Wednesday, November 23, 2016

Motorcycles Aren't Cars and Cigarettes Aren't Smoke-Free Tobacco

What if the federal government told you that cars are as dangerous as motorcycles?  Well, you would be living – and dying – in TobaccoWorld.  Read my commentary that appeared in the Washington Examiner (here) and is reprinted below.

Motorcycles are more dangerous than cars. We know this because a government agency, the National Highway Traffic Safety Administration, routinely provides data that confirms it.

For example, the NHSTA reports there were 0.85 auto-related deaths for every 100 million miles Americans drove in 2014. By contrast, the death rate for motorcycles was 22.96 for every 100 million miles, making motorcycles 27 times deadlier than cars.

What if the government ignored this difference in risk and assumed the motorcycle death rate applied to all vehicles? In other words, what if all vehicle manufacturers had to be governed by motorcycle regulations and what if insurance premiums for car owners were pegged at the much higher rates for motorcycles?

The effect of such irrationality would be intolerable, with cars priced out of reach, companies put out of business and consumers left without choice. Policymakers would never inflict such pain on the American driving public – at least, not on purpose.

But that's just the sort of irrationality being imposed on the nation’s consumers of smoke-free tobacco products, with tragic consequences. Federal agencies routinely conflate the risks of using smoke-free tobacco products with the risks of smoking, despite decades of scientific studies demonstrating that smoke-free products are vastly safer than cigarettes.

Smokeless tobacco products are required by the Food and Drug Administration to carry demonstrably inaccurate and misleading safety warnings. Companies that attempt to challenge those messages are held to the unnecessary and financially crippling standard of proving that their products would have virtually no health impact on the population.

Even when a company did provide irrefutable proof to change the warning labels in 2011, the FDA took four years to deny its citizen’s petition. Another company’s formal application from 2014 remains in FDA limbo.

The FDA ignores extensive evidence from federal surveys of the role e-cigarettes are playing in helping smokers to quit—including some 2.5 million successes—while the Centers for Disease Control and Prevention withholds evidence that smokeless tobacco is safer

The Affordable Care Act permits health insurers to charge higher premiums for any recreational nicotine use, not just smoking.  Most life insurance companies also fail to recognize established risk differences, as they charge higher premiums for users of all nicotine products, even medicines. 

No one confuses motorcycles with cars, just as no one, other than government officials, confuses cigarettes with e-cigarettes or cans of moist snuff. The risk differential between combustible and smoke-free tobacco products is proven and profound. It’s time to tell the public the truth, and to regulate accordingly. 

Wednesday, November 16, 2016

Another Engineered Study Claims Teen Vaping Leads to Smoking

A research letter published last week in JAMA asserts that teens who used e-cigarettes became “heavy” smokers.  The research appears to have been engineered to produce that result.

The lead author is Adam Leventhal, a University of Southern California psychologist with a history of exaggerated anti-e-cigarette claims (here).  Promoting his new research, Leventhal told the media (here) his work “…is the first to show that teenagers who vape not only experiment with cigarettes, but are also more likely to become regular smokers…It is also the first time teenage vaping has been linked to heavier smoking patterns involving use of multiple cigarettes per day.”
Leventhal conducted repeat surveys of Los Angeles-area high schoolers.  A baseline survey of 10th graders was followed six months later by a second.  Critical to the outcome, Leventhal defined vapers and smokers differently, as seen in this table.

Leventhal’s Definitions and Classification of Baseline Vapers and Smokers
NeverNever vaperNon-smoker
PriorEver vaperNon-smoker
Past 30 daysCurrent vaperCurrent smoker
Infrequent1-2 days1-2 days
Frequent3+ days3+ days

Why did Leventhal use different definitions for vapers and smokers?  Why did he separate past and never vaping, but combine past and never smoking?  One possible explanation is that he wanted to record more “non-smokers” at baseline, some, perhaps many of whom, were “prior” smokers.  This allowed Leventhal to count prior smokers as vaping gateway cases to subsequent smoking. 

There are additional problems.  Leventhal labeled those smoking on three or more days in the past month as “frequent,” and those consuming two or more cigarettes on days they smoked as “heavy” smokers.  He provided no reference for these cutoffs, which help support his vaping-leads-to-smoking screed. 

For context, note that the 2014 National Youth Tobacco Survey showed that nearly half of current 10th grade smokers smoked five or fewer days in the past month, and smoked five or fewer cigarettes (on days they smoked).  These were likely weekend party smokers.  Labeling infrequent users as “frequent” or “heavy” is inappropriate. 

Leventhal’s study was supported by NIH grants to him ($3.4 million over five years) and Jonathan Samet ($15.9 million over four years). 

The number of engineered e-cigarette gateway studies is growing, and they will have a major impact on FDA regulations.  Federal grant support requires the authors to share their data (here).  With the stakes so high, independent investigators who aren’t biased against e-cigarettes will eventually obtain Leventhal’s data, and his analysis, results and interpretation will surely be investigated.    

Thursday, November 10, 2016

Snus Not Associated with Gastroesophageal Reflux, Says Norwegian Study

Norwegian researchers report that snus users had lower risks for gastroesophageal reflux symptoms (GERS) than never users (abstract here). This builds on Swedish findings of six years ago that snus use was not linked to gastrointestinal problems (here). 

The new study, published in the Scandinavian Journal of Gastroenterology, used surveys from 2006 to 2009 in Norway’s large rural North TrΓΈndelag County.  The authors “hypothesized that snus use would increase the risk of GERS.  However, the overall result was that snus use seems to protect against GERS.”  They concluded, “Compared to never snus users, daily snus users had a reduced risk of GERS (OR = 0.77, 95% confidence interval [CI] = 0.64–0.93).”

Surprised by their data, the authors questioned whether they were seeing “reverse causality”, where snus users who developed GERS may have quit, shifting GERS to “former” snus users.  The researchers did find that former users had an insignificant elevation (OR = 1.20, CI = 1.00 – 1.46).  However, while higher snus consumption should be associated with higher risk of GERS, this study found the opposite.  The lowest consumption level (less than two boxes a month) was associated with a 41% increase in GERS, but higher consumption levels were not associated with increases.

GERS rates were significantly elevated in two groups of snus users: those who also smoked (OR = 2.26, CI = 1.17 – 4.35) and those who had switched from cigarettes (OR = 1.50, CI = 1.13 – 1.99).  Smoking is a factor in some GERS studies.  Two years ago, some of the current study’s authors published research asserting that “Tobacco smoking increases the risk of…GERS,” and that quitting resulted in symptom improvement in selected survey participants.  It is surprising that this work is not referenced in the new study, as it is directly relevant.

Snus users, rest easy.  Your habit involves little to no risk of reflux.