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.
Passage of BBW may have a substantial impact on the utilization of certain medications. 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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