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For more than a decade, the companies did not act on this knowledge out of fear of FDA regulation. But once the federal agency started regulating cigarettes in 2009, they went all out in their bid to develop and sell NRT. The Tobacco Papers reveal that companies conjectured that their new nicotine products could successfully compete with pharmaceutical NRT and they set the goal of gaining market control of all products containing nicotine. "It was surprising to discover the industry came to view NRT as just another product," Dorie Apollonio, associate professor in clinical pharmacy and lead author of the study, was quoted as saying in a UCSF news release. "The tobacco companies want people to get nicotine - and they're open-minded about how they get it." Smoking is responsible for more than 480,000 deaths every year in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC), and another 16 million Americans live with a smoking-related disease. The costs of such illnesses total more than 300 billion U.S. dollars each year, when including both costs of direct medical care and lost productivity due to secondhand smoke exposure. Clinical trials show that NRT can help people quit smoking, but only if used in conjunction with counseling and in tapering doses. Over-the-counter availability of NRT made it easy for smokers to get a nicotine fix in non-smoking environments like offices and inside airplanes, with the net result that they were less likely to quit. And given that NRT products are widely available, one of the questions is whether they encourage nicotine abuse.
In 2009, the FDA required a black box warning (BBW) on bupropion and varenicline, the two commonly prescribed smoking cessation agents due to reports of adverse neuropsychiatric events. We investigated if there was a decline in use of bupropion and varenicline after the BBW by comparing the percent using these medications before and after BBW. We conducted a retrospective observational study using data from the Medical Expenditure Panel Survey from 2007 to 2014. The study sample consisted of adult smokers, who were advised by their physicians to quit smoking. We divided the time period into “pre-warning”, “post-warning: immediate”, and “post-warning: late.” Unadjusted analysis using chi-square tests and adjusted analyses using logistic regressions were conducted to evaluate the change in bupropion and varenicline use before and after the BBW. Secondary analyses using piecewise regression were also conducted. On an average, 49.04% of smokers were advised by their physicians to quit smoking. We observed a statistically significant decline in varenicline use from 22.1% in year 2007 to 9.23% in 2014 (p value < 0.001). In the logistic (Adjusted Odds Ratio = 0.36, 95% CI = 0.22–0.58) and piecewise regressions (Odds Ratio = 0.64, 95% CI = 0.41–0.99) smokers who were advised to quit smoking by their physicians were less likely to use varenicline in the immediate post-BBW period as compared to pre-BBW period.
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