Wednesday, December 28, 2016

Sacramento Bee Errs Twice with Fake News on E-Cigarettes

The Sacramento Bee on January 21 published a column written by a hearing aids company executive.  Titled “E-cigarettes may also cause hearing loss” (here), the piece asserted that “damage to inner ear of teen [sic] is an overlooked potential health risk to vaping” and that “nicotine – regardless of whether it is inhaled in smoke or in vapor – presents a significant risk to hearing.”

These claims are fallacious.  On January 27, the newspaper published my correction online:

“There is virtually no scientific evidence to support Dave Fabry's claim.  I conducted a search of Medline, which contains journal citations and abstracts for biomedical literature from around the world for the period 1946-2016.  Nicotine is identified as a topic in 22,218 medical publications, and hearing loss is identified in 11,984 articles.  There are only two articles matching both terms: a 1956 article on vitamin therapy of chronic deafness published in Italian, and a 1964 article entitled "Are You Smoking More But Hearing Less?"  It is almost impossible for Dave Fabry's claim to be valid if these two articles are the only relevant scientific publications in the world's biomedical literature for the past 70 years.”

Days later, the Bee deleted the correction but left other comments.  Reader Jim McDonald observed:

“Why did you delete Dr. Rodu's comments? He did a search for studies on this topic, going back to 1946 and found nothing to support Mr. Fabry's claim. Dr. Rodu is a professor at the School of Medicine at the University of Louisville. That seems relevant.

“You also deleted mine from earlier today. I was not disrespectful.

“If you print opinions and offer a place for comment, you should expect opposing points of view.”

Nicotine has nothing to do with hearing loss, but smoking might worsen age-related impairment (here, here and here) via damage to small blood vessels in the ear.

Kudos to Mr. McDonald and another reader who brought the deletion to my attention.  The newspaper erred in publishing fake news, then compounded its mistake by suppressing truthful corrective responses.

Wednesday, December 21, 2016

FDA Rejects Plea to Correct Smokeless Tobacco Warnings; A Closer Look at Flawed Interpretations

After two and a half years’ review, the FDA Center for Tobacco Products rejected Swedish Match’s request to eliminate or revise the 30-year-old, egregiously inaccurate warnings that are required to appear on snus products sold in the United States. 

In 2014, Swedish Match sought to:

·         Remove the warning, “This product can cause gum disease and tooth loss”;
·         Remove the warning, “This product can cause mouth cancer”; and,
·         Replace the warning, “This product is not a safe alternative to cigarettes” with this text: “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

I explored this issue earlier (here).

The FDA justified its rejections in a six-page letter to the company (here) in a 115-page supporting document (here), and subsequently in an announcement proclaiming, “FDA Issues Science-Based Decisions on First MRTP Applications.” 

Science-based?  Following is my review of the FDA’s tortured interpretation of the scientific evidence in its decisions on the gum disease/tooth loss and mouth cancer warnings. 

Gum Disease/Tooth Loss Warning Decision

The agency interpreted removal of a warning as a marketing claim, obligating Swedish Match to prove that snus was entirely without risk – a virtually impossible task.  The FDA advised, for example, that “Omission of [the gum disease tooth loss warning] from a subset of smokeless tobacco products indicates that unlike other smokeless tobacco products, the eight General Snus products cannot cause gum disease or tooth loss.” (emphasis in original).

For this decision, the agency reviewed published studies of “dental conditions (e.g., plaque, caries, tooth wear or tooth loss), gingivitis, gingival recession and periodontal disease” that it claimed were related.  Here are the conclusions for each of these, with the FDA findings in bold:

·         Dental conditions: “Overall, the dental conditions data included no studies that evaluated tooth loss over time…The results on caries were mixed, and the only study to examine the association between Swedish snus and tooth wear found an association. No association was seen between Swedish snus and plaque…”

·         Gingivitis: “Overall the results of the studies on gingivitis were mixed.”

·         Gum recession: “Overall, the only adjusted study of gingival recession to include non-users found a significant positive association between Swedish snus and gingival recession, and several unadjusted studies found significant associations between Swedish snus and gingival recession, although the direction of the association was mixed.”

·         Periodontal disease: “Overall, nearly all of the studies which examine the association between Swedish snus and indicators of periodontal disease (plaque, pocket depth, attachment loss, bone loss) found no association…”

Note the repeated finding of “mixed,” suggesting that some studies showed a positive association while others showed no association or a negative one.  For periodontal, or gum, disease, there was no association. 

Despite these equivocal or nil findings, the FDA concluded: “Overall, the totality of the evidence demonstrates that the eight General snus products can cause gum disease and tooth loss, and, correspondingly, does not support the removal of the warning that these products can cause gum disease and tooth loss.”  The FDA's decision is entirely unsupported by the "totality of evidence."

Mouth Cancer Warning Decision

The FDA decision on mouth cancer is based on an improper analysis of six published studies.  Peter Lee in 2010 published a formal meta-analysis of these studies and one more (abstract here).  Here are his findings for mouth cancer:

“No overall association is seen for oropharyngeal cancer, the most studied cancer type.  For the whole population, an increase (RR 3.1, 95% CI 1.5–6.6) seen in the Uppsala county study (Roosaar et al., 2008), based on 11 cases, contrasts with six studies showing no increase, the overall estimate being 0.97 (0.68–1.37). The never smoker estimate, 1.01 (0.71–1.45), based on four studies, is also null. These results are supported by long-term follow-up of 1115 individuals with ‘‘snuff-dippers lesion’’ (AxĂ©ll et al., 1976), which observed no oral cancers at the sites of lesions seen initially (Roosaar et al., 2006).”

When Lee included Roosaar with the other studies in his analysis, there was no association of snus and mouth cancer.  The FDA basically agreed with Lee that Roosaar was the lone work that was positive for snus and mouth cancer, but it cited this study as the sole reason for maintaining the warning.  In fact, the FDA is saying it will ignore the broad consensus of scientific research (i.e. the "totality of evidence") if any one study reports a positive finding.

Having set this impossibly high bar for safer tobacco products, the FDA went further by focusing on tobacco-specific nitrosamines in snus.  Research documents that TSNAs exist in vanishingly small concentrations in snus – about two parts per million or lower (here), and there is no scientific evidence directly linking TSNAs to mouth cancer.  Still, the FDA cited “the presence of nitrosamines in the products that are the subject of these applications, the lack of a threshold dose for mouth cancer” as additional reasons to sustain the warning.  The FDA is effectively saying that TSNAs must be reduced to zero for the warning to be removed.

The FDA closed the door on the gum disease tooth loss warning, but it gave Swedish Match the option of submitting a revised application for the other warnings.  It appears that the agency’s revision/amendment pathway is designed to defeat all the but wealthiest and most determined applicants, leaving millions of smokers and future smokers with demonstrably false warnings against the use of safer smoke-free products.

Thursday, December 15, 2016

The Surgeon General’s Misguided Report on E-Cigarettes

Teen smoking declined to record-low levels in 2016, according to the latest University of Michigan annual Monitoring the Future Study, which examines youth tobacco, alcohol and drug use (data tables here).  The figure at left shows the percentage of high school seniors using alcohol, marijuana, cigarettes and e-cigarettes in the past 30 days over the period 1990-2016.

Cigarette smoking among high school seniors plummeted from 19.2% in 2010 to 10.5% this year.  That is, the smoking rate was cut almost in half after e-cigarettes became readily available.  E-cigarette use also dropped over the past two years. 

Days ago, U.S. Surgeon General Vivek Murthy issued a report asserting that e-cigarette use among youth is “a major public health concern.”  The report recycles dire warnings about vaping that have been issued by FDA tobacco director Mitch Zeller and CDC director Tom Frieden, despite the lack of evidence of significant health risks associated with e-cigarettes.

The report is ostensibly a full review of scientific literature relevant to e-cigarettes and smoking among youth.  But as Case Western University law professor Jonathan Adler pointed out in the Washington Post (here), “there are now several studies that look at the effect of restricting teen access to vaping products showing that such measures increase teen smoking (including among pregnant women). I’ll say that again: Reducing youth access to e-cigarettes appears to increase youth smoking rates…Despite their relevance, these studies are completely ignored by the surgeon general. They’re not even listed in the report’s references.” 

Those studies were discussed in this blog (here and here).  Their omission in the Surgeon General’s report is inexcusable.

Why does the government focus on youth as it wars against e-cigarettes?  These products are responsible for virtually no health problems and certainly no deaths among youth and young adults.  In contrast, the MTF survey documents that alcohol is by far youth’s drug of choice.  In 2016, one-third of high school seniors had an alcoholic drink in the past 30 days, and one in five had been drunk, despite laws against underage sales and consumption. 

Young Americans die from alcohol consumption and abuse.  From 2007 to 2014, CDC data (here) shows that accidental alcohol poisoning killed 930 people age 15-24 years.  And alcohol also contributes to traffic fatalities.  With the exception of the elderly, this age group (15-24 years) suffers the highest death rates due to auto accidents.  Comprising just 14% of the U.S. population, this young cohort accounts for 25% of auto deaths (1,544 in 2014).

The Surgeon General’s report is the latest in a series of misleading and unsupported tobacco diatribes (here and here).  The public would be better served if government committed its limited resources based on the relative impact of a substance on children’s health.  Tobacco products should not be ignored, but Dr. Murthy’s report wrongly damns a safer and satisfying product that is currently helping 2.5 million former smokers (here) become or remain smoke-free.

Wednesday, December 7, 2016

Smokers: It’s Never Too Late to Quit or Switch to Smoke-Free

A new study from researchers at the National Cancer Institute and the National Institute on Aging finds that even smokers in their 60s who quit can reduce their chances of dying early. 

In 1995, 160,000 people age 50-71 years were enrolled in the study; data on their smoking and quitting was collected in 2004-2005.  Researchers documented causes of death and calculated rates through 2011 among never, current and former smokers, with adjustment for other risk factors.  The study appears in the American Journal of Preventive Medicine (abstract here).

Current smokers were three times as likely to die during the study as never smokers.  Compared with current smokers, former smokers had significantly lower death rates; the magnitude of the reduction correlated with the age when they quit.  For example, smokers who quit in their 30s had a death rate that was 57% lower, while those who quit in their 50s had a 36% lower rate.  Even smokers who quit in their 60s had a 23% lower rate.

This study should give hope to smokers of all ages, but this is not new information.  In 1996, Dr. Philip Cole and I published similar research in the journal Epidemiology (here).  We estimated how long never and current smokers of various ages would live on average.  In addition, we estimated remaining years for quitters and switchers.  Here are our results: 

Average Years of Life Remaining According to Tobacco Use and Age

Sex and Age (years)Never SmokerContinuing SmokerQuitterSwitcher




The good news: No matter what age, smokers can improve their life expectancy if they quit or switch.  It’s never too late to move to a smoke-free substitute.