Tuesday, August 15, 2017

American Heart Association Still Clings to Alternative Facts: Claims that Smoking is No Safer than Vaping

Scientists like myself are often frustrated by "denialists" who refuse to acknowledge global warming, disseminate false information about adverse effects of vaccines, or - historically - failed to acknowledge the severe health effects of cigarette smoking. But I never expected this denialism to be coming from within my own movement in public health.

Today, it appears that the American Heart Association is still taking a public denialist stance with regards to the health benefits of quitting smoking by switching to vaping. Despite overwhelming scientific evidence that vaping is much safer than smoking and that quitting smoking by switching to electronic cigarettes has dramatic and immediate health benefits, the American Heart Association is still clinging to the false message that smoking may be no safer than vaping.

According to an article appearing today in The Daily Mail:

"Dr Aruni Bhatnagar, director of the American Heart Association's Tobacco Research and Addiction Center, added: 'We just don't know if moving to e-cigarettes is good enough to reduce the harm.'"

As the Daily Mail is not necessarily a trustworthy source (note the headline that a single e-cigarette can potentially lead to a heart attack), I confirmed this quote with other sources. The same quote appeared in the San Diego Union-Tribune two weeks ago. It seems clear that the American Heart Association, through its Tobacco Research and Addiction Center, is still clinging to the belief that smoking may be no more hazardous than vaping. Furthermore, the American Heart Association is disseminating this false information to the public.

The Rest of the Story

The American Heart Association's claim that quitting smoking by switching to electronic cigarettes does not reduce the harm of cigarette smoking flies in the face of overwhelming scientific evidence that switching from smoking to vaping leads to an immediate improvement in respiratory symptoms and improves lung function. Improvement in spirometry measurements was observed even in dual users, but was most substantial in smokers who switched completely to e-cigarettes. Remarkably, respiratory symptoms improved in patients with chronic obstructive pulmonary disease (COPD) who switched to electronic cigarettes.

In addition to improving respiratory health, e-cigarettes also lower carcinogenic risk compared to smoking, as they deliver many fewer and much lower levels of carcinogens. 

The American Heart Association's claim is not only false, but it is potentially damaging. If smokers believe this false information, they may decide that there is no reason to quit smoking using e-cigarettes. Or, even worse, ex-smokers who quit using e-cigarettes may return to smoking. After all, if it is not clear that vaping reduces harm compared to smoking, then what's the point of vaping? You might as well enjoy the real thing.

I'm surprised that cigarette companies haven't jumped on the opportunity to use the American Heart Association's endorsement of smoking:

"We at Philip Morris believe the public should heed the advice of respected public health organizations. According to the American Heart Association, we just don't know if quitting smoking by switching to e-cigarettes reduces the harm. So if you're thinking of trying to quit smoking by switching to vaping, don't bother. There's no certainty that it will reduce your health risks. But it will certainly decrease your enjoyment of the tobacco smoking experience."

Thursday, August 10, 2017

It's Official: Anti-Tobacco Groups Willing to Throw Away the Lives of Smokers to Promote Radical Ideology

For months, I have been arguing that the major anti-tobacco groups in the United States have been waging a war against electronic cigarettes that is motivated not by a pure concern for the public's health, but by an ideological opposition to the idea that anyone could get pleasure from nicotine in whatever form -- even if they are improving their health and saving their life.

Today, the American Thoracic Society (ATS) made it official.

In a letter to the editor published in the Washington Post, the American Thoracic Society confirmed what I have been suggesting for months.

The vice chair of the American Thoracic Society’s Tobacco Action Committee essentially confirmed that the ATS is willing to throw away the lives of smokers in order to promote the radical ideology that no one should derive pleasure from nicotine in any form, even if it is a life-saving switch from deadly cigarettes to very low-risk e-cigarettes.

In the letter, Dr. Enid Neptune writes: "As a physician who treats patients devastated by tobacco-caused lung disease, I was concerned by the Aug. 5 editorial “Breaking nicotine’s grip,” which embraced Food and Drug Administration Commissioner Scott Gottlieb’s plan for regulating tobacco products. The commissioner seems unconcerned about switching one form of nicotine addiction with another. Nicotine in any form is bad for your health, adversely affecting neurological and cardiovascular systems and reproductive health. Evidence shows that nicotine can be a gateway drug. ... The FDA’s job is to protect youths from all types of tobacco and nicotine addiction, not to negotiate which types of nicotine addiction it will allow."

The title of the letter is: "The FDA’s new plans could just switch one form of nicotine addiction with another."

The Rest of the Story

The writer makes a great point. We should never promote the idea of people switching from one addiction to another. And it is not the concern of public health what health risks are associated with any form of addiction. All addiction is bad and our job in public health is to make sure that no one, anywhere, at any time, is addicted to any substance.

For example, when heroin addicts are treated with methadone or bupenorphine, the physician is just substituting one addiction for another. These physicians seem unconcerned about switching one form of nicotine addiction with another. Opiates in any form are bad for your health, adversely affecting neurological and cardiovascular systems and reproductive health. Evidence shows that opiates can be a gateway drug and there is a great risk of overdose with any opiate. The job of physicians is to protect people from all types of opiate addiction, not to negotiate which types of opiate addiction they will allow.

OK - I was being facetious. But this demonstrates the insanity of the argument that the e-cigarette industry should be decimated through burdensome regulations because vaping is just another form of nicotine addiction and all nicotine addiction is equally evil.

I, and fortunately the new FDA Commissioner, strongly reject this radical ideology. Risk does matter. Addiction is a public health problem not because the concept of someone being addicted to a substance is severely damaging, but because the addictive substance carries severe health risks. Switching from a high-risk addictive substance to a low-risk addictive substance is not a zero-sum game. It is a critical and life-saving intervention. Just as methadone maintenance programs have saved thousands of lives from heroin-associated morbidity and mortality, electronic cigarettes are saving thousands of lives from smoking-associated disease and death.

While this writer speaks only for the American Thoracic Society, it is clear to me that this is indeed the underlying philosophy of all the major anti-tobacco groups, and even of many health departments and agencies, including the Centers for Disease Control and Prevention and the state health departments in California, Vermont, and Washington (to name a few).

Fortunately, Commissioner Gottlieb has rejected this philosophy, strongly and definitively. Public health is about saving lives, not fighting for some ideological principle of no addiction to any substance, regardless of how low-risk the product might be or how the product might be saving a life by switching someone to a much safer form of drug delivery.

Of course we need to restrict the sale and marketing of vaping products to youth and educate them about the health risks of all types of nicotine products, including real cigarettes and fake ones. But discouraging youth from using e-cigarettes should not come at the expense of wiping out 99% of the e-cigarette market, depriving millions of former smokers of the product they are using successfully to stay off tobacco cigarettes, and risking tens of thousands of these former smokers returning to cigarette smoking because their vaping products are taken off the market.

Saturday, August 05, 2017

New Study Provides Strong Empirical Support for New FDA Approach to Tobacco Product Regulation

A new study published in the journal Tobacco Control reports that the modeled cancer risk associated with vaping is less than 1% of that associated with smoking and is only slightly higher than, if not comparable to the cancer risk associated with nicotine replacement therapy (NRT). In select circumstances, electronic cigarettes produced high levels of aldehydes but only when the voltage was cranked up to excessive levels. Thus, under conditions of normal use, this study finds that tobacco-free e-cigarettes present a drastically reduced carcinogenic risk compared to tobacco cigarettes.

The study methods were as follows: "The cancer potencies of various nicotine-delivering aerosols are modelled using published chemical analyses of emissions and their associated inhalation unit risks. Potencies are compared using a conversion procedure for expressing smoke and e-cigarette vapours in common units. Lifetime cancer risks are calculated from potencies using daily consumption estimates."

The results were as follows: "The aerosols form a spectrum of cancer potencies spanning five orders of magnitude from uncontaminated air to tobacco smoke. E-cigarette emissions span most of this range with the preponderance of products having potencies less than 1% of tobacco smoke and falling within two orders of magnitude of a medicinal nicotine inhaler; however, a small minority have much higher potencies. These high-risk results tend to be associated with high levels of carbonyls generated when excessive power is delivered to the atomiser coil. Samples of a prototype heat-not-burn device have lower cancer potencies than tobacco smoke by at least one order of magnitude, but higher potencies than most e-cigarettes. Mean lifetime risks decline in the sequence: combustible cigarettes much greater than heat-not-burn, which is much greater than e-cigarettes (normal power), which are greater than or equal to nicotine inhaler."

The study concludes that: "Optimal combinations of device settings, liquid formulation and vaping behaviour normally result in e-cigarette emissions with much less carcinogenic potency than tobacco smoke, notwithstanding there are circumstances in which the cancer risks of e-cigarette emissions can escalate, sometimes substantially. These circumstances are usually avoidable when the causes are known."

The Rest of the Story

This study should put to rest any doubt within the tobacco control movement about whether vaping greatly reduces health risk compared to smoking. Numerous anti-tobacco groups and health departments have repeatedly asserted that vaping is no less hazardous than smoking, but this claim is false, and the present study adds significantly to the already substantial evidence that vaping is orders of magnitude safer than smoking. The anti-tobacco groups and health agencies that have made such statements should immediately correct them and issue retractions to alert the public to these important findings.

These results add strong empirical support to the new FDA approach to tobacco products, announced one week ago by FDA commissioner Dr. Scott Gottlieb, which emphasizes the regulation of tobacco products and e-cigarettes based on the wide differential in their health risk. It makes no sense to lump e-cigarettes in the same basket as tobacco cigarettes, given their drastically different health risks. However, that is precisely what the FDA was doing prior to Dr. Gottlieb's appointment as the new commissioner. Now, the agency is taking a much more sensible and evidence-based approach.

While this study does find that there are conditions under which e-cigarettes can be made to produce rather high levels of certain hazardous chemicals -- most notably aldehydes -- these conditions involve jacking up the voltage to excessive levels that typically produce dry puff conditions, something that vapers would almost certainly detect immediately and not tolerate. Nevertheless, the results do suggest that FDA safety standards related to the maximum allowable voltage or coil temperature may be warranted.

Monday, July 31, 2017

New FDA Commissioner Saves the Day: Embraces Harm Reduction Strategy for Tobacco Control

On Friday, the new FDA Commissioner - Dr. Scott Gottlieb - saved the day for the public's health by officially embracing a harm reduction approach to tobacco control. Commissioner Gottlieb announced a new approach to the regulation of tobacco products that, unlike the FDA's previous strategy, acknowledges the vastly different risks of tobacco cigarettes compared to electronic cigarettes and proposes to regulate each product in alignment with its risk level.

Previously, the FDA had simply lumped e-cigarettes into the exact same category as tobacco cigarettes and in fact, regulated e-cigarettes much more stringently. The FDA previously required e-cigarettes to complete burdensome and expensive pre-market applications just to remain on the market, a process from which all cigarettes were exempted. The old approach would have destroyed about 99% of the existing vaping product market, leading to a major reduction in smoking cessation in the U.S. and with that, an increase in smoking-related morbidity and mortality.

Instead, the FDA will now delay the implementation of the pre-market application requirement for e-cigarettes while seeking ways to ease the expense and burden of the process. At the same time, the FDA will - for the first time - actually set safety standards for e-cigarettes so that the benefits of these products can be realized while minimizing potential harms. And, to top it all off, the agency will consider - also for the first time - actually setting a safety standard for real cigarettes that would require the reduction of nicotine to non-addictive levels if that is found to be technologically and practically feasible.

Commissioner Gottlieb also, for the first time, tied implementation of a harm reduction approach based on vaping products to the idea of making combustible cigarettes less addictive through substantial nicotine reduction, thus reducing the demand for real cigarettes but at the same time, making a viable alternative available to smokers to help ease them through the transition to the tobacco-free, smoke-free cigarettes.

Dr. Gottlieb emphasized that while nicotine is largely responsible for the addictive potential of cigarettes, the nicotine itself is not what kills smokers. As he stated: "the nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.  Yes, it got them all addicted and kept them addicted for the long term.  And it got most of them addicted when they were still teenagers.  But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine."

Commissioner Gottlieb unveiled his vision of " a world where cigarettes lose their addictive potential through reduced nicotine levels.  And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them."

Specifically, the strategy outlined by Commissioner Gottlieb involves the following:

1. Implementation of the requirement for pre-market applications for electronic cigarettes will be delayed until 2022, giving vaping product manufacturers another four years to remain on the market and to prepare the necessary application materials.

2. New guidance for the pre-market applications will be developed, which will presumably greatly simplify the requirements and reduce the burden and expense of preparing these applications.

3. Safety standards for electronic cigarettes will be developed, addressing issues such as battery safety, e-liquid ingredients, and flavorings.

4. The agency will examine the effectiveness and feasibility of requiring a reduction of nicotine levels in real, tobacco cigarettes to a non-addictive level.

5. Ideally, the reduction of nicotine levels in real cigarettes would be paired with the development and promotion of electronic cigarettes and vaping products as a viable alternative to smoking.

The Rest of the Story

This is truly a great day for public health. For the first time since 2009, when the FDA began regulating tobacco products, we now have a rationale approach to their regulation. This approach explicitly acknowledges the differential in risk between smoking and vaping and proposes to regulate these products according to the level of risk they present. It acknowledges that while nicotine is a critical contributor to the addiction potential of tobacco products, it is not what actually kills smokers. It aims to maximize the benefits of electronic cigarettes while minimizing their harms by both embracing e-cigarettes for harm reduction and easing their ability to stay on the market and setting safety standards to make these products as safe as possible. Finally, it aims to reduce the attractiveness of cigarettes and facilitate a transition from combusted to non-combusted nicotine products by reducing the addictive potential of cigarettes, thus promoting a shift to safer forms of nicotine delivery.

More than anything else, the greatest contribution of this new approach is that it is evidence-based, rather than based on ideology or political concerns. Instead of punishing smokers by depriving them of potentially life-saving alternatives, it embraces the idea of giving them much lower-risk choices that have already been shown to help millions of smokers quit.

The greatest risk to successful implementation of this sensible approach comes from the anti-tobacco groups themselves. Already, the Campaign for Tobacco-Free Kids is complaining about the pre-market tobacco application deadline extension for e-cigarettes. In a statement released Friday by the Campaign, it attacked the agency for attempting to save the e-cigarette industry, arguing that: "it is a serious error for the FDA to significantly delay critical deadlines for complying with the FDA’s 2016 rule establishing oversight of electronic cigarettes, cigars and other previously unregulated tobacco products. This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight."

This complaint is complete crap. There is nothing in the deeming regulations that directs the agency to eliminate "kid-friendly" flavors. To do that, the agency would almost certainly have had to formally consider the issue and make a decision regarding the overall public health impact of such a restriction. It would have also had to carefully consider exactly how to define "kid-friendly" flavors. It is almost inconceivable that such a decision would have been made arbitrarily through the process of approving or denying pre-market tobacco applications. Moreover, in the approach outlined by Dr. Gottlieb on Friday, he specifically stated that the agency would examine the issue of "kid-friendly" flavors and make a decision about whether and how to implement such a policy. In contradiction with the Campaign's false claims, the FDA has full authority and oversight over e-cigarette flavorings and can regulate these flavorings completely independently of the pre-market application process.

It is great to see this major change in the FDA's approach to the regulation of tobacco products and especially, to see the shift from an ideologically-driven approach to an evidence-based one. It is time for the anti-tobacco groups to make such a change as well. The ideological crap that is coming out of these groups has to end. Frankly, that crap is the greatest threat to the successful implementation of the sensible, evidence-based public health approach to tobacco control that the FDA has now embraced. 

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.