proved for sale without prescription (i.e., "over the counter"), and nicotine nasal sprays, lozenges, and aerosols are in the pipeline. Ironically, the market for smoking cessation means that firms making cessation products may apply sophisticated marketing and promotion techniques to entice tobacco users to quit34 similar to those tobacco firms have used to lure people into taking up tobacco use in the first place.35 Competition among cessation product manufacturers and service providers also appears to be intensifying. This has the potential to increase public education, encourage a social norm friendly to cessation, and reduce the costs of cessation products and services. The annual Great American Smokeout sponsored by the American Cancer Society is the focus of enhanced media attention and in 1996 incorporated paid public service announcements in tandem with increased advertisements by nontobacco nicotine products. The event was associated with an increase in cessation attempts as measured by surveys and sales of nicotine products.36
As more products and services become available, the infrastructure supporting cessation programs will have to grow, and some of this infrastructure will depend on publicly funded health programs at the state and federal levels, in addition to activities in the private sector. With increased attention to cessation however, the quality of cessation programs must be maintained; allowing a proliferation of programs of limited efficacy just because program funding is available would be a waste of resources. C. Tracy Orleans observed that "far and away the greatest need is to do a much better job of disseminating and delivering the treatments we [already] have.37 Cessation programs must be monitored for their effectiveness as well as participation levels. This will be possible only with continued support of training, monitoring of program quality, and refinement of cost-effectiveness measures.
Federal research agencies must increase their commitment to research on tobacco control.
The federally funded ASSIST and IMPACT programs have augmented the innovation at the state level noted previously. As more states implement higher intensity tobacco control measures, the value of information to guide those efforts will increase. Any funding derived from new taxes or settlement payments will further increase the need for information to guide tobacco control efforts. Leadership on the research to help guide national tobacco control efforts should come from federal health research agencies. NCI served the nation well by pioneering demonstrations of COMMIT and ASSIST. The National Institute on Drug Abuse (NIDA) has supported important work on addiction, ranging from neuroscience to behavioral and social science. The health toll of tobacco use is as significant for heart and lung disease as it is for cancer. The National Heart, Lung, and Blood Institute has demonstrably improved the nation's health through its National High Blood Pressure Education Program,38 a major public education program, and its Framingham and MRFIT studies have contributed insights about the health effects of tobacco. It could contribute more of its considerable expertise and resources to the problem of tobacco control.39
Two working groups of NCI's Board of Scientific Advisors recently made recommendations to the National Cancer Advisory Board. A report on cancer control observed that:
Although effective interventions have been developed, their efforts tend to diminish over time as a result of competing messages and lack of booster programs. Few effective interventions are available for youth most at risk, such as those from low-income, less-educated families.... Particular attention needs to be given to developing effective interventions for children at early ages, when influence from adults is likely to be most effective. Attention must also be paid to children's social contexts influencing tobacco use, including parents, schools, and communities.40
That working group went on to observe the salutary effect of the ASSIST program. A different working group on prevention previously recommended that NCI "Increase the investment in developing effective interventions for prevention and cessation of tobacco use, particularly in populations where tobacco use has remained high, e.g., adolescents, women, and those with less education and income." The working group on prevention differed from the one on cancer control working group about ASSIST, recommending that NCI "Increase the proportion of the tobacco control investment in basic research and in the development of effective interventions, and decrease the investment in large-scale dissemination efforts, e.g., ASSIST."
The board believes that both reports clearly point to a need for an enhanced research effort, including a grants program for social, behavioral, and biological questions pertinent to tobacco control. They also point to a need for large-scale demonstrations and evaluations that will require significant funding and staff effort.41 The purpose of the ASSIST program was to demonstrate the potential for intervention, and it has done this, becoming the model for nationwide implementation recommended above. Yet a national ASSIST program cannot be an end, but only a beginning. Are workplace and public smoking bans the most effective control measures at the local level? Do youth access restrictions work, and do they reduce youth consumption, or just purchases by minors? Do public education and counteradvertising campaigns have an impact, and is there a "dose" effect? What counteradvertising approaches actually work? Should prevention messages be targeted at youths, or is that counterproductive? These and many other questions needed to help guide future tobacco control efforts cannot be addressed through small research grants alone. They require federal research agencies to commit significant resources to help design and fund high-intensity interventions, to fund rigorous evaluation of federal and state-funded programs, and to disseminate those findings. They will also entail interactions with nongovernmental groups with expertise in social marketing, social science, and community interventions. The resources freed from research budgets by the transfer of ASSIST should be augmented and devoted (a) to fund research grants, (b) to support trials of new preventive and treatment interventions, and (c) to plan and carry out intensive new demonstrations needed to guide national tobacco control efforts.
The U.S. Congress and Public Health Service agencies should intensify research on tobacco-related diseases.
The federal government, through NIH and other Public Health Service agencies, is uniquely capable of sustaining a robust research program on the health consequences of tobacco use as a component of the tobacco control research agenda suggested above. Several of the recommendations in earlier sections implicitly call for research, ranging from research in areas of molecular biology to social science, behavior, and prevention. In a July 31, 1997, statement to the Senate Judiciary Committee, the American Association for Cancer Research urged "Congress to ensure that the resources provided through the tobacco settlement will: (1) markedly increase the cancer research budget of the NCI; (2) underwrite the cost of participation in clinical research trials on tobacco-related cancers that will contribute to curative or preventive new therapies; and (3) supplement, not supplant, current resources provided to the NIH and NCI." The Society for Research on Nicotine and Tobacco similarly noted that "research must be substantially expanded to ensure progress in our ability to curtail the development of nicotine addiction and to effectively treat a broader range of nicotine-addicted people. This includes research ranging from the molecular basis of nicotine's action to genetic influences on the vulnerability to addiction and the chemical, behavioral, and social modulators of the addictive process."42 The board concurs and recommends a research effort led by Public Health Service agencies, including not only NCI, NIDA, the National Heart, Lung, and Blood Institute, and other NIH institutes but also AHCPR, CDC, and FDA.
Federal support for research is needed, even without a settlement. Some research must focus on tobacco-related disease, but the foundation of basic epidemiological, behavioral, social, and biological research is equally important in the long term. Research is thus needed in two areas: (1) tobacco-related diseases and (2) basic underlying factors.
Some research can be driven by a need to fill gaps in knowledge that obstruct specific policy actions. The rates of initiation of tobacco use among youths have risen in recent years, for example, but the reasons are not fully understood, neither are the factors that underlie substantial differences in tobacco use among population subgroups.43 Smoking plateaued among Caucasian youths from the early 1980s to the early 1990s, but it continued its previous decline among African-American youths, with intermediate declines among Latino youths. Some groups now show an alarming escalation in their level of cigar smoking, whereas use of spit and snuff tobacco has risen among other groups. An understanding of the underlying factors is important in crafting strategies for preventing the initiation and promoting the cessation of tobacco use among the relevant populations.
The section on cessation above indicates the importance of knowledge about what does and does not work. This includes knowledge of basic neuroscience, to discover how nicotine affects cells, as well as knowledge of behavioral and social sciences to understand cessation processes and to study different interventions rigorously. Health services research on the financing, cost-effectiveness, and efficacy of programs with various intensities and costs and on how services are provided in different settings will be as essential to developing better treatments as the discovery of new drugs or clinical trials of drugs and services. Behavioral and social science research is needed to understand factors that contribute to tobacco dependence; experimentation, initiation, and addiction in
youths; novel treatment approaches (behavioral and pharmacological) for diverse tobacco-dependent populations; prevention, treatment, and cessation in different age groups; and factors influencing tobacco use and biological differences in health consequences among different ethnic, racial, and geographical population groups.
Beyond the topics directly related to prevention, cessation, and tobacco-related disease, broad basic scientific research is equally important. Some fraction of new funding must support such basic research. The initial findings about health risks came from basic epidemiology, and the current knowledge of nerve cell receptors that guides drug discovery has built on decades of work in molecular and cellular biology. One promising new cessation treatment, the use of the antidepressant drug bupropion,44 traces its intellectual roots to behavioral knowledge about addiction and drug treatment for depression as much as or more than to studies of nicotine receptors or tobacco use.
California's Proposition 99 set aside 5 percent of its new excise tax revenues to support research. This has produced a research program on tobacco control that can serve as a national model. State research programs are laudable, but research is one area in which federal responsibility is clear. In other areas of biomedical research, federal leadership is unquestioned, and that should also be the case for tobacco-related disease. Public Health Service agencies, including NIH, already have in place effective mechanisms for allocating research funds. The board believes that a significant fraction of the funds generated by tax increases or settlement payments should be devoted to research at NIH, CDC, AHCPR, and FDA as an increment to (not a substitute for) current appropriations.
FDA and NIH should mount research programs to improve future regulation.
Research is needed to inform decisions about regulatory strategy. How to measure nicotine and tar, how to adjust measurements for actual smoking or spit tobacco behavior, whether there is a threshold of addiction, and how tobacco additives enhance nicotine absorption or amplify health hazards are all important questions that current data do not answer. Regulatory decisions about tobacco control, focused on the production, distribution, price, and availability of tobacco products to various categories of customers, especially youths, can build on an existing body of knowledge about regulatory regimes for both licit and illicit products (e.g., alcohol and controlled substances). Some regulatory choices, especially those specific to smoking behavior and nicotine addiction, will require data specific to tobacco. With the prospect of federal regulation, the importance of these data increases. It is by no means premature to start building the necessary scientific and normative foundation for nicotine regulation with the intention of establishing a regulatory framework as knowledge accrues. The board recommends that the federal government create a mechanism to assess current scientific foundations for alternative regulatory strategies and to identify and support areas of research needed to lay the foundation for future regulation. Establishing such a mechanism should be a major priority. It is an essential predicate for the congressional action so strongly desired by the public health community. Moreover, even if the U.S. Congress fails to act, such an assessment will assist FDA with developing and implementing further steps in tobacco regulation under the Food, Drug, and Cosmetics Act. If Congress or the executive branch, as recommended
above, establishes a government-wide process, then FDA's process can be a constituent part, and it can focus on the measures over which it has authority. FDA should establish a scientific panel to perform the functions recommended above, even if Congress and other parts of the executive branch fail to do so.
The federal government must support research to clarify the feasibility, risks, and benefits of "harm reduction" strategies.
Health risk is proportional to the degree and duration of exposure to tobacco products. One way to reduce health risk is thus to reduce exposure. A history of product modifications that were marketed as health improvements but did not actually reduce exposure—two examples are filter cigarettes that did not reduce tar or nicotine intake and "low-nicotine" cigarettes that merely led smokers to inhale deeper and longer to achieve the same nicotine dose—has raised doubts about harm reduction strategies, as opposed to complete cessation and primary prevention. The advent of new cessation products, however, has turned attention once again to treating tobacco dependence through long-term nicotine maintenance, to reducing tobacco use without eliminating it, and to designing tobacco products that cause less exposure to toxins. The 1994 IOM report noted great uncertainty surrounding harm reduction strategies, and three years later, that uncertainty is not much diminished. The value of long-term use of nicotine products to enhance cessation is, however, the subject of increased study.45 In addition, an international body recently concluded that "whereas total cessation remains the ultimate goal of tobacco control policy, reduction of exposure to tobacco toxins should be added to the existing treatment approaches."46 Many questions can be addressed through empirical research. Can safer tobacco products be developed for those who do not quit? What are their individual and public health impacts? Is it more effective to provide tobacco without nicotine (e.g., nicotine-free cigarettes proposed for marketing in the near future) or nicotine without tobacco (e.g., nicotine gum, patches, nasal sprays, lozenges, and inhalers), or are both useful for different users? How will such products affect nonsmoking teenagers? Would they increase the level of initiation of tobacco use in the short or long term by reducing perceived risk or reduce the level of initiation because such risk is part of the attraction to young people? These and many other questions are closely related to those about long-term regulatory strategies and would rest on some of the same research foundation. That foundation is extremely weak now.
The two principal sources of new public knowledge will be (1) documents made public about studies now available only to private tobacco firms and (2) new research published in the public domain. This implies a need to scrutinize documents that become public in cases such as the Minnesota Medicaid suit to see if information pertinent to harm reduction or other regulatory questions comes to light. More important, the federal government needs to initiate research programs to address the questions that arise in connection with a harm reduction approach.