Background

At its first two meetings in March and April, 1997, the National Cancer Policy Board decided to make its first policy statement on tobacco control, for three reasons. First, tobacco use is the single most important cause of cancer in the nation, accounting for an estimated 30 percent of cancer deaths. Second, tobacco control policy is in flux, and there are opportunities to influence policy choices with enormous potential impact on public health. And finally, the Board can build on the Institute of Medicine's previous report, Growing Up Tobacco Free, which called for a national youth-centered tobacco control strategy.

Enormous changes have taken place since that report was issued in 1994. As it was being completed, the Attorney General of Mississippi was pursuing a lawsuit against private tobacco firms to recover state funds expended on health care for tobacco-related diseases. That suit has since been joined by another 39 states. Also as the IOM committee was completing its work, the Food and Drug Administration (FDA) began an investigation, which led to precedent-setting regulation of tobacco products. This effort began with a petition to FDA Commissioner David Kessler in February 1994 from the Coalition on Smoking OR Health, and culminated in President Clinton's assertion of jurisdiction over tobacco products under the Food, Drug and Cosmetic Act in August 1996. A chronology of events leading to the FDA action is available online.

In addition to the state attorneys general and FDA actions, several other events have moved tobacco control policies to center stage. Individual and class-action lawsuits against tobacco firms have forced documents to the surface and have introduced considerable uncertainty about potential industry liability, whistleblowers have stepped forward with public disclosure of previously secret documents, and the 1996 presidential campaign included a lively debate about tobacco control. In March 1997, the Liggett Group's settlement with the attorneys general of five states and, a few days later, with plaintiffs in one of the class action suits, inter alia acknowledged that nicotine is addictive, that marketing is directed at youth, and agreed to make public many previously secret industrial documents. On June 20, 1997, the state attorneys general of 40 states announced an agreement with other tobacco firms, which could entail as much as $368.5 billion over 25 years. It covers FDA regulation, marketing and promotion, and sets aside funds to settle lawsuits. And just last week, on July 3, 1997, the State of Mississippi reached its own settlement of $3.4 billion, which will be superseded by the federal agreement if it comes to fruition. The next major state trial is slated to begin the first week of August in Florida, where the state legislature passed a law authorizing a suit against tobacco firms and unlike Mississippi, the governor stands foursquare behind the suit.

On July 9,1997, the Advisory Committee on Tobacco Policy and Public Health, co-chaired by former Surgeon General C. Everett Koop and former Food and Drug Administration Commissioner David A. Kessler, released its report, briefing Vice President Albert Gore, Jr., Secretary of Health and Human Services Donna Shalala and Bruce Reed of the Domestic Policy Council. Reed and Shalala are chairing a group to analyze the proposed national settlement with tobacco firms for President Clinton, expected to complete its work in late July.

The purpose of the workshop
The Board decided to host a workshop on tobacco control to gather current information and to lay the foundation for a Board white paper on tobacco control. That workshop took place on July 15 (see appendix A: agenda). Initially, the workshop was intended as an update and extension of Growing Up Tobacco Free, focusing on those recommendations which have not been implemented and reviewing more recent events. In light of developments over the past several months, however, it seems more opportune to use the proposed settlement and reactions to it as the launch pad for discussion, while not losing track of the issues raised by the 1994 report (most of which are part of the proposed settlement). The prospect of a settlement has focused attention on critical policy choices and has led to disagreements within the public health community about political strategy at three levels: whether a settlement is wise at all, whether this is the time to reach one, and about the details of any deal. A June 29, 1997, exchange in the Outlook section of the Washington Post captures some of the tenor of this debate, and clearly shows both that these issues are salient now, and also that health advocates have not reached a consensus (see the views of Congressman Henry Waxman and of Matthew Myers from the National Campaign for Tobacco-Free Kids).

The context for the July 15 workshop has thus changed but the underlying purpose has not--to help the Board prepare a white paper on tobacco control to influence national policy decisions as they are being made. Some items on the agenda are impossible to predict in advance, in part because events are moving so fast. An important report will be released later this week, for example, from a committee co-chaired by former Surgeon General C. Everett Koop and former FDA Commissioner David Kessler. Despite these uncertainties, one can predict with some confidence that certain elements are sure to emerge as important topics of discussion at next week's workshop. The remainder of this document lays out a few issues, roughly in parallel to the recommendations of the 1994 report and the format for the workshop, that may become part of the final Board white paper.

Update and extension of the 1994 report

Excise tax increase
Growing Up Tobacco Freemade several major recommendations: three items for immediate action and four to sustain long-term progress in tobacco control. The first recommendation was for the federal government to increase its excise tax on tobacco products to suppress demand, with the recommended target of a $2 per pack tax. Congress has not implemented such a tax, although several bills have been suggested, including a 43 cent per pack tax to cover children's health insurance (Hatch-Kennedy, S. 526) and a 25 cent per pack tax to establish a medical research fund allocated to the National Institutes of Health (S. 1251 in the 104th Congress, but when introduced as S. 441 in the 105th Congress, the tobacco tax was dropped in favor of a 1 percent tax on health insurance premiums). Any settlements that entail significant payments by tobacco firms would also lead to increased prices, achieving some of the same effects on demand. The 1994 report cited preliminary data about increased price sensitivity among young people, with the likelihood that higher cost would disproportionately reduce youth initiation, but the data on this are not at all firm.

Removal of federal preemption
The second immediate action recommendation was to remove federal preemption of state efforts to regulate advertising and promotion. No action has been taken on this front, but it is likely to be a strong recommendation of the Koop-Kessler group.

Building capacity for community-based tobacco control
The final recommended immediate action was to increase the capacity of state and local communities to control tobacco use, with funding levels comparable to those states with dedicated funds (California, Massachusetts, Arizona, and Oregon) or with funding from NCI's ASSIST program. The report noted that the IMPACT program at CDC served the same ends but was underfunded. The Robert Wood Johnson Foundation and American Medical Association have boosted tobacco control efforts in many states through their Smoke Less States program.

Funding for community-based tobacco control remains unresolved. A recent report to the NCI director on prevention research lauds the ASSIST program as an effective demonstration, but recommends that NCI draw back from such large demonstration programs and concentrate on research questions. In Congress, the respective roles of NCI, CDC, states, and private health organizations have been debated. Federal funding for community and state-based tobacco control efforts has to date been resolved mainly through separate appropriations for CDC and NCI, which makes coordination difficult and perpetuates year-by-year uncertainty. Funding and governance for these programs, as well as their linkage to state-funded and nonprofit programs, are important but unresolved. Many of the functions performed by the large state programs are among the activities that could be funded out of the public health trust to be built up in years 1 through 8 of the proposed settlement ($20 billion in total). Of this amount, $75 million for each of the first two years and $100 million thereafter would be allocated for programs "modeled on the ASSIST program."

Regulation of tobacco products
The first long-term recommendation from the 1994 report was to establish a regulatory process for tobacco products. FDA's action to regulate tobacco products is by far the most significant change since 1994. The committee expected Congress to take the initiative when it wrote its report during 1993 and 1994, but action came instead from the executive branch. Commissioner Kessler and FDA staff proposed FDA regulation under the Food Drug and Cosmetic Act, based on extensive investigation and legal analysis. The FDA regulation was challenged in federal court. On April 25, 1997 Judge Osteen ruled that FDA did indeed have authority to regulate tobacco products, including rules constraining sales to youth, banning use of vending machines, and some other measures. He ruled that FDA did not have jurisdiction over certain advertising and promotional activities. Judge Osteen's ruling is now under appeal. Continued FDA regulation is a central feature of the settlement proposal, and the extent and timing of FDA authority are among the contentious elements.

The first action taken by FDA, already in effect, was to limit youth access to tobacco products at point of sale. This action matches several recommendations of the IOM report. FDA's authority for this action was left intact by Judge Osteen's decision.

Constraining advertisement and promotion
The 1994 committee's second long-term recommendation also bears directly on the FDA appeal and the proposed settlement. The advertising and promotion measures proposed by FDA were in close harmony with the IOM committee's recommendations, and some specifics of the proposed settlement go even further toward the committee's recommendation to reduce the enticements for children and youths to initiate tobacco use (e.g., removal of all cartoon characters and human figures from advertisements and banning of trade-name logos on promotional materials). The significance of advertising and promotion is well summarized online by the American Medical Association, and a 1996 review article is also available online. If FDA's initial position is sustained on appeal, or if the Federal Trade Commission (FTC) effectively steps in , then progress could be substantial regarding the committee's recommendation about advertising and promotion. (FTC has taken action on youth-targeted advertising of Camel cigarettes and has issued a report on smokeless tobacco, and on July 11, Action on Smoking and Health petitioned FTC to ban cartoon ads for tobacco products, just two days after tobacco firm R.J. Reynolds announced it would retire its "Old Joe" Camel ads). Many provisions of the proposed settlement address constraints on adversing and promotion along the lines recommended in the 1994 report.

Changing norms

The sixth major recommendation in the 1994 report encouraged a broad national effort to change social norms regarding youth tobacco use. Revelations arising from court actions and in reaction to the FDA action are among the most important factors that have drawn attention to the health risks of tobacco use. Among other things, publicity about documents coming to light in court proceedings appears to be reinforcing the social norm against tobacco use. Public revelation of data derived from the research undertaken by tobacco firms, part of the settlement proposal, would greatly augment the data now available about why people begin to smoke, why they stop, and how to change their behavior.

Understanding population differences and impacts of interventions
Better understanding of why youths start to use tobacco, how populations differ in their use rates and why, the health effects in different groups, and how to determine whether policy interventions are having an impact were among the research priorities identified in the 1994 report. Progress on these fronts has continued incrementally, although the reasons underlying considerable differences in initiation rates and brand preferences among different ages and ethnic groups are still only poorly understood, and differences between children, youths, and adults remain hazy. Response to the the research recommendations of the 1994 IOM report would require further federally funded research on tobacco use patterns, contributing causes, and health consequences. Specifically, the report urged that increased revenues gained from taxes (or presumably from a settlement) include a provision to use some funds for research on tobacco-related disease. Research on how best to promote, monitor, and evaluate public health interventions is a major priority, and progress on this front will be essential to any long-term strategy to guide tobacco policy.

In summary, action on the seven major recommendations of the 1994 IOM report varies from remarkable change (assertion of FDA authority), to incremental progress (norm changes and understanding population differences), to prospects for change but highly uncertain outcome (price increases, advertising and promotion, the fate of federal funding for state and local tobacco control, and removal of federal preemption). The next few years will surely mark a period of unusual opportunity, but also danger of missteps, to change fundamentally how the nation acts to mitigate the health effects of tobacco use. Prospects of a settlement with private tobacco firms have escalated the national debate about tobacco control. Even if no settlement is reached, the debate is useful because the objectives of disparate constituencies are becoming clearer and a national consensus may emerge. A less desirable outcome can, of course, also result--a fractious squabble among tobacco control advocates that squanders the opportunity for progress. The National Cancer Policy Board can contribute if it articulates arguments that help forge a consensus to take advantage of the current opportunities.

Performance monitoring in communities
No matter what the final agreements about federal policy prove to be, federal action alone is insufficient to achieve tobacco control. Regardless of which tobacco control measures are put in place, there must be both local and national capacities to measure progress and provide feedback for subsequent policy decisions. The massive national effort that went into Healthy People 2000 is a good place to start a discussion of public health goals. Healthy People 2000 devoted a chapter to tobacco use, specifying national goals on a timetable; we are now further from the goals for youth tobacco use than we were even a few years ago. A recent IOM report, Improving Health in the Community (1997), notes the gap between national goals and community action, and the need to identify specific organizations or groups accountable for progress towards goals. The general approach discussed in the report is embodied in the Community Health Improvement Process (CHIP) that applies the measurement tools of performance monitoring to promote the achievement of health improvement goals. The strategy entails specifying goals, breaking them down into local interventions monitored by quantitative indicators, then collecting performance data, and mapping the results to actions of specific accountable entities at the community level. The accountable groups will vary among communities, as will the relative priority of goals and the resources available to attain them.

The CHIP approach might be adapted for use at the national level. National health improvement goals might be translated into intervention strategies that federal agencies and a variety of national organizations might be expected to act on and for which performance indicators might be developed and monitored. Such activities at the national level might help shape related efforts at the state and local levels. The approach is described at greater length, and with its theoretical underpinning, in a separate background paper prepared for the Board by Michael Stoto and Jane Durch of IOM. The approach is perhaps best explained by way of illustration, showing some possible national and local performance measures: see tables.

Performance measures will be crucial to a balanced national tobacco control effort. There is real danger of focusing on one or a few measures to the exclusion of others. The proposed settlement, for example, stipulates extra payments from tobacco firms if youth smoking measures do not improve. The trigger is the level of reported daily smoking in youth surveys conducted by the University of Michigan. This measure, part of a larger Monitoring the Future study, could be swayed with little impact on the underlying rate of smoking if self-reporting habits change or if those surveyed subtly change how they interpret the questions. This is not an argument that the youth survey is an inappropriate trigger or a bad measure--all measures are limited in one way or another--but reducing tobacco use will require a broader public health strategy and must rely on more than a single self-reported measure. And it will require assessment at the community level as well as the single national measure. The measures in the table above are merely a first rough cut to illustrate the possibilities of performance monitoring. The specific measures and objectives can surely be refined, but any long-term strategy for tobacco control must confront the problem: we need broader and more robust ways to promote and monitor progress and to evaluate the relative success of different interventions in diverse communities.

International health impacts of tobacco use
Most discussion about tobacco control has recently focused on domestic issues, but most of the loss of life to tobacco in the future will occur in developing countries. Tobacco use is ranked just behind malnutrition as the cause of death worldwide, and is ranked fourth as a cause of disability-adjusted life years in table 6.2 (Vol. 1) of the monumental Global Burden of Disease prepared by Christopher Murray and Alan Lopez for the World Health Organization (see WHO fact sheet, and further information) and the World Bank. At the July 15 workshop, Prabhat Jha of World Bank will show data projecting an enormous burden of disease, based on data from Richard Peto and his colleagues.

Many of the policy choices will require international action, but U.S. national policies can have a significant impact in several ways. First, international action is much easier if U.S. actions set a useful precedent. Second, the U.S. government has actively promoted tobacco trade that can cause ill health abroad. And third, some U.S. actions taken to promote tobacco trade block public health actions abroad. When trade advantage and foreign health interests have come into conflict, the U.S. government has often in the past favored trade interests; that should be reversed, and public health concerns should take priority over trade interests. U.S. policies have promoted the opening of foreign markets to U.S. tobacco products while simultaneously attempting to constrain U.S. domestic tobacco use. This situation can only become more troublesome with time. Foreign nationals will surely come to appreciate their health risks more fully--the reason the U.S. is implementing tobacco control at home. The U.S. government's efforts to promote tobacco exports, and particularly the rise in tobacco use among women and children that attends the introduction of Western marketing methods, is then likely to be seen by citizens of the affected countries at best as hypocritical, and quite possibly far worse. Short term economic gain for a few U.S. and European firms may give way to a devastating toll of disease and disability in the affected countries, attributed to the actions of specific firms backed by U.S. government action. Awareness that U.S. exports were promoted with full knowledge of the health implications may well constitute a foreign policy time bomb.

The U.S. government could encourage international tobacco control efforts and remove U.S. trade policies that can interfere with foreign health authorities' efforts to implement tobacco control measures in their own countries. The report from the Koop-Kessler group will contain several specific recommendations that can be discussed at the workshop.

At the least, international organizations need the capacity to monitor tobacco use and its health effects worldwide. This will require more resources than such efforts now receive. International performance monitoring is quite in keeping with the community-based and national efforts noted above, and a call for such capacity from the Institute of Medicine and National Academy of Sciences might well carry considerable weight in international organizations. Any recommendations on international tobacco control would be most useful if released publicly at or before the tenth World Conference on Tobacco or Health in Beijing, August 24-28, 1997.