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; http://dx.doi.org/10.1136/tobaccocontrol-2016-053563.)

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.

Monday, February 20, 2017

Tobacco Control Journal: There Can Be No Legitimate Discussion of Our Articles Without Our Permission

In a revelation of the religious-like character of the modern-day tobacco control movement, the journal Tobacco Control has suggested that there can be no legitimate discussion about articles it publishes without its permission; that is, on the Rapid Response forum at the journal's own web site. All other discussion of the scientific validity of journal articles is apparently illegitimate and inappropriate.

In an unprecedented editorial (I've never before seen a journal argue that the only legitimate forum for discussion of its articles is in the journal itself), the journal writes:

"the growing use of personal blogs to criticise published articles has led us to reflect on appropriate ways of engaging in such debate ... the proper place to pose questions and debate conclusions from research published in Tobacco Control is directly to the authors, in the form of a Rapid Response. ... placing personal blog posts or social media messages complaining about a study ... do not advance the field or allow an appropriate scientific dialogue and debate. ... As a result of discussion about these issues, the Tobacco Control editorial team has now established a policy that editors will not respond to external blog posts or social media messages about specific studies. ... We will always welcome legitimate criticism of methods, results and interpretation of published research. But we will discourage engagement with and dissemination of polemics that contribute to public misunderstandings and create conflict. As journal editors, we encourage constructive criticism and debate in ways that strengthen the evidence base for effective tobacco control policy rather than amplifying individual voices."

The Rest of the Story

I have never seen a scientific journal make such a bold statement. Do you mean to tell me that the only legitimate scientific discussion of an article published in a journal is that which takes place in the journal itself, in a forum that is managed and controlled by the journal? Do you mean to tell me that any other discussion or criticism of research articles is not constructive and serves only to "amplify individual voices?"

Moreover, what is wrong with creating "conflict" if it is warranted because the conclusions of an article are not supported by its findings? In fact, a blogger who is criticizing the conclusions of a study because they are warranted is not "creating" conflict. What is creating conflict is the fact that the paper disseminated those unwarranted conclusions and that the journal chose to publish this shoddy science in the first place.

The editorial does not specify exactly what irked the journal so much that it boldly went where no journal has gone before and declared that any discussion of its articles outside of its own purview is illegitimate. However, I think it's quite clear that what irked the journal was criticism on several blogs - including my own - of an article that concluded vaping is a gateway to youth smoking based on a sample of 4 nonsmoking youth who experimented with e-cigarettes and then went on to try one or two cigarettes.

In this study, the sample size of youth who were nonsmoking, recent vapers at baseline was only 13 and the number of youth in this category who "initiated" smoking was only 4. Thus, the sweeping conclusion of the paper, which has been publicized internationally, was based on only 4 kids! Moreover, despite having a sample size of 347 high school seniors, the study could not find a single student who became an actual new smoker after having experimented with e-cigarettes. The few students (a grand total of 4) who did try a cigarette or two did not progress beyond having one or two cigarettes.

Rather than simply admit that it made a mistake and this unwarranted conclusion slipped through the cracks, the journal instead tried to divert attention from its mistake by attacking the messengers: those like myself who pointed out the error.

It's unfortunate that the journal chose to respond in an ad hominem manner rather than to actually address the substantive scientific question, which is whether or not the conclusion that vaping is a "one-way bridge" to smoking among youth can be justified based on the finding that 4 youth who were nonsmokers at baseline and who had experimented with e-cigarettes went on to smoke one or two cigarettes in the next year (and did not become smokers).

The issue is whether that is the kind of scientific evidence that legitimately supports the paper's conclusion that vaping is a gateway to smoking, rather than the method by which a blogger who notes this study weakness should attempt to correct the public health damage done by the publication of the article.

I don't know whether the editorial was directed at me or at other bloggers, or both, but I can assure my readers that I will not stop providing discussion of the scientific research regarding electronic cigarettes just because one journal wants to control the entire discourse on the subject.

Monday, February 13, 2017

Kentucky Health Group is Deceiving Public About Risks of Smoking ... and It's Working

A Kentucky health group has orchestrated a campaign to deceive the public about the terrible health hazards associated with smoking by downplaying those risks. Sadly, a recent public opinion poll commissioned by the group demonstrated that its campaign of deceit is working. Adults in Kentucky have been completely fooled about the serious health risks of smoking.

According to the Foundation for a Healthy Kentucky: "Research suggests that e-cigs may be a gateway to using other forms of tobacco, and they can be just as harmful."

The Rest of the Story

There is abundant evidence that vaping is much safer than smoking. In stating that vaping is just as harmful as smoking, the Foundation for a Healthy Kentucky is lying to the public. Moreover, this campaign of deceit is undermining the public's appreciation of the severe health hazards associated with smoking. If smoking is no more hazardous than vaping - which doesn't involve the burning of tobacco - then it must not be as harmful as previously thought.

I can assure you that if the tobacco industry were making the same claims, we would be attacking them and taking them to court for public fraud. But the Foundation for a Healthy Kentucky is making precisely that claim which would have us dragging Big Tobacco into the courtroom. Why is it OK for us to lie, but not the tobacco companies?

A recent public opinion poll commissioned by the Foundation for a Healthy Kentucky showed how successful its campaign of deceit has been. According to this poll, 64% of Kentucky adults believe that smoking is no more hazardous than vaping. And nearly one in five (19%) actually believe that vaping is more hazardous than smoking!

Interestingly, nowhere in its report or press release does the Foundation point out that these 64% of Kentuckians are wrong in thinking that smoking is no more hazardous than vaping. If anything, the report appears to lament the fact that 29% of adults in Kentucky think that vaping is safer than smoking.

What a tremendous disservice the Foundation for a Health Kentucky is doing by misleading the people of Kentucky into thinking that smoking is no worse for your health than using a product which doesn't even contain any tobacco and doesn't involve any combustion.

It is also contrary to public health to bemoan the fact that a segment of the public has a correct understanding of relative health risks. Our goal should be to aim for 100% of the public to have a correct understanding of relative health risks, not to try to deceive the public so that they don't have correct information.

I'll be watching to see if the Foundation for a Healthy Kentucky corrects this misinformation. Until that happens, they are harming the public's health by decreasing the likelihood that smokers will quit and increasing the likelihood that vapers will return to smoking.

Thursday, February 09, 2017

Tobacco Control Study Provides Strong Evidence that Vaping is Not a One-Way Bridge to Smoking

I have already shown (post 1; post 2) why the recently published study in Tobacco Control which purported to demonstrate that vaping is a "one-way bridge to cigarette smoking among youth" actually provides no evidence that e-cigarette experimentation is a gateway to smoking.

First, the exposed group consisted of any youth who had even puffed once on an e-cigarette in the past 30 days. Second, the outcome variable was having puffed even once on a cigarette in the past year. Thus, the study cannot document either that the "recent vapers" were actually regular vapers or that the youth who "initiated" smoking were actually smokers. A more likely explanation of the study findings is that youth who engage in e-cigarette experimentation are also more likely to try cigarettes.

Second, I revealed that the sample size of youth who were nonsmoking, recent vapers at baseline was only 13 and that the number of youth in this category who "initiated" smoking was only 4. Thus, the sweeping conclusion of the paper, which has been publicized internationally, was based on only 4 kids.

Today, I reveal that not only does the study fail to provide any evidence that vaping is a gateway to smoking, but it actually provides strong evidence that vaping is not a gateway to smoking.

The Rest of the Story

If you read the fine print in the paper, there is a key finding which is not mentioned anywhere in the abstract, the discussion, or in any of the newspaper articles written about this study. The fine print is this:

"Among the group of new smokers at follow-up who had recently vaped at baseline, all reported that they had smoked cigarettes at the level of ‘once or twice’ in the past 12 months at follow-up."

Another way of stating this is that:

"Among the group of new smokers at follow-up who had recently vaped at baseline, not a single one had smoked more than two cigarettes in the entire past year."

In other words, this study actually confirms that none of the nonsmoking, recent vapers became actual smokers. Apparently, they tried a cigarette or two, but not a single one of them continued to smoke beyond that!

What this means is that despite having a sample size of 347 high school seniors, this study could not find a single student who became an actual new smoker after having experimented with e-cigarettes. The few students (a grand total of 4) who did try a cigarette or two did not progress beyond having one or two cigarettes.

It is striking to me that this study, which provides strong evidence that vaping is not a gateway to smoking, could conclude quite definitively that vaping is a "one-way bridge" to smoking. It creates the appearance that the study reached a pre-determined conclusion and was going to twist the findings any way it could to come up with this conclusion.

It is puzzling that not a single reviewer nor editor at Tobacco Control was able to detect this sleight-of-hand.

How do you get from a finding that not a single nonsmoking youth who experimented with vaping at baseline progressed to become an actual smoker at follow-up (and that only 4 kids in that category even tried a cigarette in the first place) to a sweeping conclusion that vaping is a one-way bridge to cigarette smoking among youth?

The answer, and the rest of the story, is that this is essentially hocus pocus. And while it may have gotten by the peer reviewers and editors, it doesn't get by me or any of the many colleagues with whom I have discussed this study. Even my students with whom I have discussed this easily see what is going on here.

Wednesday, February 08, 2017

Failure to Disclose Sample Size: A Flaw at Multiple Levels

Yesterday, I revealed that a new study published in the journal Tobacco Control which concluded that e-cigarettes are a "one-way bridge" to youth smoking failed to disclose the sample size upon which its major conclusion was based. It turns out that the paper's sweeping conclusion was based on only 4 kids who had tried an e-cigarette at baseline and went on to try a cigarette in the next year. That sample size was not even revealed in the online supplement to the article. I had to calculate it from the raw data. The supplement did reveal that there were only 13 nonsmokers in the study who had vaped in the past month. Thus, I argued that the paper really should have concluded not that vaping is a gateway to smoking but that e-cigarette experimentation among nonsmokers doesn't appear to even be a gateway to regular vaping.

A further analysis of the paper reveals that among the 4 youth who had supposedly progressed to smoking, none of them had smoked more than two cigarettes in the past year. According to the paper: "Among the group of new smokers at follow-up who had recently vaped at baseline, all reported that they had smoked cigarettes at the level of ‘once or twice’ in the past 12 months at follow-up."

What the paper doesn't reveal is that this "group" of new smokers consists of only about 4 kids.

This raises the question of why the paper doesn't share this information with the reader. To talk about a "group" of new smokers who had vaped at baseline, but without informing the reader that there are only 4 kids in this "group" seems misleading.

The Rest of the Story

It appears to me that there were three levels of failure which explain why this paper violated what is perhaps the most important aspect of scientific reporting: revealing the sample size upon which your major conclusion is based.

First, the paper itself should have disclosed this sample size. It seems critical for readers to understand that the paper's major conclusion - that there was a 4.8 times higher rate of "smoking initiation" among nonsmokers who had vaped in the past month - was based on 4 kids having tried a cigarette or two in the past year.

This failure has already led to deceptive headlines, such as this one in the Daily Mail: "E-cigarettes are a One-Way Bridge to Tobacco." A more accurate headline would have said something like: "Researchers Can't Find More than 4 Kids Who Progressed from Vaping to Smoking, and Even Those Four Had Only Smoked Once or Twice in their Lifetimes." Or: "E-cigarette Experimentation among Nonsmokers Found Not to Be a One-Way Bridge to Vaping, Much Less Smoking."

The second failure is upon the peer reviewers of the manuscript. How could the reviewers possibly have not caught the glaring omission from the paper of the sample size underlying its most important conclusion?

The third failure is that of the journal itself. It, too, should have caught the glaring omission from the paper of the sample size underlying its most important conclusion. I used to be a statistical/methodological editor for Tobacco Control and I can tell you that I never would have let a paper through that did not reveal the sample size upon which its major conclusion was drawn. It's difficult for me to understand how this occurred.

The rest of the story is that it is difficult not to agree with Professor Robert West's conclusion that e-cigarette researchers in the United States are "waging a ‘moral crusade’ against e-cigarettes" and that they are "exaggerating their findings." This may not be a conscious decision, but may reflect a deeper underlying bias against e-cigarettes.

Tuesday, February 07, 2017

New Study Concludes that Vaping is a One-Way Bridge to Cigarette Smoking among Youth

A new study published online ahead of print in the journal Tobacco Control concludes that vaping is “a one-way bridge to cigarette smoking among youth.”

(See: Miech R, Patrick ME, O’Malley PM, Johnston LD. E-cigarette use as a predictor of cigarette smoking: results from a 1-year follow-up of a national sample of 12th grade students. Tobacco Control. http://dx.doi.org/10.1136/tobaccocontrol-2016-0532910).

The study involved a one-year follow-up of 347 high school seniors who were surveyed at baseline in 2014 and at follow-up in 2015. At baseline, they were classified as recent vapers (used an e-cigarette in the past 30 days) or non-vapers. At follow-up, smoking initiation was defined as having smoked a cigarette in the past year.

In the key analysis, smoking initiation (smoking a cigarette in the past year) was compared between recent vapers (used an e-cigarette in the past 30 days) and non-vapers who had never smoked at the time of the baseline survey. The paper reports that the rate of smoking initiation was 31% among the recent vapers and 7% among non-vapers. In an adjusted analysis, recent vapers were 4.8 times more likely than non-vapers to initiate smoking during the follow-up period.

The paper concludes that “vaping is a one-way bridge to cigarette smoking among youth.”

The Rest of the Story

At first glance, this paper appears to demolish the claim that vaping is not a known gateway to youth smoking. The conclusion that is drawn is a sweeping one: e-cigarettes are a one-way bridge to cigarette smoking among youth. If this conclusion is true, then I believe e-cigarettes are not a tenable harm reduction strategy because the benefits of adults quitting using e-cigarettes would be offset by a substantial increase in youth becoming addicted to smoking and possibly suffering life-long health effects, disease, disability, and premature death.

So am I going to renounce my earlier conclusions (that there is no evidence vaping causes kids to start smoking)?

Perhaps, but not without a closer look at the study.

To be a valid conclusion, there must not be a plausible, alternative explanation for the study findings. The paper does not present any alternative explanations. But this doesn’t mean that there isn’t one.

In fact, there is a very plausible (and in fact, highly likely) alternative interpretation of these findings:

Experimenting with e-cigarettes is a sensitive marker of substance-related, risk-taking behavior in general, which strongly predisposes a youth to trying cigarettes.

What could easily explain the observed findings is that youth who experiment with e-cigarettes are also more likely to experiment with other substances, including cigarettes. Therefore, of course you are going to find a higher rate of cigarette experimentation among youth who have already experimented with electronic cigarettes. This should come as a surprise to no one.

The observed relationship between e-cigarette experimentation and cigarette experimentation could well be a spurious one, confounded by an underlying predisposition to substance-related, risk-taking behavior. Importantly, the study did not make any attempt to control for any measures of risk-taking behavior. Moreover, the study did not even control for underlying susceptibility to smoking.

There are two additional and related factors that cast serious doubt on the study’s conclusion.

First, the exposure variable – recent vaping – was defined as having tried even one e-cigarette in the past month. All we know about the baseline “vapers” is that they had taken a puff on an e-cigarette in the past month. We do not know that they were regular vapers. We do not know that they had become addicted to nicotine or to vaping. We don’t even know that they had tried vaping more than once in their entire life! So to conclude that this study demonstrates that vaping is a one-way bridge to smoking is not warranted.

Second, the outcome variable – smoking initiation – was defined as having tried even one cigarette in the past year. All we know about the smoking initiators is that they had taken a puff on a cigarette in the past year. We don’t even know that they had tried more than one cigarette in the past year. So to conclude that vaping is a bridge to smoking based on this definition is not warranted.

The question that arises is why the study did not examine whether frequent vapers were more likely to progress to regular smoking (or at very least, current or established smoking). According to the paper, the sample size was not large enough to allow such an analysis. But that raises the question: If the sample size was not large enough to allow an analysis of frequent vapers, was it large enough to allow an analysis of all vapers? And most critically, how many youths were there who were nonsmoking, recent vapers at baseline who tried a cigarette in the next year? After all, this is the sample upon which the entire conclusion of the study is based.

So I took a closer look at the study – well, not the actual study because the sample size of baseline nonsmokers who had recently vaped is not reported anywhere in the study. You have to go to a separate, online appendix to find this out.

So take a guess: How many youths is the sweeping conclusion of this paper based on? (i.e., how many nonsmoking, recent vapers at baseline progressed to having tried a cigarette at follow-up?)

a. 122
b. 84
c. 42
d. 21
e. 9

If you guessed E (9) ...

… then you are wrong.

The correct answer is none of the above. The total number of nonsmoking, recent vapers who tried a cigarette in this study appears to be just 4!

So you mean to tell me that the sweeping conclusion of this paper – that vaping is a one-way bridge to smoking – is based on 4 youth? Moreover, on 4 youth about whom all we know is that they tried an e-cigarette during the month prior to the baseline survey and then tried a cigarette in the following year. That hardly seems like a sufficient sample of youth upon which to rely to formulate national policy.

In fact, there were apparently only 13 nonsmokers who were recent vapers in the entire study of 347 youth. That itself should tell you something. Namely, that it is very difficult to find nonsmokers who vape with any significant frequency. In other words, e-cigarette experimentation is not any kind of significant bridge to youth smoking because it doesn’t even appear to be a bridge to regular or frequent vaping.

The rest of the story is that far from providing evidence that vaping is a one-way bridge to cigarette smoking among youth, this study provides further evidence that e-cigarette experimentation among nonsmoking youth doesn’t even appear to be a bridge to regular vaping. It is very difficult to find nonsmoking youth who experiment with e-cigarettes and then progress to become frequent vapers. In fact, it’s such a rare phenomenon that this study failed to achieve a high enough sample size to even analyze the rate at which these nonsmoking frequent vapers progressed to smoking. That itself is really the key finding of the paper.

This story illustrates why you have to be very careful in reading and interpreting the scientific literature. If you didn’t look at the supplemental material, which was not part of the article itself, you would never even be aware that the sweeping conclusions of this study were based on 4 kids.

All I can say is that when the FDA commissioner signs his first order putting a vape shop out of business, these 4 kids should be invited to the signing ceremony. Because it’s based on those 4 kids that vaping opponents apparently would like us to formulate national smoking policy.

Monday, February 06, 2017

Anti-Smoking Leader Demands Prosecution of Tobacco Company Executives for "Crimes Against Humanity"

An international anti-smoking leader has called for prosecution of the heads of the tobacco companies for "crimes against humanity."

According to an article in the Jerusalem Post:

"Prof. Judith Mackay, the British, Hong Kong-based physician who has been described by the tobacco industry as “one of the three most dangerous people in the world,” has called for heads of the industry to be prosecuted for their “crimes against humanity.” Mackay, an international anti-tobacco advocate who has led a campaign against tobacco in Asia since 1984, appeared by video conference at the annual meeting, held in a Caesarea on Friday, of the Medical Society for the Prevention and Cessation of Smoking of the Israel Medical Association."

The Rest of the Story

While the tobacco industry has done many despicable things and should be held civilly liable for damages caused by its products to users who became addicted prior to the time when the industry acknowledged that its products were deadly, prosecuting tobacco industry executives for "crimes against humanity" is going way too far.

Not only does this accusation go beyond reason, but it also undermines the significance of world leaders who have committed real crimes against humanity and is insensitive to the victims of these crimes. Moreover, it obscures the fact that the tobacco industry is not the only entity that was complicit in the tobacco epidemic.

Despite the condemnation-worthy actions of the tobacco companies, it must be remembered that it was the government that sanctioned the sale of tobacco products. At all times, the tobacco companies were acting in an environment in which the government made it legal to sell cigarettes. And although smokers did not necessarily make an informed decision to smoke, neither were they forced to smoke. There is an element of behavioral decision-making involved. So to compare the sale of tobacco to "crimes against humanity" is an injustice to the many victims of actual crimes against humanity who did not play any role in their persecution.

In addition, many entities played a role in the tobacco epidemic. Should the owners of convenience stores which actually sold the cigarettes also be prosecuted for crimes against humanity? What about the government officials who accepted tobacco industry contributions and voted against policies to regulate cigarettes? How about the publishers of magazines that advertised cigarettes and the producers of movies who accepted money to depict branded cigarettes? The list goes on.

But there is a particularly ironic aspect to the rest of this story. It could be argued that Professor Mackay herself has helped to protect cigarette sales. How? Well, she supported a ban on nicotine-containing electronic cigarettes in Hong Kong. So apparently, she is OK with the youth and adults in Hong Kong purchasing deadly tobacco cigarettes but she doesn't want them to be able to buy much safer tobacco-free alternatives that could save their lives.

Moreover, Professor Mackay has publicly claimed that smoking may be no more hazardous than vaping. As recently as last May, she wrote a widely publicized op-ed in which she claimed that: "There have been signs that increasing numbers of young people are taking up vaping thinking that it is a less harmful alternative to smoking even though science is far from conclusive on this presumption."

So what she is saying is that we don't know for sure that smoking is any more hazardous than using a completely tobacco-free product that involves absolutely no combustion and which has no significant known chronic health effects. If this doesn't undermine the public's appreciation of the severe hazards of smoking, then I don't know what does. Furthermore, this is exactly the kind of false propaganda about the hazards of smoking that we have condemned the tobacco industry for spewing.

On top of this, her organization - the World Lung Foundation - has spread false information about vaping, claiming that it is a gateway to smoking. In fact, the World Lung Foundation disseminated the conclusion that e-cigarettes are a gateway to smoking based on a barely comprehensible quote of a single kid in Fife.

Hyperbole is often acceptable to make a point. But not when it involves placing individuals in jail or being insensitive to the victims of horrible human rights violations.