Washington, D.C. 1998 |
National Cancer Policy BoardInstitute of Medicine and Commission on Life SciencesNational Research Council |
Contenuti e Argomenti Principali
Taking Action to Reduce Tobacco Use
The nation needs a strategy to reduce the death and disability caused by use of tobacco
products. That strategy may develop out of a renascent public debate about tobacco control
policies that has intensified over the past three years. When the Institute of Medicine
(IOM) released its 1994 report, Growing Up Tobacco Free,[1]
prospects for federal action were highly uncertain. That same year, the surgeon general's report was
also focused on youth tobacco use [2]. Prospects for tobacco control grew brighter when
the Food and Drug Administration (FDA) asserted jurisdiction over tobacco products, with
strong presidential support, state attorneys general brought suit against tobacco firms on
a new legal basis, and class-action lawsuits became more palpable threats to the financial
future of private tobacco firms. Media coverage of these events and revelations of
hitherto secret files and depositions from former tobacco firm employees has been intense.
These and other developments have resulted in a vigorous national debate about tobacco
control among the various groups with a stake in tobacco policy--tobacco firms, attorneys
general and health officials, public health groups, tobacco growers, tobacco control
advocates, and others. Attention now focuses on the U.S. Congress and the executive
branch, which are seriously considering federal legislation.
Although public debate has intensified, tobacco use among youths has escalated. Smoking
rates among youths have increased for four years in succession (1993-1996), as measured by
the largest national survey, the University of Michigan's "Monitoring the Future" project
[3]. Today's tobacco use will become tomorrow's health statistics. As a four-decade
longitudinal study of smoking in British physicians concludes, "about half of all
regular cigarette smokers will eventually be killed by their habit."[4] New users
will become addicted to nicotine, followed years later by a sharply increased incidence of
tobacco-related diseases. Cancer, cardiovascular disease, and lung disorders cause most
tobacco-related deaths, although tobacco use is associated with many other medical
conditions. Among the 419,000 Americans who died from smoking in 1990, for example, 151,000 died of cancer. The
increased numbers of deaths among women are particularly alarming. Since 1987, more women
have died each year of lung cancer than breast cancer. An American Cancer Society graph
illustrates the dramatic rise in the rate of lung cancer among women, which follows the
rise in women's smoking that began several decades earlier [5].
There are only three basic ways to reduce the death toll: to prevent the initiation of
tobacco use, to get current users to quit, and to reduce exposure to tobacco toxins. The
vast majority of those who use tobacco start doing so in childhood or youth, so prevention
efforts must focus there. Individuals of all ages can quit using tobacco, and the
cessation of tobacco use is associated with immediate economic and health benefits from
reduced cardiovascular disease [6] and long-term reductions in the likelihood of
developing cancer [7]. Reduced exposure to tobacco toxins has followed from bans in public
places.
Preventing the initiation of tobacco use among children and youths remains the
preeminent long-term goal, but cessation of tobacco use by individuals in all age groups
is also essential. The projection that 10 million people will die of tobacco-related
illness in the year 2030 is mainly based on the number of current users [8]. This enormous
health toll will thus drop only if current users quit and are not replaced by other users,
and if tobacco exposure is reduced. The worldwide health consequences also clearly
indicate that national tobacco control policies must look beyond national borders.
At its first two meetings in the spring of 1997, the National Cancer Policy Board
identified tobacco control as a priority, and tobacco control was the subject of its
initial policy statements. The board organized a workshop on July 15, 1997 in Washington,
D.C., and summarized its views in a July
18, 1997 letter to Secretary of Health and Human Services Donna Shalala, the
president's Domestic Policy Advisor Bruce Reed, and members of the U.S. Congress. This
white paper builds on those efforts, addressing (a) price increases, (b) federal
regulation, (c) state and local tobacco control programs, (d) performance monitoring, (e)
cessation programs, (f) research, and (g) international health impacts.
Even as the IOM Committee on Preventing Nicotine Addiction in Children and Youths was
completing its work in 1994, FDA was beginning an investigation that culminated in the
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 an assertion
of FDA's jurisdiction over tobacco products under the Food, Drug, and Cosmetics Act.
Following an extensive FDA investigation, in August 1995 President Bill Clinton announced
his intention to assert
FDA jurisdiction over tobacco products as nicotine-delivery devices. (A more complete chronology of
events leading to the FDA action is available on-line.)
Most states have also brought suit against tobacco firms to recoup state funds expended
on health care for those suffering from tobacco-related diseases. In May 1994, Michael
Moore, the attorney general of Mississippi, filed the first such lawsuit. In August 1994,
Minnesota Attorney General Hubert H. Humphrey III filed a similar suit. Since then 38 more
states and many city and county governments have joined Mississippi and Minnesota in filing suits against tobacco manufacturers.
In March 1997, the Liggett Group, Inc., reached a settlement with the attorneys general
of five states and, a few days later, with the plaintiffs in one of the class-action
suits. This agreement acknowledged that nicotine is addictive and that marketing has been
directed at youths. Liggett also agreed to make public previously secret industry
documents.
On June 20, 1997, the attorneys general of 40 states announced an agreement (hereafter
"the settlement") with five additional tobacco firms, which among them account
for more than 95 percent of tobacco sales in the United States. The settlement would
entail payments of up to $368.5 billion over 25 years. The settlement proposed FDA
regulation, marketing and promotion restrictions, some antitrust exemptions for tobacco
firms, and liability limits with escrow funds for class-action, individual, and state
suits. On July 3, 1997, Mississippi reached
its own settlement of more than $3 billion, but this will be superseded by the
congressionally ratified settlement if it comes to fruition. On August 25, 1997, Florida
reached an $11.3 billion settlement that
would likewise be superseded by federal legislation, except that a $150 million tobacco
control pilot program will continue with or without federal settlement. A three-phase Texas Medicaid suit was
scheduled to begin in October 1997, but this was delayed until January 1998 due to the
judge's illness. The suit brought by Minnesota
is scheduled to go to trial in January 1998.
In addition to the actions of the state attorneys general and FDA, dozens of individual
and class-action lawsuits have been filed against tobacco firms. Suits have also been
filed in several countries in Europe, Latin America, Asia, and Africa. On October 9, 1997,
a class-action suit brought by flight attendants was settled out of court, creating a $300
million fund. Those funds "shall be used solely to establish a Foundation [the Norma Broin Foundation,
named for the flight attendant who initiated the suit] whose purpose will be to sponsor
scientific research with respect to the early detection and cure of diseases associated
with cigarette smoking."
The various lawsuits have forced to the surface documents related to the tobacco industry.
In December 1997, the House Committee on Commerce issued subpoenas for over 800 documents
identified in connection with the Minnesota state suit, and made them publicly available.
In addition to the courtroom drama, industry whistleblowers have publicly disclosed previously secret documents and
practices, and the 1996 U.S. presidential campaign featured a lively debate about
tobacco control.
Despite a mounting debate, consensus about the details of national tobacco control
policy is not complete. Public health advocates differ sharply about whether a national
settlement is desirable at all, let alone about the terms of such a settlement. With
expressions of support for legislation from both the president and the leaders in the U.S.
Congress, however, the debate has shifted from theory into the political arena. The
findings and recommendations of this report are directly pertinent to the policy decisions
now under active consideration, including but by no means restricted to legislation
related to the settlement.
Several bills have been introduced in late 1997, and several other bills are being
actively drafted with the expectation they will be introduced early in 1998 [9]. Federal
tobacco control legislation will touch upon the jurisdictions of diverse committees in
both houses of Congress. Judiciary committees may address the liability and antitrust
provisions, health committees (the Senate Labor and Human Resources Committee and the
House Commerce Committee) may address the public health and research provisions,
agriculture committees may address the implications for tobacco growers, commerce
committees may address the marketing and advertising of tobacco products, education
committees may address the components dealing with public education, and tax policy
committees (the Senate Finance Committee and the House Ways and Means Committee) may
address the revenue implications. These committees held many hearings in the last four
months of 1997, and congressional attention is expected to continue in the final session
of the 105th Congress in 1998. In addition to legislation growing out of debate about a
settlement, Congress will be making decisions about appropriations for enforcement of the
FDA rule, federal research and tobacco control programs, and oversight and conduct of U.S.
contributions to international tobacco control. This report is intended to inform the
debate about federal tobacco control policies in Congress, in the executive branch, and
among other stakeholders. The remainder of this white paper addresses recommendations to
policymakers, organized according to methods for reducing tobacco use.
The price of tobacco products must be increased substantially.
Raising the prices of tobacco products is a proven way of reducing tobacco use in the
short and medium terms. Price hikes both encourage cessation and thwart initiation. Higher
prices have the added benefit of reducing use among people not yet addicted to nicotine,
including young people, whose level of tobacco consumption may be more sensitive to price
[10]. The impact and simplicity of price hikes were the main reasons that the 1994 IOM
report's first recommendation was a $2 per pack cigarette tax increase (and an equivalent
increase for other tobacco products). The recommended increment had three goals: to
achieve the desired reduction in demand, to attain rough parity with the most effective
tobacco control programs in other countries, [11] and to avoid creating a black market. A
significant price increase was also recommended recently in the report of a committee
chaired by former Surgeon General C. Everett Koop and former FDA Commissioner David A.
Kessler. The National Cancer Policy Board believes that a $2 price increment remains the
single most effective way of reducing overall tobacco consumption. Such a price increase
should also have the desired disproportionately greater impact on preventing the
initiation of tobacco use among young people.
There are many ways to raise prices. A federal excise tax is simple and direct and
would create a revenue stream that could be used for research and tobacco control
measures. An excise tax increment has the virtue of being collected through existing
structures appropriated with other federal funds. The main argument against a federal
excise tax increment is political pragmatism--any tax increase is suspect, and a tobacco
excise tax hike of this magnitude has never been passed by Congress. The federal tobacco
excise tax was increased by 15 cents (to be phased in) in the Balanced Budget Act of 1997,
but this is far less than recommended and encountered stiff opposition. There are also
concerns about any new taxes and about the regressive nature of taxes that fall on current
tobacco users.
The settlement proposes that the tobacco industry make payments into a fund and
stipulates certain broad principles for spending those funds, subject to allocation by a
board. The industry payments are an alternative mechanism to a tax and would similarly
raise prices. This process leaves many unanswered questions and relies on institutions
that must be created de novo. Negotiation of the allocation process could well prove to be
complicated, with many interested parties staking contending claims, because tobacco
firms, tobacco farmers, health researchers, tobacco control activists, state governments,
state and federal health programs, international tobacco control efforts, and others all
have a stake.
The proposed settlement has the virtue of ensuring that some funds are used to promote
public health, to advertise the health dangers of tobacco use, to carry out research, and
to support other tobacco control measures. This link between tobacco revenues and tobacco
control measures has been implemented in state efforts, such as those in Arizona,
California, Massachusetts, and Oregon. This linkage mitigates the unpopularity of tax
increases. The mixed uses of funds derived from tobacco revenues for health programs or
education as well as tobacco control, however, has proven to be troublesome, particularly
in the first years of the California program [12]. Use of tobacco excise tax funds has
also been contentious elsewhere, but a fraction of the funds from state excise taxes has
successfully been devoted to tobacco control efforts in Arizona and Massachusetts. Tobacco
tax collection has never been linked to tobacco control efforts at the federal level, and
partially for this reason, federal tobacco control initiatives have been anemic. The State
of California, for example, spends more on tobacco control than the entire federal
government [13]. Ensuring that some tobacco revenues go to tobacco control could be
achieved by legislative set-asides in combination with tax increases, without the need to
create a new mechanism for obtaining payments from industry or for the allocation of a new
pool of funds. Regardless of whether existing processes are used to allocate funds or new
ones are created, the process should be insulated to the degree possible from raw
politics. Funds allocated for research, for example, would most fruitfully be directed
through peer-reviewed channels at the National Institutes of Health (NIH). In program
areas in which such peer-review mechanisms do not exist, they should be created.
Failure to achieve targeted reductions in youth consumptionshould
result in further manufacturer-specific penalties.
Goals for reducing tobacco use among youths and adults are specified in Healthy
People 2000, [14] and the settlement proposes that the rate of smoking among youths be
reduced by 60 percent over a decade. The proposed settlement incorporates some penalty
payments if the rate of smoking among youths is not reduced, but the penalties are capped
and there are provisions for rebates to be given to firms on the basis of good faith
efforts. Price increases and other measures incorporated into the settlement would surely
result in improvements to public health compared to the status quo, but they may fall
short of achieving the specified goals.
The payments in the proposed settlement will likely not raise tobacco prices
sufficiently to achieve demand reduction goals through price increase alone. Analysts have
reached widely differing conclusions about the impact of the proposed settlement on
tobacco consumption among youths. Despite wide agreement that higher prices reduce the
level of tobacco consumption, [15] the magnitude of the effect depends not only on price
but also on what other measures are taken and how effective they are. A drop in youth
consumption is likely, but its magnitude cannot be predicted with precision. A 10 percent
price increase could reduce consumption by as little as 4 percent, according to some
estimates, or by as much as 12 or 13 percent, according to others [16]. Tobacco use may
also be influenced, moreover, by restrictions on access to tobacco by youths, advertising
and promotion, and other measures.
The Federal Trade Commission recently released a report on the economic implications of the
proposed settlement. It projects an ultimate price increase in the range of 62 cents
per pack and estimates that the actual present value of the proposed settlement is in the
neighborhood of $100 billion to $120 billion (as opposed to the face value of $368.5
billion, with the lower amount resulting from inflation, demand reduction, and other
factors). Jeffrey Harris of the Massachusetts Institute of Technology, in a report for the
American Cancer Society, estimates the net current value of the settlement to be $195
billion [17]. An analysis
by researchers at the University of California at San Francisco finds that the funding
would be insufficient to recoup Medicaid costs for the treatment of tobacco-related
illnesses, let alone to cover the desired tobacco control expenses. An industry analysis
differs with these assessments. It projects an eventual price increase of 83 cents per
pack under the settlement, with a greater reduction in the level of tobacco consumption
and sharply lower profits [18]. A response
from the Federal Trade Commission notes the out-year price projections in the industry
analysis are not adjusted for inflation. FTC also challenges the assertions about effects
on profits [19].
The board cannot resolve the uncertainty over how much tobacco prices will increase,
the effect of price increases on consumption, or the additive effect of price on other
tobacco control measures. The board believes, however, that the desired health goals
should dictate tax rates (or settlement payments) rather than the reverse. Fixing the tax
rate or payment amount in advance, with no provisions for adjustments later in light of
data about levels of consumption and the initiation of tobacco use among youths, invites
failure to achieve the public health goals. If tobacco consumption and initiation do not
recede, taxes on tobacco products should be increased to further reduce demand. Any tax
increases or penalty payments should be indexed to inflation, so the effects on
consumption and the revenues to support tobacco control and other goals are not eroded
over time. A system of public health monitoring, as suggested below, is needed to guide
pricing interventions, such as taxes or penalties under any settlement legislation.
The American Cancer Society urges
elimination of the penalty caps and rebates in the settlement. The American Society of Clinical
Oncology suggests a "fail-safe mechanism," with excise tax increases
triggered by failure to attain youth tobacco-use targets. The American Medical
Association lists several provisions to redesign the penalties if youth consumption
goals are not met, including a provision that "payments should be assessed against
each individual company based on reductions in underage use achieved by that company. They
should not be assessed on the basis of collective industry responsibility." [20]
Incentives to reduce youth tobacco use will be most powerful if penalties for failure
to achieve goals fall hardest on those firms making brands attractive to underage users.
If youth tobacco initiation goals are not met, financial penalties should be targeted to
manufacturers, based on brands used disproportionately by youths [21]. The board
recommends that payments triggered by failure to reach public health goals should be
structured into any federal legislation. A flat excise tax, based on the weight of the
tobacco content, does not provide this incentive because each firm retains the incentive
to lure young smokers, thus building a future market, yet penalties are distributed evenly
across all tobacco products.
Even states with active tobacco control campaigns have seen increases in tobacco use
among young people in recent years, although at rates lower than the national average
[22]. These states, however, have not seen tax increases of the magnitude now
contemplated. Effects of Alaska's tax increase to $1 per pack that went into effect in
October, Hawaii's two-step increase scheduled to reach $1 per pack in June, and New
Jersey's recently doubled tobacco tax (to $0.80 per pack) should generate data soon, but
those increases are still only half the increment recommended by the board. If an initial
tax increase (or settlement payment) of $2 per pack (and the equivalent for other tobacco
products) fails to reduce use among youths to target levels, payments from firms making
brands popular among should be increased to induce further price increases.
FDA must continue to regulate tobacco products,and the U.S. Congress
must strengthen and clarify FDA's role.
In 1994, IOM recommended that the U.S. Congress enact a comprehensive regulatory
statute delegating to an appropriate agency "the necessary authority to regulate
tobacco products, for the dual purpose of discouraging consumption and reducing the
morbidity and mortality associated with use of tobacco products." The report
recommended that the agency be authorized to regulate the design and constituents of
tobacco products, and specifically discussed the possibility of setting and gradually
reducing ceilings on the nicotine content of tobacco products. FDA was noted as one agency
that could exercise the recommended authority. The board believes subsequent events have
demonstrated that FDA is the logical lead for tobacco regulation.
A year after the release of the IOM report, FDA formally proposed to
regulate tobacco products using its existing authority under the Food, Drug, and
Cosmetics Act. The agency enacted final regulations in 1996. FDA's Tobacco Rule regulates
the advertising and marketing of tobacco products and the distribution of these products
to minors, but it does not address the design and constituents of tobacco products. If the
courts uphold FDA's assertion of jurisdiction over tobacco products, the agency will have
broad authority to move beyond the current rule to regulate the design and content of
tobacco products as well.
The courts may or may not ratify FDA's jurisdiction over tobacco products. On April 25,
1997, Federal District Court Judge
William Osteen upheld FDA's assertion of jurisdiction, but he struck down certain
provisions. That ruling is now on appeal to the Fourth U.S. Circuit Court of Appeals. The
case is likely to be reviewed by the U.S. Supreme Court. This process might take several
years, and the outcome cannot be predicted with confidence. Moreover, even if FDA's
jurisdiction over tobacco products is upheld, its scope of authority under existing law is
likely to remain uncertain. Although the district court upheld the agency's regulation of
distribution to minors, for example, it held that the act did not empower the agency to
regulate the advertising and marketing of tobacco products.
In light of the indeterminacy of FDA's existing legal authority--and the imperfect fit
between the unique challenges of tobacco control and the regulatory regime set up under
the Food, Drug, and Cosmetics Act--national policy would be clearer if Congress were to
enact a specific regulatory statute for tobacco products, as recommended in the 1994 IOM
report. Congressional action would avoid wasteful and unnecessary litigation and would
establish a strong political and legal foundation for future regulatory initiatives.
Congress must also appropriate funding to FDA commensurate with its authority. The
settlement proposes that FDA regulatory authority expand beyond the terms of the
settlement only if FDA can establish that such measures will not create a black market.
Proving that something that already exists in many countries will not occur here is an
unreasonable burden and would hamstring FDA before it is clear whether the current
regulations and new measures proposed in the settlement will achieve their goals.
Moreover, it is also premature to foreclose any regulatory authority until there has been
full public disclosure of information about the health risks and addictive potential of
tobacco products. Congress, FDA, and the public need time to review information currently
held by private firms and their attorneys before making irrevocable choices about
regulatory strategy and regulatory authority.
The need for congressional action regarding FDA's efforts to restrict tobacco
advertising, promotion, and marketing is particularly urgent. Most FDA provisions
restricting advertising and promotion are in abeyance pending the federal appeals court
decision, and there will be further delay if the case goes to the U.S. Supreme Court.
Advertising and promotion constraints may not have dramatic short-term effects, but they
are integral parts of all successful tobacco control efforts in states and foreign
countries and must be part of any long-term U.S. national tobacco control program. The
1994 IOM report recommended comprehensive regulation of advertising and promotion that
tends to encourage young people to use tobacco products. Recommendations included
restricting advertisements to text-only format and bans on promotional campaigns
attractive to youths. Although the FDA regulation implements many of these ideas, the
federal district court ruled that the agency does not have the statutory authority to
regulate tobacco advertising and marketing, without even reaching the industry's argument
that these regulations violate the First Amendment to the Constitution. Even if the
agency's jurisdiction to regulate youth access to tobacco products is upheld, FDA's scope
of authority over advertising and marketing will be in litigation for many years.
Congressional action to implement IOM's 1994 recommendations would expedite the nation's
tobacco control agenda by many years.
Public debate regarding the desirability of the proposed settlement has highlighted the
thorny issues of regulatory design. Is the best course, for example, to follow the logic
of progressively reducing nicotine exposure? What criteria should govern the regulatory
agency's decision to initiate, implement, or terminate such a strategy? In what way should
the agency take into account the emergence of a black market for illicit tobacco products?
Some leaders of the public health community have criticized the criteria set forth in the
proposed settlement on the grounds that they would unduly constrain FDA authority compared
with the authority now conferred by the Food, Drug, and Cosmetics Act. Others have pointed
out that the courts may not uphold FDA's assertion of jurisdiction over tobacco products.
They have also argued that the criteria outlined in the proposed settlement provide a
suitable starting point for congressional deliberation and the drafting of legislation.
The board cannot resolve this debate, and it does not intend to try to do so. The board
does, however, urge Congress and the executive branch to take the necessary steps to
ensure that possible strategies for regulating the design and constituents of tobacco
products are given careful and systematic study. FDA's authority must be broad enough to
allow it to protect the public health on the basis of scientific knowledge as it
accumulates. Under some possible regulatory initiatives, an adequate scientific foundation
already exists. Studies
clearly indicate, for example, that smokers adapt to cigarettes labeled and machine-tested
as low in nicotine by inhaling more often or more deeply [23]. Informational requirements
regarding tar and nicotine yield could be changed in light of actual human exposures from
tobacco products, for example cigarette labeling that takes account of smoking behavior
and not just machine-determined yield. On some issues, such as nicotine reduction,
regulation must await new research or access to the results of studies now available only
to private tobacco firms. In other areas, new information should be available in the
coming years. Proposals for long-term nicotine maintenance using FDA-approved nicotine
products will require further research. Studies of antidepressant and antiopiate drugs to
enhance cessation are also promising, but not enough studies have been completed to reach
firm conclusions. Yet the success of treating tobacco dependence and consumer acceptance
may well indicate whether regulation of nicotine in tobacco products is a viable option.
As another example, some states are experimenting with higher age limits for legal tobacco
sales. Such experiments should be encouraged, because the results can help guide national
policy. Some regulatory decisions, however, cannot be made until entirely new studies are
designed and carried out, and their results are analyzed.
SUPPORT STATE AND LOCAL TOBACCO CONTROL EFFORTS
Current attention to tobacco control follows many years of innovative work at the state
and local levels initiated by governments and private organizations. States such as
California and Massachusetts have mounted effective public education campaigns, supported
research, encouraged local nonsmoking ordinances, restricted some forms of advertising and
promotion, and implemented other tobacco control measures. These efforts are funded by
increases in state excise taxes on tobacco products. Such increases have also become law
in Arizona, Hawaii, and Oregon. As noted previously, Alaska and Hawaii have each raised
the state excise tax on cigarettes to $1.00, with Washington and New Jersey approaching
that level. Maine, Wisconsin, and Utah are mounting new tobacco control programs. Much of
the action in tobacco control has been and will continue to occur at the state, county,
and community levels.
The federal government must support state and local infrastructure
for tobacco control.
Many increases in nonfederal excise taxes and restrictions on advertising, promotion,
and levels of exposure to environmental tobacco smoke depend on the actions of state and
local governments. Bans on smoking in public places and in workplaces not only reduce
environmental tobacco exposure to nonsmokers, but have also proven to be powerful
interventions to enhance cessation and to reduce the dose exposure among smokers. The vast
majority of progress on this front has taken place at the state and local levels.
Counteradvertising and public education have also been largely state and local efforts,
although they would likely be more effective if implemented nationally. All of these are
elements of tobacco control efforts and complement federal measures. Success at the
federal, state, and local levels has depended in part on funding not only government
efforts, but also nongovernment organizations that can hold federal, state, and local
governments to account. This pattern of funding should be designed into future tobacco
control programs. For now, attention is focused on the terms of the proposed national
settlement. If the settlement is translated into legislation, it should provide funding
for state and local tobacco control efforts. If no settlement results, however, state and
local efforts will nonetheless likely remain the bulwark of tobacco control.
Most federal support comes from the ASSIST program of the National Cancer (NCI)
Institute and the IMPACT program of the Centers for Disease Control and Prevention (CDC).
California and Massachusetts fund the largest state programs. States that are part of the
ASSIST program spend less, but more per state and with more intensive interventions than
IMPACT states. In effect, for the past few years, states have engaged in a dose-response
test of tobacco control. Evidence from that experiment was presented at the July 1997 IOM
workshop; it showed that the program impact roughly parallels the intensity (dose) of
tobacco control efforts. California and Massachusetts have the largest programs and
greater decrements in tobacco consumption than ASSIST states, which in aggregate show a 7
to 10 percent greater reduction in consumption than IMPACT states (i.e., all others).
These programs are reviewed in the 1994 IOM report, which recommended that federal support
for state efforts be increased to the level of ASSIST in all states, with the increase in
funding that would entail. This is, in essence, a recommendation to implement ASSIST as a
universal program, based on its demonstration in one third of the states. The new evidence
reinforces the 1994 recommendation. It is time to apply the lessons of ASSIST nationwide.
Implementing the transition has several implications. First, it is important that the
program content of ASSIST be carried forward as it is expanded. This includes retaining
program elements as well as drawing on the expertise of those at NCI, in the ASSIST
states, and in the nongovernmental organizations that have made it a success. Second, it
entails a differentiation in function. As a universal program, it is logical to shift
responsibility to the nation's public health agency, CDC. This would entail a significant
scaling-up of current efforts. Yet expansion of the CDC effort should not detract from
further progress. Tobacco control efforts will be expanding in Alaska, Arizona, Hawaii,
Maine, Oregon, Utah, Wisconsin, and other states. The ASSIST program has shown that a more
intense intervention produces results, but it does not clearly show which elements are
most powerful, and ASSIST states could not test counteradvertising, public education, or
other interventions at the level possible in California and Massachusetts. An expanded
commitment to tobacco control increases the importance of knowing which interventions
matter most, requiring demonstrations at sufficient dose and duration to enable credible
evaluation. That is, many questions remain for research, high-intensity demonstrations,
and rigorous program evaluation. This is no time to retrench from research or to stop
testing even larger-scale demonstrations. The goal for the next decade should be to
achieve tobacco control rivaling that in California and Massachusetts, through the use of
a combination of state, local, and federal funds and any payments resulting from a
national settlement, and to improve the programs in all states through research,
demonstrations, and program evaluation.
Congress must repeal the federal preemption of state and local
regulation of advertising and promotion.
The most successful efforts to curb tobacco use have grown from mobilization at the
state and community levels and have entailed collaborations among private health
organizations and federal, state, and local governments. Federal legislation currently
prohibits state and local governments from regulating any form of advertising and
promotional activities based on smoking and health, even if the activity occurs
exclusively within states' jurisdictional borders. The opportunity for innovation at the
state and local levels would be enhanced if this federal impediment were removed, as
recommended in the 1994 IOM report.
The federal government must establish a system for performance
monitoring in collaboration with other levels of government and private organizations.
No matter what the final settlements 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, both local and national capacities must be in place to
translate goals into actions, to measure progress, and to 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 [24]. Healthy People 2000
devoted a chapter to tobacco use, specifying national goals on a timetable; the goals for
reducing tobacco use among youths, however, are further from achievement than they were
even a few years ago.
A recent IOM report, Improving
Health in the Community [25], proposes ways of bridging the gap between national
goals and community action and identifying specific organizations or groups at the
community level accountable for making progress toward those goals. The general approach
discussed in the report is embodied in the Community Health Improvement Process (CHIP).
CHIP applies the tools used to monitor performance. To promote the achievement of health
improvement goals, the approach entails (a) specifying goals, (b) developing a strategy to
achieve them, (c) identifying and implementing local interventions that can be monitored
by quantitative indicators, and then (d) collecting and assessing performance data for the
specific accountable entities at the community level to evaluate the effectiveness of the
intervention strategy and the contributions of the specific accountable entities in the
community. The accountable entities will vary among communities, as will the relative
priorities of the goals and the resources available to attain those goals.
The CHIP approach might be adapted for use at the national level as well. 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, with its theoretical underpinning and with specific
consideration of tobacco control issues, in a separate background paper prepared for
the board by Michael Stoto and Jane Durch of IOM.
Three elements are central to the IOM CHIP model: (1) a broad view of health as a
product of the interaction of many factors; (2) recognition that protecting and improving
health is a shared responsibility of many entities, each of which needs to be accountable
for its activities; and (3) a performance monitoring framework, in which sets of
actionable measures are tied to specific entities that can help to ensure the necessary
accountability. Accountability is a concern because responsibility diffused among many
entities can easily be ignored or abandoned. This approach also points to the importance
of interventions that focus not only on individuals but also on collective actions such as
the adoption of policies to limit smoking in workplaces or restaurants or the enforcement
of laws prohibiting the sale of tobacco products to persons under age 18. In extending the
CHIP concept to the national level, there may be opportunities to focus on interventions
that target communities and organizations rather than individuals.
A well-chosen set of performance measures could help to reinforce a balanced national
and local tobacco control effort. The CHIP approach calls for the use of sets of
indicators to make meaningful assessments of overall performance because health issues
have many dimensions and can be addressed by various sectors. These sets of indicators
should cover critical features of a health improvement effort. They should, however,
remain selective; too many details can obscure the broader picture. Indicators must be
carefully selected to provide insight into the progress that has been achieved. For an
issue such as tobacco control, for which changes in health outcomes such as a reduction in
lung cancer deaths will not be observable in the near term, the set of indicators should
balance measures of shorter-term gains (e.g., reductions in smoking prevalence or sales of
tobacco products to minors) and more fundamental longer-term changes in health (e.g.,
reductions in the incidence of lung cancer or lung cancer mortality). The approach is
perhaps best explained by way of an illustration, showing some possible national and local
performance measures (see table).
The objectives in Healthy People 2000 are an essential reference point for
developing performance measures at the national or the community level. The proposed FDA
regulations that mandate restrictions on the sale of tobacco products to youths will be an
appropriate focus for performance monitoring, even if other FDA provisions are not
implemented. The proposed settlement also stipulates specific goals for reductions in the
rate of smoking among youths that could guide the development of performance indicators.
Likewise, the recommendations made by the Koop-Kessler Advisory Committee on
Tobacco and Public Health suggest a variety of performance measures that might be used
to monitor progress.
Without an overall monitoring plan, 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 smoking measures for youths do not improve. The
trigger is the level of daily smoking reported in surveys of youths conducted by
the University of Michigan. This measure, part of the larger Monitoring the Future study,
could change, even without real changes in the rate of initiation [26]. Initiation of
tobacco use often begins well before high school and often progresses over two to three
years. A more sensitive indicator, such as whether tobacco products were used in the
previous 30 days, could also be used (with differential weight) earlier in the process
to monitor tobacco use among those in younger age groups. These measures hinge on how
students, excluding those not attending school, recall and report their smoking behavior.
These measures are useful, but they should be balanced with other independent measures,
such as smoking rates among those in the youngest age categories of the National Health Interview Survey, as
suggested in the proposed performance measures (see table). Otherwise, the high stakes
create strong incentives to "game" a single indicator without changing the
underlying behavior. Self-report measures are notoriously subject to interpretation and
recall bias. The point is not that levels of smoking among youths reported in one survey
or another are inaccurate or misleading--all measures are limited in one way or
another--but rather that caution must be taken against relying on a single measure to
monitor performance.
Some fraction of any additional revenues that become available should be devoted to
getting better measures more frequently and to making them publicly available. Credible
brand-specific penalties or tax increases as recommended above, for example, would require
firm data the government could rely on when assessing the payments or taxes. At present
the public health monitoring process is slow and coarse compared to the data available to
individual tobacco firms.
Reducing tobacco use will require a broader set of measures, reflecting not only the
initiation of tobacco use among youths but also the cessation of tobacco use among
individuals in all age groups and the attainment of policy objectives. It will also
require assessment at the community level as well as in national measures. The performance
measures in the table mentioned above are merely first rough cuts 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:
Broader and more robust ways of promoting and monitoring progress and evaluating the
relative success of different interventions in diverse communities are needed.
More than 50 million Americans use tobacco products regularly, including 44 million who
smoke cigarettes or cigars or who use spit and snuff tobacco [27]. Approximately 70
percent of smokers express a desire to stop smoking (CDC, 1996). Half attempt to quit each
year, but only 2.5 percent succeed (CDC, 1993). At present, approximately 3,000 children
and youths start to smoke each day, contributing 1 million new smokers annually (Surgeon
General, 1994; IOM, 1994). Even if prevention efforts reduce this figure by 60 percent,
the goal stipulated in the settlement each year, the nation will have 400,000 new smokers
each year, the majority of whom will become addicted and have difficulty stopping. On top
of these compelling public health reasons, there is also a moral reason to intensify
cessation efforts: Current tobacco users will be paying the increased prices, and some
fraction of that revenue should redound to help them directly.
Dependence on tobacco, including smoking, is a pharmacologically based, behavioral
disorder. Treatment is not uniformly integrated into medical practice, and coverage of
cessation services is fragmented and incomplete. Addiction to tobacco is a chronic,
relapsing disorder; multiple attempts to quit smoking are often required to attain
permanent cessation. More than 45 million former smokers in the United States attest to
the feasibility of cessation, but the process is difficult. It needs to be made easier,
through research and routine integration of cessation services into medical practice.
Effective smoking cessation interventions, as identified by the AHCPR
guidelines, should be widely disseminated and incorporated into the standard of practice.
The Agency for Health Care Policy and Research (AHCPR), with cofunding from CDC, has
prepared a clinical practice
guideline on smoking cessation for primary care physicians and other health
professionals. This guideline is based on an exhaustive review of studies performed
between 1978 and 1994 [28]. The American Medical Association used a grant from the Robert
Wood Johnson Foundation to disseminate this guideline to 200,000 doctors and is working
with the American Association of Health Plans on the guidelines to be used in managed care
organizations. These are welcome steps, but implementing the recommendations of the AHCPR
guideline will take time and will require sustained commitment until use of the guideline
becomes routine. This requires educating physicians and other health professionals as well
as incorporating coverage for cessation programs into insurance and health plans.
Moreover, guidelines will need to be updated periodically.
Government health programs and private insurance and health
plansshould cover treatment programs for tobacco dependence.
The AHCPR guideline notes that successful smoking cessation correlates with the
intensity of the cessation regimen. In the short term, cessation is associated with lower
rates of cardiovascular disease [29]. In the long term, cancer risks are reduced
dramatically, although some genetic damage does appear to be permanent [30]. The Robert Wood Johnson Foundation recently
called for proposals to address treatment for tobacco dependence in managed care [31].
The Koop-Kessler report
notes that "coverage for tobacco use cessation programs and services should be
required under all health insurance, managed care and employee benefit plans, as well as
all Federal health financing programs (e.g., Medicare and Medicaid)." The board
concurs. Many who quit do so only after repeated attempts, so effective coverage cannot be
a one-time benefit but must recognize the cyclical nature of quitting, and health programs
must provide coverage for repeat attempts at cessation.
Treatment programs for tobacco dependence should be incorporated into
quality of care measures, "report cards" on health plans, and public health
performance monitoring.
Assisting smokers with smoking cessation is a powerful intervention for promoting
health and reducing dramatically the risk of cancer, heart disease, lung disorders, and
other medical conditions. Instruments used to evaluate the quality of health plans and the
adequacy of insurance coverage should include an indicator of whether tobacco cessation
services are covered. When coverage is included, the effectiveness of the cessation
methods needs to be continually measured and reported. This will require ongoing research
to improve smoking cessation methods and to assess their cost-effectiveness. The HEDIS
measures of health plan quality developed by the National Committee for Quality Analysis,
for example, assess whether those enrolled in the plan are advised to quit smoking. Test indicators (provisional measures
being evaluated for their usefulness) include how many smokers quit and what fraction of
enrollees smoke. These are welcome initial steps, but there is a large gap between
rendering advice and affecting quit rates. Access to treatments for tobacco dependence,
beyond the general "chemical dependence" measure currently in place, would be a
more specific and direct measure. A recent survey of those in health plans asked "Is
smoking cessation a covered service in your plan?" and 40 percent of respondents said
no; access was higher in staff model health maintenance organizations than in practice
associations or network plans [32].
Adolescent smokers have proven to be more resistant to treatment than adults, and in
research trials they have exhibited higher failure rates than adults. This suggests that
among research priorities, aspects of treatment for adolescents (motivation, recruitment,
retention, adherence, and the long-term effectiveness of behavioral and pharmacological
treatments) should rank high. A recently announced NIH
program on prevention and cessation of tobacco use among youths should begin to fill
this gap [33].
Programs and norms outside the medical care systemmust also support
prevention, cessation, and harm reduction.
Many tobacco users succeed in quitting without a cessation program and without formal
care in the medical system. In recent years, nicotine gum and patches have been approved
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 techniquest to entice tobacco users to quit [34], 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 purchasing 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 agenciesshould 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 "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 geographic 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 clarifythe
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.
Only 4-5 percent of the more than 1 billion people who regularly use tobacco live in
the United States, whereas nearly three quarters live in developing countries [47].
Economic and political factors combine to make tobacco control efforts less likely and
less effective, and a U.S.-centered tobacco control policy will not reach this population.
Tobacco will kill approximately 10 million people in developing countries annually by
2030, triple the present mortality rate [48]. Without effective international tobacco
control programs, by 2025 the number of smokers will increase 50 percent to a world total
of 1.64 billion [49]. Because smoking, along with AIDS, is one of the major growing causes
of death worldwide [50], it is possible to avert the devastating future health toll that
these projections imply only if developing countries adopt policies to reduce tobacco
exposure and to prevent youths from starting to use tobacco.
Diseases in developing countries are undergoing an epidemiological transition from
infectious to chronic diseases. In most developed countries the epidemiological transition
has been followed by a behavioral transition to unhealthy behavior, including smoking
[51]. In the United States and other developed nations, public health measures are
designed to convince people to change their behavior and promote their health.
Comprehensive tobacco control policies in other nations, such as Australia and Norway,
have clearly reduced the level of tobacco use [52]. One study evaluated the effects of
advertising restrictions, warning labels, price, and income on tobacco consumption in 22
member countries of the Organization for Economic Cooperation and Development over 26
years and found that a combination of these measures resulted in decreased tobacco use
[53].
Because the transition to unhealthy behavior has not occurred in some developing
countries, these countries have the opportunity to halt the tobacco epidemic before it
starts. Yet tobacco control is a low priority in many developing countries, where
infectious diseases and other health problems demand more immediate attention. Advocates
in developing countries have limited resources to fight government-owned or heavily
supported tobacco industries, which bring in significant tax revenues, [54] have a strong
lobbying influence, and face few advertising and marketing restrictions [55].
The international tobacco control community, including 1,800 delegates from 103
countries, addressed the predicted increase in tobacco consumption among women and in
developing countries at the Tenth World Conference on
Tobacco or Health in Beijing, China, in August 1997. The conference approved a
resolution that:
Recommends governments consider the international implications of tobacco control
policies or settlements with the tobacco industry, and to ensure that:
The United States bears a particular responsibility in the tobacco control movement
because U.S. tobacco companies are major international players, producing nearly 25
percent of the cigarettes in the world export market [56]. The United States cannot solve
international tobacco control problems itself, but domestic tobacco policy has unavoidable
international implications.
The international market has become more important to tobacco firms: Cigarette exports
tripled from 1984 to 1994 [57], and Philip Morris's foreign sales rose from 40 percent in
1990 to 70 percent in 1996 [58]. Until recently, U.S. policies generally favored trade
export interests over international health. The stark contrast between promoting tobacco
control domestically and promoting tobacco exports risks long-term foreign policy
repercussions, because foreign nations cannot help but notice the different treatment of
domestic and foreign citizens. It can only intensify as the health toll rises in
subsequent decades.
The United States must promote, participate in, and contribute funds
to the building of a capacity for evaluating and monitoring international tobacco control
efforts.
The success of tobacco control efforts in developed countries has largely been due to
the cultivation of a receptive social and political climate through the availability of
information about the real risks of tobacco use, supported by research on appropriate
pricing and regulation [59]. The United States can make a significant contribution to the
international tobacco control effort by supporting research on the determinants of tobacco
use, including the impact of advertising, promotion, and price; the extent of
tobacco-related mortality; the costs of tobacco use; and disclosure of the marketing
strategies that induce consumer demand. Although much of the U.S.-based research is
relevant across borders, some research must be country or region specific to address the
local dynamics of tobacco use. Coordination of international research and program
evaluation would provide a thorough, reliable, and accessible information network
comprising local studies that follow international standards, along with collaborative
overviews from academia and international organizations. U.S. leadership has been powerful
in the efforts to combat AIDS; comparable efforts for tobacco control are now warranted.
The board believes that international tobacco control efforts should be significantly
expanded both among governments and in collaboration with nongovernmental organizations.
Current international monitoring is limited: the World Health Organization (WHO) allocates
$60,000 and the equivalent of one full-time position to tobacco control. Special projects,
country-specific activities, and additional positions are supported by approximately
$500,000 in extra budgetary contributions from a few countries, including $75,000 from the
United States [60]. Tobacco-related research has been concentrated in developed countries
and receives only $50 per 1990 tobacco-related death ($148 million-$164 million worldwide)
[61]. Tobacco control is usually best organized at the national level because only
national governments can enact most measures. Some functions, however, including
monitoring and evaluation, must have an international component. WHO has a program on Tobacco OR Health. Information on
that program includes background
documents and a series of country summaries. WHO estimates that a strong tobacco
control program, with a staff of 150, including a team of experts in trade, national and
international law, behavioral sciences, epidemiology, and economics, [62] would demand an
annual budget of $150 million [63]. The World Bank has operational policies
regarding tobacco use that include recommendations to client
nations and has identified tobacco control as a high priority [64]. The World Bank
estimates that it would cost $20 million for it to mount an effective tobacco control
effort [65]. The International Union Against Cancer sponsors GlobalLink, an international tobacco control
digital network. The United States should contribute toward such international efforts.
The Koop-Kessler report recommended
$150 million in federal funding (or equivalent amounts from settlement payments) for
international tobacco control.
The United States can finance the efforts of and provide expertise to countries
developing tobacco control programs. Dictating tobacco control policies is both unwise and
impractical. The board believes that tobacco control advocates in other countries most
often simply need financial and technical support, not U.S. or international initiative,
to develop and implement tobacco control programs. A number of international
nongovernmental organizations have strong, established tobacco control programs, and the
World Health Assembly is drafting an International Framework Convention (IFC) on Tobacco
Control [66]. The IFC will move nations toward the implementation of comprehensive tobacco
control strategies through a series of individual protocols that will vary in degree to
allow a state to be a signatory only to protocols feasible in that country. Through these
protocols, the IFC will lead cooperative efforts in research and in program and policy
development; share information, technology, and knowledge; meet regularly to facilitate
development; address international issues; and finance tobacco control measures. The
convention approach is flexible and has proven to be successful in the implementation of
environmental policies. Success will depend on several agencies working to support tobacco
control, including the U.S. Department of State, the U.S. Agency for International
Development, the U.S. Department of Agriculture, and the office of the U.S. Trade
Representative.
The August 1997 Beijing World Conference on Tobacco or Health recommended the support,
funding, and implementation of the IFC by all governments. The IFC is based on evidence
that legislation can lay the foundation for continued research and has the potential to
mobilize policymakers in various industries--including agriculture, commerce, and trade,
as well as health--to support tobacco control efforts. Individual protocols could be
organized by levels of comprehensiveness rather than by subject matter, allowing states to
"progress from comprehensive but relatively mild tobacco control measures to a
sweeping and complete comprehensive programme of tobacco control." [67] International
implementation of the IFC would include the establishment of an international fund to
train personnel, fund crop substitution activities, and support monitoring and evaluation
of state commitments to international obligations.
The United States should refrain from implementing trade policiesthat
undermine foreign tobacco control efforts.
Section 301 of the 1974 U.S. Trade Act, which "permits the U.S. Trade
Representative to investigate and sanction countries whose trade practices are deemed
'unfair' to U.S. interests," [68] has been used to facilitate the export of tobacco.
When foreign practices merely protect domestic tobacco firms or a state-owned tobacco
business, this policy has a reasonable trade rationale, but economic goals must be
balanced against the health implications of facilitating entry of the powerful U.S.
tobacco industry--with its highly sophisticated marketing and advertising methods--into a
new market. A few case studies illustrate how U.S. policies can undermine public health
measures abroad.
In Thailand, Section 301 resulted in a compromise between trade and public health
interests. Profits from the Thai Tobacco Monopoly made up a significant portion of the
government's revenue, and the United States claimed that the introduction of U.S. tobacco
companies was solely a trade issue [69]. Thai tobacco control advocates, who had achieved
a complete advertising ban in 1988, disagreed, and fought the Section 301 agreement
proposed between the Thai Ministry of Finance and the United States. The issue went to the
World Trade Organization, and in 1990, a General Agreement on Tariffs and Trade (GATT)
panel evaluated Thai restrictions on the imports of and the internal taxes on cigarettes
that Thailand maintained were necessary for public health [70].
GATT found that Thailand could "give priority to human health over trade
liberalization" as long as the proposed measure was "necessary."[71] The
panel determined that "Thailand's practice of permitting the sale of domestic
cigarettes while not permitting the importation of foreign cigarettes was not 'necessary,'
" [72] but that requiring foreign tobacco companies to abide by regulations that
applied equally to domestic and foreign tobacco products was appropriate. The GATT
decision states that restrictions on the advertising, promotion, and sale are allowable
"provided they do not thereby accord treatment to imported products less favorable
than that accorded to 'like' products of national origin."
In Taiwan, protectionist trade practices limited foreign brands to 1 percent of the
market, in part because they sold for triple the price of brands produced by the
government monopoly [73]. Comprehensive tobacco control programs were being developed in
1988, however, when the United States used Section 301 to open the market. Taiwan proposed
retaining advertising restrictions to prevent foreign tobacco companies from targeting
young people, but the United States rejected such restrictions and within two years the
smoking rate among high school students increased 50 percent [74]. Concerned Taiwanese
health officials tried to limit U.S. promotions, but the United States claimed that the
restrictions did not qualify as health measures and again threatened sanctions [75].
Although Taiwan's trade practices were initially discriminatory, the introduction of U.S.
tobacco products undermined public health initiatives.
In Japan, Section 301 was used to place U.S. tobacco products on an even footing with
domestic ones. Before the United States threatened sanctions against Japan in 1986, the
Japanese government encouraged tobacco use and employed discriminatory trade practices.
Japanese government policies were aimed not at tobacco control but at expanding and
protecting a domestic monopoly. Japan's native tobacco industry, including the government
monopoly Japan Tobacco, Inc., was protected. In the face of a 90 percent tariff, foreign
brands held only 2 percent of the market [76]. Once the market was opened, U.S. cigarette
brands accounted for 95 percent of import sales, and within the first year they captured
10 percent of the total market [77]. Even in Japan, where tobacco control efforts are
minimal, the introduction of U.S. cigarettes under Section 301 had the regrettable effect
of contributing to an increase in overall tobacco consumption, especially among those
under age 20. The trade goal was appropriate given Japan's discriminatory trade practices
and lack of antismoking health campaigns, but U.S. action, including active advertising
and promotion by the U.S. firms that gained entry through U.S. government efforts, also
led to increased consumption, most tellingly among youths.
Adverse health impacts militate against invoking Section 301 to facilitate export of
tobacco products. Even when the purpose is solely to open unfair markets in countries that
have not undertaken significant measures for tobacco control, such as Japan, the health
impact should be taken into account before invoking Section 301. In cases in which
national governments are actively attempting to rein in tobacco use, U.S. action to
facilitate the entry of U.S. tobacco products is clearly in conflict with the public
health policies of the foreign governments and is even less justified.
Most countries with unfair tobacco trade practices also protect other industries whose
products do not have the adverse health effects of tobacco products. The U.S. Trade
Representative should focus first on those products that confer trade benefits without the
dire health consequences of tobacco products. A provision new to the 1998 appropriations
act for the U.S. Department of Commerce directs the U.S. Trade Representative to use
Section 301 for tobacco products only in very limited circumstances [78]. The current
administration has signaled that any tobacco-related dealings of the U.S. Trade
Representative will include consultations with the Department of Health and Human
Services. U.S. actions that conflict with credible tobacco control efforts in other
countries are clearly inappropriate.
The United States can study and learn from effective foreign tobacco
control policies.
The United States has the potential to influence international policy significantly. A
handful of countries have been in the forefront of tobacco control for decades and are
well in advance of the United States. Familiarity with their successes and failures can
help predict the efficacy of proposed U.S. tobacco control measures. International data
consistently indicate, for example, that in many diverse countries, price increases and
bans on advertising and promotion and on smoking in public places reduce consumption [79].
The international expert panel on nicotine maintenance without tobacco, cited above, is
another example of how international groups can enhance tobacco control efforts.
The Koop-Kessler Report
notes that U.S. leadership in tobacco control is not only a domestic issue but is also a
foreign policy issue [80]. U.S. tobacco policy will be an important international
benchmark; it should therefore be a high one. As the home of large, multinational tobacco
companies, the United States can set standards for tobacco production and marketing and
can "ensure that the conduct of U.S. corporations abroad is consistent with our
domestic policies and national values." [81] The Koop-Kessler report recommends
several principles for addressing international issues, including promoting the
international adoption of U.S. standards, emphasizing public health over trade interests,
funding international tobacco control activities, and preventing U.S. tobacco companies
from undermining these efforts [82]. It also warns that "a weak scheme of U.S.
tobacco control regulation will be cited aggressively by tobacco lobbyists in other
countries and international bodies as grounds for resisting stronger regulation."
The United States has a significant self-interest in developing a strong international
tobacco control policy. The 1997 IOM report, America's Vital Interest in Global
Health suggests that by becoming a leader in international health issues,
"the United States will fulfill its national responsibility to protect Americans'
health, enhance U.S. economic interests, and project U.S. influence internationally."
[83]
U.S. government action will often require concerted action with other countries as
well. Unilateral actions would merely encourage U.S. firms to shift operations abroad or
open the door for foreign firms to take over markets now dominated by U.S. firms, with no
change in underlying behavior. The tobacco industry has long operated from an
international perspective, and public health measures must be similarly global. Adoption
of a comprehensive domestic tobacco control program is of unquestioned importance in the
United States, but it will be incomplete without commitment to an international
collaborative effort.
The National Cancer Policy Board chose to issue its first policy statement on tobacco
control because tobacco use is the single largest cause of cancer deaths, [84] and because
tobacco joins AIDS as one of two major growing health threats worldwide [85]. The board
believes that:
[1]Lynch, B.S. and R.J. Bonnie, Eds., Growing Up Tobacco Free: Preventing Nicotine
Addiction in Children and Youths. Institute of Medicine, National Academy Press,
Washington, DC, 1994.
[2]Centers for Disease Control and Prevention. Preventing Tobacco Use Among Young
People: A Report of the Surgeon General. Department of Health and Human Services,
Washington, DC, 1994.
| [3]Data on Youth Tobacco Use from the University of Michigan's Monitoring the Future" Study | |||||||
| (percent respondents) | |||||||
| 1991 | 1992 | 1993 | 1994 | 1995 | 1996 | ||
| Any daily use of cigarettes | |||||||
| 8th grade | 7.2 | 7 | 8.3 | 8.8 | 9.3 | 10.4 | |
| 10th grade | 12.6 | 12.3 | 14.2 | 14.6 | 16.3 | 18.3 | |
| 12th grade | 18.5 | 17.2 | 19 | 19.4 | 21.6 | 22.2 | |
| More than 1/2 pack/day | |||||||
| 8th grade | 3.1 | 2.9 | 3.5 | 3.6 | 3.4 | 4.3 | |
| 10th grade | 6.5 | 6 | 7 | 7.6 | 8.3 | 9.4 | |
| 12th grade | 10.7 | 10 | 10.9 | 11.2 | 12.4 | 13 | |
| Smokeless tobacco | |||||||
| 8th grade | 1.6 | 1.8 | 1.5 | 1.9 | 1.2 | 1.5 | |
| 10th grade | 3.3 | 3 | 3.3 | 3 | 2.7 | 2.2 | |
| 12th grade | 4.3 | 3.3 | 3.9 | 3.6 | 3.3 | ||
| 30-day prevalence of cigarette use | |||||||
| 12th grade | 28.3 | 27.8 | 29.9 | 31.2 | 33.5 | 34 |
| Life-time | Last 30 days | |||||||||||||
| Cigarettes, any use | 1991 | 1992 | 1993 | 1994 | 1995 | 1996 | 1991 | 1992 | 1993 | 1994 | 1995 | 1996 | ||
| 8th grade | 44 | 45.2 | 45.3 | 46.1 | 46.4 | 49.2 | 14.3 | 15.5 | 16.7 | 18.6 | 19.1 | 21 | ||
| 10th grade | 55.1 | 53.5 | 56.3 | 56.9 | 57.6 | 61.2 | 20.8 | 21.5 | 24.7 | 25.4 | 27.9 | 34 | ||
| 12th grade | 63.1 | 61.8 | 61.9 | 62 | 64.2 | 63.5 | 28.3 | 27.8 | 29.9 | 31.2 | 33.5 | 34 | ||
| Smokeless tobacco | 1991 | 1992 | 1993 | 1994 | 1995 | 1996 | 1991 | 1992 | 1993 | 1994 | 1995 | 1996 | ||
| 8th grade | 22.2 | 20.7 | 18.7 | 19.9 | 20 | 20.4 | 6.9 | 7 | 6.6 | 7.7 | 7.1 | 7.1 | ||