Thursday, September 22, 2016

“ENDS” Don’t Justify the Means with E-Cigarettes

E-cigarettes and vaping are transforming tobacco use in the U.S. and worldwide.  The innovative products are being used almost exclusively by smokers looking for substitutes for more harmful conventional combustible tobacco.  This revolution is progressing despite widespread opposition from public health officials and tobacco prohibitionists, some of whom are combating the products with linguistics. They’re trying to label e-cigs “electronic nicotine delivery systems,” or ENDS (here). 

Carl Phillips (here) traced the beginning of ENDS to a World Health Organization report in 2010 (here).  To be fair, it is common for researchers to invent terminology and acronyms as shorthand to communicate efficiently; Dr. Philip Cole and I used ANDS – alternative nicotine delivery systems – in a 1999 professional article describing safer nicotine substitutes for smokers (here). 

Still, obfuscating popular terms as a form of social engineering is not appropriate, as two recent publications in Tobacco Regulatory Science (here) and Nicotine & Tobacco Research (here) demonstrate.

In the first study, staff at RTI International and the FDA in 2014 interviewed 12 focus groups of vapers.  They found that “participants understood the umbrella term ‘e-cigarettes’ to refer to a variety of device types,” that “vaper” was an acceptable term among e-cigarette users, and that “‘vapor’ was generally well-known overall.”  More importantly, they wrote that “conceptual clarity, including using specific and familiar terminology and descriptions of products for users and nonusers alike, is crucial,” but they concluded that ENDS did not meet that standard.

The second study, by researchers at the American Legacy Foundation and several universities, was more critical of ENDS.  Examining the public posts of 1,023 users of a Legacy quit-smoking website, they found “that ‘e-cigarette’ and ‘vape’ are recognizable terms among US treatment-seeking smokers. Conversely, terms such as ‘ENDS,’ commonly employed by researchers and public health advocates, are not used by smokers and may be an impediment to tobacco control research.”

FDA and tobacco prohibitionists: When you talk to smokers and vapers, use the right terms.  End the ENDS.

Note: This isn’t the first time anti-tobacco forces have attempted to abuse linguistics in order to change behavior.  In 2010, I advised the American Cancer Society and federal agencies that their use of the term “spit tobacco” instead of “smokeless tobacco” was disrespectful, unprofessional and perjorative (here and here).  All agreed to discontinue the practice (here).  

Thursday, September 15, 2016

Selling Tobacco to Kids: FDA Inspection Data from 2015 and 2016

A September 15 Food & Drug Administration press release (here) states that the agency “has taken action against 55 tobacco retailers by issuing the first warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids and cigars, to minors.” 

The FDA compliance check program aims to assure that retailers – both brick-and-mortar and online – don’t sell tobacco products to children.  If a retailer is noncompliant, the FDA issues a warning letter; subsequent violations can result in a fine, and the “FDA may pursue a No-Tobacco-Sale Order (NTSO) against retailers that have a total of five or more repeated violations of certain restrictions within 36 months.” (here) 

Let’s take a look at the compliance results for the past two years.  Data is reported for fiscal years (October 1 to September 30), so the 2015 data is complete, while the 2016 data extends only to August 31 (available here).

So far this year, 89% of retailers have been compliant in 151,190 inspections.  Warning letters resulted from 9% (n = 13,124) of inspections, and fines have been levied to another 3,015 retailers (2%).  As the chart shows, these numbers are almost identical to those from 2015.

It is noteworthy that these results are substantially worse than five years ago, when the FDA was just starting its compliance program.  In 2011, data I examined from 16 states showed an overall compliance rate of 96% (here).  By now, the rate should have risen to near 100%; it is unacceptable that it has fallen to 89%.

By extrapolation, 9 out of 10 retailers in the U.S. do not sell tobacco products to kids.  As a society, we should not tolerate the fact that 10% of retailers put children at risk.  The percentage should be zero.

Thursday, September 8, 2016

American Cancer Society & CDC Withheld Evidence on Safer Smokeless Products

The Centers for Disease Control (CDC) and the American Cancer Society (ACS) have a long history of suppressing information about the relative risks of smokeless tobacco (ST) products. (CDC example here)

CDC and ACS researchers in 2007 jointly published a mortality study of smokers who had switched to ST (here).  Using data from the ACS 2nd Cancer Prevention Survey (CPS-II), they reported that smokers who switched to ST had slightly higher risks than smokers who became abstinent.  However, the authors omitted a critically important comparison group: smokers who continued smoking. 

The ACS and the CDC had always avoided direct comparison of smokers with ST users because they knew that ST users incurred vastly lower risks.  This time, their omission was glaring.   

In February 2007, I filed a federal Freedom of Information Act request for access to the ACS dataset.  The CDC denied my request seven months later, claiming that the CDC authors had not had access to the data.

A month later, in October 2007, I filed an appeal with the HHS Deputy Assistant Secretary for Public Affairs, raising two issues:

  • CDC co-authors would not willingly violate the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, a mandate that authorship be based on substantial contribution to the conception and design, acquisition of data, or analysis and interpretation of data.  My position was that CDC authors were effectively co-owners of the data.

  • There was incontrovertible evidence that the CDC possessed or had access to the CPS-II Dataset.  I noted, “The CDC maintains the SAMMEC website, which ‘calculates annual smoking-attributable deaths, years of potential life lost, smoking-attributable expenditures, and productivity losses for adults in the United States, individual states, and user-defined populations.’  The methodology section of SAMMEC states that it ‘uses unpublished age-adjusted RR estimates for persons aged 35 years and older from the second wave of the American Cancer Society's Cancer Prevention Study (CPS-II), 6-year follow-up.’”

More than two years later, in June 2010, HHS denied my appeal, asserting, “These primary data are in the possession of the ACS. CDC did not have any role in collecting or defining these data and never had possession of it. ACS never sent CDC its CPS-II primary data and it never allowed CDC to access the data or to submit computer programs to access the data. The ACS never showed any intent to relinquish control over the data.”

For 30 years, the CDC has been the source for smoking-related U.S. and global mortality estimates (discussed here).  Critical measures used to generate these numbers are the relative risk estimates from CPS-II, which are apparently the private property of the ACS and which have never been validated by external experts, even those at the CDC. 

I wrote ACS CEO John Seffrin in 2010: “I urge the ACS to release comparable risk estimates for male smokers, smokeless tobacco users and switchers in CPS-II…In addition, the ACS should release the CPS-II data, so that the risk estimates for all tobacco users can be validated by external scientists.”  I pointed out, “Earlier this year, Lawrence Deyton, director of the FDA Center for Tobacco Products, Principal Deputy Commissioner Joshua Sharfstein and Commissioner Margaret Hamburg authored a commentary about tobacco regulation for the New England Journal of Medicine, in which smoking and tobacco use were used synonymously (here). These physicians wrote that ‘tobacco use causes more than 400,000 deaths in the United States annually…,’ and they described ‘tobacco products’ as ‘the leading cause of preventable death in the United States.’”

I explained, “When FDA officials characterize all tobacco products as equally lethal, they are effectively denying smokers lifesaving information about safer cigarette substitutes…The public health is not well served when information that can save lives is buried and/or ignored. The selective and incomplete provision of risk information by the ACS is contrary to its public health mission and will only serve to hamper the FDA from undertaking an independent assessment of this issue in pursuit of its overarching mission: reducing the harm associated with tobacco use.”

ACS Chief Medical Officer Otis Brawley denied my information request, writing, “We have not found it productive to share the CPS-II data with researchers supported by the tobacco industry, because of their repeated misuse and misrepresentation of the data.”  Both letters were copied to Deyton, Sharfstein and Hamburg.

I described the ACS correspondence in my blog (here), where I noted, “I have conducted research on tobacco harm reduction for almost 20 years; published numerous studies in professional journals; written dozens of articles in the general media; and given hundreds of lectures. No one has ever accused me of misusing or misrepresenting any data.”

This is how the CDC and ACS have for years ignored and buried evidence documenting that smokeless tobacco use is vastly safer than smoking.