Thursday, April 30, 2015

CDC Campaign of Deception is Working: Lawmakers are Repeating the Lies to Sell Legislation

According to an article in the Legislative Gazette, New York state Assemblywoman Linda Rosenthal (D-Manhattan) is publicly claiming that electronic cigarettes will lead to an entire generation of youth becoming lifetime smokers. She also attacked the tobacco companies for lying about these products.

In the article, she is quoted as stating: "The tobacco companies are using the same tactics and lies they used to say about regular cigarettes. By accepting e-cigs we are hooking a new generation on a lifetime of smoking."

Rosenthal also blasted the Conservative Party, claiming that they want to "wait until people get sick" and that
they are "standing up for something that is harmful."

The Rest of the Story

While Assemblywoman Rosenthal is accusing the tobacco companies of lying about electronic cigarettes, the only one in this article who is lying about e-cigarettes is Assemblywoman Rosenthal.

She is telling three lies.

First, she claims that e-cigarettes are hooking a new generation on a lifetime of smoking. There is no evidence to support even the contention that e-cigarettes are leading to nicotine addiction among youth. In fact, the existing evidence suggests that despite widespread youth experimentation with these products, very few nonsmoking youth have become nicotine addicts because of that experimentation. Furthermore, there is strong evidence that e-cigarette use is actually pushing kids away from smoking combustible tobacco cigarettes.

I don't necessarily blame Assemblywoman Rosenthal because it appears that she is drawing her information directly from the CDC. She is merely repeating the lies that CDC disseminated widely to the public.

Rosenthal's second lie is that the tobacco companies are lying about e-cigarettes. I challenge her to specify a specific lie that the tobacco companies are telling about these products. If anything, the tobacco companies are bending over backwards to provide warnings about the potential risks of e-cigarettes.

For example, Lorillard warns that the product contains nicotine, that nicotine is addictive, and that nicotine has been associated with birth defects and other reproductive harm. The company states that e-cigarettes are addicting. It also states that e-cigarettes "should not be used by children, pregnant or breast feeding women, people with heart disease, high blood pressure, diabetes or people taking medicines for asthma or depression." Moreover, the company does not claim that its products are smoking cessation devices, that they are safe, that they are safer than cigarettes, or that they will improve health.

Similarly, Reynolds American emphasizes that its product contains nicotine, is not safe, is not for minors, and is not a smoking cessation device.

Altria also provides its customers with an extensive series of warnings:

"WARNING: This product is not a smoking cessation product and has not been tested as such. This product is intended for use by persons of legal age or older, and not by children, women who are pregnant or breast-feeding, or persons with or at risk of heart disease, high blood pressure, diabetes, or taking medicine for depression or asthma. Nicotine is addictive and habit forming, and it is very toxic by inhalation, in contact with the skin, or if swallowed. Nicotine can increase your heart rate and blood pressure and cause dizziness, nausea, and stomach pain. Inhalation of this product may aggravate existing respiratory conditions. Ingestion of the non-vaporized concentrated ingredients in the cartridges can be poisonous."

"CA Proposition 65 Warning: This product contains nicotine, a chemical known to the state of California to cause birth defects or other reproductive harm."

"The U.S. Food and Drug Administration has not determined that any tobacco product presents less risk compared to any other tobacco product."

"For tobacco product consumers concerned about the health effects from tobacco product use, the best thing to do is quit. For tobacco product consumers who decide to quit, Altria’s tobacco companies offer QuitAssist®, an information resource that helps consumers who have decided to quit with cessation information from public health authorities."

So where is the lie? Before Assemblywoman Rosenthal publicly accuses the tobacco companies of lying to the public, she ought to provide the specific statement(s) that she asserts are false. The rest of the story is that it is she who is lying to the public.

Rosenthal's third lie is that the Conservative Party is standing up for a product that is harmful. The truth is that the Conservative Party is standing up for a product that is not known to cause any substantial harm and which, instead, is helping many smokers quit smoking, and thus improving their health and potentially saving their lives. Ironically, it is the Conservative Party which is standing up for the protection of the public's health and Rosenthal who is protecting the sales of the most toxic tobacco products on the market: real cigarettes.

Tuesday, April 28, 2015

CDC's Lies to the Public Called Out in Forbes Magazine and Reason Online

In a commentary that appears both at Forbes.com and Reason.com, Jacob Sullum, senior editor at Reason magazine calls out the CDC for lying to the public about electronic cigarettes.

Sullum takes issues with the fact that the CDC classifies electronic cigarettes as tobacco products. But they are not tobacco products, as they contain no tobacco. As Sullum points out:

"e-cigarettes do not burn and contain no tobacco, which is why they are so much safer than traditional cigarettes. It is more than a little misleading to classify them as tobacco products."

"Yet that is what the CDC does. When it claims "there was no decline in overall tobacco use between 2011 and 2014," it is counting e-cigarettes as tobacco products. That makes as much sense as counting nicotine gum or patches (which also contain nicotine derived from tobacco) as tobacco products. This is no mere word game, because it is not true that "there was no decline in overall tobacco use between 2011 and 2014." The CDC is lying to us."

Sullum also points out that the American Lung Association is lying to the public by claiming that the dramatic decline in youth smoking is being offset by the increase in e-cigarette use. This is blatantly false from a public health perspective and also requires an additional lie: once again, that e-cigarettes are tobacco products. Sullum writes:

"Similarly, the American Lung Association suggests that the decline in smoking is "offset by the dramatic increase in use of e-cigarettes," which is scientifically absurd given the clear health advantages of vaping. This is not simply a matter of emphasis or opinion. In terms of health effects, it cannot possibly be true that the increase in e-cigarette use offsets the decline in smoking."

Finally, Sullum points out that the CDC is also lying about e-cigarettes serving as a gateway to cigarette smoking among youth:

"For years anti-smoking activists and public health officials have tried to justify their irrational hatred of electronic cigarettes by arguing that vaping leads to smoking, especially among impressionable young people who otherwise would never touch tobacco. But that is not happening. To the contrary, vaping and smoking rates among teenagers are moving in opposite directions. Rather than admit they were wrong to claim that e-cigarettes are a “gateway” to the conventional kind, opponents of vaping have escalated their prevarications by implying, in defiance of all scientific evidence, that there is no important difference between the two kinds of nicotine delivery devices."

The Rest of the Story

It is gratifying to see that the CDC's lies are being called out to the public. While the agency itself has done nothing to retract or correct the misinformation it has been disseminating, it is my hope that the revelation to the public that CDC is not being truthful will force the agency to respond.

I also think that it is only a matter of time before a Congressmember or a Congressional oversight committee files a formal inquiry to the CDC, which would also force the agency to respond and explain to the legislative branch why a public health agency is lying to and seriously misleading the public.

It is quite clear at this point that the CDC's statements are not simply mistakes or oversights. The deception is intentional, and it is part of a deliberate campaign to pull the wool over the eyes of the public. The CDC wants the public to think that e-cigarettes contain tobacco to help prevent people froom believing (quite correctly) that vaping is safer than smoking.

The CDC also wants the public to believe (quite incorrectly) that e-cigarette experimentation is leading to smoking addiction among youth. Only such a dramatic piece of misinformation could offset the clear public health benefits that vaping has provided to smokers. One way to alter the true cost-benefit mix is to lie about there being no benefits and at the same time, lie about there being severe costs.

With regards to the electronic cigarette issue, the CDC has long since left the realm of practicing public health. It has also left the realm of scientific rigor and of ethical public health practice.

In another Forbes column, Sally Satel, resident scholar at the American Enterprise Institute, also calls out the CDC for its lying. She also calls for Congressional hearings to force CDC to explain why it is running a campaign to deceive the American public. Satel writes:

"It is shameful that the CDC, the nation’s leading institute of public health, doesn’t acknowledge the value of e-cigarettes as a substitute for cancer-causing cigarettes. In an ad campaign launched three weeks ago, Dr. Frieden, a longtime critic of vaping, went so far as to warn that e-cigarettes do not help people quit and even lead to collapsed lungs. These claims are patently false but they are part of a larger anti-e-cigarette agenda that simply keeps smokers puffing on deadly cigarettes – after all, why switch if vaping is as bad as smoking? ... Director Frieden is playing fast and loose with public trust. It is time he defended his misleading rhetoric about e-cigarettes to members of the oversight subcommittee of the House Energy and Commerce Committee. His latest alarmist stance about vaping corrupting the youth of America is belied by his agency’s own data which tell a different, more encouraging story: e-cigs are not leading to smoking and may well be a diversion from it."

Monday, April 27, 2015

Another Pilot Study Shows Great Promise for Electronic Cigarettes in Smoking Cessation

A study published last October in the International Journal of Environmental Research and Public Health, which had escaped my attention until today, found a sizable six-month smoking cessation rate among smokers unwilling to quit at baseline who were exposed to electronic cigarettes.

(See: Adriaens K, Van Gucht D, Declerck P, Baeyens F. Effectiveness of the electronic cigarette: an eight-week Flemish study with six-month follow-up on smoking reduction, craving and experienced benefits and complaints. International Journal of Environmental Research and Public Health 2014; 11, 11220-11248.)

This was a small pilot study from Belgium in which 48 smokers who were unwilling to quit at baseline were introduced to electronic cigarettes over an eight-week period and then followed for six months. By the end of the eight-week intake period (during which laboratory sessions were conducted to assess participants' responses to electronic cigarettes), all participants had been given electronic cigarettes, information about these products, and a web site address at which they could purchase e-liquid refills. They were then followed up for six months. Subjects who were lost to follow-up were considered to be treatment failures (i.e., continuing smokers with no reduction in cigarette consumption. The main study outcomes were smoking cessation, reduction of cigarette consumption by more than 80%, and reduction of cigarette consumption by more than 50%.

Interestingly, the researchers decided to include a subgroup of smokers who were not provided with e-cigarettes until after the initial eight-week period.

At six month follow-up, 21% of the subjects had quit smoking, 15% had reduced their cigarette consumption by more than 80%, 8% had reduced their cigarette consumption by more than 50%, and 56% were treatment failures.

Of note, at the eight week mark, none of the smokers in the group that was not provided with e-cigarettes had quit smoking.

The Rest of the Story

This is a small pilot study involving only 48 participants so the results must be interpreted with caution. In addition, there was no comparison group that received standard treatment (e.g., the nicotine patch) or no treatment, so it is somewhat difficult to assess the proportion of subjects who would have been expected to quit without having been introduced to electronic cigarettes.

Nevertheless, despite these limitations, the observed smoking cessation rate of 21% over six months is remarkable, especially given the fact that none of the smokers had any interest in quitting smoking at the time they were recruited into the study. Moreover, a total of 44% of the smokers had succeeded in either quitting or reducing their cigarette consumption by more than 50%.

One indication that the observed results are largely due to the electronic cigarettes is that none of the smokers in the group which did not receive these devices for the first two months of the study successfully quit smoking during that two-month period. However, at six month follow-up, 25% of these smokers had quit.

These results are consistent with those of Dr. Polosa and colleagues in Italy, who found similarly high cessation and reduction rates among smokers unwilling to quit at baseline.

It is possible that these favorable results are attributable to the use of a second-generation vaping device.

The results suggest that one distinct advantage of electronic cigarettes as a smoking cessation tool is that they can be effective even for smokers who have no initial desire to quit, unlike traditional cessation treatment, in which success if extremely low among unmotivated smokers.

Despite the repeated claims of e-cigarette opponents that vaping devices inhibit smoking cessation, actual studies which follow smokers over time continue to report favorable outcomes, both in terms of complete cessation and in terms of significant reduction.

Clearly, a rigorous clinical trial is needed. But until such time, the existing evidence suggests that electronic cigarettes are a bona fide smoking cessation strategy. They are not for everyone, but they can be helpful for many smokers. To reduce access to these products by banning online sales or eliminating all flavorings would likely cause significant public health harm by increasing smoking. These policies would undoubtedly inhibit smoking cessation.


(Thanks to Dr. Jean-Francois Etter for the tip.)

Journal Commentary on Electronic Cigarettes is a Scientifically Unsupportable Hatchet Job and Fails to Disclose Author's Conflict of Interest

A commentary that appears in the current issue of the journal Pediatric Allergy, Immunology, and Pulmonology demonizes electronic cigarettes, claiming that they are not necessarily safer than cigarettes, that they are a gateway to nicotine addiction and smoking, and that they are not helpful in smoking cessation.

(See: Schraufnagel DE. Electronic cigarettes: vulnerability of youth. Pediatric Allergy, Immunology, and Pulmonology 2015; 28(1):2-6.)

The commentary argues that e-cigarettes are not necessarily safer than tobacco cigarettes:

"Electronic cigarettes are widely promoted as a safe alternative to smoking and even many health advocates and medical journals declare how much safer they are than combustible cigarettes. Their premise is that electronic cigarettes produce less tar than combustible cigarettes, and tar causes emphysema, bronchitis, and cancer. Therefore, electronic cigarette use is a harm reduction strategy compared with combustible cigarettes. There are several problems with this reasoning: (1) the comparator, tobacco, is the most deadly substance to which humans are commonly exposed; (2) it assumes that electronic cigarettes are well-manufactured regulated products; (3) it ignores nicotine and its harmful effects; (4) it assumes that the harms of electronic cigarettes are known; and (5) it does not account for population effects, including the potential harm to nonsmokers."
The commentary also argues that e-cigarettes are a gateway to nicotine addiction and smoking:

"Youthful experimentation and susceptibility to the brain-modifying effects of nicotine may be the start of a lifelong addiction. ... Initiating nicotine use and increasing dependence in the population may be linked with increased tobacco and other addictive substance abuse... ."

The commentary also argues that e-cigarettes are not helpful for smoking cessation:

"Although many smokers used electronic cigarettes to stop smoking, the record of electronic cigarettes for smoking cessation is poor. It was generally not different from a placebo. The studies also did not find a difference from medicinal nicotine patches, but the patches were often not used by the study participants. ... Recently quit smokers felt that electronic cigarettes were not associated with success." 

The Rest of the Story

Unfortunately, this commentary is a heavily biased, unscientific hatchet job. All three of its major points are completely unsupported by scientific evidence. Moreover, the commentary misinterprets much of the scientific literature and misrepresents the major findings. It also ignores the literature where convenient so as not to ruin what appear to be pre-determined conclusions.

First, the article challenges the premises that: (1) "electronic cigarettes produce less tar than combustible cigarettes, and tar causes emphysema, bronchitis, and cancer"; and that (2) electronic cigarettes are "much safer ... than combustible cigarettes." But both of these premises have been solidly established with abundant scientific evidence.

There is no question that electronic cigarettes produce less tar than combustible cigarettes. In fact, they produce no tar. By definition, tar is the residue formed by the combustion of tobacco in cigarettes. Since e-cigarettes involve no combustion and do not contain tobacco, no tar is produced. Moreover, it is quite true that the tar in tobacco smoke causes emphysema, bronchitis, and cancer. Even the tobacco industry readily admits as such.

There is also no question that e-cigarettes are much safer than tobacco cigarettes. How could smoking possibly be no more hazardous than occasional use of a non-tobacco containing, non-combustible product that eliminates exposure to more than 10,000 of the chemicals and more than 60 of the carcinogens in tobacco smoke? In addition, electronic cigarettes have tobacco-specific nitrosamine levels that are two to three orders of magnitude lower than real cigarettes, have been shown not to cause acute changes in spirometry-measured lung function (unlike real cigarettes), are not known to have caused any deaths in the U.S (compared to more than 400,000 per year for real cigarettes), and have been shown to reduce respiratory symptoms and improve lung function in asthmatic smokers who switch to them. It is also well-documented that there is dramatic clinical improvement in smokers who switch to electronic cigarettes.

Second, there is absolutely no evidence that e-cigarettes are a gateway to smoking, and there is not even any evidence that e-cigarette experimentation is leading to nicotine addiction among youth. The studies which have examined this question have found that nonsmoking youth who experiment with e-cigarettes almost uniformly use these products only occasionally, not on a regular basis as would be the case if they were addicted. Moreover, there is strong evidence that as the use of e-cigarettes rose dramatically among youth, the rate of decline in youth smoking has accelerated. If anything, the current evidence supports the conclusion that e-cigarettes are a gateway away from smoking and over to vaping. These products do not normalize smoking. On the contrary, they denormalize smoking by drawing people away from it. What they normalize is vaping, not smoking.

Third, there is clinical trial evidence that e-cigarettes are helpful for smoking cessation. In fact, they are at least as helpful as the nicotine patch, which is a well-accepted smoking cessation approach. The commentary acknowledges as much. However, it misinterprets this evidence and/or misrepresents it by arguing that it shows that e-cigarettes are not effective for cessation. But how could that be the case if these products are as effective as the nicotine patch?

The commentary tries to write off this finding by arguing that "the patches were often not used by the study participants." But that is exactly the point! You have to be quite biased to not count as a failure subjects who try to quit smoking using the patch but discontinue using it. And you would also have to dismiss all of the e-cigarette users who stop using those products, which would greatly increase the observed cessation rate among e-cigarette users.

Furthermore, while the commentary cites one study to support the contention that "smokers felt that electronic cigarettes were not associated with success," it ignores a number of studies in which smokers overwhelmingly indicated the helpfulness of e-cigarettes in smoking cessation. This is what we call "cherrypicking."

Finally, the commentary argues that e-cigarettes are ineffective because in the New Zealand clinical trial, nicotine-containing e-cigarettes performed no better than what the commentary calls "placebo." But what the commentary fails to mention is that in the trial, "placebo" was actually the use of e-cigarettes, only without nicotine in the e-liquid. What the finding demonstrates is that the delivery of nicotine is only part of the reason why e-cigarettes can help smokers quit. The e-cigarette, in and of itself, aids in cessation because it simulates the smoking behavior. E-cigarettes are potentially more effective than nicotine replacement therapy because they address not only the pharmacologic aspect of smoking addiction, but also the behavioral, physical, psychological, and social aspects of the addiction to smoking.

Despite these serious flaws in the article, what I find most problematic is that the commentary fails to disclose a significant conflict of interest of its author. The author of the article is a past president and vice-president of the American Thoracic Society, and during his tenure as president and vice-president, the Society received financial support from two pharmaceutical companies that manufacture smoking cessation drugs: GlaxoSmithKline and Pfizer.

In fact, the American Thoracic Society readily acknowledges that it partners with the pharmaceutical industry and that its corporate partners include GlaxoSmithKline and Pfizer, along with at least nine other drug companies. Both GlaxoSmithKliine and Glaxo market smoking cessation drugs. Electronic cigarettes are a direct competitor of these drugs for the smoking cessation market. Thus, being president of an organization that takes money from these companies is a significant financial interest that should have been disclosed in the article. But the article states that there are no conflicts of interest.

Imagine if I were president of the American Heart Health Association (AHHA), and during my tenure as president, the AHHA received financial support from several electronic cigarette companies. Suppose I went on to publish a commentary arguing that e-cigarettes are a great strategy for smoking cessation and harm reduction. It would certainly be expected that I disclose my being president of the AHHA and receiving e-cigarette industry funding as a conflict of interest. I can guarantee that anti-smoking advocates, including Stan Glantz, would try to vilify and discredit me for not revealing this financial conflict.

The American Thoracic Society continues to receive financial support from Pfizer, which is supporting its 2015 international conference in May. The commentary's author is still affiliated with the American Thoracic Society, as he is listed as being a member of the Board of Trustees of the American Thoracic Society Foundation, on which also sits the Vice President of MedCenter Sales for GlaxoSmithKline.

The rest of the story is that the commentary fails to disclose a significant financial conflict of interest of its author, which has the appearance of creating a bias in the reporting of the scientific evidence and in the formation of the opinions expressed in the article.

It is particularly unfortunate that this conflict of interest was hidden from the public and the media, because news articles are reporting that e-cigarettes are a "gateway to addiction" and that they are "not a safer option." These unsupported and false conclusions are misleading the public and causing public health damage by undermining years of progress in convincing the public of the severe hazards of cigarette smoking. And unfortunately, the media and the public are not being made aware of the financial conflict of interest of the commentary's author, which would at least allow the conclusions to be taken with a grain of salt.

Thursday, April 23, 2015

Worst Lie of them All: CDC Tells Public that Smoking is No Worse than Vaping

According to an article published this past Tuesday in New Scientist, the Centers for Disease Control and Prevention (CDC), our nation's leading public health agency, doesn't see smoking as any worse than experimenting with e-cigarettes.

The agency also continues to claim, despite evidence it the contrary from its own surveys, that e-cigarettes are leading nonsmoking youth to start smoking.

And CDC also continues to claim, without any evidence, that experimentation with e-cigarettes is causing youth addiction to vaping, along with brain damage.

According to the article:

"The study [the National Youth Tobacco Survey] was carried out by the US Centers for Disease Control (CDC). Its thinking on the matter is clear. "In the case of kids, e-cigarettes are harmful all by themselves because of the effects of nicotine on children's brains," says Brian King of the organisation's Office on Smoking and Health. "The big picture here is we're seeing a striking increase. It's very concerning. It more than counterbalances the decrease in cigarette smoking, which we've seen occurring over the last few years."

"King says the CDC rejects any notion that replacing cigarettes with e-cigarettes is positive, and claims that e-cigarettes are actually prompting youngsters to take up smoking, not just taking the place of cigarettes. "In just one year, the number of kids using hookah doubled, and the number of kids using e-cigarettes appears to have tripled," he says. "These increases are driving an uptick in the total number of our children who are using tobacco products for the first time in a generation."

The Rest of the Story

How can the CDC possibly claim that a youth smoker switching completely to e-cigarette use is not a good thing? Has the CDC not seen its own data on the number of smokers who die every year? Is the CDC not aware of the devastating toll that long-term smoking takes on the health and lives of the population? Does the agency not recognize that youth smokers are at great risk of long-term addiction to cigarettes, and that half of these youths will eventually end up dying because of it?

I can guarantee you that if I were still working at CDC, that statement would never have come out of the Office on Smoking and Health. Back then, we were extremely careful in documenting the scientific support for any statement we made. And we would never have even considered lying to the public. We also never would have undermined the public's appreciation of the severe hazards of smoking by telling the public that smoking is no worse than occasional use of a non-tobacco containing, non-combustible product that eliminates exposure to more than 10,000 of the chemicals and more than 60 of the carcinogens in tobacco smoke. We certainly wouldn't have claimed that smoking is no worse than vaping given the abundant scientific data that demonstrates exactly the opposite.

I have already discussed in detail why the assertion that e-cigarettes are a gateway to smoking is incorrect and why the claim that e-cigarettes are causing brain damage among youth who experiment with them cannot be verified.

To top it all off, the statement made by the CDC above is dishonest because it implies that e-cigarettes contain tobacco, which is not true. Electronic cigarettes are not tobacco products. They contain no tobacco. They burn no tobacco. They heat no tobacco. They are "tobacco products" only in a strictly legal sense (under the definition in one particular statute). Why does the CDC continue to tell the public that e-cigarettes are tobacco products? Furthermore, by lumping e-cigarettes into the same category as real cigarettes, the CDC is further deceiving the public into thinking that smoking is no worse than vaping.

The truth is that there is no actual evidence that e-cigarettes have caused any substantial health damage to any youth. To tell the public that experimentation with e-cigarettes is causing brain damage among our nation's youth is a hysterical, unsupported claim, and an irresponsible one.

I have long detested the idea of using Congressional inquiries into the actions of executive agencies as a tactic to interfere with the work of these agencies, and I am acutely sensitive to the political uses to which these inquiries have been used. However, as much as I hate to say it, I actually think that a Congressional inquiry into the recent CDC actions is warranted. I think the agency needs to be asked to defend the accuracy of these statements. I think the agency needs to be asked to provide scientific evidence to back up these statements. And I think the agency needs to explain why it is running a deceptive campaign whose effect is to undermine the public's appreciation of the hazards of smoking.

Why is the American Cancer Society Promoting Cancer by Favoring Real Cigarettes Over Fake Ones?

According to an article published in The Hill, the American Cancer Society (ACS) is discouraging smokers from quitting or trying to quit using e-cigarettes, claiming that vaping impedes, rather than aids smoking cessation.

The ACS was quoted as stating: “Every bit of delay is a new opportunity for the tobacco industry to hook new people on nicotine and get in the way of helping tobacco users quit."

At least one chapter of the ACS has gone even beyond discouraging smokers from trying to quit. The New York chapter has actually called for a ban on the sale of electronic cigarettes (to anyone, not just kids)!

According to the ACS web site: "We certainly support the development of therapies that help people quit smoking.  If these devices work as the manufacturers claim they do, we urge them to submit their products for clinical research and present the findings to the FDA to determine if they indeed should be classified as a smoking cessation product.  In the meantime, New York State should absolutely halt the sale of these products to children and prevent their sale to adults until they're proven safe."

The Rest of the Story

There are a huge number of smokers out there who have tried to quit using FDA-approved methods and failed. For these thousands of smokers, e-cigarettes represent their only viable option to quit smoking. Yet the American Cancer Society apparently wants to take this option away from them. That leaves them with no realistic option other than to continue smoking. Thus, by discouraging the use of e-cigarettes to quit smoking and by calling for a ban on these products, the American Cancer Society is actually favoring tobacco cigarettes over non-tobacco-containing e-cigarettes and promoting, instead of preventing cancer.

There is no evidence to support either of the major contentions of the ACS. First, there is no evidence that new people (i.e., youth) are becoming "hooked" on nicotine due to their experimentation with e-cigarettes. In fact, the preliminary evidence suggests that e-cigarettes are not particularly addictive and that youth experimenters are largely using these products only sporadically and in a social manner (e.g, at parties or in the presence of friends). Unlike cigarette smoking, an addictive pattern of e-cigarette use among youth has not been demonstrated. And as I discussed yesterday, evidence from the UK documents that few, if any, nonsmoking youth are using e-cigarettes regularly.

Second, there is no evidence to support the contention that vaping interferes with smoking cessation. The most rigorous studies conducted to date, clinical trials of e-cigarette use, found that e-cigarettes are as effective as the nicotine patch in promoting smoking cessation. These clinical trials did not find that vaping impeded smoking. Quite the opposite. They found that e-cigarette use significantly enhanced smoking cessation.

Recent data from the UK (Smoking Toolkit Study) have revealed that electronic cigarettes have now surpassed all the FDA-approved smoking cessation methods (including NRT, Chantix and other drugs, and behavioral therapy) as the most commonly used method in smoking cessation attempts. The same study found that electronic cigarette use led to a rather dramatic increase in smoking cessation attempts.

Far from impeding smoking cessation, e-cigarettes are a bona fide strategy for smoking cesation that have helped huge numbers of smokers to finally get off cigarettes.

Why is the American Cancer Society ignoring the science and simply making up its own conclusions? I believe it is because the scientific facts do not comport with the organization's deeply-entrenched ideology. But when ideology leads you to take a position and to take actions that run counter to the interests of public health, it is time to re-examine that ideology. This is something which few tobacco control organizations have been able to do.

Fortunately, the vapers out there know the truth. They can testify to the degree to which e-cigarettes have helped them to quit smoking or to greatly reduce their cigarette consumption and the level of their addiction. No one in the anti-smoking movement appears to be taking them seriously. But some of us are listening. And we'll keep fighting. It's sad that we have to fight our own organizations in this battle against cancer, but we can't give up that fight simply because our colleagues are the ones who are standing in the way of progress towards potentially taking a huge chunk out of smoking-related disease and death.

Wednesday, April 22, 2015

CDC Refuses to Ask Critical Survey Question So that Results Don't Foul Up Its Attack on E-Cigarettes

Since 2012, the CDC has known that past 30 day use of electronic cigarettes has been increasing dramatically among youth. This makes it essential for the agency to determine whether these kids are becoming addicted to vaping or whether they are merely experimenting with e-cigarettes on an occasional basis. So you would figure that the CDC would add a question to find out exactly how often youths are using e-cigarettes.

The CDC has failed to ask that question, and the only reason I can see for this glaring omission is that the agency doesn't want to find out that few youths are actually addicted to vaping because it would destroy CDC's propaganda about e-cigarettes being a gateway to smoking, addiction, and serious brain damage.

In the UK, however, they are not afraid to ask this question. In both 2013 and 2014, Action on Smoking and Health (ASH-UK) has asked youth not merely whether they used an e-cigarette in the past 30 days, but whether they use them regularly (more than once per week). The answer will astound you.

The Rest of the Story

ASH-UK found that among nonsmoking youth, all use of e-cigarettes was mere experimentation. There was zero (0) regular use of e-cigarettes (defined as using e-cigarettes more than once per week) (data presented by Martin Dockrell, Tobacco Control Programme Lead of Public Health England, at the 16th World Conference on Tobacco or Health). The only regular use of e-cigarettes was observed among current and former smokers.

These data suggest that CDC's gateway hypothesis may be incorrect and that e-cigarette experimentation is not leading to nicotine addiction and then to cigarette smoking. Instead, it appears that e-cigarette experimentation is not leading to anything other than e-cigarette experimentation (and perhaps diversion away from regular tobacco cigarettes, since these experimenters are largely kids who are at risk for smoking).

The CDC doesn't ask the same question. The answer would most likely ruin the agency's story about how e-cigarettes are a gateway to smoking, to nicotine addiction, and to brain damage.

Thus, in my opinion, CDC is misleading the public not only through its outright lies, dishonesty, and deception about e-cigarettes, but also by its failure to ask the right questions to actually test its pre-determined conclusions. Perhaps it's not surprising that CDC shows no interest in testing those conclusions. The answer might destroy the e-cigarette myths that the agency is trying to create.

Tuesday, April 21, 2015

E-Cigarette Opponent Admits that He Wants to Suppress the Truth About Vaping Success

Dr. Stan Glantz has admitted on his tobacco blog that he opposes an ad campaign in which a vaper truthfully informs the public that thanks to flavored e-cigarettes, he was able to quit smoking. Glantz wants FDA Center for Tobacco Products director Mitch Zeller to refuse to attend the upcoming SFATA meeting because of the group's involvement in this campaign.

The ad features a picture of Stefan Didek holding a vaping device, with the following text: "27 Year Smoker: Smoke and tobacco free for nearly 3 years thanks to vapor products and candy flavors."

Glantz accuses the ad campaign of trying to deceive the public and compares it to historic tobacco industry deception campaigns.

The Rest of the Story

The strategy of e-cigarette opponents is now clear: Suppress the truth! Prevent vapers from telling their real stories about how e-cigarettes and vaping devices have saved their lives by helping them quit smoking. Hide from the public the fact that thousands of smokers who were unable to quit using any "FDA-approved" method were finally able to quit using e-cigarettes and have experienced dramatic improvement in their health because of it.

In many ways, Stefan's story is a lot more sincere than the way the CDC depicted Kristy's story. Kristy is a smoker who failed to quit using e-cigarettes and went on to experience a collapsed lung. The CDC ad is actually somewhat disingenuous because the agency specifically recruited nationally and offered money to try to find someone who failed to quit using e-cigarettes and then experienced a smoking-related consequence. In contrast, Stefan created this campaign on his own, motivated solely by a desire to combat the misleading information being disseminated by numerous health organizations, which continue to insist that e-cigarettes cannot help with smoking cessation.

The facts are now so strongly against e-cigarette opponents that their only resort is to either suppress the facts or to just make them up. In addition to Glantz's attempts to silence the voices of vapers who have saved their lives by quitting smoking, e-cigarette opponents are insinuating to the public that e-cigarettes contain tobacco, that e-cigarettes are leading kids to become addicted to smoking, that e-cigarette experimenters are addicted to vaping, that kids who use e-cigarettes are experiencing serious brain damage, that e-cigarettes are no safer than real cigarettes, and that dual users who cut down substantially on their cigarette consumption experience no health benefits.

Why the need to lie, deceive, and suppress the truth? Because the truth is not on their side.

Monday, April 20, 2015

CDC is Running a Dishonest Campaign Against E-Cigarettes Which is Re-Normalizing Smoking

Almost the Entire Tobacco Control Movement is Helping to Spread CDC's Deception

In an ironic twist of devastating proportions, the Centers for Disease Control and Prevention (CDC) is running an enormous, dishonest campaign against electronic cigarettes that is being spread by almost the entire tobacco control movement and which is serving to re-normalize smoking and undermine decades of progress in educating the public about the hazards of cigarette smoking.

The CDC's campaign involves lying, dishonesty, and massive deception:

Lying

The CDC has been telling the public that its data from the National Youth Tobacco Survey provides evidence that e-cigarettes are a gateway to cigarette smoking among youth. The CDC misrepresented cross-sectional CDC survey data as conclusive evidence that electronic cigarettes are a gateway to smoking. Specifically, CDC Director Dr. Thomas Frieden stated, in response to the 2011-2012 increase in youth e-cigarette use: "Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." In addition, Dr. Frieden was quoted as stating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine."

However, the CDC surveys do not provide any evidence that e-cigarette use is a gateway to smoking. If anything, they suggest the opposite: experimentation with e-cigarettes appears to be diverting kids away from smoking and contributing to the dramatic, accelerated decline in youth smoking that is contemporaneous with the more than tripling in youth e-cigarette use.

The surveys are cross-sectional and cannot determine whether youth are starting with e-cigarettes and progressing to smoking or whether dual users of e-cigarettes are smokers who subsequently starting using e-cigarettes. But this hasn't stopped CDC from drawing a conclusion, apparently a pre-determined one.

Moreover, the CDC surveys do not provide any evidence that e-cigarettes are condemning youth to a lifelong addiction to nicotine. In fact, what the current evidence suggests is that e-cigarettes are not particularly addictive. Despite the widespread use of these devices, very few youths have been found to be using e-cigarettes regularly, in a pattern that suggests nicotine addiction.

The surveys do not inquire about regular use of e-cigarettes, and thus they are not able to determine whether even a single youth has become addicted to vaping. But again, this hasn't stopped the CDC from disseminating what appears to be a pre-determined conclusion. 

I maintain that the CDC has intentionally failed to ask kids how often they use e-cigarettes because if they find out that most e-cigarette use is only occasional (as suggested by evidence from several studies), it would destroy the myth that e-cigarettes are a major gateway to long-term or lifelong nicotine addiction.

Dishonesty

The CDC is being dishonest with the public by classifying electronic cigarettes as tobacco products and by repeatedly referring to e-cigarettes as a form of tobacco use. Electronic cigarettes are not tobacco products, as understood by the public, because they do not contain any tobacco. Vaping is not a form of tobacco use.

E-cigarettes are tobacco products in only one sense: from purely a legal perspective, these products meet the definition of "tobacco product" under the Family Smoking Prevention and Tobacco Control Act because they contain nicotine, which is derived from tobacco and they are not marketed as drugs or devices. Were the very same product marketing as a drug or device, it would no longer be considered a tobacco product.

By dishonestly classifying e-cigarettes as tobacco products and by telling the public that e-cigarette use is a form of tobacco use, the CDC is deceiving perhaps millions of people into believing that electronic cigarettes contain tobacco. This is simply not true. I believe that it is both dishonest and unethical for CDC to repeatedly refer to e-cigarettes as a form of tobacco use and to classify e-cigarettes as tobacco products because this is dishonest, massively deceives the public, and completely undermines the public's appreciation of how severely toxic real cigarettes are. By essentially equating smoking and vaping, CDC is undermining its own campaign to highlight the severe dangers of smoking.

The CDC is also being dishonest with the public by failing to find out whether youth who are using e-cigarettes are using them regularly or only occasionally, such as in social situations. The CDC has only been able to report on the percentage of kids who have used e-cigarettes in the past month. However, these could easily be kids who picked up an e-cigarette to try it once and will never use one again. These could also be kids who use e-cigarettes only in social situations and so they may vape once a week or less. This would hardly constitute addiction.

The CDC is being particularly dishonest because it has failed to ask youth how often they use e-cigarettes. Moreover, the CDC is hoodwinking the public by not acknowledging that it has failed to document a single youth who is addicted to vaping.

Deception

The CDC is deceiving the public by implying that youth who use e-cigarettes are going to experience brain damage from the inhaled nicotine. The CDC is repeatedly scaring the public into believing that the pattern of e-cigarette use we are observing among youth is likely to cause brain damage. The CDC is repeatedly emphasizing that "nicotine can cause serious damage to the developing brains of teens."

This is very deceptive because it is unlikely that the sporadic exposure to the low levels of nicotine delivered by e-cigarettes is sufficient to cause serious brain damage. There is absolutely no evidence to support this contention. Moreover, the evidence that nicotine causes brain damage is based largely on animal studies and it is not clear whether one can extrapolate from animal models to humans. Furthermore, the few human studies that suggest possible neurological consequences from nicotine inhalation involve smokers, whose nicotine exposure is much higher and more frequent than that of the typical teenage e-cigarette experimenter. The observed decrease in pre-frontal cortex activity was highly correlated with the level of nicotine addiction.

The Rest of the Story

These lies, dishonesty, and deception have been widely incorporated as part of the tobacco control movement's mantra and are being spread like wildfire by virtually all major tobacco control organizations and policy makers who purport to be concerned about the long-term health of our nation's youth. Here is just a small sample of examples:

The chair of the New Jersey Breathes coalition stated: "This [the increase in e-cigarette use] could introduce a whole generation to cigarettes that may have not otherwise smoked." 

The American Heart Association stated: "We cannot stand by [while e-cigarette use increases] while more and more youth put themselves at risk for heart disease, stroke or even an early death."

Senator Dick Durbin (D-IL) stated: "While the FDA continues to drag its feet on finalizing commonsense regulations to protect children and teenagers from the dangers of e-cigarettes, the number of young people getting hooked on this potentially deadly habit is growing exponentially."

Senator Richard Blumenthal (D-CT) stated: "As a gateway to nicotine addiction, e-cigarettes are a burgeoning market and public health menace."

The Campaign for Tobacco-Free Kids stated: "We cannot allow the tobacco industry to keep addicting kids and create another epidemic with a new generation of tobacco products."

The Campaign for Tobacco-Free Kids also stated: "the explosion of e-cigarette use among kids means these products are being taken up in record numbers with totally unknown long-term consequences that could potentially undermine all the progress we’ve made."

The FDA stated: "In today’s rapidly evolving tobacco marketplace, the surge in youth use of novel products, like e-cigarettes, forces us to confront the reality that the progress we have made in reducing youth cigarette smoking rates is being threatened."

The Massachusetts Medical Association stated: "We’re running the risk of creating a whole new generation of smokers which will undo 50 years of public health efforts in smoking-reduction."

It is clear that almost the entire tobacco control movement has fallen for the CDC's lies and dishonesty about electronic cigarettes hook, line, and sinker. These groups are now helping to widely disseminate this inaccurate information to the public. I don't recall any previous tobacco-related public information campaign as dishonest and deceptive as this one since the tobacco industry itself battled to undermine the public's appreciation of the health hazards of smoking.

In fact, the truth appears to be the exact opposite of what these groups are telling the public. Electronic cigarettes are not creating a whole new generation of smokers. Instead, they appear to be diverting smokers and potential smokers away from tobacco cigarettes and toward the fake ones, which are orders of magnitude safer. And by equating the health hazards of smoking with those of vaping, these groups are the ones who are actually guilty of undermining 50 years of public health efforts in smoking reduction.

Not only is the CDC undermining our progress in reducing smoking by suggesting that non-tobacco-containing, non-combusted e-cigarettes are just as bad as tobacco cigarettes, but it is also undermining progress by completely diverting attention away from the problem of youth smoking (which is the real problem that is causing disease and death) to the problem of e-cigarette experimentation (for which there is presently no evidence that existing patterns of use will cause disease and death).

In fact, the CDC failed to even celebrate the finding that youth smoking has reached its lowest level in decades and that the decline in youth smoking accelerated from 2013 to 2014. Instead, all the CDC wanted to talk about was how horrible it is that youth are experimenting with e-cigarettes, how this is going to lead to nicotine addiction and serious brain damage, and how it is going to reverse progress in reducing youth smoking (via a rather strange mechanism, since the dramatic rise in youth vaping was associated with an acceleration in the decline in youth smoking).

Joe Nocera, in his New York Times column, astutely points out this strange behavior for an agency that is supposed to be focused on preventing disease and death. He writes:

"equating smoking cigarettes with inhaling e-cigarettes, as the C.D.C. is doing in its messaging around teen tobacco use, is a huge disservice to public health. On the scale of potential harms, e-cigarettes aren’t even in the same ballpark as combustible cigarettes. They have the potential to save millions of lives if smokers could be convinced to switch—which is what the C.D.C. ought to be stressing. Jack Henningfield, a tobacco expert at Pinney Associates, told me that while youths should be discouraged from using nicotine, “putting electronic products in the same basket as cigarettes is not truthful, credible or helpful.” Invariably, teens do things they shouldn’t; that’s part of growing up. For decades, smoking cigarettes has been one of those things. The fact that they are doing less of it than ever before is not a cause for dismay. It is a cause for celebration."

Thursday, April 16, 2015

New Study Which Purports to Have Found that E-Cigs Inhibit Quitting is Complete Junk Science

A new study, released just moments ago and published online today in the American Journal of Public Health, purports to have found evidence that smokers who use e-cigarettes are significantly less likely to quit smoking than those who do not.

(See: Al-Delaimy W et al. E-cigarette use in the past and quitting behavior in the future: a population-based study. American Journal of Public Health. Published online ahead of print on April 16, 2015.)

The study involved a survey of 1000 smokers in California who were followed for one year to determine whether they had quit smoking at follow-up. Quit rates were compared between those who stated at both baseline and follow-up that they had ever used e-cigarettes and those who reported at both baseline and follow-up that they would never use e-cigarettes.

The study claims to have found that smokers "who ever used e-cigarettes" were less than half as likely to have quit smoking than those "who never used e-cigarettes."

The study concludes that e-cigarettes inhibit smoking cessation.

The Rest of the Story

The conclusions of this article are completely invalid, and the article's description of its own findings borders on being deceitful (or it may actually be deceitful: I'll let readers decide for themselves).

First of all, this was not a study of 1000 smokers. The authors present results only for 368 participants. What happened to the other 632 smokers (almost two-thirds of the sample)?

1. Well, anyone who had not heard of e-cigarettes was completely thrown out of the study. This eliminated a whopping 9% of the sample!

2. Next, anyone who had never used e-cigarettes but who reported that they "might" use e-cigarettes in the future was excluded from the primary analysis.

3. Then, anyone who stated at baseline that they had used e-cigarettes but at follow-up that they had not was thrown out of the study.

4. Finally, anyone who responded at baseline that they would never use e-cigarettes but at follow-up that they had used e-cigarettes or might use e-cigarettes was excluded from the analysis.

Second of all, the study abstract claims that it compared smokers "who ever used e-cigarettes" with those "who never used e-cigarettes." This is not true. The study actually compared smokers who had ever used e-cigarettes at baseline with those who reported, both at baseline and follow-up, that they would "never" use e-cigarettes.

This introduces a huge bias into the study. Why might someone say that they will never use e-cigarettes?

At baseline, a plausible reason why a respondent might have no interest in e-cigarettes is that the individual has a high degree of confidence in his or her ability to quit smoking on his or her own, or with traditional methods, and thus has no desire or need to try e-cigarettes. Such a person is at a much higher likelihood of quitting smoking because of their high level of confidence. Clearly, this would bias the results toward finding a higher quitting rate among the supposed "control" group compared to the e-cigarette group.

At follow-up, a plausible reason why a respondent might have no interest in e-cigarettes is that the individual has stopped smoking! Thus, by using as a criteria for defining the control group a variable derived at follow-up, the study has introduced a strong bias towards finding a much higher quit rate among the control group.

Generally, in a cohort study, the cohort groups should be defined based on the baseline variables, not based on the follow-up variables. Defining a cohort based on follow-up variables almost invariably introduces severe selection bias into a study.

Here, the study has specifically excluded smokers who did not quit smoking, and for that reason, may have changed their mind and decided that perhaps they might try e-cigarettes. Also excluded were smokers who thought they would not or might not use e-cigarettes, but who ended up using these devices between baseline and follow-up. Thus, all smokers in the study who quit successfully were excluded from the study if they made the decision to try e-cigarettes between the baseline and follow-up interviews. This most likely led to the exclusion of a number of successful quitters (successful in using e-cigarettes to quit).

Furthermore, one can easily imagine that smokers who have never even heard of e-cigarettes are most likely not particularly interested in quitting. In fact, these smokers are likely to have no interest whatsoever in quitting because with even a little effort looking into cessation approaches, they would likely have come across e-cigarettes. These smokers were thrown out of the study! Because these smokers probably had a very low quit rate, the effect of this procedure was to artificially increase the observed quit rate in the control group.

In summary, you can see that there are numerous sources of severe selection bias in this study, all of which would bias the results towards finding a lower quit rate among the e-cigarette users.

But the problems don't end there.

The study included anyone who had ever used e-cigarettes, even if they had done so on only one occasion. All smokers who had ever used e-cigarettes were included in the "intervention" group, even if they had not used the e-cigarette with an intent to quit and even if they had absolutely no intention to quit smoking. A person could have tried an e-cigarette two years ago on one occasion and that person would still be included in the e-cigarette group. Even more problematic is that such an individual might actually have tried to use NRT or a cessation drug to quit smoking at baseline and failed. But that failure to quit would be counted against the e-cigarette group!

The fundamental problem with the study design is that it relies upon self-selection to assign smokers to the e-cigarette group and the non-e-cigarette group. It is almost certainly the case that smokers who try e-cigarettes are much more addicted to smoking. In fact, the failure to quit using traditional therapies is often the driving force behind a smoker wanting to try e-cigarettes. Numerous surveys have demonstrated that in fact, one of the main reasons why some smokers use e-cigarettes is that they have failed using many other approaches. By definition, the group of ever e-cigarette users is going to be expected to have substantially lower quit rates. Thus, this type of study design incorporates a profound bias towards finding that e-cigarettes inhibit smoking cessation, even if that is not the case.

This study has so many flaws that I find its conclusions to be meaningless. It is an example of junk science at (almost) its worst. But what makes it even more problematic is the apparent deception with which the results and conclusions of the study were presented. They left out important details that are critical to understand what the study did and did not do. Anyone but the most thorough and critical reader would easily be deceived by these omissions.

To top things off, the press release accompanying this study includes one of the most ironic statements of all time. The director of the California Department of Public Health is quoted as stating that: "There is a lot of misinformation about e-cigarettes."

This from the Department which claimed that (1) "E-cigarettes are just as addictive as regular cigarettes" and (2) "Studies show that e-cigarettes do not help people quit smoking cigarettes." Moreover, the Department's web site is full of lies, including the whopper that e-cigarettes are no healthier than regular cigarettes. Other web site lies include the insinuation  that e-cigarettes are actually more harmful than regular cigarettes because they contain more particles, that vaping causes asthma attacks, that e-cigarettes cause heart attacks, that vaping causes as much lung inflammation as smoking, and that nicotine is as addictive as heroin.

The pot is truly calling the kettle black.

The rest of the story is that this poorly conducted study is going to do great public health damage. It is going to add to the propaganda campaign that aims to demonize e-cigarettes, and which is using severely biased research to try to discredit the solid evidence that e-cigarettes can and do help many smokers quit smoking. This is further evidence that ideology has become more important than science in the modern anti-smoking movement.

New CDC Report on E-Cigarettes Shatters Gateway Myth, Suggests Shift from Hazardous Smoking to Much Safer Vaping among Youth

A new CDC report released moments ago and published in tomorrow's MMWR (Morbidity and Mortality Weekly Report) presents new data from the 2014 National Youth Tobacco Survey which show a tripling of past 30-day ("current") e-cigarette use from 2013 to 2014 among both high school and middle school students.

(See: Arrazola RA et al. Tobacco use among middle and high school students -- United States, 2011-2014. MMWR, Vol. 64, No. 14, April 17, 2015.)

The report shows a dramatic and statistically significant increase in current use of e-cigarettes among both high school and middle school students over the period 2011-2014. The actual data are as follows:

Current (past 30-day) E-Cigarette Use 

High school students
2011: 1.5%
2012: 2.8%
2013: 4.5%
2014: 13.4%

Middle school students
2011: 0.6%
2012: 1.1%
2013: 1.1%
2014: 3.9%

In a press release issued by CDC, the director of the FDA's Center for Tobacco Products stated: "In today’s rapidly evolving tobacco marketplace, the surge in youth use of novel products like e-cigarettes forces us to confront the reality that the progress we have made in reducing youth cigarette smoking rates is being threatened."

The Rest of the Story

The CDC, FDA, and anti-smoking groups are only telling one aspect of the story. There is indeed a "rest" of the story, and here it is:
What the CDC fails to mention in its report is that these new data pretty much shatter the gateway myth that the CDC has been disseminating over the past two years.

The CDC has been telling the public that its data from the National Youth Tobacco Survey provides evidence that e-cigarettes are a gateway to cigarette smoking among youth. Remember that the CDC misrepresented cross-sectional CDC survey data as conclusive evidence that electronic cigarettes are a gateway to smoking. Specifically, CDC Director Dr. Thomas Frieden stated, in response to the 2011-2012 increase in youth e-cigarette use: "Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." In addition, Dr. Frieden was quoted as stating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine."

However, today's CDC report reveals that something very different appears to be occurring. It appears that rather than serving as a gateway toward cigarette smoking, e-cigarettes may actually be acting as a diversion away from cigarettes. Perhaps the most important finding of the new report is that despite the dramatic increase in e-cigarette use among youth, the prevalence of smoking among youth has fallen dramatically during the same time period.

Among high school students, while current use of e-cigarettes increased from 1.5% in 2011 to 13.4% in 2014, current use of real cigarettes declined from 15.8% to 9.2%. Moreover, the prevalence of overall tobacco use among youth has remained steady during this time period, both among high school and middle school students.

These data do not support, and in fact, help to refute the CDC's assertions that e-cigarettes are a gateway to cigarette smoking among youth. These new data are simply not consistent with such a conclusion. Moreover, the data suggest the opposite. The data suggest that overall tobacco use among youth is not changing, but the form of that use is shifting dramatically: away from combustible cigarettes and towards non-tobacco-containing and much safer electronic cigarettes.

This is actually a good thing. While we of course do not want the reduction in smoking among youth to be "offset" by increases in the use of safer products, such as e-cigarettes, because we would prefer that youth not use any form of nicotine, the reality is that the observed shift away from real tobacco cigarettes and towards the fake cigarettes is actually a positive phenomenon in terms of improving the public's health. This shift is going to result in a great reduction in disease and death down the road, because vaping is far safer than smoking.

The truth is that the increase in e-cigarette use is not "offsetting" the decline in cigarette smoking because a large component of the increase in non-cigarette tobacco products is a dramatic rise in hookah use, which among high school students increased from 4.1% in 2011 to 9.4% in 2014.

The rest of the story, then, is that what the CDC data show, but the CDC fails to acknowledge, is that overall use of tobacco among youth is stable, but the form of that use is shifting from the most hazardous type of nicotine-delivering product (real tobacco cigarettes) to less hazardous products (especially electronic cigarettes). There is no question that we need to redouble our efforts to discourage youth from all forms of tobacco and that our goal should be to reduce all tobacco use, not just cigarette use. However, that goal does not justify misrepresenting the scientific data as indicating that the rise in e-cigarette use is troubling because it is going to lead to eventual smoking addiction.

The rest of the story is that the opposite phenomenon appears to be occurring. The advent of this novel product (e-cigarettes) actually appears to be diverting youth who are at high risk of smoking away from tobacco cigarettes and towards e-cigarettes. In essence, e-cigarettes are a gateway product, but they are a gateway away from, rather than towards cigarette smoking.

Wednesday, April 15, 2015

Tobacco Companies Sue FDA Over Required Pre-Approval of Cigarette Label Changes in Substantial Equivalence Guidance

This Tuesday, the major tobacco companies filed suit against the FDA in federal district court. The chief claim is that in its March guidance on substantial equivalence, the FDA essentially promulgated a new rule requiring pre-approval of many cigarette package labeling changes, even if there is no change whatsoever in the cigarettes in the package.

According to a Reuters article: "the tobacco companies said the FDA's authority to regulate labeling was limited to products that claim to reduce tobacco-related harm or other circumstances addressed by formal rulemaking. The guidelines go far beyond that authority, the plaintiffs said, by requiring FDA authorization to make any labeling changes that would render a product already on the market "distinct," like a name change. Although the FDA has framed the guidelines as non-binding recommendations, they create "specific legal obligations with clear and draconian consequences for violations," including civil or criminal penalties, the lawsuit said. The companies said the guidelines violated First Amendment protections for commercial speech by presumptively blocking certain labeling statements until they receive FDA approval. They also accused the FDA of depriving stakeholders of the chance to weigh in on the directive by issuing it as guidance and not through formal rulemaking."

The contentious part of the FDA's guidance is the following:

"In the draft of this guidance issued September 2011, FDA indicated that it would consider the “label” of the tobacco product to be a “part” of that tobacco product, and accordingly, any modification to a tobacco product’s label after February 15, 2007 would make the product a new product subject to premarket review. After reviewing the comments and information submitted in response to the September 2011 draft guidance, FDA has carefully reconsidered this policy. We have concluded that a label is not a “part” of the tobacco product. FDA does conclude, however, that if a product’s label is modified in any way that renders the product distinct from the predicate, even if its characteristics remain the same, the modified product is a new product under section 910(a)(1)(A) of the FD&C Act because that product was not commercially marketed in the United States as of February 15, 2007."

The FDA provides some examples of what labeling changes might be considered to make a product distinct and thus to require pre-approval.

For example, changing the background color from green to red would make a product distinct, but changing the color from white to cream would not. Changing the logo from a star to a lion would render a product distinct, while changing the logo from a small lion to a large lion would not. Adding the words "premium tobacco" to a product label would make the product distinct, while italicizing descriptors already on the label would not.

The tobacco companies argue that these requirements are arbitrary and capricious. Moreover, they were issued without a formal rulemaking process and the FDA does not have such authority, according to the tobacco industry complaint.

Ultimately, the tobacco companies argue that by requiring pre-approval of certain package labeling changes, the agency is exercising prior restraint over the commercial speech of the companies and thus violating the First Amendment rights of these companies.

The Rest of the Story

There are two rather complex legal issues here. The first is whether or not the FDA guidance actually represents the promulgation of specific legal obligations or whether they are simply non-binding recommendations or guidance. The second is whether the pre-approval of cigarette package labeling is unauthorized under the Tobacco Act or whether it is simply a part of enforcing its pre-market application rules.

Several things, however, are quite clear. First, the FDA has completely contradicted itself in this guidance. On the one hand, the FDA concludes that the product labeling is not part of the product. But if the labeling is not part of the product, then how can a change in the labeling - with no change whatsoever in the product - constitute the creation of a new "product?" It would seem that a label change is not changing the product because the label is not part of the product. How then, can the agency declare authority to require pre-approval of labeling changes (unless it were to exercise its formal rule-making authority)?

Second, the requirements do appear to be problematic. Essentially, the agency has issued a rule that bans the use of the term "premium tobacco" on a cigarette label without agency pre-approval, an action that appears to go beyond its existing statutory authority under the Tobacco Act. Nowhere in the Tobacco Act is the FDA granted the authority to pre-approve all cigarette package labeling for products already on the market.

Third, the requirements do appear to be quite arbitrary. Why would changing a logo from a star to a lion create a new product, but a change from a tiny lion to an enormous lion not create a new product? If a change from white to cream does not create a new product, what about a change from beige to brown? How about a change from purple to fuchsia or from Navy blue to azure?

At the very least, this lawsuit helps to expose how inane the requirements of the Tobacco Act are, how arbitrary they are, how little direct connection they have with protecting the public's health. Never has such a huge bureaucratic system of applications, reviews, and guidances been created without having any substantial, tangible, and direct connection to protection of the public's health.

Banning lions on cigarette packs is not going to save lives. However, setting actual product standards to make cigarettes safer could save lives. But in six years, the FDA has yet to issue a single product standard or to do anything to make cigarettes safer and/or less addictive. The agency is wasting all of its time in creating and managing a huge bureaucratic nightmare in which its resources are wasted trying to regulate the changes in colors of cigarette packaging, rather than the safety and addictiveness of the actual product that is within the packaging.

Monday, April 13, 2015

Two Prominent Tobacco Control Researchers are Not Sure Smoking is Any More Harmful than Vaping

According to an article from Healthline News, two prominent tobacco control researchers are telling the public they are not sure that cigarette smoking is any more harmful than vaping.

For reference, electronic cigarettes contain no tobacco, involve no combustion, have tobacco-specific nitrosamine levels that are two to three orders of magnitude lower than real cigarettes, eliminate most of the more than 10,000 chemicals and 60+ carcinogens that are present in tobacco smoke, have been shown not to cause acute changes in spirometry-measured lung function (unlike real cigarettes), are not known to have caused any deaths in the U.S (compared to more than 400,000 per year for real cigarettes), and have been shown to reduce respiratory symptoms and improve lung function in asthmatic smokers who switch to them.

According to the article:

"someone who quits smoking before they turn 40 can expect to live as healthy a life as someone who never smoked at all, according to Dr. Jonathan Samet, a pulmonary physician and epidemiologist at the University of Southern California. ... But how about people who quit smoking regular cigarettes and switch to electronic cigarettes? Does their health likewise improve? The short answer is medical researchers aren’t sure. “We just don’t have the data,” Samet, scientific editor of the 2014 Surgeon General Report on smoking, told Healthline. “Getting into issues of long-term harm reduction, it’s something we need to sort through.”

Also according to the article:

"Jed Rose is a professor at Duke University who specializes in addiction and behavioral science. He told Healthline it’s difficult to say anything conclusive about e-cigarettes because they vary from one brand to another. ... As for those who switch from smoking to vaping, the verdict on whether they truly are improving their health is still being studied. It’s a question researchers are competing for millions of dollars to investigate.
“Using an e-cigarette exclusively may be advantageous when the results come in,” Rose said."

The Rest of the Story

Apparently, according to these prominent tobacco control researchers, the question of whether cigarette smoking is any more hazardous than vaping is a difficult one to which we don't yet have an answer. We "just don't have the data." It's something "we need to sort through." We won't know until "the results come in."

I find it difficult to believe that in 2015, we are telling the public that we're not yet sure whether cigarette smoking poses any more of a hazard than using non-tobacco-containing, non-combusted electronic cigarettes. And we're telling the public this despite our knowledge that smoking is killing more than 400,000 people a year, that tobacco smoke contains more than 10,000 chemicals and more than 60 carcinogens, that e-cigarettes have been found to eliminate most of these chemicals and carcinogens, and that several clinical studies have demonstrated dramatic clinical improvement in smokers who switch to electronic cigarettes.

What exactly is it that we need to wait for?

In my view, it is not only wrong but irresponsible to tell the public that smoking may be no more hazardous than using an electronic cigarette. Even the tobacco companies are not telling people this to defend their products. In fact, if any cigarette company made such a statement, I can guarantee that anti-smoking groups would have them in court the next day.

To me, telling the public that smoking may not be any more harmful than vaping is essentially public health malpractice. It is negligent because it really doesn't take a rocket scientist to figure out that heating a solution of nicotine and propylene glycol (that does not even contain any tobacco) is not going to be nearly as dangerous as burning tobacco. Moreover, it ignores the overwhelming scientific evidence that smokers who switch to vaping experience immediate improvement in their health, as well as abundant evidence that the exposure to harmful chemicals and carcinogens is greatly reduced in electronic cigarettes compared to the real ones. Even the tobacco companies understand that their combustible tobacco products are much more hazardous than their heated non-tobacco products.

Furthermore, I believe this is essentially public health malpractice because it is not only negligent, but it is also harmful to the public's health. It undermines the dangers of smoking while exaggerating the risks of vaping, which is almost certainly going to deter many smokers from quitting using e-cigarettes and may even encourage smokers who have quit using e-cigarettes to return to smoking. After all, if we're not sure that smoking is any worse than vaping, then what's the point of vaping? You might as well go back to your Marlboros, Camels, and Newports rather than your Logic, NJOY, or Vuse.

These researchers obviously recognize that quitting smoking yields immeasurable health benefits. Why, then, could they possibly think that smokers who quit smoking (but by switching to e-cigarettes) might not experience any health benefit?

Perhaps the contradiction lies in the ideology rampant in the tobacco control movement that views a complete switch from smoking to vaping as a continuation of smoking. Numerous public health groups are telling smokers that they need to quit smoking "completely," by which they mean quitting not only smoking but vaping. But that view is inaccurate. Someone who quits smoking via electronic cigarettes is no longer a smoker. He or she is a successful quitter. And until the tobacco control movement finally recognizes that, we are going to continue to see this malpractice of public health.

Thursday, April 09, 2015

New CDC Ads Challenge Value of NRT in Quitting Smoking

A new ad campaign released today by the Centers for Disease Containment (CDC) targets nicotine replacement therapy (NRT) for the first time. The agency says it is taking aim at NRT because its statistics show that the majority of users aren't quitting smoking.

One of the new ads takes on NRT directly. In the print ad, a 35-year-old woman named Kirsty says: "I started using the nicotine patch but it didn't work and I kept smoking. Right up until my lung collapsed." The image shows a surgical scar.

The CDC has expanded its anti-smoking campaign to include NRT because "the majority of users aren’t giving up smoking," said the senior medical officer at the CDC’s Office on Smoking and Health.

The CDC cited a 2013 article published in Future Medicine which reported that 87.5% of smokers who try NRT continue to smoke cigarettes.

Kirsty's full story was revealed on the CDC web site. After smoking for 20 years, she tried the nicotine patch in an attempt to quit smoking. However, she failed. Two weeks later, her lung collapsed.

Anti-smoking groups blasted CDC's new ads. The Campaign for Kid-Free Tobacco released the following response: "The anti-NRT side has been spewing crap like this constantly, but the NRT market continues to grow. People know the truth about NRT."

The American Pulmonary Association also attacked the new ads: "While NRT may have an 87.5% failure rate, it has a 12.5% success rate. It isn't fair to condemn this product entirely just because it doesn't work for everyone. We know it works for many people and that's what counts."

The American Cardiac Association expressed concern that this campaign could seriously undermine smokers' attempts and motivation to quit. Its chief medical scientist told the Rest of the Story: "This is a completely unfair attack on NRT. By pointing out the failure of NRT in the majority of users, this campaign is going to discourage smokers from trying to quit using these products. Thousands of smokers who would otherwise have quit are going to keep smoking instead, and that is going to cost lives."

The anti-smoking groups' harshest criticism for the campaign was directed at the way in which the actor - Kirsty - was recruited. The CDC put out an ad recruiting specifically for a smoker who had tried NRT and failed and then shortly thereafter suffered a smoking-related complication. According to the president of the American Pulmonary Association: "This was at best dubious, and at worst unethical. Why recruit for the smoker who tried NRT and failed? Why not recruit one of the many thousands of smokers who tried NRT and quit? Their stories also need to be told."

The CDC's recruitment ad stated: "Are you a former smoker who used the nicotine patch or nicotine gum to try to quit cigarettes, but ended up continuing to smoke cigarettes? Did you use nicotine replacement therapy because you thought it would successfully help you quit smoking? Share your story. We will provide an initial recruitment payment of $2500 as well as all travel and lodging expenses to the location for the filming and recording. Ongoing and residual talent fees will be based on Screen Actors Guild (SAG) rates and guidelines."

Specifically, the CDC was recruiting for a smoker who tried to quit using NRT but failed and then suffered a smoking-related complication, prompting them to quit cold turkey without medication. Kirsty's story fit the bill.


ADDENDUM: This is obviously a satire. The CDC did not challenge the value of NRT in quitting smoking. Instead, they challenged the value of e-cigarettes. But the current scientific evidence shows that the value of these two products is roughly similar (although I think the value of e-cigarettes greatly exceeds that of NRT because a huge proportion of its users greatly reduce their cigarette consumption and the level of addiction to smoking is reduced in dual users). By substituting NRT for e-cigarettes, you can see exactly what CDC has done with this campaign in terms of undermining smoking cessation.

Tuesday, April 07, 2015

CDC's False Statements About E-Cigs are Still Doing Damage; Agency Needs to Retract Statements Immediately

Although it has been a year and a half since the CDC disseminated to the public inaccurate information about electronic cigarettes being a gateway to smoking among youth, this false propaganda is still doing damage.

It was in fall 2013 that CDC made the following statements regarding electronic cigarettes being a gateway to smoking:

1. The CDC misrepresented cross-sectional CDC survey data as conclusive evidence that electronic cigarettes are a gateway to smoking. Specifically, CDC Director Dr. Thomas Frieden stated: "Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." 

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

This past Sunday, in an article in the Newburyport Daily News, the CDC was again quoted as concluding that electronic cigarettes are a gateway to youth smoking.

According to the article: "While supporters say e-cigarettes are a less dangerous alternative to cigarettes, health officials said they worry the devices could spur teen cigarette use, possibly undermining decades of work to reduce smoking rates. At least 10 percent of high school students say they tried e-cigarettes in 2012, up from 4.7 percent in 2011, according to a National Youth Tobacco Survey by the US Centers for Disease Control and Prevention. “The increased use of e-cigarettes by teens is deeply troubling,” CDC director Thomas Frieden said in a recent statement. “Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes.”"

Even a brief search of the internet reveals that this statement continues to be relied upon by anti-smoking groups throughout the country in pressing the case that e-cigarettes are a gateway to youth smoking. The quote is even featured in an argumentative writing assignment for 9th graders at the Moore public schools in
Oklahoma.

The Rest of the Story

I can certainly understand if the CDC made a mistake. I do it all the time. Anyone can misspeak or say something in an interview that is not correct. The important thing is that you correct the error, especially if it will have a major effect on public policy.

But here we are a year and a half after the original statements and the CDC has failed to make any attempt to retract or correct these statements. They even have the original press release up with no note of any correction.

Given this failure to correct what is obviously a completely unsupported statement and one which appears to be false, one has to at this point infer that the deception of the public is intentional.

I call on the CDC to immediately retract these statements before any further damage is done. Failing to do so will only solidify my conclusion that the agency is intentionally misleading the public to promote its anti-e-cigarette agenda.

Monday, April 06, 2015

March E-Cigarette Madness: CDC Wins National Championship for Worst E-Cigarette Lie

The national championship for worst e-cigarette lie was held between CDC and the California Department of Health Services.

Here are the relevant statements (lies) of each finalist organization:

California Department of Health Services: The California Department of Health Services (CDHS), under a grant funded by the Centers for Disease Control and Prevention (CDC), produced a brochure entitled "Protect Your Family from E-Cigarettes: The Facts You Need to Know," which claimed that: (1) "E-cigarettes are just as addictive as regular cigarettes" and (2) "Studies show that e-cigarettes do not help people quit smoking cigarettes."

CDC: The CDC misrepresented cross-sectional CDC survey data as conclusive evidence that electronic cigarettes are a gateway to smoking. Specifically, CDC Director Dr. Thomas Frieden stated: "Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." In addition, Dr. Frieden was quoted as stating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine."

While it was a closely contested match, the CDC pulled out the victory because the damage caused by its lies are likely to be much greater than those of the California state health department. Some of the lies from the state health department are so blatant that no one will actually believe them. However, the CDC's lies about e-cigarettes being a gateway to smoking have been widely accepted and repeated by local health departments and policy makers and are already serving as the basis for some local policies. Moreover, the CDC's lies are potentially devastating to the e-cigarette industry because if these statements were true, then it would be difficult, if not impossible, to show that e-cigarettes will have a net benefit for the public's health, and therefore, no e-cigarette pre-market applications could be approved. The effect of CDC's lies, if they are accepted as truth, could therefore be the complete destruction of the e-cigarette market. That would have a severe detrimental effect on the public's health, and it brought the CDC the championship trophy.

THE NATIONAL CHAMPION for Worst E-Cigarette Lie:

Centers for Disease Control and Prevention (CDC)

Thursday, April 02, 2015

March E-Cigarette Madness: Semifinal Results for Worst E-Cigarette Lie

Today, I reveal the semifinalists for the 2015 Rest of the Story Worst E-Cigarette Lie Championship. The champion will be revealed next week. Criteria for selection included: (1) the extent of the misinformation provided to the public about e-cigarettes; and (2) the amount of probable damage to the public's health resulting by the misinformation. See my previous post for a full description of the Elite Eight organizations that made it to the quarterfinals.

The semifinal matchups were as follows:

SEMIFINAL MATCHUPS

1. California Department of Health Services vs. Mayo Clinic

2. CDC vs. FDA

Here are the relevant statements (lies) of each semifinalist organization:

California Department of Health Services: The California Department of Health Services (CDHS), under a grant funded by the Centers for Disease Control and Prevention (CDC), produced a brochure entitled "Protect Your Family from E-Cigarettes: The Facts You Need to Know," which claimed that: (1) "E-cigarettes are just as addictive as regular cigarettes" and (2) "Studies show that e-cigarettes do not help people quit smoking cigarettes."

Mayo Clinic: The Mayo Clinic stated that: "with nicotine inhalers you receive only nicotine." Even the arch-enemy of electronic cigarettes - Dr. Stanton Glantz - has acknowledged that nicotine inhalers deliver to users the following chemicals: Formaldehyde; Acetaldehyde; o-methylbenzene; Cadmium; Nickel; and Lead. In fact, I have shown that nicotine inhalers actually deliver higher amounts of six carcinogens than electronic cigarettes. The Mayo Clinic also stated that: "No studies have been done to examine the safety of e-cigarettes." However, there have been many studies that examined the safety of electronic cigarettes.
 
CDC: The CDC misrepresented cross-sectional CDC survey data as conclusive evidence that electronic cigarettes are a gateway to smoking. Specifically, CDC Director Dr. Thomas Frieden stated: "Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." In addition, Dr. Frieden was quoted as stating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine."

FDA: The FDA stated, in its proposed deeming regulations: "Many consumers believe that e-cigarettes are "safe" tobacco products or are "safer" than cigarettes. FDA has not made such a determination and conclusive research is not available." That the FDA is not sure whether smoking is any more hazardous than vaping does not say a lot for the agency's scientific standards.

THE WINNERS
 
 1. California Department of Health Services vs. Mayo Clinic

The California Department of Health Services wins in a blowout. Buoyed up by further lies coming out of the state health department, the team was in rare form. The Department's web site is full of lies, including the whopper that e-cigarettes are no healthier than regular cigarettes. Other web site lies include the insinuation  that e-cigarettes are actually more harmful than regular cigarettes because they contain more particles, that vaping causes asthma attacks, that e-cigarettes cause heart attacks, that vaping causes as much lung inflammation as smoking, and that nicotine is as addictive as heroin. In addition, the Department is running a campaign to keep smokers from quitting by switching to electronic cigarettes.

2. The Centers for Disease Control and Prevention vs. the Food and Drug Administration

In a close contest, CDC defeats the FDA. This was a tightly contested battle, and the CDC only pulled ahead in the final minutes. The CDC's lies about e-cigarettes being a gateway to smoking have had such a huge impact on public policy throughout the nation that CDC pulled away with the victory.

FINAL MATCHUP

California Department of Health Services vs. CDC