- Speech by
Scott Gottlieb, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( May 2017 - April 2019 )
Smoking is a major global public health problem that merits serious consideration of new policy solutions. Globally, prevalence persists at a high level, more than a half century after the 1964 U.S. Surgeon General’s landmark report that smoking causes cancer1 and nearly two decades after the World Bank’s highly influential 1999 report Curbing the Epidemic: Governments and the Economics of Tobacco Control.2 According to the World Health Organization (WHO) and the US National Cancer Institute (NCI), global prevalence in 2015 among people 15 and older was 20.7 percent, down from 24 percent in 2005.3 WHO and NCI have estimated that global prevalence is falling only modestly and will reach 18.9 percent by 2025, with current tobacco control policies.
Trends in public health harm from smoking are worse, reaching 6.3 million deaths in 2016, up by about 250,000 per year from 2006, according to the Global Burden of Disease project.4 Tobacco use is the most preventable risk factor for noncommunicable disease and the only risk factor common to the four main groups— cardiovascular disease, cancer, chronic lung disease and diabetes. Smoking also adversely affects smoking-related disease heavily stresses healthcare payment systems and labor productivity.
In virtually all regions, given that smoking--inhaling the results of tobacco combustion—poses higher risk than other methods of nicotine delivery, these trends in prevalence and the resulting preventable harm seem very unsatisfactory. Surely there are potentially very large public health gains that could result from adoption of effective new policy approaches.
At the FDA, we are launching a new approach, which includes our plan to issue an Advance Notice of Proposed Rulemaking asking critical questions about the effects of a potential reduction in the nicotine content of combustible cigarettes to minimally or nonaddictive levels. This is part of a reframing of how to look at tobacco and nicotine. Our goal is to do all we can to dramatically reduce the disease and death from combustible cigarettes, while recognizing and clarifying the role that potentially less harmful tobacco products could play in improving public health.
The key here is to acknowledge that the nicotine in tobacco products, though by no means a safe compound, does not directly cause the cancer, lung disease, and heart disease linked to tobacco use. In fact, a continuum of risk exists for nicotine delivery, with cigarettes being the deadliest form. Our plan includes using regulatory tools to spur innovation when it comes to new and novel technologies that deliver nicotine without burning tobacco leaves. It also involves working with FDA’s Center for Drug Evaluation and Research to enhance the role that medicinal nicotine products can play in helping more smokers quit.
The wide diversity of trends in prevalence of smoking among countries strongly suggests that public policies can influence prevalence. Some countries have enjoyed remarkable success in reducing prevalence. For example, in Iceland prevalence fell from nearly 30 percent to 15.7 from 2000 to 2015, and is projected to fall to 10.6 percent by 2025. Prevalence in Mexico fell from nearly 24.7 percent to 13.5 from 2000 to 2015, and is projected to fall to 9.1 percent by 2025. Other countries have seen smoking prevalence increase. Prevalence in Egypt rose from 17.6 percent to 24.7 percent from 2000 to 2015, and is projected to reach 31.3 percent by 2025. Prevalence in Indonesia rose from 29.7 percent to 39.5 percent from 2000 to 2015 and is projected to reach 44.9 percent by 2025, when the vast majority of smokers will be men. In the United States, the prevalence of current tobacco smoking among adults 18 years and over in 2015 was 18.5 percent.5 Between 2005 and 2015, the prevalence of current cigarette smoking, a subset of tobacco smoking, fell from 20.9 percent to 15.1 percent. We believe that this is still too high and wish to reduce it greatly.
The percent of all deaths attributable to tobacco smoking has also changed in very different ways in different countries.6 For example, in Egypt it grew from 8.3 percent to 9.7 percent from 2006 to 2016. In Indonesia, it grew from 10.8 percent to 12.6 percent during that same period. On the other hand, in Iceland, it fell from 17.1 percent to 15.8 percent, while in Mexico it fell from 6.3 percent to 5.9 percent over this interval. These data illustrate the linkage between trends in smoking and deaths from smoking and strongly suggest that many governments can and should do more to curtail smoking and smoking related disease and death. At FDA, we hope our new tobacco control policies will greatly reduce death and disease.
1 U.S. Office of the Surgeon General, 1964, Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service, Public Health Service, https://profiles.nlm.nih.gov/NN/B/B/M/Q/
2 World Bank, 1999, Curbing the Epidemic: Governments and the Economics of Tobacco Control, The International Bank for Reconstruction and Development, Washington D.C., ISBN 0-8213-4519-2. Available at http://documents.worldbank.org/curated/en/914041468176678949/pdf/multi-page.pdf
3 Table 2.1. US National Cancer Institute and World Health Organization. The Economics of Tobacco and Tobacco Control. National Cancer Institute Tobacco Control Monograph 21. NIH Publication No. 16-CA-8029A. Bethesda, MD: US Department of Health and Human Services, National Institutes of Health, National Cancer Institute; and Geneva, CH: World Health Organization; 2016
4 Extracted from online database: Institute for Health Metrics and Evaluation, University of Washington. (n.d.). Global Health Data Exchange. Retrieved January 3, 2018, from http://ghdx.healthdata.org/gbd-results-tool
5 Supplement eTable 12. Ng M, Freeman MK, Fleming TD, Robinson M, Dwyer-Lindgren L, Thomson B, Wollum A, Sanman E, Wulf S, Lopez AD, Murray CJL, Gakidou E. Smoking prevalence and cigarette consumption in 187 countries, 1980-2012. Journal of the American Medical Association. 2014; 311(2):183-192. Doi:10.1001/jama.2013.284692
6 Extracted from online database: Institute for Health Metrics and Evaluation, University of Washington. (n.d.). Global Health Data Exchange. Retrieved January 3, 2018, from http://ghdx.healthdata.org/gbd-results-tool