Wednesday, November 19, 2014

Proof of Concept Study Shows Great Promise for Second Generation Electronic Cigarettes

Riccardo Polosa and colleagues have just published a six month pilot study, in which 50 smokers who were not interested in quitting were provided with a second generation electronic cigarette (personal vaporizer). The specific product was the EGO/CE4 model. Participants were also provided with chargers and e-liquids throughout the study period.

At six months, a sustained 50% or greater reduction in cigarette consumption was observed in 15 subjects (30%), with mean consumption dropping from 25 cigarettes per day to 6 cigarettes per day. Of these 15 subjects, 7 (14% of the total sample) experienced a sustained reduction of 80% or more in their cigarette consumption, with their mean consumption dropping to just 3 cigarettes per day.

Also at six months, smoking abstinence was reported by 18 subjects (36% of the sample).

Therefore, in total, 33 subjects, or 66%, were either able to quit smoking or cut down on the amount they smoke by at least 50%.

The Rest of the Story

This is a small pilot study and there is no control group or randomization of subjects, so it must be interpreted cautiously. Nevertheless, considering that these were smokers who expressed no interest in quitting, the finding that two-thirds either quit or cut down by more than 50% is encouraging.

This study also demonstrates some of the complexities of studying the effectiveness of electronic cigarettes. There are a wide range of products on the market with different abilities to effectively deliver nicotine and to produce a full vapor that delivers a sufficient throat hit to satisfy many smokers. It may be that the effectiveness of these products could improve over time, as inefficient products are replaced with ones that are better able to satisfy the needs of smokers.

This is why the FDA's proposed deeming regulations make no sense. They would prohibit the introduction of new products into the market, keeping the older and antiquated products going and stifling innovation. The process to get a new product approved is complex and involves showing that the product is beneficial to the public's health. I interpret this as meaning that a new product would have to conduct a clinical trial that shows the effectiveness of the particular product whose approval is being sought. This barrier is a huge one.

This would be unfortunate because the quality and effectiveness of electronic cigarettes appear to be increasing over time. Why would the FDA want to stifle innovation and essentially force the market to be stuck with the less effective products? This is not a recipe designed to maximize the number of smokers who successfully quit smoking. If anything, it is a recipe designed to protect traditional cigarette sales.

Hopefully, the FDA will reconsider this provision of the deeming regulations and will remove it from the final regulation. Innovation in this industry should be encouraged and promoted, not stifled.

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. 

Thursday, November 13, 2014

New CDC Study Reveals that Youth Smoking has Declined Despite Tripling of Electronic Cigarette Use Among High Schoolers

A new study released today by the CDC reports that although electronic cigarette use has doubled among middle-school students and tripled among high school students, there was a marked reduction in cigarette smoking in both groups from 2011/12 to 2013.

During this time period, current e-cigarette use among middle-school students increased from 0.6% to 1.1%. At the same time, current cigarette smoking declined from 4.3% to 2.9%.

Among high school students, current e-cigarette use increased from 1.5% to 4.5%. Concurrently, current cigarette smoking dropped from 15.8% to 12.7%.

The study also reported that there were very few never smokers who were currently using electronic cigarettes.

The Rest of the Story

The finding that despite a tripling of current e-cigarette use among high school students, the smoking prevalence among this group dropped substantially suggests that electronic cigarettes are not serving as a major gateway to cigarette smoking among youth.

Although the CDC has been disseminating to the public its contention that electronic cigarettes are a gateway to youth smoking, it has yet to produce a shred of evidence that this is the case. In fact, it has not identified a single youth who started with electronic cigarettes and then progressed to cigarette smoking.

Nevertheless, the CDC director stated last year that: "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes."

Given the absence of evidence that e-cigarette use is a gateway to smoking and the lack of any documentation that kids are starting out with e-cigarettes and then progressing to cigarette smoking, it seems that the CDC should correct its earlier statement and apologize for letting it sit out there in the media for more than a year.

It is doing damage because policy makers are accepting this unsupported statement as the truth, and are using it as the basis for stringent regulations of electronic cigarettes which may end up causing more public health harm than good. The benefits of electronic cigarettes in terms of helping smokers to quit or cut down needs to be weighed against the harms in terms of potentially recruiting new smokers or e-cigarette addicts. However, so far there is no evidence that either of these phenomena are occurring.

Certainly, we need to continue to carefully monitor the situation and to conduct research to clearly identify the trajectory and time course of electronic cigarette and tobacco cigarette use among youth. But as a start, we need our public health agencies to be honest with us about the facts. Distorting the science to create more compelling stories or to fulfill predetermined conclusions is not appropriate.

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.

Tuesday, November 11, 2014

New State Study Shows Dramatic Reduction in Youth Smoking Despite Sharp Rise in E-Cigarette Use

New data out of Minnesota shows that despite a marked increase in e-cigarette use among Minnesota teenagers, there was a corresponding dramatic decline in tobacco cigarette smoking.

According to the report: "The 2014 Minnesota Youth Tobacco Survey found that the percent of high school students who smoked cigarettes in the past 30 days dropped from 18.1 percent in 2011 to 10.6 percent in 2014."

At the same time: "12.9 percent of high school students used or tried an electronic cigarette in the past 30 days. The survey found that 28 percent of high school students reported ever having tried an e-cigarette."

The Rest of the Story

These findings add further evidence that electronic cigarettes are not currently serving as any kind of major gateway to cigarette smoking. Despite massive levels of experimentation with electronic cigarettes, youth smoking rates are falling dramatically. This pretty much rules out the hypothesis that e-cigarettes are a major gateway to smoking.

Stan Glantz has reviewed additional evidence which documents rather dramatic increases in electronic cigarette use in the past few years, some of which is occurring among nonsmokers. However, these data actually add to the evidence that e-cigarettes are not a major gateway to smoking because they demonstrate that this experimentation, even among nonsmokers, is occurring at a time when smoking rates among youth have fallen to historic low levels.

Bottom line: There is no evidence at the current time that electronic cigarettes are serving as a gateway to smoking among youth.

Unfortunately, the lack of evidence did not stop the CDC director from proclaiming publicly that e-cigarettes are a gateway to youth smoking. And sadly, I am not aware that the director has made any sort of retraction, correction, or apology.

Meanwhile, the bogus conclusion that youth electronic cigarette use is a major risk for increased youth smoking continues to deceive policy makers throughout the country and risks the formation of inappropriate and unsupported state and federal policies regarding electronic cigarettes.

Despite all the attention to the hypothetical risks of electronic cigarettes, which so far have not been shown to pose any substantial risk to young people, the policy makers remain silent about menthol cigarettes, which - according to the Minnesota report - are currently smoked by 44% of youth smokers. This is not a hypothetical risk. This is not a slight chance of progression to smoking. These are kids who are already smoking and most likely already addicted to smoking. And half of these kids who continue to smoke over a lifetime will die prematurely of this addiction.

But nobody in the anti-smoking movement seems to care. It appears that we just can't stand hypothetical or unknown risks. But known epidemics of disease and death are just fine.

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.

Thursday, November 06, 2014

New Study Suggests that Menthol Cigarettes May Be Worse for Lung Health; Policy Makers Respond by Calling for Ban on Flavored Electronic Cigarettes

I'm not much kidding in making that connection. If there is any flavor in tobacco products that is contributing toward youth addiction and ultimately, disease, it is menthol. Menthol cigarettes are preferred by nearly 50% of youth smokers. And menthol is the one flavoring that was exempt from prohibition under the Family Smoking Prevention and Tobacco Control Act.

Who was responsible for that exemption? Ironically, the policy makers who are currently calling for a ban on flavorings in electronic cigarettes.

Despite the lack of evidence that electronic cigarettes are leading to any tobacco use among youth, and despite the strength of the evidence that menthol cigarettes make up about 50% of the tobacco cigarettes that youth do smoke, it makes absolutely no sense for policy makers to call for a ban on flavorings in electronic cigarettes, but not to demand a similar policy for the menthol in cigarettes.

Unfortunately, this is exactly the state of affairs among the leading politicians who supported the Family Smoking Prevention and Tobacco Control Act and who are now switching their attention over to electronic cigarettes, which they are treating like a far greater scourge on the health of our nation's children.

The new study found that menthol smokers had higher rates of hospitalization for chronic lung disease. Beware, however. There were major differences between the populations of menthol and non-menthol smokers in this study, and I do not personally feel that the study controlled adequately enough for these differences to be able to attribute the observed health differences specifically to the presence of menthol.

Similarly, I have long argued that a policy which aims to ban menthol because menthol cigarettes pose a greater health risk than non-menthol cigarettes is flawed from the start, because the scientific evidence doesn't support such a judgment.

In fact, the reason for the flavorings ban in the Tobacco Control Act is not that flavored cigarettes are any more hazardous, but that - hypothetically - youth would be more attracted to such products. But on that basis, not only should menthol cigarettes have been banned, but all flavorings that are added to cigarettes should have been banned as well. In other words, the policy made little sense and was internally and externally inconsistent from day one.

Now is the time for the politicians to put up or shut up. Either back up your supposed concern for kids' health by sponsoring legislation to ban menthol and all flavorings in cigarettes, or cut the crap about the need to ban the flavorings from e-cigarettes in order to end the scourge that these flavors are having on our nation's children.

Tuesday, November 04, 2014

Anti-Smoking Groups and Politicians are Way Off the Mark in Accusing Altria and Reynolds American of Targeting Children with their E-Cigarettes

In recent months, a host of anti-smoking groups as well as several leading politicians in Congress and at the state level have attacked the Big Tobacco companies - including Reynolds American and Altria - for targeting their electronic cigarette products to children.

While it may sound like a great sound bite, it fits the mantra of tobacco control, and it may be consistent with historical practices of these tobacco companies in marketing cigarettes to youth, there is much more here than meets the eye. As much as the anti-smoking groups might like, things are not that simple.

Specifically, this claim by anti-smoking groups and politicians is demonstrably false. And by continuing to make this false accusation, it detracts from the anti-smoking groups' legitimate complaints against a small number of e-cigarette companies that do appear to be crossing the line.

The Rest of the Story

In their complaints, the anti-smoking groups and politicians have specified the ways in which e-cigarette companies are targeting kids. First, according to these groups, the use of candy and fruit-flavored products is a sure sign of youth targeting. Second, selling their products over the internet is an attempt to recruit youth customers, since it is much easier for underage customers to purchase over the internet than to purchase in face-to-face sales in brick-and-mortar facilities. Third, electronic cigarette companies are targeting kids by offering disposable products at cheap prices.

Let's now examine Reynolds American's e-cigarette product (Vuse) and Altria's product (Nu Mark) to see how they fare on each of these youth targeting criteria:

Candy and fruit flavors: None. Only tobacco and menthol.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

Candy and fruit flavors: None. Only tobacco and menthol.
Internet sales:  None. Only available in retail stores.
Disposable products: None. Only available in more expensive, rechargeable sets.

Not only is there a lack of evidence that Vuse and Nu Mark are not targeting youth, but there is very strong evidence that these products are not targeting youth. 

Nevertheless, I am not aware of any mainstream tobacco control group which has so much as acknowledged that Vuse and Nu Mark are indeed being responsibly marketed toward adult smokers. 

My readers know that I can certainly dish out criticism when it is warranted. But at the same time, I feel it is important to be discriminating, and to withhold criticism unless it is warranted and backed up by adequate evidence. 

Unfortunately, the anti-smoking groups and politicians seems incapable of such discrimination. Everything is black and white, and there is no need to actually examine the scientific evidence. 

Except that the rest of the story is that for Vuse and Nu Mark, it isn't black and white. It's exclusively classic tobacco and menthol.

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.