Wednesday, February 10, 2016

CDC Exaggerates Smoking Quitline Success

Acting Surgeon General Boris Lushniak marked the 50th year of the federal government’s war on tobacco two years ago, noting, “We are at a historic moment in our fight to end the epidemic of tobacco use.” (here)  “The good news,” he continued, “is that we know which strategies work best… [to make] the next generation tobacco-free.”  The declaration left no room for consideration of tobacco harm reduction. The government’s grand plan does include telephone quitlines and web-based interventions for current tobacco users – two programs that in 2012 cost taxpayers about $100 million (here).

According to new study from the Centers for Disease Control, “…only 1% to 2% of adult tobacco users in the U.S. access quitlines each year.” (abstract here).  That's about one half to one million individuals. 

Do quitlines work?  The CDC offered results for calendar year 2011 telephone and web-based quitlines in Alabama, Arizona, Florida and Vermont.  Dr. Antonio Neri and CDC colleagues assessed rates of cessation (defined as not smoking by self-report for the past 30 days) seven months after each subject’s enrollment. 

The reported rates – 32% for quitline users and 27% for web-based users – were actually inflated by manipulating the numbers.

Of the 16,332 participants in the programs, just over half (n=8,277) were lost to follow-up.  The CDC researchers sought the missing subjects via email, postal mail, express mail, computer-assisted phone calls and $40 inducements.  These plus another 3,969 participants were dropped from the critical denominator. 

The fact that Neri et. al. based their calculations on only 25% of the original enrollees skewed the results.  Using the original enrollment numbers, success rates are only 8.1% for quitline users and 6.7% for web users.  Considering that in any given year about 5% of smokers quit on their own, about 800 of this study’s 16,000 smokers would have quit with no assistance.  The quitlines and web therefore generated about 400 quitters, a paltry number.

My estimates are consistent with real-world numbers.  The quitlines provided free nicotine medicines (which have been shown to work for 7% of smokers who try them) and counseling, which likely included current coping tips from the National Cancer Institute, such as, “take a time out; call or text a friend; take a walk, play a game, read a good book; make a list of fun events, do one a day; get out of the house when you can.”  It is doubtful that many of the 12,000 drop-outs actually used these tips to quit.

This CDC study was supported by the American Recovery and Reinvestment Act of 2009.  That legislation was aimed at creating jobs, assisting those most impacted by the recession, investing in infrastructure and stabilizing state and local government budgets (here), with $1 billion earmarked for “prevention and wellness.”  Using tax dollars to defend wasteful programs with contrived analytics is bad public policy.

Wednesday, February 3, 2016

Fueling the E-Cigarette Gateway Crusade with Tax Dollars

In an extraordinary leap of logic, a report in Tobacco Control (here) links ever use of e-cigarettes – even a single experimental puff – to subsequent ever use of cigarettesResearchers from the Universities of Hawaii and Connecticut, and from the Norris Cotton Cancer Center in New Hampshire base their findings on surveys of high school students on the Hawaiian island Oahu.  The journal’s press release publicizing the study (here) quotes first author Thomas Wills, “Teens who use e-cigarettes are more likely to try the real thing a year later…”   

In the journal and the release, the terms “use” and “try” are used interchangeably to make the case for the e-cigarette as a gateway to smoking.  The news media eagerly took the bait (here and here). 

Wills defines an e-cig user as anyone who “smoked [sic] e-cigarettes 1-2 times,…3-4 times,…a few e-cigarettes a year,…a few e-cigarettes a month,…a few e-cigarettes a week,…[or] every day.”  In other words, students who ever took a puff on an e-cig were counted together with students who used them more often.  Wills similarly distorts the definition of cigarette smoking. 

Such broad definitions are pointless from a scientific perspective, but they have one advantage: by inflating the number of users, they support a (false) linkage between e-cigs and cigarettes. 

If we use the generally accepted definition for adolescent substance use – i.e., used in the past month – the prevalence of e-cig use was 8% and cigarette use was 4% during the study.  By manipulating the definitions, Wills claims that 31-38% of students used e-cigs and 15-21% of students smoked.        

Those numbers are then used to suggest that students who were e-cigarette users were two to four times more likely to use cigarettes at the one-year follow-up than students who had never used an e-cigarette.  This is not a surprising finding.  As I have repeatedly noted (here and here), “If you have ever used one tobacco product, you are likely to have ever used another.”

Even if we accept the authors’ definitions and analysis, the majority of new smokers at follow-up were students who had never used e-cigarettes, as shown in this table.

Number of Ever Cigarette Smokers at Follow-Up Among Never Smokers at Baseline, According to E-Cigarette Use
E-Cigarette Use at Baseline (n)Percent Smoking at Follow-upNumber
Never (926)5%46
Ever 1-2 times (60)148
Ever 3-4 times (82)119
More often (73)1914
All (1,141)77

The bottom line: Although ever e-cig users were more likely to ever use a cigarette than never e-cig users, the numbers still show that most new ever users of cigarettes at follow-up (46 of 77) were teens who had never used an e-cig.

Another flaw in the Tobacco Control article is that the authors write that they completed a “Longitudinal school-based survey with a baseline sample of 2338 students (9th and 10th graders…) in Hawaii…in 2013…and followed up 1 year later…”  (The number was repeated in the journal’s press release [here].)  That is, in fact, a gross overstatement as there was only complete follow-up information for 1,302 students.  Since, of those, 161 had used cigarettes at baseline, my results in the table above are based on 1,141 students from Table 2 of the publication.  However, Wills’ results are based on only 1,070 students.

A co-author of the article, James Sargent, was cited in this blog last year for co-authoring a “fatally flawed” gateway article about youth e-cig use.  My examination of that study (here) revealed similar problems with defining ever or current use.  The first author of that study, Brian Primack, is quoted in a Reuters’ story about the current study, as is Adam Leventhal, first author on a third flawed gateway study analyzed in this blog (here).

I have described how the National Institutes of Health is spending hundreds of millions of dollars to fund anti-tobacco research (here).  These studies are prime examples.  Primack reported that his work was supported by $1.3 million in grants from the NIH’s National Cancer Institute; Leventhal listed NCI grants totaling nearly $13 million; the Wills study acknowledges a $660,000 NCI grant. 

Taxpayers continue unwittingly to finance an ill-conceived battle against tobacco harm reduction.    

Wednesday, January 27, 2016

It’s Too Early to Prove Absolute Safety, But Smokers Shouldn’t Wait to Vape

Tobacco opponents say that we’ve had too little experience with e-cigarettes to know whether they are safe.  While it is true that we don’t yet know the health consequences of long-term use, that should not discourage smokers from switching. 

We know that smoke contains high levels of thousands of agents, many of which are toxic or carcinogenic.  In contrast, e-cigarette vapor contains water, propylene glycol and/or vegetable glycerin, nicotine, flavors and perhaps a few contaminants at minuscule levels.  None of these – with the exception of buttery flavors (here) – are linked to any specific disease.  This difference alone justifies encouraging smokers to switch to e-cigarettes.

In the case of cigarettes, the effects of long-term use were not apparent for 20 years.

As I discuss in my book, For Smokers Only, smoking prevalence increased substantially around World War I (1914-1918).  The first clinical report of an increase in lung cancer and the suggestion of a link to smoking was published in 1939 by Alton Oschner and Michael Debakey in the journal Surgery, Gynecology & Obstetrics (68: 435-451, 1939).  “Until recently,” they wrote, “[cancer] of the lung has been considered a relatively infrequent condition.  However, recent studies demonstrate that [lung cancer] is one of the most frequent [cancers] of the body.”  But they acknowledged, “…it is controversial whether the increase in [lung cancer] is apparent or real.”  Oschner and DeBakey described 79 previous cases and presented seven cases that they had seen.

German pathologist Dietrich Eberhard Schairer and colleague Erich Schöniger published perhaps the first epidemiologic case-control study of smoking and lung cancer in their native language in 1943. Now considered a groundbreaking study, it was republished in English by the International Journal of Epidemiology in 2001 (reference here).  They confirmed “the [earlier] report of Müller [1940] that non-smokers rarely get lung cancer whereas heavy smokers get it more frequently than average.”

The smoking-lung cancer link did not appear in mainstream medical literature until 1950, when studies by Ernst Wynder and Evarts Graham (Journal of the American Medical Association, here), and by Richard Doll and Austin Hill in the (British Medical Journal, here) were published. 

While the strong link between smoking and lung cancer was not discovered for decades, today’s advanced surveillance techniques may detect a vapor-linked problem sooner.  It should be noted, however, that evaluating the effects of vaping will likely be complicated by the fact that most vapers already have smoking histories.

Smokers shouldn’t wait to vape. 

Thursday, January 21, 2016

Dr. Philip Cole Discovered the Decline in Cancer 20 Years Ago

Last week the American Cancer Society issued a press release that gained global coverage (here, here, here, here, here, here) by emphasizing a “23% drop in the cancer death rate since its peak in 1991.”  Sadly, the organization failed to credit a world renown cancer epidemiologist for discovering that trend two decades ago. 

The Cancer Society has, in fact, steadfastly refused to credit the original work, even though it was published in the organization’s journal Cancer in 1996.  This blackout also extends to the society’s technical reports (latest version here).

In the 1980s and 1990s, epidemiologists from the National Cancer Institute, the American Cancer Society and other organizations published hundreds of cancer studies, driven by a belief that cancer rates were surging.  The data showed otherwise: the cancer death rate by the late 1980s was, in fact, flat and poised to decline.  Only one epidemiologist appreciated this fact, and had predicted the decline – Dr. Philip Cole of the University of Alabama at Birmingham.

In a 1996 report (abstract here), Dr. Cole attributed the decline in cancer deaths primarily to reductions in smoking that had begun in 1965, and to improvements in diagnosis and treatment.  Dr. Cole predicted that “the decline…is likely to continue for at least 20 years and may accelerate.” (my emphasis)

Why does the Cancer Society embrace key elements of Dr. Cole’s landmark work, but defy the norm of formally citing the source?

The answer may be that the organization is averse to acknowledging that the decline in cancer is linked primarily to the decline in smoking.

Dr. Cole and I published a follow-up study in the Journal of Clinical Oncology in 2001, demonstrating that if lung cancer had never existed, the death rate in the U.S. from all other forms of cancer would have declined continuously, starting in 1950. (abstract here).   

Dr. Cole is a world-renown epidemiologist whose insightful analysis two decades ago has proven prescient.  The American Cancer Society should recognize his scientific contribution.

Wednesday, January 13, 2016

“Bootleggers, Baptists and E-Cigarettes”

E-cigarette users should be concerned about proposed FDA regulations that may eliminate most brands of these potentially life-saving cigarette alternatives, leaving only those products marketed by large tobacco companies with the resources to complete expensive FDA applications.  

Who is responsible for the pending e-cigarette regulatory nightmare?

A brilliant analysis of e-cigarette regulation titled “Bootleggers, Baptists and E-Cigarettes” has been published online (here) by economists and legal scholars from Clemson University (Bruce Yandle), the University of Texas at Arlington (Roger Meiners), Case Western Reserve University (Jonathan Adler) and George Mason University (Andrew Morriss, now at Texas A&M).  A shorter version with Adler as lead author appeared last year in Cato’s flagship publication, Regulation (here).  I’ll use quotes from both in this column.

According to Yandle and colleagues, “Durable regulation emerges most often when there are two distinctly different special interest groups that seek the same policy outcome. One group takes the moral high ground by pursuing a public-interested goal [Baptists] and gives the cooperative politician the ability to justify his actions on normative grounds. The other [Bootleggers], seeking the same policy outcome, is motivated by pecuniary interests, hopes to feather its nest, is often willing to share some of the gains with the politicians who deliver the goods, and does not generally conspire with its publicly interested counterpart that seeks the same regulatory goal.”

Yandle developed this concept in 1983, and he recently authored a comprehensive book on the subject (here).  He labeled the two groups “in homage to the political pairing of unlikely interests that was successful in championing laws that shuttered liquor stores on Sunday…the two interest groups would never form a visible coalition in the strict sense of the word. They merely sought the same outcome and were willing to struggle mightily to succeed.  At the height of its success, this powerful pairing entirely shut down the legal sale of alcoholic beverages in counties, states, and—during Prohibition (1920-1933)—the nation as a whole.” 

Yandle and colleagues identify the Baptists and the Bootleggers undermining the nascent e-cigarette market.  “Private and public health officials…are the Baptists in this story…  Based on what is known about the health effects of e-cig use, it would seem e-cigs might be hailed as an advance in public health insofar as they offer cigarette smokers a safer product.  Even small reductions in the number of smokers or the amount of tobacco products smokers consume would likely produce substantial gains for public health. Yet e-cigs have been greeted with scorn by health researchers who focus on what is not known about e-cig health effects rather than what is known.”

The Bootleggers are a more diverse group.  They consist of cigarette manufacturers, which “have
an incentive to either enter the e-cig market themselves, suppress competition from upstart e-cig manufacturers, or both.”  They are joined by “Pharmaceutical companies that make NRT products…They have benefitted from government encouragement that smokers use their products to aid in smoking cessation and government limitations on information on tobacco harm reduction through the use of e-cigs or smokeless tobacco products. [emphasis mine]  Insofar as e-cigs are an alternative for smokers to satisfy their nicotine cravings, they are a threat to the profitability of NRT products.  This is particularly so given recent research suggesting that NRT products do not help many smokers quit.”

Perhaps more surprising, state governments are also Bootleggers, as “Tobacco sellers have become, in effect, tax collectors.”  The booty includes excise taxes that have skyrocketed over the past ten years, and payments made from smokers to cigarette manufacturers to the states courtesy of the 1998 Master Settlement Agreement.  Yandle et al. note that “Some states securitized all or part of the MSA cash flow by selling tobacco revenue bonds so they could immediately spend the present value of the future revenue.  The sale of tobacco bonds created a new group of Bootleggers—the bondholders and the state agencies that issued the bonds—with intense interest in the future fortunes of the tobacco companies, their sales, and any competitor that might reduce those revenues.”

This is a powerful coalition arrayed against e-cigarettes.  “There is an obvious irony here.  To the extent that e-cigs provide a less hazardous alternative to consumers who seek to break their smoking habit, Bootlegger/Baptist induced regulations that limit e-cig competition and evolution bring with them a social cost measured in lost opportunities to improve human health.  Going further, regulatory actions that limit e-cig marketability introduce uncertainty for yet-to-be-discovered smoking alternatives that might also threaten the market share of traditional tobacco and smoking cessation products. For the sake of human health and freedom of choice, such innovation should be welcomed, not chilled.”

The Campaign for Tobacco Free Kids, the American Cancer Society, the Centers for Disease Control, the National Institutes of Health and the Food and Drug Administration (Baptists) are aligned in a powerful coalition with tobacco and pharmaceutical manufacturers and state governments (Bootleggers) against e-cigarettes.  There is more than just irony here.  The e-cigarette is a “disruptive innovation” that not only “threatens the established order”, but holds the potential to help millions of smokers quit.  If this unholy alliance triumphs, public health is doomed.