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Drug and Alcohol Dependence 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. While the use of varenicline continued to be significantly low in the late post-BBW period (AOR = 0.45, 95% CI = 0.31–0.64) as compared to the pre-BBW period, the trend in use as seen in piecewise regression remained stable (OR = 0.90, 95% CI = 0.75–1.06).

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What's more, American cigarette makers embraced NTR as a business opportunity. Combined with counseling, nicotine patches, gum, lozenges, inhalers or nasal sprays - together known as NRT - came into play in 1984 as prescription medicine. In 1996, at the urging of pharmaceutical companies, the U.S. Food and Drug Administration (FDA) allowed those products to be sold over-the-counter. The tobacco industry once viewed nicotine patches and gum as a threat to their cigarette sales. However, with formerly secret internal documents known as the "Tobacco Papers," dated between 1960 and 2010 from the seven major tobacco companies operating in the United States, researchers at the University of California, San Francisco, revealed that cigarette makers had started investing in alternative forms of nicotine delivery as early as the 1950s, but stopped short because people largely regarded nicotine as harmful, and such products might have attracted the attention of FDA regulators. Published this week in the American Journal of Public Health (AJPH), the study titled "Tobacco Industry Research on Nicotine Replacement Therapy: 'If Anyone Is Going to Take Away Our Business It Should Be Us'" found that in 1987, three years after FDA first approved nicotine gum as a quitting aid, the tide had turned on the public perception of nicotine; and that by 1992, the tobacco industry had determined that patches and gum by themselves do not help smokers quit. 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.

NEW YORK: Tobacco giants Altria and BAT are to spend millions of dollars over the next year on self-critical advertising on broadcast television networks and in leading newspapers as part of a legal settlement of a case brought almost 20 years ago. In 1999 the US Department of Justice initiated a lawsuit over misleading statements the industry had made about cigarettes and their health effects; a document filed in the US District Court for the District of Columbia Monday evening by attorneys for Altria, BAT and the Justice Department, outlined the agreement all parties have reached. This involves Altria and BAT buying television spots, mostly on ABC, CBS or NBC, and full print ads in 45 or more newspapers, starting as soon as next month, the Wall Street Journal reported . The TV spots will run in prime time five days a week for 52 weeks, while the print ads will run on five weekends spread over four months and ads will also appear on the newspapers’ websites. These will display court-mandated text , with copy including: “Altria, R.J. Reynolds Tobacco, Lorillard, and Philip Morris USA intentionally designed cigarettes to make them more addictive” and “More people die every year from smoking than from murder, AIDS, suicide, drugs, car crashes, and alcohol, combined” . Altria, which owns Philip Morris USA, estimated that it will spend $31m fulfilling its obligations; BAT declined to cite a figure. “I think they’re getting off kind of lightly,” said John Boiler, co-founder of the 72andSunny agency, which also does work for the anti-tobacco, non-profit Truth campaign. “The good news for the tobacco companies is they’ll avoid a lot of their younger audience,” he explained, since those consumers would be more likely to see a video ad on Facebook than a prime-time TV ad. 2016 research by the Centers for Disease Control and Prevention in Atlanta has suggested that younger consumers are more likely to be exposed to ads for e-cigarettes: 70% of US teens had seen ads for e-cigarettes – most often in-store (55%), but also online (40%), on TV or in movies (37%) and in print (30%).

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