Proof of Concept Study Shows Great Promise for Second Generation Electronic Cigarettes

Riccardo Polosa and colleagues have just published a six month pilot study, in which 50 smokers who were not interested in quitting were provided with a second generation electronic cigarette (personal vaporizer). The specific product was the EGO/CE4 model. Participants were also provided with chargers and e-liquids throughout the study period.

At six months, a sustained 50% or greater reduction in cigarette consumption was observed in 15 subjects (30%), with mean consumption dropping from 25 cigarettes per day to 6 cigarettes per day. Of these 15 subjects, 7 (14% of the total sample) experienced a sustained reduction of 80% or more in their cigarette consumption, with their mean consumption dropping to just 3 cigarettes per day.

Also at six months, smoking abstinence was reported by 18 subjects (36% of the sample).

Therefore, in total, 33 subjects, or 66%, were either able to quit smoking or cut down on the amount they smoke by at least 50%.

The Rest of the Story

This is a small pilot study and there is no control group or randomization of subjects, so it must be interpreted cautiously. Nevertheless, considering that these were smokers who expressed no interest in quitting, the finding that two-thirds either quit or cut down by more than 50% is encouraging.

This study also demonstrates some of the complexities of studying the effectiveness of electronic cigarettes. There are a wide range of products on the market with different abilities to effectively deliver nicotine and to produce a full vapor that delivers a sufficient throat hit to satisfy many smokers. It may be that the effectiveness of these products could improve over time, as inefficient products are replaced with ones that are better able to satisfy the needs of smokers.

This is why the FDA's proposed deeming regulations make no sense. They would prohibit the introduction of new products into the market, keeping the older and antiquated products going and stifling innovation. The process to get a new product approved is complex and involves showing that the product is beneficial to the public's health. I interpret this as meaning that a new product would have to conduct a clinical trial that shows the effectiveness of the particular product whose approval is being sought. This barrier is a huge one.

This would be unfortunate because the quality and effectiveness of electronic cigarettes appear to be increasing over time. Why would the FDA want to stifle innovation and essentially force the market to be stuck with the less effective products? This is not a recipe designed to maximize the number of smokers who successfully quit smoking. If anything, it is a recipe designed to protect traditional cigarette sales.

Hopefully, the FDA will reconsider this provision of the deeming regulations and will remove it from the final regulation. Innovation in this industry should be encouraged and promoted, not stifled.

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior.