Saturday, June 17, 2017

American Lung Association in Wisconsin is Lying About Health Effects of Smoking

It used to be that the tobacco industry lied to the public in order to downplay the severe health effects of cigarette smoking. Today, it is the Wisconsin branch of the American Lung Association (ALA) that is lying about the risks of smoking.

According to the director of tobacco control and public policy for the ALA in Wisconsin: "there’s still a perception that e-cigarettes are less harmful than regular cigarettes and so for some kids who never would have tried smoking cigarettes they get the idea this might be a safer alternative."

Clearly, the ALA is telling the public that kids are actually mistaken and that e-cigarettes are no less harmful than regular cigarettes. Of course, this also means that cigarettes are no more dangerous than e-cigarettes.

The Rest of the Story

The truth is that e-cigarettes are much safer than regular cigarettes. Dr. Stan Glantz - a highly respected, long-time scientist in the anti-tobacco movement - has stated unequivocally that e-cigarettes are safer than regular cigarettes and that if a smoker switches to e-cigarettes exclusively, they will experience an improvement in their health. Dr. Glantz may quibble with some of us who support harm reduction in terms of the exact magnitude of the risk differential, but there is no credible scientific doubt that vaping is safer than smoking.

Even the cigarette companies are not lying to the public about this point. In fact, they readily admit that their cigarettes are much more dangerous than regular cigarettes and they are even making efforts to market e-cigarettes as a less hazardous alternative.

So why is the American Lung Association picking up where the historical fraud and deception of the tobacco industry ended?

Like the ALA, I do not want youth to be taking up vaping. However, unlike the ALA, I don't condone lying to our nation's youth in order to try to deter them from vaping. Especially since the ultimate effect of downplaying the health hazards of smoking is that it will produce less deterrence to youth smoking. If kids think that smoking is only as bad as inhaling cherry vapes and blowing a few vape rings, then their appreciation of the serious health hazards of smoking will be undermined, which of course will lead to more kids smoking.

As Alan Selk said eloquently in his comment to the article in which the ALA was quoted:

"Donna Wininsky's statement that there is still a perception that e-cigarettes are less harmful than regular statements is a pretty bizarre statement, considering that e-cigarettes are in fact significantly less harmful then regular cigarettes. All the real evidence points to that fact. It has also been shown that about 80% of kids who are using e-cigs are not using nicotine. They are simply playing with the vapor. A great majority of the youth who are using nicotine are using it as a substitute (and a much less harmful one) for smoking. ... "

"As far as health goes there is only one number that matters, and that is how many people are inhaling smoke from cigarettes. Those numbers are at historic lows among youth and adults. There is good evidence that the reason for the drop is because people are switching to low risk alternatives. That is a very positive news. (in the UK, where e-cigs are endorsed by the health establishment as a viable harm reduction tool, and people are generally better informed as to the relative risk of smoking verses vaping, 50% of people who take up vaping end up completely quitting cigarettes)."

"I would like to know why, instead of encouraging people to switch to a far less harmful alternative to cigarettes, the American Lung Association of Wisconsin is misinforming the people of Wisconsin on the relative risk of vaping verses smoking. They are in fact killing people with there misinformation campaign."

The ALA is not only wrong in its assessment of the relative health effects of vaping compared to smoking, but it is also wrong in suggesting that e-cigarette use among youth in Wisconsin is a problem because it leads to cigarette use. The evidence from Wisconsin suggests exactly the opposite. According to the state's Youth Tobacco Survey, while e-cigarette use among high school students in Wisconsin continued to increase substantially from 7.9% in 2014 to 13.3% in 2016, smoking prevalence declined by 24%, from 10.7% to 8.1%. These data are not consistent with the assertion that e-cigarettes are serving as a gateway to smoking among Wisconsin youth. In fact, they suggest the opposite. As Alan Selk correctly argues, e-cigarettes appear to be serving as a deterrent to smoking as a culture of vaping replaces, rather than reinforces, a culture of smoking.

Thursday, June 15, 2017

New CDC Data Should Put to Rest the Contention that E-Cigarettes are a Gateway to Youth Smoking

New data released moments ago by the Centers for Disease Control and Prevention (CDC) should put to rest the contention that electronic cigarettes are a gateway to smoking among youth. These new data show that the prevalence of smoking among high school students was cut in half in just five years - from 2011 to 2016 - at the same time as the use of e-cigarettes among these very same students increased dramatically from 1.5% to a peak of 16.0% in 2015.

There is more good news from the CDC. Not only has youth smoking declined at an unprecedented pace in the last five years, but for the first time, the prevalence of youth use of e-cigarettes has also declined, dropping from 16.0% in 2015 to 11.3% in 2016 (among high school students). Use of cigarettes among high school students continued to fall between 2015 and 2016, dropping from 9.3% to 8.0%.

The Rest of the Story

This is great news because it reveals that smoking is truly becoming unpopular among youth. The rate of decline in youth smoking is unprecedented. This despite the rapid rise in e-cigarette experimentation. These data are simply not consistent with the hypothesis that vaping is going to re-normalize smoking and that e-cigarettes are a gateway to youth smoking.

The drop in e-cigarette use is also reassuring because it suggests that vaping is largely a social phenomenon that involves experimentation and that the addictive potential of these products is quite low. It also suggests that the popularity of youth vaping has peaked and that concerns about vaping taking over and leading to nicotine addiction among a huge proportion of youth are not warranted.

If anything, the real concern at this point is whether the decline in e-cigarette use might actually slow the unprecedented declines we have seen in youth smoking.

Friday, May 26, 2017

CDC Bemoans the Fact that the Public Has an Accurate Understanding of Secondhand Vaping Risks

In an article published in the journal Preventing Chronic Disease, researchers from the Centers for Disease Control and Prevention (CDC) report the results of a national survey of U.S. adults to assess their opinion regarding the harmfulness of exposure to "secondhand" vaping (i.e., exposure to the air in a place where vaping is taking place).

The results of the study were as follows: "Overall, 5.3% of adults responded that secondhand EVP exposure caused “no harm” to children, 39.9% responded “little harm” or “some harm,” 21.5% responded “a lot of harm,” and 33.3% responded “don’t know.”"

The article concludes: "Current cigarette smokers and EVP users had greater odds of reporting that exposure to secondhand EVP aerosol causes “no harm” or “little harm” or “some harm” to children compared with never cigarette smokers and never EVP users. However, scientific evidence indicates that EVP aerosol exhaled into the air potentially exposes nonusers to aerosolized nicotine and other harmful and potentially harmful substances, including heavy metals, ultrafine particulates, and volatile organic compounds."

It appears that CDC has concluded that the correct answer to the question is "a lot of harm" and that answers of "no harm," "little harm," or even "some harm" are incorrect. Therefore, more education is needed to inform the public of the "harms" (apparently, the substantial harms) of secondhand vaping.

The basis of the CDC's contention that secondhand vaping is very harmful is that "this aerosol is not as safe as clean air" and that it "is not harmless and that it can contain harmful and potentially harmful chemicals, including nicotine."

The Rest of the Story

Apparently, the CDC has forgotten one of the major principles of environmental health, which is that the dose of exposure to a chemical is critical in assessing its health impact. Just because e-cigarette aerosol has been found to contain nicotine and some other chemicals does not mean that it is substantially harmful. What matters is the actual exposure, which is dependent upon the levels of these chemicals in ambient air under actual (real-life) conditions and the duration of exposure. To date, there is no evidence that there is any substantial exposure to harmful chemicals in real-life situations that most adults and children encounter. On the contrary, there is evidence that secondhand "vapor" dissipates rapidly and that exposure to nicotine and other chemicals is very low.

While I agree that public education about the risks of vaping is needed, I believe that "public education" implies giving people the actual facts, not making things up or exaggerating harms that are not known to exist.

Here, the CDC is clearly suggesting that we mislead the public by trying to convince them that secondhand vaping is a significant public health hazard when in fact the evidence suggests the opposite.

The worst that the CDC can document about secondhand "EVP" is that it is "not as safe as clean air" and that it is "not harmless." That is hardly a ringing endorsement of EVP representing a substantial public health problem or of EVP being very harmful.

Moreover, people who state that they "do not know" the hazards cannot be viewed as being ignorant, as the CDC would have us believe, because there is not a huge body of literature on this topic and the exact risks have not yet been quantified. But there is certainly no evidence at present that secondhand vaping is harmful. Therefore, we cannot say that people who believe that EVP is "not harmful" are wrong.

Clearly, the CDC is not interested in the actual scientific facts. They are simply interested in scaring people about the harms of secondhand vapor - harms that have not been shown to exist. The CDC is engaging in an unwarranted scare campaign against e-cigarettes and apparently is trying to demonize these products because, for some reason, it doesn't like them.

The unfortunate part of this is not merely that the CDC is violating principles of public health by deceiving the public and by making claims that are not substantiated by scientific evidence. The CDC's statements are also a tangible threat to the public's health. By deceiving people about the risks of e-cigarettes, CDC is actually undermining the public's appreciation of the hazards of smoking and the tremendous difference in risk between the use of combustible tobacco products and the use of tobacco-free, smoke-free, non-combusted products. This could lead to smokers deciding not to quit because there is no point to vaping if it is just as harmful as smoking. It could also lead to former smokers returning to smoking for the same reason.

In this era of the government relying upon and disseminating "alternative facts," it is especially inappropriate for the CDC to be waging a campaign of deception about the health effects of vaping and secondhand vaping.

Thursday, May 25, 2017

Why is the Campaign for Tobacco-Free Kids Congratulating a Political Leader Accused of the Murder of Thousands of Innocent Civilians?

In a press release issued this past Tuesday, the Campaign for Tobacco-Free Kids congratulated Dr. Tedros Adhanom Ghebreyesus on his election as the new Director-General of the World Health Organization (WHO).

Dr. Ghebreyesus' CV notes that he "facilitated critical health investments and reforms that helped expand health care access to tens of millions of Ethiopians," which sounds like a strong qualification for his election to this position as leader of WHO. However, the CV is only telling part of the story.

The Rest of the Story

The rest of the story is that Dr. Ghebreyesus, as one of the nine executive members of the politburo of the Tigray People’s Liberation Front (TPLF) - according to the Ethiopian Advocacy Network, has been accused of leading a campaign of repression and murder that some have even called a genocide.

According to multiple sources, the TPLF has allegedly engaged in severe repression of civilian protests in Oromia and Amhara, including a military response in which more than 1,000 innocent civilians were killed, hundreds of thousands imprisoned, and millions displaced.

The repression of dissent in Oromia is documented by a 2014 Amnesty International report, which confirms the TPLF's role in arbitrary arrest of civilians based purely on dissent or suspected dissent, the arrest of peaceful protestors and students, violations of free speech and assembly rights, violation of the right to education, and even "arbitrary detention," "enforced disappearance," "extra-judicial executions," and "torture," including rape, psychological torture, torture in and out of detention, and forced labor.

A 2016 report at Genocide Watch outlines numerous human rights violations by the TPLF and concludes that TPLF orchestrated a "genocidal plan systematically designed by the TPLF regime using the unfair land use policy as a tool in Oromia and Southern Ethiopia to achieve the political goal of complete ownership of the land through silent eradication of the indigenous communities in the long-term. “Genocide Watch considers Ethiopia to have already reached Stage 7, genocidal massacres, against many of its peoples, including the Anuak, Ogadeni, Oromo, and Omo tribes.” The people of Oromia in particular, and all oppressed peoples of Ethiopia in general, are struggling to reverse this policy of systematic genocide waged on them by successive regimes of Ethiopia."

While some of this alleged genocidal campaign occurred prior to Dr. Ghebreyesus' tenure, it has been estimated that "more than 1000 civilians have been killed by the regime in last 10 months (November 2015 to September 2016)."

The Oramian Economist describes the TPLF's rule as a system of social and economic "apartheid."

Dr. Ghebreyesus' campaign for the WHO directorship is widely characterized as a political campaign funded by the TPLF for political gain. His election was opposed by massive numbers of Ethiopians, apparently on the basis of his alleged "involvement in the killings hundreds of thousands of peaceful protestants. Last year alone, more than well over 1000 civilians were killed by the regime that Tedros Adhanom is fiercely and passionately supporting – the ethnic TPLF government."

Under these circumstances, I find it shameful that the Campaign for Tobacco-Free Kids offered its congratulations to Dr. Ghebreyesus and is supporting his election to the Director-General position of the World Health Organization. It appears that Dr. Ghebreyesus is someone who should be investigated by the World Health Organization for public health atrocities, not someone who should be leading the organization.

The Campaign for Tobacco-Free Kids' support for Dr. Ghebreyesus casts a dark cloud on the entire tobacco control movement. 

I call on the Campaign for Tobacco-Free Kids to retract its statement and apologize for its support of a political leader who is accused of being involved in the murder of thousands, participation in human rights violations, and supporting a policy of systematic genocide.

I expect an immediate response, given the grave nature of the alleged human rights violations.

Tuesday, May 09, 2017

Government Testing of Another Vape Shop Reveals No Cause for Concern about Secondhand Vaping

Government officials have now completed an investigation of a second vape shop, finding that levels of chemicals of concern are minimal in the ambient air of the vape shop, thus not posing any significant risk to customers.

The evaluation was performed by the National Institute for Occupational Health and Safety (NIOSH). Breathing zone air samples were tested for formaldehyde, acetaldehyde, and three chemicaals associated with "popcorn lung."

Results showed that all of these chemicals were well within the NIOSH recommended exposure levels. The formaldehyde and acetaldehyde concentrations were similar to those observed in typical U.S. homes. The "popcorn" lung associated-chemicals were not detected in most samples and detected only at very low levels in the remaining samples.

The Rest of the Story

This is now the second study conducted under the extreme conditions inside a vape shop, and like the first study, it finds that there is no evidence of significant exposure to hazardous chemicals among bystanders in this setting.

This study, although conducted under very high exposure conditions in a small, non-ventilated vape shop with many employees and customers vaping and clouds of vapor visible, did not document any dangerous levels of exposure to any hazardous chemical. Formaldehyde and acetaldehyde exposure was no different than in many indoor and outdoor environments at baseline. Chemicals that have been associated with "popcorn lung" were either not detected or detected at very low concentrations.

This study adds to the evidence that under real-life conditions, "secondhand vaping" does not appear to pose any significant health risks.

Despite the claims of many anti-vaping organizations, the documented health risks of "secondhand vaping" appear to be minimal. Based on the current scientific evidence, I fail to see the justification for banning vaping in most public places. There must be reasonable evidence before the government intervenes to ban a behavior such as smoking or vaping. With regards to vaping, I just don't see any reasonable evidence at this time that it poses any significant health hazard to bystanders.

Thursday, May 04, 2017

Smokeless Tobacco Company Admits that Its Products Cause Oral Cancer

In its defense of a lawsuit brought by the family of former San Diego Padres great Tony Gwynn who died of oral cancer in 2014, the U.S. Smokeless Tobacco Company has admitted that its products cause oral cancer and that the public was widely aware of it, to the extent that it was "obvious."

As reported by USA Today: "The U.S. Smokeless Tobacco Company has filed a response to the family of deceased baseball legend Tony Gwynn, saying that Gwynn was warned about the alleged risks of using smokeless tobacco and that such risks are “commonly known” but Gwynn accepted them anyway. ... “Plaintiffs (the Gwynns) are barred from recovering any damages because the dangers claimed by Plaintiffs, if any, are and were open and obvious,” says the company’s response, filed by attorneys at the firm Shook, Hardy & Bacon."

Furthermore, the company argued that: "Gwynn “had the means of knowing, by the exercise of ordinary intelligence, the truth of alleged statements concerning smokeless tobacco use and health.”"

The company's primary defenses are two-fold:

First, the company argues that the oral cancer risks of smokeless tobacco were widely known, to the point that they should have been obvious to everyone. Second, the company argues that Gwynn's oral cancer was not due to smokeless tobacco, but to some unspecified "pre-existing condition."

The Rest of the Story

This is about the weakest defense imaginable. On the one hand, the company argues that the link between smokeless tobacco use and oral cancer is so clear, so obvious, and so obviously true, that anyone with ordinary intelligence knows that smokeless tobacco causes oral cancer. On the other hand, the company is arguing that despite such an obvious link, Tony Gwynn's oral cancer -- which occurred in the exact spot where he used smokeless tobacco -- was not related to his smokeless tobacco use.

This duo of conflicting arguments should not deceive any jury member with "ordinary intelligence."

You can't have it both ways. You can't argue that the link between smokeless tobacco and oral cancer is so obvious that anyone should have known that if you put smokeless tobacco into one area in your oral cavity for years, you are likely to develop cancer in that area, but that for some reason, this individual who did exactly that and got cancer at that site got cancer for some other reason. That reasoning should fool exactly no one.

I also agree with Northeastern Law School professor Richard Daynard's comment: "Tobacco companies "do what they can to blame the victim,” said Richard Daynard, a law professor at Northeastern University and tobacco industry critic who is not involved in the case. “Their basic defense is, `Only a very weak-willed person would use this product, and it’s his fault and not ours.’ My understanding is that ain’t going to work with Tony Gwynn, with what people know about him. It’s working less and less with people who are not celebrities.”"

The company is also going to have a hard time convincing a jury that the link between smokeless tobacco and oral cancer was obvious to anyone with any intelligence, but that the company itself denied such a link, or downplayed and undermined it.

Gwynn's death is widely recognized as having helped changed the culture in baseball regarding smokeless tobacco use and has led to an increasing number of bans on the use of smokeless tobacco during professional baseball games.

Tuesday, May 02, 2017

Op-Ed: Don't Let Alternative Facts Deter Congress from Fixing E-Cigarette Regulations

Here is a link to my op-ed, published today in the Washington Examiner, and entitled: "Don't Let Alternative Facts Deter Congress from Fixing E-Cigarette Regulations."

Monday, May 01, 2017

Vape Shop Air Sampling by California State Health Department Suggests that Secondhand Vape Exposure is Minimal

As part of its investigation into the potential health effects of electronic cigarettes, the California Department of Public Health has been conducting air sampling and personal exposure monitoring in vape shops throughout the state. The results of sampling in one of these vape shops, obtained by The Rest of the Story, reveal that "secondhand vaping" appears to result in minimal exposure of bystanders to hazardous chemicals.

In this particular vape shop, sampling was conducted under quite adverse conditions. Many of the employees vaped throughout the sampling and 13 customers vaped while in the shop. There was no active ventilation system, and visible clouds of vapor were visible at times. So this seems to represent a high level of exposure compared to what one might expect in a public place outside a vape shop (e.g., a restaurant, bar, or office workplace).

Here are the major results of the air sampling:

Nicotine: Not detected
Glycidol: Not detected
Formaldehyde: 7.2 ppb
Diacetyl: Not detected using standard method
2,3-Pentanedione: Not detected using standard method
Acetyl butyryl: Not detected using standard method
Acetoin: Not detected using standard method
Acetone: Not detected
Ethyl benzene: Not detected
m,p-Xylene: Not detected
o-Xylene: Not detected
Toluene: Not detected
Acetaldehyde: Not detected
Acetonitrile: Not detected
alpha-pinene: Not detected
Benzene: Not detected
Chloroform: Not detected
d-Limonene: Not detected
Methylene chloride: Not detected
Methyl methacrylate: Not detected
n-Hexane: Not detected
Styrene: Not detected

The level of formaldehyde detected is consistent with normal indoor and outdoor air levels of formaldehyde under baseline conditions.

Other than the small concentration of formaldehyde, the only other chemicals that were quantified were ethanol (alcohol) and isopropyl alcohol.

The Rest of the Story

This study, although conducted under very high exposure conditions in a small, non-ventilated vape shop with many employees and customers vaping and clouds of vapor visible, did not document any dangerous levels of exposure to any hazardous chemical. Nicotine exposure was essentially non-existent. Formaldehyde exposure was no different than in many indoor and outdoor environments at baseline. Acetone, acetoin, other aldehydes, toluene, benzene, and xylene were not detected. Chemicals that have been associated with "popcorn lung" were also not detected by the standard method.

This study adds to the evidence that under real-life conditions, "secondhand vaping" does not appear to pose any significant health risks.

Despite the claims of many anti-vaping organizations, the documented health risks of "secondhand vaping" appear to be minimal. And this is in an environment with relatively extreme conditions -- there was a visible cloud of vapor at times.

Based on the current scientific evidence, I fail to see the justification for banning vaping in most public places. And remember, this is coming from a guy who has devoted virtually his entire career to banning smoking in bars, restaurants, casinos, and every other indoor workplace (and even outdoor seating areas of restaurants). So I'm certainly not one to minimize the health risks of preventable environmental exposures.

However, I believe that there must be reasonable evidence before the government intervenes to ban a behavior such as smoking or vaping. With regards to vaping, I just don't see any reasonable evidence at this time that it poses any significant health hazard to bystanders.

Wednesday, April 26, 2017

A Major Embarrassment for the FDA: Congressman to Introduce E-Cigarette Regulatory Bill Tomorrow

According to multiple sources, Representative Duncan Hunter (R-CA) will introduce legislation tomorrow in the House of Representatives that will create a new regulatory framework for electronic cigarettes and vaping products. The bill is titled “The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017.”

Briefly, here is what the bill would do, in order of importance:

1.     The FDA would be precluded from regulating electronic cigarettes under the same framework as tobacco cigarettes. Thus, the bill would put an end to the requirement for e-cigarette companies to submit pre-market tobacco applications and would not apply modified risk provisions to vaping products.
2.     The bill would set up a distinct regulatory framework for electronic cigarettes, under the jurisdiction of the FDA’s Center for Tobacco Products.
3.     The bill would establish safety standards for e-liquids and vaping devices that would go into effect one year after the enactment of the legislation. These standards include:
a.       Immediate adoption of the e-liquid standards developed by the American E-Liquid Manufacturing Standards Association (AEMSA);
b.       Subsequent adoption of the e-liquid standards being developed by the American National Standards Institute (ANSI) once they are established;
c.       Immediate adoption of battery safety standards set by the International Electrotechnical Commission;
d.       Immediate requirement for short-circuit protection for the heating element;
e.       Battery overcharge protection;
f.        Battery discharge protection; and
g.       Tracking of all devices by serial and lot numbers.
4.     The FDA would be required to review any subsequent e-liquid standards established by AEMSA or ANSI and adopt such standards if they are deemed to be appropriate for the protection of the public’s health.
5.     The FDA would be authorized to promulgate regulations to prevent marketing of vaping products to minors.
6.     The FDA would be required to conduct a health safety assessment comparing the risks of different tobacco products as well as vaping products and submit this report to Congress.
7.     The FDA’s Center for Tobacco Products would be renamed the “Center for Tobacco Products and Tobacco Harm Reduction.”

The Rest of the Story

This is critical and much-needed legislation that would put an end to the lunacy going on with the current regulation by the FDA of cigarettes and e-cigarettes. Right now, the FDA regulates e-cigarettes much more stringently than real cigarettes, putting an almost insurmountable obstacle in front of the development and marketing of electronic cigarettes – all to the advantage of the real, maximum harm, tobacco cigarettes. The current regulations will decimate the electronic cigarette industry, removing 99% of vaping products from the market and eliminating much of the competition faced by cigarettes for the nicotine market. This legislation would finally put an end to such nonsense.

It makes perfect sense to carve out a separate regulatory framework for electronic cigarettes that is separate from that for real cigarettes. This is something I have been calling for repeatedly during the past five years, and it is gratifying to see this potential approach finally seeing the light of day.

The most interesting aspect of this story is what an embarrassment it is for the FDA. While the FDA has had regulatory jurisdiction over electronic cigarettes for the past seven years, it has not established a single safety standard for these products. It has watched scores of people being injured by exploding batteries and done nothing. Even worse, the agency has actually prohibited companies from repairing this defective battery problem because any such change would render the product a “new tobacco product,” meaning that it could not be marketed without pre-approval – a process that would take years and is prohibitively expensive for all but the largest of companies.

Now, in one fell swoop, Representative Hunter and co-sponsors are stepping in establishing almost immediate safety standards (that go into effect in one year) that not only regulate battery safety, but also regulate all aspects of e-liquid manufacturing. This is something that the FDA could have and should have done years ago. But it has been too busy developing its prohibitory approach to e-cigarettes rather than actually working to protect the public’s health by assuring the maximum safety of e-cigarettes being used by millions of Americans.

This bill is not perfect, but it is a superb start and with a couple of amendments could be ideal. Here are the two major changes that I believe are necessary:
1.     The FDA should be given authority to set additional safety standards, beyond the e-liquid standards established by AEMSA and ANSI and the battery standards outlined in the bill. This is critical because we don’t know what safety features will be uncovered as research into e-cigarette safety continues and evolves. The FDA needs the flexibility to establish additional safety standards as they are warranted.
2.     The statute should explicitly address what claims are allowed and disallowed in e-cigarette marketing; in particular, what claims represent therapeutic claims and what claims are allowable without making a product subject to regulation as a drug or device. Specifically, I would like to see language that allows companies to truthfully inform their consumers that vaping is much safer than smoking and that it can be effective in helping many smokers to quit. Neither of these should be considered to be drug claims and should be allowed as long as they are accurate.

Please note that this commentary pertains to the merits of the legislation. I am not commenting on the political strategy, the wisdom of introducing this bill at the same time as the Cole-Bishop rider is considered, or other political concerns. I defer to others who know more about the political climate than I do.

But from purely a public health policy perspective, this legislation makes sense. It needs to be strengthened by allowing the FDA to set additional safety standards and by explicitly allowing reduced risk and smoking cessation claims. However, it is a great start to correcting the lunacy of today's federal regulation of electronic cigarettes.

Tuesday, April 25, 2017

New Article on Graphic Warning Labels is Wrong on the Law: Why Strict Scrutiny is the Proper Standard for Proposed FDA Warnings

In 2011, the Food and Drug Administration (FDA) issued regulations that required graphic warning labels on cigarette packages. The FDA chose nine graphic images, such as a picture of a man with a chest scar from cardiac surgery, along with a telephone number for smokers to call for help with smoking cessation (1-800-QUIT-NOW). The tobacco companies subsequently challenged the rule, arguing that it violated their First Amendment rights by compelling them to commercial speech which is against their economic interests (i.e., speech which strongly encourages consumers to stop using the product). The D.C. district court overturned the regulations on this basis, a decision that was affirmed by the appellate court.

One of the issues in the case was whether the required warning labels represent merely factual and uncontroversial information or whether they are intended to elicit an emotional response that goes beyond merely the provision of factual information. In an apparent attempt to defend the regulations, new research published in the journal Tobacco Control reports the results of a study showing that graphic images can be informative and textual messages can evoke emotion, thus (supposedly) invalidating the court's reasoning in rejecting the rule.

(See: Popova L, et al. Factual text and emotional pictures: overcoming a false dichotomy of cigarette warning labels. Tobacco Control 2017;

The article concludes: "Our findings contradict courts’ conclusions that pictorial messages are emotional and not factual. Pictorial labels are rated as informative and factual, textual labels evoke emotion, and emotionality and informativeness are strongly correlated. These findings serve as evidence for the Food and Drug Administration (FDA) to counteract the claim that pictorial warning labels, by definition, are not ‘purely factual and uncontroversial’."

The Rest of the Story

There are a number of reasons why this analysis is wrong on the law, but the first is that it ignores the word "purely." What this paper shows is that graphic images can not only invoke emotion, but also provide information. If the criterion for applying a low level of scrutiny (i.e., using the Zauderer standard) was that a compelled statement must have factual content, then this research might be relevant. However, the issue at hand is whether the compelled statement is "purely" factual. With the FDA's proposed graphic warning labels, this was clearly not the case. The graphic images were specifically chosen to evoke high levels of emotion and therefore to accomplish the government's purpose of persuading smokers to quit. That this was the real purpose of the required labels is evidenced by the fact that the FDA included the 1-800-QUIT-NOW hotline number on the packages.

In order to apply the Zauderer standard, the intended purpose of the compelled speech must be to prevent the dissemination of misleading, deceptive, or false information. Compelling a manufacturer to include a warning message that persuades the consumer not to purchase the product has never been the type of commercial speech to which Zauderer has been applied, even if such a message conveys some factual information.

For example, the government can certainly require an alcohol manufacturer to include a warning on a bottle informing consumers that alcohol consumption is linked to adverse pregnancy outcomes, liver disease, or cancer. However, requiring the bottle to include the message "PLEASE DO NOT PURCHASE THIS PRODUCT. PLEASE STOP DRINKING IMMEDIATELY AND COMPLETELY" would obviously not fall under the Zauderer standard.

The bottom line is that the government cannot compel a company to provide warning labels that essentially hijack the packaging and use it as an anti-smoking billboard. The government is free to convey anti-smoking messages through its own advertisements. But it cannot hijack the companies' packaging and advertisements and compel speech that is specifically urging consumers not to purchase the product. Even if some factual information is conveyed, this does not fall under the Zauderer standard for a low level of scrutiny.

Monday, April 24, 2017

Is the Campaign for Tobacco-Free Kids Even Capable of Being Honest?

In a press release issued last Friday, the Campaign for Tobacco-Free Kids once again accused the tobacco companies of marketing cotton candy e-cigarettes to youth.

The press release states: "This bill would make it much harder for the FDA to limit the sale or marketing of these products and, by making current products the industry standard, much easier for tobacco companies to continue marketing products in kid-friendly flavors like cotton candy and cherry crush."

The Rest of the Story

After an extensive internet search, I am unable to find a single tobacco company that markets cotton candy e-cigarettes.

It is now clear that the Campaign for Tobacco-Free Kids' repeated false statements are not merely a careless mistake. They are intentionally lying to the public in order to create a story that fits their pre-conceived model.

In my view, this behavior violates the public health code of ethics. Two key principles in this code are "truth telling" and "transparency" (i.e., not concealing information).

Not only is the Campaign failing to tell the truth regarding cotton candy e-cigarettes but it is also concealing information about the actual effect of the Cole-Bishop rider on the FDA's ability to restrict the marketing of e-cigarettes to youth. This amendment would not curtail the FDA's ability to regulate the marketing of e-cigarettes at all. The FDA remains free to promulgate any regulations it wants to restrict marketing of these products to youth. All the amendment does is to make it more difficult to market deadly tobacco cigarettes by ensuring that competition from much safer tobacco-free vapor products can continue. But the FDA is free to subject those products to any marketing restrictions that it deems advisable.

Honesty is critical in public health not only because it is essential to ethical conduct, but also because without it we risk losing the public's trust. The actions of the Campaign are therefore quite selfish: they are risking the credibility of the entire tobacco control movement just so that they can tell a more damning story about the tobacco industry to potential donors.

Monday, April 03, 2017

Penn Medicine Expert: Smoking May Be No More Hazardous than Vaping

An expert at Penn Medicine - the University of Pennsylvania's health care system - is telling the public that smoking cigarettes, like Marlboros, Camels, and Newports, may be no more hazardous to your health than vaping a tobacco-free e-liquid.

According to the expert: "We know that cigarettes are unsafe after 40 years of exposure. We don’t have 40 years of exposure to e-cigarettes to know what the danger is. We don’t know the safety profile, so we can’t say that e-cigarettes are safer than traditional cigarettes."

The Rest of the Story

Well, if we can't say that e-cigarettes are safer than traditional cigarettes, then what the expert is saying is that we can't say that smoking is any more hazardous than vaping.

This is an absurd statement, completely in conflict with scientific evidence, and not even the tobacco companies would make such a claim.

In fact, the tobacco companies could have a field day with this. If I were Altria, I would take out huge newspaper advertisements in all the leading papers stating: "Medical Expert Says that Smoking May Be No More Hazardous than Tobacco-Free Vaping."

In other words, the statement of this expert is essentially a huge advertisement for tobacco cigarettes, the most deadly consumer product on the market in terms of its toll on the lives and health of Americans.

The evidence that smoking is more hazardous than vaping is overwhelming. Asthmatic smokers who switch from smoking to vaping experience an immediate and dramatic improvement in their lung function, both measured subjectively in terms of respiratory symptoms and objectively in terms of spirometry testing. Hypertensive smokers who switch to vaping also experience a lowering of their blood pressure. A substantial decline in blood levels of many toxins and carcinogens has been documented in vapers compared to smokers.

In short, there just isn't any doubt that smoking is more hazardous than vaping. To suggest otherwise is not only incorrect, but it is damaging to the public's health.

Even the tobacco companies are not willing to lie to that extreme in order to promote cigarette smoking. While they easily could capitalize on statements like that of this Penn Medicine expert, they are refraining from doing so.

It's not clear to me why a medical professional would promote cigarette smoking in this way, but he has good company. A large number of medical and health organizations and agencies have made exactly the same claim.

The FDA and the CDC need to come out immediately with unequivocal statements that vaping is safer than smoking. Their failure to do so is a huge part of what is contributing to the deception of the public about the relative risks of vaping and smoking.

Friday, March 31, 2017

Vaping Opponents Have Lost Scientific Rigor; Now Concluding that E-Cigarettes Cause Heart Attacks Based on a Science Fair Project

Vaping opponents are using the results of a new "study" as evidence that vaping causes heart attacks.

Here is what my colleague Dr. Stan Glantz wrote about this "study":

"Every time I have posted a comment on a new study showing that e-cigarettes adversely affect blood vessels and blood in ways that increase risk of a heart attack, a friend and colleague who remains part of the (shrinking) collection of e-cigarette enthusiasts emails me and with he comment that, “if they are so bad where’s the evidence that e-cigarettes increase the risk of a heart attack?”  The first evidence just appeared. Using the National Health Interview Survey (NIHS), a large national survey done in the US, Nardos Temesgen and colleagues at George Washington University, found that the odds of a heart attack  increased by 42% among people who used e-cigarettes. This increase in risk was on top of the increases in risk due to any smoking that the e-cigarette users were doing. ... E-cigarette use increases the risk of a heart attack about as much as having diabetes. ... e-cigarettes represent an independent cause of heart attacks."

The Rest of the Story

Claiming that vaping causes heart attacks is a hugely important conclusion. And it is particularly important if vaping is as strong a risk factor for heart attacks as diabetes. If true, then the cardiovascular risks associated with vaping are not much lower than those associated with smoking, and the health benefits of switching from smoking to vaping are grossly overstated.

Before condemning electronic cigarettes, however, let's take a look at the rest of the story.

First, let's take a closer look at this "study." In what journal was it published?

It turns out, it was not published in any journal. It is not a peer-reviewed study.

In fact, it turns out that this study is merely an abstract that was presented by medical students at what is essentially a "science fair" project -- a "research day" in which medical students present posters summarizing their research. Now I'm not trying to demean medical student research, because that's how I started out myself, and two papers that I published as a medical student were actually quite interesting (one was the first to show that a dietary supplement - L-tryptophan - could cause pulmonary hypertension). However, these were peer-reviewed publications accepted by reputable medical journals. I wouldn't base a far-reaching conclusion on a medical school research day abstract.

Second, let's take a closer look at the study itself.

The study was merely a cross-sectional examination of the relationship between any history of a heart attack in the past and current e-cigarette use. The study did not follow people over time to see whether those using e-cigarettes were more likely to have a heart attack. Nor did it identify heart attack cases and retrospectively assess e-cigarette use. Instead, it was just a cursory, cross-sectional look at e-cigarette use prevalence among people with and without a lifetime history of a heart attack.

The study in no way proves that e-cigarettes cause heart attacks. It merely shows an association between ever having had a heart attack and currently using e-cigarettes, after controlling for smoking status. It is very possible (and quite likely) that many, if not most of the people with a history of myocardial infarction had experienced heart attacks years ago. And it is similarly likely that many of these heart attack victims had experienced the heart attack prior to starting to vape. In fact, it is likely that having a heart attack or a history of a heart attack was a stimulus that led the person to try vaping (because of the urgent need to quit smoking).

What the paper might actually be showing is simply that smokers who have experienced a heart attack are more motivated to try vaping to quit than smokers who have not had similar health problems. This makes complete sense and is certainly a plausible alternative explanation for the study findings.

Even the medical students who conducted the study do not conclude that vaping causes heart attacks. Appropriately, they merely conclude that they found a cross-sectional association and that further research is necessary before any conclusions can be drawn.

This is a great demonstration of what social scientists call "confirmation bias." When people have a pre-existing belief (i.e., vaping is terrible), they tend to interpret any scientific information in a way that reinforces their pre-existing beliefs (i.e., this study shows that vaping causes heart attacks). But science and scientific research is supposed to overcome this confirmation bias by establishing principles and procedures to promote objectivity.

Clearly, this is not happening with regards to the science of vaping. Now, vaping opponents have lost any semblance of scientific rigor and are willing to promote any research - even what essentially amounts to a science fair project - as supporting their pre-existing beliefs.

Thursday, March 30, 2017

My Response to Campaign for Tobacco-Free Kids' Article Published in The Hill

In a letter to the editor published in The Hill, I respond to an op-ed piece published a few days ago in The Hill by the Campaign for Tobacco-Free Kids. In that piece, the Campaign once again suggested that Big Tobacco is "peddl[ing] candy-flavored wares to kids." It also argues that the current FDA e-cigarette deeming regulations are the best way to: "ensure that smokers have access to products that will actually benefit their health."

In my letter, I take issue with the contention that the current FDA regulations are in any way helping to ensure that smokers have access to products that will benefit their health (namely, e-cigarettes) and that in fact, the regulations make it nearly impossible for e-cigarettes to enter or continue on the market. Instead, the regulations protect cigarette sales from competition by much safer tobacco-free vaping products.

The piece begins: "In his op-ed (“Congress, don’t help Big Tobacco peddle candy-flavored wares to kids,” March 26), Matthew Myers of the Campaign for Tobacco-Free Kids argues that the current FDA regulations regarding electronic cigarettes do not impede the ability of companies to put truly safer products on the market to compete with conventional tobacco cigarettes. But the opposite is true. By requiring every new product to submit burdensome and expensive applications, the regulations make it nearly impossible for companies to introduce new and safer vaping products into the market."

You can read the rest of the letter, entitled "Why is the FDA favoring real cigarettes over fake ones?" here

NOTE: The letter mistakenly refers to the legislation as HR 1156, but the current bill number is HR 1136.

Monday, March 27, 2017

IN MY VIEW: Campaign for Tobacco-Free Kids' Lying Has Got to Stop

In an action alert emailed today to its constituents, the Campaign for Tobacco-Free Kids insinuated that the tobacco companies are producing gummy worm electronic cigarettes. The title of the email is "Gummy worms," and the headline of the action alert states that "tobacco companies" are "luring kids with candy-flavored e-cigarettes and cigars."

As I've noted previously, this is simply not true. None of the tobacco companies is producing gummy worm-flavored electronic cigarettes.

While the Campaign for Tobacco-Free Kids has every right to fight for a ban on e-cigarette flavorings (a policy with which I vigorously disagree), it has no business lying to and deceiving its constituents in order to promote such a ban.

Telling the truth to its constituents would apparently not be glitzy enough for the Campaign. So instead, it has to lie by making the public think that Big Tobacco has sunk to the level of trying to get kids to use gummy worm-flavored nicotine products. This may be a catchy and eye-grabbing claim that succeeds in getting people riled up, opening up their pocket books, and eliciting donations, but it does so by misleading and deceiving them. That's fundamentally dishonest and unethical, and I don't believe a campaign like this has any place in public health.

Why is the truth not enough?

The Rest of the Story

Perhaps the reason that the truth is not enough is that the truth destroys the made-up story that the Campaign for Tobacco-Free Kids is trying to tell. Their story is that Big Tobacco is up to its old tricks, trying to seduce and addict kids to electronic cigarettes through outrageously blatant appeals to obvious youth-appealing flavors like gummy bear, gummy worm, and cotton candy. But unfortunately for the Campaign, that's not the truth. The truth is that the largest cigarette company in the United States - Altria - produces its MarkTen XL Bold e-cigarettes in only two flavors: tobacco and menthol. And their original MarkTen e-cigarettes come in only four flavors: tobacco, menthol, fusion, and winter mint.

If Altria were truly interested in getting kids addicted to e-cigarettes, I hardly think that it would restrict itself to tobacco, menthol, fusion, and winter mint, when there are thousands of sweet-tasting, candy, fruit, and dessert flavors available that they could be marketing.

The truth just destroys the Campaign's story. But apparently, the Campaign's motto is "never let the truth get in the way of a great story."

The real story is not a pretty one. The rest of the story is that the Campaign for Tobacco-Free Kids continues to incessantly deceive the public by falsely accusing tobacco companies of marketing gummy worm, gummy bear, and cotton candy electronic cigarettes to children.

Look - I have issued my fair share of accusations against the tobacco companies. I testified in about 10 cases against Big Tobacco, one of which resulted in a $145 billion verdict against the companies. But my testimony was always based on the facts. There were different ways to interpret those facts, but I would never lie or deceive the jury in order to try to make a point or embellish the case.

If we issue false accusations like this against the tobacco companies, then what reason is there for anyone to believe us when we complain about actions that they really have taken?

Perhaps this is why the actions of the Campaign for Tobacco-Free Kids are so disturbing to me. They tarnish the reputation of the entire tobacco control movement, including myself.

Tuesday, March 21, 2017

Anti-Vaping Advocates Support Indoor Vaping Bans Because We Don't Know if Secondhand Vaping is Harmful

In an interesting twist from the usual reasoning in public health, anti-vaping advocates are promoting the enactment of policies that ban vaping in public places not because secondhand vaping has been shown to have serious health hazards, but because it hasn't been proven to be benign.

In an opinion piece published in Tobacco Control, Dr. Simon Chapman and colleagues support a ban on vaping in public places because we don't know yet whether secondhand vaping is harmful. The authors write that: 

"those advocating for vaping to be allowed in smoke-free public places centre their case on gossamer-thin evidence that vaping emissions are all but benign and therefore pose negligible risks to others akin to inhaling steam from showers, kettles or saunas. This is likely to be baseless. Unlike vapourised water, electronic nicotine delivery system (ENDS) emissions comprise nicotine, carbonyls, metals, organic volatile compounds, besides particulate matter, and putative carcinogenic polycyclic aromatic hydrocarbon. ... Importantly, the short time span since the advent of ENDS and the latency of candidate respiratory and cardiovascular diseases that may be caused or exacerbated by ambient exposure to ENDS emissions preclude definitive risk inference. Taking the current immature evidence as a proof of safety and using it to advocate for policy that allows ENDS indoors could prove reckless."

The only known evidence of the hazards of secondhand vaping that the article is able to cite is that exhaled e-cigarette aerosol is "not harmless water vapor." And the only evidence it presents showing that vaping can result in high levels of particulate exposure is from the measurement of particle concentrations at a "vapefest," where literally hundreds of vapers are present in an enclosed location.

The Rest of the Story

In all the time that I spent lobbying for smoke-free bars and restaurants because of substantial evidence of life-threatening public health harm, little did I know that at a time in the future, we would be advocating for vape-free environments because a potential exposure was "not harmless." Little did I know that we would be supporting bans on a behavior in private facilities (like restaurants) because we did not have definitive evidence that the behavior in question was benign.

I thought it was the other way around. I always thought that to justify interfering with individual rights and freedom as well as business owners' autonomy, we had to demonstrate that there was a substantial public health hazard. These anti-vaping advocates suggest that it is the other way around. In order not to ban vaping, we have to prove that it is not harmful. In my view, this is antithetical to the justification for public health regulation. 

In order to justify societal policy that interferes with individual freedom and autonomy, we should be required to document - with reasonable evidence - that a significant public health hazard exists. We don't just ban everything that may or may not have significant risks and wait until behaviors are proven to be benign before we allow them.

When I testified at public hearings in support of smoke-free bars and restaurants, opponents would often argue that I only wanted to ban smoking in these workplaces because I was annoyed by smoke and that it didn't matter if secondhand smoke was actually known to be harmful. I countered this by explaining that in tobacco control, we respect individual rights and autonomy, including that of business owners, and that we would not call for a ban on smoking in these establishments in the absence of significant evidence that secondhand smoke exposure represents a substantial public health hazard.

What bothers me about this article, and about the campaign to ban vaping in public places generally, is that it essentially proves our opponents to be right. We aren't basing our support for bans on vaping on the presence of substantial evidence of a public health hazard. Instead, we're basing our support for these bans on the absence of substantial evidence that there is a public health hazard. If there were sufficient evidence to know that secondhand vaping is a significant public health hazard, this would be a no-brainer. So in essence, it is the lack of evidence of known health effects that is the basis of current campaigns.

New York State Senator Uses "Alternative Facts" to Promote Ban on Flavored E-Cigarettes

A New York State senator - Brad Hoylman (D-Manhattan) - has introduced legislation to ban the sale of flavored electronic cigarettes in New York. To promote this ban, he argued that cigarette companies are seducing kids to vape by selling fruit punch, gummy bear, and cotton candy e-cigarettes: "Kids are attracted to the numerous flavors that the cigarette companies are selling, such as fruit punch, gummy bear, cotton candy."

The Rest of the Story

Senator Hoylman's position is based on "alternative facts," or what prior to 2016 would have more simply been called a "lie."

Not a single one of the tobacco companies is producing gummy bear, cotton candy, or fruit punch e-cigarettes.

Altria's MarkTen e-cigarettes come in four flavors: classic (tobacco), menthol, fusion, and winter mint. Their MarkTen XL Bold e-cigarettes only come in two flavors: classic and menthol.

R.J. Reynolds Vapor Company's Vuse e-cigarettes come in seven flavors: original, mint, melon, nectar, berry, chai, and crema.

Imperial Brands' blu e-cigarettes come in 14 flavors: tobacco, menthol, vanilla, cherry, blueberry, peach schnapps, strawberry mint, Carolina bold, pina colada, mint chocolate, glacier mint, caramel cafe, gold leaf, and berry cobbler.

British American Tobacco's Vype e-cigarettes come in 12 basic flavor types: tobacco, apple, master blend, vanilla, mint, wild berry, green snap, scarlet kick, indigo dive, dark cherry, oriental spice, and rich aniseed.

Thus, not a single one of the tobacco companies are producing gummy bear, cotton candy, or fruit punch e-cigarettes.

The cotton candy, gummy bear, and fruit punch flavors of e-liquids are being produced by independent companies that have nothing to do with Big Tobacco. However, that apparently does not make a good enough story to support this legislation. So instead of just telling the truth, the senator decided to lie and tell people that Big Tobacco is the culprit for marketing these flavors.

This is not just bad legislation because it is based on a lie. It is bad legislation because if enacted, it would have a devastating effect on the public's health. Removing flavored e-cigarettes from the market is tantamount to a complete ban on e-cigarettes. There are literally millions of adults who use flavored e-cigarettes to stay off real cigarettes. Banning these products would result in tens of thousands of ex-smokers returning to smoking. It would also prevent quit attempts by many current smokers who are just not attracted by tobacco-flavored e-cigarettes. 

Any legislation so weak that you have to lie to support it is clearly not worth voting for. I hope the state Senate in New York sends this bill to a quick defeat.

Sunday, March 19, 2017

Campaign for Tobacco-Free Kids Admits that Its Secret Campaign Promoted Youth Cigarette Addiction

Through a shocking revelation, we learned last week that a major, national anti-tobacco organization ran a secret campaign to promote youth cigarette addiction.

The organization: The Campaign for Tobacco-Free Kids

The secret campaign: Federal lobbying against a ban on menthol-flavored cigarettes.

The admission: This campaign promoted youth cigarette addiction by protecting the cigarette companies' ability to market the most popular flavored cigarette (menthol) to youth and the campaign worked: menthol cigarette use among youth increased significantly thanks to the lobbying efforts of the Campaign for Tobacco-Free Kids.

The reason I call this revelation shocking is that I find it scandalous that an organization which is supposedly dedicated to fighting youth addiction to cigarettes would secretly lobby for legislation that protects cigarette companies' profits by blocking public health efforts to prohibit the companies' ability to use flavored cigarettes to attract and addict kids to smoking.

And instead of admitting its mistake and apologizing, the Campaign for Tobacco-Free Kids is now bemoaning the devastating damage that was caused by menthol cigarettes without acknowledging that it was largely responsible for this damage because it lobbied against taking menthol cigarettes off the market.

The Rest of the Story

When Congress debated the Family Smoking Prevention and Tobacco Control Act, which was signed into law by President Obama in 2009, perhaps the most critical issue it considered was whether or not to curtail the cigarette companies' ability to use menthol flavoring to attract and recruit kids to a lifetime of addiction to smoking.

The proposal on the table already banned non-menthol flavorings, but there was a problem: there were no non-menthol flavorings on the market. So while the proposal banned cherry, strawberry, banana, and pineapple cigarettes, there were no such products on the market. Candy-flavored cigarettes were not the problem. Menthol cigarettes were.

So the United States Senate debated whether to actually ban flavored cigarettes (i.e., menthol cigarettes) or whether to pretend to ban flavored cigarettes while exempting the only flavored cigarettes that were actually on the market (menthol cigarettes).

Understandably, a number of public health organizations came out strongly in favor of banning menthol cigarettes. But one organization - the Campaign for Tobacco-Free Kids - turned its back to the public's health and to the children it was supposedly committed to protecting.

Instead of lobbying for the menthol ban, it lobbied against it. The Campaign went to war, not to protect youth from a lifetime of addiction, but to protect the cigarette companies' ability to use flavored cigarettes to recruit and entice kids into a lifetime of addiction to smoking.

Last week, in a report entitled "The Flavor Trap," the Campaign for Tobacco-Free Kids revealed that data from the National Youth Tobacco Surveys demonstrates that its lobbying efforts resulted in the increased addiction of youth to menthol cigarette smoking, acknowledging that the "use of menthol cigarettes, the only remaining flavored cigarettes, increased significantly after the ban."

It is disingenuous for the Campaign to call menthol cigarettes "the only remaining flavored cigarettes" because menthol cigarettes were the only existing flavored cigarettes at the time the legislation was enacted. So yes, it is technically true that menthol cigarettes were the only remaining flavored cigarettes after the ban but they were the only remaining flavored cigarettes before the ban as well.

This admission - that the use of menthol cigarettes by kids increased significantly as a result of the legislation's menthol exemption - is quite damning. It essentially acknowledges that it was the Campaign for Tobacco-Free Kids' lobbying that was responsible for this rise in menthol cigarette use. Had this exemption not been granted, it is likely that youth cigarette smoking would have declined even more substantially.

What makes the report even more damning, however, is that the Campaign for Tobacco-Free Kids' hides from the public the fact that it actively lobbied against a ban on menthol-flavored cigarettes. While it boasts about having banned lime, bubble gum, chocolate, and raspberry cigarettes - none of which were on the market to begin with - the Campaign fails to disclose its role in protecting menthol cigarettes.

The Campaign hides the fact that it chose to come down on the side of Big Tobacco rather than on the side of America's youth.

Now - after the fact - the Campaign appears to be giving lip-service to the idea of extending the cigarette flavor ban to menthol. However, most of its attention is focused on banning flavored e-cigarettes - which are not addicted any nonsmoking youth- not on banning flavored real cigarettes, which the Campaign admits are addicting an increasing number of kids.

The rest of the story is that when it really mattered, the Campaign for Tobacco-Free Kids opted to protect the interests of Big Tobacco rather than to protect our nation's youth from a lifetime of addiction to the most deadly products on the market.

Wednesday, March 15, 2017

New York State Department of Health Urges Physicians to Discourage Patients from Quitting Unless They Use Big Pharma Products and Tells Vapers They Might as Well Go Back to Smoking

The New York State Department of Health has sent out a letter to medical professionals in the state, urging them to discourage patients from quitting smoking using e-cigarettes, even if they indicate unwillingness or lack of interest in nicotine replacement therapy or other smoking cessation drugs.

In the February 2017 letter, the state health commissioner writes:

"I encourage all health care providers to talk to their patients -- young and old alike -- about the dangers of e-cigarettes and to discourage their use. For patients who are already using traditional cigarettes or e-cigarettes, there are currently seven FDA-approved medications for smoking cessation, including five nicotine replacement therapies."

Further, in a letter sent to VapeNY five days ago, the director of the state health department's chronic disease prevention division castigates vapers by denying that switching from smoking to vaping has any public health value, thus telling vapers that they might as well return to cigarette smoking.

The director of the division writes:

"To date, the evidence on vapor products, electronic cigarettes and similar devices finds the products have no credible public health value in real world use...".

The Rest of the Story

I could hardly believe my eyes when I saw these letters. In the first letter, the New York state health department actually urges physicians to discourage patients from quitting smoking unless they are prepared to use nicotine replacement therapy, Zyban, or Chantix. For patients who have no interest in using one of those three products (or have used them and failed in the past) and wish to try quitting by switching to vaping, the official recommendation from the state of New York is to discourage these patients from using e-cigarettes to quit. In other words, physicians should essentially discourage such smokers from making such a quit attempt, since the reality is that they are not interested in using medication.

This advice to physicians to discourage quit attempts using e-cigarettes is unqualified. It does not say: "Encourage smokers to try an FDA-approved medication first, and recommend e-cigarettes only if that fails." It advises physicians to discourage e-cigarettes under all circumstances. Obviously, this includes the circumstance where the patient tells the physician that she has no interest in using Big Pharma products and instead, wants to try vaping.

This blanket recommendation is inappropriate and in my view, damaging. Essentially, smokers are being told that if they don't want to quit the way the health commissioner thinks they should quit, then they shouldn't even try. Clearly, this attitude from the state health department is going to discourage many quit attempts and therefore promote continued smoking by many.

The advice is particularly inappropriate because the scientific literature shows that smoking cessation medications only have a 10% success rate in the real world. Thus, 90% of smokers who take the health department's advice are going to fail, and thus remain smokers.

The existing evidence suggests that electronic cigarettes are at least as effective as nicotine replacement therapy. And newer products currently on the market are almost certainly more effective than the nicotine patch, since the products tested in the existing clinical trials were first-generation products with very poor nicotine delivery. The delivery of nicotine by vaping devices has increased substantially since that time, meaning that these devices are almost certainly more effective than the early products. But even those early products performed equally to the nicotine patch in the clinical trial setting.

The Department of Health's declaration that e-cigarettes have "no credible public health value" means that there must be no value in switching from smoking to vaping. The health department is essentially telling the millions of smokers in the United States who have done exactly that (quit smoking by switching to vaping), that they might as well return to smoking. After all, if vaping has no public health value, then why bother vaping? You might as well go back to smoking, and you haven't lost anything.

The problem is that this is patently false. There is abundant evidence that vaping is much safer than smoking and that smokers who switch to vaping experience an immediate and dramatic improvement in their health, especially in respiratory symptoms and lung function. Several studies by Dr. Riccardo Polosa and his colleagues have demonstrated significant improvement in respiratory symptoms and objectively measured lung function (spirometry) among smokers who switched to electronic cigarettes. Positive effects on health were observed for patients with both asthma and COPD. And while the improvement was most dramatic for smokers who switched completely to vaping, many of the dual users who cut down substantially on the amount they smoked did experience health improvement. Dr. Polosa also found that smokers with hypertension who switched to e-cigarettes experienced a significant decrease in their blood pressure.

While we can argue about the potential long-term risks associated with vaping, it is simply not the case that e-cigarettes have no credible public health value in real world use. What do you call more than one million smokers quitting using e-cigarettes? If that doesn't have public health value, then I don't know what does. And that is a conservative estimate, since there are an estimated 2.5 million ex-smokers who currently vape. (While some of them may represent ex-smokers who picked up vaping, the vast majority almost certainly are smokers who switched to vaping.)

The New York State Department of Health is also being irresponsible in its direct communications to the public. In a press release issued just 2 days ago, it incorrectly claimed that e-cigarettes are a form of tobacco use. The truth is that e-cigarettes are not a form of tobacco use because they don't actually contain any tobacco. They are no more a form of tobacco use than nicotine replacement therapy. We don't say that using the nicotine patch is a form of tobacco use. Neither is vaping.

The department, in the same press release, claimed that e-cigarette use can be a gateway to nicotine addiction. There is no evidence to support this conclusion. Despite dramatic increases in youth e-cigarette use, the prevalence of nonsmoking youth who have become regular users of e-cigarettes (and thus potentially addicted) is miniscule. Thus, the current evidence is that e-cigarettes actually have a very low potential to serve as a gateway to nicotine addiction.

New York's own data demonstrate that e-cigarettes are not serving as a gateway to smoking. Despite a doubling of e-cigarette use among youth between 2014 and 2016, youth smoking in New York in 2016 reached a historic low. Current smoking among youth in 2016 was only 4.3%.

In fact, while e-cigarette use among youth in New York state rose dramatically from 10.5% in 2014 to 20.6% in 2016, youth smoking plummeted from 7.3% to 4.3%. And if you go back to 2012, when youth e-cigarette use wasn't even measured, the decline in youth smoking is from 11.9% to 4.3%. These data are simply not consistent with the hypothesis that e-cigarette use is a gateway to smoking among youth. If anything, it appears that e-cigarettes may be contributing to the further de-normalization of youth smoking. The emergence of a vaping culture appears to serve as an alternative to the smoking culture, not the other way around.

The rest of the story is that the New York Department of Health is spreading dangerous misinformation and irresponsible medical advice that has the potential to do public health damage. Hopefully, they will correct this misinformation and retract their misguided advice to physicians. They need to do this in order to prevent the unintended effect of their communications, which is to promote smoking by protecting it from competition by vaping products.

Tuesday, March 14, 2017

New Survey Shows that Most Physicians are Completely Misguided on E-Cigarette Recommendations; Anti-Tobacco Groups' Propaganda is Wreaking Havoc on the Public's Health

A paper published in the current issue of the Annals of the American Thoracic Society reports the results of a survey regarding physician recommendations to their patients about the use of electronic cigarettes for smoking cessation.

(See: Nickels AS, Warner DO, Jenkins SM, Tilburt J, Hays JT. Pulmonologists’ and Primary Care Physicians’ Responses to an Adult Patient with Asthma Who Inquires about Using Electronic Cigarettes as a Smoking Cessation Tool. Annals of the American Thoracic Society 2017; 14(3): 466-468.)

Physicians were given a clinical scenario in which a patient who smokes seeks advice about smoking cessation. Most physicians report that they would recommend the patient try FDA-approved medication before trying e-cigarettes. However, physicians who recommended against e-cigarettes initially were then given a further scenario in which the patient tells the physician that they tried other medications to quit before, that they refuse a prescription, and that they ask the physician again whether they should try e-cigarettes to quit.

Shockingly, the survey finds that in this situation, only 27% of physicians would recommend e-cigarettes. The remaining 73% of physicians would recommend against the use of e-cigarettes, even after the patient indicated that using FDA-approved medications is not an option.

The Rest of the Story

The results of this survey are truly appalling. What they tell us is that more than two-thirds of physicians are essentially counseling their patients to continue to smoke rather than to attempt to quit by switching to electronic cigarettes.

After all, those are the only options that the patient is asking about in the scenario. The patient has made it clear that using FDA-approved medications is not an option. She has explicitly refused to take a prescription, meaning that she will almost certainly not be using NRT or other drugs to quit smoking. Essentially, the only options she is presenting to the physician are continuing to smoke are giving e-cigarettes a try.

And what the physicians are saying, or at least 73% of them, is: "In that case, continue smoking."

While this is truly appalling, I do not blame the physicians. They have been misled and confused by a major campaign of deception being waged by anti-tobacco groups and some health agencies, including the FDA and the CDC. These groups have lied to physicians and deceived them about the nature of e-cigarettes, their risks, and the relative risks of smoking compared to vaping.

For example, the CDC has told physicians that e-cigarettes are simply another "form of tobacco use." The FDA has told physicians that there is no evidence that vaping is any safer than smoking. Many anti-tobacco groups have told physicians that vaping is actually worse than smoking. Several anti-tobacco researchers have told physicians that vaping poses a higher cancer risk than smoking. Recently, some anti-tobacco researchers told physicians that vaping poses a higher risk of stroke than smoking. And many organizations have told physicians that vaping causes bronchiolitis obliterans ("popcorn lung") without even a suggestion that smoking also causes this severe, progressive lung disease.

Interestingly, the Mayo Clinic itself (with which four of this paper's authors are affiliated) has been a huge part of the problem. The Mayo Clinic lied to physicians about e-cigarettes, telling them that vaping is not any safer than smoking. The Mayo Clinic even went as far as to question the sanity of electronic cigarette users.

One thing I find surprising about this paper is that it fails to point out that there is a major problem with physicians advising patients who will not use NRT or other medications not to try e-cigarettes. While the paper does not explicitly state its position with regard to the appropriateness of this physician recommendation, it appears to be suggesting that the problem is not the physicians who recommend against e-cigarettes, but those who actually support this approach. I get this sense from the way that the paper frames the major result.

Instead of describing the major finding as "73% of physicians recommend against smoking cessation using e-cigarettes for smokers not willing to quit using other methods," the paper describes the major finding as follows:

"When confronted with a patient who prefers not to use FDA-approved medications, the majority of respondents either recommended electronic cigarette use or at least tolerated it."

One final point is worth mention. The authors fail to disclose any conflicts of interest related to this article. However, one of the study authors is a co-author of a manuscript reporting the results of a clinical trial of Chantix in which Pfizer was a collaborator (providing the study medication free of charge). And further, that co-author acknowledged having served "as an investigator for clinical trials funded by Pfizer." I believe that this conflict of interest should have been disclosed in the paper because Pfizer clearly has a significant financial interest in the information discussed in this study. In fact, e-cigarettes and Chantix are direct competitors in the smoking cessation market.

The rest of the story is that it appears that the majority of physicians are giving misguided advice to their patients regarding smoking cessation using e-cigarettes. Apparently, the campaign of deception being waged by anti-tobacco groups and some health agencies has been quite effective. It has led to the perverse result that the majority of physicians are actually recommending that some patients continue smoking rather than attempt to quit.

Sunday, March 12, 2017

Surgeon General Continues to Lie about Tobacco in E-Cigarettes

In an article published earlier this month in JAMA Pediatrics, the Surgeon General claimed that electronic cigarettes: "are now the most commonly used form of tobacco among youth in the United States, surpassing cigarettes, chewing tobacco, cigars, and hookah." The article repeatedly refers to e-cigarettes as a form of tobacco. In fact, the article contains four statements indicating that e-cigarettes are a "form of tobacco" or that vaping is a "form of tobacco use."

The Rest of the Story

There's just one problem with the Surgeon General's claim that vaping is a form of tobacco use: it's not true.

There is no tobacco in electronic cigarettes. Using e-cigarettes, even if they contain nicotine, is not a form of tobacco use. You are not using tobacco if you vape because the e-liquids do not contain tobacco. In fact, the entire point of vaping is that it represents a tobacco-free and smoke-free method of inhaling nicotine.

Even if the Surgeon General wrongly believes that consuming any product that contains nicotine is a form of tobacco use, then he is still lying to the public. Under that definition, e-cigarettes are not the most commonly used form of tobacco among youth. Potatoes are.

According to the Surgeon General, about one in six high school students have consumed e-cigarettes in the past month. But according to the National Youth Physical Activity and Nutrition Study, a whopping 69% of high school students have consumed potatoes in the past seven days. And if you include french fries, that percentage goes up to 79.4%.

The rest of the story is that the Surgeon General owes a huge apology. Either way, he was lying. The only question is whether he owes that apology to the American public (and especially vapers) or to the United Potato Growers of America.

Thursday, March 02, 2017

American Heart Association Sticks to Its Guns: "E-Cigarettes May Pose the Same or Higher Risk of Stroke" than Smoking

Earlier this week, I discussed a press release from the American Heart Association which claimed that vaping causes severe strokes and poses a higher risk of severe strokes than smoking. According to the press release: "E-cigarettes may pose the same or higher risk of stroke severity as tobacco smoke." 

In my commentary, I noted that the American Heart Association's conclusion that vaping poses an equal or higher risk of suffering a severe stroke is based on a single mouse study. In that study, which has not been published or peer reviewed, but was presented last week at the American Stroke Association’s International Stroke Conference, the investigators found that mice exposed to e-cigarette aerosol for 10 days or 30 days had more severe strokes than those exposed to tobacco smoke. To extrapolate from this single pre-clinical, animal study to population-based human health effects, as I pointed out, is ludicrous.

I sent my commentary to the American Heart Association, calling for an immediate retraction, correction, and apology for this action. I noted that if that happened, I would report it here as soon as I became aware of it.

The Rest of the Story

As a result of my notifying the American Heart Association of the mistake in its press release ...

... nothing happened.

There was no response, and the claim remains unchanged on its web site.

What am I to think? Can I continue to give the American Heart Association the benefit of the doubt and assume that this was just some sort of mistake or oversight? Hardly, when they failed to correct it after being notified of the error.

At this point, I have little choice but to consider this as a deliberate attempt to mislead and deceive the American public into believing that vaping is just as hazardous, or even more hazardous than smoking.

I have no choice but to view this as a negligent action on the part of the American Heart Association. Any reasonable health organization, after being made aware of a blatant factual error such as this one, would be expected to correct the error. It is therefore difficult not to see negligence in the AHA's apparent decision not to correct this ridiculously false claim.

I am frustrated because this is like banging my head against a brick wall. Despite pointing out factual errors, most anti-tobacco and health organizations or agencies are unwilling to, or uninterested in, correcting their misinformation. I have little choice left but to conclude that this is a deliberate campaign of deception.

Sunday, February 26, 2017

American Heart Association Claims that Vaping Causes Severe Strokes and is More Risky than Smoking

In a press release issued last Thursday, the American Heart Association claimed that vaping causes severe strokes and poses a higher risk of severe strokes than smoking.

According to the press release: "E-cigarettes may pose the same or higher risk of stroke severity as tobacco smoke. ... Electronic cigarette (e-cigarettes) vaping may pose just as much or even higher risk as smoking tobacco for worsening a stroke, according to a preliminary study in mice presented at the American Heart Association's International Stroke Conference 2017. ... From a brain health perspective, researchers said, electronic-cigarette vaping is not safer than tobacco smoking, and may pose a similar, if not higher risk for stroke severity."

The American Heart Association's statement was spread widely through the media. For example, here's just one headline that appeared: "E-cigs could raise the risk of suffering a stroke more than smoking."

The Rest of the Story

The American Heart Association's conclusion that vaping poses an equal or higher risk of suffering a severe stroke is based on a single mouse study. In this study, which has not been published or peer reviewed, but was presented last week at the American Stroke Association’s International Stroke Conference, the investigators found that mice exposed to e-cigarette aerosol for 10 days or 30 days had more severe strokes than those exposed to tobacco smoke.

To extrapolate from this single pre-clinical, animal study to population-based human health effects is ludicrous. There are many reasons why stroke-related findings from rodent studies do not translate well to humans. For example, as Braeuninger and Kleinschnitz point out:

"There are, of course, significant physiological, neuroanatomical and metabolic differences between humans and small rodents, which are the most widely used experimental animals in preclinical stroke research. For example, small rodents usually require higher drug doses on a mg/kg body weight basis for a similar effect than larger mammals. Thus, effective doses derived from preclinical stroke studies in small rodents cannot simply be transferred to the situation in humans, even if adjusted for body weight."

There is no scientific justification for the American Heart Association spreading the conclusion that vaping causes strokes. Nor is there any scientific justification for spreading the message that vaping poses a higher risk of suffering a stroke than smoking.

This blatant disregard for the truth, which I would term "public health malpractice," is not only unscientific but it is also damaging to public health. There are literally millions of smokers who have considered, or are currently considering, the question of whether or not to switch from smoking to vaping. Thanks to the American Heart Association, we can expect that huge numbers of smokers will choose to stick with smoking and that many ex-smokers - who quit via e-cigarettes - will decide to return to smoking.

After all, if vaping poses a greater risk of stroke than smoking, then there is absolutely no reason to quit smoking using e-cigarettes. You'd be better off smoking. And if you already quit smoking by switching to e-cigarettes, then you'd be better off returning to smoking than continuing to vape. Why take a chance of increasing your risk of suffering a stroke?

You can see why I call this an example of public health malpractice. The American Heart Association is essentially advising smokers that they are better off continuing to smoke than quitting smoking and switching completely to vaping. This is perhaps the most absurd medical advice I have ever heard in my entire career in medicine and public health. Even the tobacco companies - in the worst of their behavior - never told smokers that they would be at greater risk of disease if they quit smoking. But that is precisely what the American Heart Association is essentially telling smokers.

If the American Heart Association has any regard for scientific accuracy and professional responsibility in communication, it will offer an immediate retraction, correction, and apology for this action.

If that happens, I will report it here as soon as I become aware of it.