Thursday, July 26, 2018

More Proof from FDA Population Data Showing E-Cigarettes As Popular Quit-Smoking Aids


While the number of American vapers declined over the last three years (as I reported here), e-cigarettes were still far more popular quit-smoking aids than medicinal nicotine or other drugs, according to researchers at the University of California San Diego (here).

Tarik Benmarhnia and colleagues used information from Waves 1 and 2 of the FDA-funded Population Assessment of Tobacco and Health (PATH) Study to evaluate “the influence of [e-cigarettes] and pharmaceutical cessation aids [varenicline, bupropion and nicotine medicines, NRT] on persistent abstinence (≥30 days) from cigarettes, and reduced cigarette consumption” during the period 2013 to 2015.  They concluded:

“Our results indicate that [e-cigarettes] are a more popular choice than approved pharmaceutical products as a smoking cessation aid among US quit attempters, over three quarters of whom were daily smokers.  In the future, as [vapor] products continue to evolve to make nicotine delivery more similar to that obtained from a cigarette, it is possible that they may play a bigger role in assisting smokers to quit combustible tobacco.”

This study confirms my research group’s earlier analysis of Wave 1 PATH data: E-cigarettes are among the most commonly used quit aids for American smokers, and they are the only aid more likely to make one a former smoker (i.e., a successful quitter) than trying to quit cold-turkey (here). 



Thursday, July 19, 2018

CDC Data Shows That E-Cigarette Use Declined Again in 2017


About 6.9 million Americans were current users of e-cigarettes in 2017, according to data in the 2017 National Health Interview Survey, the source for CDC national smoking estimates.  That’s a million fewer vapers than the prior year, and over two million fewer than in 2014, the first year NHIS surveyed for vaping.    

The number of current vapers who were former smokers had increased through 2016, but dropped in 2017, from 2.62 to 2.3 million.  This is not good news for tobacco harm reduction.

Another fascinating detail from 2017 is that 1.17 million never smokers currently used e-cigs, and over two-thirds of those were 18-24 years old.  This may be an extension of the recent increase in high school vaping (here), but it’s important to note that smoking in this age group is way down (here). 

Vaping has been portrayed as a menacing new epidemic by tobacco and nicotine prohibitionists in government and elsewhere.  It now appears that the misinformation in their anti-vaping messages has been effective (here).  The number of vapers has tragically declined. 

Friday, July 13, 2018

FDA: You Can Run Models, But You Can’t Hide Facts About Smokeless Tobacco


In a recent New England Journal of Medicine article, FDA researchers went to great lengths to conceal the fact that smokeless tobacco (ST) use has an entirely negligible impact on life expectancy.

The article, “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States,” (here) by Benjamin Apelberg and colleagues, was the centerpiece of FDA Commissioner Scott Gottlieb’s March 15 announcement of a radical nicotine reduction rule for cigarettes.  Drawing from the research, an FDA press announcement (here) declared that if cigarettes were minimally- or non-addictive by 2020, approximately 5 million additional adult smokers would quit smoking within just one year; only about 1.4 percent of the U.S. adult population would smoke cigarettes by 2100, in part, because more than 33 million people would avoid becoming regular smokers; more than 134 million years of life [would be] gained among the U.S. population.

While it is entirely unclear how nicotine reduction would produce the first two results, there is a fundamental flaw in Apelberg’s model that mainly affects the third, years-of-life, claim.  Correcting for that error, the model would likely confirm that ST products are nearly risk-free.

Apelberg estimates excess deaths among smokers by linking participants from National Health Interview Surveys (NHIS, 1997-2004) to the National Death Index (NDI) through 2006.  He also estimates deaths among users of ST, but uses an entirely different dataset – smokeless users who were enrolled in 1982 in the American Cancer Society Cancer Prevention Study II.

Apelberg’s use of two data sets -- NHIS for smokers and CPS-II for ST users – violates a basic rule of modeling: all inputs should be from the same or similar sources.  NHIS should have been used for analysis of both groups.  That was the procedure, for example, when Michael Fisher and colleagues used NHIS and NDI to produce a stable estimate for all-cause mortality among smokers and ST users (here). 

Apelberg may have used CPS-II because it shows that ST users’ mortality rate was 18% higher than that of never tobacco users.  Had he used NHIS, he would have had to acknowledge that smokeless users had no significant risks, as Fisher documented only a 5% excess that was not significant (HR= 1.05, CI = 0.90 – 1.23) (here).

The FDA analysis was biased through the use of exaggerated risks from an American Cancer Society study that has never been evaluated by independent researchers (here, here and here).  In this way, the FDA hid the negligible health impact of ST use.

A letter I submitted to the New England Journal of Medicine describing the flaw was not accepted.