Wednesday, August 9, 2017

E-Cigarettes: The Case for Regulatory Restraint



Debate over FDA regulation of e-cigarettes often degenerates into bitter argument and ad hominem attack.  In contrast, a point/counterpoint presentation in the Journal of Policy Analysis and Management is calm, thoughtful and enlightening.

The case for stringent FDA regulation (citations here and here) is presented by Kurt Ribisl, a professor at the University of North Carolina, along with graduate students Andrew Seidenberg and Elizabeth Orlan (hereafter RSO).  Cornell University Professor Donald Kenkel makes the case for light regulation (here and here).

Describing the problem – “Smoking is estimated to result in 480,000 deaths per year in the United States” – Kenkel underscores a death toll that has not changed in 20 years, despite increasingly harsh anti-smoking policies.  Tobacco prohibitionists frequently cite this horrid data, but they rarely support vastly safer alternative products like e-cigarettes, referred to by Kenkel as “perhaps the most revolutionary product innovation in the market…”

Kenkel puts the risk differences in striking contrast.  He notes that if Britain’s health authorities are correct that vaping is no more than 5% as hazardous as smoking, then a world in which all smokers vape would suffer only 24,000 deaths attributable to e-cigarettes, compared to 480,000 actual deaths due to smoking.  This projection is similar to that in my 1994 publication (here), where I estimated 6,000 deaths among an imagined 46 million smokeless tobacco users – a mere 2% of the 419,000 actual deaths from smoking.

RSO acknowledge that vaping is less risky than smoking, but they reject the 5% estimate, arguing that it “lacks empirical basis, as it came from a multicriteria decision analysis model developed from one meeting of 12 people. This type of expert opinion is at the bottom rung of the evidence hierarchy…”  That is true, but the North Carolinians offer no counter-estimate.  Kenkel suggests that even if the e-cigarette risk was as high as 10% as that of smoking – which is highly implausible, the result “would still be a revolutionary public health gain.”

RSO “supports regulating e-cigarettes less stringently than combustible tobacco products,” however that position is not fully reflected in their policy recommendations.  As Kenkel notes, they still call for “restrictions on flavors, advertising and marketing restrictions, taxes, bans on indoor vaping, and mandatory product warnings.” 

Using “the conceptual framework of economics,” Kenkel brings a refreshing perspective to e-cigarette use: “the key question is whether vaping and smoking are substitutes or complements… if they are complements, a policy that encourages vaping will increase smoking… If they are substitutes, a policy that encourages vaping will cause consumers to substitute vaping products for combustible cigarettes and thus reduce smoking.”

Kenkel finds that “Accumulating evidence suggests that vaping is a substitute for smoking,” and he concludes: “Policies to encourage vaping could facilitate such a revolutionary change in the U.S. market for tobacco products.”

Government and insurance incentives are worth considering, says Kenkel: “the benefits of reducing smoking could also justify a more activist policy approach. Taxing cigarettes and subsidizing a substitute good are alternative approaches to correct market and individual failures in the cigarette market. Many private and public health insurance plans provide generous coverage for one class of substitute goods—nicotine replacement products approved as smoking cessation aids. The same rationale might support subsidies for vaping products.”

Observing that vaping is “an existential threat to the market for combustible cigarettes, unless their spread is restricted by government regulation,” Kenkel seems to be in sync with new FDA Commissioner Scott Gottlieb, who has signaled a lighter approach toward e-cigarette regulation.



Monday, July 31, 2017

FDA’s New Vision for Tobacco Harm Reduction



U.S. Food and Drug Administration Commissioner Scott Gottlieb on July 28 fully endorsed tobacco harm reduction. In a speech (here), he clearly defined the problem: “[I]t’s cigarettes that are the primary cause of tobacco-related disease and death.” 

Dr. Gottlieb cited facts about nicotine, emphasizing its addictive qualities and the need to keep children away from all tobacco products. He also made one critical distinction:

“[T]he nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.  Yes, it got them all addicted and kept them addicted for the long term.  And it got most of them addicted when they were still teenagers.  But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine.”

This has been one of my principle themes for over two decades.

Dr. Gottlieb called for reduction of nicotine in cigarettes to non-addictive levels, an idea that I criticized in my 1995 book, For Smokers Only (updated version here) and more recently in my blog (here and here).  However, I was critical because advocates of nicotine fadeout were deluded in thinking it would work in the absence of viable tobacco substitutes.  Unlike them, Dr. Gottlieb embraces the harm reduction component: “…we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels.  And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them…”

The new commissioner underscored the value of less harmful products: “I also hope that we can all see the potential benefits to addicted cigarette smokers, in a properly regulated marketplace, of products capable of delivering nicotine without having to set tobacco on fire.  The prospective benefit may be even greater for the subset of current cigarette smokers who find themselves unable or unwilling to quit.”

Note two key phrases above: (1) “less harmful forms [of tobacco], efficiently delivering satisfying levels of nicotine, are available for adults who need or want them;” and (2) “…current cigarette smokers who find themselves unable or unwilling to quit.”

I used the latter words in 1994 to describe my vision for a new approach to smoking control:

“In a review of the avoidable causes of cancer, Doll and Peto observed that ‘No single measure is known that would have as great an impact on the number of deaths attributable to cancer as a reduction in the use of tobacco or a change to the use of tobacco in a less dangerous way.’  Unfortunately, the second part of this observation has not received attention.  Because smokeless tobacco causes far fewer and considerably less serious health effects than does smoking, it should be promulgated as an alternative to cigarettes for smokers unable or unwilling to overcome their nicotine addiction.” (article here, emphasis added)

Dr. Gottlieb’s use of “unable or unwilling” acknowledges the effectiveness of tobacco harm reduction, without judging smokers. 

This theme is repeated in Dr. Gottlieb’s closing: “A renewed focus on nicotine can help us to achieve a world where cigarettes no longer addict future generations of our kids; and where adults who still need or want nicotine can get it from alternative and less harmful sources.  FDA stands ready to do its share.”

Many of the commissioner’s talking points are virtually identical to the policies I have researched and advocated for two decades.  Dr. Gottlieb notes the rancor in this field, saying, “…there’s the ongoing divisive debate around the pros and cons of e-cigarettes.  Precious little progress has been made as competing camps dig in on the benefits and risks of a harm reductionist approach to this new technology.  Both sides are convinced that they’re right, but we’ve seen little progress, and virtually no common ground.”  He encouraged “…participants from all sectors in the ongoing harm reduction debate…to take a step back and work together to reach greater common ground.”

I applaud Dr. Gottlieb’s leadership on this issue and offer my support in turning his vision into reality.




Wednesday, July 26, 2017

Government’s Abstinence from Smokeless Truth Detailed by Wall Street Journal



The Wall Street Journal on July 21 reported what readers of this blog already know: “Many scientists agree that…smokeless tobacco, including chewing and dipping tobacco, is significantly less harmful than cigarettes.  But rather than encouraging the country’s 37 million smokers to switch to less-risky products, U.S. health officials have so far stuck with an abstinence-only message to the public.”

Journalist Jennifer Maloney underscored the government’s withholding of relative risk information about smokeless tobacco: “Online fact sheets published by the Centers for Disease Control, the Food and Drug Administration and the National Cancer Institute list multiple health risks associated with smokeless tobacco…but give no indication it is less harmful than cigarettes. ‘There is no safe form of tobacco,’ the cancer institute says on its website.”

Scientific research says otherwise.  Although it is impossible to prove absolute safety, dozens of epidemiologic studies over three decades have documented that health risks among American chewers and dippers are not significantly elevated.  Last year, a government study failed to find any mouth cancer risk among men who chew or dip (here). 

The CDC claims that it is unable to provide risk estimates for smokeless users (here, here and here).  Yet researchers from Altria produced them from CDC data; these are seen in the chart above (source here).  Smokeless users’ risks were comparable to those of nonusers of tobacco, whereas smokers had twice the risk of dying.

That Altria was able produce these dramatic results from CDC’s data underscores the government’s refusal to acknowledge the scientific truth about smokeless tobacco’s reduced harm profile. That is irresponsible and contrary to public health interests.

Federal health officials told Maloney, “more research needs to be done on the potential population-level consequences of broadcasting the fact that some tobacco products are safer than cigarettes.” 

Such facts should not be withheld from the American public.  Here is the consequence of public health officials’ persistent obfuscation and mendacity:

There were 8.1 million smokeless users in 2014, according to the National Survey on Drug Use and Health (NSDUH) (here), and 41% of them were also smokers.  This means that 3.36 million Americans are equally comfortable and satisfied using nearly harmless chew or dip, and smoking, which is deadly.  Government data shows that smokers have no idea that they are needlessly putting their lives at risk (here).  Federal agency leaders are aware of the differential risks, but choose not to push that potentially life-saving information to the public. 

The Wall Street Journal is to be applauded for helping to expose this transgression.