Should Clinicians Recommend E-cigarettes to Their Patients Who Smoke? No.

Clare Meernik; Adam O. Goldstein

doi:10.1370/afm.1961

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Need for improved data on safety, effectiveness, and regulatory standards for e-cigarettes
Clare Meernik

Published on: 03 August 2016
Discouraging Vaping Will Do More Harm than Good
Michael B. Siegel

Published on: 25 July 2016
No credible case against advising smokers to switch to e-cigarettes
Clive D Bates

Published on: 12 July 2016

Published on: (3 August 2016)
Page navigation anchor for Need for improved data on safety, effectiveness, and regulatory standards for e-cigarettes
Need for improved data on safety, effectiveness, and regulatory standards for e-cigarettes
Clare Meernik, Researcher
Other Contributors:
Whether clinicians should routinely recommend electronic nicotine delivery systems (ENDS) to patients who smoke is complex, particularly as evidence changes and grows, and a point/counterpoint discussion, where different points of views can be presented, is valuable.
Importantly, critics of our essay do not refute any of the four key issues that our recommendation is based: inadequate data on safety, stronger...
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Whether clinicians should routinely recommend electronic nicotine delivery systems (ENDS) to patients who smoke is complex, particularly as evidence changes and grows, and a point/counterpoint discussion, where different points of views can be presented, is valuable.
Importantly, critics of our essay do not refute any of the four key issues that our recommendation is based: inadequate data on safety, stronger evidence-base for more effective existing treatments, inadequate regulation, and ethical frameworks to do no harm.
Though evidence is certainly mixed on the degree of ENDS harms, ENDS and their current technology are by no means harmless. For instance, see the new article from Berkeley National Laboratory (http://pubs.acs.org/doi/abs/10.1021/acs.est.6b01741) with 31 ENDS vapor compounds, including irritants and carcinogens that may form from thermal degradation byproducts.
Contrary to claims, we acknowledged a clinical trial that found similar quit rates among smokers who used ENDS and those who used nicotine patches. However, the quality of this evidence was low, due to imprecision from the small number of events. We also cited population-based longitudinal studies that showed ENDS users with lower odds of quitting smoking.
An important consideration is the lack of regulation ENDS have been subject to until now. ENDS package labeling is often inadequate and misleading (e.g., often inaccurate nicotine concentrations) and serious safety concerns result from explosions of ENDS devices. Clinicians and researchers alike can agree that common sense regulations will improve safety.
Our position does not "throw patients under the bus." Instead, our Nicotine Dependence Program has helped thousands of tobacco users to successfully quit nicotine addictions. We never advise tobacco users who do not want to quit, or have not successfully quit, to continue smoking. Rather, we listen and support, and when a tobacco user says they have cut down, quit or are trying to quit, and they feel ENDS have been helpful, we celebrate their progress towards becoming tobacco and nicotine-free.
Consistent with the Annals guidelines, our manuscript was not sponsored directly or indirectly by any pharmaceutical company, medical device manufacturer, public relations firm, or other commercial entity. UNC's Nicotine Dependence Program received a two year unrestricted educational grant from Pfizer in 2010 to help establish and disseminate inpatient tobacco use treatment programs--programs that do not advocate varenicline as pharmacotherapy for medical inpatients. Suggestions that our commentary for the Annals is designed to help 'big pharma' (rather than a respected record of caring for and helping patients quit nicotine addiction) are baseless.
Until more independent and longer term data on ENDS safety, effectiveness, and regulatory standards emerges, clinicians who believe that they should not routinely counsel patients to use ENDS have legitimate views, no matter how vehemently those positions are attacked.
Competing interests: None declared
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Competing Interests: None declared.
Published on: (25 July 2016)
Page navigation anchor for Discouraging Vaping Will Do More Harm than Good
Discouraging Vaping Will Do More Harm than Good
Michael B. Siegel, Professor
By advising physicians not to recommend e-cigarettes for smoking cessation, this article is actually advising them to recommend that smokers who don't want to quit using FDA-approved methods should continue smoking, rather than trying to quit by switching to vaping.
This is a dangerous and misguided recommendation that is completely non-evidence-based and which is destructive to the health of patients by discou...
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By advising physicians not to recommend e-cigarettes for smoking cessation, this article is actually advising them to recommend that smokers who don't want to quit using FDA-approved methods should continue smoking, rather than trying to quit by switching to vaping.
This is a dangerous and misguided recommendation that is completely non-evidence-based and which is destructive to the health of patients by discouraging them from quitting smoking unless the quit using a particular method favored by the physician.
If a patient is not interested in quitting using NRT or another drug, he or she should be advised to find some other method of quitting, including e-cigarettes. That patient should not be thrown under the bus, as is being recommended in this article. Better that the patient attempt to quit using e-cigarettes than not try to quit at all. Moreover, if the patient expresses particular interest in e-cigarettes and a disdain for or previous failure with FDA-approved therapies, he or she should be strongly advised to go for it. Millions of ex-smokers have successfully quit using vaping products and there is no justification for promoting continued smoking over a quit attempt with e-cigarettes.
Not only is the medical recommendation in the article misguided and damaging, but the evidence presented to support it is highly biased and incomplete. The paper cites research which identified potential risks of vaping but fails to cite any of the many articles which have documented the significant benefits associated with switching to e-cigarettes.
For example, the paper cites two articles which found sub-clinical increases in airways resistance among e-cigarette users, but failed to cite two other articles which documented significant improvement in lung function among asthmatic smokers. The recommendation against asthmatic smokers trying to quit using e-cigarettes ignores solid evidence that asthmatic smokers experience dramatic improvement in their respiratory symptoms and clinical lung function if they are able to switch to e- cigarettes.
The paper also fails to cite the most important study of all: the one and only clinical trial conducted on e-cigarettes, which happened to find that these products are just as effective as the nicotine patch for smoking cessation.
Unfortunately, the bias apparent in the paper has the appearance of being related to an unreported conflict of interest. Specifically, the lead author - Dr. Goldstein - failed to disclose that he has received funding from Big Pharma; in particular, funding from a company that makes Chantix, for which e-cigarettes are a major market competitor. It is imperative that a physician who publishes a medical recommendation like this disclose any relevant conflicts of interest, especially prior funding from a company that stands to benefit tremendously from the recommendation being made.
By his own acknowledgment, Dr. Goldstein has received research funding from Pfizer, the maker of Chantix. Pfizer certainly stands to gain financially from the recommendation that physicians discourage patients from using e-cigarettes to quit. So this conflict should have been disclosed. It appears that Dr. Goldstein received a $500,000 grant from Pfizer from 2010-2012. I think that a half million dollar grant from a corporation which stands to gain financially from the medical recommendation made in the article is something that readers deserve being made aware of.
Elsewhere, Dr. Goldstein acknowledges that he has served on advisory boards for Pfizer and for Boehringer Pharmaceuticals. In addition, the UNC Nicotine Dependence Program, of which Dr. Goldstein is listed as a member, has received funding from Pfizer.
There is no greater health risk for patients who smoke than continuing to smoke. Physicians should encourage smokers to quit by whatever method seems most likely to succeed for that individual patient. While e-cigarettes may not be a first-line approach, there is no reason to discourage quit attempts using this novel technology, especially for patients who have tried and failed with traditional approaches and who express a particular interest in trying vaping.
Competing interests: None declared
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Competing Interests: None declared.
Published on: (12 July 2016)
Page navigation anchor for No credible case against advising smokers to switch to e-cigarettes
No credible case against advising smokers to switch to e-cigarettes
Clive D Bates, Director
The authors base their advice four main pillars, each of which is unreliable.
First, that we lack evidence of safety. We lack evidence of the complete safety of anything, including medicines, and notably those used in smoking cessation. What matters is the relative risk. We do have good evidence that e-cigarette vapour is much less hazardous than cigarette smoke [1]. Most of the hazardous agents in cigarette smoke are e...
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The authors base their advice four main pillars, each of which is unreliable.
First, that we lack evidence of safety. We lack evidence of the complete safety of anything, including medicines, and notably those used in smoking cessation. What matters is the relative risk. We do have good evidence that e-cigarette vapour is much less hazardous than cigarette smoke [1]. Most of the hazardous agents in cigarette smoke are either not present at detectable levels in e-cigarette aerosol or at levels far below those found cigarette smoke. The authors mention diacetyl but fail the basic requirement of risk presentation, which is quantification - magnitude and materiality matter. The levels of diacetyl found in e-cigarettes (if it is used at all) are several hundred times lower than in cigarette smoke, and there are no known cases of 'popcorn lung' in smokers [2]. Overall, the Royal College of Physicians reviewed the safety of e-cigarettes and concluded [3]:
"Although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure". (Section 5.5 page 87)
Second, the authors argue that e-cigarettes may be ineffective as a smoking cessation aid. There are few RCTs evaluating these products because they are not medicines, but low-risk consumer alternatives to cigarettes. RCTs are not well suited to evaluating complex behaviour change in a rapidly evolving marketplace. However, there is considerable evidence of smokers using these products as alternatives to smoking and the studies cited by the authors are limited by confounding, selection bias and inappropriate aggregation of heterogeneous studies. May I suggest that interested clinicians cut through the thicket of claims and counterclaims, and read some of the accounts of smokers who's lives have been revolutionised by these products [4]? For the more cautious, e-cigarettes may be an option to suggest once the other options have been exhausted, but the approach certainly should not be discarded in its entirety.
Third, the authors argue that these products are not approved by the FDA and that there are fire and poisoning risks. Regulation by the FDA is no guarantee of safety - many medicines have severe side-effects and cigarettes are regulated by the FDA under the Tobacco Control Act. There have been a few cases of highly publicised e-cigarette battery fires - a small risk with all lithium-ion batteries. But this should be set against fire risks from smoking, which the National Fire Protection Service estimates causes the following damage [5]
"In 2011, U.S. fire departments responded to an estimated 90,000 smoking-material fires in the U.S., largely unchanged from 90,800 in 2010. These fires resulted in an estimated 540 civilian deaths, 1,640 civilian injuries and $621 million in direct property damage".
It is true that calls to poison centers rose 'exponentially' along with the growth of the product category from a low base. But the word 'exponential' does not mean 'large'. Calls to US Poison Centers amounted to 4,014 for e-cigarettes in 2014, but that compares with 291,062 for analgesics and 199,291 for cosmetics, and 2.2 million in total [6]. It is a small risk amongst many others common in the home.
Fouth and finally, the authors make a 'first-do-no harm" argument. But paradoxically they create potential serious harm with their chosen analogy:
"Jumping from the 10th floor of a burning building rather than the 15th floor offers no real benefit".
This is an implied relative risk claim, which can be interpreted in two ways. First, that cigarettes and e-cigarettes are equally lethal (the likely result of jumping from the 10th and 15th floor is near certain death) or that e-cigarettes offer about two-thirds of the risk of smoking, based on the relative energy of impact (proportional to the distance fallen). Neither is remotely supportable by any evidence, but it this kind of casually misleading risk communication that is likely to cause fewer smokers to switch and more e-cigarette users to relapse. The debate about the relative risk of e-cigarette risk and smoking is better represented by a comparison of stumbling on the building's entrance steps with jumping from the 4th floor, the estimated height causing death in 50% of falls [7].
The responsible clinician should be providing accurate, realistic information and advice conveyed in a way that promotes understanding rather than unwarranted fear or confusion and helps the patient make an informed choice. It is important to recognise that smokers are at great risk, and if these products offer and attractive and appealing way out of smoking that works for them the clinician should not be an barrier to them taking that path.
[1] Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf 2014;5:67-86. Link to NCBI
[2] Siegel M. New Study Finds that Average Diacetyl Exposure from Vaping is 750 Times Lower than from Smoking, The Rest of the Story, 10 December 2015. Link to Dr Siegel's blog
[3] Royal College of Physicians, London. Nicotine without smoke:tobacco harm reduction, 28 April 2016 Link to Royal College of Physicians
[4] Consumer Advocates for Smoke-free Alternatives Associations (CASAA) User testimonials, accessed 12 July 2016 Link to CASAA testimonials
[5] Hall J. The Smoking-Material Fire Problem, National Fire Protection Service, July 2013 Link to NFPA
[6] Mowry JB, Spyker DA, Brooks DE, et al. 2014 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 32nd Annual Report. Clin Toxicol 2015;53:962-1147. Link to AAPCC
[7] Marx J, Hockberger R, Walls R. Rosen's Emergency Medicine - Concepts and Clinical Practice, 8th EditionTable 36-1 page 290, August 2013. Link to Google Books
Competing interests: I am a longstanding advocate for 'harm reduction' approaches to public health. I was director of Action on Smoking and Health UK from 1997-2003. I have no competing interests with respect to any of the relevant industries.
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Competing Interests: None declared.