Thursday, May 26, 2016

CDC Knows that Its Data Puts Smokeless Tobacco Risks Near Zero

Knowing that the Centers for Disease Control (CDC) has the means to calculate deaths due to smokeless tobacco – a statistic that is likely to be near zero – I encouraged readers (here) to call the agency at 800-232-4636 or email them (here) to demand data and sources on the precise dangers of smokeless tobacco use.

Three of my blog readers requested this information from the CDC and shared the agency’s responses.

Brenden Rudnick made the first request (here) in March, after reading one of my blog entries.  The CDC replied:

“ this time, we do not provide estimates of deaths attributed to the use smokeless tobacco products…We are not aware of a source of this estimate.”

Another reader, F. Chambers, reported a similar response on April 21 (here):

“We do not estimate deaths resulting from the use of smokeless tobacco products and we are not aware of a source of these estimates.”

On April 22, reader Rob advised that the CDC had a more elaborate excuse:

“there are methodological limitations, including in regard to sample size, which impact our ability to calculate comparable estimates for smokeless tobacco. Chapter 12 of the 2015 Surgeon General’s Report (here) describes the limitations in establishing estimates on the cause of death for products other than cigarettes…the lack of appropriate relative risks related to tobacco products other than cigarettes. Further, dual use of cigarettes and another product may complicate estimates, particularly if dual use extends to persons in age ranges where most smoking-caused deaths occur. Therefore, at this time, we do not have an estimate or a timeframe to provide.”

These excuses are unacceptable.  The CDC has all the data it needs to make informed estimates.  Here is proof: Dr. Michael Fisher, a scientist at Altria, used CDC data to calculate the following tobacco use risks, an analysis he presented at a recent tobacco research meeting (here). 

Adjusted Risks* for Tobacco Users in National Health Interview Surveys
Tobacco UseAll Causes of DeathAll CancersHeart Diseases
Exclusive Smokeless1.05 (0.90 – 1.23)1.05 (0.77 – 1.43)0.94 (0.70 – 1.28)
Exclusive Smoking2.17 (2.09 – 2.26)3.08 (2.84 – 3.33)1.98 (1.85 – 2.13)
Dual Use2.34 (1.80 – 3.02)2.78 (1.89 – 4.10)1.76 (1.03 – 3.01)
Former Smoking1.35 (1.30 – 1.40)1.64 (1.52 – 1.78)1.21 (1.13 – 1.29)
Former Smoking, Current Smokeless1.38 (1.14 – 1.67)1.62 (1.13 – 2.31)1.62 (1.16 – 2.25)
*Compared with never tobacco use

The headline here is that the risks for exclusive ST users are not significantly different from those for never users.  In other words, ST users had ZERO excess risks for all causes of death, all cancers and heart diseases.  The rest of the estimates are significantly elevated.  Note that, by Dr. Fisher’s calculation, the risks for dual users are not very different from those for exclusive smokers.  Also note that the risks for former smokers who use ST are about the same as those who quit altogether; both were lower than smokers.

By continuing to obfuscate about the existence and implications of it smokeless risk data, the CDC is failing in its mission to promote public health. Worse, by supporting the false claim that smoke-free products are just as risky as cigarettes, the agency denies smokers vital and persuasive reasons to quit.

Wednesday, May 18, 2016

The Robust Public Health Case for Tobacco Harm Reduction

Last year, Margarete Kulik and Stanton Glantz (“KG”) proclaimed in Tobacco Control that there is no public health basis for telling smokers about smokeless tobacco and e-cigarettes as safer cigarette alternatives, because the smoking population in the U.S. was “softening,” i.e., becoming more likely to quit (abstract here).    

KG based their conclusion in part on an analysis of public survey data from the Tobacco Use Supplements of the Current Population Survey.  They had information on the percentage of smokers (prevalence), the percentage of smokers who made a quit attempt in the past 12 months, the proportion of former smokers among ever smokers (also called the quit ratio), and daily cigarette consumption (cigarettes per day, or CPD) for each state and for several survey years from 1992 to 2011. Using linear regression, they found that a 1% decline in smoking prevalence is associated with a 0.6% increase in quit attempts, a 1.1% increase in the quit ratio, and a reduction in consumption of 0.3 cigarettes per day (CPD). 

The KG analysis was seriously flawed, as the authors failed to consider other factors that may significantly affect smoking.  For example, KG should have considered data on the percentage of smokers who faced workplace or home smoking bans – information that was available in the survey datasets.  The effect of state cigarette excise taxes should have been weighed.  Additional factors, such as differences in smoking norms and anti-smoking sentiments in the various states, are commonly analyzed through the use of a standard fixed effects variable.  KG did none of this.

My research group has recreated the KG analysis and taken into account the missing variables.  Our results have now been published in the journal Addiction (here).  We found that “KG’s results are not robust…The inclusion of state fixed effects and state-level policies led to a large drop in the coefficients…and became statistically non-significant…the omitted state-level characteristics are most likely responsible for…KG’s results.”

We also note: “One further point needs to be made.  KG claim that their study bears on the question of whether smoke-free tobacco products have a contribution to make to tobacco control.  They claim that much of the argument for smokeless tobacco and e-cigarettes is dependent on the assumption that the smoking population is hardening.  This is not the case. The argument for these considerably safer products is simply that they may be short-term aids to cessation or permanent substitutes for tobacco cigarettes.  In a population such as that in the US, that argument is relevant as long as there are substantial numbers of smokers who will use them.”

For the 39 million smokers in the U.S., there is no public health basis to withhold either safer cigarette substitutes or the potentially life-saving facts about such products.

Wednesday, May 11, 2016

U.S. Policymakers Ignore Royal College of Physicians’ Smoke-Free Tobacco Report – Again

A new Royal College of Physicians (RCP) report, “Nicotine Without Smoke: Tobacco Harm Reduction” (here), provides “a fresh update on the use of harm reduction in tobacco smoking, in relation to all non-tobacco nicotine products but particularly e-cigarettes.  It concludes that, for all the potential risks involved, harm reduction has huge potential to prevent death and disability from tobacco use, and to hasten our progress to a tobacco-free society.”  The RCP is among the world’s oldest and most prestigious medical societies.

Note that UK tobacco authorities are not bound by American tobacco legislation that classifies e-cigarettes as tobacco products, so the RCP call for a “tobacco-free society” is less egregious than the U.S. mantra.

Among the RCP’s findings:

·  “E-cigarettes are marketed as consumer products and are proving much more popular than [nicotine replacement therapy, NRT] as a substitute and competitor for tobacco cigarettes.

·  “E-cigarettes appear to be effective when used by smokers as an aid to quitting smoking.

·  “E-cigarettes are not currently made to medicines standards and are probably more hazardous than NRT.  However, the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco.

·  “There are concerns that e-cigarettes will increase tobacco smoking by renormalising the act of smoking, acting as a gateway to smoking in young people, and being used for temporary, not permanent, abstinence from smoking.  To date, there is no evidence that any of these processes is occurring to any significant degree in the UK.  Rather, the available evidence to date indicates that e-cigarettes are being used almost exclusively as safer alternatives to smoked tobacco, by confirmed smokers who are trying to reduce harm to themselves or others from smoking, or to quit smoking completely.

·  “…in the interests of public health it is important to promote the use of e-cigarettes, NRT and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK.”

The RCP’s strong endorsement of tobacco harm reduction is significant.  In 1962, the college became the first organization to conduct a formal study on the health effects of smoking (available here).  That report generated global headlines and likely was responsible for President John F. Kennedy being asked on May 23, 1962, whether smoking causes cancer and heart disease (here and here).  The president dodged the question, but two weeks later announced (here) that Surgeon General Luther Terry would study the health effects of tobacco, leading to release in 1964 of the seminal report, “Smoking and Health”.

The sharp contrast between the new RCP report and the FDA’s just-published e-cigarette regulations comes as no surprise to this observer.  In 2002, the RCP issued a report titled “Protecting Smokers, Saving Lives” (available here), stating, “As a way of using nicotine, the consumption of non-combustible [smokeless] tobacco is on the order of 10-1,000 times less hazardous than smoking, depending on the product.”  The RCP noted that some smokeless manufacturers might market their products “as a 'harm reduction' option for nicotine users, and they may find support for that in the public health community.”

From the U.S. public health establishment, no such support was forthcoming.   

The RCP issued its second report in 2007: “Harm Reduction in Nicotine Addiction: Helping People Who Can't Quit.” (here)  The message was clear and unequivocal: “…that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved… Harm reduction is a fundamental component of many aspects of medicine and, indeed, everyday life, yet for some reason effective harm reduction principles have not been applied to tobacco smoking…This report makes the case for radical reform to the way that nicotine products are regulated and used in society. The ideas presented are controversial, and challenge many current and entrenched views in medicine and public health. The principles behind them have the potential to save millions of lives. They deserve consideration.”

Although the current RCP report received some positive press coverage in the U.S. (here), the Centers for Disease Control maintained its prohibitionist position, noting: “There is currently no conclusive scientific evidence supporting the use of e-cigarettes as a safe and effective cessation tool at the population level.” 

University of California, San Francisco professor Stanton Glantz rebuked his British colleagues: “These guys, in my view, are going off a cliff.”  Unfortunately, it is U.S. smokers who are being pushed off a cliff by government policymakers who deny them vastly safer alternatives.  

Wednesday, May 4, 2016

NIH Wastes More Tax Dollars on Misguided Smokeless Tobacco Research

Psychiatrist Matthew Carpenter and colleagues at the Medical University of South Carolina have published in the journal Tobacco Control (here) a quit-smoking study that was five years in the making.  At its start, I opined that the work could be valuable, depending upon its design (here).  The journal article, “Snus undermines quit attempts but not abstinence,” disappoints, yielding minimal useful data.

While the authors describe their work as a “nationwide clinical trial,” they actually recruited, online, smokers who didn’t want to quit; all contact with their subjects was by phone, email and post.  The “treatment” group received six weeks’ worth of Camel Snus, while the control group received none; all were given behavioral counseling and an unspecified amount of money.  After the treatment, participants in both groups were given a brief prompt to quit all tobacco products, including snus if still being used.  All participants were given a referral to their state quitline.”

Dr. Carpenter made quit attempts the major goal of his study, which was odd, given that he enrolled only smokers who did not want to quit.  It turns out that 26% of the snus group made quit attempts, compared with 31% of the control group, a difference that was not statistically significant and therefore does not justify the title of his article.   Quit attempts lasting 24 hours were significantly less frequent in the snus group (19% vs. 26%).

Quit attempts are not nearly as important as actual quitting.  The number of subjects who achieved abstinence in both the snus and control groups was the same – about 6%.  As I noted previously (here), when smoking is the “illness,” snus is the “treatment,” and nicotine/tobacco abstinence the “cure,” low success rates are almost guaranteed.   

Still, the trial yielded some valuable data.  At the end of the study, Dr. Carpenter grouped participants who were offered snus into four groups: (1) never used it, (2) tried it but didn’t use it, (3) were using it infrequently and (4) were using it frequently.  He reported that, “with never users as a referent, participants who become current frequent users at the end of the sampling period were more likely to try (RR=2.24; 95% CI 1.30 to 3.86) and succeed (at any point) in quitting (RR=2.21; 95% CI1.18 to 4.13).”

Snus did help some smokers quit, even though they had to become abstinent to be counted.  

Why were success rates so low?  Probably the biggest factor in getting smokers to switch to snus is informing them about the huge difference in risk.  The article mentions that the snus group was told that snus “might be considered safer than cigarettes.”  I wrote Dr. Carpenter, asking for details, and he graciously responded by providing the script that operators followed when talking with participants.  They told smokers that “some research suggests that [snus] could be safer to you [sic] than cigarette smoking.”  That is a gross understatement of the facts.

The authors advise that this project was supported by a National Cancer Institute grant of $410,000, but they also acknowledge other NIH grants totaling about $14.3 million over the last three years. 

Carpenter’s “caution against wide-scale unguided use of snus as an aid to cessation” is not supported by the evidence.  It’s time for Congress, the public and the research community to dedicate scarce research dollars to legitimate tobacco harm reduction efforts.