Standing on the Threshold of Change

Abstract

Tobacco use remains the nation's leading cause of preventable premature mortality. Lung cancer, one of the many cancers caused by tobacco use, is both the leading cause of cancer death in the United States and the leading cause of male cancer death globally. This special issue of Risk Analysis features the work of the National Cancer Institute's Cancer Intervention and Surveillance Modeling Network (CISNET), which finds that changes in Americans’ smoking behaviors that began in the mid 1950s averted nearly 800,000 U.S. lung cancer deaths in the period 1975–2000 alone. However, this figure represents only about 30% of the lung cancer deaths that could potentially have been averted during this period. Despite dramatic declines in smoking prevalence since the mid 1960s, tobacco use is still far too common; today about one in five American adults smokes cigarettes. The tobacco industry's role in promoting tobacco use is now well documented and, as noted by the President's Cancer Panel, “can no more be ignored in seeking solutions to the tobacco problem than mosquitoes can be ignored in seeking to eradicate malaria.” Recent developments, including the passage of legislation granting the Food and Drug Administration broad authority to regulate tobacco products, and the entry into force of the Framework Convention on Tobacco Control, an evidence-based treaty developed by the World Health Organization, hold great promise to more swiftly end the epidemic of lung cancer and other tobacco-caused diseases that exacts such a heavy toll in human suffering in the United States and around the world.

More than 45 years after the publication of the first Surgeon General's report on Smoking and Health in 1964, tobacco use remains the nation's leading cause of preventable premature mortality. Each year, more than 440,000 Americans die from causes attributed to tobacco use, including lung and other cancers, cardiovascular disease and stroke, pulmonary disease, and myriad other diseases.⁽¹⁾ The economic burden of smoking in the United States (direct health care expenditures and productivity losses) is estimated at $193 billion per year.⁽²⁾ Although overall tobacco use is slowly declining in the United States and most other high-income countries, it is increasing in many low- and middle-income countries (LMICs).⁽³⁾ Fueled in part by transnational tobacco companies’ aggressive marketing efforts, smoking prevalence appears to be increasing among women in many LMICs, where culture and tradition have long constrained women's cigarette use.^(4,5) The World Health Organization (WHO) estimates that in the 20th century, tobacco use caused the death of 100 million persons worldwide, but that during the 21st century it could kill as many as 1 billion persons.⁽⁶⁾

Lung cancer, only one of the many cancers caused by tobacco use, is the leading cause of cancer death in both men and women in the United States.⁽⁷⁾ It is also the leading cause of male cancer death globally.⁽⁸⁾ Lung cancer accounts for nearly one in three U.S. cancer deaths, and 18% of global cancer deaths.⁽⁹⁾ These facts highlight the importance of the work featured in this special issue of Risk Analysis on the efforts of the National Cancer Institute's Cancer Intervention and Surveillance Modeling Network (CISNET) to model the relationship between cigarette smoking and mortality from lung cancer in the United States between 1975 and 2000, a time when lung cancer death rates for men and women changed dramatically. As noted in the special issue's Introduction, “while the basic relationships between smoking and lung cancer are well understood, the relationships between population trends in smoking, mortality from other causes, and mortality from lung cancer are more complex.” (Feuer et al., Chapter 1 in this issue)⁽¹⁰⁾ Six different CISNET modeling groups used a common set of “inputs” to consider how changes in smoking prevalence help explain observed changes in lung cancer mortality. The CISNET project represents the most sophisticated modeling effort to date to consider the impact of changing smoking prevalence on changes in lung cancer mortality.

The United States has experienced dramatic reductions in smoking prevalence since the mid 1960s, a time when half of adult men and nearly one-third of adult women smoked cigarettes.⁽¹¹⁾ Nonetheless, tobacco use remains far too common; today, about one in five adults and one in five high school seniors smoke cigarettes, and progress in reducing both adult and youth smoking has recently stalled or slowed.^(12,13) Additionally, overall prevalence figures mask far higher use among some racial/ethnic groups, individuals of low socioeconomic status, persons with mental health conditions and substance abuse disorders, military personnel, and others.^(14,15) Smoking has often been cited as a significant contributor to health disparities. Indeed, Jha and colleagues recently estimated the contribution of smoking to social inequalities in mortality in England, Wales, Poland, Canada, and the United States and concluded that “most but not all, of the substantial social inequalities in adult male mortality during the 1990s were due to the effects of smoking,” and that “widespread cessation of smoking could eventually halve the absolute differences between these social strata in the risk of premature death.”⁽¹⁶⁾

The role of the tobacco industry in promoting tobacco use in the United States and around the world is now well documented. In 2006, U.S. District Judge Gladys Kessler found the major U.S. cigarette manufacturers to have violated racketeering laws, noting that the cigarette industry “survives, and profits, from selling a highly addictive product which causes diseases that lead to a staggering number of deaths per year, an immeasurable amount of human suffering and economic loss, and a profound burden on our national health care system,” and that the industry “marketed and sold their lethal product with zeal, with deception, with a single-minded focus on their financial success, and without regard for the human tragedy or social costs that success exacted.”⁽¹⁷⁾ In “Promoting Healthy Lifestyles, Policy, Program and Personal Recommendations for Reducing Cancer Risk,” the President's Cancer Panel stated “it is not an exaggeration to characterize the tobacco industry as a vector of disease and death that can no more be ignored in seeking solutions to the tobacco problem than mosquitoes can be ignored in seeking to eradicate malaria.”⁽¹⁸⁾ A report commissioned by the Director General of the WHO concluded that “tobacco companies have operated for many years with the deliberate purpose of subverting the efforts of the WHO to control tobacco use,” that these activities “slowed and undermined effective tobacco control programs around the world,” and that “the tobacco companies’ subversion of WHO's tobacco control activities has resulted in significant harm.”⁽¹⁹⁾ Finally, the Institute of Medicine (IOM) noted that “as scientific evidence about addiction and initiation has grown and the tobacco industry's strategies have been exposed … the ethical and political context of tobacco policy making has been transformed. A widespread popular consensus in favor of aggressive policy initiatives is now emerging, and this shift in popular sentiment has also been accompanied by support across most of the political spectrum.”⁽²⁰⁾

Other barriers, besides the tobacco industry, stand in the way of achieving the IOM's goal of “ending the tobacco problem,” which they describe as reducing “smoking so substantially that it is no longer a significant public health problem for our nation.”⁽²⁰⁾ As Schroeder and Warner point out, given the “important strides that have been made in tobacco control … it is tempting to believe that the battle is largely won.” Indeed, it is likely that many affluent, educated people, whose personal tobacco use rates are very low, believe that the tobacco problem has been solved. But, as Schroeder and Warner state, this mistaken assumption consigns millions of the most vulnerable Americans to preventable, premature death.⁽²¹⁾ Additionally, we must recognize that most Americans hold smokers, rather than tobacco companies, primarily responsible for the problem of tobacco use.⁽²²⁾ The narrow view that smoking is largely a self-inflicted harm helps explain why patients with lung cancer—the cancer most closely associated with smoking by the public—often feel “blamed” for their disease.^(23,24)

We stand on the threshold of enormous potential for progress. Enacted in 2009, the Family Smoking Prevention and Tobacco Control Act provides the U.S. Food and Drug Administration (FDA) with broad authority to regulate tobacco products, including the ability to set and enforce standards for tobacco product ingredients and design, establish good manufacturing practices, institute product labeling and health warnings, and regulate the promotion and marketing of tobacco products. FDA's activities to date include banning cigarettes with characterizing fruit, candy, or clove flavors; reissuing the final 1996 rule, “Regulation Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Children and Adolescents”; and prohibiting the advertising or labeling of tobacco products with descriptors such as “light,”“low,” and “mild” that have been shown to mislead the public.⁽²⁵⁾ These and other actions that FDA will take in the future will make an important contribution to U.S. tobacco prevention and control efforts.

The objective of the Framework Convention on Tobacco Control (FCTC), the first treaty ever negotiated under the auspices of the WHO, is “to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke by providing a framework for tobacco control measures. …”⁽²⁶⁾ Countries that are signatories to the treaty are required to put in place evidence-based measures to reduce the demand for and supply of tobacco products. These include price and tax measures to reduce the demand for tobacco, adoption of measures to protect people from secondhand smoke exposure, large warning messages on tobacco products, and many others. As of January 2011, 172 countries (but not the United States) are parties to the FCTC, which has already become a crucial force spurring the adoption of evidence-based tobacco control policies around the world.

In the past, the United States has often looked to the states and localities to demonstrate novel approaches to controlling tobacco use. Increasingly, however, tobacco control efforts will be informed by the international experience. The examples of Ireland—the first country to implement a comprehensive nation-wide ban on smoking in public places, including restaurants and bars (pubs)—and Canada—the first country to implement graphic warning labels—have now been widely emulated.^(27,28) WHO has called Thailand the best “success story” for dedicating revenues from tobacco taxes to health purposes; Thailand's 2001 Health Promotion Foundation Act earmarks 2% of total national tax revenue on tobacco (and alcohol) to the Thai Health Promotion Foundation, which provides support for organizations working on public health issues.⁽²⁹⁾ Since 2005, the government of India has sought to prohibit most depictions of tobacco products and their use in films or on television to address the well documented problem of youth's exposure to depictions of tobacco use in film.⁽³⁰⁾ And, the government of Australia has announced that, as of July 1, 2012, it will permit cigarettes to be sold only in “plain packages”—packages that are plain, standardized, carrying only graphic warnings against smoking, with minimal brand information permitted on the bottom and sides of the package; provided this proposal survives the expected legal challenges, it will be carefully studied to determine its effect.⁽³¹⁾

New and provocative ideas continue to emerge and challenge conventional thinking. Neal Benowitz and Jack Henningfield first proposed the idea of gradually reducing nicotine levels in cigarettes to nonaddictive levels, with the aim of preventing the development of nicotine addiction among youth in 1994.⁽³²⁾ A recent article, which reviews the expanding scientific literature on this topic and provides guidance for future research, indicates the serious interest in this proposal and its strong potential to reduce smoking-related death and disease.⁽³³⁾ And a number of authors have put forth what are referred to as “end-game” proposals to put tobacco use on an accelerated downward trajectory. Among the earliest proposals is that of Callard, Thompson, and Collishaw, suggesting a supply-side approach to phasing out tobacco.⁽³⁴⁾ Chapman and Liberman explore the idea of a “smoker licensing scheme—under which it would be illegal to sell to smokers who had not demonstrated an adequate level of awareness” of the hazards of smoking.⁽³⁵⁾ In a recent Tobacco Control editorial, Ruth Malone accurately describes “end-game” thinkers as “the visionaries of the tobacco control movement,” whose proposals “seek to propel the tobacco control movement more quickly toward a time when the global tobacco disease pandemic that began in the 20th century will be ended.”⁽³⁶⁾

Despite the strong successes of tobacco control, lung cancer will remain a major contributor to cancer mortality for some years to come because, currently, about one in five Americans smoke cigarettes and because former smokers remain at higher risk for lung cancer than never smokers for many years after they have quit. However, the recently released findings of the National Lung Screening Trial (NLST) are encouraging. The NLST, a randomized national trial of more than 53,000 current and former heavy smokers (at least 30 pack years) aged 55–74 to compare the effects of low-dose helical computed tomography (LDCT) with standard chest x-ray on lung cancer mortality found 20% fewer lung cancer deaths among participants screened with LDCT. The trial provides evidence that older populations at high risk for lung cancer may derive significant benefit from LDCT screening.⁽³⁷⁾ This is an important development, because while the five-year relative survival rate for all lung cancer stages combined is only 15%, the five-year relative survival rate for patients with stage I disease is 57%.⁽³⁸⁾ Additional research will be needed to assess the potential impact of screening on other groups, such as younger individuals and those will less smoking history, to improve the diagnostic accuracy of LDCT to minimize the high false-positive rate and enhance distinction between benign and malignant nodules, and to determine how best to use LDCT screening as a “teachable moment” to promote smoking cessation.

2014 marks the 50th anniversary of the publication of the landmark first Surgeon General's report on smoking and health, which famously stated that “cigarette smoking is a health hazard of sufficient importance in the United States to warrant appropriate remedial action.”⁽³⁹⁾ As the authors of this special journal supplement demonstrate, changes in Americans’ smoking behaviors that began in the mid 1950s averted nearly 800,000 lung cancer deaths in the period 1975–2000 alone. However, this figure represents only about 30% of the lung cancer deaths that could potentially have been averted during this period. We can do better. The fact of the matter is that the vast majority of lung cancer deaths could be prevented if tobacco smoking were to be effectively controlled. More visionary and more vigorous measures—the “appropriate remedial action” recommended in 1964—can more swiftly end the epidemic of lung cancer and other tobacco-caused diseases that exact such a heavy toll in human suffering in the United States and around the world.

ACKNOWLEDGMENTS

The views and opinions expressed in this article are those of the authors and do not necessarily represent the views of the National Institute on Drug Abuse, the National Institutes of Health, or any other governmental agency. M. Bloch provided depositions on behalf of the U.S. government in the U.S. Department of Justice lawsuit against the major U.S. cigarette manufacturers (U.S. v. Philip Morris U.S.A. Inc., et al.,) as part of her official duties. All other authors report no conflicts of interest.