Research Agenda

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Vocalek

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Electronic nicotine delivery systems: a research a... [Tob Control. 2011] - PubMed result

Tob Control. 2011 May;20(3):243-8. Epub 2011 Mar 17.
Electronic nicotine delivery systems: a research agenda.

Etter JF, Bullen C, Flouris AD, Laugesen M, Eissenberg T.
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Institute of social and preventive medicine, University of Geneva, CMU, case postale, CH-1211 Geneva 4, Switzerland. jean-francois.etter@unige.ch.

Abstract

Electronic nicotine delivery systems (ENDS, also called electronic cigarettes or e-cigarettes) are marketed to deliver nicotine and sometimes other substances by inhalation. Some tobacco smokers report that they used ENDS as a smoking cessation aid. Whether sold as tobacco products or drug delivery devices, these products need to be regulated, and thus far, across countries and states, there has been a wide range of regulatory responses ranging from no regulation to complete bans. The empirical basis for these regulatory decisions is uncertain, and more research on ENDS must be conducted in order to ensure that the decisions of regulators, health care providers and consumers are based on science. However, there is a dearth of scientific research on these products, including safety, abuse liability and efficacy for smoking cessation. The authors, who cover a broad range of scientific expertise, from basic science to public health, suggest research priorities for non-clinical, clinical and public health studies. They conclude that the first priority is to characterize the safety profile of these products, including in long-term users. If these products are demonstrated to be safe, their efficacy as smoking cessation aids should then be tested in appropriately designed trials. Until these studies are conducted, continued marketing constitutes an uncontrolled experiment and the primary outcome measure, poorly assessed, is user health. Potentially, this research effort, contributing to the safety and efficacy of new smoking cessation devices and to the withdrawal of dangerous products, could save many lives.
 
lectronic nicotine delivery systems (ENDS, also called electronic cigarettes or e-cigarettes) are marketed to deliver nicotine and sometimes other substances by inhalation. Some tobacco smokers report that they used ENDS as a smoking cessation aid. Whether sold as tobacco products or drug delivery devices, these products need to be regulated, and thus far, across countries and states, there has been a wide range of regulatory responses ranging from no regulation to complete bans.

This abstract begins by labeling e-cigarettes as a nicotine delivery device, but who exactly is marketing as "delivering nicotine"? Some e-cig manufacturers market their products as containing "ZERO, low, medium, or high" levels of nicotine, but I've never seen anybody bragging about how much nicotine they deliver. Even when making truthful health claims that haven't been proven by clinical trial they say things like "you can use them to help quit smoking" not "you'll get a great nic buzz!"

ETA: Also notice that it defines them as marketed "to deliver nicotine AND sometimes other substances". This is a logical fallacy e-cigarettes have been marketed that do NOT purport to deliver nicotine or anything other than a visible vapor and/or flavoring.

The empirical basis for these regulatory decisions is uncertain, and more research on ENDS must be conducted in order to ensure that the decisions of regulators, health care providers and consumers are based on science. However, there is a dearth of scientific research on these products, including safety, abuse liability and efficacy for smoking cessation. The authors, who cover a broad range of scientific expertise, from basic science to public health, suggest research priorities for non-clinical, clinical and public health studies. They conclude that the first priority is to characterize the safety profile of these products, including in long-term users. If these products are demonstrated to be safe, their efficacy as smoking cessation aids should then be tested in appropriately designed trials. Until these studies are conducted, continued marketing constitutes an uncontrolled experiment and the primary outcome measure, poorly assessed, is user health.

How safe do they need to be demonstrated? Is Chantix safe or does its continued marketing constitute an uncontrolled experiment?

Potentially, this research effort, contributing to the safety and efficacy of new smoking cessation devices and to the withdrawal of dangerous products, could save many lives.

Here's the rub. Here you see that the intention of this research effort is to withdraw "dangerous" products, but they don't define what constitutes a dangerous product. Is it valid to withdraw Electronic Nicotine Delivery Systems while more dangerous Nicotine Delivery Systems (ie. CIGARETTES) are allowed?

Thomas Eissenberg's own study shows that e-cigarettes that do NOT deliver nicotine still have value as smoking cessation devices. The fact that Chantix continues to be sold worldwide with a black label warning of deadly side effects shows that products that are provably dangerous still have value as smoking cessation devices. This research agenda is fatally and fundamentally FLAWED.
 
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Vocalek

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Why is more research on the safety of pvs a bad thing?

Until these studies are conducted, continued marketing constitutes an uncontrolled experiment and the primary outcome measure, poorly assessed, is user health.

And in local news the American Lung Association has said that they would like to see sales of e-cigarettes suspended until research proves them safe. How safe is safe enough? How much research? Are we talking keeping them experimental for 20 years to prove there are zero long-term negative effects before we allow smokers to buy them and switch away from smoking? Frankly, I'm pretty sure that my lungs would not have lasted another 20 years with smoke going into them. The wheezing was keeping me awake at night.

So the point is not that research is a bad thing. What's the bad thing is insisting on getting and keeping them off the market until the scientists have done all the research their little hearts desire.
 

Bill Godshall

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I was especially disappointed with this article, as a more accurate title (that actually represented the article's content) would have been:
Electronic nicotine delivery systems: a prohibition agenda.

It appears that Etter, Laugesen and Bullen (and obviously Eissenberg) are more interested in studying banned e-cigarettes than in allowing smokers to reduce their health risks by having legal access to e-cigarettes.
 

rolygate

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It might be better to wait before accusing them all of taking the pharma dollar. Who knows what scheme is being proposed here? It might be a punt for research funding phrased in a way to attract establishment money. That doesn't necessarily mean the results will suit the establishment.

You have to sympathize with their position: their oath is to do no harm, and their inclination is to help people. But their wages directly or indirectly flow down from the pharmaceutical industry, whose agenda is to make money at any cost. So - do what the man says and see thousands die, or go out on a limb, see your salary fall, see your future job prospects shrinking. Difficult.

One or two of them will do the right thing, at great personal cost.
 

Bill Godshall

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rolygate wrote

You have to sympathize with their position: their oath is to do no harm,

Except that their regulatory recommendations for e-cigarettes have already caused harm (in countries that have banned e-cigarettes) and may cause harm (in the US, UK and elsewhere depending upon what specific regulations are ultimately applied to e-cigarettes).

The so-called precautionary principle that has been widely adopted by many government agencies in Europe and old British colonies is realy a prohibitionist principle.
 
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It might be better to wait before accusing them all of taking the pharma dollar. Who knows what scheme is being proposed here? It might be a punt for research funding phrased in a way to attract establishment money. That doesn't necessarily mean the results will suit the establishment.

You have to sympathize with their position: their oath is to do no harm, and their inclination is to help people. But their wages directly or indirectly flow down from the pharmaceutical industry, whose agenda is to make money at any cost. So - do what the man says and see thousands die, or go out on a limb, see your salary fall, see your future job prospects shrinking. Difficult.

One or two of them will do the right thing, at great personal cost.

Unfortunately, it actually goes even deeper than just pharma dollars--you could almost call it a pharma "sensibility" that is at work. It illustrates the "dirty little secret" that many scientists don't want to admit: Science is constantly on the edge of a slippery slope into the depths of morally questionable areas like weapons technology and eugenics...:banana: that is how groups with an agenda can intentionally or accidentally come to conclusions based on fundamentally flawed premises like the one above.

I didn't object so strongly to the term "ENDS", for example, simply because its not quite the best description for e-cigarettes, but because the term demonstrates the fundamental misunderstanding of the issue from looking at the issue from a pharmaceutical point of view first, and Harm Reduction second. The problem with the agenda is that by looking at e-cigs as a "drug delivery system" first and examining its effectiveness as a smoking or nicotine cessation therapy is that is completely BACKWARDS: There is no inherent advantage of e-cigarettes as a drug delivery system over any other delivery systems UNLESS e-cigarettes prove to be more acceptable than other methods. In other words, if an product is good or bad at delivering nicotine or other substances doesn't necessarily mean it will be an acceptable reduced harm alternative...but if e-cigs are acceptable reduced harm alternatives for people who are otherwise unable or unwilling to quit, THEN we might look to see if e-cigarettes are a good way to deliver nicotine or other substances. :sneaky:

I encourage Dr. Eissenberg to craft a research agenda that examines e-cigarettes as a reduced harm CONSUMER product first and examine possible pharmaceutical applications second. Attempts to quantify effective nicotine delivery in a product are worthless without data showing that the delivery mechanism is acceptable to users who would otherwise be unwilling or unable to completely stop using tobacco or recreational nicotine.
 
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Vocalek

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We are on the same wave length, Thad. I wrote this response to the article and submitted it to Tobacco Control:

A goal of the World Health Organization’s Tobacco Control Framework is to totally eradicate tobacco use (1). The underlying belief is that anyone who exerts enough will power can overcome addition to nicotine. The situation may not be as simple as they would like to believe.

The Tobacco Advisory Group of the Royal College of Physicians found that the development of nicotine addiction includes changes in brain structure and function that impair the ability to achieve and sustain abstinence. They note that some of these changes may not be entirely reversible; consequently some smokers may never be able to quit all nicotine use (2).

Sweden has one of the lowest rates of smoking and lowest lung cancer rates in the world; however this is not due to the eradication of tobacco use. It is most likely due to the high percentage of smokers who switched to low-nitrosamine Swedish snus (3).

Thus it is troubling that Etter, et al, discuss concerns about electronic cigarettes (e-cigarettes) that are more appropriate for a medication. This focus ignores the primary purpose for the invention of the e-cigarette: To allow smokers to save their health and their lives by switching to a safer alternative source of nicotine (4).

One of the reasons that more smokers have not switched to the Nicotine Replacement Therapy (NRT) products is that the dosages are kept low because of concerns about “abuse potential” (5). These doses are inadequate replacement for many smokers.

In a national survey, Action on Smoking and Health (ASH) found that 9% of UK smokers had tried e-cigarettes and 3% were still using them. This amounts to 300,000 people who have achieved smoking abstinence thanks to these products. In a focus group, those who had not tried e-cigarettes pictured a device that looks and performs much like a real cigarette. Those who had tried e-cigarettes put greater importance on an “authentic smoking experience” and strength of nicotine (6).

So when the Research Agenda suggests “a standard dosing regimen” be developed for e-cigarettes, we consumers cringe. In all the years that we were smokers, we self-regulated our nicotine intake. We smoked more often or inhaled more deeply in times of high stress or when we had the need to remain alert. We smoked less often when we were relaxed and ready to go to sleep.

In addition, our overall intake varied widely across individuals. Most smokers averaged a pack a day; but many got along just fine on 5 or 10 cigarettes a day, and some required several packs per day. These varying needs are reflected in the range of nicotine strengths and quantity of liquid used per day by e-cigarette consumers (7). Regulating the products to the point where dosages are kept low for fear of abuse potential most likely would make the products just as ineffective an alternative as pharmaceutical NRTs.

It is unquestionably in the best interests of public health to help as many smokers as possible make the switch as soon as possible to safer alternatives. If “continued marketing constitutes an uncontrolled experiment,” so what? Continued smoking guarantees irreversible damage to the lungs, cardiovascular systems, and DNA of smokers who can’t quit during the years that the researchers are satisfying themselves that e-cigarettes are “safe.”

E-cigarettes don’t need to be safe in any absolute sense. They only need to be safer than continued smoking. If they were more harmful than smoking, we would know that by now.


(1) World Health Organization. Tobacco Cessation: A Manual for Nurses, Health Workers, and Other Health Professionals. ISBN 978-92-9022-384-9
http://www.searo.who.int/LinkFiles/Tobacco_Free_Initiative_manual-hsw.pdf (Accessed May 2011).

(2) Tobacco Advisory Group of the Royal College of Physicians. Harm reduction in nicotine addiction: Helping people who can’t quit. October 2007. Royal College of Physicians. http://www.tobaccoprogram.org/pdf/4fc74817-64c5-4105-951e-38239b09c5db.pdf (Accessed May 2011).

(3) Ferberg (2005). Is Swedish snus associated with smoking initiation or smoking cessation? Tobacco Control 2005;14:422пїЅ424. http://tobaccocontrol.bmj.com/content/14/6/422.abstract (Accessed May 2011).

(4) Demick B. A high tech approach to getting a nicotine fix. Los Angeles Times. April 25, 2009. A high-tech approach to getting a nicotine fix - Los Angeles Times (Accessed May 2011).

(5) McNeill A, Foulds J, Bates C. Regulateion of nicotine replacement therapies (NRT): a critique of current practice. Addiction (2001) 965, 1757-1768. http://www.tobaccoprogram.org/pdf/nrtcritique.pdf (Accessed May 2011).

(6) Dockrell M, Indu SD, Lashkari HG, McNeill A. “It sounds like the replacement I need to help me stop smoking”: Use and acceptability of “e-cigarettes” among UK smokers. 12th annual meeting of the Society for Research on Nicotine and Tobacco Europe. Bath, UK, 2010.

(7) Consumer Advocates for Smoke-free Alternatives Association. Survey Results. https://www.surveymonkey.com/sr.aspx?sm=HrpzL8PN5cP366RWhWvCTjggiZM_2b8yQJHfwE9UXRNhE_3d (Accessed May 2011).
 
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