Finally, while it is true that the typical RCT is limited because it does not simulate the real-life situation where smokers can choose between different products, change products over time, and engage in social networks to support their vaping, the study we had proposed would have allowed for all of these things. We would have given smokers a wide range of products to choose from and allowed them to experiment with different products and make changes if they desired, and we would have referred them to a number of vaping web sites and support groups. In fact, we had decided to include a training and information session with an actual vaper as part of the study. This would still not have simulated the real-life situation exactly, but it would have significantly helped to make the study more meaningful by making it more similar to what happens in "real life."

Think of it this way: Individual X has smoked 2 packs per day for 30 years. She has tried, unsuccessfully, to quit smoking using the nicotine patch and nicotine gum. Finally, she has successfully quit smoking using electronic cigarettes.

Since Dr. Foulds' addiction scale correlates significantly with actual quitting behavior, one would expect that these results would eventually translate into higher rates of complete nicotine cessation in smokers who switch to electronic cigarettes.

Perhaps the most discouraging aspect of the story is that the FDA failed to acknowledge these conflicts of interest. I explained in a why the guidelines used by the FDA to determine eligibility for the TPSAC were inappropriate. Hopefully, this decision - having exposed the ridiculousness of those guidelines - will force the FDA to reformulate the guidelines so that they do actually screen out expert panelists with relevant conflicts of interest.

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