The requirement by the FDA that this black box warning be placed on Chantix is based on the agency's assessment of hundreds of cases of suicides that occurred in patients who had recently been treated with the drug, as well as thousands of cases of other serious adverse neuropsychiatric symptoms associated with the use of Chantix. In making a decision to require a black box warning, the agency takes into consideration the likelihood that the observed association between the drug and the adverse effects is a causal one.

"According tothe, e-cigarette use in England has been rising since2011, when the survey began. Meanwhile, the percentage of smokerswho reported quitting in the previous year rose from 4.6 percent in2011 to 6.2 percent in 2012. The cessation rate was 6.1 percentlast year and 8.7 percent in the first quarter of this year. Duringthe same period the success rate of smokers who tried to quit rosefrom 13.7 percent to 21.4 percent. Those numbers suggest the real promise of e-cigarettes—not as anefarious plot to hook teenagers on nicotine but as a harm-reducingalternative to smoking. If the FDA follows Durbin's advice, it willban most e-cigarette flavors, making the switch less appealing tosmokers who prefer the prohibited varieties, and restricte-cigarette advertising, making smokers less aware of a competingproduct that could literally save their lives."

1. The financial conflicts of interest involved in these commentaries were not with tobacco companies, but with pharmaceutical companies. Every instance where "tobacco company" appears should be replaced with "pharmaceutical company," and "Big Tobacco" should be replaced with "Big Pharma." The article errantly refers to R.J. Reynolds, Lorillard, Brown & Williamson, Star Scientific, U.S. Tobacco, Liggett, and Santa Fe Natural Tobacco Company. These companies should have been listed as Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, GlaxoSmithKline, Nabi Biopharmaceuticals, Pfizer, Sanofi-Synthelabo, sanofi-aventis, Lederle, Ciba-Geigy, McNeil Consumer Products, and Pharmacia. We apologize for any inconvenience these errors may have caused.

"This is a blatant attempt at rent-seeking by an obvious vested interest. We know that the pharmaceutical industry has been lobbying hard to hamper the growth of e-cigarettes so it comes as no surprise to find Glaxo using the tired old gateway argument. The truth is that e-cigarettes will only "seriously disadvantage" the NRT market if they work better as quitting aids. In my experience—and the experience of countless other people—e-cigarettes are much better substitutes for smoking. If they were really a "gateway" to smoking, e-cigarettes would be good for companies like Glaxo as they would create more smokers (NRT companies need there to be smokers just as much as cigarette companies do)."

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