco blog, Stan Glantz is citing research published this month in the journal Nicotine & Tobacco Research to support his contention that electronic cigarettes are not useful in smoking cessation. Stan goes so far as to direct former Surgeon General Carmona to stop claiming that these products may help people to quit smoking.

Stan writes: "Katrina Vickerman and colleagues collected information on e-cigarette use from people who called state quitlines in Connecticut, Louisiana, Nebraska, North Carolina, South Carolina, and Texas.  Nearly one third (30.9%) of respondents reported ever using or trying e-cigarettes; most used for a short period of time (61.7% for less than 1 month). Consistent with what other surveys have found, the most frequently reported reasons for use were to help quit other tobacco (51.3%) or to replace other tobacco products (15.2%). Most important, both e-cigarette user groups were significantly less likely to have quit smoking 7 months after first calling the quitline compared with participants who had never tried e-cigarettes: Only 21.7% of people who used e-cigarettes to help quit and 16.6% of those who used e-cigarettes to replace other tobacco products had quit compares to 31.3% of people who did not use e-cigarettes (p < .001)."

The Rest of the Story

What Stan does not reveal is that instead of estimating cessation rates among a cohort of smokers who made quit attempts using these products, the study analyzed cessation rates of a large number of smokers who had previously tried to quit using e-cigarettes but failed, and then called a quitline because they had failed and wanted to try again. Then, they compared the quit rate among these smokers to that among smokers without such a history of a failed quit attempt using electronic cigarettes.

In other words, this study did not estimate quit rates among smokers trying to quit using e-cigarettes. Instead, it estimated quit rates among many smokers who were not using e-cigarettes in their quit attempt at all!

The truth is that many of the electronic cigarette users in the study did not use electronic cigarettes in their quit attempts! According to data provided in the paper, a full 28% of the sample of electronic cigarettes did not use these products in their quit attempts.

It should be clear to readers that this study was poorly designed to investigate the efficacy of electronic cigarettes. The study systematically sampled a group of quitline callers who were unsuccessful using electronic cigarettes. These people tried and failed using electronic cigarettes. How do we know they failed? Because they wouldn’t have had to call the quitline if they weren’t still smoking. This is clearly a harder core group of smokers and it is no surprise that their cessation rates were lower after 6-months than the comparison group. The study tells us nothing about the effectiveness of electronic cigarettes, other than that they do not work for everyone. This is exactly the kind of biased research, designed specifically NOT to find an effect of electronic cigarettes, that is characterizing the anti-smoking movement today, guided by an ideology that is apparently opposed to anything that merely looks like smoking, no matter how much safer it may be. Apparently, the researchers had already reached a pre-determined conclusion and the study was apparently designed to find no effect. Any researcher sincerely interested in testing the efficacy of electronic cigarettes would not test the research question in this way.

If the tobacco industry conducted precisely this same study in order to conclude that electronic cigarettes are ineffective as a smoking cessation tool, we would call it scientific fraud. What should we call the same study, but conducted by a company that makes its money by convincing the public that traditional methods for smoking cessation should remain the mainstay of treatment?

 

The rest of the story is that leading anti-tobacco researchers and advocates are now relying upon shoddy science to support what appears to be their pre-determined conclusions. I continue to be dismayed by the loss of scientific integrity in the tobacco control movement. The movement is so blinded by ideology that it has truly lost sight of the scientific quality of evidence. The quality no longer matters, merely the direction of the findings.

Study Shows No Acute Respiratory Health Effects from Active or Passive Vaping

A study published earlier this year in the journal Inhalation Toxicology reports that neither active nor passive vaping has any acute adverse effects on lung function among adult subjects.

(See: Flouris AD, et al. Acute impact of active and passive electronic cigarette smoking on serum cotinine and lung function. Inhalation Toxicology 2013; 25(2): 91-101.)

In the study, a sample of 15 smokers had their lung function measured before and after smoking, and before and after using an electronic cigarette. A sample of 15 nonsmokers had their lung function measured before and after exposure to secondhand smoke, and before and after exposure to secondhand vapor from electronic cigarettes.

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 Rest of the Story

This is an important study because it demonstrates that neither active nor passive vaping is associated with any significant impairment of lung function, as measured by spirometry. While this does not rule out a long-term respiratory effect, it is the first step in demonstrating the respiratory safety of these products, as long-term damage from inhaled substances usually results from mechanisms that occur acutely. Certainly, for tobacco smoke, acute respiratory impairment can be readily demonstrated. That this is not the case with e-cigarette vapor helps support the notion that these products are not damaging to the respiratory tract and certainly supports the conclusion that vaping is much safer than smoking in terms of respiratory health impact.

Will the anti-smoking groups which oppose electronic cigarette use pay any attention to this study? I doubt it because they have apparently reached a pre-determined conclusion regarding these products and I don't think scientific evidence is of much concern to them.

The Dangers of Funding Government Programs With Cigarette Tax Revenues: French Government Delays Tobacco Price Increase Because Too Many Smokers Have Quit

According to an article in the New York Times, the French government, in an effort to prevent too many smokers from quitting and therefore seeing a decline in cigarette tax revenue, has reached an agreement with tobacco manufacturers to delay a price increase that had been scheduled to take effect in July.

According to the article: "Governments have an ambivalent attitude about tobacco, on the one hand lecturing smokers at every turn to abandon nicotine, while with the other hand raking in cigarette sales taxes to finance their treasuries. The anomaly was underlined on Friday with a reported agreement by the French government and tobacco manufacturers to delay a scheduled price increase for three months because too many smokers have quit. In the first quarter of 2013, for the first time in 10 years, the value of French tobacco sales fell. ... The next price and tax increases were due in July, but the makers have agreed to take a short-term hit by delaying an estimated 5 percent price increase until October, according Les Echos, the French business daily.

“Neither the manufacturers nor the finance ministry has an interest in seeing the volume of sales continue to fall,” Les Echos wrote. Government policy is based on moderate and progressive price rises to encourage smokers to give up, without precipitating a fall in the value of tobacco sales that would also hit tax revenues, according to the newspaper."

The Rest of the Story

This story beautifully illustrates the folly of funding essential government programs using cigarette tax revenue. As I have repeatedly argued, this creates a dependence of the government on continued high levels of cigarette consumption and removes any incentive to substantially reduce smoking.

When cigarette smoking falls dramatically, it reduces revenue and therefore makes essential government programs fiscally insolvent. This creates an ironic incentive for the government to join the tobacco industry in helping to promote continued cigarette smoking. This story is a perfect illustration of this phenomenon.

New Study Warns of Dangers of Thirdhand Smoke in Nonsmoking Hotel Rooms Located in Hotels that Allow Smoking in Some Rooms

A study published online ahead of print in Tobacco Control warns of the dangers of thirdhand smoke (THS) exposure in nonsmoking hotel rooms in hotels with partial smoking bans (meaning that both smoking and nonsmoking rooms are available).

(See: Matt GE, et al. Thirdhand smoke and exposure in California hotels: non-smoking rooms fail to protect non-smoking hotel guests from tobacco smoke exposure.)

The methods are described as follows: "A stratified random sample of hotels with (n=10) and without (n=30) complete smoking bans was examined. Surfaces and air were analysed for tobacco smoke pollutants (ie, nicotine and 3-ethynylpyridine, 3EP)."

The results were as follows: "Compared with hotels with complete smoking bans, surface nicotine and air 3EP were elevated in non-smoking and smoking rooms of hotels that allowed smoking. Air nicotine levels in smoking rooms were significantly higher than those in non-smoking rooms of hotels with and without complete smoking bans. Hallway surfaces outside of smoking rooms also showed higher levels of nicotine than those outside of non-smoking rooms."

The study concludes as follows: "Partial smoking bans in hotels do not protect non-smoking guests from exposure to tobacco smoke and tobacco-specific carcinogens. Non-smokers are advised to stay in hotels with complete smoking bans. Existing policies exempting hotels from complete smoking bans are ineffective."

The Rest of the Story

Readers of the conclusions of this study might be surprised to find out that the study found no significant difference in air nicotine levels in nonsmoking rooms in hotels with partial smoking bans and those in nonsmoking rooms in hotels with complete smoking bans.

In fact, the most significant finding of the study with regards to significant health effects was that the mean level of air nicotine in nonsmoking rooms in hotels with partial smoking bans was 28.9 ng/m3 (95% confidence interval, 14.2-57.9), compared to a mean level of 20.5 ng/m3 (95% confidence interval, 7.4-54.2) in nonsmoking rooms in hotels with complete smoking bans. These confidence intervals greatly overlap and the differences in mean air nicotine levels are not significantly different.

In contrast, the mean air nicotine level in smoking rooms was 452.4 ng/m3.

A reasonable interpretation of these data is that there was no evidence that staying in a nonsmoking room in a hotel with a partial smoking ban posed any significant health effects, as it was not associated with any significant increase in exposure to airborne tobacco smoke.

How, then, can the authors conclude that designated nonsmoking rooms in hotels are not sufficient to protect nonsmokers?

Well, they rely upon the finding that nonsmoking rooms in hotels with partial smoking bans had slightly higher levels of surface nicotine. The surface nicotine levels averaged 3.7 ug/m2, as opposed to 1.4 ug/m2, and compared to an average of 51.8 ug/m2 in smoking rooms. This slight increase in surface nicotine resulted in higher finger nicotine levels. However, it did not result in increased nicotine exposure, as the urine cotinine levels were not significantly higher in nonsmoking confederates who stayed in hotels with a partial smoking ban compared to hotels with a complete smoking ban.

Thus, the study has demonstrated that there is no significant difference in nicotine exposure (and presumably exposure to other constituents of tobacco smoke) among nonsmokers who stay in a hotel with a partial smoking ban compared to those who stay in a hotel with a complete smoking ban.

That major finding would lead me to conclude that there is no significant health risk associated with staying in a nonsmoking room in a hotel that allows smoking in some rooms. It would also lead me to conclude that partial smoking bans do indeed work in terms of preventing tobacco smoke exposure for guests staying in nonsmoking rooms.

That the paper suggests the opposite is in conflict with the actual findings of the paper and suggests that there was a pre-determined conclusion and a pre-determined agenda that guided this research.

Live Blogging from the TMA Annual Meeting: Mitch Zeller Address

I am listening to Mitch Zeller, the new director of the FDA Center for Tobacco Products, address the TMA Annual Meeting. I will try to summarize his main points as he speaks:

1. The FDA is committed to enhancing communication with all stakeholders, including the tobacco industry.

2. The FDA has three immediate priorities:
a. To deal with the backlog of substantial equivalence determinations.
b. To deal with the menthol issue.
c. To issue regulations regarding alternative tobacco products (e.g., electronic cigarettes, dissolvable tobacco).

3. The FDA is close to releasing scientific guidance regarding substantial equivalence applications, and is close to making decisions on many of those applications.

4. The FDA is relatively close to releasing decisions and/or regulations regarding menthol cigarettes and alternative tobacco products. However, no definite timeline can be provided at this time.

5. In terms of modified risk products: although a product may greatly reduce harm at the individual level, the agency must look at population-level effects, including whether the marketing of the product will lead to higher rates of smoking initiation and/or lower rates of smoking cessation.

6. In terms of his long-term view of what the FDA can do to reduce tobacco-related disease, the development of tobacco product standards is critical and can play a major role.

In response to questions posed by the audience, here is a quick summary of my take-away:

1. It is clear that the agency is going to be doing something about menthol. It is not clear what, but my sense of Mitch's response to a question on this issue is that there is something underway at the agency regarding menthol.

2. The FDA is happy to meet with any and all stakeholders to obtain their input.

3. The CTP will be much more responsive to industry queries moving forward.

New Study Purports to Estimate Efficacy of Electronic Cigarettes By Studying Quit Rates for Select Group of Smokers who Failed to Quit Using E-Cigarettes

Imagine that you are a tobacco company and you are concerned about the potential threat posed by electronic cigarettes. You want to deflate the enthusiasm about these products by producing a study which shows that quit rates among smokers who try to quit using electronic cigarettes are very low and are in fact lower than quit rates for smokers who use other cessation methods.

Clearly, the proper way to conduct such a study would be to take a sample of smokers who made quit attempts using electronic cigarettes and compare their success with a sample of smokers who made quit attempts using other methods.

However, conducting such a study presents a risk: you might find that smokers who try to quit using e-cigarettes actually do better than those who try to quit using traditional methods, which you know have dismal success rates.

What, then, is a sure way of finding low quit rates that you can then report in a paper?

A great way to "manufacture" such a result would be to selectively choose a sample of smokers who tried to quit using electronic cigarettes and failed, and then to wait until they call a quitline and then see what proportion are able to quit at that point. Even though these smokers may not be actually trying to quit using electronic cigarettes when they call the quitline, you would count them as electronic cigarette users and attribute their cessation rates to the electronic cigarette group. You could then compare this group with smokers who did not fail a quit attempt using electronic cigarettes.

Or course, if a tobacco company conducted such a study in this way, it would be considered an example of scientific fraud. This is not objective science.

The Rest of the Story

Yesterday, a new study appeared online ahead of print in the journal Nicotine & Tobacco Research. To my shock, the study did exactly what the hypothetical tobacco industry study above did!

The study was purported designed to examine the efficacy of electronic cigarettes in smoking cessation. However, instead of estimating cessation rates among a cohort of smokers who made quit attempts using these products, the study analyzed cessation rates of a large number of smokers who had previously tried to quit using e-cigarettes but failed, and then called a quitline because they had failed and wanted to try again.

Then, they compared the quit rate among these smokers to that among smokers without such a history of a failed quit attempt using electronic cigarettes.

In other words, this study did not estimate quit rates among smokers trying to quit using e-cigarettes. Instead, it estimated quit rates among many smokers who were not using e-cigarettes in their quit attempt at all!

Here is how the study describes its methods and findings:

"This study ... describes differences among state quitline callers who used e-cigarettes for 1 month or more, used e-cigarettes for less than 1 month, or never tried e-cigarettes. ... Both e-cigarette user groups were significantly less likely to be tobacco abstinent at the 7-month survey compared with participants who had never tried e-cigarettes (30-day point prevalence quit rates: 21.7% and 16.6% vs. 31.3%, p < .001)."

The authors conclude that: "This study indicates that e-cigarette users were less likely than those who had never used to have quit tobacco at the time of the survey...".

But the truth is that many of the electronic cigarette users in the study did not use electronic cigarettes in their quit attempts!

According to data provided in the paper, a full 28% of the sample of electronic cigarettes did not use these products in their quit attempts.

It should be clear to readers that this study was poorly designed to investigate the efficacy of electronic cigarettes. The study systematically sampled a group of quitline callers who were unsuccessful using electronic cigarettes. These people tried and failed using electronic cigarettes. How do we know they failed? Because they wouldn’t have had to call the quitline if they weren’t still smoking. This is clearly a harder core group of smokers and it is no surprise that their cessation rates were lower after 6-months than the comparison group. The study tells us nothing about the effectiveness of electronic cigarettes, other than that they do not work for everyone. This is exactly the kind of biased research, designed specifically NOT to find an effect of electronic cigarettes, that is characterizing the anti-smoking movement today, guided by an ideology that is apparently opposed to anything that merely looks like smoking, no matter how much safer it may be. Apparently, the researchers had already reached a pre-determined conclusion and the study was apparently designed to find no effect. Any researcher sincerely interested in testing the efficacy of electronic cigarettes would not test the research question in this way.

That the organization which conducted this study had already drawn a pre-determined conclusion about electronic cigarettes is evidenced by its rant against these products, published back in September of last year, in which it warned that electronic cigarettes might kill "millions" of smokers. 

At that time, a director of the organization wrote: "E-cigs continue to gain market share with customers relying on assurances by the vendors that the product is safe. Those of us who work to help smokers quit remain skeptical and unconvinced. We remember all too well the light and ultra-light promotions by the tobacco industry back in the 70’s and 80’s. Like these, e-cigs are also being promoted as an alternative to quitting smoking. Let’s hope they don’t kill millions of Americans the way light and ultra-light cigarettes did 30 years ago."

If the tobacco industry conducted precisely this same study in order to conclude that electronic cigarettes are ineffective as a smoking cessation tool, we would call it scientific fraud. What should we call the same study, but conducted by a company that makes its money by convincing the public that traditional methods for smoking cessation should remain the mainstay of treatment?

To Many Anti-Smoking Advocates, Nicotine is the Problem, Rather than Disease and Death

According to an article in the Toledo Blade, electronic cigarettes have helped many smokers to quit, producing profound health benefits among patients with COPD and cancer who were unable to quit using traditional methods.

While this seems like something to applaud, the article notes that health officials are frowning upon, rather than praising, the tremendous health benefits that smokers have achieved from quitting or cutting down on tobacco cigarettes.

According to the article:

"Health officials argue the long-term effects of the unregulated products are unknown and require more research. “There are fewer chemicals in e-cigarettes and no carbon dioxide is emitted. Those certainly would be a reduction in harmful inhalants,” said Holly Kowalczk, a registered respiratory therapist at Promedica St. Luke’s Hospital. “However, some of the brands still contain harmful chemicals, such as diethylene glycol, which is used in antifreeze.” Ms. Kowalczk, who also is a certified tobacco treatment specialist, said it's unlikely that using e-cigarettes as a means to quit smoking will cure a smoking addiction. “Nicotine addiction has always been the problem. People trying to use e-cigarettes aren’t really addressing that issue,” Ms. Kowalczk said. “They’re still putting nicotine in their bodies and they’re still engaging in smoking behaviors.”"

The Rest of the Story

This is an open admission that illustrates the blind ideology that is leading many anti-smoking advocates and groups to oppose an innovation that is saving thousands of lives.

These advocates view nicotine as the problem, not disease and death. It is the addiction to nicotine that seems to bother these health officials, rather than the actual health effects of smoking. If research subsequently showed that nicotine has no serious long-term health effects, these advocates would still consider electronic cigarette use to be an evil and to consider it to simply be a "smoking behavior" because it involves nicotine use.

How ludicrous, however, for a health practitioner to argue that if a smoker quits smoking using e-cigarettes, that ex-smoker is still "engaging in smoking behaviors." No the person is not.

What do you call a smoker who substitutes electronic cigarettes completely for tobacco cigarettes?

The answer ...

... an ex-smoker.

Would this health practitioner also argue that someone who quits smoking using the nicotine patch (and continues to apply the patch for many months) has not actually quit smoking?

An additional problem with this practitioner's statement is that she asserts that electronic cigarettes still contain diethylene glycol. There is no evidence that this is the case. All of the lab testing of electronic cigarettes during the past two years of which I am aware has not detected diethylene glycol in these products. The practitioner is citing outdated data that only applied to one brand and probably resulted from the use of non-pharmaceutical grade propylene glycol, which is no longer in use by virtually all e-cigarette companies in 2013.

Why not simply state that you don't know, rather than pretend to be an expert on a topic about which you know very little? Why risk giving the public misinformation, which this practitioner is doing.

The rest of the story is that this admission illustrates the basic ideology that is leading anti-smoking advocates to oppose electronic cigarettes. As I stated previously, the health of smokers is not the paramount concern of all of our health professionals. Instead, the ideology of opposing anything that "looks" like smoking has overtaken in prominence the concern over the best interests of the health of smokers. The health of smokers is being sacrificed to the blind adherence to the ideology that anything that looks like smoking is evil.

Pulmonologist Unsure that Smoking is Any More Hazardous than Quitting Smoking via Electronic Cigarettes

It doesn't take a rocket toxicologist to understand that smoking burning tobacco, which contains more than 10,000 chemicals including 60 known human carcinogens - and which has already been demonstrated to cause more than 400,000 deaths each year in the U.S. - is much more harmful than vaping from a non-tobacco solution containing little more than nicotine and glycerin or propylene glycol.

If any tobacco company even hinted that smoking is as benign as inhaling vapor from a solution of propylene glycol with nicotine, that company would find itself in a courtroom the next day, defending itself against charges of fraud.

Apparently, however, a physician can make precisely the same claim with impunity.

Last week, a Stanford pulmonologist claimed that it is unclear that smoking is any more harmful than vaping. According to an article in the San Francisco Chronicle:

"There are a lot of public health questions surrounding the use of e-cigarettes, but one thing is not in question - they are becoming a popular alternative to tobacco cigarettes. ... But nicotine, whether from a cigarette or an e-cigarette, is "a known addictive agent that is not helpful in any way," said Dr. Daya Upadhyay, former assistant professor of pulmonary critical care at Stanford. So she says she encourages her patients to quit smoking entirely rather than switch to e-cigarettes. She added that e-cigarettes still contain toxic chemicals. "We can't say yet whether it's less harmful than tobacco," she said."

The Rest of the Story

Claiming that it is unclear whether smoking is any safer than vaping is equivalent to claiming that it is not clear whether smoking is any safer than using a nicotine inhaler.

Both electronic cigarettes and nicotine inhalers deliver essentially "clean" nicotine: nicotine with just a few other chemicals. Neither product has undergone long-term studies to determine whether they produce any long-term adverse effects in terms of respiratory irritation or carcinogenesis. Both products deliver nicotine via inhalation. While electronic cigarettes generally deliver nicotine from a propylene glycol or glycerin solution, nicotine inhalers generally add menthol. While the long-term effects of propylene glycol are not clear, neither are the long-term effects of menthol. The nicotine in both products is derived from tobacco, and thus contains trace levels of carcinogens: tobacco-specific nitrosamines.

Imagine, however, that a physician instructed a patient not to quit smoking using a nicotine inhaler because it is not clear that the use of the inhaler is any safer than continuing to smoke. This would almost certainly be considered malpractice.

But the rest of the story is that this is exactly the same advice that some physicians are apparently giving patients regarding electronic cigarettes. To instruct a patient that he or she should not quit smoking using electronic cigarettes because it is not clear that doing so is any safer than continuing to smoke is contrary to the overwhelming medical science. It is a claim that represents, in my opinion, malpractice. 

Perhaps the most important excerpt from the article is the following:

"Companies do not market the product as a smoking cessation tool because that would put it in a category of products, like nicotine gum or patches, that the Food and Drug Administration regulates. But a British study out last month showed that 75 percent of the 1,400 e-cigarette users who responded to a survey said they've entirely replaced tobacco cigarettes with e-cigarettes."

What is there not to like about that? Huge numbers of smokers are completely switching from tobacco to electronic cigarettes. In other words, thanks to e-cigarettes, they are successfully quitting smoking.

You would think that physicians and public health practitioners would be jumping for joy. But unfortunately, the health of smokers is not the paramount concern of all of our health professionals. Instead, the ideology of opposing anything that "looks" like smoking has overtaken in prominence the concern over the best interests of the health of smokers.

The rest of the story is that the health of smokers is being sacrificed to the blind adherence to an ideology: anything that looks like smoking is evil.

UK Study Fails to Find a Single Nonsmoker - Youth or Adult - Who Regularly Uses Electronic Cigarettes

In a second study that blows out of the water the anti-smoking groups' contention that electronic cigarettes appeal to nonsmokers, especially youth, and will lead to increased smoking, Action on Smoking and Health (ASH-UK) was unable to find a single nonsmoker in Great Britain - either youth or adult - who regularly uses electronic cigarettes.

The study, released this week, involved a survey of 12,171 adults and 2,178 children ages 11-18 in February and March of this year. Despite widespread awareness of electronic cigarettes among youth and adults, the survey failed to find a single adult or youth never smoker who regularly uses electronic cigarettes.

Awareness of electronic cigarettes was 67% among 11-18 year-olds and 83% among the 16-18 year-olds. Nevertheless, "among young people who have never smoked ... 0% report continued e-cigarette use and 0% expect to try an e-cigarette soon."

The study reports that: "Among adults, electronic cigarette current use ... remains at 0% among those who have never smoked."

The Rest of the Story

This study corroborates the evidence I reported yesterday from the U.S. which indicates that despite the dire warnings of anti-smoking groups and the FDA, electronic cigarettes apparently have little appeal to young people who do not already smoke, little appeal to adults who do not already smoke, and virtually no long-term appeal to anyone but smokers.

Electronic cigarettes are marketed towards smokers, not towards youth and/or nonsmokers. These products are intended to help smokers quit or cut down in order to improve their health. They are an alternative to tobacco cigarettes. There is little if any appeal to nonsmokers to use these products.

This evidence minimizes any public health concerns that electronic cigarettes might increase cigarette smoking. On the contrary, electronic cigarettes represent a promising intervention to reduce cigarette use. It is time that the FDA and anti-smoking groups open their eyes to the evidence, pay attention to the hundreds of thousands of vapers out there, and embrace the possibility that electronic cigarettes may be a life-saving harm reduction approach to the smoking problem.

National Study of Adults Can Find Only Six Nonsmokers Who Have Ever Tried Electronic Cigarettes

Anti-smoking groups continue to oppose electronic cigarettes, in part because they claim these products will increase smoking by inducing nonsmokers to become addicted to nicotine. A number of anti-smoking advocates expressed these concerns at an FDA-sponsored press conference in July 2009. At that press conference, anti-smoking advocates warned that "these products could encourage smoking" and alarmed the public about "the risk that electronic cigarettes may increase nicotine addiction among young people." The American Lung Association went so far as to "urge[s] the FDA to act immediately to halt the sale and distribution of all e-cigarettes...".

At the press conference, Dr. Jonathan Winickoff, chairman of the American Academy of Pediatrics' tobacco consortium, warned that electronic cigarettes are likely to appeal to young people and will encourage nicotine addiction, ultimately leading to the initiation of cigarette smoking. The FDA continues to this day to warn the public that electronic cigarettes may appeal to young people and lead them to become addicted to nicotine and then to start smoking.

The Rest of the Story

In an article published in the Journal of Environmental and Public Health and co-authored by Dr. Winickoff himself, the authors examined the use of electronic cigarettes and other "emerging" tobacco products among a national sample of 3,240 adults.

Despite all of the anti-smoking groups' dire warnings about the appeal of electronic cigarettes to nonsmokers, the study was able to find only 6 (six) nonsmokers who had ever used these products. This is 6 out of a total of approximately 2000 nonsmokers and 3240 total adults in the sample. It is unclear if any of these 6 reported continued use of electronic cigarettes.

(See: McMillen R, Maduka J, Winickoff J. Use of emerging tobacco products in the United States. Journal of Environmental and Public Health. Volume 2012 (2012), Article ID 989474, doi:10.1155/2012/989474.)

So much for electronic cigarettes being appealing to young adults and other nonsmokers. These findings seem to confirm what I have argued for months: that electronic cigarettes are marketed towards smokers, not towards youth and/or nonsmokers. These products are intended to help smokers quit or cut down in order to improve their health. They are an alternative to tobacco cigarettes. There is little if any appeal to nonsmokers to use these products.

It is a good thing that the FDA was prevented by the courts from following the American Lung Association's advice (and that of numerous other anti-smoking groups) and removing electronic cigarettes from the market. Such an action would certainly have led to the initiation of tobacco use among literally thousands of ex-smokers who had successfully quit using e-cigarettes but would have been essentially forced to return to tobacco cigarettes.

It is also a good thing that many vapers are ignoring the dire warnings from anti-smoking groups and that they have taken their chances on this product, which for many of them, has likely saved their lives.

It is worth mentioning that in addition to electronic cigarettes, the article examined the use of dissolvable tobacco products, snus, and waterpipes. Importantly, while very few nonsmokers reported using electronic cigarettes (0.3%) or dissolvable tobacco products (0.2%), a substantial proportion did report using snus (2.7%) or waterpipes (5.4%).

These data dispel any serious concern that electronic cigarettes or dissolvable tobacco products are appealing to nonsmokers and will lead eventually to nicotine addiction and the initiation of cigarette smoking. On the other hand, these data are consistent with the hypothesis that the same is not the case with snus and waterpipe tobacco use. 

Unfortunately, however, the authors do not make this distinction in their article. They lump all these forms of "tobacco use" together.

The article concludes by recommending that clinicians "offer counseling about the risks of these products as another form of tobacco use."

But that is a false statement, as electronic cigarettes are not a form of tobacco use. They contain no tobacco, as these authors should well know and should have pointed out. Why the need to lie to the public about the facts? It appears as if there is a pre-ordained agenda against electronic cigarettes.

But apparently, the arguments against electronic cigarettes are so weak that opponents need to lie to the public and claim that vaping is a form of "tobacco use" which they should know is simply not the case.

The rest of the story is that: (1) there is strong evidence that electronic cigarettes do not appeal to nonsmokers and that there is little reason to believe that they will lead to any substantial increase in cigarette smoking; and (2) opponents of electronic cigarettes continue to resort to lying to the public; in this case, misrepresenting electronic cigarettes as a form of tobacco use when in fact the product contains no tobacco.

In Ultimate Irony, Duke is Recognized for Smoking Cessation Programs

In an irony of epic proportions, Duke has been recognized by the North Carolina Prevention Partners for its model smoking cessation efforts.

According to an article in Duke Today: "Duke's tobacco cessation programs for employees have been recognized by the NC Prevention Partners with the designation as a Gold Star Standard Hospital. The Gold Star Standard recognizes Duke's efforts to refers employees to effective quit programs, provide comprehensive benefits such as nicotine replacement therapy and prescription medications and offer attractive incentives to encourage employees to quit tobacco use. ... 'Duke University Medical Center continues to set a high bar in terms of their cessation program for employees,' said Anne Thornhill, director at NC Prevention Partners. 'They are doing a great job in supporting their employees in quitting the use of tobacco. I applaud their great effort.'"

The Rest of the Story

The rest of the story is that for about 8 years (from 2004-2012), Duke served as a public relations arm for Philip Morris, accepting $37 million in funding from Big Tobacco to help the nation's leading tobacco company achieve its marketing goal of legitimizing itself as a corporation sincerely interested in helping smokers to quit.

According to Philip Morris: "Since 2004, PM USA has supported the Duke Center for Nicotine and Cessation Research. PM USA expects to provide a total of $37 million to the center through June 2012 to develop, evaluate and disseminate improved methods for quitting smoking."

According to the agreement between Duke and Philip Morris, the director of Duke's nicotine research center (or a designee) became a formal part of Philip Morris' public relations efforts, by virtue of appointment to the Advisory Board of the company's "smoker cessation support initiative."

The rest of the story is that rather than being a model for tobacco control for the nation, Duke is instead an example of exactly the opposite. It is perhaps a model, but a model for the most egregious violation of medical ethics. Duke allowed itself and its reputation and good name to be used as a public relations ploy for a tobacco company. Duke allowed itself to be used as a pawn in the public relations and marketing strategy of Philip Morris.

Clearly, since the purpose of this research funding was demonstrably not to dramatically reduce the number of smokers, its purpose was therefore to serve as a public relations ploy - by which Philip Morris could improve its public image by being able to argue that it really cares and that it is a responsible corporate citizen which is trying to help its customers break their addiction to its products. By associating its name with that of Duke University, Philip Morris used Duke to gain public relations marketing value from that association. Clearly, there was no sincere research interest operating here on the part of Philip Morris. This was public relations 101. Using corporate funding to secure public credibility and respect. It was part of Philip Morris' (and the other tobacco companies') playbook for decades.

The rest of the story is that Duke undermined its own scientific integrity and that of academia as a whole by allowing itself to serve as a pawn in the tobacco industry's public relations and marketing strategy. A university - and especially a medical center - should not play a role in marketing the most deadly consumer product. But that is exactly what Duke did.

Rather than being recognized as a model for tobacco control, Duke should instead be entered into the Hall of Shame as a medical center that put money over ethical integrity.

Pennsylvania Department of Health Says It Does Not Support Smokers Quitting, Will Not Acknowledge that Smoking is More Harmful than Non-Tobacco E-Cigarettes

According to an article in the Johnstown (PA) Tribune-Democrat, the Pennsylvania Department of Health, with all of its scientific expertise, is not sure that smoking cigarettes - which kills more than 400,000 Americans each year - is any more hazardous than using non-tobacco e-cigarettes, which have not been reported to ever have killed a single person.

According to the article, the Department of Health was quoted as stating: "Consumers may believe this is a safer way to smoke when, in fact, there is a lack of long-term studies that have been done on the product, therefore leaving the long-term effects unknown."

Not only did the Department of Health deny that vaping is any safer than smoking, but it also stated that it does not support smokers quitting using e-cigarettes.

According to the article: "The state Department of Health says that while there is currently no regulation on this, the department does not support their use for a number of reasons."

The Rest of the Story

This position of the Pennsylvania Department of Health is shameful for two reasons.

First, it is based on politics and not science. If the Department of Health is not sure that a non-tobacco product which merely heats propylene glycol and nicotine is any safer than cigarettes, which burn tobacco and emit thousands of chemicals and scores of carcinogens, then it needs to review some basic biology and chemistry textbooks.

Second, this position is untenable with protection of the public's health because a public health department should not oppose smokers quitting and potentially saving their lives simply because the method they used to quit simulates smoking behavior.

What an insult to the thousands of Pennsylvania smokers who have successfully quit smoking using e-cigarettes. The state Department of Health is telling them that have done a bad thing. What does the Department want these ex-smokers to do? Return to smoking their Marlboros?

If Physicians Prescribing a Drug Need to Monitor Those Patients for Death, What Business Does the FDA Have Approving that Drug?

Today, the Rest of the Story is questioning the wisdom of keeping a drug on the market when its required black box warning admonishes doctors to observe their patients for death.

Here is the start of the black box warning that appears on Chantix:

"All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide."

Attempted suicide? 

Let's get this straight. Physicians are instructed by the FDA to monitor their patients for attempted suicide, which is of course, in some cases, successful. In other words, doctors are being told that a significant possible side effect of the medication is death and that it behooves them to monitor their patients to see if they die from the drug.

The Rest of the Story

What good does it do to monitor a patient for death? How does that protect the patient?

One situation in which a black box warning may be appropriate is when monitoring of early side effects can prevent serious consequences. For example, if a side effect of a medication is liver damage, then monitoring a patient's liver enzymes for evidence of early liver injury can prevent serious disease by alerting the physician to this side effect so that the medication can be discontinued before it causes actual liver damage.

Chantix does not meet this criterion because its most worrisome side effect - sudden suicide - often occurs without warning, often in a matter of days following initiation of therapy. Relying on patients who become depressed to call their physician to report the symptoms is ineffective because one of the symptoms of depression is the inability to do just that. That the most worrisome side effect is not just depression but frank suicidality makes the black box warning ineffective in this regard.

I do not see how the benefits of keeping Chantix on the market outweigh the many deaths that it has caused. It is not like this is some sort of wonder drug that is very effective in helping people quit smoking, nor is it like this drug is so much more effective than other smoking cessation drugs on the market.

But most importantly, I don't see how the FDA can keep a drug on the market when it feels compelled to warn physicians that they need to carefully monitor their patients for possible death.