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.