FDA Smokeless Tobacco Campaign is Incompatible with Science-Based Regulation

Congress gave the FDA regulatory oversight of the tobacco industry in 2009.  In 2013, Mitch Zeller, director of the FDA Center for Tobacco Products (CTP), observed, “There are some very powerful tools that Congress has given FDA to use wisely and supported by evidence. That’s where I think, the greatest opportunity lies: to use the tools relying on regulatory science to try to protect consumers and reduce the death and disease toll from tobacco.” 

Despite this avowed focus on scientific evidence, the CTP is engaged in an unfounded crusade against the products it is tasked to regulate.  Typical of the agency’s action is a March 18 Tweet that grossly distorts the facts; it reads: “Smokeless tobacco causes cancers of the mouth, esophagus, and pancreas.”  

It appears that this claim is based on the 3-page summary of a 400-page smokeless tobacco monograph from the International Agency for Research on Cancer (IARC)(here), making the FDA Tweet a case study in the cherry-picking of evidence.  Worse, as shown below, some of this paltry data doesn’t even apply to Swedish and American products.   

In defining mouth cancer risks, the IARC monograph relies heavily on a 1981 New England Journal of Medicine article that exaggerated the health effects of powdered dry snuff use and falsely implicated moist snuff and chewing tobacco, as I have detailed earlier (here and here).  Other studies cited by IARC mainly come from India, Pakistan, Sudan, Saudi Arabia, central Asia and Africa, where smokeless products are far more toxic than those in the US. and Sweden.    

As for cancer of the esophagus, the IARC monograph cites one study from India, along with cherry-picked and minimally elevated risks from one Swedish and one Norwegian study.  For cancer of the pancreas, selective data points are offered from one Norwegian and three U.S. studies.

The problem is that the IARC never conducted a systematic and comprehensive analysis of all available studies.  As I have discussed (here), when all the evidence is weighed, snus users in Scandinavia and dip/chew users in the U.S. have no elevated risks for any of these cancers.  I have also documented how cherry-picked data has been used to falsely blame pancreatic cancer on the use of smokeless products (here). 

Although it lacks the FDA’s tobacco enforcement powers, the Centers for Disease Control (CDC) makes the same unscientific claims about smokeless tobacco.  The CDC supports the disinformation campaign by failing to report deaths due to smokeless tobacco use when it releases annual smoking death estimates.  The failure is likely driven by the fact that the number for smokeless is close to zero, which undercuts the government’s anti-smokeless campaign. 

The FDA, with its ongoing anti-science attack on nearly risk-free smokeless tobacco, continues to demonstrate that it cannot be trusted to base tobacco regulation on scientific evidence.

Clinical Trials and Errors Blur Consumer Tobacco Preferences

Doctors, myself included (here, here and here), value clinical trials, for good reason: They are powerful tools using sophisticated scientific methods to precisely determine the effectiveness of treatments for specific diseases.  But clinical trials are ill-suited to the measurement of consumers' preferences for products in the marketplace.  The appropriate tool for that is post-market surveillance.

The latter mechanism can be used, for example, to analyze whether coffee drinkers can be induced to switch to Coca Cola.  Looking at the American South, for example, observational research will show that some consumers prefer the cold caffeinated, carbonated beverage over coffee, giving rise to the jest, “Coke, it’s not just for breakfast anymore.”  In this case, one survey is more informative and accurate than a dozen clinical trials.

In reality, and contrary to the notions of many clinicians, there are distinct parallels in the consumption of smoke-free tobacco and coffee.  Both products are addictive but largely harmless. Most importantly, use of either product is not itself a disease.  The vast majority of smokers aren’t “sick” and don’t want to be “treated,” yet most smoking cessation efforts are designed around the clinical trial model where smoking is the “illness,” pharmaceutical nicotine, e-cigarettes or snus is the “treatment,” and nicotine/tobacco abstinence is the “cure.”  Given this, it is not surprising that most smokers don’t want to enroll in quit-smoking trials – leading researchers to select only smokers who are highly motivated to quit, then paid and pampered to remain in the trial.  Even so, most trials end with abysmally low compliance, completion and success rates.

The futility of the clinical trial model is illustrated by a new UK study appearing in Annals of Internal Medicine (abstract here).  Twenty-three nurses enrolled nearly 700 highly motivated smokers; the treatment was quitting abruptly or gradually two weeks later, accompanied by intense behavioral support and medicinal nicotine; the desired outcome (i.e., the “cure”) was abstinence.

In public comments, the lead author touted abrupt quitting as the best strategy, effectively celebrating a 73% failure rate at six months compared to an 82% failure rate among gradual quitters.  One-year rates, which are the gold standard for cessation trials, were not reported; they were likely higher.

Why does the medical research establishment demand clinical trial proof for quit-smoking aids, including e-cigarettes and smokeless tobacco products?  Perhaps because the clinical trial model enables the tobacco prohibitionist establishment to maintain the “illness-treatment-cure” perception of smoking and healthcare.  In fact, as I note in my book, For Smokers Only, tobacco harm reduction puts smokers in control of their health choices and consequences.

Clinical trials are the wrong way to evaluate cigarette substitutes as smoking cessation aids, and they should not be the standard by which these products are judged.  Instead, the FDA, along with other health authorities, should endorse e-cigarettes and smokeless tobacco products as safer cigarette substitutes.  The success or failure of smoke-free products in deterring smoking should be analyzed through post-market surveillance – that is, simply observing consumer activity.

Association of Youth E-Cigarette Bans with Increased Smoking Confirmed

There is fresh evidence indicating that attempts to prohibit youth access to e-cigarettes increase youth smoking rates.

Last November, I discussed a Yale research finding that smoking increased significantly among teens aged 12-17 in states that banned e-cigarette sales to minors compared with states with no bans (here).  Now this from researchers at Cornell University: “We document a concerning trend of cigarette smoking among adolescents increasing when [e-cigarettes] become more difficult to purchase.”

Michael Pesko and colleagues at the Cornell medical school compared adolescent smoking in states that implemented e-cigarette purchasing restrictions during the period 2007 to 2013, compared with states that had no restrictions.  Using federal Youth Risk Behavior Surveillance System surveys, they examined smoking rates over the past 30 days: recent (smoked at least 1 day), casual (1-19 days), regular (20+ days) and heavy (all 30 days).  They also accounted for state differences in cigarette taxes and indoor use laws, and they included a fixed effects variable to account for additional unmeasured differences in states’ smoking norms and anti-smoking sentiments.  The study was published in Preventive Medicine (abstract here).

Pesko et al. found “…that [e-cigarette] age purchasing restrictions are associated with a 3.1 percentage point (17.9% of the mean) increase in adolescent cigarette use (p < 0.05) in the period of implementation.  Most of this effect is accounted for within casual cigarette using adolescents… Our results suggest that adolescents are willing to substitute [e-cigarettes] for cigarettes depending on legal purchasing opportunities of [e-cigarettes].”

The researchers’ finding that e-cigs had no effect on use of cigars, smokeless tobacco or marijuana provides confidence about the specificity of the e-cig effect.    

While the Cornell researchers do not claim that the restrictions caused smoking to increase, they note that their results are consistent with those of the Yale study, and they add: “All policymaking bodies should be aware of a potential increase in cigarette use following [e-cigarette] age purchasing restrictions.”  They recommend raising cigarette excise taxes and they endorse the Yale researchers’ support for setting the e-cig sales age lower than the cigarette age in order to take advantage of the substitution effect.

This is Pesko’s second notable paper this year.  Earlier, he published an experimental study (abstract here) concluding that: “Increased taxes, a proposed US Food and Drug Administration warning label for [e-cigarettes] and a more severe warning label may discourage adult smokers from switching to [e-cigarettes].  Reducing the availability of flavours may reduce [e-cigarette] use by young adult smokers.”

It is important to note that none of these studies were funded by the National Institutes of Health.  The NIH predominantly funds researchers who endorse the federal government’s vision of a tobacco-free society. 

Human Papillomaviruses (HPVs) Cause Mouth, Throat & Voicebox Cancers

I noted four years ago that “there is emerging scientific evidence that human papillomaviruses (HPVs), which are recognized to cause cervical cancer in women, may cause oral cancer.”  Now, JAMA Oncology (abstract here) reports the first epidemiologic study showing that several HPVs may increase mouth, throat and voicebox cancers. 

Lead author Ilir Agalliu writes that after researchers detected HPVs in mouthwash samples from nearly 100,000 participants age 50+ years in two large studies, participants were followed for about four years.  During that time, 132 subjects developed squamous cell cancers; about 40% of those tumors were in the voicebox, 35% in the mouth and 25% in the throat.  Agalliu compared the HPV profile in those cases with controls who were carefully matched for age, sex and race.  The results were adjusted for smoking and alcohol use, known risk factors for these cancers.  In this study, only 14% of subjects had never smoked, compared with 46% in the control group.

HPV-16, which spreads via sexual contact and is a major risk factor for cervical cancer, in this study was associated with throat cancer (odds ratio, OR = 22), but it was not a risk for mouth or voicebox cancer.  Because the throat cancer finding was based on only five cases, the association needs to be confirmed by additional research.  Other HPV types were linked to mouth and voicebox cancers, but again the number of cases was small.  While at least 170 different HPVs have been identified, experts believe there may be 200 additional types.    

There is now clear and compelling data about the most important risk factors for mouth and throat cancer: (1) Smoking and/or heavy alcohol consumption, and (2) sexually transmitted human papillomaviruses.  Dozens of other studies provide equally clear and compelling evidence that smokeless tobacco use is NOT a significant risk factor for these cancer types (here).

British Government Tells Smokers & Vapers the Tobacco Truth

While U.S. government health agencies include e-cigarettes in their decades-long attack on tobacco harm reduction and safer tobacco alternatives, public health leaders in Britain are telling the truth about e-cigarettes. 

The UK’s National Centre for Smoking Cessation and Training last week issued e-cigarette recommendations for practitioners and services via a “briefing” document.  As Clive Bates noted (here), it “represents a new worldwide high point in the blending of evidence with empathy in official public health advice.”  Furthermore, it represents a powerful antidote to the dangerous misinformation campaign being waged by the FDA, CDC, NIH and other U.S. agencies and organizations.

The new briefing follows positive British government reports on e-cigarettes issued in 2011 (here), 2014 (here) and 2015 (here).

Britain’s message is clear: “We begin by acknowledging that e-cigarettes are considerably safer than smoking cigarettes, are popular with smokers and that they have a role to play in reducing smoking rates.”  The briefing dispels dark myths that are the staple of tobacco abolitionists, including the shibboleth about nicotine.

“Nicotine does not cause smoking related disease, such as cancers and heart disease. These are caused by other chemicals found in tobacco smoke. Nicotine is addictive however and it is why people continue to smoke despite knowing about the harmful effects of tobacco. Nicotine in e-cigarettes poses little danger to adult users.”

The briefing addresses, in common sense terms, the risk of e-cigarette-related poisoning of children, a subject that is wildly exaggerated in the U.S. (here):

Should health professionals recommend e-cigarettes to smokers?  This is anathema in the U.S.; in Britain, practitioners are encouraged to:

“Familiarise yourself with e-cigarettes…Be positive when speaking about e-cigarettes. When you say: ‘We can’t recommend e-cigarettes’, people hear: ‘E-cigarettes are no good’. Instead choose words that convey a positive message such as: ‘We can’t supply them, but we can certainly offer the extra support that will help you stop smoking if you buy your own e cigarette’… Don’t push people to come off their e-cigarette…Some practitioners feel it is important to get people off nicotine as soon as possible, but in fact longer-term e-cigarette use can be a protective factor against relapse back to smoking.” (original emphasis)

 Regarding the chance of exploding e-cigarettes, the briefing advises:

“As with any rechargeable device, like mobile phones and laptops, it is important to charge with the correct charger and not to leave an e-cigarette unattended whilst charging. Ensure that you buy from reputable suppliers and avoid generic charging equipment.”

What about harmful chemicals and secondhand vapor?

“Some studies have detected chemicals in e-cigarette vapour that are known to cause health problems. However, these chemicals have been found at very low levels that are unlikely to represent a serious risk to health. When e-cigarettes are used within normal operating levels (e.g. not overheated), there are far fewer harmful chemicals present in their vapour than in tobacco smoke. If the e-liquid is being overheated it tends to produce an acrid, unpleasant taste – you will know if this happens!...There is no evidence that secondhand vapour is dangerous to others; however, it helps to be respectful when using e-cigarettes around others, especially non-smokers.”

These are only a few examples of the “evidence and empathy” offered in this enlightened British report.  Available here, it should be required reading for all federal, state and local authorities in the U.S.