October 18, 2015

Stanton A. Glantz, PhD

NY Times' Nocera continues promoting e-cigs while ignoring the industry's behavior and real use patterns

Joe Nocera, the New York Times business columnist, ran another column extolling the virtues of e-cigarettes on October 17, 2015.  He posed the rhetorical question, “Can e-cigarettes save lives?” and, not surprisingly, answered it “Of course they can.”  Consistent with the industry’s position, he argued that public health would be better off if smokers switched from cigarettes to less dangerous e-cigarettes.
 
He would be right if that was all that was happening, but it isn’t.  While some smokers do switch to e-cigarettes, most continue to use both at the same time (so called dual users).  More important, there is consistent evidence that smokers who use e-cigarettes are less (not more) likely to quit smoking than smokers who do not use e-cigarettes.
 
He blames the public health community for not working with the e-cigarette companies for not working with the companies to “come up with a set of standards for marketing … and keeping e-cigarettes away from kids.”  The ignores the fact that the companies control the marketing now and, thanks to their aggressive use of flavors (including NJOY’s use of flavors in violation of a California court order) and mass media marketing in channels favored by youth, has been followed by doubling or tripling use every year, including among many who are at low risk of starting to smoke cigarettes. 
 
Nocera also repeats the 40-year-old assertion that “Though nicotine is addictive, it is the tobacco that kills.”  While this view was innovative back in 1976, we now know that, while not the worst thing in cigarettes, nicotine has many toxic effects beyond addiction, particularly on the developing brain. 
 
He also attached Campaign for Tobacco Free Kids President Matt Myers for suggesting that the FDA (I would say the Obama Administration) deserved criticism for not yet acting to regulate e-cigarettes.  Nocera ignores the fact that the FDA did try to regulate e-cigarettes as nicotine delivery devices in 2009, which would have required the companies to demonstrate the reduced harm benefits that Nocera trumpets.  NJOY blocked the FDA in court, which led to the current slow rulemaking process.  Back in 2009 NJOY could have just submitted the scientific evidence to support the claim – as yet unproven – that e-cigarettes are an effective harm reduction tool.

Comments

Comment: 

Most daily ecig users don't smoke according to data from ASH (ash.org.uk/files/documents/ASH_891.pdf).

Comment: 

Most e-cig smokers are dual users in both US and UK.

Comment: 

I smoked 3 packs per day plus 3-10 premium cigars.
In just three days time I QUIT SMOKING like many of the former smokers I know.
Personally except for my mother I don't know a single vapor
who is a dual daily user!
Please provide data that isn't linked to any of your known associates.
Thank you,
C. B.

Comment: 

I've met hundreds of vapers, and my conclusion is that Long term Dual use is a myth. What is reported in the studies are people who are either;
1. In the process of finding their right device/tank/flavor/nicotine strength, or
2. Smokers who don't really use their e-cigarette and are "pleasing" the interviewer.
More often, those is category two are smokers who don't really have any intention of quitting, and the only device they own is a "cigalike" or some cheaper variant produced by one of the tobacco companies.
Those who are in the process of becoming an exclusive vaper are often enthusiastic about quitting smoking, and are willing to invest in a vaporiser tank setup between $50 and $150 produced by small to medium enterprises, rather than some cheap device and cartridge with very small battery and liquid capacity that the tobacco companies sell. 
Either way, a smoker will either become an exclusive vaper, or remain smoking. What percentage of smokers will follow which path is something not even business owners know. But most businesses and investors are well aware now that the only growth in the market is in e-cig devices that provide enough battery charge, and enough liquid capacity to allow the user to use their product solely throughout the day. If you scan the online stores, you will see many products now are being shoved into clearance sales, and the only ones that are surviving are the "long charge-high volume" setups that mainly apeall to those who use e-cigarettes exclusively. There's just no money in trying to attract smokers who have no real iontention of quitting. I assume they would rather spend their money on a pack of cigarettes rather than another "symbolic" device to keep in their bedside cupboard to remind them that they should quit.
To conflate the two categories of devices and claim that dual use exists across the board only leads to a distorted view about where the market is heading, and as the vapor-tank market grows, there will be a siginificant difference between what the market data shows and what these studies show.
The question that needs to be put forward is;
With all their billions of dollars, and with all their influence, why is there not a single tobacco company that is investing in the fastest sector of the e-cigarrette market?

Comment: 

... through the links in my original blog post.
 
While there is no question that <em;some</em; people successfully quit smoking with e-cigarettes, the data shows that for most smokers e-cig use <em;reduces</em; the odds that they will quit.
&nbsp;

Comment: 

Marketing e-cigarettes that keep people smoking makes sense for cigarette companies.

Comment: 

; There's just no money in trying to attract smokers who have no real intention of quitting.
Hello? Their money is just as good as anyone else's.
The incentive for the e-cigarette industry is to make the sale. Selling to dual users makes money just like any other sale. The industry doesn't lose any money if the user doesn't quit smoking.
And of course, the incentive for the tobacco industry is even stronger: it gets both sales. That's probably why 80% of all e-cigarettes sold at Nielsen tracked channels are product made by cigarette companies:
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; dollar sales&nbsp;&nbsp; unit sales
RJ Reynolds &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 34.6%&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 45.2%
Lorillard &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 19.2%&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 15.2%
Philip Morris&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 11.6%&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 13.5%
Japan Tobacco&nbsp;&nbsp;&nbsp;&nbsp; 16.2%&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 9.0%
---------------------------------------------
&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; totals: &nbsp; &nbsp;&nbsp; 81.6%&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 82.9%
&nbsp;
Jon Krueger
&nbsp;

Comment: 

<strong;To the Editor:</strong;
&nbsp;
In “http://www.nytimes.com/2015/10/17/opinion/can-e-cigarettes-save-lives.ht... E-Cigarettes Save Lives?” (column, Oct. 17), Joe Nocera expresses certainty about the health benefits of e-cigarettes and argues that it is time to “forget about the F.D.A.” in regulating these products.
&nbsp;
Whether e-cigarettes can reduce the number of Americans who die from tobacco use is far from certain. E-cigarettes may reduce the risk of disease for addicted cigarette smokers, but any benefit will come only if they are shown to be effective at helping smokers stop using cigarettes completely and if they are marketed so they do not re-glamorize smoking among young people. These goals can be achieved only through effective oversight by the Food and Drug Administration, not by circumventing it.
&nbsp;
The concern about youth use is serious. In 2013, over a http://www.cdc.gov/media/releases/2014/p0825-e-cigarettes.html";quarter of a million youths who had never smoked a cigarette had used e-cigarettes.
&nbsp;
For more than 75 years, the Food, Drug and Cosmetic Act has required manufacturers, including manufacturers of products that claim to help people quit smoking, to present their scientific evidence to the F.D.A. To our knowledge, not one e-cigarette manufacturer has done so.
&nbsp;
The 2009 law giving the F.D.A. authority over tobacco products also sets out common-sense standards to govern the relative safety claims of tobacco products, including e-cigarettes. No other manufacturer of products regulated by the F.D.A. is allowed to make safety claims without first conducting the science to demonstrate the accuracy of their statements; neither should e-cigarette makers.
&nbsp;
The skyrocketing youth use and irresponsible marketing of e-cigarettes show what happens in the absence of meaningful rules. To realize any potential benefits of e-cigarettes and minimize their risks, the Obama administration must promptly issue an effective final rule asserting F.D.A. authority over e-cigarettes.
&nbsp;
MATTHEW L. MYERS
President
Campaign for Tobacco-Free Kids
Washington
&nbsp;
The letter is in the October 24, 2015 issue of the <em;http://www.nytimes.com/2015/10/24/opinion/the-uncertainties-about-e-ciga... target="_blank";New York Times.</em;
&nbsp;
Matt had to shorten his letter to meet the <em;Times'</em; space limits.&nbsp; Here is the original unedited letter:
&nbsp;
In his October 16, 2015, column in The New York Times (“Can E-Cigarettes Save Lives?”), Joe Nocera asserts that the use of e-cigarettes will “dramatically reduce” the dangers of smoking. He also excoriates all who say that we don’t yet know whether the emergence of e-cigarettes will reduce the number of Americans who die from tobacco use or whether it will encourage a new generation of tobacco users. He is so certain about his conclusion that he says it is time to “forget about the FDA” in regulating these products.
&nbsp;
If there is a public health benefit to the emergence of e-cigarettes, it will only come if they are effective at helping smokers end the use of cigarettes and if they are marketed in a way that prevents the re-glamorization of smoking among young people. Addicted smokers who switch completely to e-cigarettes in all probability reduce their risk of disease, but those who continue to use cigarettes gain little health benefit.
&nbsp;
Nocera is wrong when he advises to “forget the FDA”: These goals can be achieved only through effective oversight by the Food and Drug Administration, not by circumventing it. The answer isn’t to ignore the protections in current law; it is to press the Obama Administration to quickly issue rules designed to regulate e-cigarettes in a way that will minimize deaths from tobacco.
&nbsp;
The concern about youth use is serious. From 2013 to 2014, past-month e-cigarette use among high school students tripled to 13.4 percent. We’re also seeing high prevalence of e-cigarette use among youth who have never used these products. In 2013, http://www.cdc.gov/media/releases/2014/p0825-e-cigarettes.html";over a quarter of a million youth who had never smoked a cigarette used e-cigarettes.
&nbsp;
For more than 75 years, the Food, Drug and Cosmetic Act has required drug manufacturers, including manufacturers of products that claim to help people quit smoking, to present their scientific evidence to objective, independent, expert scientific review by the FDA. It is the only way to protect consumers from irresponsible, dangerous claims. Not one e-cigarette manufacturer has produced that kind of evidence or applied to the FDA to make such claims.
&nbsp;
When it comes to claims that cigarette smokers will reduce their risk if they switch to an e-cigarette, the 2009 law giving FDA jurisdiction over tobacco products sets out a common-sense standard that weighs the product’s impact both on current tobacco users and on the population as a whole.
&nbsp;
No other manufacturer of products regulated by the FDA is allowed to make claims about the safety of their products without first conducting the science to demonstrate the accuracy of their statements; neither should e-cigarette makers.
&nbsp;
The Obama Administration has taken too long to finalize its proposed rule asserting authority over e-cigarettes, but e-cigarette manufacturers also bear significant responsibility for the delay. Even before the 2009 law was passed, they sought to exempt their products from FDA oversight. Then they fought the FDA’s initial efforts to regulate e-cigarettes in court. Subsequently, they have lobbied heavily to delay and/or weaken action by the FDA.
&nbsp;
Without thoughtful new government action, the incentives are upside down. Manufacturers have little incentive to spend the money to make products that will be most effective at helping cigarettes smokers quit or switch and, if they do so, aren’t able to tell consumers which products are most effective at doing so. The current situation rewards those whose marketing reaches the widest audience, including kids, whether or not they help adult cigarette smokers looking to reduce their risk of disease by switching completely to e-cigarettes.
&nbsp;
Finalizing the proposed rule asserting jurisdiction over e-cigarettes is a long-overdue first step. There is an equally critical next step. Claims that a product is effective at helping cigarette smokers quit are drug claims overseen by FDA’s Center for Drug Evaluation and Research (CDER), not by FDA’s Center for Tobacco Products.&nbsp; Without CDER’s review and approval, no such claims can be made.
&nbsp;
When the AIDS epidemic swept across the nation, the FDA and CDER worked with stakeholders to expedite the process of bringing to market products that could make a difference quickly without compromising public safety. FDA recognized that there was a huge cost to “business as usual.”
&nbsp;
Today, close to half a million Americans die every year from tobacco use. We don’t know whether some form of e-cigarette technology could make a fundamental difference. But we do know that the FDA and CDER could play a critical role that they are not now playing by providing incentives and a path forward to those who produce products, backed up by sound science, that help cigarette smokers reduce their risk of disease by switching completely to e-cigarettes and who market those products in a way that does not make them appealing to our nation’s youth.
&nbsp;
The emergence of e-cigarettes calls out for urgent and decisive action by the Obama Administration.&nbsp; Until the Administration acts, there will continue to be more questions than answers with potentially tragic consequences.

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