In a commentary, Drs. Ted Wagener, Belinda Borrelli and I argue that in the previous literature, the potential harms of electronic cigarettes have been exaggerated or over-emphasized relative to the benefits and that these products could play a role in smoking cessation. We write: "Concerns have been raised that the advent of electronic cigarettes (e-cigarettes) may be harmful to public health, and smokers have been advised by important agencies such as the US Food and Drug Administration not to use them. This paper argues that, while more research is needed on the cost–benefit equation of these products and the appropriate level and type of regulation for them, the harms have tended thus far to be overstated relative to the potential benefits. In particular: concern over repeated inhalation of propylene glycol is not borne out by toxicity studies with this compound; risk of accidental poisoning is no different from many household devices and chemicals available in supermarkets; concern that e-cigarettes may promote continued smoking by allowing smokers to cope with no-smoking environments is countered by the observation that most smokers use these products to try to quit and their use appears to enhance quitting motivation; concerns over low nicotine delivery are countered by evidence that the products provide significant craving reduction despite this in some cases; and e-cigarettes may help reduce toxin exposure to non-smokers."
In the first response, Dr. Peter Hajek supports our perspective, suggesting that electronic cigarettes or a product similar to them could eventually be a viable competitive alternative to conventional cigarettes. Hajek writes: "The consideration of EC [electronic cigarettes] as a consumer product is even more exciting. If a harmless nicotine delivery device appeared which would be capable of competing with tobacco products in the market-place, the public health benefit would be enormous. I personally do not think that the current versions of EC are as yet up to the task of replacing CC [conventional cigarettes], but they can be seen as a trial run of a hugely promising new development. The first evidence is emerging that perhaps 20% of smokers who try EC become regular users . Our reaction to this first dawn of a credible non-tobacco consumer nicotine product is likely to influence future developments profoundly. If we ban EC or make them jump through hoops and choke them in red tape, the deadly CC will continue to rule unchallenged. ... EC are the first sign that such a product can be commercially viable. The public health community should support this development."
In the second response, Dr. Linda Bauld suggests that electronic cigarettes show promise but that more rigorous evaluation studies are needed. She writes that "the limited evidence we have about e-cigarettes suggests that users are treating them as a replacement for tobacco smoking and are using them to cut down and to quit, as outlined by Wagener and colleagues. This evidence should be treated with some caution, as it is drawn largely from surveys that may attract those who are positive rather than negative about the products. However, if it can be confirmed in larger population studies or trials then these products may have a role to play in reducing smoking prevalence."
In the third response, Dr. Jean Francois-Etter recommends that while further research is a priority, based on the existing evidence, clinicians might consider recommending electronic cigarettes to some patients: "Clinicians should inform users about the scarcity of relevant data on safety and efficacy, but they should also tell users that the risks are lower than for smoking. If users say that e-cigarettes help them to quit smoking, counsellors should focus on smoking cessation rather than on e-cigarette cessation. Advising smokers to stop using e-cigarettes might be deleterious in many situations, in particular in people who failed to quit with other treatments. Hopefully, the timely paper by Wagener et al. will stimulate research and debate."
In the fourth and final response, Drs. Nathan Cobb and David Abrams accuse us of arguing that electronic cigarettes should remain completely unregulated, setting the clock back on the history of public health protection and the FDA's role in ensuring a safe drug supply. They write: "In 1906, in an effort to end the sale of unsafe and ineffective patent medicines, the US Congress passed the Food and Drug Act, bringing regulation to what had been a chaotic and dangerous laissez-faire market-place. Thirty years later mass poisonings from a diethylene glycol antibiotic solution led to the subsequent creation of the Food and Drug Administration (FDA), and a move to proactive monitoring and oversight. Wagener, Siegel & Borrelli appear to be in favor of turning back the clock... ."
In a final reply from the authors, we thank Drs. Hajek, Bauld, and Francois-Etter for their thoughtful comments on our piece and their additional insights on the electronic cigarette issue. However, we then point out that in contrast, Drs. Cobb and Abrams completely misrepresent our position, falsely claiming that we oppose the regulation of e-cigarettes and would therefore turn the clock back more than a century. There is not a shred of truth to this claim. This is a straw man argument that we would ourselves beat down if anyone were senseless enough to propose that these products continue on the market without any regulation.
We write: "We believe that our thesis was misconstrued by Cobb & Abrams. The main goal of our article was a call for a more balanced perspective regarding the potential utility of e-cigarettes by researchers, tobacco control experts and the FDA. The current FDA website, for example, does not cite any of the potential promise of e-cigarettes and overstates some of the data on risk. We concluded our initial commentary by stating that the ‘initial evidence suggests that e-cigarettes offer more promise than peril’ and we called for future discussion to be ‘based on a balanced view of the available science rather than an ideology that opposes harm reduction’. At no point in the article did we call for ‘turning back the clock’ on the FDA and public health or an e-cigarette market ‘unfettered by national regulatory agencies’. We are strongly in favor of FDA regulation of e-cigarettes under the Family Smoking Prevention and Tobacco Control Act (FSPTCA) through the Center for Tobacco Products (CTP). ... What we were disputing was Cobb & Abrams presentation of the scientific information regarding the potential effectiveness of these products, concerns over repeated propylene glycol inhalation, and risks of potential child or adult overdose of nicotine liquid or ‘e-juice’—selecting pieces of information from studies that supported their hypotheses while ignoring information that did not."
The Rest of the Story
It appears to me that Cobb and Abrams have such a strong bias against electronic cigarettes that they are unable to debate the merits of a substantive argument supporting the potential role of these products in smoking cessation. Instead of dealing with the actual argument, they instead misrepresent our position, setting up a straw man argument to then beat down.
Is there a potential explanation for this strong apparent bias against a potentially effective new smoking cessation product that might compete with the mainstay of current treatment: quitlines and smoking cessation drugs? (Stay tuned until tomorrow.)