I attended the meeting and it was quite the day. I stayed overnight at a hotel with CASAA's resident scientist
Dr. Carl Phillips. I woke up at 5:30 A.M. to get revise my speech and get breakfast, and we headed over to the meeting at around 7:15 A.M.
The FDA campus was really, really pushing the fact that HHS properties are "tobacco-free." There were, however, no upper lip checkers during the meeting, so shockingly the enforcement seemed to be rather lax on the smokeless side.
I was on first at around 8:10 A.M. I had no idea where the time indicator was, so I ran through my 1,250 words pretty fast. I also didn't know how close to get to the microphone, as my voice when public speaking is quite bold and loud, so I didn't want to end up sounding muffled.
Unfortunately, there was not one person on the panel who seemed to recognize that there is a *problem* with the efficacy of NRTs. Yes, they recognize that the current standards need work, but none of the questioned the GSK and J&J reps on the low success rates or why NRTs should even continue to be a drug if they can't get even 20% of users to quit. I didn't expect anything of the two representatives from the Center for Tobacco Products, but I expected a bit more from the those from the Center for Drug Evaluation and Research.
David Abrams from the American Legacy Foundation briefly spoke on electronic cigarettes. Abrams and Legacy had long called for a ban on electronic cigarettes, and he has since argued that until large, specially qualified clinical trials show their efficacy, there is no evidence that e-cigarettes help smokers quit.* Today, Abrams sounded like he had long resigned himself to the fact that e-cigarettes are going to beat out NRTs once those clinical trials are revealed. However, he still highlighted the need for that evidence, and having seen him get incredibly preachy on Huffington Post Live when talking about e-cigs, I still came away thinking that he'd be thrilled to have e-cigarettes off the market entirely.
*Of course, the problem with this argument is that once it's shown that the Super Vapor 303 is better than NRT for smoking abstinence, those who are against e-cigarettes will continue to argue that all the other e-cigarettes on the market are unproven.
One really annoying moment during the hearing was a presentation from a law professor from the University of Maryland. She came off like a rabid prohibitionist, and even accused R.J. Reynolds of having ulterior motives for getting into the NRT business.
Wiz!
