Wednesday, February 15, 2017

Complicated Models Can’t Alter the Data - Part 2: Youth Smoking Is Way Down

As reported here last week, University of California San Francisco researchers Lauren Dutra and Stanton Glantz tortured data from the National Youth Tobacco Survey (NYTS) to support a purported “lack of a demonstrable acceleration in the long-term rate of decline” in youth smoking after 2009.  This was despite the fact the survey data showed that smoking among high school students declined from almost 16% in 2011 to 9% in 2014 – a reduction of 43% in just three years (here). 

The “untortured” NYTS findings can be confirmed by charting data from another federal survey: the National Survey on Drug Use and Health (NSDUH), which I have used for smoking research for many years (discussed here).

Once again, I used 2010 as the anchor year for equal intervals before widespread e-cigarette use (2006-2010) and after (2010-2014, the latest year for public access of NSDUH data).  I tallied smoking rates among boys and girls age 14-18 years, which is comparable to high school students in the NYTS.  The definition of a current smoker is also the same in the two surveys: anyone who smoked on at least one day in the past 30.

The accompanying chart clearly illustrates that smoking declined among boys (-13%) and girls (-20%) from 2006 to 2010.  However, during the next four years, the rate of decline doubled – to   -31% for boys and -41% for girls.

Findings from both federal surveys are consistent: The decline in smoking among high school students accelerated as demonstrably safer (here) e-cigarette use increases. 

Wednesday, February 8, 2017

Complicated Models Can’t Alter the Data: Smoking Among Youth and Young Adults Is Way Down

Smoking among high school students declined from almost 16% in 2011 to 9% in 2014 – a reduction of 43% in just three years.  That is according to data from the National Youth Tobacco Survey (NYTS) that I recently published (here). 

Now two researchers at the University of California San Francisco, Lauren Dutra and Stanton Glantz, torture the NYTS data to support a perceived “lack of a demonstrable acceleration in
the long-term rate of decline” in youth smoking after 2009. 

Dutra and Glantz analyzed smoking among children from 2004 to 2014.  They used a complicated model to determine the rate of decline from 2004 to 2009, then compared that to the 2011-2014 rate, when e-cigarette use was increasing among youths. 

The UCSF publicity statement on their work (here) states: “E-cigarettes …are actually attracting a new population of adolescents who might not otherwise have smoked tobacco products…”  Professor Glantz is quoted: “E-cigarettes are encouraging, not discouraging, youth to smoke and to consume nicotine, and are expanding the tobacco market.”  This resulted in headlines such as “Vaping encouraging youth to smoke” (here) and “E-cigarettes are creating a brand new generation of cigarette smokers” (here).

If Dutra-Glantz’s claims are true, we should see evidence of the “new generation” in the young adult population, particularly in current smoking rates among 18- to19-year-olds.  I used the CDC’s annual National Health Interview Survey to analyze two five-year periods: first, when e-cig use was minimal to nonexistent (2005-10), and then when e-cigs were in wide and growing use (2010-15).  I used the standard definition of current smokers: those who had smoked at least 100 cigarettes in their lifetime and smoke every day or some days.

The accompanying chart clearly illustrates that smoking declined among 18- to 19-year-olds during the first five years.  However, from 2010 to 2015 the rate dropped by over half among 18-19 year-old males, and by nearly two-thirds among females.

One fact is crystal clear: The decline of smoking in young adults is accelerating.

Wednesday, February 1, 2017

Experts to FDA: End the Smokeless Tobacco Misinformation Campaign

Two internationally renowned tobacco policy experts are urging “the FDA and like campaigns and health information websites” to “follow established ethical principles and accepted communication methods to inform the public of less-harmful tobacco/nicotine products as well as the greater harms of smoking.”

Lynn Kozlowski, professor at the University of Buffalo School of Public Health and Health Professions, and David Sweanor, adjunct professor of law at the University of Ottawa, published their commentary online in Addictive Behaviors (open access, here).  Their focus is a $36 million FDA campaign against smokeless tobacco “that fails to directly warn about the much greater harms from smoked tobacco (predominantly cigarettes).” 

Shortly after the campaign’s launch in April 2016, I produced a detailed analysis showing that it was based “on population cancer estimates derived from unreliable and inappropriate relative risks” (here).  I insisted that “the FDA should publish an honest estimate of the risks and consequences of smoking and smokeless use, and issue public messages that inform rather than mislead.  The current campaign wastes taxpayer resources, obfuscates the truth about smokeless tobacco and, ultimately, denies smokers information that could save their lives.”

Kozlowski and Sweanor echo my criticism of the FDA’s war on smokeless, noting that “consumers and potential consumers have a fundamental right (based on the principles of autonomy, health communication, and health literacy) to be well aware of the dramatic differential harms from the various products they are already or might consider using (reference here).”  Consumers don’t have that information, and the authors blame “…health authorities [that] have failed to provide accurate differential risk information on tobacco products” for decades.  They highlight misinformation from the Mayo Clinic, which I have criticized for 12 years (here), and former U.S. Surgeon General Richard Carmona’s congressional testimony of  2003, which, as I noted at the time (here), ignored decades of published research and the findings of Britain’s esteemed Royal College of Physicians.

Kozlowski and Sweanor offer clear policy prescriptions:

  • “The public and especially users of multiple tobacco/nicotine products need to be provided accurate and actionable information on major differential tobacco/nicotine product risk.
  • “This recommendation applies equally to youth who are using prohibited products and adults who are using legal products.
  • “Deception or evasion about major differences in product risks is not supported by public health ethics, health communication or consumer practices.
  • “Public health agencies have an obligation to correct the current dramatic level of consumer misinformation on relative risks that they have fostered.”

The Kozlowski/Sweanor commentary mirrors my 23-year science-based argument that government and other health authorities must stop lying about vastly safer tobacco products.  “Health-focused agencies,” they write, “need to regain some credibility in communicating about tobacco/nicotine product risks and work to place it responsibly in the context of comprehensive public health activities.”

Tuesday, January 24, 2017

Federal Studies: ZERO Mouth Cancer Deaths Among Men Who Dip or Chew Tobacco

The U.S. Food & Drug Administration (FDA) on January 23, 2017 published a proposed smokeless tobacco (ST) regulation (here) that is based on erroneous calculations of ST risks.

The agency would require a radical reduction in N-nitrosonornicotine (NNN), a tobacco-specific nitrosamine, in smokeless tobacco (ST) products.  Most American ST products today have very low NNN levels: about 2-10 millionths of a gram per gram of product – that is, 2-10 parts per million (ppm), while a limited number of products contain 10-15 ppm (here).  The FDA proposes to limit the NNN level in ST products to one ppm or lower. 

As is typical with FDA action on ST (here and here), this proposal is based on obscure calculations and flawed assumptions and interpretation.  Here is a summary of the FDA logic:

  • Compared with never users, ST users have an excess risk of mouth and throat cancer (Relative risk, RR = 2.16). 

  • ST use causes 276 deaths from mouth and throat cancer in the U.S. each year (this number was rounded to 300 in the proposed rule) – 268 men and 8 women. 

  • ST products contain NNN, a human carcinogen that causes mouth and throat cancer. 

  • Reducing NNN levels to no more than 1 ppm will reduce the number of deaths by about 115 per year.

While the latter two statements are by no means scientific certainties, in this post I will focus on the demonstrably inaccurate first assertion, which is the flawed basis for the FDA’s calculation of “300” deaths due to ST use.

The FDA’s use of an RR of 2.16 is in error. The figure, based on a 2008 report (abstract here), combines radically different RRs for men and women.  In 2002, I documented (here) that men, who generally use moist snuff (also called dip) or chew, do not have significantly elevated risk for mouth and throat cancer (RR ~ 1).  In contrast, women, who primarily use powdered dry snuff, have significantly elevated risk (RR ~ 4-6). 

My research is in general agreement with risk estimates published last year by the National Institute of Environmental Health Sciences’ Annah Wyss and colleagues at the National Cancer Institute and over a dozen universities and health centers in the U.S. and beyond (abstract here).  They determined odds ratios (ORs, interpreted the same as RRs) among snuff and chew users for head and neck cancer – which includes voicebox cancer in addition to mouth and throat, but the risk estimates are applicable.  The combined OR among snuff users, men and women combined, was 3.0, which is similar to the FDA estimate.  However, the OR among men was 0.86, while the OR among women was 8.89.  The ORs for chewing tobacco were not significantly elevated for men or women. 

I will use the Wyss ORs to show how the application of risks specific to men and women change the FDA estimates.  First, the following table (adapted from Table 5 in the FDA’s proposed rule) summarizes the data the FDA used (ST prevalence, RRs and total numbers of deaths from mouth-throat cancer in the U.S.) and the agency’s estimates for deaths attributable to ST (last column).  The FDA erred in applying a single RR (2.16) for men and women when, in fact the RR is 0.86 for men and 8.89 for women.

Table 1. FDA Estimate of Annual Deaths from Mouth and Throat Cancer Attributable to Smokeless Tobacco (ST), Men and Women in the U.S.
Prevalence of ST Use (%)Relative RiskAll Mouth/Throat Cancer DeathsPercentage Attributable to STNumber Attributable to ST
Age 35-64 years4.62.162,7705.1140
Age 65+ years3.92.162,9974.3128
Age 35-64 years0.22.168320.32
Age 65+ years0.32.161,6990.36

In the next table I illustrate how the death estimates change if the specific ORs for men (0.86) and women (8.89) from the Wyss study are used. 

Table 2. Revised Estimate of Annual Deaths from Mouth and Throat Cancer Attributable to Snuff Use, Men and Women in the U.S.
Prevalence of ST Use (%)Relative RiskAll Mouth/Throat Cancer DeathsPercentage Attributable to STNumber Attributable to ST
Age 35-64 years4.60.862,77000
Age 65+ years3.90.862,99700
Age 35-64 years0.28.898321.5613
Age 65+ years0.38.891,6992.3139

As noted earlier, my revised estimates are specific to snuff use – powdered dry snuff for women and moist snuff for men.  However, the risks for chewing tobacco in the Wyss study are not significantly elevated for men or women, so that product would add zero deaths. 

In summary, the FDA failed to use RRs specific to men and women, resulting in overestimation of cancer deaths in the former and underestimation in the latter.  Using the same FDA formula and assigning the proper risks, I estimate that 52 women using powdered dry snuff die each year from mouth-throat cancer, but the number of deaths among men who use dip or chew is zero.  The proposed regulation is therefore unjustified for dip and chew products.