Thursday, July 27, 2017

IN MY VIEW: American Lung Association Guilty of Public Health Malpractice

Yesterday, researchers from the University of California, San Diego published a landmark paper in the BMJ (British Medical Journal) which reported that for the first time in 15 years, the smoking cessation rate among adults in the U.S. has increased. The researchers tie this unprecedented increase in the smoking cessation rate to the availability of electronic cigarettes. The paper reports that the advent of electronic cigarettes was associated with a significant increase in the population smoking cessation rate. It also finds that smokers who use e-cigarettes are more likely to quit smoking than those who do not.

Combined with abundant existing research, the findings of this study make it clear that among adult smokers, electronic cigarettes have had a huge public health benefit. They have increased the number of quit attempts as well as the proportion of successful quit attempts. The reason for this is clear: many smokers have trouble quitting not simply because of nicotine addiction, but because of addiction to the physical, behavioral, and social aspects of smoking. None of these are addressed by existing FDA-approved cessation methods, but they are specifically addressed by e-cigarettes, which replace almost all aspects of the smoking experience other than the tar, smoke, and high levels of 60+ carcinogens and 10,000+ toxins.

It is also clear that smokers who are able to quit using e-cigarettes have greatly improved their health. Even dual users have improved their health, as lung disease risk drops with a decline in cigarette consumption, albeit not as much as quitting entirely. There is also a decline in cancer risk, although again, not as much as quitting altogether. (There is probably not a significant decline in heart disease risk among dual users).

One would think that public health groups would hail this study and, if making recommendations to smokers, advise them to quit any way they are able to, including with the use of e-cigarettes if that works for them. 

But no ... that's not the case with many health groups. One in particular -- the American Lung Association -- is still urging smokers not to quit using e-cigarettes. Instead, they are urging smokers to only use FDA-approved methods that are clearly not going to work for many smokers. And if you are one of those smokers, the American Lung Association would apparently rather that you continue smoking than try to quit by switching to vaping.

While many public health researchers affirmed the value of electronic cigarettes for many adult smokers, an article on the new study in the San Diego Union-Tribune quoted the American Lung Association as continuing to advise smokers not to try to quit using e-cigarettes. There was no qualifying clause, so the American Lung Association is giving this advice even to those smokers who are unable to quit using FDA-approved drugs.

According to the article: "People who had tried e-cigarettes in the previous 12 months were significantly more likely to have quit smoking traditional cigarettes than in previous years. The quit rate remained virtually the same for those who didn’t try e-cigarettes. ... “It’s important to remember that no e-cigarette has yet been found by the FDA to be safe and effective in helping smokers quit,” said Erika Sward, the American Lung Association’s assistant vice president of national advocacy."

The Rest of the Story

The American Lung Association's advice is tantamount to a physician telling a smoker who has failed to quit multiple times using FDA-approved drugs and who expresses interest in e-cigarettes that she should not try vaping and instead should stick to the failed methods in which she has no interest. This is precisely the advice that the American Lung Association is giving to America's smokers. And it is inappropriate and health-damaging advice. I view it as a form of public health malpractice.

Most physicians will advise smokers to quit in whatever way they are able to. Quitting smoking is so difficult, and individuals are so different in what works for them, that physicians should not take any reasonable options off the table. It is one thing for a physician to make recommendations about what methods are most effective based on the evidence. But it is quite another for a physician to tell a patient for whom those methods have failed to continue hitting their head against a wall, rather than trying a new, promising method in which the patient has expressed interest and which has worked successfully for millions of other smokers. This is exactly the medical advice that the American Lung Association is giving.

In my opinion, the American Lung Association should either correct this misinformed and dangerous advice or it should get out of the business of making medical recommendations altogether. With this advice, the American Lung Association is doing far more harm than good. The central principle of medicine and public health is "to do no harm." The American Lung Association is violating this core principle.

The rest of the story is that the American Lung Association is guilty of public health malpractice because despite clear evidence that e-cigarettes have helped millions of smokers quit, it continues to advise smokers not to use this method to quit. Apparently, the American Lung Association is more concerned that smokers quit "the right way" than that they quit. Smoking is apparently a moral issue, not merely a health issue, and if you quit the wrong way, you apparently haven't paid the proper penance for your addiction.

Tuesday, July 25, 2017

Yet Another Group of Anti-Tobacco Researchers Encourage Lying to Kids About Relative Health Effects of Vaping and Smoking

It seems that honesty has disappeared as a core principle in tobacco control. Today, I report that yet another group of tobacco control researchers is bemoaning the fact that many youth understand the relative health effects of vaping and smoking and is encouraging lying to kids instead.

In a paper published in Tobacco Prevention and Cessation, investigators from the University of Louisville examined YouTube videos promoting electronic cigarettes. They found that one of the major selling points for vaping in these videos was the claim that using e-cigarettes is safer than smoking and switching from cigarettes to e-cigarettes can therefore improve health. However, here is how they report this finding and how they describe its implications:

"Our findings extend similar conclusions in related work: that the majority of YouTube videos promoting e-cigarettes demonstrate the social benefit and acceptability of e-cigarettes in part by claiming that using e-cigarettes is safer and healthier than consuming traditional tobacco products. This comparison perpetuates a narrative that e-cigarettes are safe because they are “healthier” or “safer” than other traditional tobacco products. Promoting a product by claiming that it is better than a hazardous substance, like traditional tobacco, only has merit when targeting cigarette users who are considering quitting or cutting back. Given that scientific information about safety is largely inconclusive, claims using words like “safer” to describe e-cigarettes could contribute to confusion about the overall safety of these products, especially among youth. A recent analysis found that 34.2% of youth believe that e-cigarettes are less harmful than traditional cigarettes, and 45% are not sure. Furthermore, e-cigarette use among youth who did not use traditional cigarettes was more likely when they perceived e-cigarettes to be less harmful than traditional cigarettes."

The paper concludes that: "There is a need for “anti” e-cigarette videos on YouTube, especially ones targeted at youth, to more accurately convey current scientific understanding about the safety of these products."

The Rest of the Story

To be clear, this paper is suggesting that e-cigarette promotional videos are inaccurately asserting that vaping is safer than smoking. The paper calls for anti-vaping videos that "more accurately" convey scientific understanding about the safety of these products, condemning videos that claim that e-cigarettes are safer than real, tobacco cigarettes.

In other words, the paper is clearly calling for public health practitioners to lie to our nation's youth by telling them that vaping is no safer than smoking or by hiding the fact that vaping is much safer than smoking.

Ironically, the paper argues that telling kids the truth - that vaping is safer than smoking - is creating "confusion" because a recent analysis showed that one-third of youth believe that e-cigarettes are less harmful than traditional cigarettes. How is that confusion? What the paper calls "confusion" is actually the truth.

The investigators appear to be upset that many youth have a correct understanding of the relative safety of vaping compared to smoking.

A core principle of public health is honesty. Another core principle of public health is transparency. And a key element of health communication is telling the truth. We do not mislead, deceive, or lie to the public in order to promote health behavior change. That is what we have incessantly attacked the tobacco companies for doing. Deceiving people is not a valid or appropriate strategy in public health.

But the rest of the story is that many tobacco control practitioners are encouraging precisely such a strategy. They can't stand the fact that youth may have a correct understanding of the relative health effects of vaping compared to smoking, and they want youth to be lied to in order to confuse them or even worse, deceive them into thinking that vaping is actually just as hazardous as smoking.

While the overall goal of this dishonesty may be valid - trying to discourage kids from vaping - the means being urged to reach this end are inappropriate. In public health, we do not lie to the public to promote our agenda. That's what the tobacco companies used to do. And there is no excuse for us to sink to that level.

Thursday, July 13, 2017

IN MY VIEW: Campaign for Tobacco-Free Kids is Deliberately Lying to the Public

In a press release issued yesterday lamenting the passage by the House Appropriations Committee of a bill that grandfathers in existing e-cigarettes from the pre-market approval requirements of FDA vaping product regulations, the Campaign for Tobacco-Free Kids claimed that the bill strips the FDA of authority to review the public health impact of e-cigarettes.

Specifically, the Campaign for Tobacco-Free Kids stated that the bill:

"would “grandfather” e-cigarettes and cigars already on the market and exempt them from FDA review of their public health impact, including whether they appeal to kids." 

The Rest of the Story

The rest of the story is that the Campaign for Tobacco-Free Kids is lying. And I now believe that they are doing so deliberately with the specific intention of deceiving the public.

The truth is that the Bishop-Cole bill would not exempt e-cigarettes from FDA review of their public health impact. All it does is to prevent the FDA from requiring expensive and burdensome pre-market applications in order for e-cigarettes to remain on the market. The bill does nothing to take away the FDA's ability to review the public health impact of these products and to issue product standards, including restrictions on product flavorings, to protect the public's health.

For as long as I could, I tried to convince myself that the Campaign was just stretching the truth to protect its political interests and was not deliberately lying. While the Campaign was spreading misinformation, I did not necessarily believe that the Campaign lacked ethical integrity.

However, it is now clear to me that the Campaign for Tobacco-Free Kids is a organization that has neither scientific nor ethical integrity.

How do we know that the Campaign is deliberately lying? Well, later in the press release, the Campaign essentially admits as such. In trying to downplay the significance of a provision in the bill which requires the FDA to promulgate a standard regarding product flavorings within three years, the Campaign emphasizes that the FDA already has the authority to issue product standards, including standards to regulate flavorings. They state: "In one change this year, the House bill gives the FDA three years to develop a product standard addressing “characterizing flavors” in e-cigarettes. The FDA already has the authority under current law to issue such a product standard, so this provision does not provide the FDA with any new authority."

So any thought that the Campaign's false statement that the bill strips the FDA of its ability to review the impact of e-cigarettes was just an oversight is clearly laid to rest. The Campaign is fully aware that this is not the case and in fact makes this very argument in response to its opponents.

Furthermore, the Campaign for Tobacco-Free Kids is wrong on this point. The Bishop-Cole bill is significant because it requires the FDA to promulgate standards to regulate vaping product flavorings. The agency has had the authority to do so for 8 years, but has failed to issue a single product standard during that time. Thus, forcing the FDA to act within 3 years is a very significant impact of the Bishop-Cole legislation.

The bottom line is that I now believe the Campaign for Tobacco-Free Kids is intentionally lying, with a deliberate aim of deceiving the public and its constituents. It is no more ethical than many of our public health opponents. However, I view their dishonesty as more troubling because the Campaign has incessantly attacked the tobacco companies for lying to the American people. The Campaign should therefore be beyond reproach in its own statements to the public.

Tuesday, July 11, 2017

IN MY VIEW: Position of Australian Medical Association (and Many U.S. Health Groups) on Vaping is Just Plain Evil

In a submission to the Australian government, the Australian Medical Association (AMA) argues that there is no evidence that e-cigarettes can help smokers quit, that e-cigarettes are harmful to health because they simply substitute one addiction for another, and that physicians must fight to prevent vaping from becoming an acceptable alternative to smoking.

According to an article published by the Australian Journal of Pharmacy: "Commenting on its submission to an inquiry into the devices, the AMA says it believes that there is currently no compelling evidence that e-cigarettes are successful in helping people to stop smoking. ... AMA President Dr Michael Gannon says that the growth in e-cigarette products internationally has provided sections of the tobacco industry with the opportunity to rebrand themselves as part of the effort to reduce smoking – but there is no evidence that e-cigarettes work as a deterrent. ... “E-cigarettes must not be allowed to be marketed with claims that they are a smoking cessation aid,” Dr Gannon says. “There is no such evidence. ... “We must not allow e-cigarettes to become a socially acceptable alternative to smoking.”"

The Rest of the Story

Up to this point, I have been criticizing many anti-tobacco groups for presenting false information about the relative safety and effectiveness of vaping and for supporting public policy that would harm the public's health. However, I have refrained from attacking the motives or intentions of these groups, assuming instead that they are simply misguided or uninformed about the scientific evidence.

That all changes today.

After reading the position statement of the Australian Medical Association, it is now clear to me that there is thinking going on in the anti-tobacco movement that is just plain evil.

Specifically, I am now convinced that in order to preserve a certain misguided ideology in tobacco control (the idea that addiction itself is unacceptable under any circumstances), anti-tobacco groups are willing to sacrifice the health and lives of smokers.

In other words, this really isn't about helping smokers and reducing the morbidity and mortality from smoking-related diseases. This is instead about protecting the world from the scourge of addiction itself, without regard to the impact of these statements and policies on the lives of smokers.

Smokers are literally being sacrificed for what is viewed as the "greater good," which is protecting the world from nicotine addiction.

To be blunt, the idea that anyone might actually derive enjoyment from, and health benefit from the use of nicotine is so unacceptable to anti-tobacco groups that it must be destroyed, even if that comes at the expense of smokers' lives.

I apologize, but this is just plain evil. This is not what public health and medicine are supposed to be about.

These groups are now admitting that they would rather not see smokers have a safer alternative that could save their lives. They do not want to see vaping become an alternative to smoking.

Think about that: They would rather smokers continue to smoke than to quit smoking if they are still deriving pleasure from nicotine. This equates to the position that they would rather see smokers die than save their lives but continue to derive pleasure from the use of nicotine.

This is a cruel position to take.

Many readers have inquired as to why the frequency of my posts have decreased recently. Part of that is of course due to the summer season. But a major part of it has been that I have been beset with a sense of utter frustration and disillusionment. I have realized that the ultimate goals of the modern anti-tobacco movement do not align with my goals and I fail to see any change in the movement, no matter how much I point out the incoherence of current tobacco policy. I can't think of a single anti-smoking groups that has revised or corrected its false statements on the health effects of vaping after being informed about the errors in their communications. It's not clear that anyone actually cares.

But today marks a turning point from even that level of frustration. Because it is now clear that we are not just dealing with scientific misinterpretation, poor communication, and misguided policy. We are dealing with cruel intent. And that is not something that some posts on a blog are able to change.

Wednesday, July 05, 2017

NIAAA Prostitutes Its Scientific Integrity and Helps Alcohol Industry Promote Drinking

In one of the greatest episodes of corruption of a U.S. governmental health agency during my career, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) has sold itself out to the alcohol industry by agreeing to accept $68 million for a shoddily-designed study intended to examine the potential health benefits of moderate drinking but without similarly assessing the potential risks.

According to the New York Times: "the National Institutes of Health is starting a $100 million clinical trial to test for the first time whether a drink a day really does prevent heart attacks. And guess who is picking up most of the tab? Five companies that are among the world’s largest alcoholic beverage manufacturers — Anheuser-Busch InBev, Heineken, Diageo, Pernod Ricard and Carlsberg — have so far pledged $67.7 million to a foundation that raises money for the National Institutes of Health, said Margaret Murray, the director of the Global Alcohol Research Program at the National Institute on Alcohol Abuse and Alcoholism, which will oversee the study."

The Rest of the Story

According to the New York Times article: "George F. Koob, the director of the alcohol institute, said the trial will be immune from industry influence and will be an unbiased test of whether alcohol “in moderation” protects against heart disease. “This study could completely backfire on the alcoholic beverage industry, and they’re going to have to live with it,” Dr. Koob said. “The money from the Foundation for the N.I.H. has no strings attached. Whoever donates to that fund has no leverage whatsoever — no contribution to the study, no input to the study, no say whatsoever.”"

What a bunch of crap!

The money has huge strings attached: namely, the money is to be used for a trial to examine the potential benefits of drinking

In other words, the alcohol industry doesn't need any further leverage because they have already won. They have succeeded in getting the NIAAA to spend 20% of its entire budget on a study which is designed to identify potential benefits of drinking. The study is not examining potential negative health effects of moderate drinking: namely, increased cancer risk, and especially breast cancer risk.

Very few people understand that the greatest influence that industry can have on research is not on the way the research is conducted, but on the topic of the research in the first place. The tobacco industry also funded research with "no strings attached." The tobacco industry completely divorced itself from the decisions of many of its funded scientists. However, the industry had already won because it essentially dictated the research agenda. The industry made decisions about what to fund and what not to fund. That is the true, critical point of leverage.

So, for example, the tobacco industry funded many studies on genetic causes of lung cancer, non-tobacco-related causes of cancer, etc., while funding few, if any, studies on the severity of nicotine addiction, nicotine addiction in youth, the exposure of youth to tobacco advertising, the positive impact of anti-tobacco regulations, etc. 

No strings attached? The strings have already been attached.

If the alcohol companies were willing to donate money to NIH that could be used for any purpose that an NIH researcher proposed, such as a study to examine the effects of increased alcohol taxes on reducing youth alcohol consumption, then one could say that there are no strings attached. But this money is clearly earmarked - and beyond that, earmarked for a study that is essentially designed to show some positive health effects of moderate alcohol consumption.

Dr. Koob's contention that this trial is an "unbiased" test is also laughable. How can it be unbiased when its major funder is the industry that markets the product under study? But the bias doesn't end there. It turns out that many of the investigators running the study have individual conflicts of interest with the alcohol industry. At my institution, such researchers would not even be allowed to be involved in a clinical trial in which they have a significant conflict of interest. Our general policy is that an investigator with a significant conflict of interest cannot conduct a clinical trial on a product made by the relevant company. We do allow conflicted investigators to conduct pre-clinical studies, such as laboratory research; however, the line is drawn definitively at the level of a clinical trial.

Just how strong are the conflicts of interest of the lead researchers for the study?

According to the New York Times article: "Harvard, the hub of the clinical trial, has a long relationship with the alcoholic beverage industry. In 2015 the university accepted $3.3 million from the Foundation for Advancing Alcohol Responsibility, a group founded by distillers, to establish an endowed professorship in psychiatry and behavioral science." 

In addition: "One of the trial’s principal investigators, Dr. Eric Rimm of the Harvard T. H. Chan School of Public Health, has acknowledged through various financial disclosures that he has been paid to speak at conferences sponsored by the alcohol industry and received reimbursement for travel expenses."

Moreover: "Dr. Diederick Grobbee, another principal investigator, who is based in the Netherlands and is in charge of clinical sites outside the United States, said in a telephone interview that he has received research money from the International Life Sciences Institute, an industry group that supports scientific research."

Furthermore: "In Baltimore, the trial will be run by Dr. Mariana Lazo-Elizondo of Johns Hopkins, who received research grants in 2013 and 2014 totaling $100,000 from the Alcoholic Beverage Medical Research Foundation. She declined to be interviewed."

And to add insult to injury: "The Barcelona study arm will be run by Dr. Ramon Estruch, who in February helped lead a “Wine & Health” conference in the wine region of La Rioja, Spain, that was supported by the wine industry. Dr. Estruch recently refused to disclose his financial conflicts of interest to The Journal of Studies on Alcohol and Drugs and has not responded to requests for comment."

It is clear that many of the principal investigators in the trial have personal conflicts of interest with the alcohol industry. And the lead investigator for the Barcelona study arm not only has severe personal conflicts of interest but has failed to disclose them, apparently despite numerous requests from the journal to do so. But his conflicts with Big Alcohol run deep. As I revealed in a 2016 column:

Dr. Ramon Estruch - is on the board of or receives money from three different research foundations, each of which is funded by alcohol companies. According to a published article: "Dr. Estruch reports serving on the board of and receiving lecture fees from the Research Foundation on Wine and Nutrition (FIVIN); serving on the boards of the Beer and Health Foundation and the European Foundation for Alcohol Research (ERAB)."

Well, it turns out that the Research Foundation on Wine and Nutrition is funded by alcohol companies.

And the Beer and Health Foundation is funded by the Spanish beer industry.

And the European Foundation for Alcohol Research acknowledges that it: "is supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production."

I have also previously discussed why Harvard's objectivity regarding this research has already been severely compromised (see: Harvard Medical School Teams Up with Makers of Bacardi Rum, Smirnoff Vodka, Jim Beam Bourbon, and Jack Daniels Whiskey, Providing Great PR at Bargain Rates).

The study design doesn't even pass the laugh test in terms of basic epidemiology. The study is excluding nondrinkers, who are the only people who really matter because they are the ones who would potentially benefit - or be harmed - by efforts to promote moderate drinking. People who are already drinking aren't the ones who would be most affected by such a campaign.

The study is also excluding problem drinkers. People who are already drinking, but are not problem drinkers, have already demonstrated that they are capable of moderate drinking. The real issue is what happens when you successfully convince a non-drinker to start drinking every day. This trial specifically avoids (and is designed to avoid) examining that research question. But that research question is really what is at the heart of any evaluation of whether promoting moderate drinking might have public health benefit.

Even the tobacco industry, to the best of my knowledge, never succeeded in persuading the prestigious NIH to accept industry funding for a study of interest to the tobacco companies. The tobacco companies had to resort to funding their own research bodies (e.g., the Council for Tobacco Research). But here, the NIAAA is giving the alcohol industry an unprecedented gift: the acceptance of industry money to conduct a clinical trial, under the pretense of being an objective government study.

The rest of the story is that by accepting this funding from the alcohol industry to support what is supposed to be an objective NIH research agenda, the NIAAA has compromised its scientific integrity, selling out to the alcohol industry and helping the industry to promote drinking. This is not the appropriate role of the NIAAA.

This clinical trial is tainted before it has even begun. Hopefully, its participants will be informed that the study is essentially a sham - that it is funded by the alcohol industry, which has -- in a dream come true scenario -- somehow gotten the NIAAA to agree to conduct a study that is designed only to examine potential positive health effects of moderate drinking, while ignoring (and not looking for) any serious potential risks, such as cancer.

The study investigators may not reveal this critical information to the human subjects in these trials; however, there are a number of public health groups that are planning to publicize this information so that the public is aware of this scam before it does real damage to the public's health. It has already done damage to the scientific credibility of the NIAAA specifically, and of government public health research in general.

Saturday, June 17, 2017

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

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

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

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

The Rest of the Story

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

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

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

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

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

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

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

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

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

Thursday, June 15, 2017

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

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

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

The Rest of the Story

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

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

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

Friday, May 26, 2017

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

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

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

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

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

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

The Rest of the Story

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

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

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

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

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

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

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

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

Thursday, May 25, 2017

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

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

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

The Rest of the Story

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

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

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

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

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

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

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

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

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

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

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

Tuesday, May 09, 2017

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

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

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

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

The Rest of the Story

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

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

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

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

Thursday, May 04, 2017

Smokeless Tobacco Company Admits that Its Products Cause Oral Cancer

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

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

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

The company's primary defenses are two-fold:

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

The Rest of the Story

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

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

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

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

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

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

Tuesday, May 02, 2017

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

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

Monday, May 01, 2017

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

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

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

Here are the major results of the air sampling:

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

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

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

The Rest of the Story

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

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

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

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

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

Wednesday, April 26, 2017

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

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

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

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

The Rest of the Story

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

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

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

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

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

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

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

Tuesday, April 25, 2017

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

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

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

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